European Parliament legislative resolution on the proposal for a Council regulation amending Regulation (EC) No 1785/2003 as regards the arrangements for importing rice (COM(2006)0098
– C6-0085/2006
– 2006/0028(CNS)
)
–
having regard to the Commission proposal to the Council (COM(2006)0098
)(1)
,
–
having regard to Article 36 and Article 37(2), third subparagraph, of the EC Treaty, pursuant to which the Council consulted Parliament (C6-0085/2006
),
–
having regard to Rules 51 and 43(1) of its Rules of Procedure,
–
having regard to the report of the Committee on Agriculture and Rural Development (A6-0142/2006
),
1.
Approves the Commission proposal;
2.
Calls on the Council to notify Parliament if it intends to depart from the text approved by Parliament;
3.
Asks the Council to consult Parliament again if it intends to amend the Commission proposal substantially;
4.
Instructs its President to forward its position to the Council and Commission.
Aid for processing flax and hemp grown for fibre *
64k 32k
European Parliament legislative resolution on the proposal for a Council regulation amending Regulation (EC) No 1673/2000, as regards the processing aid for flax and hemp grown for fibre, and Regulation (EC) No 1782/2003, as regards hemp eligible for the Single Payment Scheme (COM(2006)0125
– C6-0119/2006
– 2006/0043(CNS)
)
EC-Albania Agreement on certain aspects of air services *
62k 31k
European Parliament legislative resolution on the proposal for a Council decision on the conclusion of the Agreement between the European Community and the Republic of Albania on certain aspects of air services (COM(2005)0349
– C6-0113/2006
– 2005/0143(CNS)
)
–
having regard to the proposal for a Council decision (COM(2005)0349
)(1)
,
–
having regard to Articles 80(2) and 300(2), first subparagraph, first sentence, of the EC Treaty,
–
having regard to Article 300(3), first subparagraph, of the EC Treaty, pursuant to which the Council consulted Parliament (C6-0113/2006
),
–
having regard to Rules 51 and 83(7) of its Rules of Procedure,
–
having regard to the report of the Committee on Transport and Tourism (A6-0129/2006
),
1.
Approves conclusion of the agreement;
2.
Instructs its President to forward its position to the Council and Commission, and the governments and parliaments of the Member States and the Republic of Albania.
EC-Serbia and Montenegro Agreement on certain aspects of air services *
62k 29k
European Parliament legislative resolution on the proposal for a Council decision on the conclusion of the Agreement between the European Community and Serbia and Montenegro on certain aspects of air services (COM(2005)0353
– C6-0114/2006
– 2005/0141(CNS)
)
–
having regard to the proposal for a Council decision (COM(2005)0353
)(1)
,
–
having regard to Articles 80(2) and 300(2), first subparagraph, first sentence, of the EC Treaty,
–
having regard to Article 300(3), first subparagraph, of the EC Treaty, pursuant to which the Council consulted Parliament (C6-0114/2006
),
–
having regard to Rules 51 and 83(7) of its Rules of Procedure,
–
having regard to the report of the Committee on Transport and Tourism (A6-0126/2006
),
1.
Approves conclusion of the agreement;
2.
Instructs its President to forward its position to the Council and Commission, and the governments and parliaments of the Member States and Serbia and Montenegro.
EC-Former Yugoslav Republic of Macedonia Agreement on certain aspects of air services *
63k 32k
European Parliament legislative resolution on the proposal for a Council decision on the conclusion of the Agreement between the European Community and the Former Yugoslav Republic of Macedonia on certain aspects of air services (COM(2005)0355
– C6-0115/2006
– 2005/0146(CNS)
)
–
having regard to the proposal for a Council decision (COM(2005)0355
)(1)
,
–
having regard to Articles 80(2) and 300(2), first subparagraph, first sentence of the EC Treaty,
–
having regard to Article 300(3), first subparagraph, of the EC Treaty, pursuant to which the Council consulted Parliament (C6-0115/2006
),
–
having regard to Rules 51 and 83(7) of its Rules of Procedure,
–
having regard to the report of the Committee on Transport and Tourism (A6-0130/2006
),
1.
Approves conclusion of the agreement;
2.
Instructs its President to forward its position to the Council and Commission, and the governments and parliaments of the Member States and the Former Yugoslav Republic of Macedonia.
EC-Romania Agreement on certain aspects of air services *
62k 31k
European Parliament legislative resolution on the proposal for a Council decision on the conclusion of the Agreement between the European Community and Romania on certain aspects of air services (COM(2005)0369
– C6-0116/2006
– 2005/0148(CNS)
)
–
having regard to the proposal for a Council decision (COM(2005)0369
)(1)
,
–
having regard to Articles 80(2) and 300(2), first subparagraph, first sentence of the EC Treaty,
–
having regard to Article 300(3), first subparagraph, of the EC Treaty, pursuant to which the Council consulted Parliament (C6-0116/2006
),
–
having regard to Rules 51 and 83(7) of its Rules of Procedure,
–
having regard to the report of the Committee on Transport and Tourism (A6-0128/2006
),
1.
Approves conclusion of the agreement;
2.
Instructs its President to forward its position to the Council and Commission, and the governments and parliaments of the Member States and Romania.
EC-Moldova Agreement on certain aspects of air services *
61k 31k
European Parliament legislative resolution on the proposal for a Council decision on the conclusion of the Agreement between the European Community and the Republic of Moldova on certain aspects of air services (COM(2005)0371
– C6-0117/2006
– 2005/0151(CNS)
)
–
having regard to the proposal for a Council decision (COM(2005)0371
)(1)
,
–
having regard to Article 80(2) and Article 300(2), first subparagraph, first sentence, of the EC Treaty,
–
having regard to Article 300(3), first subparagraph, of the EC Treaty, pursuant to which the Council consulted Parliament (C6-0117/2006
),
–
having regard to Rules 51 and 83(7) of its Rules of Procedure,
–
having regard to the report of the Committee on Transport and Tourism (A6-0127/2006
),
1.
Approves conclusion of the agreement;
2.
Instructs its President to forward its position to the Council and Commission, and the governments and parliaments of the Member States and the Republic of Moldova.
EC-Morocco Agreement on certain aspects of air services *
63k 31k
European Parliament legislative resolution on the proposal for a Council decision on the conclusion of the Agreement between the European Community and the Kingdom of Morocco on certain aspects of air services (COM(2005)0393
– C6-0118/2006
– 2005/0161(CNS)
)
–
having regard to the proposal for a Council decision (COM(2005)0393
)(1)
,
–
having regard to Article 80(2) and Article 300(2), first subparagraph, first sentence, of the EC Treaty,
–
having regard to Article 300(3), first subparagraph, of the EC Treaty, pursuant to which the Council consulted Parliament (C6-0118/2006
),
–
having regard to Rules 51 and 83(7) of its Rules of Procedure,
–
having regard to the report of the Committee on Transport and Tourism (A6-0125/2006
),
1.
Approves conclusion of the agreement;
2.
Instructs its President to forward its position to the Council and Commission, and the governments and parliaments of the Member States and the Kingdom of Morocco.
Protocol to the fisheries agreement with São Tomé and Príncipe *
91k 40k
European Parliament legislative resolution on the proposal for a Council regulation on the conclusion of the Agreement in the form of an exchange of letters extending the Protocol setting out, for the period 1 June 2005 to 31 May 2006, the fishing opportunities and the financial contribution provided for by the Agreement between the European Economic Community and the Government of the Democratic Republic of São Tomé and Príncipe on fishing off the coast of São Tomé and Príncipe (COM(2005)0630
– C6-0045/2006
– 2005/0249(CNS)
)
–
having regard to the proposal for a Council regulation (COM(2005)0630
)(1)
,
–
having regard to Article 37 and Article 300(2) of the EC Treaty,
–
having regard to Article 300(3), first subparagraph, of the EC Treaty, pursuant to which the Council consulted Parliament (C6-0045/2006
),
–
having regard to Rules 51 and 83(7) of its Rules of Procedure,
–
having regard to the report of the Committee on Fisheries and the opinions of the Committee on Budgets and the Committee on Development (A6-0132/2006
),
1.
Approves the proposal for a Council regulation as amended and approves conclusion of the agreement;
2.
Instructs its President to forward its position to the Council and the Commission, and to the governments and parliaments of the Member States and the Democratic Republic of São Tomé e Príncipe.
Text proposed by the Commission
Amendments by Parliament
Amendment 1 Recital 2 a (new)
(2a) The Community financial contribution should also be used for the development of coastal communities living on fisheries and the creation of small local fish-canning and processing firms.
Amendment 2 Article 1 a (new)
Article 1a The European Parliament's opinion on the extension or conclusion of fisheries partnership agreements shall be sought as swiftly as possible, so that such an opinion is not requested after the date of payment of any financial compensation.
Amendment 3 Article 3 a (new)
Article 3a During the final year of the Protocol's validity and before any agreement is concluded on its renewal, the Commission shall submit to the European Parliament and the Council a report on the application of the agreement and the conditions under which it was implemented.
Amendment 4 Article 3 b (new)
Article 3b The Commission shall report to the European Parliament and the Council on the results of the targeted actions described in Article 4 of the Protocol.
Amendment 5 Article 3 c (new)
Article 3c The Commission shall submit to the European Parliament a copy of the report relating to the evaluation study on "deep-water crab" stocks scheduled for 2006.
Amendment 6 Article 3 d (new)
Article 3d Before concluding negotiations on the renewal of this agreement, the Commission shall forward to the European Parliament the positions of the Member States which have an interest in its renewal.
European Parliament legislative resolution on the proposal for a Council regulation denouncing the Agreement between the European Economic Community and the Government of the People's Republic of Angola on fisheries off Angola and derogating from Regulation (EC) No 2792/1999 (COM(2005)0677
– C6-0035/2006
– 2005/0262(CNS)
)
–
having regard to the proposal for a Council regulation (COM(2005)0677
)(1)
,
–
having regard to Article 300(2), first subparagraph, of the EC Treaty ,
–
having regard to Article 300(3), first subparagraph, of the EC Treaty, pursuant to which the Council consulted Parliament (C6-0035/2006
),
–
having regard to Rules 51 and 83(7) of its Rules of Procedure,
–
having regard to the report of the Committee on Fisheries and the opinions of the Committee on Budgets and the Committee on Development (A6-0133/2006
),
1.
Approves the proposal for a Council regulation and denunciation of the Agreement;
2.
Approves the derogations from Regulation (EC) No 2792/1999 contained in the regulation now approved;
3.
Instructs its President to forward its position to the Council and Commission, and the governments and parliaments of the Member States and the Republic of Angola.
European Parliament legislative resolution on the amended proposal for a Council directive amending Directive 77/388/EEC as regards the place of supply of services (COM(2005)0334
– C6-0322/2005
– 2003/0329(CNS)
)
–
having regard to the Commission proposal to the Council (COM(2005)0334
)(1)
,
–
having regard to Article 93 of the EC Treaty, pursuant to which the Council consulted Parliament (C6-0322/2005
),
–
having regard to Rule 51 of its Rules of Procedure,
–
having regard to the report of the Committee on Economic and Monetary Affairs and the opinion of the Committee on Culture and Education (A6-0153/2006
),
1.
Approves the Commission proposal as amended;
2.
Calls on the Commission to alter its proposal accordingly, pursuant to Article 250(2) of the EC Treaty;
3.
Calls on the Council to notify Parliament if it intends to depart from the text approved by Parliament;
4.
Asks the Council to consult Parliament again if it intends to amend the Commission proposal substantially;
5.
Instructs its President to forward its position to the Council and the Commission.
Text proposed by the Commission
Amendments by Parliament
Amendment 1 RECITAL 1
(1)
The realisation of the internal market, globalisation, deregulation and technology change have all combined to create enormous changes in the volume and pattern of trade in services. It is increasingly possible for a number of services to be supplied at a distance. In response, piecemeal steps have been taken to address this over the years and many defined services are in fact at present taxed on the basis of the destination principle.
(1)
The realisation of the internal market, globalisation, deregulation and technology change have all combined to create enormous changes in the volume and pattern of trade in services. It is increasingly possible for a number of services, such as electronically delivered services and telecommunication services,
to be supplied at a distance. In response, piecemeal steps have been taken to address this over the years and many defined services are in fact at present taxed on the basis of the destination principle.
Amendment 2 RECITAL 6
(6)
In certain circumstances, the general rules as regards the place of supply of services for both taxable and non-taxable persons are not applicable and specified exclusions apply. These exclusions should be largely based on existing criteria and reflect the principle of taxation at the place of consumption, while not imposing disproportionate administrative burdens upon certain traders.
(6)
In certain circumstances, the general rules as regards the place of supply of services for both taxable and non-taxable persons are not applicable and specified exclusions apply. These exclusions should be largely based on existing criteria and reflect the principle of taxation at the place of consumption, while not imposing disproportionate administrative burdens upon certain traders, and this requires value added tax obligations to be simplified by measures such as the introduction of a 'one-stop scheme'.
Amendment 3 RECITAL 8 A (new)
(8a) In order to ensure the proper application of VAT on services that are subject to the reverse charge mechanism, the data collected by the Member State where the supplier is established should be communicated to the Member State where the recipient is established. Council Regulation (EC) No 1798/2003 of 7 October 2003 on administrative cooperation in the field of value added tax
1 should provide for such communication and should be amended accordingly. The adoption of this Directive is closely linked to the necessary amendments of Regulation (EC) No 1798/2003, as well as to the effective modification of the VAT information exchange system (VIES) in order to include services in the exchange of information. ____
1 OJ L 264, 15.10.2003, p. 1.
3.
For the purposes of paragraphs 1 and 2, where a person is a taxable person who also performs activities or transactions that are not considered to be taxable supplies of goods and services, he shall be deemed to be a taxable person in respect of all services supplied to him except where the services are for his own private use or that of his staff.
3.
For the purposes of paragraphs 1 and 2, where a person is a taxable person who also performs activities or transactions that are not considered to be taxable supplies of goods and services, he shall be deemed to be a taxable person in respect of all services supplied to him.
Amendment 6 ARTICLE 1, POINT 2 Article 9g, paragraph 1, point (c) (Directive 77/388/EEC)
(c) radio
and television broadcasting services;
(c)
linear and non-linear radio, television,
and other audiovisual media services
;
–
having regard to the request for waiver of the immunity of Tobias Pflüger, forwarded by the German Federal Ministry of Justice on 29 November 2005, and announced in plenary sitting on 15 December 2005,
–
having heard Tobias Pflüger in accordance with Rule 7(3) of its Rules of Procedure,
–
having regard to Article 10 of the Protocol of 8 April 1965 on the privileges and immunities of the European Communities and Article 6(2) of the Act of 20 September 1976 concerning the election of the members of the European Parliament by direct universal suffrage,
–
having regard to the judgments of 12 May 1964 and 10 July 1986 of the Court of Justice of the European Communities(1)
,
–
having regard to Article 46 of the Basic Law of the Federal Republic of Germany,
–
having regard to Rules 6(2) and 7 of its Rules of Procedure,
–
having regard to the report of the Committee on Legal Affairs (A6-0156/2006
),
1.
Decides to waive the immunity of Tobias Pflüger;
2.
Instructs its President to forward this decision, and the report of the committee responsible, immediately to the proper German authorities.
European Parliament legislative resolution on the Council common position for adopting a regulation of the European Parliament and of the Council on nutrition and health claims made on foods (9858/3/2005 – C6-0018/2006
– 2003/0165(COD)
)
–
having regard to the Council common position (9858/3/2005 – C6-0018/2006
),
–
having regard to its position at first reading(1)
on the Commission proposal to Parliament and the Council (COM(2003)0424
)(2)
,
–
having regard to Article 251(2) of the EC Treaty,
–
having regard to Rule 62 of its Rules of Procedure,
–
having regard to the recommendation for second reading of the Committee on the Environment, Public Health and Food Safety (A6-0122/2006
),
1.
Approves the common position as amended;
2.
Instructs its President to forward its position to the Council and Commission.
Position of the European Parliament adopted at second reading on 16 May 2006 with a view to the adoption of Regulation (EC) No .../
2006
of the European Parliament and of the Council on nutrition and health claims made on foods
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof,
Having regard to the proposal from the Commission,
Having regard to the Opinion of the European Economic and Social Committee(3)
,
Acting in accordance with the procedure laid down in Article 251 of the Treaty(4)
,
Whereas:
(1)
An increasing number of foods labelled and advertised in the Community bear nutrition and health claims. In order to ensure a high level of protection for consumers and to facilitate their choice, products put on the market, including imported products,
must be safe and adequately labelled. A varied and balanced diet is a prerequisite for good health and single products have a relative importance in the context of the total diet.
(2)
Differences between national provisions relating to such claims may impede the free movement of foods and create unequal conditions of competition. They thus have a direct impact on the functioning of the internal market. It is therefore necessary to adopt Community rules on the use of nutrition and health claims on foods.
(3)
General labelling provisions are contained in Directive 2000/13/EC of the European Parliament and of the Council of 20 March 2000 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs(5)
. Directive 2000/13/EC generally prohibits the use of information that would mislead the purchaser or attribute medicinal properties to food. This Regulation should complement the general principles in Directive 2000/13/EC and lay down specific provisions concerning the use of nutrition and health claims concerning foods to be delivered as such to the consumer.
(4)
This Regulation should apply to all nutrition and health claims made in commercial communications, including inter alia
generic advertising of food and promotional campaigns, such as those supported in whole or in part by public authorities. It should not apply to claims which are made in non-commercial communications, such as dietary guidelines or advice issued by public health authorities and bodies, or non-commercial communications and information in the press and in scientific publications. This Regulation should also apply to trade marks and other brand names which may be construed as nutrition or health claims.
(5)Generic descriptors (denominations) which have traditionally been used to indicate a particularity of a class of foods or beverages which could imply an effect on human health, such as "digestive" or "cough drops", could be exempted from the application of this Regulation.
(6
)
Non-beneficial nutrition claims are not covered by the scope of this Regulation; Member States intending to introduce national schemes relating to non-beneficial nutrition claims should notify such schemes to the Commission and to other Member States in accordance with Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on Information Society services(6)
.
(7
)
At international level the Codex Alimentarius has adopted General Guidelines on Claims in 1991 and Guidelines for the Use of Nutrition Claims in 1997. An amendment to the latter has been adopted by the Codex Alimentarius Commission in 2004. That amendment concerns the inclusion of health claims in the 1997 Guidelines. Due consideration is given to the definitions and conditions set in the Codex Guidelines.
(8
)
The possibility of using the claim "low fat" for spreadable fats provided for in Council Regulation (EC) No 2991/94 of 5 December 1994 laying down standards for spreadable fats(7)
should be adapted to the provisions of this Regulation as soon as possible. In the meantime, Regulation (EC) No 2991/94 applies for the products it covers.
(9
)
There is a wide range of nutrients and other substances including, but not limited to, vitamins, minerals including trace elements, amino-acids, essential fatty acids, fibre, various plants and herbal extracts with a nutritional or physiological effect that might be present in a food and be the subject of a claim. Therefore, general principles applicable to all claims made on foods should be established in order to ensure a high level of consumer protection, give the consumer the necessary information to make choices in full knowledge of the facts, as well as creating equal conditions of competition for the food industry.
(10
)
Foods promoted with claims may be perceived by consumers as having a nutritional, physiological or other health advantage over similar or other products to which such nutrients and other substances are not added. This may encourage consumers to make choices which directly influence their total intake of individual nutrients or other substances in a way which would run counter to scientific advice. To address this potential undesirable effect, it is appropriate to impose certain restrictions as regards the products bearing claims. In this context, factors such as the presence of certain substances, or
the nutrient profile of a
product, are appropriate criteria for determining whether the product can bear claims. The use of such criteria at national level, whilst justified for the purpose of allowing consumers to make informed nutritional choices, is likely to result in barriers to intra-Community trade and should therefore be harmonised at Community level. Health information and communication supporting national authority or Community messages about the dangers of misuse of alcohol should not fall under the scope of this Regulation.
(11
)
The application of nutrient profiles as a criterion would aim to avoid a situation where nutrition or health claims mask the overall nutritional status of a food product, which could mislead consumers when trying to make healthy choices in the context of a balanced diet. Nutrient profiles as provided for in this Regulation would be intended for the sole purpose of governing the circumstances in which claims may be made. They should be based on generally accepted scientific evidence
relative to the relationship between diet and health. However, profiles should also allow for product innovation and should take into account the variability of dietary habits and traditions,
and the fact that individual products may have an important role in the context of an overall diet.
