Commission Regulation (EU) 2018/98Show full title

Commission Regulation (EU) 2018/98

of 22 January 2018

amending Annexes II and III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council and the Annex to Commission Regulation (EU) No 231/2012 as regards calcium sorbate (E 203)

(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) and Article 14 thereof,

Whereas:

(1) Annex II to Regulation (EC) No 1333/2008 lays down a Union list of food additives approved for use in foods and their conditions of use.

(2) Annex III to Regulation (EC) No 1333/2008 lays down a Union list of food additives approved for use in food additives, food enzymes, food flavourings, nutrients and their conditions of use.

(3) Commission Regulation (EU) No 231/2012(2) lays down specifications for food additives that are listed in Annexes II and III to Regulation (EC) No 1333/2008.

(4) Calcium sorbate (E 203) is a substance authorised as a preservative in a variety of foods, as well as in food colour preparations and food flavourings, in accordance with Annexes II and III to Regulation (EC) No 1333/2008.

(5) Article 32(1) of Regulation (EC) No 1333/2008 provides that all food additives that were already permitted in the Union before 20 January 2009 are subject to a new risk assessment by the European Food Safety Authority (‘the Authority’).

(6) For that purpose, a program for the re-evaluation of food additives is laid down in the Commission Regulation (EU) No 257/2010(3). Pursuant to Regulation (EU) No 257/2010 the re-evaluation of preservatives had to be completed by 31 December 2015.

(7) On 30 June 2015 the Authority delivered a Scientific Opinion on the re-evaluation of sorbic acid (E 200), potassium sorbate (E 202) and calcium sorbate (E 203) as food additives(4). The opinion stated that there was a lack of genotoxicity data on calcium sorbate. Consequently the Authority was not able to confirm the safety of calcium sorbate as a food additive and concluded that it should be excluded from the group Acceptable Daily Intake (ADI) defined for sorbic acid (E 200) and potassium sorbate (E 202). The opinion stated that genotoxicity studies on calcium sorbate need to be performed in order to consider including calcium sorbate in that group ADI.

(8) On 10 June 2016 the Commission launched a public call for scientific and technological data on sorbic acid (E 200), potassium sorbate (E 202) and calcium sorbate (E 203)(5), targeting the data needs identified in the Scientific Opinion on the re-evaluation of those substances as food additives. However, no business operator committed to providing the requested genotoxicity data for calcium sorbate (E 203). Without those data the Authority cannot complete the re-evaluation of the safety of calcium sorbate as a food additive and consequently it cannot be determined whether that substance still fulfils the conditions pursuant to Article 6(1) of Regulation (EC) No 1333/2008 for inclusion in the Union list of approved food additives.

(9) It is therefore appropriate to remove calcium sorbate (E 203) from the Union list of approved food additives.

(10) Pursuant to Article 10(3) of Regulation (EC) No 1333/2008, the Union list of approved food additives shall be amended in accordance with the procedure referred to in Regulation (EC) No 1331/2008 of the European Parliament and of the Council(6).

(11) Article 3(1) of Regulation (EC) No 1331/2008 provides that the Union list of food additives may be updated either on the initiative of the Commission or following an application.

(12) Therefore, Annexes II and III to Regulation (EC) No 1333/2008 and the Annex to Regulation (EU) No 231/2012 should be amended by deleting calcium sorbate (E 203) from the Union list of authorised food additives since due to the absence of appropriate genotoxicity data its inclusion in the list can no longer be justified.

(13) In order to enable food business operators to adapt to the new requirements or to find alternatives to calcium sorbate (E 203), this Regulation should apply 6 months after its entry into force.

(14) 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 U.K.

Annexes II and III to Regulation (EC) No 1333/2008 are amended in accordance with the Annex to this Regulation.

Article 2 U.K.

In the Annex to Regulation (EU) No 231/2012, the entry for food additive E 203 calcium sorbate is deleted.

Article 3 U.K.

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

It shall apply from 12 August 2018.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 22 January 2018.

For the Commission

The President

Jean-Claude Juncker

ANNEX U.K.

