ANNEX. to the COMMISSION REGULATION (EU) /..

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1 EUROPEAN COMMISSION Brussels, XXX SANTE/12055/2015 ANNEX (POOL/E7/2015/12055/ ANNEX.doc) D042507/03 [ ](2015) XXX ANNEX 1 ANNEX to the COMMISSION REGULATION (EU) /.. amending and correcting Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of the Council as regards the use of certain food additives permitted in all categories of foods

2 Annex II to Regulation (EC) No 1333/2008 is amended as follows: ANNEX 1. The following entry 13 is added in Table 1 of Part A after the entry for "12. Dry pasta, excluding gluten-free and/or pasta intended for hypoproteic diets, in accordance with Directive 2009/39/EC": " 13 Foods for infants and young children as referred to in Regulation (EU) No 609/2013, including foods for special medical purposes for infants and young children. 2. Part E of Annex II to Regulation (EC) No 1333/2008 is amended as follows: (a) the title of food category 0. Food additives permitted in all categories of foods is replaced as follows: " " 0 Food additives permitted in all categories of foods excluding foods for infants and young children, except where specifically provided for. " (b) the entries for additives in the food category 0. Food additives permitted in all categories of foods are replaced by the following: " E 290 Carbon dioxide quantum satis May be used in foods for infants and young children. E Phosphoric acid - phosphates - di - triand polyphosphates (1) (4) (57) Only foods in dried powdered form (i.e. foods dried during the production process, and mixtures thereof), excluding foods listed in table 1 of Part A of this Annex. E 459 Beta-cyclodextrin quantum satis Only foods in tablet and coated tablet form, excluding the foods listed in table 1 of Part A of this Annex. E Silicon dioxide silicates (1) (57) Only foods in dried powdered form (i.e. foods dried during the production process, and mixtures thereof), excluding foods listed in table 1 of Part A of this Annex. E Silicon dioxide silicates quantum satis (1) Only foods in tablet and coated tablet form, excluding the foods 2

3 listed in table 1 of Part A of this Annex. E 938 Argon quantum satis May be used in foods for infants and young children. E 939 Helium quantum satis May be used in foods for infants and young children. E 941 Nitrogen quantum satis May be used in foods for infants and young children. E 942 Nitrous oxide quantum satis May be used in foods for infants and young children. E 948 Oxygen quantum satis May be used in foods for infants and young children. E 949 Hydrogen quantum satis May be used in foods for infants and young children. " 3

4 EUROPEAN COMMISSION Brussels, XXX SANTE/12055/2015 Rev. 2 (POOL/E7/2015/12055/12055R2-.doc) D042507/03 [ ](2015) XXX draft COMMISSION REGULATION (EU) / of XXX amending and correcting Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of the Council as regards the use of certain food additives permitted in all categories of foods (Text with EEA relevance)

5 COMMISSION REGULATION (EU) / of XXX amending and correcting Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of the Council as regards the use of certain food additives permitted in all categories of foods (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 foods and their conditions of use. (2) 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. (3) The Union list of food additives was established based on the 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, 8 and 16 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. (4) 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, foods for infants and young children were not transferred from Article 2(3)(b) of Directive 95/2/EC to table 1 of Part A of Annex II to Regulation (EC) No 1333/2008. It should be ensured that the carry-over principle does not apply to those foods. Therefore, that 1 Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives (OJ L 354, , p. 16). 2 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, , p. 1). 3 European Parliament and Council Directive 94/35/EC of 30 June 1994 on sweeteners for use in foodstuffs (OJ L 237, , p. 3). 4 European Parliament and Council Directive 94/36/EC of 30 June 1994 on colours for use in foodstuffs (OJ L 237, , 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, , p. 1). 2

