CHAPTER II AUTHORISATION, USE, MONITORING AND TRANSITIONAL MEASURES APPLICABLE FOR FEED ADDITIVES

Article 3 Placing on the market, processing and use
1. No person shall place on the market, process or use a feed additive unless:
(a) it is covered by an authorisation granted in accordance with this Regulation;
(b) the conditions for use set out in this Regulation, including the general conditions set out in Annex IV, unless otherwise provided for in the authorisation, and in the authorisation of the substance are met; and
(c) the conditions on labelling set out in this Regulation are met.
2. For experiments for scientific purposes, the appropriate authority may authorise the use, as additives, of substances which are not authorised ..., with the exception of antibiotics, provided that the experiments are carried out in accordance with the principles and conditions laid down in Regulation (EC) No 767/2009 or the guidelines set out in Article 7(4) of this Regulation and provided that there is adequate official supervision. The animals concerned may be used for food production only if the authorities establish that this will have no adverse effect on animal health, human health or the environment.
Words in Art. 3(2) substituted (31.12.2020) by The Animal Feed (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/654), regs. 1, 11(a)(i); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 3(2) omitted (31.12.2020) by virtue of The Animal Feed (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/654), regs. 1, 11(a)(ii); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 3(2) substituted (31.12.2022) by The Food and Feed (Miscellaneous Amendments) Regulations 2022 (S.I. 2022/1351), regs. 1(1), 8(4)(a)
3. In the case of additives belonging to categories (d) and (e) of Article 6(1) and of those additives falling within the scope of ... legislation relating to the marketing of products consisting of, containing or produced from genetically modified organisms (GMOs), no person other than the holder of the authorisation named in the authorisation ... referred to in Article 9, his legal successor or successors, or a person acting under his written authority, shall first place the product on the market.
Word in Art. 3(3) omitted (31.12.2020) by virtue of The Animal Feed (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/654), regs. 1, 11(b); 2020 c. 1, Sch. 5 para. 1(1)
Word in Art. 3(3) omiited (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), 3(3) (with reg. 23)
4. Unless otherwise specified, the mixing of additives to be sold directly to the end-user shall be allowed, subject to compliance with the conditions for use laid down in the authorisation for each single additive. Consequently, the mixing of authorised additives shall not be subject to specific authorisations other than the requirements laid down in Regulation (EC) No 183/2005.
Words in Art. 3(4) substituted (31.12.2022) by The Food and Feed (Miscellaneous Amendments) Regulations 2022 (S.I. 2022/1351), regs. 1(1), 8(4)(b)
5. Where necessary, as a result of technological progress or scientific development, the appropriate authority may prescribe changes to the general conditions set out in Annex 4.
Art. 3(5) substituted (31.12.2020) by The Animal Feed (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/654), regs. 1, 11(c); 2020 c. 1, Sch. 5 para. 1(1)

Article 4 Authorisation
1. Any person seeking an authorisation for a feed additive or for a new use of a feed additive shall submit an application in accordance with Article 7.
2. An authorisation shall not be granted, refused, ... modified, suspended or revoked except on the grounds and under the procedures set out in this Regulation, or in accordance with Article 53 of Regulation (EC) No 178/2002.
Word in Art. 4(2) omitted (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), 3(4) (with regs. 23, 24)
Words in Art. 4(2) substituted (31.12.2022) by The Food and Feed (Miscellaneous Amendments) Regulations 2022 (S.I. 2022/1351), regs. 1(1), 8(5)
3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Art. 4(3) omitted (31.12.2020) by virtue of The Animal Feed (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/654), regs. 1, 12; 2020 c. 1, Sch. 5 para. 1(1)