(1)

Annex II to Regulation (EC) No 1333/2008 is amended as follows:

(a)

in Part B, in Table 3: Additives other than colours and sweeteners, the entry for the food additive E 203 calcium sorbate is deleted;

(b)

Part C, Table 5: Other additives that may be regulated combined, is amended as follows:

(i)

point (a) ‘E 200 – 203: Sorbic acid – sorbates (SA)’ is replaced by the following:

‘(a)

E 200 – 202: Sorbic acid – potassium sorbate (SA)

E-number	Name
E 200	Sorbic acid
E 202	Potassium sorbate’

(ii)

in point (c) ‘E 200 – 213: Sorbic acid – sorbates; Benzoic acid – benzoates (SA + BA)’, the entry for the food additive E 203 calcium sorbate is deleted;

(iii)

in point (d) ‘E 200 – 219: Sorbic acid – sorbates; Benzoic acid – benzoates; p-hydroxybenzoates (SA + BA + PHB)’, the entry for the food additive E 203 calcium sorbate is deleted;

(iv)

point (e) ‘E 200 – 203; 214 – 219: Sorbic acid – sorbates; p-hydroxybenzoates (SA + PHB)’ is replaced by the following:

‘(e)

E 200 – 202; 214 – 219: Sorbic acid – potassium sorbate; p-hydroxybenzoates (SA + PHB)

E-number	Name
E 200	Sorbic acid
E 202	Potassium sorbate
E 214	Ethyl-p-hydroxybenzoate
E 215	Sodium ethyl p-hydroxybenzoate
E 218	Methyl p-hydroxybenzoate
E 219	Sodium methyl p-hydroxybenzoate’

(c)

Part E is amended as follows:

1.

In category 01.3 (Unflavoured fermented milk products, heat-treated after fermentation), the entry concerning food additives E 200 – 203 (Sorbic acid – sorbates) is replaced by the following:

‘E 200 – 202

Sorbic acid – potassium sorbate

1 000

(1) (2)

only curdled milk’

2.

In category 01.4 (Flavoured fermented milk products including heat-treated products), the entry concerning food additives E 200 – 213 (Sorbic acid – sorbates; Benzoic acid – benzoates) is replaced by the following:

‘E 200 – 213

Sorbic acid – potassium sorbate; Benzoic acid – benzoates

300

(1) (2)

only non-heat-treated dairy based desserts’

3.

In category 01.7.1 (Unripened cheese excluding products falling in category 16), the entry concerning food additives E 200 – 203 (Sorbic acid – sorbates) is replaced by the following:

‘E 200 – 202

Sorbic acid – potassium sorbate

1 000

(1) (2)’

4.

In category 01.7.2 (Ripened cheese), the entries concerning food additives E 200 – 203 (Sorbic acid – sorbates) are replaced by the following:

	‘E 200 – 202	Sorbic acid – potassium sorbate	1 000	(1) (2)	only cheese, pre-packed, sliced and cut; layered cheese and cheese with added foods
	E 200 – 202	Sorbic acid – potassium sorbate	quantum satis		only ripened products surface treatment’

5.

In category 01.7.4 (Whey cheese), the entry concerning food additives E 200 – 203 (Sorbic acid – sorbates) is replaced by the following:

‘E 200 – 202

Sorbic acid – potassium sorbate

1 000

(1) (2)

only cheese, pre-packed, sliced; layered cheese and cheese with added foods’

6.

In category 01.7.5 (Processed cheese), the entry concerning food additives E 200 – 203 (Sorbic acid – sorbates) is replaced by the following:

‘E 200 – 202

Sorbic acid – potassium sorbate

2 000

(1) (2)’

7.

In category 01.7.6 (Cheese products (excluding products falling in category 16)), the entries concerning food additives E 200 – 203 (Sorbic acid – sorbates) are replaced by the following:

	‘E 200 – 202	Sorbic acid – potassium sorbate	1 000	(1) (2)	only unripened products; ripened products, pre-packed, sliced; layered ripened products and ripened products with added foods
	E 200 – 202	Sorbic acid – potassium sorbate	quantum satis		only ripened products surface treatment’

8.

In category 01.8 (Dairy analogues, including beverage whiteners), the entries concerning food additives E 200 – 203 (Sorbic acid – sorbates) are replaced by the following:

	‘E 200 – 202	Sorbic acid – potassium sorbate	2 000	(1) (2)	only analogues of cheese based on protein
	E 200 – 202	Sorbic acid – potassium sorbate	quantum satis	(1) (2)	only cheese analogues (surface treatment only)’

9.

