European Parliament legislative resolution of 14 June 2012 on the proposal for a regulation of the European Parliament and of the Council amending Council Regulation (EC) No 1300/2008 of 18 December 2008 establishing a multi-annual plan for the stock of herring distributed to the west of Scotland and the fisheries exploiting that stock (COM(2011)0760 – C7-0432/2011 – 2011/0345(COD))
– having regard to the Commission proposal to Parliament and the Council (COM(2011)0760),
– 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 (C7-0432/2011),
– 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 18 January 2012(1),
– having regard to Rule 55 of its Rules of Procedure,
– having regard to the report of the Committee on Fisheries (A7-0145/2012),
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 14 June 2012 with a view to the adoption of Regulation (EU) No .../2012 of the European Parliament and of the Council amending Council Regulation (EC) No 1300/2008 establishing a multi-annual plan for the stock of herring distributed to the west of Scotland and the fisheries exploiting that stock
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,
Having regard to the opinion of the European Economic and Social Committee(2),
After transmission of the draft legislative act to the national parliaments,
Acting in accordance with the ordinary legislative procedure(3),
Whereas:
(1) Council Regulation (EC) No 1300/2008 [of 18 December 2008] establishing a multi-annual plan for the stock of herring distributed to the West of Scotland and the fisheries exploiting that stock(4) empowers the Council to follow-up and revise the maximum fishing mortality rates and associated spawning stock biomass levels specified in Article 3(2) and referred to in Articles 4(2), 4(5) and 9 thereoftherein. [Am. 1]
(2)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. 2]
(3) In order to allow for an efficient achievement ofensure that the targets set in the multi-annual plan are achieved efficiently and for a swiftthat the reaction to changes in stock conditions is swift, 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 to revise maximum fishing mortality rates and associated spawning stock biomass levels, when scientific data indicate that these values are no longer appropriate to achieve the objective of the plan, should be delegated to the Commission in accordance with Article 290 of the Treaty. 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. [Am. 3]
(4) Since herring in the west of Scotland is a migratingmigratory species, the specification of the area itthat the stock of herring distributed to the west of Scotland currently inhabits should serve to identifydistinguish it from other stocks, but should not prevent this plan forfrom applying in the event that the speciesthat stock changes its mobility patterns. Articles 1 and 2 should be modified accordingly. [Am. 4]
(5)It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level.[Am. 5]
(6)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.[Am. 6]
(7)At the occasion of this amendment, a mistake in the heading of Article 7 should be corrected.[Am. 7]
(8) Regulation (EC) No 1300/2008 should therefore be amended accordingly,
HAVE ADOPTED THIS REGULATION:
Article 1
Regulation (EC) No 1300/2008 is amended as follows:
(1) Article 1 is replaced by the following:"
Article 1
Subject-matter
This Regulation establishes a multi-annual plan for the fisheries exploiting the stock of herring in the Westarea west of Scotland.' [Am. 8]
(2) [In Article 2 the following point (e) is added:
“(e) ”herring stock of herring in the Westarea west of Scotland' means the stock of herring (clupea harengus) distributed to the west of Scotland which currently inhabits Union and international waters of ICES divisionszones Vb, VIa and VIb and the part of ICES zone VIa which lies east of the meridian of longitude 7°W and north of the parallel of latitude 55°N, or west of the meridian of longitude 7°W and north of the parallel of latitude 56°N, excluding the Clyde.“ [Am. 9]
(3) Article 7 is replaced by the following:
“Article 7
Revision of maximum fishing mortality rates and associated spawning stock biomass levels
Where the Commission, on the basis of advice from STECF and possibly other scientific data indicatesand after consulting fully with the Pelagic Regional Advisory Council, finds that the values for the fishing mortality rates and associated spawning stock biomass levels specified in Article 3(2), Article 4(2) to (5) and Article 9 are no longer appropriate to achieve the objective set forthout in Article 3(1), the Commissionit shall fixadopt delegated acts in accordance with Article 9a fixing new values for suchthose rates and levels by means of delegated acts in accordance with Article 9a.“ [Am. 10]
(4) Article 8 is replaced by the following:
“Article 8
Evaluation and review of the multi-annual plan
1.At least every four years, starting from 18 December 2008, the Commission shall evaluate the operation and performance of the multi-annual plan. For the purpose of this evaluation, the Commission shall seek the advice of STECF and of the Pelagic Regional Advisory Council. Where appropriatenecessary, the Commission may propose adaptations toshall make 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 7.“
"
2.Paragraph 1 shall be without prejudice to the delegation of power in Article 7.' [Am. 11]
(5) The following Article 9a is inserted:"
'Article 9a
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 Article 7 and 8 shall be conferred on the Commission for an indeterminatea period of timethree years from ...(5)[dd/mm/yyyy] [insert date of entry into force of this the Regulation]. 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. 12]
3. The delegation of power referred to in ArticlesArticle 7 and 8 may be revoked at any time by the European Parliament or by the Council. A decision of revocationto 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. [Am. 13]
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 ArticlesArticle 7 and 8 shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of 2two 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 2two months at the initiative of the European Parliament or of the Council.
"
[Am. 14]
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.
European Parliament legislative resolution of 14 June 2012 on the proposal for a directive of the European Parliament and of the Council on control of major-accident hazards involving dangerous substances (COM(2010)0781 – C7-0011/2011 – 2010/0377(COD))
– having regard to the Commission proposal to Parliament and the Council (COM(2010)0781),
– having regard to Article 294(2) and Article 192(1) of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C7-0011/2011),
– 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 15 June 2011(1),
– after consulting the Committee of the Regions,
– having regard to the undertaking given by the Council representative by letter of 25 April 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 the Environment, Public Health and Food Safety and the opinions of the Committee on Industry, Research and Energy and the Committee on the Internal Market and Consumer Protection (A7-0339/2011),
1. Adopts its position at first reading hereinafter set out;
2. Takes note of the Commission statement annexed to this resolution;
3. 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;
4. 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 14 June 2012 with a view to the adoption of Directive 2012/.../EU of the European Parliament and of the Council on the control of major-accident hazards involving dangerous substances, amending and subsequently repealing Council Directive 96/82/EC
(As an agreement was reached between Parliament and Council, Parliament's position corresponds to the final legislative act, Directive 2012/18/EU).
Annex to the legislative resolution
Statement by the Commission
Declaration on the exclusion of category acute toxic 3 dermal
(Seveso Annex I, part 1)
The Commission acknowledges that the compromise reached on its proposal implies an improvement of the level of protection of human health and safety and of the environment as compared with that provided by the current Seveso II Directive 96/82/EC.
The Commission intends to undertake further analysis of the likelihood, risks and potential consequences of major accidents involving dangerous substances classified acute toxic 3 dermal. Depending on the outcome of this analysis, the Commission may present a legislative proposal to also include this category within the scope of the Directive.
European Parliament legislative resolution of 14 June 2012 on the proposal for a regulation of the European Parliament and of the Council on food intended for infants and young children and on food for special medical purposes (COM(2011)0353 – C7-0169/2011 – 2011/0156(COD))
– having regard to the Commission proposal to Parliament and the Council (COM(2011)0353),
– 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 (C7-0169/2011),
– 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 the Protocol (No 2) on the application of the principles of subsidiarity and proportionality, by the Italian Senate, asserting that the draft legislative act does not comply with the principle of subsidiarity,
– having regard to the opinion of the European Economic and Social Committee of 26 October 2011(1),
– having regard to Rule 55 of its Rules of Procedure,
– having regard to the report of the Committee on the Environment, Public Health and Food Safety and the opinions of the Committee on Industry, Research and Energy and the Committee on the Internal Market and Consumer Protection (A7-0059/2012),
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 14 June 2012 with a view to the adoption of Regulation (EU) No .../2012 of the European Parliament and of the Council on food intended for infants and young children and, on food for special medical purposes, on food for people intolerant to gluten and on food intended for use in low and very low calorie diets [Am. 1]
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(2),
Acting in accordance with the ordinary legislative procedure(3),
Whereas:
(1) Article 114 of the Treaty on the Functioning of the European Union (TFEU) provides that measures having as their object the establishment and functioning of the internal market and which concern inter alia health, safety and consumer protection must take as a base a high level of protection taking account in particular of any new development based on scientific facts.
(2) The free movementsafety of safe and wholesome food, especially when it is intended for vulnerable groups, such as infants, young children and persons with special diseases, is a aspect of the internal market and contributes significantly to the health and well-being of citizens, and to their social and economic interestsprerequisite for the free movement of such persons and the proper functioning of the internal market. [Am. 2]
(2a)In this context, given that the relevant Union law has been drawn up to ensure that no food is placed on the market if it is dangerous, any substances that are liable to be harmful to the health of the groups of the population concerned should be excluded from the composition of the categories of foods covered by this Regulation. [Am. 3]
(3) Directive 2009/39/EC of the European Parliament and of the Council of 6 May 2009 on foodstuffs intended for particular nutritional uses(4) lays down general rules on the composition and preparation of such foods that are specially designed to meet the particular nutritional requirements of the persons to whom they are intended. The majority of the provisions laid down in that Directive date back to 1977 and should therefore be reviewedfail to address the difficulty experienced by consumers in making an informed choice between dietetic foods, fortified foods, foods bearing claims and foods for normal consumption. The interaction between that legislation and Union law adopted more recently, such as Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements(5), Regulation (EC) No 1924/2006 of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods(6), Regulation (EC) No 1925/2006 of the European Parliament and of the Council of 20 December 2006 on the addition of vitamins and minerals and of certain other substances to food(7) and Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers(8), is a further factor making it necessary to thoroughly overhaul Directive 2009/39/EC. [Am. 4]
(4) Directive 2009/39/EC establishes a common definition for ‘foodstuffs for particular nutritional uses’ and general labelling requirements, including that such foods should bear an indication of their suitability for the claimed nutritional purposes.
(5) The general composition and labelling requirements laid down in Directive 2009/39/EC are complemented by a number of non-legislative Union acts, which are applicable to specific categories of food. In that respect, Commission Directive 2006/141/EC(9) lays down harmonised rules with respect to infant formulae and follow-on formulae, whereas Commission Directive 2006/125/EC(10) lays down certain harmonised rules with respect to processed cereal-based foods and baby foods for infants and young children. Similarly, harmonised rules are also laid down by Commission Directive 96/8/EC of 26 February 1996 on foods intended for use in energy-restricted diets for weight reduction(11), Commission Directive 1999/21/EC of 25 March 1999 on dietary foods for special medical purposes(12) and Commission Regulation (EC) No 41/2009 of 20 January 2009 concerning the composition and labelling of foodstuffs suitable for people intolerant to gluten(13).
(6) In addition, Council Directive 92/52/EEC(14) lays down harmonised rules with respect to infant formulae and follow-on formulae intended for export to third countries.
(6a)According to the Council Resolution of 18 June 1992(15), the Union should contribute to the application of appropriate practices for the marketing of breast-milk substitutes in third countries by Community-based manufacturers.[Am. 5]
(7) Directive 2009/39/EC foresees that specific provisions could be adopted regarding the two following specific categories of food falling within the definition of foodstuffs for particular nutritional uses: ‘food intended to meet the expenditure of intense muscular effort, especially for sportsmen’ and ‘food for persons suffering from carbohydrate metabolism disorders (diabetes)’. With regard to food intended to meet the expenditure of intense muscular effort, no successful conclusion could be reached as regard the development of specific provisions due to widely diverging views among Member States and stakeholders concerning the scope of the specific legislation, the number of sub-categories of the food to be included, the criteria for establishing composition requirements and the potential impact on innovation in product development. As regards special provisions for food for persons suffering from carbohydrate metabolism disorders (diabetes), a Commission report(16) concludes that the scientific basis for setting specific compositional requirements is lacking. Nevertheless, the undertaking made by the Commission in Directive 2009/39/EC to recognise the nutritional requirements of sportspeople should still apply, as supported by scientific opinions of the European Food Safety Authority (the ‘Authority’) on claims relevant to active individuals, and the report of the Scientific Committee on Food of 28 February 2001 on composition and specification of food intended to meet the expenditure of intense muscular effort, especially for sportsmen. Therefore, the Commission should assess, not later than 1 July 2015, the need to review general food law in this regard. [Am. 6]
(7a)The Commission report of 26 June 2008 on food for persons suffering from carbohydrate metabolism disorders (diabetes)(17) concludes that the scientific basis for setting specific compositional requirements is lacking. This Regulation is therefore not the appropriate legal framework for that category of food. According to the Commission, it is more important, as regards persons with diabetes, to consider the quantity and model of food absorbed. This conclusion is in no way contrary to the establishment of a Union-wide strategy comprehensively targeting diabetes (Type 1 and Type 2), which affects more than 32 million Union citizens. Those figures, which are expected to increase by 16 % by 2030 as a result of the obesity epidemic and the ageing of the European population, therefore merit careful consideration at Union level, including in the area of research and development. [Am. 7]
(8) Directive 2009/39/EC also requires a general notification procedure at national level for food presented by food business operators as falling under the definition of ‘foodstuffs for particular nutritional uses’ and for which no specific provisions are laid down in Union law, prior to their placing on the Union market, in order to facilitate the efficient monitoring of such food by the Member States.
(9) A report from the Commission to the European Parliament and the Council on the implementation of that notification procedure(18) showed that difficulties may arise from different interpretations of the definition of foodstuffs for particular nutritional uses which appeared to be open to different interpretations by the national authorities. It therefore concluded that a revision of the scope of Directive 2009/39/EC would be required to ensure a more effective and harmonised implementation of the Union legislation.
(10) A study report(19)concerning the revision of the legislation on foodstuffs for particular nutritional uses confirms the findings of the abovementioned Commission report on the implementation of the notification procedure and indicates that an increasing number of foodstuffs are today marketed and labelled as foodstuffs suitable for particular nutritional uses, due to the broad definition laid down in Directive 2009/39/EC. The study report also points out that the type of food regulated under that legislation differs significantly between Member States; similar food could at the same time be marketed in different Member States as food for particular nutritional uses and/or as food for normal consumption addressed to the population in general or to certain sub-groups thereof such as pregnant women, postmenopausal women, older adults, growing children, adolescents, variably active individuals and others. This state of affairs undermines the functioning of the internal market, creates legal uncertainty for competent authorities, food business operators and consumers, while the risks of marketing abuse and distortion of competition cannot be ruled out.
(11) It appears that other Union acts recently adopted are more adapted to an evolving and innovative food market than Directive 2009/39/EC. Of particular relevance and importance in that respect are: Directive 2002/46/EC, Regulation (EC) No 1924/2006 and Regulation (EC) No 1925/2006. Furthermore, the provisions of these Union acts would adequately regulate a number of the categories of food covered by Directive 2009/39/EC with less administrative burden and more clarity as to the scope and objectives.
(11a)There is therefore a need to remove differences in interpretation and to tackle difficulties for Member States and food business operators in combining the different pieces of food legislation, by simplifying the regulatory environment. This would ensure that similar products are treated in the same way across the Union and would create a more level playing field for all operators across the internal market, especially small and medium-sized enterprises (SMEs). [Am. 8]
(12) Moreover, experience shows that certain rules included in or adopted under Directive 2009/39/EC are no longer effective to ensure the functioning of the internal market.
(13) Therefore, the concept of ‘foodstuffs for particular nutritional uses’ should be abolished and Directive 2009/39/EC should be replaced by the present act. To simplify its application and to ensure consistency throughout the Member States, the present act should take the form of a Regulation.