Article 5 Conditions for authorisation
1. No feed additive shall be authorised unless the applicant for such authorisation has adequately and sufficiently demonstrated in accordance with the implementing measures referred to in Article 7 that, when used in accordance with conditions to be set out in the authorisation concerned in respect of the use of the additive, it satisfies the requirements of paragraph 2, and has at least one of the characteristics set out in paragraph 3.
Words in Art. 5(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), 3(5) (with reg. 23)
2. The feed additive shall not:
(a) have an adverse effect on animal health, human health or the environment,
(b) be presented in a manner which may mislead the user,
(c) harm the consumer by impairing the distinctive features of animal products or mislead the consumer with regard to the distinctive features of animal products.
3. The feed additive shall:
(a) favourably affect the characteristics of feed,
(b) favourably affect the characteristics of animal products,
(c) favourably affect the colour of ornamental fish and birds,
(d) satisfy the nutritional needs of animals,
(e) favourably affect the environmental consequences of animal production,
(f) favourably affect animal production, performance or welfare, particularly by affecting the gastro-intestinal flora or digestibility of feedingstuffs, or
(g) have a coccidiostatic or histomonostatic effect.
4. Antibiotics, other than coccidiostats or histomonostats, shall not be authorised as feed additives.

Article 6 Categories of feed additives
1. A feed additive shall be allocated to one or more of the following categories, depending on its functions and properties, in accordance with the procedure set out at Articles 7, 8 and 9:
(a) technological additives: any substance added to feed for a technological purpose;
(b) sensory additives: any substance, the addition of which to feed improves or changes the organoleptic properties of the feed, or the visual characteristics of the food derived from animals;
(c) nutritional additives;
(d) zootechnical additives: any additive used to affect favourably the performance of animals in good health or used to affect favourably the environment;
(e) coccidiostats and histomonostats.
2. Within the categories referred to in paragraph 1, feed additives shall further be allocated within one or more of the functional groups mentioned in Annex I, according to their principal function or functions, in accordance with the procedure specified in Articles 7, 8 and 9.
3. Where necessary, as a result of technological progress or scientific development, the appropriate authority may prescribe additional feed additive categories and functional groups.
Art. 6(3) substituted (31.12.2020) by The Animal Feed (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/654), regs. 1, 13; 2020 c. 1, Sch. 5 para. 1(1)

Article 7 Application for authorisation
1. An application for an authorisation as provided for in Article 4 must be sent to the appropriate authority. The appropriate authority must without delay forward the application to the Food Safety Authority.
2. The Food Safety Authority must—
(a) acknowledge receipt of the application, including the particulars and documents referred to in paragraph 3, in writing, to the applicant within 15 days of its receipt, stating the date of receipt;
(b) make any information supplied by the applicant available to the appropriate authority;
(c) make the summary of the dossier mentioned in paragraph 3(h) available to the public, subject to the confidentiality requirements laid down in Article 18(2).
3. At the time of application, the applicant must send the following particulars and documents directly to the Food Safety Authority—
(a) the applicant's name and address;
(b) the identification of the feed additive, a proposal for its classification by category and functional group under Article 6, and its specifications, including, where applicable, purity criteria;
(c) a description of the method of production, manufacturing and intended uses of the feed additive, of the method of analysis of the additive in feed according to its intended use and, where appropriate, of the method of analysis for the determination of the level of residues of the feed additive, or its metabolites, in food;
(d) a copy of the studies which have been carried out and any other material which is available to demonstrate that the feed additive satisfies the criteria laid down in Article 5(2) and (3);
(e) proposed conditions for placing the feed additive on the market, including labelling requirements and, where appropriate, specific conditions for use and handling (including known incompatibilities), use levels in complementary feed and animal species and categories for which the feed additive is intended;
Word in Art. 7(3)(e) substituted (31.12.2022) by The Food and Feed (Miscellaneous Amendments) Regulations 2022 (S.I. 2022/1351), regs. 1(1), 8(6)(a)(i)
(f) a written statement that three samples of the feed additive will be made available, upon request, to the reference laboratory referred to in Article 21, in accordance with the requirements set out in Annex 2;
Words in Art. 7(3)(f) substituted (31.12.2022) by The Food and Feed (Miscellaneous Amendments) Regulations 2022 (S.I. 2022/1351), regs. 1(1), 8(6)(a)(ii)
(g) for additives which, according to the proposal under point (b), do not belong to either category (a) or category (b) referred to in Article 6(1), and for additives falling within the scope of assimilated law relating to the marketing of products consisting of, containing or produced from GMOs, a proposal for post-market monitoring;
Word in Art. 7(3)(g) 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. 6(a)
(h) a summary containing the information provided under points (a) to (g);
(i) for additives falling within the scope of assimilated law relating to the marketing of products consisting of, containing or produced from GMOs, details of any authorisation granted in accordance with the applicable legislation.
Word in Art. 7(3)(i) 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. 6(a)
4. The appropriate authority, having first consulted the Food Safety Authority, may prescribe rules for the application and implementation of this Article, including rules concerning the preparation and the presentation of the application. ...
Words in Art. 7(4) omitted (31.12.2022) by virtue of The Food and Feed (Miscellaneous Amendments) Regulations 2022 (S.I. 2022/1351), regs. 1(1), 8(6)(b)
5. After the Food Safety Authority has been consulted, specific guidelines for the authorisation of additives may be established, where necessary for each category of additive referred to in Article 6(1). These guidelines must take account of the possibility of extrapolating the results of the studies carried out on major species to minor species.
6. Rules to allow for simplified provisions for the authorisation of additives which have been authorised for use in food may be prescribed by the appropriate authority.
7. Other implementing rules may be prescribed by the appropriate authority, which rules must, where appropriate, differentiate between requirements for feed additives in respect of food-producing animals and requirements in respect of other animals, in particular pets.
8. The Food Safety Authority must publish detailed guidance to assist the applicant in the preparation and the presentation of its application.
Art. 7 substituted (31.12.2020) by The Animal Feed (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/654), regs. 1, 14; 2020 c. 1, Sch. 5 para. 1(1)

