Regulation (EC) No 1829/2003 of the European Parliament and of the Council
of 22 September 2003
on genetically modified food and feed
(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty establishing the European Community, and in particular Articles 37, 95 and Article 152(4)(b) thereof,
Having regard to the proposal from the Commission,
OJ C 304 E, 30.10.2001, p. 221.
Having regard to the opinion of the European Economic and Social Committee,
OJ C 221, 17.9.2002, p. 114.
Having regard to the opinion of the Committee of the Regions,
OJ C 278, 14.11.2002, p. 31.
Acting in accordance with the procedure referred to in Article 251 of the Treaty,
Opinion of the European Parliament of 3 July 2002 (not yet published in the Official Journal), Council Common Position of 17 March 2003 (OJ C 113 E, 13.5.2003, p. 31), Decision of the European Parliament of 2 July 2003 (not yet published in the Official Journal) and Council Decision of 22 July 2003.
Whereas:
(1) The free movement of safe and wholesome food and feed is an essential aspect of the internal market and contributes significantly to the health and well-being of citizens, and to their social and economic interests.
(2) A high level of protection of human life and health should be ensured in the pursuit of Community policies.
(3) In order to protect human and animal health, food and feed consisting of, containing or produced from genetically modified organisms (hereinafter referred to as genetically modified food and feed) should undergo a safety assessment through a Community procedure before being placed on the market within the Community.
(4) Differences between national laws, regulations and administrative provisions concerning the assessment and authorisation of genetically modified food and feed may hinder their free movement, creating conditions of unequal and unfair competition.
(5) An authorisation procedure involving Member States and the Commission has been established for genetically modified foods in Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients. This procedure should be streamlined and made more transparent.
OJ L 43, 14.2.1997, p. 1.
(6) Regulation (EC) No 258/97 also provides for a notification procedure for novel foods which are substantially equivalent to existing foods. Whilst substantial equivalence is a key step in the procedure for assessment of the safety of genetically modified foods, it is not a safety assessment in itself. In order to ensure clarity, transparency and a harmonised framework for authorisation of genetically modified food, this notification procedure should be abandoned in respect of genetically modified foods.
(7) Feed consisting of or containing genetically modified organisms (GMOs) has so far been authorised, subject to the authorisation procedure provided by Council Directive 90/220/EEC of 23 April 1990 and Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms; no authorisation procedure exists for feed produced from GMOs; a single, efficient and transparent Community authorisation procedure for feed consisting of, containing or produced from GMOs should be established.
OJ L 117, 8.5.1990, p. 15. Directive repealed by Directive 2001/18/EC.
OJ L 106, 17.4.2001, p. 1. Directive as last amended by Council Decision 2002/811/EC (OJ L 280, 18.10.2002, p. 27).
(8) The provisions of this Regulation should also apply to feed intended for animals which are not destined for food production.
(9) The new authorisation procedures for genetically modified food and feed should include the new principles introduced in Directive 2001/18/EC. They should also make use of the new framework for risk assessment in matters of food safety set up by Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority, and laying down procedures in matters of food safety. 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 (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 cooperation between the Commission and the Member States.
OJ L 31, 1.2.2002, p. 1.
(10) 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.
(11) Under this Regulation, authorisation may be granted either to a GMO to be used as a source material for production of food or feed and products for food and/or feed use which contain, consist of or are produced from it, or to foods or feed produced from a GMO. Thus, where a GMO used in the production of food and/or feed has been authorised under this Regulation, foods and/or feed containing, consisting of or produced from that GMO will not need an authorisation under this Regulation, but will be subject to the requirements referred to in the authorisation granted in respect of the GMO. Furthermore, foods covered by an authorisation granted under this Regulation will be exempted from the requirements of Regulation (EC) No 258/97 concerning novel foods and novel food ingredients, except where they fall under one or more of the categories referred to in Article 1(2)(a) of Regulation (EC) No 258/97 in respect of a characteristic which has not been considered for the purpose of the authorisation granted under this Regulation.
(12) Council Directive 89/107/EEC of 21 December 1988 on the approximation of laws of the Member States concerning food additives authorised for use in foodstuffs intended for human consumption 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 within the scope of this Regulation for the safety assessment of the genetic modification, while the final authorisation should be granted under the procedure referred to in Directive 89/107/EEC.
OJ L 40, 11.2.1989, p. 27. Directive as amended by Directive 94/34/EC of the European Parliament and of the Council (OJ L 237, 10.9.1994, p. 1).
(13) Flavourings falling within the scope of Council Directive 88/388/EEC of 22 June 1988 on the approximation of the laws of the Member States relating to flavourings for use in foodstuffs and to source materials for their production which contain, consist of or are produced from GMOs should also fall within the scope of this Regulation for the safety assessment of the genetic modification.
OJ L 184, 15.7.1988, p. 61. Directive as amended by Commission Directive 91/71/EEC (OJ L 42, 15.2.1991, p. 25).
(14) Council Directive 82/471/EEC of 30 June 1982 concerning certain products used in animal nutrition 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 within the scope of this Regulation.
OJ L 213, 21.7.1982, p. 8. Directive as last amended by Directive 1999/20/EC (OJ L 80, 25.3.1999, p. 20).
(15) Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs, provides for an authorisation procedure for placing on the market additives used in feedingstuffs. In addition to this authorisation procedure, feed additives containing, consisting of or produced from GMOs should also fall within the scope of this Regulation.
OJ L 270, 14.12.1970, p. 1. Directive as last amended by Regulation (EC) No 1756/2002 (OJ L 265, 3.10.2002, p. 1).
(16) This Regulation should cover 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 source material is present in the food or in the feed. Processing aids 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 included in the scope of this Regulation. Thus, 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 referred to in this Regulation.
(17) In accordance with Article 153 of the Treaty, the Community is to contribute to promoting the right of consumers to information. In addition to other types of information to the public provided for in this Regulation, the labelling of products enables the consumer to make an informed choice and facilitates fairness of transactions between seller and purchaser.
(18) Article 2 of Directive 2000/13/EC of the European Parliament and of the Council of 20 March 2000 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs provides that labelling must not mislead the purchaser as to the characteristics of the foodstuff and among other things, in particular, as to its nature, identity, properties, composition, method of production and manufacturing.
OJ L 109, 6.5.2000, p. 29. Directive as amended by Commission Directive 2001/101/EC (OJ L 310, 28.11.2001, p. 19).
(19) Additional requirements for the labelling of genetically modified foods are laid down in Regulation (EC) No 258/97, in Council Regulation (EC) No 1139/98 of 26 May 1998 concerning the compulsory indication, on the labelling of certain foodstuffs produced from genetically modified organisms, of particulars other than those provided for in Directive 79/112/EEC and in Commission Regulation (EC) No 50/2000 of 10 January 2000 on the labelling of foodstuffs and food ingredients containing additives and flavourings that have been genetically modified or have been produced from genetically modified organisms.
OJ L 159, 3.6.1998, p. 4. Regulation as amended by Commission Regulation (EC) No 49/2000 (OJ L 6, 11.1.2000, p. 13).
OJ L 6, 11.1.2000, p. 15.
(20) 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, thereby enabling the user to make an informed choice.
(21) The labelling should include objective information to the effect 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 methods of manufacture or production.
(22) In addition, the labelling should give information about any characteristic or property which renders a food or feed different from its conventional counterpart with respect to composition, nutritional value or nutritional effects, intended use of the food or feed and health implications for certain sections of the population, as well as any characteristic or property which gives rise to ethical or religious concerns.
(23) Regulation (EC) No 1830/2003 of the European Parliament and of the Council of 22 September 2003 concerning the traceability and labelling of genetically modified organisms and traceability of food and feed products produced from genetically modified organisms and amending Directive 2001/18/EC ensures that relevant information concerning any genetic modification is available at each stage of the placing on the market of GMOs and food and feed produced therefrom and should thereby facilitate accurate labelling.
See page 24 of this Official Journal.
(24) Despite the fact that some operators avoid using genetically modified food and feed, such material may be present in minute traces in conventional food and feed as a result of adventitious or technically unavoidable presence during seed production, cultivation, harvest, transport or processing. In such cases, this food or feed should not be subject to the labelling requirements of this Regulation. In order to achieve this objective, a threshold should be established for the adventitious or technically unavoidable presence of genetically modified material in foods or feed, both when the marketing of such material is authorised in the Community and when this presence is tolerated by virtue of this Regulation.
(25) It is appropriate to provide that, when the combined level of adventitious or technically unavoidable presence of genetically modified materials in a food or feed or in one of its components is higher than the set threshold, such presence should be indicated in accordance with this Regulation and that detailed provisions should be adopted for its implementation. The possibility of establishing lower thresholds, in particular for foods and feed containing or consisting of GMOs or in order to take into account advances in science and technology, should be provided for.
(26) It is indispensable that operators strive to avoid any accidental presence of genetically modified material not authorised under Community legislation in food or feed. However, in order to ensure the practicability and feasibility of this Regulation, a specific threshold, with the possibility of establishing lower levels in particular for GMOs sold directly to the final consumer, should be established as a transitional measure for minute traces in food or feed of this genetically modified material, where the presence of such material is adventitious or technically unavoidable and provided that all specific conditions set in this Regulation are met. Directive 2001/18/EC should be amended accordingly. The application of this measure should be reviewed in the context of the general review of the implementation of this Regulation.
(27) 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.
(28) Operators should avoid the unintended presence of GMOs in other products. The Commission should gather information and develop on this basis guidelines on the coexistence of genetically modified, conventional and organic crops. Moreover, the Commission is invited to bring forward, as soon as possible, any further necessary proposal.
(29) The traceability and labelling of GMOs at all stages of placing on the market, including the possibility of establishing thresholds, is ensured by Directive 2001/18/EC and Regulation (EC) No 1830/2003.
(30) It is necessary to establish harmonised procedures for risk assessment and authorisation that are efficient, time-limited and transparent, and criteria for evaluation of the potential risks arising from genetically modified foods and feed.
(31) In order to ensure a harmonised scientific assessment of genetically modified foods and feed, such assessments should be carried out by the Authority. However, as specific acts or omissions on the part of the Authority under this Regulation could produce direct legal effects on applicants, it is appropriate to provide for the possibility of an administrative review of such acts or omissions.
(32) It is recognised that, in some cases, scientific risk assessment alone cannot provide all the information on which a risk management decision should be based, and that other legitimate factors relevant to the matter under consideration may be taken into account.
(33) Where the application concerns products containing or consisting of a genetically modified organism, the applicant should have the choice of either supplying an authorisation for the deliberate release into the environment already obtained under part C of Directive 2001/18/EC, without prejudice to the conditions set by that authorisation, or of applying for the environmental risk assessment to be carried out at the same time as the safety assessment under this Regulation. In the latter case, it is necessary for the evaluation of the environmental risk to comply with the requirements referred to in Directive 2001/18/EC and for the national competent authorities designated by Member States for this purpose to be consulted by the Authority. In addition, it is appropriate to give the Authority the possibility of asking one of these competent authorities to carry out the environmental risk assessment. It is also appropriate, in accordance with Article 12(4) of Directive 2001/18/EC, for the national competent authorities designated under the said Directive in all cases concerning GMOs and food and/or feed containing or consisting of a GMO to be consulted by the Authority before it finalises the environmental risk assessment.
(34) In the case of GMOs to be used as seeds or other plant-propagating materials falling within the scope of this Regulation, the Authority should be under an obligation to delegate the environmental risk assessment to a national competent authority. Nonetheless, authorisations under this Regulation should be without prejudice to the provisions of Directives 68/193/EEC, 2002/53/EC and 2002/55/EC, which provide in particular for the rules and the criteria for the acceptance of varieties and their official acceptance for inclusion in common catalogues; nor should they affect the provisions of Directives 66/401/EEC, 66/402/EEC, 68/193/EEC, 92/33/EEC, 92/34/EEC, 2002/54/EC, 2002/55/EC, 2002/56/EC or 2002/57/EC which regulate in particular the certification and the marketing of seeds and other plant-propagating materials.
OJ L 93, 17.4.1968, p. 15. Directive as last amended by Directive 2002/11/EC (OJ L 53, 23.2.2002, p. 20).
OJ L 193, 20.7.2002, p. 1.
OJ L 193, 20.7.2002, p. 33.
OJ 125, 11.7.1966, p. 2298/66. Directive as last amended by Directive 2001/64/EC (OJ L 234, 1.9.2001, p. 60).
OJ 125, 11.7.1966, p. 2309/66. Directive as last amended by Directive 2001/64/EC.
OJ L 157, 10.6.1992, p. 1. Directive as last amended by Regulation (EC) No 806/2003 (OJ L 122, 16.5.2003, p. 1).
OJ L 157, 10.6.1992, p. 10. Directive as last amended by Regulation (EC) No 806/2003.
OJ L 193, 20.7.2002, p. 12.
OJ L 193, 20.7.2002, p. 60. Directive amended by Commission Decision 2003/66/EC (OJ L 25, 30.1.2003, p. 42).
OJ L 193, 20.7.2002, p. 74. Directive amended by Commission Directive 2003/45/EC (OJ L 138, 5.6.2003, p. 40).
(35) It is necessary to introduce, where appropriate and on the basis of the conclusions of the risk assessment, post-market monitoring requirements for the use of genetically modified foods for human consumption and for the use of genetically modified feed for animal consumption. In the case of GMOs, a monitoring plan concerning environmental effects is compulsory under Directive 2001/18/EC.
(36) To facilitate controls on genetically modified food and feed, applicants for authorisation should propose appropriate methods for sampling, identification and detection, and deposit samples of the genetically modified food and feed with the Authority; methods of sampling and detection should be validated, where appropriate, by the Community reference laboratory.
(37) Technological progress and scientific developments should be taken into account when implementing this Regulation.
(38) Food and feed falling within the scope of this Regulation which have been lawfully placed on the Community market before the date of application of this Regulation should continue to be allowed on the market, subject to the transmission to the Commission by the operators of information concerning the risk assessment, methods for sampling, identification and detection as appropriate, including the transmission of samples of the food and feed and their control samples within six months after the date of application of this Regulation.
(39) A register of genetically modified food and feed authorised under this Regulation should be established, including product specific information, studies which demonstrate the safety of the product, including, where available, references to independent and peer-reviewed studies, and to methods for sampling, identification and detection. Non-confidential data should be made available to the public.
(40) In order to stimulate research and development into GMOs for food and/or feed use, it is appropriate to protect the investment made by innovators in gathering the information and data supporting an application under this Regulation. This protection should however be limited in time in order to avoid the unnecessary repetition of studies and trials which would be against the public interest.
(41) The measures necessary for the implementation of this Regulation should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission.
OJ L 184, 17.7.1999, p. 23.
(42) Provision should be made for consultation of the European Group on Ethics in Science and New Technologies established by Commission Decision of 16 December 1997, or any other appropriate body established by the Commission, with a view to obtaining advice on ethical issues regarding the placing on the market of genetically modified food or feed. Such consultations should be without prejudice to the competence of Member States as regards ethical issues.
(43) In order to provide a high level of protection of human life and health, animal health and welfare, environment and consumer interests in relation to genetically modified food and feed, requirements arising from this Regulation should apply in a non-discriminatory manner to products originating in the Community and imported from third countries, in accordance with the general principles referred to in Regulation (EC) No 178/2002. The content of this Regulation takes account of the international trade commitments of the European Communities and of the requirements of the Cartagena Protocol on Biosafety to the Convention on Biological Diversity as regards importer obligations and notification.
(44) Certain instruments of Community law should be repealed and others amended as a result of this Regulation.
(45) The implementation of this Regulation should be reviewed in the light of experience gained in the short term, and the impact of the application of this Regulation on human and animal health, consumer protection, consumer information and the functioning of the internal market should be monitored by the Commission,
HAVE ADOPTED THIS REGULATION:

