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- Point in Time (08/10/2018)
- Original (As adopted by EU)
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)
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Annex II to Regulation (EC) No 1333/2008 is amended as follows:
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’ |
Part E is amended as follows:
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.’ |
the entry for food subcategory 17.1 is amended as follows:
the title is replaced by the following:
‘17.1 | Food supplements supplied in a solid form, excluding food supplements for infants and young children’ |
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’ |
the entry for food subcategory 17.2 is amended as follows:
the title is replaced by the following:
‘17.2 | Food supplements supplied in a liquid form, excluding food supplements for infants and young children’ |
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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