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Procedure : 2001/0173(COD)
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A5-0225/2002

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P5_TA(2002)0354

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Wednesday, 3 July 2002 - Strasbourg
Genetically modified food and feed ***I
P5_TA(2002)0354A5-0225/2002
Resolution
 Consolidated text
 Annex

European Parliament legislative resolution on the proposal for a European Parliament and Council regulation on genetically modified food and feed (COM(2001) 425 – C5&nbhy;0368/2001 – 2001/0173(COD))

(Codecision procedure: first reading)

The European Parliament,

–   having regard to the Commission proposal to the European Parliament and the Council (COM(2001) 425(1)),

–   having regard to Article 251(2) and Articles 37, 95 and 152(4) of the EC Treaty, pursuant to which the Commission submitted the proposal to Parliament (C5-0368/2001),

–   having regard to Rule 67 of its Rules of Procedure,

–   having regard to the report of the Committee on the Environment, Public Health and Consumer Policy and the opinions of the Committee on Legal Affairs and the Internal Market and the Committee on Agriculture and Rural Development (A5-0225/2002),

1.  Approves the Commission proposal as amended;

2.  Asks to be consulted again should the Commission intend to amend the proposal substantially or replace it with another text;

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

(1) OJ C 304E, 30.10.2001, p. 221.


Position of the European Parliament adopted at first reading on 3 July 2002 with a view to the adoption of European Parliament and Council Regulation (EC) No .../2002 on genetically modified food and feed
P5_TC1-COD(2001)0173

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Articles 37, 95 and 152 (4) (b) thereof,

Having regard to the proposal from the Commission(1),

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

Having regard to the opinion of the Committee of the Regions(3),

Acting in accordance with the procedure laid down in Article 251 of the Treaty(4),

Whereas:

(1)  The free movement of safe and wholesome food and feed is an essential aspect of the internal market and contributes significantly to the health and well-being of citizens, and to their social and economic interests.

(2)  A high level of protection of human life and health should be ensured in the pursuit of Community policies.

(3)  Account must be taken of the precautionary principle in implementing this Regulation. In exceptional cases, where there is a risk to health or the environment, but where scientific data is as yet uncertain, the precautionary principle may be used to decide which risk management measures or other steps will be taken to ensure the high level of health protection that the Community desires.

(4)  In order to protect human and animal health, food and feed consisting of, containing or produced from genetically modified organisms (hereunder called "genetically modified food and feed") should undergo a safety assessment through a Community procedure before being placed on the market within the Community.

(5)  Differences between national laws, regulations and administrative provisions concerning the assessment and authorisation of genetically modified food and feed may hinder their free movement, creating conditions of unequal and unfair competition.

(6)  The requirements arising from the directives, regulations and administrative provisions concerning the evaluation and authorisation of food and feed and of raw materials intended for their production should be identical for all products imported into the European Union, in order to avoid the creation of unequal and unfair conditions of competition.

(7)  An authorisation procedure involving Member States and the Commission has been established for genetically modified foods in European Parliament and Council Regulation (EC) No 258/97 of 27 January 1997 on novel foods and novel food ingredients(5). This procedure should be streamlined and made more transparent.

(8)  Regulation (EC) No 258/97 also provides for a notification procedure for novel foods which are substantially equivalent to existing foods. Whilst substantial equivalence is a key step in the safety assessment process of genetically modified foods, it is not a safety assessment in itself. In order to ensure clarity, transparency and a harmonised framework for authorisation of genetically modified food, this notification procedure should be abandoned in respect of genetically modified foods.

(9)  Feed consisting of or containing genetically modified organisms (GMOs) has so far been authorised in accordance with Council Directive 90/220/EEC of 23 April 1990 on the deliberate release into the environment of genetically modified organisms(6); no authorisation procedure exists for feed produced from GMOs; a single, efficient and transparent Community authorisation procedure for feed consisting of, containing or produced from GMOs should be established.

(10)  The new authorisation procedures for genetically modified food and feed should include the new principles introduced in European Parliament and Council Directive 2001/18/EC of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC(7). They should further make use of the new framework for risk assessment in matters of food safety set up by European Parliament and Council Regulation (EC) No 178/2002 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(8). Thus, genetically modified food and feed should only be authorised for placing on the Community market after a scientific evaluation of the highest possible standard, to be undertaken under the responsibility of the European Food Safety Authority, of any risks which they present for human and animal health and, as the case may be, for the environment. This scientific evaluation should be followed by a risk management decision by the Community, under a regulatory procedure ensuring close co-operation between the Commission and the Member States.

(11)  Experience has shown that authorisation should not be granted for a single use, when a product is likely to be used both for food and feed purposes; therefore such products should only be authorised when fulfilling authorisation criteria for both food and feed.

(12)  Under this Regulation, authorisation may be granted either to a GMO and products for food and/or feed use which consist of, contain or are produced from it, or to foods or feed produced from a GMO. Thus, where a GMO used in the production of food and/or feed has been authorised under this Regulation, foods and/or feed consisting of, containing or produced from that GMO do not need an authorisation under this Regulation, but are subject to the requirements laid down in the authorisation granted in respect of the GMO. Furthermore, foods covered by an authorisation granted under this Regulation are exempted from the requirements of Regulation (EC) No 258/97, except where they fall under one or more of the categories laid down in Article 1 (2) (a) of that Regulation in respect of a characteristic which has not been considered for the purpose of the authorisation granted under this Regulation.

(13)  Council Directive 89/107/EEC of 21 December 1988 on the approximation of the laws of the Member States concerning food additives authorised for use in foodstuffs intended for human consumption(9) provides for authorisation of additives used in foodstuffs. In addition to this authorisation procedure, food additives consisting of, containing or produced from GMOs should fall also under the scope of this Regulation for the safety assessment of the genetic modification, while the final authorisation should be granted under the procedure laid down in Directive 89/107/EEC.

(14)  Flavourings falling under the scope of Council Directive 88/388/EEC of 22 June 1988 on the approximation of the laws of the Member States relating to flavourings for use in foodstuffs and to source materials for their production(10), which consist of, contain or are produced from GMOs should fall also under the scope of this Regulation for the safety assessment of the genetic modification.

(15)  Council Directive 82/471/EEC of 30 June 1982 concerning certain products used in animal nutrition(11) provides for an approval procedure for feed materials produced using different technologies that may pose risk to human or animal health and the environment; these feed materials consisting of, containing or produced from GMOs should fall instead under the scope of this Regulation.

(16)  Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs(12) provides for an authorisation procedure for placing on the market additives used in feedingstuffs. In addition to this authorisation procedure, feed additives consisting of, containing or produced from GMOs should fall also under the scope of this Regulation for the safety assessment of the genetic modification, while the final authorisation should be granted under the procedure laid down in Directive 70/524/EEC.

(17)  This Regulation covers food and feed produced "from" a GMO but not food and feed "with" a GMO. The determining criterion is whether or not material derived from the genetically modified starting material is present in the food or in the feed. Processing aids as defined in Council Directive 89/107/EEC, which are only used during the food or feed production process, are not covered by the definition of food or feed and, therefore, are not included in the scope of this Regulation. Nor are food and feed which are manufactured with the help of a genetically modified processing aid. Thus, food produced with a genetically modified enzyme that does not remain in the final product and products obtained from animals fed with genetically modified feed or treated with genetically modifed medicinal products will be subject neither to the authorisation requirements, nor to the labelling requirements laid down in this Regulation.

(18)  In accordance with Article 153 of the Treaty, the Community shall contribute to promoting the right of consumers to information. Additional to other types of information to the public established in this Regulation, labelling of products is a means that enables the consumer to make an informed choice and facilitates fairness of transactions between seller and purchaser.

(19)  Article 2 of Directive 2000/13/EC of 20 March 2000 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs(13) requires that the labelling must not mislead the purchaser as to the characteristics of the foodstuff and, in particular, as to its nature, identity, properties, composition, method of manufacture or production, inter alia.

(20)  Additional requirements for the labelling of genetically modified foods are laid down in Regulation (EC) No 258/97, in Council Regulation (EC) No 1139/98 of 26 May 1998 concerning the compulsory indication, on the labelling of certain foodstuffs produced from genetically modified organisms, of particulars other than those provided for in Directive 79/112/EEC(14), and in Commission Regulation (EC) No 50/2000 of 10 January 2000 on the labelling of foodstuffs and food ingredients containing additives and flavourings(15).

(21)  Harmonised labelling requirements should be laid down for genetically modified feed to provide final users, in particular livestock farmers, with accurate information on the composition and properties of feed, which enable the user to make an informed choice.

(22)  The labelling should include objective information that a food or feed consists of, contains or is produced from GMOs; clear labelling, irrespective of the detectability of DNA or protein resulting from the genetic modification in the final product, meets the demands expressed in numerous surveys by a large majority of consumers, facilitates informed choice and precludes potential misleading of consumers as regards method of manufacture or production.

(23)  Additionally, the labelling should inform about any characteristic or property which renders a food or feed not equivalent to its conventional counterpart in respect of composition, nutritional value or nutritional effects, intended use of the food or feed and health implications for certain sections of the population, as well as any characteristic or property which gives rise to ethical or religious concerns.