CHAPTER I OBJECTIVE AND DEFINITIONS

Article 1 Objective
The objective of this Regulation, in accordance with the general principles laid down in Regulation (EC) No 178/2002, is to:
(a) provide the basis for ensuring a high level of protection of human life and health, animal health and welfare, environment and consumer interests in relation to genetically modified food and feed, whilst ensuring the effective functioning of the ... market;
Word in Art. 1(a) omitted (31.12.2020) by virtue of The Genetically Modified Food and Feed (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/705), regs. 1, 5(a); 2020 c. 1, Sch. 5 para. 1(1)
(b) lay down ... procedures for the authorisation and supervision of genetically modified food and feed;
Word in Art. 1(b) omitted (31.12.2020) by virtue of The Genetically Modified Food and Feed (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/705), regs. 1, 5(b); 2020 c. 1, Sch. 5 para. 1(1)
(c) lay down provisions for the labelling of genetically modified food and feed.

Article 2 Definitions
For the purposes of this Regulation:
1. the definitions of ‘food’, ‘feed’, ‘final consumer’, ‘food business’ and ‘feed business’ given in Regulation (EC) No 178/2002 shall apply;
2. the definition of ‘traceability’, laid down in Regulation (EC) No 1830/2003;
3. ‘operator’ means the natural or legal person responsible for ensuring that the requirements of this Regulation are met within the food businesses or feed businesses under its control;
4. the definitions of ‘organism’, ‘deliberate release’ and ‘environmental risk assessment’ referred to in Directive 2001/18/EC shall apply;
5. ‘genetically modified organism’ or ‘GMO’ means a genetically modified organism as defined in Article 2(2) of Directive 2001/18/EC, excluding organisms obtained through the techniques of genetic modification listed in Annex I B to Directive 2001/18/EC and, in relation to England, excluding precision bred plants;
Words in Art. 2(5) inserted (13.11.2025) by The Genetic Technology (Precision Breeding) Regulations 2025 (S.I. 2025/581), reg. 1(1), Sch. 5 para. 1(2)
6. ‘genetically modified food’ means food containing, consisting of or produced from GMOs;
7. ‘genetically modified feed’ means feed containing, consisting of or produced from GMOs;
8. ‘genetically modified organism for food use’ means a GMO that may be used as food or as a source material for the production of food;
9. ‘genetically modified organism for feed use’ means a GMO that may be used as feed or as a source material for the production of feed;
10. ‘produced from GMOs’ means derived, in whole or in part, from GMOs, but not containing or consisting of GMOs;
11. ‘control sample’ means the GMO 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);
12. ‘conventional counterpart’ means a similar food or feed produced without the help of genetic modification and for which there is a well-established history of safe use;
13. ‘ingredient’ means ‘ingredient’ as referred to in Article 6(4) of Directive 2000/13/EC;
14. ‘placing on the market’ means the holding of food or feed for the purpose of sale, including offering for sale, or any other form of transfer, whether free of charge or not, and the sale, distribution and other forms of transfer themselves.
15. ‘pre-packaged food’ means any single item for presentation as such consisting of a food and the packaging into which it was put before being offered for sale, whether such packaging encloses the food completely or only partially, provided that the contents cannot be altered without opening or changing the packaging.
16. ‘mass caterer’ means ‘mass caterer’ as referred to in Article 1 of Directive 2000/13/EC. .
17. "Food Safety Authority“” means—
(a) as regards England and Wales, the Food Standards Agency;
(b) as regards Scotland, Food Standards Scotland;
Art. 2(17)-(23) inserted (31.12.2020) by The Genetically Modified Food and Feed (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/705), regs. 1, 6 (as amended by The Food and Feed Hygiene and Safety (Miscellaneous Amendments etc.) (EU Exit) Regulations 2020 (S.I. 2020/1504), regs. 1(2), 17(2)); 2020 c. 1, Sch. 5 para. 1(1)
18. "appropriate authority“” means—
(a) in relation to England, the Secretary of State;
(b) in relation to Wales, the Welsh Ministers;
(c) in relation to Scotland, the Scottish Ministers;
19. ‘prescribe’ means prescribe by regulations;
20. ‘third country’ means any country or territory other than the British Islands;
21. ‘public analyst’ has the meaning it bears in the Food Safety Act 1990;
23. ‘preference laboratory’ means the laboratory appointed by the appropriate authority in accordance with Article 32.
24. ‘Register’ means the register of genetically modified food and feed referred to in Article 28.
Art. 2(24) inserted (1.4.2025) by The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), regs. 1(2), 14(2) (with reg. 23)
25. ‘precision bred plant’ has the same meaning as in section 1, as read with section 2(1), of the Genetic Technology (Precision Breeding) Act 2023.
Art. 2(25) inserted (13.11.2025) by The Genetic Technology (Precision Breeding) Regulations 2025 (S.I. 2025/581), reg. 1(1), Sch. 5 para. 1(3)

CHAPTER II GENETICALLY MODIFIED FOOD

Section 1 Authorisation and supervision

Article 3 Scope
1. This Section shall apply to:
(a) GMOs for food use;
(b) food containing or consisting of GMOs;
(c) food produced from or containing ingredients produced from GMOs.
2. Where necessary, the appropriate authority may prescribe measures designed to amend non-essential elements of this Regulation by supplementing it and determining whether a type of food falls within the scope of this Section.
Art. 3(2) substituted (31.12.2020) by The Genetically Modified Food and Feed (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/705), regs. 1, 7; 2020 c. 1, Sch. 5 para. 1(1)

Article 4 Requirements
1. Food referred to in Article 3(1) must not:
(a) have adverse effects on human health, animal health or the environment;
(b) mislead the consumer;
(c) differ from the food which it is intended to replace to such an extent that its normal consumption would be nutritionally disadvantageous for the consumer.
2. No person shall place on the market a GMO for food use or food referred to in Article 3(1) unless it is covered by an authorisation granted in accordance with this Section and the relevant conditions of the authorisation are satisfied.
3. No GMO for food use or food referred to in Article 3(1) shall be authorised unless the applicant for such authorisation has adequately and sufficiently demonstrated that it satisfies the requirements of paragraph 1 of this Article.
4. The authorisation referred to in paragraph 2 may cover:
(a) a GMO and foods containing or consisting of that GMO as well as foods produced from or containing ingredients produced from that GMO; or
(b) food produced from a GMO as well as foods produced from or containing that food;
(c) an ingredient produced from a GMO as well as food containing that ingredient.
5. An authorisation as referred to in paragraph 2 shall not be granted, refused, ... modified, suspended or revoked except on the grounds and under the procedures set out in this Regulation.
Word in Art. 4(5) omitted (1.4.2025) by virtue of The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), regs. 1(2), 14(3) (with reg. 23)
6. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Art. 4(6) omitted (31.12.2020) by virtue of The Genetically Modified Food and Feed (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/705), regs. 1, 8; 2020 c. 1, Sch. 5 para. 1(1)
7. Authorisation under this Regulation shall be without prejudice to Directive 2002/53/EC, Directive 2002/55/EC and Directive 68/193/EEC.

