CHAPTER I SCOPE AND DEFINITIONS

Article 1 Scope

1.^F1,F2The purpose of this Regulation is to establish a ... procedure for authorising the placing on the market and use of feed additives and to lay down rules for the supervision and labelling of feed additives and premixtures in order to provide the basis for the assurance of a high level of protection of human health, animal health and welfare, environment and users' and consumers' interests in relation to feed additives, whilst ensuring the effective functioning of the ... market.

2.This Regulation shall not apply to:

(a)processing aids;

(b)^F3veterinary medicinal products ..., with the exception of coccidiostats and histomonostats used as feed additives.

[^F4 3. In this Article ‘veterinary medicinal product’ means:

(a)any substance or combination of substances presented as having properties for treating or preventing disease in animals; or

(b)any substance or combination of substances which may be used in, or administered to, animals with a view either to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis.

For the purposes of the definition of ‘veterinary medicinal product’, ‘substance’ means any matter, irrespective of origin, which may be:

(a)human, including human blood and human blood products;

(b)animal, including micro-organisms, whole animals, parts of organs, animal secretions, toxins, extracts and blood products;

(c)vegetable, including micro-organisms, plants, parts of plants, vegetable secretions and extracts; or

(d)chemical, including elements, naturally occurring chemical materials and chemical products obtained by chemical change or synthesis.^F4]

Article 2 Definitions

1. For the purpose of this Regulation, the definitions of ‘feed’, ‘feedingstuff’, ‘feed business’, ‘feed business operator’, ‘placing on the market’ and ‘traceability’ laid down in Regulation (EC) No 178/2002 shall apply.

2.The following definitions shall also apply:

(a) ‘feed additives’ means substances, micro-organisms or preparations, other than feed material and premixtures, which are intentionally added to feed or water in order to perform, in particular, one or more of the functions mentioned in Article 5(3);

[^F5 (b) ‘feed materials’ means products of vegetable or animal origin, whose principal purpose is to meet animals’ nutritional needs, in their natural state, fresh or preserved, and products derived from their industrial processing, and organic or inorganic substances, whether or not containing feed additives, which are intended for use in oral animal-feeding either directly as such, or after processing, or in the preparation of compound feed, or as a carrier of premixtures;

(c) ‘compound feed’ means a mixture of at least two feed materials, whether or not containing feed additives, for oral animal-feeding in the form of complete feed or complementary feed;

(d) ‘complementary feed’ means compound feed which has a high content of certain substances but which, by reason of its composition, is sufficient for a daily ration only if used in combination with other feed; ^F5]

(e) ‘premixtures’ means mixtures of feed additives or mixtures of one or more feed additives with feed materials or water used as carriers, not intended for direct feeding to animals;

(f) ‘daily ration’ means the average total quantity of feedingstuffs, calculated on a moisture content of 12 %, required daily by an animal of a given species, age category and yield, to satisfy all its needs;

[^F6 (g) ‘complete feed’ means compound feed which, by reason of its composition, is sufficient for a daily ration; ^F6]

(h) ‘processing aids’ means any substance not consumed as a feedingstuff by itself, intentionally used in the processing of feedingstuffs or feed materials to fulfil a technological purpose during treatment or processing which may result in the unintentional but technologically unavoidable presence of residues of the substance or its derivatives in the final product, provided that these residues do not have an adverse effect on animal health, human health or the environment and do not have any technological effects on the finished feed;

(i) ‘antimicrobials’ means substances produced either synthetically or naturally, used to kill or inhibit the growth of micro-organisms, including bacteria, viruses or fungi, or of parasites, in particular protozoa;

(j) ‘antibiotic’ means antimicrobials produced by, or derived from, a micro-organism, which destroys or inhibits the growth of other micro-organisms;

(k) ‘coccidiostats’ and ‘histomonostats’ means substances intended to kill or inhibit protozoa;

(l) ‘maximum residue limit’ means the maximum concentration of residue resulting from the use of an additive in animal nutrition which may be accepted by the [^F7 appropriate authority ^F7] as being legally permitted or recognised as acceptable in or on a food;

(m) ‘micro-organism’ means: colony-forming micro-organisms.

