Статья 26Регламент № 1831/2003 Европейского парламента и Совета Европейского Союза

1. Настоящий Регламент вступает в силу на 20-й день после его опубликования в Официальном Журнале Европейского Союза.

2. Настоящий Регламент подлежит применению через 12 месяцев после даты опубликования настоящего Регламента.

Настоящий Регламент является обязательным в полном объеме и непосредственно применяется во всех государствах-членах ЕС.

Совершено в Брюсселе, 22 сентября 2003 г.

1. В категорию «технологические добавки» включаются следующие функциональные группы:

(a) консерванты: вещества или в зависимости от ситуации микроорганизмы, которые защищают корм для животных от порчи, вызванной микроорганизмами или их метаболитами;

(b) антиоксиданты: вещества, увеличивающие срок хранения кормов для животных и сырья для производства кормов путем их защиты от порчи, возникшей в результате окисления;

(c) эмульсификаторы: вещества, которые обеспечивают возможность создания или поддержания однородной смеси двух или более несмешивающихся фаз в кормах для животных;

(d) стабилизаторы: вещества, которые позволяют поддерживать физико-химическое состояние кормов для животных;

(e) загустители: вещества, которые повышают вязкость кормов для животных;

(f) желирующие агенты: вещества, которые придают кормам для животных студнеобразную структуру;

(g) связующие вещества: вещества, которые повышают способность частиц кормов для животных склеиваться;

(h) вещества для контроля за радионуклидной контаминацией: вещества, которые подавляют абсорбцию радионуклидов или способствуют их выведению;

(i) антислеживающие агенты: вещества, которые снижают способность конкретных частиц кормов для животных склеиваться;

(j) регуляторы кислотности: вещества, которые регулируют показатель концентрации водородных ионов в кормах для животных;

(k) силосные добавки: вещества, в том числе энзимы и микроорганизмы, предназначенные для добавления в корма для животных с целью улучшения производства силоса;

(l) денатураты: вещества, которые при использовании в производстве переработанных кормов для животных обеспечивают идентификацию происхождения отдельных кормов для животных или сырья для производства кормов;

(m) вещества для сокращения контаминации кормов для животных микотоксинами: вещества, которые могут подавить или сократить абсорбцию, способствуют выведению микотоксинов или изменяют их принцип действия;

(n) улучшители гигиенических условий: вещества или в соответствующих случаях микроорганизмы, которые положительно влияют на гигиенические характеристики кормов для животных посредством сокращения конкретной микробиологической контаминации;

(o) иные технологические добавки: вещества или в соответствующих случаях микроорганизмы, добавляемые в корма для животных в технологических целях, которые положительно влияют на характеристики кормов для животных.

2. В категорию «сенсорные добавки» включаются следующие функциональные группы:

(a) красители:

(i) вещества, которые добавляют или восстанавливают цвет в кормах для животных;

(ii) вещества, которые добавляют цвет пищевым продуктам животного происхождения при кормлении животных;

(iii) вещества, которые положительно влияют на окрас декоративных рыб и птиц;

(b) пищевые ароматизаторы: вещества, включение которых в корма для животных, улучшает запах и вкусовые характеристики кормов для животных.

3. В категорию «питательные добавки» включаются следующие функциональные группы:

(a) витамины, провитамины и химические вещества с четко определенным составом, обладающие аналогичным действием;

(b) соединения микроэлементов;

(c) аминокислоты, их соли и аналоги;

(d) мочевина и ее производные.

4. В категорию «зоотехнические добавки» включаются следующие функциональные группы:

(a) усилители усвояемости: вещества, которые при кормлении животных повышают усвояемость корма посредством воздействия на сырье для производства кормов;

(b) стабилизаторы микрофлоры кишечника: микроорганизмы или иные химические вещества с определенным составом, которые при кормлении животных оказывают положительное влияние на микрофлору кишечника;

(c) вещества, которые благоприятно влияют на окружающую среду;

(d) иные зоотехнические добавки;

(e) стабилизаторы физиологического состояния: вещества или в соответствующих случаях микроорганизмы, которые при кормлении здоровых животных благоприятно влияют на их физиологическое состояние, в том числе на их приспособляемость к факторам, вызывающим стресс.

