7 June 2002 [455 kb] [417 kb] FINAL A5-0225/2002 ***I REPORT on the proposal for a European Parliament and Council regulation on genetically modified food and feed (COM(2001) 425 – C5‑0368/2001 – 2001/0173(COD)) Committee on the Environment, Public Health and Consumer Policy Rapporteur: Karin Scheele 314.354

CONTENTS PROCEDURAL PAGE DRAFT LEGISLATIVE RESOLUTION EXPLANATORY STATEMENT OPINION OF THE COMMITTEE ON LEGAL AFFAIRS AND THE INTERNAL MARKET OPINION OF THE COMMITTEE ON AGRICULTURE AND RURAL DEVELOPMENT

Symbols for procedures *   Consultation procedure majority of the votes cast **I   Cooperation procedure (first reading) majority of the votes cast **II   Cooperation procedure (second reading) majority of the votes cast, to approve the common position majority of Parliament’s component Members, to reject or amend the common position ***   Assent procedure majority of Parliament’s component Members except in cases covered by Articles 105, 107, 161 and 300 of the EC Treaty and Article 7 of the EU Treaty ***I   Codecision procedure (first reading) majority of the votes cast ***II   Codecision procedure (second reading) majority of the votes cast, to approve the common position majority of Parliament’s component Members, to reject or amend the common position ***III   Codecision procedure (third reading) majority of the votes cast, to approve the joint text (The type of procedure depends on the legal basis proposed by the Commission) Amendments to a legislative text In amendments by Parliament, amended text is highlighted in bold italics. Highlighting in normal italics is an indication for the relevant departments showing parts of the legislative text for which a correction is proposed, to assist preparation of the final text (for instance, obvious errors or omissions in a given language version). These suggested corrections are subject to the agreement of the departments concerned.

PROCEDURAL PAGE By letter of 30 July 2001 the Commission submitted to Parliament, pursuant to Article 251(2) and Articles 37, 95 and 152(4) of the EC Treaty, the proposal for a European Parliament and Council regulation on genetically modified food and feed (COM(2001) 425 - 2001/0173 (COD)). At the sitting of 3 September 2001 the President of Parliament announced that he had referred this proposal to the Committee on the Environment, Public Health and Consumer Policy as the committee responsible and the Committee on Legal Affairs and the Internal Market and the Committee on Agriculture and Rural Development for their opinions (C5‑0368/2001). The Committee on the Environment, Public Health and Consumer Policy appointed Karin Scheele rapporteur at its meeting of 13 September 2001. The committee considered the Commission proposal and draft report at its meetings of 16 April, 22 May and 4 June 2002. At the last meeting it adopted the draft legislative resolution by 28 votes to 22, with 2 abstentions. The following were present for the vote: Caroline F. Jackson, chairman; Alexander de Roo, vice-chairman; Karin Scheele, rapporteur; Per-Arne Arvidsson, María del Pilar Ayuso González, David Robert Bowe, John Bowis, Martin Callanan, Dorette Corbey, Chris Davies, Véronique De Keyser (for María Sornosa Martínez), Jillian Evans (for Hiltrud Breyer), Anne Ferreira, Christel Fiebiger (for Laura González Álvarez), Francesco Fiori (for Raffaele Costa), Marialiese Flemming, Karl-Heinz Florenz, Cristina García-Orcoyen Tormo, Robert Goodwill, Cristina Gutiérrez Cortines, Jutta D. Haug (for Catherine Stihler), Anneli Hulthén, Karin Jöns, Christa Klaß, Eija-Riitta Anneli Korhola, Hans Kronberger, Bernd Lange, Paul A.A.J.G. Lannoye (for Marie Anne Isler Béguin), Peter Liese, Torben Lund, Jules Maaten, Minerva Melpomeni Malliori, Helmuth Markov (for Pernille Frahm), Jorge Moreira da Silva, Emilia Franziska Müller, Rosemarie Müller, Riitta Myller, Ria G.H.C. Oomen-Ruijten, Neil Parish (for Avril Doyle), Béatrice Patrie, Frédérique Ries, Didier Rod (for Patricia McKenna), Dagmar Roth-Behrendt, Guido Sacconi, Inger Schörling, Ilka Schröder (for Mihail Papayannakis), Jonas Sjöstedt, Renate Sommer (for Françoise Grossetête), Marianne L.P. Thyssen (for Horst Schnellhardt), Antonios Trakatellis, Elena Valenciano Martínez-Orozco and Kathleen Van Brempt. The opinions of the Committee on Legal Affairs and the Internal Market and the Committee on Agriculture and Rural Development are attached. The report was tabled on 7 June 2002. The deadline for tabling amendments will be indicated in the draft agenda for the relevant part-session.

DRAFT LEGISLATIVE RESOLUTION European Parliament legislative resolution on the proposal for a European Parliament and Council regulation on genetically modified food and feed (COM(2001) 425 – C5‑0368/2001 – 2001/0173(COD)) (Codecision procedure: first reading) The European Parliament, –   having regard to the Commission proposal to the European Parliament and the Council and the amendments to the proposal (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. Text proposed by the Commission Amendments by Parliament Amendment 1 Recital 2 a (new)     (2a)   The precautionary principle must be taken into account in implementing this regulation. In special cases where the risk to health or the environment is scientifically uncertain, the precautionary principle provides a basis for determining risk management measures or other measures to safeguard the high level of protection of health which has been opted for in the Community. Justification Both in the Commission’s communication 2000/1 of 2 February 2000 on the precautionary principle and in Regulation 2002/178 laying down the general principles of food law (Article 6(3), Article 7 and Recitals 20 and 21), this new approach to European food policy is stressed, and the precautionary principle is also expressly provided for in Directive 2001/18/EC (Articles 1 and 4 and Annex II). Accordingly, the precautionary principle should also have a place in this proposal for a regulation. Amendment 2 Recital 3 (3)   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.   (3)   In order to protect human and animal health, food and feed consisting of, containing or produced from or with the aid of 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. (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.) Justification Consumers may not object to the use of genetically modified organisms in the production of foods solely out of fears for their personal health or that of their families. There are a wide range of reasons why they may not wish to purchase products in the processing of which GMOs have been used. These include religious, ethical and environmental reasons: followers of certain religions may object to any use of pig products, strict vegetarians to any use of animal products, and so on. For some, therefore, the actual presence or otherwise of GMOs in the final product is not the issue. As it is in all of our interests to respect the diversity and multicultural nature of our European societies, it is imperative that all of these consumers should have the right to make an informed choice on the basis of their beliefs. Amendment 3 Recital 4a (new)     (4 a) 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. Justification Self-explanatory. Amendment 4 Recital 9 (9)   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.   (9)   Experience has shown that authorisation must 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. Justification Intended to strengthen the provisions. Amendment 5 Recital 13 (13)   Council Directive 82/471/EEC of 30 June 1982 concerning certain products used in animal nutrition, as last amended by Council Directive 1999/20/EC, 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 containing, consisting of or produced from GMOs should fall instead under the scope of this Regulation.   (13)   Council Directive 82/471/EEC of 30 June 1982 concerning certain products used in animal nutrition, as last amended by Council Directive 1999/20/EC, 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 containing, consisting of or produced from GMOs must fall instead under the scope of this Regulation. Justification Intended to strengthen the provisions. Amendment 6 Recital 15 (15)   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 modified medicinal products will be subject neither to the authorisation requirements, nor to the labelling requirements laid down in this Regulation.   (15)   This Regulation covers food and feed produced “from” a GMO and 'with the aid of a GMO', as well as food obtained from animals which at a certain stage were fed with feed labelled in accordance with the provisions of this Regulation. The provisions set out in this Regulation shall apply regardless of whether or not the GMO is present in the final food or feed product. Processing aids as defined in Council Directive 89/107/EEC, which are used during the food or feed production process, come within the scope of this Regulation. Similarly, food and feed produced with the aid of a genetically modified processing aid shall be included. In this way, food produced with a genetically modified enzyme which does not remain in the final product and products obtained from animals fed with genetically modified feed or feed obtained with the aid of a GMO, or treated with genetically modified medicinal products, shall be subject to the authorisation and labelling requirements laid down in this Regulation. Justification The proposal for a regulation under consideration must not concentrate exclusively on regulating the traceability of GMOs and food and feed obtained from them, but must also consider food and feed obtained with a GMO. In fact, an enzyme, like any other molecule which accelerates the chemical process of transformation, plays an active role in all the various chemical and molecular reactions which the production of the food product entails and hence the principle of substantial equivalence of two end products cannot be applied, if one is obtained in a natural manner and the other with a GMO, because in any event they are unnatural substances for which at present there is no experimental evidence that they may lead to the production of identical foodstuffs, either organoleptically or as regards taste, flavour, etc. It is therefore fair that the rules on labelling and traceability of GMOs should also apply to products obtained with a GMO. The whole structure of the proposal for a regulation should therefore be revised in the light of this amendment to the recital. Amendment 7 Recital 19 (19)   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.   (19)   Harmonised labelling requirements must 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. Justification Intended to strengthen the provisions. Amendment 8 Recital 24 (24)   In order to establish that the presence of this material is adventitious or technically unavoidable, operators must be in a position to demonstrate to the competent authorities that they have taken appropriate steps to avoid the presence of the genetically modified food or feed.   (24)   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. Justification Strengthens the obligation on operators. Amendment 9 Recital 25 (25)   In order to ensure the practicability and feasibility of this Regulation, a threshold of 1 %, with the possibility of establishing lower levels, should be established for minute traces in food or feed of genetically modified material not authorised under Community legislation, where the presence of such material is adventitious or technically unavoidable; Directive 2001/18/EC should be amended accordingly.   (25)   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; Article 21(2) of Directive 2001/18/EC lays down the possibility of setting maximum thresholds. Justification Under Article 21(2) of Directive 2001/18/EC, a maximum threshold may be introduced for ‘products where adventitious or technically unavoidable traces of authorised GMOs cannot be excluded’. Similarly, Commission Regulation (EC) No 49/2000 of 10 January 2000 fixes a threshold of 1% only for authorised food produced from ingredients produced from authorised GMOs or containing such ingredients. In contrast, the maximum threshold put forward in Article 5 of the proposal applies to non-authorised products. A threshold for non-authorised GMOs and for products produced from non-authorised GMOs would undermine all the European Union’s legislation on biosafety. Amendment 10 Recital 25a (new)     (25a)   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 contamination by genetically modified organisms. Justification With a view to safeguarding the supply of non-genetically modified foodstuffs and, thereby, consumer choice, many food operators have already introduced effective traceability and segregation systems aimed at avoiding the risk of adventitious contamination by genetically modified organisms. Guides to good segregation practice based on an analysis of risks at all stages in the food chain, from seed supplier to distributor, have been drawn up and introduced by trade associations. Encouragement should be given to such guides (along the lines of the guides to good hygiene practice developed pursuant to the 1993 directive on food hygiene) aimed at operators wishing to remain below the threshold for adventitious contamination by GMOs. Amendment 11 Recital 29 (29)   Risks to the environment may be associated with foods and feed which contain or consist of 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.   (29)   Risks to the environment may be associated with foods and feed which contain or consist of 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. Food and feed which also fall within the scope of Directive 2001/18/EC may be authorised only if approval for placing on the market has previously been granted in accordance with Directive 2001/18/EC. In so far as the regulation has the status in future of ‘sectoral legislation’ within the meaning of the first sentence of Article 12(3) of Directive 2001/18/EC, the Commission will propose a regulation of the European Parliament and of the Council in accordance with these provisions. Pending the entry into force of that regulation, any GMOs as or in products, in so far as they are authorised by the provisions of this regulation, may be placed on the market only after having been accepted for placing on the market in accordance with Directive 2001/18/EC (third sentence of Article 12(3) of Directive 2001/18/EC). Justification This is not a sectoral directive, and cannot therefore be treated as such. It is also necessary to ensure that the provisions of Directive 2001/18/EC, which were adopted following a lengthy and complicated conciliation procedure between Parliament and the Council last year, are not undermined by this regulation. The consistency of European legislation must be ensured. Amendment 12 Recital 34 (34)   A register of genetically modified food and feed authorised under this Regulation shall be established, including product specific information, studies which demonstrate the safety of the product, and sampling and detection methods; non-confidential data should be made available to the public.   (34)   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. Justification Any study may be useful, but only independent, peer-reviewed studies should be accepted by legislators and public authorities as reliable indicators. Amendment 13 Article 1, introductory part The objective of this Regulation is:   The objective of this Regulation, in accordance with the precautionary principle, is: Justification This new approach to European Food Policy is stressed both in Commission communication COM(2000) 0001 of 2 February 2000 on the precautionary principle and in Regulation 178/2002 laying down the general principles of food law (Article 7(3), Article 7, and recitals 20 and 21); and the precautionary principle is also expressly enshrined in Directive 2001/18/EC (Articles 1 and 4, and Annex II). For that reason, the precautionary principle should also be enshrined in this proposal for a regulation. Amendment 14 Article 1, point (ca) (new)     (ca)   to prevent the unintended presence of material consisting of, containing or produced from GMOs in food and feed. Justification The need to respect consumers' and producers' freedom of choice means that measures must be taken to ensure the co-existence of GM production and Non-GM production. The amendment is in line with Action 17 of the Commission Communication 'Life Sciences and biotechnology - A Strategy for Europe' (COM(2002) 27) which calls for 'agronomic and other measures to ensure the viability of conventional and organic farming and their sustainable coexistence with genetically modified crops'. Amendment 15 Article 2, point 2 (2)   the definitions of 'organism', 'genetically modified organism' ('GMO'), 'deliberate release' and 'environmental risk assessment' laid down in Directive 2001/18/EC 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; this Regulation shall not apply to organisms which have been genetically modified using a technique or method referred to in Annex I B to Directive 2001/18/EC; Justification Article 2(2) of Directive 2001/18 defines ‘GMO’. Article 3(1) of the Directive explicitly excludes from its scope organisms obtained through the techniques of genetic modification listed in Annex I B. In the interests of legal certainty and consistency, the definitions applicable in the fields of traceability and labelling in Directive 2001/18 and in this Regulation must be coherent. Amendment 16 Article 2, paragraph 3 (3)   'genetically modified food or feed' means food or feed containing, consisting of or produced from genetically modified organisms;   (3)   'genetically modified food' means food containing, consisting of or produced from genetically modified organisms;     (3a)   'genetically modified feed' means feed containing, consisting of or produced from genetically modified organisms; Justification Clarification of the text, in particular through reference to genetically modified organisms within the meaning of the definition laid down in Directive 2001/18/EC and to the exemption of certain GMOs from the scope of the provisions in accordance with Annex I B of the directive. Amendment 17 Article 2, paragraph 4 (4)   'Genetically modified organisms for food use' means a genetically modified organism which is not exempted from the application of Directive 2001/18/EC and that may be used as food or as a source material for the production of food;   (4)   '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; Justification Article 2(4) of this regulation assumes that certain GMOs can be exempted from the authorisation requirement under Directive 2001/18/EC. There is no such exemption possibility, however, nor should it be possible to introduce one. Amendment 18 Article 2, paragraph 5 (5)   'Genetically modified organisms for feed use' means a genetically modified organism which is not exempted from the application of Directive 2001/18/EC and that may be used as feed or as a source material for the production of feed;   (5)   '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; Justification Article 2(5) of this regulation assumes that certain GMOs can be exempted from the authorisation requirement under Directive 2001/18/EC. There is no such exemption possibility, however, nor should it be possible to introduce one. Amendment 19 Article 2, paragraph 7 (7)   'Control sample' means the genetically modified organism or its genetic material (positive sample) or the parental organism or its genetic material that has been used for the purpose of the genetic modification (negative sample);   (7)   '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); Justification The parental organism or its genetic material used for the purpose of the genetic modification refers to the negative sample, and the wording must therefore make a clear distinction between it and the positive control sample. Amendment 20 Article 2, paragraph (7a) (new)     (7a)   '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, feeds containing, consisting of or produced from genetically modified organisms. Justification The term 'final consumer' needs to be defined in the regulation. Amendment 21 Article 3, paragraph 1, point (ca) (new)     (ca)   food derived from animals fed at any stage with feed consisting of GMOs, containing GMOs, produced from them or containing such ingredients, provided that the feed is labelled in accordance with this Regulation. Justification The current practice of many operators clearly shows that consumers wish to know whether animal products offered for human consumption stem from animals fed on genetically modified feed. The regulation should therefore enable operators and consumers to exercise their freedom of choice also with regard to such products. Consequently, the regulation should require a pre-marketing approval for products derived from animals fed on GM feed and should make the labelling of such products obligatory. Amendment 22 Article 3, paragraph 2 2.   Where necessary, it may be determined in accordance with the procedure laid down in Article 36 (2) whether a type of food falls within the scope of this Section.   