(24)  Regulation (EC) No …/2002 of the European Parliament and of the Council of ... [concerning traceability and labelling of genetically modified organisms and traceability of food and feed products produced from genetically modified organisms](16) ensures that the specific information concerning the genetic modification is available at each stage of the placing on the market of GMOs and food and feed produced therefrom and should thereby facilitate accurate labelling.

(25)  Despite the fact that some operators avoid using genetically modified food and feed, such material may be present in minute traces in conventional food and feed as a result of adventitious or technically unavoidable contamination during cultivation, harvest, transport and processing; in such cases, this food or feed should not be subject to the labelling requirements of this Regulation; in order to achieve this objective, it is necessary to establish thresholds for the adventitious or technically unavoidable presence of genetically modified material in foods or feed.

(26)  In order to establish that the presence of this material is adventitious or technically unavoidable, operators must demonstrate to the competent authorities that they have taken appropriate steps to avoid the presence of the genetically modified food or feed.

(27)  In order to ensure the practicability and feasibility of this Regulation, a threshold of 0,5 %, with the possibility of establishing lower levels, should be established for minute traces in food or feed of genetically modified material authorised under Community legislation, where the presence of such material is adventitious or technically unavoidable; as and when advances in science and technology allow, appropriately lower thresholds should be established.

(28)  Member States should encourage and contribute to the drawing up of guides to good segregation practice to be applied by food operators in order to avoid adventitious or technically unavoidable contamination by genetically modified material.

(29)  It is necessary to establish harmonised procedures for risk assessment and authorisation, that are efficient, time-limited and transparent, and criteria for evaluation of the potential risks arising from genetically modified foods and feed.

(30)  In order to ensure a harmonised scientific assessment of genetically modified foods and feed, such assessments should be carried out by the European Food Safety Authority.

(31)  It is recognised that scientific risk assessment alone cannot, in some cases, provide all the information on which a risk management decision should be based, and that other legitimate factors relevant to the matter under consideration may be taken into account.

(32)  Risks to the environment may be associated with foods and feed which consist of or contain GMOs. Part C of Directive 2001/18/EC provides that no product consisting of or containing a GMO may be placed on the market without inter alia a risk assessment having been carried out in accordance with that part of the Directive. However, that requirement is waived in respect of any product covered by sectoral Community legislation that provides for a specific environmental risk assessment at least equivalent to the environmental risk assessment carried out in accordance with Annexes II and III to that Directive. This Regulation should satisfy the conditions for the waiver to apply the requirements of that Directive. It is therefore also necessary that its provisions in regard to risk management, labelling, monitoring, information to the public and safeguard clause, must be at least equivalent to those laid down in Directive 2001/18/EC.

(33)  It is necessary to introduce, where appropriate and based on the conclusions of the risk assessment, post-market monitoring requirements for the use of the genetically modified foods for human consumption and for the use of the genetically modified feed for animal consumption. In the case of genetically modified organisms, a monitoring plan concerning environment effects is compulsory in accordance with Directive 2001/18/EC.

(34)  To facilitate controls on genetically modified foods and feed, applicants for authorisation should propose appropriate methods of sampling and detection, and deposit samples of the genetically modified food and feed with the European Food Safety Authority; methods of sampling and detection should be validated, where appropriate, by the Community reference laboratory.

(35)  Technological progress and scientific developments should be taken into account when implementing this Regulation.

(36)  Existing authorisations and notifications for placing on the market genetically modified foods under Regulation (EC) No 258/97 and existing authorisations of genetically modified food and feed, granted under Directives 90/220/EEC and 2001/18/EC, Directive 82/471/EEC or Directive 70/524/EEC, should continue to remain in force, subject to that the European Food Safety Authority is provided with information concerning the risk assessment, methods for sampling and detection as appropriate, including samples of the food and feed and their control samples within six months of the entry into force of this Regulation.

(37)  A register of genetically modified food and feed authorised under this Regulation shall be established, including product specific information, independent, peer-reviewed studies which demonstrate the safety of the product, and sampling and detection methods; non-confidential data should be made available to the public.

(38)  In order to stimulate research and development into genetically modified organisms for food and/or feed use, 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 which should be against the public interest.

(39)  The measures necessary for the implementation of this Regulation are to 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(17). The Commission shall be assisted by the Committee referred to in Article 58(1) of Regulation (EC) No 178/2002.

(40)  Provision should be made for consultation of the European Group on Ethics in Science and New Technologies established by Decision of 16 December 1997 with a view to obtaining advice on ethical issues regarding the placing on the market of genetically modified food or feed. Such consultations should be without prejudice to the competence of Member States as regards ethical issues.

(41)  The content of this Regulation takes account of the international trade commitments of the European Communities and of the requirements of the Cartagena Protocol on Biosafety to the Convention on Biological Diversity as regards importer obligations and notification.

(42)  This Regulation respects the fundamental rights and observes the principles recognised in particular by the Charter of Fundamental Rights of the EU,

HAVE ADOPTED THIS REGULATION:

Chapter I

Objective and definitions

Article 1

Objective

The objective of this Regulation, in accordance with the precautionary principle, is:

   a) to provide the basis for the assurance of a high level of protection of human life and health, animal health and welfare, environment and consumers' interest in relation to genetically modified food and feed, whilst ensuring the effective functioning of the internal market;
   b) to lay down Community procedures for the authorisation and supervision of genetically modified food and feed;
   c) to lay down provisions for the labelling of genetically modified food and feed;
   d) to prevent the unintended presence of material consisting of, containing or produced from GMOs in food and feed.

Article 2

Definitions

For the purposes of this Regulation:

   1) the definitions of "food', "feed', "placing on the market' and "traceability', laid down in Regulation (EC) No 178/2002 shall apply;
   2) the definitions of "organism', "genetically modified organism' ("GMO'), "deliberate release' and "environmental risk assessment' laid down in Directive 2001/18/EC shall apply;
   3) 'genetically modified food' means food consisting of, containing or produced from genetically modified organisms;
   4) 'genetically modified feed' means feed consisting of, containing or produced from genetically modified organisms;
   ( 5) 'genetically modified organisms for food use' means a genetically modified organism which may be used as food or as a source material for the production of food;
   ( 6) 'genetically modified organisms for feed use' means a genetically modified organism which may be used as feed or as a source material for the production of feed;
   ( 7) "produced from genetically modified organisms' means derived, in whole or in part, from genetically modified organisms, but not consisting of or containing genetically modified organisms ;
   ( 8) 'control sample' means the genetically modified organism or its genetic material (positive sample) and the parental organism or its genetic material that has been used for the purpose of the genetic modification (negative sample);
  9) 'final consumer' means:
   - as regards food, anyone who purchases a foodstuff for their personal or private consumption;
   - as regards feed, a farmer who purchases, for the purpose of feeding animals intended in any way for human consumption, feed consisting of, containing or produced from genetically modified organisms.

Chapter II

Genetically modified food

Section 1

Authorisation and Monitoring

Article 3

Scope

1.  This Section shall apply to:

   a) genetically modified organisms for food use,
   b) food consisting of or containing genetically modified organisms,
   c) food produced from or containing ingredients produced from genetically modified organisms.

2.  Where necessary, it may be determined in accordance with the procedure laid down in Article 36(2) that further types of food fall within the scope of this Section.

Article 4

Requirements

1.  Food falling within the scope of this Section must not:

   - present a danger to human health or the environment,
   - mislead the consumer,
   - differ from the food which it is intended to replace to such an extent that its normal consumption would be nutritionally disadvantageous for the consumer.

2.  No person shall place on the market a genetically modified organism for food use or food falling within the scope of this Section unless it is covered by an authorisation granted in accordance with this Section and the relevant conditions of the authorisation are adhered to.

3.  No genetically modified organism for food use or food falling within the scope of this Section shall be authorised unless the applicant for such authorisation has adequately and sufficiently demonstrated that it satisfies the requirements of paragraph 1.

4.  The authorisation referred to in paragraph 2 may cover:

   - a genetically modified organism and foods consisting of or containing that genetically modified organism as well as foods produced from or containing ingredients produced from that genetically modified organism, or
   - a food produced from or containing an ingredient produced from a genetically modified organism as well as foods produced from or containing that food.

5.  An authorisation as referred to in paragraph 2 shall not be granted, refused, renewed, modified, suspended or revoked except on the grounds and under the procedures set out in this Regulation.

6.  The applicant for an authorisation as referred to in paragraph 2 and, after the authorisation is granted, the authorisation-holder, shall be established in the Community.

7.  Authorisation under this Regulation is without prejudice to Council Directive 70/457/EEC of 29 September 1970 on the common catalogue of varieties of agricultural plant species(18) and Council Directive 70/458/EEC of 29 September 1970 on the marketing of vegetable seed(19).

Article 5

Application for authorisation

1.  To obtain the authorisation referred to in Article 4 (2), an application shall be submitted to the European Food Safety Authority, hereinafter referred to as "the Authority'.

2.  The Authority shall acknowledge receipt of the application, in writing, to the applicant within 15 working days of its receipt. The acknowledgement shall state the date of receipt of the application.