Article 5 Application for authorisation
1. To obtain the authorisation referred to in Article 4(2), an application shall be submitted in accordance with the following provisions.
2. The application must be sent to the Food Safety Authority, who must—
(a) acknowledge receipt of the application, and confirm the date of its receipt, in writing to the applicant within 14 days of its receipt;
(b) make the summary of the dossier referred to in paragraph 3(1) available to the public.
Art. 5(2) substituted (31.12.2020) by The Genetically Modified Food and Feed (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/705), regs. 1, 9(a); 2020 c. 1, Sch. 5 para. 1(1)
3. The application shall be accompanied by the following:
(a) the name and the address of the applicant;
(b) the designation of the food, and its specification, including the transformation event(s) used;
(c) where applicable, the information to be provided for the purpose of complying with Annex II to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity (hereinafter referred to as the Cartagena Protocol);
(d) where applicable, a detailed description of the method of production and manufacturing;
(e) a copy of the studies, including, where available, 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 referred to in Article 4(1);
(f) either an analysis, supported by appropriate information and data, showing that the characteristics of the food are not different from those of its conventional counterpart, having regard to the accepted limits of natural variations for such characteristics and to the criteria specified in Article 13(2)(a), or a proposal for labelling the food in accordance with Article 13(2)(a) and (3);
(g) either a reasoned statement that the food does not give rise to ethical or religious concerns, or a proposal for labelling it in accordance with Article 13(2)(b);
(h) where appropriate, the conditions for placing on the market the food or foods produced from it, including specific conditions for use and handling;
(i) methods for detection, sampling (including references to existing official or standardised sampling methods) 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;
(j) samples of the food and their control samples, and information as to the place where the reference material can be accessed;
(k) where appropriate, a proposal for post-market monitoring regarding use of the food for human consumption;
(l) a summary of the dossier in a standardised form.
4. In the case of an application relating to a GMO for food use, references to ‘food’ in paragraph 3 shall be interpreted as referring to food containing, consisting of or produced from the GMO in respect of which an application is made.
5. In the case of GMOs or food containing or consisting of GMOs, 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 GMO has been authorised under part C of Directive 2001/18/EC, a copy of the authorisation decision;
(b) a monitoring plan for environmental effects conforming with Annex VII to Directive 2001/18/EC, including a proposal for the duration of the monitoring plan; this duration 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.
6. Where the application concerns a substance, the use and placing on the market of which is subject, under other provisions of assimilated law, to its inclusion on a list of substances registered or authorised to the exclusion of others, this must be stated in the application and the status of the substance under the relevant legislation must be indicated.
Word in Art. 5(6) substituted (27.2.2025) by The Retained EU Law (Revocation and Reform) Act 2023 (Consequential Amendments) Regulations 2025 (S.I. 2025/82), reg. 1(2), Sch. 11 para. 5(a)
7. The appropriate authority, having first consulted the Food Safety Authority, may prescribe rules concerning the preparation and presentation of the application.
Art. 5(7) substituted (31.12.2020) by The Genetically Modified Food and Feed (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/705), regs. 1, 9(c); 2020 c. 1, Sch. 5 para. 1(1)
8. The Food Safety Authority must publish detailed guidance to assist the applicant in the preparation and the presentation of the application.
Words in Art. 5(8) substituted (31.12.2020) by The Genetically Modified Food and Feed (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/705), regs. 1, 9(d); 2020 c. 1, Sch. 5 para. 1(1)

Article 6 Opinion of the Authority
1. In giving its opinion, the Authority shall endeavour to respect a time limit of six months as from the receipt of a valid application. Such time limit shall be extended whenever the Authority seeks supplementary information from the applicant as provided for in paragraph 2.
2. The Authority ... may, where appropriate, request the applicant to supplement the particulars accompanying the application within a specific time limit.
Words in Art. 6(2) omitted (31.12.2020) by virtue of The Genetically Modified Food and Feed (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/705), regs. 1, 10(a); 2020 c. 1, Sch. 5 para. 1(1)
3. In order to prepare its opinion, the Food Safety Authority—
a) must verify that the particulars and documents submitted by the applicant are in accordance with Article 5 and examine whether the food complies with the criteria referred to in Article 4(1);
b) may ask a competent authority designated in accordance with Article 4 of Directive 2001/18/EC to carry out an environmental risk assessment; however, if the application concerns GMOs to be used as seeds or other plant-propagating material, the Food Safety Authority must ask a competent authority to carry out the environmental risk assessment;
c) may ask a public analyst to carry out a safety assessment of the food;
d) must forward to the reference laboratory referred to in Article 32 the particulars referred to in Article 5(3)(i) and (j). The reference laboratory must test and validate the method of detection and identification proposed by the applicant;
e) must, in verifying the application of Article 13(2)(a), examine the information and data submitted by the applicant to show that the characteristics of the food are not different from those of its conventional counterpart, having regard to the accepted limits of natural variations for such characteristics.
Art. 6(3) substituted (31.12.2020) by The Genetically Modified Food and Feed (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/705), regs. 1, 10(b); 2020 c. 1, Sch. 5 para. 1(1)
4. In the case of GMOs or food containing or consisting of GMOs, the environmental safety requirements referred to 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 GMOs. During evaluation of requests for the placing on the market of products consisting of or containing GMOs, the competent authority designated in accordance with Directive 2001/18/EC designated by each Member State for this purpose shall be consulted by the Authority. The competent authorities shall have three months after the date of receiving the request within which to make their opinion known.
Words in Art. 6(4) substituted (31.12.2020) by The Genetically Modified Food and Feed (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/705), regs. 1, 10(c); 2020 c. 1, Sch. 5 para. 1(1)
5. In the event of an opinion in favour of authorising the food, the opinion shall also include the following particulars:
(a) the name and address of the applicant;
(b) the designation of the food, and its specification;
(c) where applicable, the information required under Annex II to the Cartagena Protocol;
(d) the proposal for the labelling of the food and/or foods produced from it;
(e) where applicable, any conditions or restrictions which should be imposed on the placing on the market and/or specific conditions or restrictions for use and handling, including post-market monitoring requirements based on the outcome of the risk assessment and, in the case of GMOs or food containing or consisting of GMOs, conditions for the protection of particular ecosystems/environment and/or geographical areas;
(f) the method, validated by the ... reference laboratory, for detection, including sampling, 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; an indication of where appropriate reference material can be accessed;
Word in Art. 6(5)(f) omitted (31.12.2020) by virtue of The Genetically Modified Food and Feed (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/705), regs. 1, 10(d); 2020 c. 1, Sch. 5 para. 1(1)
(g) where appropriate, the monitoring plan referred to in Article 5(5)(b).
6. The Food Safety Authority must forward its opinion to the appropriate authority and the applicant, including a report describing its assessment of the food and stating the reasons for its opinion and the information on which this opinion is based.
Art. 6(6) substituted (31.12.2020) by The Genetically Modified Food and Feed (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/705), regs. 1, 10(e); 2020 c. 1, Sch. 5 para. 1(1)
7. The Food Safety Authority must make its opinion public, after deletion of any information identified as confidential in accordance with Article 30 of this Regulation. The public may make comments to the Food Safety Authority within 30 days from such publication.
Art. 6(7) substituted (31.12.2020) by The Genetically Modified Food and Feed (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/705), regs. 1, 10(f); 2020 c. 1, Sch. 5 para. 1(1)

Article 7 Authorisation
1. Within three months after receiving the opinion of the Food Safety Authority, the appropriate authority must determine, taking account of the opinion of the Food Safety Authority, any relevant provisions of assimilated law, and other legitimate factors relevant to the matter under consideration, the decision to be taken in respect of the application.
Word in Art. 7(1) substituted (27.2.2025) by The Retained EU Law (Revocation and Reform) Act 2023 (Consequential Amendments) Regulations 2025 (S.I. 2025/82), reg. 1(2), Sch. 11 para. 5(b)
2. Where the decision is not in accordance with the opinion of the Food Safety Authority, the appropriate authority must provide an explanation for the differences.
3. Where the appropriate authority determines that there is to be an authorisation in respect of an application, the appropriate authority must specify the date on which the authorisation is to have effect and communicate the determination to the Food Safety Authority, and the authorisation must include—
a) the particulars referred to in Article 6(5);
b) the name of the authorisation holder;
c) where appropriate, the unique identifier attributed to the GMO as referred to in Regulation (EC) No. 1830/2003.
Art. 7(3) substituted (18.4.2022) by The Food and Feed Safety (Miscellaneous Amendments and Transitional Provisions) Regulations 2022 (S.I. 2022/377), regs. 1(2), 5(2)
Words in Art. 7(3) substituted (1.4.2025) by The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), regs. 1(2), 14(4)(a) (with reg. 23)
4. ... The authorised food must be entered , by the Food Safety Authority, in the Register referred to in Article 28. Each entry in the Register must mention the date of authorisation and must include the particulars referred to in paragraph 3.
Words in Art. 7(4) omitted (1.4.2025) by virtue of The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), regs. 1(2), 14(4)(b)(i) (with reg. 23)
Words in Art. 7(4) inserted (1.4.2025) by The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), regs. 1(2), 14(4)(b)(ii) (with reg. 23)
5. The authorisation under this Section is without prejudice to other provisions of assimilated law governing the use and placing on the market of substances which may only be used if they are included in a list of substances registered or authorised to the exclusion of others.
Word in Art. 7(5) substituted (27.2.2025) by The Retained EU Law (Revocation and Reform) Act 2023 (Consequential Amendments) Regulations 2025 (S.I. 2025/82), reg. 1(2), Sch. 11 para. 5(b)
6. References made in parts A and D of Directive 2001/18/EC to GMOs authorised under part C of that Directive shall be considered as applying equally to GMOs authorised under this Regulation.
Art. 7 substituted (31.12.2020) by The Genetically Modified Food and Feed (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/705), regs. 1, 11; 2020 c. 1, Sch. 5 para. 1(1)

