11.2.2009 Official Journal of the European Union L 40/19 COMMISSION DIRECTIVE 2009/8/EC of 10 February 2009 amending Annex I to Directive 2002/32/EC of the European Parliament and of the Council as regards maximum levels of unavoidable carry-over of coccidiostats or histomonostats in non- target feed (Text with EEA relevance) THE COMMISSION OF THE EUROPEAN COMMUNITIES, (3)  Regulation (EC) No 183/2005 of the European Having regard to the Treaty establishing the European Community, Having regard to Directive 2002/32/EC of the European Parliament and of the Council of 7 May 2002 on undesirable substances in animal feed ('), and in particular Article 8(1) thereof, Whereas: Coccidiostats and histomonostats are substances intended to kill or inhibit protozoa, which may, inter alia, be authorised for use as feed additives in accordance with Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (?). Authoris- ations of coccidiostats and histomonostats as feed additives lay down specific conditions for use such as the target animal species or categories for which the additives are intended. Feed business operators may produce within one estab- lishment a broad range of feeds and different types of products may have to be manufactured after each other in the same production line. It may happen that unavoidable traces of a product remain in the production line and end up in the beginning of the production of another feed product. This transfer from one production lot to another is called ‘carry-over’ or ‘cross-contamina- tion’ and may occur for instance when coccidiostats or histomonostats are used as authorised feed additives. This may result in the contamination of feed produced subse- quently by the presence of technically unavoidable traces of those substances in ‘non-target feed’, ie. in feed for which the use of coccidiostats or histomonostats are not authorised, such as feed intended for animal species or categories not provided for in the additive authorisation. This unavoidable cross-contamination may occur at all stages of production and processing of feed but also during storage and transport of feed. Parliament and of the Council of 12 January 2005 laying down requirements for feed hygiene (}) provides for specific requirements for feed businesses using cocci- diostats and histomonostats in the production of feed. In particular, the operators concerned have to take all appropriate  measures  concerning facilities  and equipment, production, storage and transport in order to avoid any cross-contamination, and this in accordance with the obligations provided for in Articles 4 and 5 of the above mentioned Regulation. The establishment of maximum levels of unavoidable carry-over of cocci- diostats and histomonostats in non-target feed in accordance with Directive 2002/32/EC should not interfere with the primary obligation of operators to apply good manufacturing practices aiming at avoiding this cross-contamination. Continued effort is therefore still needed by the operators concerned in order to avoid the presence of such undesirable substances in animal feed. Taking into account the application of good manufac- turing practices, the 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 the above mentioned unavoidable carry-over, a carry- over rate of approximately 3 % compared to the authorised maximum content should be considered as regards feed for less sensitive non-target animal species, while a carry-over rate of approximately 1 % compared to the authorised maximum content should be retained for feed intended to sensitive non-target animal species and ‘withdrawal feed’, i.c. feed used for the period before slaughter. The carry-over rate of 1% should also be considered for cross-contamination of other feed for target species to which no coccidiostats or histomo- nostats 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. If feed materials are fed directly to the animals or if complementary feeding- stuffs are used, their use in a daily ration should not lead to the animal being exposed to a higher levels of an coccidiostat or histomonostat than the corresponding maximum levels of exposure where only complete feedingstuffs are used in a daily ration.