(14) Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety(20) establishes common principles and definitions for Union food law in order to ensure a high level of health protection andof human health and consumer interests, while ensuring the effective functioning of the internal market. It establishes the principles of risk analysis in relation to food, sets out that pursuant to the precautionary principle provisional risk management measures can be adopted, and establishes the structures and mechanisms for the scientific and technical evaluations which are undertaken by the Authority. Therefore, certain definitions laid down in that Regulation must also apply in the context of the present Regulation. Moreover, for the purpose of this Regulation, the Authority should be consulted on all matters likely to affect public health. [Am. 9]
(14a)Where a risk to life or health exists, whether immediate or in the long term, but scientific uncertainty persists, the precautionary principle should apply to ensure a high level of health protection, taking into account cumulative toxic effects and the particular health sensitivities of the particularly vulnerable groups of the population specified in this Regulation. [Am. 10]
(15) A limited number of categories of food constitutes the sole source of nourishment of certain groups of the population or represent a partial source of nourishment; such categories of food are vital for the management of certain conditions and/or are essential to maintain the intended nutritional adequacy for certain well-established vulnerable groups of the population. Those categories of food include infant formulae and follow-on formulae, processed cereal-based food and baby food and, food for special medical purposes, food for people intolerant to gluten and food intended for use in low and very low calorie diets. Experience has shown that the provisions laid down in Directive 2006/141/EC, Directive 2006/125/EC, as well as Directive 1999/21/EC ensure the free movement of such food in a satisfactory manner, while ensuring a high level of protection of public health. Food intended for use in very low calorie diets is currently not covered by Directive 96/8/EC but solely by Directive 2009/39/EC. It is appropriate that this Regulation focuses on the general compositional and information requirements for infant formula and follow-on formulae, processed cereal-based food and baby food for infants and young children and to, food for special medical purposes, food for people intolerant to gluten and food intended for use in low and very low calorie diets, while taking into account Directive 2006/141/EC, Directive 2006/125/EC and Directive 1999/21/EC. [Am. 11]
(16) To ensure legal certainty, definitions laid down in Directive 2006/141/EC, Directive 2006/125/EC and, Directive 1999/21/EC, Regulation (EC) No 41/2009 and Directive 96/8/EC should be transferred to this Regulation. However, the definitions of infant formulae and follow-on formulae, processed cereal-based food and baby food, and food for special medical purposes, food for people intolerant to gluten and food intended for use in low and very low calorie diets should be regularly adapted taking into account technical and scientific progress and relevant developments at international level, as appropriate. [Am. 12]
(16a)According to the recommendations of the World Health Organization, low-birth-weight infants should be fed their mother's own milk. Nonetheless, low-birth-weight and pre-term infants often have special nutritional requirements which cannot be met by the mother's own milk or standard infant formulae. Food for such infants should comply with rules applicable to food for special medical purposes, when this kind of food is chosen as the most appropriate formula, taking into account the specific medical situation of the infant. Formula intended for low-birth-weight or pre-term infants should in any event comply with the requirements of Directive 2006/141/EC. [Am. 13]
(17) It is important that ingredients used in the manufacture of the categories of food covered by this Regulation are appropriate to satisfy the nutritional requirements of, and are suitable for the persons to whom they are intended and that their nutritional adequacy has been established by generally accepted scientific data. Such adequacy should be demonstrated through a systematic and independent review of the available scientific data. [Am. 14]
(17a)It is important that pesticides, maximum residue levels for which are authorised by Directive 2006/141/EC and Directive 2006/125/EC and which do not satisfy the safety conditions set out in 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(21) be banned from the market and that they not be used in the production of food covered by this Regulation. [Am. 15]
(17b)Maximum residue levels of pesticides set out in relevant Union law, in particular Regulation (EC) No 396/2005 of the Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin(22), should apply without prejudice to specific provisions set out in this Regulation and the delegated acts adopted in accordance with this Regulation. [Am. 16]
(17c)However, given the vulnerable nature of infants and young children, severe limitations on pesticide residues are required in infant formula and follow-on formula and processed cereal-based food and baby food for infants and young children. Specific maximum residue levels of pesticides for such products are set in Directive 2006/141/EC and Directive 2006/125/EC. Particular attention should be paid to pesticides containing substances classified as specifically hazardous to human health. [Am. 17]
(17d)At all stages of the food production chain, food businesses and food business operators, as defined in Regulation (EC) No 178/2002, should ensure that the food covered by this Regulation comply with the requirements of food law in general and of this Regulation in particular. [Am. 18]
(18) General labelling requirements are laid down in Directive 2000/13/EC of the European Parliament and of the Council of 20 March 2000 on the approximation of the law of the Member States relating to labelling, presentation and advertising of foodstuffs(23)Regulation (EU) No 1169/2011. Those general labelling requirements should, as a general rule, apply to the categories of food covered by this Regulation. However, this Regulation should also provide for additional requirements to, or derogations from, the provisions of Directive 2000/13/ECRegulation (EU) No 1169/2011, where necessary, in order to meet the specific objectives of this Regulation. [Am. 19]
(19) This Regulation should provide the criteria for the establishment of the specific compositional and information requirements for infant formula, follow-on formula, processed cereal-based food and baby food, and food for special medical purposes, food for people intolerant to gluten and food intended for use in low and very low calorie diets, taking into account Directive 2006/141/EC, Directive 2006/125/EC and Directive 1999/21/EC. In order to adapt the definitions of infant formula, follow-on formula, processed cereal-based food and baby food, and food for special medical purposes laid down in this Regulation taking into account technical and scientific progress and relevant developments at international level, to lay down the specific compositional and information requirements with respect to the categories of food covered by this Regulation, including for additional labelling requirements to, or derogations from, the provisions of Directive 2000/13/EC and for the authorisation of nutrition and health claims, 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. It is of particular importance that the Commission carries 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. [Am. 20]
(19a)The Commission should, after consulting the Authority, clarify the status of milks intended for children between 12 and 36 months, which are currently regulated by different legal acts of the Union, such as Regulation (EC) No 178/2002, Regulation (EC) No 1924/2006, Regulation (EC) No 1925/2006 and Directive 2009/39/EC, and submit a report to the European Parliament and the Council assessing whether further legislative action is required, at the latest 1 year after the date of the entry into force of this Regulation. If appropriate the report should be accompanied by a legislative proposal. [Am. 21]
(20) It is appropriate to establish and update a Union list annexed to this Regulation of vitamins, minerals, amino acids and other substances that may be added to infant formula, follow-on formula, processed cereal-based food and baby food, and food for special medical purposes and food intended for use in low and very low calorie diets, subject to certain criteria laid down in this Regulation. The annexed list should be adopted taking due account of the specific dietary habits of the groups of the population concerned and should take into account and replace the lists set out in Directives 2006/141/EC and 2006/125/EC, and Commission Regulation (EC) No 953/2009 of 13 October 2009 on substances that may be added for specific nutritional purposes in foods for particular nutritional uses(24), which does not apply to liquid or solid formula for infants and young children. Given the fact that the adoption and updating of the listthe Anneximplies theis a measure of general application of criteria set out in this Regulation, implementing powers should be conferred on the Commission in that respect. 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(25)to supplement or amend certain non-essential elements of this Regulation, 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 that respect. The Commission should adopt immediately applicable implementingdelegated acts updating the Union listAnnex, where, in duly justified cases relating to public health, imperative grounds of urgency so require. [Am. 22]
(21) At present, pursuant to the Opinion of the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) on the risk assessment of products of nanotechnologies, dated 19 January 2009, there is inadequate information on the risks associated with engineered nanomaterials and existing test methods may not be sufficient to address all of the issues arising in relation to engineered nanomaterials. ThereforeTaking account of that scientific opinion and in view of the particular sensitivity of the vulnerable groups for whom foods covered by this Regulation are intended, engineered nanomaterials should not be included in the Union list annexed to this Regulation for the categories of food covered by this Regulation, until an evaluationas long as their safety, based on adequate and sufficient test methods, their nutritional value and their suitability for the persons for whom the food is intended have not been demonstrated by the Authority is carried out. [Am. 23]
(22) In the interests of efficiency and legislative simplification and a clear desire to support innovation, there should be a medium-term examination of the question whether to extend the scope of the Union list annexed to this Regulation to other categories of food governed by other specific Union legislation. Such an extension should be decided by the European Parliament and the Council in accordance with the ordinary legislative procedure, on the basis of an evaluation by the Authority. [Am. 24]
(23) It is necessary to establish procedures for the adoption of emergency measures in situations where food covered by this Regulation constitutes a serious risk to human health. In order to ensure uniform conditions for the implementation of emergency measures, 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(26). The Commission should adopt immediately applicable implementing acts relating to emergency measures, where, in duly justified cases relating to public health, imperative grounds of urgency so require.
(24) Directive 92/52/EEC states that infant formulae and follow-on formulae exported or re-exported from the European Union have to comply with Union law unless otherwise required by the importing country. This principle has already been established for food in Regulation (EC) No 178/2002. For the sake of simplification and legal certainty, Directive 92/52/EEC should therefore be repealed.
(25) Regulation (EC) No 1924/2006 establishes the rules and conditions for the use of nutrition and health claims on food. Those rules should apply as a general rule to the categories of food covered by this Regulation, unless otherwise specified in this Regulation or non-legislative acts adopted pursuant to this Regulation.
(26) Currently, the statements ‘gluten-free’ and ‘very low gluten’ may be used for food intended for particular nutritional uses and for food for normal consumption under the rules specified in Regulation (EC) No 41/2009. SuchThose statements could be construed as nutrition claims, as defined in Regulation (EC) No 1924/2006. For the sake of simplification, those statements should be regulated solely by Regulation (EC) No 1924/2006this Regulation and comply with requirements therein. It is necessary that technical adaptations pursuant to Regulation (EC) No 1924/2006, incorporating the nutrition claims ‘gluten-free’ and ‘very low gluten’ and their associated conditions of use as regulated underherein. Regulation (EC) No 41/2009 be completed prior to the entry into application of this Regulationshould therefore be repealed. [Am. 90]
(26a)Labelling indicating ‘lactose free’ and ‘very low lactose content’ is currently not covered by Union law. Those indications are, however, important for people who are intolerant to lactose. The Commission should therefore clarify their status under general food law. [Am. 25]
(27) ‘Meal replacement for weight control’ and ‘total diet replacement for weight control’ are currently considered as food for particular nutritional uses and are governed by specific rules adopted under Directive 96/8/EC, while foods intended for use in very low calorie diets are governed by Directive 2009/39/EC only. However, more and more food intended for the general population has appeared on the market carrying similar declarations which are presented as health claims for weight control. Against the background of the growing number of food products containing generic claims and the risk of disorders in dietary habits arising from certain unsupervised diets, the Authority regularly carries out scientific assessments of health claim applications relating to meal replacement. The assessment carried out by the Authority does not cover the safety of compositional criteria put forward by the food business operator applying for the use of a claim or certain labelling methods. Specific provisions are therefore needed in this Regulation on food intended for use in low and very low calorie diets. Such provisions are an important nutrition and health safety tool for people seeking to lose weight. In order to eliminate any potential confusion between food marketed for weight control and in the interests of legal certainty and coherence of Union legislation, while protecting the most vulnerable, such statements on food intended for the general population should be regulated by Regulation (EC) No 1924/2006 and comply with requirements therein, with the exception of foods intended for use in low and very low calorie diets, which should comply with this Regulation. It is necessary that technical adaptations pursuant to Regulation (EC) No 1924/2006, incorporating the health claims referring to the body weight control for food presented as ‘total diet replacement for weight control’ and as ‘meal replacement for weight control’ and associated conditions of use as regulated under Directive 96/8/EC be completed prior to the entry into application of this Regulation. [Am. 26]
(27a)In order to ensure a high level of consumer protection, adequate procedures for oversight, in respect of both hygiene and composition, both before and after foods are placed on the market, should be established at Member State level. [Am. 27]
(27b)Pursuant to Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules(27), Member States should conduct inspections on the compliance of undertakings with this Regulation and the delegated acts adopted pursuant thereto, following a risk-based approach. [Am. 28]
(28) Since the objectives of this Regulation cannot be sufficiently achieved by the Member States and can therefore be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives.
(29) The Commission should take adequate transitional measures are necessaryto ensure legal certainty between entry into force and application of this Regulation and provide the assistance and up-to-date information necessary to the food business operators to enable food business operatorsthem to adapt to the requirements of this Regulation. [Am. 29]
(29a)To ease access of SMEs to the market which in some sectors, for example baby food and medical food, appear to be dominated by a few large companies, the Commission should, in close cooperation with concerned stakeholders, adopt guidelines, by means of delegated acts, in order to help undertakings, in particular SMEs, to comply with the requirements laid down in this Regulation and thus facilitate competitiveness and innovation. [Am. 30]
(29b)In order to facilitate market access for food business operators – especially SMEs – wishing to sell foods resulting from scientific and technological progress, the Commission, in close cooperation with the relevant stakeholders, should adopt guidelines on the procedure for placing such food on the market on a temporary basis. [Am. 31]
(29c)The Commission should be empowered to authorise, by means of delegated acts, food resulting from scientific and technological progress to be placed on the market on a temporary basis in order that proper benefit may be derived from the fruits of industry research pending the amendment of the delegated act for the specific food category concerned. However, in the interests of consumer health protection, a marketing authorisation may be granted only after the Authority has been consulted. [Am. 91]
HAVE ADOPTED THIS REGULATION:
Chapter I
Subject matter and definitions
Article 1
Subject matter
1. This Regulation, which complements Union law on food, establishes compositional and information requirements for the following categories of food: [Am. 33]
(a)
infant formula and follow-on formula;
(b)
processed cereal-based food and baby food for infants and young children;
(c)
food for special medical purposes, including formula intended for low-birth-weight and pre-term infants; [Am. 34]
(ca)
food for people intolerant to gluten; and [Am. 35]
(cb)
foods intended for use in low and very low calorie diets. [Am. 36]
2. This Regulation lays down rules for the establishment and updating of a clearly defined Union list, in Annex I, of vitamins, minerals and other substances that can be added to the categories of food referred to in paragraph 1 for a specific nutritional purpose. [Am. 37]
2a.The requirements laid down in this Regulation shall prevail over any other conflicting requirement of Union law applicable to food. [Am. 38]
Article 2
Definitions
1. For the purposes of this Regulation, the following definitions shall apply:
(a)
the definitions of ‘food’, ‘retail’ and ‘placing on the market’ set out in Article 2 and Article 3(7) and 3(8) of Regulation (EC) No 178/2002; [Am. 39]
(b)
the definitions of 'prepacked food' and 'labelling' and ‘pre-packaged foodstuffset out in points (a)(e) and (b)(j) of Article 1(3)2(2) of Directive 2000/13/ECRegulation (EU) No 1169/2011; [Am. 40]
(c)
the definitions of ’nutrition claim' and ‘health claim’ set out in points (4) and (5) of Article 2(2) of Regulation (EC) No 1924/2006;
(d)
the definition of ‘other substance’ set out in Article 2(2) of Regulation (EC) No 1925/2006; and
(da)
the definition of ‘engineered nanomaterial’ set out in point (t) of Article 2(2) of Regulation (EU) No 1169/2011. [Am. 41]
2. The following definitions shall also apply:
(a) ‘Authority’ means the European Food Safety Authority established by Regulation (EC) No 178/2002;
(b)
‘infant’ means a child under the age of 12 months;
(c)
‘young child’ means a child between one and three years;
(d)
‘infant formula’ means food used by infants during the first months of life and satisfying by itself the nutritional requirements of such infants until the introduction of appropriate complementary feeding;
(e)
‘follow-on formula’ means food used by infants when appropriate complementary feeding is introduced and constituting the principal liquid element in a progressively diversified diet of such infants;
(f)
‘processed cereal-based food’ means food:
(i)
intended to fulfil the particular requirements of infants in good health while they are being weaned, and of young children in good health as a supplement to their diet and/or for their progressive adaptation to ordinary food; and
(ii)
falling within the following four categories:
–
simple cereals which are or have to be reconstituted with milk or other appropriate nutritious liquids;
–
cereals with an added high protein food which are or have to be reconstituted with water or other protein-free liquid;
–
pastas which are to be used after cooking in boiling water or other appropriate liquids;
–
rusks and biscuits which are to be used either directly or, after pulverisation, with the addition of water, milk or other suitable liquids;
(g)
‘baby food’ means food intended to fulfil the particular requirements of infants in good health while they are being weaned, and of young children in good health as a supplement to their diet and/or for their progressive adaptation to ordinary food, excluding:
(i)
processed cereal-based food and
(ii)
milk intended for young children;
(h)
‘food for special medical purposes’ means food specially processed or formulated and intended for the dietary management of patients to be used under medical supervision. It is intended for the exclusive or partial feeding of patients with a limited, impaired or disturbed capacity to take, digest, absorb, metabolise or excrete ordinary food or certain nutrients contained therein or metabolites, or with other medically-determined nutrient requirements, whose dietary management cannot be achieved only by modification of the normal diet. Food for special medical purposes also includes formula intended for low-birth-weight and pre-term infants. Such formula also has to comply with Directive 2006/141/EC;[Am. 92]
(ha)
'formula intended for low-birth-weight and pre-term infants' means a food specifically developed to meet the medically-determined nutrient requirements of infants who are born prematurely or at a low birth weight; [Am. 43]
(hb)
'food for people intolerant to gluten' means foodstuffs for particular nutritional uses which are specially produced, prepared or processed to meet the special dietary needs of people intolerant to gluten; [Am. 44]
(hc)
'gluten' means a protein fraction from wheat, rye, barley, oats or their crossbred varieties and derivatives thereof and which is insoluble in water and 0,5 M sodium chloride solution; [Am. 45]
(hd)
'food intended for use in low calorie diets' or ‘LCD products’, and ‘food intended for use in very low calorie diets’ or ‘VLCD products’ means specifically formulated food which, when used as instructed by the manufacturer, replaces the total daily diet.
VLCD products contain between 400 and 800 kcal per day.
LCD products contain between 800 and 1 200 kcal per day. [Am. 46]
Food for special medical purposes within the meaning of point (h) of the first subparagraph falls within one of the following three categories:
(i)
nutritionally complete foods with a standard nutrient formulation which, when used in accordance with the manufacturer's instructions, may constitute the sole source of nourishment for the persons for whom they are intended;
(ii)
nutritionally complete foods with a nutrient-adapted formulation specific for a disease, disorder or medical condition which, when used in accordance with the manufacturer's instructions, may constitute the sole source of nourishment for the persons for whom they are intended;
(iii)
nutritionally incomplete foods with a standard formulation or a nutrient-adapted formulation specific for a disease, disorder or medical condition which are not suitable to be used as the sole source of nourishment. [Am. 47]
3.The Commission shall be empowered to adopt delegated acts in accordance with Article 15 to adapt the definitions of ‘infant formula’, ‘follow-on formula’, ‘processed cereal-based food’ and ‘baby food’ and ‘food for special medical purposes’ taking into account technical and scientific progress and relevant developments at international level, as appropriate. [Am. 48]
Chapter II
Placing on the market
Article 3
Placing on the market
1.Food referred to in Article 1(1) may be placed on the market only if it complies with the provisions of this Regulation and Union law applicable to food.
2.Food referred to in Article 1(1) that is imported into the Union for the purpose of being placed on the market shall comply with the applicable provisions of Union food law. Food referred to in Article 1(1) that is exported or re-exported from the Union for the purpose of being placed on the market in a third country shall comply with the applicable provisions of Union food law, save if specific circumstances in the importing country, linked, for example, to climate or topography, justify a different composition and a different market preparation.
3.Food referred to in Article 1(1) may be placed on the market only in the form of pre-packed food.
4.Member States may not restrict or forbid the placing on the market of food which complies with this Regulation, for reasons related to their composition, manufacturing, presentation or labelling. [Am. 49]
4a.In order to enable food referred to in Article 1(1) and resulting from scientific and technological progress to be placed on the market rapidly, the Commission may, after consulting the Authority, adopt delegated acts in accordance with Article 15, authorising, for a two-year period, the placing on the market of food referred to in Article 1(1) that does not comply with the rules on composition laid down by this Regulation or by the delegated acts adopted pursuant to this Regulation. [Am. 50]
Article 4
Pre-packaged food
Food referred to in Article 1(1) shall only be allowed on the retail market in the form of pre-packaged food. [Am. 51]
Article 5
Free movement of goods
Member States may not, for reasons related to their composition, manufacturing, presentation or labelling, restrict or forbid the placing on the market of food which complies with this Regulation.[Am. 52]
Article 6
Emergency measures
1. Where it is evident that a food referred to in Article 1(1) is likely to constitute a serious risk to human health and that that risk cannot be contained satisfactorily by means of measures taken by the Member State(s) concerned, the Commission on its own initiative or at the request of a Member State, shall without delay take appropriate interim emergency measures, including measures restricting or prohibiting the placing on the market of the food concerned, depending on the gravity of the situation. Those measures shall be adopted by means of implementing acts in accordance with the examination procedure referred to in Article 14(2).
2. On duly justified imperative grounds of urgency to contain or address a serious risk to human health, the Commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 14(3).
3. Where a Member State officially informs the Commission of the need to take emergency measures and the Commission has not taken action pursuant to paragraph 1, the Member State concerned may adopt appropriate interim emergency measures, including measures restricting or prohibiting the placing on the market of the food concerned, depending on the gravity of the situation, within its territory. It shall immediately inform the other Member States and the Commission thereof, giving the grounds for its decision. The Commission shall adopt implementing acts aiming at extending, amending or abrogating the national interim emergency measures. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 14(2). The Member State may maintain its national interim emergency measures until the implementing acts mentioned in this paragraph have been adopted.
Article 6a
Precautionary principle
Where, following an assessment of available scientific information, there are reasonable grounds for concern for the possibility of adverse effects but scientific uncertainty persists, provisional risk management measures may be adopted that are necessary to ensure a high level of protection of the vulnerable groups of the population for whom the food referred to in Article 1(1) is intended. [Am. 53]
Article 6b
Oversight
The national competent authorities shall ensure that an adequate system of oversight is put in place to ensure that food business operators comply with this Regulation and with the relevant health requirements. [Am. 54]
Chapter III
Requirements
Section 1
Introductory provisions
Article 7
Introductory provision
Food referred to in Article 1(1) shall comply with requirements of Union law applicable to food.