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. Justification Clarifies the grounds for amending the scope of the text through the commitology procedure, and specifies that the regulatory committee cannot decide to exclude a food from the scope of the provisions if it was originally included. Amendment 23 Article 4, paragraph 1, indent 1 -   present a risk for human health or the environment,   -   present a danger to human health or the environment, Justification There is no such thing as zero risk; alternative wording is consistent with that used in Regulation (EC) 258/97, concerning novel foods. Amendment 24 Article 4, paragraph 4 4.   The authorisation referred to in paragraph 2 may cover: -   a genetically modified organism and foods containing or consisting of that genetically modified organism as well as foods 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.   4.   The authorisation referred to in paragraph 2 may cover: -   foods containing or consisting of genetically modified organisms as well as foods produced from such genetically modified organisms, 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, or -   food derived from animals fed at any stage with feed consisting of, containing or produced from GMOs, provided the feed is labelled in accordance with this regulation. Justification The amendment clarifies that marketing approvals granted under this regulation shall be without prejudice to Community law which addresses aspects other than food safety. Amendment 25 Article 5 Adventitious or technically unavoidable presence of genetically modified material   Deleted The presence in food of material which contains, consists of or is produced from genetically modified organisms in a proportion no higher than 1 % or lower thresholds established in accordance with the procedure laid down in Article 36 (2), shall not be considered to be in breach of Article 4 (2), provided that this presence is adventitious or technically unavoidable and that the genetically modified material has been subject to a scientific risk assessment made by the relevant Scientific Committee(s) or the European Food Authority, which concludes that this material does not present a risk for human health or the environment.     In order to establish that the presence of this material is adventitious or technically unavoidable, operators must be in a position to demonstrate to the competent authorities that they have taken appropriate steps to avoid the presence of the genetically modified organisms (or produce thereof).     Justification The threshold provided for in Article 5 applies to non-authorised GMOs. Such a threshold undermines the European Union's legislation on biosafety. Under Article 21(2) of Directive 2001/18/EC, a maximum threshold may be introduced for 'products where adventitious or technically unavoidable traces of unauthorised GMOs cannot be excluded'. The threshold for food produced from GMOs authorised in the Community is regulated in new Article 13a(1). Amendment 26 Article 6, paragraph 2 2.   The Authority shall acknowledge receipt of the application, in writing, to the applicant within 15 days of its receipt. The acknowledgement shall state the date of receipt of the application.   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. Justification References to time periods are made variously to “X days”, or “Y months”. Time periods should be described consistently and should, ideally, specify whether the number of days is absolute or “working” days, and in accordance with which Member State’s calendar of Bank Holidays. Amendment 27 Article 6, paragraph 3, point (ba) (new)     (ba)   in the case of GMOs for food use, food containing or consisting of GMOs and in accordance with article 14.3 of directive 2001/18, the assessment report indicating the GMO in question may be placed on the market; Justification For simplification, this addition to Article 6(b) replaces the provisions of Article 6.5, which can be deleted, as these provisions are covered by the authorisation under Directive 2001/18/EC on deliberate release to the environment. Amendment 28 Article 6, paragraph 3, point (e) (e)   a copy of the 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);   (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); Justification Any study may be useful, but only independent, peer-reviewed studies should be accepted by legislators and public authorities as reliable indicators. Amendment 29 Article 6, paragraph 3, point (ga (new)     (ga)   a proposal for the labelling of the food or foods produced from it accordance with Article 14(1); Justification It is appropriate to have the applicant comment on the type of labelling, in particular as, under Article 7(5)(d) of the regulation, the European Food Safety Authority is expected to provide a labelling proposal. Amendment 30 Article 6, paragraph 3, point (ja) (new)     (ja)   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; Justification The EFSA and the competent authorities of the Member States (or monitoring laboratories) need this information in order to enforce the legislation, but operators also need it in order to be able to monitor and keep a check on their own supplies. Ready access to the applicant’s samples or reference material is also important to operators in the EU for use in their own checks. Amendment 31 Article 6, paragraph 3, point 1 (1)   a summary of the dossier.   (1)   a summary of the dossier in a standardised form. Justification Standardised guidelines serve to make it easier to handle dossiers. Amendment 32 Article 6, paragraph 4 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 containing, consisting of or produced from the GMO in respect of which an application is made.   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 containing, consisting of, or produced from the GMO in respect of which an application is made or derived from animals fed with feed consisting of, containing or produced from GMOs if the feed is labelled in accordance with this regulation. Justification The Regulation should require pre-marketing approval of food derived from animals which have been fed with GMOs 'Food' should therefore also refer to such animal products. Amendment 33 Article 6, paragraph 5 5.   In the case of genetically modified organisms or foods containing or consisting of genetically modified organisms, the application shall also be accompanied by:   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 or, where the placing on the market of the genetically modified organism has been authorised under part C of Directive 2001/18/EC, a copy of the authorisation decision;   (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.   (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. In such case, Articles 13 to 24 of Directive 2001/18/EC shall not apply.   Deleted Justification In the case of products simply produced from GMOs but containing no GMOs, too, the documents for the GMO authorisation procedure under Directive 2001/18/EC should be examined by the competent authorities. That is the purpose of the proposed amendments in the introductory clause and subparagraph (a). Furthermore, the regulation should not replace Directive 2001/18/EC, but, rather, complement it. Amendment 34 Article 6, paragraph 7 7.   The Commission, having first consulted the Authority, may establish, in accordance with the procedure laid down in Article 36 (2), implementing rules for the application of this Article.   7.   The Commission, having first consulted the Authority and the competent national offices under 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. Justification An optional provision must be avoided at all costs so as to counter the risk of a legal vacuum. Amendment 35 Article 6, paragraph 8 8.   The Authority shall publish detailed guidance concerning the preparation and the presentation of the application.   8.   Before the entry into force of this Regulation, the Authority shall publish detailed guidance concerning the preparation and the presentation of the application. Justification Detailed guidance should be in place before the adoption of the Regulation to assist the application process. Amendment 36 Article 6a (new)     Article 6a 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 the risk of adventitious or technically unavoidable contamination of food by genetically modified material. Justification With a view to safeguarding the supply of non-genetically modified foodstuffs and, thereby, consumer choice, many food operators have already introduced effective traceability and segregation systems aimed at avoiding the risk of adventitious contamination by genetically modified organisms. Guides to good segregation practice based on an analysis of risks at all stages in the food chain, from seed supplier to distributor, have been drawn up and introduced by trade associations. Encouragement should be given to such guides (along the lines of the guides to good hygiene practice developed pursuant to the 1993 directive on food hygiene) aimed at operators wishing to remain below the threshold for adventitious contamination by GMOs. Amendment 37 Article 7, paragraph 2 a (new)     2a.   The Authority shall within 15 days of its receipt forward the application 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. Justification It is essential that the Authority makes full use of the capacity and expertise of the competent authorities of the Member States. Amendment 38 Article 7, paragraph 3, subparagraph (c) (c)   shall make the summary of the dossier mentioned in Article 6 (3) (l) available to the public;   (c)   shall make the summary of the dossier mentioned in Article 6(3)(l) 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; Justification Only access to the complete dossier will enable the public to make an informed judgment. Information which, if circulated, could harm an applicant’s competitive position, must be treated confidentially, however (see also Article 31, Confidentiality). Amendment 39 Article 7, paragraph 3, subparagraph (e) (e)   may ask a competent authority designated in accordance with Article 4 of Directive 2001/18/EC to carry out an environmental risk assessment;   (e)   shall take account of the results of the environmental risk assessment under Directive 2001/18/EC; Justification Necessary environmental risk assessments (ERAs) must continue to be carried out by the competent authorities under Directive 2001/18/EC. The European Food Safety Authority should be called in an advisory capacity. Amendment 40 Article 7, paragraph 3, point (ea) (new)     (ea)   shall ask the appropriate human and animal health risk assessment body of the Member State in which the person applying for authorisation is established to carry out a human and animal health risk assessment, and shall take due account of the findings of the assessment; Justification As with assessments of the environmental risks of GMOs, the Authority should take due account of the findings of human and animal health risk assessments carried out by the relevant bodies. Amendment 41 Article 7, paragraph 3, subparagraph (f) (f)   shall forward to the Community reference laboratory referred to in Article 33 the particulars referred to in Article 6 (3) (h) and (i) and shall ask it to test and validate the method of detection and identification proposed by the applicant;   (f)   shall forward to the Community reference laboratory referred to in Article 33 the particulars referred to in Article 6 (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; Justification Testing and validating detection procedures are the Community laboratory's task. The wording ‘shall ask it’ is therefore too weak and unclear. Amendment 42 Article 7, paragraph 4 4.   In the case of genetically modified organisms or food containing or consisting of genetically modified organisms falling within the scope of this Section, the evaluation shall respect the environmental safety requirements laid down in Directive 2001/18/EC 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 containing or consisting of genetically modified organisms, the necessary consultations shall be held by the Authority with the bodies set up by the Community and/or the Member States in accordance with Directive 2001/18/EC.   4.   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 containing or consisting of genetically modified organisms, the Authority shall give the Commission and the competent national bodies under Directive 2001/18/EC a decisive role along similar lines to the provisions in Directive 2001/18/EC. Justification In general, appraisals of the deliberate release of genetically modified organisms must be made in accordance with Directive 2001/18/EC. The competent national bodies under Directive 2001/18/EC must be involved in a decisive way in evaluating applications for placing on the market. Amendment 43 Article 7, paragraph 5, point (e) (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;   (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 or foods produced from it in other products; Justification The need to respect consumers' and producers' freedom of choice means that measures must be taken to ensure the co-existence of GM production and Non-GM production. The amendment is in line with Action 17 of the Commission Communication 'Life Sciences and biotechnology - A Strategy for Europe' (COM(2002) 27) which calls for 'agronomic and other measures to ensure the viability of conventional and organic farming and their sustainable coexistence with genetically modified crops'. Amendment 44 Article 7, paragraph 5, subparagraph (f) (f)   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;   (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; Justification The EFSA and the competent authorities of the Member States (or monitoring laboratories) need this information in order to enforce the legislation, but operators also need it in order to be able to monitor and keep a check on their own supplies. Ready access to the applicant’s samples or reference material is also important to operators in the EU for use in their own checks. Amendment 45 Article 7, paragraph 5, point (g) a (new)     (ga)   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; Justification Ready access to the applicant’s samples or reference material is important to operators in the EU for use in their own checks and to test their supplies of raw materials for possible GMO origin. Amendment 46 Article 7, paragraph 6 6.   The Authority shall forward its opinion to the Commission, the Member States and the applicant, including a report describing its assessment of the food and stating the reasons for its opinion.   6.   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. Justification Given that the appropriate bodies in the two areas referred to have been consulted, it seems paradoxical for them not to receive a copy of the Authority's opinion. Amendment 47 Article 7, paragraph 7 7.   The Authority shall make its opinion public, after deletion of any information identified as confidential, in accordance with Article 31. The public may make comments to the Commission within 30 days from this publication.   7.   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 3 months from this publication. Reference shall be made to the possibility for the public to have access to the entire application, excluding confidential information. Justification To make an informed judgment, the public must have access to all significant documents relating to the authorisation procedure. In the process, the information which, if circulated, could harm the applicant’s competitive position, must be treated confidentially. Amendment 48 Article 8, paragraph 1 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 provide an explanation of the reasons for the differences.   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 be immediately made public. Justification Where the Commission's decision differs from the Authority's opinion, the Commission should state exactly why it took that decision. Amendment 49 Article 8, paragraph 2, new subparagraph     The draft decision shall also include the opinions of the authorities required to be consulted in accordance with Directive 2001/18/EC. Justification With a view to fully informing consumers, all aspects taken into account in drawing up the opinion of the Food Safety Authority must be incorporated into the authorisation. Amendment 50 Article 8, paragraph 3 3.   A final decision on the application shall be adopted in accordance with the procedure laid down in Article 36 (2).   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. Justification The decision must be transparent and comprehensible. Amendment 51 Article 8, paragraph 4 4.   The Commission shall without delay inform the applicant of the decision taken. The decision shall be published in the Official Journal of the European Communities.   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. Justification See justification to the amendment to Article 8(1). Amendment 52 Article 8, paragraph 5 5.   The authorisation granted in accordance with the procedure laid down in this Regulation shall be valid throughout the Community for 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.   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 and shall indicate how and where interested members of 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 the context of the decision on risk management and the outcome of the vote.. Justification Clarification of the text, with a view to avoiding any risk of conflicting with Article 11. The documents accessible to the public must include the opinions delivered by the local authorities. Amendment 53 Article 9, paragraph 1, point (b) (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.   (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. The Register entry shall also include the indication as to how and where the public can have access to the application dossier and information submitted subsequently, including the Authority’s assessment and, where applicable, opinions by national bodies and by the public, plus the issues discussed and results of votes in connection with risk management. Justification The product register provided for in Article 9 should also contain information on public bodies from which, where appropriate, product information can be obtained. Amendment 54 Article 9, paragraph 4 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. Such a measure may provide for a limited period of time within which existing stocks of the product may be used up.   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. Justification A product either presents a potential danger or it does not. If it does, or gives reasonable grounds for concern that it may do, then there can be no justification for delaying its withdrawal. Amendment 55 Article 10, paragraph 1 1.   After an authorisation has been issued in accordance with this Regulation, the authorisation-holder shall comply with any conditions or restrictions which have been imposed in the authorisation. Where post-market monitoring as referred to in Article 6 (3) (k) and Article 6 (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.   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 6 (3) (k) and Article 6 (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. Justification In order to provide maximum protection and ensure maximum clarity, all parties concerned and not only the authorisation-holder must bear responsibility for compliance with conditions attached to the authorisation. It is essential to ensure public accessibility, excluding confidential information, even after authorisation has been issued. Amendment 56 Article 10, paragraph 3 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.   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 and the Member States. The information forwarded shall be made accessible to the public. Justification Involvement of the Member States and the public must be ensured at all stages of the process of placing a product on the market. Amendment 57 Article 11, paragraph 1 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.   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 interested members of the public. Justification The authorisation-holder has a right to be informed of the intention to modify or revoke the authorisation. Even in the event of authorisation being revoked, suspended or modified, the Authority shall be obliged to communicate the fact to the local authorities. Amendment 58 Article 11, paragraph 2 2.   The Commission shall examine the opinion of the Authority as soon as possible and prepare a draft of the decision to be taken.   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. Justification Public accessibility must be ensured. Amendment 59 Article 11, paragraph 5 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.   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 and results of votes in connection with the risk management decision. Justification Public accessibility must be ensured. Amendment 60 Article 12, paragraph 2, point b (b)   a report on the results of the monitoring, if so specified in the authorisation;   (b)   a report on the results of the post‑market monitoring of the use of food for human consumption, if so specified in the authorisation in accordance with Article 6(3)(k) of this Regulation; Justification Clarification of the text. Amendment 61 Article 12, paragraph 2, point c (c)   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;   (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; Justification Intended to avoid a conflict between Article 10(3) and Article 12(2)(c) Amendment 62 Article 12, paragraph 4 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 period of authorisation of the product shall automatically be extended until the Commission takes a decision.   