COMMISSION REGULATION (EU) 2015/647
of 24 April 2015
amending and correcting Annexes II and III to Regulation (EC) No 1333/2008 of the European
Parliament and of the Council as regards the use of certain food additives
(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,
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, flavourings, nutrients and their conditions of use.
(3) Those lists may be updated in accordance with the common procedure referred to in Article 3(1) of Regulation
(EC) No 1331/2008 of the European Parliament and of the Council (
2
) either on the initiative of the Commission
or following an application.
(4) The Union list of food additives was established based on food additives permitted for use in foods in accordance
with Directives of the European Parliament and of the Council 94/35/EC (
3
), 94/36/EC (
4
), and 95/2/EC (
5
) and
after reviewing their compliance with Articles 6, 7 and 8 of Regulation (EC) No 1333/2008. The Union list
includes food additives on the basis of the categories of food to which those additives may be added to.
(5) Due to the difficulties encountered during the transfer of food additives to the new categorisation system
provided in Annex II to Regulation (EC) No 1333/2008, certain errors have been detected and should be
corrected, other provisions need to be further clarified.
(6) Annex II does not list the different forms under which a food additive can be used, e.g. Sorbitols (E 420) exist in
the form of Sorbitol (E 420 (i)) or Sorbitol syrup (E 420 (ii)); Sodium citrates (E 331) exist in the form of
25.4.2015 EN Official Journal of the European Union L 107/1
(
1
) OJ L 354, 31.12.2008, p. 16.
(
2
) Regulation (EC) No 1331/2008 of the European Parliament and of the Council of 16 December 2008 establishing a common authori-
sation procedure for food additives, food enzymes and food flavourings (OJ L 354, 31.12.2008, p. 1).
(
3
) 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).
(
4
) 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).
(
5
) 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). Monosodium citrate (E 331 (i)), Disodium citrate (E 331 (ii)) and Trisodium citrate (E 331 (iii)). These forms are
specified in Commission Regulation (EU) No 231/2012 (
1
). It should be clarified that those different forms of the
authorised food additives can be used.
(7) Canthaxanthin (E 161g) should not be sold directly to the consumer. Therefore, Annex II of Regulation (EC)
No 1333/2008, part A, Section 2, point 5 should be amended.
(8) Konjac (E 425) should not be used to produce dehydrated foods intended to be rehydrated upon ingestion.
Therefore, in Annex II, Part C, Section 1, Group I, the entry for E 425 the footnote (2) should be introduced.
(9) In food categories 01.7.2: ‘Ripened cheese’ and 01.7.6 ‘Cheese products (excluding products falling in
category 16)’, it should be clarified that Natamycin (E 235) may only be used for external treatment of uncut
cheeses and uncut cheese products.
(10) A consistent approach should be taken as regards the wording of the footnotes referring to maximum limits for
aluminium coming from aluminium lakes introduced by Commission Regulation (EU) No 380/2012 (
2
). A
sentence ‘No other aluminium lakes may be used’ should be included in all footnotes referring to specific food
additives in the categories: 01.7.3: ‘Edible cheese rind’, 01.7.5: ‘Processed cheese’, 04.2.5.2: ‘Jam, jellies and
marmalades and sweetened chestnut purée as defined by Directive 2001/113/EC’, 08.2: ‘Meat preparations as
defined by Regulation (EC) No 853/2004’, 08.3.1: ‘Non-heat-treated meat products’, 08.3.2 ‘Heat-treated meat
products’, 08.3.3 ‘Casings and coatings and decorations for meat’ and 09.3: ‘Fish roe’.
(11) In category 02.1: ‘Fats and oils essentially free from water (excluding anhydrous milkfat)’, certain additives should
not be used in virgin oils and olive oil.
(12) In category 04.2.3: ‘Canned or bottled fruit and vegetables’, the use of Sulphur dioxide — sulphites (E 220-228)
should be permitted in processed mushrooms.
(13) In food category 05.2: ‘Other confectionery including breath freshening microsweets’ and in food category 05.4:
‘Decorations, coatings and fillings, except fruit based fillings covered by category 4.2.4’, the maximum level of
Neotame (E 961) used as flavour enhancer in starch-based confectionery should be set at 3 mg/kg.
(14) In food category 05.4: ‘Decorations, coatings and fillings, except fruit based fillings covered by category 4.2.4’,
the use of Cyclamic acid and its Na and Ca salts (E 952) should be permitted in flavoured cream spray cans.