6 table should be corrected to include foods for infants and young children provided in Directive 2009/39/EC of the European Parliament and of the Council 6, as replaced by Regulation (EU) No 609/2013 of the European Parliament and the Council 7. (5) In view of Article 16 on the use of food additives in foods for infants and young children of Regulation (EC) No 1333/2008, it is important to clarify the conditions of use of the food additives listed in food category 0. Food additives permitted in all categories of foods of part E of Annex II of that Regulation and to amend the title of that category. (6) Therefore, the Union list of food additives should be clarified in order to reflect all the uses in accordance with Articles 6, 7, 8 and 16 of Regulation (EC) No 1333/2008. (7) 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 clarify uses already in accordance with Directives 94/35/EC, 94/36/EC and 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. (8) Annex II to Regulation (EC) No 1333/2008 should therefore be amended and corrected accordingly. (9) 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. 6 Directive 2009/39/EC of the European Parliament and of the Council of 6 May 2009 on foodstuffs intended for particular nutritional uses (OJ L 124, , p. 21). 7 Regulation (EU) No 609/2013 of the European Parliament and of the Council of 12 June 2013 on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control and repealing Council Directive 92/52/EEC, Commission Directives 96/8/EC, 1999/21/EC, 2006/125/EC and 2006/141/EC, Directive 2009/39/EC of the European Parliament and of the Council and Commission Regulations (EC) No 41/2009 and (EC) No 953/2009 (OJ L 181, , p. 35). 3

7 This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, For the Commission The President Jean-Claude JUNCKER 4

8 EUROPEAN COMMISSION Brussels, XXX SANTE/12107/2015 ANNEX (POOL/E7/2015/12107/ ANNEX.doc) D042508/03 [ ](2015) XXX ANNEX 1 ANNEX to the COMMISSION REGULATION (EU) /.. amending Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of the Council as regards the use of Steviol glycosides (E 960) as a sweetener in certain energy-reduced or with no added sugars beverages

9 ANNEX Part E of Annex II to Regulation (EC) No 1333/2008 is amended as follows: (1) In food subcategory Other the following entries for E 960 are inserted after the entry for E Sorbitan esters: 'E 960 Steviol glycosides 30 (60) (93) only coffee, tea and herbal infusion beverages, energy-reduced or with no added sugars E 960 Steviol glycosides 30 (60) (93) only flavoured instant coffee and instant cappuccino products, energy-reduced or with no added sugars E 960 Steviol glycosides 20 (60) (93) only malt-based and chocolate/cappuccino flavoured drinks, energy-reduced or with no added sugars' (2) In food subcategory Other, the following footnotes are added: (60): Expressed as steviol equivalents (93): Maximum level applies to the ready-to-drink products (e.g. canned) and their mixes and concentrates after preparation and ready for consumption. 2

10 EUROPEAN COMMISSION Brussels, XXX SANTE/12107/2015 CIS (POOL/E7/2015/12107/ CIS.doc) D042508/03 [ ](2015) XXX draft COMMISSION REGULATION (EU) / of XXX amending Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of the Council as regards the use of Steviol glycosides (E 960) as a sweetener in certain energy-reduced or with no added sugars beverages (Text with EEA relevance)

11 COMMISSION REGULATION (EU) / of XXX amending Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of the Council as regards the use of Steviol glycosides (E 960) as a sweetener in certain energy-reduced or with no added sugars beverages (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 food and their conditions of use. (2) That list 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. (3) On 25 March 2013 an application was submitted for authorisation of the use of steviol glycosides (E 960) as a sweetener in certain energy-reduced or with no added sugars beverages falling under the food subcategory Other of Annex II to Regulation (EC) No 1333/2008. The application was subsequently made available to the Member States pursuant to Article 4 of Regulation (EC) No 1331/2008. (4) Steviol glycosides are non-caloric sweet-tasting constituents and may be used to replace caloric sugars in certain beverages, thus reducing the caloric content of those products. Consequently, steviol glycosides provide sweetness to those beverages without delivering additional calories to the final product, offering consumers energyreduced or with no added sugars products, in accordance with Article 7 of Regulation (EC) No 1333/2008. (5) Pursuant to Article 3(2) of Regulation (EC) No 1331/2008, the Commission is 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. (6) In 2010, the Authority adopted a scientific opinion 3 on the safety of steviol glycosides for the proposed uses as a food additive (E 960) and established an Acceptable Daily Intake (ADI) of 4 mg/kg body weight/day, expressed as steviol equivalents. In view of the proposed extension of uses as a food additive, the Authority revised the exposure 1 OJ L 354, , p 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, , p. 1). 3 EFSA Journal 2010;8(4):