Article 8 Status of existing products
1. By way of derogation from Article 4(2), products falling within the scope of this Section which have been lawfully placed on the market in the Community before the date of application of this Regulation may continue to be placed on the market, used and processed provided that the following conditions are met:
(a) in the case of products 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 referred to in Regulation (EC) No 258/97, operators responsible for placing on the market the products concerned shall, within six months after the date of application of this Regulation, notify the Commission of the date on which they were first placed on the market in the Community;
(b) in the case of products which have been lawfully placed on the market in the Community but are not covered by point (a), operators responsible for placing on the market the products concerned shall, within six months after the date of application of this Regulation, notify the Commission that the products were placed on the market in the Community before the date of application of this Regulation.
2. The notification referred to in paragraph 1 shall be accompanied by the particulars mentioned in Article 5(3) and (5), as appropriate, which the Commission shall forward to the Authority and the Member States. The Authority shall forward to the Community reference laboratory the particulars referred to in Article 5(3)(i) and (j). The Community reference laboratory shall test and validate the method of detection and identification proposed by the applicant.
3. Within one year from the date of application of this Regulation and after verification that all the information required has been submitted and examined, the products concerned shall be entered in the Register. Each entry in the Register shall include the particulars referred to in Article 7(2) as appropriate and, in the case of the products referred to in paragraph 1(a), shall mention the date on which the products concerned were first placed on the market.
4. Within nine years from the date on which the products referred to in paragraph 1(a) were first placed on the market, but in no case earlier than three years after the date of application of this Regulation, operators responsible for placing them on the market shall submit an application in accordance with Article 11, which shall apply mutatis mutandis.
Within three years from the date of application of this Regulation, operators responsible for placing on the market products referred to in paragraph 1(b) shall submit an application in accordance with Article 11, which shall apply mutatis mutandis.
5. Products referred to in paragraph 1 and food containing them or produced from them shall be subject to the provisions of this Regulation, in particular Articles 9, 10 and 34, which shall apply mutatis mutandis.
6. Where the notification and accompanying particulars referred to in paragraphs 1 and 2 are, or were, not supplied within the period specified or are, or were, found to be incorrect, or where an application is, or was, not submitted as required by paragraph 4 within the period specified, the appropriate authority may prescribe-
a) that the product concerned, and any products derived from it, be withdrawn from the market;
b) a period of time within which existing stocks of the product concerned, and any products derived from it, may be used up.
Art. 8(6) inserted (31.12.2022) by The Food and Feed (Miscellaneous Amendments) Regulations 2022 (S.I. 2022/1351), regs. 1(1), 7(2)
6. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Art. 8(6) omitted (31.12.2020) by virtue of The Genetically Modified Food and Feed (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/705), regs. 1, 12; 2020 c. 1, Sch. 5 para. 1(1)
7. In the case of authorisations not issued to a specific holder, the operator who imports, produces or manufactures the products referred to in this Article shall submit the information or the application to Commission.
8. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Art. 8(8) omitted (31.12.2020) by virtue of The Genetically Modified Food and Feed (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/705), regs. 1, 12; 2020 c. 1, Sch. 5 para. 1(1)

Article 9 Supervision
1. After an authorisation has been issued in accordance with this Regulation, the authorisation-holder and parties concerned shall comply with any conditions or restrictions which have been imposed in the authorisation and shall in particular make sure that products not covered by the authorisation are not placed on the market as food or feed. Where post-market monitoring as referred to in Article 5(3)(k) and/or monitoring as referred to in Article 5(5)(b) has been imposed on the authorisation-holder, the authorisation-holder shall ensure that it is carried out and shall submit reports to the Food Safety Authority in accordance with the terms of the authorisation. The monitoring reports referred to shall be made accessible to the public after deletion of any information identified as confidential in accordance with Article 30.
Words in Art. 9(1) substituted (31.12.2020) by The Genetically Modified Food and Feed (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/705), regs. 1, 13(a); 2020 c. 1, Sch. 5 para. 1(1)
2. If the authorisation-holder proposes to modify the terms of the authorisation, the authorisation-holder shall submit an application in accordance with Article 5(2). Articles 5, 6 and 7 shall apply mutatis mutandis.
3. The authorisation-holder shall forthwith inform the Food Safety 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 Food Safety Authority of any prohibition or restriction imposed by the competent authority of any third country in which the food is placed on the market.
Words in Art. 9(3) substituted (31.12.2020) by The Genetically Modified Food and Feed (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/705), regs. 1, 13(b); 2020 c. 1, Sch. 5 para. 1(1)
4. The Food Safety Authority must make the information supplied by the applicant available to the appropriate authority without delay.
Art. 9(4) substituted (31.12.2020) by The Genetically Modified Food and Feed (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/705), regs. 1, 13(c); 2020 c. 1, Sch. 5 para. 1(1)

Article 9A Supervision: supplementary
1. This Article applies where the Food Safety Authority receives, or becomes aware of, any information which might affect the assessment of the safety, or the suitability of the method of detection, of the authorised food concerned.
2. Where the Food Safety Authority receives, or becomes aware of, information under paragraph 1, the Food Safety Authority must consider whether it is necessary to issue an opinion under Article 10.
3. The Food Safety Authority may ask a relevant person to provide, within a specified period, such other information as the Food Safety Authority considers necessary for the purposes of deciding whether to issue an opinion under Article 10.
4. The Food Safety Authority may extend the period of time described in paragraph 3.
5. Where the Food Safety Authority makes a request under paragraph 3 and the relevant person fails to provide the information requested within the specified period (including any extension of that period), the Food Safety Authority must consider whether it is necessary to issue an opinion under Article 10 based on such information as the Food Safety Authority has which might affect the assessment of the safety of the food concerned or the suitability of the method of detection.
6. In this Article, “relevant person” means any person who is—
(a) the authorisation-holder;
(b) a producer or manufacturer of the food concerned; or
(c) any food business placing on the market the food concerned.
Art. 9A inserted (1.4.2025) by The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), regs. 1(2), 14(5) (with reg. 23)

Article 10 Modification, suspension and revocation of authorisations
1. On its own initiative, the Food Safety Authority may, or following a request from the appropriate authority, must, issue an opinion on whether an authorisation for a product referred to in Article 3(1) still meets the conditions set by this Regulation. It shall immediately transmit this opinion to the appropriate authority and the authorisation-holder. The Food Safety Authority must make its opinion public, after deletion of any information identified as confidential in accordance with Article 30 of this Regulation. The public may make comments to the Food Safety Authority within 30 days from such publication.
Art. 10(1)(2) substituted (31.12.2020) by The Genetically Modified Food and Feed (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/705), regs. 1, 14; 2020 c. 1, Sch. 5 para. 1(1)
2. The appropriate authority must examine the opinion of the Food Safety Authority as soon as possible. Any appropriate measures must be taken in accordance with Article 34. The appropriate authority must, having regard to the opinion of the Food Safety Authority, determine whether to modify, suspend or revoke the authorisation.
Words in Art. 10(2) substituted (1.4.2025) by The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), regs. 1(2), 14(6)(a) (with reg. 23)
(2A. Where the appropriate authority determines that an authorisation is to be modified, suspended or revoked, the appropriate authority must specify the date on which the modification, suspension or revocation is to have effect and communicate the determination to the Food Safety Authority, and the Food Safety Authority must update the Register accordingly.
Art. 10(2A) inserted (1.4.2025) by The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), regs. 1(2), 14(6)(b) (with reg. 23)
3. Articles 5(2), 6 and 7 shall apply mutatis mutandis.
(4. For the purposes of this Article, a modification, suspension or revocation of an authorisation may specify a period of time, or different periods of time, within which—
(a) existing stocks of the product concerned, and any products derived from it or containing it, may be placed on the market or used;
(b) the product concerned, and any products derived from it or containing it, may continue to be produced, placed on the market or used;
(c) the labelling of the product concerned, and any products derived from it or containing it, may continue to be applied.
Art. 10(4)(5) inserted (1.4.2025) by The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), regs. 1(2), 14(6)(c) (with reg. 23)
(5. The appropriate authority may prescribe other transitional measures not falling within paragraph 4 in relation to the modification, suspension or revocation of an authorisation.

Article 11 Renewal of authorisations
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Art. 11 omitted (1.4.2025) by virtue of The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), regs. 1(2), 14(7) (with reg. 23)

Section 2 Labelling

Article 12 Scope
1. This Section shall apply to foods which are to be delivered as such to the final consumer or mass caterers in Great Britain and which:
(a) contain or consist of GMOs; or
(b) are produced from or contain ingredients produced from GMOs.
Words in Art. 12(1) substituted (31.12.2020) by S.I. 2019/705, reg. 16(a) (as substituted by The Food and Feed Hygiene and Safety (Miscellaneous Amendments etc.) (EU Exit) Regulations 2020 (S.I. 2020/1504), regs. 1(2), 17(3))
2. This Section shall not apply to foods containing material which contains, consists of or is produced from GMOs in a proportion no higher than 0,9 per cent of the food ingredients considered individually or food consisting of a single ingredient, provided that this presence is adventitious or technically unavoidable.
3. 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 such material.
4. The appropriate authority may prescribe amendments to non-essential elements of this Regulation by supplementing it and establishing lower thresholds, in particular in respect of foods containing or consisting of GMOs, or taking account of advances in science and technology.
Art. 12(4) substituted (31.12.2020) by The Genetically Modified Food and Feed (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/705), regs. 1, 16(b); 2020 c. 1, Sch. 5 para. 1(1)

Article 13 Requirements
1. Without prejudice to the other requirements of assimilated law concerning the labelling of foodstuffs, foods falling within the scope of this Section shall be subject to the following specific labelling requirements:
(a) where the food consists of more than one ingredient, the words ‘genetically modified’ or ‘produced from genetically modified (name of the 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;
(b) where the ingredient is designated by the name of a category, the words ‘contains genetically modified (name of organism)’ or ‘contains (name of ingredient) produced from genetically modified (name of organism)’ shall appear in the list of ingredients;
(c) where there is no list of ingredients, the words ‘genetically modified’ or ‘produced from genetically modified (name of organism)’ shall appear clearly on the labelling;
(d) the indications referred to in (a) and (b) may appear in a footnote to the list of ingredients. In this case they shall be printed in a font of at least the same size as the list of ingredients. Where there is no list of ingredients, they shall appear clearly on the labelling;
(e) where the food is offered for sale to the final consumer as non-pre-packaged food, or as pre-packaged food in small containers of which the largest surface has an area of less than 10 cm2, the information required under this paragraph must be permanently and visibly displayed either on the food display or immediately next to it, or on the packaging material, in a font sufficiently large for it to be easily identified and read.
Word in Art. 13(1) substituted (27.2.2025) by The Retained EU Law (Revocation and Reform) Act 2023 (Consequential Amendments) Regulations 2025 (S.I. 2025/82), reg. 1(2), Sch. 11 para. 5(c)
2. In addition to the labelling requirements referred to in paragraph 1, the labelling shall also mention any characteristic or property, as specified in the authorisation, in the following cases:
(a) where a food is different from its conventional counterpart as regards the following characteristics or properties:
(i) composition;
(ii) nutritional value or nutritional effects;
(iii) intended use of the food;
(iv) implications for the health of certain sections of the population;
(b) where a food may give rise to ethical or religious concerns.
3. In addition to the labelling requirements referred to in paragraph 1 and as specified in the authorisation, the labelling of foods falling within the scope of this Section which do not have a conventional counterpart shall contain appropriate information about the nature and the characteristics of the foods concerned.