Article 8 Opinion of the Food Safety Authority
1. The Food Safety Authority shall give an opinion within six months of receipt of a valid application. This time limit shall be extended whenever the Food Safety Authority seeks supplementary information from the applicant under paragraph 2.
2. The Food Safety Authority may, where appropriate, request the applicant to supplement the particulars accompanying the application within a time limit specified by the Food Safety Authority after consultation with the applicant.
3. In order to prepare its opinion, the Food Safety Authority:
(a) shall verify that the particulars and documents submitted by the applicant are in accordance with Article 7 and undertake an assessment in order to determine whether the feed additive complies with the conditions laid down in Article 5;
(b) shall verify the report of the reference laboratory.
Words in Art. 8(3)(b) substituted (31.12.2020) by The Animal Feed (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/654), regs. 1, 15(b); 2020 c. 1, Sch. 5 para. 1(1)
4. In the event of an opinion in favour of authorising the feed additive, the opinion shall also include the following elements:
(a) the name and address of the applicant;
(b) the designation of the feed additive including its categorisation and allocation within functional groups provided for in Article 6, its specification, including, where applicable, purity criteria and method of analysis;
(c) depending on the outcome of the assessment, specific conditions or restrictions in relation to handling, post-market monitoring requirements and use, including animal species and categories of animal species for which the additive is to be used;
(d) specific additional requirements for the labelling of the feed additive necessary as a result of conditions and restrictions imposed under (c);
(e) a proposal for the establishment of Maximum Residues Limits (MRLs) in the relevant foodstuffs of animal origin, unless the opinion of the Food Safety Authority concludes that the establishment of MRLs is not necessary for the protection of consumers or MRLs have already been established in Regulation (EC) No 470/2009.
Words in Art. 8(4)(e) substituted (31.12.2022) by The Food and Feed (Miscellaneous Amendments) Regulations 2022 (S.I. 2022/1351), regs. 1(1), 8(7)
5. The Food Safety Authority must without delay forward its opinion to the appropriate authority including a report describing its assessment of the feed additive and stating the reasons for its conclusion.
Art. 8(5) substituted (31.12.2020) by The Animal Feed (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/654), regs. 1, 15(c); 2020 c. 1, Sch. 5 para. 1(1)
6. The Food Safety Authority shall make its opinion public, after deletion of any information identified as confidential in accordance with Article 18(2).
Words in Art. 8 substituted (31.12.2020) by The Animal Feed (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/654), regs. 1, 15(a); 2020 c. 1, Sch. 5 para. 1(1)

