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Document 32018R1497

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.)

C/2018/6410

OJ L 253, 9.10.2018, p. 36–44 (BG, ES, CS, DA, DE, ET, EL, EN, FR, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)

Date of entry into force unknown (pending notification) or not yet in force., Date of effect: 29/10/2018

ELI: http://data.europa.eu/eli/reg/2018/1497/oj

9.10.2018   

EN

Official Journal of the European Union

L 253/36


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 (1), 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 (2), 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 (3) 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 (4), 94/36/EC (5) and 95/2/EC (6).

(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


(1)  OJ L 354, 31.12.2008, p. 16.

(2)  OJ L 354, 31.12.2008, p. 1.

(3)  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).

(4)  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).

(5)  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).

(6)  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).


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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