1. Справочная лаборатория Сообщества, указанная в Статье 21, представляет собой объединенный исследовательский центр Европейской Комиссии (JRC).

2. Для осуществления функций и задач, установленных в настоящем Приложении, CRL <*> осуществляет свою деятельность при содействии консорциума национальных справочных лабораторий.

---

<*> Community reference laboratory, CRL — прим. перевод.

CRL несет ответственность за:

2.1. получение, хранение и содержание образцов добавок к кормам для животных, направляемых заявителем, как предусмотрено в Статье 7(3)(f) настоящего Регламента;

2.2. оценку метода анализа добавки к кормам для животных, а также иных соответствующих методов анализа, связанных с указанной добавкой, на основе данных, предусмотренных в заявлении на получение разрешения на использование добавки в корма для животных в части, касающейся ее пригодности для государственного контроля в соответствии с требованиями имплементационных правил, указанных в Статье 7(4) и (5), а также в соответствии с руководством Органа, указанным в Статье 7(6);

2.3. представление Органу полного отчета об оценке результатов выполнения функций и задач, указанных в настоящем Приложении;

2.4. при необходимости тестирование методов анализа.

3. CRL несет ответственность за координацию утверждения методов анализа добавок в соответствии с процедурой, предусмотренной в Статье 10 Регламента (ЕС) 378/2005 <*>. Указанная задача может включать в себя подготовку тестовых образцов пищевых продуктов и кормов для животных.

---

<*> ОЖ № L 59, 5.3.2005, стр. 8.

4. CRL оказывает научную и техническую помощь Европейской Комиссии, в частности, в тех случаях, когда государства-члены ЕС оспаривают результаты анализов, касающиеся функций и задач, указанных в настоящем Приложении, без ущерба какой-либо роли, определенной для нее в соответствии со Статьями 11 и 32 Регламента (ЕС) 882/2004 Европейского Парламента и Совета ЕС <*>.

---

<*> ОЖ № L 165, 30.4.2004, стр. 1. Исправление: ОЖ № L 191, 28.5.2004, стр. 1.

5. По запросу Европейской Комиссии CRL также несет ответственность за осуществление специальных аналитических или связанных с ними исследований в порядке, аналогичном выполнению функций и задач, указанных в пункте 2. Это может иметь место, в частности, для существующих добавок, заявленных в соответствии со Статьей 10 и включенных в Реестр, и на период до предоставления в соответствии со Статьей 10(2) заявления на получение разрешения в соответствии со Статьей 10(2).

6. CRL несет ответственность за общую координацию действий консорциума национальных справочных лабораторий. CRL должна удостовериться в том, что данные, касающиеся заявлений, являются доступными для лабораторий.

7. Без ущерба для обязанностей справочных лабораторий Сообщества, указанных в Статье 32 Регламента (ЕС) 882/2004, CRL может создавать и поддерживать базу данных методов анализа, доступных для контроля за добавками в корма для животных и предоставлять ее в распоряжение лабораторий государственного контроля государств-членов ЕС и иных заинтересованных лиц.

(a) Зоотехнические добавки, кокцидиостатики и гистомоностатики:

• дата истечения гарантийного срока или срока хранения с даты производства;
• указания по применению; и
• концентрация.

(b) Энзимы, в дополнение к вышеуказанным сведениям:

• специальное наименование активного компонента или компонентов согласно их ферментативной активности в соответствии с выданным разрешением;
• идентификационный номер Международного союза биохимии; и
• вместо концентрации: единицы активности (единицы активности в расчете на 1 грамм или единицы активности в расчете на 1 миллилитр).

(c) Микроорганизмы:

• дата истечения гарантийного срока или срока хранения с даты производства;
• указания по применению;
• регистрационный номер штамма; и
• номер колониеобразующих единиц в расчете на один грамм.

(d) Питательные добавки:

• уровень активного вещества; и
• дата истечения гарантийного срока или срока хранения с даты производства.

(e) Технологические и сенсорные добавки, за исключением пищевых ароматизаторов:

• уровень активного вещества.