Article 9 Authorisation by the appropriate authority...
1. Within three months of receipt of the opinion of the Food Safety Authority, the appropriate authority must determine whether to authorise the feed additive and the conditions upon which the feed additive is authorised. In making its determination, the appropriate authority must take into account the requirements of Article 5(2) and (3), assimilated law and other legitimate factors relevant to the matter under consideration and in particular benefits for animal health and welfare and for the consumer of animal products. Where the appropriate authority determines that the feed additive is to be authorised, the authorisation must include the elements mentioned in Article 8(4)(b), (c), (d) and (e) and an identification number. Where the authorisation is not in accordance with the opinion of the Food Safety Authority, the appropriate authority must provide an explanation of the reasons for the differences. Where, in the opinion of the appropriate authority, the application raises exceptionally complex issues, the three-month deadline may be extended.
Word in Art. 9(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. 6(b)
Words in Art. 9(1) substituted (18.4.2022) by The Food and Feed Safety (Miscellaneous Amendments and Transitional Provisions) Regulations 2022 (S.I. 2022/377), regs. 1(2), 6(2)
Words in Art. 9(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), 3(6)(b) (with reg. 23)
2. Rules for the implementation of this Article and in particular concerning an identification number for authorised additives may be prescribed by the appropriate authority.
3. The appropriate authority must without delay inform the applicant of the authorisation made in accordance with paragraph 1.
Word in Art. 9(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), 6(3)
4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Art. 9(4) omitted (18.4.2022) by virtue of The Food and Feed Safety (Miscellaneous Amendments and Transitional Provisions) Regulations 2022 (S.I. 2022/377), regs. 1(2), 6(4)
5. An authorisation for additives belonging to categories (d) and (e) referred to in Article 6(1) and also for additives consisting of, containing or produced from GMOs, must include the name of the holder of the authorisation, and, where appropriate, the unique identifier attributed to the GMO as referred to in Regulation (EC) No 1830/2003 of the European Parliament and of the Council concerning traceability and labelling of genetically modified organisms and traceability of food and feed products produced from genetically modified organisms and amending Directive 2001/18/EC.
6. Where the levels of residues of an additive in food from animals fed with that additive might have a detrimental effect on human health, the authorisation must include MRLs for the active substance or for its metabolites in the relevant foodstuffs of animal origin. In this case the active substance must be considered for the purposes of Council Directive 96/23/EC as falling under Annex 1 to that Directive. Where an MRL for the substance concerned has already been established in assimilated law, that MRL must also apply to residues of the active substance or its metabolites originating from the use of the substance as a feed additive.
Word in Art. 9(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. 6(b)
7. Where the appropriate authority determines that a feed additive is, or is not, to be authorised:
(a) in the event of a determination to authorise the feed additive:
(i) the appropriate authority must specify the date on which the authorisation is to have effect; and
(ii) the Food Safety Authority must enter the authorisation, including the elements mentioned in Article 8(4)(b), (c), (d) and (e) and an identification number, in the Register;
(b) the appropriate authority must communicate the determination to the Food Safety Authority.
Art. 9(7) 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), 3(6)(c) (with reg. 23)
Art. 9 substituted (31.12.2020) by The Animal Feed (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/654), regs. 1, 17; 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 9 heading 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), 3(6)(a) (with reg. 23)
Words in Art. 9 heading omitted (31.12.2020) by virtue of The Animal Feed (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/654), regs. 1, 16; 2020 c. 1, Sch. 5 para. 1(1)