(12
)
The establishment of nutrient profiles should take into account the content of different nutrients and substances with a nutritional or physiological effect, in particular those such as fat, saturated fat, trans-fatty acids, salt/sodium and sugars, excessive intakes of which in the overall diet are not recommended, as well as poly- and mono-unsaturated
fats, available carbohydrates other than sugars, vitamins, minerals, protein and fibre. When setting the nutrient profiles, the different categories of foods and the place and role of these foods in the overall diet should be taken into account and due regard should be given to the various dietary habits and consumption patterns existing in the Member States
. Exemptions from the requirement to respect established nutrient profiles may be necessary for certain foods or categories of foods depending on their role and importance in the diet of the population. These would be complex technical tasks and the adoption of the relevant measures should be entrusted to the Commission, taking into account the advice of the European Food Safety Authority.
(13
)
Food supplements as defined in 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(8)
presented in a liquid form and containing more than 1,2% by volume of alcohol are not considered as beverages under this Regulation.
(14
)
There is a wide variety of claims currently used in the labelling and advertising of foods in some Member States relating to substances that have not been shown to be beneficial or for which at present there is not sufficient scientific agreement. It is necessary to ensure that the substances for which a claim is made have been shown to have a beneficial nutritional or physiological effect.
(15
)
In order to ensure that the claims made are truthful, it is necessary that the substance that is the subject of the claim is present in the final product in quantities that are sufficient, or that the substance is absent or present in suitably reduced quantities, to produce the nutritional or physiological effect claimed. The substance should also be available to be used by the body. In addition, and where appropriate, a significant amount of the substance producing the claimed nutritional or physiological effect should be provided by a quantity of the food that can reasonably be expected to be consumed.
(16
)
It is important that claims on foods can be understood by the consumer and it is appropriate to protect all consumers from misleading claims. However, since the enactment of Council Directive 84/450/EEC of 10 September 1984 concerning misleading and comparative advertising(9)
, the Court of Justice of the European Communities has found it necessary in adjudicating on advertising cases to examine the effect on a notional, typical consumer. In line with the principle of proportionality, and to enable the effective application of the protective measures contained in it, this Regulation takes as a benchmark the average consumer, who is reasonably well-informed and reasonably observant and circumspect, taking into account social, cultural and linguistic factors, as interpreted by the Court of Justice, but makes provision to prevent the exploitation of consumers whose characteristics make them particularly vulnerable to misleading claims. Where a claim is specifically aimed at a particular group of consumers, such as children, it is desirable that the impact of the claim be assessed from the perspective of the average member of that group. The average consumer test is not a statistical test. National courts and authorities will have to exercise their own faculty of judgment, having regard to the case-law of the Court of Justice, to determine the typical reaction of the average consumer in a given case.
(17
)
Scientific substantiation should be the main aspect to be taken into account for the use of nutrition and health claims and the food business operators using claims should justify them. A claim should be scientifically substantiated by taking into account the totality of the available scientific data, and by weighing the evidence.
(18
)
A nutrition or health claim should not be made if it is inconsistent with generally accepted nutrition and health principles or if it encourages or condones excessive consumption of any food or disparages good dietary practice.
(19
)
Given the positive image conferred on foods bearing nutrition and health claims and the potential impact these foods may have on dietary habits and overall nutrient intakes, the consumer should be able to evaluate their global nutritional quality. Therefore, nutrition labelling should be compulsory and should be extensive on all foods bearing health claims.
(20
)
General nutritional labelling provisions are contained in Council Directive 90/496/EEC of 24 September 1990 on nutrition labelling for foodstuffs(10)
. According to that Directive, where a nutrition claim appears on labelling, in presentation or in advertising, with the exclusion of generic advertising, nutrition labelling should be compulsory. Where a nutrition claim is made for sugars, saturates, fibre or sodium, the information to be given should be that of Group 2 as defined in Article 4(1) of Directive 90/496/EEC. In order to achieve a high level of consumer protection, this obligation to provide the information of Group 2 should apply mutatis mutandis where any health claim is made, with the exception of generic advertising.
(21
)
A list of permitted nutrition claims and their specific conditions of use should also be created based on the conditions for the use of such claims that have been agreed at national or international level and laid down in Community legislation. Any claim considered to have the same meaning for consumers as a nutrition claim included in the above-mentioned list should be subject to the same conditions of use indicated therein. For example, claims related to the addition of vitamins and minerals such as "with…", "restored…", "added…", or "enriched…" should be subject to the conditions set for the claim "source of…". The list should be regularly updated in order to take into account scientific and technological developments. Furthermore, for comparative claims it is necessary that the products being compared be clearly identified to the final consumer.
(22
)
Conditions for claims such as "lactose-free" or "gluten-free", addressed to a group of consumers with specific disorders, should be dealt with in Council Directive 89/398/EEC of 3 May 1989 on the approximation of the laws of the Member States relating to foodstuffs intended for particular nutritional uses(11)
. In addition, that Directive provides the possibility that foodstuffs for normal consumption can indicate their suitability for use by these groups of consumers if they fulfil the conditions for such statement. Until the conditions for such statements are set at Community level, Member States may maintain or adopt relevant national measures.
(23
)
Health claims should only be authorised for use in the Community after a scientific assessment of the highest possible standard. In order to ensure harmonised scientific assessment of these claims, the European Food Safety Authority should carry out such assessments. The applicant may have access on request to his file to check the state of the procedure.
(24
)
There are many factors, other than dietary ones, that can influence psychological and behavioural functions. Communication on these functions is thus very complex and it is difficult to convey a comprehensive, truthful and meaningful message in a short claim to be used in the labelling and advertising of foods. Therefore, it is appropriate, when using psychological and behavioural claims, to require scientific substantiation.
(25
)
In the light of Commission Directive 96/8/EC of 26 February 1996 on foods intended for use in energy-restricted diets for weight reduction(12)
which prohibits, in the labelling, presentation and advertising of products covered by that Directive, any reference to the rate or amount of weight loss which may result from their use, it is considered appropriate to extend this restriction to all foods.
(26
)
Health claims other than those referring to the reduction of disease risk and to children's development and health
, based on generally accepted scientific evidence
, should undergo a different type of assessment and authorisation. It is therefore necessary to adopt a Community list of such permitted claims after consulting the European Food Safety Authority. Furthermore, in order to stimulate innovation, those health claims which are based on newly developed scientific evidence should undergo an accelerated type of authorisation.
(27
)
In order to keep up with scientific and technological developments, the list referred to above should be revised promptly whenever necessary. Such revisions are implementing measures of a technical nature and their adoption should be entrusted to the Commission in order to simplify and expedite the procedure.
(28
)
The
diet is one of the many factors influencing the onset of certain human diseases. Other factors such as age, genetic predisposition, the level of physical activity, the consumption of tobacco and other drugs, environmental exposure and stress may all influence the onset of human diseases. Specific labelling requirements should therefore apply in respect of claims relating to the reduction of a disease risk.
(29
)
In order to ensure that health claims are truthful, clear, reliable and useful to the consumer in choosing a healthy diet, the wording and the presentation of health claims should be taken into account in the opinion of the European Food Safety Authority and in subsequent procedures
.
(30
)
In some cases, scientific risk assessment alone cannot provide all the information on which a risk management decision should be based. Other legitimate factors relevant to the matter under consideration should therefore be taken into account.
(31
)
For the sake of transparency and in order to avoid multiple applications in respect of claims which have already been assessed, a public Register containing the lists of such claims should be established and updated by the Commission.
(32
)
In order to stimulate research and development within the agri-food industry, it is appropriate to protect the investment made by innovators in gathering the information and data supporting an application under this Regulation. This protection should however be limited in time in order to avoid the unnecessary repetition of studies and trials, and to facilitate access to claims by small and medium-sized enterprises (SMEs), which rarely have the financial capacity to carry out research activities
.
(33)SMEs represent an important added value to European food industry in terms of quality and preservation of different dietary habits. In order to facilitate the implementation of this Regulation, the Agency should make available appropriate technical guidance and tools, in due time, especially for SMEs.
(34
)
Given the particular nature of foods bearing claims, additional means to those usually available to monitoring bodies should be available in order to facilitate efficient monitoring of those products.
(35
)
Adequate transitional measures are necessary to enable food business operators to adapt to the requirements of this Regulation.
(36
)
Since the objective of this Regulation, namely to ensure the effective functioning of the internal market as regards nutrition and health claims whilst providing a high level of consumer protection, cannot be sufficiently achieved by the Member States and can therefore be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. 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 that objective.
(37
)
The measures necessary for the implementation of this Regulation should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission(13)
,
HAVE ADOPTED THIS REGULATION:
CHAPTER I
SUBJECT MATTER, SCOPE AND DEFINITIONS
Article 1
Subject matter and scope
1.
This Regulation harmonises the provisions laid down by law, regulation or administrative action in Member States which relate to nutrition and health claims in order to ensure the effective functioning of the internal market whilst providing a high level of consumer protection.
2.
This Regulation shall apply to nutrition and health claims made in commercial communications, whether in the labelling, presentation or advertising of foods to be delivered as such to the final consumer.
In the case of non-prepackaged foodstuffs (including fresh products such as fruit, vegetables or bread) put up for sale to the final consumer or to mass caterers and foodstuffs packed at the point of sale at the request of the purchaser or pre-packaged with a view to immediate sale, Article 7 and Article 10(2)(a) and (b) shall not apply. National provisions may apply until the eventual adoption of Community measures in accordance with the procedure laid down in Article 25(2).
It shall also apply in respect of foods intended for supply to restaurants, hospitals, schools, canteens and similar mass caterers.
3.
A trade mark, brand name or fancy name appearing in the labelling, presentation or advertising of a food which may be construed as a nutrition or health claim may be used without undergoing the authorisation procedures provided for in this Regulation, provided that it is accompanied by a related nutrition or health claim in that labelling, presentation or advertising which complies with the provisions of this Regulation.
4.For generic descriptors (denominations) which have traditionally been used to indicate a particularity of a class of foods or beverages which could imply an effect on human health, a derogation from paragraph 3 may be adopted in accordance with the procedure laid down in Article 25(2), on application by the food business operators concerned. The application shall be sent to the national competent authority of a Member State which will forward it to the Commission without delay. The Commission shall adopt and make public the rules for food business operators according to which such applications shall be made, so as to ensure that the application is dealt with transparently and within a reasonable time.
5
. This Regulation shall apply without prejudice to the following Community provisions:
(a)
Directive 89/398/EEC and Directives adopted relating to foodstuffs for particular nutritional uses;
(b)
Council Directive 80/777/EEC of 15 July 1980 on the approximation of the laws of the Member States relating to the exploitation and marketing of natural mineral waters(14)
;
(c)
Council Directive 98/83/EC of 3 November 1998 on the quality of water intended for human consumption(15)
;
(d)
Directive 2002/46/EC.
Article 2
Definitions
1. For the purposes of this Regulation:
a)
the definitions of "food", "food business operator", "placing on the market", and "final consumer" set out in Articles 2, 3(3), 3(8) and 3(18) of 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(16)
shall apply;
b)
the definition of "food supplement" set out in Directive 2002/46/EC shall apply;
c)
the definitions of "nutrition labelling", "protein", "carbohydrate", "sugars", "fat", "saturates", "mono-unsaturates", "poly-unsaturates", "fibre" set out in Directive 90/496/EEC shall apply;
d)
the definition of "labelling" set out in Article 1(3)(a) of Directive 2000/13/EC shall apply.
2. The following definitions shall also apply:
1)
"claim" means any message or representation, which is not mandatory under Community or national legislation, including pictorial, graphic or symbolic representation, in any form, which states, suggests or implies that a food has particular characteristics;
2)
"nutrient" means protein, carbohydrate, fat, fibre, sodium, vitamins and minerals listed in the Annex to Directive 90/496/EEC, and substances which belong to or are components of one of those categories;
3)
"other substance" means a substance other than a nutrient that has a nutritional or physiological effect;
4)
"nutrition claim" means any claim which states, suggests or implies that a food has particular beneficial nutritional properties due to:
a)
the energy (calorific value) it
i)
provides,
ii)
provides at a reduced or increased rate, or
iii)
does not provide, and/or
b)
the nutrients or other substances it
i)
contains,
ii)
contains in reduced or increased proportions, or
iii)
does not contain;
5)
"health claim" means any claim that states, suggests or implies that a relationship exists between a food category, a food or one of its constituents and health;
6)
"reduction of disease risk claim" means any health claim that states, suggests or implies that the consumption of a food category, a food or one of its constituents significantly reduces a risk factor in the development of a human disease;
7)
"Authority" means the European Food Safety Authority established by Regulation (EC) No 178/2002.
CHAPTER II
GENERAL PRINCIPLES
Article 3
General principles for all claims
Nutrition and health claims may be used in the labelling, presentation and advertising of foods placed on the market in the Community only if they comply with the provisions of this Regulation.
Without prejudice to Directives 2000/13/EC and 84/450/EEC, the use of nutrition and health claims shall not:
a)
be false, ambiguous or misleading;
b)
give rise to doubt about the safety and/or the nutritional adequacy of other foods;
c)
encourage or condone excess consumption of a food;
d)
state, suggest or imply that a balanced and varied diet cannot provide appropriate quantities of nutrients in general. Derogations in the case of nutrients for which sufficient quantities cannot be provided by a balanced and varied diet, including the conditions for their application, may be adopted in accordance with the procedure referred to in Article 25
(2), taking into account the special conditions present in Member States;
e)
refer to changes in bodily functions which could give rise to or exploit fear in the consumer, either textually or through pictorial, graphic or symbolic representations.
Article 4
Conditions for the use of nutrition and health claims
1.
By ...(17)
, the Commission shall, in accordance with the procedure referred to in Article 25
(2),
establish specific nutrient profiles, including
exemptions, which food or certain categories of food must comply with in order to bear nutrition or health claims and the conditions for the use of nutrition or health claims for foods or categories of foods with respect to the nutrient profiles
.
The
nutrient profiles for
food and/or certain categories of food shall be established
taking into account in particular:
a)
the quantities of certain nutrients and other substances contained in the food, such as fat, saturated fatty acids, trans-fatty acids
, sugars and salt/sodium;
b)
the role and importance of the food (or of categories of food
) and the contribution to
the diet of the population in general or, as appropriate, of certain risk groups including children;
c)
the overall nutritional composition of the food and the presence of nutrients that have been scientifically recognised as having an effect on health.
The nutrient profiles shall be based on scientific knowledge about diet and nutrition, and their relation to health.
In setting the nutrient profiles, the Commission shall request the Authority to provide within 12 months relevant scientific advice, focusing in particular on:
i)
whether profiles should be set for food in general and/or categories of food;
ii)
the choice and balance of nutrients to be taken into account;
iii)
the choice of reference quantity/basis for profiles;
iv)
the approach to the calculation of the profiles, and
v)
the feasibility and
testing of a proposed system.
In setting the nutrient profiles, the Commission shall carry out consultations with interested parties, in particular food business operators and consumer groups.
Nutrient profiles and their conditions of use shall be updated to take into account relevant scientific developments in accordance with the procedure referred to in Article 25
(2) and after consultation of interested parties, in particular food business operators and consumer groups
.
2. By way of derogation from paragraph 1, nutrition claims
a)
referring to the reduction of fat, saturated fatty acids, trans-fatty acids, sugars and salt/sodium shall be allowed without reference to a profile for the specific nutrient/s for which the claim is made, provided they comply with the conditions laid down in this Regulation;
b)
shall be allowed, where a single nutrient exceeds the nutrient profile provided that a statement about the specific nutrient appears in close proximity to, on the same side and with the same prominence as the claim. This statement shall read as follows: "High [ (18)] content".
3.
Beverages containing more than 1,2% by volume of alcohol shall not bear health
claims.
As far as
nutrition claims are concerned, only nutrition claims referring to low alcohol levels, or the reduction of the alcohol content, or the reduction of the energy content for beverages containing more than 1,2% by volume of alcohol, shall be permitted.
4.
In the absence of specific Community rules regarding nutrition claims referring to low alcohol levels, or
the reduction or absence of alcohol or energy in beverages which normally contain alcohol, relevant national rules may apply in compliance with the provisions of the Treaty.
5.
Foods or categories of foods other than those referred to in paragraph 3, for which nutrition or health claims are to be restricted or prohibited, may be determined in accordance with the procedure referred to in Article 25
(2) and in the light of scientific evidence.
Article 5
General conditions
1. The use of nutrition and health claims shall only be permitted if the following conditions are fulfilled:
a)
the presence, absence or reduced content in a food or category of food of a nutrient or other substance in respect of which the claim is made has been shown to have a beneficial nutritional or physiological effect, as established by generally accepted scientific evidence
;
b)
the nutrient or other substance for which the claim is made:
i)
is contained in the final product in a significant quantity as defined in Community legislation or, where such rules do not exist, in a quantity that will produce the nutritional or physiological effect claimed as established by generally accepted scientific evidence
; or
ii)
is not present or is present in a reduced quantity that will produce the nutritional or physiological effect claimed as established by generally accepted scientific evidence
;
c)
where applicable, the nutrient or other substance for which the claim is made is in a form that is available to be used by the body;
d)
the quantity of the product that can reasonably be expected to be consumed provides a significant quantity of the nutrient or other substance to which the claim relates, as defined in Community legislation or, where such rules do not exist, a significant quantity that will produce the nutritional or physiological effect claimed as established by generally accepted scientific evidence
;
e)
compliance with the specific conditions set out in Chapter III or Chapter IV as the case may be.
2.
The use of nutrition and health claims shall only be permitted if the average consumer can be expected to understand the beneficial effects as expressed in the claim.
3.
Nutrition and health claims shall refer to the food ready for consumption in accordance with the manufacturer's instructions.
Article 6
Scientific substantiation for claims
1.
Nutrition and health claims shall be based on and substantiated by generally accepted scientific evidence
.
2.
A food business operator making a nutrition or health claim shall justify the use of the claim.
3.
The competent authorities of the Member States may request a food business operator or a person placing a product on the market to produce all relevant elements and data establishing compliance with this Regulation.
Article 7
Nutrition information
The obligation and the modalities for providing information pursuant to Directive 90/496/EEC where a nutrition claim is made shall apply mutatis mutandis where a health claim is made, with the exception of generic advertising. However, the information to be provided shall consist of information in Group 2 as defined in Article 4(1) of Directive 90/496/EEC.
In addition and as the case may be, the amount(s) of the substance(s) to which a nutrition or health claim relates that does not appear in the nutrition labelling shall also be stated in the same field of vision as
the nutrition information and be expressed in accordance with Article 6 of Directive 90/496/EEC.
In the case of food supplements, the nutrition information shall be provided in accordance with Article 8 of Directive 2002/46/EC.
CHAPTER III
NUTRITION CLAIMS
Article 8
Specific conditions
1.
Nutrition claims shall only be permitted if they are listed in the Annex and are in conformity with the conditions set out in this Regulation.
2.
Amendments to the Annex shall be adopted in accordance with the procedure referred to in Article 25
(2) and, where appropriate, after consulting the Authority. Where appropriate, the Commission shall involve interested parties, in particular food business operators and consumer groups, in order to evaluate the perception and understanding of the claims in question.
Article 9
Comparative claims
1.
Without prejudice to Directive 84/450/EEC, a comparison may only be made between foods of the same category, taking into consideration a range of foods of that category. The difference in the quantity of a nutrient and/or the energy value shall be stated and the comparison shall relate to the same quantity of food.
2.
Comparative nutrition claims shall compare the composition of the food in question with a range of foods of the same category, which do not have a composition which allows them to bear a claim, including foods of other brands.
CHAPTER IV
HEALTH CLAIMS
Article 10
Specific conditions
1.
Health claims shall be prohibited unless they comply with the general requirements in Chapter II and the specific requirements in this Chapter and are authorised in accordance with this Regulation and included in the lists of authorised claims provided for in Articles 13 and 14.
2. Health claims shall only be permitted if the following information is included in the labelling, or if no such labelling exists, in the presentation and advertising:
a)
a statement indicating the importance of a varied and balanced diet and a healthy lifestyle;
b)
the quantity of the food and pattern of consumption required to obtain the claimed beneficial effect;
c)
where appropriate, a statement addressed to persons who should avoid using the food; and
d)
an appropriate warning for products that are likely to present a health risk if consumed to excess.
3.
Reference to general, non-specific benefits of the nutrient or food for overall good health or health-related well-being may only be made if accompanied by a specific health claim included in the lists provided for in Article 13 or 14.
4.
Where appropriate, guidelines on the implementation of this Article shall be adopted in accordance with the procedure referred to in Article 25
(2) and, if necessary, in consultation with interested parties, in particular food business operators and consumer groups.
Article 11
National medical associations and health-related charities
In the absence of specific Community rules concerning recommendations of or endorsements by national associations of medical, nutrition or dietetic professionals
and health-related charities, relevant national rules may apply in compliance with the provisions of the Treaty.
Article 12
Restrictions on the use of certain health claims
The following health claims shall not be allowed:
a)
claims which suggest that health could be affected by not consuming the food;
b)
claims which make reference to the rate or amount of weight loss;
c)
claims which make reference to recommendations of individual doctors or health professionals and other associations not referred to in Article 11.