2.The requirements laid down in this Regulation shall prevail over any other conflicting requirement of Union law applicable to food. [Am. 55]
Article 8
Opinions of the Authority
The Authority shall provide scientific opinions in accordance with Articles 22 and 23 of Regulation (EC) No 178/2002 for the purpose of applying this Regulation.
Article 8a
Food for normal consumption
In the labelling, presentation and advertising of food for normal consumption the following shall be prohibited:
(a)
the use of the expression ‘specialised nutrition’, either alone or in conjunction with other words, to designate such food;
(b)
all other markings or any presentation likely to give the impression that the food belongs to one of the categories referred to in Article 1(1). [Am. 56]
Section 2
General requirements
Article 9
General composition and information requirements
1. The composition of food referred to in Article 1(1) shall be such that it is appropriate to satisfy the nutritional needs of, and it is suitable for the persons to whom it is intended, in accordance with generally accepted peer-reviewed and independently evaluated scientific data and medical opinion. [Am. 57]
2. Food referred to in Article 1(1) shall not contain any substance in such quantity as to endanger the health of the persons to whom they are intended.
3. The labelling, presentation and advertising of food referred to in Article 1(1) shall provide adequate consumer informationbe accurate, clear and easy to understand for consumers and shall not be misleading. It shall not attribute properties to such food for the prevention, treatment or cure of human disease, or imply such properties. [Am. 58]
3a.The labelling of infant formula and follow-on formula shall not include pictures of infants, nor shall it include other pictures or text which may idealise the use of the product. Graphic representations for easy identification of the product and for illustrating methods of preparation shall, however, be permitted. Directive 2006/141/EC shall be amended accordingly. [Am. 59]
4. The dissemination of useful information or recommendations with reference to the categories of food referred to in points (a), (b), (c) and (ca) of Article 1 (1) may be made exclusively by to persons with qualifications in medicine, nutrition,or pharmacy or other. Additional information disseminated by healthcare professionals responsible for maternal and child health care to the final consumer shall only be of a scientific and factual nature and shall not contain advertising. [Am. 60]
4a.In order to ensure efficient official monitoring, food business operators shall notify the competent authority of each Member State in which they place on the market food referred to in Article 1(1), by forwarding it a model of the product's label. [Am. 61]
4b.The use of pesticides in agricultural products intended for the production of food referred to in Article 1(1) shall be restricted as far as possible, without prejudice to Directive 2006/125/EC and Directive 2006/141/EC. [Am. 62]
4c.Specific requirements relating to food referred to in Article 1(1) that lay down limitations on the use of, or that ban, certain pesticides shall be updated regularly, with particular attention being paid to pesticides containing active substances, safeners or synergists classified under 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(28)as mutagen category 1A or 1B, carcinogen category 1A or 1B, toxic for reproduction category 1A or 1B, considered to have endocrine-disrupting properties that may cause adverse effects in humans, or active substances approved as ‘candidate for substitution’ pursuant to Article 24 of Regulation (EC) No 1107/2009. [Am. 63]
Section 3
Specific requirements
Article 10
Specific composition and information requirements
1. Food referred to in Article 1(1) shall comply with the requirements of Article 7 and composition and information requirements provided in Article 9.
2. Subject to the general requirements of Articles 7 and 9, and to the specific requirements of Articles 10a and 10b, and taking into account Directive 2006/141/EC, Directive 2006/125/EC and Directive 1999/21/EC as well as any technical and scientific progress, in particular the results of risk evaluations and the precautionary principle as referred to in Article 6a, the Commission shall be empowered to adopt delegated Regulations,acts no later than ...(29) , in accordance with Article 15, with respect to the following: [Am. 64]
(a)
the specific compositional requirements of food referred to in Article 1(1);
(b)
the specific requirements on the use of pesticides in agricultural products intended for the production of such food and on pesticides residues in such food;
(c)
the specific requirements on labelling, presentation and advertising of food referred to in Article 1(1) including the authorisation of nutrition and health claims thereof; those requirements shall include the specific related rules already in force for food referred to in Article 1(1); [Am. 66]
(ca)
the requirements for information to be provided on recommendations for appropriate use of food referred to in Article 1(1);[Am. 67]
(d)
the notification procedure for the placing on the market of a food referred to in Article 1(1) in order to facilitate the efficient official monitoring of such food on the basis of which food business operators shall notify the competent authority of the Member State(s) where the product is being marketed;
(e)
the requirements on promotional and commercial practices relating to infant formulae;
(f)
the requirements on information to be provided on infant and young child feeding in order to ensure adequate information on appropriate feeding practices; and
(fa)
a requirement for post-market monitoring of food referred to in Article 1(1), in order to verify whether the specific requirements are being complied with. [Am. 68]
3. Subject to the general requirements of Articles 7 and 9, and to the specific requirements of Articles 10a and 10b, and taking into account relevant technical and scientific progress, in particular the results of new risk assessments and the precautionary principle as referred to in Article 6a, the Commission shall update the delegated acts mentioned in paragraph 2 of this Article in accordance with Article 15. [Am. 69]
Where, in the case of emerging health risks, imperative grounds of urgency so require, the procedure provided for in Article 16 shall apply to delegated acts adopted pursuant to this paragraph.
Article 10a
Food for people intolerant to gluten
1.In addition to the requirements of Article 9, food intended for people intolerant to gluten consisting of or containing one or more ingredients made from wheat, rye, barley, oats or their crossbred varieties which have been especially processed to reduce gluten, shall contain a level of gluten not exceeding 100 mg/kg in the food as sold to the final consumer.
2.Food intended for people intolerant to gluten sold to the final consumer which contain a level of gluten:
–
not exceeding 100 mg/kg may be labelled ‘very low gluten content’;
–
not exceeding 20 mg/kg may be labelled ‘gluten free’.
3.Food intended for people intolerant to gluten shall also comply with the following criteria:
–
it shall provide roughly the same amount of vitamins and mineral salts as the foodstuffs they are replacing,
–
it shall be prepared with special care, in compliance with good manufacturing practice (GMP), to avoid gluten contamination,
–
where the terms ‘very low gluten content’ or ‘gluten free’ are used, they shall appear in proximity to the name under which the food is marketed.[Am. 70]
Article 10b
Foods intended for use in low calorie diets and very low calorie diets
1.LCD and VLCD products shall comply with the compositional requirements set out in Annex II to this Regulation.
2.All individual components making up LCD and VLCD products, as sold, shall be contained in a single package.
3.The name under which LCD and VLCD products are sold shall be:
(a)
for VLCD products,
'Total diet replacement for use in very low calorie diets‘;
(b)
for LCD products,
'Total diet replacement for use in low calorie diets‘.
4.The labelling of LCD and VLCD products shall bear, in addition to those provided for in Chapter IV of Regulation (EU) No 1169/2011, the following mandatory particulars:
(a)
the available energy value expressed in kJ and kcal, and the content of proteins, carbohydrates and fat, expressed in numerical form, per specified quantity of the product ready for use as proposed for consumption;
(b)
the average quantity of each mineral and each vitamin for which mandatory requirements are stipulated in paragraph 5 of AnnexII, expressed in numerical form, per specified quantity of the product ready for use as proposed for consumption;
(c)
instructions for appropriate preparation, when necessary and a statement as to the importance of following those instructions;
(d)
if a product provides a daily intake of polyols in excess of 20 g per day, when used as instructed by the manufacturer, there shall be a statement to the effect that the food may have a laxative effect;
(e)
a statement on the importance of maintaining an adequate daily fluid intake;
(f)
a statement that the product provides adequate amounts of all essential nutrients for the day;
(g)
a statement that the product should not be used for more than three weeks without medical advice.
5.The labelling, advertising and presentation of LCD and VLCD products concerned shall not make any reference to the rate or amount of weight loss which may result from their use. [Am. 71]
Article 10c
Access for SMEs to the internal market
The Commission shall, in close cooperation with all stakeholders and the Authority, adopt appropriate guidelines and provide technical guidance to enable undertakings, in particular SMEs, to comply with this Regulation and assist them in the preparation and presentation of the application for scientific assessment. The Commission shall be empowered to adopt delegated acts in accordance with Article 15 in order to adopt those guidelines. [Am. 72]
Chapter IV
Union List of permitted substances
Article 11
UnionEstablishment of alist of permitted substances
1. Taking account of Directives 2006/141/EC and 2006/125/EC and Regulation (EC) No 953/2009, the Commission shall be empowered to adopt, no later than ...(30), delegated acts in accordance with Article 15, in order to insert in Annex I a list of vitamins, minerals and other substances which may be added to each category of food referred to in Article 1(1).
1.2. Vitamins, minerals, amino acids and other substances may be added to food referred to in Article 1(1), provided that such substances meet the following conditions:
(a)
they do not, on the basis of the generally accepted and peer-reviewed scientific evidence available, pose a safety concern to the health of the consumer; and,
(b)
they are available for use by the human body;
(ba)
they are suitable for the nutritional use for which they are intended; and
(bb)
they have, on the basis of generally accepted scientific evidence, a nutritional or physiological effect.
2.No later than [2 years after the date of the entry into force of this Regulation], the Commission shall establish and subsequently update a Union list of permitted substances that meet the conditions of paragraph 1, by means of implementing Regulations. The entry of a substance in the Union list shall include a specification of the substance, and, where appropriate, specify the conditions of use and the applicable purity criteria. Those implementing Regulations shall be adopted in accordance with the examination procedure referred to in Article 14(2). On duly justified grounds of extreme urgency relating to emerging health risks, the Commission shall adopt immediately applicable implementing acts updating the Union list in accordance with Article 14(3).
2a.For substances referred to in paragraph 2 that are engineered nanomaterials, the following additional conditions shall apply:
(a)
the condition in point (a) of paragraph 2 has been demonstrated on the basis of adequate test methods; and
(b)
their nutritional value and the suitability for the persons for whom they are intended has been shown.[Am. 87]
Article 11a
Updating of the list of permitted substances
1. The addition of a new substance in the Union list referred to in paragraph 2to Annex I may be initiated either on the initiative of the Commission or following an application. Applications may be made by a Member State or by an interested party, who may also represent several interested parties (hereinafter referred to as the ‘applicant’). Applications shall be sent to the Commission, in accordance with paragraph 4.
1a.The applicant shall submit an application to the Commission in accordance with paragraph 2. The Commission shall acknowledge receipt in writing within 14 days of its receipt.
2. The application shall include:
(a)
the name and the address of the applicant;
(b)
the name and a clear description of the substance
(c)
the composition of the substance;
(d)
the proposed use of the substance and conditions thereof;
(e)
a systematic review of the scientific data and appropriate peer-reviewed studies performed following generally accepted expert guidance on the design and conduct of such studies;
(f)
scientific evidence demonstrating the quantity of the substance which does not endanger the health of the persons to whom it isintended and its suitability for the intended uses;
(g)
scientific evidence demonstrating that the substance is available for use by the human body and has a nutritional or physiological effect;
(h)
a summary of the content of the application.
3. If a substance is already included in the Union listAnnex I and there is a significant change in the production methods, or there is a change in particle size, for example through nanotechnology, the substance prepared by those new methods or with a change in particle size shall be considered as a different substance and the Union listbe modified accordingly before it can be placed on the Union market.A separate application shall be required for its inclusion in Annex I.
4.If a substance that is in Annex I no longer meets the conditions referred to in Article 11(2) and (2a), the Commission shall decide to remove that substance from Annex I.
5.The entry for a substance into Annex I shall include:
–
a specification of the substance;
–
where appropriate, a specification of the conditions of use; and
–
where appropriate, a specification of the applicable purity criteria.
6.The Commission shall be empowered to adopt delegated acts in accordance with Article 15 in order to update Annex I. Where, in the case of emerging health risks, imperative grounds of urgency so require, the procedure provided for in Article 16 shall apply to delegated acts adopted pursuant to this paragraph. [Am. 88]
Article 12
Confidential information relating to applications
1. Among the information provided in the application referred to in Article 11, confidential treatment may be given to information the disclosure of which might significantly harm the competitive position of the applicant.
2. Information relating to the following shall not, in any circumstances, be regarded as confidential:
(i)
the name and address of the applicant;
(ii)
the name and description of the substance;
(iii)
the justification for the use of the substance in or on specific food;
(iv)
information that is relevant to the assessment of the safety of the substance;
(v)
where applicable, the analysis method(s) used by the applicant;
(va)
any scientific data gathered from animal testing for the assessment of the safety of the substance. [Am. 75]
3. Applicants shall indicate which of the information provided they wish to be treated as confidential. Verifiable justification must be given in such cases.
4. The Commission shall decide after consulting with the applicants which information can remain confidential and shall notify applicants and the Member States accordingly.
5. After being informed of the Commission's position, applicants shall have three weeks in which to withdraw their application so as to preserve the confidentiality of the information provided. Confidentiality shall be preserved until this period expires.
Chapter V
Confidentiality
Article 13
General transparency andconfidentiality clause
The Commission, the Authority and the Member States shall, in accordance with Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents(31), guarantee the broadest possible access to documents and, in particular, shall assist members of the public with, and inform them about, the procedures for submitting applications for access to documents. They shall also take the necessary measures to ensure appropriate confidentiality of the information received by them under this Regulation, except for information which must be made public if circumstances so require in order to protect human health, animal health or the environment. [Am. 76]
Chapter VI
Procedural provisions
Article 14
Committee
1. The Commission shall be assisted by the Standing Committee on the Food Chain and Animal Health. 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.
Where the opinion of the committee is to be obtained by written procedure, that procedure shall be terminated without result when, within the time-limit for delivery of the opinion, the chair of the committee so decides or a simple majority of committee members so request.
3. Where reference is made to this paragraph, Article 8 of Regulation (EU) No 182/2011, in conjunction with Article 5 thereof, shall apply.
Article 15
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 2(3) and 103(4a), 10(2) and (3), 10c, 11(1) and 11a(6) of this Regulation shall be conferred for an indeterminatea period of time from the (*) [(*) Date of entry into force of the basic legislative act or from any other date set by the legislator.] of 5 years from ...(32). The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five 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. 77]
3. The delegation of powerspower to adopt delegated acts referred to in Articles 2(3) and 103(4a), 10(2) and (3), 10c, 11(1) and 11a(6) may be revoked at any time by the European Parliament or by the Council. A decision of revocation 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. 78]
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 Articles2(3)3(4a), 10(2) and (3), 10c, 11(1) and 1011a(6) 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 the Council. [Am. 79]
Article 16
Urgency procedure
1. Delegated acts adopted under this Article shall enter into force without delay and shall apply as long as no objection is expressed in accordance with paragraph 2. The notification of a delegated act to the European Parliament and to the Council shall state the reasons for the use of the urgency procedure.
2. Either the European Parliament or the Council may object to a delegated act in accordance with the procedure referred to in Article 15. In such a case, the Commission shall repeal the act without delay following the notification of the decision to object by the European Parliament or the Council.
Chapter VII
Final provisions
Article 16a
Food for people intolerant to lactose
By ...(33), the Commission shall present a report, if appropriate accompanied by a legislative proposal, to the European Parliament and to the Council, in order to clarify the status of labelling indications of ‘lactose free’ and ‘very low lactose content’ under general food law. [Am. 80]
Article 16b
Milks intended for young children
By ...(34), the Commission shall, after consulting the Authority, submit a report to the European Parliament and to the Council assessing the need for special provisions regarding the composition and labelling of milks intended for young children. This report shall consider the nutritional needs, the pattern of consumption, the nutritional intake and the levels of exposure to contaminants and pesticides of these young children. The report shall also consider whether these milks have any nutritional benefits when compared to a normal diet for a child who is being weaned. In the light of the conclusions of that report, the Commission shall either:
(a)
decide that there is no need for special provisions regarding the composition and labelling of milks intended for young children; or
(b)
if appropriate, submit, in accordance with the ordinary legislative procedure and on the basis of Article 114 of the TFEU, a legislative proposal.
Prior to the preparation of the Commission report referred to in the first paragraph, the milks intended for young children shall continue to fall within the scope of the relevant Union legislation such as Regulation (EC) No 178/2002, Regulation (EC) No 1925/2006 and Regulation (EC) No 1924/2006.[Am. 81]
Article 17
Repeal
1. Directive 92/52/EEC and Directive 2009/39/EC are repealed from ...(35). References to the repealed acts shall be construed as references to this Regulation.
2. Directive 96/8/EC and Regulation (EC) No 41/2009 are repealed from ...*.
Article 18
Transitional measures
Food not complying with this Regulation but complying with Directives 2009/39/EC and 96/8/EC, Regulations (EC) No 41/2009 and (EC) No 953/2009, and labelled prior to ...(36) may continue to be marketed after that date until stocks are exhausted.
Article 19
Entry into force
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
Annex I
List of permitted substances [Am. 89]
Annex II
Compositional requirements for LCD and VLCD products
These specifications refer to LCD and VLCD products ready for use, marketed as such or reconstituted as instructed by the manufacturer.
1.Energy
1.1.The energy provided by a VLCD product shall not be less than 1 680 kJ (400 kcal) and shall not exceed 3 360 kJ (800 kcal) for the total daily ration.
1.2.The energy provided by a LCD product shall not be less than 3 360 kJ (800 kcal) and shall not exceed 5 040 kJ (1 200 kcal) for the total daily ration.
2.Protein
2.1.The protein contained in LCD and VLCD products shall provide not less than 25 % and not more than 50 % of the total energy of the product. In any event the amount of protein of these products shall not exceed 125 g.
2.2.Point 2.1 refers to a protein the chemical index of which is equal to that of the FAO/WHO (1985) reference protein set out in Table 2. If the chemical index is lower than 100 % of the reference protein, the minimum protein levels shall be correspondingly increased. In any event the chemical index of the protein shall at least be equal to 80 % of that of the reference protein.
2.3.The ‘chemical index’ shall mean the lowest of the ratios between the quantity of each essential amino acid of the test protein in and the quantity of each corresponding amino acid of the reference protein.
2.4.In every event, the addition of amino acids is permitted solely for the purpose of improving the nutritional value of the proteins, and only in the proportions necessary for that purpose.
3.Fat
3.1.The energy derived from fat shall not exceed 30 % of the total available energy of the product.
3.2.The linoleic acid (in the form of glycerides) shall not be less than 4,5 g.
4.Dietary fibre
The dietary fibre content of LCD and VLCD products shall not be less than 10 g and shall not exceed 30 g for the daily ration.
5.Vitamins and minerals
The LCD and VLCD products shall provide for the whole of the daily diet at least: 100 % of the amounts of vitamins and minerals specified in Table 1.