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 by one year. Justification Self-explanatory. Amendment 63 Article 13, paragraph 1, indent 2 a (new)     -   are derived from animals which have received feed which is labelled in accordance with the provisions of this regulation. Justification In order to ensure that consumers are informed and can choose freely, the labelling of GMO products must be as comprehensive as possible. Amendment 64 Article 13, paragraph 1 a (new)     1a.   This Section shall not apply to processing aids. Justification This amendment not only promotes enforceability and prevention of fraud, it also aims to prevent a situation in which practically all foods will have to be labelled and the labelling exercise does not achieve its aim of providing choice to consumers. Amendment 65 Article 13, paragraph 2, subparagraph 2 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 organisms (or produce thereof).   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 organisms (or produce thereof). The Commission shall draw up a list of criteria for determining these ‘appropriate steps’. Justification This is essential in order to ensure legal certainty for all parties concerned. Amendment 66 Article 13 a (new)     Article 13 a Adventitious or technically unavoidable presence of genetically modified material 1.   There shall not be any requirement to label in accordance with this section foods which contain 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. 2.   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 all appropriate steps to avoid the presence of genetically modified organisms (or products derived from them or obtained with the aid of a GMO). In cooperation with the Authority, the Member States and the local authorities, the Commission shall lay down appropriate measures to ensure that the utmost care is taken and to avoid contamination. Standard criteria for assessing ‘adventitious and technically unavoidable contamination’ shall be defined. Justification Under Article 21(2) of Directive 2001/18/EC, a threshold may be introduced for ‘products where adventitious or technically unavoidable traces of authorised GMOs cannot be excluded’. In contrast, the threshold put forward in Article 5 of the proposal applies to non-authorised products. A threshold for non-authorised GMOs and for products produced from non-authorised GMOs would undermine all the European Union’s legislation on biosafety. The last sentence is important because for example maize protein is contaminated with various Bt-maize varieties and herbicide-resistant maize varieties, so that the possible sources of contamination could continually multiply. If the threshold applies to each individual contaminant, the total contamination could therefore be higher. Local authorities must be included among the bodies responsible for ensuring the utmost care and avoiding contamination. Amendment 67 Article 14, paragraph 1 (b) (a)   Where the food consists of more than one ingredient, the words ‘genetically modified’ or ‘produced from genetically modified [name of organism] but not containing a genetically modified 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.   (a)   Where the food consists of more than one ingredient, the words ‘genetically modified’ or ‘produced from genetically modified [name of organism] or 'produced from animals fed with genetically modified organisms' or 'produced with the aid of genetically modified (name of organism)' or 'product obtained from animals fed with feed obtained with the aid of a genetically modified 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, in a font at least as large as that in which the ingredient's name appears. 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. Justification In order to enable consumers to make an informed choice, the print must be sufficiently large and easy to read. The proposal for a regulation under consideration must not concentrate exclusively on regulating the traceability of GMOs and food and feed obtained from them, but must also consider food and feed obtained with a GMO. In fact, an enzyme, like any other molecule which accelerates the chemical process of transformation, plays an active role in all the various chemical and molecular reactions which the production of the food product entails and hence the principle of substantial equivalence of two end products cannot be applied, if one is obtained in a natural manner and the other with a GMO, because in any event they are unnatural substances for which at present there is no experimental evidence that they may lead to the production of identical foodstuffs, either organoleptically or as regards taste, flavour, etc. It is therefore fair that the rules on labelling and traceability of GMOs should also apply to products obtained with a GMO. Amendment 68 Article 14, paragraph 1, point (b) (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] but not containing a genetically modified organism’ shall appear in 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]’ or ‘contains [name of ingredient] produced from animals fed with genetically modified organisms’ shall appear in the list of ingredients printed in a font at least the same size as the list of ingredients. Justification The purpose of the amendment is to make labelling clearer. Consumer irritation should be avoided. The print must be sufficiently large and easy to read. Amendment 69 Article 14, paragraph 1, point (c) (c)   Where there is no list of ingredients, the words ‘genetically modified’ or ‘produced from genetically modified [name of organism] but not containing a genetically modified organism’ shall appear clearly on the labelling.   (c)   Where there is no list of ingredients, the words ‘genetically modified’ or ‘produced from genetically modified [name of organism]’ or ‘contains [name of ingredient] produced from animals fed with genetically modified organisms’ shall appear clearly on the labelling in a font sufficiently large to enable them to be easily identified and read. Justification The purpose of the amendment is to make labelling clearer. Ingredients derived from animals fed with GMOs should be labelled accordingly. The print must be sufficiently large and easy to read. Amendment 70 Article 14, paragraph 1, point (d) (d)   Where the food is offered for sale to the ultimate consumer or to mass caterers without pre-packaging, the information required under this paragraph must be displayed on or in connection with the display of the food.   (d)   Where the food is offered for sale to the ultimate consumer or to mass caterers without pre-packaging, or in small pre-package containers, 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. Justification Labelling must be clear, so as to prevent any confusion on the part of consumers about the goods they are purchasing. Furthermore, in order to enable consumers to make an informed choice, the print must be sufficiently large and easy to read. Amendment 71 Article 14, paragraph 2, point (a) (a)   Where a food is not equivalent to its conventional counterpart as regards:   (a)   Where a food is not equivalent to its conventional counterpart as regards these characteristics or properties: -   composition,   -   composition, -   nutritional value or nutritional effects,   -   nutritional value or nutritional effects, -   intended use of the food,   -   intended use of the food, -   implications for the health of certain sections of the population.   -   implications for the health of certain sections of the population. Justification Clarification of the text. Amendment 72 Article 16, paragraph 2 2.   Where necessary, it may be determined in accordance with the procedure laid down in Article 36 (2) whether a type of feed falls within the scope of this Section.   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. Justification See amendment to Article 3, paragraph 2. Amendment 73 Article 17, paragraph 4, point (a), first indent -   a genetically modified organism and feed containing or consisting of that genetically modified organism as well as feed produced from that genetically modified organism, or   -   feed containing or consisting of genetically modified organisms as well as feed produced from such genetically modified organisms, or Justification The amendment clarifies that marketing approvals granted under this Regulation address the food and feed safety aspect of genetically modified food and feed whereas the release of GMOs into the environment is covered by Directive 90/220/EEC which as of 17 October 2002 will be replaced by Directive 2001/18/EC. Amendment 74 Article 18 Adventitious or technically unavoidable presence of genetically modified material   Deleted The presence in feed of material which contains, consists of or is produced from genetically modified organisms in a proportion no higher than 1 % or lower thresholds established in accordance with the procedure laid down in Article 36 (2), shall not be considered to be in breach of Article 17 (2), provided that this presence is adventitious or technically unavoidable and that the genetically modified material has been subject to a scientific risk assessment made by the relevant Scientific Committee(s) or the European Food Authority, which concludes that this material does not present a risk for human health, animal health or the environment.     In order to establish that the presence of this material is adventitious or technically unavoidable, operators must be in a position to demonstrate to the competent authorities that they have taken appropriate steps to avoid the presence of the genetically modified organisms (or produce thereof).     Justification The threshold provided for in Article 18 applies to non-authorised GMOs. Such a threshold undermines the European Union’s legislation on biosafety. Under Article 21(2) of Directive 2001/18/EC, a threshold may be introduced for ‘products where adventitious or technically unavoidable traces of authorised GMOs cannot be excluded’. The threshold for GMOs authorised in the Community is regulated in new Article 26a(1). Amendment 75 Article 19, paragraph 3, point (e) (e)   a copy of the 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 Directive 83/228/EEC on the fixing of guidelines for the assessment of certain products used in animal nutrition;   (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 Directive 83/228/EEC on the fixing of guidelines for the assessment of certain products used in animal nutrition; Justification Any study may be useful, but only peer-reviewed studies should be accepted by legislators and authorities as a basis for decision-making. Amendment 76 Article 19, paragraph 3, point (f) (f)   either an analysis, supported by appropriate information and data, demonstrating that the feed referred to in Article 16 (1) is not different to a conventional feed, having regard to the criteria specified in Article 27(3) (c), or a proposal for labelling the feed referred to in Article 16 (1) in accordance with Article 27(3) (c) and (4);   (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 27(3) (a), (c)and (4); Justification It is appropriate to have the applicant comment on the type of labelling, in particular as, under Article 20(5)(d) of the Regulation, the European Food Safety Authority is expected to provide a labelling proposal. Amendment 77 Article 19, paragraph 3, point (ja) (new)     (ja)   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; Justification The EFSA and the competent authorities of the Member States (or monitoring laboratories) need this information in order to enforce the legislation, but operators also need it in order to be able to monitor and keep a check on their own supplies. Ready access to the applicant’s samples or reference material is also important to operators in the EU for use in their own checks. Amendment 78 Article 19, paragraph 3, point 1 (1)   a summary of the dossier.   (1)   a summary of the dossier in a standardised form. Justification Standardised guidelines serve to make it easier to handle dossiers. Amendment 79 Article 19, paragraph 5 5.   For genetically modified organisms and feed referred to respectively in Article 16 (1)(a) and (b), the application shall also be accompanied by:   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 or, where the placing on the market of the genetically modified organism has been authorised under Part C of Directive 2001/18/EC, a copy of the authorisation decision;   (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.   (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. In such case, Articles 13 to 24 of Directive 2001/18/EC shall not apply.   Deleted Justification In the case of products simply produced from GMOs but containing no GMOs, too, the documents for the GMO authorisation procedure under Directive 2001/18/EC should be examined by the competent authorities. That is the purpose of the proposed amendments in the introductory clause and subparagraph (a). Furthermore, the regulation should not replace Directive 2001/18/EC, but, rather, complement it. Amendment 80 Article 19, paragraph 7 7.   The Commission, having first consulted the Authority, may establish, in accordance with the procedure laid down in Article 36 (2), implementing rules for the application of this Article.   7.   The Commission, having first consulted the Authority and the competent national offices under 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. Justification An optional provision must be avoided at all costs so as to counter the risk of a legal vacuum. Amendment 81 Article 20, paragraph 2 a (new)     2a.   The Authority shall within 15 days of its receipt forward the application 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 Justification It is essential that the Authority makes full use of the capacity and expertise of the competent authorities of the Member States. Amendment 82 Article 20, paragraph 3, subparagraph (c) (c)   shall make the summary of the dossier mentioned in Article 19 (3) (l) available to the public;   (c)   shall make the summary of the dossier mentioned in Article 19(3)(l) 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; Justification Only access to the complete dossier will enable the public to make an informed judgment. Information which, if circulated, could harm an applicant’s competitive position, must be treated confidentially, however (see also Article 31, Confidentiality). Amendment 83 Article 20, paragraph 3, point (d) (d)   may ask the appropriate feed assessment body of a Member State to carry out a safety assessment of the feed referred to in Article 16 (1);   (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; Justification As with environmental risk assessments, the Authority should take due account of the findings of food safety assessments carried out by the appropriate bodies. Amendment 84 Article 20, paragraph 3, subparagraph (e) (e)   may ask a competent authority designated in accordance with Article 4 of Directive 2001/18/EC to carry out an environmental risk assessment;   (c)   shall take account of the results of the environmental risk assessment under Directive 2001/18/EC; Justification Necessary environmental risk assessments (ERAs) must continue to be carried out by the competent authorities under Directive 2001/18/EC. The European Food Safety Authority should be called in in an advisory capacity. Amendment 85 Article 20, paragraph 3, point (ea) (new)     (ea)   shall ask the appropriate human and animal health risk assessment body of the Member State in which the person applying for authorisation is established to carry out a human and animal health risk assessment, and shall take due account of the findings of the assessment; Justification As with assessments of the environmental risks of GMOs, the Authority should take due account of the findings of human and animal health risk assessments carried out by the appropriate bodies. Amendment 86 Article 20, paragraph 3, subparagraph (f) (f)   shall forward to the Community reference laboratory referred to in Article 33 the particulars referred to in Article 19 (3) (i) and (j) and shall ask it to test and validate the method of detection and identification proposed by the applicant;   (f)   shall forward to the Community reference laboratory referred to in Article 33 the particulars referred to in Article 19 (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; Justification Testing and validating detection procedures are the Community laboratory's tasks. The wording ‘shall ask it’ is therefore too weak and unclear. Amendment 87 Article 20, paragraph 4 4.   In the case of genetically modified organisms and feed referred to respectively in Article 16 (1) (a) and (b), the evaluation shall respect the environmental safety requirements laid down in Directive 2001/18/EC 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 containing or consisting of genetically modified organisms, the necessary consultations shall be held by the Authority with the bodies set up by the Community and/or the Member States in accordance with Directive 2001/18/EC.   4.   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 containing or consisting of 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 Directive 2001/18/EC. Justification During the evaluation of requests the Authority must take account of the contribution of the local authorities. Amendment 88 Article 20, paragraph 5, point (e) (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;   (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; Justification The need to respect consumers' and producers' freedom of choice means that measures must be taken to ensure the co-existence of GM production and Non-GM production. The amendment is in line with Action 17 of the Commission Communication 'Life Sciences and biotechnology - A Strategy for Europe' (COM(2002) 27) which calls for 'agronomic and other measures to ensure the viability of conventional and organic farming and their sustainable coexistence with genetically modified crops'. Amendment 89 Article 20, paragraph 5, subparagraph (f) (f)   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(l);   (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); Justification For clarification. Amendment 90 Article 20, paragraph 5, point (g) a (new)     (ga)   information on the place where the reference material or the samples of the applicant are to be made available to operators in the EU; Justification The EFSA and the competent authorities of the Member States (or monitoring laboratories) need this information in order to enforce the legislation, but operators also need it in order to be able to monitor and keep a check on their own supplies. Ready access to the applicant’s samples or reference material is also important to operators in the EU for use in their own checks. Amendment 91 Article 20, paragraph 6 6.   The Authority shall forward its opinion to the Commission, the Member States 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.   6.   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. Justification Given that the appropriate bodies in the two areas referred to have been consulted, it seems paradoxical for them not to receive a copy of the Authority's opinion. Amendment 92 Article 20, paragraph 7 7.   The Authority shall make its opinion public, after deletion of any information identified as confidential, in accordance with Article 31. The public may make comments to the Commission within 30 days from this publication.   7.   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 3 months from this publication. Reference shall be made to the possibility for the public to have access to the entire application, excluding confidential information. Justification To make an informed judgment, the public must have access to all significant documents relating to the authorisation procedure. In the process, information which, if circulated, could harm the applicant’s competitive position must be treated confidentially. Amendment 93 Article 20, paragraph 8 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.   Deleted Justification The Authority should decide itself on the nature of the risk assessment it is to undertake for the purpose of preparing its opinion. Amendment 94 Article 21, paragraph 1 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 provide an explanation of the reasons for the differences.   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 provide an explanation of the reasons for the differences. The Commission’s draft decision shall be immediately made public. Justification It is important that the public should have access to the information. That should be ensured as early as at the draft stage. Amendment 95 Article 21, paragraph 2, subparagraph 1 a (new)     The draft decision shall also include the opinions of the authorities required to be consulted in accordance with Directive 2001/18/EC. Justification See justification to amendment to Article 8(2). Amendment 96 Article 21, paragraph 3 3.   A final decision on the application shall be adopted in accordance with the procedure laid down in Article 36 (2).   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. Justification The decision must be transparent and comprehensible. Amendment 97 Article 21, paragraph 4 4.   