13.1.2004 Official Journal of the European Union L 7/45 COMMISSION DIRECTIVE 2004/1/EC of 6 January 2004 amending Directive 2002/72[EC as regards the suspension of the use of azodicarbonamide as blowing agent (Text with EEA relevance) THE COMMISSION OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Com- munity, Having regard to Council Directive 89/109/EEC of 21 December 1988 on the approximation of the laws of the Member States relating to materials and articles intended to come into contact with foodstuffs (), and in particular Article 3 thereof, Whereas: 1 Commission Directive 2002/72/EC of 6 August 2002 relating to plastic materials and articles intended to come into contact with foodstuffs () authorises the use of azodicarbonamide as a blowing agent in plastic materials and articles intended to come into contact with food- stuffs in accordance with the opinion of the Scientific Committee on Food (SCF). Azodicarbonamide is used as blowing agent in the manufacture of plastic gaskets in metal lids used for the closure of glass jars. New findings have shown that azodicarbonamide decomposes into semicarbazide (SEM) when heated during production of the foamed gasket and during sterilisation of the sealed glass jar. On 8 July 2003 the European Food Safety Authority (hereinafter called ‘the Authority’) was informed by industry that SEM had been found in a number of foods contained in glass jars. The levels of SEM in these foods were variable (up to 25 pg/kg), with the highest concen- trations found in baby foods. Based on the existing scientific data, including recent research commissioned by the Authority, the Scientific Panel on food additives, flavourings, processing aids and materials in contact with food (hereinafter called ‘the Panel’) concluded, in its statement of 1 October 2003, that SEM has a weak carcinogenic activity in laboratory animals and weak genotoxicity in vitro but that it was not possible according to the current scientific knowl- edge to conclude whether SEM poses a carcinogenic risk to humans. An ad hoc expert group was specifically commissioned by the Authority to advise further on possible risks to infants, the consumer group for which potential expo- (") OJ L 40, 11.2.1989, p. 38. Directive as amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council (O] L 284, 31.10.2003, p. 1). () OJ L 220, 15.8.2002, p. 18. sure to SEM per body weight is likely to be the highest. In evaluating the possible consequences of SEM in baby foods, the expert group reviewed toxicological aspects alongside microbiological and nutritional considerations. On 9 October 2003 they advised that, taking into account the current available information on the levels of SEM in food, intake and toxicology, the risk to both infants and adults eating foods containing SEM was probably very small. However, the Panel stated that the presence of SEM in baby food was undesirable and recommended that it would be prudent to reduce expo- sure to SEM as swiftly as technological progress safely allows. Considering the conclusions of the Panel and the ad hoc expert group and the remaining scientific uncertainties it is appropriate, in order to achieve the high level of health protection chosen in the Community, to suspend the use of azodicarbonamide in accordance with the precautionary principle referred to in Article 7 of Regu- lation (EC) No 178/2002 of the European Parliament and of the Council ) (Food law). The suspension of azodicarbonamide from the incomplete list of additives fully harmonised at Community level should apply while the Community seeks more complete information from any source, which could clarify the gaps in the present state of knowledge of SEM. The Commission has been informed that alternatives for azodicarbonamide will become available in the near future. With respect to the possible replacement of azodicarbonamide in packaging materials for baby foods, it is critical that careful consideration and evaluation of seal integrity be carried out prior to their introduction in order not to compromise the microbiological safety of the food. It is therefore necessary to provide for a transi- tional period of 18 months to allow such evaluation to be carried out over a time period, which takes account of the minimum shelf-life for such packaged foods. A transitional period should also be provided for in respect of materials and articles which are brought into contact with foodstuffs before the deadline for imple- mentation of this Directive. () OJ L 31, 1.2.2002, p. 1. Regulation as amended by Regulation (EC) No 1642/2003 (O] L 245, 29.9.2003, p. 4).