L 204/10 Official Journal of the European Union 26.7.2006 DIRECTIVE 2006/52/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 July 2006 amending Directive 95/2/EC on food additives other than colours and sweeteners and Directive 94/35/EC on sweeteners for use in foodstuffs THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty establishing the European Commu- nity, and in particular Article 95 thereof, Having regard to the proposal from the Commission, Having regard to the opinion of the European Economic and Social Committee (1), Acting in accordance with the procedure laid down in Article 251 of the Treaty (3, Whereas: 1 Food additives may be approved for use in foodstuffs only if they comply with Annex II to Council Directive 89/107/ EEC of 21 December 1988 on the approximation of the laws of the Member States concerning food additives authorized for use in foodstuffs intended for human consumption (3). Directive 95/2/EC (*) lays down a list of food additives that may be used in the Community and the conditions for their use. Directive 94/35/EC (°) lays down a list of sweeteners that may be used in the Community and the conditions for their use. O] C 255, 14.10.2005, p. 59. Opinion of the European Parliament of 26 October 2005 (not yet published in the Official Journal). Council Decision of 2 June 2006. OJ L 40, 11.2.1989, p. 27. Directive as last amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council (OJ L 284, 31.10.2003, p. 1). O] L 61, 18.3.1995, p. 1. Directive as last amended by Directive 2003/114[EC (O] L 24, 29.1.2004, p. 58). OJ L 237, 10.9.1994, p. 3. Directive as last amended by Directive 2003/115[EC (O] L 24, 29.1.2004, p. 65). 4 There have been technical developments in the field of food additives since the adoption of Directives 95/2/EC and 94/35/EC. These Directives should be adapted to take account of those developments. On the basis of an opinion of the European Food Safety Authority (EFSA), expressed on 26 November 2003, changes are made to current authorisations in order to keep the level of nitrosamines as low as possible by bringing down the levels of nitrites and nitrates added to food whilst maintaining the microbiological safety of food products. EFSA recommends that the levels of nitrite and nitrate are set in the legislation as ‘added amount’. EFSA is of the opinion that the added amount of nitrite rather than the residual amount contributes to the inhibitory activity against C. botulinum. The current provisions should be amended in such a way that the maximum levels permitted, as mentioned by EFSA, in non-heat-treated or heat-treated meat products, in cheese and in fish are expressed as added amounts. Exceptionally, however, for certain traditionally manufactured meat products maximum residual levels should be set, on the condition that the products are adequately specified and identified. The levels set should ensure that the acceptable daily intake (ADI) established by the Scientific Committee on Food in 1990 is not exceeded. Products which are not specifically named in this Directive, but which are traditionally produced in a similar manner (i. e. similar products) can if necessary be categorised in accordance with Articles 5 and 6 of Directive 95/2/EC. For cheese, the level should be expressed as the amount added to the cheese milk. If a process is used where addition of nitrate follows removal of whey and addition of water, this should lead to levels identical to those which would have been obtained had the nitrate been added directly to the cheese milk. Directive 2003/114/EC amending Directive 95/2/EC required the Commission and EFSA to review the conditions for the use of E 214 to E 219 p-hydroxybenzo- ates and their sodium salts before 1 July 2004. EFSA assessed the information on the safety of p-hydroxybenzo- ates and expressed its opinion on 13 July 2004. EFSA established a full-group ADI of 0 to 10 mg/kg body weight for the sum of methyl and ethyl p-hydroxybenzoic acid esters and their sodium salts. EFSA considered that propyl paraben should not be included in this group ADI because propyl paraben, contrary to methyl and ethyl paraben, had effects on sex hormones and the male reproductive organs in juvenile rats. Therefore, EFSA was unable to recommend an ADI for propyl paraben because of the lack of a clear no- observed-adverse-effect-level (NOAEL). It is necessary to withdraw E 216 propyl p-hydroxybenzoate and E 217 sodium propyl p-hydroxybenzoate from Directive 95/2/EC. In addition, it is necessary to withdraw the use of p- hydroxybenzoates in liquid dietary food supplements.