Source

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.)

Regulation (EU) 2018/1497 · Regulation · 3 articles

Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗

Article 1

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Annex II to Regulation (EC) No 1333/2008 is amended in accordance with the Annex to this Regulation.

Article 2

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This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .

Supplementary provisions

ANNEXSupplementary provisions

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ANNEX Annex 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 17.1 Food supplements supplied in a solid form, excluding food supplements for infants and young children 17.2 Food 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: ‘17.1 Food 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 I Additives E 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 II Colours at quantum satis quantum satis Period of application: until 31 July 2014 Group II Colours at quantum satis quantum satis (69) Period of application: from 1 August 2014 Group III Colours with combined maximum limit 300 Period of application: until 31 July 2014 Group III Colours with combined maximum limit 300 (69) Period of application: from 1 August 2014 Group IV Polyols quantum satis E 104 Quinoline Yellow 35 (61) Period of application: from 1 January 2014 to 31 July 2014 E 104 Quinoline Yellow 35 (61)(69) Period of application: from 1 August 2014 except food supplements in chewable form E 104 Quinoline Yellow 10 (61) Period of application: from 1 January 2014 to 31 July 2014 E 104 Quinoline Yellow 10 (61)(69) Period of application: from 1 August 2014 only food supplements in chewable form E 110 Sunset Yellow FCF/Orange Yellow S 10 (61) Period of application: from 1 January 2014 to 31 July 2014 E 110 Sunset Yellow FCF/Orange Yellow S 10 (61)(69) Period of application: from 1 August 2014 E 124 Ponceau 4R, Cochineal Red A 35 (61) Period of application: from 1 January 2014 to 31 July 2014 E 124 Ponceau 4R, Cochineal Red A 35 (61)(69) Period of application: from 1 August 2014 except food supplements in chewable form E 124 Ponceau 4R, Cochineal Red A 10 (61) Period of application: from 1 January 2014 to 31 July 2014 E 124 Ponceau 4R, Cochineal Red A 10 (61)(69) Period of application: from 1 August 2014 only food supplements in chewable form E 160d Lycopene 30 E 200-213 Sorbic acid — sorbates; Benzoic acid — benzoates 1 000 (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 310-321 Propyl gallate, TBHQ, BHA and BHT 400 (1) E 338-452 Phosphoric acid — phosphates — di-, tri- and polyphosphates quantum satis E 392 Extracts of rosemary 400 (46) E 405 Propane-1, 2-diol alginate 1 000 E 416 Karaya gum quantum satis E 426 Soybean hemicellulose 1 500 E 432-436 Polysorbates quantum satis E 459 Beta-cyclodextrin quantum satis only food supplements in tablet and coated tablet form E 468 Cross-linked sodium carboxy methyl cellulose 30 000 except food supplements in chewable form E 473-474 Sucrose esters of fatty acids — sucroglycerides quantum satis (1) E 475 Polyglycerol esters of fatty acids quantum satis E 491-495 Sorbitan esters quantum satis (1) E 551-559 Silicon dioxide — silicates quantum satis Period of application: until 31 January 2014 E 551-553 Silicon dioxide — silicates quantum satis Period of application: from 1 February 2014 E 900 Dimethyl polysiloxane 10 (91) only food supplements in effervescent tablet form E 901 Beeswax, white and yellow quantum satis E 902 Candelilla wax quantum satis E 903 Carnauba wax 200 E 904 Shellac quantum satis E 950 Acesulfame K 500 E 950 Acesulfame K 2 000 only food supplements in chewable form E 951 Aspartame 2 000 E 951 Aspartame 5 500 only food supplements in chewable form E 952 Cyclamic acid and its Na and Ca salts 500 (51) E 952 Cyclamic acid and its Na and Ca salts 1 250 (51) only food supplements in chewable form E 954 Saccharin and its Na, K and Ca salts 500 (52) E 954 Saccharin and its Na, K and Ca salts 1 200 (52) only food supplements in chewable form E 955 Sucralose 800 E 955 Sucralose 2 400 only food supplements in chewable form E 957 Thaumatin 400 only food supplements in chewable form E 959 Neohesperidine DC 100 E 959 Neohesperidine DC 400 only food supplements in chewable form E 960 Steviol glycosides 670 (60) E 960 Steviol glycosides 1 800 (60) only food supplements in chewable form E 961 Neotame 60 E 961 Neotame 185 only food supplements in chewable form E 