3.  The application shall be accompanied by the following particulars and documents:

   a) the name and the address of the applicant;
   b) the designation of the food, and its specification, including the transformation event(s) used;
   c) where appropriate, the information for the purpose of complying with Annex II of the Cartagena Protocol on Biosafety to the Convention on Biological Diversity;
   d) where appropriate, a detailed description of the method of production and manufacturing;
   e) a copy of the studies, including independent, peer-reviewed studies, which have been carried out and any other material which is available to demonstrate that the food complies with the criteria laid down in Article 4(1);
   f) either an analysis, supported by appropriate information and data, demonstrating that the food is not different to a conventional food, having regard to the criteria specified in Article 14(2)(a), or a proposal for labelling the food in accordance with Article 14(2)(a) and (3);
   g) either a reasoned statement that the food does not give rise to ethical or religious concerns, or a proposal for labelling it in accordance with Article 14(2)(b);
   h) a proposal for the labelling of the food and/or foods produced from it in accordance with Article 14(1);
   ( i) where appropriate, the conditions for placing on the market the food or foods produced from it , including specific conditions for use and handling;
   ( j) a method for detection, including sampling and identification of the transformation event and, where applicable, for the detection and identification of the transformation event in the food and/or in foods produced from it;
   ( k) samples of the food and their control samples;
   l) information on the place where the reference material or the samples of the applicant are to be made available to authorities and operators in the EU;
   ( m) where appropriate, a proposal for post-market monitoring for the use of the food for human consumption;
   ( n) a summary of the dossier in a standardised form.

4.  In the case of an application relating to a GMO for food use, references to "food" in paragraph 3 shall be interpreted as referring to food consisting of, containing or produced from the GMO in respect of which an application is made.

5.  The application shall also be accompanied by:

   a) the complete technical dossier supplying the information required by Annexes III and IV to Directive 2001/18/EC and information and conclusions about the risk assessment carried out in accordance with the principles set out in Annex II to Directive 2001/18/EC and a copy of the decision authorising the placing on the market of the genetically modified organism under part C of Directive 2001/18/EC;
   b) a monitoring plan for environmental effects according to Annex VII to Directive 2001/18/EC, including a proposal for the time-period of the monitoring plan; this time-period may be different from the proposed period for the consent.

6.  Where the application concerns a substance the use and placing on the market of which is subject under other provisions of Community law to its inclusion on a list of substances registered or authorised to the exclusion of others, this must be stated in the application and the status of the substance under the relevant legislation must be indicated.

7.  The Commission, having first consulted the Authority and the national and local authorities competent within the meaning of Directive 2001/18/EC, shall establish, in accordance with the procedure laid down in Article 36(2), implementing rules for the application of this Article.

8.  Before the entry into force of this Regulation, the Authority shall publish detailed guidance concerning the preparation and the presentation of the application.

Article 6

Guides to good segregation practice for food and food ingredients

The Member States shall encourage and contribute to the drawing up of guides to good segregation practice to be applied by food operators in order to avoid adventitious or technically unavoidable contamination of food by genetically modified material.

Article 7

Opinion of the Authority

1.  Save in exceptionally complex cases, the Authority shall give an opinion within six months of the receipt of a valid application.

2.  The Authority may, where appropriate, request the applicant to supplement the particulars accompanying the application within a specific time limit. Where the Authority requests supplementary information, the time limit laid down in paragraph 1 shall be suspended until such time that this information has been provided. Likewise, this time limit shall be suspended for the time allowed to the applicant to prepare oral or written explanations.

3.  The Authority shall forward the application within 15 days of its receipt to the competent authority or authorities of the Member States. The competent authorities, designated by the Member States, shall forward comments or reasoned objections within four months of the receipt of the application to the Authority which shall immediately circulate them to all competent authorities. Where the Authority's opinion is not in accordance with the opinion of a competent authority of a Member State, the Authority's opinion shall provide an explanation of the reasons for the differences.

4.  In order to prepare its opinion, the Authority:

   a) shall verify that the particulars and documents submitted by the applicant are in accordance with Article 5, and examine whether the food complies with the criteria laid down in Article 4 (1);
   b) shall make the application and any supplementary information supplied by the applicant available to the Member States and to the Commission;
   c) shall make the summary of the dossier mentioned in Article 5 (3) (n) available to the public; it shall also be ensured that, on request, the public has reasonable access to the entire application, excluding confidential information. An appropriate reference shall be made in connection with publication of the summary;
   d) may ask the appropriate food assessment body of a Member State to carry out a safety assessment of the food;
   e) shall take account of the results of the environmental risk assessment under Directive 2001/18/EC;
   f) shall forward to the Community reference laboratory referred to in Article 33 the particulars referred to in Article 5(3)(i) and (j). The reference laboratory shall test and validate the method of detection and identification proposed by the applicant and shall subsequently publish that method;
   g) shall, in verifying the application of Article 14 (2) (a), examine the information and data submitted by the applicant showing that the characteristics of the food are not different in comparison with the conventional counterpart, having regard to the accepted limits of natural variations for such characteristics.

5.  In the case of genetically modified organisms or food containing or consisting of genetically modified organisms falling within the scope of this Section, the environmental safety requirements laid down in Directive 2001/18/EC shall apply to the evaluation to ensure that all appropriate measures are taken to prevent the adverse effects on human health and the environment which might arise from the deliberate release of genetically modified organisms. During evaluation of requests for the placing on the market of products consisting of or containing genetically modified organisms, the Commission and the national and local authorities competent within the meaning of Directive 2001/18/EC shall be involved by the Authority in accordance with the provisions of that Directive.

6.  In the event of an opinion in favour of authorising the food, the opinion shall also include the following particulars:

   a) the name and address of the applicant;
   b) the designation of the food, and its specification;
   c) where appropriate, the information required under Annex II of the Cartagena Protocol on Biosafety to the Convention on Biological Diversity;
   d) the proposal for the labelling of the food and/or foods produced from it;
   e) where appropriate, any conditions or restrictions which should be imposed on the supply or use of the food and/or foods produced from it, including post-market monitoring requirements based on the outcome of the risk assessment and effective measures to prevent the unintended presence of the food and/or foods produced from it in other products;
   f) the method, validated by the reference laboratory, for detection, including sampling, access to appropriate reference material, identification of the sequence of the transformation event and, where applicable, for the detection and identification of the transformation event in the food and/or in foods produced from it or with it;
   g) where appropriate, the monitoring plan referred to in Article 5 (5) (b);
   h) information as to where the reference material or the samples of the applicant are to be made available to operators in the EU and for analytical purposes.

7.  The Authority shall forward its opinion to the Commission, the Member States, the appropriate national food safety, environmental risk and human and animal health risk assessment authorities or bodies and the applicant, including a report describing its assessment of the food and stating the reasons for its opinion.

8.  The Authority shall also immediately make public its opinion, the assessment report and the grounds for the opinion. The public may make comments to the Commission within three months from this publication. Reference shall be made to the possibility for the public to have access to the entire application, excluding confidential information.

9.  Before the entry into application of this Regulation, the Commission shall publish a recommendation on the nature of the risk assessment to be undertaken by the Authority for the purpose of preparing its opinion.

Article 8

Authorisation by the Community

1.  Save in exceptionally complex cases, within three months of receipt of the opinion of the Authority, the Commission shall prepare a draft of the decision to be taken in respect of the application, taking into account 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 give reasons for taking a decision that differs from the Authority's opinion.

The Commission's draft decision shall immediately be made public.

2.  In the event of a draft decision which envisages the granting of authorisation, the draft decision shall include the particulars mentioned in Article 7 (6), the name of the authorisation-holder and, where appropriate, the unique code attributed to the genetically modified organism as referred to in Regulation (EC) No ../2002 [concerning traceability and labelling of genetically modified organisms and traceability of food and feed products produced from genetically modified organisms].

The draft decision shall also include the opinions of the authorities required to be consulted in accordance with Directive 2001/18/EC.

3.  A final decision on the application shall be adopted in accordance with the procedure laid down in Article 36(2). The public shall be given access to the issues discussed in connection with the risk management decision and the result of the vote.

4.  The Commission shall without delay inform the applicant of the decision taken. It shall also, at the earliest opportunity, notify its decision to the European Parliament, the Member States and the appropriate food safety, environmental risk and human and animal health risk assessment authorities or bodies. The decision shall be published in the Official Journal of the European Communities.

5.  Without prejudice to the procedure provided for in Article 11, the authorisation granted in accordance with the procedure laid down in this Regulation shall, throughout the Community, terminate after ten years and shall be renewable in accordance with Article 12. The authorised food shall be entered in the Register referred to in Article 30. Each entry in the Register shall mention the date of authorisation and shall include the particulars referred to in paragraph 2. It shall also indicate how and where the public can access the files relating to the application for authorisation, including the evaluation by the Authority, the opinions of the national bodies, the local authorities and public opinion, as well as the issues discussed in connection with the risk management decision and the result of the vote.

6.  The authorisation under this Section shall be without prejudice to other provisions of Community law governing the use and placing on the market of substances which may only be used subject to their inclusion in a list of substances registered or authorised to the exclusion of others.

7.  The granting of authorisation shall not diminish the general civil and criminal liability of any food operator in respect of the food concerned.