(f) пищевые ароматизаторы:

• степень накопления в премиксах.

(a) Добавки, принадлежащие к категориям, указанным в Статье 6(1)(a), (b) и (c), и состоящие из препаратов:

(i) указание на упаковке или контейнере специального наименования, идентификационного номера и уровень содержания технологической добавки, содержащейся в препарате, для которой максимальные уровни установлены в соответствующем разрешении;

(ii) следующая информация на любом письменном носителе или прилагаемая к препарату:

• специальное наименование и идентификационный номер любой технологической добавки, содержащейся в препарате; и
• наименование другого вещества или продукта, содержащегося в препарате, указанного в порядке убывания по весу.

(b) Премиксы, содержащие добавки, которые принадлежат к категориям, указанным в Статье 6(1)(a), (b) и (c) настоящего Регламента, и состоят из препаратов:

(i) в соответствующих случаях указание на упаковке или контейнере, что премикс содержит технологические добавки, включенные в присадочные препараты, для которых максимальные уровни установлены в соответствующем разрешении;

(ii) по запросу от покупателя или пользователя информация о специальном наименовании, идентификационном номере и указание об уровне содержания технологических добавок, указанных в пункте (i) настоящего параграфа, включенных в присадочные препараты.

Приложение IV

ОБЩИЕ УСЛОВИЯ ИСПОЛЬЗОВАНИЯ

1. Количество добавок, которое также присутствует в естественном состоянии в некотором сырье для производства кормов для животных, должно рассчитываться таким образом, чтобы общее количество добавленных элементов и элементов, имеющих естественное происхождение, не превышало максимального уровня, предусмотренного в разрешении.

Commission Regulation (EC) No 386/2009 of 12 May 2009, Regulation (EC) No 596/2009 of the European Parliament and of the Council of 18 June 2009, Regulation (EC)

Parliament and of the Council of 20 June 2019)

---

<*> This text is meant purely as a documentation tool and has no legal effect. The Union's institutions do not assume any liability for its contents. The authentic versions of the relevant acts, including their preambles, are those published in the Official Journal of the European Union and available in EUR-Lex. Those official texts are directly accessible through the links embedded in this document

Article 1

1. The purpose of this Regulation is to establish a Community 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 internal market.

2. This Regulation shall not apply to:

(a) processing aids;

(b) veterinary medicinal products as defined in Directive 2001/82/EC <*>, with the exception of coccidiostats and histomonostats used as feed additives.

---

<*> OJ L 311, 28.11.2001, p. 1.

Article 2

Definitions

1. For the purpose of this Regulation, the definitions of «feed», «feed-ingstuff», «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);

(b) «feed materials» means products as defined in Article 2(a) of Council Directive 96/25/EC of 29 April 1996 on the circulation of feed materials <*>;

---

<*> OJ L 125, 23.5.1996, p. 35. Directive as last amended by Regulation (EC) No 806/2003 (OJ L 122, 16.5.2003, p. 1).

(c) «compound feedingstuffs» means products as defined in Article 2(b) of Directive 79/373/EEC;

(d) «complementary feedingstuffs» means products as defined in Article 2(e) of Directive 79/373/EEC;

(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;

(g) «complete feedingstuffs» means products as defined in Article 2(c) of Council Directive 1999/29/EC of 22 April 1999 on the undesirable substances and products in animal nutrition <*>;

---

<*> OJ L 115, 4.5.1999, p. 32. Directive as last amended by Regulation (EC) No 806/2003.

(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.

3. Where necessary, it may be determined, in accordance with the procedure referred to in Article 22(2), whether a substance, micro-organism or preparation is a feed additive within the scope of this Regulation.

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, Member States may authorise the use, as additives, of substances which are not authorised at Community level, with the exception of antibiotics, provided that the experiments are carried out in accordance with the principles and conditions laid down in Directive 87/153/EEC, Directive 83/228/EEC <*> 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.

---

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 Directive 95/69/EC <*>.

