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Wednesday, 16 January 2013 - Strasbourg
Classification, packaging and labelling of dangerous preparations ***I
 Sustainable exploitation of fishery resources in the Mediterranean Sea ***I
 Conclusion of the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress to the Cartagena Protocol on Biosafety ***
 Public finances in EMU - 2011 and 2012
 Credit rating agencies ***I
 Undertakings of collective investment in transferable securities (UCITS) and alternative investment funds managers ***I
 Multi-annual plan for cod stocks in the Baltic Sea***I
 Amendment of Parliament's Rules of Procedure on the order of precedence of Vice-Presidents elected by acclamation
 Youth guarantee
 Role of EU cohesion policy in implementing the new European energy policy
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Classification, packaging and labelling of dangerous preparations ***I
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European Parliament legislative resolution of 16 January 2013 on the proposal for a directive of the European Parliament and of the Council on the classification, packaging and labelling of dangerous preparations (recast) (COM(2012)0008 – C7-0021/2012 – 2012/0007(COD))
P7_TA(2013)0008A7-0391/2012

(Ordinary legislative procedure – recast)

The European Parliament,

–  having regard to the Commission proposal to Parliament and the Council (COM(2012)0008),

–  having regard to Article 294(2) and Article 114 of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C7-0021/2012),

–  having regard to Article 294(3) of the Treaty on the Functioning of the European Union,

–   having regard to the opinion of the European Economic and Social Committee of 28 March 2012(1),

–  having regard to the Interinstitutional Agreement of 28 November 2001 on a more structured use of the recasting technique for legal acts(2),

–  having regard to the letter of 9 November 2012 from the Committee on Legal Affairs to the Committee on the Environment, Public Health and Food Safety in accordance with Rule 87(3) of its Rules of Procedure,

–  having regard to Rules 87 and 55 of its Rules of Procedure,

–  having regard to the report of the Committee on the Environment, Public Health and Food Safety (A7-0391/2012),

A.  whereas, according to the Consultative Working Party of the legal services of the European Parliament, the Council and the Commission, the proposal in question does not include any substantive amendments other than those identified as such in the proposal and whereas, as regards the codification of the unchanged provisions of the earlier acts together with those amendments, the proposal contains a straightforward codification of the existing texts, without any change in their substance;

1.  Adopts its position at first reading hereinafter set out, taking into account the recommendations of the Consultative Working Party of the legal services of the European Parliament, the Council and the Commission;

2.  Calls on the Commission to refer the matter to Parliament again if it intends to amend the proposal substantially or replace it with another text;

3.  Instructs its President to forward its position to the Council, the Commission and the national parliaments.

Position of the European Parliament adopted at first reading on 16 January 2013 with a view to the adoption of Directive 2013/…/EU of the European Parliament and of the Council on the classification, packaging and labelling of dangerous preparations (recast)

P7_TC1-COD(2012)0007


THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 thereof,

Having regard to the proposal from the European Commission,

After transmission of the draft legislative act to the national Parliaments,

Having regard to the opinion of the European Economic and Social Committee(3),

Acting in accordance with the ordinary legislative procedure(4),

Whereas:

(1)  Directive 1999/45/EC of the European Parliament and of the Council of 31 May 1999 concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations(5) has been substantially amended several times(6). Since further amendments are to be made, that Directive should be recast in the interests of clarity.

(2)  The approximation of the rules existing in the Member States relating to classification, packaging and labelling of certain dangerous preparations is essential for setting equal competition conditions and the functioning of the internal market.

(3)  Measures for the approximation of the provisions of the Member States affecting the functioning of the internal market should, in so far as they concern health, safety and protection of man and the environment, adopt a high level of protection as a basis. This Directive should, at the same time, ensure protection for the general public, and, in particular, persons who come into contact with dangerous preparations in the course of their work or in the pursuit of a hobby, protection for consumers and for the environment.

(4)  The number of animals used for experiments should be reduced to a minimum, in accordance with the provisions of Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes(7).  Pursuant to Article 4(1) of that Directive, Member States are to ensure that, wherever possible, a scientifically satisfactory method or testing strategy, not entailing the use of live animals, are used instead of a procedure within the meaning of that Directive, defined as any use, invasive or non-invasive, of an animal for experimental or other scientific purposes, with known or unknown outcome, or educational purposes, which may cause the animal a level of pain, suffering, distress or lasting harm equivalent to, or higher than, that caused by the introduction of a needle in accordance with good veterinary practice. Therefore, this Directive makes use of the results of assessments of toxicological and ecotoxicological properties only when these are already known and entails no obligation to conduct further experiments on animals.

(5)  Although munitions are not covered by this Directive, explosives marketed to produce an explosive or pyrotechnic effect may, through their chemical composition, present dangers to health. It is therefore necessary as part of a transparent information process to classify them  in accordance with this Directive  and assign to them a safety data sheet in accordance with  Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) and establishing a European Chemicals Agency(8),  and also to label them in accordance with the international rules used for the transport of dangerous goods.

(6)  Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market(9) and Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market(10), in contrast to the provisions applicable to chemical preparations covered by this Directive, provide for an authorisation procedure for each product on the basis of a dossier presented by the applicant and an assessment carried out by the competent authority in each Member State. Furthermore, that authorisation procedure includes a control relating specifically to the classification, packaging and labelling of each product before it is placed on the market. It is appropriate, as part of a clear and transparent information process, to classify and label plant protection products  and biocidal products  in accordance with this Directive, and also to provide instructions for use in accordance with the results of the evaluation carried out in the framework of  Regulation (EC) No 1107/2009 and Directive 98/8/EC  and to ensure that the labelling satisfies the high level of protection sought by both this Directive and  Regulation (EC) No 1107/2009 or Directive 98/8/EC respectively . In addition, a safety data sheet has to be established for plant protection products and biocidal products in accordance with Regulation (EC) No 1907/2006.

(7)  It is necessary to provide for concentration limits expressed as a volume/volume percentage in the case of preparations marketed in gaseous form.

(8)  It is necessary to define what human experience might be considered for the evaluation of the health hazards of a preparation. If clinical studies may be accepted, it is taken as given that such studies comply with the Helsinki Declaration and the Guidelines for Good Clinical Practice of the Organisation for Economic Co-operation and Development.

(9)  As the existing safety data sheet is already being used as a communication tool within the supply chain of substances and preparations, has been developed further and has been made an integral part of the system established by Regulation (EC) No 1907/2006, it should be removed from this Directive .

(10)  Due to the adoption of Regulation (EC) No 1907/2006, Council Directive 67/548/EEC of 27 June 1967 on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances(11)  has been  adapted and its rules on the notification and risk assessment of chemicals  have been  deleted.  This Directive should be adapted accordingly. 

(11)  Annex V to Directive 67/548/EEC, setting out methods for the determination of the physico-chemical properties, toxicity and ecotoxicity of substances and preparations, has been deleted by Directive 2006/121/EC of the European Parliament and of the Council(12) with effect from 1 June 2008.  The references to that Annex in this Directive should be adapted accordingly. 

(12)  In order to take full account of the work and experience accumulated under Directive 67/548/EEC, including the classification and labelling of specific substances listed in Annex I to that Directive, all existing harmonised classifications should be converted into new harmonised classifications using the new criteria. Moreover, as the applicability of Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures(13) is deferred and the harmonised classifications in accordance with the criteria of Directive 67/548/EEC are relevant for the classification of substances and mixtures during the ensuing transition period, all existing harmonised classifications should also be placed unchanged in an annex to  that  Regulation. By subjecting all future harmonisations of classifications to that Regulation, inconsistencies in harmonised classifications of the same substance under the existing and the new criteria should be avoided.

(13)  Preparations composed of more than one substance being classified in Table 3.2 of Part 3 of Annex VI to Regulation (EC) No 1272/2008 as carcinogenic, mutagenic and/or toxic for reproduction had to be labelled with risk phrases (R phrases) to indicate both category 1 or 2 and category 3 classification. However, providing both R phrases sends a conflicting message. Preparations should therefore only be classified and labelled with the higher category.

(14)  The references to R phrase R40 in Directive 67/548/EEC were amended by Commission Directive 2001/59/EC(14) when R phrase R40 was assigned to carcinogens of category 3. Consequently, the old wording of R phrase R40 became R68 and was used for mutagens of category 3 and for certain substances with non-lethal irreversible effects. The references to R phrase R40 in this Directive should be adapted accordingly.

(15)  Annex VI to Directive 67/548/EEC as amended by Directive 2001/59/EC gives clear advice on the classification of substances and preparations for corrosive effects.  In this Directive, preparations should therefore be classified accordingly.

(16)  It is known that cement preparations containing chromium (VI) may cause allergic reactions in certain circumstances. Such preparations should display the relevant warning label.

(17)  Directive 67/548/EEC as amended by Commission Directive 98/98/EC(15) provides for new criteria and a new R phrase (R67) for vapours which may cause drowsiness and dizziness.  Preparations should be classified and labelled accordingly.

(18)  Criteria developed for classifying and labelling substances dangerous for the environment were introduced  together with the appropriate symbols, indications of danger, risk phrases and safety advice required to appear on labelling,  by  Council Directive 92/32/EEC of 30 April 1992 amending for the seventh time Directive 67/548/EEC (16) and by Commission Directive 93/21/EEC of 27 April 1993 adapting to technical progress for the 18th time Council Directive 67/548/EEC(17).  Provisions are required at Union level on the classification and labelling of preparations to take account of their effects on the environment, and it is therefore necessary to  provide for  a method for assessing the hazards of a given preparation for the environment either by a calculation method, or by determining the ecotoxicological properties by test methods under certain conditions.

(19)  For substances very toxic to the aquatic environment (classified as N) and assigned the R phrases R50 or R50/53, specific concentration limits (SCLs) are applied to substances listed in Table 3.2 of Part 3 of Annex VI to Regulation (EC) No 1272/2008 in order to avoid an underestimation of the hazard. This measure creates distortions between preparations containing substances listed in that Annex, to which SCLs are applied, and those preparations containing substances not yet included in that Annex, but classified and labelled provisionally in accordance with Article 6 of Directive 67/548/EEC and to which no SCLs are applicable. It is therefore necessary to ensure that SCLs are applied in the same way to all preparations containing substances very toxic to the aquatic environment.

(20)  Directive 2001/59/EC revised the criteria in Annex VI to Directive 67/548/EEC for the classification and labelling of ozone depleting substances. The revised Annex III now only provides for the assignment of the symbol N in addition to R phrase R59.  Preparations should be classified and labelled accordingly. 

(21)  The confidentiality of certain substances contained in the preparations should be guaranteed, and it is therefore necessary to institute a system which allows the person responsible for placing the preparation on the market to request confidentiality for such substances.

(22)  The label constitutes a basic tool for users of the dangerous preparations in so far as it provides them with the initial essential concise information. It nevertheless needs to be supplemented by a two-fold system of more detailed information, consisting firstly of the safety data sheet intended for professional users  as provided for in Regulation (EC) No 1907/2006  and secondly of the bodies appointed by the Member States which are responsible for the provision of information solely for medical purposes, both preventive and curative.

(23)  Containers containing certain categories of dangerous preparations offered or sold to the general public must be fitted with child-resistant fastenings and/or carry a tactile warning of danger. Certain preparations not falling within these categories of danger may nevertheless, owing to their composition, present a danger for children. The packaging of such preparations should therefore be equipped with child-resistant fastenings.

(24)  In order to take account of certain preparations which, although they are not considered dangerous under this Directive, may nevertheless present a danger for users, it is necessary that certain provisions of this Directive cover such preparations.

(25)  This Directive contains special labelling provisions applicable to certain preparations. To ensure an adequate level of protection for man and the environment, special labelling provisions should also be laid down for certain preparations which, although not dangerous within the meaning of this Directive, may nevertheless present a danger to the user.

(26)  In the case of preparations classified as dangerous within the meaning of this Directive, it is appropriate to permit Member States to allow certain derogations with respect to labelling where the packaging is too small, or otherwise unsuitable for labelling, or where such small packaging or such small quantities are involved that there is no reason to fear any danger to man or the environment. In such cases appropriate consideration should also be given to the approximation of the relevant provisions at Union level.

(27)  It is appropriate to provide, in relation to environmental labelling, that specific exemptions or specific provisions may be decided upon in specific cases where it can be demonstrated that the overall environmental impact of the product types in question is lower than that of corresponding product types.

(28)  In order to supplement or amend certain non-essential elements of this Directive, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of determining exemptions to certain provisions on environmental labelling, deciding on measures in the framework of the special provisions on the labelling of certain preparations and adapting the Annexes to technical progress. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing-up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and to the Council.

(29)  In order to ensure uniform conditions for the implementation of this Directive, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers(18).

(30)  This Directive should be without prejudice to the obligations of the Member States relating to the time-limits for transposition into national law of the Directives set out in Annex VIII, Part B,

HAVE ADOPTED THIS DIRECTIVE:

Article 1

Objectives and scope

1.  This Directive aims at the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations, and to the approximation of specific provisions for certain preparations which may present hazards, whether or not they are classified as dangerous within the meaning of this Directive, when such preparations are placed on the market of the Member States.

2.  This Directive shall apply to preparations which:

   (a) contain at least one dangerous substance within the meaning of Article 2;  and 
   (b) are considered dangerous within the meaning of Article 5, 6 or 7.

3.  The specific provisions set out in Article 9 and Annex IV, and those set out in Article 10 and Annex V shall also apply to preparations which are not considered dangerous within the meaning of Article 5, 6 or 7 but which may nevertheless present a specific hazard.

4.  Without prejudice to Regulation (EC) No 1107/2009, the articles on classification, packaging and labelling of this Directive shall apply to plant protection products.

5.  This Directive shall not apply to the following preparations in the finished state, intended for the final user:

   (a) veterinary medicinal products and medicinal products for human use, as defined in Directives 2001/82/EC(19) and 2001/83/EC(20) of the European Parliament and of the Council respectively;
   (b) cosmetic products as defined in Council Directive 76/768/EEC(21);
   (c) mixtures of substances which, in the form of waste, are covered by Directive 2008/98/EC of the European Parliament and of the Council(22);
   (d) foodstuffs;
   (e) animal feedingstuffs;
   (f) preparations containing radioactive substances as defined by Council Directive 96/29/Euratom(23);
   (g) medical devices which are invasive or used in direct physical contact with the human body in so far as Union measures lay down provisions for the classification and labelling of dangerous substances and preparations which ensure the same level of information provision and protection as this Directive.

6.  This Directive shall not apply to:

   (a) the carriage of dangerous preparations by rail, road, inland waterway, sea or air;
   (b) preparations in transit which are under customs supervision, provided they do not undergo any treatment or processing.

Article 2

Definitions

1.  For the purposes of this Directive, the following definitions shall apply:

   (a) ‘substances’ means chemical elements and their compounds in the natural state or obtained by any production process, including any additive necessary to preserve the stability of the products and any impurity deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition;
   (b) ’preparations’ means mixtures or solutions composed of two or more substances;
   (c) ‘polymer’ means a substance consisting of molecules characterised by the sequence of one or more types of monomer units and comprising a simple weight majority of molecules containing at least three monomer units which are covalently bound to at least one other monomer unit or other reactant and consists of less than a simple weight majority of molecules of the same molecular weight. Such molecules must be distributed over a range of molecular weights wherein differences in the molecular weight are primarily attributable to differences in the number of monomer units. In the context of this definition a ’monomer unit’ means the reacted form of a monomer in a polymer;
   (d) ‘placing on the market’ means making available to third parties. Importation into the customs territory of the Union shall be deemed to be placing on the market for the purposes of this Directive;
   (e) ’scientific research and development’ means scientific experimentation, analysis or chemical research carried out under controlled conditions; it includes the determination of intrinsic properties, performance and efficacy as well as scientific investigation related to product development;
   (f) ‘process-orientated research and development’ means the further development of a substance in the course of which pilot plant or production trials are used to test the fields of application of the substance;
   (g) ’Einecs’ means the European Inventory of Existing Commercial Chemical Substances. This inventory contains the definitive list of all chemical substances deemed to be on the Union market on 18 September 1981.

2.  The following are ‘dangerous’ within the meaning of this Directive:

   (a) explosive substances and preparations: solid, liquid, pasty or gelatinous substances and preparations which may also react exothermically without atmospheric oxygen thereby quickly evolving gases, and which, under defined test conditions, detonate, quickly deflagrate or upon heating explode when partially confined;
   (b) oxidising substances and preparations: substances and preparations which give rise to a highly exothermic reaction in contact with other substances, particularly flammable substances;
   (c) extremely flammable substances and preparations: liquid substances and preparations having an extremely low flash-point and a low boiling-point and gaseous substances and preparations which are flammable in contact with air at ambient temperature and pressure;
  (d) highly flammable substances and preparations:
   (i) substances and preparations which may become hot and finally catch fire in contact with air at ambient temperature without any application of energy; or
   (ii) solid substances and preparations which may readily catch fire after brief contact with a source of ignition and which continue to burn or to be consumed after removal of the source of ignition; or
   (iii) liquid substances and preparations having a very low flash-point; or
   (iv) substances and preparations which, in contact with water or damp air, evolve extremely flammable gases in dangerous quantities;
   (e) flammable substances and preparations: liquid substances and preparations having a low flash-point;
   (f) very toxic substances and preparations: substances and preparations which in very low quantities cause death or acute or chronic damage to health when inhaled, swallowed or absorbed via the skin;
   (g) toxic substances and preparations: substances and preparations which in low quantities cause death or acute or chronic damage to health when inhaled, swallowed or absorbed via the skin;
   (h) harmful substances and preparations: substances and preparations which may cause death or acute or chronic damage to health when inhaled, swallowed or absorbed via the skin;
   (i) corrosive substances and preparations: substances and preparations which may, on contact with living tissues, destroy them;
   (j) irritant substances and preparations: non-corrosive substances and preparations which, through immediate, prolonged or repeated contact with the skin or mucous membrane, may cause inflammation;
   (k) sensitising substances and preparations: substances and preparations which, if they are inhaled or if they penetrate the skin, are capable of eliciting a reaction of hypersensitisation such that on further exposure to the substance or preparation, characteristic adverse effects are produced;
   (l) carcinogenic substances and preparations: substances or preparations which, if they are inhaled or ingested or if they penetrate the skin, may induce cancer or increase its incidence;
   (m) mutagenic substances and preparations: substances and preparations which, if they are inhaled or ingested or if they penetrate the skin, may induce heritable genetic defects or increase their incidence;
   (n) substances and preparations which are toxic for reproduction: substances and preparations which, if they are inhaled or ingested or if they penetrate the skin, may produce, or increase the incidence of, non-heritable adverse effects in the progeny and/or an impairment of male or female reproductive functions or capacity;
   (o) substances and preparations which are dangerous for the environment: substances and preparations which, were they to enter the environment, would or could present an immediate or delayed danger for one or more components of the environment.

Article 3

Determination of dangerous properties of preparations

1.  The evaluation of the hazards of a preparation shall be based on the determination of:

   (a) physico-chemical properties;
   (b) properties affecting health;
   (c) environmental properties.

Those different properties shall be determined in accordance with Articles 5, 6 and 7.

Where laboratory tests are conducted, they shall be carried out on the preparation as placed on the market.

2.  Where the determination of dangerous properties is carried out in accordance with Articles 5, 6 and 7, all dangerous substances within the meaning of Article 2 and in particular the following shall be taken into consideration in accordance with the provisions laid down in the method used:

   (a) substances listed in Part 3 of Annex VI to Regulation (EC) No 1272/2008;
   (b) substances classified and labelled provisionally by the person responsible for the placing on the market in accordance with Article 6 of Directive 67/548/EEC.

3.  For preparations covered by this Directive, dangerous substances as referred to in paragraph 2 which are classified as dangerous on the basis of their health and/or environmental effects, whether they are present as impurities or additives, shall be taken into consideration when their concentrations are equal to, or greater than, those defined in the following table unless lower values are given in Part 3 of Annex VI to Regulation (EC) No 1272/2008 , or in Part B of Annex II to this Directive or in Part B of Annex III thereto, unless otherwise specified in Annex V to this Directive.

Category of danger of the substance

Concentration to take into consideration for

gaseous preparations

% vol/vol

other preparations

% w/w

Very toxic

≥ 0,02

≥ 0,1

Toxic

≥ 0,02

≥ 0,1

Carcinogenic

Category 1 or 2

≥ 0,02

≥ 0,1

Mutagenic

Category 1 or 2

≥ 0,02

≥ 0,1

Toxic for reproduction

Category 1 or 2

≥ 0,02

≥ 0,1

Harmful

≥ 0,2

≥ 1

Corrosive

≥ 0,02

≥ 1

Irritant

≥ 0,2

≥ 1

Sensitising

≥ 0,2

≥ 1

Carcinogenic

Category 3

≥ 0,2

≥ 1

Mutagenic

Category 3

≥ 0,2

≥ 1

Toxic for reproduction

Category 3

≥ 0,2

≥ 1

Dangerous for the environment N

≥ 0,1

Dangerous for the environment

ozone

≥ 0,1

≥ 0,1

Dangerous for the environment

≥ 1

Article 4

General principles of classification and labelling

1.  The classification of dangerous preparations according to the degree and specific nature of the hazards involved shall be based on the definitions of categories of danger laid down in Article 2.

2.  The general principles of the classification and labelling of preparations shall be applied in accordance with the criteria laid down in Annex VI to Directive 67/548/EEC, save where alternative criteria referred to in Article 5, 6, 7 or 10 and the relevant Annexes of this Directive are applied.

Article 5

Evaluation of the hazards deriving from physico-chemical properties

1.  The hazards of a preparation deriving from its physico-chemical properties shall be assessed by determining, by means of the methods specified in Part A of the Annex to Council Regulation (EC) No 440/2008(24), the physico-chemical properties of the preparation necessary for appropriate classification and labelling in accordance with the criteria laid down in Annex VI to Directive  67/548/EEC.

2.  By way of derogation from paragraph 1, the determination of the explosive, oxidising, extremely flammable, highly flammable, or flammable properties is not necessary provided that:

   (a) none of the constituents possesses such properties and that, on the basis of the information available to the manufacturer, the preparation is unlikely to present hazards of this kind;
   (b) in the event of a change in the composition of a preparation of known composition, scientific evidence indicates that a reassessment of the hazards will not lead to a change in classification;
   (c) preparations placed on the market in the form of aerosols satisfy the provisions of Article 8(1a) of Council Directive 75/324/EEC(25).

3.  For certain cases for which the methods laid down in Part A of the Annex to Regulation (EC) No 440/2008 are not appropriate, alternative calculation methods are laid down in Part B of Annex I to this Directive.

4.  Certain exemptions from the application of the methods laid down in Part A of the Annex to Regulation (EC) No 440/2008 are referred to in Part A of Annex I to this Directive.

5.  The hazards deriving from the physico-chemical properties of a preparation covered by Regulation (EC) No 1107/2009  shall be assessed by determining the physico-chemical properties of the preparation necessary for appropriate classification in accordance with the criteria set out in Annex VI to Directive 67/548/EEC. Those properties shall be determined by means of the methods laid down in Part A of the Annex to Regulation (EC) No 440/2008 unless other internationally recognised methods are acceptable in accordance with the provisions of Commission Regulations (EU) No 544/2011(26) and (EU) No 545/2011(27).

Article 6

Evaluation of health hazards

1.  The health hazards of a preparation shall be assessed by one or more of the following procedures:

   (a) by a conventional method described in Annex II;
   (b) by determining the toxicological properties of the preparation necessary for appropriate classification in accordance with the criteria in Annex VI to Directive 67/548/EEC. Those properties shall be determined by means of the methods laid down in Part B of the Annex to Regulation (EC) No 440/2008, unless, in the case of plant protection products, other internationally recognised methods are acceptable in accordance with the provisions of Regulations (EU) No 544/2011 and (EU) No 545/2011.

2.  Without prejudice to the requirements of  Regulation (EC) No 1107/2009 , only where it can be scientifically demonstrated by the person responsible for placing the preparation on the market that the toxicological properties of the preparation cannot correctly be determined by the method outlined in point (a) of paragraph 1, or on the basis of existing test results on animals, the methods outlined in point (b) of paragraph 1 may be used, provided they are justified or specifically authorised under Article 12 of Directive 86/609/EEC.

When a toxicological property is established by the methods outlined in point (b) of paragraph 1 to obtain new data, the test shall be conducted in compliance with the principles of good laboratory practice provided for in Directive 2004/10/EC of the European Parliament and the Council(28) and the provisions of Directive 86/609/EEC, in particular Articles 7 and 12 thereof.

Subject to the provisions of paragraph 3, where a toxicological property has been established on the basis of both the methods outlined in points (a) and (b) of paragraph 1, the results from the methods outlined in point (b) of paragraph 1 shall be used for classifying the preparation, except in the case of carcinogenic, mutagenic or toxic effects for reproduction for which only the method outlined in point (a) of paragraph 1 shall be used.

Any of the toxicological properties of the preparation which are not assessed by the method outlined in point (b) of paragraph 1 shall be assessed in accordance with the method outlined in point (a) of paragraph 1.

3.  Furthermore, where it can be demonstrated by epidemiological studies, by scientifically valid case studies as specified by Annex VI to Directive 67/548/EEC or by statistically backed experience, such as the assessment of data from poison information units or concerning occupational diseases:

   that toxicological effects on man differ from those suggested by the application of the methods outlined in paragraph 1, then the preparation shall be classified according to its effects on man,
   that, owing to effects such as potentiation, a conventional assessment would underestimate the toxicological hazard, those effects shall be taken into account in classifying the preparation,
   that, owing to effects such as antagonism, a conventional assessment would overestimate the toxicological hazard, those effects shall be taken into account in classifying the preparation.

4.  For preparations of a known composition, with the exception of those covered by  Regulation (EC) No 1107/2009 , classified in accordance with point (b) of paragraph 1, a new evaluation of health hazard by the methods outlined in either point (a) or point (b) of paragraph 1 shall be performed whenever:

   changes of composition of the initial concentration, as a weight/weight or volume/volume percentage, of one or more of the dangerous constituents are introduced by the manufacturer, in accordance with the following table:

Initial concentration range of the constituent

Permitted variation in initial concentration of the constituent

≤ 2,5 %

± 30 %

> 2,5 ≤ 10 %

± 20 %

> 10 ≤ 25 %

± 10 %

> 25 ≤ 100 %

± 5 %

   changes of composition involving the substitution or addition of one or more constituents, which may or may not be dangerous within the meaning of the definitions set out in Article 2, are introduced by the manufacturer.

This new evaluation will apply unless there is valid scientific justification for considering that a re-evaluation of the hazard will not result in a change of classification.

Article 7

Evaluation of environmental hazards

1.  The hazards of a preparation for the environment shall be assessed by one or more of the following procedures:

   (a) by a conventional method described in Annex III;
   (b) by determining the hazardous properties of the preparation for the environment necessary for appropriate classification in accordance with the criteria set out in Annex VI to Directive 67/548/EEC. Those properties shall be determined by means of the methods laid down in Part C of the Annex to Regulation (EC) No 440/2008 unless, in the case of plant protection products, other internationally recognised methods are acceptable in accordance with the provisions of Regulations (EU) No 544/2011 and (EU) No 545/2011. Without prejudice to the testing requirements  laid down in or pursuant to Regulation (EC) No 1107/2009 , the conditions for application of the test methods are described in Part C of Annex III to this Directive.

2.  Where an ecotoxicological property is established by one of the methods outlined in point (b) of paragraph 1 to obtain new data, the test shall be conducted in compliance with the principles of good laboratory practice provided for in Directive 2004/10/EC and with the provisions of Directive 86/609/EEC.

Where the environmental hazards have been assessed in compliance with both of the procedures mentioned above, the results of the methods referred to in point (b) of paragraph 1 shall be used for classifying the preparation.

3.  For preparations of a known composition, with the exception of those covered by Regulation (EC) No 1107/2009, classified in accordance with the method outlined in point (b) of paragraph 1, a new evaluation of environmental hazard either by the method outlined in point (a) of paragraph 1 or that outlined in point (b) of paragraph 1 shall be performed whenever:

   changes of composition of the initial concentration, as a weight/weight or volume/volume percentage, of one or more of the dangerous constituents are introduced by the manufacturer, in accordance with the following table:

Initial concentration range of the constituent

Permitted variation in initial concentration of the constituent

≤ 2,5 %

± 30 %

> 2,5 ≤ 10 %

± 20 %

> 10 ≤ 25 %

± 10 %

> 25 ≤ 100 %

± 5 %

   changes of composition involving the substitution or addition of one or more constituents, which may or may not be dangerous within the meaning of the definitions set out in Article 2, are introduced by the manufacturer.

This new evaluation will apply unless there is valid scientific justification for considering that a re-evaluation of the hazard will not result in a change of classification.