Article 9

Status of existing products

1.  By derogation to Article 4 (2), a product falling within the scope of this Section which has been placed on the market under Directive 90/220/EEC before the entry into force of Regulation (EC) No 258/97 or in accordance with the provisions laid down in Regulation (EC) No 258/97 may continue to be placed on the market, used and processed provided that the following conditions are met:

   a) within six months of the entry into force of this Regulation, the person responsible for placing on the market the concerned product shall notify the Authority of the date at which it was first placed on the market in the Community. This notification shall be accompanied by the particulars mentioned in Article 5 (3) and (5), as appropriate, which the Authority shall forward to the Commission and the Member States. The Authority shall forward to the Community reference laboratory referred to in Article 33 the particulars referred to in Article 5 (3) (j) and (k) and shall ask it to test and validate the method of detection and identification proposed by the applicant;
   b) within one year of the entry into force of this Regulation, the Authority shall, after verification that all the information required has been submitted, notify the Commission that it has received the information required under this Article. The product concerned shall be entered in the Register. Each entry in the Register shall mention the date at which the concerned product was first placed on the market and shall include the particulars referred to in Article 8(2) as appropriate. It shall also indicate how and where the public can access the files relating to the application and any information submitted subsequently, including the Authority's assessment and, where applicable, opinions of national bodies and of the public, as well as the issues discussed in connection with the risk management decision and the result of the vote.

2.  Within nine years from the date at which the concerned product was first placed on the market, the person responsible for placing it on the market shall submit an application in accordance with Article 12, which shall apply in a like manner.

3.  Products referred to in paragraph 1 and foods containing them or produced from them shall be subject to the provisions of this Regulation, in particular Articles 10, 11 and 35, which shall apply in a like manner.

4.  Where the notification and accompanying particulars referred to in paragraph 1(a) are not supplied within the period specified or are found to be incorrect, or where an application is not submitted as required by paragraph 2 within the period specified, the Commission, acting in accordance with the procedure laid down in Article 36(2), shall adopt a measure requiring the product concerned and any products derived from it to be withdrawn from the market.

5.  Detailed rules for implementing this Article shall be adopted in accordance with the procedure laid down in Article 36 (2).

Article 10

Supervision

1.  After an authorisation has been issued in accordance with this Regulation, all parties concerned shall comply with any conditions or restrictions which have been imposed in the authorisation. Where post-market monitoring as referred to in Article 5(3)(m) and Article 5(5)(b) has been imposed on the authorisation-holder, he shall ensure that it is carried out and shall submit reports to the Authority in accordance with the authorisation. The monitoring reports, excluding confidential information, shall be made accessible to the public.

2.  If the authorisation-holder proposes to modify the terms of the authorisation, he shall submit an application to the Authority.

3.  The authorisation-holder shall forthwith inform the Authority of any new scientific or technical information which might influence the evaluation of the safety in use of the food. In particular, the authorisation-holder shall forthwith inform the Authority of any prohibition or restriction imposed by the competent authority of any third country in which the food is placed on the market. The Authority shall examine the information forwarded and shall notify the Commission, the Member States and the local authorities. The information forwarded shall be made accessible to the public.

Article 11

Modification, suspension and revocation of authorisations

1.  Where, on its own initiative or following a request from a Member State or from the Commission, the Authority is of the opinion that an authorisation granted in accordance with this Regulation should be modified, suspended or revoked, it shall forthwith transmit this opinion to the Commission, the authorisation-holder, the Member States and the local authorities. The opinion shall be made accessible to the public.

2.  The Commission shall examine the opinion of the Authority as soon as possible and prepare a draft of the decision to be taken. The draft shall be made accessible to the public.

3.  In the event of a draft decision which envisages the modification of the authorisation, the draft decision shall include any amendment needed to the particulars mentioned in Article 8 (2).

4.  A final decision on the modification, the suspension or the revocation of the authorisation shall be adopted in accordance with the procedure laid down in Article 36 (2).

5.  The Commission shall without delay inform the authorisation-holder of the decision taken. The decision shall be published in the Official Journal of the European Communities. The Register shall be amended as appropriate. The public shall be given access to the issues discussed in connection with the risk management decision and the result of the vote.

Article 12

Renewal of authorisations

1.  Without prejudice to the right of a third party to submit an application for authorisation for a food essentially similar to a food for which an authorisation has already been granted, authorisations under this Regulation shall be renewable for ten-year periods, on application to the Authority by the authorisation-holder at the latest one year before the expiry date of the authorisation.

The Authority shall acknowledge receipt of the application, in writing, to the authorisation-holder within 15 days of its receipt. The acknowledgement shall state the date of receipt of the application.

2.  The application shall be accompanied by the following particulars and documents:

   a) a copy of the authorisation for placing the food on the market;
   b) a report on the results of the post&nbhy;market monitoring of the use of food for human consumption, if so specified in the authorisation in accordance with Article 5(3)(m);
   c) without prejudice to the obligations laid down in Article 10(3), any other new information which has become available with regard to the evaluation of the safety in use of the food and the risks of the food to the consumer or the environment;
   d) where appropriate, a proposal for amending or complementing the conditions of the original authorisation, inter alia the conditions concerning future monitoring.

3.  Article 7 and Article 8 shall apply in a like manner.

4.  Where, for reasons beyond the control of the authorisation-holder, no decision is taken on the renewal of an authorisation before its expiry date, the authorisation of the product shall automatically be extended once by one year or until the Commission takes a decision within that year.

5.  The implementing rules for the application of this Article shall be established by the Commission after consulting the Authority, in accordance with the procedure laid down in Article 36 (2).

6.  The Authority shall publish detailed guidance concerning the preparation and the presentation of the application.

Section 2

Labelling

Article 13

Scope

1.  This Section shall apply to foods which are to be delivered as such to the final consumer or mass caterers in the Community and which:

   - consist of or contain genetically modified organisms, or
   - are produced from or contain ingredients produced from genetically modified organisms.

2.  This Section shall not apply to processing aids.

3.  This Section shall not apply to foods produced from animals fed with GMOs or products thereof.

4.  This Section shall not apply to foods containing material produced from genetically modified organisms in a proportion no higher than 0,5% or a lower threshold established in accordance with the procedure laid down in Article 36(2), provided that this presence is adventitious or technically unavoidable. As and when advances in science and technology allow, appropriately lower thresholds shall be established.

In order to establish that the presence of this material is adventitious or technically unavoidable, operators must be in a position to supply evidence to satisfy the competent authorities that they have taken appropriate steps to avoid the presence of the genetically modified material. The Commission shall draw up a list of criteria for determining these "appropriate steps". In cooperation with the Authority, the Member States and the local authorities, the Commission shall also lay down appropriate measures to ensure that the utmost care is taken to avoid contamination.

Article 14

Requirements

1.  Without prejudice to the other requirements of Community law concerning the labelling of foodstuffs, foods falling within the scope of this Section shall be subject to the following additional specific labelling requirements:

(a)  Where the food consists of more than one ingredient, the words "genetically modified" or "produced from genetically modified [name of organism]" shall appear in the list of ingredients provided for in Article 6 of Directive 2000/13/EC in parentheses immediately following the ingredient concerned. Alternatively, these words may appear in a footnote to the list of ingredients. It shall be printed in a font of at least the same size as the list of ingredients.

(b)  Where the ingredient is designated by the name of a category, the words "contains [name of ingredient] produced from genetically modified [name of organism]" shall appear in the list of ingredients.

(c)  Where there is no list of ingredients, the words "genetically modified" or "produced from genetically modified (name of organism)" shall appear clearly on the labelling.

(d)  Where the food is offered for sale to the final consumer or to mass caterers without pre-packaging, or in small pre-packaged units, the information required under this paragraph must be permanently and visibly displayed either on the food display or right next to it, or on the packaging material, in a font sufficiently large for it to be easily identified and read.

2.  In addition to the labelling requirements laid down in paragraph 1, the labelling shall also mention any characteristic or property, as specified in the authorisation, in the following cases:

(a)  Where a food is not equivalent to its conventional counterpart as regards these characteristics or properties:

   - composition,
   - nutritional value or nutritional effects,
   - intended use of the food,
   - implications for the health of certain sections of the population.

(b)  Where a food may give rise to ethical or religious concerns.

3.  In addition to the labelling requirements laid down in paragraph 1 and as specified in the authorisation, the labelling of foods falling within the scope of this Section which do not have a conventional counterpart shall contain appropriate information about the nature and the characteristics of the foods concerned.

Article 15

Implementing measures

Detailed rules for implementing this Section may be adopted in accordance with the procedure laid down in Article 36 (2).

Chapter III

Genetically modified feed

Section 1

Authorisation and Monitoring

Article 16

Scope

1.  This Section shall apply to:

   a) genetically modified organisms for feed use;
   b) feed consisting of or containing genetically modified organisms;
   c) feed produced from genetically modified organisms.

2.  Where necessary, it may be determined in accordance with the procedure laid down in Article 36(2) that further types of feed fall within the scope of this Section.

Article 17

Requirements

1.  Feed referred to in Article 16 (1) must not:

   a) present a risk for animal health, human health or the environment;
   b) mislead the user;
   c) harm the consumer by impairing the distinctive features of the animal products;
   d) differ from feed which it is intended to replace to such an extent that its normal consumption would be nutritionally disadvantageous for animals or humans.