(n) ‘first placing on the market’ means the initial placing on the market of an additive after its manufacture, the import of an additive, or, where an additive has been incorporated into feed without being placed on the market, the first placing on the market of that feed.

[^F8 (o) “ third country ” means any country or territory other than the British Islands;

(p) “ prescribe ” means prescribe by regulations;

(q) “ appropriate authority ” means—

(i)in relation to England, the Secretary of State;

(ii)in relation to Wales, the Welsh Ministers;

(iii)in relation to Scotland, the Scottish Ministers;

(r) “ Food Safety Authority ” means—

(i)as regards England and Wales, the Food Standards Agency;

(ii)as regards Scotland, Food Standards Scotland;

(s) “ reference laboratory ” means a laboratory designated by the appropriate authority under Article 100 of Regulation 2017/625; ^F8]

[^F9 (t) ‘Register’ means the Register of Feed Additives referred to in Article 17. ^F9]

^F103.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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.^F12For experiments for scientific purposes, [^F11the appropriate authority^F11] 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 [^F13Regulation 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.(EC) No 767/2009^F13]

3.^F14,F15In 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.

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 [^F16Regulation .(EC) No 183/2005^F16]

[^F17 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.^F17]

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.^F18An 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 [^F19Article 53^F19] of Regulation (EC) No 178/2002.

^F203.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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 [^F21authorisation concerned in respect of^F21] 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.

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.

[^F22 3.Where necessary, as a result of technological progress or scientific development, the appropriate authority may prescribe additional feed additive categories and functional groups.^F22]

[^F23Article 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 _dfncomplementary [^F24 feed^F24] and animal species and categories for which the feed additive is intended;

(f)a written statement that three samples of the feed additive [^F25 will be made available, upon request,^F25] to the reference laboratory referred to in Article 21, in accordance with the requirements set out in Annex 2;

(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 [^F26 assimilated^F26] law relating to the marketing of products consisting of, containing or produced from GMOs, a proposal for post-market monitoring;

(h)a summary containing the information provided under points (a) to (g);

(i)for additives falling within the scope of [^F27 assimilated^F27] 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.

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. ^F28...

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.^F23]

Article 8 Opinion of the [^F29Food Safety Authority^F29]

1.The [^F29Food Safety Authority^F29] shall give an opinion within six months of receipt of a valid application. This time limit shall be extended whenever the [^F29Food Safety Authority^F29] seeks supplementary information from the applicant under paragraph 2.

2.The [^F29Food Safety Authority^F29] may, where appropriate, request the applicant to supplement the particulars accompanying the application within a time limit specified by the [^F29Food Safety Authority^F29] after consultation with the applicant.

3.In order to prepare its opinion, the [^F29Food Safety Authority^F29] :

(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 [^F30reference laboratory^F30] .

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 [^F29Food Safety Authority^F29] concludes that the establishment of MRLs is not necessary for the protection of consumers or MRLs have already been established in [^F31Regulation .(EC) No 470/2009^F31]

[^F32 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.^F32]

6.The [^F29Food Safety Authority^F29] shall make its opinion public, after deletion of any information identified as confidential in accordance with Article 18(2).

[^F33Article 9 Authorisation [^F34by the appropriate authority^F34] ^F35...

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), [^F36 assimilated^F36] 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. [[^F37,F38 Where the appropriate authority determines that the feed additive is to be authorised, the authorisation^F38] must include the elements mentioned in Article 8(4)(b), (c), (d) and (e) and an identification number.^F37] 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.

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 [^F39 authorisation^F39] made in accordance with paragraph 1.

^F404.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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 [^F41 assimilated^F41] 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.

[^F42 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.^F42,F33]]

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.

[^F43 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.^F43]

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 [^F44appropriate authority^F44] takes a decision. The [^F44appropriate authority^F44] shall inform the applicant of this extension of the authorisation.

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.

^F45Article 11 Phasing out

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[^F46Article 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.^F46]

[^F47Article 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.^F47]

[^F48Article 13 Modification, suspension and revocation of authorisation

1.On its own initiative [^F49 , the Food Safety Authority may, or following a request from the appropriate authority, the Food Safety Authority must,^F49] 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.