Article 8

Obligations and duties of the Member States

1.  Member States shall take all necessary measures to ensure that the preparations covered by this Directive cannot be placed on the market unless they comply with it.

2.  In order to ensure compliance with this Directive, the authorities of the Member States may request information on the composition of the preparation and any other pertinent information from any person responsible for placing the preparation on the market.

3.  Member States shall take all necessary measures to ensure that those responsible for placing the preparation on the market keep at the disposal of the authorities of the Member States:

   (a) the data used for the classification and labelling of the preparation;
   (b) any pertinent information relating to packaging requirements in accordance with point (c) of Article 9, including the test certificate issued in accordance with Part A of Annex IX to Directive 67/548/EEC;
   (c) the data used for establishing the safety data sheet, in accordance with Article 31 of Regulation (EC) No 1907/2006.

4.  Member States and the Commission shall exchange information concerning the name and full address of the national authority or authorities responsible for communicating and exchanging information relating to the practical application of this Directive.

Article 9

Packaging

1.  Member States shall take all necessary measures to ensure that:

  (a) preparations within the meaning of Article 1(2) and preparations covered by Annex IV pursuant to Article 1(3) cannot be placed on the market unless their packaging satisfies the following requirements:
   (i) it shall be so designed and constructed that its contents cannot escape; this requirement shall not apply where special safety devices are prescribed;
   (ii) the materials constituting the packaging and fastenings must not be susceptible to adverse attack by the contents, or liable to form dangerous compounds with the contents;
   (iii) packaging and fastenings must be strong and solid throughout to ensure that they will not loosen and will safely meet the normal stresses and strains of handling;
   (iv) containers fitted with replaceable fastening devices shall be so designed that the packaging can be refastened repeatedly without the contents escaping;
  (b) containers which contain preparations within the meaning of Article 1(2) and preparations covered by Annex IV pursuant to Article 1(3) offered or sold to the general public do not have:
   (i) either a shape and/or graphic decoration likely to attract or arouse the active curiosity of children or to mislead consumers; or
   (ii) a presentation and/or a designation used for foodstuffs or animal feeding stuffs or medicinal or cosmetic products;
  (c) containers which contain certain preparations offered or sold to the general public covered by Annex IV :
   (i) are fitted with child-resistant fastenings;  and/or 
   (ii) carry a tactile warning of danger.

The devices must conform to the technical specifications given in Parts A and B of Annex IX to Directive 67/548/EEC.

2.  The packaging of preparations shall be deemed to satisfy the requirements of points (a)(i), (ii) and (iii) of paragraph 1 if it complies with the requirements for carriage of dangerous goods by rail, road, inland waterway, sea or air.

Article 10

Labelling

1.  Member States shall take all necessary measures to ensure that:

   (a) preparations within the meaning of Article 1(2) cannot be placed on the market unless the labelling on their packaging satisfies all the requirements of this Article and the specific provisions of Parts A and B of Annex V;
   (b) preparations within the meaning of Article 1(3) as defined in Parts B and C of Annex V cannot be placed on the market unless the labelling on their packaging satisfies the requirements of points (a) and (b) of paragraph 3 of this Article and the specific provisions of Parts B and C of Annex V.

2.  With respect to plant protection products subject to Regulation (EC) No 1107/2009, the labelling requirements in accordance with this Directive shall be accompanied by the following wording:"

To avoid risks to man and the environment, comply with the instructions for use.

"

This labelling shall be without prejudice to the information required in accordance with Article 65 of  Regulation (EC) No 1107/2009  and  Annexes I and III  to  Commission Regulation (EU) No 547/2011(29) .

3.  The following information shall be clearly and indelibly marked on any package:

   (a) the trade name or designation of the preparation;
   (b) the name, full address and telephone number of the person established in the  Union  who is responsible for placing the preparation on the market, whether it be the manufacturer, the importer or the distributor;
  (c) the chemical name of the substance or substances present in the preparation in accordance with the following detailed rules:
   (i) for preparations classified T+, T, Xn in accordance with Article 6, only the substances T+, T, Xn present in concentrations equal to, or greater than, the lowest limit (limit Xn) for each of them laid down in Part 3 of Annex VI to Regulation (EC) No 1272/2008 or, failing that, Part B of Annex II to this Directive have to be taken into consideration;
   (ii) for preparations classified C in accordance with Article 6, only C substances present in concentrations equal to, or greater than, the lowest limit (limit Xi) laid down in Part 3 of Annex VI to Regulation (EC) No 1272/2008  or, failing that, Part B of Annex II to this Directive have to be taken into consideration;
  (iii) the name of the substances which have given rise to the classification of the preparation in one or more of the following danger categories  shall be mentioned on the label :
   carcinogen category 1, 2 or 3,
   mutagen category 1, 2 or 3,
   toxic for reproduction category 1, 2 or 3,
   very toxic, toxic or harmful due to non-lethal effects after a single exposure,
   toxic or harmful due to severe effects after repeated or prolonged exposure,
   sensitising.

The chemical name shall be one of the designations listed in Part 3 of Annex VI to Regulation (EC) No 1272/2008 or an internationally recognised chemical nomenclature if no corresponding designation is yet listed in that Annex;

  (iv) the name of any substance which led to the classification of the preparation in the following danger categories  need not be mentioned on the label, unless the substance has to be mentioned pursuant to points (i), (ii) or (iii) :
   explosive,
   oxidising,
   extremely flammable,
   highly flammable,
   flammable,
   irritant,
   dangerous for the environment;
   (v) as a general rule, a maximum of four chemical names shall suffice to identify the substances primarily responsible for the major health hazards which have given rise to the classification and the choice of the corresponding phrases referring to the risk involved. In some cases, more than four chemical names may be necessary;
   (d) the danger symbol(s) and indication(s) of danger.  The danger symbols, where specified in this Directive, and indications of the dangers involved in the use of the preparation, shall be in accordance with Annexes II and VI to Directive 67/548/EEC and shall be applied in accordance with the evaluation of the hazards carried out in accordance with Annexes I, II and III to this Directive.

Where more than one danger symbol must be assigned to a preparation the obligation to apply the symbol:

   (i) T shall make the symbols C and X optional unless otherwise specified in Part 3 of Annex VI to Regulation (EC) No 1272/2008;
   (ii) C shall make the symbol X optional;
   (iii) E shall make the symbols F and O optional;
   (iv) Xn shall make the symbol Xi optional.

The symbol(s) shall be printed in black on an orange-yellow background;

   (e) the risk phrases (R phrases). The indications concerning special risks (R phrases) shall comply with Annexes III and VI to Directive 67/548/EEC and shall be assigned in accordance with the results of the hazard evaluation carried out in accordance with Annexes I, II, and III to this Directive.

As a general rule, a maximum of six R phrases shall suffice to describe the risks; for this purpose, the combined phrases listed in Annex III to Directive 67/548/EEC shall be regarded as single phrases. However, if the preparation falls within more than one danger category, those standard phrases shall cover all the principal hazards associated with the preparation. In some cases more than six R phrases may be necessary.

The standard phrases ‘extremely flammable’ or ’highly flammable’ need not be used where they describe an indication of danger used in accordance with point (d) of this paragraph;

   (f) the safety advice (S phrases).  The indications giving safety advice (S phrases) shall comply with Annex IV and with Annex VI to Directive 67/548/EEC and shall be assigned in accordance with the results of the hazard evaluation carried out in accordance with Annexes I, II and III to this Directive.

As a general rule, a maximum of six S phrases shall suffice to formulate the most appropriate safety advice; for this purpose the combined phrases listed in Annex IV to Directive 67/548/EEC shall be regarded as single phrases. However, in some cases more than six S phrases may be necessary.

Where it is physically impossible to include the advice on the label or package itself, the package shall be accompanied by safety advice on the use of the preparation;

   (g) the nominal quantity (nominal mass or nominal volume) of the contents in the case of preparations offered or sold to the general public.

4.  In relation to certain preparations classified as dangerous within the meaning of Article 7, by way of derogation from points (d), (e) and (f) of paragraph 3 of this Article, the Commission shall be empowered to adopt delegated acts in accordance with Article 20 for the purpose of determining exemptions to certain provisions on environmental labelling or specific provisions in relation to environmental labelling, where it can be demonstrated that there would be a reduction in the environmental impact. Those exemptions or specific provisions are defined and laid down in Part A or B of Annex V.

5.  If the contents of the package do not exceed 125 ml:

   (a) in the case of preparations that are classified as highly flammable, oxidising, irritant, with the exception of those assigned R41, or dangerous for the environment and assigned the N symbol it shall not be necessary to indicate the R phrases or the S phrases;
   (b) in the case of preparations that are classified as flammable or dangerous for the environment and not assigned the N symbol it shall be necessary to indicate the R phrases but it shall not be necessary to indicate the S phrases.

6.  Without prejudice to point 3 of Annex I to Regulation (EU) No 547/2011 , indications such as ‘non-toxic’, ’non-harmful’, ‘non-polluting’, ’ecological’ or any other statement indicating that the preparation is not dangerous or likely to lead to underestimation of the dangers of the preparation in question shall not appear on the packaging or labelling of any preparation subject to this Directive.

Article 11

Implementation of the labelling requirements

1.  Where the particulars required by Article 10 appear on a label, that label shall be firmly affixed to one or more surfaces of the packaging so that those particulars can be read horizontally when the package is set down normally. The dimensions of the label are laid down in Annex VI to Directive 67/548/EEC and the label is intended solely for provision of the information required by this Directive and if necessary of any supplementary health or safety information.

2.  A label shall not be required when the particulars are clearly shown on the package itself, as specified in paragraph 1.

3.  The colour and presentation of the label – or, in the case of paragraph 2, of the package – shall be such that the danger symbol and its background stand out clearly from it.

4.  The information required on the label under Article 10 shall stand out clearly from its background and shall be of such size and spacing as to be easily read.

Specific provisions regarding the presentation and format of this information shall be laid down in Annex VI to Directive 67/548/EEC.

5.  Member States may make the placing on the market of preparations covered by this Directive within their territories subject to the use of their official language or languages in respect of the labelling thereof.

6.  For the purposes of this Directive, labelling requirements shall be deemed to be satisfied:

   (a) in the case of an outer package containing one or more inner packages, if the outer package is labelled in accordance with international rules on the transport of dangerous goods and the inner package or packages are labelled in accordance with this Directive;
  (b) in the case of a single package:
   (i) if such a package is labelled in accordance with international rules on the transport of dangerous goods and with points (a), (b), (c), (e) and (f) of Article 10(3); for preparations classified in accordance with Article 7, the provisions of Article 10(3)(d) shall additionally apply with respect to the property in question when it has not been so identified on the label; or
   (ii) where appropriate, for particular types of packaging such as mobile gas cylinders, if the specific requirements referred to in Annex VI to Directive 67/548/EEC are complied with.

Where dangerous preparations do not leave the territory of a Member State, labelling may be permitted which complies with national rules instead of with international rules on the transport of dangerous goods.

Article 12

Exemptions from the labelling and packaging requirements

1.  Articles 9, 10 and 11 shall not apply to explosives placed on the market with a view to obtaining an explosive or pyrotechnic effect.

2.  For certain dangerous preparations within the meaning of Article 5, 6 or 7 defined in Annex VII which, in the form in which they are placed on the market, do not present any physico-chemical risk, or risk to health or to the environment, Articles 9, 10 and 11 shall not apply.

3.  Member States may also:

   (a) permit the labelling required by Article 10 to be applied in some other appropriate manner on packages which are either too small or otherwise unsuitable for labelling in accordance with Article 11(1) and (2);
   (b) by way of derogation from Articles 10 and 11 permit the packaging of dangerous preparations which are classified as harmful, extremely flammable, highly flammable, flammable, irritant or oxidising to be unlabelled or to be labelled in some other way, if they contain such small quantities that there is no reason to fear any danger to persons handling such preparations or to other persons;
   (c) by way of derogation from Articles 10 and 11, for preparations classified in accordance with Article 7, permit the packaging of dangerous preparations to be unlabelled or labelled in some other way if they contain such small quantities that there is no reason to fear any dangers to the environment;
   (d) by way of derogation from Articles 10 and 11 permit the packaging of dangerous preparations which are not mentioned in points (b) or (c) to be labelled in some other appropriate way, if the packages are too small for the labelling provided for in Articles 10 and 11 and there is no reason to fear any danger to persons handling such preparations or to other persons.

Where this paragraph is applied, the use of symbols, indications of danger, risk (R) phrases or safety (S) phrases different to those laid down in this Directive shall not be permitted.

4.  If a Member State makes use of the options provided for in paragraph 3, it shall forthwith inform the Commission and Member States thereof. 1 The Commission  shall be empowered to adopt delegated acts in accordance with Article 20 for the purpose of amending  Annex V on the basis of such information .  

Article 13

Distance selling

Any advertisement for a preparation within the meaning of this Directive which enables a member of the general public to conclude a contract for purchase without first having sight of the label for that preparation shall make mention of the type or types of hazard indicated on the label. This requirement is without prejudice to Directive 97/7/EC of the European Parliament and of the Council(30).

Article 14

Confidentiality of chemical names

Where the person responsible for placing the preparation on the market can demonstrate that the disclosure on the label or safety data sheet of the chemical identity of a substance which is exclusively classified as:

   irritant with the exception of those assigned R41 or irritant in combination with one or more of the other properties mentioned in point (c)(iv) of Article 10(3), or
   harmful or harmful in combination with one or more of the properties mentioned in point (c)(iv) of Article 10(3) presenting acute lethal effects alone
  

will put at risk the confidential nature of his intellectual property, he may, in accordance with the provisions of Annex VI, be permitted to refer to that substance either by means of a name that identifies the most important functional chemical groups or by means of an alternative name. This procedure may not be applied where the substance concerned has been assigned a Union exposure limit.

Where the person responsible for placing a preparation on the market wishes to take advantage of confidentiality provisions, he shall make a request to the competent authority of the Member State in which the preparation is to be first placed on the market.

This request shall be made in accordance with the provisions of Annex VI and shall provide the information required in the form in Part A of that Annex. The competent authority may nevertheless request further information from the person responsible for placing the preparation on the market if such information appears necessary in order to evaluate the validity of the request.

The authority of the Member State receiving a request for confidentiality shall notify the applicant of its decision. The person responsible for placing the preparation on the market shall forward a copy of this decision to each of the Member States where he wishes to market the product.

Confidential information brought to the attention of the authorities of a Member State or of the Commission shall be kept secret.

In all cases such information:

   may be brought to the attention only of the competent authority or authorities responsible for receiving the information necessary for evaluating the foreseeable risks which the preparations may entail for man and the environment, and examining its conformity with the requirements of this Directive,
   may, however, be divulged to persons directly involved in administrative or legal proceedings involving sanctions which are undertaken for the purpose of controlling substances placed on the market and to persons who are to participate or be heard in legislative proceedings.

Article 15

Rights of Member States regarding safety of workers

This Directive shall not affect the right of Member States to specify, in compliance with the Treaty, the requirements they deem necessary to ensure that workers are protected when using the dangerous preparations in question, provided that this does not mean that the classification, packaging, and labelling of dangerous preparations are modified in a way not provided for in this Directive.

Article 16

Bodies responsible for receiving information relating to health

Member States shall appoint the body or bodies responsible for receiving information, including chemical composition, relating to preparations placed on the market and considered dangerous on the basis of their health effects or on the basis of their physico-chemical effects.

Member States shall take the necessary steps to ensure that the appointed bodies provide all the requisite guarantees for maintaining the confidentiality of the information received. Such information may only be used to meet any medical demand by formulating preventive and curative measures, in particular in case of emergency.

Member States shall ensure that the information is not used for other purposes.

Member States shall ensure that the appointed bodies have at their disposal all the information required from the manufacturers or persons responsible for marketing to carry out the tasks for which they are responsible.

Article 17

Free movement clause

Without prejudice to the provisions set out in other  Union  legislation, Member States may not prohibit, restrict or impede the placing on the market of preparations because of their classification, packaging  and  labelling if such preparations comply with the provisions laid down in this Directive.

Article 18

Safeguard clause

1.  Where a Member State has detailed evidence that a preparation, although satisfying the provisions of this Directive, constitutes a hazard for man or the environment on grounds relating to the provisions of this Directive, it may provisionally prohibit the placing on the market of that preparation or subject it to special conditions in its territory. It shall immediately inform the Commission and the other Member States of such action and give reasons for its decision.

2.  In the case referred to in paragraph 1, the Commission shall consult the Member States as soon as possible.

3.  The Commission shall decide by means of implementing acts. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 21(2).

Article 19

Adaptation to technical progress

The Commission shall adopt delegated acts in accordance with Article 20 for the purpose of adapting  Annexes I to VII to technical progress.

Article 20

Exercise of the delegation

1.  The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.

2.  The power to adopt delegated acts referred to in Article 10(4), Article 12(4) and Article 19 shall be conferred on the Commission for an indeterminate period of time from …(31)

3.  The delegation of powers referred to in Article 10(4), Article 12(4) and Article 19 may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.

4.  As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.

5.  A delegated act adopted pursuant to Article 10(4), Article 12(4) and Article 19 shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by one monthtwo months at the initiative of the European Parliament or of the Council. [Am. 1]

Article 21

Committee procedure

1.  The Commission shall be assisted by the committee established by Article 29(1) of Directive 67/548/EEC.  That Committee shall be a Committee within the meaning of Regulation (EU) No 182/2011. 

2.  Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.

Article 22

Repeal

Directive 1999/45/EC, as amended by the Acts listed in Part A of Annex VIII, is repealed, without prejudice to the obligations of the Member States relating to the time-limits for transposition into national law of the Directives set out in Part B of Annex VIII to the repealed Directive and in Part B of Annex VIII to this Directive.

References to the repealed Directive shall be construed as references to this Directive and shall be read in accordance with the correlation table in Annex IX.

Article 23

Entry into force

This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

Article 24

Addressees

This Directive is addressed to the Member States.

Done at ,

For the European Parliament

The President

For the Council

The President

For the Council

The President

ANNEX I

METHODS FOR THE EVALUATION OF PHYSICO-CHEMICAL PROPERTIES OF PREPARATIONS IN ACCORDANCE WITH ARTICLE 5

PART A

Exemptions to test methods of Part A of the Annex to Regulation (EC) No 440/2008

See point 2.2.5 of Annex VI to Directive 67/548/EEC.

PART B

Alternative calculation methods

B.1.  Non-gaseous preparations

1.  Method for the determination of oxidising properties of preparations containing organic peroxides.

See point 2.2.2.1 of Annex VI to Directive 67/548/EEC.

B.2.  Gaseous preparations

1.  Method for the determination of oxidising properties

See point 9.1.1.2 of Annex VI to Directive 67/548/EEC.

2.  Method for the determination of flammability properties

See point 9.1.1.1 of Annex VI to Directive 67/548/EEC.

ANNEX II

METHODS FOR THE EVALUATION OF HEALTH HAZARDS OF PREPARATIONS IN ACCORDANCE WITH ARTICLE 6

Introduction

An assessment must be made for all the health effects corresponding to the health effects of substances contained in a preparation. This conventional method described in Parts A and B of this Annex is a calculation method which is applicable to all preparations and which takes into consideration all the health hazards of substances contained in the preparation. For that purpose the dangerous health effects have been subdivided into:

   1. acute lethal effects;
   2. non-lethal irreversible effects after a single exposure;
   3. severe effects after repeated or prolonged exposure;
   4. corrosive effects, irritant effects;
   5. sensitising effects;
   6. carcinogenic effects, mutagenic effects, toxic effects for reproduction.

The health effects of a preparation are to be assessed in accordance with Article 6(1)(a) by the conventional method described in Parts A and B of this Annex using individual concentration limits:

   (a) where the dangerous substances listed in Part 3 of Annex VI to Regulation (EC) No 1272/2008  are assigned concentration limits necessary for the application of the method of assessment described in Part A of this Annex, these concentration limits must be used;
   (b) where the dangerous substances do not appear in Part 3 of Annex VI to Regulation (EC) No 1272/2008  or appear there without the concentration limits necessary for the application of the method of evaluation described in Part A of this Annex, the concentration limits must be assigned in accordance with the specifications in Part B of this Annex.

The procedure for classification is set out in Part A of this Annex.

The classification of the substance(s) and the resulting classification of the preparation are expressed:

   either by a symbol and one or more risk phrases, or
   by categories (category 1, category 2 or category 3) also assigned risk phrases when substances and preparations are shown to be carcinogenic, mutagenic or toxic for reproduction. Therefore it is important to consider, in addition to the symbol, all the phrases denoting specific risks which are assigned to each substance under consideration.

The systematic assessment of all the dangerous health effects is expressed by means of concentration limits, expressed as a weight/weight percentage except for gaseous preparations where they are expressed as a volume/volume percentage and in conjunction with the classification of the substance.

Where they are not given in Part 3 of Annex VI to Regulation (EC) No 1272/2008 , the concentration limits to be taken into account for the application of this conventional method are those set out in Part B of this Annex.

PART A

Procedure for evaluation of health hazards

The evaluation proceeds stepwise as follows:

  1. The following preparations are to be classified as very toxic:
   1.1. owing to their acute lethal effects and assigned the symbol ‘T+’, the indication of danger ’very toxic’ and the risk phrases R26, R27 or R28:

1.1.1.  preparations containing one or more substances classified as very toxic that produce such effects, in individual concentrations equal to or greater than:

   (a) either the concentration specified in Part 3 of Annex VI to Regulation (EC) No 1272/2008  for the substance or substances under consideration, or
  (b) the concentration specified at point 1 in Part B of this Annex (Table 1 and 1a) where the substance or substances do not appear in Part 3 of Annex VI to Regulation (EC) No 1272/2008  or appear in it without concentration limits;
   1.1.2. preparations containing more than one substance classified as very toxic in lower individual concentrations than the limits specified in point 1.1.1(a) or (b) if:

20130116-P7_TA(2013)0008_EN-p0000001.jpg

where:

PT+

=

is the percentage by weight or by volume of each very toxic substance in the preparation,

LT+

=

is the very toxic limit specified for each very toxic substance, expressed as a percentage by weight or by volume;

   1.2. owing to their non-lethal irreversible effects after a single exposure and assigned the symbol ‘T+’, the indication of danger ’very toxic’ and the risk phrase R39/route of exposure.

Preparations containing at least one dangerous substance that produces such effects in individual concentrations equal to or greater than:

   (a) either the concentration specified in Part 3 of Annex VI to Regulation (EC) No 1272/2008  for the substance or substances under consideration, or
   (b) the concentration specified at point 2 in Part B of this Annex (Table 2 and 2a) where the substance or substances do not appear in Part 3 of Annex VI to Regulation (EC) No 1272/2008  or appear in it without concentration limits.

2.  The following preparations shall be classified as toxic:

   2.1. owing to their acute lethal effects and assigned the symbol ‘T’, the indication of danger ’toxic’ and the risk phrases R23, R24 or R25;
  2.1.1. preparations containing one or more substances classified as very toxic or toxic that produce such effects in individual concentrations equal to or greater than:
   (a) either the concentration specified in Part 3 of Annex VI to Regulation (EC) No 1272/2008  for the substance or substances under consideration, or
   (b) the concentration specified at point 1 in Part B of this Annex (Table 1 and 1a) where the substance or substances do not appear in Part 3 of Annex VI to Regulation (EC) No 1272/2008  or appear in it without concentration limits;
   2.1.2. preparations containing more than one substance classified as very toxic or toxic in lower individual concentrations than the limits specified in point 2.1.1(a) or (b) if:

20130116-P7_TA(2013)0008_EN-p0000002.jpg

where:

PT+

=

is the percentage by weight or by volume of each very toxic substance in the preparation,

PT

=

is the percentage by weight or by volume of each toxic substance in the preparation,

LT

=

is the respective toxic limit specified for each very toxic or toxic substance, expressed as a percentage by weight or by volume;

  2.2 owing to their non-lethal irreversible effects after a single exposure and assigned the symbol ‘T’, the indication of danger ’toxic’ and the risk phrase R39/route of exposure.

Preparations containing at least one dangerous substance classified as very toxic or toxic that produce such effects in individual concentrations equal to or greater than:
   (a) either the concentration specified in Part 3 of Annex VI to Regulation (EC) No 1272/2008  for the substance or substances under consideration, or
   (b) the concentration specified at point 2 in Part B of this Annex (Table 2 and 2a) where the substance or substances do not appear in Part 3 of Annex VI to Regulation (EC) No 1272/2008  or appear in it without concentration limits;
   2.3. owing to their long-term effects and assigned the symbol ‘T’, the indication of danger ’toxic’ and the risk phrase R48/route of exposure.
  

Preparations containing at least one dangerous substance that produces such effects in individual concentrations equal to or greater than:

   (a) either the concentration specified in Part 3 of Annex VI to Regulation (EC) No 1272/2008  for the substance or substances under consideration, or
   (b) the concentration specified at point 3 in Part B of this Annex (Table 3 and 3a) where the substance or substances do not appear in Part 3 of Annex VI to Regulation (EC) No 1272/2008  or appear in it without concentration limits.

3.  The following preparations shall be classified as harmful:

  3.1. owing to their acute lethal effects and assigned the symbol ‘Xn’ and the indication of danger ’harmful’ and the risk phrases R20, R21 or R22;
  3.1.1. preparations containing one or more substances classified as very toxic, toxic or harmful and that produce such effects in individual concentrations equal to or greater than:
   (a) either the concentration specified in Part 3 of Annex VI to Regulation (EC) No 1272/2008  for the substance or substances under consideration, or
   (b) the concentration specified at point 1 in Part B of this Annex (Table 1 and 1a) where the substance or substances do not appear in Part 3 of Annex VI to Regulation (EC) No 1272/2008  or appear in it without concentration limits;
   3.1.2. preparations containing more than one substance classified as very toxic, toxic or harmful in lower individual concentrations than the limits specified in point 3.1.1(a) or (b) if:

20130116-P7_TA(2013)0008_EN-p0000003.jpg

where:

PT+

=

is the percentage by weight or by volume of each very toxic substance in the preparation,

PT

=

is the percentage by weight or by volume of each toxic substance in the preparation,

PXn

=

is the percentage by weight or by volume of each harmful substance in the preparation,

LXn

=

is the respective harmful limit specified for each very toxic, toxic or harmful substance, expressed as percentage by weight or by volume;

   3.2. owing to their acute effects to the lungs if swallowed and assigned the symbol ‘Xn’, and the indication of danger ’harmful’ and the risk phrase R65.

Preparations classified as harmful according to the criteria specified in point 3.2.3 of Annex VI to Directive 67/548/EEC. In applying the conventional method in accordance with point 3.1  of this Part  no account shall be taken of the classification of a substance as R65;

   3.3. owing to their non-lethal irreversible effects after a single exposure and assigned the symbol ‘Xn’, the indication of danger ’harmful’ and the risk phrase 1 R68 /route of exposure.

Preparations containing at least one dangerous substance classified as very toxic, toxic or harmful that produces such effects in individual concentrations equal to or greater than:

   (a) either the concentration specified in Part 3 of Annex VI to Regulation (EC) No 1272/2008  for the substance or substances under consideration, or
   (b) the concentration specified at point 2 in Part B of this Annex (Table 2 and 2a) where the substance or substances do not appear in Part 3 of Annex VI to Regulation (EC) No 1272/2008  or appear in it without concentration limits;
   3.4. owing to their long-term effects and assigned the symbol ‘Xn’, the indication of danger ’harmful’ and the risk phrase R48/route of exposure.
  

Preparations containing at least one dangerous substance classified as toxic or harmful that produces such effects in individual concentrations equal to or greater than:

   (a) either the concentration specified in Part 3 of Annex VI to Regulation (EC) No 1272/2008  for the substance or substances under consideration, or    (b) the concentration specified at point 3 in Part B of this Annex (Table 3 and 3a) where the substance or substances do not appear in Part 3 of Annex VI to Regulation (EC) No 1272/2008  or appear in it without concentration limits.