Article 13
Health claims other than those referring to the reduction of disease risk
and to children's development and health
1. Health claims describing or referring to:
a)
the role of a nutrient or other substance in growth, development and the functions of the body, or
b)
psychological and behavioural functions, or
c)
without prejudice to Directive 96/8/EC, slimming or weight-control or a reduction in the sense of hunger or an increase in the sense of satiety or to the reduction of the available energy from the diet, which are indicated
in the list provided for in paragraph 3 may be made without undergoing the procedures
laid down in Articles 15 to 19
, if they are:
i)
based on generally accepted scientific evidence
, and
ii)
well understood by the average consumer.
2.
Member States shall provide the Commission with lists of claims as referred to in paragraph 1 by …(19)
at the latest accompanied by the conditions applying to them and by references to the relevant scientific justification.
3.
After consulting the Authority, the Commission shall adopt, in accordance with the procedure referred to in Article 25
(2), a Community list of permitted claims as referred to in paragraph 1, and all necessary conditions for the use of these claims by …(20)
at the latest.
4.
Any changes to the list referred to in paragraph 3, based on generally accepted scientific evidence
, shall be adopted in accordance with the procedure referred to in Article 25
(2), after consulting the Authority, on the Commission's own initiative or following a request by a Member State.
5.
Any additions of claims to the list referred to in paragraph 3 based on newly developed scientific evidence
and/or which include a request for the protection of proprietary data shall be adopted following the procedure laid down in Article 18, except claims referring to children's development and health, which should be authorised in accordance with the procedure laid down in
Articles 15, 16, 17 and19
.
Article 14
Reduction of disease risk claims
and claims referring to children's development and health
1.
Notwithstanding Article 2(1)(b) of Directive 2000/13/EC, reduction of disease risk claims and claims referring to children's development and health
may be made where they have been authorised in accordance with the procedure laid down in Articles 15, 16, 17 and19
of this Regulation for inclusion in a Community list of such permitted claims together with all the necessary conditions for the use of these claims.
2.
In addition to the general requirements laid down in this Regulation and the specific requirements of paragraph 1, for reduction of disease risk claims the labelling or, if no such labelling exists, the presentation or advertising shall also bear a statement indicating that the disease to which the claim is referring has multiple risk factors and that altering one of these risk factors may or may not have a beneficial effect.
Article 15
Application for authorisation
1.
When reference is made to this Article, an application for authorisation shall be submitted in accordance with the following paragraphs.
2.
The application shall be sent to the national competent authority of a Member State.
(a) The national competent authority shall:
i)
acknowledge receipt of an application in writing within 14 days of its receipt. The acknowledgement shall state the date of receipt of the application;
ii)
inform without delay the Authority; and
iii)
make the application and any supplementary information supplied by the applicant available to the Authority;
(b) The Authority shall:
i)
inform without delay the other Member States and the Commission of the application and shall make the application and any supplementary information supplied by the applicant available to them;
ii)
make the summary of the application referred to in paragraph 3(g) available to the public.
3. The application shall include the following:
a)
the name and address of the applicant;
b)
the nutrient or other substance, or the food or the category of food, in respect of which the health claim is to be made and its particular characteristics;
c)
a copy of the studies, including, where available, independent, peer-reviewed studies, which have been carried out with regard to the health claim and any other material which is available to demonstrate that the health claim complies with the criteria provided for in this Regulation;
d)
where appropriate, an indication of the information which should be regarded as proprietary accompanied by verifiable justification;
e)
a copy of other scientific studies which are relevant to that health claim;
f)
a proposal for the wording of the health claim for which authorisation is sought including, as the case may be, specific conditions for use;
g)
a summary of the application.
4.
The Commission, having first consulted the Authority, shall establish in accordance with the procedure referred to in Article 25
(2) implementing rules for the application of this Article, including rules concerning the preparation and presentation of the application.
5.
The Commission, in close cooperation with the Authority, shall make available appropriate technical guidance and tools to assist food business operators, in particular SMEs, in the preparation and the presentation of the application for scientific assessment.
Article 16
Opinion of the Authority
1.
In giving its opinion, the Authority shall respect
a time limit of five months
from the date of receipt of a valid application. Whenever
the Authority seeks supplementary information from the applicant as provided for in paragraph 2, such time limit shall be extended by up to two months following the date of receipt of the requested information submitted by the applicant
.
2.
The Authority or a national competent authority through the Authority may, where appropriate, request the applicant to supplement the particulars accompanying the application within a specified time limit.
3. In order to prepare its opinion, the Authority shall verify
:
a)
that the
health claim is substantiated by scientific evidence
;
b)
that
the wording of the health claim complies with the criteria laid down in this Regulation
.
4. In the event of an opinion in favour of authorising the health claim, the opinion shall include the following particulars:
a)
the name and address of the applicant;
b)
the nutrient or other substance, or the food or the category of food, in respect of which a claim is to be made and its particular characteristics;
c)
a proposal for the wording of the
health claim, including, as the case may be, the specific conditions of use;
d)
where applicable, conditions or restrictions of use of the food and/or an additional statement or warning that should accompany the health claim on the label and in advertising.
5.
The Authority shall forward its opinion to the Commission, the Member States and the applicant, including a report describing its assessment of the health claim and stating the reasons for its opinion and the information on which its opinion was based.
6.
The Authority, in accordance with Article 38(1) of Regulation (EC) No 178/2002, shall make its opinion public.
The applicant or members of the public may make comments to the Commission within 30 days from such publication.
Article 17
Community authorisation
1.
Within two months
after receiving the opinion of the Authority, the Commission shall submit to the Committee referred to in Article 23
(2) a draft decision on the lists of permitted health claims, taking into account the opinion of the Authority, any relevant provisions of Community law and other legitimate factors relevant to the matter under consideration. Where the draft decision
is not in accordance with the opinion of the Authority, the Commission shall provide an explanation for the differences.
2.
Any draft decision to amend the lists of permitted health claims shall include the particulars referred to in Article 16(4).
3.
A final decision on the application shall be adopted in accordance with the procedure referred to in Article 25
(2).
4.
The Commission shall without delay inform the applicant of the decision taken and publish details of the decision in the Official Journal of the European Union.
5.
Health claims included in the lists provided for in Articles 13 and 14 may be used, in conformity with the conditions applying to them, by any food business operator, if they are not restricted for use in accordance with the provisions of Article 21
.
6.
The granting of authorisation shall not lessen the general civil and criminal liability of any food business operator in respect of the food concerned.
Article 18
Claims referred to in Article 13(5)
1.A food business operator intending to use a health claim not included in the list provided for in Article 13(3) may apply for the inclusion of the claim in that list.
2.The application for this inclusion shall be submitted to the national competent authority of a Member State which shall acknowledge receipt of the application in writing within 14 days of its receipt. The acknowledgement shall state the date of receipt of the application. The application shall include the data provided for in Article 15(3) and the reasons for the request.
3.The valid application, in line with the guidance referred to in Article 15(5), and any information supplied by the applicant shall be sent without delay to the Authority for a scientific assessment as well as to the Commission and the Member States for information. The Authority shall issue its opinion within a time limit of five months from the date of receipt of the request. Such time limit may be extended by up to one month if the Authority considers it necessary to seek supplementary information from the applicant. In such a case the applicant shall submit the requested information within 15 days from the date of receipt of the Authority's request.
The procedure laid down in Article 16(3)(a) and (b), (5) and (6) shall apply mutatis mutandis.
4.Where the Authority, following scientific assessment, issues an opinion in favour of the inclusion of the claim in the list provided for in Article 13(3), the Commission shall take a decision on the application, taking into account the opinion of the Authority, any relevant provisions of Community law and other legitimate factors relevant to the matter under consideration, after having consulted the Member States and within two months of receiving the opinion of the Authority.
Where the Authority issues an opinion that would not support the inclusion of the claim in that list, a decision on the application shall be taken in accordance with the procedure referred to in Article 25(2).
Article 19
Modification, suspension and revocation of authorisations
1.
The applicant/user of a claim included in one of the lists provided for in Articles 13 and 14 may apply for a modification of the relevant list. The procedures
laid down in Articles 15 to 18
shall apply mutatis mutandis.
2.
On its own initiative or following a request from a Member State or from the Commission, the Authority shall issue an opinion on whether a health claim included in the lists provided for in Articles 13 and 14 still meets the conditions laid down in this Regulation.
It shall forthwith transmit its opinion to the Commission, the Member States and, where relevant, to the original applicant of the claim in question. The Authority, in accordance with Article 38(1) of Regulation (EC) No 178/2002, shall make its opinion public.
The applicant/user or a member of the public may make comments to the Commission within 30 days of such publication.
The Commission shall examine the opinion of the Authority and any comments received as soon as possible. If appropriate, the authorisation shall be modified, suspended or revoked in accordance with the procedures
laid down in Articles 17 and 18
.
CHAPTER V
GENERAL AND FINAL PROVISIONS
Article 20
Community Register
1.
The Commission shall establish and maintain a Community Register of nutrition and health claims made on food, hereinafter referred to as "the Register".
2. The Register shall include the following:
a)
the nutrition claims and the conditions applying to them as set out in the Annex;
b)
restrictions adopted in accordance with Article 4(5);
c)
the authorised health claims and the conditions applying to them provided for in Articles 13(3) and (5),
14(1), 19
(2), 21
, 24
(2) and 28
(6) and the national measures referred to in Article 23
(3);
d)
a list of rejected health claims and the reasons for their rejection.
Health claims authorised on the basis of proprietary data shall be recorded in a separate Annex to the Register together with the following information:
1)
the date the Commission authorised the health claim and the name of the original applicant that was granted authorisation;
2)
the fact that the Commission authorised the health claim on the basis of proprietary data;
3)
the fact that the health claim is restricted for use unless a subsequent applicant obtains authorisation for the claim without reference to the proprietary data of the original applicant.
3.
The Register shall be made available to the public.
Article 21
Data protection
1. The scientific data and other information in the application required under Article 15(3)
may not be used for the benefit of a subsequent applicant for a period of five
years from the date of authorisation, unless the subsequent applicant has agreed with the prior applicant that such data and information may be used, where:
a)
the scientific data and other information has been designated as proprietary by the prior applicant at the time the prior application was made; and
b)
the prior applicant had exclusive right of reference to the proprietary data at the time the prior application was made; and
c)
the health claim could not have been authorised without the submission of the proprietary data by the prior applicant.
2.
Until the end of the five-year
period specified in paragraph 1, no subsequent applicant shall have the right to refer to data designated as proprietary by a prior applicant unless and until the Commission takes a decision on whether a claim could be or could have been included in the list provided for in Article 14 or, where appropriate, Article 13 without the submission of data designated as proprietary by the prior applicant.
Article 22
National provisions
Without prejudice to the Treaty, in particular Articles 28 and 30 thereof, Member States may not restrict or forbid trade in or advertising of foods which comply with this Regulation by the application of non-harmonised national provisions governing claims made on certain foods or on foods in general.
Article 23
Notification procedure
1.
If a Member State considers it necessary to adopt new legislation, it shall notify the Commission and the other Member States of the envisaged measures and give the reasons justifying them.
2.
The Commission shall consult the Standing Committee on the Food Chain and Animal Health instituted by Article 58(1) of Regulation (EC) No 178/2002 (hereinafter referred to as "the Committee") if it considers such consultation to be useful or if a Member State so requests, and shall give an opinion on the envisaged measures.
3.
The Member State concerned may take the envisaged measures six months after the notification referred to in paragraph 1, provided that the Commission's opinion is not negative.
If the Commission's opinion is negative, it shall determine, in accordance with the procedure referred to in Article 25
(2) and before the expiry of the period referred to in the first subparagraph of this paragraph, whether the envisaged measures may be implemented. The Commission may require certain amendments to be made to the envisaged measures
.
Article 24
Safeguard measures
1.
Where a Member State has serious grounds for considering that a claim does not comply with this Regulation, or that the scientific substantiation provided for in Article 6 is insufficient, that Member State may temporarily suspend the use of that claim within its territory.
It shall inform the other Member States and the Commission and give reasons for the suspension.
2.
In accordance with the procedure referred to in Article 25
(2), a decision shall be taken, where appropriate after obtaining an opinion from the Authority.
The Commission may initiate this procedure on its own initiative.
3.
The Member State referred to in paragraph 1 may maintain the suspension until the decision referred to in paragraph 2 has been notified to it.
Article 25
Committee procedure
1.
The Commission shall be assisted by the Committee.
2.
Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
The period laid down in Article 5(6) of Decision 1999/468/EC shall be three months.
3.
The Committee shall adopt its rules of procedure.
Article 26
Monitoring
To facilitate efficient monitoring of foods bearing nutrition or health claims, Member States may require the manufacturer or the person placing such foods on the market in their territory to notify the competent authority of that placing on the market by forwarding to it a model of the label used for the product.
Article 27
Evaluation
By …(21)
at the latest, the Commission shall submit to the European Parliament and to the Council a report on the application of this Regulation, in particular on the evolution of the market in foods in respect of which nutrition or health claims are made and on the consumers' understanding of claims, together with a proposal for amendments if necessary. The report shall also include an evaluation of the impact of this Regulation on dietary choices and the potential impact on obesity and non-communicable diseases.
Article 28
Transitional measures
1.
Foods placed on the market or labelled prior to the date of application of this Regulation which do not comply with this Regulation may be marketed until their expiry date, but not later than ...(22)
*. With regard to the provisions in Article 4(1), foods may be marketed until twenty-four
months following adoption of the relevant nutrient profiles and their conditions of use.
2.
Products bearing trade marks or brand names existing before 1 January 2005 which do not comply with this Regulation may continue to be marketed until …(23)
after which time the provisions of this Regulation shall apply.
3.
Nutrition claims which have been used in a Member State before 1 January 2006
in compliance with national provisions applicable to them and which are not included in the Annex, may continue to be used until …(24)
* under the responsibility of food business operators and without prejudice to the adoption of safeguard measures as referred to in Article 24
.
4. Nutrition claims in the form of pictorial, graphic or symbolic representation, complying with the general principles of this Regulation, which are not included in the Annex and are used according to specific conditions and criteria elaborated by national provisions or rules, shall be subject to the following:
(a)
Member States shall communicate to the Commission, by …(25)
** at the latest, such nutrition claims and the national provisions or rules applicable, accompanied by scientific data in support of such provisions or rules;
b)
the Commission shall, in accordance with the procedure referred to in Article 25
(2), adopt a Decision concerning the use of such claims.
Nutrition claims not authorised under this procedure may continue to be used for twelve months following the adoption of the Decision.
5.
Health claims as referred to in Article 13(1)(a) may be made from the date of entry into force of this Regulation until the adoption of the list referred to in Article 13(3), under the responsibility of food business operators provided that they comply with this Regulation and with existing national provisions applicable to them, and without prejudice to the adoption of safeguard measures as referred to in Article 24
.
6. Health claims other than those referred to in Articles
13(1)(a) and 14, which have been used in compliance with national provisions before the date of entry into force of this Regulation, shall be subject to the following:
a)
health claims which have been the subject of evaluation and authorisation in a Member State shall be authorised as follows:
(i)
Member States shall communicate to the Commission, by …(26)
at the latest, such claims accompanied by a report evaluating the scientific data in support of the claim;
ii)
after consulting the Authority, the Commission shall, in accordance with the procedure referred to in Article 25
(2), adopt a Decision concerning the health claims authorised in this way.
Health claims not authorised under this procedure may continue to be used for six months following the adoption of the Decision;
b)
health claims which have not been the subject of evaluation and authorisation in a Member State: such claims may continue to be used provided an application is made pursuant to this Regulation before …(27); health
claims not authorised under this procedure may continue to be used for six months after a decision is taken pursuant to Article 17(3).
Article 29
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 For the Council
The President The President
ANNEX
Nutrition claims and conditions applying to them
LOW ENERGY
A claim that a food is low in energy, and any claim likely to have the same meaning for the consumer, may only be made where the product does not contain more than 40kcal (170kJ)/100g for solids or more than 20kcal (80kJ)/100ml for liquids. For table-top sweeteners the limit of 4kcal (17kJ)/portion, with equivalent sweetening properties to 6g of sucrose (approximately 1 teaspoon of sucrose), applies.
ENERGY-REDUCED
A claim that a food is energy-reduced, and any claim likely to have the same meaning for the consumer, may only be made where the energy value is reduced by at least 30%, with an indication of the characteristic(s) which make(s) the food reduced in its total energy value.
ENERGY-FREE
A claim that a food is energy-free, and any claim likely to have the same meaning for the consumer, may only be made where the product does not contain more than 4kcal (17kJ)/100ml. For table-top sweeteners the limit of 0,4kcal (1,7kJ)/portion, with equivalent sweetening properties to 6g of sucrose (approximately 1 teaspoon of sucrose), applies.
LOW FAT
A claim that a food is low in fat, and any claim likely to have the same meaning for the consumer, may only be made where the product contains no more than 3g of fat per 100g for solids or 1,5g of fat per 100ml for liquids (1,8g of fat per 100ml for semi-skimmed milk).
FAT-FREE
A claim that a food is fat-free, and any claim likely to have the same meaning for the consumer, may only be made where the product contains no more than 0,5g of fat per 100g or 100ml. However, claims expressed as "X% fat-free" shall be prohibited.
LOW SATURATED FAT
A claim that a food is low in saturated fat, and any claim likely to have the same meaning for the consumer, may only be made if the sum of saturated fatty acids and trans-fatty acids in the product does not exceed 1,5g per 100g for solids or 0,75g/100ml for liquids and in either case the sum of saturated fatty acids and trans-fatty acids must not provide more than 10% of energy.
SATURATED FAT-FREE
A claim that a food does not contain saturated fat, and any claim likely to have the same meaning for the consumer, may only be made where the sum of saturated fat and trans-fatty acids does not exceed 0,1g of saturated fat per 100g or 100ml.
LOW SUGARS
A claim that a food is low in sugars, and any claim likely to have the same meaning for the consumer, may only be made where the product contains no more than 5g of sugars per 100g for solids or 2,5g of sugars per 100ml for liquids.
SUGARS-FREE
A claim that a food is sugars-free, and any claim likely to have the same meaning for the consumer, may only be made where the product contains no more than 0,5g of sugars per 100g or 100ml.
WITH NO ADDED SUGARS
A claim stating that sugars have not been added to a food, and any claim likely to have the same meaning for the consumer, may only be made where the product does not contain any added mono- or disaccharides or any other food used for its sweetening properties. If sugars are naturally present in the food, the following indication should also appear on the label: "CONTAINS NATURALLY OCCURRING SUGARS".
LOW SODIUM/SALT
A claim that a food is low in sodium/salt, and any claim likely to have the same meaning for the consumer, may only be made where the product contains no more than 0,12g of sodium, or the equivalent value for salt, per 100g or per 100ml. For waters, other than natural mineral waters falling within the scope of Directive 80/777/EEC, this value should not exceed 2mg of sodium per 100ml.
VERY LOW SODIUM/SALT
A claim that a food is very low in sodium/salt, and any claim likely to have the same meaning for the consumer, may only be made where the product contains no more than 0,04g of sodium, or the equivalent value for salt, per 100g or per 100 ml. This claim shall not be used for natural mineral waters and other waters.
SODIUM-FREE or SALT-FREE
A claim that a food is sodium-free or salt-free, and any claim likely to have the same meaning for the consumer, may only be made where the product contains no more than 0,005g of sodium, or the equivalent value for salt, per 100g.
SOURCE OF FIBRE
A claim that a food is a source of fibre, and any claim likely to have the same meaning for the consumer, may only be made where the product contains at least 3g of fibre per 100g or at least 1,5g of fibre per 100kcal.
HIGH FIBRE
A claim that a food is high in fibre, and any claim likely to have the same meaning for the consumer, may only be made where the product contains at least 6g of fibre per 100g or at least 3g of fibre per 100kcal.
SOURCE OF PROTEIN
A claim that a food is a source of protein, and any claim likely to have the same meaning for the consumer, may only be made where at least 12% of the energy value of the food is provided by protein.
HIGH PROTEIN
A claim that a food is high in protein, and any claim likely to have the same meaning for the consumer, may only be made where at least 20% of the energy value of the food is provided by protein.
SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S]
A claim that a food is a source of vitamins and/or minerals, and any claim likely to have the same meaning for the consumer, may only be made where the product contains at least a significant amount as defined in the Annex to Directive 90/496/EEC or an amount provided for by derogations granted according to Article 7 of Regulation (EC) No …/… [
of the European Parliament and of the Council of … on the addition of vitamins and minerals and of certain other substances to foods](29)
.
HIGH [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S]
A claim that a food is high in vitamins and/or minerals, and any claim likely to have the same meaning for the consumer, may only be made where the product contains at least twice the value of "source of [NAME OF VITAMIN/S] and/or [NAME OF MINERAL/S]".