961 Neotame 2 only as flavour enhancer, except food supplements in chewable form E 961 Neotame 2 only vitamins and/or mineral based food supplements in chewable form, as a flavour enhancer E 962 Salt of aspartame-acesulfame 500 (11)a (49) (50) E 962 Salt of aspartame-acesulfame 2 000 (11)a (49) (50) only food supplements in chewable form E 969 Advantame 20 E 969 Advantame 55 only food supplements in chewable form E 1201 Polyvinylpyrrolidone quantum satis only food supplements in tablet and coated tablet form E 1202 Polyvinylpolypyrrolidone quantum satis only food supplements in tablet and coated tablet form E 1203 Polyvinyl alcohol (PVA) 18 000 only food supplements in capsule and tablet form E 1204 Pullulan quantum satis only food supplements in capsule and tablet form E 1205 Basic methacrylate copolymer 100 000 except food supplements in chewable form E 1206 Neutral methacrylate copolymer 200 000 except food supplements in chewable form E 1207 Anionic methacrylate copolymer 100 000 except food supplements in chewable form E 1208 Polyvinylpyrrolidone-vinyl acetate copolymer 100 000 except food supplements in chewable form E 1209 Polyvinyl alcohol-polyethylene glycol-graft-co-polymer 100 000 except food supplements in chewable form E 1505 Triethyl citrate 3 500 only food supplements in capsule and tablet form E 1521 Polyethylene glycol 10 000 only 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: ‘17.2 Food 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 I Additives Group II Colours at quantum satis quantum satis Group II Colours at quantum satis quantum satis Period of application: until 31 July 2014 Group II Colours at quantum satis quantum satis (69) Period of application: from 1 August 2014 only food supplements in syrup form Group III Colours with combined maximum limit 100 Group IV Polyols quantum satis E 104 Quinoline Yellow 10 (61) Period of application: from 1 January 2014 to 31 July 2014 E 104 Quinoline Yellow 10 (61)(69) Period of application: from 1 August 2014 E 110 Sunset Yellow FCF/Orange Yellow S 10 (61) Period of application: from 1 January 2014 to 31 July 2014 E 110 Sunset Yellow FCF/Orange Yellow S 10 (61)(69) Period of application: from 1 August 2014 E 124 Ponceau 4R, Cochineal Red A 10 (61) Period of application: from 1 January 2014 to 31 July 2014 E 124 Ponceau 4R, Cochineal Red A 10 (61)(69) Period of application: from 1 August 2014 E 160d Lycopene 30 E 200-213 Sorbic acid — sorbates; Benzoic acid — benzoates 2 000 (1) (2) except food supplements in syrup form E 310-321 Propyl gallate, TBHQ, BHA and BHT 400 (1) E 338-452 Phosphoric acid — phosphates — di-, tri- and polyphosphates quantum satis E 392 Extracts of rosemary 400 (46) E 405 Propane-1, 2-diol alginate 1 000 E 416 Karaya gum quantum satis E 426 Soybean hemicellulose 1 500 E 432-436 Polysorbates quantum satis E 473-474 Sucrose esters of fatty acids — sucroglycerides quantum satis (1) E 475 Polyglycerol esters of fatty acids quantum satis E 491-495 Sorbitan esters quantum satis (1) E 551-559 Silicon dioxide — silicates quantum satis Period of application: until 31 January 2014 E 551-553 Silicon dioxide — silicates quantum satis Period of application: from 1 February 2014 E 950 Acesulfame K 350 E 950 Acesulfame K 2 000 only food supplements in syrup form E 951 Aspartame 600 E 951 Aspartame 5 500 only food supplements in syrup form E 952 Cyclamic acid and its Na and Ca salts 400 (51) E 952 Cyclamic acid and its Na and Ca salts 1 250 (51) only food supplements in syrup form E 954 Saccharin and its Na, K and Ca salts 80 (52) E 954 Saccharin and its Na, K and Ca salts 1 200 (52) only food supplements in syrup form E 955 Sucralose 240 E 955 Sucralose 2 400 only food supplements in syrup form E 957 Thaumatin 400 only food supplements in syrup form E 959 Neohesperidine DC 50 E 959 Neohesperidine DC 400 only food supplements in syrup form E 960 Steviol glycosides 200 (60) E 960 Steviol glycosides 1 800 (60) only food supplements in syrup form E 961 Neotame 20 E 961 Neotame 185 only food supplements in syrup form E 961 Neotame 2 only as flavour enhancer, except food supplements in syrup form E 961 Neotame 2 only vitamins and/or mineral based food supplements in syrup form, as a flavour enhancer E 962 Salt of aspartame-acesulfame 350 (11)a (49) (50) E 962 Salt of aspartame-acesulfame 2 000 (11)a (49) (50) only food supplements in syrup form E 969 Advantame 6 E 969 Advantame 55 only food supplements in syrup form’

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