In category 02.2.2 (Other fat and oil emulsions including spreads as defined by Council Regulation (EC) No 1234/2007 and liquid emulsions), the entries concerning food additives E 200 – 203 (Sorbic acid – sorbates) are replaced by the following:

	‘E 200 – 202	Sorbic acid – potassium sorbate	1 000	(1) (2)	only fat emulsions (excluding butter) with a fat content of 60 % or more
	E 200 – 202	Sorbic acid – potassium sorbate	2 000	(1) (2)	only fat emulsions with a fat content less than 60 %’

10.

In category 04.1.1 (Entire fresh fruit and vegetables), the entry concerning food additives E 200 – 203 (Sorbic acid – sorbates) is replaced by the following:

‘E 200 – 202

Sorbic acid – potassium sorbate

20

only surface treatment of unpeeled fresh citrus fruit’

11.

In category 04.2.1 (Dried fruit and vegetables), the entry concerning food additives E 200 – 203 (Sorbic acid – sorbates) is replaced by the following:

‘E 200 – 202

Sorbic acid – potassium sorbate

1 000

(1) (2)

only dried fruit’

12.

Category 04.2.2 (Fruit and vegetables in vinegar, oil, or brine) is amended as follows:

(i)

the entry concerning food additives E 200 – 213 (Sorbic acid – sorbates; Benzoic acid – benzoates) is replaced by the following:

‘E 200 – 213

Sorbic acid – potassium sorbate; Benzoic acid – benzoates

2 000

(1) (2)

only vegetables (excluding olives)’

(ii)

the entry concerning food additives E 200 – 203 (Sorbic acid – sorbates) is replaced by the following:

‘E 200 – 202

Sorbic acid – potassium sorbate

1 000

(1) (2)

only olives and olive-based preparations’

(iii)

the entry concerning food additives E 200 – 213 (Sorbic acid – sorbates; Benzoic acid – benzoates) is replaced by the following:

‘E 200 – 213

Sorbic acid – potassium sorbate; Benzoic acid – benzoates

1 000

(1) (2)

only olives and olive-based preparations’

13.

Category 04.2.4.1 (Fruit and vegetable preparations excluding compote) is amended as follows:

(i)

the entry concerning food additives E 200 – 203 (Sorbic acid – sorbates) is replaced by the following:

‘E 200 – 202

Sorbic acid – potassium sorbate

1 000

(1) (2)

only fruit and vegetable preparations including seaweed-based preparations, fruit-based sauces, aspic, excluding purée, mousse, compote, salads and similar products, canned or bottled’

(ii)

the entry concerning food additives E 200 – 213 (Sorbic acid – sorbates; Benzoic acid – benzoates) is replaced by the following:

‘E 200 – 213

Sorbic acid – potassium sorbate; Benzoic acid – benzoates

1 000

(1) (2)

only olive-based preparations’

14.

In category 04.2.5.1 (Extra jam and extra jelly as defined by Directive 2001/113/EC), the entry concerning food additives E 200 – 213 (Sorbic acid – sorbates; Benzoic acid – benzoates) is replaced by the following:

‘E 200 – 213

Sorbic acid – potassium sorbate; Benzoic acid – benzoates

1 000

(1) (2)

only low-sugar and similar low calorie or sugar-free products, mermeladas’

15.

In category 04.2.5.2 (Jam, jellies and marmalades and sweetened chestnut puree as defined by Directive 2001/113/EC), the entry concerning food additives E 200 – 213 (Sorbic acid – sorbates; Benzoic acid – benzoates) is replaced by the following:

‘E 200 – 213

Sorbic acid – potassium sorbate; Benzoic acid – benzoates

1 000

(1) (2)

only low-sugar and similar low calorie or sugar-free products, spreads, mermeladas’

16.

In category 04.2.5.3 (Other similar fruit or vegetable spreads), the entries concerning food additives E 200 – 213 (Sorbic acid – sorbates; Benzoic acid – benzoates) are replaced by the following:

	‘E 200 – 213	Sorbic acid – potassium sorbate; Benzoic acid – benzoates	1 000	(1) (2)	other fruit-based spreads, mermeladas
	E 200 – 213	Sorbic acid – potassium sorbate; Benzoic acid – benzoates	1 500	(1) (2)	only marmelada’

17.