CONTAINS [NAME OF THE NUTRIENT OR OTHER SUBSTANCE]
A claim that a food contains a nutrient or another substance, for which specific conditions are not laid down in this Regulation, or any claim likely to have the same meaning for the consumer, may only be made where the product complies with all the applicable provisions of this Regulation, and in particular Article 5. For vitamins and minerals the conditions of the claim "source of" shall apply.
INCREASED [NAME OF THE NUTRIENT]
A claim stating that the content in one or more nutrients, other than vitamins and minerals, has been increased, and any claim likely to have the same meaning for the consumer, may only be made where the product meets the conditions for the claim "source of" and the increase in content is at least 30% compared to a similar product.
REDUCED [NAME OF THE NUTRIENT]
A claim stating that the content in one or more nutrients has been reduced, and any claim likely to have the same meaning for the consumer, may only be made where the reduction in content is at least 30% compared to a similar product, except for micronutrients, where
a 10% difference in the reference values as set in Directive 90/496/EEC shall be acceptable, and
for sodium, or the equivalent value for salt, where a 25% difference shall be acceptable.
LIGHT/LITE
A claim stating that a product is "light" or "lite", and any claim likely to have the same meaning for the consumer, shall follow the same conditions as those set for the term "reduced"; the claim shall also be accompanied by an indication of the characteristic(s) which make(s) the food "light" or "lite".
NATURALLY/NATURAL
Where a food naturally meets the condition(s) laid down in this Annex for the use of a nutritional claim, the term "naturally/natural" may be used as a prefix to the claim.
Position
of the European Parliament of 26 May 2005 (OJ C 117 E, 18.5.2006, p. 187
), Council common position of 8 December 2005 (OJ C 80 E, 4.4.2006, p. 43
) and Position of the European Parliament of 16 May 2006
.
OJ L 250, 19.9.1984, p. 17. Directive as last amended by Directive 2005/29/EC of the European Parliament and of the Council (OJ L 149, 11.6.2005, p. 22).
OJ L 186, 30.6.1989, p. 27. Directive as last amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council (OJ L 284, 31.10.2003, p. 1).
European Parliament legislative resolution on the Council common position for adopting a regulation of the European Parliament and of the Council on the addition of vitamins and minerals and of certain other substances to foods (9857/3/2005 – C6-0017/2006
– 2003/0262(COD)
)
–
having regard to the Council common position (9857/3/2005 – C6-0017/2006
)(1)
,
–
having regard to its position at first reading(2)
on the Commission proposal to Parliament and the Council (COM(2003)0671
)(3)
,
–
having regard to Article 251(2) of the EC Treaty,
–
having regard to Rule 62 of its Rules of Procedure,
–
having regard to the recommendation for second reading of the Committee on the Environment, Public Health and Food Safety (A6-0078/2006
),
1.
Approves the common position as amended;
2.
Instructs its President to forward its position to the Council and Commission.
Position of the European Parliament adopted at second reading on 16 May 2006 with a view to the adoption of Regulation
(EC) No .../2006
of the European Parliament and of the Council on the addition of vitamins and minerals and of certain other substances to foods
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof,
Having regard to the proposal from the Commission,
Having regard to the Opinion of the European Economic and Social Committee (4)
,
Acting in accordance with the procedure laid down in Article 251 of the Treaty (5)
,
Whereas:
(1)
There is a wide range of nutrients and other ingredients that might be used in food manufacturing, including, but not limited to, vitamins, minerals including trace elements, amino acids, essential fatty acids, fibre, various plants and herbal extracts. Their addition to foods is regulated in Member States by differing national rules that impede the free movement of these products, create unequal conditions of competition and thus have a direct impact on the functioning of the internal market. It is therefore necessary to adopt Community rules harmonising national provisions relating to the addition of vitamins and minerals and of certain other substances to foods.
(2)
This Regulation aims to regulate the addition of vitamins and minerals to foods and the use of certain other substances or ingredients containing substances other than vitamins or minerals that are added to foods or used in the manufacture of foods under conditions that result in the ingestion of amounts greatly exceeding those reasonably expected to be ingested under normal conditions of consumption of a balanced and varied diet and/or would otherwise represent a potential risk to consumers. In the absence of specific Community rules regarding prohibition or restriction of use of substances or ingredients containing substances other than vitamins or minerals under this Regulation or under other specific Community provisions, relevant national rules may apply without prejudice to the provisions of the Treaty.
(3)
Some Member States require the mandatory addition of some vitamins and minerals to certain ordinary foods, for reasons dictated by public health considerations. These reasons may be pertinent at national or even regional level, but would not currently justify harmonisation of the mandatory addition of nutrients across the Community. However, if and when this became appropriate, such provisions could be adopted at Community level. Meanwhile, it would be useful for information on such national measures to be compiled.
(4)
Vitamins and minerals may be added to foods voluntarily by food manufacturers or must be added as nutritional substances as provided for by specific Community legislation. They may also be added for technological purposes as additives, colourings, flavourings or other such uses including authorised oenological practices and processes provided for by relevant Community legislation. This Regulation should apply without prejudice to the specific Community rules concerning the addition or
use of vitamins and minerals in
specific products or groups of products or their addition for purposes other than those covered by this Regulation.
(5)
Given that detailed rules on food supplements containing vitamins and minerals have been adopted by 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 (6)
, provisions of this Regulation regarding vitamins and minerals should not apply to food supplements.
(6)
Vitamins and minerals are added to foods by manufacturers for a number of purposes including to restore their content where this has been reduced during manufacturing, storage or handling procedures or to provide a similar nutritional value to foods for which they are intended as alternatives.
(7)
An adequate and varied diet can, under normal circumstances, provide all necessary nutrients for normal development and maintenance of a healthy life in quantities such as those established and recommended by generally acceptable scientific data. However, surveys show that this ideal situation is being achieved neither for all vitamins and minerals nor by all groups of the population across the Community. Foods to which vitamins and minerals have been added appear to make an appreciable contribution to the intake of these nutrients and as such may be considered to make a positive contribution to overall intakes.
(8)
Some nutrient deficiencies, although not very frequent, can be demonstrated to exist at present in the Community. Changes in the socio-economic situation prevailing in the Community and the life styles of different groups of the population have led to different nutritional requirements and to changing dietary habits. This in turn has led to changes in the energy and nutrient requirements of various groups of the population and to intakes of certain vitamins and minerals for these groups that would be below those recommended in different Member States. In addition, progress in scientific knowledge indicates that intakes of some nutrients for maintaining optimal health and well-being could be higher than those currently recommended.
(9)
Only vitamins and minerals normally found in and consumed as part of the diet and considered essential nutrients should be allowed to be added to foods although this does not mean that their addition thereto is necessary. Controversy as to the identity of these essential nutrients that could potentially arise should be avoided. It is therefore appropriate to establish a positive list of these vitamins and minerals.
(10)
The chemical substances used as sources of vitamins and minerals which may be added to foods should be safe and also be bio-available i.e. available to be used by the body. For this reason a positive list of these substances should also be established. Such substances that have been approved by the Scientific Committee on Food in an Opinion expressed on 12 May 1999, on the basis of the above criteria of safety and bio-availability, and can be used in the manufacture of foods intended for infants and young children, other foods for particular nutritional uses or food supplements should appear in this positive list. Although sodium chloride (common salt) does not appear among the substances in this list, it may continue to be used as an ingredient in the preparation of food.
(11)
In order to keep up with scientific and technological developments, it is important to revise the above lists promptly, when necessary. Such revisions would be implementing measures of a technical nature and their adoption should be entrusted to the Commission in order to simplify and expedite the procedure.
(12)
Foods to which vitamins and minerals are added are in most cases promoted by manufacturers and may be perceived by consumers as products having a nutritional, physiological or other health advantage over similar or other products without such nutrients added. This may induce consumer choices that may be otherwise undesirable. To counter this potential undesirable effect, it is considered appropriate to impose some restrictions on the products to which vitamins and minerals can be added, in addition to those that would result naturally from technological considerations or become necessary for safety reasons when maximum limits of vitamins and minerals in such products are set. The content in the product of certain substances, such as alcohol, would, in this context, be an appropriate criterion for not allowing vitamins and minerals to be added to it. Any derogation from banning the addition of vitamins and minerals to alcoholic beverages should be limited to protecting traditional wine recipes, with the relevant products being notified to the Commission. No claims about any nutritional or health benefits of the additions should be made. Moreover, in order to avoid any confusion for the consumer as to the natural nutritional value of fresh foods, the addition of vitamins and minerals thereto should not be allowed.
(13)
This Regulation is not intended to cover the use of vitamins and minerals in trace quantities as authenticity markers used with the objective of combating fraud.
(14)
Excessive intakes of vitamins and minerals may result in adverse effects and it is therefore necessary to set maximum amounts
for them when they are added to foods, as the case may be. These amounts
must ensure that the normal use of the products, under the instructions for use provided by the manufacturer and in the context of a diversified diet, will be safe for the consumer. Therefore those amounts
should be total upper
safe levels for the vitamins and minerals present in the food naturally and/or added to the food for whatever purpose, including for technological uses.
(15)
For that reason those maximum amounts
and any other conditions restricting their addition to foods, where necessary, should be adopted taking into account their upper safe levels established by scientific risk assessment based on generally acceptable scientific data and their potential intake from other foods. Due account should also be taken of the population reference intakes of vitamins and minerals. Where it is necessary, for certain vitamins and minerals, to establish restrictions regarding the foods to which they can be added (e.g. the addition of iodine to salt)
, priority should be given to the purposes of restoring their content where this has been reduced during manufacturing, storage or handling procedures and of providing a similar nutritional value to foods for which those foods are intended as alternatives.
(16)
Vitamins and minerals added to foods should result in a minimum amount being present in the food. Otherwise the presence of too small and insignificant amounts in these fortified foods would not offer any benefit to consumers and would be misleading. The same principle underlies the requirement that these nutrients should be present in a significant amount in the food in order to be allowed to be declared in nutrition labelling. Therefore it would be appropriate that the minimum amounts of vitamins and minerals in foods to which vitamins and minerals have been added should be the same as those significant amounts that should be present for those nutrients to be declared in nutrition labelling unless otherwise provided for by appropriate derogations.
(17)
The adoption of maximum amounts
and any conditions of use based on the application of the principles and criteria stipulated in this Regulation and the adoption of minimum amounts
would be implementing measures of a technical nature and their adoption should be entrusted to the Commission in order to simplify and expedite the procedure.
(18)
General labelling provisions and definitions are contained in Directive 2000/13/EC of the European Parliament and of the Council of 20 March 2000 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs (7)
. This Regulation should therefore be confined to the necessary additional provisions. Those additional provisions should also apply without prejudice to Regulation (EC) No ../.. of the European Parliament and of the Council of …. [
on nutrition and health claims made on foods](8)
.
(19)
Given the nutritional importance of products to which vitamins and minerals have been added and their potential impact on dietary habits and overall nutrient intakes, the consumer should be able to evaluate the global nutritional quality of those products. Therefore, by derogation from Article 2 of Council Directive 90/496/EEC of 24 September 1990 on nutrition labelling for foodstuffs (9)
, nutrition labelling should be compulsory.
(20)
A normal and varied diet contains many ingredients, which in turn contain many substances. The intake of these substances or ingredients resulting from their normal and traditional use in current diets would not cause concern and does not need to be regulated. Some substances other than vitamins and minerals or ingredients containing them are added to foods as extracts or concentrates and may result in intakes that are significantly higher than those that could be ingested through eating an adequate and varied diet. The safety of such practices is in some cases seriously contested and the benefits are unclear; therefore they should be regulated. It is appropriate, in such cases, that food operators, responsible for the safety of the foods they place on the market, assume the burden of proof in relation to their safety.
(21)
Given the particular nature of foods to which vitamins and minerals are added, means additional to those usually available to monitoring bodies should be available in order to facilitate efficient monitoring of those products.
(22)
Since the objective of this Regulation, namely to ensure the effective functioning of the internal market as regards the addition of vitamins and minerals and certain other substances to foods whilst providing a high level of consumer protection, cannot be sufficiently achieved by the Member States, and can therefore be better achieved at Community level, the Community may adopt measures in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. 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 that objective.
(23)
The measures necessary for the implementation of this Regulation should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (10)
,
HAVE ADOPTED THIS REGULATION:
CHAPTER I
SUBJECT MATTER, SCOPE AND DEFINITIONS
Article 1
Subject matter and scope
1.
This Regulation harmonises the provisions laid down by law, regulation or administrative action in Member States which relate to the addition of vitamins and minerals and of certain other substances to foods, with the purpose of ensuring the effective functioning of the internal market, whilst providing a high level of consumer protection.
2.
The provisions of this Regulation regarding vitamins and minerals shall not apply to food supplements covered by Directive 2002/46/EC.
3. This Regulation shall apply without prejudice to specific provisions laid down in Community legislation concerning:
a)
foods for particular nutritional uses and, in the absence of specific provisions, compositional requirements of such products rendered necessary by the particular nutritional requirements of the persons for whom they are intended;
b)
novel foods and novel food ingredients;
c)
genetically modified food;
d)
food additives and flavourings;
e)
authorised oenological practices and processes.
Article 2
Definitions
For the purposes of this Regulation:
(1)
"Authority" means the European Food Safety Authority established by 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
(11);
2)
"other substance" means a substance other than a vitamin or a mineral that has a nutritional or physiological effect.
CHAPTER II
ADDITION OF VITAMINS AND MINERALS
Article 3
Requirements for the addition of vitamins and minerals
1.
Only vitamins and/or minerals listed in Annex I, in the forms listed in Annex II, may be added to foods, subject to the rules laid down in this Regulation.
2. Vitamins and minerals in a form that is bio-available to the human body
may be added to foods, whether or not they are usually contained therein, in order to take into account, in particular
:
a)
a deficiency of one or more vitamins and/or minerals in the population or specific population groups that can be demonstrated by clinical or sub-clinical evidence of deficiency or indicated by estimated low levels of intake of nutrients; or
b)
the potential to improve the nutritional status of the population or specific population groups and/or correct possible deficiencies in dietary intakes of vitamins or minerals due to changes in dietary habits; or
c)
evolving generally acceptable scientific knowledge on the role of vitamins and minerals in nutrition and consequent effects on health.
3.
Modifications to the lists referred to in paragraph 1 shall
be adopted in accordance with the procedure referred to in Article 14(2), taking account of the opinion of the Authority.
Prior to making these modifications, the Commission shall carry out consultations with interested parties, in particular food business operators and consumer groups.
Article 4
Restrictions on the addition of vitamins and minerals
Vitamins and minerals may not be added to:
a)
unprocessed foodstuffs, including, but not limited to, fruit, vegetables, meat, poultry and fish;
b)
beverages containing more than 1,2% by volume of alcohol, except and by way of derogation from Article 3(2), to products:
i)
referred to in Article 44(6) and (13) of Council Regulation (EC) No 1493/1999 of 17 May 1999 on the common organisation of the market in wine (12)
; and
ii)
which were marketed prior to the adoption of this Regulation; and
iii)
which have been notified to the Commission by a Member State in accordance with Article 11, and provided that no nutrition or health claim is made.
Additional foods or categories of foods to which particular
vitamins and minerals may not be added may be determined in accordance with the procedure referred to in Article 14(2) in the light of scientific evidence and taking into account their nutritional value.
Article 5
Purity criteria
1.
The purity criteria for vitamin formulations and mineral substances listed in Annex II shall be adopted in accordance with the procedure referred to in Article 14(2), except where they apply pursuant to paragraph 2 of this Article.
2.
Purity criteria for vitamin formulations and mineral substances listed in Annex II, specified by Community legislation for their use in the manufacture of foodstuffs for purposes other than those covered by this Regulation, shall apply.
3.
For those vitamin formulations and mineral substances listed in Annex II for which purity criteria are not specified by Community legislation, and until such specifications are adopted, generally acceptable purity criteria recommended by international bodies shall be applicable and national rules setting stricter purity criteria may be maintained.
Article 6
Conditions for the addition of vitamins and minerals
1.
When a vitamin or a mineral is added to foods, the total amount of the vitamin or mineral present, for whatever purpose, in the food as sold shall not exceed maximum amounts that shall be set in accordance with the procedure referred to in Article 14(2). The Commission may, to this end, submit proposals for the maximum amounts by …(13)
. For concentrated and dehydrated products, the maximum amounts set shall be those present in the foods when prepared for consumption according to the manufacturer's instructions.
2.
Any conditions restricting or prohibiting the addition of a specific vitamin or mineral to a food or a category of foods shall be adopted in accordance with the procedure referred to in Article 14(2).
3. The maximum amounts referred to in paragraph 1 and the conditions referred to in paragraph 2 shall be set taking the following into account:
a)
upper safe levels of vitamins and minerals established by scientific risk assessment based on generally acceptable scientific data, taking into account, as appropriate, the varying degrees of sensitivity of different groups of consumers;
b)
intakes of vitamins and minerals from other dietary sources.
4.
When the maximum amounts referred to in paragraph 1 and the conditions referred to in paragraph 2 are set, due account shall also be taken of reference intakes of vitamins and minerals for the population.
5. When the maximum amounts referred to in paragraph 1 and the conditions referred to in paragraph 2 are set for vitamins and minerals whose reference intakes for the population are close to the upper safe levels, the following shall also be taken into account, as necessary:
a)
the contribution of individual products to the overall diet of the population in general or of sub-groups of the population;
b)
the nutrient profile of the product established as provided for by Regulation (EC) No .../… [on nutrition and health claims made on foods]
.
6.
The addition of a vitamin or a mineral to a food shall result in the presence of that vitamin or mineral in the food in at least a significant amount where this is defined according to the Annex to Directive 90/496/EEC. The minimum amounts, including any lower amounts, by derogation from the significant amounts mentioned above, for specific foods or categories of foods shall be adopted in accordance with the procedure referred to in Article 14(2).
Article 7
Labelling, presentation and advertising
1.
The labelling, presentation and advertising of foods to which vitamins and minerals have been added shall not include any mention stating or implying that a balanced and varied diet cannot provide appropriate quantities of nutrients. Where appropriate, a derogation concerning a specific nutrient may be adopted in accordance with the procedure referred to in Article 14(2).
2.
The labelling, presentation and advertising of foods to which vitamins and minerals have been added shall not mislead or deceive the consumer as to the nutritional merit of a food that may result from the addition of these nutrients.
3.
Nutrition labelling of products to which vitamins and minerals have been added and which are covered by this Regulation shall be compulsory. The information to be provided shall consist of that specified in Article 4(1), Group 2 of Directive 90/496/EEC and of the total amounts present of the vitamins and minerals when added to the food.
4.
The labelling of products to which vitamins and minerals have been added may bear a statement indicating such addition under the conditions laid down in Regulation (EC) No …/… [on nutrition and health claims made on foods]
.
5.
This Article shall apply without prejudice to other provisions of food law applicable to specified categories of foods.
6.
Rules for implementing this Article may be specified in accordance with the procedure referred to in Article 14(2).
CHAPTER III
ADDITION OF CERTAIN OTHER SUBSTANCES
Article 8
Substances prohibited, restricted or under Community scrutiny
1.
The procedure provided for in this Article shall be followed where a substance other than vitamins or minerals, or an ingredient containing a substance other than vitamins or minerals, is added to foods or used in the manufacture of foods under conditions that would result in the ingestion of amounts of this substance greatly exceeding those reasonably expected to be ingested under normal conditions of consumption of a balanced and varied diet and/or would otherwise represent a potential risk to consumers.
2. On its own initiative or on the basis of information provided by Member States, the Commission may take a decision, following in each case an assessment of available information by the Authority and in accordance with the procedure referred to in Article 14(2), to include, if necessary, the substance or ingredient in Annex III. In particular:
a)
if a harmful effect on health has been identified, the substance and/or the ingredient containing the substance shall:
i)
be placed in Annex III, Part A, and its addition to foods or its use in the manufacture of foods shall be prohibited; or
ii)
be placed in Annex III, Part B, and its addition to foods or its use in the manufacture of foods shall only be allowed under the conditions specified therein;
b)
if the possibility of harmful effects on health is identified but scientific uncertainty persists, the substance shall be placed in Annex III, Part C.
3.
Community provisions applicable to specified foods may provide for restrictions or prohibitions on the use of certain substances in addition to those laid down in this Regulation.
4.
Food business operators, or any other interested parties, may at any time submit for evaluation to the Authority a file containing the scientific data demonstrating the safety of a substance listed in Annex III, Part C, under the conditions of its use in a food or in a category of foods and explaining the purpose of that use. The Authority shall inform without delay the Member States and the Commission of the submission and shall make the file available to them.
5.
Within four years from the date a substance has been listed in Annex III, Part C, a decision shall be taken, in accordance with the procedure referred to in Article 14(2) and taking into account the opinion of the Authority on any files submitted for evaluation as mentioned in paragraph 4 of this Article, to generally allow the use of a substance listed in Annex III, Part C, or to list it in Annex III, Part A or B, as appropriate.