Article 10 Status of existing products
1. By way of derogation from Article 3, a feed additive which has been placed on the market pursuant to Directive 70/524/EEC and urea and derivatives, an amino acid, salt of an amino acid or analogous substance, which was listed in points 2.1, 3 and 4 of the Annex to Directive 82/471/EEC, may be placed on the market and used in accordance with the conditions specified in Directives 70/524/EEC or 82/471/EEC and their implementing measures, including in particular specific labelling provisions concerning compound feed and feed materials, provided that the following conditions are met:
(a) within one year of the entry into force of this Regulation, persons first placing the feed additive on the market or any other interested parties shall notify this fact to the Commission. At the same time, the particulars mentioned in Article 7(3)(a), (b) and (c) shall be directly sent to the Authority;
(b) within one year of the notification mentioned under (a), the Authority shall, after verification that all the information required has been submitted, notify the Commission that it has received the information required under this Article. The products concerned shall be entered in the Register. Each entry in the Register shall mention the date on which the product concerned was first entered in the Register and, where applicable, the expiry date of the existing authorisation.
2. An application shall be submitted in accordance with Article 7, at the latest one year before the expiry date of the authorisation given pursuant to Directive 70/524/EEC for additives with a limited authorisation period, and within a maximum of seven years after the entry into force of this Regulation for additives authorised without a time limit or pursuant to Directive 82/471/EEC. A detailed calendar listing in order of priority the different classes of additives to be re-evaluated may be adopted in accordance with the procedure referred to in Article 22(2). The Authority shall be consulted in drawing up the list.
3. Products entered in the Register shall be subject to the provisions of this Regulation, in particular Articles 8, 9, 12, 13, 14 and 16, which without prejudice to specific conditions concerning the labelling, placing on the market and use of each substance pursuant to paragraph 1, shall apply to such products as if they had been authorised pursuant to Article 9.
4. In the case of authorisations not issued to a specific holder, any person who imports or manufactures the products referred to in this Article or any other interested party may submit the information as referred to in paragraph 1 or the application as referred to in paragraph 2 to the Commission.
5. Where the notification and accompanying particulars referred to in paragraph 1(a) are not supplied within the period specified or are found to be incorrect, or where an application is not submitted as required by paragraph 2 within the period specified, the appropriate authority may prescribe that—
(a) the additives concerned must be withdrawn from the market;
(b) that, for a limited period of time, existing stocks of the product may remain, or continue to be placed, on the market.
Art. 10(5) substituted (31.12.2020) by The Animal Feed (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/654), regs. 1, 18(a); 2020 c. 1, Sch. 5 para. 1(1)
6. Where, for reasons beyond the control of the applicant, no decision is taken on the renewal of an authorisation before its expiry date, the period of authorisation of the product shall automatically be extended until the appropriate authority takes a decision. The appropriate authority shall inform the applicant of this extension of the authorisation.
Words in Art. 10(6) substituted (31.12.2020) by The Animal Feed (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/654), regs. 1, 18(b); 2020 c. 1, Sch. 5 para. 1(1)
7. By way of derogation from Article 3, substances, micro-organisms and preparations used in the Community as silage additives at the date referred to in Article 26(2), may be placed on the market and used provided that points (a) and (b) of paragraph 1 and paragraph 2 are complied with. Paragraphs 3 and 4 shall apply accordingly. For these substances, the deadline for application as referred to in paragraph 2 shall be seven years after the entry into force of this Regulation.

Article 11 Phasing out
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Art. 11 omitted (31.12.2020) by virtue of The Animal Feed (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/654), regs. 1, 19; 2020 c. 1, Sch. 5 para. 1(1)

Article 12 Supervision
1. After an additive has been authorised in accordance with this Regulation, any person using or placing on the market that substance, or a feedingstuff into which it has been incorporated, or any other interested party must comply with any conditions or restrictions which have been imposed on the placing on the market, use and handling of the additive or feedingstuffs containing it.
2. Where monitoring requirements, as referred to in Article 8(4)(c), have been imposed, the holder of the authorisation must ensure that monitoring is carried out and must submit reports to the appropriate authority in accordance with the authorisation. The holder of the authorisation must immediately communicate to the Food Safety Authority any new information that might influence the evaluation of the safety in use of the feed additive, in particular health sensitivities of specific categories of consumers. The holder of the authorisation must immediately inform the Food Safety Authority of any prohibition or restriction imposed by the competent authority of any third country in which the feed additive is placed on the market.
Art. 12 substituted (31.12.2020) by The Animal Feed (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/654), regs. 1, 20; 2020 c. 1, Sch. 5 para. 1(1)

Article 12A 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 analysis, of the feed additive.
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 13.
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 13.
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 13 based on such information as the Food Safety Authority has which might affect the assessment of the safety, or the suitability of the method of analysis, of the feed additive.
6. In this Article, “relevant person” means any person who is—
(a) the holder of the authorisation concerned;
(b) a producer or manufacturer of the feed additive concerned; or
(c) any feed business placing on the market, processing or using the feed additive concerned.
Art. 12A 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), 3(7) (with reg. 23)