In category 04.2.6 (Processed potato products), the entry concerning food additives E 200 – 203 (Sorbic acid – sorbates) is replaced by the following:

‘E 200 – 202

Sorbic acid – potassium sorbate

2 000

(1) (2)

only potato dough and pre-fried potato slices’

18.

Category 05.2 (Other confectionery including breath refreshening microsweets) is amended as follows:

(i)

the entry concerning food additives E 200 – 219 (Sorbic acid – sorbates; Benzoic acid – benzoates; p-hydroxybenzoates) is replaced by the following:

‘E 200 – 219

Sorbic acid – potassium sorbate; Benzoic acid – benzoates; p-hydroxybenzoates

1 500

(1) (2) (5)

except candied, crystallized or glacé fruit and vegetables’

(ii)

the entry concerning food additives E 200 – 213 (Sorbic acid – sorbates; Benzoic acid – benzoates) is replaced by the following:

‘E 200 – 213

Sorbic acid – potassium sorbate; Benzoic acid – benzoates

1 000

(1) (2)

only candied, crystallized or glacé fruit and vegetables’

19.

In category 05.3 (Chewing gum), the entry concerning food additives E 200 – 213 (Sorbic acid – sorbates; Benzoic acid – benzoates) is replaced by the following:

‘E 200 – 213

Sorbic acid – potassium sorbate; Benzoic acid – benzoates

1 500

(1) (2)’

20.

Category 05.4 (Decorations, coatings and fillings, except fruit based fillings covered by category 4.2.4) is amended as follows:

(i)

the entry concerning food additives E 200 – 203 (Sorbic acid – sorbates) is replaced by the following:

‘E 200 – 202

Sorbic acid – potassium sorbate

1 000

(1) (2)

only toppings (syrups for pancakes, flavoured syrups for milkshakes and ice cream; similar products)’

(ii)

the entry concerning food additives E 200 – 219 (Sorbic acid – sorbates; Benzoic acid – benzoates; p-hydroxybenzoates) is replaced by the following:

‘E 200 – 219

Sorbic acid – potassium sorbate; Benzoic acid – benzoates; p-hydroxybenzoates

1 500

(1) (2) (5)’

21.

In category 06.4.4 (Potato Gnocchi), the entry concerning food additives E 200 – 203 (Sorbic acid – sorbates) is replaced by the following:

‘E 200 – 202

Sorbic acid – potassium sorbate

1 000

(1)’

22.

In category 06.4.5 (Fillings of stuffed pasta (ravioli and similar)), the entry concerning food additives E 200 – 203 (Sorbic acid – sorbates) is replaced by the following:

‘E 200 – 202

Sorbic acid – potassium sorbate

1 000

(1) (2)’

23.

In category 06.6 (Batters), the entry concerning food additives E 200 – 203 (Sorbic acid – sorbates) is replaced by the following:

‘E 200 – 202

Sorbic acid – potassium sorbate

2 000

(1) (2)’

24.

In category 06.7 (Precooked or processed cereals), the entries concerning food additives E 200 – 203 (Sorbic acid – sorbates) are replaced by the following:

	‘E 200 – 202	Sorbic acid – potassium sorbate	200	(1) (2)	only polenta
	E 200 – 202	Sorbic acid – potassium sorbate	2 000	(1) (2)	only Semmelknödelteig’

25.

In category 07.1 (Bread and rolls), the entry concerning food additives E 200 – 203 (Sorbic acid – sorbates) is replaced by the following:

‘E 200 – 202

Sorbic acid – potassium sorbate

2 000

(1) (2)

only prepacked sliced bread and rye-bread, partially baked, prepacked bakery wares intended for retail sale and energy-reduced bread intended for retail sale’

26.

In category 07.2 (Fine bakery wares), the entry concerning food additives E 200 – 203 (Sorbic acid – sorbates) is replaced by the following:

‘E 200 – 202

Sorbic acid – potassium sorbate

2 000

(1) (2)

only with a water activity of more than 0,65’

27.

In category 08.3.1 (Non-heat–treated meat products), the entry concerning food additives E 200 – 219 (Sorbic acid – sorbates; Benzoic acid – benzoates; p-hydroxybenzoates) is replaced by the following:

‘E 200 – 219

Sorbic acid – potassium sorbate; Benzoic acid – benzoates; p-hydroxybenzoates

quantum satis

(1) (2)

only surface treatment of dried meat products’

28.