6.
The Commission shall establish, in accordance with the procedure referred to in Article 14(2), implementing rules for the application of this Article, including rules concerning the submission referred to in paragraph 4 of this Article.
CHAPTER IV
GENERAL AND FINAL PROVISIONS
Article 9
Community Register
1.
The Commission shall establish and maintain a Community Register on the addition of vitamins and minerals and of certain other substances to foods, hereinafter referred to as "the Register".
2. The Register shall include the following:
a)
the vitamins and minerals which may be added to foods as listed in Annex I;
b)
the vitamin formulations and mineral substances which may be added to foods as listed in Annex II;
c)
the maximum and minimum amounts of vitamins and minerals which may be added to foods and any associated conditions set in accordance with Article 6;
d)
the information regarding national provisions on the mandatory addition of vitamins and minerals referred to in Article 11;
e)
any restrictions on the addition of vitamins and minerals as set out in Article 4;
f)
the substances for which dossiers have been submitted as provided for in Article 17(1)(b);
g)
information about the substances referred to in Annex III and the reasons for their inclusion therein;
h)
information about the substances listed in Annex III, Part C, whose use is generally allowed as referred to in Article 8(5).
3.
The Register shall be made available to the public.
Article 10
Free movement of goods
Without prejudice to the Treaty, in particular Articles 28 and 30 thereof, Member States may not restrict or forbid trade in foods which comply with this Regulation and Community acts adopted for its implementation by the application of non-harmonised national provisions governing the addition of vitamins and minerals to foods.
Article 11
National provisions
1.
By … (14)
, Member States shall inform the Commission of existing national provisions on the mandatory addition of vitamins and minerals and of products covered by the derogation provided for in Article 4(b).
2. If a Member State, in the absence of Community provisions, considers it necessary to adopt new legislation:
a)
on the mandatory addition of vitamins and minerals to specified foods or categories of foods; or
b)
on the prohibition or restriction on the use of certain other substances in the manufacture of specified foods, it shall notify the Commission in accordance with the procedure laid down in Article 12.
Article 12
Notification procedure
1.
If a Member State considers it necessary to adopt new legislation, it shall notify the Commission and the other Member States of the envisaged measures and give the reasons justifying them.
2.
The Commission shall consult the Committee referred to in Article 14, if it considers such consultation to be useful or if a Member State so requests, and shall give an opinion on the envisaged measures.
3.
The Member State concerned may take the envisaged measures only six months after the notification referred to in paragraph 1, and provided that the Commission's opinion is not negative.
If the Commission's opinion is negative, it shall determine, in accordance with the procedure referred to in Article 14(2) and before the expiry of the period referred to in the first subparagraph of this paragraph, whether the envisaged measures may be implemented. The Commission may require certain amendments to be made to the envisaged measures.
Article 13
Safeguard measures
1.
Where a Member State has serious grounds for considering that a product endangers human health despite complying with this Regulation, that Member State may temporarily suspend or restrict application of the provisions in question within its territory.
It shall immediately inform the other Member States and the Commission thereof and give reasons for its decision.
2.
In accordance with the procedure referred to in Article 14(2), a decision shall be taken, where appropriate after obtaining an opinion from the Authority.
The Commission may initiate this procedure on its own initiative.
3.
The Member State referred to in paragraph 1 may maintain the suspension or restriction until the decision referred to in paragraph 2 has been notified to it.
Article 14
Committee procedure
1.
The Commission shall be assisted by the Standing Committee on the Food Chain and Animal Health established by Article 58(1) of Regulation (EC) No 178/2002, hereinafter referred to as "the
Committee".
2.
Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.
3.
The Committee shall adopt its Rules of Procedure.
Article 15
Monitoring
To facilitate efficient monitoring of foods to which vitamins and minerals have been added, and of foods containing substances listed in Annex III, Parts B and C, Member States may require the manufacturer or the person placing such foods on the market in their territory to notify the competent authority of that placing on the market by providing a model of the label used for the product. In such cases, information on the withdrawal of the product from the market may also be required.
Article 16
Evaluation
By … (15)
, the Commission shall submit to the European Parliament and the Council a report on the effects of implementing this Regulation, in particular concerning the evolution of the market in foods to which vitamins and minerals have been added, their consumption, nutrient intakes for the population and changes in dietary habits, and
the addition of certain other substances, accompanied by any proposals for amendment of
this Regulation which the Commission deems necessary. In this context Member States shall provide the necessary relevant information to the Commission by … (16)
*. Rules for implementing this Article shall be specified in accordance with the procedure referred to in Article 14(2).
Article 17
Tra
nsitional measures
1. By way of derogation from Article 3(1) and until … (17)
, Member States may allow in their territory the use of vitamins and minerals not listed in Annex I, or in forms not listed in Annex II, provided that:
a)
the substance in question is used for addition to foods marketed in the Community on … (18)
*; and
b)
the Authority has not given an unfavourable opinion in respect of the use of that substance, or its use in that form, in the manufacture of food, on the basis of a dossier supporting use of the substance in question to be submitted to the Commission by the Member State not later than … (19)
**.
2.
Until … *, Member States may, in compliance with the rules of the Treaty, continue to apply existing national restrictions or bans on trade in foods to which vitamins and minerals not included in the list in Annex I or in the forms not listed in Annex II are added.
3.
Member States may, in compliance with the rules of the Treaty, continue to apply existing national provisions on maximum and minimum amounts of vitamins and minerals listed in Annex I added to foods and on the conditions applicable to this addition until the adoption of corresponding Community measures in accordance with Article 6 or under other specific Community provisions.
Article 18
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.
Foods placed on the market or labelled prior to … * which do not comply with this Regulation may be marketed until their expiry date, but not later than …(21)
*.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at ,
For the European Parliament For the Council
The President The President
ANNEX I
Vitamins and minerals which may be added to foods
1.
Vitamins
Vitamin A
Vitamin D
Vitamin E
Vitamin K
Vitamin B1
Vitamin B2
Niacin
Pantothenic acid
Vitamin B6
Folic acid
Vitamin B12
Biotin
Vitamin C
2.
Minerals
Calcium
Magnesium
Iron
Copper
Iodine
Zinc
Manganese
Sodium
Potassium
Selenium
Chromium
Molybdenum
Fluoride
Chloride
Phosphorus
ANNEX II
Vitamin formulations and mineral substances which may be added to foods
1.
Vitamin formulations
VITAMIN A
retinol
retinyl acetate
retinyl palmitate
beta-carotene
VITAMIN D
cholecalciferol
ergocalciferol
VITAMIN E
D-alpha-tocopherol
DL-alpha-tocopherol
D-alpha-tocopheryl acetate
DL-alpha-tocopheryl acetate
D-alpha-tocopheryl acid succinate
VITAMIN K
phylloquinone (phytomenadione)
VITAMIN B1
thiamin hydrochloride
thiamin mononitrate
VITAMIN B2
riboflavin
riboflavin 5'-phosphate, sodium
NIACIN
nicotinic acid
nicotinamide
PANTOTHENIC ACID
D-pantothenate, calcium
D-pantothenate, sodium
dexpanthenol
VITAMIN B6
pyridoxine hydrochloride
pyridoxine 5'-phosphate
pyridoxine dipalmitate
FOLIC ACID
pteroylmonoglutamic acid
VITAMIN B12
cyanocobalamin
hydroxocobalamin
BIOTIN
D-biotin
VITAMIN C
L-ascorbic acid
sodium-L-ascorbate
calcium-L-ascorbate
potassium-L-ascorbate
L-ascorbyl 6-palmitate
2.
Mineral substances
calcium carbonate
calcium chloride
calcium salts of citric acid
calcium gluconate
calcium glycerophosphate
calcium lactate
calcium salts of orthophosphoric acid
calcium hydroxide
calcium oxide
calcium sulphate
magnesium acetate
magnesium carbonate
magnesium chloride
magnesium salts of citric acid
magnesium gluconate
magnesium glycerophosphate
magnesium salts of orthophosphoric acid
magnesium lactate
magnesium hydroxide
magnesium oxide
magnesium sulphate
ferrous carbonate
ferrous citrate
ferric ammonium citrate
ferrous gluconate
ferrous fumarate
ferric sodium diphosphate
ferrous lactate
ferrous sulphate
ferric diphosphate (ferric pyrophosphate)
ferric saccharate
elemental iron (carbonyl + electrolytic + hydrogen reduced)
cupric carbonate
cupric citrate
cupric gluconate
cupric sulphate
copper lysine complex
sodium iodide
sodium iodate
potassium iodide
potassium iodate
zinc acetate
zinc chloride
zinc citrate
zinc gluconate
zinc lactate
zinc oxide
zinc carbonate
zinc sulphate
manganese carbonate
manganese chloride
manganese citrate
manganese gluconate
manganese glycerophosphate
manganese sulphate
sodium bicarbonate
sodium carbonate
sodium citrate
sodium gluconate
sodium lactate
sodium hydroxide
sodium salts of orthophosphoric acid
sodium selenate
sodium hydrogen selenite
sodium selenite
sodium fluoride
potassium fluoride
potassium bicarbonate
potassium carbonate
potassium chloride
potassium citrate
potassium gluconate
potassium glycerophosphate
potassium lactate
potassium hydroxide
potassium salts of orthophosphoric acid
chromium (III) chloride and its hexahydrate
chromium (III) sulphate and its hexahydrate
ammonium molybdate (molybdenum (VI))
sodium molybdate (molybdenum (VI))
ANNEX III
Substances whose use in foods is prohibited, restricted or under Community scrutiny
Position
of the European Parliament of 26 May 2005 (OJ C 117 E, 18.5.2006, p. 206
), Council Common Position of 8 December 2005 (OJ C 80 E, 4.4.2006, p. 27)
and Position of the European Parliament of 16 May 2006
.
OJ L 276, 6.10.1990, p. 40. Directive as last amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council (OJ L 284, 31.10.2003, p. 1).
** The
last day of the thirty-fifth month
following the date of entry into force of this Regulation.
Recovery of the stock of European Eel *
125k 83k
European Parliament legislative resolution on the proposal for a Council regulation establishing measures for the recovery of the stock of European Eel (COM(2005)0472
– C6-0326/2005
– 2005/0201(CNS)
)
–
having regard to the Commission proposal to the Council (COM(2005)0472
)(1)
,
–
having regard to Article 37 of the EC Treaty, pursuant to which the Council consulted Parliament (C6-0326/2005
),
–
having regard to Rule 51 of its Rules of Procedure,
–
having regard to the report of the Committee on Fisheries (A6-0140/2006
),
1.
Approves the Commission proposal as amended;
2.
Calls on the Commission to alter its proposal accordingly, pursuant to Article 250(2) of the EC Treaty;
3.
Calls on the Council to notify Parliament if it intends to depart from the text approved by Parliament;
4.
Calls for initiation of the conciliation procedure under the Joint Declaration of 4 March 1975 if the Council intends to depart from the text approved by Parliament;
5.
Asks the Council to consult Parliament again if it intends to amend the Commission proposal substantially;
6.
Instructs its President to forward its position to the Council and Commission.
Text proposed by the Commission
Amendments by Parliament
Amendment 1 Recital 4 a (new)
(4a) On 15 November 2005 the European Parliament adopted a resolution on the development of a Community Action Plan for the recovery of European eels1 calling on the Commission to immediately submit a proposal for a regulation for the recovery of European eel stocks.
(8)
The success of measures for the recovery of the European eel stock depends on close cooperation and coherent action at Community, Member State and local level as well as on information, consultation and involvement of the public sectors involved.
(8)
The success of measures for the recovery of the European eel stock depends on close cooperation and coherent action at Community, Member State and local and regional
level as well as on information, consultation and involvement of the public sectors involved.
Amendment 3 Recital 10
(10)
Within a river basin where fisheries and other human activities affecting eels may have transboundary effects, all programmes and measures should be coordinated for the whole of the relevant river basin. For river basins extending beyond the boundaries of the Community, the Community should endeavour to ensure appropriate coordination with the third countries concerned. However, the need for such coordination should not prevent urgent action being taken by Member States.
(10)
Within a river basin where fisheries and other human activities affecting eels may have transboundary effects, all programmes and measures should be coordinated for the whole of the relevant river basin. However, coordination must not take place at the expense of the rapid introduction of the national parts of Eel Management Plans.
For river basins extending beyond the boundaries of the Community, the Community should endeavour to ensure appropriate coordination with the third countries concerned. In the context of international coordination, both within the Community and outside it, special attention should be devoted to the Baltic Sea and European coastal waters falling outside the scope of Directive 2000/60/EC.
However, the need for such coordination should not prevent urgent action being taken by Member States.
Amendment 4 Recital 10 a (new)
(10a) As, naturally, many of the arriving glass eels are lost, the Commission should without delay investigate how Europe's aquaculture could be involved in the recovery of European eel stocks, inter alia by means of continued rearing of glass eels which have been caught, until they develop into yellow eels and are used to restock European inland waters communicating with the sea.
Amendment 5 Recital 10 b (new)
(10b) In the context of the recovery of the European eel stock, it is noted that the glass eel is particularly vulnerable because large quantities of glass eels are exported. Special measures to increase the numbers of glass eels released into European waters should therefore be implemented.
Amendment 6 Article 2
From the first to the fifteenth day of each month it shall be prohibited to fish for, land or retain eel of the species Anguilla anguilla.
The fishing season shall be shortened so that fishing effort is reduced by half.
Amendment 7 Article 3, introductory wording
By way of derogation from Article 2, until 30 June 2007 it shall be permitted to fish for, to retain and to land eel of the species Anguilla anguillafrom the first to the fifteenth day of each month
provided that:
By way of derogation from Article 2, until 30 June 2007 it shall be permitted to fish for, to retain and to land eel of the species Anguilla anguillaoutside the fishing season laid down
provided that:
Amendment 8 Article 3, point (b)
(b) all the eel captured are released into European inland waters having access to the sea for the purpose of increasing the escapement levels of adult silver eels
(b) all the eel captured:
-
are released into European inland waters having access to the sea for the purpose of increasing the escapement levels of adult silver eels or - are used for aquaculture in the European Union, subject to the condition that a percentage, to be determined by the Commission, of the eel used in aquaculture is used for the breeding of and restocking with yellow eels in European inland waters communicating with the sea, in order to increase the escape rate of mature silver eels; and
Amendment 9 Article 3, point (b a) (new)
(ba)Member States adopt extra measures to obstruct as little as possible the natural migration of glass eels during certain periods.
Amendment 10 Article 4, paragraph 1
1.
If existing national measures already ensure, for specified river basins, that the objective referred to in Article 6(4) is met, the Member State concerned may submit a request for exemption until 30 June 2007
from the measures provided for in Article 2 for those basins.
1.
If existing national measures already ensure, for specified river basins, that the objective referred to in Article 6(4) is met, the Member State concerned may submit a request for exemption until 30 June 2008
from the measures provided for in Article 2 for those basins.
Amendment 11 Article 4 a (new)
Article 4a
Additional protection for glass eels
Fishing for eels less than 12 cm long is allowed, providing one of the following requirements is fulfilled:
(a) most of the eels caught are used to restock European inland waters communicating with the sea, in order to increase the escape rate of mature silver eels;
(b) eels caught for aquaculture in the European Union are subject to the condition that a percentage, to be determined by the Commission, of the eel used in aquaculture is used for rearing eel fry and restocking European inland waters communicating with the sea, in order to increase the escape rate of mature silver eels.
If a Member State so wishes, the Commission may also institute a quota for exports of glass eels, provided that this does not violate the sustainability criterion or the recovery of the stock of European eel.
If in a Member State or region the catch of glass eel is used for consumption, the Commission may allow this provided that this does not violate the sustainability criterion.
Amendment 12 Article 5
By way of derogation from Article 2, from 1 July 2007 it shall be permitted to fish for, to retain and to land eel of the species Anguilla anguilla from the first to the fifteenth day of each month provided that such
fisheries conform to the specifications and restrictions set out in an Eel Management Plan.
By way of derogation from Article 2, from 1 July 2008
fisheries shall
conform to the specifications and restrictions set out in an Eel Management Plan.
Amendment 13 Article 5, paragraph 1 a (new)
For Member States which, before 31 December 2006, have submitted an Eel Management Plan to the Commission for approval, the effect of Article 2 shall be suspended until the Commission takes a definitive decision.
Amendment 14 Article 6, paragraph 1
1.
Member States shall identify and define the individual river basins lying within their national territory that, prior to human intervention, constituted natural habitats for the European eel ("eel river basins").
1.
Member States shall identify and define the individual river basins lying within their national territory that, prior to human intervention, constituted natural habitats for the European eel ("eel river basins"). A Member State may opt justifiably to designate the whole of its national territory or an existing regional administrative unit as one river basin.
Amendment 15 Article 6, paragraph 2
2.
In defining eel river basins, Member States shall have due
regard to the administrative arrangements referred to in Article 3 of Directive 2000/60/EC.
2.
In defining eel river basins, Member States shall have the maximum possible
regard to the administrative arrangements referred to in Article 3 of Directive 2000/60/EC.
Amendment 16 Article 6, paragraph 3 a (new)
3a. Member States shall implement in river basins an Eel Management Plan which will ensure the effective recovery of eel stocks. The Member States shall propose the river basins which are to be the subject of those intervention plans.
Amendment 17 Article 6, paragraph 3 b (new)
3b. Management plans for river basins shared between one or more Member States shall be drawn up jointly and submitted to the Commission.
Amendment 18 Article 6, paragraph 4
4.
The objective of each Eel Management Plan shall be, for each eel river basin, to permit with high probability the escapement to the sea of at least 40%
of the biomass of adult eel relative to the best estimate of the potential escapement from the river basin in the absence of
human activities affecting the fishing area or the stock.
4.
The objective of each Eel Management Plan shall be, for each eel river basin, to permit with high probability the escapement to the sea of a high percentage
of the biomass of adult eel relative to the best estimate of the potential escapement from the river basin, taking into account all the
human activities affecting the fishing area or the stock.
Amendment 19 Article 6, paragraph 5 a (new)
5a. The European Union shall support measures allowing the restocking of river basins in the various Member States.
Amendment 20 Article 6, paragraph 5 b (new)
5b. The European Union shall support measures to aid the construction and/or adaptation of barrier-crossing mechanisms to prevent migration along rivers from being compromised.
Amendment 21 Article 7, paragraph 1
1.
Member States shall communicate by 31 December 2006
to the Commission all individual Eel Management Plans prepared in accordance with Article 6.
1.
Member States shall communicate by 30 June 2007
to the Commission all individual Eel Management Plans prepared in accordance with Article 6.
Amendment 22 Article 7, paragraph 3
3.
Member States shall implement the Eel Management Plans approved under paragraph 2 from 1 July 2007
.
3.
Member States shall implement the Eel Management Plans approved under paragraph 2 from 1 July 2008, or from the earliest feasible time before that date
.
Amendment 23 Article 8, paragraph 1
1.
For eel river basins extending to the territory of more than one Member State, the Member States involved shall jointly prepare an Eel Management Plan.
1.
For eel river basins extending to the territory of more than one Member State, the Member States involved shall jointly prepare an Eel Management Plan. If coordination is in danger of resulting in such a delay that it will become impossible to submit the Management Plan on time, Member States may submit Management Plans for their national part of the river basin.
Amendment 24 Article 8, paragraph 2
2.
Where an eel river basin extends beyond the territory of the Community, the Member States involved shall endeavour to develop an Eel Management Plan in coordination with the relevant third countries.
2.
Where an eel river basin extends beyond the territory of the Community, the Member States involved shall endeavour to develop an Eel Management Plan in coordination with the relevant third countries. In this connection, special attention shall be devoted to the Baltic Sea and European coastal waters falling outside the scope of Directive 2000/60/EC.
Amendment 25 Article 8 a (new)
Article 8a Special measures in respect of glass eels
As part of the plan for recovery of the European eel stock, the Commission shall draw up special measures to ensure an increase in the number of glass eels released, focusing on the problems caused by large-scale exports of glass eels.
Amendment 26 Article 9, paragraph 1
1.
For each Eel Management Plan, each Member State shall report to the Commission by 31 December 2009 on the monitoring, effectiveness and outcome of the plan, and in particular shall estimate for each river basin that proportion of the biomass of the eel that escape to the sea to spawn relative to the escapement achieved in the absence of fishing or other human activities affecting the fishery or the stock
.
1.
For each Eel Management Plan, each Member State shall report to the Commission by 31 December 2009 on the monitoring, effectiveness and outcome of the plan.
Amendment 27 Article 9, paragraph 2
2.
The Commission shall, by 1 July 2010
, present a report to the European Parliament and the Council with a statistical and scientific evaluation of the outcome of the implementation of the Eel Management Plans accompanied by the opinion of the Scientific, Technical and Economic Committee for Fisheries.