12 assessment of steviol glycosides and expressed its opinions on 2 May and on 30 June As regards those extensions of uses, the Authority concluded that the exposure estimates are below the ADI for all age groups, except for toddlers at the upper range of the high level (95th percentile) estimates, in one country. Exposure calculations carried out by Rijksinstituut voor Volksgezondheid en Milieu showed that the proposed extension of use did not affect the 95th percentile of exposure in young children aged two to six years in the Netherlands and that non-alcoholic beverages and flavoured fermented milk products remained the main contributors to exposure to steviol glycosides in that age group. (7) Considering that food subcategory covers products not intended to be consumed by toddlers (12 to 35 months old) the proposed uses and use levels of steviol glycosides (E 960) as a sweetener are not of a safety concern. (8) Therefore, it is appropriate to authorise the use of steviol glycosides (E 960) as a sweetener added to the energy-reduced or with no added sugars beverages in food subcategory Other : coffee, tea and herbal infusion beverages (at maximum level of 30 mg/l), flavoured instant coffee and instant cappuccino products (at maximum level of 30 mg/l) and malt-based and chocolate/cappuccino flavoured drinks (at maximum level of 20 mg/l). (9) Therefore, Annex II to Regulation (EC) No 1333/2008 should 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, For the Commission The President Jean-Claude JUNCKER 4 EFSA Journal 2014;12(5): EFSA Journal 2015;13(6):

13 EUROPEAN COMMISSION Brussels, XXX SANTE/12074/2015 ANNEX (POOL/E7/12074/ ANNEX.doc) D042509/03 [ ](2015) XXX ANNEX 1 ANNEX to the COMMISSION REGULATION (EU) /.. amending Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of the Council as regards the use of Steviol glycosides (E 960) as a sweetener in mustard

14 ANNEX Part E of Annex II to Regulation (EC) No 1333/2008 is amended as follows: (1) In food subcategory 12.4 Mustard, the following entry is inserted after the entry for E 959: E 960 Steviol glycosides 120 (60) (2) The following footnote is added: (60): Expressed as steviol equivalents. 2

15 EUROPEAN COMMISSION Brussels, XXX SANTE/12074/2015 (POOL/E7/2015/12074/ doc) D042509/03 [ ](2015) XXX COMMISSION REGULATION (EU) / of XXX amending Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of the Council as regards the use of Steviol glycosides (E 960) as a sweetener in mustard (Text with EEA relevance)

16 COMMISSION REGULATION (EU) / of XXX amending Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of the Council as regards the use of Steviol glycosides (E 960) as a sweetener in mustard (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/ of the European Parliament and of the Council of 16 December 2008 on food additives, 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 food and their conditions of use. (2) That list 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. (3) On 23 January 2015 an application was submitted for authorisation of the use of steviol glycosides (E 960) as a sweetener in mustard. The application was subsequently made available to the Member States pursuant to Article 4 of Regulation (EC) No 1331/2008. (4) Steviol glycosides are non-caloric sweet-tasting constituents which may be used to replace sucrose in the production of mustard thus allowing for an extension of its shelf life and its microbiological stability (decreasing the content of sugar prevents the process of fermentation for which sugar is a substrate) whilst retaining the demanded organoleptic properties of the product. Permitting steviol glycosides in mustard will make it possible to widen the assortment of this product by means of a product containing a sweetener different than those applied hitherto and having slightly other flavour properties. (5) The European Food Safety Authority ( the Authority ) evaluated the safety of steviol glycosides, extracted from the leaves of the Stevia rebaudiana Bertoni plant, as a sweetener and expressed its opinion on 14 April The Authority established an Acceptable Daily Intake (ADI) for steviol glycosides, expressed as steviol equivalents, of 4 mg/kg body weight/day. (6) Authorising this sweetener in mustard at 120 mg/kg (as steviol equivalents) would lead to an increase in the intake of E960 within the following limits: between 0 up to 1 OJ L 354, , p 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, , p. 1). 3 EFSA Journal 2010;8(4):