2.  No person shall place on the market, use or process a product referred to in Article 16 (1) for feed use or feed falling within the scope of this Section unless it is covered by an authorisation granted in accordance with this Section and the relevant conditions of the authorisation are adhered to.

3.  No product referred to in Article 16(1) for feed use or feed falling within the scope of this Section shall be authorised unless the applicant for such authorisation has adequately and sufficiently demonstrated that it satisfies the requirements of paragraph 1.

4.  The authorisation referred to in paragraph 2 may cover:

   - feed consisting of or containing genetically modified organisms as well as feed produced from such genetically modified organisms, or
   - a feed produced from a genetically modified organism as well as feed produced from or containing that feed.

5.  An authorisation as referred to in paragraph 2 shall not be granted, refused, renewed, modified, suspended or revoked except on the grounds and under the procedures set out in this Regulation.

6.  The applicant for an authorisation as referred to in paragraph 2 and, after the authorisation is granted, the authorisation-holder, shall be established in the Community.

7.  7 Authorisation under this Regulation is without prejudice to Directive 70/457/EEC and Directive 70/458/EEC.

Article 18

Application for authorisation

1.  To obtain the authorisation referred to in Article 17 (2), an application shall be submitted to the Authority.

2.  The Authority shall acknowledge receipt of the application, in writing, to the applicant within 15 working days of its receipt. The acknowledgement shall state the date of receipt of the application.

3.  The application shall be accompanied by the following:

   a) the name and the address of the applicant;
   b) the designation of the feed referred to in Article 16 (1), and its specification, including the transformation event(s) used;
   c) where appropriate, the information for the purpose of complying with Annex II of the Cartagena Protocol on Biosafety to the Convention on Biological Diversity;
   d) where appropriate, a detailed description of the method of production, manufacturing and intended uses of the feed referred to in Article 16 (1);
   e) a copy of the studies, including independent, peer-reviewed studies, which have been carried out and any other material which is available to demonstrate that the feed referred to in Article 16(1) complies with the criteria laid down in Article 17(1), and in particular for feed falling within the scope of Directive 82/471/EEC, the information required under Council Directive 83/228/EEC of 18 April 1983 on the fixing of guidelines for the assessment of certain products used in animal nutrition(20);
   f) a proposal for labelling the feed referred to in Article 16(1) consisting of, containing or produced from genetically modified organisms in accordance with Article 26(3)(a) and (c) and (4);
   g) either a reasoned statement that the feed referred to in Article 16 (1) does not give rise to ethical or religious concerns, or a proposal for labelling it in accordance with Article 26(3)(d);
   h) where appropriate, the conditions for placing the feed referred to in Article 16 (1) on the market, including specific conditions for use and handling;
   i) a method for detection, including sampling and identification of the transformation event and, where applicable, for the detection and identification of the transformation event in the feed referred to in Article 16 (1);
   j) samples of the feed referred to in Article 16 (1) and their control samples;
   k) information on the place where the reference material or the samples of the applicant are to be made available to authorities and operators in the EU;
   ( l) where appropriate, a proposal for post-market monitoring for the use of the feed referred to in Article 16 (1) for animal consumption;
   ( m) a summary of the dossier in a standardised form.

4.  In the case of an application relating to a GMO for feed use, references to "feed" in paragraph 3 shall be interpreted as referring to feed consisting of, containing or produced from the GMO in respect of which an application is made.

5.  The application shall also be accompanied by:

   a) the complete technical dossier supplying the information required by Annexes III and IV to Directive 2001/18/EC and information and conclusions about the risk assessment carried out in accordance with the principles set out in Annex II to Directive 2001/18/EC and a copy of the decision authorising the placing on the market of the genetically modified organism under Part C of Directive 2001/18/EC;
   b) a monitoring plan for environmental effects according to Annex VII to Directive 2001/18/EC, including a proposal for the time-period of the monitoring plan; this time-period may be different from the proposed period for the consent.

6.  Where the application concerns a substance the use and placing on the market of which is subject under other provisions of Community law to its inclusion on a list of substances authorised to the exclusion of others, this must be stated in the application and the status of the substance under the relevant legislation must be indicated.

7.  The Commission, having first consulted the Authority and the national and local authorities competent within the meaning of Directive 2001/18/EC, shall establish, in accordance with the procedure laid down in Article 36 (2), implementing rules for the application of this Article.

8.  The Authority shall publish detailed guidance concerning the preparation and the presentation of the application.

Article 19

Opinion of the Authority

1.  Save in exceptionally complex cases, the Authority shall give an opinion within 6 months of the receipt of a valid application.

2.  The Authority may, where appropriate, request the applicant to supplement the particulars accompanying the application within a specific time limit. Where the Authority requests supplementary information, the time limit laid down in paragraph 1 shall be suspended until such time that this information has been provided. Likewise, this time limit shall be suspended for the time allowed to the applicant to prepare oral or written explanations.

3.  The Authority shall forward the application within 15 days of its receipt to the competent authority or authorities of the Member States. The competent authorities, designated by the Member States, shall forward comments or reasoned objections within four months of the receipt of the application to the Authority which shall immediately circulate them to all competent authorities. Where the Authority's opinion is not in accordance with the opinion of a competent authority of a Member State, the Authority's opinion shall provide an explanation of the reasons for the differences.

4.  In order to prepare its opinion, the Authority:

   a) shall verify that the particulars and documents submitted by the applicant are in accordance with Article 18, and examine whether the feed referred to in Article 16 (1) complies with the criteria laid down in Article 17 (1);
   b) shall make the application and any supplementary information supplied by the applicant available to the Member States and to the Commission;
   c) shall make the summary of the dossier mentioned in Article 18 (3) (m) available to the public; it shall also be ensured that, on request, the public has reasonable access to the entire application, excluding confidential information. An appropriate reference shall be made in connection with publication of the summary;
   d) shall ask the appropriate feed assessment body of the Member State in which the person applying for authorisation is established to carry out a safety assessment of the feed referred to in Article 16(1), and shall take due account of the findings of the assessment;
   e) shall take account of the results of the environmental risk assessment under Directive 2001/18/EC;
   f) shall forward to the Community reference laboratory referred to in Article 33 the particulars referred to in Article 18(3)(i) and (j). The reference laboratory shall test and validate the method of detection and identification proposed by the applicant and shall subsequently publish that method;
   g) shall, in verifying the application of Article 26 (3) (c), examine the information and data submitted by the applicant showing that the characteristics of the feed referred to in Article 16 (1) are not different in comparison with the conventional counterpart, having regard to the accepted limits of natural variations for such characteristics.

5.  In the case of genetically modified organisms and feed referred to respectively in Article 16(1)(a) and (b), the environmental safety requirements laid down in Directive 2001/18/EC shall apply to the evaluation to ensure that all appropriate measures are taken to prevent the adverse effects on human and animal health and the environment which might arise from the deliberate release of genetically modified organisms. During evaluation of requests for the placing on the market of products consisting of or containing genetically modified organisms, the Commission and the national and local authorities competent within the meaning of Directive 2001/18/EC shall be involved by the Authority in accordance with the provisions of that Directive.

6.  In the event of an opinion in favour of authorising the feed referred to in Article 16 (1), the opinion shall also include the following particulars:

   a) the name and address of the applicant;
   b) the designation of the feed referred to in Article 16 (1), and its specification;
   c) where appropriate, the information required under Annex II of the Cartagena Protocol on Biosafety to the Convention on Biological Diversity;
   d) the proposal for the labelling of the feed referred to in Article 16 (1);
   e) where appropriate, any conditions or restrictions which should be imposed on the placing on the market, including specific conditions or restrictions for use and handling, including post-market monitoring requirements based on the outcome of the risk assessment and effective measures to prevent the unintended presence of the feed or feed produced from it in other feed products;
   f) the method, validated by the reference laboratory, for detection, including sampling and identification of the transformation event and, where applicable, for the detection and identification of the transformation event in the feed referred to in Article 16(l);
   g) where appropriate, the monitoring plan as referred to in Article 18 (5) (b);
   h) information on the place where the reference material or the samples of the applicant are to be made available to operators in the EU.

7.  The Authority shall forward its opinion to the Commission, the Member States, the appropriate national food safety, environmental risk and human and animal health risk assessment authorities or bodies and the applicant, including a report describing its assessment of the feed referred to in Article 16(1) and stating the reasons for its opinion.

8.  The Authority shall also immediately make public its opinion, the assessment report and the grounds for the opinion. The public may make comments to the Commission within three months from this publication. Reference shall be made to the possibility for the public to have access to the entire application, excluding confidential information.

Article 20

Authorisation by the Community

1.  Save in exceptionally complex cases, within three months of receipt of the opinion of the Authority, the Commission shall prepare a draft of the decision to be taken in respect of the application, taking into account 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 give reasons for taking a decision that differs from the Authority's opinion.

The Commission's draft decision shall immediately be made public.