4.  The following preparations are to be classified as corrosive:

   4.1. and assigned the symbol ‘C’, the indication of danger ’corrosive’ and the risk phrase R35;
  4.1.1. preparations containing one or more substances classified as corrosive to which is assigned the phrase R35 in individual concentrations equal to or greater than:
   (a) either the concentration specified in Part 3 of Annex VI to Regulation (EC) No 1272/2008  for the substance or substances under consideration, or
   (b) the concentration specified at point 4 in Part B of this Annex (Table 4 and 4a) where the substance or substances do not appear in Part 3 of Annex VI to Regulation (EC) No 1272/2008  or appear in it without concentration limits;
   4.1.2. preparations containing more than one substance classified as corrosive to which is assigned phrase R35 in lower individual concentrations than the limits specified in point 4.1.1(a) or (b) if:

20130116-P7_TA(2013)0008_EN-p0000004.jpg

where:

PC, R35

=

is the percentage by weight or by volume of each corrosive substance which is assigned phrase R35 in the preparation,

LC, R35

=

is the corrosive limit R35 specified for each corrosive substance to which is assigned phrase R35, expressed as a percentage by weight or by volume;

  4.2. and assigned the symbol ‘C’, the indication of danger ’corrosive’ and the risk phrase R34;
  4.2.1. preparations containing one or more substances classified as corrosive to which is assigned the phrase R35 or R34 in individual concentrations equal to or greater than:
   (a) either the concentration specified in Part 3 of Annex VI to Regulation (EC) No 1272/2008  for the substance or substances under consideration, or
   (b) the concentration specified at point 4 in Part B of this Annex (Table 4 and 4a) where the substance or substances do not appear in Part 3 of Annex VI to Regulation (EC) No 1272/2008  or appear in it without concentration limits;
   4.2.2. preparations containing more than one of the substances classified as corrosive to which is assigned the phrase R35 or R34 in lower individual concentrations than the limits specified in point 4.2.1(a) or (b) if:

20130116-P7_TA(2013)0008_EN-p0000005.jpg

where:

PC, R35

=

is the percentage by weight or by volume of each corrosive substance to which is assigned phrase R35 in the preparation,

PC, R34

=

is the percentage by weight or by volume of each corrosive substance to which is assigned phrase R34 in the preparation,

LC, R34

=

is the respective corrosive limit R34 specified for each corrosive substance to which is assigned phrase R35 or R34, expressed as a percentage by weight or by volume.

5.  The following preparations are to be classified as irritants:

  5.1. liable to cause serious eye damage and assigned the symbol ‘Xi’, the indication of danger ’irritant’ and the risk phrase R41;
  5.1.1. preparations containing one or more substances classified as irritant to which is assigned phrase R41 in individual concentrations equal to or greater than:
   (a) either the concentration specified in Part 3 of Annex VI to Regulation (EC) No 1272/2008  for the substance or substances under consideration, or
   (b) the concentration specified at point 4 in Part B of this Annex (Table 4 and 4a) where the substance or substances do not appear in Part 3 of Annex VI to Regulation (EC) No 1272/2008  or appear in it without concentration limits;
   5.1.2. preparations containing more than one of the substances classified as irritant and to which is assigned phrase R41, or classified as corrosive and to which is assigned phrase R35 or R34, in lower individual concentrations than the limits specified in point 5.1.1(a) or (b) if:

20130116-P7_TA(2013)0008_EN-p0000006.jpg

where:

PC, R35

=

is the percentage by weight or by volume of each corrosive substance to which is assigned phrase R35 in the preparation,

PC, R34

=

is the percentage by weight or by volume of each corrosive substance to which is assigned phrase R34 in the preparation,

PXi, R41

=

is the percentage by weight or by volume of each irritant substance to which is assigned phrase R41 in the preparation,

LXi, R41

=

is the respective irritant limit R41 specified for each corrosive substance to which is assigned phrase R35 or R34 or irritant substance to which is assigned phrase R41, expressed as percentage by weight or by volume;

  5.2. irritant to eyes and assigned the symbol ‘Xi’, the indication of danger ’irritant’ and the risk phrase R36;
  5.2.1. preparations containing one or more substances classified as corrosive to which is assigned phrase R35 or R34 or as irritant and to which is assigned phrase R41 or R36 in individual concentrations equal to or greater than:
   (a) either the concentration specified in Part 3 of Annex VI to Regulation (EC) No 1272/2008  for the substance or substances under consideration, or
   (b) the concentration specified at point 4 in Part B of this Annex (Table 4 and 4a) where the substance or substances do not appear in Part 3 of Annex VI to Regulation (EC) No 1272/2008  or appear in it without concentration limits;
   5.2.2. preparations containing more than one substance classified as irritant to which is assigned phrase R41 or R36, or as corrosive and to which is assigned phrase R35 or R34, in lower individual concentrations than the limits specified in point 5.2.1(a) or (b) if:

20130116-P7_TA(2013)0008_EN-p0000007.jpg

where:

PC, R35

=

is the percentage by weight or by volume of each corrosive substance to which is assigned phrase R35 in the preparation,

PC, R34

=

is the percentage by weight or by volume of each corrosive substance to which is assigned phrase R34 in the preparation,

PXi, R41

=

is the percentage by weight or by volume of each irritant substance to which is assigned phrase R41 in the preparation,

PXi, R36

=

is the percentage by weight or by volume of each irritant substance to which is assigned phrase R36 in the preparation,

LXi, R36

=

is the respective irritant limit R36 specified for each corrosive substance to which is assigned phrase R35 or R34 or irritant substance to which is assigned phrase R41, or R36 expressed as percentage by weight or by volume;

  5.3. irritant to skin and assigned the symbol ‘Xi’, the indication of danger ’irritant’ and the risk phrase R38;
  5.3.1. preparations containing one or more substances classified as irritant and to which is assigned phrase R38 or as corrosive and to which is assigned phrase R35 or R34 in individual concentrations equal to or greater than:
   (a) either the concentration specified in Part 3 of Annex VI to Regulation (EC) No 1272/2008  for the substance or substances under consideration, or
   (b) the concentration specified at point 4 in Part B of this Annex (Table 4 and 4a) where the substance or substances do not appear in Part 3 of Annex VI to Regulation (EC) No 1272/2008  or appear in it without concentration limits;
   5.3.2. preparations containing more than one of the substances classified as irritant and to which is assigned phrase R38, or as corrosive and to which is assigned phrase R35 or R34 in lower individual concentrations than the limits specified in point 5.3.1(a) or (b) if:

20130116-P7_TA(2013)0008_EN-p0000008.jpg

where:

PC, R35

=

is the percentage by weight or by volume of each corrosive substance to which is assigned phrase R35 in the preparation,

PC, R34

=

is the percentage by weight or by volume of each corrosive substance to which is assigned phrase R34 in the preparation,

PXi, R38

=

is the percentage by weight or by volume of each irritant substance to which is assigned phrase R38 in the preparation,

LXi, R38

=

is the respective irritant limit R38 specified for each corrosive substance to which is assigned phrase R35 or R34 or irritant substance to which is assigned phrase R38, expressed as percentage by weight or by volume;

  5.4. irritant to respiratory system and assigned the symbol ‘Xi’, the indication of danger ’irritant’ and the risk phrase R37;
  5.4.1. preparations containing one or more substances classified as irritant and to which is assigned phrase R37 in individual concentrations equal to or greater than:
   (a) either the concentration specified in Part 3 of Annex VI to Regulation (EC) No 1272/2008  for the substance or substances under consideration, or
   (b) the concentration specified at point 4 in Part B of this Annex (Table 4 and 4a) where the substance or the substances do not appear in Part 3 of Annex VI to Regulation (EC) No 1272/2008  or appear in it without concentration limits;
   5.4.2. preparations containing more than one substance classified as irritant and to which is assigned phrase R37 in lower individual concentrations than the limits specified in point 5.4.1(a) or (b) if:

20130116-P7_TA(2013)0008_EN-p0000009.jpg

where:

PXi, R37

=

is the percentage by weight or by volume of each irritant substance to which is assigned phrase R37 in the preparation,

LXi, R37

=

is the irritant limit R37 specified for each irritant substance to which is assigned phrase R37, expressed as percentage by weight or by volume;

   5.4.3. gaseous preparations containing more than one of the substances classified as irritant to which is assigned phrase R37 or as corrosive and to which is assigned phrase R35 or R34 in lower individual concentrations than the limits specified in point 5.4.1(a) or (b) if:

20130116-P7_TA(2013)0008_EN-p0000010.jpg

where:

PC, R35

=

is the percentage by volume of each corrosive substance to which is assigned phrase R35 in the preparation,

PC, R34

=

is the percentage by volume of each corrosive substance to which is assigned phrase R34 in the preparation,

PXi, R37

=

is the percentage by volume of each irritant substance to which is assigned phrase R37 in the preparation,

LXi, R37

=

is the respective irritant limit R37 specified for each gaseous corrosive substance to which is assigned phrase R35 or R34 or gaseous irritant substance to which is assigned phrase R37, expressed as percentage by weight or by volume.

6.  The following preparations are to be classified as sensitising:

  6.1. by skin contact and assigned the symbol ‘Xi’, the indication of danger ’irritant’ and the risk phrase R43.

Preparations containing at least one substance classified as sensitising and to which is assigned phrase R43 that produces such effects in individual concentrations equal to or greater than:
   (a) either the concentration specified in Part 3 of Annex VI to Regulation (EC) No 1272/2008  for the substance or substances under consideration, or
   (b) the concentration specified at point 5 in Part B of this Annex (Table 5 and 5a) where the substance or substances do not appear in Part 3 of Annex VI to Regulation (EC) No 1272/2008  or appear in it without concentration limits;
  6.2. by inhalation and assigned the symbol ‘Xn’, the indication of danger ’harmful’ and the risk phrase R42.

Preparations containing at least one substance classified as sensitising to which is assigned phrase R42 that produces such effects in individual concentrations equal to or greater than:
   (a) either the concentration specified in Part 3 of Annex VI to Regulation (EC) No 1272/2008  for the substance or substances under consideration, or
   (b) the concentration specified at point 5 in Part B of this Annex (Table 5 and 5a) where the substance or substances do not appear in Part 3 of Annex VI to Regulation (EC) No 1272/2008  or appear in it without concentration limits.

7.  The following preparations are to be classified as carcinogenic:

   7.1. those of category 1 or 2 which are assigned the symbol ‘T’ and the phrase R45 or R49.
  

Preparations containing at least one substance producing such effects, classified as carcinogenic and to which is assigned phrase R45 or R49 which denotes carcinogenic substances in category 1 and category 2, in individual concentrations equal to or greater than:

   (a) either the concentration specified in Part 3 of Annex VI to Regulation (EC) No 1272/2008  for the substance or substances under consideration, or
   (b) the concentration specified at point 6 in Part B of this Annex (Table 6 and 6a) where the substance or substances do not appear in Part 3 of Annex VI to Regulation (EC) No 1272/2008  or appear in it without concentration limits;
   7.2. those of category 3 which are assigned the symbol ‘Xn’ and the phrase R40.   

Preparations containing at least one substance producing such effects classified as carcinogenic and to which is assigned phrase R40 which denotes carcinogenic substances in category 3, in individual concentrations equal to or greater than:

   (a) either the concentration specified in Part 3 of Annex VI to Regulation (EC) No 1272/2008  for the substance or substances under consideration, or
   (b) the concentration specified at point 6 in Part B of this Annex (Table 6 and 6a) where the substance or substances do not appear in Part 3 of Annex VI to Regulation (EC) No 1272/2008  or appear in it without concentration limits.

8.  The following preparations are to be classified as mutagenic:

   8.1. those of category 1 or 2 which are assigned the symbol ‘T’ and the phrase R46.
  

Preparations containing at least one substance producing such effects, classified as mutagenic and to which is assigned phrase R46 which denotes mutagenic substances in category 1 and category 2, in individual concentrations equal to or greater than:

   (a) either the concentration specified in Part 3 of Annex VI to Regulation (EC) No 1272/2008  for the substance or substances under consideration, or
   (b) the concentration specified at point 6 in Part B of this Annex (Table 6 and 6a) where the substance or substances do not appear in Part 3 of Annex VI to Regulation (EC) No 1272/2008  or appear in it without concentration limits;
   8.2. those of category 3 which are assigned the symbol ‘Xn’ and the phrase 1 R68 .   

Preparations containing at least one substance, producing such effects, classified as mutagenic and to which is assigned phrase 1 R68  which denotes mutagenic substances in category 3, in individual concentrations equal to or greater than:

   (a) either the concentration specified in Part 3 of Annex VI to Regulation (EC) No 1272/2008  for the substance or substances under consideration, or
   (b) the concentration specified at point 6 in Part B of this Annex (Table 6 and 6a) where the substance or substances do not appear in Part 3 of Annex VI to Regulation (EC) No 1272/2008  or appear in it without concentration limits.

9.  The following preparations are to be classified as toxic for reproduction:

   9.1. those of category 1 or 2 which are assigned the symbol ‘T’ and the phrase R60 (fertility).
  

Preparations containing at least one substance producing such effects, classified as toxic for reproduction and to which is assigned phrase R60 which denotes substances toxic for reproduction of category 1 and category 2, in individual concentrations equal to or greater than:

   (a) either the concentration specified in Part 3 of Annex VI to Regulation (EC) No 1272/2008  for the substance or substances under consideration, or
   (b) the concentration specified at point 6 in Part B of this Annex (Table 6 and 6a) where the substance or substances do not appear in Part 3 of Annex VI to Regulation (EC) No 1272/2008  or appear in it without concentration limits;
   9.2. those of category 3 which are assigned the symbol ‘Xn’ and the phrase R62 (fertility).   

Preparations containing at least one substance producing such effects, classified as toxic for reproduction and to which is assigned phrase R62 which denotes substances toxic for reproduction of category 3, in individual concentrations equal to or greater than:

   (a) either the concentration specified in Part 3 of Annex VI to Regulation (EC) No 1272/2008  for the substance or substances under consideration, or
   (b) the concentration specified at point 6 in Part B of this Annex (Table 6 and 6a) where the substance or substances do not appear in Part 3 of Annex VI to Regulation (EC) No 1272/2008  or appear in it without concentration limits;
   9.3. those of category 1 or 2 which are assigned the symbol ‘T’ and the phrase R61 (development).   

Preparations containing at least one substance producing such effects, classified as toxic for reproduction and to which is assigned phrase R61 which denotes substances toxic for reproduction of category 1 and category 2, in individual concentrations equal to or greater than:

   (a) either the concentration specified in Part 3 of Annex VI to Regulation (EC) No 1272/2008  for the substance or substances under consideration, or
   (b) the concentration specified at point 6 in Part B of this Annex (Table 6 and 6a) where the substance or substances do not appear in Part 3 of Annex VI to Regulation (EC) No 1272/2008  or appear in it without concentration limits;
   9.4. those of category 3 which are assigned the symbol ‘Xn’ and the phrase R63 (development).   

Preparations containing at least one substance producing such effects, classified as toxic for reproduction and to which is assigned phrase R63 which denotes substances toxic for reproduction of category 3, in individual concentrations equal to or greater than:

   (a) either the concentration specified in Part 3 of Annex VI to Regulation (EC) No 1272/2008  for the substance or substances under consideration, or
   (b) the concentration specified at point 6 in Part B of this Annex (Table 6 and 6a) where the substance or substances do not appear in Part 3 of Annex VI to Regulation (EC) No 1272/2008  or appear in it without concentration limits.

PART B

Concentration limits to be used in evaluation of health hazards

For each health effect, the first table (Tables 1 to 6) sets out the concentration limits (expressed as a weight/weight percentage) to be used for non-gaseous preparations and the second table (Tables 1a to 6a) sets out the concentration limits (expressed as a volume/volume percentage) to be used for gaseous preparations. These concentration limits are used in the absence of specific concentration limits for the substance under consideration in Part 3 of Annex VI to Regulation (EC) No 1272/2008 .

1.  Acute lethal effects

1.1.  Non-gaseous preparations

The concentration limits fixed in Table 1, expressed as a weight/weight percentage, determine the classification of the preparation in relation to the individual concentration of the substance(s) present whose classification is also shown.

Table 1

Classification of the substance

Classification of the preparation

T+

T

Xn

T+ with R26, R27, R28

concentration ≥ 7 %

1 % ≤ concentration < 7 %

0,1 % ≤ concentration < 1 %

T with R23, R24, R25

concentration ≥ 25 %

3 % ≤ concentration < 25 %

Xn with R20, R21, R22

concentration ≥ 25 %

The R phrases denoting risk are to be assigned to the preparation in accordance with the following criteria:

   the label shall include one or more of the abovementioned R phrases according to the classification used,
   in general, the R phrases selected should be those applicable to the substance(s) present in the concentration which gives rise to the most severe classification.

1.2.  Gaseous preparations

The concentration limits expressed as a volume/volume percentage in Table 1a determine the classification of the gaseous preparations in relation to the individual concentration of the gas(es) present whose classification is also shown.

Table 1a

Classification of the substance

(gas)

Classification of the gaseous preparation

T+

T

Xn

T+ with R26, R27, R28

concentration ≥ 1 %

0,2 % ≤ concentration < 1 %

0,02 % ≤ concentration < 0,2 %

T with R23, R24, R25

concentration ≥ 5 %

0,5 % ≤ concentration < 5 %

Xn with R20, R21, R22

concentration ≥ 5 %

The R phrases denoting risk shall be assigned to the preparation in accordance with the following criteria:

   the label shall include one or more of the abovementioned R phrases according to the classification used,
   in general, the R phrases selected should be those applicable to the substance(s) present in the concentration which gives rise to the most severe classification.

2.  Non-lethal irreversible effects after a single exposure

2.1.  Non-gaseous preparations

For substances that produce non-lethal irreversible effects after a single exposure (R39/route of exposure, 1 R68 /route of exposure), the individual concentration limits specified in Table 2, expressed as a weight/weight percentage, determine, when appropriate, the classification of the preparation.

Table 2

Classification of the substance

Classification of the preparation

T+

T

Xn

T+ with R39/route of exposure

concentration ≥ 10 %

R39 (*) obligatory

1 % ≤ concentration < 10 %

R39 (*) obligatory

0,1 % ≤ concentration < 1 %

1 R68  (*) obligatory

T with R39/route of exposure

concentration ≥ 10 %

R39 (*) obligatory

1 % ≤ concentration < 10 %

1 R68  (*) obligatory

Xn with 1 R68 /route of exposure

concentration ≥ 10 %

1 R68  (*) obligatory

(*) In order to indicate the route of administration/exposure (route of exposure) the combined R phrases listed in points 3.2.1, 3.2.2 and 3.2.3 of the labelling guide (Annex VI to Directive 67/548/EEC) are to be used.

2.2.  Gaseous preparations

For gases that produce non-lethal irreversible effects after a single exposure (R39/route of exposure, 2 R68 /route of exposure), the individual concentration limits specified in Table 2a, expressed as a volume/volume percentage, determine, when appropriate, the classification of the preparation.

Table 2a

Classification of the substance (gas)

Classification of the gaseous preparation

T+

T

Xn

T+ with R39/route of exposure

concentration ≥ 1 %

R39 (*) obligatory

0,2 % ≤ concentration < 1 %

R39 (*) obligatory

0,02 % ≤ concentration < 0,2 %

2 R68  (*) obligatory

T with R39/route of exposure

concentration ≥ 5 %

R39 (*) obligatory

0,5 % ≤ concentration < 5 %

2 R68  (*) obligatory

Xn with 2 R68 /route of exposure

concentration ≥ 5 %

2 R68  (*) obligatory

(*) In order to indicate the route of administration/exposure (route of exposure) the combined R phrases listed in points 3.2.1, 3.2.2 and 3.2.3 of the labelling guide (Annex VI to Directive 67/548/EEC) are to be used.

3.  Severe effects after repeated or prolonged exposure

3.1.  Non-gaseous preparations

For substances that produce severe effects after repeated or prolonged exposure (R 48/route of exposure), the individual concentration limits specified in Table 3, expressed as a weight/weight percentage, determine, when appropriate, the classification of the preparation.

Table 3

Classification of the substance

Classification of the preparation

T

Xn

T with R48/route of exposure

concentration ≥ 10 %

R48 (*) obligatory

1 % ≤ concentration < 10 %

R48 (*) obligatory

Xn with R48/route of exposure

concentration ≥ 10 %

R48 (*) obligatory

(*) In order to indicate the route of administration/exposure (route of exposure) the combined R phrases listed in points 3.2.1, 3.2.2 and 3.2.3 of the labelling guide (Annex VI to Directive 67/548/EEC) are to be used.

3.2.  Gaseous preparations

For gases that produce severe effects after repeated or prolonged exposure (R48/route of exposure), the individual concentration limits specified in Table 3a, expressed as a volume/volume percentage, determine, when appropriate, the classification of the preparation.

Table 3a

Classification of the substance

(gas)

Classification of the gaseous preparation

T

Xn

T with R48/route of exposure

concentration ≥ 5 %

R48 (*) obligatory

0,5 % ≤ concentration < 5 %

R48 (*) obligatory

Xn with R48/route of exposure

concentration ≥ 5 %

R48 (*) obligatory

(*) In order to indicate the route of administration/exposure (route of exposure) the combined R phrases listed in points 3.2.1, 3.2.2 and 3.2.3 of the labelling guide (Annex VI to Directive 67/548/EEC) are to be used.

4.  Corrosive and irritant effects including serious damage to the eye

4.1.  Non-gaseous preparations

For substances that produce corrosive effects (R34, R35) or irritant effects (R36, R37, R38, R41), the individual concentration limits specified in Table 4, expressed as a weight/weight percentage, determine, when appropriate, the classification of the preparation.

Table 4

Classification of the substance

Classification of the preparation

C with R35

C with R34

Xi with R41

Xi with R36, R37, R38

C with R35

concentration ≥ 10 %

R35 obligatory

5 % ≤ concentration < 10 %

R34 obligatory

5 % (*)

1 % ≤ concentration < 5 %

R36/38 obligatory

C with R34

concentration ≥ 10 %

R34 obligatory

10 % (*)

5 % ≤ concentration < 10 %

R36/38 obligatory

Xi with R41

concentration ≥ 10 %

R41 obligatory

5 % ≤ concentration < 10 %

R36 obligatory

Xi with R36, R37, R38

concentration ≥ 20 %

R36, R37, R38 are obligatory in the light of the concentration present if they apply to the substances under consideration

(*) According to the labelling guide (Annex VI to Directive 67/548/EEC), corrosive substances assigned risk phrases R35 or R34 must also be considered as being assigned phrase R41. Consequently, if the preparation contains corrosive substances with R35 or R34 below the concentration limits for a classification of the preparation as corrosive, such substances can contribute to a classification of the preparation as irritant with R41 or irritant with R36.

     NB: Simple application of the conventional method to preparations containing substances classified as corrosive or irritant may result in under-classification or over-classification of the hazard, if other relevant factors (e.g. pH of the preparation) are not taken into account. Therefore, in classifying for corrosivity, consider the advice given in point 3.2.5 of Annex VI to Directive 67/548/EEC and in the second and third indents of Article 6(3), of this Directive.

4.2.  Gaseous preparations

For gases that produce such effects (R34, R35 or R36, R37, R38, R41), the individual concentration limits specified in Table 4a, expressed as a volume/volume percentage determine, when appropriate, the classification of the preparation.

Table 4a

Classification of the substance

(gas)

Classification of the gaseous preparation

C with R35

C with R34

Xi with R41

Xi with R36, R37, R38

C with R35

concentration ≥ 1 %

R35 obligatory

0,2 % ≤ concentration < 1 %

R34 obligatory

0,2 % (*)

0,02 % ≤ concentration < 0,2 %

R36/37/38 obligatory

C with R34

concentration ≥ 5 %

R34 obligatory

5 % (*)

0,5 % ≤ concentration < 5 %

R36/37/38 obligatory

Xi with R41

concentration ≥ 5 %

R41 obligatory

0,5 % ≤ concentration < 5 %

R36 obligatory

Xi with R36, R37, R38

concentration ≥ 5 %

R36, R37, R38 obligatory as appropriate

(*) According to the labelling guide (Annex VI to Directive 67/548/EEC), corrosive substances assigned risk phrases R35 or R34 must also be considered as being assigned phrase R41. Consequently, if the preparation contains corrosive substances with R35 or R34 below the concentration limits for a classification of the preparation as corrosive, such substances can contribute to a classification of the preparation as irritant with R41 or irritant with R36.

     NB: Simple application of the conventional method to preparations containing substances classified as corrosive or irritant may result in under-classification or over-classification of the hazard, if other relevant factors (e.g. pH of the preparation) are not taken into account. Therefore, in classifying for corrosivity, consider the advice given in point 3.2.5 of Annex VI to Directive 67/548/EEC and in the second and third indents of Article 6(3), of this Directive.

5.  Sensitising effects

5.1.  Non-gaseous preparations

Preparations that produce such effects are classified as sensitising and assigned:

   the symbol Xn and phrase R42 if this effect can be produced by inhalation,
   the symbol Xi and phrase R43 if this effect can be produced through contact with the skin.
  

The individual concentration limits specified in Table 5, expressed as a weight/weight percentage, determine, when appropriate, the classification of the preparation.

Table 5

Classification of the substance

Classification of the preparation

Sensitising with R42

Sensitising with R43

Sensitising with R42

concentration ≥ 1 %

R42 obligatory

Sensitising with R43

concentration ≥ 1 %

R43 obligatory

5.2.  Gaseous preparations

Gaseous preparations that produce such effects are classified as sensitising and assigned:

   the symbol Xn and phrase R42 if this effect can be produced by inhalation,
   the symbol Xi and phrase R43 if this effect can be produced through contact with the skin.
  

The individual concentration limits specified in Table 5a, expressed as a volume/volume percentage, determine, when appropriate, the classification of the preparation.

Table 5a

Classification of the substance

(gas)

Classification of the gaseous preparation

Sensitising with R42

Sensitising with R43

Sensitising with R42

concentration ≥ 0,2 %

R42 obligatory

Sensitising with R43

concentration ≥ 0,2 %

R43 obligatory

6.  Carcinogenic/mutagenic/toxic effects for reproduction

6.1.  Non-gaseous preparations

For substances which produce such effects, the concentration limits laid down in Table 6, expressed as a weight/weight percentage, shall determine, where appropriate, the classification of the preparation. The following symbol and risk phrases are assigned:

Carcinogenic categories 1 and 2:

T; R45 or R49

Carcinogenic category 3:

Xn; R40

Mutagenic categories 1 and 2:

T; R46

Mutagenic category 3:

Xn; 1 R68 

Toxic for reproduction fertility categories 1 and 2:

T; R60

Toxic for reproduction development categories 1 and 2:

T; R61

Toxic for reproduction fertility category 3:

Xn; R62

Toxic for reproduction development category 3:

Xn; R63

Table 6

Classification of the substance

Classification of the preparation

Categories 1 and 2

Category 3

Carcinogenic substances of category 1 or 2 with R45 or R49

Concentration ≥ 0,1 % carcinogenic

R45, R49 obligatory as appropriate

Carcinogenic substances of category 3 with R40

Concentration ≥ 1 % carcinogenic

R40 obligatory (unless already assigned R45 (*))

Mutagenic substances of category 1 or 2 with R46

Concentration ≥ 0,1 % mutagenic

R46 obligatory

Mutagenic substances of category 3 with R68

Concentration ≥ 1 %

mutagenic

R68 obligatory (unless already assigned R46)

Substances ‘toxic for reproduction’ of category 1 or 2 with R60 (fertility)

Concentration ≥ 0,5 % toxic for reproduction (fertility)

R60 obligatory

Substances ‘toxic for reproduction’ of category 3 with R62 (fertility)

Concentration ≥ 5 % toxic for reproduction (fertility)

R62 obligatory (unless already assigned R60)

Substances ‘toxic for reproduction’ of category 1 or 2 with R61 (development)

Concentration ≥ 0,5 % toxic for reproduction (development)

R61 obligatory

Substances ‘toxic for reproduction’ of category 3 with R63 (development)

Concentration ≥ 5 % toxic for reproduction (development)

R63 obligatory (unless already assigned R61)

(*) In cases where the preparation is assigned R49 and R40, both R phrases shall be kept, because R40 does not distinguish between the exposure routes, whereas R49 is only assigned for the inhalation route.

6.2.  Gaseous preparations

For gases which produce such effects, the concentration limits laid down in Table 6a, expressed as a volume/volume percentage, shall determine, where appropriate, the classification of the preparation. The following symbol and risk phrases are assigned:

Carcinogenic categories 1 and 2:

T; R45 or R49

Carcinogenic category 3:

Xn; R40

Mutagenic categories 1 and 2:

T; R46

Mutagenic category 3:

Xn; 1 R68 

Toxic for reproduction fertility categories 1 and 2:

T; R60

Toxic for reproduction development categories 1 and 2:

T; R61

Toxic for reproduction fertility category 3:

Xn; R62

Toxic for reproduction development category 3:

Xn; R63

Table 6a

Classification of the substance

Classification of the preparation

Categories 1 and 2

Category 3

Carcinogenic substances of category 1 or 2 with R45 or R49

Concentration ≥ 0,1 % carcinogenic

R45, R49 obligatory as appropriate

Carcinogenic substances of category 3 with R40

Concentration ≥ 1 % carcinogenic

R40 obligatory (unless already assigned R45 (*))

Mutagenic substances of category 1 or 2 with R46

Concentration ≥ 0,1 % mutagenic

R46 obligatory

Mutagenic substances of category 3 with R68

Concentration ≥ 1 %

mutagenic

R68 obligatory (unless already assigned R46)

Substances ‘toxic for reproduction’ of category 1 or 2 with R60 (fertility)

Concentration ≥ 0,2 % toxic for reproduction (fertility)

R60 obligatory

Substances ‘toxic for reproduction’ of category 3 with R62 (fertility)

Concentration ≥ 1 % toxic for reproduction (fertility)

R62 obligatory (unless already assigned R60)

Substances ‘toxic for reproduction’ of category 1 or 2 with R61 (development)

Concentration ≥ 0,2 % toxic for reproduction (development)

R61 obligatory

Substances ‘toxic for reproduction’ of category 3 with R63 (development)

Concentration ≥ 1 % toxic for reproduction (development)

R63 obligatory (unless already assigned R61)

(*) In cases where the preparation is assigned R49 and R40, both R phrases shall be kept, because R40 does not distinguish between the exposure routes, whereas R49 is only assigned for the inhalation route.