---

<*> Council Directive 95/69/EC of 22 December 1995 laying down the conditions and arrangements for approving and registering certain establishments and intermediaries operating in the animal feed sector and amending Directives 70/524/EEC, 74/63/EEC, 79/373/EEC and 82/471/EEC (OJ L 332, 30.12.1995, p. 15). Directive as last amended by Regulation (EC) No 806/2003.

5. The Commission is empowered to adopt delegated acts in accordance with Article 21a amending Annex IV in order to adapt the general conditions set out therein to technological progress or scientific development.

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, renewed, modified, suspended or revoked except on the grounds and under the procedures set out in this Regulation, or in accordance with Articles 53 and 54 of Regulation (EC) No 178/2002.

3. The applicant for an authorisation or his representative shall be established in the Community.

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 Regulation authorising 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,

(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:

(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. The Commission is empowered to adopt delegated acts in accordance with Article 21a amending Annex I in order to adapt feed additive categories and functional groups as a result of technological progress or scientific development.

Article 7

Application for authorisation

1. An application for an authorisation as provided for in Article 4 shall be sent to the Commission. The Commission shall without delay inform the Member States and forward the application to the European Food Safety Authority (hereinafter referred to as the Authority).

2. The Authority shall:

(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 Member States and the Commission;

(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 shall send the following particulars and documents directly to the Authority:

(a) his 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 feedingstuffs and animal species and categories for which the feed additive is intended;

(f) a written statement that three samples of the feed additive have been sent by the applicant directly to the Community reference laboratory referred to in Article 21, in accordance with the requirements set out in Annex 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 Community legislation 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 Community legislation relating to the marketing of products consisting of, containing or produced from GMOs, details of any authorisation granted in accordance with the applicable legislation.

After the Authority has been consulted, further rules for the implementation of this Article may be established.

The Commission is empowered to adopt delegated acts in accordance with Article 21a in order to supplement this Regulation by establishing rules to allow for simplified provisions for the authorisation of additives which have been authorised for use in food.

Other implementing rules may be adopted in accordance with the regulatory procedure referred to in Article 22(2). Those rules should, where appropriate, differentiate between requirements for feed additives in respect of food-producing animals and requirements in respect of other animals, in particular pets.

6. The Authority shall publish detailed guidance to assist the applicant in the preparation and the presentation of its application.

Article 8

Opinion of the Authority

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

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

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

(a) shall verify that the particulars and documents submitted by the applicant are in accordance with Article 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 Community Reference Laboratory.

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;

---

<*> OJ L 224, 18.8.1990, p. 1. Regulation as last amended by Commission Regulation (EC) No 1490/2003 (OJ L 214, 26.8.2003, p. 3).

5. The Authority shall without delay forward its opinion to the Commission, the Member States and the applicant, including a report describing its assessment of the feed additive and stating the reasons for its conclusion.

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

Article 9

Authorisation by the Community

1. Within three months of receipt of the opinion of the Authority, the Commission shall prepare a draft Regulation to grant authorisation or to deny authorisation. This draft shall take into account the requirements of Article 5(2) and (3), Community 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 draft is not in accordance with the opinion of the Authority, it shall provide an explanation of the reasons for the differences.

In exceptionally complex cases, the three-month deadline may be extended.

2. The draft shall be adopted in accordance with the procedure referred to in Article 22(2).

3. Rules for the implementation of this Article and in particular concerning an identification number for authorised additives may be established in accordance with the procedure referred to in Article 22(2).

4. The Commission shall without delay inform the applicant of the Regulation adopted in accordance with paragraph 2.

5. A Regulation granting the authorisation shall include the elements mentioned in Article 8(4)(b), (c), (d) and (e) and an identification number.

6. A Regulation granting 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, shall 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 of 22 September 2003 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 <*>.

---

<*> See page 24 of this Official Journal.

---

<*> OJ L 125, 23.5.1996, p. 10.

8. The authorisation granted in accordance with the procedure laid down in this Regulation shall be valid throughout the Community for 10 years and shall be renewable in accordance with Article 14. The authorised feed additive shall be entered in the Register referred to in Article 17 (hereinafter referred to as the Register). Each entry in the Register shall state the date of authorisation and shall include the particulars referred to in paragraphs 5, 6 and 7.

