Characteristics of types of feed
1. In accordance with the regulatory procedure referred to in Article 28(3), the Commission may adopt guidelines clarifying the distinction between feed materials, feed additives and other products such as veterinary drugs.
2. The Commission may, where necessary, adopt measures in order to clarify whether a certain product constitutes feed for the purposes of this Regulation.
Those measures, designed to amend non-essential elements of this Regulation, by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 28(4).
Content of feed additives
1. Without prejudice to the conditions of use provided for in the relevant legal act authorising the respective feed additive, feed materials and complementary feed shall not contain levels of feed additives that are higher than 100 times the relevant fixed maximum content in complete feed or five times in case of coccidiostats and histomonostats.
2. The level of 100 times the relevant fixed maximum content in complete feed referred to in paragraph 1 may only be exceeded if the composition of the products concerned fulfils the particular nutritional purpose in respect of the relevant intended use under Article 10 of this Regulation. The conditions of use for such feed shall be further specified in the list of intended uses. Establishments under the control of a producer of such feed who uses feed additives referred to in Chapter 2 of Annex IV to Regulation (EC) No 183/2005 must be approved in accordance with point 1(b) of Article 10 of that Regulation.
Marketing of feed intended for particular nutritional purposes
Feed intended for particular nutritional purposes may only be marketed as such if its intended use is included in the list of intended uses established in accordance with Article 10 and if it meets the essential nutritional characteristics for the respective particular nutritional purpose set forth in that list.
List of intended uses of feed intended for particular nutritional purposes
1. The Commission may update the list of intended uses set out in Directive 2008/38/EC by adding an intended use, withdrawing an intended use or by adding, removing or changing the conditions associated with a particular intended use.
2. The procedure for updating the list of intended uses may be started by the submission to the Commission of an application by a natural or legal person established in the Community or by a Member State. A valid application shall include a dossier demonstrating that the specific composition of the feed fulfils the particular intended nutritional purpose and that it has no adverse effects on animal health, human health, the environment or animal welfare.
3. The Commission shall make the application, including the dossier, available to the Member States without delay.
4. If, on the basis of available scientific and technological information, the Commission, has reason to believe that the use of the specific feed may not fulfil the particular intended nutritional purpose or may have adverse effects on animal health, human health, the environment or animal welfare, the Commission shall, within three months of receipt of a valid application, seek an opinion from the European Food Safety Authority (hereinafter referred to as ‘the Authority’). The Authority shall give an opinion within six months of receipt of the request. This time limit shall be extended whenever the Authority seeks supplementary information from the applicant.
5. Within six months of receipt of a valid application or, where appropriate, after receiving the opinion of the Authority, the Commission shall adopt a Regulation updating the list of intended uses if the conditions laid down in paragraph 2 are met.
Those measures, designed to amend non-essential elements of this Regulation, by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 28(6).
6. By way of derogation from paragraph 5, within six months after receiving a valid application or, where appropriate, after receiving the opinion of the Authority, the Commission shall end the procedure and decide not to proceed with the update, at any stage of the procedure, if it considers that such an update is not justified. The Commission shall do so in accordance with the regulatory procedure referred to in Article 28(3).
In such cases, where applicable, the Commission shall inform the applicant and the Member States directly, indicating in its letter the reasons for failing to consider the update justified.
7. The Commission may, in accordance with the regulatory procedure referred to in Article 28(3), adopt implementing measures concerning the preparation and presentation of the application.