Article 13 Modification, suspension and revocation of authorisation
1. On its own initiative , the Food Safety Authority may, or following a request from the appropriate authority, the Food Safety Authority must, issue an opinion on whether an authorisation still meets the conditions set out by this Regulation. The Food Safety Authority must immediately transmit this opinion to the appropriate authority and, where applicable, to the holder of the authorisation. The opinion must be made public.
Words in Art. 13(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), 3(8)(a) (with reg. 23)
2. The appropriate authority must examine the opinion of the Food Safety Authority without delay. 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. 13(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), 3(8)(b) (with reg. 23)
3. If the holder of the authorisation proposes changing the terms of the authorisation by submitting an application to the appropriate authority, accompanied by the relevant data supporting the request for the change, the Food Safety Authority must transmit its opinion on the proposal to the appropriate authority. 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. 13(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), 3(8)(b) (with reg. 23)
(3A. The appropriate authority must, in relation to any determination it makes under this Article:
(a) specify the date on which the modification, suspension or revocation is to have effect; and
(b) communicate the determination to the Food Safety Authority.
Art. 13(3A) 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), 3(8)(c) (with reg. 23)
4. The Food Safety Authority, without delay after being informed by the appropriate authority, must—
(a) inform the applicant of any determination the appropriate authority makes under this Article;
(b) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Art. 13(4)(b) 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), 3(8)(d)(ii) (with reg. 23)
Words in Art. 13(4) 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), 3(8)(d)(i) (with reg. 23)
(4A. Where the appropriate authority determines that an authorisation of a feed additive is to be modified, suspended or revoked, the Food Safety Authority must update the Register accordingly.
Art. 13(4A) 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), 3(8)(e) (with reg. 23)
5. Articles 7(1) and (2), 8 and 9 apply accordingly.
(6. 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. 13(6)(7) 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), 3(8)(f) (with reg. 23)
(7. The appropriate authority may prescribe other transitional measures not falling within paragraph 6 in relation to the modification, suspension or revocation of an authorisation.
6. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Art. 13(6) omitted (31.12.2022) by virtue of The Food and Feed (Miscellaneous Amendments) Regulations 2022 (S.I. 2022/1351), regs. 1(1), 8(8)
Art. 13 substituted (31.12.2020) by The Animal Feed (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/654), regs. 1, 21; 2020 c. 1, Sch. 5 para. 1(1)

Article 14 Renewal of authorisation
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Art. 14 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), 3(9) (with regs. 23, 24)

Article 15 Urgent authorisation
1. In specific cases where urgent authorisation is needed to ensure the protection of animal welfare, the appropriate authority may provisionally authorise the use of an additive for a maximum period of five years. ...
Art. 15 renumbered as Art. 15(1) (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), 3(10)(a) (with reg. 23)
Words in Art. 15(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), 3(10)(b) (with reg. 23)
2. The appropriate authority may withdraw a provisional authorisation given under paragraph 1.
Art. 15(2)-(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), 3(10)(c) (with reg. 23)
3. Where the appropriate authority determines that a provisional authorisation is to be withdrawn, the appropriate authority may specify, in relation to the withdrawal of a provisional authorisation, 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.
4. The appropriate authority may prescribe other transitional measures not falling within paragraph 3 in relation to the withdrawal of a provisional authorisation.
5. Where the appropriate authority determines that a feed additive is, or is not, to be provisionally authorised (including a determination to withdraw a provisional authorisation), the appropriate authority must communicate the determination to the Food Safety Authority and:
(a) in the event of a determination to provisionally authorise a feed additive:
(i) the provisional authorisation must, to the extent that it is possible to do so, include information equivalent to that which must be included for an authorisation under Article 9(1);
(ii) the appropriate authority must specify the date on which the provisional authorisation is to have effect; and
(iii) the Food Safety Authority must enter the provisional authorisation, including the information mentioned in paragraph (i), in the Register;
(b) in the event of a determination to withdraw a provisional authorisation:
(i) the appropriate authority must specify the date on which the withdrawal is to have effect; and
(ii) the Food Safety Authority must update the Register accordingly.
Art. 15 substituted (31.12.2020) by The Animal Feed (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/654), regs. 1, 23; 2020 c. 1, Sch. 5 para. 1(1)