Category 08.3.2 (Heat–treated meat products) is amended as follows:

(i)

the entry concerning food additives E 200 – 203; 214 – 219 (Sorbic acid – sorbates; p-hydroxybenzoates) is replaced by the following:

‘E 200 – 202; 214 – 219

Sorbic acid – potassium sorbate; p-hydroxybenzoates

1 000

(1) (2)

only pâté’

(ii)

the entry concerning food additives E 200 – 203 (Sorbic acid – sorbates) is replaced by the following:

‘E 200 – 202

Sorbic acid – potassium sorbate

1 000

(1) (2)

only aspic’

(iii)

the entry concerning food additives E 200 – 219 (Sorbic acid – sorbates, Benzoic acid – benzoates; p-hydroxybenzoates) is replaced by the following:

‘E 200 – 219

Sorbic acid – potassium sorbate, Benzoic acid – benzoates; p-hydroxybenzoates

quantum satis

(1) (2)

only surface treatment of dried meat products’

29.

Category 08.3.3 (Casings and coatings and decorations for meat) is amended as follows:

(i)

the entry concerning food additives E 200 – 203 (Sorbic acid – sorbates) is replaced by the following:

‘E 200 – 202

Sorbic acid – potassium sorbate

quantum satis

only collagen-based casings with water activity greater than 0,6’

(ii)

the entry concerning food additives E 200 – 203; 214 – 219 (Sorbic acid – sorbates; p-hydroxybenzoates) is replaced by the following:

‘E 200 – 202; 214 – 219

Sorbic acid – potassium sorbate; p-hydroxybenzoates

1 000

(1) (2)

only jelly coatings of meat products (cooked, cured or dried)’

30.

Category 09.2 (Processed fish and fishery products including molluscs and crustaceans) is amended as follows:

(i)

the entry concerning food additives E 200 – 203 (Sorbic acid – sorbates) is replaced by the following:

‘E 200 – 202

Sorbic acid – potassium sorbate

1 000

(1) (2)

aspic’

(ii)

the entries concerning food additives E 200 – 213 (Sorbic acid – sorbates; Benzoic acid – benzoates) are replaced by the following:

	‘E 200 – 213	Sorbic acid – potassium sorbate; Benzoic acid – benzoates	200	(1) (2)	only salted, dried fish
	E 200 – 213	Sorbic acid – potassium sorbate; Benzoic acid – benzoates	2 000	(1) (2)	only semi-preserved fish and fisheries products including crustaceans, molluscs, surimi and fish/crustacean paste; cooked crustaceans and molluscs
	E 200 – 213	Sorbic acid – potassium sorbate; Benzoic acid – benzoates	6 000	(1) (2)	only cooked Crangon crangon and Crangon vulgaris’

31.

In category 09.3 (Fish roe), the entry concerning food additives E 200 – 213 (Sorbic acid – sorbates; Benzoic acid – benzoates) is replaced by the following:

‘E 200 – 213

Sorbic acid – potassium sorbate; Benzoic acid – benzoates

2 000

(1) (2)

only semi-preserved fish products including fish roe products’

32.

Category 10.2 (Processed eggs and egg products) is amended as follows:

(i)

the entry concerning food additives E 200 – 203 (Sorbic acid – sorbates) is replaced by the following:

‘E 200 – 202

Sorbic acid – potassium sorbate

1 000

(1) (2)

only dehydrated and concentrated frozen and deep-frozen egg products’

(ii)

the entry concerning food additives E 200 – 213 (Sorbic acid – sorbates; Benzoic acid – benzoates) is replaced by the following:

‘E 200 – 213

Sorbic acid – potassium sorbate; Benzoic acid – benzoates

5 000

(1) (2)

only liquid egg (white, yolk or whole egg)’

33.

In category 11.4.1 (Table-Top Sweeteners in liquid form), the entry concerning food additives E 200 – 219 (Sorbic acid – sorbates; Benzoic acid – benzoates; p-hydroxybenzoates) is replaced by the following:

‘E 200 – 219

Sorbic acid – potassium sorbate; Benzoic acid – benzoates; p-hydroxybenzoates

500

(1) (2)

only if the water content higher than 75 %’

34.