2.
The Commission shall, by 1 July 2011
, present a report to the European Parliament and the Council with a statistical and scientific evaluation of the outcome of the implementation of the Eel Management Plans accompanied by the opinion of the Scientific, Technical and Economic Committee for Fisheries.
Amendment 28 Article 9, paragraph 3 a (new)
3a. The Commission shall before 1 January 2007 determine, in consultation with the ICES, the European Inland Fisheries Advisory Commission, the Member States and the fishing industry, whether the norm laid down in Article 6(4) is sufficiently measurable and applicable in practice, after which the Commission shall, if necessary, submit a modified or adjusted proposal.
Amendment 29 Article 11, paragraph 1
This Regulation shall enter into force on the third day following that of its publication in the Official Journal of the European Union.
This Regulation shall enter into force on the third day following that of its publication in the Official Journal of the European Union, but not before 1 January 2007
.
European Parliament legislative resolution on the proposal for a Council regulation on the conclusion of the Fisheries Partnership Agreement between the European Community and the Kingdom of Morocco (COM(2005)0692
– C6-0040/2006
– 2005/0280(CNS)
)
–
having regard to the Commission proposal for a Council regulation (COM(2005)0692
)(1)
,
–
having regard to Articles 37 and 300(2) of the EC Treaty,
–
having regard to Article 300(3), first subparagraph, of the EC Treaty, pursuant to which the Council consulted Parliament (C6-0040/2006
),
–
having regard to Rules 51 and 83(7) of its Rules of Procedure,
–
having regard to the opinion issued by its Legal Service (SJ-0085-06),
–
having regard to the report of the Committee on Fisheries and the opinion of the Committee on Development (A6-0163/2006
),
1.
Approves the proposal for a Council regulation as amended and approves conclusion of the agreement;
2.
Instructs its President to forward its position to the Council and Commission, and the governments and parliaments of the Member States and the Kingdom of Morocco.
Text proposed by the Commission
Amendments by Parliament
Amendment 1 Recital 2 a (new)
(2a) The Community financial contribution should also be used for the development of coastal populations living on fishing in Morocco and Western Sahara and the creation of small and medium-sized local firms in the fisheries sector.
Amendment 2 Recital 3 a (new)
(3a) The quality of the information made available to the European Parliament should be improved - hence the Commission should draw up an annual report on the implementation of the Agreement which covers each and every one of the fishing methods to which the Agreement applies and which includes any favourable opinions issued by the Commission pursuant to Article 6(2) of the Agreement.
Amendment 3 Article 1, paragraph 1
The Fisheries Partnership Agreement between the European Community and the Kingdom of Morocco is hereby approved on behalf of the Community.
The Fisheries Partnership Agreement between the European Community and the Kingdom of Morocco is hereby approved on behalf of the Community, subject to its implementation in accordance with international law
.
Amendment 4 Article 2, introductory wording
The fishing opportunities set out in the Protocol to the Agreement shall be allocated among the Member States as follows:
The fishing opportunities set out in the Protocol to the Agreement and determined in accordance with the principles which enable relative stability to be maintained
shall be allocated among the Member States as follows:
Amendment 5 Article 3, paragraph 1 a (new)
On the basis of those notifications and of information supplied by the Joint Committee established under Article 10 of the Agreement, the Commission shall report annually to the European Parliament and to the Council on its implementation.
Amendment 6 Article 3, paragraph 1 b (new)
In the event of evidence that the use to which the Agreement is being put is in contravention of international obligations, the Commission shall take immediate steps to suspend the Agreement as provided for in Article 15 of the Agreement.
Amendment 7 Article 3 a (new)
Article 3a In its annual report to the European Parliament the Commission shall also include information relating to any changes in the state of the fish resources, to measures designed to manage and conserve those resources and to the outcome of exploratory fishing trips conducted in respect of new species pursuant to Article 5 of the Protocol.
Amendment 8 Article 3 b (new)
Article 3b Pursuant to Article 4 of the Protocol the Commission shall - in the event of an improvement in the biological situation of cephalopod and crustacean stocks as confirmed by favourable scientific reports - endeavour to incorporate possible new fishing opportunities for those two categories into the Agreement.
Amendment 9 Article 3 c (new)
Article 3c The technical and fisheries-management measures adopted by the Moroccan authorities for the benefit of local fleets shall also apply to the Community fleet operating under the terms of this Agreement.
Amendment 10 Article 3 d (new)
Article 3d In the course of the final year of the Protocol's validity and before any agreement to renew the Protocol is concluded, the Commission shall submit to the European Parliament and the Council a report on the implementation of the Agreement.
Amendment 11 Article 3 e (new)
Article 3e On the basis of the report referred to in Article 3d and after consulting the European Parliament, the Council shall, if appropriate, confer upon the Commission a negotiating mandate with a view to the adoption of a new Protocol.
Amendment 12 Article 3 f (new)
Article 3f
The meetings and proceedings of the Joint Committee provided for in Article 10 of the Agreement may be attended by a Member of the European Parliament in an observer capacity, and also by representatives of the fisheries sector operating under the Agreement.
Amendment 13 Article 3 g (new)
Article 3g
The Commission shall inform the European Parliament of any initiative to amend the substance of the Agreement, including the Protocol, the datasheets and the appendices.
Monitoring the application of Community law (2003-2004)
113k 63k
European Parliament resolution on the Commission's 21st and 22nd Annual reports on monitoring the application of Community law (2003 and 2004) (2005/2150(INI)
)
–
having regard to the Commission's staff working papers (SEC(2004)1638
and SEC(2005)1446
and 1447),
–
having regard to Rules 45 and 112(2) of its Rules of Procedure,
–
having regard to the report of the Committee on Legal Affairs and the opinion of the Committee on Petitions (A6-0089/2006
),
A.
whereas the Commission's annual reports establish the state of transposition of directives by the Member States in order to ensure that the application of legislation is efficiently monitored; whereas according to the 21st report, 3 927 infringement cases were ongoing on 31 December 2003, including 1 855 cases for which proceedings had commenced, 999 cases for which a reasoned opinion had been issued, 411 cases which had been referred to the Court of Justice and only 69 cases (of which 40 concerned the environmental sector) for which proceedings under Article 228 of the EC Treaty had begun,
B.
whereas proper monitoring of the application of Community law involves not merely assessing transposition in quantitative terms but also evaluating the quality of transposition and of the practices adopted in actually applying Community law,
C.
whereas correct and swift implementation of Community legislation is an integral and essential part of "better regulation"; whereas clear and well-written legislation is an indispensable condition for the good application of Community law throughout the European Union; whereas the quality of legislation and the clarity of the obligations incumbent on Member States are not always satisfactory owing to the fact that the legislation is often the result of difficult political compromises,
D.
whereas the Commission may adapt the means it uses to carry out its mission effectively and make innovations designed to improve the application of Community law,
E.
whereas the Commission is currently working on the adaptation of existing procedures and on ways of making them faster and more efficient; whereas, however, this is not a sufficient reason for failing to transmit on time the information requested as to the total resources allocated to infringements in the relevant Directorates-General and the General Secretariat,
F.
whereas the number of complaints relating to infringements of Community law shows that European citizens play a vital role in its application, and that the capability properly to address their concerns is important for the credibility of the European Union,
G.
whereas citizens' complaints are not merely symbolic in building a "people's Europe" but constitute a cost-effective and efficient tool for monitoring the application of Community law,
H.
whereas effective legal protection and uniform application and interpretation are essential elements of Community law,
I.
whereas Parliament received the Commission's 22nd annual report only in January 2006 and whereas, because of this consistent delay, only partial reference to that report is made in the present resolution, the core analysis being of the Commission's 21st annual report dealing with the application of Community law in 2003,
1.
Is convinced of the real need for all European institutions to give serious, visible consideration and more convinced priority to the question of monitoring implementation, especially in view of the emphasis which has latterly been placed on the urgency of reducing the amount of Community legislation and legislative initiatives;
2.
Insists that any reduction in the amount of legislation must be off-set by more emphasis on implementation; stresses that complaints are a cost-effective and efficient tool for monitoring the application of Community law and calls on the Commission to make sure that at least some of the resources previously allocated to the drafting and follow-up of legislation are dedicated to the effective and correct implementation of existing Community legislation in the various units dealing with individual complaints and infringement cases;
3.
Is convinced that Parliament's committees should also pay attention to the issue of the application of Community legislation, and in particular that the rapporteur responsible should play a more active role in monitoring the implementation of Community legislation in the Member States, whereby the regular sessions on implementation organised by the Committee for the Environment, Public Health and Food Safety can serve as an example;
4.
Understands that comitology is not the subject of this resolution and maintains that the matter accordingly needs to be dealt with in a separate resolution;
5.
Stresses that Article 211 of the EC Treaty assigns to the Commission institutional responsibility for ensuring the application of the provisions of the Treaty and of the measures taken by the institutions pursuant thereto, and that Article 226 of the EC Treaty empowers the Commission to take action against Member States for any failure to fulfil their obligations under the Treaty;
6.
Notes that the main problems with the infringement procedure (Articles 226 and 228 of the EC Treaty) are its length (54 months elapsing on average from registration of the complaint to referral to the Court) and the limited use of Article 228;
7.
Notes that the Commission organises four meetings a year to decide on infringement procedures and that all decisions (from the first letter of formal notice, aimed at obtaining information from the Member State concerned, to the decision to seise the Court of Justice) are taken by the College of Commissioners; whilst appreciating the relevance of, and the need for, collective intervention for the infringement phases, proposes that careful thought be given to the possibility of the internal procedure being shortened in the initial stage of proceedings by authorising each Member of the Commission to send letters of formal notice to the Member States within the field of his or her responsibility, as is already the practice in cases where a Member State has not transposed Community law into its national legislation within the set deadline;
8.
Notes the insufficient level of cooperation by the national courts in most Member States, which are still reluctant to apply the principle of the primacy of Community law;
9.
Welcomes the Commission's Communication entitled "Better Monitoring of the application of Community law" (COM(2002)0725
), which sets out various actions to achieve its aim;
10.
Regrets nevertheless that the Commission has not presented any structured, detailed follow-up to some of the commitments announced in the above-mentioned Communications, such as the commitment that "the application of the priority criteria will be assessed annually, when the report on the monitoring of the application of Community law is discussed";
11.
Calls on the Commission to conduct a specific evaluation of the application of the priority criteria listed in the above-mentioned Communication, with the aim of assessing whether such an exercise is really needed and whether it may not risk reducing excessively the scope of infringement procedures, for which the Treaty does not provide any hierarchy; calls on the Commission to assess whether a simple increase in the available resources in the most exposed Directorates-General would not be a preferable solution with a view to improving the capacity to follow up complaints; points out that legal experts are needed in the Commission departments responsible for transposition to analyse whether legislation has been transposed in all its complexity; notes that it is not possible to rely solely on an automatic concordance system in order to analyse transpositions;
12.
Calls on the Commission to keep Parliament informed of the results of such evaluations; insists that the definition of priorities should not lead to a decreased response to citizens" complaints and urges the Commission to consult Parliament on any possible change in the priority criteria;
13.
Calls on the Commission to place the principle of the rule of law and citizens' experience above purely economic criteria and evaluations; urges the Commission to monitor carefully the respect of the fundamental freedoms and general principles of the Treaty as well as the respect of regulations and framework directives; invites the Commission to use secondary legislation as a criterion for determining whether there has been an infringement of fundamental freedoms;
14.
Urges the Commission to re-evaluate cooperation with the Member States within the meaning of Article 10 of the EC Treaty, in light of the fact that most Member States are not prepared to do much to improve the implementation of Community law as was confirmed during the negotiations on the Interinstitutional Agreement of 16 December 2003 on better law-making(1)
, when the Council refused to make any commitment in matters concerning transposition and implementation; declares its support for re-opening negotiations with the Council on this issue, with a view to amending the Interinstitutional Agreement;
15.
Calls on the Commission seriously to reassess its indulgence of Member States when it comes to meeting deadlines for submitting requested information to the Commission, adopting and communicating national implementing measures and correctly applying Community legislation at national, regional and local levels;
16.
Notes that the Member States have decided to set up specific structures dealing with implementation; welcomes the Commission's efforts in supporting the setting-up of appropriate coordination points in each Member State, with the aim of improving the entire transposition and implementation policy and the efficiency of the pre-litigation stage of infringement proceedings; suggests that the Member States should not only establish technical structures but also appoint political figure(s) responsible at national level for infringement policy;
17.
Points out that emphasis on organisational issues and communication flows should not hide the fact that many cases of incorrect implementation are the result of poor-quality legislation and reflect Member States' deliberate efforts to undermine Community legislation for political, administrative and economic reasons; in this connection, notes that the Commission is in the habit of accepting late intervention by the Member States in order to close infringement proceedings; calls on the Commission to ask the Member States to guarantee retroactive application of the Community provisions which have been infringed, in order to remove all effects of the infringement, with an immediate recourse to Article 228 of the EC Treaty in the event of persistent failure to comply;
18.
Notes that the Internal Market Problem Solving System (SOLVIT network) has proved its effectiveness in the internal market as a complementary non-judicial mechanism which has increased voluntary cooperation among Member States, but considers that such mechanisms should not be regarded as a substitute for infringement proceedings which are designed to oblige the Member States to apply Community legislation; calls on the Member States to make allocate greater human and financial resources to their national contact points for the SOLVIT network;
19.
Considers it essential for legislation to be drafted in a way that is more enforcement-friendly; considers it equally important to improve citizens' understanding of Community legislation and therefore proposes that a citizen's summary be included in the form of a non-legalistic explanatory statement accompanying all legislative acts;
20.
Is convinced that, while it is important to devote time and effort to developing dialogue with Member States and improving the assistance afforded to them in order to facilitate swift, correct transposition of Community legislation, tighter discipline is necessary, notably after enlargement, in order to avoid excessive delays and persistent differences in the quality of national transposition;
21.
Believes that a specific clause obliging Member States to draft a concordance table when transposing directives should be inserted systematically into each newly adopted directive;
22.
Notes that in 2004 about 41% of new directives included provision for a concordance table; believes that the European Parliament, as co-legislator, should support proposals to introduce into directives provisions obliging the Member States to use the concordance table for notification; calls on the Commission to report to Parliament regularly on the application of such provisions;
23.
Welcomes the effort made by some Directorates-General of the Commission – and notably DG Environment – to improve the conformity checks on the relevant directives, in particular following enlargement; calls on the Commission to publish on its website the studies requested by the various Directorates-General on the evaluation of the conformity of national implementation measures with Community legislation;
24.
Notes that there are several procedures available for dealing with non-conformity and that such procedures are sometimes repeated without attaining the objective of persuading the Member States to modify their transposition acts; stresses that in such cases delays in the procedure can be highly detrimental to citizens, because the focus is not on individual cases but rather reflects a general problem; therefore calls on the Commission to take a tough stance on cases of non-communication and non-conformity of national implementing measures with Community legislation and to move through the various stages of the procedure laid down by Article 226 of the EC Treaty in accordance with fixed, non-negotiable time-limits, laid down in appropriate soft-law instruments (communications, guidelines), in order to arrive as soon as possible at the imposition of fines pursuant to Article 228 of the EC Treaty;
25.
Invites the Commission to present a list of those directives which have the worst record in terms of their implementation and to explain what it considers the underlying reasons for this to be; points out that, under the case-law of the Court of Justice and Article 10 of the EC Treaty, the Member States are required to ensure that an adequate system is in place for effective and proportionate sanctions, to act as a deterrent against infringement of Community provisions; considers that failure to adopt an effective system of sanctions should be pursued with due severity under the infringement procedure;
26.
Notes that the present procedures give citizens no rights beyond lodging a complaint and that the Commission, in its role as guardian of the Treaty, has a broad discretion as to whether to register a complaint and start proceedings; considers that there is nothing in the Treaty or the case-law of the Court of Justice to prevent the use of appropriate legislative instruments to give further rights to complainants, and therefore calls on the Commission to take steps to adopt such instruments; is convinced that this important and exclusive prerogative should correspond to a duty of transparency and accountability as to the reasons why decisions are taken, notably decisions not to pursue complaints;
27.
Welcomes the Commission's Communication to the European Parliament and the European Ombudsman on "Relations with the complainant in respect of infringements of Community law" (COM(2002)0141
);
28.
Urges the Commission to respect the principles stated in that Communication to the effect that all complaints likely to denounce a real violation of Community law that are received by the Commission should be registered, without any selection, unless they fall within the exceptional circumstances referred to in point 3 of the Annex to the Communication; notes that the European Ombudsman has recently received specific complaints denouncing the non-registration of complaints and is currently investigating them; calls on the Commission to submit a regular report to Parliament on cases of non-registration of complaints in line with the above-mentioned Communication;
29.
Notes that the time-limit of one year laid down in the Communication between the registration of a complaint and the actual sending of a letter of formal notice or the decision to shelve the case is too long; notes furthermore that this deadline is not always met, leaving the complainant in a state of unacceptable uncertainty; therefore calls on the Commission to send letters of formal notice, which do not imply any "negotiations" yet with the Member States, within a short period of the registration of the complaint and to strive to move ahead quickly with the procedure on the basis of prompt deadlines from which exemption is possible only in exceptional cases;
30.
Urges all services of the Commission to keep complainants – and where appropriate also the MEP involved – fully informed of the progress of their complaints at the expiry of each pre-defined deadline (letter of formal notice, reasoned opinion, referral to the Court), to provide reasons for their decisions and to communicate them in full detail to the complainant in accordance with the principles stated in its Communication of 2002, which should allow the complainant to make further observations (such information should include, notably in the cases in which the Commission envisages shelving the complaint, the arguments presented by the Member State involved);
31.
Calls on the Commission to adopt a specific procedure which would allow the complainant and the MEP involved to have access to the documentation and to the substance of the correspondence exchanged with the Member State;
32.
Calls on the Commission to provide specific data on compliance with time-limits as set out in its internal Manual of Operational Procedures, which could only be obtained informally; reiterates the importance of setting deadlines from the date of registration of a complaint for providing the complainant with an answer and for sending out a letter of formal notice;
33.
Notes that, since their inception, proceedings under Article 228 of the EC Treaty have led to judgments of the Court of Justice in only three cases; welcomes the Commission's Communication on the Application of Article 228 of the EC Treaty (SEC (2005)1658), which clarifies and develops the policy of the Commission in asking the Court of Justice to impose a periodic payment order and a lump sum payment order on a Member State which fails to comply with the judgment of the Court;
34.
Asks the Commission formally to specify that, in accordance with its Communication of 2005, all cases already subject to letters of formal notice and reasoned opinions under Article 228, as well as cases currently subject to Article 226 proceedings, will be subject to the new policy (if not resolved before referral to the Court);
35.
Recalls that petitions forwarded by individuals to the Commission, to the European Ombudsman and to the relevant parliamentary committees should encourage the European Institutions to assess the way in which Community law is being implemented at national and European level;
36.
Reiterates its belief that close cooperation and monitoring arrangements between the Commission, the Council, the European Ombudsman and the relevant parliamentary committees are essential in order to ensure effective intervention in all cases where the petitioner has justifiably complained of an infringement of Community law;
37.
Insists that, in its future annual reports, the Commission must present data that accurately reflect the important and distinct contribution made by petitions to the monitoring of the application of Community law, and reiterates the request made in its resolution of 9 March 2004(2)
for the inclusion of a chapter devoted exclusively to petitions;
38.
Considers it necessary for the procedural rights of petitioners to be defined in a similar way to the rights of complainants, which were set out in the Commission's Communication of 2002; considers that procedural questions related to the parallel treatment of complaints and petitions need to be clarified and that coordination between the services concerned must be further improved so that the Committee on Petitions can ensure that the rights of petitioners are respected;
39.
Notes from its experience that it is difficult for citizens petitioning Parliament to invoke rights derived from Community law before national courts and to obtain reparation for loss or damage sustained on account of breaches of Community law by Member States;
40.
Deplores the Commission's unwillingness to investigate alleged violations of Community law that lie in the past and have since been remedied, such as those raised in the "Equitable Life" and "Lloyd's of London" petitions; urges the Commission to investigate such cases when the alleged failures are said to have caused significant damage to individuals, since the outcome of such investigations could be immensely helpful to citizens in obtaining compensation through the appropriate legal channels;
41.
Considers it necessary to examine ways of improving procedures at an inter-institutional level in order to provide more effective non-judicial means of redress for European citizens, as a corollary to the right of petition contained in the Treaty; suggests in this regard that consideration might be given to the setting-up of a "SOLVIT"-type organisation within the European Parliament whose function it would be to assist Members with casework of a legal nature;
42.
Calls for increased cooperation between national parliaments and the European Parliament and their respective parliamentarians, so as to promote and increase effective scrutiny of European matters at national level; considers that national parliaments have a valuable role to play in monitoring the application of Community law, thus helping to strengthen the democratic legitimacy of the Union and bring it closer to the citizens;
43.
