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:
Article 1Annex II to Regulation (EC) No 1333/2008 is amended in accordance with the Annex to this Regulation.
Article 2This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.Done at Brussels, 8 October 2018.For the CommissionThe PresidentJean-Claude JunckerANNEXAnnex II to Regulation (EC) No 1333/2008 is amended as follows:(1)in Part D, the entries for food category 17. "Food supplements as defined in Directive 2002/46/EC of the European Parliament and of the Council excluding food supplements for infants and young children" are replaced by the following:
"17.Food supplements as defined in Directive 2002/46/EC
17.1Food supplements supplied in a solid form, excluding food supplements for infants and young children
17.2Food supplements supplied in a liquid form, excluding food supplements for infants and young children"
(2)Part E is amended as follows:(a)the entry for food category 17. "Food supplements as defined in Directive 2002/46/EC excluding food supplements for infants and young children" is replaced as follows:
"17.Food supplements as defined in Directive 2002/46/EC
INTRODUCTION PART, APPLIES TO ALL SUBCATEGORIES
The maximum levels of use indicated for colours, polyols, sweeteners, and E 200-213, E 338-452, E 405, E 416, E 426, E 432-436, E 459, E 468, E 473-475, E 491-495, E 551-553, E 901-904, E 961, E 1201-1204, E 1505 and E 1521 refer to the food supplements ready for consumption prepared following the instructions of use provided by the manufacturer.The dilution factor for those food supplements that have to be diluted or dissolved has to be communicated together with the instructions of use."
(b)the entry for food subcategory 17.1 is amended as follows:(i)the title is replaced by the following:
"17.1Food supplements supplied in a solid form, excluding food supplements for infants and young children"
(ii)all the entries therein are replaced by the following entries, inserted in their numerical order:
"Group IAdditivesE 410, E 412, E 415, E 417 and E 425 may not be used to produce dehydrated food supplements intended to rehydrate on ingestion
Group IIColours at quantum satisquantum satisPeriod of application: until 31 July 2014
Group IIColours at quantum satisquantum satis(69)Period of application: from 1 August 2014
Group IIIColours with combined maximum limit300Period of application: until 31 July 2014
Group IIIColours with combined maximum limit300(69)Period of application: from 1 August 2014
Group IVPolyolsquantum satis
E 104Quinoline Yellow35(61)Period of application: from 1 January 2014 to 31 July 2014
E 104Quinoline Yellow35(61)(69)Period of application: from 1 August 2014except food supplements in chewable form
E 104Quinoline Yellow10(61)Period of application: from 1 January 2014 to 31 July 2014
E 104Quinoline Yellow10(61)(69)Period of application: from 1 August 2014only food supplements in chewable form
E 110Sunset Yellow FCF/Orange Yellow S10(61)Period of application: from 1 January 2014 to 31 July 2014
E 110Sunset Yellow FCF/Orange Yellow S10(61)(69)Period of application: from 1 August 2014
E 124Ponceau 4R, Cochineal Red A35(61)Period of application: from 1 January 2014 to 31 July 2014
E 124Ponceau 4R, Cochineal Red A35(61)(69)Period of application: from 1 August 2014except food supplements in chewable form
E 124Ponceau 4R, Cochineal Red A10(61)Period of application: from 1 January 2014 to 31 July 2014
E 124Ponceau 4R, Cochineal Red A10(61)(69)Period of application: from 1 August 2014only food supplements in chewable form
E 160dLycopene30
E 200-213Sorbic acid — sorbates; Benzoic acid — benzoates1000(1) (2)only food supplements in dried form and containing preparations of vitamin A and of combinations of vitamins A and D, except in chewable form
E 310-321Propyl gallate, TBHQ, BHA and BHT400(1)
E 338-452Phosphoric acid — phosphates — di-, tri- and polyphosphatesquantum satis
E 392Extracts of rosemary400(46)
E 405Propane-1, 2-diol alginate1000
E 416Karaya gumquantum satis
E 426Soybean hemicellulose1500
E 432-436Polysorbatesquantum satis
E 459Beta-cyclodextrinquantum satisonly food supplements in tablet and coated tablet form
E 468Cross-linked sodium carboxy methyl cellulose30000except food supplements in chewable form
E 473-474Sucrose esters of fatty acids — sucroglyceridesquantum satis(1)
E 475Polyglycerol esters of fatty acidsquantum satis
E 491-495Sorbitan estersquantum satis(1)
E 551-559Silicon dioxide — silicatesquantum satisPeriod of application: until 31 January 2014
E 551-553Silicon dioxide — silicatesquantum satisPeriod of application: from 1 February 2014
E 900Dimethyl polysiloxane10(91)only food supplements in effervescent tablet form
E 901Beeswax, white and yellowquantum satis
E 902Candelilla waxquantum satis
E 903Carnauba wax200
E 904Shellacquantum satis
E 950Acesulfame K500
E 950Acesulfame K2000only food supplements in chewable form
E 951Aspartame2000
E 951Aspartame5500only food supplements in chewable form
E 952Cyclamic acid and its Na and Ca salts500(51)