In category 12.2.2 (Seasonings and condiments), the entry concerning food additives E 200 – 213 (Sorbic acid – sorbates; Benzoic acid – benzoates) is replaced by the following:

‘E 200 – 213

Sorbic acid – potassium sorbate; Benzoic acid – benzoates

1 000

(1) (2)’

35.

In category 12.4 (Mustard), the entry concerning food additives E 200 – 213 (Sorbic acid – sorbates; Benzoic acid – benzoates) is replaced by the following:

‘E 200 – 213

Sorbic acid – potassium sorbate; Benzoic acid – benzoates

1 000

(1) (2)’

36.

In category 12.5 (Soups and broths), the entry concerning food additives E 200 – 213 (Sorbic acid – sorbates; Benzoic acid – benzoates) is replaced by the following:

‘E 200 – 213

Sorbic acid – potassium sorbate; Benzoic acid – benzoates

500

(1) (2)

only liquid soups and broths (excluding canned)’

37.

Category 12.6 (Sauces) is amended as follows:

(i)

the entries concerning food additives E 200 – 203 (Sorbic acid – sorbates) are replaced by the following:

	‘E 200 – 202	Sorbic acid – potassium sorbate	1 000	(1) (2)	only emulsified sauces with a fat content of 60 % or more
	E 200 – 202	Sorbic acid – potassium sorbate	2 000	(1) (2)	only emulsified sauces with a fat content of less than 60 %’

(ii)

the entries concerning food additives E 200 – 213 (Sorbic acid – sorbates; Benzoic acid – benzoates) are replaced by the following:

	‘E 200 – 213	Sorbic acid – potassium sorbate; Benzoic acid – benzoates	1 000	(1) (2)	only emulsified sauces with a fat content of 60 % or more; non emulsified sauces
	E 200 – 213	Sorbic acid – potassium sorbate; Benzoic acid – benzoates	2 000	(1) (2)	only emulsified sauces with a fat content of less than 60 %’

38.

In category 12.7 (Salads and savoury based sandwich spreads), the entry concerning food additives E 200 – 213 (Sorbic acid – sorbates; Benzoic acid – benzoates) is replaced by the following:

‘E 200 – 213

Sorbic acid – potassium sorbate; Benzoic acid – benzoates

1 500

(1) (2)’

39.

In category 12.9 (Protein products, excluding products covered in category 1.8), the entry concerning food additives E 200 – 203 (Sorbic acid – sorbates) is replaced by the following:

‘E 200 – 202

Sorbic acid – potassium sorbate

2 000

(1) (2)

only analogues of meat, fish, crustaceans and cephalopods and cheese based on protein’

40.

In category 13.2 (Dietary foods for special medical purposes defined in Directive 1999/21/EC (excluding products from food category 13.1.5)), the entry concerning food additives E 200 – 213 (Sorbic acid – sorbates; Benzoic acid – benzoates) is replaced by the following:

‘E 200 – 213

Sorbic acid – potassium sorbate; Benzoic acid – benzoates

1 500

(1) (2)’

41.

In category 13.3 (Dietary foods for weight control diets intended to replace total daily food intake or an individual meal (the whole or part of the total daily diet)), the entry concerning food additives E 200 – 213 (Sorbic acid – sorbates; Benzoic acid – benzoates) is replaced by the following:

‘E 200 – 213

Sorbic acid – potassium sorbate; Benzoic acid – benzoates

1 500

(1) (2)’

42.

Category 14.1.2 (Fruit juices as defined by Directive 2001/112/EC and vegetable juices) is amended as follows:

(i)

the entry concerning food additives E 200 – 203 (Sorbic acid – sorbates) is replaced by the following:

‘E 200 – 202

Sorbic acid – potassium sorbate

500

(1) (2)

only Sød … saft and sødet … saft’

(ii)

the entry concerning food additives E 200 – 213 (Sorbic acid – sorbates; Benzoic acid – benzoates) is replaced by the following:

‘E 200 – 213

Sorbic acid – potassium sorbate; Benzoic acid – benzoates

2 000

(1) (2)

only grape juice, unfermented, for sacramental use’

43.