9. The granting of authorisation shall be without prejudice to the general civil and criminal liability of any feed operator in respect of the feed additive concerned.

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;

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, a Regulation shall be adopted, in accordance with the procedure referred to in Article 22(2), requiring the additives concerned to be withdrawn from the market. Such a measure may provide for a limited period of time within which existing stocks of the product may be used up.

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 Commission takes a decision. The Commission 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.

Phasing out

1. With a view to a decision on the phasing out of the use of coccidiostats and histomonostats as feed additives by 31 December 2012, the Commission shall submit to the European Parliament and the Council before 1 January 2008 a report on the use of these substances as feed additives and available alternatives, accompanied, where appropriate, by legislative proposals.

2. By way of derogation from Article 10 and without prejudice to Article 13, antibiotics, other than coccidiostats and histomonostats, may be marketed and used as feed additives only until 31 December 2005; as from 1 January 2006, those substances shall be deleted from the Register.

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 shall ensure that any conditions or restrictions which have been imposed on the placing on the market, use and handling of the additive or feedingstuffs containing it are respected.

2. Where monitoring requirements, as referred to in Article 8(4)(c), have been imposed, the holder of the authorisation shall ensure that monitoring is carried out and shall submit reports to the Commission in accordance with the authorisation. The holder of the authorisation shall forthwith communicate to the Commission 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 shall forthwith inform the Commission of any prohibition or restriction imposed by the competent authority of any third country in which the feed additive is placed on the market.

Article 13

2. The Commission shall examine the opinion of the Authority without delay. Any appropriate measures shall be taken in accordance with Articles 53 and 54 of Regulation (EC) No 178/2002. A decision on the modification, suspension or revocation of an authorisation shall be taken in accordance with the procedure referred to in Article 22(2) of this Regulation.

3. If the holder of the authorisation proposes changing the terms of the authorisation by submitting an application to the Commission, accompanied by the relevant data supporting the request for the change, the Authority shall transmit its opinion on the proposal to the Commission and the Member States. The Commission shall examine the opinion of the Authority without delay and decide in accordance with the procedure referred to in Article 22(2).

4. The Commission shall without delay inform the applicant of the decision taken. The Register shall be amended where appropriate.

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

Article 14

Renewal of authorisations

1. Authorisations under this Regulation shall be renewable for 10-year periods. An application for renewal shall be sent to the Commission at the latest one year before the expiry date of the authorisation.

In the case of authorisations not issued to a specific holder, any person who first places the additive on the market or any other interested party may submit the application to the Commission and shall be considered as the applicant.

In the case of authorisations issued to a specific holder, the holder of the authorisation or his legal successor or successors may submit the application to the Commission and shall be deemed to be the applicant.

(c) any other new information which has become available with regard to the evaluation of the safety in use of the feed additive and the risks of the feed additive to animals, humans or the environment;

(d) where appropriate, a proposal for amending or supplementing the conditions of the original authorisation, inter alia, the conditions concerning future monitoring.

3. Articles 7(1), (2), (4) and (5), 8 and 9 shall apply accordingly.

In specific cases where urgent authorisation is needed to ensure the protection of animal welfare, the Commission may, in accordance with the procedure referred to in Article 22(2), provisionally authorise the use of an additive for a maximum period of five years.

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 the Community and bears the following information, in a conspicuous, clearly legible and indelible manner, in at least the national language or languages of the Member State in which it is marketed, 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;

(d) where appropriate, the approval number of the establishment manufacturing or placing on the market the feed additive or the premixture pursuant to Article 10 of Regulation (EC) No 183/2005 of the European Parliament and of the Council of 12 January 2005 laying down requirements for feed hygiene <*> or, as applicable, to Article 5 of Directive 95/69/EC;

---

<*> OJ L 35, 8.2.2005, p. 1.

(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.

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

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.

---

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.

6. The Commission is empowered to adopt delegated acts in accordance with Article 21a amending Annex III to take technological progress and scientific development into account.

Community Register of Feed Additives

1. The Commission shall establish and keep up to date a Community Register of Feed Additives.

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

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 Commission 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.

---

<*> OJ L 145, 31.5.2001, p. 43.