Article 14 Implementing measures
The appropriate authority may prescribe the following measures designed to amend non-essential elements of this Regulation by supplementing it—
(a) the measures necessary for operators to satisfy the competent authorities as referred to in Article 12(3);
(b) the measures necessary for operators to comply with the labelling requirements set out in Article 13;
(c) measures concerning the information to be given by mass caterers providing food to the final consumer. In order to take account of the specific situation of mass caterers, such measures may provide for adaptation of the requirements set out in Article 13(1)(e); and
(d) measures to facilitate the uniform application of Article 13.
Art. 14 substituted (31.12.2020) by The Genetically Modified Food and Feed (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/705), regs. 1, 18; 2020 c. 1, Sch. 5 para. 1(1)

CHAPTER III GENETICALLY MODIFIED FEED

Section 1 Authorisation and supervision

Article 15 Scope
1. This Section shall apply to:
(a) GMOs for feed use;
(b) feed containing or consisting of GMOs;
(c) feed produced from GMOs.
2. Where necessary, the appropriate authority may prescribe measures designed to amend non-essential elements of this Regulation by supplementing it and determining whether a type of feed falls within the scope of this Section.
Art. 15(2) substituted (31.12.2020) by The Genetically Modified Food and Feed (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/705), regs. 1, 19; 2020 c. 1, Sch. 5 para. 1(1)

Article 16 Requirements
1. Feed referred to in Article 15(1) must not:
(a) have adverse effects on human health, animal health or the environment;
(b) mislead the user;
(c) harm or mislead the consumer by impairing the distinctive features of the animal products;
(d) differ from feed which it is intended to replace to such an extent that its normal consumption would be nutritionally disadvantageous for animals or humans.
2. No person shall place on the market, use or process a product referred to in Article 15(1) unless it is covered by an authorisation granted in accordance with this Section and the relevant conditions of the authorisation are satisfied.
3. No product referred to in Article 15(1) shall be authorised unless the applicant for such authorisation has adequately and sufficiently demonstrated that it satisfies the requirements of paragraph 1 of this Article.
4. The authorisation referred to in paragraph 2 may cover:
(a) a GMO and feed containing or consisting of that GMO as well as feed produced from that GMO; or
(b) feed produced from a GMO as well as feeds produced from or containing that feed.
5. An authorisation as referred to in paragraph 2 shall not be granted, refused, ... modified, suspended or revoked except on the grounds and under the procedures set out in this Regulation.
Word in Art. 16(5) omitted (1.4.2025) by virtue of The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), regs. 1(2), 14(8) (with reg. 23)
6. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Art. 16(6) omitted (31.12.2020) by virtue of The Genetically Modified Food and Feed (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/705), regs. 1, 20; 2020 c. 1, Sch. 5 para. 1(1)
7. Authorisation under this Regulation shall be without prejudice to Directive 2002/53/EC, Directive 2002/55/EC and Directive 68/193/EEC.

Article 17 Application for authorisation
1. To obtain the authorisation referred to in Article 16(2), an application must be submitted in accordance with the following provisions.
Art. 17(1)(2) substituted (31.12.2020) by The Genetically Modified Food and Feed (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/705), regs. 1, 21(a); 2020 c. 1, Sch. 5 para. 1(1)
2. The application must be sent to the Food Safety Authority, who must—
(a) acknowledge receipt of the application, and confirm the date of its receipt, in writing to the applicant within 14 days of its receipt;
(b) make the summary of the dossier referred to in paragraph 3(1) available to the public.
3. The application shall be accompanied by the following:
(a) the name and the address of the applicant;
(b) the designation of the feed and its specification, including the transformation event(s) used;
(c) where applicable, the information to be provided for the purpose of complying with Annex II to the Cartagena Protocol;
(d) where applicable, a detailed description of the method of production and manufacturing and intended uses of the feed;
(e) a copy of the studies including, where available, independent, peer-reviewed studies, which have been carried out and any other material which is available to demonstrate that the feed complies with the criteria referred to in Article 16(1), and, in particular for feed falling within the scope of Directive 82/471/EEC, the information required under Council Directive 83/228/EEC of 18 April 1983 on the fixing of guidelines for the assessment of certain products used in animal nutrition;
OJ L 126, 13.5.1983, p. 23.
(f) either an analysis, supported by appropriate information and data, showing that the characteristics of the feed are not different from those of its conventional counterpart, having regard to the accepted limits of natural variations for such characteristics and to the criteria specified in Article 25(2)(c), or a proposal for labelling the feed in accordance with Article 25(2)(c) and (3);
(g) either a reasoned statement that the feed does not give rise to ethical or religious concerns, or a proposal for labelling it in accordance with Article 25(2)(d);
(h) where appropriate, the conditions for placing the feed on the market, including specific conditions for use and handling;
(i) methods for detection, sampling (including references to existing official or standardised sampling methods) and identification of the transformation event and, where applicable, for the detection and identification of the transformation event in the feed and/or in the feed produced from it;
(j) samples of the feed and their control samples and information as to the place where the reference material can be accessed;
(k) where appropriate, a proposal for post-market monitoring for the use of the feed for animal consumption;
(l) a summary of the dossier in a standardised form.
4. In the case of an application relating to a GMO for feed use, references to ‘feed’ in paragraph 3 shall be interpreted as referring to feed containing, consisting of or produced from the GMO in respect of which an application is made.
5. In the case of GMOs or feed containing or consisting of GMOs, 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 GMOs has been authorised under part C of Directive 2001/18/EC, a copy of the authorisation decision;
(b) a monitoring plan for environmental effects conforming with Annex VII to Directive 2001/18/EC, including a proposal for the duration of the monitoring plan; this duration 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.
6. Where the application concerns a substance, the use and placing on the market of which is subject under other provisions of assimilated law to its inclusion on a list of substances registered or authorised to the exclusion of others, this must be stated in the application and the status of the substance under the relevant legislation must be indicated.
Word in Art. 17(6) substituted (27.2.2025) by The Retained EU Law (Revocation and Reform) Act 2023 (Consequential Amendments) Regulations 2025 (S.I. 2025/82), reg. 1(2), Sch. 11 para. 5(d)
7. The appropriate authority, having first consulted the Food Safety Authority, may prescribe rules concerning the preparation and presentation of the application.
Art. 17(7) substituted (31.12.2020) by The Genetically Modified Food and Feed (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/705), regs. 1, 21(c); 2020 c. 1, Sch. 5 para. 1(1)
8. The Food Safety Authority must publish detailed guidance to assist the applicant in the preparation and the presentation of the application.
Words in Art. 17(8) substituted (31.12.2020) by The Genetically Modified Food and Feed (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/705), regs. 1, 21(d); 2020 c. 1, Sch. 5 para. 1(1)

Article 18 Opinion of the Authority
1. In giving its opinion, the Authority shall endeavour to comply with a time limit of six months as from the receipt of a valid application. Such time limit shall be extended whenever the Authority seeks supplementary information from the applicant as provided in paragraph 2.
2. The Authority ... may, where appropriate, request the applicant to supplement the particulars accompanying the application within a specific time limit.
Words in Art. 18(2) omitted (31.12.2020) by virtue of The Genetically Modified Food and Feed (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/705), regs. 1, 22(a); 2020 c. 1, Sch. 5 para. 1(1)
3. In order to prepare its opinion, the Food Safety Authority—
a) must verify that the particulars and documents submitted by the applicant are in accordance with Article 17 and examine whether the food complies with the criteria referred to in Article 16(1);
b) may ask a competent authority designated in accordance with Article 4 of Directive 2001/18/EC to carry out an environmental risk assessment; however, if the application concerns GMOs to be used as seeds or other plant-propagating material, the Food Safety Authority must ask a competent authority to carry out the environmental risk assessment;
c) may ask a public analyst to carry out a safety assessment of the feed;
d) must forward to the reference laboratory the particulars referred to in Article 17(3)(i) and (j). The reference laboratory must test and validate the method of detection and identification proposed by the applicant;
e) must, in verifying the application of Article 25(2)(c), examine the information and data submitted by the applicant to show that the characteristics of the feed are not different from those of its conventional counterpart, having regard to the accepted limits of natural variations for such characteristics.
Art. 18(3) substituted (31.12.2020) by The Genetically Modified Food and Feed (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/705), regs. 1, 22(b); 2020 c. 1, Sch. 5 para. 1(1)
4. In the case of GMOs or feed containing or consisting of GMOs, the environmental safety requirements referred to 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 GMOs. During evaluation of requests for the placing on the market of products consisting of or containing GMOs, the competent authority designated in accordance with Directive 2001/18/EC shall be consulted by the Authority. The competent authorities shall have three months after the date of receiving the request within which to make their opinion known.
Words in Art. 18(4) substituted (31.12.2020) by The Genetically Modified Food and Feed (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/705), regs. 1, 22(c); 2020 c. 1, Sch. 5 para. 1(1)
5. In the event of an opinion in favour of authorising the feed, the opinion shall also include the following particulars:
(a) the name and address of the applicant;
(b) the designation of the feed, and its specification;
(c) where applicable, the information required under Annex II to the Cartagena Protocol;
(d) the proposal for the labelling of the feed;
(e) where applicable, any conditions or restrictions which should be imposed on the placing on the market and/or specific conditions or restrictions for use and handling, including post-market monitoring requirements based on the outcome of the risk assessment and, in the case of GMOs or feed containing or consisting of GMOs, conditions for the protection of particular ecosystems/environment and/or geographical areas;
(f) the method, validated by the ... reference laboratory, for detection, including sampling, identification of the transformation event and, where applicable, for the detection and identification of the transformation event in the feed and/or in feed produced from it; an indication of where appropriate reference material can be accessed;
Word in Art. 18(5)(f) omitted (31.12.2020) by virtue of The Genetically Modified Food and Feed (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/705), regs. 1, 22(d); 2020 c. 1, Sch. 5 para. 1(1)
(g) where appropriate, the monitoring plan as referred to in Article 17(5)(b).
6. The Food Safety Authority must forward its opinion to the appropriate authority and the applicant, including a report describing its assessment of the feed and stating the reasons for its opinion and the information on which this opinion is based.
Art. 18(6) substituted (31.12.2020) by The Genetically Modified Food and Feed (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/705), regs. 1, 22(e); 2020 c. 1, Sch. 5 para. 1(1)
7. The Food Safety Authority must make its opinion public, after deletion of any information identified as confidential in accordance with Article 30 of this Regulation. The public may make comments to the Food Safety Authority within 30 days from such publication.
Art. 18(7) substituted (31.12.2020) by The Genetically Modified Food and Feed (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/705), regs. 1, 22(f); 2020 c. 1, Sch. 5 para. 1(1)

Article 19 Authorisation
1. Within three months after receiving the opinion of the Food Safety Authority, the appropriate authority must determine, taking account of the opinion of the Food Safety Authority, any relevant provisions of assimilated law, and other legitimate factors relevant to the matter under consideration, the decision to be taken in respect of the application.
Word in Art. 19(1) substituted (27.2.2025) by The Retained EU Law (Revocation and Reform) Act 2023 (Consequential Amendments) Regulations 2025 (S.I. 2025/82), reg. 1(2), Sch. 11 para. 5(e)
2. Where the decision is not in accordance with the opinion of the Food Safety Authority, the appropriate authority must provide an explanation for the differences.
3. Where the appropriate authority determines that there is to be an authorisation in respect of an application, the appropriate authority must specify the date on which the authorisation is to have effect and communicate the determination to the Food Safety Authority, and the authorisation must include—
a) the particulars referred to in Article 18(5);
b) the name of the authorisation holder;
c) where appropriate, the unique identifier attributed to the GMO as referred to in Regulation (EC) No. 1830/2003.
Art. 19(3) substituted (18.4.2022) by The Food and Feed Safety (Miscellaneous Amendments and Transitional Provisions) Regulations 2022 (S.I. 2022/377), regs. 1(2), 5(3)
Words in Art. 19(3) substituted (1.4.2025) by The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), regs. 1(2), 14(9)(a) (with reg. 23)
4. ... The authorised feed must be entered , by the Food Safety Authority, in the Register referred to in Article 28. Each entry in the Register must mention the date of authorisation and must include the particulars referred to in paragraph 3.
Words in Art. 19(4) omitted (1.4.2025) by virtue of The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), regs. 1(2), 14(9)(b)(i) (with reg. 23)
Words in Art. 19(4) inserted (1.4.2025) by The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), regs. 1(2), 14(9)(b)(ii) (with reg. 23)
5. The authorisation under this Section is without prejudice to other provisions of assimilated law governing the use and placing on the market of substances which may only be used if they are included in a list of substances registered or authorised to the exclusion of others.
Word in Art. 19(5) substituted (27.2.2025) by The Retained EU Law (Revocation and Reform) Act 2023 (Consequential Amendments) Regulations 2025 (S.I. 2025/82), reg. 1(2), Sch. 11 para. 5(e)
6. References made in parts A and D of Directive 2001/18/EC to GMOs authorised under part C of that Directive shall be considered as applying equally to GMOs authorised under this Regulation.
Art. 19 substituted (31.12.2020) by The Genetically Modified Food and Feed (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/705), regs. 1, 23; 2020 c. 1, Sch. 5 para. 1(1)