Table 1
Vitamin A
(µg RE)
700
Vitamin D
(µg)
5
Vitamin E
(mg-TE)
10
Vitamin C
(mg)
45
Thiamin
(mg)
1,1
Riboflavin
(mg)
1,6
Niacin
(mg-NE)
18
Vitamin B6
(mg)
1,5
Folate
(µg)
200
Vitamin B12
(µg)
1,4
Biotin
(µg)
15
Pantothenic acid
(mg)
3
Calcium
(mg)
700
Phosphorus
(mg)
550
Potassium
(mg)
3 100
Iron
(mg)
16
Zinc
(mg)
9,5
Copper
(mg)
1,1
Iodine
(µg)
130
Selenium
(µg)
55
Sodium
(mg)
575
Magnesium
(mg)
150
Manganese
(mg)
1
Table 2
AMINO ACID REQUIREMENT PATTERN (1)
g/100 g protein
Cystine + methionine
1,7
Histidine
1,6
Isoleucine
1,3
Leucine
1,9
Lysine
1,6
Phenylalanine + tyrosine
1,9
Threonine
0,9
Tryptophan
0,5
Valine
1,3
(1) World Health Organisation. Energy and protein requirements. Report of a Joint FAO/WHO/UNU Meeting. Geneva: World Health Organisation, 1985. (WHO Technical Report Series, 724).
COM (2008) 392 Report from the Commission to the European Parliament and the Council on foods for persons suffering from carbohydrate metabolism disorders (diabetes), Brussels, 26.6.2008.
Report from the Commission to the European Parliament and the Council on the implementation of Article 9 of Council Directive 89/398/EEC on the approximation of the laws of the member States relating to foodstuffs intended for particular nutritional uses, COM (2008)0393, dated 27.6.2008.
An analysis of the European, social and environmental impact of the policy options for the revision of the Framework Directive on dietetic foods – Study report Agra CEAS Consulting, dated 29.4.2009.
– having regard to the Commission Communication of 8 October 2010 on smart regulation in the European Union (COM(2010)0543), announcing that the Commission would carry out a review of its consultation policy in 2011,
– having regard to the Commission Communication of 13 April 2011 entitled ‘Single Market Act – Twelve levers to boost growth and strengthen confidence – ’Working together to create new growth'' (COM(2011)0206),
– having regard to the Cracow declaration adopted at the Single Market Forum on 3-4 October 2011,
– having regard to the written question of 14 March 2011 to the Commission, entitled ‘Commission communications strategy / Languages for public consultation’ (E-002327/2011),
– having regard to Rule 110(2) of its Rules of Procedure,
A. whereas the Commission has proposed designating 2013 as the European Year of Citizens in order to raise people's awareness of the benefits and rights afforded by EU citizenship and stimulate their active participation in Union policy-making;
B. whereas disabled people have greater difficulties since they need accessible formats to facilitate communication;
C. whereas the involvement of the public is a fundamental component of democratic governance, whereas well designed and communicated public consultations are one of the main tools giving substance to the EU's policy of transparency, and whereas to date their potential for bridging the communication and information gap between citizens and the EU has not been fully exploited;
1. Calls on the Commission to actively seek communication with ordinary citizens by making full use of existing communication channels to distribute consultations to the general public and conduct them, in a targeted way, in conjunction with NGOs and other stakeholders;
2. Urges the Commission to ensure that every EU citizen's right to address the EU institutions in any of the EU official languages is fully respected and implemented by ensuring that public consultations are available in all EU official languages, that all consultations are treated equally and that there is no language-based discrimination between consultations;
3. Asks the Commission to ensure that all consultations are understandable to ordinary citizens and are carried out over a sufficiently long period of time to allow for increased participation;
4. Urges the Commission to guarantee the right of disabled people to be consulted using accessible formats;
5. Instructs its President to forward this resolution to the Commission.
Situation in Tibet
122k
43k
European Parliament resolution of 14 June 2012 on the human rights situation in Tibet (2012/2685(RSP))
– having regard to its previous resolutions on China and Tibet, in particular its resolutions of 27 October 2011(1) and 25 November 2010(2),
– having regard to its previous resolution of 7 April 2011 on the ban on the elections for the Tibetan government in exile in Nepal(3),
– having regard to the Universal Declaration of Human Rights of 1948,
– having regard to Article 36 of the Constitution of the People's Republic of China, which guarantees all citizens the right to freedom of religious belief,
– having regard to Rule 110(2) and (4) of its Rules of Procedure,
A. whereas respect for human rights, freedom of identity, culture, religion and association are founding principles of the EU and of its foreign policy;
B. whereas the EU raised the question of Tibetan minority rights during the 31st round of the EU-China Human Rights Dialogue held in Brussels on 29 May 2012; whereas the EU-China Human Rights Dialogue has not resulted in any significant improvements in the human rights situation of the Tibetans;
C. whereas the envoys of His Holiness the Dalai Lama have approached the Government of the People's Republic of China to find a peaceful and mutually beneficial solution to the issue of Tibet; whereas the talks between the two sides have delivered no concrete results and are currently frozen;
D. whereas the authorities of the People's Republic of China used disproportionate force while dealing with the protests of 2008 in Tibet and have, ever since, imposed restrictive security measures that curtail freedom of expression, freedom of association and freedom of belief;
E. whereas the number of victims of the 2008 protests may have exceeded 200, the number of those detained varies from 4 434 to more than 6 500, and there were 831 known political prisoners in Tibet at the end of 2010, of whom 360 were judicially convicted and 12 were serving life sentences;
F. whereas torture, including beating, use of electroshock weapons, long-term solitary confinement, starvation and other similar measures are reportedly used to extract confessions in the prisons of Tibet by the authorities of the People's Republic of China;
G. whereas 38 Tibetans, mostly monks and nuns, have reportedly set themselves on fire since 2009 in protest against restrictive Chinese policies in Tibet and in support of the return of the Dalai Lama and the right to religious freedom in the Aba/Ngaba county prefecture in Sichuan Province and other parts of the Tibetan plateau;
H. whereas the current state of wellbeing and the whereabouts of a number of victims of self-immolation remain unknown or unclear, namely Chimey Palden, Tenpa Darjey, Jamyang Palden, Lobsang Gyatso, Sona Rabyang, Dawa Tsering, Kelsang Wangchuck, Lobsang Kelsang, Lobsang Kunchok and Tapey;
I. whereas Gedhun Choekyi Nyima, the 11th Panchen Lama, was detained by the authorities of the People's Republic of China and has not been seen since 14 May 1995;
J. whereas Tibetan identity, language, culture and religion – the testimony to a historically rich civilisation – are endangered by the resettlement of Han people in the historical territory of Tibet and the extermination of the traditional nomadic lifestyle of the Tibetans;
K. whereas the EU is in the process of appointing and laying down the mandate of the EU Special Representative for Human Rights;
L. whereas the European Parliament's previous calls on the Vice-President of the Commission / High Representative of the Union for Foreign Affairs and Security Policy of the EU to address the situation in Tibet with her Chinese counterparts have not delivered the expected results;
1. Reiterates that the Strategic Partnership between the EU and the People's Republic of China should be based on shared principles and values;
2. Calls on the Vice-President of the Commission / High Representative of the Union for Foreign Affairs and Security Policy of the EU to increase and intensify efforts to address the human rights situation of the Tibetans in the framework of the EU-China Human Rights Dialogue;
3. Regrets, in this respect, the unwillingness of the Chinese authorities to hold the dialogue twice a year and their stance concerning the modalities and frequency of the meetings, with regard in particular to the strengthening of the civil society segment and the involvement of civil society in the dialogue; urges the Vice-President of the Commission / High Representative of the Union to make every effort to ensure that the human rights dialogue is more effective and result-oriented;
4. Commends the very important and successful democratisation process in the governance of Tibetans in exile by His Holiness the Dalai Lama and the recent transfer by him of his political powers and responsibilities to the democratically elected Kalon Tripa of the Central Tibetan Administration, which represents the aspirations of the Tibetan people;
5. Commends the decision of the democratically elected new Tibetan political leadership to continue to abide by the Middle-Way Policy of His Holiness the Dalai Lama, which seeks genuine autonomy for Tibetans within the People's Republic of China and within the framework of the Chinese Constitution;
6. Endorses the principles set out in the Memorandum on Genuine Autonomy for the Tibetan people, proposed by the envoys of His Holiness the Dalai Lama to their Chinese counterparts in 2008, which provide the basis for a realistic and sustainable political solution to the issue of Tibet;
7. Rejects the argument made by the Government of the People's Republic of China that the engagement of governments with His Holiness the Dalai Lama and members of the elected Tibetan leadership and the expression of support by governments for a peaceful resolution of the issue of Tibet through dialogue and negotiations constitute breaches of the ‘One China Policy’;
8. Calls on the authorities of the People's Republic of China to grant meaningful autonomy to the historical territory of Tibet;
9. Expresses disappointment that the Government of the People's Republic of China has been unwilling to continue the dialogue with the envoys of His Holiness the Dalai Lama since January 2010 and encourages the Chinese authorities to engage in a meaningful discussion with the representatives of the Central Tibetan Administration on the future of Tibet;
10. Insists that the authorities of the People's Republic of China respect the freedom of expression, freedom of association and freedom of belief of the Tibetans;
11. Urges the authorities of the People's Republic of China to allow an independent international investigation to be conducted into the 2008 protests and their aftermath, and calls for the release of the political prisoners;
12. Condemns any form of torture of persons in custody and invites and asks the authorities of the People's Republic of China to allow the independent international inspection of the prisons and detention centres in Tibet;
13. Reiterates its condemnation of the Chinese authorities' continued crackdown on Tibetan monasteries, and calls on the Chinese Government to guarantee freedom of religion both for the people of Tibet and for all of its citizens;
14. Insists that the Chinese authorities reveal the fate and whereabouts of all the victims of self-immolations in Tibet;
15. Reiterates its call to the Chinese authorities to reveal the fate and whereabouts of Chedun Choekyi Nyima, the 11th Panchen Lama;
16. Calls on the Chinese authorities to uphold the linguistic, cultural, religious and other fundamental freedoms of Tibetans and to refrain from settlement policies in favour of the Han people and to the disadvantage of the Tibetans in historical territories of Tibet, as well as from forcing Tibetan nomads to abandon their traditional lifestyle;
17. Calls on the Chinese authorities to lift all restrictions and allow unfettered access and freedom of movement throughout Tibet to independent media, journalists and human rights monitors;
18. Calls on the EU Special Representative for Human Rights, once appointed, to report regularly on the human rights situation in the People's Republic of China, in particular with regard to Tibet;
19. Urges the Vice-President of the Commission / High Representative of the Union for Foreign Affairs and Security Policy of the EU to appoint a special coordinator with a mandate to report regularly on Tibet in order to advance respect for the human rights of the Tibetan people, including their right to preserve and develop their distinctive identity and its religious, cultural and linguistic manifestations, to support constructive dialogue and negotiations between the Government of the People's Republic of China and the envoys of His Holiness the Dalai Lama, and to provide assistance to Tibetan refugees, in particular in Nepal and India;
20. Calls on the Vice-President of the Commission / High Representative of the Union for Foreign Affairs and Security Policy of the EU to address the human rights situation in Tibet at every meeting with the representatives of the People's Republic of China;
21. Instructs its President to forward this resolution to the Council, the Commission, the Vice-President of the Commission / High Representative of the Union for Foreign Affairs and Security Policy of the EU, the governments and parliaments of the Member States, the Government and Parliament of the People's Republic of China, the Secretary-General of the United Nations, the Tibetan Government-in-exile, the Tibetan Parliament-in-exile and His Holiness the Dalai Lama.
– having regard to the Commission Communication of 13 April 2011 entitled ‘Single Market Act. Twelve levers to boost growth and strengthen confidence ’Working together to create new growth'' (COM(2011)0206),
– having regard to the Commission Communication of 27 October 2010 entitled ‘Towards a Single Market Act for a highly competitive social market economy: 50 proposals for improving our work, business and exchanges with one another’ (COM(2010)0608),
– having regard to the Commission staff working document of 24 February 2012 entitled ‘Making the Single Market Deliver Annual Governance check-up 2011’ (SWD(2012)0025),
– having regard to the Commission staff working paper of 16 August 2011 entitled ‘The Single Market through the lens of the people: A snapshot of citizens’ and businesses' 20 main concerns' (SEC(2011)1003),
– having regard to the Conclusions of the Competitiveness Council of 10 December 2010,
– having regard to its resolution of 20 May 2010 on delivering a single market to consumers and citizens(1),
– having regard to its resolution of 6 April 2011 on a single market for enterprises and growth(2),
– having regard to its resolution of 6 April 2011 on a single market for Europeans(3),
– having regard to its resolution of 6 April 2011 on governance and partnership in the Single Market(4),
– having regard to its resolution of 1 December 2011 on the outcome of the Single Market Forum(5), held in Krakow (Poland) on 3-4 October 2011, and the European Council conclusions of 23 October 2011,
– having regard to Rule 110(2) of its Rules of Procedure,
A. whereas the European Single Market has brought tremendous benefits to the citizens of Europe, whilst opening up new opportunities for European businesses, especially small and medium-sized enterprises (SMEs);
B. whereas the Single Market is a key driver for economic growth and employment in the European Union; whereas Europeans have not yet fully benefited from the potential of the Single Market in many areas and whereas new incentives are needed, in particular to ensure effective labour mobility across Europe, together with adequate social cohesion, and to facilitate selling and buying across borders;
C. whereas the Single Market must not be seen in isolation from other horizontal policy areas, particularly health, social and consumer protection, labour law, the environment, sustainable development and external policies; whereas the concrete implementation of the EU 2020 Strategy needs a fully-fledged approach to the deepening of the Single Market;
D. whereas the current economic downspin, and the re-emergence of protectionist economic attitudes in Member States, have threatened some of the most visible achievements of the European integration process, which means that it is necessary to achieve the objectives originally set by the Services Directive, in the meantime avoiding damage to traditional economical sectors; whereas the Single Market is needed more than ever as a means to revitalise the European economy, by providing a concrete response to the current long-standing crisis, and to ensure the viability of the European project in the long term;
E. whereas the Member States and the EU institutions should agree on a binding calendar, and on the concrete measures needed to enforce the Single Market legislation and to abolish all remaining unjustified obstacles to the free circulation of goods, services and workers;
F. whereas the Member States and the EU institutions should focus on adopting and swiftly implementing the key pieces of legislation on growth, giving priority to tackling youth unemployment and cutting red tape;
I.Introduction
1. Stresses that strengthening the Single Market and underpinning it with the right economic governance should be at the core of the EU's growth agenda, and calls for the Single Market to be completed with utmost determination and speed, taking due account of the economic, social and environmental dimensions;
2. Highlights the strategic relevance of the Single Market Act, and of the identification of the ‘twelve levers’ for sustainable, smart and inclusive growth, as an important contribution to strengthening the Single Market in a comprehensive and balanced manner; emphasises that the Single Market Act is the result of a broad stakeholder and inter-institutional consultation process;
3. Is of the opinion that immediate priority should be given to the adoption of the 12 key actions of the Single Market Act, especially those which will facilitate completion of the digital single market, wherever possible, by the end of 2012; calls on the Commission to assist Member States in ensuring the implementation of the key actions aiming at early transposition, well ahead of the deadline;
4. Believes that there is a need to maintain the momentum achieved with the Single Market Act and proposes, therefore, that the Single Market Act should be a rolling programme to be updated and reviewed annually; welcomes the Commission's plan to further deepen the Single Market by taking stock of progress achieved with the Single Market Act before the end of 2012, with the aim of facilitating growth and improving the governance of the Single Market; reiterates that the Single Market Act should also address the EU's socio-economic problems and should work towards a market that is at the service of citizens;
5. Takes the view that the next steps for priority actions should largely be based on the growth-boosting ‘twelve levers’ of the Single Market Act, in order to focus political attention, ensure consensus around a balanced way forward, and deepen and modernise the Single Market, with special attention given to promoting its benefits to consumers and business; takes the view that the Single Market should also preserve social welfare and ensure fair working conditions;
6. Requests the Commission to make relevant detailed proposals by spring 2013;
II.Single Market governance
7. Reiterates that strong leadership on the part of the European institutions, and political ownership on the part of the Member States, is required to restore the credibility of – and confidence in – the Single Market;
8. Stresses that poor and late transposition, and inadequate implementation and enforcement of rules, prevent citizens and businesses from taking full advantage of the benefits of the Single Market;
9. Reiterates the need to reduce the transposition deficit of Single Market Directives to 0,5 % for outstanding legislation and 0,5 % for incorrectly transposed legislation by the end of 2012;
10. Stresses that there is a need for better and less EU legislation; calls on the Commission, therefore, to choose, where appropriate and principally where there is no need for further discretion when implementing EU legislation, regulations rather than directives as the preferred legal instrument for regulating the Single Market since they have clear advantages in terms of efficiency and effectiveness and create a level playing field for citizens and business, with greater potential for private enforcement;
11. Calls on the Commission to focus its efforts to improve the enforcement of Single Market legislation, especially in the services and goods sector, which are expected to have the highest potential for boosting economic growth in Europe; calls, therefore, on the Commission to pursue Single Market infringements swiftly and vigorously;
12. Asks the Commission to consider expanding innovative mechanisms, such as the mutual evaluation procedure of the Services Directive, to new areas in order to ensure better application of EU law;
13. Considers that correlation tables increase transparency in the process of ensuring the application of EU law;
14. Calls on the EU and the Member States to commit themselves to cut administrative burdens by an additional 25 % by 2015 and to modernise their public administrations;
15. Calls on the Commission to develop a ‘proportionality test’ to identify disproportionate EU legislation, and to repeal such legislation;
16. Welcomes the Commission's 2011 ‘Governance Check-Up’, which presents for the first time an integrated view of the various tools used in a ‘Single Market governance cycle’, including the Internal Market Scoreboard, the Solvit Annual Report and the ‘Your Europe’ website; strongly reaffirms its position regarding the importance of one-stop shops; commends the Commission for its work on the Your Europe portal, and encourages completion of the development of this innovative tool which serves as an essential complement to the ‘Points of Single Contact’ network by providing a single gateway to all the information and help services that citizens and businesses need in order to make use of their rights in the Single Market;