ANNEX III

METHODS FOR THE EVALUATION OF THE ENVIRONMENTAL HAZARDS OF PREPARATIONS IN ACCORDANCE WITH ARTICLE 7

Introduction

The systematic assessment of all the dangerous properties for the environment is expressed by means of concentration limits, expressed as a weight/weight percentage except for gaseous preparations where they are expressed as a volume/volume percentage and in conjunction with the classification of a substance.

Part A sets out the calculation procedure in accordance with Article 7(1)(a) and gives the R phrases to be assigned to the classification of the preparation.

Part B sets out the concentration limits to be used when applying the conventional method and relevant symbols and R phrases for classification.

In accordance with Article 7(1)(a) the environmental hazards of a preparation shall be assessed by the conventional method described in Parts A and B of this Annex, using individual concentration limits.

(a)  Where the dangerous substances listed in Part 3 of Annex VI to Regulation (EC) No 1272/2008  are assigned concentration limits necessary for the application of the method of assessment described in Part A of this Annex, these concentration limits must be used.

(b)  Where the dangerous substances do not appear in Part 3 of Annex VI to Regulation (EC) No 1272/2008  or appear there without the concentration limits necessary for the application of the method of evaluation described in Part A of this Annex, the concentration limits shall be assigned in accordance with the specification in Part B of this Annex.

Part C sets out the test methods for the evaluation of the hazards for the aquatic environment.

PART A

Procedure for the evaluation of environmental hazards

(a)  Aquatic environment

I.  Conventional method for the evaluation of hazards to the aquatic environment

The conventional method for the evaluation of hazards to the aquatic environment 2 takes into account all the hazards that a preparation may entail  for this medium in accordance with the following specifications.

The following preparations are to be classified as dangerous for the environment:

  1. and assigned the symbol ‘N’, the indication of danger ’dangerous for the environment’ and the risk phrases R50 and R53 (R50-53):
   1.1. preparations containing one or more substances classified as dangerous to the environment and to which is assigned phrases R50-53 in individual concentrations equal to or greater than:
   (a) either the concentration specified in 3 Part 3 of Annex VI to Regulation (EC) No 1272/2008  for the substance or substances under consideration, or
   (b) the concentration specified in Part B of this Annex (Table 1) where the substance or substances do not appear in 3 Part 3 of Annex VI to Regulation (EC) No 1272/2008  or appear in it without concentration limits;
   1.2. preparations containing more than one substance classified as dangerous for the environment and to which is assigned phrases R50–53 in lower individual concentrations than the limits specified in point I.1.1(a) or (b) if:

20130116-P7_TA(2013)0008_EN-p0000011.jpg

where:

PN, R50‐53

=

is the percentage by weight of each substance dangerous for the environment to which is assigned phrases R50–53 in the preparation,

LN, R50‐53

=

is the limit R50–53 for each substance dangerous for the environment to which is assigned the phrases R50–53, expressed as percentage by weight;

  2. and assigned the symbol ‘N’, the indication of danger ’dangerous for the environment’ and the risk phrases R51 and R53 (R51–53) unless the preparation is already classified in accordance with point I.1;
  2.1. preparations containing one or more than one substance classified as dangerous to the environment and to which is assigned phrases R50–53 or R51–53 in individual concentrations equal to or greater than:
   (a) either the concentration specified in Part 3 of Annex VI to Regulation (EC) No 1272/2008  for the substance or substances under consideration, or
   (b) the concentration specified in Part B of this Annex (Table 1) where the substance or substances do not appear in Part 3 of Annex VI to Regulation (EC) No 1272/2008  or appear in it without concentration limits;
   2.2. preparations containing more than one of the substances classified as dangerous for the environment and to which is assigned phrases R50–53 or R51–53 in lower individual concentrations than the limits specified in point I.2.1 (a) or (b) if:

20130116-P7_TA(2013)0008_EN-p0000012.jpg

where:

PN, R50‐53

=

is the percentage by weight of each substance dangerous for the environment to which is assigned phrases R50–53 in the preparation,

PN, R51‐53

=

is the percentage by weight of each substance dangerous for the environment to which is assigned phrases R51–53 in the preparation,

LN, R51‐53

=

is the respective limit R51–53 for each substance dangerous for the environment to which is assigned phrases R50–53 or R51–53, expressed as percentage by weight;

  3. and assigned the risk phrases R52 and R53 (R52–53) unless the preparation is already classified in accordance with point I.1 or I.2;
  3.1. preparations containing one or more than one substance classified as dangerous to the environment and to which is assigned phrases R50–53 or R51–53 or R52–53 in individual concentrations equal to or greater than:
   (a) either the concentration specified in Part 3 of Annex VI to Regulation (EC) No 1272/2008  for the substance or substances under consideration, or
   (b) the concentration specified in Part B of this Annex (Table 1) where the substance or substances do not appear in Part 3 of Annex VI to Regulation (EC) No 1272/2008  or appear in it without concentration limits;
   3.2. preparations containing more than one of the substances classified as dangerous for the environment and to which is assigned phrases R51–53 or R50–53 or R52–53 in lower individual concentrations than the limits specified in point I.3.1(a) or (b) if:

20130116-P7_TA(2013)0008_EN-p0000013.jpg

where:

PN, R50‐53

=

is the percentage by weight of each substance dangerous for the environment to which is assigned phrases R50–53 in the preparation,

PN, R51‐53

=

is the percentage by weight of each substance dangerous for the environment to which is assigned phrases R51–53 in the preparation,

PR52‐53

=

is the percentage by weight of each substance dangerous for the environment to which is assigned phrases R52–53 in the preparation,

LR52‐53

=

is the respective limit R52–53 for each substance dangerous for the environment to which is assigned phrases R50–53 or R51–53 or R52–53, expressed as percentage by weight;

  4. and assigned the symbol ‘N’, the indication of danger ’dangerous for the environment’ and the risk phrase R50 unless the preparation is already classified in accordance with point I.1:
  4.1. preparations containing one or more than one substance classified as dangerous to the environment and to which is assigned phrase R50 in individual concentrations equal to or greater than:
   (a) either the concentration specified in Part 3 of Annex VI to Regulation (EC) No 1272/2008  for the substance or substances under consideration, or
   (b) the concentration specified in Part B of this Annex (Table 2) where the substance or substances do not appear in Part 3 of Annex VI to Regulation (EC) No 1272/2008  or appear in it without concentration limits;
   4.2. preparations containing more than one substance classified as dangerous for the environment and to which is assigned phrase R50 in lower individual concentrations than the limits specified in point I.4.1(a) or (b) if:

20130116-P7_TA(2013)0008_EN-p0000014.jpg

where:

PN, R50

=

is the percentage by weight of each substance dangerous for the environment to which is assigned phrase R50 in the preparation,

LN, R50

=

is the limit R50 for each substance dangerous for the environment to which is assigned phrase R50, expressed as percentage by weight;

   4.3. preparations containing one or more than one of the substances classified as dangerous for the environment and to which is assigned phrase R50 not meeting the criteria in point I.4.1 or I.4.2 and containing one or more than one substance classified as dangerous for the environment and to which is assigned phrases R50–53 if:

20130116-P7_TA(2013)0008_EN-p0000015.jpg

where:

PN, R50

=

is the percentage by weight of each substance dangerous for the environment to which is assigned phrase R50 in the preparation,

PN, R50‐53

=

is the percentage by weight of each substance dangerous for the environment to which is assigned phrases R50–53 in the preparation,

LN, R50

=

is the perspective limit R50 for each substance dangerous for the environment to which is assigned phrases R50 or R50–53, expressed as percentage by weight;

  5. and assigned the risk phrase R52 unless the preparation is already classified in accordance with point I.1, I.2, I.3, or I.4:
  5.1. preparations containing one or more than one substance classified as dangerous to the environment and to which is assigned phrase R52 in individual concentrations equal to or greater than:
   (a) either the concentration specified in Part 3 of Annex VI to Regulation (EC) No 1272/2008  for the substance or substances under consideration, or
   (b) the concentration specified in Part B of this Annex (Table 3) where the substance or substances do not appear in Part 3 of Annex VI to Regulation (EC) No 1272/2008  or appear in it without concentration limits;
   5.2. preparations containing more than one substance classified as dangerous for the environment and to which is assigned phrase R52 in lower individual concentrations than the limits specified in point I.5.1 (a) or (b) if:

20130116-P7_TA(2013)0008_EN-p0000016.jpg

where:

PR52

=

is the percentage by weight of each substance dangerous for the environment to which is assigned phrase R52 in the preparation,

LR52

=

is the limit R52 for each substance dangerous for the environment to which is assigned phrase R52, expressed as percentage by weight;

  6. and assigned the risk phrase R53 unless the preparation is already classified in accordance with point I.1, I.2, or I.3 :
  6.1. preparations containing one or more than one substance classified as dangerous to the environment and to which is assigned phrase R53 in individual concentrations equal to or greater than:
   (a) either the concentration specified in Part 3 of Annex VI to Regulation (EC) No 1272/2008  for the substance or substances under consideration, or
   (b) the concentration specified in Part B of this Annex (Table 4) where the substance or substances do not appear in Part 3 of Annex VI to Regulation (EC) No 1272/2008  or appear in it without concentration limits;
   6.2. preparations containing more than one substance classified as dangerous for the environment and to which is assigned phrase R53 in lower individual concentrations than the limits specified in point I.6.1(a) or (b) if:

20130116-P7_TA(2013)0008_EN-p0000017.jpg

where:

PR53

=

is the percentage by weight of each substance dangerous for the environment to which is assigned phrase R53 in the preparation,

LR53

=

is the limit R53 for each substance dangerous for the environment to which is assigned phrase R53, expressed as percentage by weight;

   6.3. preparations containing one or more than one of the substances classified as dangerous for the environment and to which is assigned phrase R53 not meeting the criteria in point I.6.2 and containing one or more than one substance classified as dangerous for the environment and to which is assigned phrases R50–53 or R51–53 or R52–53 if:

20130116-P7_TA(2013)0008_EN-p0000018.jpg

where:

PR53

=

is the percentage by weight of each substance dangerous for the environment to which is assigned phrase R53 in the preparation,

PN, R50‐53

=

is the percentage by weight of each substance dangerous for the environment to which is assigned phrase R50–53 in the preparation,

PN, R51‐53

=

is the percentage by weight of each substance dangerous for the environment to which is assigned phrase R51–53 in the preparation,

PR52‐53

=

is the percentage by weight of each substance dangerous for the environment to which is assigned phrase R52–53 in the preparation,

LR53

=

is the respective limit R53 for each substance dangerous for the environment to which is assigned phrase R53 or R50–53 or R51–53 or R52–53, expressed as percentage by weight.

(b)  Non-aquatic environment

(1)  OZONE LAYER

I.  Conventional method for the evaluation of preparations dangerous for the ozone layer

The following preparations  shall be  classified as dangerous for the environment:

  1. and assigned the symbol ‘N’, the indication of danger ’dangerous for the environment’ and the risk phrase R59;
  1.1. preparations containing one or more substances classified as dangerous to the environment and to which is assigned the symbol ‘N’ and the risk phrase R59 in individual concentrations equal to or greater than:
   (a) either the concentration specified in Part 3 of Annex VI to Regulation (EC) No 1272/2008  for the substance or substances under consideration, or
   (b) the concentration specified in Part B of this Annex (Table 5) where the substance or substances do not appear in Part 3 of Annex VI to Regulation (EC) No 1272/2008  or appear in it without concentration limits.

(2)  TERRESTRIAL ENVIRONMENT

I.  Evaluation of preparations dangerous for the terrestrial environment

Classification of preparations using the risk phrases below will follow after the detailed criteria for use of the phrases have been incorporated in Annex VI to Directive 67/548/EEC.

R54

Toxic to flora

R55

Toxic to fauna

R56

Toxic to soil organisms

R57

Toxic to bees

R58

May cause long-term adverse effects in the environment.

PART B

Concentration limits to be used for the evaluation of environmental hazards

I.  For the aquatic environment

The concentration limits fixed in the following tables, expressed as a weight/weight percentage, determine the classification of the preparation in relation to the individual concentration of the substance(s) present whose classification is also shown.

Table 1a

Acute aquatic toxicity and long-term adverse effects

Classification of the substance

Classification of the preparation

N, R50-53

N, R51-53

R52-53

N, R50-53

see Table 1b

see Table 1b

see Table 1b

N, R51-53

Cn ≥ 25 %

2,5 % ≤ Cn< 25 %

R52-53

Cn ≥ 25 %

Preparations containing a substance classified with N, R50–53, the concentration limits and the resulting classification given in table 1b are applicable.

Table 1b

Acute aquatic toxicity and long-term adverse effects of substances very toxic to the aquatic environment

LC50 or EC50 value (‘L(E)C50’) of substance classified as N, R50–53 (mg/l)

Classification of the preparation

N, R50-53

N, R51-53

R52-53

0,1 < L(E)C50 ≤ 1

Cn ≥ 25 %

2,5 % ≤ Cn< 25 %

0,25 % ≤ Cn< 2,5 %

0,01 < L(E)C50 ≤ 0,1

Cn ≥ 2,5 %

0,25 % ≤ Cn< 2,5 %

0,025 % ≤ Cn< 0,25 %

0,001 < L(E)C50 ≤ 0,01

Cn ≥ 0,25 %

0,025 % ≤ Cn< 0,25 %

0,0025 % ≤ Cn< 0,025 %

0,0001 < L(E)C50 ≤ 0,001

Cn ≥ 0,025 %

0,0025 % ≤ Cn< 0,025 %

0,00025 % ≤ Cn< 0,0025 %

0,00001 < L(E)C50 ≤ 0,0001

Cn ≥ 0,0025 %

0,00025 % ≤ Cn< 0,0025 %

0,000025 % ≤ Cn< 0,00025 %

For preparations containing substances with a lower LC50 or EC50 value than 0,00001 mg/l, the corresponding concentrationlimits are calculated accordingly (in factor 10 intervals).

Table 2

Acute aquatic toxicity

LC50 or EC50 value (‘L(E)C50’) of substance classified either as N, R50 or as N, R50-53 (mg/l)

Classification of the preparation N, R50

0,1 < L(E)C50 ≤ 1

Cn ≥ 25 %

0,01 < L(E)C50 ≤ 0,1

Cn ≥ 2,5 %

0,001 < L(E)C50 ≤ 0,01

Cn ≥ 0,25 %

0,0001 < L(E)C50 ≤ 0,001

Cn ≥ 0,025 %

0,00001 < L(E)C50 ≤ 0,0001

Cn ≥ 0,0025 %

For preparations containing substances with a lower LC50 or EC50 value than 0,00001 mg/l, the corresponding concentration limits are calculated accordingly (in factor 10 intervals).

Table 3

Aquatic toxicity

Classification of the substance

Classification of the preparation R52

R52

Cn ≥ 25 %

Table 4

Long-term adverse effects

Classification of the substance

Classification of the preparation R53

R53

Cn ≥ 25 %

N, R50‐53

Cn ≥ 25 %

N, R51‐53

Cn ≥ 25 %

R52‐53

Cn ≥ 25 %

II.  For the non-aquatic environment

The concentration limits fixed in the following tables, expressed as weight/weight percentage or, for gaseous preparations as a volume/volume percentage, determine the classification of the preparation in relation to the individual concentration of the substance(s) present whose classification is also shown.

Table 5

Dangerous for the ozone layer

Classification of the substance

Classification of the preparation N, R59

N with R59

Cn ≥ 0,1 %

PART C

Test methods for the evaluation of the hazards for the aquatic environment

Normally, the classification of a preparation is made on the basis of the conventional method. However, for the determination of the acute aquatic toxicity, there may be cases for which it is appropriate to carry out tests on the preparation.

The result of these tests on the preparation may only modify the classification concerning acute aquatic toxicity which would have been obtained by the application of the conventional method.

If such tests are chosen by the person responsible for the placing on the market, it must be ensured that the quality criteria of the test methods in Part C  of the Annex to  Regulation (EC) No 440/2008 have been complied with.

Furthermore, the tests are to be carried out on all three species in conformity with the criteria of Annex VI to Directive 67/548/EEC (algae, daphnia and fish), unless the highest hazard classification relating to acute aquatic toxicity has been assigned to the preparation after testing on one of the species or a test result was already available before this Directive entered into force.

ANNEX IV

SPECIAL PROVISIONS FOR CONTAINERS CONTAINING PREPARATIONS OFFERED OR SOLD TO THE GENERAL PUBLIC

PART A

Containers to be fitted with child-resistant fastenings

1.  Containers of whatever capacity, containing preparations offered or sold to the general public and labelled as very toxic, toxic or corrosive in accordance with Article 10 and under the conditions laid down in Article 6, are to  be  fitted with child-resistant fastenings.

2.  Containers of whatever capacity containing preparations presenting an aspiration hazard (Xn, R65) and classified and labelled in accordance with point 3.2.3 of Annex VI to Directive 67/548/EEC with the exception of preparations placed on the market in the form of aerosols or in a container fitted with a sealed spray attachment.

3.  Containers of whatever capacity, having at least one of the substances mentioned below present in a concentration equal to or greater then the maximum individual concentration specified,

No

Identification of the substance

Concentration limit

CAS-Reg No

Name

Einecs No

1

67-56-1

Methanol

2006596

≥ 3 %

2

75-09-2

Dichloromethane

2008389

≥ 1 %

which are offered or sold to the general public are to be fitted with child-resistant fastenings.

PART B

Containers to be fitted with a tactile warning of danger

Containers of whatever capacity, containing preparations offered or sold to the general public and labelled as very toxic, toxic, corrosive, harmful, extremely flammable or highly flammable in accordance with Article 10 and under the conditions laid down in Articles 5 and 6,are to carry a tactile warning of danger.

This provision does not apply to aerosols classified and labelled only as extremely flammable or highly flammable.

ANNEX V

SPECIAL PROVISIONS CONCERNING THE LABELLING OF CERTAIN PREPARATIONS

A.  For preparations classified as dangerous within the meaning of Articles 5, 6 and 7

1.  Preparations sold to the general public

1.1.  The label on the packaging containing such preparations, in addition to the specific safety advice, must bear the relevant safety advice S1, S2, S45 or S46 in accordance with the criteria laid down in Annex VI to Directive 67/548/EEC.

1.2.  When such preparations are classified as very toxic (T+), toxic (T) or corrosive (C) and where it is physically impossible to give such information on the package itself, packages containing such preparations must be accompanied by precise and easily understandable instructions for use including, where appropriate, instructions for the destruction of the empty package.

2.  Preparations intended for use by spraying

The label on the packaging containing such preparations must compulsorily bear the safety advice S23 accompanied by safety advice S38 or S51 assigned to it in accordance with the criteria laid down in Annex VI to Directive 67/548/EEC.

3.  Preparations containing a substance assigned phrase R33: Danger of cumulative effects

When a preparation contains at least one substance assigned the phrase R33, the label on the packaging of the preparation must carry the wording of this phrase as set out in Annex III to Directive 67/548/EEC, when the concentration of this substance present in the preparation is equal to or higher than 1 %, unless different values are set in Part 3 of Annex VI to Regulation (EC) No 1272/2008 .

4.  Preparations containing a substance assigned phrase R64: May cause harm to breastfed babies

When a preparation contains at least one substance assigned phrase R64, the label on the packaging of the preparation must carry the wording of this phrase as set out in Annex III to Directive 67/548/EEC, when the concentration of this substance present in the preparation is equal to or higher than 1 %, unless different values are set in Part 3 of Annex VI to Regulation (EC) No 1272/2008 .

B.  For preparations irrespective of their classification within the meaning of Articles 5, 6 and 7

1.  Preparations containing lead

1.1.  Paint and varnishes

The label on the packaging of paints and varnishes containing lead in quantities exceeding 0,15 % (expressed as weight of metal) of the total weight of the preparation, as determined in accordance with ISO standard 6503/1984, must show the following particulars:"

Should not be used on surfaces liable to be chewed or sucked by children

"

In the case of packages the contents of which are less than 125 millilitres, the particulars may be as follows:"

Warning! Contains lead

"

2.  Preparations containing cyanoacrylates

2.1.  Adhesives

The label on the immediate packaging of adhesives based on cyanoacrylate must bear the following inscriptions:"

Cyanoacrylate.

Danger.

Bonds skin and eyes in seconds.

Keep out of the reach of children

"

Appropriate advice on safety must accompany the package.

3.  Preparations containing isocyanates

The label on the packaging of preparations containing isocyanates (as monomers, oligomers, prepolymers, etc., or as mixtures thereof) must bear the following inscriptions:"

Contains isocyanates.

See information supplied by the manufacturer

"

4.  Preparations containing epoxy constituents with an average molecular weight ≤ 700

The label on the packaging of preparations containing epoxy constituents with an average molecular weight ≤ 700 must bear the following inscriptions:"

Contains epoxy constituents.

See information supplied by the manufacturer

"

5.  Preparations sold to the general public which contain active chlorine

The label on the packaging of preparations containing more than 1 % of active chlorine must bear the following particular inscriptions:"

Warning! Do not use together with other products. May release dangerous gases (chlorine)

"

6.  Preparations containing cadmium (alloys) and intended to be used for brazing or soldering

The label on the packaging of the above mentioned preparations must bear the following inscription printed in clearly legible and indelible characters:"

Warning! Contains cadmium.

Dangerous fumes are formed during use.

See information supplied by the manufacturer.

Comply with the safety instructions

"

7.  Preparations available as aerosols

Without prejudice to the provisions of this Directive, preparations available as aerosols are also subject to the labelling provisions in accordance with points 2.2 and 2.3 of the Annex to Directive 75/324/EEC.

8.  Preparations containing substances not yet tested completely

Where a preparation contains at least one substance which, in accordance with Directive 67/548/EEC, bears the inscription 2 ‘Caution ‐ substance not yet fully tested’,  the label on the packaging of the preparation must bear the inscription
’Warning ‐ this preparation contains a substance not yet tested completely’ if this substance is present in a concentration ≥ 1 %.

9.  Preparations not classified as sensitising but containing at least one sensitising substance

The label on the packaging of preparations containing at least one substance classified as sensitising and being present in a concentration equal to or greater than 0,1 % or in a concentration equal to or greater than that specified under a specific note for the substance in 3 Part 3 of Annex VI to Regulation (EC) No 1272/2008  must bear the inscription: "

“Contains (name of sensitising substance). May produce an allergic reaction’.

"

10.  Liquid preparations containing halogenated hydrocarbons

For liquid preparations which show no flashpoint or a flashpoint higher than 55 °C and contain a halogenated hydrocarbon and more than 5 % flammable or highly flammable substances, the label on the packaging must bear the following inscription as appropriate:

Can become highly flammable in use’ or ‘Can become flammable in use’.

11.  Preparations containing a substance assigned phrase R67: vapours may cause drowsiness and dizziness

When a preparation contains one or more substances assigned the phrase R67, the label on the packaging of the preparation must carry the wording of this phrase as set out in Annex III to Directive 67/548/EEC, when the total concentration of these substances present in the preparation is equal to or higher than 15 %, unless:

   the preparation is already classified with phrases R20, R23, R26, R68/20, R39/23 or R39/26,
   or the preparation is in a package not exceeding 125 ml.

12.  Cements and cement preparations

The label on the packaging of cements and cement preparations containing more than 0,0002 % soluble chromium (VI) of the total dry weight of the cement must bear the inscription:"

“Contains chromium (VI). May produce an allergic reaction

"

unless the preparation is already classified and labelled as a sensitiser with phrase R43.

C.  For preparations not classified within the meaning of Articles 5, 6 and 7 but containing at least one dangerous substance

1.  Preparations not intended for the general public

The label on the packaging of preparations referred to in Article 31(3)(a) and (c) of Regulation (EC) No 1907/2006 must bear the following inscription:"

Safety data sheet available for professional user on request

"

ANNEX VI

CONFIDENTIALITY FOR THE CHEMICAL IDENTITY OF A SUBSTANCE

PART A

Information to be communicated in the request for confidentiality

Introductory notes

A.  Article 14 indicates the conditions in which the person responsible for placing a preparation on the market may avail himself of the confidentiality.

B.  To avoid multiple requests for confidentiality relating to the same substance used in different preparations, a single request for confidentiality may suffice if a certain number of preparations have:

   the same dangerous constituents present in the same concentration range,
   the same classification and labelling,
   the same expected uses.

A single alternative denomination must be used to mask the chemical identity of the same substance in the preparations concerned. Furthermore, the request for confidentiality must contain all information indicated in the following request, without forgetting the name or the trade name of each preparation.

C.  The alternative designation used on the label must be the same as that given under Heading 3 ‘Composition/information on ingredients’ of  Annex II  to Regulation (EC) No 1907/2006.

This implies that the alternative designation used will contain enough information about the substance to ensure risk-free handling.

D.  In making the request to use an alternative designation the person responsible for placing on the market must take into account the need to provide enough information for necessary health and safety precautions to be taken in the workplace and to ensure that risks from handling the preparation can be minimised.

Request for confidentiality

In accordance with Article 14 the request for confidentiality must obligatorily contain the following information:

1.  Name and full address (including telephone number) of the person established in the  Union  who is responsible for placing the preparation on the market (manufacturer, importer or distributor).

2.  Precise identification of the substance(s) for which confidentiality is proposed and the alternative designation.

CAS No

Einecs No

Chemical name according to international nomenclature and classification

(Part 3 of Annex VI to Regulation (EC) No 1272/2008  or provisional classification)

Alternative designation

(a)

(b)

(c)

NB: Where substances are classified provisionally, accompanying information (bibliographical references) should be provided as evidence that the provisional classification takes account of all existing pertinent information available on the properties of the substance.

3.  Justification for confidentiality (probability ‐ plausibility).

4.  Designation(s) or commercial name(s) of the preparation(s).

5.  Is the designation or commercial name the same for all the  Union ?

YES

NO

If no, specify the designation(s) or commercial name(s) used in the different Member States:

Belgium:

Bulgaria:

Czech Republic:

Denmark:

Germany:

Estonia:

Ireland:

Greece:

Spain:

France:

Italy:

Cyprus:

Latvia:

Lithuania:

Luxembourg:

Hungary:

Malta:

Netherlands:

Austria:

Poland:

Portugal:

Romania:

Slovenia:

Slovakia:

Finland:

Sweden:

United Kingdom:

6.  Composition of the preparation(s) defined in Heading 3 of Annex II to Regulation (EC) No 1907/2006.

7.  Classification of the preparation(s) in accordance with Article 6 of this Directive.

8.  Labelling of the preparation(s) in accordance with Article 10 of this Directive.

9.  Intended uses for the preparation(s).

10.  Safety data sheet(s) conforming to Regulation (EC) No 1907/2006.

PART B

Lexicon guide for establishing the alternative designations (generic names)

1.  Introductory note

The lexicon guide is based on the procedure for the classification of dangerous substances (division of substances into families) which appears in Part 3 of Annex VI to Regulation (EC) No 1272/2008 .

Alternative designations to those based on this guide may be used. However, in all cases the names chosen must provide enough information to ensure the preparation can be handled without risk and that necessary health and safety precautions can be taken in the workplace.

The families are defined in the following manner:

   inorganic or organic substances whose properties are identified by having a common chemical element as their chief characteristic. The family name is derived from the name of the chemical element. These families are identified as in 2 Part 3 of Annex VI to Regulation (EC) No 1272/2008  by the atomic number of the chemical element (001 to 103),
   organic substances whose properties are identified by having a common functional group as their chief characteristics.

The family name is derived from the functional group name.

These families are identified by the conventional number found in 2 Part 3 of Annex VI to Regulation (EC) No 1272/2008  (601‐650).

Sub-families bringing together substances with a common specific character have been added in certain cases.

