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)
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 additives , 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 flavourings , 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 Council 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/EC , 94/36/EC and 95/2/EC .
(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 1
Annex II to Regulation (EC) No 1333/2008 is amended in accordance with the Annex to this Regulation.
Article 2
This 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 Commission
The President
Jean-Claude Juncker
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:
  1. 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.
  2. the entry for food subcategory 17.1 is amended as follows:
    1. the title is replaced by the following:
17.1 | Food supplements supplied in a solid form, excluding food supplements for infants and young children
    2. 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
  3. the entry for food subcategory 17.2 is amended as follows:
    1. the title is replaced by the following:
17.2 | Food supplements supplied in a liquid form, excluding food supplements for infants and young children
    2. 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
OJ L 354, 31.12.2008, p. 16.
OJ L 354, 31.12.2008, p. 1.
Directive 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).
European 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).
European 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).
European 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).