2.The appropriate authority must examine the opinion of the Food Safety Authority without delay. The appropriate authority must, [^F50 having regard to^F50] the opinion of the Food Safety Authority, determine whether to modify, suspend or revoke the authorisation.

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, [^F51 having regard to^F51] the opinion of the Food Safety Authority, determine whether to modify, suspend or revoke the authorisation.

[^F52 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.^F52]

4.The [^F53 Food Safety Authority, without delay after being informed by the appropriate authority, must^F53] —

(a)inform the applicant of any determination the appropriate authority makes under this Article;

^F54(b). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[^F55 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.^F55]

5.Articles 7(1) and (2), 8 and 9 apply accordingly.

[^F56 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.

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.^F56]

^F576.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .^F48]

^F58Article 14 Renewal of authorisation

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[^F59Article 15 Urgent authorisation

[^F60 1.^F60] 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. ^F61...^F59]

[^F62 2.The appropriate authority may withdraw a provisional authorisation given under paragraph 1.

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.^F62]

CHAPTER III LABELLING AND PACKAGING

Article 16 Labelling and packaging of feed additives and premixtures

1.No person shall place on the market a feed additive or a premixture of additives unless its packaging or container is labelled under the responsibility of a producer, packer, importer, seller or distributor established within [^F63the British Islands^F63] and bears the following information, in a conspicuous, clearly legible and indelible manner, in [^F64English or in English and Welsh^F64] in relation to each additive contained in the material:

(a)the specific name given to the additives upon authorisation, preceded by the name of the functional group as mentioned in the authorisation;

(b)the name or business name and the address or registered place of business of the person responsible for the particulars referred to in this Article;

(c)the net weight or, in the case of liquid additives and premixtures, either the net volume or the net weight;

[^F65 (d) where appropriate, the approval number of the establishment manufacturing or placing on the market the feed additive or the premixture pursuant to ^F66... Regulation (EC) No 183/2005 of the European Parliament and of the Council of 12 January 2005 laying down requirements for feed hygiene (12) ^F67...;^F65]

(e)directions for use, and any safety recommendations regarding the use and, where applicable, the specific requirements mentioned in the authorisation, including animal species and categories for which the additive or premixture of additives is intended;

(f)the identification number;

(g)the batch reference number and date of manufacture.

[^F68 In the case of premixtures, points (b), (d), (e) and (g) shall not apply to the incorporated feed additives.^F68]

2. For flavouring compounds, the list of additives may be replaced by the words ‘mixture of flavouring compounds’. This shall not apply to flavouring compounds subject to a quantitative limitation when used in feed and drinking water.

[^F65 3 . In addition to the information specified in paragraph 1, the packaging or container of a feed additive belonging to a functional group specified in Annex III or of a premixture containing an additive belonging to a functional group specified in Annex III shall bear the information, presented in a conspicuous, clearly legible and indelible manner, indicated in that Annex.^F65]

[^F65 4 . In the case of premixtures, the word ‘premixture’ shall appear on the label. Carriers shall be declared, in the case of feed materials, in compliance with Article 17(1)(e) of Regulation (EC) No 767/2009 of the European Parliament and of the Council of 13 July 2009 on the placing on the market and use of feed ( 13 ) , and, where water is used as a carrier, the moisture content of the premixture shall be declared. Only one minimum storage life may be indicated in respect of each premixture as a whole; such minimum storage life shall be determined on the basis of the minimum storage life of each of its components. ^F65]

5.Additives and premixtures shall be marketed only in closed packages or closed containers which must be closed in such a way that the fastener is damaged on opening and cannot be re-used.

[^F69 6 .The appropriate authority may prescribe amendments to Annex 3 to take technological progress and scientific development into account.^F69]

CHAPTER IV GENERAL AND FINAL PROVISIONS

[^F71Article 17 ^F70...Register of Feed Additives

1.The Food Safety Authority must establish and keep up to date a Register of Feed Additives.^F71]

[^F72 2.The Food Safety Authority must make the Register available to the public.^F72]

Article 18 Confidentiality

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

2.The [^F73appropriate authority^F73] shall determine, after consultation with the applicant, which information other than that specified in paragraph 3 should be kept confidential and shall inform the applicant of its decision.