Article 20 Status of existing products
1. By way of derogation from Article 16(2), products falling within the scope of this Section which have been lawfully placed on the market in the Community before the date of application of this Regulation may continue to be placed on the market, used and processed provided that the following conditions are met:
(a) in the case of products which have been authorised under Directives 90/220/EEC or 2001/18/EC, including use as feed, under Directive 82/471/EEC, which are produced from GMOs, or under Directive 70/524/EEC, which contain, consist of or are produced from GMOs, operators responsible for placing on the market the products concerned shall, within six months after the date of application of this Regulation, notify the Commission of the date on which they were first placed on the market in the Community;
(b) in the case of products which have been lawfully placed on the market in the Community but which are not referred to in point (a), operators responsible for placing on the market in the Community the products concerned shall, within six months after the date of application of this Regulation, notify the Commission that the products were placed on the market in the Community before the date of application of this Regulation.
2. The notification referred to in paragraph 1 shall be accompanied by the particulars mentioned in Article 17(3) and (5), as appropriate, which the Commission shall forward to the Authority and the Member States. The Authority shall forward to the Community reference laboratory the particulars referred to in Article 17(3)(i) and (j). The Community reference laboratory shall test and validate the method of detection and identification proposed by the applicant.
3. Within one year from the date of application of this Regulation and after verification that all the information required has been submitted and examined, the products concerned shall be entered in the Register. Each entry in the Register shall include the particulars referred to in Article 19(2) as appropriate and, in the case of the products referred to in paragraph 1(a), shall mention the date on which the products concerned were first placed on the market.
4. Within nine years from the date on which the products referred to in paragraph 1(a) were first placed on the market, but in no case earlier than three years after the date of application of this Regulation, operators responsible for placing them on the market shall submit an application in accordance with Article 23, which shall apply mutatis mutandis.
Within three years from the date of application of this Regulation, operators responsible for placing on the market products referred to in paragraph 1(b) shall submit an application in accordance with Article 23, which shall apply mutatis mutandis.
5. Products referred to in paragraph 1 and feed containing them or produced from them shall be subject to the provisions of this Regulation, in particular Articles 21, 22 and 34, which shall apply mutatis mutandis.
6. Where the notification and accompanying particulars referred to in paragraphs 1 and 2 are, or were, not supplied within the period specified or are, or were, found to be incorrect, or where an application is, or was, not submitted as required by paragraph 4 within the period specified, the appropriate authority may prescribe—
a) that the product concerned, and any products derived from it, be withdrawn from the market;
b) a period of time within which existing stocks of the product concerned, and any products derived from it, may be used up.
Art. 20(6) inserted (31.12.2022) by The Food and Feed (Miscellaneous Amendments) Regulations 2022 (S.I. 2022/1351), regs. 1(1), 7(3)
6. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Art. 20(6) omitted (31.12.2020) by virtue of The Genetically Modified Food and Feed (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/705), regs. 1, 24; 2020 c. 1, Sch. 5 para. 1(1)
7. In the case of authorisations not issued to a specific holder, the operator who imports, produces or manufactures the products referred to in this Article shall submit the information or the application to the Commission.
8. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Art. 20(8) omitted (31.12.2020) by virtue of The Genetically Modified Food and Feed (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/705), regs. 1, 24; 2020 c. 1, Sch. 5 para. 1(1)

Article 21 Supervision
1. After an authorisation has been issued in accordance with this Regulation, the authorisation-holder and the parties concerned shall comply with any conditions or restrictions which have been imposed in the authorisation and shall in particular make sure that products not covered by the authorisation are not placed on the market as food or feed. Where post-market monitoring as referred to in Article 17(3)(k) and/or monitoring as referred to in Article 17(5)(b) has been imposed on the authorisation-holder, the authorisation-holder shall ensure that it is carried out and shall submit reports to the Food Safety Authority in accordance with the terms of the authorisation. The monitoring reports referred to shall be made accessible to the public after deletion of any information identified as confidential in accordance with Article 30.
Words in Art. 21(1) substituted (31.12.2020) by The Genetically Modified Food and Feed (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/705), regs. 1, 25(a); 2020 c. 1, Sch. 5 para. 1(1)
2. If the authorisation-holder proposes to modify the terms of the authorisation, the authorisation-holder shall submit an application in accordance with Article 17(2). Articles 17, 18 and 19 shall apply mutatis mutandis.
3. The authorisation-holder shall forthwith inform the Food Safety Authority of any new scientific or technical information which might influence the evaluation of the safety in use of the feed. In particular, the authorisation-holder shall forthwith inform the Food Safety Authority of any prohibition or restriction imposed by the competent Authority of any third country in which the feed is placed on the market.
Words in Art. 21(3) substituted (31.12.2020) by The Genetically Modified Food and Feed (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/705), regs. 1, 25(b); 2020 c. 1, Sch. 5 para. 1(1)
4. The Food Safety Authority must make the information supplied by the applicant available to the appropriate authority without delay.
Art. 21(4) substituted (31.12.2020) by The Genetically Modified Food and Feed (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/705), regs. 1, 25(c); 2020 c. 1, Sch. 5 para. 1(1)

Article 21A Supervision: supplementary
1. This Article applies where the Food Safety Authority receives, or becomes aware of, any information which might affect the assessment of the safety, or the suitability of the method of detection, of the authorised feed concerned.
2. Where the Food Safety Authority receives, or becomes aware of, information under paragraph 1, the Food Safety Authority must consider whether it is necessary to issue an opinion under Article 22.
3. The Food Safety Authority may ask a relevant person to provide, within a specified period, such other information as the Food Safety Authority considers necessary for the purposes of deciding whether to issue an opinion under Article 22.
4. The Food Safety Authority may extend the period of time described in paragraph 3.
5. Where the Food Safety Authority makes a request under paragraph 3 and the relevant person fails to provide the information requested within the specified period (including any extension of that period), the Food Safety Authority must consider whether it is necessary to issue an opinion under Article 22 based on such information as the Food Safety Authority has which might affect the assessment of the safety of the feed concerned or the suitability of the method of detection.
6. In this Article, “relevant person” means any person who is—
(a) the authorisation-holder;
(b) a producer or manufacturer of the feed concerned; or
(c) any feed business placing on the market, processing or using the feed concerned.
Art. 21A inserted (1.4.2025) by The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), regs. 1(2), 14(10) (with reg. 23)

Article 22 Modification, suspension and revocation of authorisations
1. On its own initiative, the Food Safety Authority may, or following a request from the appropriate authority, must, issue an opinion on whether an authorisation for a product referred to in Article 15(1) still meets the conditions set by this Regulation. It shall immediately transmit this opinion to the appropriate authority and the authorisation-holder. The Food Safety Authority must make its opinion public, after deletion of any information identified as confidential in accordance with Article 30 of this Regulation. The public may make comments to the Food Safety Authority within 30 days from such publication.
Art. 22(1)(2) substituted (31.12.2020) by The Genetically Modified Food and Feed (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/705), regs. 1, 26; 2020 c. 1, Sch. 5 para. 1(1)
2. The appropriate authority must examine the opinion of the Food Safety Authority as soon as possible. Any appropriate measures shall be taken in accordance with Article 34. The appropriate authority must, having regard to the opinion of the Food Safety Authority, determine whether to modify, suspend or revoke the authorisation.
Words in Art. 22(2) substituted (1.4.2025) by The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), regs. 1(2), 14(11)(a) (with reg. 23)
(2A. Where the appropriate authority determines that an authorisation is to be modified, suspended or revoked, the appropriate authority must specify the date on which the modification, suspension or revocation is to have effect and communicate the determination to the Food Safety Authority, and the Food Safety Authority must update the Register accordingly.
Art. 22(2A) inserted (1.4.2025) by The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), regs. 1(2), 14(11)(b) (with reg. 23)
3. Articles 17(2), 18 and 19 shall apply mutatis mutandis.
(4. For the purposes of this Article, a modification, suspension or revocation of an authorisation may specify a period of time, or different periods of time, within which—
(a) existing stocks of the product concerned, and any products derived from it or containing it, may be placed on the market or used;
(b) the product concerned, and any products derived from it or containing it, may continue to be produced, placed on the market or used;
(c) the labelling of the product concerned, and any products derived from it or containing it, may continue to be applied.
Art. 22(4)(5) inserted (1.4.2025) by The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), regs. 1(2), 14(11)(c) (with reg. 23)
(5. The appropriate authority may prescribe other transitional measures not falling within paragraph 4 in relation to the modification, suspension or revocation of an authorisation.

Article 23 Renewal of authorisations
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Art. 23 omitted (1.4.2025) by virtue of The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), regs. 1(2), 14(12) (with reg. 23)

Section 2 Labelling

Article 24 Scope
1. This Section shall apply to feed referred to in Article 15(1).
2. This Section shall not apply to feed containing material which contains, consists of or is produced from GMOs in a proportion no higher than 0,9 per cent of the feed and of each feed of which it is composed, provided that this presence is adventitious or technically unavoidable.
3. 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 such materials.
4. The appropriate authority may prescribe amendments to non-essential elements of this Regulation by supplementing it and establishing lower thresholds, in particular in respect of feed containing or consisting of GMOs, or taking account of advances in science and technology.
Art. 24(4) substituted (31.12.2020) by The Genetically Modified Food and Feed (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/705), regs. 1, 28; 2020 c. 1, Sch. 5 para. 1(1)

Article 25 Requirements
1. Without prejudice to the other requirements of assimilated law concerning the labelling of feed, feed referred to in Article 15(1) shall be subject to the specific labelling requirements laid down below.
Word in Art. 25(1) substituted (27.2.2025) by The Retained EU Law (Revocation and Reform) Act 2023 (Consequential Amendments) Regulations 2025 (S.I. 2025/82), reg. 1(2), Sch. 11 para. 5(f)
2. No person shall place a feed referred to in Article 15(1) on the market unless 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.
Each feed of which a particular feed is composed shall be subject to the following rules:
(a) for the feeds referred to in Article 15(1) (a) and (b), the words ‘genetically modified (name of the organism)’ shall appear in parentheses immediately following the specific name of the feed.
Alternatively, these words may appear in a footnote to the list of feed. It shall be printed in a font of at least the same size as the list of feed;
(b) for the feed referred to in Article 15(1)(c), the words ‘produced from genetically modified (name of the organism)’ shall appear in parentheses immediately following the specific name of the feed.
Alternatively, these words may appear in a footnote to the list of feed. It shall be printed in a font of at least the same size as the list of feed;
(c) as specified in the authorisation, any characteristic of the feed referred to in Article 15(1) such as those indicated hereunder, which is different from its conventional counterpart:
(i) composition;
(ii) nutritional properties;
(iii) intended use;
(iv) implications for the health of certain species or categories of animals;
(d) as specified in the authorisation, any characteristic or property where a feed may give rise to ethical or religious concerns.
3. In addition to the requirements referred to in paragraph 2(a) and (b) and as specified in the authorisation, the labelling or accompanying documents of feed falling within the scope of this Section which does not have a conventional counterpart shall contain appropriate information about the nature and the characteristics of the feed concerned.