(15) In food category 06.4.4: ‘Potato Gnocchi’, the use of additives in fresh refrigerated potato Gnocchi should be
restricted to a limited number of additives that belong to Group I.
(16) In food category 07.2: ‘Fine bakery wares’, the use of Sulphur dioxide — sulphites (E 220-228) should be
clarified.
(17) In food category 08.2: ‘Meat preparations as defined by Regulation (EC) No 853/2004’, the entry for Potassium
acetate (E 261) should be corrected to Potassium acetates.
(18) In food category 08.3.1: ‘Non-heat-treated meat products’, the double entries for Erythorbic acid (E 315) and
Sodium erythorbate (E 316) should be removed.
(19) In food categories 08.2: ‘Meat preparations as defined by Regulation (EC) No 853/2004’, 08.3.1: ‘Non-heat-
treated meat products’, 08.3.2: ‘Heat-treated meat products’ and 08.3.4: ‘Traditionally cured meat products with
specific provisions concerning nitrites and nitrates’, the expression of the maximum levels of Nitrites (E 249-250)
and/or Nitrates (E 251-252) should be clarified.
(20) In food category, 08.3.2: ‘Heat-treated meat products’ the use of Gallates, TBHQ and BHA (E 310-320) should be
permitted in dehydrated meat.
L 107/2 EN Official Journal of the European Union 25.4.2015
(
1
) 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).
(
2
) Commission Regulation (EU) No 380/2012 of 3 May 2012 amending Annex II to Regulation (EC) No 1333/2008 of the European
Parliament and of the Council as regards the conditions of use and the use levels for aluminium-containing food additives (OJ L 119,
4.5.2012, p. 14). (21) In food category 08.3.3: ‘Casings and coatings and decorations for meat’, the number of footnote (80) should be
corrected to (89).
(22) In food category 08.3.4.2: ‘Traditional dry cured products’, the maximum level for nitrites (E 249-250) should be
reintroduced for jamón curado, paleta curada, lomo embuchado and cecina and similar products.
(23) In food categories 09.1.2: ‘Unprocessed molluscs and crustaceans’ and 09.2: ‘Processed fish and fishery products
including molluscs and crustaceans’, it should be clarified that the units according to which the maximum limits
for Sulphur dioxide and Sulphites (E 220-228) depend are expressed per kilogram, and the footnote related to
4-Hexylresorcinol (E 586) should be clarified and corrected.
(24) In food category 09.2: ‘Processed fish and fishery products including molluscs and crustaceans’, the use of
Titanium dioxide (E 171) and Iron oxides and hydroxides (E 172) should be restricted to smoked fish.
(25) In food category 09.2: ‘Processed fish and fishery products including molluscs and crustaceans’, it should be
clarified that the maximum level for Sorbic acid — sorbates; Benzoic acid — benzoates (E 200-213), applies to
the additives individually or in combination and to the sum and that the levels are expressed as the free acid.
(26) In category 10.2: ‘Processed eggs and egg products’, the maximum level for Triethyl citrate (E 1505) should apply
only to dried egg white.
(27) In food categories 14.2.7.1: ‘Aromatised wines’ and 14.2.7.2: ‘Aromatised wine-based drinks’, the use of colours
belonging to Group II and Group III should be corrected according to the uses of colours that were permitted in
Directive 94/36/EC.
(28) In food category 17.1: ‘Food supplements supplied in a solid form including capsules and tablets and similar
forms, excluding chewable forms’, the number of footnote (79) should be changed and introduced in the entry
for the food additive Dimethyl polysiloxane (E 900).
(29) In Annex III to Regulation (EC) No 1333/2008, in Part 4, ‘Food additives including carriers in food flavourings’,
the maximum limits for Octenyl succinic acid modified gum arabic (E 423) should apply to the final food. In
Part 6, ‘Definitions of groups of food additives for the purposes of Parts 1 to 5’, in Table 7 ‘Alginic acid —
alginates’, Calcium alginate (E 404) should be included.
(30) 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 the update in question is not liable to have an effect
on human health. Since the Union list is amended in order to include uses of additives already permitted in
accordance with Directive 94/35/EC, Directive 94/36/EC and Directive 95/2/EC, 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.
(31) Annexes II and III to Regulation (EC) No 1333/2008 should therefore be amended and corrected accordingly.
(32) 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 Annex I to this Regulation.
Article 2
Annex III to Regulation (EC) No 1333/2008 is amended in accordance with Annex II to this Regulation.
25.4.2015 EN Official Journal of the European Union L 107/3 Article 3
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, 24 April 2015.
For the Commission
The President
Jean-Claude JUNCKER