3.The following information shall not be considered confidential:

(a)name and composition of the feed additive and, where appropriate, indication of the production strain;

(b)physico-chemical and biological characteristics of the feed additive;

(c)the conclusions of the study results on effects of the feed additive on human and animal health and on the environment;

(d)the conclusions of the study results on effects of the feed additive on the characteristics of animal products and its nutritional properties;

(e)methods for detection and identification of the feed additive and, where applicable, monitoring requirements and a summary of the results of the monitoring.

[^F74 4.The Food Safety Authority must, on request, supply the appropriate authority with all information in its possession, including any identified as confidential pursuant to paragraph 2.^F74]

^F755.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[^F76 6.The appropriate authority and the Food Safety Authority must keep confidential all the information identified as confidential under paragraph 2 except where it is appropriate for such information to be made public in order to protect human health, animal health or the environment.^F76]

7.If an applicant withdraws or has withdrawn an application, the [^F77appropriate authority and the Food Safety Authority must^F77] respect the confidentiality of commercial and industrial information, including research and development information, as well as information on which the [^F78appropriate authority^F78] and the applicant disagree as to its confidentiality.

[^F79Article 18A Regulations and devolved powers

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—

(a)to make different provision in relation to different cases or classes of case (including different provision for different areas or different classes of business); and

(b)to provide for such exceptions, limitations and conditions, and to make such supplementary, incidental, consequential or transitional provisions, as the appropriate authority considers necessary or expedient.

4.Any statutory instrument or Scottish statutory instrument containing regulations made under this Regulation is 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;^F79]

Article 19 Administrative review

^F82Any decision taken under, or failure to exercise, the powers vested in the [^F80Food Safety Authority^F80] by this Regulation may be reviewed by the [^F81appropriate authority^F81] on its own initiative or in response to a request from ... any person directly and individually concerned.

For that purpose, a request shall be submitted to the [^F81appropriate authority^F81] within two months after the day on which the party concerned became aware of the act or omission in question.

The [^F81appropriate authority^F81] shall take a decision within two months requiring, if appropriate, the [^F80Food Safety Authority^F80] to withdraw its decision or to remedy its failure to act within a set time limit.

Article 20 Data protection

1.The scientific data and other information in the application dossier required under Article 7 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 previous applicant that such data and information may be used.

2.In order to stimulate efforts to obtain authorisations for minor species for additives whose use is authorised for other species, the 10-year data protection period shall be extended by one year for each minor species for which a use extension authorisation is granted.

3.The applicant and the previous applicant shall take all necessary steps to reach agreement on sharing the use of information, in order not to repeat toxicological tests on vertebrates. If, however, no such agreement is reached on sharing the information, the [^F83appropriate authority^F83] may decide to disclose information necessary to avoid repeating toxicological tests on vertebrates, while ensuring a reasonable balance between the interests of the parties concerned.

4.On the expiry of the 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 [^F84Food Safety Authority^F84] for the benefit of another applicant.

[^F85Article 21 Reference laboratory

1.The duties and tasks of the reference laboratory are laid down in Annex 2.

2.Applicants for the authorisation of additives must contribute to supporting the cost of the duties and tasks of the reference laboratory.

3.The appropriate authority may prescribe rules for implementing Annex 2.

4.The appropriate authority may prescribe amendments to Annex 2.^F85]

^F86 Article 21a Exercise of the delegation

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

^F87Article 22 Committee procedure

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Article 23 Repeals

1.Directive 70/524/EEC shall be repealed with effect from the date of application of this Regulation. However, Article 16 of Directive 70/524/EEC shall remain in force until Directive 79/373/EEC has been revised to include rules concerning the labelling of feedingstuffs incorporating additives.

2.Points 2.1, 3 and 4 of the Annex to Directive 82/471/EEC shall be deleted with effect from the date of application of this Regulation.

3.Directive 87/153/EEC shall be repealed with effect from the date of application of this Regulation. However, the Annex to that Directive shall remain in force until the implementing rules provided for in Article 7(4) of this Regulation are adopted.

4.References to Directive 70/524/EEC shall be construed as references to this Regulation.