Article 26 Implementing measures
The appropriate authority may prescribe the following measures designed to amend non-essential elements of this Regulation by supplementing it—
a) measures necessary for operators to satisfy the competent authorities as referred to in Article 24(3);
b) measures necessary for operators to comply with the labelling requirements set out in Article 25;
c) measures to facilitate the uniform application of Article 25.
Art. 26 substituted (31.12.2020) by The Genetically Modified Food and Feed (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/705), regs. 1, 30; 2020 c. 1, Sch. 5 para. 1(1)

CHAPTER IV COMMON PROVISIONS

Article 27 Products likely to be used as both food and feed
1. Where a product is likely to be used as both food and feed, a single application under Articles 5 and 17 must be submitted and must give rise to a single opinion from the Food Safety Authority and a single decision of the appropriate authority.
2. The Food Safety Authority must consider whether the application for authorisation of a product should be submitted as a single application for authorisation as both food and feed and advise the appropriate authority accordingly.
Art. 27 substituted (31.12.2020) by The Genetically Modified Food and Feed (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/705), regs. 1, 31; 2020 c. 1, Sch. 5 para. 1(1)

Article 28 ... Register
1. The appropriate authority shall establish ... a ... register of genetically modified food and feed, in this Regulation referred to as ‘the Register’.
Words in Art. 28(1) substituted (31.12.2020) by The Genetically Modified Food and Feed (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/705), regs. 1, 32(b); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 28(1) omitted (1.4.2025) by virtue of The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), regs. 1(2), 14(13)(a)(i) (with reg. 23)
Word in Art. 28(1) omitted (31.12.2020) by virtue of The Genetically Modified Food and Feed (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/705), regs. 1, 32(a); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 28(1) substituted (1.4.2025) by The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), regs. 1(2), 14(13)(a)(ii) (with reg. 23)
2. The Food Safety Authority must maintain the Register and make it available to the public.
Art. 28(2) substituted (1.4.2025) by The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), regs. 1(2), 14(13)(b) (with reg. 23)
Word in Art. 28 heading omitted (31.12.2020) by virtue of The Genetically Modified Food and Feed (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/705), regs. 1, 32(a); 2020 c. 1, Sch. 5 para. 1(1)

Article 29 Public access
1. The application for authorisation, supplementary information from the applicant, opinions from the competent authorities designated in accordance with Article 4 of Directive 2001/18/EC, monitoring reports and information from the authorisation holder, excluding confidential information, shall be made accessible to the public.
2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Art. 29(2) omitted (31.12.2020) by virtue of The Genetically Modified Food and Feed (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/705), regs. 1, 33; 2020 c. 1, Sch. 5 para. 1(1)
3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Art. 29(3) omitted (31.12.2020) by virtue of The Genetically Modified Food and Feed (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/705), regs. 1, 33; 2020 c. 1, Sch. 5 para. 1(1)

Article 30 Confidentiality
1. The applicant may indicate which information submitted under this Regulation it wishes to be treated as confidential on the ground that its disclosure might significantly harm its competitive position. Verifiable justification must be given in such cases.
2. Without prejudice to paragraph 3, the Food Safety Authority shall determine, after consultation with the applicant, which information should be kept confidential and shall inform the applicant of its decision.
Words in Art. 30(2) substituted (31.12.2020) by The Genetically Modified Food and Feed (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/705), regs. 1, 34(a); 2020 c. 1, Sch. 5 para. 1(1)
3. Information relating to the following shall not be considered confidential:
(a) name and composition of the GMO, food or feed referred to in Articles 3(1) and 15(1) and, where appropriate, indication of the substrate and the micro-organism;
(b) general description of the GMO and the name and address of the authorisation-holder;
(c) physico-chemical and biological characteristics of the GMO, food or feed referred to in Articles 3(1) and 15(1);
(d) effects of the GMO, food or feed referred to in Articles 3(1) and 15(1) on human and animal health and on the environment;
(e) effects of the GMO, food or feed referred to in Articles 3(1) and 15(1) on the characteristics of animal products and its nutritional properties;
(f) methods for detection, including sampling and identification of the transformation event and, where applicable, for the detection and identification of the transformation event in the food or feed referred to in Articles 3(1) and 15(1);
(g) information on waste treatment and emergency response.
4. Notwithstanding paragraph 2, the Food Safety Authority must on request supply the appropriate authority with all information in its possession.
Art. 30(4) substituted (31.12.2020) by The Genetically Modified Food and Feed (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/705), regs. 1, 34(b); 2020 c. 1, Sch. 5 para. 1(1)
5. The use of the detection methods and the reproduction of the reference materials, provided under Article 5(3) and 17(3) for the purpose of applying this Regulation to the GMOs, food or feed to which an application refers, shall not be restricted by the exercise of intellectual property rights or otherwise.
6. The appropriate authority and the Food Safety Authority must take the necessary measures to ensure appropriate confidentiality of the information received by them under this Regulation except for information which must be made public if circumstances so require in order to protect human health, animal health or the environment.
Art. 30(6) substituted (31.12.2020) by The Genetically Modified Food and Feed (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/705), regs. 1, 34(c); 2020 c. 1, Sch. 5 para. 1(1)
7. If an applicant withdraws or has withdrawn an application, the Food Safety Authority and the appropriate authority must respect the confidentiality of commercial and industrial information, including research and development information, as well as any information in respect of which a claim of confidentiality is disputed.
Art. 30(7) substituted (31.12.2020) by The Genetically Modified Food and Feed (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/705), regs. 1, 34(d); 2020 c. 1, Sch. 5 para. 1(1)

Article 31 Data protection
The scientific data and other information in the application dossier required under Article 5(3) and (5) and Article 17(3) and (5) may not be used for the benefit of another applicant for a period of 10 years from the date of authorisation, unless the other applicant has agreed with the authorisation-holder that such data and information may be used.
On the expiry of this 10-year period, the findings of all or part of the evaluation conducted on the basis of the scientific data and information contained in the application dossier may be used by the Authority for the benefit of another applicant if the applicant can demonstrate that the food or feed for which it is seeking authorisation is essentially similar to a food or feed already authorised under this Regulation.

Article 32 Reference laboratory
1. The appropriate authority may designate in accordance with Article 100 of Regulation (EU) 2017/625 a reference laboratory to perform the duties and tasks set out in the Annex.
2. Applicants for authorisation of genetically modified food and feed shall contribute to supporting the costs of the duties and tasks of the reference laboratory.
3. The contributions from applicants shall not exceed the costs incurred in carrying out the validation of detection methods.
3. The appropriate authority may prescribe—
a) measures for implementing this Article and the Annex; and
b) measures designed to amend non-essential elements of this Regulation and adapting the Annex.
Art. 32 substituted (31.12.2020) by The Genetically Modified Food and Feed (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/705), regs. 1, 35 (as amended by The Food and Feed Hygiene and Safety (Miscellaneous Amendments etc.) (EU Exit) Regulations 2020 (S.I. 2020/1504), regs. 1(2), 17(4)); 2020 c. 1, Sch. 5 para. 1(1)

Article 33 Consultation with the European Group on Ethics in Science and New Technologies
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Art. 33 omitted (31.12.2020) by virtue of S.I. 2019/705, reg. 36 (as substituted by The Food and Feed Hygiene and Safety (Miscellaneous Amendments etc.) (EU Exit) Regulations 2020 (S.I. 2020/1504), regs. 1(2), 17(5))

Article 34 Emergency measures
Where it is evident that products authorised by or in accordance with this Regulation are likely to constitute a serious risk to human health, animal health or the environment, or where, in the light of an opinion of the Food Safety Authority issued under Article 10 or Article 22, the need to suspend or modify urgently an authorisation arises, measures shall be taken under the procedures provided for in Articles 53 ... of Regulation (EC) No 178/2002.
Words in Art. 34 inserted (31.12.2020) by S.I. 2019/705, reg. 36(a) (as inserted by The Food and Feed Hygiene and Safety (Miscellaneous Amendments etc.) (EU Exit) Regulations 2020 (S.I. 2020/1504), regs. 1(2), 17(6))
Words in Art. 34 omitted (31.12.2020) by virtue of S.I. 2019/705, reg. 36(b) (as inserted by The Food and Feed Hygiene and Safety (Miscellaneous Amendments etc.) (EU Exit) Regulations 2020 (S.I. 2020/1504), regs. 1(2), 17(6))

Article 35 Committee procedure
1. Any power to make regulations under this Regulation—
(a) so far as exercisable by a Minister of the Crown, is exercisable by statutory instrument;
(b) so far as exercisable by the Welsh Ministers, is exercisable by statutory instrument;
2. For regulations made under this Regulation by the Scottish Ministers, see also section 27 of the Interpretation and Legislative Reform (Scotland) Act 2010 (Scottish statutory instruments).
3. Any power to make regulations under this Regulation includes power—
4. Any statutory instrument or Scottish statutory instrument containing regulations under this Regulation shall be subject to annulment in pursuance of a resolution—
(a) in the case of England, of either House of Parliament;
(b) in the case of Wales, of Senedd Cymru;
(c) in the case of Scotland, of the Scottish Parliament;
5. In this Regulation, any power—
(a) of the Secretary of State to make regulations is limited to regulations which apply in relation to England only;
(b) of the Welsh Ministers to make regulations is limited to regulations which apply in relation to Wales only;
(c) of the Scottish Ministers to make regulations is limited to regulations which apply in relation to Scotland only;
Art. 35 substituted (31.12.2020) by The Genetically Modified Food and Feed (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/705), regs. 1, 37 (as amended by The Food and Feed Hygiene and Safety (Miscellaneous Amendments etc.) (EU Exit) Regulations 2020 (S.I. 2020/1504), regs. 1(2), 17(7)); 2020 c. 1, Sch. 5 para. 1(1)

Article 36 Administrative review
(1) Any decision taken under, or failure to exercise, the powers vested in the Food Safety Authority by this Regulation may be reviewed by the appropriate authority on its own initiative or in response to a request from any person directly and individually concerned.
(2) To this effect a request shall be submitted to the appropriate authority within two months from the day on which the party concerned became aware of the act or omission in question.
(3) The appropriate authority must take a decision within two months requiring, if appropriate, the Food Safety Authority to withdraw its decision or to remedy its failure to act.
Art. 36 substituted (31.12.2020) by The Genetically Modified Food and Feed (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/705), regs. 1, 38; 2020 c. 1, Sch. 5 para. 1(1)

Article 37 Repeals
The following Regulations shall be repealed with effect from the date of application of this Regulation:
Regulation (EC) No 1139/98,
Regulation (EC) No 49/2000,
Regulation (EC) No 50/2000.