17 0.133% of the ADI in the case of mean consumption and between 0 up to 1.143% of the ADI in the case of high level consumption. This is considered to be an additional negligible exposure of the consumer and therefore is not of safety concern. (7) Pursuant to Article 3(2) of Regulation (EC) No 1331/2008, the Commission is to seek the opinion of 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 that update is not liable to have an effect on human health. Since the authorisation of use of steviol glycosides (E 960) as a sweetener in mustard constitutes an update of that list which is not liable to have an effect on human health, it is not necessary to seek the opinion of the Authority. (8) Therefore, it is appropriate to authorise the use of steviol glycosides (E 960) as a sweetener added to mustard (food subcategory 12.4) at maximum level of 120 mg/kg. (9) Therefore, Annex II to Regulation (EC) No 1333/2008 should 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, For the Commission The President Jean-Claude JUNCKER 3

18 L 13/46 Official Journal of the European Union COMMISSION REGULATION (EU) 2016/56 of 19 January 2016 amending Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of the Council as regards the use of extracts of rosemary (E 392) in spreadable fats (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 food and their conditions of use. (2) That list 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. (3) On 18 April 2013 an application was submitted for the authorisation of the use of extracts of rosemary (E 392) as an antioxidant in spreadable fats, i.e. in foods falling under the food category of Annex II to Regulation (EC) No 1333/2008. The application was subsequently made available to the Member States pursuant to Article 4 of Regulation (EC) No 1331/2008. (4) According to the application the use of extracts of rosemary (E 392) is required to keep the quality and stability of spreadable fats with a fat content less than 80 % where content of polyunsaturated fatty acids is higher than 15 % w/w of the total fatty acid and/or where content of fish oil or algal oil is higher than 2 % w/w of the total fatty acid by protecting them against deterioration caused by oxidation. (5) On 7 March 2008 the European Food Safety Authority ( the Authority ) adopted an opinion ( 3 ) on the use of rosemary extracts as a food additive. Based on the margins of safety identified using the NOAELs ( 4 ) from the different studies, in which generally the NOAELs were the highest dose levels tested, and using the conservative dietary exposure estimates it was concluded that the use of the rosemary extracts described in that scientific opinion at the proposed uses and use levels would not be of safety concern. The use of extracts of rosemary (E 392) in spreadable fats was not included in the opinion. (6) On 7 May 2015 the Authority issued an opinion ( 5 ) on the extension of use of extracts of rosemary (E 392) in spreadable fats. The assessment took into account the consumption of fat emulsions with a fat content less than 80 %. The Authority concluded that the proposed extension of use would not change the estimated exposure to the food additive, compared with the already approved permitted uses, and that the conclusions of the opinion of 7 March 2008 remain valid. (7) For that reason, it is appropriate to authorise the use of extracts of rosemary (E 392) as an antioxidant in spreadable fats with a fat content less than 80 %, food category of Annex II to Regulation (EC) No 1333/2008. (8) Therefore, Annex II to Regulation (EC) No 1333/2008 should be amended accordingly. ( 1 ) OJ L 354, , p. 16. ( 2 ) 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, , p. 1). ( 3 ) EFSA Journal (2008) 721, ( 4 ) NOAEL (no observed adverse effect level) dose or concentration of a substance tested at which no adverse effect is found. ( 5 ) EFSA Journal 2015;13(5):4090.