2.  In the event of a draft decision which envisages the granting of authorisation, the draft decision shall include the particulars mentioned in Article 19 (6), the name of the authorisation holder, and, where appropriate, the unique code attributed to the genetically modified organism as referred to in Regulation (EC) No .../2002 [concerning traceability and labelling of genetically modified organisms and traceability of food and feed products produced from genetically modified organisms].

The draft decision shall also include the opinions of the authorities required to be consulted in accordance with Directive 2001/18/EC.

3.  A final decision on the application shall be adopted in accordance with the procedure laid down in Article 36(2). The public shall be given access to the issues discussed in connection with the risk management decision and the result of the vote.

4.  The Commission shall without delay inform the applicant of the decision taken. It shall also, at the earliest opportunity, notify its decision to the European Parliament, the Member States and the appropriate food safety, environmental risk and human and animal health risk assessment authorities or bodies. The decision shall be published in the Official Journal of the European Communities.

5.  Without prejudice to the procedure provided for in Article 23, the authorisation granted in accordance with the procedure laid down in this Regulation shall, throughout the Community, terminate after ten years and shall be renewable in accordance with Article 24. The authorised feed shall be entered in the Register referred to in Article 30. Each entry in the Register shall mention the date of authorisation and shall include the particulars referred to in paragraph 2. It shall also indicate how and where the public can access the files relating to the application for authorisation, including the evaluation by the Authority, the opinions of the national bodies, the local authorities and public opinion, as well as the issues discussed in connection with the risk management decision and the result of the vote.

6.  The authorisation under this Section shall be without prejudice to other provisions of Community law governing the use and placing on the market of substances which may only be used subject to their inclusion in a list of substances authorised to the exclusion of others.

7.  The granting of authorisation shall not diminish the general civil and criminal liability of any feed operator in respect of the feed concerned.

Article 21

Status of existing products

1.  By derogation to Article 17 (2), products as referred to in Article 16 (1) which have been authorised before the date of application of this Regulation

   - under Directives 90/220/EEC or 2001/18/EC, including use as feed,
   - under Directive 82/471/EEC, which are produced from GMOs, or
   - under Directive 70/524/EEC which consist of, contain or are produced from GMOs,
  

may continue to be placed on the market, used and processed provided that the following conditions are met:

   a) within six months of the entry into force of this Regulation, the person responsible for placing on the market the concerned products shall notify the Authority of the date at which they were first placed on the market in the Community. This notification shall be accompanied by the particulars mentioned in Article 18 (3) and (5), as appropriate, which the Authority shall forward to the Commission and the Member States. The Authority shall forward to the Community reference laboratory referred to in Article 33 the particulars referred to in Article 18 (3) (i) and (j) and shall ask it to test and validate the method of detection and identification proposed by the applicant;
   b) within one year of the entry into force of this Regulation, the Authority shall, after verification that all the information required has been submitted, notify the Commission that it has received the information required under this Article. The products concerned shall be entered in the Register. Each entry in the Register shall mention the date at which the concerned products were first placed on the market and shall include the particulars referred to in Article 20(2) as appropriate. It shall also indicate how and where the public can access the files relating to the application and any information submitted subsequently, including the Authority's assessment and, where applicable, opinions of national bodies and of the public, as well as the issues discussed in connection with the risk management decision and the result of the vote.

2.  Within nine years from the date at which the concerned products were first placed on the market, the person responsible for placing them on the market shall submit an application in accordance with Article 24, which shall apply in a like manner.

3.  Products referred to in paragraph 1 and feed containing them or produced from them shall be subject to the provisions of this Regulation, in particular Articles 22, 23 and 35, which shall apply in a like manner.

4.  Where the notification and accompanying particulars referred to in paragraph 1(a) are not supplied within the period specified or are found to be incorrect, or where an application is not submitted as required by paragraph 2 within the period specified, the Commission, acting in accordance with the procedure laid down in Article 36(2), shall adopt a measure requiring the product concerned and any products derived from it to be withdrawn from the market.

5.  In the case of authorisations not issued to a specific holder, the person who imports, produces or manufactures the products referred to in this Article shall submit the information or the application to the Authority.

6.  Detailed rules for implementing this Article shall be adopted in accordance with the procedure laid down in Article 36 (2).

Article 22

Supervision

1.  After an authorisation has been issued in accordance with this Regulation, all parties concerned shall comply with any conditions or restrictions which have been imposed in the authorisation. Where post-market monitoring as referred to in Article 18(3)(l)and Article 18(5)(b) has been imposed on the authorisation-holder, he shall ensure that it is carried out and shall submit reports to the Authority in accordance with the authorisation. The monitoring reports, excluding confidential information, shall be made accessible to the public.

2.  If the authorisation-holder proposes to modify the terms of the authorisation, he shall submit an application to the Authority.

3.  The authorisation-holder shall forthwith inform the Authority of any new scientific or technical information which might influence the evaluation of the safety in use of the feed referred to in Article 16(1). In particular, the authorisation-holder shall forthwith inform the Authority of any prohibition or restriction imposed by the competent authority of any third country in which the feed referred to in Article 16(1) is placed on the market. The Authority shall examine the information forwarded and inform the Commission, the Member States and the local authorities. The information forwarded shall be made accessible to the public.

Article 23

Modification, suspension and revocation of authorisations

1.  Where, on its own initiative or following a request from a Member State or from the Commission, the Authority is of the opinion that an authorisation granted in accordance with this Regulation should be modified, suspended or revoked, it shall forthwith transmit this opinion to the Commission, the authorisation-holder, the Member States and the local authorities. The opinion shall be made accessible to the public.

2.  The Commission shall examine the opinion of the Authority as soon as possible and prepare a draft of the decision to be taken. The draft shall be made accessible to the public.

3.  In the event of a draft decision which envisages the modification of the authorisation, the draft decision shall include any amendment needed to the particulars mentioned in Article 20 (2).

4.  A final decision on the modification, the suspension or the revocation of the authorisation shall be adopted in accordance with Article 36 (2).

5.  The Commission shall without delay inform the authorisation-holder of the decision taken. It shall also, at the earliest opportunity, notify its decision to the European Parliament, the Member States and the appropriate food safety, environmental risk and human and animal health risk assessment authorities or bodies. The decision taken shall be published in the Official Journal of the European Communities. The Register shall be amended as appropriate. The public shall be given access to the issues discussed in connection with the risk management decision and the result of the vote.

Article 24

Renewal of authorisations

1.  Without prejudice to the right of a third party to submit an application for authorisation for a feed essentially similar to a feed for which an authorisation has already been granted, authorisations under this Regulation shall be renewable for ten-year periods, on application to the Authority by the authorisation-holder at the latest one year before the expiry date of the authorisation.

The Authority shall acknowledge receipt of the application, in writing, to the authorisation-holder within 15 days of its receipt. The acknowledgement shall state the date of receipt of the application.

2.  The application shall be accompanied by the following particulars and documents:

   a) a copy of the authorisation for placing the feed on the market;
   b) a report on the results of the monitoring, if so specified in the authorisation;
   c) any other new information which has become available with regard to the evaluation of the safety in use of the feed and the risks of the feed to animals, humans or the environment;
   d) where appropriate, a proposal for amending or complementing the conditions of the original authorisation, inter alia the conditions concerning future monitoring.

3.  Article 19 and Article 20 shall apply in a like manner.

4.  Where, for reasons beyond the control of the authorisation-holder, no decision is taken on the renewal of an authorisation before its expiry date, the authorisation of the product shall automatically be extended once by one year or until the Commission takes a decision within that year.

5.  The implementing rules for the application of this Article shall be established by the Commission after consulting the Authority, in accordance with the procedure laid down in Article 36 (2).

6.  The Authority shall publish detailed guidance concerning the preparation and the presentation of the application.

Section 2

Labelling

Article 25

Scope

1.  This Section shall apply to feed referred to in Article 16 (1).

2.  This Section shall not apply to feed containing material produced from genetically modified organisms in a proportion no higher than 0,5% or a lower threshold established in accordance with the procedure laid down in Article 36(2), provided that this presence is adventitious or technically unavoidable. As and when advances in science and technology allow, appropriately lower thresholds shall be established.

In order to establish that the presence of this material is adventitious or technically unavoidable, operators must be in a position to supply evidence to satisfy the competent authorities that they have taken appropriate steps to avoid the presence of the genetically modified material. The Commission shall draw up a list of criteria for determining these "appropriate steps". In cooperation with the Authority, the Member States and the local authorities, the Commission shall also lay down appropriate measures to ensure that the utmost care is taken to avoid contamination.

Article 26

Requirements

1.  Without prejudice to the other requirements of Community law concerning the labelling of feed, feed referred to in Article 16 (1) shall be subject to the additional specific labelling requirements laid down in this Article.

2.  By way of derogation from paragraph 1 the exemptions from labelling requirements provided for in Article 6 (3) of Council Directive 96/25/EC of 29 April 1996 on the circulation of feed materials, amending Directives 70/524/EEC, 74/63/EEC, 82/471/EEC and 93/74/EEC and repealing Directive 77/101/EEC(21) shall not be applicable for feed referred to in Article 16 (1).