The Commission shall without delay inform the applicant of the decision taken. The decision shall be published in the Official Journal of the European Communities.   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. Justification See justification to the amendment to Article 8(1). Amendment 98 Article 21, paragraph 5 5.   The authorisation granted in accordance with the procedure laid down in this Regulation shall be valid throughout the Community for ten years and shall be renewable in accordance with Article 25. 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.   5.   Without prejudice to the procedure provided for in Article 24, 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 25. 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 and shall indicate how and where interested members of 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 the context of the decision on risk management and the outcome of the vote. Justification The decision must be transparent and comprehensible. Amendment 99 Article 22, paragraph 1, point (b) (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 21 (2) as appropriate.   (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 21 (2) as appropriate.     The Register entry shall also include the indication as to how and where the public can have access to the application dossier and information submitted subsequently, including the Authority’s assessment and, where applicable, opinions by national bodies and by the public, plus the issues discussed and results of votes in connection with risk management. Justification The product register provided for in Article 22 should also contain information on public bodies from which, where appropriate, product information can be obtained. Amendment 100 Article 22, paragraph 4 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. Such a measure may provide for a limited period of time within which existing stocks of the product may be used up.   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. Justification A product either presents a danger or it does not. If it does, or gives reasonable grounds for concern that it may do, then there can be no justification for delaying its withdrawal. Amendment 101 Article 23, paragraph 1 1.   After an authorisation has been issued in accordance with this Regulation, the authorisation-holder shall comply with any conditions or restrictions which have been imposed in the authorisation. Where post-market monitoring as referred to in Article 19 (3) (k) and Article 19 (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.   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 19 (3) (k) and Article 19 (5) (b) has been imposed on the authorisation-holder, he shall do everything in his power to 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. Justification In order to ensure maximum legal certainty, all parties concerned and not only the authorisation-holder must bear responsibility for compliance with conditions attached to the authorisation. It is essential to ensure public accessibility, excluding confidential information, even after authorisation has been issued. Amendment 102 Article 23, paragraph 3 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.   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 interested members of the public. Justification Once the information received has been checked, the Authority shall be obliged to communicate it to the local authorities too. Amendment 103 Article 24, paragraph 1 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.   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 interested members of the public. Justification The authorisation-holder has a right to be informed of the intention to modify or revoke the authorisation. Even in the event of authorisation being revoked, suspended or modified, the Authority shall be obliged to communicate the fact to the local authorities. Amendment 104 Article 24, paragraph 2 2.   The Commission shall examine the opinion of the Authority as soon as possible and prepare a draft of the decision to be taken.   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. Justification Public accessibility must be ensured. Amendment 105 Article 24, paragraph 5 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.   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 and results of votes in connection with the risk management decision. Justification See justification to the amendment to Article 8(1). Public accessibility must be ensured. Amendment 106 Article 26, paragraph 2, first subparagraph 2.   This Section shall not apply to feed containing, consisting of or produced from genetically modified organisms in a proportion no higher than the thresholds established in accordance with the procedure laid down in Article 36 (2), provided that this presence is adventitious or technically unavoidable.   2.   This Section shall not apply to feed containing material which is produced from genetically modified organisms in a proportion no higher than the lowest achievable tolerance level established on a product-by-product basis in accordance with the procedure laid down in Article 21 (3) and Article 36 (2), provided that this presence is adventitious or technically unavoidable. In establishing the lowest achievable tolerance level, the most recent state of science and technology shall be taken into account. Justification Thresholds for the labelling of GMO derivatives should be established in comitology, taking into account the most recent state of science and technology. Amendment 107 Article 26, paragraph 2, second subparagraph In order to establish that the presence of this feed 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 organisms (or produce thereof).   Deleted Justification Article 26(2) has been replaced by new Article 26a, ‘Adventitious or technically unavoidable presence of genetically modified material’. New Article 26a makes it clear that the threshold provided for applies only to GMOs authorised in the Community. Amendment 108 Article 26 a (new)     Article 26a Adventitious or technically unavoidable presence of genetically modified material 1.   Feed containing material produced from genetically modified organisms in a proportion no higher than 0.5% or lower maximum values established in accordance with the procedure laid down in Article 36 (2), need not be labelled in accordance with this Section, provided that this presence is adventitious or technically unavoidable. 2.   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 genetically modified organisms in products produced from them. In cooperation with the Authority and Member States, the Commission shall lay down appropriate measures to be complied with to ensure that the utmost care is taken and to avoid contamination, so as to guarantee a uniform assessment of ‘adventitious and technically unavoidable contamination’ or, as the case may be, to create the same basis for this to be established. Justification Under Article 21(2) of Directive 2001/18/EC, a threshold may be introduced for ‘products where adventitious or technically unavoidable traces of authorised GMOs cannot be excluded’. In contrast, the threshold put forward in Article 5 of the proposal applies to non-authorised products. A threshold for non-authorised GMOs and for products produced from non-authorised GMOs would undermine all the European Union’s legislation on biosafety. Amendment 109 Article 27, paragraph 3 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 an accompanying document or, where appropriate, on the packaging, on the container or on a label attached thereto:   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, container or the label and on the accompanying documents: Justification To protect farmers, feed coming within the scope of this regulation must be clearly labelled. A reference on accompanying documents is not enough. Amendment 110 Article 27, paragraph 3, subparagraph (a), indent 2 -   for feed produced from genetically modified organisms: “produced from genetically modified [name of the feed from which the feed is produced] but not containing a genetically modified organism”;   -   for feed produced from genetically modified organisms: “produced from genetically modified [name of the feed from which the feed is produced]”; Justification The purpose of the amendment is to make labelling clear. Irritations are to be avoided. Amendment 111 Article 27, paragraph 3 (b) (b)   for feed referred to in Article 16 (1) (b) the name of the feed shall be accompanied by the relevant unique code as established in Regulation (EC)…/… of the European Parliament and of the Council concerning traceability and labelling of genetically modified organisms and traceability of food and feed products produced from genetically modified organisms;   (b)   for feed referred to in Article 16 (1) (b) the name of the feed on the packaging, containers, a label or an accompanying document shall be accompanied by the relevant unique code as established in Regulation (EC)…/… of the European Parliament and of the Council concerning traceability and labelling of genetically modified organisms and traceability of food and feed products produced from genetically modified organisms or obtained with the aid of a genetically modified organism; Justification See justification to amendment to Recital 15. Amendment 112 Article 27, paragraph 3, point (d) a (new)     (da)   Where the feed consists of more than one ingredient and is a compound feeding stuff as defined in Council Directive 79/373/EEC as amended, 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 at least the same size as the list of ingredients. Justification To be consistent with the corresponding proposal on compound foods (Article 14 (a) of the Commission’s proposal) and to take into account relevant legislation on the labelling of animal feed. Amendment 113 Article 27, paragraph 4 4.   In addition to the requirements laid down in paragraph 3(a) and (b) and as specified in the authorisation, the labelling or accompanying documents of feed 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 feed concerned.   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 do not have a conventional counterpart shall contain appropriate information about the nature and the characteristics of the feed concerned. Justification A mere reference on accompanying documents is insufficient. Amendment 114 Article 28a (new)     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. Justification Self-explanatory. Amendment 115 Article 29, paragraph 2 2.   The Authority may consider whether the application for authorisation should be submitted both as food and feed.   2.   The Authority shall consider whether the application for authorisation should be submitted both as food and feed. Justification The word 'may' must not be used, as it is likely to create legal uncertainty. Amendment 116 Article 30(2a) (new)     2a.   The register shall include information on the method(s) validated by the Community reference laboratory, pursuant to Articles 7(3)(f) and 20(3)(f), and on the methods used by the national reference laboratories. Justification All the methods used by the reference laboratories in the context of monitoring and implementation by the Member States should be made public. In particular, where a method has not been validated reliable information must be provided on the different methods used, in order to avoid confusion. Amendment 117 Article 35, paragraph 1 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 shall immediately inform the Authority and the Commission.   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 24, as appropriate. Justification In the event of force majeure, the Member States must be in a position to take rapid decisions and apply the precautionary principle on their territory. The wording corresponds to the safeguard clause laid down in Article 23 of Directive 2001/18/EC. It is imperative that member state authorities be allowed to act swiftly. This in no way interferes with their, or the Commission's, ability to take more considered steps at a later date. Amendment 118 Article 35, paragraph 2 2.   If the Commission, following information received from a Member State pursuant to paragraph 1 or on its own initiative, considers that emergency measures are necessary, it may adopt them in accordance with Article 36 (3). These emergency measures may remain in place until a final decision is taken in accordance with Article 11 or Article 24, 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). Justification In the event of force majeure, Member States must be in a position to take decisions quickly and apply the precautionary principle within their territory. The formulation accords with the protection clause laid down in Article 23 of Directive 2001/18. Amendment 119 ARTICLE 38, PARAGRAPH 3 Article 12, paragraph 1 (Regulation (EC) 258/97) (3)   In Article 12 (1), the words “or the environment” are deleted.   Deleted Justification The emergency clause of the Novel Food Regulation (EC) No 258/97 allows Member States to restrict or suspend trade in and use of novel food if the Member State has "detailed grounds for considering that the use of the novel food or food ingredient endangers human health or the environment." The clause which will continue to apply to novel foods and food ingredients should remain unchanged. Amendment 120 ARTICLE 40, PARAGRAPH 1 A (new) Article 7, paragraph 4 (Directive 70/457/EEC)     1b.   Article 7 (4) is replaced by the following paragraph:'     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 Directive 2001/18/EC shall be carried out.     (b)   Until 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 enters into force, genetically modified varieties shall only be accepted for inclusion in a national catalogue after having being accepted for marketing 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. Justification This amendment updates Article 7 (4) of Directive 70/458/EEC and adjusts it to Article 12 (3) of Directive 2001/18/EC. While under the current Directive genetically modified plant varieties may simply be regulated through a Council Regulation, Art. 12 (3) of Directive 2001/18/EC requires for all such "sectoral legislation", that horizontal European Parliament and Council Regulation on sectoral legislation has to be adopted before a GMO may be excluded from the scope of Part C of Directive 2001/18/EC. Amendment 121 ARTICLE 40, PARAGRAPH 2 Article 7, paragraph 5 (Directive 70/457/EEC) (2)   Article 7 (5) is replaced by the following: “5. Member States shall ensure that a variety intended to be used in food or feed as defined in Articles 2 and 3 of Regulation (EC) No …./2001 laying down the general principles and requirements of food law, establishing the European Food 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 under Directive 90/220/EEC or Directive 2001/18/EC for feed or Regulation ---/---/EC on genetically modified food and feed.”   (2)   Article 7 (5) is replaced by the following: “5. Member States shall ensure that a variety intended to be used in food or feed as defined in Articles 2 and 3 of Regulation (EC) No 178/2002 laying down the general principles and requirements of food law, establishing the European Food Authority, and laying down procedures in matters of food safety, is accepted only if it has been authorised under the relevant legislation. Justification There is no need to list in detail the various regulations and directives under which a plant variety should have been approved before it is accepted for registration. Amendment 122 Article 42 Amendments to Directive 2001/18/EC Directive 2001/18/EC is amended with effect from the date of entry into force of this Regulation as follows: "The following Article 12a is inserted: Article 12a Adventitious presence of GMOs in products Articles 13 to 21 shall not apply to the placing on the market of traces of a GMO or combination of GMOs in products intended for direct use as food or feed, or for processing, in a proportion no higher than 1 % or lower thresholds established in accordance with the procedure laid down in Article 30 (2), provided that these traces of GMOs are adventitious or technically unavoidable and that the GMOs have been subject to a scientific risk assessment made by the relevant Scientific Committee(s) or the European Food Authority, which concludes that the GMOs do not present a risk for human health or the environment. In order to establish that traces of GMOs are adventitious or technically unavoidable, operators must be in a position to demonstrate to the competent authorities that they have taken appropriate steps to avoid them".   Deleted Justification It makes no sense to decisively alter a directive which was adopted only a year ago following a lengthy and complicated conciliation procedure between Parliament and the Council. As a result of the proposed amendment, in addition, the directive would legalise the marketing of unauthorised genetically modified organisms in flagrant breach of the precautionary principle to which express reference is made in Article 1 of Directive 2001/18/EC. Amendment 123 Article 45, paragraph 2 2.   The labelling requirements laid down in this Regulation 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 date of application of this Regulation.   2.   For a period of not more than twelve months following the date of its application, the labelling requirements laid down in this Regulation 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. Justification The Commission's proposal is in essence reasonable, but should be subject to a time limit, as the shelf life of some processed foods is extremely long. Amendment 124 Article 46, paragraph 1 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.   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, where appropriate, any suitable proposal shall be made accessible to the public. Justification The public should have access to the appropriate information.

EXPLANATORY STATEMENT Following the revised GMO Release Directive (2001/18/EC), the proposal for a regulation is an important step in regulating the GMO field at Community level. The proposal for a regulation essentially covers: ▪ authorisation and labelling of genetically modified food ▪ authorisation and labelling of genetically modified feed. Scope To ensure a high level of protection for human and animal health, this proposal extends the scope of current Community legislation on GMOs to feed produced from GMOs. The provisions for food are also more far-reaching than has been the case to date. The scope has been extended to products produced from GMOs. The traceability of genetic modification in an end product is no longer a prerequisite for authorisation and labelling. That means, for instance, that highly refined soya and maize oils would be authorised and labelled. In the interests of maximising consumers' freedom of choice, the labelling provisions under this proposal are also to apply to products derived from animals fed with genetically modified feed. Adventitious or technically unavoidable presence of genetically modified material Thresholds for adventitious and technically unavoidable contamination are necessary. The proposal provides for a 1% threshold for the presence of GMOs. It is unacceptable that that provision should also apply to GMOs which are not authorised in the Community. It is vital that this be avoided, otherwise all European Union biosafety legislation will be undermined. The rapporteur has therefore removed Articles 5 and 18 ('Adventitious or technically unavoidable presence of genetically modified material') from the authorisation section and reinserted them in the labelling section (new Articles 13a and 26a). The threshold laid down is to be reduced to 0.5% and should be taken as an aggregate value for contamination in the ingredient concerned. This should be determined on the basis of the raw ingredient. Authorisation procedure In order to streamline and rationalise the current authorisation procedure for genetically modified foods, the Commission proposes that the European Food Safety Authority should carry out risk assessments. As provided for in the proposal for a European Food Safety Authority, that Authority should also carry out risk assessment for genetically modified feed. The proposed regulation is based on the 'one door - one key' principle. Thus, so it is intended, a single application will suffice for: ▪ authorisation for the deliberate release of a GMO into the environment in accordance with the criteria under Directive 2001/18/EC ▪ and authorisation for the use of that GMO in food and/or feed in accordance with the criteria under the proposed regulation. The authorisation procedure is excessively localised and over-specific. The release of genetically modified organisms into the environment is regulated by the Release Directive (2001/18/EC). It must be ensured that the provisions of the new regulation are compatible with the Release Directive and complement rather than supersede it. It makes no sense to decisively alter a directive which was adopted only one year ago following a lengthy and complex conciliation procedure between Parliament and the Council. Transparency of the authorisation procedure Recitals 5 and 6 call for a clear and transparent authorisation procedure. Accordingly, amendments have been tabled to several articles with a view to guaranteeing the public's right to information.

