(EC) No 884_2007 on emergency measures suspending the use of E 128 Red 2G as food colour

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92D6FFC7CAA845A9B91584EAFC0D09A6

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2013-4-11

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COMMISSION REGULATION (EC) No 884/2007,of 26 July 2007,on emergency measures suspending the use of E 128 Red 2G as food colour,(Text with EEA relevance),THE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European,Community,Having regard to Regulation (EC) No 178/2002 of the European,Parliament and the Council of 28 January 2002 laying down,the general principles and requirements of food law, establishing,the European Food Safety Authority and laying down,procedures in matters of food safety (1) and in particular,Article 53(1) thereof,Whereas:,(1) Under Article 53(1) of Regulation (EC) No 178/2002 the,Commission may suspend the placing on the market or,use of a food that is likely to constitute a serious risk to,human health, when such risk cannot be contained satisfactorily,by means of measures taken by the Member,States concerned.,(2) European Parliament and Council Directive 94/36/EC of,30 June 1994 on colours for use in foodstuffs (2),authorises in its Annex I the use of the colour E 128,Red 2G in foodstuffs. Pursuant to Annex IV of that,Directive the colour E 128 Red 2G is permitted for use,in breakfast sausages with a minimum cereal content of,6 % and burger meat with a minimum vegetable and/or,cereal content of 4 %. In both foods a maximum level of,20 mg/kg is allowed.,(3) The use of that colour has been permitted on the basis of,the opinion of the Scientific Committee on Food,expressed on 27 June 1975 (3). That Committee,allocated an acceptable daily intake (ADI) of 0,1 mg/kg,body weight for E 128 Red 2G.,(4) Food additives must be kept under continuous observation,and must be re-evaluated whenever necessary in,the light of changing conditions of use and new scientific,information. As the original assessments of many of food,additives date back over a number of years, the European,Commission considered that there is a need for a,systematic re-evaluation of all authorised food additives,to verify whether the existing safety assessment remain,valid. Therefore, the Commission requested the European,Food Safety Authority (EFSA) to re-evaluate all currently,permitted food additives in the EU.,(5) In this context the EFSA Scientific Panel on food,additives, flavourings, processing aids and materials in,contact with food has re-evaluated the safety of the,colour E 128 Red 2G and adopted an opinion (4) on,5 July 2007.,(6) EFSA based its evaluation on the conclusions of the,European Union risk assessment report (5) on aniline.,That report concluded that aniline should be considered,as a carcinogen for which a genotoxic mechanism cannot,be excluded. Since the colour E 128 Red 2G is readily,and extensively metabolised to aniline, EFSA concluded,that it would be prudent to regard that substance as,being of safety concern. Consequently, EFSA withdrew,the ADI for the colour E 128 Red 2G. EFSA, however,considered that should the tumour inducing mechanism,of aniline be further elucidated, shown to be thresholded,and/or its relevance for man discounted, the colour E,128 Red 2G could be re-evaluated once again for use,as a food additive.,(7) Considering that a food additive may only be used when,there is evidence that its use is not harmful to health,Directive 94/36/EC should be amended to prohibit the,use of the colour E 128 Red 2G.,(8) In the interim, since the colour E 128 Red 2G is likely to,constitute a serious risk to human health, it is appropriate,in order to ensure the high level of health,protection chosen in the Community, to suspend with,immediate effect the use of the colour E 128 Red 2G in,food and the placing on the market and import of food,containing the colour E 128 Red 2G.,(9) By virtue of Directive 94/36/EC, the colour E 128 Red,2G is legally authorised for use in all Member States.,Therefore, a Community-wide measure is necessary.,L 195/8 EN Official Journal of the European Union 27.7.2007,(1) OJ L 31, 1.2.2002, p. 1. Regulation as last amended by Commission,Regulation (EC) No 575/2006 (OJ L 100, 8.4.2006, p. 3).,(2) OJ L 237, 10.9.1994, p. 13. Directive as amended by Regulation,(EC) No 1882/2003 of the European Parliament and of the Council,(OJ L 284, 31.10.2003, p. 1).,(3) SCF (1975). Reports of the Scientific Committee for Food (First,series), p. 17, 19, 24.,(4) EFSA (2007). Opinion of the Scientific Panel on Food Additives,Flavourings, Processing aids and Materials in contact with Food,(AFC) on re-evaluation of food colours Red 2G (E 128).,(5) ECB, 2004, European Chemicals Bureau, Institute for Health and,Consumer Protection. European Union Risk Assessment Report on,Aniline. Volume 50.,(10) The Commission will keep this Reg……

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