19 L 13/47 Official Journal of the European Union (9) 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, 19 January For the Commission The President Jean-Claude JUNCKER

20 ANNEX Part E of Annex II to Regulation (EC) No 1333/2008, food category Other fat and oil emulsions including spreads as defined by Council Regulation (EC) No 1234/2007 and liquid emulsions is amended as follows: (a) the following entry is inserted after the entry for food additive E 385: E 392 Extracts of rosemary 100 (41) (46) only spreadable fats with a fat content less than 80 % (b) the following footnotes are added after footnote (4): (41): Expressed on fat basis (46): As the sum of carnosol and carnosic acid L 13/48 Official Journal of the European Union

21 Official Journal of the European Union L 50/25 COMMISSION REGULATION (EU) 2016/263 of 25 February 2016 amending Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of the Council as regards the title of the food category 12.3 Vinegars (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), 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) That list 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. (3) 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 the food additives on the basis of the categories of food to which they may be added to. (4) In Part D of the Union list, food category 12 covers salts, spices, soups, sauces, salads and protein products and includes subcategory 12.3 vinegars. Part E of the Union list sets out the following authorised additives for food category 12.3: Group I additives, caramels (E 150a-d) and sulphur dioxide sulphites (E ) only in fermentation vinegar. (5) Acetic acid (also used as a food additive E 260) when diluted with water (4-30 % by volume) could be used as a food or food ingredient in the same manner as vinegars from agricultural origin. (6) In some Member States only vinegars obtained from the fermentation of agricultural products are allowed to be named vinegars. In other Member States, however, both products obtained from the dilution with water of acetic acid and vinegars obtained from the fermentation of agricultural products are marketed under the name vinegar. (7) It followed from the discussions with Member States at the Working Party of Governmental Experts on Additives that there is an equivalent technological need for food additives for diluted acetic acid and for vinegars from agricultural origin. Therefore, it is appropriate to revise the title of food category 12.3 Vinegars to specify that it includes diluted acetic acid (diluted with water to 4-30 % by volume) fit for human consumption in order to ensure that there is transparency and legal certainty regarding the use of food additives in that food. (8) The Comprehensive European Food Consumption Database ( 6 ) of the European Food Safety Authority ( the Authority ) provides information on food consumption across the European Union. The statistics include the data on food consumption of vinegars from agricultural origin that is taken into account when the Authority ( 1 ) OJ L 354, , p. 16. ( 2 ) 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, , p. 1). ( 3 ) European Parliament and Council Directive 94/35/EC of 30 June 1994 on sweeteners for use in foodstuffs (OJ L 237, , p. 3). ( 4 ) European Parliament and Council Directive 94/36/EC of 30 June 1994 on colours for use in foodstuffs (OJ L 237, , 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, , p. 1). ( 6 )

22 L 50/26 Official Journal of the European Union performs the exposure assessment. As diluted acetic acid is used in the same manner as vinegars from agricultural origin it is not expected that the proposed amendment as regards the title of the food category 12.3 would have an impact on the exposure to additives authorised for use in that food category. (9) Pursuant to Article 3(2) of Regulation (EC) No 1331/2008, the Commission has to seek the opinion of 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 inclusion of diluted acetic acid in food category 12.3 in Parts D and E of the Union list of food additives constitutes an update of that list which is not liable to have an effect on human health, it is not necessary to seek the opinion of the Authority. (10) Annex II to Regulation (EC) No 1333/2008 should therefore be amended accordingly. (11) 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, 25 February For the Commission The President Jean-Claude JUNCKER ANNEX In Parts D and E of Annex II to Regulation (EC) No 1333/2008, the entry for food category 12.3 is replaced by the following: 12.3 Vinegars and diluted acetic acid (diluted with water to 4-30 % by volume)