17. Encourages the Commission to adopt, without delay, an action plan to further reinforce and strengthen the role of SOLVIT, Your Europe Advice and the European Consumers' Centres, among others assistance services, in order to make them more visible to citizens and businesses;
18. Emphasises the importance of a stronger and earlier involvement of stakeholders in designing, adopting, implementing and monitoring the measures needed to boost growth and citizens' rights in the Single Market; emphasises, furthermore, that dialogue with social partners, national parliaments and civil society plays an essential part in restoring confidence in the Single Market, and should therefore be at the core of the renewed Single Market;
19. Calls on the Member States and the Commission to involve citizens more closely in the development of the Single Market, in particular by providing clearer information that will allow them to monitor the enforcement of Single Market rules, by fostering dialogue and communication with citizens in order to better understand their expectations, and by ensuring that citizens and businesses are able to exercise their rights and meet their obligations;
20. Reiterates the need for the continuous monitoring of the implementation of the Single Market Act at the highest political level; welcomes the engagement of the European Council with the monitoring of the implementation of the Single Market Act; calls on the Commission and the Member States to ensure proper implementation and transposition of Single Market legislation through more systematic, independent monitoring in order to guarantee a level playing field throughout the Union; proposes that transposition can be improved by working closely with Member States to discover the problems that they face when transposing legislation, including conflicts with national legislation, so that the Commission can assist them;
21. Calls on the Commission to monitor the completion of the Single Market within the annual exercise of the European Semester, taking account of the annual SMA Governance Check-up and the Scoreboard reporting mechanisms; takes the view that the annual monitoring should assess the extent to which consumers and businesses alike benefit from the Single Market, and should report on obstacles to its functioning;
22. Invites the Commission to propose a dedicated Growth initiative built on the concept of a competitive European Social Market Economy, based on the European semester, the SMA, the EU2020 Strategy and relevant existing decisions, and underpinned by funding from, inter alia, the Structural Funds, project bonds and the Research Framework Programme; suggests that the Growth initiative should be endorsed politically by the European Council and the European Parliament, following the consultation of the national parliaments, and that this process should feed into distinct country-specific recommendations that take into account the state of implementation of the Single Market;
III.The next steps to growth
23. Believes that it is important that sectors which have a direct impact on the daily lives of citizens and consumers' need to be at the centre of the Single Market policies and legislation;
24. Recalls the importance of an effective redress mechanism as a means of ensuring that consumers can pursue their rights; stresses that citizens should be better informed about these redress mechanisms and problem-solving tools with a view to facilitating consumer redress in cross-border purchases of goods and services;
25. Calls on all EU Member States to ensure full and complete implementation of the Services Directive, inter alia, by setting up user-friendly and comprehensive Points of Single Contact, and to follow up the mutual evaluation process and the performance checks; considers that the Member States should consider integrating these with the Points of Single Contact required under the Goods Package;
26. Calls on the Commission to bring forward the transparency mechanism provided in Article 59 of the MRPQ (Mutual Recognition of Professional Qualifications) Directive to identify areas where Member States are disproportionately blocking access to regulated professions;
27. Highlights the crucial role of public procurement in enhancing innovation and competitiveness and calls, therefore, for momentum to be maintained in this area; calls on the Commission, the Member States and local authorities to implement the new legislation on public procurements in a strategic manner that guarantees that public money invested in works, services and supplies engender sustainable growth, employment and social cohesion;
28. Underlines the need to quickly use unspent EU funds for measures tackling efficiently high youth unemployment; calls on Member States and the EU institutions to swiftly agree on binding targets and measures in the area of youth mobility (‘Youth on the Move’), as well as to speedily implement the Youth Opportunities Initiative;
29. Underscores that, in the digital era, the Union must fully realise the potential and opportunities that the internet, e-commerce and the diffusion of ICT – in SMEs and in public administration – present to the further development of the Single Market, making it available to all EU citizens; emphasises that the development of new technologies must take into account the need to protect all citizens, consumers and SMEs;
30. Calls on the Commission to look upon the development of the digital single market as a priority, so that consumers have full access to more competitive offers of goods and services; demands further action from the Member States in coordination with the Commission to overcome hurdles preventing citizens from having access to online services;
31. Calls for an ambitious Consumer agenda, encompassing legislative and policy actions, aimed at fully empowering average as well as vulnerable consumers;
32. Highlights the role of retail as a driver for growth and jobs, and as a building-block of the Single Market; welcomes the planned adoption of the Commission's comprehensive Retail Action Plan, setting out a strategy for a more efficient and fair retail market in Europe, building on positive achievements and addressing outstanding challenges, as well as a Communication assessing national measures in place to deal with contractual relations; recalls that the Action Plan, and the results of the multi-stakeholder dialogue on B2B (business-to-business) practices, will be presented at the first Retail Market Roundtable, to be convened by the end of 2012;
33. Believes that the external dimension of the Single Market needs to be reinforced, in particular by enhancing cooperation in the field of international standardisation, and that synergies achievable between the Union's internal and external economic policies, namely between the Single Market and trade, should be pursued;
34. Calls on the Commission, and urges the Member States, to promote the implementation of the Single European Sky II, for which the deployment of SESAR will play an important role, and calls on the Commission to put forward, by 2013, a proposal on the completion of a single European airspace through the reduction of the number of functional airspace blocks;
35. Emphasises the importance of developing infrastructures for large network industries and public services – including energy, transport services such as Cross-European railway networks, and electronic communications such as broadband access throughout the EU – as leverage for competitiveness, growth and employment; stresses the need to create a single European energy market in order to reduce EU energy dependence, enhance EU energy efficiency and improve affordability of prices;
36. Calls on the Commission to submit, no later than 31 December 2012, a proposal for a directive containing provisions on the relationship between infrastructure management and transport operations, and a proposal for opening-up the domestic rail passenger market which does not detract from the quality of rail transport services and which safeguards public service obligations;
37. Stresses the need to foster the role of SMEs in the Single Market by ensuring access to credit and financing, and by fully implementing the Small Business Act;
38. Calls on the Commission to propose measures to improve framework conditions for industry, and for SMEs, especially by enhancing the European Investment Bank's actions to support access to finance, and to foster research and innovation by substantially increasing key EU programmes for R&D and innovation and by making better use of unspent EU funds for growth-enhancing projects;
39. Recalls its request for the 14th Company Law Directive on the cross-border transfer of company seats, pointing out that such a directive would considerably facilitate companies' mobility in Europe; asks the Commission, moreover, to present legislative proposals that follow up on the Green Paper on Corporate Governance and to include them in the 2013 Work Programme;
40. Deplores the withdrawal of the proposed regulation for the statute of European mutual societies, and asks the European Commission to put forward a new proposal; requests that the Commission resume its work on the Ninth Company Law Directive on groups of companies in order to provide a regulatory framework for this common form of business association, and thereby create a set of common rules with regard to, inter alia, the protection of subsidiaries and stakeholders, and greater transparency in the legal and ownership structure;
41. Calls on the Commission to bring forward proposals to improve the financial instruments available to support sustainable growth, such as project bonds for long-term investments, and to issue a communication on the contribution of competition policy to innovation and growth, reviewing existing rules as necessary;
42. Request that the Commission urgently brings forward proposals to improve the protection of investors and other retail clients with regard to financial services, notably packaged retail investment products (PRIPS), undertakings for collective investments in transferable securities (UCITS), and insurance mediation and insurance guarantee schemes;
43. Underlines the importance of a robust financial market infrastructure to support the Single Market, and calls, therefore, on the Commission to bring forward early proposals for crisis resolution mechanisms for such an infrastructure; emphasises, furthermore, the importance of an early follow-up to the Commission's strategy paper on the future of VAT;
44. Stresses the importance of the fight against tax evasion and tax avoidance at national and European level, and calls on the Commission and the Member States to coordinate taxation policies adequately in order to avoid distortion in the functioning of the Single Market, guarantee a level playing field for business and citizens and ensure sound public finances;
45. Reiterates its call on the Commission to produce a scoreboard presenting the obstacles faced by Union workers wishing to make use of their right to free movement, describing how these obstacles are being tackled in the Member States and serving to assess whether they are dealt with in a thorough and effective manner, not least by examining the phenomenon of ‘social dumping’; calls on the Commission to present an action plan to remove the persistent obstacles facing Union citizens wishing to make use of their right to move and work in another Member State;
46. Takes the view that Europeans have not yet fully exploited the potential of the Single Market in many areas, including the free movement of persons and workers, and that important incentives are needed, in particular, to ensure effective labour mobility across Europe, notably through the guarantee of the portability of social security and pensions rights;
47. Calls on the Commission and the Member States, while complying with Regulation (EC) No 883/2004 and Article 153 TFEU, to undertake studies to ensure the continuity of social security protection for mobile citizens in the EU and equal treatment with nationals, also taking into consideration an optional, voluntary and transferable social security system at European level, complementary to the general system, in order to set up closer cooperation on social policy;
o o o
48. Instructs its President to forward this resolution to the Council and Commission.
– having regard to the public consultation on the future of European company law launched by the Commission on 20 February 2012(1),
– having regard to the conference on ‘European Company Law: the way forward’ held by the Commission on 16 and 17 May 2011(2),
– having regard to the report of the Reflection Group on the Future of European Company Law of 5 April 2011(3),
– having regard to the Commission communication of 13 April 2011 entitled ‘Single Market Act – Twelve levers to boost growth and strengthen confidence – ’Working together to create new growth'' (COM(2011)0206),
– having regard to the Commission communication of 25 October 2011 entitled ‘Social Business Initiative – Creating a favourable climate for social enterprises, key stakeholders in the social economy and innovation’ (COM(2011)0682),
– having regard to the Commission communication of 10 July 2007 on a simplified business environment for companies in the areas of company law, accounting and auditing (COM(2007)0394),
– having regard to the Commission communication of 21 May 2003 entitled ‘Modernising Company Law and Enhancing Corporate Governance in the European Union – A Plan to Move Forward’ (COM(2003)0284),
– having regard to its resolution of 21 April 2004 on ‘the communication from the Commission to the Council and the European Parliament: Modernising company law and enhancing corporate governance in the European Union – a plan to move forward’(4),
– having regard to its resolution of 4 July 2006 on recent developments and prospects in relation to company law(5),
– having regard to its resolution of 25 October 2007 on the European Private Company and the Fourteenth Company Law Directive on the transfer of the company seat(6),
– having regard to its resolution of 10 March 2009 with recommendations to the Commission on the cross-border transfer of the registered office of a company(7),
– having regard to its resolution of 23 November 2010 on civil law, commercial law, family law and private international law aspects of the Action Plan Implementing the Stockholm Programme(8),
– having regard to its resolution of 2 February 2012 with recommendations to the Commission on a 14th company law directive on the cross-border transfer of company seats(9),
– having regard to the question of 7 May 2012 to the Commission on the future of European company law (O-000110/2012 – B7-0117/2012),
– having regard to Rules 115(5) and 110(2) of its Rules of Procedure,
A. whereas the EU regulatory framework for company law and corporate governance needs to be adapted to reflect the growing trend for European companies to operate across borders within the EU and the continuing integration of European markets;
B. whereas the overall objective is to enable businesses in Europe to compete more effectively and to achieve greater success in a highly competitive global environment, while ensuring appropriate protection of the interests of creditors, shareholders, members and employees;
C. whereas a user-friendly regulatory framework would encourage businesses, in particular SMEs, to seize the opportunities offered by the single market;
D. whereas any future initiatives should be compatible with national corporate governance systems and national laws on worker involvement, while striving for increased flexibility and freedom of choice in respect of company forms, internal distribution of powers and sustainable company strategies;
E. whereas there is untapped potential in company legal forms at European level that should be further explored, developed and promoted;
F. whereas cross-border mobility for companies should be facilitated;
G. whereas the financial crisis has demonstrated the need for a clearer corporate governance framework which focuses more strongly on stakeholder participation;
1. Welcomes the Commission's recent public consultation on the future of European company law, which should help to shape future initiatives designed to simplify the business environment for companies, reduce unnecessary administrative burdens and enable companies to operate effectively within the single market, while ensuring appropriate protection of the interests of creditors, shareholders, members and employees;
2. Takes the view that EU company forms supplementing the existing forms available under national law have considerable potential and should be further developed and promoted; urges the Commission, in order to serve the specific needs of SMEs, to make further efforts with a view to the adoption of the Private Company Statute (SPE)(10), which could take full account of the interests of all stakeholders, in order to overcome the impasse in the Council;
3. Welcomes the fact that the Commission is conducting a study on European mutual societies, as announced in its aforementioned Social Business Initiative(11), and urges it to move swiftly towards submitting a new proposal for a statute;
4. Believes that possible reforms of the Second Company Law Directive(12) should focus on further simplification instead of introducing an alternative regime for capital formation and maintenance;
5. Welcomes the review of the accounting directives and suggests that the Commission further explore possibilities for developing European accounting standards, in particular with regard to the specific needs of SMEs, taking into account the traditional ideas of sustainability, long-term planning, family ownership and other traditional aspects of SMEs;
6. Believes that due consideration should be given to the resumption of work on the Fifth Company Law Directive with regard to the structure and operation of public limited companies;
7. Reiterates its request to the Commission that it submit a legislative proposal laying down measures designed to facilitate cross-border mobility for companies within the EU (14th Company Law Directive on the cross-border transfer of company seats);
8. Recalls that, in the Framework Agreement on relations between Parliament and the Commission, the latter committed itself to report on concrete follow-up to any request to submit a proposal pursuant to Article 225 TFEU within three months of the adoption of the corresponding resolution in plenary; deplores the fact that this commitment has not been honoured in respect of Parliament's resolution with recommendations on a 14th company law directive; calls on the Commission to comply with the framework agreement by submitting more detailed follow-up reports in future;
9. Suggests that the Commission resume its work on the Ninth Company Law Directive on groups of companies in order to provide a regulatory framework for this common form of business association; believes that there is no need for fully harmonised European corporate legislation on groups, but rather a need for a set of common rules on, inter alia, the protection of subsidiaries and stakeholders and greater transparency as regards legal and ownership structure;
10. Recalls that, according to the Commission's Smart Regulation Agenda, legislation needs to be clearer and more accessible; takes the view that the Commission should codify EU company law in order to provide a user-friendly set of rules and to ensure the consistency of EU law; recognises the merits of a single EU company law instrument, but believes that company law directives need to be grouped together as a first step; suggests grouping them in categories, including formation and operation (e.g. the First and Second Directives and the accounting and audit directives), mobility (e.g. the Third(13), Sixth(14), Tenth(15), Eleventh(16) and 13th(17) Directives and the future 14th Directive) and EU company law forms (e.g. SE, SCE, EEIG); emphasises that this codification project should not, of course, lead to a halt in the necessary reform activities;
11. Takes the view that conflict-of-law issues also need to be tackled in the field of company law and that an academic proposal in this field(18) could serve as a starting point for further work on conflict-of-law rules with regard to companies' cross-border operations;
12. Urges the Commission to present an action plan indicating the way forward after the consultation, which should outline short-, medium- and long-term initiatives to improve the regulatory framework for EU company law; believes that short-term initiatives should include the14th Company Law Directive and measures improving the EU framework for corporate governance, while mid-term initiatives should address, for instance, the Ninth Company Law Directive, and long-term initiatives the codification of EU company law;
13. Stresses that it expects the short-term initiatives to be formally included in the legislative work programme for 2013, and target dates to be set for the medium- and long-term initiatives;
14. Reiterates its earlier calls on the Commission to analyse the problems in the implementation of existing legislation so that the findings can be taken into account when considering new legislative proposals;
15. Recalls that any legislative proposal put forward by the Commission should be based on an impact assessment taking into account the interests of all stakeholders, including investors, owners, creditors and employees, in full compliance with the principles of subsidiarity and proportionality;
16. Calls on the Commission comprehensively to inform Parliament of the results of its consultation on the future of European company law and to explain in detail the decisions it will take as a result of the outcome of that consultation;
17. Instructs its President to forward this resolution to the Council, the Commission and the parliaments and governments of the Member States.
H.-J. Sonnenberger (ed.), Vorschläge und Berichte zur Reform des europäischen und deutschen internationalen Gesellschaftsrechts – Vorgelegt im Auftrag der zweiten Kommission des Deutschen Rates für Internationales Privatrecht, Spezialkommission Internationales Gesellschaftsrecht, Mohr Siebeck, Tübingen, 2007.
