Commission Regulation (EU) 2018/1497 of 8 October 2018 amending Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of the Council as regards food category 17 and the use of food additives in food supplements (Text with EEA relevance.)
Commission Regulation (EU) 2018/1497of 8 October 2018amending Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of the Council as regards food category 17 and the use of food additives in food supplements(Text with EEA relevance)THE EUROPEAN COMMISSION,Having regard to the Treaty on the Functioning of the European Union,Having regard to Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additivesOJ L 354, 31.12.2008, p. 16., and in particular Article 10(3) thereof,Having regard to Regulation (EC) No 1331/2008 of the European Parliament and of the Council of 16 December 2008 establishing a common authorisation procedure for food additives, food enzymes and food flavouringsOJ L 354, 31.12.2008, p. 1., and in particular Article 7(5) thereof,Whereas:(1)Annex II to Regulation (EC) No 1333/2008 lays down a Union list of food additives approved for use in food and their conditions of use.(2)Only food additives included in the Union list in Annex II to Regulation (EC) No 1333/2008 may be placed on the market as such and used in foods under the conditions of use specified therein.(3)That list may be updated in accordance with the common procedure referred to in Article 3(1) of Regulation (EC) No 1331/2008, either on the initiative of the Commission or following an application.(4)The Union list includes food additives which are listed on the basis of the categories of food to which they may be added. In Part D of that list, food category 17 covers food supplements as defined in Directive 2002/46/EC of the European Parliament and of the CouncilDirective 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements (OJ L 183, 12.7.2002, p. 51). excluding food supplements for infants and young children. Food category 17 includes three subcategories: 17.1 "Food supplements supplied in a solid form including capsules and tablets and similar forms, excluding chewable forms", 17.2 "Food supplements supplied in a liquid form" and 17.3 "Food supplements supplied in a syrup-type or chewable form". Part E of the Union list sets out the authorised additives for each of these subcategories and their conditions of use.(5)It followed from the discussions with Member States (at the Working Party of Governmental Experts on Additives) that there are difficulties with the implementation of Annex II to Regulation (EC) No 1333/2008 on food additives, in particular for food subcategory 17.3 "Food supplements supplied in a syrup-type or chewable form". This classification has led to misinterpretation and in order to avoid it, syrup- and chewable-forms should be categorised as liquid and solid forms, respectively.(6)Therefore, it is appropriate to delete food subcategory 17.3 and to reword the titles of food subcategories 17.1 and 17.2 to "Food supplements supplied in a solid form, excluding food supplements for infants and young children" and "Food supplements supplied in a liquid form, excluding food supplements for infants and young children" respectively. This will better reflect which products are covered by/included in each of the food subcategories. As a result of the deletion of food subcategory 17.3 food additives' entries which were included in that food subcategory should be transferred to either food subcategory 17.1 or 17.2 to ensure that there is transparency and legal certainty regarding the use of food additives in those foods. For clarity and enforcement purposes also the title of food category 17 should be amended to "Food supplements as defined in Directive 2002/46/EC".(7)It also followed from the discussions with Member States that it should be clarified whether a maximum (use) level for the food additives in food category 17 applies to the food as marketed or to the food ready for consumption. Therefore, an introduction section should be included referring to certain food additives authorised in that food category. This is in line with the previous entries of those food additives within the Directives of the European Parliament and of the Council 94/35/ECEuropean Parliament and Council Directive 94/35/EC of 30 June 1994 on sweeteners for use in foodstuffs (OJ L 237, 10.9.1994, p. 3)., 94/36/ECEuropean Parliament and Council Directive 94/36/EC of 30 June 1994 on colours for use in foodstuffs (OJ L 237, 10.9.1994, p. 13). and 95/2/ECEuropean Parliament and Council Directive 95/2/EC of 20 February 1995 on food additives other than colours and sweeteners (OJ L 61, 18.3.1995, p. 1)..(8)Pursuant to Article 3(2) of Regulation (EC) No 1331/2008, the Commission has to seek the opinion of the European Food Safety Authority ("the Authority") in order to update the Union list of food additives set out in Annex II to Regulation (EC) No 1333/2008, except where such update is not liable to have an effect on human health. Since the Union list is amended to provide clarification to the current authorised uses of additives, it constitutes an update of that list which is not liable to have an effect on human health. Therefore, it is not necessary to seek the opinion of the Authority.(9)Annex II to Regulation (EC) No 1333/2008 should therefore be amended accordingly.(10)The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,HAS ADOPTED THIS REGULATION: