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,
Whereas:
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.
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.
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.
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.
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’.
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.
Annex II to Regulation (EC) No 1333/2008 should therefore be amended accordingly.
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:
- (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’
- (i)
- (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’
- (i)
- (a)