Towards a job-rich recovery
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European Parliament resolution of 14 June 2012 on ‘Towards a job-rich recovery’ (2012/2647(RSP))
– having regard to the Commission Communication of 18 April 2012 entitled ‘Towards a job-rich recovery’ (COM(2012)0173),
– having regard to the Commission Staff Working Document of 18 April 2012 entitled ‘Quality Framework for Traineeships’ (SWD(2012)0099),
– having regard to the Commission Staff Working Document of 18 April 2012 on exploiting the employment potential of the personal and household services (SWD(2012)0095),
– having regard to the Commission Staff Working Document of 18 April 2012 entitled ‘Reforming EURES to meet the goals of Europe 2020’ (SWD(2012)0100),
– having regard to the Commission Staff Working Document of 18 April 2012 entitled ‘Implementing the Youth Opportunities Initiative: first steps taken’ (SWD(2012)0098),
– having regard to the Commission Staff Working Document of 18 April 2012 on labour market trends and challenges (SWD(2012)0090),
– having regard to the Commission Staff Working Document of 18 April 2012 entitled ‘Open, dynamic and inclusive labour markets’ (SWD(2012)0097),
– having regard to the Commission Staff Working Document of 18 April 2012 entitled ‘Exploiting the employment potential of ICTs’ (SWD(2012)0096),
– having regard to the Commission Staff Working Document of 18 April 2012 on an Action Plan for the EU Health Workforce (SWD(2012)0093),
– having regard to the Commission Staff Working Document of 18 April 2012 entitled ‘Exploiting the employment potential of green growth’ (SWD(2012)0092),
– having regard to the Commission Communication of 23 November 2010 entitled ‘An Agenda for new skills and jobs: a European contribution towards full employment’ (COM(2010)0682) and its resolution of 26 October 2011(1) thereon,
– 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 its resolution of 6 July 2010 on atypical contracts, secured professional paths, and new forms of social dialogue(3),
– having regard to its resolution of 7 September 2010 on developing the job potential of a new sustainable economy(4),
– having regard to the Council Conclusions of 6 December 2010 on ‘Employment policies for a competitive, low-carbon, resource-efficient and green economy’,
– having regard to the study of the European Centre for the Development of Vocational Training (Cedefop) ‘Skills for Green Jobs’, 2010,
– having regard to its resolution of 25 October 2011 on promoting workers' mobility within the European Union(5)
– having regard to the communication from the Commission of 3 March 2010 entitled ‘Europe 2020: a strategy for smart, sustainable and inclusive growth’ (COM(2010)2020),
– having regard to the communication from the Commission of 12 January 2011 entitled ‘Annual Growth Survey: advancing the EU's comprehensive response to the crisis’ (COM(2011)0011), and the Draft Joint Employment Report annexed thereto,
– having regard to the Commission staff working document of 18 April 2011 entitled ‘Progress Towards the Common European Objectives in Education and Training’ (SEC(2011)0526),
– having regard to its resolution of 8 June 2011 on European cooperation in vocational education and training to support the Europe 2020 strategy(6),
– having regard to its resolution of 15 November 2011 on the European Platform against poverty and social exclusion(7),
– having regard to Rule 110(2) of its Rules of Procedure,
A. whereas, due to persisting structural weaknesses and the economic crisis, unemployment rates have risen from 9,5 % to 10,2 % in 2010 and 2012 respectively, equalling a total of 6 million job losses since 2008;
B. whereas the challenge in terms of employment, social inclusion and combating poverty is increasing, together with the widening of divergences between Member States and between regions;
C. whereas the outlook for 2012, according to Commission forecasts, is even more unfavourable, predicting stagnation of the EU GDP in 2012 and recessions in several Member States;
D. whereas 17,6 million new jobs will have to be filled in order to meet the employment target set out in the EU 2020 Strategy for smart, sustainable and inclusive growth, which calls for 75 % of 20-64 year olds to be in employment by 2020;
E. whereas job instability is, above all, a human tragedy for workers and their families and entails a waste of productive capacity, as skills tend to be lost as a result of excessive rotation between jobs and long periods of unemployment or inactivity;
F. whereas unemployment is particularly high among young people, partly due to mismatches between skills supply and demand but often also regardless of their level of education;
G. whereas austerity measures aimed at fiscal consolidation being pursued in a number of Member States have contributed to significant increases in unemployment;
H. whereas the financial crisis has led to significant increases in unemployment and economies in many Member States are failing to produce adequate growth to address this problem;
I. whereas reaching a high level of employment is also necessary to implement fiscal consolidation and the recovery of the economy, both by maintaining the level of internal consumption and by making more people contribute to the financing of the welfare state;
J. whereas labour law reforms in many Member States have not led to more qualitative employment opportunities but have instead promoted a two-tier labour market where increasing numbers of workers – and often the most vulnerable groups of workers, such as women, young workers and migrants – are working under conditions of permanent precariousness and poor salaries;
K. whereas the commitments set out in Member States' National Reform Programmes are often insufficient to meet most of the EU-level targets stipulated in the EU 2020 Strategy;
L. whereas the EU's 2012 Annual Growth Survey calls for resolute action to step up job creation and ensure job-intensive recovery, and whereas this message was forcefully echoed at the March 2012 European Council;
M. whereas it is the responsibility of policy-makers, both at national and EU level, to ensure that appropriate education and training facilities are available to workers to adapt their skill sets to changing economic structures and employment patterns;
N. whereas the promotion of a social, resource-efficient, sustainable and competitive economy is one of the objectives of the EU 2020 Strategy;
O. whereas deficits in qualified job-specific skills can already be observed in areas critical for innovation and at least 40 % of employment is expected to be in high-skilled, non-manual occupations by 2020;
P. whereas, according to recent statistics, one in four employers in Europe reports difficulty in filling jobs, with skilled trade workers, technicians, and engineers the hardest to find;
Q. whereas investment in research, innovation, education and training, which is vital for economic growth and job creation, is still lower in the EU than in its economic partners and competitors elsewhere in the world;
1. Welcomes the Commission's proposals to complement the employment priorities of the Annual Growth Survey with medium-term policy guidance aimed at reaching the targets set out in the EU 2020 Strategy; welcomes the broad range addressed by the Employment Package and applauds the long-requested change of policy towards job creation; calls for the necessary investment in job and growth potentials in the green economy, the health and social services sector and ICT, including investment in skills, training and higher wages;
2. Deplores the fact that, despite their political commitment during the 2012 Spring European Council and the Commission's guidance in the Communication, most Member States did not submit a National Job Plan as part of their National Reform Programme 2012, specifying comprehensive measures for job creation, green employment, the link between employment policies and financial instruments, labour market reforms and a clear timetable on how the multiannual reform agenda will be rolled out over the next 12 months;
3. Points out that labour market policies cannot compensate for failing macro-economic policies and calls on the Commission to mainstream the four objectives of the ILO Decent Work Agenda in all the proposals aimed at job creation: creating jobs, guaranteeing rights at work, extending social protection and promoting social dialogue;
4. Welcomes the Commission's initiative of a labour market monitoring system and individual tracking scheme for countries that do not comply with country-specific recommendations; urges the Commission to include monitoring to help move towards the EU2020 poverty and social inclusion objective in this system;
5. Urges the Heads of State or Government of the EU to commit to a European investment package before the end of 2012; believes that such a package could push Europe out of the crisis if it includes concrete commitments at national and European level for investment to create sustainable growth and jobs in key sectors such as resource efficiency and management, renewables, energy efficiency or recycling/reusing; points to the Energy Efficiency Directive as a concrete example of European legislation which could create up to 2 million new jobs;
6. Welcomes the proposal to reduce the tax wedge on labour in a budgetary-neutral way; recalls that the average tax wedge between what it costs for an employer to hire a worker and the worker's real pay is often above 40 % in the EU; believes that shifting the tax burden may enable companies benefiting from these exemptions/reductions to create new jobs or to increase wages;
7. Agrees with the Commission that more ambitious renewable energy targets trigger investments and hence employment in knowledge-intensive generation technologies; urges Member States to move towards an economic model based on the principle of resource efficiency; points to the Commission's finding that every percentage point reduction in resource use could lead to up to 100 000 to 200 000 new jobs;
8. Supports the idea that entrepreneurship, business-start-ups and self-employment should be promoted as a means of creating more jobs, in particular since SMEs and microenterprises provide over two thirds of the EU's private sector jobs, and calls on the Commission and the Member States to increase investment in these areas, in particular through public procurement and access to finance;
9. Welcomes investment in social business and social entrepreneurship, which provides a good option to meet social needs that are not satisfied by public goods and services;
10. Calls on the Commission to observe the ‘Think Small First’ principle and to carefully monitor the implementation of appropriate reductions in order to ensure that SMEs do not suffer from disproportionate administrative burden or obstacles to free trade within the Single Market, while ensuring that labour law and social regulations are properly respected at all levels;
11. Urges the Member States to remove immediately all restrictions on free labour market access to workers from Bulgaria and Romania; points to the negative impact these restrictions have on undeclared, irregular employment and to the abuse which takes place;
12. Calls on the Member States to step up their fight against informal or undeclared work and ‘forced self employment’ by providing sufficient means to labour inspection, introducing information campaigns about the risks and disadvantages of illegal work, combining more and better enforcement of existing labour laws and labour standards to combat undeclared work, the general application of the equal treatment principle, a stronger role of the EU in promoting more and better cooperation and coordination between national labour and social inspectorates, with preventive measures with controls and appropriate sanctions and by closely monitoring progress made in this area;
13. Welcomes the launch of the public consultation on employment in the health and social care sectors; considers that these sectors can play an important role in the achievement of the EU 2020 employment and social inclusion targets; calls on the Commission, in any future policy proposals, to take into account the ILO Convention, supplemented by a recommendation on domestic workers to improve the existing working conditions in these sectors;
14. Agrees with the Commission that cohesion policy, EAFRD and EMFF funds are important sources of investment which stimulate sustainable growth and job creation; calls on the Commission and the Member States to ensure the efficient use of these funds and of the Microfinance Facility to their full potential for investment in education, training, self-employment, labour mobility and productivity;
15. Calls for faster and easier processing of application and approval procedures for EU funding programmes for growth and innovation;
16. Welcomes the Commission proposal that stresses the benefit of setting minimum wages at Member State level to fight in-work poverty and social dumping and to boost aggregate demand; considers that any such proposal must take note of and respect national practices of collective bargaining;
17. Is convinced that employment protection legislation must be adapted to encourage companies to create new jobs, to help increase mobility and the adjustment capacity of labour markets and at the same time to help to address segmentation across the EU;
18. Calls on the Commission to address the real causes of labour market segmentation, such as gender inequality and the lack of policies to support the work-life balance;
19. Agrees that internal flexibility of working time organisation can help to maintain employment and lower adjustment costs in times of economic contraction, although it cannot replace growth policies; stresses however that measures must be tailored to social circumstances, negotiated with social partners and consistent with the interests of both employers and workers;
20. Agrees with the Commission that all types of contractual arrangements should give jobholders access to a core set of rights, including pension rights, social protection and access to lifelong learning;
21. Welcomes the Commission's initiative to launch the EU Skills Panorama, which will improve transparency and access for jobseekers and will increase workers' mobility;
22. Welcomes the recent legislative initiative by the Commission on professional qualifications; considers it crucial to strengthen the mutual recognition of diplomas and professional qualifications and to develop a mechanism for enhanced mutual recognition of competences and skills;
23. Calls on the Commission to make the European Skills Passport a reality before the end of 2012 in order to ensure equality and non-discrimination in terms of the means and the place where skills have been acquired, to allow for more efficiency in the matching of skills demand and supply and to promote workers' mobility across borders;
24. Welcomes the Commission's Staff Working Document on the Quality Framework for Traineeships and looks forward to the results of the study on the overview of traineeship arrangements in the Member States, and calls on the Commission to propose that internships should always be associated with a qualification process; invites the Commission to present as soon as possible a proposal for a Council Recommendation on a Quality Framework for Traineeships and a Council Recommendation on Youth Guarantees Regulation, and to define minimum standards supporting the provision and take-up of high-quality traineeships;
25. Stresses that the employment situation of young people is highly dependent on the overall economic situation; stresses the importance of support, guidance and monitoring of young people in their move from education to professional life; calls on the Commission to align any future policy proposals in this area with the ‘Youth on the Move’ and ‘Youth Opportunities’ initiatives; calls on Member States to start an exchange on best practice in fighting youth unemployment;
26. Calls on the Member States, the Commission and the Council to use, in close cooperation with social partners, every opportunity to ensure that every young EU citizen can start work or training after a maximum period of four months of unemployment by implementing the European Youth Guarantee; believes that Member States should make the Youth Guarantee legally enforceable in order to effectively improve the situation of young people who are neither in employment nor in education or training and to gradually overcome the problem of youth unemployment in the EU; stresses that the Youth Guarantee needs specific European financial support, especially in the Member States with the highest youth unemployment rates;
27. Calls on the Commission to support the Member States in their fight against unemployment and youth unemployment with unused allocations from the Structural Funds;
28. Joins the Commission in its call for the Member States to enhance their use of the EURES system; stresses the key role of EURES in the functioning of the Internal Market through advising workers and jobseekers as regards their rights in other Member States; calls for full involvement of the European Parliament with regard to the reform of the structure and governance of the EURES network;
29. Welcomes the Commission's initiatives aimed at reducing disadvantages and the integration of women in the labour market by providing equal pay and adequate childcare, and by eliminating all discrimination and tax-benefits disincentives that prevent female participation in the labour market; calls on the Member States to take further action in these areas;
30. Urges the Commission to speed up the work on the Pension Portability Directive, as legal uncertainty concerning social security provisions and pension rights is one of the main obstacles to the free movement of workers;
31. Calls on the Member States to adopt or maintain growth-friendly policies, including the prioritisation of spending in the areas of education, life-long learning, research and innovation, despite the austerity measures necessitated by the economic crisis and the need to minimise the burden of public debt, especially in the euro area;
32. Urges the Commission to strengthen fair mobility and combat any misuse of posted workers, both in host and home countries;
33. Instructs its President to forward this resolution to the Commission and the Council.
– having regard to the reports submitted under the UN Convention on the Elimination of All Forms of Discrimination against Women (CEDAW) and the Optional Protocol thereto, and to the Convention against Torture and Other Cruel, Inhuman or Degrading Treatment or Punishment,
– having regard to its resolution of 24 March 2009 on combating female genital mutilation in the EU(1),
– having regard to the report of the UN Secretary-General of 5 December 2011 entitled ‘Ending female genital mutilation’,
– having regard to the EPSCO Council Conclusions of 8 March 2010 on the eradication of violence against women in the European Union, which call for an international approach to fighting female genital mutilation,
– having regard to the Council of Europe Convention of 12 April 2011 on preventing and combating violence against women and domestic violence,
– having regard to the EU Guidelines on violence against women and girls and combating all forms of discrimination against them, adopted by the General Affairs Council of 8 December 2008,
– having regard to its resolution of 5 April 2011 on priorities and outline of a new EU policy framework to fight violence against women(2),
– having regard to its resolution of 18 April 2012 on the Annual Report on Human Rights in the World and the European Union's policy on the matter, including implications for the EU's strategic human rights(3),
– having regard to Rule 110(2) and (4) of its Rules of Procedure,
A. whereas female genital mutilation is an irreparable abuse that intentionally alters or causes injury to female genitals for non-medical reasons, with irreversible consequences which affect 140 million women and girls alive today, and whereas a further three million girls are at risk of undergoing the procedure each year;
B. whereas at least 500 000 women and girls in Europe are living with female genital mutilation and an estimated 180 000 girls are at risk, according to the WHO; whereas, according to experts, these figures are underestimated and do not take into account second-generation or undocumented migrants;
C. whereas any form of female genital mutilation is a harmful traditional practice that cannot be considered part of a religion, but is an act of violence against women and girls which constitutes a violation of their fundamental rights, particularly the right to personal security and integrity and physical and mental health, and of their sexual and reproductive health, while also constituting child abuse in the case of girls who are minors; whereas such violations can under no circumstances be justified on grounds of respect for cultural traditions of various kinds or for initiation ceremonies;
D. whereas, as well as being in itself a violation of human rights, female genital mutilation causes very serious and irreparable injuries in the short and long term to the physical and mental health and rights of the women and girls who undergo it, constituting a grave assault on their person and integrity, and in some cases can even be fatal; whereas the use of rudimentary instruments and the lack of antiseptic precautions have further harmful effects, such that sexual intercourse and childbirth may become painful, the affected organs are irreparably damaged and there may be complications such as haemorrhaging, shock, infection, transmission of the AIDS virus, tetanus, benign tumours and serious complications affecting pregnancy and childbirth;
E. whereas female genital mutilation is an expression of unequal power relations and a form of violence against women, alongside other serious forms of gender-based violence, and whereas it is absolutely necessary to embed the fight against female genital mutilation in a general and coherent approach to combating gender-based violence and violence against women;
1. Welcomes the decision of the 56th session of the Commission on the Status of Women of 8 March 2012 that the issue of female genital mutilation should be taken up by the United Nations General Assembly at its forthcoming 67th session;
2. Calls upon the UN General Assembly to adopt a resolution at its 67th session with a view to ending female genital mutilation worldwide – as requested by the African Union Summit on 1 July 2011 – by harmonising the action taken by member states and issuing recommendations and guidelines for the development and strengthening of regional and international legal instruments and national legislation;
3. States that, since female genital mutilation is mostly performed on young girls between infancy and 15 years of age, it constitutes a violation of the rights of the child; reiterates that all 27 Member States have committed themselves to protecting children's rights under the UN Convention on the Rights of the Child;
4. Calls on the Member States to continue to ratify international instruments and implement them through comprehensive legislation that prohibits all forms of female genital mutilation and provides for effective sanctions against the perpetrators of this practice; notes that legislation should also mandate a full range of prevention and protection measures, including mechanisms to coordinate, monitor and evaluate law enforcement, and should improve the conditions permitting women and girls to report cases of female genital mutilation;
5. Calls upon the relevant UN entities and civil society, through the allocation of appropriate financial resources, actively to support targeted, innovative programmes and to disseminate best practices that address the needs and priorities of girls in vulnerable situations, including those subjected to female genital mutilation, who have difficulty accessing services and programmes;
6. Requests the UN Secretary-General to ensure that all relevant UN organisations and bodies, in particular the UN Children's Fund, the UN Population Fund, the World Health Organisation, the UN Educational, Scientific and Cultural Organisation (UNESCO), the UN Entity for Gender Equality and the Empowerment of Women, the UN Development Fund for Women, the UN Development Programme and the Office of the UN High Commissioner for Human Rights, individually and collectively, incorporate the protection and promotion of the rights of girls not to be subjected to female genital mutilation into their country programmes, as appropriate, and in accordance with national priorities, in order to step up further their efforts in this regard;
7. Emphasises the need to support members of civil society, in particular women's organisations, working within their communities to end violence against women, including female genital mutilation;
8. Urges the Commission to ensure that measures aimed at combating gender-based violence and promoting the empowerment of women are mainstreamed in all EU development policies and programmes through its 2010 Gender Action Plan; stresses the importance of awareness-raising, community mobilisation, education and training, and of involving national, regional and local authorities and civil society in partner countries; points out that efforts to eliminate attitudes and harmful practices that negatively affect girls will succeed only with the full involvement of all key actors, including religious and community leaders and those working directly with girls, including parents, families and communities;
9. Urges the Commission to give specific attention to female genital mutilation as part of an overall strategy for combating violence against women, including joint action against female genital mutilation;
10. Urges the Commission to make it a priority to end violence against women and girls and, through the allocation of appropriate financial resources, to support targeted and innovative programmes both within the EU and in third countries;
11. Urges the Member States to take firm action to combat this illegal practice;
12. Instructs its President to forward this resolution to the Council, the Commission, the UN Secretary-General and the Member States.