6. The Member States, the Commission and the Authority shall 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. Member States shall handle applications for access to documents received under this Regulation in accordance with Article 5 of Regulation (EC) No 1049/2001.

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

Any decision taken under, or failure to exercise, the powers vested in the Authority by this Regulation may be reviewed by the Commission on its own initiative or in response to a request from a Member State or from any person directly and individually concerned.

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

The Commission shall take a decision within two months requiring, if appropriate, the Authority to withdraw its decision or to remedy its failure to act within a set time limit.

Article 20

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 Commission 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 Authority for the benefit of another applicant.

Article 21

The Community Reference Laboratory and its duties and tasks shall be those laid down in the Annex II.

Applicants for the authorisation of additives shall contribute to supporting the cost of the tasks of the Community Reference Laboratory and the consortium of National Reference Laboratories mentioned in Annex II.

Detailed rules for implementing Annex II shall be adopted in accordance with the regulatory procedure referred to in Article 22(2).

The Commission is empowered to adopt delegated acts in accordance with Article 21a amending Annex II.

Article 21a

Exercise of the delegation

1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.

2. The power to adopt delegated acts referred to in Article 3(5), Article 6(3), Article 7(5), Article 16(6) and Article 21 shall be conferred on the Commission for a period of five years from 26 July 2019. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.

---

<*> OJ L 123, 12.5.2016, p. 1.

5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.

6. A delegated act adopted pursuant to Article 3(5), Article 6(3), Article 7(5), Article 16(6) and Article 21 shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.

1. The Commission shall be assisted by the Standing Committee on the Food Chain and Animal Health established by Article 58 of Regulation EC No 178/2002 (hereinafter referred to as the Committee).

2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.

The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.

Article 23

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.

Member States shall lay down the rules on penalties applicable to infringements of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided for must be effective, proportionate and dissuasive.

Member States shall notify those rules and measures to the Commission at the latest 12 months after the date of publication of this Regulation and shall notify it without delay of any subsequent amendment affecting them.

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.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Annex I

ADDITIVE GROUPS

1. In the category «technological additives», the following functional groups are included:

(a) preservatives: substances or, when applicable, micro-organisms which protect feed against deterioration caused by micro-organisms or their metabolites;

(b) antioxidants: substances prolonging the storage life of feedingstuffs and feed materials by protecting them against deterioration caused by oxidation;

(c) emulsifiers: substances that make it possible to form or maintain a homogeneous mixture of two or more immiscible phases in feedingstuffs;

(d) stabilisers: substances which make it possible to maintain the physicochemical state of feedingstuffs;

(e) thickeners: substances which increase the viscosity of feedingstuffs;

(f) gelling agents: substances which give a feedingstuff texture through the formation of a gel;

(g) binders: substances which increase the tendency of particles of feedingstuffs to adhere;

(h) substances for control of radionucleide contamination: substances that suppress absorption of radionucleides or promote their excretion;

(i) anticaking agents: substances that reduce the tendency of individual particles of a feedingstuff to adhere;

(j) acidity regulators: substances which adjust the pH of feedingstuffs;

(k) silage additives: substances, including enzymes or micro-organisms, intended to be incorporated into feed to improve the production of silage;

(l) denaturants: substances which, when used for the manufacture of processed feedingstuffs, allow the identification of the origin of specific food or feed materials;

(m) substances for reduction of the contamination of feed by mycotoxins: substances that can suppress or reduce the absorption, promote the excretion of mycotoxins or modify their mode of action;

(n) hygiene condition enhancers: substances or, when applicable, microorganisms which favourably affect the hygienic characteristics of feed by reducing a specific microbiological contamination;

(o) other technological additives: substances or, when applicable, micro-organisms added to feed for a technological purpose and which favourably affect the characteristics of the feed.

2. In the category «sensory additives», the following functional groups are included:

(a) colourants:

(i) substances that add or restore colour in feedingstuffs;

(ii) substances which, when fed to animals, add colours to food of animal origin;

(iii) substances which favourably affect the colour of ornamental fish or birds;

(b) flavouring compounds: substances the inclusion of which in feedingstuffs increases feed smell or palatability.

