Commission Regulation (EU) No 574/2011
of 16 June 2011
amending Annex I to Directive 2002/32/EC of the European Parliament and of the Council as regards maximum levels for nitrite, melamine, Ambrosia spp. and carry-over of certain coccidiostats and histomonostats and consolidating Annexes I and II thereto
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Whereas:
Directive 2002/32/EC provides that the use of products intended for animal feed that contain levels of undesirable substances exceeding the maximum levels laid down in Annex I to that Directive is prohibited. For certain undesirable substances, Member States are to carry out investigations identifying the sources of those substances if the thresholds set out in Annex II of that Directive are exceeded.
As regards coccidiostats and histomonostats, transfer from one production lot to another may occur when such substances are used as authorised feed additives. Such transfer may result in the contamination of feed produced subsequently by the presence of technically unavoidable traces of such substances, referred to as unavoidable carry-over or cross-contamination, in feed for which coccidiostats and histomonostats are not authorised, referred to as non-target feed. Taking into account the application of good manufacturing practices, maximum levels of unavoidable carry-over of coccidiostats or histomonostats in non-target feed should be established following the ALARA (As Low As Reasonably Achievable) principle. For the purpose of enabling the feed manufacturer to manage unavoidable carry-over, a carry-over rate of approximately 3 % of the authorised maximum content should be considered acceptable as regards feed for less sensitive non-target animal species while a carry-over rate of approximately 1 % of the authorised maximum content should be considered acceptable for feed intended to sensitive non-target animal species and feed used for the period before slaughter. The carry-over rate of 1 % should also be considered acceptable for cross-contamination of other feed for target species to which no coccidiostats or histomonostats are added, and as regards non-target feed for ‘continuous food-producing animals’, such as dairy cows or laying hens, where there is evidence of transfer from feed to food of animal origin. Where feed materials are fed directly to the animals or where complementary feedingstuffs are used, this should not lead to an exposure of the animals to a higher level of coccidiostats or histomonostats than the corresponding maximum levels of exposure where only complete feedingstuffs are used in a daily ration.
Annexes I and II to Directive 2002/32/EC had already been adapted substantially and many times in the past. It is therefore appropriate to consolidate those Annexes. To improve the clarity and readability of those Annexes, it is appropriate to restructure them and to harmonise terminology. Given that the provisions contained in the Annexes have a direct application and are binding in their entirety, it is appropriate to establish these Annexes by a Regulation.
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health and neither the European Parliament nor the Council has opposed them,
HAS ADOPTED THIS REGULATION