– having regard to Article 184 of the Treaty on the Functioning of the European Union,
– having regard to the Council conclusions on innovation in the medical device sector(1),
– having regard to Council Directive 93/42/EEC of 14 June 1993 concerning medical devices(2),
– having regard to Council Directive 90/385/EEC of 20 June 1990 on the approximation of laws of the Member States relating to active implantable medical devices(3),
– having regard to European Parliament and Council Directive 98/79/EC of 27 October 1998 on in vitro diagnostic medical devices(4),
– having regard to Directive 2000/70/EC of the European Parliament and of the Council of 16 November 2000 amending Council Directive 93/42/EEC as regards medical devices incorporating stable derivates of human blood or human plasma(5),
– having regard to the opinion of the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) on ‘the safety of silicone products manufactured by the Poly Implant Prothèse (PIP) Company’ published on 1 February 2012(6),
– having regard to the conclusions(7) of the High Level Health Conference on innovation in medical technology held in Brussels on 22 March 2011,
– having regard to its resolution of 13 June 2001 on the petitions declared admissible concerning silicone implants (Petitions 0470/1998 and 0771/1998)(8),
– having regard to its resolution of 2 February 2012 on ‘Towards a Coherent European Approach to Collective Redress’(9),
– having regard to Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market(10),
– having regard to the question of 18 April 2012 to the Commission on defective silicone gel breast implants made by French company PIP (O-000101/2012 – B7-0118/2012),
– having regard to Rules 115(5) and 110(2) of its Rules of Procedure,
A. whereas according to the findings of the French health authorities, a French manufacturer (Poly Implant Prothèse) is under investigation for the fraudulent use of low-quality material (industrial silicone) different from the material indicated in the documents submitted for conformity assessment (approved medical-grade silicone);
B. whereas there is a lack of both clinical and epidemiological data on the potential risks of PIP breast implants;
C. whereas for third-generation implants there is a rate of rupture within ten years of implantation of 10-15 %;
D. whereas tests conducted by the French authorities on the physical integrity of a sample of PIP silicone breast implants indicated weaknesses in PIP shells not found in other commercially available implants;
E. whereas the SCENIHR report requested by the Commission in early January 2012 stresses that there is some concern regarding the possibility of inflammation induced by ruptured or leaking PIP silicone implants;
F. whereas the lack of EU-wide registration of breast implants means that the overall number of women who have received implants is unknown; whereas, however, it is estimated on the basis of the available data provided by the European Commission that around 400 000 PIP silicone breast implants have been sold worldwide; whereas many women in the United Kingdom (40 000), France (30 000), Spain (10 000), Germany (7 500) and Portugal (2 000) have received PIP silicone breast implants;
G. whereas patients need to know that implants are not permanent and may need to be replaced or removed; whereas patients also need to be informed about the quality of implants and the potential risks associated with them;
H. whereas the transposition of EU legislation on medical devices into national legislation has not prevented this health fraud, which has had, and will continue to have, a serious negative impact on health worldwide;
I. whereas this health fraud has brought to light a malfunction at the European and national levels, notably as regards the lack of cooperation between Member States and the international community in terms of information sharing and notification of adverse effects, and lack of traceability of raw material used for medical devices;
J. whereas the case of PIP implants, like the case of hip implants, illustrates the failure of the current system of certification of compliance with essential health and safety requirements and of the control and surveillance of notified bodies by national competent authorities pursuant to the Medical Device Directive (2007/47/EC);
K. whereas the desire to provide swift access to new medical devices for patients must never take precedence over the need to ensure patient safety;
L. whereas the Medical Device Directive (2007/47/EC) will be reviewed in 2012; whereas it is essential that lessons be learned from the fraudulent marketing of PIP implants such that surveillance and safety controls and requirements for placing products on the market are strengthened at national and at European level;
M. whereas the available data indicate that many PIP implants have been manufactured from non-medical-grade silicone containing components that can weaken the implant shell and diffuse into body tissues;
1. Notes that several Member States have advised patients to consult their surgeon, or have recommended patients to have breast implants made by PIP removed as a precaution;
2. Notes, however, that inequalities exist between Member States as some have given their citizens conflicting advice as to what action to take, causing confusion among patients;
3. Calls on the Commission and the Member States to strengthen their cooperation within the existing legal framework, in particular in the fields of market surveillance, vigilance and inspection, and to tighten controls, in order to provide a better guarantee of safety of patients, especially those exposed to high-risk medical devices;
4. Stresses that after carrying out an assessment, Member States must immediately inform the Commission and the other Member States of measures that have been taken, or are being contemplated, to minimise the recurrence of such incidents;
5. Calls on the Commission to develop an appropriate legal framework to guarantee the safety of breast implants and of medical technology in general;
6. Calls for the introduction and implementation of essential and immediate specific measures on the basis of the current legislation on medical devices, in particular designed to:
–
strengthen the controls on medical devices already on the market, including those using samples;
–
ensure that, in the context of the conformity assessments, all notified bodies make full use of their powers to conduct frequent (at least once per year) unannounced inspections of the whole supply chain and of the operations of certain suppliers, notably suppliers of medical devices associated with the greatest risks and those in relation to which users' reports indicate that the number of incidents is growing;
–
strengthen the criteria for accreditation and assessment of notified bodies – with particular emphasis on the demonstrated competence of full-time staff, the use of contract resources, and transparency with regard to their functioning and tasks – and set up an EU-wide qualification management system for notified bodies, their staff, auditors and experts;
–
reinforce market surveillance by, and information sharing between, national authorities to monitor the adverse effects of medical devices and the withdrawal of such devices from the market, in order to guarantee better traceability of medical devices and better follow-up of measures to control their marketing;
–
improve supervision by national authorities of notified bodies and ensure consistency across Member States;
–
encourage innovation in medical technology, as innovation is crucial to efforts to overcome the health challenges of today and tomorrow;
–
require manufacturers of medical devices to communicate immediately to their national competent authority any ban, restriction or legal action under way in one or more Member States;
–
improve the functioning of the vigilance system for medical devices, for example by facilitating and actively encouraging patients, patients' associations, patient groups and healthcare professionals to report all adverse events and harmful effects to the competent authorities, without their being hampered by excessive red tape, by giving notified bodies systematic access to reports of adverse events and by setting up a centralised procedure for gathering and treating notifications on adverse effects and on the withdrawal of devices from the market;
–
establish tools that, while providing data protection, ensure traceability of medical devices and long-term monitoring of their safety and performance, such as a ‘Unique Device Identification’ system, an implant register and a summary of product characteristics for each medical device;
–
facilitate notification of national authorities by patients' associations and health professionals regarding adverse effects;
–
establish a single European database that brings together information about the medical devices available on the market, registration of economic operations, vigilance and market surveillance initiatives, clinical investigations, notified bodies and EC certificates issued;
7. Calls on the Commission to shift to a system of pre-market authorisation for certain categories of medical devices, including, at least, medical devices of class IIb and III;
8. Calls for the introduction – where it does not already exist at national level – of an implant recipient's passport specifying the unique product code of the implant, its special characteristics and potential adverse effects, and bearing a warning of the potential health risks and post-operative follow-up care measures associated with the implant; the passport would have to be signed by the surgeon and the patient, and would be valid as a consent form for the operation;
9. Recommends that hospitals should keep an electronic version of the passport for future reference, noting that an electronic version can easily be forwarded at the request of a patient to a new care facility, whether in the same or in a different country;
10. Calls on the Member States to raise awareness more effectively of the potential risks attached to cosmetic surgery, and to better regulate the advertising of cosmetic surgery in order to ensure that patients are fully aware of the risks as well as the benefits; stresses that women should be made aware that breast implants need to be replaced after a period of time that varies from person to person, enabling them to assess risks more effectively;
11. Recognises that patients who have already received breast implants may need retrospective information, advice, medical supervision and counselling, as well as screening for intra- and extra-capsular rupture;
12. Stresses that the testing procedures and standards for breast implants should be refined to allow a better understanding of the interaction of the shell material with the filling gel and the surrounding body fluids, and of the fatigue and tear resistance of the shell and the total implant; considers that more proposals should be made for research to develop non-destructive methods of testing of implants;
13. Urgently recommends that details of breast implant operations be recorded in the EU in the form of a compulsory National Breast Implant Register in each Member State; underlines the fact that a compulsory register would make reporting mandatory for all clinics, but stresses that the inclusion of a patient's personal details should be subject to their consent; recommends that such national registers be interconnected and allow for exchange of information when needed, for example in cases where significant defects are detected in implants;
14. Urgently recommends a revision of the Medical Devices Directive aiming at introducing a capacity to detect and minimise the risk of fraud, focusing in particular on provisions regarding market surveillance, vigilance, and the functioning and tasks of notified bodies, so as to avoid a repetition of the PIP case;
15. Calls on the Commission to consider the possibility of establishing an efficient tracking system for medical devices used as implants, particularly for the most dangerous medical devices such as those in class III;
16. Calls on the Commission to consider the following aspects in the upcoming revision of the legislation on medical devices: the need for a marketing authorisation request for dangerous medical devices which complies with, or is similar to, the requirements for medicinal products; use of mandatory unannounced inspections; the need for increased traceability of implanted medical devices; the need for increased coordination between Member States when it comes to reporting on, and warning about, serious side effects or damage caused by medical devices; enhanced control of notified bodies; and additional sample testing of products already on the market;
17. Calls on the Commission also to consider, in the upcoming revision of the legislation on medical devices, the need for adequate human testing during clinical trials, particularly of implantable medical devices, before they are put on the market;
18. Urges the Member States to carry out, at least annually, thorough unannounced inspections of those medical devices that are associated with the greatest risks and of those devices in relation to which users' reports indicate that the number of incidents is growing;
19. Urges the Member States to apply penalties in case of non-compliance;
20. Considers that this fraud provides further evidence of the need for a system of collective redress designed to help consumers and patients to obtain compensation, as stressed by its above-mentioned resolution of 2 February 2012;
21. Calls on the Member States to pool their adverse incident reports and other regulatory data in the centralised database, as required by the Medical Devices Directive, in order to enable more effective vigilance and health protection measures;
22. Calls on the Commission to require adequate toxicological assessments of all medical devices, and to propose that the use of substances that are carcinogenic, mutagenic or toxic for reproduction (category 1A or 1B) be phased out, unless no substitutes are available;
23. Instructs its President to forward this resolution to the Council, the Commission and the parliaments of the Member States.
– having regard to the Council of the European Union Conclusions on Mali/Sahel of 23 April 2012(1),
– having regard to the Council of the European Union Conclusions on Sahel of 23 March 2012(2) approving the Crisis Management Concept for a civilian CSDP Advisory, Assistance and Training mission in the Sahel,
– having regard to the EEAS report entitled ‘Strategy for Security and Development in the Sahel: Implementation Progress Report, March 2012’,
– having regard to the UN report of the assessment mission on the impact of Libyan crisis on the Sahel region, UN Security Council of 2012(3), and to the UN Security Council statements on Mali of 22 March(4), 26 March(5), 4 April(6) and 9 April(7) 2012,
– having regard to the Council Conclusions on a European Union Strategy for Security and Development in the Sahel of 21 March 2011 (3076th Foreign Affairs Council meeting),
– having regard to the ACP-EU JPA resolutions of 18 May 2011 on the democratic upheavals in North Africa and the Middle East – consequences for the ACP countries, for Europe and for the world(8) and of 23 November 2011 on the Arab Spring and its impact on neighbouring sub-Saharan states(9),
– having regard to the Foreign Affairs Council Conclusions of 1 December 2011 encouraging the High Representative to take forward preparatory work on a CSDP engagement to reinforce regional security capabilities in the Sahel region, in close cooperation with the African Union,
– having regard to the Council Conclusions on Libya of 21 March, 23 May and 18 July 2011 and 23 March 2012;
– having regard to the Council of the European Union final report on the Sahel security and development initiative of 1 October 2010(10),
– having regard to the additional relevant provisions of the Treaty on European Union (TEU), in particular Articles 3, 6, 21 and 39 thereof, and of the Treaty on the Functioning of the European Union (TFEU), in particular Articles 205, 208, 214 and 222 thereof,
– having regard to the ACP-EU Partnership Agreement (‘Cotonou Agreement’), and in particular to Articles 1, 8, 25 and 28 thereof,
– having regard to the Africa-EU Peace and Security Partnership, in particular initiatives 2, 7 and 8 of the Action Plan 2011-2013, adopted at the Africa-EU Summit held in Tripoli on 29 and 30 November 2010,
– having regard to the Protocol to the African Union Convention on the Prevention and Combating of Terrorism, adopted in Addis Ababa on 8 July 2004 at the 3rd ordinary session of the African Union Conference,
– having regard to Ban Ki-moon's address to the Luxembourg Parliament on 17 April 2012, in which he called on the international community to respond to the growing conflict and unrest in the Sahel region which is suffering a severe drought, where the number of displaced people is growing and where food and fuel prices are rising,
– having regard to the distress call to the international community sent on 5 June 2012 by the Economic Community of West African States (ECOWAS) after its high-level meeting in Lomé, Togo, aimed at addressing the issue of food security in the region, especially in Senegal, Mauritania, Mali, Burkina Faso, Niger and Chad,
– having regard to the strategic document ‘Preparation for a food and nutrition crisis in the Sahel and neighbouring countries’, prepared jointly and updated in February 2012 by Action Against Hunger, the Food and Agriculture Organisation of the United Nations (FAO), the United Nations Office for Coordination of Humanitarian Affairs (OCHA), the United Nations Children's Fund (Unicef) and the World Food Programme (WFP), and launched as a strategy to better respond to the risk of a new food and nutritional crisis in the Sahel in 2012 on behalf of the IASC Regional Food Security and Nutrition Working Group,
– having regard to the call on 10 April 2012 by various UN agencies – Unicef, UNHCR and the WHO – for additional funding for the millions of people affected by food insecurity in the Sahel region,
– having regard to Unicef's appeal for USD 26 million for Mali to enable it to meet the health and nutritional needs of children until the end of the year,
– having regard to its previous resolutions on West Africa, in particular its resolution on Mali of 20 April 2012(11),
– having regard to the ACP-EU JPA resolution on the political impact of the Libyan conflict on neighbouring ACP and EU States (101.157/fin) adopted in Horsens, Denmark on 30 May 2012,
– having regard to Rule 122(5) and 110(4) of its Rules of Procedure,
A. whereas the combination in the Sahel region of drought, floods, soil degradation, low crop yields, high food prices, displacement, a refugee crisis, chronic poverty, weak governance and, as a result of conflicts, a deteriorating situation for security and human rights is affecting millions of people across the region;
B. whereas people affected by the political and food crisis are living in conditions of extreme poverty, such that their basic human needs are not being met and social tensions are increasing; whereas the majority of those persons are women who, deprived of any form of protection, constitute a particularly vulnerable group;
C. whereas the ECOWAS member states have recorded a 9 % drop in cereal production in 2012 compared with the previous year, with Sahel's cereal production dropping by 26 %, and Chad and Gambia experiencing 50 % decreases;
D. whereas, according to the UN, 18 million people have been affected by the drought- and conflict-related crisis in the Sahel region of West Africa, where more than 200 000 children died of malnutrition in 2011 and where currently one million children are at risk of severe acute malnutrition;
E. whereas state fragility, poor governance and corruption in the Sahel countries, accompanied by economic underdevelopment resulting in chronic poverty, provide a perfect environment for terrorist groups, drug and human traffickers, and groups engaged in piracy, arms trade, money laundering, illegal immigration and organised crime networks, which combine to destabilise the region, with a negative impact also on neighbouring regions;
F. whereas the region has been experiencing an alarming strengthening of linkages between drug traffickers in Latin America and in states in West/Central Africa, and whereas the latter region now forms a key transit route for drug shipments to Europe, which accounts for more than 25 % of the global consumption of cocaine; whereas these trends require greater engagement by the European Union;
G. whereas conflicts in Libya and Mali, with hundreds of thousands of displaced people migrating towards Burkina Faso, Niger and Mauritania, have negatively influenced the security situation in the region, which suffers from acute food insecurity, water scarcity, increasing criminality and profound instability;
H. whereas the Libyan conflict has given rise to the proliferation, in the Sahel-Saharan region, of huge quantities of arms, and to a sudden influx of heavy weapons, which, in the hands of the various terrorist and criminal groups and drug traffickers that are rife in this region, poses a serious threat to the security and stability of the entire sub-region;
I. whereas former combatants returning from Libya to Niger, Chad, Mali and Mauritania, with large quantities of arms and munitions, are potential recruits for rebel movements, groups affiliated to al-Qaeda in the Islamic Maghreb (AQIM) and criminal gangs, and contribute to the destabilisation of the region as a whole;
J. having regard to the traditions of tolerance, solidarity and respect for the human person adhered to by Islam as practised in the region;
K. whereas the lack of meaningful socio-economic development, unfair distribution of resources, high rates of youth unemployment, chronic poverty, lack of job security and hopeless social deprivation play an important role in the recruitment of youth by terrorist groups;
L. whereas the rise of rebel groups such as Boko Haram in Chad and in Nigeria is a threat to the stability of the whole Sahel region;
M. whereas this development, together with the resurgence of Tuareg irredentism in countries such as Mali and Niger, jeopardise the stability and territorial integrity of the countries of the Sahel-Saharan region, especially Mauritania and Burkina Faso;
N. whereas avowed links exist between terrorist groups in the Sahel-Saharan region and traffickers in drugs, arms, cigarettes and human beings; whereas several Europeans have been abducted and held hostage, in particular in recent years;
O. whereas terrorism in the Sahel needs to be fought partly by means of an active policy to promote development, social justice, the rule of law and integration; whereas it is necessary to hold out to local population groups economic prospects which provide an alternative to the criminal economy;
P. whereas the Sahel arc is a pivotal area between Sub-Saharan Africa and Europe and whereas the situation in the Sahel-Saharan strip is therefore a key security issue for both Africa and Europe;
Q. whereas all international, regional and national stakeholders should be mobilised in order to step up the fight against terrorism and strengthen security in the region, including through structured dialogue;
R. whereas the EU's strategy identifies Mauritania, Mali and Niger as core Sahel countries and argues that lack of governmental capacity and systemic poverty are mutually reinforcing dynamics;
S. having regard to the serious repercussions of insecurity on the region's economy, in particular the mining and tourism sectors, on its development and on job creation; whereas the worsening security situation has resulted in the shelving of development projects under way in several countries in the sub-region, thus leaving many young people unemployed, whose vulnerability is likely to benefit terrorist or criminal groups;
1. Expresses deep concerns about the deterioration of the security situation in the Sahel region, and calls on the EU to work in close cooperation with the authorities and parliaments of the countries of the region, civil society and regional and international bodies, including the African Union and ECOWAS, to comprehensively address underlying political, economic, social and environmental root causes of poverty, support economic development, good governance and improved access to key infrastructures and basic services for the local population, and help consolidate state institutions, justice, police and customs in order to strengthen security and the rule of law in the region;
2. Unequivocally condemns all attempts to seize power by force, any acts of terrorism and of pillaging of hospitals, schools, aid agencies and government buildings, all forms of cruel and inhuman punishments associated with the application of Sharia law, and all war crimes, kidnappings and serious violations of human right abuses directed at the population of Mali, especially in rebel-held northern areas, and calls on the Malian authorities and the Tuareg liberation movement to reach a peaceful and lasting solution through a constructive dialogue;
3. Condemns in particular the atrocities committed against the civilian population, which have been directed against women and children more than other victims, and particularly condemns the use of abduction and rape as weapons of war;
4. Urges the Vice-President / High Representative to speed up the implementation of the various components of the EU Strategy for Security and Development in the Sahel; supports the commitment of the Council to contribute to the development of a peaceful, stable region where food self-sufficiency is secured;
5. Recalls that, as security and development are closely interlinked, improving the security situation is integral to economic growth and the reduction of poverty in the region; calls, therefore, on the EU to introduce instruments to improve the region's security, focusing especially on capacity building in the countries concerned and on promoting and strengthening a comprehensive dialogue among the main regional actors;
6. Calls on the Commission and the EEAS, in implementing the EU Strategy for Security and Development in the Sahel (focusing on four groups of action: development, good governance and internal conflict resolution; political and diplomatic action; security and rule of law; action to counter violent extremism and radicalisation), to adopt as an overriding principle the linking of security with development needs, especially food security;
7. Welcomes the Sahel counter-terrorism programme, the West Africa Information System, the ECOWAS Peace and Security Project and the ECOWAS Drug and Crime Action Plan, undertaken in the framework of the EU Strategy for Security and Development in the Sahel, as well as regional initiatives such as those organised by the African Centre for Study and Research on Terrorism (ACSRT) on the capacity of national legal systems to respond to terrorism;
8. Is of the opinion that the EU Strategy for Security and Development in the Sahel, while delivering positive results, needs to address the risk of fragmentation, and improve the synchronisation of actions undertaken by the EU within different instruments addressing Sahel-related issues;
9. Calls on the Council and the Member States to mobilise all available resources to promote security and development in the Sahel-Saharan region in cooperation with the countries of the region, the United Nations and other international partners;
10. Welcomes the West African community package of USD 80 million, pledged in response to the emergency crisis in the Sahel region, and the EU's humanitarian aid increase to the Sahel region from EUR 45 million to over EUR 120 million since the beginning of 2012, and urges all sides to make sure that this aid benefits those in need; calls, at the same time, on the international community to make the financial efforts needed to address the food crisis and the lack of security in the region;
11. Points out that the Sahel is one of the regions most affected by climate change and loss of biodiversity, which have a profound impact on agriculture, farmers and local people's lives and increase poverty and inequalities; welcomes the action taken by the FAO, in conjunction with the Permanent Interstate Committee for Drought Control in the Sahel (CILSS), the Famine Early Warning Systems Network (FEWSNET), the WFP and governments;
12. Urges the EU, while coordinating with other donors, to exercise strong leadership and take rapid action in order to prevent the crisis in the Sahel region from becoming a catastrophe, as the humanitarian situation in the region is expected to remain critical until at least the main harvest this autumn;
13. Is convinced that it is indispensible for the international community, in the medium and long-term perspective, to focus its actions on reinforcing the ability of the populations concerned to cope with future droughts and other shocks and thereby reduce their dependence on emergency aid, to improve hunger-response strategies and to fight against structural vulnerabilities, and in so doing tackle the problem in a more efficient way;
14. Urges the EU and the international community to focus their activities on efforts to protect the livelihoods of the most vulnerable households, strengthen the resilience of pastoralists, agro-pastoralists and farmers, support the management/conservation of natural resources such as water, trees and soil, provide integrated emergency nutrition assistance to the most vulnerable families, especially women, reinforce disaster risk reduction and management at local, national and regional levels, and support the coordination of, and strengthen, food security information management and early warning systems;
15. Believes that there is an urgent need to support initiatives aimed at strengthening dialogue about, and increasing the ability of local communities to resist and counter, the appeal of terrorism and the recruitment of youth by terrorist and other criminal groups, including through support for youth employment and training;
16. Urges the states of the Sahel-Saharan region, the new Libyan authorities and the competent multilateral agencies to take all necessary measures to stop the proliferation of arms in the region by establishing adequate mechanisms to control and secure national borders across the region, including mechanism to halt the transfer of small arms and light weapons, to implement programmes for collecting and destroying illegal small arms and light weapons, and to institute measures for exchanging information and launching joint security operations in the region;
17. Welcomes the establishment in 2010 of the Joint Staff Operations Committee (CEMOC) by Algeria, Mali, Mauritania and Niger to coordinate the fight against terrorism, organised crime and drug trafficking in the Sahel-Saharan region;
18. Calls on the international community in general, and the EU in particular, to step up their cooperation with the countries of the Sahel-Saharan region and with ECOWAS in the fight against terrorism and organised crime in the sub-region, especially by increasing the resources available to CEMOC;
19. Calls for all the measures taken to combat terrorism to comply with international human rights conventions and protocols;
20. Stresses that effective measures should be taken to cut off sources of funding for terrorists and their accomplices, and calls for the states of the region to take the measures advocated by the United Nations Office on Drugs and Crime (UNODC), namely reform of criminal justice systems, anti-corruption laws, improved monitoring of the trade in light weapons and the freezing of suspects' bank accounts;
21. Recalls and condemns the abduction on 24-25 November 2011 of two French nationals, a Swede, a Dutchman and a South African holding a British passport, along with the killing of a German citizen who resisted the kidnappers; notes that this brings the number of EU hostages in the Sahel area to 12, with al-Qaeda in the Islamic Maghreb still holding two Spanish nationals and an Italian national abducted in western Algeria in October 2011, four French nationals abducted in Niger in September 2010 and, on 15 April 2012, a Swiss missionary abducted in Timbuktu;
22. Hopes that any European Security Defence Policy (ESDP) mission officially requested by the Government of Mali will help the countries in the sub-region control their borders more effectively and, in particular, to combat trafficking in arms, drugs and human beings;
23. Commends the actions taken by ECOWAS, the African Union, the United Nations and neighbouring countries with a view to facilitating Mali's rapid return to constitutional order and to initiating concrete measures to protect its sovereignty, unity and territorial integrity; takes note of the outcome of the conference held in Ouagadougou on 14 and 15 April 2012 under the auspices of Burkinabe President Blaise Compaoré, the mediator appointed by ECOWAS, and hopes that the timetable and detailed arrangements for the transition will swiftly be clarified further;
24. Calls on the EU and its Member States to pay particular attention to the situation of women and girls in the Sahel region and to take all the necessary measures to ensure their protection from every type of violence and from violations of their human rights;
25. Instructs its President to forward this resolution to the Council, the Commission, the Vice-President of the Commission / High Representative of the Union for Foreign Affairs and Security Policy, the UN and AU Secretaries-General, ECOWAS and the EU Member States.