28 May 2002 OPINION OF THE COMMITTEE ON LEGAL AFFAIRS AND THE INTERNAL MARKET for the Committee on the Environment, Public Health and Consumer Policy on the proposal for a regulation of the European Parliament and of the Council on genetically modified food and feed (COM(2001) 425 – C5‑0368/2001 – 2001/0173(COD)) Draftsman: Evelyne Gebhardt PROCEDURE The Committee on Legal Affairs and the Internal Market appointed Evelyne Gebhardt draftsman at its meeting of 11 September 2001. It considered the draft opinion at its meetings of 26 February 2002, 27 March 2002, 22 April 2002 and 28 May 2002. At the last meeting it adopted the following amendments by 16 votes to 1, with 12 abstentions. The following were present for the vote: Giuseppe Gargani, chairman; Willi Rothley, vice-chairman; Ioannis Koukiadis, vice-chairman; Bill Miller, vice-chairman; Evelyne Gebhardt, draftsman; Paolo Bartolozzi, Philip Charles Bradbourn, Maria Berger, Carlos Carnero González (for François Zimeray pursuant to Rule 153(2)), Bert Doorn, Janelly Fourtou, Marie-Françoise Garaud, Fiorella Ghilardotti, José María Gil-Robles Gil-Delgado, Othmar Karas, Piia-Noora Kauppi, Kurt Lechner, Klaus-Heiner Lehne, Neil MacCormick, Toine Manders, Helmuth Markov (for Alain Krivine pursuant to Rule 153(2)), Arlene McCarthy, Manuel Medina Ortega, Elena Ornella Paciotti, Astrid Thors, Marianne L.P. Thyssen, Rijk van Dam, Rainer Wieland and Joachim Wuermeling. SHORT JUSTIFICATION The interests of the consumer and the responsible citizen should be given top priority. The right of individuals to decide whether or not they wish to consume a given product can only be guaranteed if the producer is required to provide full information. In order to create the conditions for ensuring that consumers have freedom of choice, appropriate provisions need to be laid down. The Commission proposal does not, however, contain provisions concerning this aspect. 1.   Labelling Compared with the Novel Foods Regulation, the proposal lays down more stringent rules on the labelling of genetically modified organisms. Under the new rules, labelling is no longer only required where the presence of GMOs is demonstrated in the product concerned. Rather, it is enough for GMOs to have been used in one of the stages of production, even if they are no longer found in the final product. On paper, this approach means taking more effective account of GMOs. However, there is a risk that it may not be possible to implement controls in practice and that the regulation will fail to properly fulfil its objectives. In order to ensure that GMOs which cannot be detected in the final product are labelled, it is necessary to trace the ingredient concerned through the respective production chain back to its ‘origin’. However, traceability is only possible if businesses are required to set up appropriate documentation systems. Such systems must be able to be checked, in order to ensure that consumers are not deceived and their freedom of choice is not infringed. In addition, it is imperative to press ahead with the development of techniques for detecting genetically modified material. 2.   Authorisation The authorisation requirement for GMOs does not go far enough. Additives, flavourings and extraction solvents still do not require special authorisation, even where they have been produced from GMOs. Furthermore, where a decision has not been taken on an application to renew an authorisation, for products subject to authorisation, before the relevant expiry date, the period of authorisation is automatically extended. This provision is contrary to the interests of consumers, who may possibly be continuing to consume a product likely to be harmful to human health. 3.   Threshold for the adventitious or technically unavoidable presence of GMOs The threshold of 1 % proposed by the Commission is far too high, and could have serious consequences for human beings and the environment. By way of illustration, this would mean that a consignment of 100 000t of food or feed could contain 1 000 t of genetically modified organisms, without prior tests having been carried out to verify whether the product is likely to be harmful to health and without the product undergoing checks. For these reasons, the threshold should be lowered to 0.1 %. 4.   Directive on release of GMOs Under the provisions of the directive on the deliberate release into the environment of genetically modified organisms, GMOs may be released or placed on the market by the relevant notifier only if the latter has carried out a comprehensive environmental risk assessment in respect of the risks posed by GMOs to human beings, animals and the environment. This stringent directive on the release of GMOs, which protects human beings and the environment by laying down high requirements as regards the safety of GMOs, should not be undermined by the new regulation. In the interests of legal certainty, it is therefore important to ensure that the provisions of the new GMO regulation are consistent with the provisions of the directive on the release of GMOs. 5.   Structure of the text The structure of the regulation is not easy to follow. In some places, we propose restructuring the text in order to make it clearer and more coherent and more easily comprehensible. 6.   Risks posed by GM foods No long-term studies have so far been carried out on the effects of genetically modified foods on human health and possible consequences for the environment. European Union citizens, rightly, therefore, take a very critical approach to genetically modified foods, and wish to know how the food they buy has been produced. Their right to choose or reject genetically modified products must be ensured in all cases. A prerequisite for this is to create conditions of transparency, which demands detailed disclosure and labelling of genetically modified food and feed. Freedom of choice for individuals is one of the fundamental values of a democracy, and must be reflected in the regulations of the European Union. The interests of citizens should therefore be paramount, and not those of big food companies. AMENDMENTS The Committee on Legal Affairs and the Internal Market calls on the Committee on the Environment, Public Health and Consumer Policy, as the committee responsible, to incorporate the following amendments in its report: Text proposed by the Commission(2) Amendments by Parliament Amendment 1 Recital 9 (9)   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.   (9)   Experience has shown that authorisation must 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. Justification Intended to strengthen the provisions. Amendment 2 Recital 11 (11)   Council Directive 89/107/EEC of 21 December 1988 concerning food additives authorised for use in foodstuffs intended for human consumption, as last amended by Directive 94/34/EC of 30 June 1994, provides for authorisation of additives used in foodstuffs. In addition to this authorisation procedure, food additives containing, consisting of 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.   (Does not affect English version) Justification (Does not affect English version) Amendment 3 Recital 13 (13)   Council Directive 82/471/EEC of 30 June 1982 concerning certain products used in animal nutrition, as last amended by Council Directive 1999/20/EC, 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 containing, consisting of or produced from GMOs should fall instead under the scope of this Regulation.   (13)   Council Directive 82/471/EEC of 30 June 1982 concerning certain products used in animal nutrition, as last amended by Council Directive 1999/20/EC, 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 containing, consisting of or produced from GMOs must fall instead under the scope of this Regulation. Justification Intended to strengthen the provisions. Amendment 4 Recital 19 (19)   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.   (19)   Harmonised labelling requirements must 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. Justification Intended to strengthen the provisions. Amendment 5 Recital 24 (24)   In order to establish that the presence of this material is adventitious or technically unavoidable, operators must be in a position to demonstrate to the competent authorities that they have taken appropriate steps to avoid the presence of the genetically modified food or feed.   (24)   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. Justification Strengthens the obligation on operators. Amendment 6 Recital 27a (new)     27a.   To avoid creating an unfair obstacle to trade, a list should be drawn up of countries with comparable standards, the results of whose assessments shall be recognised for the purposes of the assessment referred to in Articles 5, 18 and 22. Justification The duplication of tests should be avoided where standards are comparable, as they could be seen as obstacles to trade. It would seem sensible, therefore, to reach agreement on comparable standards, for example in the framework of the OECD. Amendment 7 Recital 29 (29)   Risks to the environment may be associated with foods and feed which contain or consist of 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.   (29)   Risks to the environment may be associated with foods and feed which contain or consist of 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. Food and feed which also fall within the scope of Directive 2001/18/EC may be authorised only if approval for placing on the market has previously been granted in accordance with Directive 2001/18/EC. In so far as the regulation has the status in future of ‘sectoral legislation’ within the meaning of the first sentence of Article 12(3) of Directive 2001/18/EC, the Commission will propose a regulation of the European Parliament and of the Council in accordance with these provisions. Pending the entry into force of that regulation, any GMOs as or in products, in so far as they are authorised by the provisions of this regulation, may be placed on the market only after having been accepted for placing on the market in accordance with Directive 2001/18/EC (third sentence of Article 12(3) of Directive 2001/18/EC). Justification This is not a sectoral directive, and cannot therefore be treated as such. It is also necessary to ensure that the provisions of Directive 2001/18/EC, which were adopted following a lengthy and complicated conciliation procedure between Parliament and the Council last year, are not undermined by this regulation. The consistency of European legislation must be ensured. Amendment 8 Article 2 For the purposes of this Regulation:   For the purposes of this Regulation: (1)   the definitions of 'food', 'feed', 'placing on the market' and 'traceability', laid down in Regulation (EC) No ..../2001 laying down the general principles and requirements of food law, establishing the European Food Authority, and laying down procedures in matters of food safety shall apply;   (1)   the definitions of 'food', 'feed', 'placing on the market' and 'traceability', laid down in Regulation (EC) No 178/2002 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 [33] shall apply; for the purposes of this Regulation 'food' and 'feed' shall include any substance which even though not consumed as a food ingredient by itself, is intentionally used in the processing of foods, feed or their ingredients, to fulfil a certain technological purpose during treatment or processing and may result in the unintentional but technically unavoidable presence of residues of the substance or its derivatives in the final product; (2)   the definitions of 'organism', 'genetically modified organism' ('GMO'), 'deliberate release' and 'environmental risk assessment' laid down in Directive 2001/18/EC shall apply;   (2)   the definitions of 'organism', 'deliberate release' and 'environmental risk assessment' laid down in Directive 2001/18/EC shall apply;     (2a)   'genetically modified organism (GMO)' means a genetically modified organism in accordance with the definition laid down in Article 2(2) of Directive 2001/18/EC, with the exception of organisms obtained through the modification techniques set out in Annex I B to Directive 2001/18/EC; (3)   'genetically modified food or feed' means food or feed containing, consisting of or produced from genetically modified organisms;   (3)   'genetically modified food' means food containing, consisting of or produced from genetically modified organisms;     (3a)   'genetically modified feed' means feed containing, consisting of or produced from genetically modified organisms; (4)   'genetically modified organism for food use' means a genetically modified organism which is not exempted from the application of Directive 2001/18/EC and that may be used as food or as a source material for the production of food;   (4)   'genetically modified organism for food use' means a genetically modified organism that may be used as food or as a source material for the production of food; (5)   'genetically modified organism for feed use' means a genetically modified organism which is not exempted from the application of Directive 2001/18/EC and that may be used as feed or as a source material for the production of feed;   (5)   'genetically modified organism for feed use' means a genetically modified organism that may be used as feed or as a source material for the production of feed; (6)   'produced from genetically modified organisms' means derived, in whole or in part, from genetically modified organisms, but not containing or consisting of genetically modified organisms ;   (6)   'produced from genetically modified organisms' means derived, in whole or in part, from genetically modified organisms, but not containing or consisting of genetically modified organisms ; (7)   'control sample' means the genetically modified organism or its genetic material (positive sample) or the parental organism or its genetic material that has been used for the purpose of the genetic modification (negative sample).   (7)   'control sample' means the genetically modified organism or its genetic material (positive sample) or the parental organism or its genetic material that has been used for the purpose of the genetic modification (negative sample). Justification Clarification of the text, in particular through reference to genetically modified organisms within the meaning of the definition laid down in Directive 2001/18/EC and to the exemption of certain GMOs from the scope of the provisions in accordance with Annex I B of the directive. Amendment 9 Article 3 1.   This Section shall apply to:   1.   This Section shall apply to: (a)   genetically modified organisms for food use,   (a)   genetically modified organisms for food use, (b)   food containing or consisting of genetically modified organisms,   (b)   food containing or consisting of genetically modified organisms, (c)   food produced from or containing ingredients produced from 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) whether a type of food falls within the scope of this Section.   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. Justification Clarifies the grounds for amending the scope of the text through the commitology procedure, and specifies that the regulatory committee cannot decide to exclude a food from the scope of the provisions if it was originally included. Amendment 10 Article 4, paragraph 1 1.   Food falling within the scope of this Section must not:   1.   Food falling within the scope of this Section must not: -   present a risk for human health or the environment,   -   present a danger for human health or the environment, -   mislead the consumer,   -   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.   -   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. Justification Consistency with the Novel Foods Regulation. Amendment 11 Article 6, paragraph 3, point (e)(a) (new)     (ea)   a proposal for the labelling of the food or foods produced from it accordance with Article 14(1); Justification Article 6(3) sets out the items to be included in all applications. Paragraphs 3(f) and (g) stipulate that the applicant must make a proposal for labelling of food which is not equivalent to their conventional counterparts or which may give rise to ethical concerns (Article 14 (2) & (3)). This amendment adds a reference to Article 14(1) which addresses the specific labelling for genetic modification. The amendment reflects the wording of Article 7(5)(d). Amendment 12 Article 6, paragraph 3, point (j)(a) (new)     (ja)   where relevant, a proposal for a maximum threshold for the adventitious or technically unavoidable presence in other foods of material produced from the genetically modified organism; Justification The tolerance threshold should be established on a case-by-case or product-by-product basis, depending on the raw materials used, the type of the product and the scientific capabilities to identify traces of DNA or protein in the final product. Amendment 13 Article 6, paragraph 3, point j b (new)     (jb)   information on where reference material or samples will be made available by the applicant to the authorities and operators in the EU; Justification The EFSA and the competent authorities of the Member States (or control laboratories) require this information in order to be able to enforce legislation, and operators need it in order to be able to control and monitor their own supplies. Easy access to samples or reference material held by the applicant is very important for operators in the EU in order to allow them to carry out their own controls. Amendment 14 Article 6, paragraph 5 5.   In the case of genetically modified organisms or foods containing or consisting of genetically modified organisms, the application shall also be accompanied by:   5.   The application shall also be accompanied by: Justification Makes the text more coherent. Amendment 15 Article 6, paragraph 5, point (a) (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 or, where the placing on the market of the genetically modified organism has been authorised under part C of Directive 2001/18/EC, a copy of the authorisation decision;   6.   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 authorisation decision; Justification Article 6 (5) (a) implies that GMOs may be authorised for food use under this Regulation although they have not been approved against Directive 2001/18/EC. Thus, the proposed Regulation shall replace as so-called sectoral legislation part C of Directive 2001/18/EC which regulates the placing on the market of GMOs. While such sectoral legislation is in principle possible, Art. 12 (4) of Directive 2001/18/EC stipulates that before such legislation is adopted "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 this Directive shall be introduced, in a Regulation of the European Parliament and of the Council." Since there has to date been no such regulation and the Commission has not proposed any such regulation or procedures, the regulation now being proposed cannot be considered ‘sectoral legislation’. Thus, Directive 2001/18/EC and the proposed regulation apply in parallel to GMOs for human or animal consumption; this approach is also more appropriate and must be upheld. Amendment 16 Article 7, paragraph 4 4.   In the case of genetically modified organisms or food containing or consisting of genetically modified organisms falling within the scope of this Section, the evaluation shall respect the environmental safety requirements laid down in Directive 2001/18/EC 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 containing or consisting of genetically modified organisms, the necessary consultations shall be held by the Authority with the bodies set up by the Community and/or the Member States in accordance with Directive 2001/18/EC.   4.   