2.  Establishing the generic name

General principles

For the purposes of establishing the generic name, the following general approach, involving two successive stages, is adopted:

   (i) identification of the functional groups and chemical elements present in the molecule;
   (ii) determination of the extent to which account should be taken of the most important functional groups and chemical elements.

The identified functional groups and elements taken into account are the names of the families and sub-families set out in point 3 in the form of a non-restrictive list.

3.  Division of substances into families and sub-families

Family No

Part 3 of Annex VI to Regulation (EC) No 1272/2008 

Families

Sub-families

001

Hydrogen compounds

Hydrides

002

Helium compounds

003

Lithium compounds

004

Beryllium compounds

005

Boron compounds

Boranes

Borates

006

Carbon compounds

Carbamates

Inorganic carbon compounds

Salts of hydrogen cyanide

Urea and derivatives

007

Nitrogen compounds

Quaternary ammonium compounds

Acid nitrogen compounds

Nitrates

Nitrites

008

Oxygen compounds

009

Fluorine compounds

Inorganic fluorides

010

Neon compounds

011

Sodium compounds

012

Magnesium compounds

Organometallic magnesium derivatives

013

Aluminium compounds

Organometallic aluminium derivatives

014

Silicon compounds

Silicones

Silicates

015

Phosphorus compounds

Acid phosphorus compounds

Phosphonium compounds

Phosphoric esters

Phosphates

Phosphites

Phosphoramides and derivatives

016

Sulphur compounds

Acid sulphur compounds

Mercaptans

Sulphates

Sulphites

017

Chlorine compounds

Chlorates

Perchlorates

018

Argon compounds

019

Potassium compounds

020

Calcium compounds

021

Scandium compounds

022

Titanium compounds

023

Vanadium compounds

024

Chromium compounds

Chromium VI compounds

025

Manganese compounds

026

Iron compounds

027

Cobalt compounds

028

Nickel compounds

029

Copper compounds

030

Zinc compounds

Organometallic zinc derivatives

031

Gallium compounds

032

Germanium compounds

033

Arsenic compounds

034

Selenium compounds

035

Bromine compounds

036

Krypton compounds

037

Rubidium compounds

038

Strontium compounds

039

Yttrium compounds

040

Zirconium compounds

041

Niobium compounds

042

Molybdenum compounds

043

Technetium compounds

044

Ruthenium compounds

045

Rhodium compounds

046

Palladium compounds

047

Silver compounds

048

Cadmium compounds

049

Indium compounds

050

Tin compounds

Organometallic tin derivatives

051

Antimony compounds

052

Tellurium compounds

053

Iodine compounds

054

Xenon compounds

055

Caesium compounds

056

Barium compounds

057

Lanthanum compounds

058

Cerium compounds

059

Praseodymium compounds

060

Neodymium compounds

061

Promethium compounds

062

Samarium compounds

063

Europium compounds

064

Gandolinium compounds

065

Terbium compounds

066

Dysprosium compounds

067

Holmium compounds

068

Erbium compounds

069

Thulium compounds

070

Ytterbium compounds

071

Lutetium compounds

072

Hafnium compounds

073

Tantalum compounds

074

Tungsten compounds

075

Rhenium compounds

076

Osmium compounds

077

Iridium compounds

078

Platinum compounds

079

Gold compounds

080

Mercury compounds

Organometallic mercury derivatives

081

Thallium compounds

082

Lead compounds

Organometallic lead derivatives

083

Bismuth compounds

084

Polonium compounds

085

Astate compounds

086

Radon compounds

087

Francium compounds

088

Radium compounds

089

Actinium compounds

090

Thorium compounds

091

Protactinium compounds

092

Uranium compounds

093

Neptunium compounds

094

Plutonium compounds

095

Americium compounds

096

Curium compounds

097

Berkelium compounds

098

Californium compounds

099

Einsteinium compounds

100

Fermium compounds

101

Mendelevium compounds

102

Nobelium compounds

103

Lawrencium compounds

601

Hydrocarbons

Aliphatic hydrocarbons

Aromatic hydrocarbons

Alicyclic hydrocarbons

Polycyclic aromatic hydrocarbons (PAH)

602

Halogenated hydrocarbons (*)

Halogenated aliphatic hydrocarbons (*)

Halogenated aromatic hydrocarbons (*)

Halogenated alicyclic hydrocarbons (*)

(*) Specify according to the family corresponding to halogen.

603

Alcohols and derivatives

Aliphatic alcohols

Aromatic alcohols

Alicyclic alcohols

Alcanolamines

Epoxy derivatives

Ethers

Glycolethers

Glycols and polyols

604

Phenols and derivatives

Halogenated phenol derivatives (*)

(*) Specify according to the family corresponding to halogen.

605

Aldehydes and derivatives

Aliphatic aldehydes

Aromatic aldehydes

Alicyclic aldehydes

Aliphatic acetals

Aromatic acetals

Alicyclic acetals

606

Ketones and derivatives

Aliphatic ketones

Aromatic ketones (*)

Alicyclic ketones

(*) Quinones included.

607

Organic acids and derivatives

Aliphatic acids

Halogenated aliphatic acids (*)

Aromatic acids

Halogenated aromatic acids (*)

Alicyclic acids

Halogenated alicyclic acids (*)

Aliphatic acid anhydrides

Halogenated aliphatic acid anhydrides (*)

Aromatic acid anhydrides

Halogenated aromatic acid anhydrides (*)

Alicyclic acid anhydrides

Halogenated alicyclic acid anhydrides (*)

Salts of aliphatic acid

Salts of halogenated aliphatic acid (*)

Salts of aromatic acid

Salts of halogenated aromatic acid (*)

Salts of alicyclic acid

Salts of halogenated alicyclic acid (*)

Esters of aliphatic acid

Esters of halogenated alicyclic acid (*)

Esters of aromatic acid

Esters of halogenated aromatic acid (*)

Esters of alicyclic acid

Esters of halogenated alicyclic acid (*)

Esters of glycol ether

Acrylates

Methacrylates

Lactones

Acyl halogenides

(*) Specify according to the family corresponding to halogen.

608

Nitriles and derivatives

609

Nitro compounds

610

Chlornitrated compounds

611

Azoxy and azo compounds

612

Amine compounds

Aliphatic amines and derivatives

Alicyclic amines and derivatives

Aromatic amines and derivatives

Aniline and derivatives

Benzidine and derivatives

613

Heterocyclic bases and derivatives

Benzimidazole and derivatives

Imidazol and derivatives

Pyrethrinoids

Quinoline and derivatives

Triazine and derivatives

Triazole and derivatives

614

Glycosides and alkaloids

Alkaloid and derivatives

Glycosides and derivatives

615

Cyanates and isocyanates

Cyanates

Isocyanates

616

Amides and derivatives

Acetamide and derivatives

Anilides

617

Organic peroxides

647

Enzymes

648

Complex coal derivatives

Acid extract

Alkaline extract

Anthracene oil

Anthracene oil extract residue

Anthracene oil fraction

Carbolic oil

Carbolic oil extract residue

Coal liquids, liquid solvent extraction

Coal liquids, liquid solvent extraction solvents

Coal oil

Coal tar

Coal tar extract

Coal tar solids residue

Coke (coal tar) low temperature, high temperature pitch

Coke (coal tar), high temperature pitch

Coke (coal tar), mixed coal high temperature pitch

Crude benzole

Crude phenols

Crude tar bases

Distillate bases

Distillate phenols

Distillates

Distillates (coal), liquid solvent extraction, primary

Distillates (coal), solvent extraction, hydrocracked

Distillates (coal), solvent extraction, hydrocracked hydrogenated middle

Distillates (coal), solvent extraction, hydrocracked middle

Extract residues (coal), low temperature coal tar alkaline

Fresh oil

Fuels, diesel, coal solvent extraction, hydrocracked, hydrogenated

Fuels, jet aircraft, coal solvent extraction, hydrocracked, hydrogenated

Gasoline, coal solvent extraction, hydrocracked naphtha

Heat treatment products

Heavy anthracene oil

Heavy anthracene oil redistillate

Light oil

Light oil extract residues, high boiling

Light oil extract residues, intermediate boiling

Light oil extract residues, low boiling

Light oil redistillate, high boiling

Light oil redistillate, intermediate boiling

Light oil redistillate, low boiling

Methylnaphthalene oil

Methylnaphthalene oil extract residue

Naphtha (coal), solvent extraction, hydrocracked

Naphthalene oil

Naphthalene oil extract residue

Naphthalene oil redistillate

Pitch

Pitch redistillate

Pitch residue

Pitch residue, heat treated

Pitch residue, oxidised

Pyrolysis products

Redistillates

Residues (coal), liquid solvent extractions

Tar brown coal

Tar brown coal, low temperature

Tar oil, high boiling

Tar oil, intermediate boiling

Wash oil

Wash oil extract residue

Wash oil redistillate

649

Complex oil derivatives

Crude oil

Petroleum gas

Low boiling point naphtha

Low boiling point modified naphtha

Low boiling point cat-cracked naphtha

Low boiling point cat-reformed naphtha

Low boiling point thermally cracked naphtha

Low boiling point hydrogen treated naphtha

Low boiling point naphtha ‐ unspecified

Straight-run kerosine

Kerosine ‐ unspecified

Cracked gas oil

Gas oil ‐ unspecified

Heavy fuel oil

Grease

Unrefined or mildly refined base oil

Base oil ‐ unspecified

Distillate aromatic extract

Distillate aromatic extract (treated)

Foots oil

Slack wax

Petrolatum

650

Various substances

Do not use this family. Instead, use the families or sub-families mentioned above.

4.  Practical application:

After having conducted a search to see if the substance belongs to one or more families or sub-families on the list, the generic name can be established in the following way:

4.1.  If the name of a family or sub-family is sufficient to characterise the chemical elements or important functional groups, this name will be chosen as the generic name.

Examples:

   1,4 dihydroxybenzen

family 604

:

phenols and derivatives

generic name

:

phenol derivatives

   – butanol

family 603

:

alcohols and derivatives

sub-family

:

aliphatic alcohols

generic name

:

aliphatic alcohol

   – 2-Isopropoxyethanol

family 603

:

alcohols and derivatives

sub-family

:

glycolethers

generic name

:

glycolether

   – methacrylate

family 607

:

organic acids and derivatives

sub-family

:

acrylates

generic name

:

acrylate

4.2.  If the name of a family or sub-family is not sufficient to characterise the chemical elements of important functional groups, the generic name will be a combination of the corresponding different family or sub-family names:

Examples:

   chlorobenzene

family 602

:

halogenated hydrocarbons

sub-family

:

halogenated aromatic hydrocarbons

family 017

:

chlorine compounds

generic name

:

chlorinated aromatic hydrocarbon

   – 2,3,6-trichlorophenylacetic acid

family 607

:

organic acids

sub-family

:

halogenated aromatic acids

family 017

:

chlorine compounds

generic name

:

chlorinated aromatic acid

   – 1-chloro-1-nitropropane

family 610

:

chloronitrated derivatives

family 601

:

hydrocarbons

sub-family

:

aliphatic hydrocarbons

generic name

:

chlorinated aliphatic hydrocarbon

   – tetrapropyl dithiopyrophosphate

family 015

:

phosphorus compounds

sub-family

:

phosphoric esters

family 016

:

sulphur compounds

generic name

:

thiophosphoric ester

     NB: In the case of certain elements, notably metals, the name of the family or sub-family may be indicated by the words‘organic’ or ’inorganic’.

Examples:

   dimercury chloride

family 080

:

mercury compounds

generic name

:

inorganic mercury compound

   – barium acetate

family 056

:

barium compounds

generic name

:

organic barium compound

   – ethyl nitrite

family 007

:

nitrogen compounds

sub-family

:

nitrites

generic name

:

organic nitrite

   – sodium hydrosulphite

family 016

:

sulphur compounds

generic name

:

inorganic sulphur compound

  

(The examples cited are substances taken from 3 Part 3 of Annex VI to Regulation (EC) No 1272/2008  in respect of which requests for confidentiality may be submitted).

ANNEX VII

PREPARATIONS COVERED BY ARTICLE 12(2)

Preparations as specified by point 9.3 of Annex VI to Directive 67/548/EEC.

ANNEX VIII

Part A

Repealed Directive with list of its successive amendments

(referred to in Article 22)

Directive 1999/45/EC of

the European Parliament and of the Council

(OJ L 200, 30.7.1999, p. 1)

Commission Directive 2001/60/EC

(OJ L 226, 22.8.2001, p. 5)

Regulation (EC) No 1882/2003 of

the European Parliament and of the Council

(OJ L 284, 31.10.2003, p. 1)

Only point 90 of Annex III

Council Directive 2004/66/EC

(OJ L 168, 1.5.2004, p. 35)

Only as regards the reference to Directive 1999/45/EC in Article 1 and point I.B of the Annex

Commission Directive 2006/8/EC

(OJ L 19, 24.1.2006, p. 12)

Council Directive 2006/96/EC

(OJ L 363, 20.12.2006, p. 81)

Only as regards the reference to Directive 1999/45/EC in Article 1 and section G of the Annex

Regulation (EC) No 1907/2006 of

the European Parliament and of the Council

(OJ L 396, 30.12.2006, p. 1)

Only Article 140

Regulation (EC) No 1137/2008 of

the European Parliament and of the Council

(OJ L 311, 21.11.2008, p. 1)

Only point 3.5 of the Annex

Regulation (EC) No 1272/2008 of

the European Parliament and of the Council

(OJ L 353, 31.12.2008, p. 1)

Only Article 56

Part B

List of time-limits for transposition into national law

(referred to in Article 22)

Directive

Time-limit for transposition

1999/45/EC

30 July 2002

2001/60/EC

30 July 2002

2004/66/EC

1 May 2004

2006/8/EC

1 March 2007

2006/96/EC

1 January 2007

ANNEX IX

Correlation Table

Directive 1999/45/EC

This Directive

Article 1(1), introductory wording

Article 1(1)

Article 1(1), first indent

Article 1(1)

Article 1(1), second indent

Article 1(1)

Article 1(1), last wording

Article 1(1)

Article 1(2), introductory wording

Article 1(2), introductory wording

Article 1(2), first indent

Article 1(2)(a)

Article 1(2), second indent

Article 1(2)(b)

Article 1(3), introductory wording

Article 1(3)

Article 1(3), first indent

Article 1(3)

Article 1(3), second indent

Article 1(3)

Article 1(3), third indent

Article 1(3), last wording

Article 1(3)

Article 1(4)

Article 1(4)

Article 1(5)

Article 1(5)

Article 1(6), introductory wording

Article 1(6), introductory wording

Article 1(6), first indent

Article 1(6)(a)

Article 1(6), second indent

Article 1(6)(b)

Article 2(1), introductory wording

Article 2(1), introductory wording

Article 2(1)(a), (b) and (c)

Article 2(1)(a), (b) and (c)

Article 2(1)(d)

Article 2(1)(e)

Article 2(1)(d)

Article 2(1)(f)

Article 2(1)(e)

Article 2(1)(g)

Article 2(1)(f)

Article 2(1)(h)

Article 2(1)(g)

Article 2(2), introductory wording

Article 2(2), introductory wording

Article 2(2)(a), (b) and (c)

Article 2(2)(a), (b) and (c)

Article 2(2)(d), introductory wording

Article 2(2)(d), introductory wording

Article 2(2)(d), first indent

Article 2(2)(d)(i)

Article 2(2)(d), second indent

Article 2(2)(d)(ii)

Article 2(2)(d), third indent

Article 2(2)(d)(iii)

Article 2(2)(d), fourth indent

Article 2(2)(d)(iv)

Article 2(2)(e) to (o)

Article 2(2)(e) to (o)

Article 3(1), first subparagraph, introductory wording

Article 3(1), first subparagraph, introductory wording

Article 3(1), first subparagraph, first indent

Article 3(1), first subparagraph, point (a)

Article 3(1), first subparagraph, second indent

Article 3(1), first subparagraph, point (b)

Article 3(1), first subparagraph, third indent

Article 3(1), first subparagraph, point (c)

Article 3(1), second and third subparagraphs

Article 3(1), second and third subparagraphs

Article 3(2), introductory wording

Article 3(2), introductory wording

Article 3(2), first indent

Article 3(2)(a)

Article 3(2), second indent

Article 3(2), third indent

Article 3(2)(b)

Article 3(2), fourth indent

Article 3(2), fifth indent

Article 3(2), sixth indent

Article 3(2), last wording

Article 3(2), introductory wording

Article 3(3)

Article 3(3)

Article 4

Article 4

Article 5(1)

Article 5(1)

Article 5(2), first introductory wording

Article 5(2), introductory wording

Article 5(2), second introductory wording

Article 5(2), introductory wording

Article 5(2), first indent

Article 5(2)(a)

Article 5(2), second indent

Article 5(2)(b)

Article 5(2), third indent

Article 5(2)(c)

Article 5(3), (4) and (5)

Article 5(3), (4) and (5)

Article 6(1) and (2)

Article 6(1) and (2)

Article 6(3), introductory wording

Article 6(3), introductory wording

Article 6(3), first indent, first part

Article 6(3), introductory wording

Article 6(3), first indent, second part

Article 6(3), first indent

Article 6(3), second indent

Article 6(3), second indent

Article 6(3), third indent

Article 6(3), third indent

Article 6(4)

Article 6(4)

Article 7

Article 7

Article 8(1) and (2)

Article 8(1) and (2)

Article 8(3), introductory wording

Article 8(3), introductory wording

Article 8(3), first indent

Article 8(3)(a)

Article 8(3), second indent

Article 8(3)(b)

Article 8(3), third indent

Article 8(3)(c)

Article 8(4)

Article 8(4)

Article 9, point 1, introductory wording

Article 9(1), first subparagraph, introductory wording

Article 9, point 1.1, introductory wording

Article 9(1), first subparagraph, point (a), introductory wording

Article 9, point 1.1, first indent

Article 9(1), first subparagraph, point (a)(i)

Article 9, point 1.1, second indent

Article 9(1), first subparagraph, point (a)(ii)

Article 9, point 1.1, third indent

Article 9(1), first subparagraph, point (a)(iii)

Article 9, point 1.1, fourth indent

Article 9(1), first subparagraph, point (a)(iv)

Article 9, point 1.2, introductory wording

Article 9(1), first subparagraph, point (b), introductory wording

Article 9, point 1.2, first indent

Article 9(1), first subparagraph, point (b)(i)

Article 9, point 1.2, second indent

Article 9(1), first subparagraph, point (b)(ii)

Article 9, point 1.3, first subparagraph, introductory wording

Article 9(1), first subparagraph, point (c), introductory wording

Article 9, point 1.3, first subparagraph, first indent

Article 9(1), first subparagraph, point (c)(i)

Article 9, point 1.3, first subparagraph, second indent

Article 9(1), first subparagraph, point (c)(ii)

Article 9, point 1.3, second subparagraph

Article 9(1), second subparagraph

Article 9(2)

Article 9(2)

Article 10, point 1.1, introductory wording

Article 10(1), introductory wording

Article 10, point 1.1(a)

Article 10(1)(a)

Article 10, point 1.1(b)

Article 10(1)(b)

Article 10, point 1.2

Article 10(2)

Article 10, point 2, introductory wording

Article 10(3), introductory wording

Article 10, point 2.1

Article 10(3)(a)

Article 10, point 2.2

Article 10(3)(b)

Article 10, point 2.3, introductory wording

Article 10(3)(c), introductory wording

Article 10, point 2.3.1

Article 10(3)(c)(i)

Article 10, point 2.3.2

Article 10(3)(c)(ii)

Article 10, point 2.3.3, first subparagraph, introductory wording

Article 10(3)(c)(iii), first subparagraph, introductory wording

Article 10, point 2.3.3, first subparagraph, first indent

Article 10(3)(c)(iii), first subparagraph, first indent

Article 10, point 2.3.3, first subparagraph, second indent

Article 10(3)(c)(iii), first subparagraph, second indent

Article 10, point 2.3.3, first subparagraph, third indent

Article 10(3)(c)(iii), first subparagraph, third indent

Article 10, point 2.3.3, first subparagraph, fourth indent

Article 10(3)(c)(iii), first subparagraph, fourth indent

Article 10, point 2.3.3, first subparagraph, fifth indent

Article 10(3)(c)(iii), first subparagraph, fifth indent

Article 10, point 2.3.3, first subparagraph, sixth indent

Article 10(3)(c)(iii), first subparagraph, sixth indent

Article 10, point 2.3.3, first subparagraph, last wording

Article 10(3)(c)(iii), first subparagraph, introductory wording

Article 10, point 2.3.3, second subparagraph

Article 10(3)(c)(iii), second subparagraph

Article 10, point 2.3.4, introductory wording

Article 10(3)(c)(iv), introductory wording

Article 10, point 2.3.4, first indent

Article 10(3)(c)(iv), first indent

Article 10, point 2.3.4, second indent

Article 10(3)(c)(iv), second indent

Article 10, point 2.3.4, third indent

Article 10(3)(c)(iv), third indent

Article 10, point 2.3.4, fourth indent

Article 10(3)(c)(iv), fourth indent

Article 10, point 2.3.4, fifth indent

Article 10(3)(c)(iv), fifth indent

Article 10, point 2.3.4, sixth indent

Article 10(3)(c)(iv), sixth indent

Article 10, point 2.3.4, seventh indent

Article 10(3)(c)(iv), seventh indent

Article 10, point 2.3.4, last wording

Article 10(3)(c)(iv), introductory wording

Article 10, point 2.3.5

Article 10(3)(c)(v)

Article 10, point 2.4, first subparagraph

Article 10(3)(d), first subparagraph

Article 10, point 2.4, second subparagraph, introductory wording

Article 10(3)(d), second subparagraph, introductory wording

Article 10, point 2.4, second subparagraph, first indent

Article 10(3)(d), second subparagraph, point (i)

Article 10, point 2.4, second subparagraph, second indent

Article 10(3)(d), second subparagraph, point (ii)

Article 10, point 2.4, second subparagraph, third indent

Article 10(3)(d), second subparagraph, point (iii)

Article 10, point 2.4, second subparagraph, fourth indent

Article 10(3)(d), second subparagraph, point (iv)

Article 10, point 2.4, third subparagraph

Article 10(3)(d), third subparagraph

Article 10, point 2.5

Article 10(3)(e)

Article 10, point 2.6

Article 10(3)(f)

Article 10, point 2.7

Article 10(3)(g)

Article 10, point 3

Article 10(4)

Article 10, point 4, introductory wording

Article 10(5), introductory wording

Article 10, point 4, first indent

Article 10(5)(a)

Article 10, point 4, second indent

Article 10(5)(b)

Article 10, point 5

Article 10(6)

Article 11(1) to (5)

Article 11(1) to (5)

Article 11(6), introductory wording

Article 11(6), introductory wording

Article 11(6)(a)

Article 11(6)(a)

Article 11(6)(b), first subparagraph, introductory wording

Article 11(6)(b), first subparagraph, introductory wording

Article 11(6)(b), first subparagraph, first indent

Article 11(6)(b), first subparagraph, point (i)

Article 11(6)(b), first subparagraph, second indent

Article 11(6)(b), first subparagraph, point (ii)

Article 11(6)(b), second subparagraph

Article 11(6)(b), second subparagraph

Articles 12 and 13

Articles 12 and 13

Article 15

Article 14, first to fifth paragraphs

Article 14, sixth paragraph

Article 16

Article 15

Article 17

Article 16

Article 18

Article 17

Article 19

Article 18

Article 20

Article 19

Article 20a(1) and (2)

Article 21

Article 20a(3)

Article 20

Article 22

Article 21

Article 22

Article 23

Article 23

Article 24

Article 24

Annex I–VII

Annex I–VII

Annex VIII

Annex IX

Annex VIII

Annex IX

(1) OJ C 181, 21.6.2012, p. 203.
(2) OJ C 77, 28.3.2002, p. 1.
(3) OJ C 181, 21.6.2012, p. 203.
(4) Position of the European Parliament of 16 January 2013.
(5) OJ L 200, 30.7.1999, p. 1.
(6) See Annex VIII, Part A.
(7) OJ L 276, 20.10.2010, p. 33.
(8) OJ L 396, 30.12.2006, p. 1.
(9) OJ L 309, 24.11.2009, p. 1.
(10) OJ L 123, 24.4.1998, p. 1.
(11) OJ 196, 16.8.1967, p. 1.
(12) OJ L 396, 30.12.2006, p. 850.
(13) OJ L 353, 31.12.2008, p. 1.
(14) OJ L 225, 21.8.2001, p. 1.
(15) OJ L 355, 30.12.1998, p. 1.
(16) OJ L 154, 5.6.1992, p. 1.
(17) OJ L 110, 4.5.1993, p. 20.
(18) OJ L 55, 28.2.2011, p. 13.
(19) OJ L 311, 28.11.2001, p. 1.
(20) OJ L 311, 28.11.2001, p. 67.
(21) OJ L 262, 27.9.1976, p. 169.
(22) OJ L 312, 22.11.2008, p. 3.
(23) OJ L 159, 29.6.1996, p. 1.
(24) OJ L 142, 31.5.2008, p. 1.
(25) OJ L 147, 9.6.1975, p. 40.
(26) OJ L 155, 11.6.2011, p. 1.
(27) OJ L 155, 11.6.2011, p. 67.
(28) OJ L 50, 20.2.2004, p. 44.
(29) OJ L 155, 11.6.2011, p. 176.
(30) OJ L 144, 4.6.1997, p. 19.
(31)* Date of entry into force of this Directive.


Sustainable exploitation of fishery resources in the Mediterranean Sea ***I
PDF 327kWORD 28k
Resolution
Consolidated text
European Parliament legislative resolution of 16 January 2013 on the proposal for a regulation of the European Parliament and of the Council amending Council Regulation (EC) No 1967/2006 concerning management measures for the sustainable exploitation of fishery resources in the Mediterranean Sea (COM(2011)0479 – C7-0216/2011 – 2011/0218(COD))
P7_TA(2013)0009A7-0180/2012

(Ordinary legislative procedure: first reading)

The European Parliament,

–  having regard to the Commission proposal to Parliament and the Council (COM(2011)0479),

–  having regard to Article 294(2) and Article 43(2) of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C7-0216/2011),

–  having regard to Article 294(3) of the Treaty on the Functioning of the European Union,

–  having regard to the opinion of the European Economic and Social Committee of 7 December 2011(1),

–  having regard to Rule 55 of its Rules of Procedure,

–  having regard to the report of the Committee on Fisheries (A7-0180/2012),

1.  Adopts its position at first reading hereinafter set out;

2.  Calls on the Commission to refer the matter to Parliament again if it intends to amend its proposal substantially or replace it with another text;

3.  Instructs its President to forward its position to the Council, the Commission and the national parliaments.

Position of the European Parliament adopted at first reading on 16 January 2013 with a view to the adoption of Regulation (EU) No .../2013 of the European Parliament and of the Council amending Council Regulation (EC) No 1967/2006 concerning management measures for the sustainable exploitation of fishery resources in the Mediterranean Sea

P7_TC1-COD(2011)0218


THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 43(2) thereof,

Having regard to the proposal from the European Commission,

After transmission of the draft legislative act to the national parliaments,

Having regard to the opinion of the European Economic and Social Committee(2),

Acting in accordance with the ordinary legislative procedure(3),

Whereas:

(-1)  In order to reflect the changes brought about by the entry into force of the Lisbon Treaty, it is necessary to carry out a general alignment of Council Regulation (EC) No 1967/2006(4). [Am. 2]

(1)  Regulation (EC) No 1967/2006 confers powers upon the Commission in order to implement some of its provisions.

(2)  The powers conferred under Regulation (EC) No 1967/2006 upon the Commission need to be aligned to Article 290 of the Treaty on the Functioning of the European Union (TFEU).

(3)  In order to apply some of the provisionssupplement or amend certain non-essential elements of Regulation (EC) No 1967/2006, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of the following: [Am. 3]

   the granting of derogations where they are specifically provided for in that Regulation;
   the designation of a fishing protected area in a Member State's territorial waters or the laying down of fisheries management measures in respect of the waters concerned if the Member State's fisheries management measures are not sufficient to ensure a high level of protection of resources and of the environment; [Am. 4]
   the decision to confirm, cancel or amend a designation of a fishing protected area that is liable to affect the vessels of another Member State; [Am. 5]
   the amendment of the derogation which authorises the use of trawl nets; [Am. 6]
   the amendment of a Member State's management plan if that management plan is not sufficient to ensure a high level of protection of resources and of the environment; [Am. 7]
   the decision to confirm, cancel or amend a Member State’s management plan that is liable to affect the vessels of another Member State; [Am. 8]
   the distribution of the surplus of available fishing capacity between the Member States in the 25-mile management zone around Malta, and [Am. 9]
   the setting of criteria to be applied for the establishment and allocation of fish aggregating devices (FAD) course lines for dolphin fish fishery in the 25-mile management zone around Malta.
   the adoption of detailed rules for further technical specifications of square mesh panels to be inserted into towed nets; [Am. 10]
   the adoption of technical specifications limiting the maximum dimension of float line, ground rope, circumference or perimeter of trawl nets along with the maximum number of nets in multi-rig trawl nets, and [Am. 11]
   the amendments to the Annexes to Regulation (EC) No 1967/2006. [Am. 12]
  

It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing-up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and Council.