3.  No person shall place a feed referred to in Article 16(1) on the market unless he ensures that the particulars specified below are shown, in a clearly visible, legible and indelible manner, on the packaging, the container, a label or an accompanying document:

  a) the name of the feed:
   - for genetically modified feed the name shall be: "genetically modified [name of the feed]";
   - for feed produced from genetically modified organisms: "produced from genetically modified [name of the feed from which the feed is produced]";
   b) for feed referred to in Article 16(1)(b) the name of the feed on the packaging, the container, a label or an accompanying document shall be accompanied by the relevant unique code as established in Regulation (EC) No…/2002 [concerning traceability and labelling of genetically modified organisms and traceability of food and feed products produced from genetically modified organisms];
  c) as specified in the authorisation, any characteristic of the feed referred to in Article 16 (1) such as those indicated hereunder, which is not equivalent to its conventional counterpart:
   - composition,
   - nutritional properties,
   - intended use,
   - implications for the health of certain species or categories of animals.
   d) as specified in the authorisation, any characteristic or property where a feed may give rise to ethical or religious concerns;
   e) where the feed consists of more than one ingredient and is a compound feedingstuff as defined in Council Directive 79/373/EEC of 2 April 1979 on the marketing of compound feedingstuffs(22), the words "genetically modified" or "produced from genetically modified [name of organism]" shall appear in the list of ingredients, provided for in Article 5c of that Directive, in parentheses immediately following the ingredient concerned. Alternatively, these words may appear in a footnote to the list of ingredients. It shall be printed in a font of at least the same size as the list of ingredients.

4.  In addition to the requirements laid down in paragraph 3(a) and (b) and as specified in the authorisation, the labelling and accompanying documents of feed falling within the scope of this Section which does not have a conventional counterpart shall contain appropriate information about the nature and the characteristics of the feed concerned.

Article 27

Implementing measures

Detailed rules for implementing this Section may be adopted in accordance with the procedure laid down in Article 36 (2).

Article 28

Imports

The Commission shall ensure that the requirements arising from the directives, regulations and administrative provisions concerning the evaluation and authorisation of food and feed and of raw materials intended for their production are no less rigorous for products imported into the European Union, in order to avoid the creation of unequal and unfair conditions of competition.

Chapter IV

Common provisions

Article 29

Products likely to be used as food and feed

1.  Where a product is likely to be used both as food and feed, a single application under Articles 6 and 18 shall be submitted and shall give rise to a single opinion from the Authority and a single Community decision.

2.  The Authority shall consider whether the application for authorisation should be submitted both as food and feed.

Article 30

Community Register

1.  The Commission shall establish and maintain a Community Register of Genetically Modified Food and Feed, referred to in this Regulation as "the Register'.

The Register shall include information on the method(s) validated by the Community reference laboratory, pursuant to Article 7(4)(f) and Article 19(4)(f), and on the methods used by the national reference laboratories.

2.  The Register shall be made available to the public.

Article 31

Confidentiality

1.  The applicant may indicate which information submitted under this Regulation he wishes to be treated as confidential because its disclosure may significantly harm his competitive position. Verifiable justification must be given in such cases.

2.  Without prejudice to paragraph 3, the Authority shall determine, after consultation with the applicant, which information should be kept confidential and shall inform the applicant of its decision.

3.  Information relating to the following shall not be considered confidential:

   a) name and composition of the genetically modified organism, food or feed referred to in Article 3(1) and Article 16(1) and, where appropriate, indication of the substrate and the micro-organism;
   b) general description of the genetically modified organism and the name and address of the authorisation-holder;
   c) physico-chemical and biological characteristics of the genetically modified organism, food or feed referred to in Article 3(1) and Article 16(1);
   d) effects of the genetically modified organism, food or feed referred to in Article 3(1) and Article 16(1) on human and animal health and on the environment;
   e) effects of the genetically modified organism, food or feed referred to in Article 3(1) and Article 16(1) on the characteristics of animal products and their nutritional properties;
   f) methods for detection, including sampling and identification of the transformation event and, where applicable, for the detection and identification of the transformation event in the food or feed referred to in Article 3(1) and Article 16(1) and, where applicable, monitoring requirements and a summary of the results of the monitoring;
   g) information on waste treatment and emergency response.

4.  Notwithstanding paragraph 2, the Authority shall on request supply the Commission and Member States with all information in its possession.

5.  The Commission, the Authority and the Member States shall keep confidential all the information identified as confidential under paragraph 2 except for information which must be made public if circumstances so require, in order to protect human health, animal health or the environment.

6.  If an applicant withdraws or has withdrawn an application, the Authority, the Commission and the Member States shall respect the confidentiality of commercial and industrial information, including research and development information as well as information on which the Authority and the applicant disagree as to its confidentiality.

Article 32

Data protection

The scientific data and other information in the application dossier required under Article 5 (3) and (5) and Article 18 (3) and (5) may not be used for the benefit of another applicant for a period of ten years from the date of authorisation, unless the other applicant has agreed with the authorisation-holder that such data and information may be used. On expiry of this ten-year period, the findings of all or part of the evaluation conducted on the basis of the scientific data and information contained in the application dossier may be used by the Authority for the benefit of another applicant if he can demonstrate that the food or feed for which he is seeking authorisation is essentially similar to a food or feed already authorised under this Regulation.

Article 33

Community reference laboratory

The Community reference laboratory and its duties and tasks shall be those laid down in the Annex.

National reference laboratories may be established in accordance with the procedure laid down in Article 36 (2).

Detailed rules for implementing this Annex and any changes to it may be adopted in accordance with the procedure laid down in Article 36 (2).

Article 34

Consultation with the European Group on Ethics in Science and New Technologies

1.  The Commission, on its own initiative or at the request of a Member State, may consult the European Group on Ethics in Science and New Technologies established by the Commission Decision of 16 December 1997, with a view to obtaining its opinion on ethical issues.

2.  The Commission shall make available to the public the opinions of the European Group on Ethics in Science and New Technologies.

Article 35

Emergency measures

1.  Where a Member State, as a result of new information or a reassessment of existing information, has detailed grounds for considering that the use of a food or feed authorised in accordance with this Regulation endangers human health, animal health or the environment, it may provisionally restrict or prohibit the use and/or sale of the food or feed on its territory, as well as suspending or otherwise restricting the import thereto or export therefrom of the food or feed in question until a final decision is taken in accordance with Article 11 or Article 23, as appropriate.

2.  Member States shall ensure that, in the event of a severe risk, emergency measures, such as suspension or termination of the placing on the market, shall be applied, including information to the public. The Member State shall immediately inform the Commission, the Authority and the other Member States of actions taken under this Article and give reasons for its decision and the new information or new assessment on which its decision is based, indicating whether and how the conditions of the consent should be amended or the consent should be terminated. A decision on this shall be taken within three months in accordance with the procedure laid down in Article 36(3).

Article 36

Implementing powers of the Commission

1.  The Commission shall be assisted by the Committee referred to in Article 58(1) of Regulation (EC) No 178/2002.

2.  When reference is made to this paragraph, the regulatory procedure laid down in Article 5 of Decision 1999/468/EC shall apply, in compliance with Article 7 and Article 8 thereof. The period provided for in Article 5 (6) of Decision 1999/468/EC shall be three months.

3.  When reference is made to this paragraph, the safeguard procedure laid down in Article 6 of Decision 1999/468/EC shall apply, in compliance with Article 7 and Article 8 thereof. Any Member State may refer the Commission's decision to the Council within 15 days from the receipt of the notification of this decision, in which case the Council, acting by a qualified majority, may take a different decision within one month from the date of referral to the Council.

Article 37

Repeals

The following Regulations are repealed with effect from the date of application of this Regulation:

   - Regulation (EC) No 1139/98;
   - Regulation (EC) No 49/2000;
   - Regulation (EC) No 50/2000.

Article 38

Amendments to Regulation (EC) No 258/97

"

"By way of derogation from paragraph 2, the procedure laid down in Article 5 shall apply to foods or food ingredients referred to in Article 1 (2) (d) and (e) which, on the basis of the scientific evidence available and generally recognised or on the basis of an opinion delivered by one of the competent bodies referred to in Article 4 (3), are substantially equivalent to existing foods or food ingredients as regards their composition, nutritional value, metabolism, intended use and the level of undesirable substances contained therein."

"

Regulation (EC) No 258/97 is amended with effect from the date of application of this Regulation as follows:

  (1) The following provisions are deleted:
   - Article 1 (2) (a) and (b),
   - Article 3 (2) second paragraph and (3),
   - Article 8 (1) (d),
   - Article 9,
   (2) In Article 3, the first sentence of paragraph 4 is replaced by the following:

Article 39

Amendments to Directive 82/471/EEC

Directive 82/471/EEC is amended with effect from the date of application of this Regulation as follows:

The following paragraph is added to Article 1:

"

3.  "3. This Directive does not apply to products which act as direct or indirect protein sources that fall within the scope of European Parliament and Council Regulation (EC) No .../2002 of .... [on genetically modified food and feed]*.

______________________

* OJ L ..."

"

Article 40

Amendments to Directive 70/457/EEC

Directive 70/457/EEC is amended with effect from the date of application of this Regulation as follows:

(1)  Article 4 (5) is replaced by the following:

"

5.  "5. Further, when material derived from a plant variety is intended to be used in food falling within the scope of Article 3, or feed falling within the scope of Article 16 of European Parliament and Council Regulation (EC) No .../2002 of ...[on genetically modified food and feed]*, the variety shall only be accepted if it has been approved in accordance with that Regulation.

