17.6.2011 Official Journal of the European Union L 159/7 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 1I thereto (Text with EEA relevance) THE EUROPEAN COMMISSION, Having regard to the Treaty on the Functioning of the European Union, 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) and the first indent of Article 8(2) thereof, Whereas: () ) Directive 2002/32[EC provides that the use of products intended for animal feed that contain levels of unde- sirable 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 nitrite, it was found that the products and by- products from sugar beet and sugarcane and from the starch production contain under certain conditions levels of nitrite exceeding the maximum levels recently estab- lished in Annex I to Directive 2002/32/EC. Furthermore, it appears that the method of analysis for the deter- mination of nitrite in feed does not always provide reliable analytical results with regard to the products and by-products from sugar beet and sugarcane and from the starch production. Given that the European Food Safety Authority (EFSA) concluded in its opinion of 25 March 2009 (?) that the presence of nitrite in animal products does not raise any concern for human health, the products concerned should be exempted for the time being from the maximum level for nitrite in feed materials, while nitrite levels in those products and appropriate methods of analysis are further examined. OJ L 140, 30.5.2002, p. 10. EFSA Panel on Contaminants in the Food Chain, Scientific Opinion on Nitrite as undesirable substances in animal feed, The EFSA Journal (2009) 1017, 1-47. Available online: http://www.efsa.europa. eufen/scdocs/doc/1017.pdf (3) ) = -~ As regards melamine, the EFSA adopted on 18 March 2010 a scientific opinion on melamine in food and feed (). EFSA findings show that exposure to melamine can result in the formation of crystals in the urinary tract. These crystals cause proximal tubular damage and have been observed in animals and children as a result of incidents involving adulteration of feed and infant formula with melamine, leading to fatalities in some instances. The Codex Alimentarius Commission has established maximum levels for melamine in feed and food (). It is appropriate to include these maximum levels in Annex I to Directive 2002/32/EC to protect animal and public health as these levels are in accordance with the conclusions of the EFSA opinion. It is appro- priate to exempt some feed additives from the maximum levels as they contain unavoidably a level of melamine above the maximum level as a result of the normal production process. As regards Ambrosia spp., EFSA concluded in its opinion of 4 June 2010 (°) that bird feed may be an important means of Ambrosia spp. dispersal, especially in previously uninfested areas, as it often contains significant quantities of unprocessed seeds of Ambrosia spp. Therefore, the prevention of the use of bird feed contaminated with unprocessed seeds of Ambrosia spp. is likely to attenuate the further dispersal of Ambrosia spp. in the Union. Ambrosia spp. are of public health concern due to the allergenic properties of their pollen. Inhalation of the plant pollen may, amongst other conditions, cause rhino-conjunctivitis and asthma. There is also some evidence for allergenicity of Ambrosia spp. pollen in animals. It is therefore appropriate to limit the presence of Ambrosia spp. seeds in feed materials and compound feed containing unground grains and seeds and to establish a maximum level of Ambrosia spp. seeds in (%) EFSA Panel on Contaminants in the Food Chain (CONTAM) and EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF); Scientific Opinion on Melamine in Food and Feed. EFSA Journal 2010; 8(4):1573. [145 pp.]. doi:10.2903j.efsa. 2010.1573. Available online: http://www.efsa.curopa.eu/en/scdocs| doc[1573.pdf Report on the Thirty-Third Session of the Joint FAO/WHO Food Standards Programme, Codex Alimentarius Commission, Geneva, Switzerland, 5-9 July 2010 (ALINORM 10/33/REP). EFSA Panel on Contaminants in the Food Chain (CONTAM), EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) and EFSA Panel on Plant Health (PLH); Scientific Opinion on the effect on public or animal health or on the environment on the presence of seeds of Ambrosia spp. in animal feed. EFSA Journal 2010; 8(6):1566 [37 pp.]. d0i:10.2903/j.efsa.2010.1566. Available online: http:/[www.efsa.europa.eufen/scdocs/doc/1566.pdf