(5)  The reference to seagrass beds of Posidonia oceanica should be clarified.

(6)  Further technical and scientific information is needed to duly take into account the specificities of the Mediterranean fisheries to enable the Commission to establish possible technical specifications limiting the maximum dimension of trawl nets and the maximum number of nets in multi-rig trawl nets, as mentioned above; [Am. 13]

(6a)  The conservation of fishery resources in the Mediterranean Sea is of particular importance and should therefore be mentioned in the title of Regulation (EC) No 1967/2006. [Am. 14]

(7)  Regulation (EC) No 1967/2006 should therefore be amended accordingly,

HAVE ADOPTED THIS REGULATION:

Article 1

Regulation (EC) No 1967/2006 is amended as follows:

(-1)  The title is replaced by the following:"

Council Regulation (EC) No 1967/2006 concerning management measures for the conservation and sustainable exploitation of fishery resources in the Mediterranean Sea

"

[Am. 1]

(1)  In Article 4(5), the introductory phrase is replaced by the following:"

5.  By way of derogation from subparagraph 1 of paragraph 1, the Commission shall be empowered to adopt delegated acts accordance with Article 30a, authorising fishing by vessels of less than or equal to 12 metres overall length and engine power of less than or equal to 85 kW with bottom towed nets traditionally undertaken above seagrass beds of the type Posidonia oceanica, provided that:

"

(1a)  In Article 6, paragraph 2 is replaced by the following:"

2.  After the period laid down in paragraph 1 and until 30 November 2009, the Council may designate additional fishing protected areas, or change their delimitation and management rules established therein, on the basis of new relevant scientific information.

From 1 December 2009, the European Parliament and the Council, acting in accordance with the ordinary legislative procedure, on a proposal from the Commission, shall designate additional fishing protected areas, or change their delimitation and management rules established therein, on the basis of new relevant scientific information.“

[Am. 15]

(1b)  Article 7 is amended as follows:

   (a) paragraph 4 is replaced by the following:

“4.  If the Commission considers that the fisheries management measures notified pursuant to paragraph 3 are not sufficient to ensure a high level of protection of resources and the environment, it may, after consulting the Member State concerned, request it to amend the measure within three months from the date of notification of the request.

If the Commission considers that the Member State's fisheries management measures have not been changed, or have been amended inappropriately, and are still not sufficient to ensure a high level of protection of resources and of the environment, it shall be empowered to adopt delegated acts, in accordance with Article 30a, designating a fishing protected area or laying down fisheries management measures in respect of the waters concerned.

"

   (b) paragraph 5 is replaced by the following:"
5.  Where a Member State proposes to designate a fishing protected area within its territorial waters that is liable to affect the vessels of another Member State, it shall notify the Commission, that other Member State and the Regional Advisory Council concerned, before adopting that designation.
The Member States and the Regional Advisory Council concerned may submit their written comments to the Commission on the proposed designation within 30 working days from the date of notification of the proposed designation.
After considering any such comments submitted, the Commission shall be empowered to adopt delegated acts, in accordance with Article 30a, that confirm, cancel or amend the designation within 60 working days from that date of notification of the proposed designation.“

[Am. 16]


(2)  Article 13 is amended as follows:
   (a) paragraph 5 is replaced by the following:

“5.  Member States may request a derogation from paragraphs 1, 2 and 3. The Commission shall be empowered to adopt delegated acts in accordance with Article 30a, allowing such derogations on condition that they are justified by specific geographical features of the sea areas concerned, such as the limited size of continental shelf along the entire coastline of a Member State or the limited extent of trawlable fishing grounds, where the fisheries have no significant impact on the marine environment and affect a determined group of vessels of the Member State or, as the case may be, of other Member States, and provided that those fisheries cannot be undertaken with another gear and are subject to a management plan as referred to in Articles 18 or 19. Member States shall provide up-to-date scientific and technical justifications for such derogations."
   (b) paragraph 10 is replaced by the following:"
10.  The Commission shall be empowered to adopt delegated acts in accordance with Article 30a allowing derogations from paragraphs 1 and 2, for fisheries benefiting from a derogation under Article 4(5)."
   (ba) in paragraph 11, subparagraph 4 is replaced by the following:"
If the Commission, on the basis of the notifications provided by Member States in accordance with subparagraphs 2 and 3, or of new scientific advice, considers that the conditions for a derogation are not met, it may, after having consulted the Member State concerned, request it to amend the derogation within three months from the date of the notification of the request. If the Commission considers that the Member State has not amended that derogation, or has amended it inappropriately, the Commission shall be empowered to adopt delegated acts, in accordance with Article 30a, amending that derogation in order to ensure the protection of resources and of the environment.

[Am. 17]


(2a)  In Article 14, paragraph 3 is deleted. [Am. 18]
(2b)  In the first subparagraph of Article 18(1), the introductory part is replaced by the following:
1.  The European Parliament and the Council, acting in accordance with the ordinary legislative procedure, on a proposal from the Commission, shall adopt management plans for specific Mediterranean fisheries, in particular, in areas totally or partially beyond the territorial waters of Member States. These plans may, in particular, include:

[Am. 19]


(2c)  Article 19 is amended as follows:
   (a) paragraph 8 is replaced by the following:

8.  If the Commission, on the basis of the notification referred to in paragraph 7 or of new scientific advice, considers that a management plan adopted under either paragraph 1 or paragraph 2 is not sufficient to ensure a high level of protection of resources and the environment, it may, after consulting the Member State concerned, request it to amend the plan within three months from the date of notification of the request.
If the Commission considers that the Member State's management plan has not been changed, or has been amended inappropriately, and that it is still not sufficient to ensure a high level of protection of resources and of the environment, it shall be empowered to adopt delegated acts, in accordance with Article 30a, amending the management plan in order to ensure the protection of the resources and of the environment."
   (b) paragraph 9 is replaced by the following:"
9.  Where a Member State proposes to adopt a management plan that is liable to affect the vessels of another Member State, it shall notify the Commission, that other Member State and the Regional Advisory Council concerned, before adopting that management plan.
The Member States and the Regional Advisory Council concerned may submit their written comments to the Commission on the proposed management plan within 30 working days from the date of notification of the proposed adoption.
After considering any such comments submitted, the Commission shall be empowered to adopt delegated acts, in accordance with Article 30a, that confirm, cancel or amend the plan within 60 working days from that date of notification of the proposed management plan.

[Am. 20]


(3)  In Article 26(3), the first subparagraph is replaced by the following:
3.  If the overall fishing capacity referred to in paragraph 2(a) exceeds the overall fishing capacity of trawlers with an overall length equal to, or less than, 24 metres and operating in the management zone in the reference period 2000-2001 (“the reference fishing capacity”), the Commission shall adopt delegated acts in accordance with Article 30a, distributing that surplus of available fishing capacity between the Member States taking into account the interest of the Member States requesting an authorisation."

(4)  In Article 27(3) the second subparagraph is replaced by the following:"

The Commission shall adopt delegated acts in accordance with Article 30a, establishing the criteria to be applied for the establishment and allocation of FAD course lines.

"

(4a)  Article 28 is deleted. [Am. 21]

(4b)  Article 29 is deleted. [Am. 22]

(5)  Article 30 is replaced by the following:deleted.

‘The Annexes shall be amended by means of delegated acts adopted in accordance with Article 30a.’

[Am. 23]

(6)  The following Article is inserted:"

Article 30a

Exercise of the delegation

1.  The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.

2.  The delegation of powerspower to adopt delegated acts referred to in Articles 4(5), 7(4) and (5), 13(5) and (10), the fourth subparagraph of Article 13(11), Article 19(8) and (9), the first subparagraph of Article 26(3),and the second subparagraph of Article 27(3), Article 30, Annex I(B)(3) and Annex II(7) shall be conferred on the Commission for aan indeterminate period of timethree years from the date of the entry into force of this Regulation ...(5). The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the three-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period. [Am. 24]

3.  The delegation of powers referred to in Articles 4(5), 7(4) and (5), 13(5) and (10), the fourth subparagraph of Article 13(11), Article 19(8) and (9), the first subparagraph of 26(3) and the second subparagraph of 27(3), Article 30, Annex I(B)(3) and Annex II(7) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.

4.  As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.

5.  A delegated act adopted pursuant to Articles 4(5), 7(4) and (5), 13(5) and (10), the fourth subparagraph of Article 13(11), Article 19(8) and (9), the first subparagraph of Article 26(3) and the second subparagraph of Article 27(3), Article 30, Annex I(B)(3) and Annex II(7) shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of 2 months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by 2 months at the initiative of the European Parliament or of the Council.

"

(7)  In Annex I, section (B) is amended as follows:

[Am. 25]

[Am. 27]

   (a) point 3 is replaced by the following:"
3.  Square mesh panels may be inserted into any towed net and shall be placed in front of any extension piece or at any point between the front of any extension piece and the posterior of the cod-end. It shall not be obstructed in any way by either internal or external attachments. It shall be constructed of knotless netting or of netting constructed with non-slip knots, and shall be inserted in such a way that the meshes remain fully open at all times while fishing. Detailed rules for further technical specifications of square mesh panels shall be established by means of delegated acts adopted in accordance with Article 30a ."
   (b) point 4 is deleted; [Am. 26]
   (c) point 5 is replaced by the following:"
5.  The carrying on board or the use of any towed net the cod-end of which is constructed wholly or in part of any type of netting material made of meshes other than square mesh or diamond mesh shall be prohibited."

(8)  In Annex II, point 7 is replaced by the following:deleted.

‘7.  Technical specifications limiting the maximum dimension of floatline, groundrope, circumference or perimeter of trawl nets along with the maximum number of nets in multi-rig trawl nets may be established by the Commission by means of delegated acts adopted in accordance with Article 30a.‘

[Am. 28]

Article 2

This Regulation shall enter into force on the third day following that of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at ...,

For the European Parliament

The President

The President

For the Council

(1) OJ C 43, 15.2.2012, p. 56.
(2) OJ C 43, 15.2.2012, p. 56.
(3) Position of the European Parliament of 16 January 2013.
(4) OJ L 409, 30.12.2006, p. 11.
(5)* Date of entry into force of this Regulation.


Conclusion of the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress to the Cartagena Protocol on Biosafety ***
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European Parliament legislative resolution of 16 January 2013 on the draft Council decision on the conclusion on behalf of the European Union of the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress to the Cartagena Protocol on Biosafety (13582/2012 – C7-0323/2012 – 2012/0120(NLE))
P7_TA(2013)0010A7-0429/2012

(Consent)

The European Parliament,

–  having regard to the draft Council decision (13582/2012),

–  having regard to the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress to the Cartagena Protocol on Biosafety adopted on 15 October 2010 at the final plenary of the fifth Conference of the Parties serving as the Meeting of the Parties (COP/MOP 5) in Nagoya and signed by the Union on 11 May 2011 (13583/2012),

–  having regard to the request for consent submitted by the Council in accordance with Article 192 and Article 218(6), second subparagraph, point (a), of the Treaty on the Functioning of the European Union (C7-0323/2012),

–  having regard to Rules 81 and 90(7) of its Rules of Procedure,

–  having regard to the recommendation of the Committee on the Environment, Public Health and Food Safety (A7-0429/2012),

1.  Consents to conclusion of the Protocol;

2.  Instructs its President to forward its position to the Council, the Commission and the governments and parliaments of the Member States.


Public finances in EMU - 2011 and 2012
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European Parliament resolution of 16 January 2013 on Public Finances in EMU – 2011 and 2012 (2011/2274(INI))
P7_TA(2013)0011A7-0425/2012

The European Parliament,

–  having regard to the Commission’s 2011 report on public finances in EMU(1),

–  having regard to the Commission’s 2012 report on public finances in EMU(2),

–  having regard to the Treaty on the Functioning of the European Union, and in particular Article 136 in combination with Article 121(2) thereof,

–  having regard to Regulation (EU) No 1175/2011 of the European Parliament and of the Council of 16 November 2011 amending Council Regulation (EC) No 1466/97 on the strengthening of the surveillance of budgetary positions and the surveillance and coordination of economic policies(3),

–  having regard to Council Directive 2011/85/EU of 8 November 2011 on requirements for budgetary frameworks of the Member States(4),

–  having regard to Regulation (EU) No 1174/2011 of the European Parliament and of the Council of 16 November 2011 on enforcement measures to correct excessive macroeconomic imbalances in the euro area(5),

–  having regard to Council Regulation (EU) No 1177/2011 of 8 November 2011 amending Regulation (EC) No 1467/97 on speeding up and clarifying the implementation of the excessive deficit procedure(6),

–  having regard to Regulation (EU) No 1176/2011 of the European Parliament and of the Council of 16 November 2011 on the prevention and correction of macroeconomic imbalances(7),

–  having regard to Regulation (EU) No 1173/2011 of the European Parliament and of the Council of 16 November 2011 on the effective enforcement of budgetary surveillance in the euro area(8),

–  having regard to Annex I to the European Council Conclusions of 24-25 March 2011 entitled ‘The Euro Plus Pact: Stronger economic policy coordination for competitiveness and convergence’(9),

–  having regards to the Conclusions of the European Council of 28-29 June 2012, and in particular its annex ‘Compact for growth and jobs’,

–  having regard to the Communication from the Commission of 23 November 2011 on the Annual Growth Survey 2012 (COM(2011)0815),

–  having regard to its resolution of 15 December 2011 on the Scoreboard for the surveillance of macroeconomic imbalances: envisaged initial design(10),

–  having regard to its resolution of 15 February 2012 on the contribution to the Annual Growth Survey 2012(11),

–  having regard to the IMF ‘World Economic Outlook’ of October 2012,

–  having regard to Rule 48 of its Rules of Procedure,

–  having regard to the report of the Committee on Economic and Monetary Affairs (A7-0425/2012),

A.  whereas the economic, financial and banking crisis has not abated and has demonstrated that public finances issues negatively affect socio-economic development and political stability;

B.  whereas the government debt-to-GDP ratio in the eurozone rose from 86,2 % in the first quarter of 2011 to 88,2 % in the first quarter of 2012;

C.  whereas the recent reforms of the economic and budgetary governance framework of the European Union cannot alone solve the crisis; whereas a comprehensive action is required for addressing excessive macro-financial imbalances in a symmetric manner and for increasing the level of overall socio-economic convergence and solidarity within the Economic and Monetary Union (EMU);

D.  whereas credible commitments to growth-friendly consolidation measures are a prerequisite for any sustainable solution of the excessive debt and deficit situation of most of the eurozone Member States;

E.  whereas significant steps have been taken in EU countries to consolidate public finances, but many challenges still remain when it comes to improving the situation; whereas the current severe economic downturn is a matter of concern as it threatens the substantial efforts made by the Member States regarding their budgetary consolidation strategies;

F.  whereas the Member States are not all in the same situation, and it is therefore necessary to implement sustainable growth-friendly strategies that are differentiated in line with the country-specific recommendations adopted by the Council and that reflect the country-specific fiscal and macro-financial risks as well as economic and social conditions;

G.  whereas the latest country specific recommendations focused disproportionately on the need to reduce wages and social security expenditure and to reform public pension frameworks; whereas their specific recommendations regarding other domains such as taxes on capital gains, consumption, real estate and polluting activities are, for the most part, given far too little weight;

H.  whereas, in particular, Member States benefiting from financial assistance programmes and those under close market scrutiny should implement credible long-term budgetary consolidation strategies; whereas negative spill-over effects across the EMU need urgently to be addressed so as to rebalance and calibrate the efforts required by all Member States to overcome the crisis;

I.  whereas democracies require intensive public scrutiny of all layers of decision-making bodies in charge of the economy and the relevant policies, as well as accountability and legitimacy mechanisms;

1.  Welcomes the projected improvement of the fiscal positions of EU Member States and the efforts they have made to reach their fiscal targets; deplores the foreseen protraction of the cyclical slow-down underway; points out that the current severe economic downturn is a matter of concern as it threatens the substantial efforts made by the Member States to consolidate their budgets;

2.  Considers that credible long-term strategies for budgetary consolidation remain a necessity, given the high level of public and private debt, and the budget deficits, in some Member States, and the difficulty they face in returning their public finances to a sustainable path, provoking strong pressures from financial markets; recalls that overall public deficits have hitherto been reduced thanks to strong consolidation efforts; notes that the Commission now foresees negative GDP growth for the EMU overall in 2013 and deteriorating fiscal balances in seven EMU Member States in 2013 or 2014; believes, therefore, that the continued need for intense fiscal adjustment needs to be balanced between strengthening sustainable growth, economic development as well as social protection;

3.  Is deeply concerned that, despite the reform and consolidation efforts of Member States, eurozone sovereign bond markets remain in distress, as reflected in high spreads and interest rate volatility; notes that the immediate trigger and root cause were the financial markets’ concerns about the solidity of public and private sector finances in some eurozone countries;

4.  Believes that the efforts towards improved coordination and fiscal consolidation will not bring the expected results if macroeconomic imbalances between Member States, and their consequences for the recovery process, are not addressed;

5.  Underlines that the long-term sustainability of public and private finances is an essential condition for growth and for maintaining appropriate levels of public expenditure, including investments; stresses that a high level of debt generates adverse effects – on health care, pensions, employment and equity among generations – as well as weak growth;

6.  Stresses that the high level of youth unemployment will damage economic growth in future too, and that Member States should therefore already now adopt concrete measures to reduce it;

7.  Encourages the Member States to follow the recommendations adopted by the Council on a recommendation by the Commission in line with the rules set by the Stability and Growth Pact, as modified by the ‘six-pack’ on economic governance’ in order to implement fiscal consolidation in a stronger, credible, timely and differentiated manner, taking into account country-specific circumstances; encourages the Council to revise these recommendations as necessary to take due account the macroeconomic environment;

8.  Invites the Member States to facilitate an agreement with Parliament with a view to adopting the ‘two-pack’ as soon as possible and no later than by the end of the year;

9.  Encourages the Commission to give both negative and positive feedback to Member States through explicit and detailed country-specific recommendations, and to acknowledge noteworthy efforts and best practices;

10.  Encourages the Commission to continue in its efforts to supplement its traditional sustainability analysis with alternative methodologies; invites the Commission to publish regularly indicators reflecting this sustainability analysis in the future releases of the ‘Public Finances in EMU’ reports and to release the assumptions on which their models are based when assessing the multiplier effect of public expenditure levels on GDP growth;

11.  Highlights the important role the Union budget must play in order successfully to reduce macroeconomic and social imbalances throughout the Union, and thereby restore the conditions for a sustainable monetary union;

12.  Welcomes the new focus on fiscal decentralisation in the Commission’s 2012 report on public finances in EMU, and suggests that a chapter on local and regional public finances be always included in future releases;

13.  Considers that budgetary consolidation can be implemented effectively, and can bring long-lasting positive effects, provided that the measures backing it are growth-friendly, so that they promote growth and job perspectives, and that they respect equity among citizens;

14.  Invites the Member States to put in place growth-oriented policies and reforms in line with the EU 2020 Strategy, having regard to social protection, social inclusion and public investment; recalls its demands on the need for making the labour market more flexible, in particular by: reducing labour taxation; optimising training schemes to stimulate older workers to stay in employment longer; reducing youth unemployment by better matching the qualifications of young people to labour demand; ensuring that wages keep in line with productivity; and shifting taxation away from labour, in particular regarding low income categories of workers, to environmentally harmful activities; invites the Member States to put in place innovation policies through investments aimed at improving productivity and aligning it with wage developments, and to create a more competitive business environment by: liberalising certain industries; removing unjustified restrictions on regulated trades and professions; facilitating credit access; and facilitating the setting-up of new businesses; encourages, lastly, the reform of the public administration sector by eliminating red tape, cutting costs and removing unnecessary layers of government;

15.  Recalls that the key element in the relationship between growth and consolidation is the composition of consolidation; stresses that the appropriate mix of expenditure- and revenue-side measures is context-dependent and should be thoroughly assessed; points out in this regard, however, that consolidations based on cutting unproductive expenditure rather than on increasing revenue tend to be more lasting and more growth-enhancing in the medium term, but more recessive in the short term; is of the opinion that consolidation strategies need to mitigate short-term recessive impact while aiming at being growth-enhancing in the medium term; believes that the possible negative impact of consolidations in the short run can be mitigated, in particular provided that the measures taken are credible, lasting and avoid a reduction in public investment in productive sectors of the economy;

16.  Encourages the Member States to focus consolidation efforts on a context-dependent and appropriate mix of expenditure- and revenue-side measures and, at the same time, safeguard EU 2020-related and sustainable growth-enhancing items such as investment in R&D, education, health and energy efficiency; considers that particular attention should also be paid to maintaining or reinforcing the coverage and effectiveness of employment services and active labour market policies such as training and further schemes for job-seekers, including a European Job Youth Guarantee for unemployed people and new entrepreneurs;

17.  Encourages the Commission to assess the consolidated fiscal stance in the eurozone as a whole, combining the budgetary measures decided at the national level and its projected impact through spill-over effects in each Member State in the eurozone;

18.  Invites the Commission to publish its methodology underpinning the assessment of the structural balances of the Member States, as well as the changes introduced in this methodology since 2008 and the impact of those changes in the assessment of the structural balances of the Member States;

19.  Underlines that the consolidation strategy should also target the revenue side of the budgets of the Member States; stresses, in particular, that consolidation measures on the revenue side should be focused on decreasing tax expenditures that create unproductive niches or inefficient rent-seeking behaviours, on decreasing environmentally harmful subsidies, as well as on creating environmental taxes targeting the source of negative externalities and which can bring double dividends in so far as they improve the budgetary situation and help fulfilling the objectives set in the EU2020 strategy;

20.  Supports the pursuit of the reform and modernisation of pension systems, while fully respecting the autonomy and the role of social partners and the specificity of national contexts, and while ensuring the long-term financial sustainability and adequacy of pensions; points out that such reforms serve as well as to maintain the contribution as automatic stabilisers and as terms of instruments of social cohesion and solidarity; encourages, in particular, measures to raise effective retirement ages; supports policies aimed at increasing the number of people that decide to continue in the labour market in the first years after reaching their retirement age;

21.  Encourages the Member States to implement consolidation procedures on the revenue side focusing on improving tax compliance and equity among citizens, in particular with respect to the fight against tax fraud and tax evasion; considers that, if this is not sufficient, a broadening of the tax base should be considered, also in view of the reduction of economic and social distortions; believes that greater efforts must be made to fight tax evasion and tax fraud;

22.  Considers that in order to attain balanced public finances for the medium and long term, it is important to apply cost-benefit analyses to all infrastructure projects with significant budgetary weight;

23.  Recalls that the Member States have committed themselves to engage in reforming fiscal policy within the Euro Plus Pact, and to hold discussions on a regular basis on the adoption of best practices;

24.  Underlines the role of local and regional public authorities in supporting public and private investments; stresses the importance of growth-oriented investments for a swift economic recovery;

25.  Invites the Member States to clarify the responsibility, role, fiscal transfers and revenue source of different levels of government (national, regional and local) in ensuring a sound and sustainable public finance framework, in particular by taking into account the impact on local and regional fiscal autonomy of the Treaty on Stability, Coordination and Governance in the Economic and Monetary Union;

26.  Is concerned by the risk that the set-up of the relationship between central and sub-national governments can harm the implementation of fiscal consolidation, particularly when decentralisation is financed predominantly through transfers from the central government and is not matched by sub-national responsibility on the revenue side;

27.  Is concerned that in some Member States, sub-sectors of government and ministries may exist without concrete powers and tasks; these sub-sectors of government make the general administration more inefficient and profligate and should therefore be eliminated as part of fiscal consolidation efforts;

28.  Notes that fiscal consolidation efforts should be shared between the different administrations in a fair way, taking into account the services they provide;

29.  Recognises that some Member States with high levels of debt are still increasing the net quantity of public workers despite their public commitment to freeze or decrease the share of public workers in the labour market;

30.  Calls on Member States with budgetary problems to give priority to fiscal consolidation measures aimed at reducing unnecessary defence expenditures such as purchases of new and expensive military equipment;

31.  Welcomes the various crisis resolution efforts, including sustainable and growth-enhancing structural reforms; underlines the new reinforced EU governance framework adopted recently; considers that, while those reforms cannot suddenly solve the crisis, they should aim at enhancing the credibility of the fiscal adjustment, reducing its negative short-term impact on growth and setting up the framework for better policy-making in the years when growth has returned;

32.  Encourages economic dialogue and cooperation between regional parliaments with legislative powers, national parliaments and the European Parliament, particularly in the context of the European Semester, to discuss the economic orientations presented in the Annual Growth Survey and the country-specific recommendations;

33.  Instructs its President to forward this resolution to the Council and the Commission, the European Central Bank and the governments and parliaments of the Member States.

(1) http://ec.europa.eu/economy_finance/publications/european_economy/2011/pdf/ee-2011-3_en.pdf
(2) http://ec.europa.eu/economy_finance/publications/european_economy/2012/pdf/ee-2012-4.pdf
(3) OJ L 306, 23.11.2011, p. 12.
(4) OJ L 306, 23.11.2011, p. 41.
(5) OJ L 306, 23.11.2011, p. 8.
(6) OJ L 306, 23.11.2011, p. 33.
(7) OJ L 306, 23.11.2011, p. 25.
(8) OJ L 306, 23.11.2011, p. 1.
(9) http://www.consilium.europa.eu/uedocs/cms_data/docs/pressdata/en/ec/120296.pdf
(10) Texts adopted, P7_TA(2011)0583.
(11) Texts adopted, P7_TA(2012)0048.


Credit rating agencies ***I
PDF 196kWORD 16k
Resolution
Text
European Parliament legislative resolution of 16 January 2013 on the proposal for a regulation of the European Parliament and of the Council amending Regulation (EC) No 1060/2009 on credit rating agencies (COM(2011)0747 – C7-0420/2011 – 2011/0361(COD))
P7_TA(2013)0012A7-0221/2012

(Ordinary legislative procedure: first reading)

The European Parliament,

–  having regard to the Commission proposal to Parliament and the Council (COM(2011)0747),

–  having regard to Article 294(2) and Article 114 of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C7-0420/2011),

–  having regard to Article 294(3) of the Treaty on the Functioning of the European Union,

–  having regard to the reasoned opinion submitted, within the framework of Protocol No 2 on the application of the principles of subsidiarity and proportionality, by the Swedish Parliament, asserting that the draft legislative act does not comply with the principle of subsidiarity,

–  having regard to the opinion of the European Central Bank of 2 April 2012(1),

–  having regard to the opinion of the European Economic and Social Committee of 29 March 2012(2),

–  having regard to the undertaking given by the Council representative by letter of 5 December 2012 to approve Parliament’s position, in accordance with Article 294(4) of the Treaty on the Functioning of the European Union,

–  having regard to Rule 55 of its Rules of Procedure,

–  having regard to the report of the Committee on Economic and Monetary Affairs and the opinion of the Committee on Legal Affairs (A7-0221/2012),

1.  Adopts its position at first reading hereinafter set out;

2.  Calls on the Commission to refer the matter to Parliament again if it intends to amend its proposal substantially or replace it with another text;

3.  Instructs its President to forward its position to the Council, the Commission and the national parliaments.

Position of the European Parliament adopted at first reading on 16 January 2013 with a view to the adoption of Regulation (EU) No .../2013 of the European Parliament and of the Council amending Regulation (EC) No 1060/2009 on credit rating agencies

P7_TC1-COD(2011)0361


(As an agreement was reached between Parliament and Council, Parliament's position corresponds to the final legislative act, Regulation (EU) No 462/2013.)

(1) OJ C 167, 13.6.2012, p. 2.
(2) OJ C 181, 21.6.2012, p. 68.