In category 14.1.3 (Fruit nectars as defined by Directive 2001/112/EC and vegetable nectars and similar products), the entries concerning food additives E 200 – 203 (Sorbic acid – sorbates) are replaced by the following:

	‘E 200 – 202	Sorbic acid – potassium sorbate	250	(1) (2)	only traditional Swedish fruit syrups, maximum applies if E 210 – 213, benzoic acid – benzoates, have also been used
	E 200 – 202	Sorbic acid – potassium sorbate	300	(1) (2)	only traditional Swedish and Finnish fruit syrups’

44.

In category 14.1.4 (Flavoured drinks), the entries concerning food additives E 200 – 203 (Sorbic acid – sorbates) are replaced by the following:

	‘E 200 – 202	Sorbic acid – potassium sorbate	250	(1) (2)	maximum applies if E 210 – 213, benzoic acid – benzoates, have also been used
	E 200 – 202	Sorbic acid – potassium sorbate	300	(1) (2)	excluding dairy-based drinks’

45.

In category 14.1.5.2 (Other), the entry concerning food additives E 200 – 213 (Sorbic acid – sorbates; Benzoic acid – benzoates) is replaced by the following:

‘E 200 – 213

Sorbic acid – potassium sorbate; Benzoic acid – benzoates

600

(1) (2)

only liquid tea concentrates and liquid fruit and herbal infusion concentrates’

46.

In category 14.2.1 (Beer and malt beverages), the entry concerning food additives E 200 – 203 (Sorbic acid – sorbates) is replaced by the following:

‘E 200 – 202

Sorbic acid – potassium sorbate

200

(1) (2)

only beer in kegs containing more than 0,5 % added fermentable sugar and/or fruit juices or concentrates’

47.

In category 14.2.2 (Wine and other products defined by Regulation (EC) No 1234/2007, and alcohol free counterparts), the entry concerning food additives E 200 – 203 (Sorbic acid – sorbates) is replaced by the following:

‘E 200 – 202

Sorbic acid – potassium sorbate

200

(1) (2)

only alcohol-free’

48.

In category 14.2.3 (Cider and perry), the entry concerning food additives E 200 – 203 (Sorbic acid – sorbates) is replaced by the following:

‘E 200 – 202

Sorbic acid – potassium sorbate

200

(1) (2)’

49.

In category 14.2.4 (Fruit wine and made wine), the entry concerning food additives E 200 – 203 (Sorbic acid – sorbates) is replaced by the following:

‘E 200 – 202

Sorbic acid – potassium sorbate

200

(1) (2)’

50.

In category 14.2.5 (Mead), the entry concerning food additives E 200 – 203 (Sorbic acid – sorbates) is replaced by the following:

‘E 200 – 202

Sorbic acid – potassium sorbate

200

(1) (2)’

51.

In category 14.2.7.1 (Aromatised wines), the entry concerning food additives E 200 – 203 (Sorbic acid – sorbates) is replaced by the following:

‘E 200 – 202

Sorbic acid – potassium sorbate

200

(1) (2)’

52.

In category 14.2.7.2 (Aromatised wine-based drinks), the entry concerning food additives E 200 – 203 (Sorbic acid – sorbates) is replaced by the following:

‘E 200 – 202

Sorbic acid – potassium sorbate

200

(1) (2)’

53.

In category 14.2.7.3 (Aromatised wine-product cocktails), the entry concerning food additives E 200 – 203 (Sorbic acid – sorbates) is replaced by the following:

‘E 200 – 202

Sorbic acid – potassium sorbate

200

(1) (2)’

54.

In category 14.2.8 (Other alcoholic drinks including mixtures of alcoholic drinks with non-alcoholic drinks and spirits with less than 15 % of alcohol), the entry concerning food additives E 200 – 203 (Sorbic acid – sorbates) is replaced by the following:

‘E 200 – 202

Sorbic acid – potassium sorbate

200

(1) (2)

only alcoholic drinks with less than 15 % of alcohol and nalewka na winie owocowym, aromatyzowana nalewka na winie owocowym, nalewka na winie z soku winogronowego, aromatyzowana nalewka na winie z soku winogronowego, napój winny owocowy lub miodowy, aromatyzowany napój winny owocowy lub miodowy, wino owocowe niskoalkoholowe and aromatyzowane wino owocowe niskoalkoholowe’

55.