In the case of genetically modified organisms or food containing or consisting of genetically modified organisms falling within the scope of this Section, the evaluation shall respect the environmental safety requirements laid down in Directive 2001/18/EC 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. Justification The competent authorities are represented on the advisory forum of the EFSA, which has sufficient powers for the purpose of evaluation. Amendment 17 Article 7, paragraph 5, point (d)(a)(new)     (da)   where relevant, a proposal for a maximum threshold for the adventitious or technically unavoidable presence in other foods of material produced from the genetically modified organism; Justification The tolerance threshold should be established on a case-by-case basis or product-by-product basis depending on the raw materials used, the type of the product and the scientific capabilities to identify traces of DNA or protein in the final product. Amendment 18 Article 7, paragraph 5, point f and point g (new) (f)   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;   (f)   a method for detection, including sampling, access to appropriate reference material, identification of the sequence for 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;     (g)   information on where reference material or samples will be made available by the applicant to operators in the EU; Justification The EFSA and the competent authorities of the Member States (or control laboratories) require this information in order to be able to enforce legislation, and operators need it in order to be able to control and monitor their own supplies. . Easy access to samples or reference material held by the applicant is very important for operators in the EU in order to allow them to carry out their own controls. Amendment 19 Article 7, paragraph 8 8.   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.   8.   The European Commission shall decide, in accordance with the procedure laid down in Article 36(2) of this Regulation, on the nature of the risk assessment to be undertaken by the Authority for the purpose of preparing its opinion. Justification The aim of this article is unclear. The impression is given that the Commission can choose which risks are to be analysed. Amendment 20 Article 8, paragraph 2 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 (5), the name of the authorisation-holder and, where appropriate, the unique code attributed to the genetically modified organism as referred to in the Regulation (EC) No ../....... of the European Parliament and of the Council concerning traceability and labelling of genetically modified organisms and traceability of food and feed products produced from genetically modified organisms.   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 (5), the name of the authorisation-holder and, where appropriate, the unique code attributed to the genetically modified organism as referred to in the Regulation (EC) No ../....... of the European Parliament and of the Council 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. Justification With a view to fully informing consumers, all aspects taken into account in drawing up the opinion of the Food Safety Authority must be incorporated into the authorisation. Amendment 21 Article 8, paragraph 5 5.   The authorisation granted in accordance with the procedure laid down in this Regulation shall be valid throughout the Community for 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.   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. Justification Clarification of the text, with a view to avoiding any risk of conflicting with Article 11. Amendment 22 Article 9, paragraph 1 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:   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 (this shall also apply to products that represent a further stage in the processing of such products): Justification Necessary in order to establish transitional rules for additionally processed products. Amendment 23 Article 12, paragraph 2, point b (b)   a report on the results of the monitoring, if so specified in the authorisation;   (b)   a report on the results of the post‑market monitoring of the use of food for human consumption, if so specified in the authorisation in accordance with Article 6(3)(k) of this Regulation; Justification Clarification of the text. Amendment 24 Article 12, paragraph 2, point c (c)   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;   (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; Justification Intended to avoid a conflict between Article 10(3) and Article 12(2)(c) Amendment 25 Article 12, paragraph 4 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 period of authorisation of the product shall automatically be extended until the Commission takes a decision.   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 by one year. Justification Self-explaining. Amendment 26 Article 13, paragraph 1 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:   1.   This Section shall apply to foods referred to in Article 3(1) which are to be delivered as such to the final consumer or mass caterers in the Community. -   contain or consist of genetically modified organisms, or     -   are produced from or contain ingredients produced from genetically modified organisms.     Justification The scope of this section should correspond to the definition contained in Article 3. Amendment 27 Article 13, paragraph 1 a (new)     1a.   This Section shall not apply to foods in which the presence of protein or DNA resulting from genetic modification cannot be detected; Justification The labelling of foods produced with GMOs must be able to be controlled and enforced. In order to ensure that labelling requirements are enforceable, they must be based on the detectable presence of protein or DNA resulting from genetic modification. Amendment 28 Article 13, paragraph 2 2.   This Section shall not apply to foods containing material which contains, consists of or is produced from genetically modified organisms in a proportion no higher than the thresholds established in accordance with the procedure laid down in Article 36 (2), provided that this presence is adventitious or technically unavoidable.   2.   This Section shall not apply to foods containing material which is produced from genetically modified organisms in a proportion no higher than the thresholds established in accordance with Article 5 of this Regulation, provided that this presence is adventitious or technically unavoidable. 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 organisms (or produce thereof).   In order to establish that the presence of this material is adventitious or technically unavoidable, operators must supply evidence to satisfy the competent authorities that they have taken appropriate steps to avoid the presence of the genetically modified organisms (or produce thereof). Justification The amendment to Article 5 ensures that the threshold is laid down by a legislative decision. Amendment 29 Article 13, paragraph 4 (new)     4.   This Section shall not apply to foods obtained from animals fed with GMOs or products derived therefrom. Justification This point is stated in the introduction to the regulation as well as in the summary report, but should also be expressly stated here in order to avoid confusion. Amendment 30 Article 14, paragraph 2 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:   2.   In addition to the labelling requirements laid down in paragraph 1, the labelling shall mention the following characteristics or properties, as specified in the authorisation: (a)   Where a food is not equivalent to its conventional counterpart as regards:   (a)   Where a food is not equivalent to its conventional counterpart as regards these characteristics or properties: -   composition,   -   composition, -   nutritional value or nutritional effects,   -   nutritional value or nutritional effects, -   intended use of the food,   -   intended use of the food, -   implications for the health of certain sections of the population.   -   implications for the health of certain sections of the population. (b)   Where a food may give rise to ethical or religious concerns.   (b)   Where the characteristics or properties of a food may give rise to ethical or religious concerns. Justification Clarification of the text. Amendment 31 Chapter III, subheading Section 1 Authorisation and Monitoring   Deleted Justification See later amendment to Chapter III, subheading. Amendment 32 Article 16 1.   This Section shall apply to:   1.   This Section shall apply to: (a)   genetically modified organisms for feed use;   (a)   genetically modified organisms for feed use; (b)   feed containing or consisting of genetically modified organisms;   (b)   feed containing or consisting of genetically modified organisms; (c)   feed produced from 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) whether a type of feed falls within the scope of this Section.   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. Justification See amendment to Article 3. Amendment 33 Chapter III, subheading     Section 1 Authorisation and Monitoring Justification Restructuring of the chapter. The scope and the thresholds laid down in Article 18 appear to be common to both sections. This subheading is therefore being moved back. Amendment 34 Article 17, paragraphs 1 to 3 1.   Feed referred to in Article 16 (1) must not:   1.   Feed falling within the scope of this Chapter must not: (a)   present a risk for animal health, human health or the environment;   (a)   present a danger for animal health, human health or the environment; (b)   mislead the user;   (b)   mislead the user; (c)   harm the consumer by impairing the distinctive features of the animal products;   (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.   (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.   2.   No person shall place on the market, use or process a product 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.   3.   No product 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. Justification Clarification of the text and consistency with the wording of the Novel Foods Regulation (paragraph 1). Amendment 35 Article 91, paragraph 3, point (f)(a)(new)     (fa)   a proposal for the labelling of the feed consisting of, containing or produced from genetically modified organisms in accordance with Article 27 (3) (a); Justification Article 19(3) sets out the items to be included in all applications. Paragraph 19(f) stipulates that the applicant must, where relevant, make a proposal for labelling if the feed is not equivalent to its conventional counterpart (Art. 27 (3)(c) or gives rise to ethical concerns (Article 27(4)). This amendment requires the applicant to propose in addition a label referring to the genetic modification of the feed (Art. 27 (3) (a)). This amendment reflects the wording of Article 20(5)(d). Amendment 36 Article 19, paragraph 3, point j a (new)     (ja)   information on where reference material or samples will be made available by the applicant to the authorities and operators in the EU; Justification The EFSA and the competent authorities of the Member States (or control laboratories) require this information in order to be able to enforce legislation, and operators need it in order to be able to control and monitor their own supplies. . Easy access to samples or reference material held by the applicant is very important for operators in the EU in order to allow them to carry out their own controls. Amendment 37 Article 19, paragraph 5 5.   For genetically modified organisms and feed referred to respectively in Article 16 (1) (a) and (b), the application shall also be accompanied by:   5.   The application shall also be accompanied by: Justification This amendment makes the text more coherent. Amendment 38 Article 19, paragraph 5, point (a) (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 or, where the placing on the market of the genetically modified organisms has been authorised under Part Cof Directive 2001/18/EC, a copy of the authorisation decision;   (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 authorisation decision; Justification Article 19 (5) (a) implies that GMOs may be authorised for feed use under this Regulation although they have not been approved against Directive 2001/18/EC. Thus, the proposed Regulation shall replace as so-called sectoral legislation part C of Directive 2001/18/EC which regulates the placing on the market of GMOs. While such sectoral legislation is in principle possible, Art. 12 (4) of Directive 2001/18/EC stipulates that before such legislation is adopted "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 this Directive shall be introduced, in a Regulation of the European Parliament and of the Council." Since there has to date been no such regulation and the Commission has not proposed any such regulation or procedures, the regulation now being proposed cannot be considered ‘sectoral legislation’. Thus, Directive 2001/18/EC and the proposed regulation apply in parallel to GMOs for human or animal consumption; this approach is also more appropriate and must be upheld. Amendment 39 Article 20, paragraph 5, point g a (new)     (ga)   information on where reference material or samples will be made available by the applicant to operators in the EU; Justification The EFSA and the competent authorities of the Member States (or control laboratories) require this information in order to be able to enforce legislation, and operators need it in order to be able to control and monitor their own supplies. Easy access to samples or reference material held by the applicant is very important for operators in the EU in order to allow them to carry out their own controls. Amendment 40 Article 20, paragraph 7 7.   The Authority shall make its opinion public, after deletion of any information identified as confidential, in accordance with Article 31. The public may make comments to the Commission within 30 days from this publication.   7.   The Authority shall make its opinion public, after deletion of any information identified as confidential, in accordance with Article 31, but including the information referred to in Article 20(5)(f) and (g). The public may make comments to the Commission within 30 days from this publication. Justification Operators need this information in order to be able to control and monitor their own supplies. Easy access to samples or reference material held by the applicant is very important for operators in the EU in order to allow them to carry out their own controls. Amendment 41 Article 21, paragraph 2 2.   In the event of a draft decision which envisages the granting of authorisation, the draft decision shall include the particulars mentioned in Article 20 (5), the name of the authorisation holder, and, where appropriate, the unique code attributed to the genetically modified organism as referred to in the Regulation (EC) No ,,/,,, of the European Parliament and of the Council concerning traceability and labelling of genetically modified organisms and traceability of food and feed products produced from genetically modified organisms.   2.   In the event of a draft decision which envisages the granting of authorisation, the draft decision shall include the particulars mentioned in Article 20 (5), the name of the authorisation holder, and, where appropriate, the unique code attributed to the genetically modified organism as referred to in the Regulation (EC) No ,,/,,, of the European Parliament and of the Council 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. Justification See amendment to Article 8(2). Amendment 42 Article 21, paragraph 5 5.   The authorisation granted in accordance with the procedure laid down in this Regulation shall be valid throughout the Community for ten years and shall be renewable in accordance with Article 25. 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.   5.   Without prejudice to the procedure provided for in Article 24, 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 25. 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. Justification See amendment to Article 8(5). Amendment 43 Article 22, paragraph 1 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   1.   By derogation to Article 17 (2), products as referred to in Article 16 (1) which have been authorised or legally placed on the market before the date of application of this Regulation -   under Directives 90/220/EEC or 2001/18/EC, including use as feed,   -   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 82/471/EEC, which are produced from GMOs, or -   under Directive 70/524/EEC which contain, consist of or are produced from GMOs,   -   under Directive 70/524/EEC which contain, consist of or are produced from GMOs, may continue to be placed on the market, used and processed provided that the following conditions are met:   may continue to be placed on the market, used and processed provided that the following conditions are met: Justification Transitional arrangement for products from third countries . Amendment 44 Article 25, paragraph 4 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 period of authorisation of the product shall automatically be extended until the Commission takes a decision.   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 by one year. Justification Self-explaining. Amendment 45 Article 26, paragraph 1 a (new)     1a.   This Section shall not apply to feed or ingredients obtained from GMOs in which the presence of protein or DNA resulting from genetic modification cannot be detected; Justification The labelling of foods produced with GMOs must be able to be controlled and enforced. In order to ensure that labelling requirements are enforceable, they must be based on the detectable presence of protein or DNA resulting from genetic modification. Amendment 46 Article 26, paragraph 2 2.   This Section shall not apply to feed containing, consisting of or produced from genetically modified organisms in a proportion no higher than the thresholds established in accordance with the procedure laid down in Article 36 (2), provided that this presence is adventitious or technically unavoidable.   2.   This Section shall not apply to feed containing, consisting of or produced from genetically modified organisms in a proportion no higher than the threshold referred to in Article 5(1), provided that this presence is adventitious or technically unavoidable. In order to establish that the presence of this feed 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 organisms (or produce thereof).   In order to establish that the presence of this feed 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 organisms (or produce thereof).     Article 5(2) shall apply mutatis mutandis. Justification Clarification of the provisions of the text. Amendment 47 Article 40, paragraph 2 (2)   Article 7(5) is replaced by the following:   (2)   Article 7(5) is replaced by the following: “5. Member States shall ensure that a variety intended to be used in food or feed as defined in Articles 2 and 3 of Regulation (EC) No …./2001 laying down the general principles and requirements of food law, establishing the European Food 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 under Directive 90/220/EEC or Directive 2001/18/EC for feed or Regulation ---/---/EC on genetically modified food and feed.”   “5. Member States shall ensure that a variety intended to be used in food or feed as defined in Articles 2 and 3 of Regulation (EC) No 178/2002 laying down the general principles and requirements of food law, establishing the European Food Authority, and laying down procedures in matters of food safety, is accepted only if it has been authorised under the relevant legislation. Justification There is no need to list in detail the various regulations and directives under which a plant variety should have been approved before it is accepted for registration.