Undertakings of collective investment in transferable securities (UCITS) and alternative investment funds managers ***I
PDF 198kWORD 17k
Resolution
Text
European Parliament legislative resolution of 16 January 2013 on the proposal for a directive of the European Parliament and of the Council amending Directive 2009/65/EC on the coordination of laws, regulations and administrative provisions relating to undertakings of collective investment in transferable securities (UCITS) and Directive 2011/61/EU on Alternative Investment Funds Managers in respect of the excessive reliance on credit ratings (COM(2011)0746 – C7-0419/2011 – 2011/0360(COD))
P7_TA(2013)0013A7-0220/2012

(Ordinary legislative procedure: first reading)

The European Parliament,

–  having regard to the Commission proposal to Parliament and the Council (COM(2011)0746),

–  having regard to Article 294(2) and Article 53(1) of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C7-0419/2011),

–  having regard to Article 294(3) of the Treaty on the Functioning of the European Union,

–  having regard to the opinion of the European Central Bank of 2 April 2012(1),

–  having regard to the opinion of the European Economic and Social Committee of 23 May 2012(2),

–  having regard to the undertaking given by the Council representative by letter of 5 December 2012 to approve Parliament’s position, in accordance with Article 294(4) of the Treaty on the Functioning of the European Union,

–  having regard to Rule 55 of its Rules of Procedure,

–  having regard to the report of the Committee on Economic and Monetary Affairs and the opinion of the Committee on Legal Affairs (A7-0220/2012),

1.  Adopts its position at first reading hereinafter set out;

2.  Calls on the Commission to refer the matter to Parliament again if it intends to amend its proposal substantially or replace it with another text;

3.  Instructs its President to forward its position to the Council, the Commission and the national parliaments.

Position of the European Parliament adopted at first reading on 16 January 2013 with a view to the adoption of Directive 2013/.../EU of the European Parliament and of the Council amending Directive 2003/41/EC on the activities and supervision of institutions for occupational retirement provision, Directive 2009/65/EC on the coordination of laws, regulations and administrative provisions relating to undertakings for collective investment in transferable securities (UCITS) and Directive 2011/61/EU on Alternative Investment Funds Managers in respect of over-reliance on credit ratings

P7_TC1-COD(2011)0360


(As an agreement was reached between Parliament and Council, Parliament's position corresponds to the final legislative act, Directive 2013/14/EU.)

(1) OJ C 167, 13.6.2012, p. 2.
(2) OJ  C 229, 31.7.2012, p. 64.


Multi-annual plan for cod stocks in the Baltic Sea***I
PDF 323kWORD 25k
Resolution
Consolidated text
European Parliament legislative resolution of 16 January 2013 on the proposal for a regulation of the European Parliament and of the Council amending Council Regulation (EC) No 1098/2007 of 18 September 2007 establishing a multi-annual plan for the cod stocks in the Baltic Sea and the fisheries exploiting those stocks (COM(2012)0155 – C7-0090/2012 – 2012/0077(COD))
P7_TA(2013)0014A7-0395/2012

(Ordinary legislative procedure: first reading)

The European Parliament,

–  having regard to the Commission proposal to Parliament and the Council (COM(2012)0155),

–  having regard to Article 294(2) and Article 43(2) of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C7-0090/2012),

–  having regard to Article 294(3) of the Treaty on the Functioning of the European Union,

–  having regard to the opinion of the European Economic and Social Committee of 11 July 2012(1),

–  having regard to Rule 55 of its Rules of Procedure,

–  having regard to the report of the Committee on Fisheries (A7-0395/2012),

1.  Adopts its position at first reading hereinafter set out;

2.  Calls on the Commission to refer the matter to Parliament again if it intends to amend its proposal substantially or replace it with another text;

3.  Instructs its President to forward its position to the Council, the Commission and the national parliaments.

Position of the European Parliament adopted at first reading on 16 January 2013 with a view to the adoption of Regulation (EU) No .../2013 of the European Parliament and of the Council amending Council Regulation (EC) No 1098/2007 of 18 September 2007 establishing a multi-annual plan for the cod stocks in the Baltic Sea and the fisheries exploiting those stocks

P7_TC1-COD(2012)0077


THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 43(2) thereof,

Having regard to the proposal from the European Commission,

After transmission of the draft legislative act to the national Parliaments,

Having regard to the opinion of the European Economic and Social Committee(2),

Acting in accordance with the ordinary legislative procedure(3),

Whereas:

(1)  To avoid any ambiguity and ensure consistency with international commitments of the Union for achieving a maximum sustainable yield for depleted stocks, the objectives of the multi-annual plan for the cod stocks in the Baltic Sea and the fisheries exploiting those stocks, established by Council Regulation (EC) No 1098/2007(4), should be clarified accordingly.

(2)  Regulation (EC) No 1098/2007 provides for the follow-up and revision of the minimum fishing mortality rates specified therein in the case of the inadequacy of those rates to meet the objectives of that plan.

(3)  In accordance with Article 290 of the Treaty the Commission may be empowered to supplement or amend non-essential elements of a legislative act by means of delegated acts. [Am. 1]

(4)  In order to achieve in an efficient way the targets set out in Regulation (EC) No 1098/2007 and be able to react swiftly to changes in stock conditions or in fishery, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of the revision of the minimumwith regard to setting the periods when fishing mortality rates, when scientific data indicate that the rates are no longer appropriate and measures are not sufficient to reach the objectives of the planwith certain types of gear is allowed in respect of certain geographical areas. It is of particular importance that the Commission carry out appropriate consultations with the Baltic Sea Regional Advisory Council and relevant stakeholders during its preparatory work, including at expert level. The Commission, when preparing and drawing up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and to the Council. [Am. 2]

(6)  In order to ensure uniform conditions for the implementation of Article 29 of Regulation (EC) No 1098/2007, implementing powers should be conferred upon the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers(5). [Am. 3]

(7)  To ensure the efficiency of an evaluation of the plan's performance the timeline of evaluation provided for in Regulation (EC) No 1098/2007 should be modified.

(8)  In addition, the decision making procedure concerning the setting of fishing opportunities referred to in Regulation (EC) No 1098/2007 should be clarified following the entry into force of the Treaty on the Functioning of the European Union.

(9)  The proposed amendments are therefore primarily aimed at changes enabling the plan to work efficiently within the new decisional framework set up by the Lisbon Treaty.

(10)  Regulation (EC) No 1098/2007 should therefore be amended accordingly,

HAVE ADOPTED THIS REGULATION:

Article 1

Regulation (EC) No 1098/2007 is amended as follows:

(1)  Article 4 is replaced by the following:"

Article 4

Objective and targets

The plan shall ensure the sustainable exploitation of the cod stocks concerned on the basis of maximum sustainable yield by gradually reducing and maintaining the fishing mortality rates at levels no lowerhigher than: [Am. 4]

   (a) 0,25 on ages three to six years for the cod stock in Area A; and [Am. 5]
   (b) 0,3 on ages four to seven years for the cod stock in Areas B and C.

"

(2)  In Article 5, paragraph 1 is replaced by the following:"

1.  Each year the Council shall decide in accordance with the Treaty on the TACs for the cod stocks concerned for the following year.

"

[Am. 6]

(3)  Article 8 is amended as follows:

[Am. 8]

[Am. 9]

   (a) paragraphs 3 and 4 are replaced by the following:"
3.  The CouncilCommission shall decidebe empowered to adopt delegated acts, in accordance with Article 29a, defining, for each year,in accordance with the Treaty on the maximum number of days absent from port outside periods specified in paragraph 1 in the following year when fishing with the gear referred to in paragraph 1 is allowed, in accordance with the rules set out in paragraphs 4 and 5. [Am. 7]
4.  Where the fishing mortality rate for one of the cod stocks concerned has been estimated by STECF to be at least 10 % higher than the target fishing mortality rate set out in Article 4, the total number of days when fishing with the gear referred to in paragraph 1 is allowed shall be reduced by 10 % compared to the total number of days allowed in the current year."
   (b) in paragraph 6, subparagraph 1 is replaced by the following:"
By way of derogation from paragraph 1, fishing vessels with an overall length of less than 12 metres shall be permitted to fish with static gear in the area up to 10 nautical miles measured from the baselines. The immersion time of the said static gears shall not exceed 48 hours."

(4)  Article 26 is replaced by the following:"

Article 26

Evaluation of the plan

Every five years from 18 September 2007, the Commission shall evaluate the operation and performance of this multi-annual plan. For the purpose of this evaluation, the Commission shall seek the advice of STECF and of the Baltic Sea Regional Advisory Council. Where appropriatenecessary, the Commission may propose adaptations toshall submit appropriate proposals, for adoption in accordance with the ordinary legislative procedure, for the amendment of the multi-annual plan or adopt delegated acts in accordance with Article 27.

"

[Am. 10]

(5)  Article 27 is replaced by the following:"

Article 27

Revision of minimum fishing mortality rates

Where the Commission shall be empowered to adopt delegated acts finds that the target fishing mortality rates set out in Article 4 are no longer appropriate to achieve the objectives of the management plan, the Commission shall, on the basis of advice from STECF and after consulting the Baltic Sea Regional Advisory Council and relevant stakeholders, submit a proposal, for adoption in accordance with Article 29a to revise the minimumthe ordinary legislative procedure, for the revision of the target fishing mortality rates set out in Article 4.when scientific data indicates that the values for the minimum fishing mortality rates are disaccording with the objectives of the management plan.

"

[Am. 11]

(6)  In Article 29 paragraphs 2, 3 and 4 are replaced by the following:"

2.  Article 8(1)(b), (3), (4) and (5) shall not apply to ICES Subdivisions 27 and/or 28.2 if there is evidence that catches of cod in those ICES Subdivisions are lower than 3 % of the total catches of cod in Area B. The Commission shall be empowered to adopt, each year, by means of implementing acts and on the basis of the reports from Member States referred to in paragraph 1 and of scientific data, confirm , on the basis of the reports from Member States referred to in paragraph 1 and of scientific data, delegated acts, in accordance with Article 29a, confirming whether such evidence exists and, consequently, whether the restrictions provided for in Article 8(1)(b), (3), (4) and (5) apply in the subdivisions concerned. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 29b(2). [Am. 12]

3.  Article 8(1)(b), (3), (4) and (5) shall only apply to ICES Subdivision 28.1, if there is evidence that the catches of cod are higher than 1,5 % of the total catches of cod in Area B. The Commission shall be empowered to adopt, each year, by means of implementing acts and on the basis of the reports from Member States referred to in paragraph 1 and of scientific data, confirmon the basis of the reports from Member States referred to in paragraph 1 and of scientific data, delegated acts, in accordance with Article 29a, confirming whether such evidence exists and, consequently, whether the restrictions provided for in Article 8(1)(b), (3), (4) and (5) apply in the subdivision concerned. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 29b(2). [Am. 13]

4.  The implementingdelegated acts referred to in paragraphs 2 and 3 shall apply from 1 January to 31 December of the following year.

"

[Am. 14]

(7)  The following Chapter is inserted:"

Chapter VIa

Article 29a

Exercise of the delegation

1.  The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.

2.  The delegation of power to adopt delegated acts referred to in Articles 26 and 27Article 8(3) and Article 29(2) and (3) shall be conferred on the Commission for an indeterminatea period of timethree years from …(6). The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the three-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period. [Am. 15]

3.  The delegation of power referred to in Articles 26 and 27Article 8(3) and Article 29(2) and (3) may be revoked at any time by the European Parliament or by the Council. A decision to revocationrevoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. [Am. 16]

4.  As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.

5.  A delegated act adopted pursuant to Articles 26, and 27Article 8(3) and Article 29(2) and (3) shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.

“Article 29b

Committee procedure

1.  The Commission shall be assisted by the Committee for Fisheries and Aquaculture established by Article 30 of Regulation (EC) No 2371/2002. That Committee shall be a committee within the meaning of Regulation (EU) No 182/2011.

2.  Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.“ [Am. 17]

Article 29c

Council decisions

Where this Regulation provides for decisions to be taken by the Council, the Council shall act in accordance with the Treaty.

"

Article 2

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at

For the European Parliament

The President

For the Council

The President

For the Council

The President

(1) OJ C 299, 4.10.2012, p. 145.
(2) OJ C 299, 4.10.2012, p. 145.
(3) Position of the European Parliament of 16 January 2013.
(4) OJ L 248, 22.9.2007, p. 1.
(5) OJ L 55, 28.2.2011, p. 13.
(6)* Date of entry into force of this Regulation.


Amendment of Parliament's Rules of Procedure on the order of precedence of Vice-Presidents elected by acclamation
PDF 187kWORD 19k
European Parliament decision of 16 January 2013 on amendment of Rule 15(2) of Parliament’s Rules of Procedure on the order of precedence of Vice-Presidents elected by acclamation (2012/2020(REG))
P7_TA(2013)0015A7-0412/2012

The European Parliament,

–  having regard to the letter from its President of 3 September 2010,

–  having regard to the interpretation of Rule 13(1) of its Rules of Procedure adopted by the Committee on Constitutional Affairs on 15 June 2011 and announced in plenary on 22 June 2011,

–  having regard to Rules 211 and 212 of its Rules of Procedure,

–  having regard to the report of the Committee on Constitutional Affairs (A7-0412/2012),

1.  Decides to amend its Rules of Procedure as shown below;

2.  Points out that the amendment will enter into force on the first day of the next part-session;

3.  Instructs its President to forward this decision to the Council and the Commission, for information.

Present text   Amendment
Amendment 1
Parliament's Rules of Procedure
Rule 15 – paragraph 2 – subparagraph 2
Where they are not elected by secret ballot, the order in which their names are read out to the House by the President shall determine the order of precedence.

Where they are elected by acclamation, a secret ballot shall be held to determine the order of precedence.


Youth guarantee
PDF 120kWORD 22k
European Parliament resolution of 16 January 2013 on a Youth Guarantee (2012/2901(RSP))
P7_TA(2013)0016B7-0007/2013

The European Parliament,

–  having regard to the proposal from the Commission of 5 December 2012 for a Council Recommendation on establishing a Youth Guarantee (COM(2012)0729),

–  having regard to the Commission Communication on the implementation of the Youth Opportunities Initiative (COM(2012)0727),

–  having regard to the Commission Communication ‘Youth Opportunities Initiative’ (COM(2011)0933), and to the European Parliament’s resolution of 24 May 2012 on the Youth Opportunities Initiative(1) and the question for oral answer to the Commission on the Youth Opportunities Initiative (O-000106/2012 – B7-0113/2012),

–  having regard to the Statement of the Members of the European Council of 30 January 2012 entitled ‘Towards growth-friendly consolidation and job-friendly growth’,

–  having regard to its resolution of 6 July 2010 on promoting youth access to the labour market, strengthening trainee, internship and apprenticeship status(2),

–  having regard to the Eurofound report of 13 June 2012 entitled ‘Youth Guarantee: Experiences from Finland and Sweden’(3),

–  having regard to the Commission Communication ‘Youth on the Move’ (COM(2010)0477),

–  having regard to the International Labour Organisation’s paper of September 2012 entitled ‘Global employment outlook: Bleak labour market prospects for youth’(4) and to the resolution and conclusions of the 101st Session of the International Labour Conference, Geneva, 2012, entitled ’The youth unemployment crisis: A call for action’(5),

–  having regard to Rules 115(5) and 110(2) of its Rules of Procedure,

A.  whereas, due to the economic crisis, the overall unemployment rate had by October 2012 risen to the unprecedented level of 10,7 %, with 25,91 million people looking for work(6);

B.  whereas the youth unemployment rate has soared to 23,4 %, leaving 5,68 million young people unemployed, in part reflecting mismatches between skills supply and labour market demands though often regardless of the education levels of job seekers; whereas research shows that youth unemployment often leaves permanent scars, such as an increased risk of future unemployment and of permanent social exclusion;

C.  whereas the Members of the European Council, in their statement of 29 June 2012, urged the Member States to step up efforts to increase youth employment with ‘the objective that within a few months of leaving school, young people receive a good quality offer of employment, continued education, apprenticeship or a traineeship’;

D.  whereas a Youth Guarantee would contribute to the attainment of three of the Europe 2020 strategy objectives, namely that 75 % of the of the population aged 20-64 should be employed, that early school-leaving rates should be below 10 %, and that at least 20 million people should be lifted out of poverty and social exclusion;

E.  whereas the crisis has led to a rise in precarious forms of employment for young people, with short-term and part-time contracts and unremunerated work placement schemes all too often replacing existing jobs;

F.  whereas the cost to the EU of inaction on the problem of young people with no employment, education or training (NEETs) is estimated to be about EUR 153 billion, corresponding to 1,2 % of the EU’s GDP, and whereas there are currently 7,5 million NEETs under 25 in the EU;

G.  whereas the Commission demands, in its Youth Employment Package, a Youth Guarantee;

1.  Strongly supports the initiative by the Commission to propose a Council Recommendation on Youth Guarantee schemes;

2.  Calls on the Member States’ ministers for employment and social affairs to agree on a Council recommendation during the EPSCO Council in February 2013 aimed at implementing Youth Guarantee schemes in all Member States; emphasises that the Youth Guarantee is not a job guarantee but an instrument ensuring that all young EU citizens and legal residents up to the age of 25 years, and recent graduates under 30, receive a good-quality offer of employment, continued education or apprenticeship within four months of becoming unemployed or leaving formal education; stresses that Youth Guarantee schemes should effectively improve the situation of NEETs; underlines that Youth Guarantee schemes should be eligible for specific forms of European funding, especially in the Member States with the highest youth unemployment rates;

3.  Takes the view that Union funding of Youth Guarantee schemes should play a key role, that the European Social Fund (ESF) in particular should be structured to enable the Youth Guarantee to be financed, and that the ESF should therefore be allocated at least 25 % of Structural and Cohesion Funds; believes, however, that an appropriate balance between EU and Member State funding should be striven for;

4.  Recognises that young people are not a homogenous group, that they face different social environments and, therefore, that Member States have different levels of readiness for the adoption of a Youth Guarantee; in this context, all young people should first receive a personalised assessment of their needs, which should be followed up with specifically tailored services;

5.  Emphasises that close cooperation between the Commission and the Member States and, at national level, among (sectoral) social partners, local and regional authorities, public and private employment services and local and regional education and training institutes is essential to the effective implementation of Youth Guarantee schemes;

6.  Notes that Youth Guarantee schemes should be accompanied by a quality framework in order to ensure that the education, training and jobs offered include appropriate pay, working conditions and health and safety standards;

7.  Welcomes the Commission’s suggestion to provide, through an ‘Employment Committee’, multilateral surveillance of the implementation of the Youth Guarantee schemes, and asks to be associated with this committee;

8.  Calls on the Member States to reform, in particular, education and training standards for young people, in order to significantly increase their employment and life opportunities;

9.  Recognises that Member States have different level of readiness for the adoption of Youth Guarantee and calls on the Commission, in particular, to support those Member States which are undergoing financial constraints; urges the Commission, within the framework of the European Semester, to closely monitor and report on the implementation of Youth Guarantees and, where needed, to name those Member States who fail to establish Youth Guarantees;

10.  Instructs its President to forward this resolution to the Commission and the Council.

(1) Texts adopted, P7_TA(2012)0224.
(2) OJ C 351 E, 2.12.2011, p. 29.
(3) http://www.eurofound.europa.eu/pubdocs/2012/42/en/1/EF1242EN.pdf
(4) http://www.ilo.org/wcmsp5/groups/public/---dgreports/---dcomm/documents/publication/wcms_188810.pdf
(5) ttp://www.ilo.org/wcmsp5/groups/public/@ed_norm/@relconf/documents/meetingdocument/wcms_185950.pdf
(6) Eurostat, November 2012: http://epp.eurostat.ec.europa.eu/cache/ITY_PUBLIC/3-30112012-BP/EN/3-30112012-BP-EN.PDF


Role of EU cohesion policy in implementing the new European energy policy
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European Parliament resolution of 16 January 2013 on the role of EU cohesion policy and its actors in implementing the new European energy policy (2012/2099(INI))
P7_TA(2013)0017A7-0437/2012

The European Parliament,

–  having regard to Article 194 of the Treaty on the Functioning of the European Union,

–  having regard to the communication of 10 November 2010 entitled ‘Energy 2020 – A strategy for competitive, sustainable and secure energy’ (COM(2010)0639),

–  having regard to the communication of 15 December 2011 entitled ‘Energy Roadmap 2050’ (COM(2011)0885),

–  having regard to the proposal for a directive of the European Parliament and of the Council on energy efficiency and repealing Directives 2004/8/EC and 2006/32/EC (COM(2011)0370),

–  having regard to Rule 48 of its Rules of Procedure,

–  having regard to the report of the Committee on Regional Development and the opinion of the Committee on Industry, Research and Energy (A7-0437/2012),

A.  whereas the common objectives of European energy policy are security of supply, sustainability and competitiveness;

B.  whereas European energy policy should also ensure the safety of energy resources, diversification of supplies, and affordable prices for end users;

C.  whereas the primary objectives of the EU cohesion policy are the economic, social and territorial cohesion of Europe’s regions through investment in growth and jobs;

D.  whereas the cohesion policy investments in the area of energy should contribute to the realisation of the objectives of both policies;

E.  whereas these policies should promote growth and local job creation in all regions, while ensuring sustainable sources of energy, and guaranteeing security of energy supply across the whole EU;

F.  whereas the European Union’s energy markets are increasingly extending beyond national borders and this trend is set to gain considerable pace in the period ahead;

G.  whereas, under the original Commission proposal, at least 80 % of ERDF resources in more developed regions and 50% in less developed regions are to be allocated to a ‘low-carbon economy’;

H.  whereas, in this thematic area, a minimum of 20 % and 6 % respectively is required to be allocated to energy efficiency and renewables, which is a significant amount of funding;

I.  whereas the price of energy has risen significantly in recent years and has now reached historic levels, posing major problems for European industries;

J.  whereas the minimum amount for an ELENA eligible project is EUR 50 million and the minimum for the Intelligent Energy programme is greater than EUR 6 million, which is more than the cost of many projects in small and rural communities;

K.  whereas the Energy Roadmap 2050 identifies renewable energy as playing a major part in the future energy policy;

General approach

1.  Welcomes the general approach of linking cohesion policy to the Europe 2020 objectives and flagship initiatives in order to move towards smart, sustainable and inclusive growth and to support the shift towards a low-carbon, energy-efficient economy in all sectors; recalls, in addition, the importance of the Structural Funds and the Cohesion Fund in achieving these short- and long-term objectives in accordance with the spirit of solidarity between Member States as enshrined in the Lisbon Treaty, and in combating energy poverty in the less developed regions of the EU and the most vulnerable households;

2.  Emphasises, as a consequence of the current crisis’ negative effect of increasing local and regional disparities in Europe, the need for strong EU support for economic, social and territorial cohesion;

3.  Believes that European energy projects could contribute to regional development and stronger cross-border cooperation by helping regions increase their capacity to manage energy resources; believes that investment in low-emission and renewable energy sources and energy efficiency can result in supporting regional growth and jobs;

4.  Stresses the need to distinguish between cohesion policy goals that contribute to the Europe 2020 strategy, on the one hand, and the EU’s wider energy policy goals, on the other, which also affect the countries eligible for cohesion funding; emphasises that cohesion funds may be used as an additional source of funding for energy projects only if a project contributes to cohesion policy goals;

5.  Believes that the regions of Europe should promote smart, sustainable and inclusive growth that takes into account local specificities and conditions, allowing the regions of Europe sufficient flexibility to focus on those sustainable energy sources which are best suited to local and regional conditions and resources, in order to achieve the EU 2020-targets, and that the EU should start measuring and implementing European energy objectives on an EU-wide scale;

6.  Recommends taking into account the fact that Europe’s energy markets are organised in regional groups and takes the view that greater attention should continue to be paid to the specific features of national and regional markets so that the proper enforcement of legislative regulations can be guaranteed;

7.  Takes the view that the European Union should act as quickly as possible to secure its energy future and protect its interests in this field, which will entail exerting additional pressure on local and regional representatives to comply with EU guidelines; takes the view that they should at the same time be offered substantial financial support for drawing up projects;

8.  Stresses that projected increases in energy pricing may place citizens in the less developed EU regions at a particular disadvantage; asks, therefore, that this be considered within cohesion policy planning and for Member States to take additional measures to diminish the effects, especially on protected consumers;

Capacity building

9.  Stresses that the current climate and energy targets and any future energy goals beyond 2020 should be based on fair burden sharing between European regions and should allow them the possibility of future development which is needed;

10.  Emphasises that bureaucracy and lack of procedural clarity have made access to the Structural Funds and the Cohesion Fund difficult and discouraged those actors most in need of such funding from applying; supports, therefore, the simplification of rules and procedures, the removal of red tape, and increased flexibility in allocating these funds at both EU and national level; believes that simplification will contribute to the efficient allocation of funds, higher absorption rates, fewer errors and reduced payment periods and allow the poorest Member States and regions to take full advantage of the financial instruments intended to reduce regional and inter-state disparities; considers that a balance needs to be struck between simplification and the stability of rules and procedures;

11.  Stresses the importance of increasing administrative capacity – but without increasing the administrative burden – in the Member States, at regional and local level and among stakeholders in order to make full and effective use of the funding that will be allocated to energy projects (including in the areas of energy efficiency and renewable energy) under cohesion policy, to overcome barriers to effective synergies between the Structural Funds and other funds and to support effective policy design and implementation; calls on the Member States to make further efforts to attract and retain qualified staff to manage EU funds;

12.  Points out, with regard to large-scale energy projects, the possible capacity deficiencies of various regional and local authorities, which might seriously hamper implementation; believes, therefore, not only that JESSICA, ELENA and IEE-MLEI should be strengthened, but that any funding allocations for low-emission economy thematic concentrations within the cohesion policy should be reviewed by 2018 in light of their absorption rate and adjusted as needed, and at the latest within the framework of prospective general review of the MFF;

13.  Welcomes the launch of the Smart Cities and Communities European Innovation Partnership and calls on the relevant partners involved in planning processes for sustainable urban development to do more to promote, and take fuller advantage of, the benefits available under the JESSICA and ELENA initiatives for sustainable energy investment at local level, with a view to helping cities and regions embark on viable investment projects in the fields of energy efficiency, renewable energy sources and sustainable urban transport;

14.  Stresses the importance of regularly reviewing the allocation of cohesion funding for energy projects, in order to increase the absorption rate and channel the funds into programmes which have a proven record of absorption, added value and effectiveness;

15.  Stresses, while supporting new financial instruments (loans, loan guarantees and equity), that this should be in addition to direct grants and co-financing of energy projects and not a replacement for them;

16.  Draws the attention of the Member States and the Commission to the fact that towns, especially small and medium-sized towns and rural communities, should be eligible for direct funding aid for energy efficiency, and building renovation projects as well as transregional and cross-border projects as they are likely to lack the necessary administrative capacity to use other financial instruments fully; suggests to the Commission, in this regard, that an energy-efficiency strategy needs to be drawn up for small communities;

17.  Believes that initiatives supporting local and regional capacities to deal with energy savings should be supported, inter alia by ERDF and ESF investments;

18.  Calls on the Commission to establish an EU-wide cooperation programme, based on the experience of the twinning programme, in order to improve cooperation between regions with high rates of absorption of EU funds and those with low absorption rates and to facilitate the dissemination of best practices;

Partnership agreements

19.  Notes that, for projects to be properly implemented, regional and local authorities should be consulted on partnership agreements in such a way as to give them a real opportunity to influence their goals, the content of expenditure and their implementation; calls, therefore, for the partnership principle to be strengthened;

20.  Supports, therefore, a multi-level governance and decentralised approach to energy policy and energy efficiency, including, among other things, the Covenant of Mayors and the further development of the Smart Cities initiative as well as the promotion of the best solutions at regional and local level by means of information campaigns;

21.  Points out that cohesion policy funding arrangements should ensure that the differing economic, social and territorial features of regions are fully taken into consideration; highlights, in this connection, the role of the regions located on the external borders of the European Union;

22.  Believes that, while the Common Provisions Regulation, provides for general earmarking and other thematic targets, these measures should be applied in a flexible manner within partnership agreements to allow Member States and their regions to pursue their most effective path towards achieving the EU 2020 goals and cohesion policy objectives;

23.  Singles out the need to apply the broad criteria for assessing energy projects put forward for cohesion policy funding; notes, in particular, that different geographical conditions mean that there cannot be a ‘one-size-fits-all’ energy policy for all regions;

Implementation and policy suggestions

24.  Notes that, while Member States are changing their energy mixes in accordance with the EU‘s climate goals, many regions are still dependent on fossil fuels; believes, therefore, that all these regions ought to be encouraged to use sources of energy compatible with the goals of smart, sustainable and inclusive growth;

25.  Stresses the need to select local sources of energy generation prudently and in such a manner as to ensure that they fit in as well as possible with the regional landscape;

26.  Takes the view that consistent rules are needed at European level along with a mechanism for authorities to access information from across the Union in order to fully understand energy market developments;

27.  Takes the view that cohesion policy can play a key role in exploiting the potential offered by innovation, research and development, so that future challenges in the field of energy can be turned into an opportunity that will revitalise the Union‘s economic strength;