Urges the Commission to send its annual reports on monitoring the application of Community law to the national parliaments, so that they are better able to monitor such application by the national authorities;
44.
Instructs its President to forward this resolution to the Council, the Commission, the Court of Justice, the European Ombudsman and the parliaments of the Member States.
–
having regard to the Commission communication of 5 June 2002 on impact assessment (COM(2002)0276
),
–
having regard to the Commission communication of 5 June 2002 on the Action plan "Simplifying and improving the regulatory environment" (COM(2002)0278
),
–
having regard to the Interinstitutional agreement of 16 December 2003 on better lawmaking(1)
concluded between the European Parliament, the Council and the Commission,
–
having regard to its resolution of 20 April 2004 on assessment of the impact of Community legislation and the consultation procedures(2)
,
–
having regard to the conclusions of the Competitiveness Council of 25-26 November 2004,
–
having regard to the Commission communication entitled "Better Regulation for Growth and Jobs in the European Union" of 16 March 2005 (COM(2005)0097
),
–
having regard to the Commission report entitled "Better lawmaking 2004" of 21 March 2005 (COM(2005)0098
),
–
having regard to the Commission's Impact Assessment guidelines of 15 June 2005 and the annexes thereto (SEC(2005)0791
),
–
having regard to the Commission communication entitled "Outcome of the screening of legislative proposals pending before the Legislator" of 27 September 2005 (COM(2005)0462
),
–
having regard to the European Economic and Social Committee opinions on "Better lawmaking" and on "How to improve the implementation and enforcement of EU legislation" of 28 September 2005(3)
,
–
having regard to the Commission communication "on an EU common methodology for assessing administrative costs imposed by legislation" of 21 October 2005 (COM(2005)0518
),
–
having regard to its resolution of 15 December 2005 on the legislative and work programme of the Commission for 2006(4)
,
–
having regard to the Treaty establishing a Constitution for Europe,
–
having regard to Rule 45 of its Rules of Procedure,
–
having regard to the report of the Committee on Legal Affairs (A6-0082/2006
),
A.
whereas, in its Communication on better regulation for growth and jobs in the European Union, the Commission establishes a clear link between achieving the Lisbon objectives and better regulation,
B.
whereas establishing a transparent, clear, effective and high-quality regulatory environment should be a priority objective of European Union policy,
C.
whereas the regulatory environment in which businesses operate is a determining factor for their competitiveness, for sustainable growth and, consequently, for their employment performance,
D.
whereas impact assessment in the context of new legislation and simplification of existing legislation could contribute to a better evaluation of its social, economic, environmental and health effects and could reduce the administrative burden that undermines the competitiveness of European businesses, in particular small and medium-sized enterprises (SMEs),
E.
whereas the reputation of the European legislature among citizens and businesses in the EU leaves much to be desired, notably because the legislation, being often a result of difficult political compromise, lacks clarity and Member States are unable or unwilling to implement it correctly,
F.
whereas, in the drafting of legislation, the Commission gives some interested parties the opportunity to react, through consultations and various working groups, but whereas there is insufficient transparency concerning the substance of those consultations, the participants and the manner in which the Commission takes the results thereof into account,
G.
whereas in its above-mentioned resolution of 20 April 2004 the Parliament declared itself, by a large majority, in favour of the use of impact assessment in the EU in order to improve legislation, and whereas the Council and the Commission have underlined the importance of impact assessment in numerous documents,
H.
whereas the impact assessment carried out by the Commission does not consistently follow the same methodology and is therefore of varying quality, and whereas the impact assessment often resembles a justification of the proposal rather than an actual objective assessment,
I.
whereas a great deal of implementing (or secondary) legislation is adopted through the comitology procedure, without proper parliamentary control or impact assessment,
J.
whereas legislation is partly a learning process in which it is possible to learn from mistakes made; whereas the impact of legislation is not made sufficiently transparent and whereas reports by the Commission on the implementation of Community legislation are confined to implementation in the Member States and do not give an insight into whether, in practice, the legislation has met the objectives set,
1.
Stresses the need for any Community legislation adopted to comply fully with the principles of subsidiarity and proportionality;
2.
Supports the ambition of improving European legislation with a view to enhancing growth and jobs, and stresses the need for an integrated and consistent approach to initiatives on "better regulation", supporting the three Lisbon pillars in case the market fails; stresses that initiatives on "better regulation" must be implemented in a transparent and democratic way;
3.
Promotes legislation based on principles and focused on quality rather than quantity; sees the "better regulation" debate as an occasion for reflection on legislation as a process designed to achieve clearly defined policy goals by committing and involving all stakeholders during all phases of the process, from preparation to enforcement;
4.
Recommends that the "better regulation" programme be piloted in certain fields and be carefully assessed before wider use; considers the experience with the Lamfalussy procedure in financial markets legislation, and the dialogue between regulators and market participants, in particular, to be a valuable test case for a dynamic legislative process;
5.
Is of the opinion that the Lamfalussy procedure is a useful mechanism; regards the convergence of supervisory practices as crucial; welcomes the work of the Level 3 committees in this respect and supports the call for an adequate toolbox; believes that, where supervisors are given room for manoeuvre, this removes much of the need for technical detail in legislation and is likely to produce more appropriate rules for a dynamic market; stresses, however, that this can never erode political responsibility for the final objectives of the legislation in question; insists that legislators should carefully monitor the process and reiterates that the legislative rights of Parliament should be fully respected;
6.
Notes the need for every legislative proposal to be accompanied by an impact assessment, which is defined in its above-mentioned resolution of 20 April 2004 as a straightforward mapping-out of the consequences in social, economic and environmental terms, as well as a mapping-out of the policy alternatives that are available to the legislature in that scenario;
7.
Is of the opinion that, when a draft proposal is presented by the Commission at the request of one or more Member States, this should be mentioned;
8.
Stresses the need for the clear guidelines and structures for impact assessment, published by the Commission in June 2005, to be implemented uniformly in all DGs without delay;
9.
Welcomes the development of impact assessments in the preparatory phase but warns that they cannot replace political debates about the advantages and disadvantages of laws; emphasises that the interests of consumers, companies and citizens cannot be reduced to a mere cost-benefit analysis; is of the opinion that laws should be executed under the full responsibility of the institutions themselves, in accordance with their political priorities; asks for full transparency during the preparatory phase, for justifications based on the results sought, and for further precision where necessary; insists on the importance of common guidelines in full respect of the three Lisbon pillars; and insists on a proper budget;
10.
Stresses that the Commission should include in the impact assessment, in a more precise way and in accordance with precise guidelines, the consequences of an absence of legislation in terms of lost benefits, notably as regards health, welfare and sustainability; insists that it must also put into operation as quickly as possible the method it has developed for calculating administrative burdens in quantitative terms as part of the impact assessment; notes that such a method is needed in order to gain an understanding of the costs associated with applying and implementing legislation; considers that a definitive methodology must be incorporated into the impact assessment by 2006 at the latest;
11.
Considers it essential, in the interests of a uniform application by the Commission of the impact assessment, that the quality of the latter be submitted to independent scrutiny; will not consider any proposals without their being accompanied by an independently scrutinised impact assessment, unless, exceptionally, this requirement is waived by Parliament in individual cases;
12.
Wants "better regulation" to follow a global approach, fully involving the Parliament, the Council and the Commission as well as the Member States, and consulting all stakeholders in order to involve citizens who have recently shown, in some Member States, their lack of trust in the European project; recommends an increase in the input and involvement of consumers and workers' representatives in the consultation processes;
13.
Stresses that consulting stakeholders during the preparatory phase is distinct from negotiating with stakeholders during the legislative process, and expresses its concern about the Commission's tendency to hold bilateral negotiations with individual Member States before presenting legislative proposals, which sometimes leads to odd, inconsistent or contradictory provisions, opt-outs or exemptions in favour of particular Member States, distorting the level playing-field;
14.
Considers it necessary that, during the preparation of legislation and the impact assessment, interested parties should be given the opportunity, and adequate time, to make their reactions known, and that the Commission should inform interested parties in what way their reactions have been processed in the proposal; takes the view that, in this connection, the Commission must observe maximum transparency by publishing the reactions of interested parties and the impact assessment in a publicly accessible register;
15.
Notes that much implementing legislation comes into being via the comitology procedure; considers that such legislation must meet the same quality requirements as implemented legislation and will therefore be subject to impact assessment, once the necessary know-how and tools have been developed;
16.
Is convinced that, if the Parliament's legislative powers are respected in the context of comitology, it will be more willing to focus on general principles and support legislative simplification and innovation;
17.
Reiterates that Parliament and the Council may also make their significant amendments to Commission proposals subject to an impact assessment and stresses that such an impact assessment makes sense only if the same methodology is used as in the case of the Commission;
18.
Calls on the Council and the Commission, in the context of interinstitutional consultation, to develop in the near future a Community method and procedure for the application of impact assessment within the European policy process, and to arrive at concrete agreements by September 2006;
19.
Warns that "better regulation" methods should respect the balance of power between and the respective roles of the Parliament, the Council and the Commission; wants the Parliament to make a wise and integrated contribution, building on previous experience; stresses the need for the political endorsement of innovations in the legislative process;
20.
Opines that highly technical legislation should not lead to the disengagement of co-legislators from the democratic process of lawmaking but should rather encourage them to concentrate on core political principles and objectives and on how to apply the process of putting them into practice, changing from a prescriptive to a responsive and participative approach and making use of the technical know-how and capacities of the regulatory authorities that have to apply the law;
21.
Calls on the Member States to exchange experiences in the use of impact assessment, and also to apply such assessments to national legislation;
22.
Welcomes the increased involvement of national parliaments in the work programme of the Commission, but warns against random cherry-picking of proposals on the basis of subsidiarity and proportionality; asks that all new proposals contain a summary of existing legislation in the relevant field and an explanation as to how the new legislation is to fit into the scheme; asks for different options to be proposed to the Council and Parliament, with a sound analysis of their respective implications as regards citizens' expectations, the three Lisbon pillars, costs, and the administrative burden, especially for SMEs;
23.
In order to guarantee an EU-wide uniform lawmaking framework, urges the Commission to ensure that this framework is not undermined by the Council through a proliferation of derogatory provisions in favour of individual Member States;
24.
Calls on the Commission to report to Parliament, no later than three years after the entry into force of new legislation, on the impact of the legislation in practice; is above all interested in the question whether the legislation has fulfilled the original purpose, what effects it has had on the international competitiveness of the relevant sector, not least in the light of different regulations (or the absence of regulation) in competing countries, and how the legislation is complied with in practice; also calls on the Commission to subject the quantitative results of the impact assessment to a regular critical analysis with a view to ascertaining whether the methodology used produces reliable predictions, and to report to Parliament on the results;
25.
Stresses the need for Parliament, and in particular the rapporteur responsible, to play a more active role in monitoring the implementation of European legislation in the Member States, and to make use of the network between the European Parliament and the national and/or regional parliaments;
26.
Is of the opinion that transposition of EC legislation should be monitored seriously and proactively in order to avoid diverging interpretations and gold-plating; wants the Commission to play an active role in transposition, together with supervisors and expert groups, at both EU and national level, since early analysis of potential pitfalls may prevent delays and unnecessary burdens on companies; suggests that Parliament should set up a proper transposition-monitoring procedure in close cooperation with its national partners;
27.
Acknowledges that the "open method of coordination" is an important policy tool in the context of the Lisbon Strategy; stresses, however, that this method cannot be seen as a general substitute for more formal coordination and common policy measures in this context; insists that the European Parliament be fully informed on the development of OMC practices and calls on the Commission to submit an evaluationreport on this method; insists that the open method of coordination must not evolve into a parallel, non-transparent legislative procedure which undermines the procedures laid down in the EC Treaty and compromises parliamentary scrutiny;
28.
Instructs its President to forward this resolution to the Council and the Commission.
–
having regard to the Commission communication of 5 June 2002 on impact assessment (COM(2002)0276
),
–
having regard to the Commission communication of 5 June 2002 entitled "Action plan 'Simplifying and improving the regulatory environment'" (COM(2002)0278
),
–
having regard to the Commission communication of 11 December 2002 on better monitoring of the application of Community law (COM(2002)0725
),
–
having regard to the Interinstitutional Agreement of 16 December 2003 on better law-making(1)
concluded between Parliament, the Council and the Commission,
–
having regard to its resolution of 20 April 2004 on the impact of Community legislation and the consultation procedure(2)
,
–
having regard to the conclusions of the Competitiveness Council of 25 and 26 November 2004,
–
having regard to the Commission communication of 16 March 2005 entitled "Better Regulation for Growth and Jobs in the European Union" (COM(2005)0097
),
–
having regard to the Commission report of 21 March 2005 entitled "Better lawmaking 2004" (COM(2005)0098
),
–
having regard to the Commission's Impact Assessment Guidelines of 15 June 2005, and the annexes thereto (SEC(2005)0791
),
–
having regard to the European Economic and Social Committee opinions on "Better lawmaking" and on "How to improve the implementation and enforcement of EU legislation" of 28 September 2005(3)
,
–
having regard to the Commission communication of 27 January 2005 entitled "Second Implementation Report of the Internal Market Strategy 2003-2006" (COM(2005)0011
),
–
having regard to the Commission communication of 25 October 2005 entitled "Implementing the Community Lisbon programme: A strategy for the simplification of the regulatory environment" (COM(2005)0535
),
–
having regard to the relaunching of the Lisbon Strategy on 22 and 23 March 2005,
–
having regard to the internal market scoreboard reports,
–
having regard to Rule 45 of its Rules of Procedure,
–
having regard to the report of the Committee on the Internal Market and Consumer Protection and the opinion of the Committee on Economic and Monetary Affairs (A6-0083/2006
),
A.
whereas in the above mentioned Interinstitutional Agreement of 16 December 2003 Parliament, the Council and the Commission gave a commitment to the better regulation agenda,
B.
whereas in the relaunched Lisbon Agenda the Commission put better regulation at the heart of the drive for jobs and growth in the European Union,
C.
whereas deregulation and reducing the amount of red tape arising from EU legislation are vital preconditions for attaining the Lisbon objectives,
D.
whereas improved European lawmaking should lead to a more competitive edge in the global economy, fair competitive conditions between companies, the stimulation of growth and the strengthening of social cohesion,
E.
whereas pursuit of the objective of better regulation must not lead to the undermining of environmental, social or consumer standards,
F.
whereas citizens and businesses will benefit from good, clear and simple internal market laws, which will facilitate implementation and enforcement,
G.
whereas stakeholders have raised concerns regarding difficulties experienced as a result of unclear or incomplete concepts, definitions or provisions in Community legislation,
H.
whereas problems of transposition and implementation often result from poorly drafted legislative texts; whereas the European legislative bodies have an important responsibility in this matter and should therefore avoid complicated and unclear compromises in negotiations,
I.
whereas textual ambiguities generate legal uncertainties and discrepancies when texts are transposed into national law, with the potential for distortion of competition and fragmentation of the internal market,
J.
whereas successive internal market scoreboard reports indicate that, despite improvements in some Member States, transposition and implementation of Community legislation continue to be a problem,
K.
whereas the better regulation agenda must prioritise the implementation and transposition of existing legislation in order to avoid discrepancies undermining Europe's competitiveness, employees" and consumers" rights and consumers" and businesses" ability to take full advantage of the internal market,
L.
whereas successive internal market scoreboard reports show that transposition continues to be a serious problem in several Member States,
M.
whereas better regulation requires both ex ante
and ex post
impact assessments to test whether objectives can be or have been achieved,
N.
whereas Parliament, Council and the Commission have recognised the need to use alternative means of regulation in suitable cases and in cases where the EC Treaty does not specifically require the use of a legal instrument,
O.
whereas under the above mentioned Interinstitutional Agreement, such means of regulation will not be applicable where fundamental rights or important political options are at stake or in situations where the rules must be applied in a uniform fashion in all Member States,
P.
whereas no formal mechanism exists to inform Parliament before it is proposed to use alternatives to legislation or to consult Parliament on the results that will be delivered by alternative regulation; whereas, this absence of checks and balances undermines the democratic prerogative of Parliament,
Q.
whereas it is vital that all three institutions invest resources and staff in establishing 'better regulation' task forces,
1.
Stresses the need for a common approach to better regulation, based on a core set of regulatory principles, namely subsidiarity, proportionality, accountability, consistency, transparency and targeting; stresses that this approach cannot bypass the rights of social consultation and must respect the principles of participative democracy;
2.
Stresses the need for Parliament, Council and the Commission to establish 'better regulation' task forces, to set up an interinstitutional working group to develop training, skills and quality control and to share and benchmark better regulation best practice;
3.
Urges the Commission to produce a short, clear guide to the better regulation process, outlining the key appraisal steps that should take place in the evolution, development and implementation of Community legislation including an ex-post evaluation on important issues, in cooperation with Parliament;
4.
Insists that all Commission proposals be accompanied by a "Better Regulation Check List" summarising the steps through which the proposal should proceed, and that this check list should be updated as each stage is completed, with cross-references to any relevant studies or impact assessments;
5.
Emphasises the fact that a strategic regulatory approach and stable framework will produce optimal results by enabling the affected sectors to plan and implement legislation in the most effective way; commends the Commission for the CARS 21 initiative, which is a good example of a strategic approach to regulation;
6.
Requests that the Commission carry out both ex ante
and ex post
impact assessments on legislation to assist in identifying whether key policy objectives have been met and to assist with the regulatory review process;
7.
Considers it essential, in the interests of the consistent use by the Commission of impact assessments, in particular in relation to internal market legislation, that their quality be monitored by a dedicated quality control function;
8.
Insists that all legislative proposals forwarded to Parliament include an executive summary of the impact assessment;
9.
Stresses that Member States must ensure that they are not
causing
new
implementation problems
by imposing additional requirements at national level
when transposing Community legislation
("gold-plating"), and confirm this by means of a formal declaration to the Commission;
10.
Insists that the Commission must continue to consolidate, simplify and codify Community legislation so as to improve accessibility and legibility;
11.
Requests that the Commission come forward with new proposals for more transparent and effective stakeholder consultation; takes the view that the social partners must be involved in this on an equal footing and that consumer and environmental organisations must be consulted;
12.
Urges the Commission to improve the effectiveness of the ex ante
scrutiny of national draft technical regulations under Directive 98/34/EC on the provision of information in the field of technical standards and regulations and of rules on Information Society services(4)
, inter alia
by increasing public access to objections raised by the Commission and other Member States;
13.
Insists that the Commission establish a transparent fast-track infringement procedure for internal market test cases and that it inform Parliament on how its priority criteria for infringement handling, as announced in its above mentioned communication on better monitoring of the application of Community law, are in practice screened and brought to the attention of complainants;
14.
Urges the Council and the Commission to improve monitoring of the implementation of and compliance with Community law; is of the opinion that this is likely to assist in improving transposition rates and the sharing of best practice between the Member States, as well as in introducing sanctions for non-compliance; insists that the Commission's reports on implementation must not be confined to a legal analysis of the implementing instruments but must also evaluate the application of the legislation in question in practice;
15.
Insists that Parliament be provided with a list of policy measures in which the Commission has used alternative means of regulation that includes an evaluation of the failure or success of such means of regulation, their impact on the situation in practice – and more specifically on employees" and consumers" rights, social cohesion, fair competition, the stimulation of growth and the EU's competitive position – and on best practice, and lessons learned from the process; insists that this information be incorporated in the Commission annual report on better law-making;
16.
Recognises that the classic method of regulation is not always the appropriate way to achieve a policy objective;
17.
Insists on the central role of Parliament, and particularly of the rapporteur responsible, in monitoring Member States" implementation of and compliance with Community law and the supervision thereof by the Commission;
18.
Recognizes the potential of the Lamfalussy process to achieve a single market in financial services, but regrets the slow progress in reaching an interinstitutional agreement which fully recognises the Parliament's role in the implementation process;
19.
Insists that, in the Annual Work Programme, the Commission provide a list of those proposals which may be the subject of alternative regulation;
20.
Insists that alternative regulatory proposals include clear objectives and defined deadlines for action, as well as sanctions for non-compliance;
21.
Proposes that Parliament's committees set up robust review mechanisms to evaluate and monitor the implementation and use of alternative means of regulation with a view to ensuring legal redress for consumers where operators fail to meet their commitments under such alternative regulatory proposals;
22.
Instructs its President to forward this resolution to the Council and the Commission.