2 April 2002 OPINION OF THE COMMITTEE ON AGRICULTURE AND RURAL DEVELOPMENT for the Committee on the Environment, Public Health and Consumer Policy on the proposal for a Council regulation on the proposal of the European Parliament and of the Council on genetically modified food and feed (COM(2001) 425 – C5‑0368/2001 – 2001/0173(COD)) Draftsman: Joseph Daul PROCEDURE The Committee on Agriculture and Rural Development appointed Danielle Auroi draftsman at its meeting of 12 September 2001. After the vote the draftsman, Danielle Auroi, decided not to table the opinion under her name. Joseph Daul, chairman of the Committee on Agriculture and Rural Development, therefore agreed to take it over. The committee considered the draft opinion at its meetings of 23 January, 19 February and 20 March 2002. At the last meeting it adopted the following amendments unopposed, with 1 abstention. The following were present for the vote: Joseph Daul (chairman), Albert Jan Maat, María Rodríguez Ramos (vice-chairmen), Danielle Auroi (draftsman), Gordon J. Adam, Alexandros Baltas (for António Campos), Carlos Bautista Ojeda, Sergio Berlato, Reimer Böge, (for Arlindo Cunha), Giorgio Celli, Alejandro Cercas (for Jean-Claude Fruteau), Francesco Fiori, Christos Folias, Georges Garot, Lutz Goepel, Willi Görlach, Cristina Gutiérrez Cortines (for Encarnación Redondo Jiménez pursuant to Rule 153(2)), Liam Hyland, Elisabeth Jeggle, Salvador Jové Peres, Heinz Kindermann, Dimitrios Koulourianos, Vincenzo Lavarra, Xaver Mayer, Emilia Franziska Müller (for Michl Ebner), Neil Parish, Mikko Pesälä, Giacomo Santini (for Hedwig Keppelhoff-Wiechert), Karin Scheele (for María Izquierdo Rojo pursuant to Rule 153(2)), Agnes Schierhuber and Robert William Sturdy. SHORT JUSTIFICATION 1.   Introduction This proposal for a regulation needs to be discussed within a specific context: that of the large-scale release of GMOs, without controls or genuine traceability, and of the contamination of conventional organisms (or products) with a slight GMO content. Its main concern is guaranteed traceability. The proposal is particularly concerned with animal feed as a whole, and even directly, in terms of cultivated fields (see the AFSSA report on the contamination of non-GMO maize fields with modified maize). There is an equally serious problem in relation to transformation products intended for human consumption, including retail products (see the study carried out by the French magazine 60 millions de consommateurs on GMOs in food). These studies also prove that scientists are now able to detect GMO traces present in a concentration of under 1%. This contamination by GMOs raises the issue of the progressive introduction of a product which the majority of consumers do not want. It represents an attack on freedom of choice, and may also be seen as a knowing tactic used by GMO producers. However, the Commission proposal seems tacitly to accept this situation. In addition, GMOs in animal feed bear no relation to the customary justification of GMOs as having a therapeutic goal. There are only two vaccines on the list of the GMOs authorised under Directive 2001/18/EC, formerly 90/220/EEC, while the other authorisations are for agricultural products for commercial purposes, and just one might be useful in animal rearing (a kit for the detection of antibiotics residues in milk). When the Council adopted Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms (repealing Directive 90/220/EEC), on 12 March 2001, six Member States reaffirmed their intention to ensure, within the framework of the powers conferred on them, that new consents for the planting and placing on the market of GMOs were suspended pending the adoption of effective provisions on total traceability for GMOs, enabling reliable labelling to be guaranteed for all products derived from GMOs. As a result, on 25 July 2001, the Commission adopted its proposals for new regulations on genetically modified food and feed and on the traceability of GMOs. This proposal by the Commission is also a response to a long-standing wish expressed by Parliament, which in December 1999 had already called on the Commission ‘to come forward rapidly with proposals for the labelling of GMOs in animal feed and products derived from animals reared on GMO feed’(3). Parliament did not imply that in accepting Directive 2001/18/EC, it was accepting a possible contamination of conventional products by GMOs. In its January 2002 issue the French monthly publication 60 millions de consommateurs published the results of an analytical investigation which revealed that of 103 items of maize‑and soya-based food intended for human consumption, 36 contained genetically modified organisms. The results of these analyses are worrying and demonstrate that products which might be thought GMO-free, since they are unlabelled, contain GMOs all the same. This means that there are questions to be answered on traceability and ways to perpetuate a GMO‑free strain. Accepting the Commission’s proposal would result in the authorisation of a level of possible contamination of food by GMOs, without precise labelling and therefore without genuine information for European citizens, and in opposition to the opinion of the majority. However, we now have the scientific means available to lower the 1% threshold, since much lower levels have been detected. In any case, such a provision must permit consumers who wish to avoid GMOs totally in their diet to exercise their freedom of choice without any constraint, as is their legitimate right. The proposal for a regulation remains ambiguous on points which must be clarified in order to have genuine traceability Animal products derived from animals fed on genetically modified feed Products derived from animals which have been fed on feed produced from GMOs are not categorised as products ‘produced from GMOs’ and are not covered by the proposed regulation. In the same way ingredients, such as enzymes, vitamins or additives, various products genetically modified with the help of micro-organisms, would not be covered by the proposed regulation. These systematic exceptions are not justified. Thresholds for traces of GMOs produced from authorised GMOs Products containing material produced from GMOs may be put on the market without labelling only if: 1.   the content of material produced from authorised GMOs does not exceed 0.5% 2.   the presence of material produced from authorised GMOs is genuinely ‘adventitious’ or ‘technically unavoidable’ 3.   There must be a guarantee of traceability for imported products. It is known that some large European retailers use rice from China in their products, and there is no guarantee that this is GMO-free. The same derogation cannot be granted to non-authorised GMOs, since this would have the effect of undermining all European Union legislation on bio-safety. Contamination by GMOs and the ‘polluter pays’ principle In order to establish that the presence of genetically modified material is adventitious or technically unavoidable, the Commission proposes that operators should be in a position to demonstrate to the competent authorities that they have taken appropriate steps to avoid the presence of genetically modified organisms (or products produced from such organisms). This concept of a maximum threshold places the burden of proof on the shoulders of producers and processors who do not wish to use GMOs or products of GMOs. They must demonstrate that they have taken appropriate steps to avoid contamination. In fact, it is those who produce and use GMOs who should be obliged to take all possible steps to avoid contamination of other products by their own. The relationship between the proposed regulation and relevant Community legislation The Commission proposes that Articles 13 to 24 of Directive 2001/18/EC should not apply to GMOs authorised under the proposed regulation because this regulation is ‘sectoral legislation’ under Article 12 of the directive. Unfortunately, the Commission has forgotten that before sectoral legislation is adopted Parliament and the Council must introduce in a regulation ‘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 this Directive’ (see Article 12(3) of Directive 2001/18/EC). Article 12(3) categorically states that ‘until the Regulation enters into force, any GMO as or in products as far as they are authorised by other Community legislation shall only be placed on the market after having been accepted for placing on the market in accordance with this Directive.’ Since there has to date been no such regulation and the Commission has not proposed any such regulation, the regulation now being proposed cannot be considered ‘sectoral legislation’ under Article 12. Thus, Directive 2001/18/EC and the proposed regulation apply in parallel to GMOs for human or animal consumption; this approach is also more appropriate and must be upheld. 2.   Conclusion These Commission proposals seem too tentative, or even woolly. Therefore, your rapporteur calls on the Committee on the Environment, Public Health and Consumer Policy, as the committee responsible, to include the following amendments in the opinion which it adopts. AMENDMENTS The Committee on Agriculture and Rural Development calls on the Committee on the Environment, Public Health and Consumer Policy, as the committee responsible, to incorporate the following amendments in its report: Text proposed by the Commission(4) Amendments by Parliament Amendment 1 Recital 3 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.   In order to protect human and animal health, food and feed consisting of, containing or obtained or derived 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. (This amendment, if adopted, shall be extended to the entire text of the regulation.) Justification The most suitable term should be used in each language. The same change is proposed in the draft opinion by Encarnación Redondo Jiménez on the Commission proposal concerning traceability and labelling of genetically modified organisms and traceability of food and feed products produced from genetically modified organisms. Amendment 2 Recital 4a (new)     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. Justification Self-explanatory. Amendment 3 Recital 8 (8)   The new authorisation procedures for genetically modified food and feed should include the new principles introduced in Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC [19]. They should further make use of the new framework for risk assessment in matters of food safety set up by Regulation (EC) No ../... laying down the general principles and requirements of food law, establishing the European Food Authority, and laying down procedures in matters of food safety [20]. 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 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.   (8)   The new authorisation procedures for genetically modified food and feed should include the new principles introduced in Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC [19]. They should further make use of the new framework for risk assessment in matters of food safety set up by Regulation (EC) No ../... laying down the general principles and requirements of food law, establishing the European Food Safety Authority, and laying down procedures in matters of food safety [20]. 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. (This amendment, if adopted, shall be extended to the entire text of the regulation.) Justification The correct name for the Authority must be employed. Amendment 4 Recital 20 (20)   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.   (20)   The labelling should include objective information that a food or feed consists of, contains or is produced from GMOs or is derived from a GMO where DNA or protein resulting from genetic modification is detected; however, if it is not possible to detect analytically DNA or protein which has been modified by means of genetic engineering, the product need not bear a GMO label. Justification If it is not possible to demonstrate analytically that a product which is to be marketed contains a detectable level of genetically modified DNA or protein, there is no reason for GMO labelling of a food or feed. In such circumstances, the labelling would not be of any benefit to the consumer. Moreover, EU importers would be placed at a competitive disadvantage, since in practice it is very difficult to monitor production in third countries. Amendment 5 Recital 22 Regulation (EC) No .../... of the European Parliament and of the Council concerning traceability and labelling of genetically modified organisms and traceability of food and feed products produced from genetically modified organisms 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 thereof and should thereby facilitate accurate labelling.   Regulation (EC) No .../... of the European Parliament and of the Council concerning traceability and labelling of genetically modified organisms and traceability and labelling of food and feed products obtained or derived from genetically modified organisms 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 thereof and should thereby facilitate accurate labelling. Justification This amendment seeks to secure consistency with the draft opinion on the Commission proposal concerning traceability and labelling of genetically modified organisms and traceability of food and feed products produced from genetically modified organisms. Amendment 6 Recital 25 In order to ensure the practicability and feasibility of this Regulation, a threshold of 1 %, with the possibility of establishing lower levels, should be established for minute traces in food or feed of genetically modified material not authorised under Community legislation, where the presence of such material is adventitious or technically unavoidable; Directive 2001/18/EC should be amended accordingly.   The feasibility of this Regulation shall be ensured by means of the establishment, under Directive 2001/18 as amended by European Parliament and Council Regulation No …/… concerning traceability and labelling of genetically modified organisms and traceability of food and feed products produced from genetically modified organisms, of a threshold of 1 %, with the possibility of establishing lower levels, for minute traces in food or feed of genetically modified material not authorised under Community legislation, where the presence of such material is adventitious or technically unavoidable. Justification This amendment seeks to secure consistency with the draft opinion on the Commission proposal concerning traceability and labelling of genetically modified organisms and traceability of food and feed products produced from genetically modified organisms. Amendment 7 Article 2, point 2 (2)   the definitions of 'organism', 'genetically modified organism' ('GMO'), 'deliberate release' and 'environmental risk assessment' laid down in Directive 2001/18/EC 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; this Regulation shall not apply to organisms which have been genetically modified using a technique or method referred to in Annex I B to Directive 2001/18/EC; Justification Article 2(2) of Directive 2001/18 defines ‘GMO’. Article 3(1) of the Directive explicitly excludes from its scope organisms obtained through the techniques of genetic modification listed in Annex I B. In the interests of legal certainty and consistency, the definitions applicable in the fields of traceability and labelling in Directive 2001/18 and in the Regulation must be coherent. Amendment 8 Article 2, point 7 (7)   'control sample' means the genetically modified organism or its genetic material (positive sample) or the parental organism or its genetic material that has been used for the purpose of the genetic modification (negative sample).   (7)   'control sample' means the genetically modified organism or its genetic material (positive sample). Justification Control samples using parental lines as negative controls are of little help for enforcement and other testing laboratories. Parental lines are hardly ever used for commercial planting and thus are of academic interest only. Amendment 9 Article 3, point 1 Scope 1.   This Section shall apply to: (a)   genetically modified organisms for food use,   Scope 1.   This Section shall apply to: (a)   genetically modified organisms for food use, falling within the scope of Directive 2001/18, (b)   food containing or consisting of genetically modified organisms,   (b)   food containing or consisting of these genetically modified organisms, (c)   food produced from or containing ingredients produced from genetically modified organisms.   (c)   food produced from or containing ingredients produced from these genetically modified organisms. Justification The scope of this proposal should be in line with the proposal on GM traceability and labelling, COM(2001) 182 final, and Directive 2001/18 on deliberate release to the environment. Amendment 10 Article 5 Adventitious or technically unavoidable presence of genetically modified material The presence in food of material which contains, consists of or is produced from genetically modified organisms in a proportion no higher than 1 % or lower thresholds established in accordance with the procedure laid down in Article 36 (2), shall not be considered to be in breach of Article 4 (2), provided that this presence is adventitious or technically unavoidable and that the genetically modified material has been subject to a scientific risk assessment made by the relevant Scientific Committee(s) or the European Food Authority, which concludes that this material does not present a risk for human health or the environment.   Adventitious or technically unavoidable presence of genetically modified material The presence in food of material which contains, consists of or is produced from genetically modified organisms in a proportion no higher than 1 % or any other threshold established in accordance with the procedure laid down in Article 36 (2), shall not be considered to be in breach of Article 4 (2), provided that this presence is adventitious or technically unavoidable and that the genetically modified material has been subject to a scientific risk assessment made by the relevant Scientific Committee(s) or the European Food Safety Authority, or by third countries with comparable food safety standards, which concludes that this material does not present a risk for human health or the environment. A list of countries with comparable food safety standards 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 demonstrate to the competent authorities that they have taken appropriate steps to avoid the presence of the genetically modified organisms (or produce thereof).   In order to establish that the presence of this material is adventitious or technically unavoidable, operators must be in a position to demonstrate to the competent authorities that they have taken appropriate steps to avoid the presence of the genetically modified organisms (or produce thereof).     The Commission shall establish within six months after the publication of this regulation and in close cooperation with the (competent authorities of the) Member States guidelines defining criteria for these appropriate steps to avoid the presence of GMOs and products thereof. These guidelines shall be made public. Justification To allow flexibility to define other thresholds in accordance with a case-by-case approach to each food crop or other food ingredient. In the context of rapid and broad development of GM crops outside the EU, food manufacturers are experiencing increased difficulty in avoiding adventitious presence of GMOs approved in third countries in the food chain. In order to achieve uniformity of requirements within the EU on the demonstration to the Competent Authorities of the Member States that the operator has taken appropriate steps to avoid the presence of the GM food and feed and facilitate the movement of goods, appropriate guidelines for “identity preserved” supplies should be defined as soon as possible. Amendment 11 Article 6, point 2 Application for authorisation 2.   The Authority shall acknowledge receipt of the application, in writing, to the applicant within 15 days of its receipt. The acknowledgement shall state the date of receipt of the application.   Application for authorisation 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. Justification References to time periods are variously made to “X days” or “Y months”. The time periods should be consistently described and should, ideally, specify whether the number of days is absolute or “working days”, and in accordance with which Member State’s calendar of Bank Holidays. Amendment 12 Article 6, point 3(i) (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 food and/or in foods produced from it;   (i)   a method for detection, including sampling and identification of the transformation event; Justification In view of the large number of food preparations and the complexity of sampling, extraction and method of determination for such a wide range of products, applicants may confine themselves to providing methods of determination for the actual genetic modification in question. Amendment 13 Article 6, point 3(k) (k)   where appropriate, a proposal for post-market monitoring for the use of the food for human consumption;   (k)   where the food is not equivalent to its conventional counterpart in accordance with Art 14(2)a, second, third and fourth indent and where appropriate, a proposal for post-market monitoring for the use of the food for human consumption; Justification Whilst post-market monitoring is included in the proposal, we are nowhere near a practical proposal for how this could be achieved across the EU, effectively a major stumbling block for authorisations. Post-market monitoring, whilst feasible for medicines, will be extremely difficult and extremely expensive to implement in the case of internationally traded foodstuffs and ingredients. For these reasons, post-market monitoring should be restricted to those cases deemed during the course of the safety assessment to be sufficiently different from the conventional product to require surveillance. Amendment 14 Article 13, point 1 a (new)     1a.   