Article 38 Amendments to Regulation (EC) No 258/97
Regulation (EC) No 258/97 is hereby amended with effect from the date of application of this Regulation as follows:
1. The following provisions shall be deleted:
Article 1(2)(a) and (b),
Article 3(2), second subparagraph, and (3),
Article 8(1)(d),
Article 9.
2. In Article 3, the first sentence of paragraph 4 shall be replaced by the following:

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

Article 39 Amendment to Directive 82/471/EEC
The following paragraph shall be added to Article 1 of Directive 82/471/EEC with effect from the date of application of this Regulation:

‘3. This Directive does not apply to products which act as direct or indirect protein sources that fall within the scope of Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed.
OJ L 268, 18.10.2003, p. 1.’

Article 40 Amendments to Directive 2002/53/EC
Directive 2002/53/EC is hereby amended with effect from the date of application of this Regulation as follows:
1. Article 4(5) shall be replaced by the following:

‘5. Further, when material derived from a plant variety is intended to be used in food falling within the scope of Article 3, or in feed falling within the scope of Article 15 of Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed, the variety shall be accepted only if it has been approved in accordance with that Regulation.
OJ L 268, 18.10.2003, p. 1.’

2. Article 7(5) shall be 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 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority, and laying down procedures in matters of food safety is accepted only if it has been authorised under the relevant legislation.
OJ L 31, 1.2.2002, p. 1.’

Article 41 Amendments to Directive 2002/55/EC
Directive 2002/55/EC is hereby amended with effect from the date of application of this Regulation as follows:
1. Article 4(3) shall be replaced by the following:

‘3. Further, when material derived from a plant variety is intended to be used in food falling within the scope of Article 3, or in feed falling within the scope of Article 15 of Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed, the variety shall be accepted only if it has been approved in accordance with that Regulation.
OJ L 268, 18.10.2003, p. 1.’

2. Article 7(5) shall be 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 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority, and laying down procedures in matters of food safety is accepted only if it has been authorised under the relevant legislation.
OJ L 31, 1.2.2002, p. 1.’

Article 42 Amendment to Directive 68/193/EEC
Article 5ba(3) of Directive 68/193/EEC shall be replaced by the following wording with effect from the date of application of this Regulation:

‘3. a) Where products derived from vine-propagating material are intended to be used as or in food falling within the scope of Article 3 or as or in a feed falling within the scope of Article 15 of Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed, the vine variety concerned shall be accepted only if it has been authorised pursuant to the said Regulation.
OJ L 268, 18.10.2003, p. 1.
b) Member States shall ensure that a vine variety, from the propagating material of which products were derived intended for use in food and feed pursuant to Articles 2 and 3 of Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority, and laying down procedures in matters of food safety shall be accepted only if it has been authorised pursuant to the relevant legislation.
OJ L 31, 1.2.2002, p. 1.’

Article 43 Amendments to Directive 2001/18/EC
Directive 2001/18/EC is hereby amended with effect from the date of entry into force of this Regulation, as follows:
1. The following Article shall be inserted:

‘Article 12a Transitional measures for adventitious or technically unavoidable presence of genetically modified organisms having benefited from a favourable risk evaluation
1. 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 shall be exempted from Articles 13 to 21 provided that they meet the conditions referred to in Article 47 of Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed.
OJ L 268, 18.10.2003, p. 1.
2. This Article shall be applicable for a period of three years after the date of application of Regulation (EC) No 1829/2003.’

2. The following Article shall be inserted:

‘Article 26a Measures to avoid the unintended presence of GMOs
1. Member States may take appropriate measures to avoid the unintended presence of GMOs in other products.
2. The Commission shall gather and coordinate information based on studies at Community and national level, observe the developments regarding coexistence in the Member States and, on the basis of the information and observations, develop guidelines on the coexistence of genetically modified, conventional and organic crops.’

Article 44 Information to be provided in accordance with the Cartagena Protocol
1. Any authorisation, ... modification, suspension or revocation of authorisation of a GMO, food or feed referred to in Articles 3(1)(a) or (b) or 15(1)(a) or (b) shall be notified by the Food Safety Authority to the Parties to the Cartagena Protocol through the biosafety clearing house in accordance with Article 11(1) or Article 12(1) of the Cartagena Protocol, as the case may be.
The Food Safety Authority shall provide a copy of the information, in writing, to the national focal point of each Party that informs the Secretariat in advance that it does not have access to the biosafety clearing house.
Word in Art. 44(1) omitted (1.4.2025) by virtue of The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), regs. 1(2), 14(14) (with reg. 23)
Words in Art. 44 substituted (31.12.2020) by The Genetically Modified Food and Feed (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/705), reg. 38A (as inserted by S.I. 2020/1504, regs. 1(2), 17(8))
2. The Food Safety Authority shall also process requests for additional information made by any Party in accordance with Article 11(3) of the Cartagena Protocol and shall provide copies of the laws, regulations and guidelines in accordance with Article 11(5) of that Protocol.

Article 45 Penalties
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Art. 45 omitted (31.12.2020) by virtue of The Genetically Modified Food and Feed (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/705), regs. 1, 39; 2020 c. 1, Sch. 5 para. 1(1)

Article 46 Transitional measures for requests, labelling and notifications
1. Requests submitted under Article 4 of Regulation (EC) No 258/97 before the date of application of this Regulation shall be transformed into applications under Chapter II, Section 1 of this Regulation where the initial assessment report provided for under Article 6(3) of Regulation (EC) No 258/97 has not yet been forwarded to the Commission, as well as in all cases where an additional assessment report is required in accordance with Article 6(3) or (4) of Regulation (EC) No 258/97. Other requests submitted under Article 4 of Regulation (EC) No 258/97 before the date of application of this Regulation shall be processed under the provisions of Regulation (EC) No 258/97, notwithstanding Article 38 of this Regulation.
2. The labelling requirements referred to in this Regulation shall not apply to products, the manufacturing process of which has commenced before the date of application of this Regulation, provided that these products are labelled in accordance with the legislation applicable to them before the date of application of this Regulation.
3. Notifications concerning products including their use as feed submitted under Article 13 of Directive 2001/18/EC before the date of application of this Regulation shall be transformed into applications under Chapter III, Section 1 of this Regulation where the assessment report provided for in Article 14 of Directive 2001/18/EC has not yet been sent to the Commission.
4. Requests submitted for products referred to in Article 15(1)(c) of this Regulation under Article 7 of Directive 82/471/EEC before the date of application of this Regulation shall be transformed into applications under Chapter III, Section 1 of this Regulation.
5. Requests submitted for products referred to in Article 15(1) of this Regulation under Article 4 of Directive 70/524/EEC before the date of application of this Regulation shall be supplemented by applications under Chapter III, Section 1 of this Regulation.

Article 47 Transitional measures for adventitious or technically unavoidable presence of genetically modified material which has benefited from a favourable risk evaluation
1. The presence in food or feed of material which contains, consists of or is produced from GMOs in a proportion no higher than 0,5 % shall not be considered to be in breach of Article 4(2) or Article 16(2), provided that:
(a) this presence is adventitious or technically unavoidable;
(b) the genetically modified material has benefited from a favourable opinion from the Community Scientific Committee(s) or the Authority before the date of application of this Regulation;
(c) the application for its authorisation has not been rejected in accordance with the relevant Community legislation; and
(d) detection methods are publicly available.
2. 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 such materials.
3. Measures designed to amend non-essential elements of this Regulation by supplementing it and lowering the thresholds referred to in paragraph 1, in particular for GMOs sold directly to the final consumer, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 35(3).
Substituted by Regulation (EC) No 298/2008 of the European Parliament and of the Council of 11 March 2008 amending Regulation (EC) No 1829/2003 on genetically modified food and feed, as regards the implementing powers conferred on the Commission.
4. Detailed rules for implementing this Article shall be adopted in accordance with the procedure referred to in Article 35(2).
5. This Article shall remain applicable for a period of three years after the date of application of this Regulation.

Article 48 Review
1. No later than 7 November 2005 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 and in particular of Article 47, accompanied, where appropriate, by any suitable proposal. The report and any proposal shall be made accessible to the public.
2. Without prejudice to the powers of national authorities, the Commission shall monitor the application of this Regulation and its impact on human and animal health, consumer protection, consumer information and the functioning of the internal market and, if necessary, will bring forward proposals at the earliest possible date.

Article 49 Entry into force
This Regulation shall enter into force on the 20th day following that of its publication in the Official Journal of the European Union.
It shall apply from six months after the date of publication of this Regulation.
...
Words in Signature omitted (31.12.2020) by virtue of The Genetically Modified Food and Feed (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/705), regs. 1, 40; 2020 c. 1, Sch. 5 para. 1(1)

ANNEX DUTIES AND TASKS OF THE ... REFERENCE LABORATORY
1. ..........................................................................
Annex para. 1 omitted (31.12.2020) by virtue of The Genetically Modified Food and Feed (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/705), regs. 1, 41(b); 2020 c. 1, Sch. 5 para. 1(1)
2. ...............................
Annex para. 2 omitted (31.12.2020) by virtue of The Genetically Modified Food and Feed (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/705), regs. 1, 41(b); 2020 c. 1, Sch. 5 para. 1(1)

3. The ... reference laboratory shall be responsible, in particular, for:
(a) ...
Annex para. 3(a) omitted (31.12.2020) by virtue of The Genetically Modified Food and Feed (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/705), regs. 1, 41(c)(ii); 2020 c. 1, Sch. 5 para. 1(1)
(b) ...
Annex para. 3(b) omitted (31.12.2020) by virtue of The Genetically Modified Food and Feed (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/705), regs. 1, 41(c)(ii); 2020 c. 1, Sch. 5 para. 1(1)
(c) evaluating the data provided by the applicant for authorisation for placing the food or feed on the market, for the purpose of testing and validation of the method for sampling and detection;
(d) testing and validating the 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 or feed;
(e) submitting full evaluation reports to the Authority.
Substituted by Commission Regulation (EC) No 1981/2006 of 22 December 2006 on detailed rules for the implementation of Article 32 of Regulation (EC) No 1829/2003 of the European Parliament and of the Council as regards the Community reference laboratory for genetically modified organisms (Text with EEA relevance).
Word in Annex para. 3 omitted (31.12.2020) by virtue of The Genetically Modified Food and Feed (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/705), regs. 1, 41(c)(i); 2020 c. 1, Sch. 5 para. 1(1)
4. The reference laboratory must help to resolve disputes concerning the results of the duties and tasks outlined in this Annex.
Annex para. 4 substituted (31.12.2020) by The Genetically Modified Food and Feed (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/705), regs. 1, 41(d); 2020 c. 1, Sch. 5 para. 1(1)
Word in Annex title omitted (31.12.2020) by virtue of The Genetically Modified Food and Feed (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/705), regs. 1, 41(a); 2020 c. 1, Sch. 5 para. 1(1)

Regulation applied (with modifications) (N.I.) (1.10.2023) by The Windsor Framework (Retail Movement Scheme: Public Health, Marketing and Organic Product Standards and Miscellaneous Provisions) Regulations 2023 (S.I. 2023/959), regs. 1(2), 4(a), Sch. 1 (with regs. 7, 8)