_____________________

* OJ L ..."

"

(2)  Article 7 (4) is replaced by the following:

"

4. a)  "4. (a) In the case of a genetically modified variety as referred to in Article 4(4) an environmental risk assessment equivalent to that laid down in European Parliament and Council Directive 2001/18/EC of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC* shall be carried out.

(b)  Pending the entry into force of a European Parliament and Council Regulation, referred to in Article 12(3) of Directive 2001/18/EC, laying down the procedures ensuring that the risk assessment, requirements regarding risk management, labelling, monitoring as appropriate, information to the public and safeguard clause are equivalent to those laid down in Directive 2001/18/EC, genetically modified varieties shall only be accepted for inclusion in a national catalogue after having being accepted for placing on the market in accordance with Directive 2001/18/EC.

(c)  Articles 13 to 24 of Directive 2001/18/EC shall no longer apply to genetically modified varieties once the Regulation referred to in subparagraph (b) and a sectoral Council Regulation regulating genetically modified plant varieties, introduced on a proposal from the Commission based on the appropriate legal basis in the Treaty, have entered into force.

(d)  The technical and scientific details of the implementation of the environmental risk assessment shall be adopted in accordance with the procedure laid down in Article 40.

_________________

* OJ L 106, 17.4.2001, p. 1."

"

(3)  Article 7 (5) is replaced by the following:

"

5.  "5. Member States shall ensure that a variety intended to be used in food or feed as defined in Articles 2 and 3 of European Parliament and Council Regulation (EC) No 178/2002 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*, is accepted only if it has been authorised under the relevant legislation.

____________________

* OJ L 31, 1.2.2002, p. 1."

"

Article 41

Amendments to Directive 70/458/EEC

Directive 70/458/EEC is amended with effect from the date of application of this Regulation as follows:

(1)  Article 4 (3) is replaced by the following:

"

3.  "3. Further, when material derived from a plant variety is intended to be used in food falling within the scope of Article 3, or feed falling within the scope of Article 16 of European Parliament and Council Regulation (EC) No .../2002 of ... [on genetically modified food and feed]*, the variety shall only be accepted if it has been approved in accordance with that Regulation.

_________________

* OJ L ..."

"

(2)  Article 7 (5) is replaced by the following:

"

5.  "5. Member States shall ensure that a variety intended to be used in food or feed as defined in Articles 2 and 3 of European Parliament and Council Regulation (EC) No 178/2002 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*, is accepted only if it has been authorised pursuant to Regulation (EC) No 258/97 for food or Directive 90/220/EEC or Directive 2001/18/EC for feed or Regulation (EC) No .../2002 [on genetically modified food and feed].

________________

* OJ L 31, 1.2.2002, p. 1."

"

Article 42

Information to be provided in accordance with the Cartagena Protocol on Biosafety

1.  Any authorisation or renewal, modification, suspension or revocation of authorisation of a genetically modified organism, food or feed referred to in Article 3 (1) (b) and Article 16 (1) (b) shall be notified by the Commission to the Parties to the Cartagena Protocol on Biosafety through the Biosafety Clearing-House in accordance with Article 11 (1) or Article 12 (1), as the case may be, of the Cartagena Protocol on Biosafety.

The Commission shall provide a copy of the information, in writing, to the national focal point of each Party that informs the Secretariat in advance that it does not have access to the Biosafety Clearing-House.

2.  The Commission shall also process requests for additional information made by any Party in accordance with Article 11 (3) and will provide copies of the laws, regulations and guidelines in accordance with Article 11 (5) of the Cartagena Protocol on Biosafety.

Article 43

Penalties

Member States shall lay down the rules on penalties applicable to infringements of the provisions of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided for must be effective, proportionate and dissuasive. Member States shall notify those provisions to the Commission by [six months after the date of publication of this Regulation] at the latest and shall notify it without delay of any subsequent amendment affecting them.

Article 44

Transitional measures

1.  Requests submitted under Article 4 of Regulation (EC) No 258/97 before the entry into force of this Regulation shall be transformed into applications under Chapter II, Section 1 of this Regulation where the initial assessment report provided for under Article 6 (3) of Regulation (EC) No 258/97 has not yet been forwarded to the Commission, as well as in all cases where an additional assessment report is required in accordance with Article 6 (3) or (4) of Regulation (EC) No 258/97.

2.  Applications which have been made concerning the placing on the market of GMOs pursuant to Directive 2001/18/EC or Regulation (EC) No 258/97, in relation to which the assessment procedure has not yet been completed on the date of entry into force of this Regulation, shall be subject to the following procedure:

   - applicants shall supplement their applications within six months of the entry into force of this Regulation in the light of the requirements thereof and shall submit this information to the Authority;
   - the Authority shall deliver an opinion pursuant to Article 7 and/or Article 19;
   - the Community authorisation shall be granted pursuant to Article 8 and/or Article 20.

These products shall be subject to all other provisions of this Regulation.

3.  For a period of not more than 12 months following the date of application of this Regulation, the labelling requirements laid down therein shall not apply to products which have been lawfully manufactured and labelled in the Community, or which have been lawfully imported into the Community and put into circulation, before the aforementioned date.

4.  Notifications concerning products including use as feed submitted under Article 13 of Directive 2001/18/EC before the entry into force of this Regulation shall be transformed into applications under Chapter III, Section 1 of this Regulation where the assessment report provided for under Article 14 of Directive 2001/18/EC has not yet been sent to the Commission.

5.  Requests submitted for products referred to in Article 16 (1) (c) under Article 7 of Directive 82/471/EEC before the entry into force of this Regulation shall be transformed into applications under Chapter III, Section 1 of this Regulation.

6.  Requests submitted for products referred to in Article 16 (1) under Article 4 of Directive 70/524/EEC before the entry into force of this Regulation shall be complemented by applications under Chapter III, Section 1 of this Regulation.

Article 45

Review

1.  No later than two years from the date of entry into force of this Regulation and in the light of experience gained, the Commission shall forward to the European Parliament and to the Council a report on the implementation of this Regulation accompanied, where appropriate, by any suitable proposal. The report and any proposal shall be made accessible to the public.

2.  Notwithstanding the review provided for in paragraph 1, the Commission shall monitor the application of this Regulation and its impact on human and animal health, consumer protection, consumer information and the functioning of the internal market and, if necessary, will bring forward proposals at the earliest possible date.

Article 46

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 Communities.

It shall apply from [six months after the date of publication of this Regulation].

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

(1) OJ C 304 E, 30.10.2001, p. 221.
(2) OJ C
(3) OJ C
(4) Position of the European Parliament of 3 July 2002.
(5) OJ L 43, 14.2.1997, p. 1.
(6) OJ L 117, 8.5.1990, p. 15.
(7) OJ L 106, 17.4.2001, p. 1.
(8) OJ L 31, 1.2.2002, p. 1.
(9) OJ L 40, 11.2.1989, p. 27. Directive as last amended by Directive 94/34/EC (OJ L 237, 10.9.1994, p. 1).
(10) OJ L 184, 15.7.1988, p. 61.
(11) OJ L 213, 21.7.1982, p. 8. Directive as last amended by Directive 1999/20/EC (OJ L 80, 25.3.1999, p. 20).
(12) OJ L 270, 14.12.1970, p. 1. Directive as last amended by Directive 1999/20/EC .
(13) OJ L 109, 6.3.2000, p. 29
(14) OJ L 159, 3.6.1998, p. 4. Regulation as last amended by Regulation (EC) No 49/2000 (OJ L 6, 11.1.2000, p. 13).
(15) OJ L 6, 11.1.2000, p. 15.
(16) OJ L
(17) OJ L 184, 17.7.1999, p. 23.
(18) OJ Special Edition, Series III, Chapter 1966-1972, p. 31.
(19) OJ Special Edition, Series I, Chapter 1970(III), p. 674.
(20) OJ L 126, 13.5.1983, p. 23.
(21) OJ L 125, 23.5.1996, p. 35.
(22) OJ L 86, 6.4.1979, p. 30. Directive as last amended by European Parliament and Council Directive 2002/2/EC (OJ L 63, 6.3.2002, p. 23).


ANNEX

Duties and Tasks of the Community reference laboratory

1.  The Community reference laboratory referred to in Article 33 is the Commission's Joint Research Centre.

2.  For the tasks outlined in this Annex, the Commission's Joint Research Centre shall be assisted by a consortium of national reference laboratories, which will be referred to as the "European Network of GMO laboratories".

3.  The Community reference laboratory shall be notably responsible for:

   - reception, preparation, storage and maintenance of the appropriate positive and negative control samples;
   - testing and validation of the method for detection, including sampling and identification of the transformation event and, where applicable, the detection and identification of the transformation event in the food or feed;
   - evaluating the data provided by the applicant for authorisation for placing the food or feed on the market, for the purpose of testing and validation of the method for sampling and detection;
   - submitting full evaluation reports to the Authority.

4.  The Community reference laboratory shall play a role in disputes settlements between Member States concerning the results of the tasks outlined in this Annex.

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