This section shall not apply to foods in which neither protein nor DNA resulting from genetic modification is detectable. Justification The intention is to prevent fraud and make the regulation applicable and enforceable. These exemptions are stated in the introduction of the regulation and also in the summary report but should also be stated here explicitly to avoid confusion. Amendment 15 Article 13, point 2 2.   This Section shall not apply to foods containing material which contains, consists of or is produced from genetically modified organisms in a proportion no higher than the thresholds established in accordance with the procedure laid down in Article 36 (2), provided that this presence is adventitious or technically unavoidable. 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 organisms (or produce thereof).   2.   This Section shall not apply to foods containing material which contains, consists of or is produced from genetically modified organisms in a proportion no higher than the thresholds established in accordance with the procedure laid down in Article 36 (2), provided that this presence is adventitious or technically unavoidable or if it is not possible to detect analytically DNA or protein which has been modified by means of genetic engineering. 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 organisms (or produce thereof). Justification If it is not possible to demonstrate by means of scientific analysis methods and measurements that genetically modified DNA or protein can be detected in a product placed on the market, there are no grounds for marking such foods as genetically modified. What is essential for consumers is to know not whether GMOs have been used at some stage in the production process but whether the end product contains GMO residues or not. Since it is also not possible to detect GMO residues in products imported from third countries, compulsory labelling could place European products at a competitive disadvantage. Amendment 16 Article 13, points 2 a and 2 b (new)     2a.   This Section shall apply to processing aids.     2b.   This Section shall not apply to foods produced from animals fed with GMOs or products thereof. Justification The intention is to prevent fraud and make the regulation applicable and enforceable. These exemptions are stated in the introduction of the regulation and also in the summary report but should also be stated here explicitly to avoid confusion. Amendment 17 Article 14, point 1 (a) (a)   Where the food consists of more than one ingredient, the words 'genetically modified' or 'produced from genetically modified [name of organism] but not containing a genetically modified 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.   (a)   Where the food consists of more than one ingredient, the words 'genetically modified' or 'produced from genetically modified [name of ingredient]' 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. Justification Labelling is dealt with in several texts relating to GMOs, namely in Directive 2001/18, Article 26, in Regulation 1139/98 (with the wordings ‘produced from genetically modified [ingredient]’ and ‘genetically modified’) and also in Regulation 50/2000 (with the wording ‘produced from genetically modified [ingredient]’). For the sake of consistency between the different texts on GMOs and to facilitate the implementation of the new package of regulations, the wordings should be changed in line with the existing wording. Amendment 18 Article 14(1)(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] but not containing a genetically modified organism' shall appear in the list of ingredients.   Where the ingredient is designated by the name of a category, the words 'contains genetically modified [name of ingredient] or produced from genetically modified [name of organism]' shall appear in the list of ingredients. Justification It is necessary to provide for the possibility that the label may also need to include GM ingredients in the list of ingredients. Amendment 19 Article 14, point 1 (c) (c)   Where there is no list of ingredients, the words 'genetically modified' or 'produced from genetically modified [name of organism] but not containing a genetically modified organism' shall appear clearly on the labelling.   (c)   Where there is no list of ingredients, the words 'genetically modified' or 'produced from genetically modified [name of ingredient’ shall appear clearly on the labelling. Justification Labelling is dealt with in several texts relating to GMOs, namely in Directive 2001/18, Article 26, in Regulation 1139/98 (with the wordings ‘produced from genetically modified [ingredient]’ and ‘genetically modified’) and also in Regulation 50/2000 (with the wording ‘produced from genetically modified [ingredient]’). For the sake of consistency between the different texts on GMOs and to facilitate the implementation of the new package of regulations, the wordings should be changed in line with the existing wording. Amendment 20 Article 14(1)(da) (new)     (da)   Paragraphs (a), (b), (c) and (d) shall not apply to food and feed obtained or derived from GMOs in which DNA or protein deriving from genetic modification is not detected. Justification The methods of analysis currently available do not always detect traces of genetic modification in products obtained from GMOs. It follows that universal labelling would give rise to numerous cases of fraud and would not help achieve the basic objective, namely to ensure informed consumer choice. Amendment 21 Article 15 Detailed rules for implementing this Section may be adopted in accordance with the procedure laid down in Article 36 (2).   Detailed rules for implementing this Section may be adopted in accordance with the procedure laid down in Article 36 (2). In particular, the provisions of Article 14(4) shall be given effect by measures which specify inter alia: (a)   the level of varietal purity required for seed planted for the production of the crop in question; (b)   the standard distances to be respected between varieties planted; (c)   the methods to be applied to cleaning harvesting equipment to eliminate traces of GMO prior to harvesting a crop in respect of which it is to be claimed that it is non-GM; (d)   the measures to be taken to avoid the presence of DNA segments of GM origin in the non-GM product, in particular insofar as such segments are present in dust; (e)   the level to which transport equipment must be cleaned to ensure the absence of GMO traces in the non-GM product; (f)   the arrangements to be made at the point of first delivery to ensure the absence of comminglement of the non-GM product, including cleaning of bins and tanks, and of transfer equipment (augers, conveyor belts, etc.); (g)   the arrangements to be made for certifying by independent surveyors, for sealing onward shipments by road, whether bagged, by container, by bulk in trucks, by rail wagon, or by barge, to the point of further loading, including the preservation of the integrity and identity of the shipment at each point of transfer before an ocean terminal or transfer point is reached; (h)   the arrangements for sampling and testing at each stage of the transport, having regard to the need to deliver the non-GM product to the final user in a form which respects the level of absence of GM material required by this regulation for the non-GM claim to feature on the labelling of the food or feed product in question. Justification These measures would ensure the preservation of the identity of a crop and enable operators claiming that a food does not contain GMOs to substantiate that claim. Amendment 22 Article 16, point 1 Scope 1.   This Section shall apply to: (a)   genetically modified organisms for feed use;   Scope 1.   This Section shall apply to: (a)   genetically modified organisms for feed use falling within the scope of Directive 2001/18; (b)   feed containing or consisting of genetically modified organisms;   (b)   feed containing or consisting of these genetically modified organisms; (c)   feed produced from genetically modified organisms.   (c)   feed produced from these genetically modified organisms. Justification The scope of this proposal should be in line with the proposal on GM traceability and Directive 2001/18. (See also reference to proposed amendment to Article 3(1)). Amendment 23 Article 17(2) No person shall place on the market, use or process a product referred to in Article 16 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.   No person shall place on the market, use or process a product referred to in Article 16 for feed use unless it is covered by an authorisation granted in accordance with this Section and the relevant conditions of the authorisation are adhered to. Justification Feed not falling within the scope of this section is already dealt with in the reference to Article 16(1). The repetition can be eliminated. Amendment 24 Article 17(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.   No product referred to in Article 16(1) for feed use shall be authorised unless the applicant for such authorisation has adequately and sufficiently demonstrated that it satisfies the requirements of paragraph 1. Justification Feed not falling within the scope of this section is already dealt with in the reference to Article 16(1). The repetition can be eliminated. Amendment 25 Article 18, paragraph 1 The presence in feed of material which contains, consists of or is produced from genetically modified organisms in a proportion no higher than 1 % or lower thresholds established in accordance with the procedure laid down in Article 36 (2), shall not be considered to be in breach of Article 17 (2), provided that this presence is adventitious or technically unavoidable and that the genetically modified material has been subject to a scientific risk assessment made by the relevant Scientific Committee(s) or the European Food Authority, which concludes that this material does not present a risk for human health, animal health or the environment.   The presence in feed of material which contains, consists of or is produced from genetically modified organisms in a proportion no higher 1 %, with the possibility of lower levels to be established in accordance with the procedure laid down in Article 36(2), shall not be considered to be in breach of Article 4 (2), provided that this presence is adventitious or technically unavoidable and that the genetically modified material has been subject to a scientific risk assessment made by the relevant Scientific Committee(s), or the European Food Safety Authority, which concludes that this material is safe for human health or the environment. Justification It is impossible to avoid unintentional contamination during production and transport. Community legislation (e.g. Directive 2001/18) recognises that technically unavoidable traces of GMOs will be present in products. An important source of these traces is commercial production in third countries. In order to ensure the practicability and feasibility of the Regulation, it is necessary to establish a threshold of 1% with the possibility to establish lower levels by comitology. The thresholds should be based on the sensitivity of analytical methods, but also on what is practically achievable taking into account production, transport and food processing practices. Amendment 26 Article 18, paragraph 3 (new)     The Commission shall establish within six months after the publication of this regulation and in close cooperation with the (competent authorities of the) Member States a protocol defining criteria for these appropriate steps to avoid the presence of GMOs and produce thereof. This Protocol shall be made public. Justification In order to allow flexibility to define other thresholds in accordance with a case-by-case approach to food crops and other food ingredients. In the context of rapid and broad development of GM crops outside the EU, food manufacturers are experiencing increased difficulty in avoiding adventitious presence of GMOs approved in third countries in the food chain. In order to achieve uniformity of requirements within the EU on the demonstration to the Competent Authorities of the Member States that the operator has taken appropriate steps to avoid the presence of the GM food and feed and facilitate the movement of goods, appropriate guidelines for ‘identity preserved’ supplies should be defined as soon as possible. Amendment 27 Article 19, point 3(i) (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);   (i)   a method for detection, including sampling and identification of the transformation event; Justification In view of the large number of feed preparations and the complexity of sampling, extraction and method of determination for such a wide range of products, applicants may confine themselves to providing methods of determination for the actual genetic modification in question. Amendment 28 Article 26, point 1 a (new)     1a.   This Section shall not apply to feed or ingredients derived from GMOs in which neither DNA nor protein resulting from genetic modification is detectable. Justification The intention is to prevent fraud and make the regulation applicable and enforceable. (See also proposed amendment in respect of Article 13(1)). Amendment 29 Article 26, point 2 2.   This Section shall not apply to feed containing, consisting of or produced from genetically modified organisms in a proportion no higher than the thresholds established in accordance with the procedure laid down in Article 36 (2), provided that this presence is adventitious or technically unavoidable. In order to establish that the presence of this feed 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 organisms (or produce thereof).   2.   This Section shall not apply to feed containing, consisting of or produced from genetically modified organisms in a proportion no higher than the thresholds established in accordance with the procedure laid down in Article 36 (2), provided that this presence is adventitious or technically unavoidable or if it is not possible to detect analytically DNA or protein which has been modified by means of genetic engineering. In order to establish that the presence of this feed 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 organisms (or produce thereof). Justification If it is not possible to demonstrate by means of scientific analysis methods and measurements that genetically modified DNA or protein can be detected in a product placed on the market, there are no grounds for marking such feeds as genetically modified. What is essential for consumers is to know not whether GMOs have been used at some stage in the production process but whether the end product contains GMO residues or not. Since it is also not possible to detect GMO residues in products imported from third countries, compulsory labelling could place European products at a competitive disadvantage. Amendment 30 Article 27(3)(da) (new)     (da)   Paragraphs (a), (b), (c) and (d) shall not apply to food and feed obtained or derived from GMOs in which DNA or protein deriving from genetic modification is not detected. Justification The methods of analysis currently available do not always detect traces of genetic modification in products obtained from GMOs. It follows that universal traceability and labelling rules would give rise to numerous cases of fraud and would not help achieve the basic objective, namely to ensure informed consumer choice. In addition, since the products concerned are effectively the same as conventional products, there is no sense in differentiating them from the latter. Amendment 31 Article 28 Detailed rules for implementing this Section may be adopted in accordance with the procedure laid down in Article 36 (2).   Detailed rules for implementing this Section may be adopted in accordance with the procedure laid down in Article 36 (2). In particular, the provisions of Article 27(5) shall be given effect by measures which specify inter alia: (a)   the level of varietal purity required for seed planted for the production of the crop in question; (b)   the standard distances to be respected between varieties planted; (c)   the methods to be applied to cleaning harvesting equipment to eliminate traces of GMO prior to harvesting a crop in respect of which it is to be claimed that it is non-GM; (d)   the measures to be taken to avoid the presence of DNA segments of GM origin in the non-GM product, in particular insofar as such segments are present in dust; (e)   the level to which transport equipment must be cleaned to ensure the absence of GMO traces in the non-GM product; (f)   the arrangements to be made at the point of first delivery to ensure the absence of comminglement of the non-GM product, including cleaning of bins and tanks, and of transfer equipment (augers, conveyor belts, etc.); (g)   the arrangements to be made for certifying by independent surveyors, for sealing onward shipments by road, whether bagged, by container, by bulk in trucks, by rail wagon, or by barge, to the point of further loading, including the preservation of the integrity and identity of the shipment at each point of transfer before an ocean terminal or transfer point is reached; (h)   the arrangements for sampling and testing at each stage of the transport, having regard to the need to deliver the non-GM product to the final user in a form which respects the level of absence of GM material required by this regulation for the non-GM claim to feature on the labelling of the food or feed product in question. Justification These measures would ensure the preservation of the identity of a crop and enable operators claiming that a food does not contain GMOs to substantiate that claim. Amendment 32 Article 28a (new)     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. Justification Self-explanatory. Amendment 33 Article 30(2a) (new)     2a.   The register shall include information on the method(s) validated by the Community reference laboratory, pursuant to Articles 7(3)(f) and 20(3)(f), and on the methods used by the national reference laboratories. Justification All the methods used by the reference laboratories in the context of monitoring and implementation by the Member States should be made public. In particular, where a method has not been validated reliable information must be provided on the different methods used, in order to avoid confusion. Amendment 34 Article 36(1) The Commission shall be assisted by the Committee referred to in Article 57 (1) of Regulation (EC) No ..../2001 laying down the general principles and requirements of food law, establishing the European Food Authority, and laying down procedures in matters of food safety.   The Commission shall be assisted by the Committee referred to in Article 58 (1) of Regulation (EC) No ..../2001 laying down the general principles and requirements of food law, establishing the European Food Authority, and laying down procedures in matters of food safety. Justification The regulation on genetically modified food and feed is based on the common position for the regulation establishing the European Food Safety Agency. However, the numbering of the articles has changed in the new text of that regulation: hence the need to alter the reference. Amendment 35 Article 42 Article 42 Directive 2001/18/EC is amended with effect from the date of entry into force of this Regulation as follows:   Deleted ‘The following Article 12a is inserted: Article 12a Adventitious presence of GMOs in products Articles 13 to 21 shall not apply to the placing on the market of traces of a GMO or combination of GMOs in products intended for direct use as food or feed, or for processing, in a proportion no higher than 1 % or lower thresholds established in accordance with the procedure laid down in Article 30 (2), provided that these traces of GMOs are adventitious or technically unavoidable and that the GMOs have been subject to a scientific risk assessment made by the relevant Scientific Committee(s) or the European Food Authority, which concludes that the GMOs do not present a risk for human health or the environment. In order to establish that traces of GMOs are adventitious or technically unavoidable, operators must be in a position to demonstrate to the competent authorities that they have taken appropriate steps to avoid them’.     Justification Under Article 21(2) of Directive 2001/18/E, a maximum threshold may be introduced for ‘products where adventitious or technically unavoidable traces of authorised GMOs cannot be excluded’. Similarly, Commission Regulation (EC) No 49/2000 of 10 January 2000 (OJ L 6, 11.1.2000, p. 13) fixes a threshold of 1% only for authorised food produced from ingredients produced from authorised GMOs or containing such ingredients. In contrast, the maximum threshold put forward in Article 5 of the proposal applies to non-authorised products. A threshold for non-authorised GMOs and for products produced from non-authorised GMOs would undermine all the European Union’s legislation on bio-safety.