E 952Cyclamic acid and its Na and Ca salts1250(51)only food supplements in chewable form
E 954Saccharin and its Na, K and Ca salts500(52)
E 954Saccharin and its Na, K and Ca salts1200(52)only food supplements in chewable form
E 955Sucralose800
E 955Sucralose2400only food supplements in chewable form
E 957Thaumatin400only food supplements in chewable form
E 959Neohesperidine DC100
E 959Neohesperidine DC400only food supplements in chewable form
E 960Steviol glycosides670(60)
E 960Steviol glycosides1800(60)only food supplements in chewable form
E 961Neotame60
E 961Neotame185only food supplements in chewable form
E 961Neotame2only as flavour enhancer, except food supplements in chewable form
E 961Neotame2only vitamins and/or mineral based food supplements in chewable form, as a flavour enhancer
E 962Salt of aspartame-acesulfame500(11)a (49) (50)
E 962Salt of aspartame-acesulfame2000(11)a (49) (50)only food supplements in chewable form
E 969Advantame20
E 969Advantame55only food supplements in chewable form
E 1201Polyvinylpyrrolidonequantum satisonly food supplements in tablet and coated tablet form
E 1202Polyvinylpolypyrrolidonequantum satisonly food supplements in tablet and coated tablet form
E 1203Polyvinyl alcohol (PVA)18000only food supplements in capsule and tablet form
E 1204Pullulanquantum satisonly food supplements in capsule and tablet form
E 1205Basic methacrylate copolymer100000except food supplements in chewable form
E 1206Neutral methacrylate copolymer200000except food supplements in chewable form
E 1207Anionic methacrylate copolymer100000except food supplements in chewable form
E 1208Polyvinylpyrrolidone-vinyl acetate copolymer100000except food supplements in chewable form
E 1209Polyvinyl alcohol-polyethylene glycol-graft-co-polymer100000except food supplements in chewable form
E 1505Triethyl citrate3500only food supplements in capsule and tablet form
E 1521Polyethylene glycol10000only food supplements in capsule and tablet form"
(c)the entry for food subcategory 17.2 is amended as follows:(i)the title is replaced by the following:
"17.2Food supplements supplied in a liquid form, excluding food supplements for infants and young children"
(ii)all the entries therein are replaced by the following entries, inserted in their numerical order:
"Group IAdditives
Group IIColours at quantum satisquantum satis
Group IIColours at quantum satisquantum satisPeriod of application: until 31 July 2014
Group IIColours at quantum satisquantum satis(69)Period of application: from 1 August 2014only food supplements in syrup form
Group IIIColours with combined maximum limit100
Group IVPolyolsquantum satis
E 104Quinoline Yellow10(61)Period of application: from 1 January 2014 to 31 July 2014
E 104Quinoline Yellow10(61)(69)Period of application: from 1 August 2014
E 110Sunset Yellow FCF/Orange Yellow S10(61)Period of application: from 1 January 2014 to 31 July 2014
E 110Sunset Yellow FCF/Orange Yellow S10(61)(69)Period of application: from 1 August 2014
E 124Ponceau 4R, Cochineal Red A10(61)Period of application: from 1 January 2014 to 31 July 2014
E 124Ponceau 4R, Cochineal Red A10(61)(69)Period of application: from 1 August 2014
E 160dLycopene30
E 200-213Sorbic acid — sorbates; Benzoic acid — benzoates2000(1) (2)except food supplements in syrup form
E 310-321Propyl gallate, TBHQ, BHA and BHT400(1)
E 338-452Phosphoric acid — phosphates — di-, tri- and polyphosphatesquantum satis
E 392Extracts of rosemary400(46)
E 405Propane-1, 2-diol alginate1000
E 416Karaya gumquantum satis
E 426Soybean hemicellulose1500
E 432-436Polysorbatesquantum satis
E 473-474Sucrose esters of fatty acids — sucroglyceridesquantum satis(1)
E 475Polyglycerol esters of fatty acidsquantum satis
E 491-495Sorbitan estersquantum satis(1)
E 551-559Silicon dioxide — silicatesquantum satisPeriod of application: until 31 January 2014
E 551-553Silicon dioxide — silicatesquantum satisPeriod of application: from 1 February 2014
E 950Acesulfame K350
E 950Acesulfame K2000only food supplements in syrup form
E 951Aspartame600
E 951Aspartame5500only food supplements in syrup form
E 952Cyclamic acid and its Na and Ca salts400(51)
E 952Cyclamic acid and its Na and Ca salts1250(51)only food supplements in syrup form
E 954Saccharin and its Na, K and Ca salts80(52)
E 954Saccharin and its Na, K and Ca salts1200(52)only food supplements in syrup form
E 955Sucralose240
E 955Sucralose2400only food supplements in syrup form
E 957Thaumatin400only food supplements in syrup form
E 959Neohesperidine DC50
E 959Neohesperidine DC400only food supplements in syrup form
E 960Steviol glycosides200(60)
E 960Steviol glycosides1800(60)only food supplements in syrup form
E 961Neotame20
E 961Neotame185only food supplements in syrup form
E 961Neotame2only as flavour enhancer, except food supplements in syrup form
E 961Neotame2only vitamins and/or mineral based food supplements in syrup form, as a flavour enhancer
E 962Salt of aspartame-acesulfame350(11)a (49) (50)
E 962Salt of aspartame-acesulfame2000(11)a (49) (50)only food supplements in syrup form
E 969Advantame6
E 969Advantame55only food supplements in syrup form"