28.  Supports the use of cohesion and energy policy funds for cross-border projects with third partner countries and connections between national networks; stresses that bordering regions should be incorporated into the EU system as much as possible to ensure sustainable development on both sides of the border; stresses that such funding should be subject to the application of the EU energy market rules, including the third energy package;

29.  Welcomes the new proposal on the Connecting Europe Facility as an additional and complementary instrument to cohesion policy, aimed at addressing the extensive need for investment in modernising and expanding Europe’s energy infrastructure, thereby contributing to the Europe 2020 strategy targets; urges the Commission to maximise the degree of coordination between the Structural Funds and the Cohesion Fund, on the one hand, and the Connecting Europe Facility, on the other;

30.  Encourages use of the European territorial cooperation objective and the Connecting Europe Facility to implement cross-border strategies on efficient energy production, distribution and use; emphasises the importance of adapting EU rules on energy infrastructure managers to the cross-border context;

31.  Believes that cohesion policy funds should be available to provide information to local and regional authorities, SMEs and individuals on national renewable energy schemes in a structured way; notes that this is needed, in particular, in those Member States where a ‘certificate of origin’ system has been adopted, which might favour only large-scale energy projects;

32.  Calls for full use to be made of synergies between public and private funds in financing energy projects;

33.  Supports the revision of the EU VAT Directive 2006/112/EC to allow for a reduction of the VAT rate applied to regional, local and cross-border projects seeking to increase energy efficiency and to the purchase of products in the highest energy efficiency class under Directive 2010/30/EU;

34.  Believes that only greenhouse gas reduction projects targeting the installations listed in Annex 1 to Directive 2003/87/EC should be excluded from the ERDF and the CF, so as not to engender a disproportionate effect on less developed regions and delay their transition to low-emission regions; asks the Commission to further clarify and define which energy sectors would not be eligible for cohesion policy funding and to withdraw this exclusion from projects located in convergence regions;

35.  Notes that district heating and cogeneration plants are widely present especially in Central and Eastern Europe; believes that the upgrade of such plants and of their distribution network, and where necessary the creation of high efficiency new plants, would have a positive environmental impact and should therefore be encouraged and supported by the cohesion policy;

Energy efficiency, renewables and infrastructure

36.  Agrees that energy efficiency is vital to the EU’s energy goals and should be promoted above all within the thematic concentration structure and Operational Programmes; believes that EU measures should support energy efficiency in the energy production, distribution and consumption phases;

37.  Considers it to be of paramount importance for investments to be made in energy efficiency and renewable energy use, in particular in the housing sector;

38.  Takes the view that, by making intelligent use of Community funds for the forthcoming programming period 2014-2020, it will be possible to achieve the 20 % target for energy efficiency and thus the sustainability and competitiveness objectives in the European Union; stresses that cutting consumption by means of energy efficiency is the most sustainable way of reducing dependence on fossil fuels, leading to a reduction in imports of around 25 %;

39.  Stresses the importance of cohesion policy, and of the financial resources allocated to it, for the full development of energy storage and transmission infrastructure and networks (with particular reference to smart grids and distribution) between the Member States and all regions of the EU, including the outermost regions, for the completion and functioning of the internal energy market, for the provision of an affordable, secure and sustainable energy supply and for achieving the goal of convergence among EU regions, taking into the account the needs of EU citizens in every Member State; stresses that no region of the Member States should remain isolated from European gas and electricity networks after 2015 or suffer from inadequate connection to energy networks;

40.  Stresses the need to develop an integrated and interconnected energy system, and local and regional smart distribution and transmission networks for electricity and gas, together with storage facilities; believes that the energy thematic concentration should support grid creation, and renovation for renewable sources of energy, i.e. sustainable production of biogas;

41.  Points out that the cohesion policy should contribute to a balance of energy flows across borders of Member States in order to avoid possible threats of black-outs (e.g. by means of transformers);

42.  Notes the need for energy efficiency and development of renewable energy in rural areas; stresses the increasing energy saving potential in rural households, which might require innovative funding schemes as these communities lack the necessary financial institutions with the ability to support such projects; supports steps to facilitate access to new technologies for rural areas, especially in the area of microgeneration;

43.  Asks the Commission to ensure that energy policy is ‘rural proof’ by addressing in a more comprehensive and coordinated way the challenges and opportunities that rural areas face when it comes to energy use and production;

44.  Points out that energy efficiency potential remains unrealised in the construction and transport sectors, where investments in the heating of buildings and energy-efficient public transport represent an opportunity to increase employment in the sectors concerned; believes that multiannual objectives should be set in this regard;

45.  Notes the imbalance in sustainable resource use between different Member States; stresses the economies of scales possible through cross-border cooperation on sustainable use of resources and energy efficiency; takes the view that measures to support resource efficiency and the recycling of materials should be stepped up; underlines the risk of carbon leakage and its effect on regional development and social cohesion, and therefore believes that a balance must be struck between the implementation of our climate objectives and the energy security of Europe’s regions, which is necessary for sustainable and competitive growth;

46.  Stresses the significant advantage of using the Structural Funds and the Cohesion Fund for the implementation of the information and communication networks needed in order to develop a secure and robust smart EU energy grid;

Competitiveness, jobs and fighting energy poverty

47.  Stresses that investments in energy infrastructure and energy-efficient construction and transport will lead directly to the creation of new jobs;

48.  Calls for the EU-wide exchange of best practices so that the impact on energy poverty of policies adopted in the area of energy may be monitored;

49.  Highlights the need to address the fragmentation of the EU energy market by removing barriers and bottlenecks in the relevant legislative frameworks and in the system of access to public and private funds for project development and implementation;

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50.  Instructs its President to forward this resolution to the Council, the Commission and the Committee of the Regions.


Feasibility of introducing stability bonds
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Resolution
Annex
European Parliament resolution of 16 January 2013 on the feasibility of introducing Stability Bonds (2012/2028(INI))
P7_TA(2013)0018A7-0402/2012

The European Parliament,

–  having regard to the enhanced economic governance framework of the Union, including the six-pack, Parliament’s agreed-upon proposals for the two-pack and the communitarised fiscal compact in accordance with Article 16 of the Treaty on Stability, Coordination and Governance in the Economic and Monetary Union (TSCG);

–  having regard to the two reports of the President of the European Council entitled ‘Towards a Genuine Economic and Monetary Union’ issued on 26June 2012(1) and 12 October 2012(2), respectively;

–  having regard to the conclusions of the European Council of 28-29 June 2012 exploring ways of improving the economic and financial architecture of the eurozone(3);

–  having regard to Article 125 of the Treaty on the Functioning of the European Union (TFEU);

–  having regard to its resolution of 18 November 2008 on the theme ‘EMU@10: The first 10 years of Economic and Monetary Union and future challenges’(4),

–  having regard to its resolution of 6 July 2011 on the financial, economic and social crisis: recommendations concerning the measures and initiatives to be taken(5),

–  having regard to the Commission Green Paper of 23 November 2011 on the feasibility of introducing Stability Bonds (COM(2011)0818),

–  having regard to its resolution of 15 February 2012 on the feasibility of introducing Stability Bonds(6),

–  having regard to the roadmap annexed to this resolution,

–  having regard to Rule 48 of its Rules of Procedure,

–  having regard to the report of the Committee on Economic and Monetary Affairs and the opinions of the Committee on the Internal Market and Consumer Protection and the Committee on Legal Affairs (A7-0402/2012),

A.  whereas Parliament requested that the Commission submit a report on the possibility of introducing eurobonds, which was an integral part of the agreement between Parliament and the Council on the economic governance package (six pack);

B.  whereas the Green Paper launched a broad public consultation exercise concerning the concept of stability bonds; whereas the Green Paper assesses the feasibility of common issuance of sovereign bonds by the Member States of the eurozone and discusses the required conditions;

C.  whereas, without overlooking the broader Union perspective, the eurozone is in a unique situation, with participating Member States sharing a single currency but no common budgetary policy or common bond market; whereas, therefore, there are grounds for welcoming the draft proposals in the two reports entitled ‘Towards a Genuine Economic and Monetary Union’ presented by the President of the European Council, which represents a good starting point for working towards a sound and genuine EMU;

D.  whereas Article 125 of the TFEU prohibits Member States from assuming liabilities of other Member States;

E.  Whereas monetary policy engaged by the European Central Bank (ECB) is not the solution to the fiscal and structural problems of Member States, and its non-standard measures have limits in their effectiveness;

F.  whereas no federal state (including the United States and Germany) issues the equivalent of eurobonds such as foreseen in options 1 and 2 of the Green Book, something which elevates eurobonds to the level of a totally new concept that cannot be compared with the tried and trusted US Treasury Bonds and German Bundesanleihen;

G.  whereas Member States face difficulties in accessing financing at reasonable rates as a result of the mistrust of the market with regard to public debt, the situation of European banks and the ability of European leaders to take definitive steps to defend and complete the single currency;

H.  whereas the crisis has demonstrated not only the interdependence between eurozone Member States but also the need for a more robust fiscal union, with effective mechanisms to correct unsustainable fiscal trajectories, macroeconomic imbalances, debt levels and the upper limits of budget balance of Member States;

I.  whereas credible commitments to growth-friendly consolidation measures are a prerequisite for any sustainable solution of the excessive debt and deficit situation of most of the eurozone Member States;

J.  whereas the mutualisation of eurozone sovereign debt cannot per se compensate for the loss of competitiveness of the euro area;

K.  whereas the common issuance of debt, with joint and several liabilities, and an enhanced fiscal integration, with budgetary discipline and control, are two faces of the same coin;

1.  Takes note of the considerable crisis mitigation and resolution efforts, and underlines the new reinforced EMU governance framework, the latest agreements reached regarding the rescue funds and the decisions taken by the ECB; believes, however, that an agreement on a lasting solution is still needed in order to build a balanced approach that combines solidarity and responsibility within the euro area; recalls that three Member States outside the euro area have also received help to overcome their sovereign debt crisis;

2.  Remains extremely concerned about the ongoing euro area crisis and the threat it represents to the well-being of millions of people experiencing poverty and unemployment across the EU; points out that, in order to preserve the integrity of the Economic and Monetary Union, while pursuing structural reforms and developing a fiscal capacity for the euro area that could help absorb country-specific economic shocks or facilitate such structural reforms, alternative ways to maintain access to the markets, or to reduce the cost of borrowing for Member States, need to be found that do not rely solely on rescue mechanisms such as the ESM and EFSF;

3.  Welcomes the European Council’s decision of 30 June 2012 to explore ways of improving the economic and financial architecture of the euro area while avoiding moral hazard and achieving sound and sustainable public finances; considers that a long-term vision for a stronger Union needs to be built on enhanced democratic legitimacy, based on the Community method and accompanied by a time-bound roadmap;

4.  Notes that the European Financial Stabilisation Mechanism (EFSM), the European Financial Stability Facility (EFSF) and the European Stability Mechanism (ESM) are the most important firewalls designed so far by the EU; is mindful that the role of the ESM regarding solvency and ring-fencing issues should not be disregarded in the future; welcomes the commitment taken by the EU Council on 18-19 October 2012 that, when an effective single supervisory mechanism is established, involving the ECB, the ESM could, following a regular decision, have the possibility to recapitalise euro area banks directly;

5.  Stresses that a credible strategy for fiscal consolidation and structural reforms throughout all Member States are necessary to restore fiscal credibility, and are essential to achieve a sustainable balance of payments and sound and sustainable public finances; sound state finances are necessary for the introduction and functioning of a common debt issuance system;

6.  Welcomes the presentation of the Green Book, which fulfils a long-standing request of Parliament; considers that the introduction of stability bonds would be an operation at par in importance with the introduction of the single currency;

7.  Welcomes the fiscal consolidation and structural reform efforts undertaken by the Member States, and acknowledges the difficult and demanding efforts that are being requested from the European citizens; urges the Member States to continue to comply with commitments and agreements concluded in terms of fiscal consolidation, while taking due account of the macroeconomic context, and to improve their efforts to reduce excessive macroeconomic imbalances;

8.  Is deeply concerned, however, that despite the efforts at reform and consolidation made by Member States, investors and players on the financial markets fail to appreciate sufficiently the efforts made so far and continue to put speculative pressure on policies, which is reflected in widening spreads and high volatility;

9.  Believes that there is an urgent need to take action with a view to endorsing a longer-term strategy for the euro area which ensures sound public finances, sustainable growth, social cohesion and high levels of employment, while preventing moral hazard and supporting convergence by moving towards fiscal union; is pleased to note that the report presented by the Presidents of the European Council, the Commission, the Euro Group and the ECB has launched a debate concerning a comprehensive, ambitious and credible strategy;

10.  Recognises the signs of distress showing on sub-sovereign debt markets and how they link to stress in the respective Member States;

11.  Calls on Member States with large sub-sovereign debts to put in place mechanisms to issue common stability bonds that, linked to fiscal discipline conditionality, relieves sub-sovereign debt stress to levels equivalent to that of their Member States;

12.  Welcomes the fact that the euro has risen to second place worldwide as a global reserve currency; points out that it is in the long-term strategic interest of the eurozone to draw every possible benefit from the single currency, such as the possibility of establishing a common liquid and diversified bond market and of reinforcing the euro as a global reserve currency; considers that this requires an integrated European financial, economic and budgetary framework;

13.  Notes that an integrated budgetary framework is essential to ensure sound fiscal policy, encompassing coordination, joint decision-making, greater enforcement and commensurate steps towards common debt issuance, and that, currently, some of the proposed schemes of mutualisation of public debt may not be compatible with provisions of constitutional law in certain Member States;

14.  Underlines that the current situation has induced, in the short run, a ‘flight to quality’ (quest for the safest assets, even with very low returns), resulting in funding challenges for banks and other financial institutions;

15.  Is concerned about banks holding large amounts domestic government bonds which is creating a perverse feedback effect when pressure on sovereign debt turns into pressure on banks; recalls that the diversification of assets and liabilities is a tool to ensure stability and one of the neglected advantages resulting from the internal market;

16.  Stresses that all existing and future instruments or institutions which are sensu stricto or sensu lato part of the economic governance framework of the Union need to be democratically legitimised;

17.  Believes that the prospect of common bonds may be a strong signal to financial markets, help preserve the integrity of the EMU, underpin a return to economic stability and reduce uncertainty, provided that progress is made with EU financial and budgetary integration and supervision; reiterates its position that sequencing is a key issue, involving a binding roadmap similar to the Maastricht criteria for introducing the single currency; asks for further clarification on the Commission’s proposal to make the common debt issuance conditional, e.g. on respect for the Stability and Growth Pact;

18.  Recommends that the Commission define exit and entry criteria based on strong fiscal consolidation and budgetary discipline, while also taking into account the current crisis and the fiscal adjustments being pursued in a number of euro area countries;

19.  Notes the positive and negative developments in the euro area since 1999 and stresses that interest-rate convergence for sovereign debt has created incentives for building up unsustainable debt levels; observes that, in the public and political debate, various possible ways of partially issuing common debt securities have been proposed, such as the pooling of certain short-term financing instruments on a limited and conditional basis (eurobills) or the gradual rollover to a European redemption fund;

20.  Underlines that any move towards the common issuance of bonds should take the single market perspective fully into account, ensuring that no unnecessary obstacle or imbalance is created between participating and non-participating Member States;

21.  Recalls that, even under a common bond issuance scheme, every Member State is obliged to pay back the entirety of its debt; recalls that common bond issuance is no guarantee against a Member State defaulting on its debt;

22.  Believes that only commonly issued bonds, ensuring strict seniority status to bond holders, should be considered, in order to protect the EU taxpayers;

23.  Acknowledges that inadequate competitiveness and a failure to undertake structural reforms are crucial factors, in real economic terms, in the continuing decline in the economic situation of a country;

24.  Notes that most proposals for eurobonds include ways to reduce access to the bonds for Member States whose budgetary positions spin out of control; calls, therefore, for mechanisms to be maintained that are able to help Member States that are experiencing difficulties in the form of a liquidity crisis (as opposed to a solvability crisis) and that are excluded from the common issuance of bonds; believes that the ESM should be maintained for that purpose; believes that the ESM should be made subject to the Community method;

25.  Asks the Commission to elaborate further on the criteria of allocation of the loans to the Member States, as the Green Book only states that this would be done ‘according to their needs’; insists that the capacity to service the debt should be one of the central allocation criteria;

26.  Points out that the Commission’s Green Book states that the upper limit of 60 % of GDP in the blue bond proposals may be too high to insure the stability of the system, and asks for further clarification concerning that limit;

27.  Believes that it is essential to establish a roadmap for finding, in the short term, an exit from the current crisis, and for moving, in the long term, towards a fiscal union by completing, strengthening and deepening the economic and monetary union;

28.  Calls on the Commission as soon as possible to present a report to Parliament and the Council examining the options for, and – if appropriate – making proposals for a roadmap towards, common issuance of public debt instruments, taking into account financial, budgetary and legal aspects; considers that, in this context and in parallel to the intermediary Van Rompuy report of 12 October 2012 , the Commission should pay particular attention to the feasibility of introducing a redemption fund which combines temporary common issuance of debt instruments, and strict rules on fiscal adjustment among those countries whose indebtedness exceeds 60 % of GDP, with the participating countries undertaking to make their repayments, in order to allow all participating countries to reduce excessive debt over a benchmark period of 25 years, which is a longer period than provided for in the renewed Stability and Growth Pact but which likewise, in practice, requires sufficient economic growth and very strict financial discipline;

29.  Calls on the Member States to consider the issuance of common short-term debt in the form of eurobills, as referenced in the Van Rompuy report of 12 October 2012, to protect those Member States with fundamentally sustainable fiscal polices from illiquidity runs, as well as from the feedback loop between sovereign and banking crises and panic-induced negative externalities which create massive market distortions and generate implicit subsidies to Member States experiencing abnormally low interest rates on their sovereign bonds;

30.  Urges the Member States to study the feasibility of moving towards a system of European Safe Bonds or to other proposals based on the concept of a basket of bonds;

31.  Considers that eurobills, which could be time- and quantity-limited, would provide the time and stability for other measures such as the Stability and Growth Pact and the ‘Two- pack’ to prove themselves, and to put in place further longer term measures for future integration of the eurozone;

32.  Calls on the Commission to engage in clarifying the legal restraints to the common issuance of bonds, especially Article 125 of the TFEU and its implication for three possible issuing modes: joint liability, several liability, and joint and several liability; urges the Commission to analyse the possible use of article 352/1 of the TFEU, or any other legal basis, for the implementation of a partial common debt issuance solution without a necessary Treaty change, including a surveillance and reporting framework, on the basis of Articles 121 and 136 of the TFEU, aiming at monitoring, on a quarterly basis, progress made by euro area Member States and by the euro area as a whole towards a reinforced and genuine Economic and Monetary Union, as well as aiming at coordinating the issuance of sovereign debt instruments not covered by any mutualisation framework;

33.  Welcomes the principles of the decision taken by the Eurogroup Summit of 29 June 2012to ensure the stability of the euro ‘in particular by using the existing EFSF/ESM instruments in a flexible and efficient manner in order to stabilise markets for Member States respecting their Country Specific Recommendations and their other commitments including their respective timelines, under the European Semester, the Stability and Growth Pact and the Macroeconomic Imbalances Procedure’; acknowledges that the conditions will be set in a memorandum of understandings and that the ECB will ‘serve as an agent to EFSF/ESM in conducting market operations in an effective and efficient manner’;

34.  Believes that, in parallel, there is an urgent need to recapitalise the European banking sector and to complete the single market for financial services in the EU; welcomes the proposals of the Commission to establish a single European supervisory mechanism for banking institutions as well as a single European recovery and resolution regime, ideally in parallel with the entry into force of the single supervisory mechanism; further requests that. in the future, the ESM may fund banks in difficulties directly after the single supervisory mechanism is made operational; stresses that the single supervisory mechanism needs to be accountable to Parliament and the Council for the actions and decisions taken in the field of European supervision and should report to the competent committee of Parliament;

35.  Reaffirms the need to implement crisis management instruments, and acknowledges that inadequate regulation of the financial sector is a significant factor in the difficult budgetary situation of a number of Member States in the euro area;

36.  Believes that the common debt issuance under separate liability, similar to the EFSF bond, risks not being sufficiently attractive for investors if some Member States participating in the scheme still lack sustainable finances;

37.  Notes that it may become necessary to choose between three scenarios: first, a single interest rate for all participating Member states, resulting in a transfer of wealth between countries; second, a differentiated interest rate; and third, a single rate associated to a compensation scheme such as floated by the Commission, where Member States with lower ratings financially compensate those with better ratings;

38.  Asks the Commission to elaborate further its option to establish a system of differentiation of the interest rates between Member States with divergent ratings, especially in order to clarify how and by whom these ratings are established once market mechanisms are neutralised by the introduction of common bonds;

39.  Shares the view expressed by the Commission in its Green Paper that the stability of a eurobond system cannot rely solely on the shoulders of a small number of Member States with sustainable finances, and that such system would require a strengthened fiscal union, and stronger budgetary discipline and control, if it is to prevent moral hazard;

40.  Believes that if a system of mutualisation of debt is deemed possible, and is well interwoven in a stability-oriented framework, a Treaty change should be envisaged in the roadmap to a genuine Economic and Monetary Union, which could result in the issuance of bonds under joint and several liability;

41.  Believes that a system of partial substitution of national issuance (such as the blue/red bonds) might, on the one hand, reduce the cost of borrowing for those Member States that have sound and sustainable public finances, and, on the other hand, create an incentive for those with excessive debt to reduce it, as the risk associated with red bonds would be higher and interest rates would increase;

42.  Calls on the Commission, in cooperation, where appropriate, with the ECB and the European Banking Authority (EBA), and in consultation with the Council and Parliament, to assess carefully all the technicalities linked to any scheme such as: guarantees, tranching and pooling structures, potential collaterals, the balance between rule-based and market based-fiscal discipline, additional safeguards (notably in terms of participation to any scheme), restructuring, issuance, relations with existing stability mechanisms, the investor base, the regulatory requirements (e.g. capital adequacy), phase-in coverage of debt and maturity; urges the Commission to reflect on a legitimate and appropriate form for governance and accountability;

43.  Stresses that following the implementation of short-term measures to exit the crisis, and among the first steps of the binding roadmap, any follow-up must be undertaken on the basis of the ordinary legislative procedure, with full democratic accountability to be held on the level where the decision is taken; points out to the Commission that it may, when preparing its proposals, establish a temporary body composed of Members of the European Parliament and representatives of the Member States and of the ECB; recalls that it will make full use of its prerogatives and rights of initiative, including its right to initiate Treaty change; takes the view that this body should also look at the possibility of issuing genuine federal bonds in conjunction with an enhanced European budget;

44.  Stresses that the Commission should study the feasibility of each and all of the options presented in the Annex to this resolution (both phase 1 and phase 2), as these options are not necessarily alternative but can be, under certain circumstances, cumulative;

45.  Is aware that an ever increasing number of proposals for the mutualisation of debt are being made, especially in the academic field; notes that these proposals vary considerably;

46.  Shares the Commission’s concerns with regard to accounting issues relating to the treatment of stability bonds under national law; urges the Commission to assess comprehensively the impact of different guarantee structures for stability bonds on national debt-to-GDP ratios;

47.  Notes the moral hazard problem referred to by the Commission in the Green Paper, but, nonetheless, considers it necessary to perform a thorough analysis of the moral hazard problem in order to be able to draw the right conclusions and to find the appropriate solutions, if possible;

48.  Believes that the problem of moral hazard could be overcome with a good definition of guarantees and incentive mechanisms for fiscal discipline;

49.  Instructs its President to forward this resolution to the Council, the Commission and the European Central Bank.

ANNEX

The Roadmap

Hereafter is a possible path made of a series of steps that are not necessarily sequential, cumulative or mutually exclusive.

Step 1 - Immediate measures to exit the crisis

1.  Setting up of a temporary European redemption fund to reduce debt to sustainable levels at affordable interest rates

The Commission makes a proposal for the immediate setting up of a temporary European redemption fund along the following principles:

   one-off transfer of debt amounts above the Maastricht reference value of 60 % of GDP to a common fund subject to joint and several liability through a roll-in phase of five years; such transfer should be phased and start with the transfer of only 10 % of the debt above the Maastricht threshold of 60 % of the GDP; subsequent transfers should be gradual;
   limit participation to Member States without full adjustment programme; provide for a phasing in of Member States that have successfully completed an adjustment programme; The bridge for participation for Member States under an adjustment programme shall be properly assessed;
   oblige Member States to autonomously redeem the transferred debt over a benchmark period of 25 years;
   apply strict conditions which could take the form of (i) posting collateral; (ii) commit to fiscal consolidations plans and structural reforms;
   implement the numerical fiscal rules of the reinforced EMU framework to limit the debts that remain exclusively with the participating Member States at a maximum of 60 % of GDP;
   strengthen the co-ordination by implementing the new framework of economic governance together with a reinforced EU 2020 agenda and a binding structural reform agenda monitored by the Commission;
   provide for transparent and predictable exit procedures for Member States. Staying should be incentivised and therefore exit should be costly; failure to respect commitments during the roll-in phase should immediately stop the roll-in phase and failure to respect commitments at any time should forfeit the collateral deposited with the Fund.

2.  Introducing eurobills to protect Member States from illiquidity runs

The Commission makes a proposal for the immediate setting up of a system for the issuance of common short-term debt along the following principles:

   establish an agency or use an already existing entity to issue eurobills with the participation of all eurozone Member States without full adjustment programmes; provide for a phasing in of Member States that have successfully completed their adjustment programmes;
   those Member States that do not comply with the rules set-out in the Stability and Growth Pact might pay a penalty interest rate;
   maximum maturity of eurobills (amounting to maximum 10 % of GDP), which allows for continued monitoring and due to short term maturity frequent renewal of guarantees;
   eurobills replace all short-term debt to be issued by Member States which consequently remain solely responsible for issuing their own debt for longer maturities which should be monitored and limited according to each country needs, fiscal situation and debt ratio;
   adopt measures for the coordination of the issuance of sovereign debt instruments non covered by any mutualisation framework;
   provide for participation by national parliaments as foreseen by constitutional rules of the Member State concerned;

The Commission should take into account the conclusions drawn by the final Van Rompuy report on a genuine Economic and Monetary Union.

Step 2 - Partial common issuance - Introducing Blue bonds: annual allocated debt ≤ 60 % of GDP to be issued without a Treaty change

The Commission shall study and report its conclusions to the European Parliament on the possibility of proposals for the setting up of a system for the allocation of debt below 60 % of GDP to be issued in common, which is safeguarded by national debt brakes or other adequate mechanisms to avoid moral hazard according to principles such as:

   limit participation to Member States that comply with the Stability and Growth Pact and the communitarised fiscal compact in accordance with Article 16 of the TSCG and are not under a full adjustment programme;
   strictly limit the amount of debt to be issued under joint and several liabilities to a part of less than 60 % of GDP by prohibiting participating Member States from issuing senior debt outside the common issuance;
   the ultimate decision on the allocation of Blue Bonds and their corresponding guarantees will have to be taken by the national parliaments of all the participating countries;
   require participating Member States to post collateral;
   design an allocation mechanism taking into account the respect of the fiscal discipline, the economic cycle, historic spreads and weighted by borrowing requirements.

Step 3 - Full common issuance of national debt involving a Treaty change

On the basis of the work of the committee, and after all eventual changes to the EU legal framework and, if necessary, a Treaty change and taking into account where necessary Member States’ constitutional changes, if appropriate, the Commission puts forward proposals for the setting up of a system for the common issuance of bonds according to the following principles:

   limit participation to Member States which comply with the conditions as set out in phase 2;
   establish a European debt agency for the issuance of bonds,
   establish appropriate, democratically legitimate institutions which would among others be in charge of the surveillance and coordination of national fiscal policies and the competitiveness agenda, as well as the external representation of the euro area in international financial institutions;

Step 4 - Common issuance of a genuine European debt in conjunction with an enhanced European budget involving a Treaty change

The Commission, after having prepared all eventual changes to the EU legal framework and where appropriate euro area legal framework, puts forward proposals for possible issuance of bonds to finance EU investments for EU public goods (e.g. infrastructure, research and development, etc.), to facilitate adjustments to country-specific shocks by providing for some degree of absorption at the central level, to facilitate structural reforms that improve competitiveness and potential growth in relation to an integrated economic policy framework.

(1) http://ec.europa.eu/economy_finance/focuson/crisis/documents/131201_en.pdf
(2) http://www.consilium.europa.eu/uedocs/cms_data/docs/pressdata/en/ec/132809.pdf
(3) http://www.consilium.europa.eu/uedocs/cms_data/docs/pressdata/en/ec/131359.pdf
(4) OJ C 16 E, 22.1.2010, p. 8.
(5) Texts adopted, P7_TA(2011)0331.
(6) Texts adopted, P7_TA(2012)0046.

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