–
having regard to its resolution of 26 October 2000 on the Commission reports to the European Council entitled "Better lawmaking 1998 – A shared responsibility" and "Better lawmaking 1999"(1)
,
–
having regard to its resolution of 29 November 2001 on the Commission White Paper on European governance(2)
,
–
having regard to its resolution of 8 April 2003 on the Commission reports to the European Council entitled "Better lawmaking 2000" and "Better lawmaking 2001"(3)
,
–
having regard to its resolution of 26 February 2004 on the Commission report entitled "Better Lawmaking 2002"(4)
,
–
having regard to its resolution of 9 March 2004 on the Commission communication on simplifying and improving the Community's regulatory activity(5)
,
–
having regard to its resolution of 20 April 2004 on assessment of the impact of Community legislation and the consultation procedures(6)
,
–
having regard to Rule 45 of its Rules of Procedure,
–
having regard to the report of the Committee on Legal Affairs and the opinions of the Committee on Constitutional Affairs, the Committee on Economic and Monetary Affairs, the Committee on the Environment, Public Health and Food Safety and the Committee on the Internal Market and Consumer Protection (A6-0080/2006
),
A.
whereas simplifying the legislative environment and ensuring the clarity, efficacy and quality of both existing and future legislation are essential prerequisites for attaining the objective of "better lawmaking", which constitutes a priority for the Union in the context of boosting growth and employment,
B.
having regard to the obligations and aims laid down in the Interinstitutional Agreement on better law-making of 16 December 2003(7)
, especially those intended to simplify, and reduce the volume of, Community legislation and those relating to the impact of Community legislation in the Member States,
C.
whereas the Commission, in its communication of 25 October 2005 entitled "Implementing the Community Lisbon programme: a strategy for the simplification of the regulatory environment" (COM(2005)0535
), rightly presents simplification not as a distinct legislative technique involving codification, recasting or straightforward repeal but as an overall approach including those tools and aimed at making Community and national legislation easier to apply and hence less costly,
D.
whereas this approach, is for the Commission, the Council and the European Parliament, a tool for use in achieving the aims of the Lisbon strategy,
E.
whereas such an approach requires a close partnership in this area, first between the European institutions and then between the latter and the national authorities,
F.
having regard to the unstinting efforts by the Commission, the Council and Parliament in recent years to bring about, define and improve the application of legislative simplification tools,
G.
whereas the simplification initiatives undertaken since the second simplification programme was launched in February 2003 following the Communication from the Commission to the Council entitled "Updating and simplifying the Community acquis" (COM(2003)0071
, 11 February 2003) have varied widely in nature and scope, ranging from the review of specific directives to overhauling the legislation of an entire sector, thus hampering a standardised procedural approach,
H.
having regard to the experience acquired in the implementation of the Interinstitutional Agreements of 20 December 1994(8)
on codification and of 28 November 2001(9)
on recasting, and considering those instruments to be essential in order to simplify the acquis communautaire,
I.
whereas since the Interinstitutional Agreement on recasting entered into force, only 12 recasting proposals have been submitted, of which 2 led ultimately to publication of the resulting acts, 2 have been withdrawn, and 8 are still pending; and whereas, compared to somewhere in the region of 2 400 families of legislative acts to which the procedure might be applicable, only 49 codification proposals have to date been submitted to Parliament,
J.
whereas the above-mentioned Commission Communication of 2005 contains, in its "Simplification Rolling Programme" (Annex 2), thirty proposals which cannot easily be classified, dealing generically with cases for "review", "revision", "modernisation", "simplification" and the like,
1. Strongly supports the process of simplification of the Union's regulatory environment, as well as the objective of ensuring that the regulatory environment is appropriate, simple and effective; stresses, however, that such a process must be based on a number of preconditions:
a)
full involvement of the European Parliament both in the interinstitutional debate on simplification and, as co-legislator, in the adoption of the legislation subject to the "simplification process";
b)
wide and transparent consultation of all relevant stakeholders, thus including not only Member States and business but also non-governmental organisations;
c)
strengthening of the general transparency of the regulatory process, in particular by opening Council discussions to the public when the Council is acting in its legislative capacity;
2.
Encourages the Commission to adopt, under the aegis of the Interinstitutional Agreement on better law-making, specifically targeted and well thought-out legislation the effects of which can be foreseen, and which will help to establish favourable conditions for boosting growth and employment by reducing unnecessary administrative costs and procedures, eliminating obstacles to adaptability and innovation and generally ensuring legal certainty;
3.
Welcomes the above-mentioned Commission communication of 2005, the commitment to submitting a programme to simplify legislative acts, and the methods and targets laid down for translating that programme into reality;
4.
Welcomes the fact that the Commission intends to include major simplification initiatives in its annual legislative programmes and the announcement that the Commission will submit additional communications to cover the different sectors of the Community economy; stresses the importance of close collaboration between the Member States and the Commission for the purpose of identifying the legislation which should be simplified;
5.
Welcomes the intention to reduce the unnecessary burden on SMEs and to reinforce the use of information technology; considers that one of the objectives of simplifying the Union's regulatory environment should be to make legislation simpler and more effective, and thus more "user-oriented";
6.
Considers that the simplification process should in no circumstances entail lowering the standards set by current legislation; warns, for example, against an excessively narrow and exclusively financial and administrative analysis of the costs and benefits of the legislation concerned; is convinced that any assessment with a view to simplification must take account equally of economic, social, environmental and health aspects, and should not restrict itself to short-term considerations;
7.
Invites the Commission to give priority to the simplification of regulations; considers that directives should be simplified only in exceptional and duly justified cases, when they are not dealing with very sensitive matters or are not the result of difficult compromises, as in the case of EC company law;
8.
Notes that the success rate of the simplification initiatives undertaken since 2003 is not disappointing and that the average length of procedures is not excessive given the complexity of the subject-matter; observes, nevertheless, that the number of simplification initiatives launched since that date has been very limited and that the targets originally set for reducing the volume of the Community acquis are far from being achieved;
9.
Takes the view that the repeal of irrelevant and obsolete acts is a priority requirement with which the Commission must comply without delay; considers, however, that when Community legislation is repealed on those grounds, a Community act must be put in place at the same time to prevent Member States from regulating matters that have been deregulated at Community level;
10.
Points out that, while there may be over-regulation in some areas, this state of affairs is due in large measure to the lawmaking activity of the Member States and that, therefore, if Community legislation is to be repealed, this must be followed by repeal of the corresponding national provisions;
11.
Proposes that the Commission constantly monitor such national legislation as might remain in force after the Community legislation that gave rise to it has been repealed; considers that the Commission should add appropriate review clauses to its proposals;
12.
Considers codification and recasting to be the primary means of simplifying the acquis communautaire and urges that they be used more widely; believes that recasting has been used only to a limited extent and that this is due to both lack of interest on the part of the Commission and a failure to gear the European Parliament's Rules of Procedure closely enough to the Interinstitutional Agreement on recasting;
13.
Supports the codification of the acquis communitaire but is sceptical about its total recasting, as this may well lead to diverging interpretations among the EU institutions; warns that simplification should not lead to a re-writing of the acquis outside democratic control;
14.
Applauds the results achieved so far through codification of Community legislation and hopes that the Commission units concerned will draw up new, and more ambitious, codification proposals extending also to sectors other than those covered to date, in particular company law, intellectual property, and consumer protection;
15.
Considers that if the institutions genuinely wish to simplify legislation and employ recasting to that end, the Interinstitutional Agreement on recasting should be applied more rigorously;
16.
Understands that, if the intention is to make recasting effective, the European Parliament and the Council will, as a matter of principle, have to refrain from amending the codified parts of acts; believes that, if the institutions genuinely wish to simplify legislation and employ recasting to that end, the codified parts of an act should, as a rule, be subject to the provisions laid down in the Interinstitutional Agreement on codification; recognises, however, that there should be a special procedure to enable the codified part to be amended whenever this is essential in order to make it consistent with, or to link it to, the part that can be altered;
17.
Considers that the institutions might usefully determine whether a third type of operation might be provided for, alongside codification and recasting, so as to afford the most appropriate means of simplifying Community legal acts; considers, however, that to date, in those cases in which the Commission has drawn up generic simplification proposals which cannot be classified as involving repeal, codification or recasting, the European Parliament cannot embark on any procedure other than the customary one and that therefore, in such cases, point 36 of the Interinstitutional Agreement on better law-making cannot be applied;
18.
Considers that the Interinstitutional Agreement on recasting should spell out the procedure to follow in cases where, during a legislative procedure, it proves necessary to alter the codified parts of the act;
19.
Calls on the Commission, taking into account the guidelines set out above, to submit a proposal without delay with a view to recasting the interinstitutional agreements governing the quality of Union legislation;
20.
Is ready to make a larger contribution to the work that needs to be done jointly by the three institutions to relaunch the simplification process;
21.
Undertakes for its part to give thought to the improvement of its procedures and its internal legislative techniques in order to speed up the simplification dossiers, while complying with the procedures laid down in primary law, in this particular case the EC Treaty;
22.
Instructs the Committee on Constitutional Affairs to determine what amendments might be made to the Rules of Procedure to enable the agreement on recasting to be effectively implemented, not least with a view to making greater use of the simplified procedures laid down in the Rules of Procedure;
23.
Emphasises the fact that traditional legislative instruments must continue to be used as a general rule to attain the objectives laid down in the Treaties; takes the view that the use of alternative regulatory methods such as co-regulation and self-regulation could usefully supplement legislative measures where these methods make improvements of equivalent or broader scope than legislation can provide; stresses that any use of alternative regulatory methods must comply with the interinstitutional agreement on "better law-making"; points out that the Commission has to lay down the conditions and limits which the parties must observe when employing such regulatory methods, and that these should in any event be used under Commission supervision and without prejudice to Parliament's right to object to their use;
24.
Asks the Commission to present a report assessing whether the current practice of standardisation as a form of co-regulation meets the requirements of the Inter-Institutional agreement on better law-making and Article 6 of the EC Treaty;
25.
Takes the view that standardisation could lead to less transparency and accountability, since the elected representatives would not be involved in decision making, and participation of non-governmental organisations and other interested parties would not be guaranteed in the same way; takes the view, therefore, that standardisation should be strictly limited to harmonising measures of a purely technical nature;
26.
Is surprised that the issue of reforming the current system of delegating rule-making ("comitology") receives only a brief mention in passing – towards the end of point 3.d – in the above-mentioned Commission communication of 2005, even though such a reform could make a major contribution to simplifying secondary Community law by allowing the Commission to adopt implementing provisions using faster procedures;
27.
Is of the opinion that the legislature could also contribute to simplification through agreement on less detailed legal acts and the use of a wider range of implementing measures by the Commission, provided that effective control by the legislature as to the substance of those implementing measures is guaranteed;
28. Reaffirms in this context that any recourse to the "comitology" procedure would necessitate a complete revision of Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission(10)
, in order to:
a)
guarantee greater openness,
b)
ensure that any conferral of implementing powers on the Commission was limited to non-essential or implementing measures and was conditional upon a clear definition of the objective, content, scope and duration of the delegation of powers, including, where appropriate, "sunset clauses",
c)
guarantee the introduction of formal equality between the powers of the European Parliament and those of the Council in considering these measures, through the introduction of call-back procedures;
29.
Takes note of the list of actions contained in the Commission simplification rolling programme and will actively cooperate in the achievement of the objective of simplifying pieces of legislation, if appropriate, in the context of the forthcoming legislative process;
30.
Expects that the various recasting and review proposals emanating from the Commission will contribute to improving the Union's level of economic and social development in the context of the sustainable development policy, as well as the level of citizens" health protection and the quality of their environment, in conformity with the objectives laid down in Article 2 of the EC Treaty;
31.
Instructs its President to forward this resolution to the Council, the Commission and the governments and parliaments of the Member States.
–
having regard to the Commission communication of 27 September 2005 to the Council and the European Parliament on the outcome of the screening of legislative proposals pending before the Legislator (COM(2005)0462
),
–
having regard to the letter from its President to the President of the Commission dated 23 January 2006(1)
,
–
having regard to the letter from the President of the Commission to the President of the Parliament dated 8 March 2006,
–
having regard to Rule 45 of its Rules of Procedure,
–
having regard to the report of the Committee on Constitutional Affairs and the opinion of the Committee on Legal Affairs (A6-0143/2006
), whereas
A.
in its above-mentioned communication, the Commission announced its intention to withdraw 68 proposals that it considers inconsistent with the objectives of the Lisbon Strategy and the principles of better regulation, while others will be subject to a reviewed economic impact assessment and, if appropriate, modified,
B.
the letter sent by the President of the Parliament to the President of the Commission at the outcome of the analysis of that communication by the parliamentary committees generally welcomes the intentions of the Commission, but specifically asks it not to withdraw several of those proposals and objects to the possible modification of some other proposals,
C.
the reply sent by the President of the Commission to the President of the Parliament states that the Commission took into due consideration the position of Parliament before adopting its final position and indicates the specific reasons why the Commission did not follow some of the requests of Parliament, as well as the possible initiatives that the Commission plans to undertake, in the future, to address some of those requests,
D.
that communication provides an excellent opportunity for a more thorough analysis of the problems connected with the withdrawal or the modification of legislative proposals by the Commission,
E.
with a few exceptions, most of the Community's legislative acts can only be adopted on the basis of a proposal from the Commission, which enjoys a quasi-monopoly over the legislative initiative,
F.
Article 250(2), of the EC Treaty stipulates that the Commission "may alter its proposal" at any moment of the procedure leading to the adoption of a Community act, "as long as the Council has not acted",
G.
although, for historical reasons, the role of Parliament is not mentioned in Article 250(2), that provision must be interpreted in conjunction with Article 251 as concerns its application to the codecision procedure, and with Article 252 as concerns the cooperation procedure,
H.
whenever a common position is adopted after the first reading, the third indent of the second subparagraph of Article 251(2) of the EC Treaty only allows the Commission to inform Parliament of its own position and if the common position is subsequently amended by Parliament, point (c) of the third subparagraph of Article 251(2) only allows the Commission to deliver an opinion, thus making it clear that the Commission is no longer the "owner" of its proposals,
I.
the Treaties are silent as to the possibility of the Commission withdrawing a legislative proposal,
J.
this absence of provisions concerning the withdrawal of legislative proposals has not prevented the Commission from regularly withdrawing legislative proposals,
K.
Parliament, Council and the Commission seem not to agree on the exact extent to which the Commission is entitled to withdraw its legislative proposals,
L.
despite these disagreements, the withdrawal of legislative proposals has been a regular practice of the Commission, without ever having given rise to a case brought before the Court,
M.
Parliament itself has sometimes in the past asked the Commission to withdraw its proposals,
N. the Framework Agreement(2)
on relations between Parliament and the Commission of 26 May 2005 stipulates that:
–
in all legislative procedures, "the Commission undertakes to carefully examine amendments to its legislative proposals adopted by Parliament, with a view to taking them into account in any amended proposal" (point 31),
–
in all legislative procedures, "the Commission shall give Parliament and the Council prior notification before withdrawing its proposals" (point 32),
–
in legislative procedures not entailing codecision, the Commission undertakes to withdraw legislative proposals that have been rejected by Parliament, "if appropriate", and also to explain the reasons for not doing so if it decides to maintain the proposal (point 33),
O.
an understanding, based on common guidelines between the three institutions, regarding the withdrawal and, to the extent necessary, the modification of legislative proposals by the Commission would positively contribute to the smooth running of legislative procedures,
1.
Welcomes the above-mentioned Commission communication, and considers that the withdrawal or modification of the great majority of the proposals mentioned in it will in fact contribute to a simplification of the Community legislative environment, but insists that the Commission should take into proper consideration the objections raised by the President of the Parliament in his letter of 23 January 2006;
2.
Welcomes the fact that, before adopting its final position, the Commission has again reviewed its proposals in the light of Parliament's objections; acknowledges that, in every case in which the Commission has not accepted those objections, it has stated reasons for not doing so and that in some cases it has also indicated possible initiatives by means of which Parliament's wishes could be met;
3.
Stresses that in future proceedings of this nature, the Commission should present specific reasons for the withdrawal or the modification of each proposal, and not confine itself to invoking general principles that do not clearly explain the reasons why the Commission believes that a specific proposal should be withdrawn or modified;
4.
Welcomes the fact that the Commission takes account of the objectives of the Lisbon Agenda before proposing that a legislative proposal should be withdrawn; regrets therefore that the Commission has withdrawn the proposal for a directive on the Statute for a European mutual society despite the fact that it is one of the key elements of the Lisbon Strategy; expresses its surprise that the Commission adduces the diversity of national legislations as an argument against Community initiatives; calls on the Commission, therefore, to adopt an initiative before the end of the year to enable a Statute for a European mutual society and a European association to be drafted;
5.
Asks the Commission, immediately after it has been appointed, to draw up and submit to Parliament and the Council a list stating which of its predecessor's legislative proposals it intends to retain;
6.
Asks the Commission to include in its annual legislative and working programme a list of the proposals it intends to withdraw or modify, in order to allow Parliament to express its point of view in accordance with its prerogatives under the Treaties and the procedures laid down in the above-mentioned Framework Agreement;
7.
Takes note of the fact that the possibility of withdrawing a legislative proposal by the Commission is not mentioned in any provision of the existing Treaties, while the possibility of modifying a legislative proposal is covered by the principle that the Commission may modify its proposal during the procedure leading to the adoption of a Community act, as expressly provided in Article 250(2) of the EC Treaty; acknowledges that that principle is also applicable to the codecision procedure, provided for in Article 251, and the cooperation procedure, provided for in Article 252;
8. Recognises, however, that, within clear limits, the ability of the Commission to withdraw a legislative proposal during a procedure leading to its adoption
–
flows from its right of legislative initiative and constitutes a logical complement to its ability to modify a proposal,
–
may contribute to enhancing the role of the Commission in the legislative procedure, and
–
can be considered as a positive element in ensuring that the procedures leading to the adoption of a Community act and the interinstitutional dialogue are aimed at promoting the "Community interest";
9.
Maintains, however, that this possibility must be viewed in the light of the prerogatives of the various institutions in the legislative process, as defined in the Treaties, and in compliance with the principle of loyal cooperation among the institutions;
10.
Stresses that the possibilities of withdrawal or modification must not alter the role of each institution in the legislative process in a way which would endanger the institutional balance, and that the possibility of withdrawing proposals does not signify recognition of some kind of "right of veto" by the Commission;
11.
Stresses that the withdrawal or modification of legislative proposals must be subject to the same general principles that guide the presentation of proposals by the Commission, namely, it must be guided by the Community interest and must be duly justified;
12.
Considers, without prejudging the competence of the Court of Justice to define the exact scope and boundaries of the prerogatives vested in the institutions by the Treaties, that the definition of common guidelines by the institutions concerning the withdrawal or the modification of legislative proposals by the Commission, as a complement to the relevant principles already laid down in the Framework Agreement on relations between Parliament and the Commission and the Interinstitutional Agreement on Better Law-Making, would constitute a positive step towards facilitating the legislative process and the dialogue between the institutions;
13. Puts forward the following guidelines on the withdrawal and the modification of legislative proposals by the Commission:
a)
the Commission may, in principle, withdraw or modify a legislative proposal at any time during the procedures leading to its adoption as long as the Council has not acted. This means that in codecision and cooperation procedures the Commission may no longer do so after the adoption of the common position by the Council unless, in its decision on the common position, the Council has exceeded its powers to amend the Commission proposal, so that the decision in reality constitutes a legislative initiative by the Council itself, for which the Treaty does not provide,
b)
where Parliament has rejected a legislative proposal or has suggested substantial amendments to it, or where Parliament has in some other way asked the Commission to withdraw or substantially modify a legislative proposal, the Commission shall take this position into proper consideration. If, for important reasons, the Commission decides not to follow the position expressed by Parliament, it shall explain the reasons for that decision in a statement to Parliament,
c)
where the Commission intends to withdraw or modify a legislative proposal on its own initiative, it shall give Parliament prior notification of its intention. This notification shall be given in good time, allowing Parliament the opportunity to give its view on the matter, and shall include a clear explanation of the reasons for which the Commission believes that a specific proposal should be withdrawn or modified. The Commission shall take the view of Parliament into proper consideration. If, for important reasons, the Commission decides to withdraw or modify its proposal, against the wishes of Parliament, it shall explain the reasons for that decision in a statement to Parliament;
14.
Stresses that the extent to which the Commission takes into consideration the views of Parliament in so far as concerns the withdrawal or the modification of legislative proposals constitutes an essential element of the political trust that forms the basis of sound cooperation between the two institutions;
15.
Considers that, should the Commission withdraw or substantially modify a legislative proposal in a way that affects the legislative prerogatives of Parliament, the question should be referred to the appropriate political bodies of Parliament for political consideration; furthermore, considers that, should the Commission withdraw a legislative proposal in a way that affects the prerogatives of the two branches of the legislative authority, these could consider this withdrawal as non-effective and continue the procedure as provided for in the Treaties up to the eventual adoption of the act in question;
16.
Considers that, where a legislative proposal has been formulated in accordance with Article 138 of the Treaty, the Commission should duly inform the European social partners about its intention to withdraw or substantially modify the legislative proposal;
17.
Instructs its President to forward this resolution to the Council and the Commission.