– having regard to the International Covenant on Civil and Political Rights and the Additional Protocol thereto, to which the Philippines is a signatory,
– having regard to the Commission's Country Strategy Paper 2007-2013 for the Philippines,
– having regard to the Financing Agreement for the EU-Philippines Justice Support Programme, signed in October 2009 and intended to speed up judicial proceedings against the perpetrators of extrajudicial killings, and to the new ‘Justice for All’ programme,
– having regard to the recent ratification by the Philippines of the Rome Statute of the ICC and of the Optional Protocol to the Convention Against Torture and Other Cruel, Inhuman or Degrading Treatment of Punishment (OPCAT),
– having regard to the report of the UN Working Group on the Universal Periodic Review (UPR) on the Philippines of 31 May 2012,
– having regard to the statement by VP/HR Catherine Ashton of 24 April 2012,
– having regard to its previous resolutions on the Philippines, notably that of 21 January 2010(1),
– having regard to Rules 122(5) and 110(4) of its Rules of Procedure,
A. whereas Esmail Amil Enog, an employee of the Ampatuan family of Maguindanao, went missing in March 2012 after having testified in court that he had driven armed militia members to the site where 57 victims were killed in 2009; whereas his dismembered body bearing traces of torture was found on 31 May 2012;
B. whereas, in an unprecedented move, the leading members of the Ampatuan family accused of masterminding the Maguindanao massacre were arrested after the events of 23 November 2009, while the assets and bank accounts of 28 clan members and associates were frozen;
C. whereas the trial of the persons accused of committing the Maguindanao massacre began on 8 September 2010 in Manila; whereas Andal Ampatuan and several of his sons are on trial for the massacre, while about 100 other suspects are still at large;
D. whereas Esmail Enog was the third witness to have been killed since the trial began in 2010, while the relatives of other witnesses have reported being attacked, threatened, offered bribes or harassed;
E. whereas Mr Enog's brutal death is a clear indicator of the fact that the climate of impunity that fostered the Maguindanao massacre is still alive in the country;
F. whereas, according to international press reports, four journalists have been killed in 2012 and the Philippines is deemed a dangerous country for the media by human rights monitoring organisations;
G. whereas extrajudicial killings and enforced disappearances have significantly declined since President Aquino assumed power; whereas, however the government's ability to effectively combat the widespread impunity of the perpetrators of such acts and tackle the politically motivated violence in the country remains insufficient;
H. whereas, according to human rights organisations, of the many hundreds of cases of extrajudicial killings in the last decade, only seven, involving 11 defendants, have been successfully prosecuted, and none since President Aquino took power;
I. whereas after the Maguindanao massacre the government established an Independent Commission Against Private Armies to dismantle private militias, but with no concrete results so far;
J. whereas according to the May 2011 report of the Independent Commission Against Private Armies there are at least 72 active private armed groups in the country;
K. whereas the most recent UPR of the Philippines reiterated the recommendations of 2008, i.e.: end impunity for extrajudicial killings, enforced disappearances and torture, and bring those responsible to justice; step up efforts for the total prohibition of torture, extrajudicial killings and enforced disappearances; end impunity by bringing the perpetrators to justice; and ensure the adequate protection of journalists and human rights defenders;
L. whereas the Enforced or Involuntary Disappearance Act was adopted by the Senate of the Philippines in June 2011 and by the country's House of Representatives in May 2012;
1. Strongly condemns the murder of the third witness of the Maguindanao massacre and the assassination of four journalists, and expresses its solidarity with the families of the deceased;
2. Expresses its serious concern over judicial independence and slow convictions for human rights violations in the country, and calls for an immediate independent investigation into the recent murder cases;
3. Calls on the Government of the Philippines to take further measures in order to end impunity for extrajudicial killings, enforced disappearances and torture and bring those responsible to justice, including the perpetrators of the Maguindanao massacre who are still at large; further calls for the release of all disappeared persons still in captivity and for light to be shed on all other unresolved cases;
4. Welcomes the indictment of 196 people over the Maguindanao massacre, but deplores the fact that no real progress has been made so far in the trial;
5. Urges the Government of the Philippines to ratify the International Convention for the Protection of All Persons from Enforced Disappearance and to enact the Enforced or Involuntary Disappearance Act;
6. Calls on the Government of the Philippines to ensure the adequate protection of human rights defenders, trade unionists and journalists, effectively investigate and prosecute attacks against journalists, and introduce into domestic law strong legislation prohibiting such acts and imposing criminal penalties;
7. Urges the state authorities to establish, under the Commission on Human Rights, a specialised programme for witness and victim protection, including the protection of the families of victims, in cases involving serious human rights violations, particularly when the perpetrators are believed to be soldiers, police or state officials;
8. Expresses its concern that the use of torture and the ill-treatment of suspects in police custody continue to be widespread, and urges the Philippine authorities to increase their efforts to rigorously combat violations of the national Anti-Terror Act of 2009;
9. Urges the government to immediately prohibit and disband paramilitary forces (including where paramilitary activity is supervised by military command) and local militias, and to establish full military and police control over the armed civilian units, notably the Civilian Armed Forces Geographical Units and Civilian Volunteer Organisations;
10. Calls on the government to take concrete steps to implement the recommendations made to the Philippines during the recent UPR; urges it to revoke, without further delay, Executive Order 546, in order to ban private armies;
11. Welcomes the ratification by the Philippines of the Rome Statute of the International Criminal Court on 30 August 2011 and of the Optional Protocol to the Convention against Torture and Other Cruel, Inhuman or Degrading Treatment or Punishment (OPCAT) on 17 April 2012;
12. Welcomes the important steps taken by the Government of the Philippines in its attempts to prevent killings and bring their perpetrators to justice, as well as the launch of a new Task Force of dedicated prosecutors to address extrajudicial killings and enforced disappearances;
13. Welcomes the successful implementation of the EPJUST programme and the new EU-Philippines justice support programme ‘Justice for All’, which will be launched soon and will allocate EUR 10 million over the period 2012-2015 in order to promote equitable access to justice and its efficient enforcement for all citizens in general, and in particular for poor and disadvantaged people, especially women, children, minorities and indigenous peoples, as well as human rights and social activists;
14. Calls on the Government of the Philippines to enable a visit by the UN Special Rapporteur to investigate the human rights situation in the country;
15. Instructs its President to forward this resolution to the EU High Representative for Foreign Affairs and Security Policy, the President and Government of the Philippines, the UN High Commissioner for Human Rights, and the governments of the ASEAN member states.
– having regard to its previous resolutions on the situation in Iran, in particular those concerning human rights,
– having regard to UN Human Rights Council Resolution 16/9 establishing a mandate for a Special Rapporteur on the situation of human rights in Iran,
– having regard to the reports on the situation of human rights in the Islamic Republic of Iran by the UN Special Rapporteur on human rights in Iran of 23 September 2011 and 6 March 2012,
– having regard to the Statement by the Spokesperson of High Representative Catherine Ashton on the use of the death penalty in Iran, issued on 30 May 2012,
– having regard to the International Covenant on Civil and Political Rights (ICCPR), the International Covenant on Economic, Social and Cultural Rights (ICESCR) and the Convention on the Elimination of All Forms of Racial Discrimination, to all of which Iran is a party,
– having regard to Rule 122(5) and 110(4) of its Rules of Procedure,
A. whereas the current human rights situation in Iran is characterised by an ongoing pattern of systematic violations of fundamental rights; whereas minorities in Iran continue to be discriminated against and harassed on the grounds of their ethnic or religious background; whereas in recent months minority groups have demonstrated for their rights, and whereas this has led to the large-scale imprisonment of participants;
B. whereas six members of Iran's Ahwazi Arab minority are on trial after they were detained without charge for almost a year in connection with their activities on behalf of this minority; whereas justified fears exist that they may not receive a fair trial and may be at risk of torture or other ill-treatment;
C. whereas, on 5 June 2012, for instance, Mohammad Mehdi Zalieh, an Iranian-Kurdish prisoner, died in Rajaee Shahr prison as a result of poor medical attention by the prison's authorities;
D. whereas the constitution of the Islamic Republic of Iran formally provides for the fair treatment of ethnic minorities; whereas, however, in practice members of ethnic minorities, such as Azeris, Arabs, Kurds and Balochs, face a wide range of human and civil rights violations, including encroachments on their right to freedom of assembly, association and expression;
E. whereas there is widespread socio-economic discrimination against persons belonging to minorities, including land and property confiscation and denial of employment, and restrictions on social, cultural and linguistic rights, in violation of the International Convention on the Elimination of All Forms of Racial Discrimination and the International Covenant on Economic, Social and Cultural Rights;
F. whereas discrimination against ethnic minorities has a considerable impact in the field of education, as schools in minority regions are often poor and dropout and illiteracy rates in these regions tend to be higher than the national average, which contributes to the underrepresentation of national and ethnic minorities in high-ranking government positions;
G. whereas non-Persian women face double discrimination as members of marginalised communities and as women in Iran, where the law specifically limits their rights;
H. whereas a dramatic increase in executions, including of juveniles, has been recorded in Iran in recent years; whereas the death penalty is regularly imposed in cases where the accused are denied their due-process rights and for crimes that do not fall into the category of ‘most serious crimes’ under international standards;
1. Expresses its serious concern at the steadily deteriorating human rights situation in Iran, including for persons belonging to ethnic and religious minorities, due to systematic political, economic, social, and cultural discrimination;
2. Calls on the Iranian authorities to eliminate all forms of discrimination against persons belonging to ethnic and religious minorities, officially recognised or otherwise; demands that all persons belonging to minorities be allowed to exercise all the rights enshrined in the Iranian constitution and in international law, including the guarantees stipulated in the International Covenant on Civil and Political Rights and the International Covenant on Economic, Social and Cultural Rights, to which Iran is a party;
3. Calls on the Iranian authorities to ensure that the arrested members of Iran's Ahwazi Arab minority – Mohammad Ali Amouri, Rahman Asakereh, Hashem Sha'bani Amouri, Hadi Rashidi, Sayed Jaber Alboshoka and Sayed Mokhtar Alboshoka – are tried in accordance with international fair-trial standards, with due protection from torture and other ill-treatment, and without recourse to the death penalty;
4. Urges the Iranian authorities to release all activists who are currently imprisoned for their peaceful advocacy of minority rights;
5. Calls on the Iranian authorities to respect the right of ethnic minorities to use their own languages, in private and public, and in particular to guarantee education in minority languages, in accordance with the constitution of the Islamic Republic of Iran;
6. Calls on the UN Independent Expert on minority issues and the UN Special Rapporteur on contemporary forms of racism, xenophobia and related intolerance to request a visit to Iran in order to report on the situation of human rights, and in particular the plight of minorities;
7. Calls on the Iranian authorities to guarantee religious freedom in accordance with the Iranian constitution and the International Covenant on Civil and Political Rights and to put a stop in practice to discrimination against and harassment of religious minorities such as non-Shia Muslims, including Assyrians and other Christian groups, the systematic persecution of the Baha'i minority and the application of the death penalty to converts from Islam;
8. Calls on the Commission, in close cooperation with Parliament, to make effective use of the new Instrument for Democracy and Human Rights in order to support democracy and respect for human rights, including the rights of persons belonging to minorities, in Iran;
9. Strongly condemns the use of the death penalty in Iran and calls on the Iranian authorities, in accordance with UN General Assembly Resolutions 62/149 and 63/168, to institute a moratorium on executions, pending the abolition of the death penalty; urges the government to prohibit the execution of juveniles and commute all capital sentences currently faced by juveniles;
10. Reaffirms its readiness to engage in human rights dialogue with Iran at all levels on the basis of universal values as enshrined in the UN Charter and UN conventions;
11. Calls on the Iranian authorities to demonstrate that they are fully committed to cooperating with the international community in improving the human rights situation in Iran; stresses the need for closer engagement with the Human Rights Council and UN human rights mechanisms;
12. Instructs its President to forward this resolution to the Council, the Commission, the Vice-President of the Commission/High Representative of the Union for Foreign Affairs and Security Policy, the Secretary-General of the United Nations, the UN Human Rights Council, and the Office of the Supreme Leader, the Government and the Parliament of the Islamic Republic of Iran.
European cardiac arrest awareness week
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Declaration of the European Parliament of 14 June 2012 on establishing a European cardiac arrest awareness week
– having regard to Rule 123 of its Rules of Procedure,
A. whereas in Europe approximately 400 000 people suffer an out-of-hospital sudden cardiac arrest every year, with a survival rate of less than 10%;
B. whereas the survival of many apparently healthy victims depends on cardiopulmonary resuscitation (CPR) administered by bystanders and early defibrillation, and whereas an intervention within 3-4 minutes may increase the chance of survival to more than 50%;
C. whereas in Europe, automated external defibrillator (AED) programmes are only partially implemented;
1. Calls on the Commission and the Council to encourage:
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the adoption of common programmes for implementing AED in public places and training lay people in all Member States,
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the adjustment of legislation in order to facilitate CPR and defibrillation by non-medical persons,
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systematic data collection for feedback and quality management in every programme;
2. Calls on the Commission and the Member States to establish a European cardiac arrest awareness week aimed at improving the awareness and education of the general public, physicians and healthcare professionals;
3. Calls on the Commission to support the Member States in adopting and implementing national strategies for equal access to high-quality CPR;
4. Calls on the Commission and the Member States to enact harmonised legislation across the EU in order to provide immunity from liability to non-medical first responders who offer voluntary assistance in cardiac emergencies;
5. Instructs its President to forward this declaration, together with the names of the signatories(1), to the Council, the Commission and the parliaments of the Member States.