In category 15.1 (Potato-, cereal-, flour- or starch-based snacks), the entry concerning food additives E 200 – 203; 214 – 219 (Sorbic acid – sorbates; p-hydroxybenzoates) is replaced by the following:

‘E 200 – 202; 214 – 219

Sorbic acid – potassium sorbate; p-hydroxybenzoates

1 000

(1) (2) (5)’

56.

In category 15.2 (Processed nuts), the entry concerning food additives E 200 – 203; 214 – 219 (Sorbic acid – sorbates; p-hydroxybenzoates) is replaced by the following:

‘E 200 – 202; 214 – 219

Sorbic acid – potassium sorbate; p-hydroxybenzoates

1 000

(1) (2) (5)

only coated nuts’

57.

Category 16 (Desserts excluding products covered in category 1, 3 and 4) is amended as follows:

(i)

the entries concerning food additives E 200 – 203 (Sorbic acid – sorbates) are replaced by the following:

	‘E 200 – 202	Sorbic acid – potassium sorbate	1 000	(1) (2)	only frugtgrød, rote Grütze and pasha
	E 200 – 202	Sorbic acid – potassium sorbate	2 000	(1) (2)	only ostkaka’

(ii)

the entry concerning food additives E 200 – 213 (Sorbic acid – sorbates; Benzoic acid – benzoates) is replaced by the following:

‘E 200 – 213

Sorbic acid – potassium sorbate; Benzoic acid – benzoates

300

(1) (2)

only non-heat-treated dairy-based desserts’

58.

In category 17.1 (Food supplements supplied in a solid form including capsules and tablets and similar forms, excluding chewable forms), the entry concerning food additives E 200 – 213 (Sorbic acid – sorbates; Benzoic acid – benzoates) is replaced by the following:

‘E 200 – 213

Sorbic acid – potassium sorbate; Benzoic acid – benzoates

1 000

(1) (2)

only when supplied in dried form and containing preparations of vitamin A and of combinations of vitamin A and D’

59.

In category 17.2 (Food supplements supplied in a liquid form), the entry concerning food additives E 200 – 213 (Sorbic acid – sorbates; Benzoic acid – benzoates) is replaced by the following:

‘E 200 – 213

Sorbic acid – potassium sorbate; Benzoic acid – benzoates

2 000

(1) (2)’

(2)

Annex III to Regulation (EC) No 1333/2008 is amended as follows:

(a)

in Part 2 (Food additives other than carriers in food additives), the entries concerning food additives E 200 – 203, E 210, E 211 and E 212 are replaced by the following:

‘E 200 – 202	Sorbic acid – potassium sorbate (Table 2 of Part 6)	1 500 mg/kg singly or in combination in the preparation 15 mg/kg in the final product expressed as the free acid	Colour preparations
E 210	Benzoic acid
E 211	Sodium benzoate
E 212	Potassium benzoate’

(b)

in Part 4 (Food additives including carriers in food flavourings), the entries concerning food additives E 200 – 203, E 210, E 211, E 212 and E 213 are replaced by the following:

‘E 200 – 202	Sorbic acid and potassium sorbate (Table 2 of Part 6)	All flavourings	1 500 mg/kg (singly or in combination expressed as the free acid) in flavourings
E 210	Benzoic acid
E 211	Sodium benzoate
E 212	Potassium benzoate
E 213	Calcium benzoate’

(c)

in Part 6 (Definitions of groups of food additives for the purposes of Parts 1 to 5), Table 2 (Table 2: Sorbic acid – sorbates) is replaced by the following:

‘Table 2

Sorbic acid – potassium sorbate

E-number	Name
E 200	Sorbic acid
E 202	Potassium sorbate’

(1)

OJ L 354, 31.12.2008, p. 16.

(2)

Commission Regulation (EU) No 231/2012 of 9 March 2012 laying down specifications for food additives listed in Annexes II and III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council (OJ L 83, 22.3.2012, p. 1).

(3)

Commission Regulation (EU) No 257/2010 of 25 March 2010 setting up the program for the re-evaluation of approved food additives in accordance with Regulation (EC) No 1333/2008 of the European Parliament and of the Council on food additives (OJ L 80, 26.3.2010, p. 19).

(4)

EFSA Journal 2015;13(6):4144.

(5)

http://ec.europa.eu/food/safety/food_improvement_agents/additives/re-evaluation_en

(6)

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 (OJ L 354, 31.12.2008, p. 1).