^F88Article 24 Penalties

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Article 25 Transitional measures

1.Applications submitted under Article 4 of Directive 70/524/EEC before the date of application of this Regulation shall be treated as applications under Article 7 of this Regulation where the initial comments provided for under Article 4(4) of Directive 70/524/EEC have not yet been forwarded to the Commission. Any Member State selected as rapporteur in respect of any such application shall immediately forward the dossier submitted in support of that application to the Commission. Notwithstanding Article 23(1), such applications shall continue to be treated in accordance with Article 4 of Directive 70/524/EEC where the initial comments provided for under Article 4(4) of Directive 70/524/EEC have already been forwarded to the Commission.

2.The labelling requirements laid down in Chapter III shall not apply to products which have been lawfully manufactured and labelled in the Community or which have been lawfully imported into the Community and put into circulation, before the date of application of this Regulation.

Article 26 Entry into force

1.This Regulation shall enter into force on the 20th day following that of its publication in the Official Journal of the European Union.

2.It shall apply from 12 months after the date of publication of this Regulation.

ANNEX I ADDITIVE GROUPS

1. In the category ‘technological additives’, the following functional groups are included:

2. In the category ‘sensory additives’, the following functional groups are included:

3. In the category ‘nutritional additives’, the following functional groups are included:

4. In the category ‘zootechnical additives’, the following functional groups are included:

ANNEX II ^F95DUTIES AND TASKS OF THE ... REFERENCE LABORATORY

1. ^F96...

[^F971A. The reference laboratory may be assisted by scientific experts or official laboratories with the performance of the duties and tasks set out in this Annex.^F97]

[^F982. ^F99...

The [^F100 reference laboratory^F100] shall be responsible for:

3. The [^F105reference laboratory is^F105] responsible for coordination of the validation of the method(s) of analysis of the additive, in accordance with the procedure provided for in Article 10 of Regulation (EC) No 378/2005 (14). This task may involve the preparation of food or feed test material.

4. The [^F106reference laboratory must^F106] provide scientific and technical assistance to the [^F107appropriate authority^F107] , especially in cases where [^F108there are reasonable grounds to^F108] contest the results of analyses related to the duties and tasks referred to in this Annex, without prejudice to any role defined for it under [^F109Regulation (EU) 2017/625^F109] .

5. On request by the [^F110appropriate authority^F110] , the [^F111reference laboratory^F111] may also be responsible for conducting special analytical or other related studies in a manner similar to the duties and tasks referred to in point 2. This may be the case, in particular, for existing products notified under Article 10 and included in the Register and for the period until an application for authorisation under Article 10(2) is submitted in accordance with Article 10(2).

[^F112 6. The reference laboratory shall:

7. Without prejudice to the responsibilities of the [^F113reference laboratory^F113] laid down in [^F114Regulation (EU) 2017/625^F114] , the [^F115reference laboratory^F115] may create and maintain a database of methods of analysis available for control of feed additives and make it available to ^F116... other interested parties.^F98]

[^F117ANNEX III

1. SPECIFIC LABELLING REQUIREMENTS FOR CERTAIN ADDITIVES AND FOR PREMIXTURES.

2. ADDITIONAL LABELLING AND INFORMATION REQUIREMENTS FOR CERTAIN ADDITIVES CONSISTING OF PREPARATIONS AND PREMIXTURES CONTAINING SUCH PREPARATIONS.

ANNEX IV GENERAL CONDITIONS OF USE

1. ^F118The quantity of additives that also exists in the natural state in certain feed materials shall be calculated so that the total of the elements added and the elements present naturally does not exceed the maximum level provided for in the authorisation ....

2. Mixing of additives shall be permitted only in premixtures and feedingstuffs where there is physico-chemical and biological compatibility between the components of the mixture in relation to the effects desired.

3. Supplementary feedingstuffs, diluted as specified, may not contain levels of the additives which exceed those fixed for [^F119complete feed^F119] .

4. In the case of premixtures containing silage additives the words ‘of silage additives’ must clearly be added on the label after ‘PREMIXTURE’.

[^F1205. Technological additives or other substances or products contained in additives consisting of preparations shall only modify the physico-chemical characteristics of the active substance of the preparation and shall be used in accordance with their conditions of authorisation where such provisions are provided for.

Physico-chemical and biological compatibility between the components of the preparation shall be ensured in relation to the effects desired.^F120]