In the category «nutritional additives», the following functional groups are included:

(a) vitamins, pro-vitamins and chemically well-defined substances having similar effect;

(b) compounds of trace elements;

(c) amino acids, their salts and analogues;

(d) urea and its derivatives.

In the category «zootechnical additives», the following functional groups are included:

(a) digestibility enhancers: substances which, when fed to animals, increase the digestibility of the diet, through action on target feed materials;

(b) gut flora stabilisers: micro-organisms or other chemically defined substances, which, when fed to animals, have a positive effect on the gut flora;

(c) substances which favourably affect the environment;

Annex II

DUTIES AND TASKS OF THE COMMUNITY REFERENCE LABORATORY

1. The Community reference laboratory referred to in Article 21 is the Joint Research Centre of the Commission (JRC).

2. For the duties and tasks set out in this Annex, the CRL may be assisted by a consortium of national reference laboratories.

The CRL shall be responsible for:

2.1. the reception, storage and maintenance of the samples of the feed additive sent by the applicant as provided for in Article 7(3)(f);

2.2. evaluating the method of analysis of the feed additive, and of other relevant methods of analysis related to it, on the basis of the data provided in the application for authorisation of the feed additive as regards its suitability for official control in accordance with the requirements of the implementing rules referred to in Article 7(4) and (5) and the guidance of the Authority referred to in Article 7(6);

2.3. submitting a full evaluation report to the Authority on the results of the duties and tasks referred to in this Annex;

2.4. where necessary, the testing of the method(s) of analysis.

3. The CRL shall be 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 <*>. This task may involve the preparation of food or feed test material.

---

<*> OJ L 59, 5.3.2005, p. 8.

4. The CRL shall provide scientific and technical assistance to the Commission, especially in cases where Member States 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 Articles 11 and 32 of Regulation (EC) No 882/2004 of the European Parliament and of the Council <*>.

---

<*> OJ L 165, 30.4.2004, p. 1. Corrigendum OJ L 191, 28.5.2004, p. 1.

5. On request by the Commission, the CRL 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).

7. Without prejudice to the responsibilities of the Community reference laboratories laid down in Article 32 of Regulation (EC) No 882/2004, the CRL may create and maintain a database of methods of analysis available for control of feed additives and make it available to official control laboratories from Member States and other interested parties.

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

(a) Zootechnical additives, coccidiostats and histomonostats:

• the expiry date of the guarantee or the storage life from the date of manufacture,
• the directions for use, and
• the concentration.

(b) Enzymes, in addition to the abovementioned indications:

• the specific name of the active component or components in accordance with their enzyme activities, in conformity with the authorisation given,
• the International Union of Biochemistry identification number, and
• instead of concentration: units of activity (units of activity per gram or units of activity per millilitre).

(c) Micro-organisms:

• the expiry date of the guarantee or the storage life from the date of manufacture,
• the directions for use,
• the strain identification number, and
• the number of colony-forming units per gram.

(d) Nutritional additives:

- the active-substance level, and

• the expiry date of the guarantee of that level or storage life from the date of manufacture.

(e) Technological and sensory additives with the exception of flavouring compounds:

• the active substance level.

(f) Flavouring compounds:

• the incorporation rate in premixtures.

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

(a) Additives belonging to the categories referred to in Article 6(1)(a), (b) and (c) and consisting of preparations:

(i) the indication on the packaging or container of the specific name, the identification number and the level of any technological additive contained in the preparation for which maximum levels are set in the corresponding authorisation;

(ii) the following information via any written medium or accompanying the preparation:

• the specific name and the identification number of any technological additive contained in the preparation, and
• the name of any other substance or product contained in the preparation, indicated in descending order by weight.

(b) Premixtures containing additives belonging to the categories referred to in Article 6(1)(a), (b) and (c) and consisting of preparations:

(ii) upon request from the purchaser or the user, information on the specific name, the identification number and an indication of the level of technological additives referred to in point (i) of this paragraph included in the additive preparations.

Annex IV

GENERAL CONDITIONS OF USE

1. The 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 Regulation.

---