# L_2023241EN.01007301.xml

| 29.9.2023 | EN | Official Journal of the European Union | L 241/73 |
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29.9.2023

EN

Official Journal of the European Union

L 241/73

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COMMISSION REGULATION (EU) 2023/2086

of 28 September 2023

amending Annex II 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 the use of buffered vinegar as a preservative and acidity regulator

(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 Articles 10(3) and 14 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. |
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(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) | Commission Regulation (EU) No 231/2012 (3) lays down specifications for food additives that are listed in Annexes II and III to Regulation (EC) No 1333/2008. |
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(2)

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

| (3) | Pursuant to Article 3(1) of Regulation (EC) No 1331/2008, the Union list of food additives and specifications for food additives may be updated either on the initiative of the Commission or following an application from a Member State or an interested party. |
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(3)

Pursuant to Article 3(1) of Regulation (EC) No 1331/2008, the Union list of food additives and specifications for food additives may be updated either on the initiative of the Commission or following an application from a Member State or an interested party.

| (4) | In March 2021, an application was submitted to the Commission for the authorisation of use of buffered vinegar as a preservative and acidity regulator in a broad variety of food categories. The application was subsequently made available to the Member States pursuant to Article 4 of Regulation (EC) No 1331/2008. |
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(4)

In March 2021, an application was submitted to the Commission for the authorisation of use of buffered vinegar as a preservative and acidity regulator in a broad variety of food categories. The application was subsequently made available to the Member States pursuant to Article 4 of Regulation (EC) No 1331/2008.

| (5) | In the opinion published on 1 July 2022 (4), the European Food Safety Authority (‘the Authority’) evaluated the safety of the proposed use of buffered vinegar as a food additive. As acetic acid and its salts are the primary constituents of buffered vinegar, the Authority referred to its previous assessment of acetic acid as a pesticide active substance in 2013 (5) in which it concluded that the establishment of an acceptable daily intake (ADI) for acetic acid is not considered necessary. Such conclusion is reached for substances of a very low safety concern and only if there is reliable information for both exposure and toxicity and there is a low probability of adverse health effects in humans at doses that do not induce nutritional imbalance in animals (6). Taking into account the assessment of acetic acid in 2013 and that buffered vinegar dissociates into the acetic anion, a natural constituent of the human diet and of the human body for which extensive data on its biological effects exist, the Authority assessed the safety of buffered vinegar without biological or toxicological data obtained with this food additive and concluded that that there is no safety concern for the use of buffered vinegar as a food additive at the proposed maximum use levels. |
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(5)

In the opinion published on 1 July 2022 (4), the European Food Safety Authority (‘the Authority’) evaluated the safety of the proposed use of buffered vinegar as a food additive. As acetic acid and its salts are the primary constituents of buffered vinegar, the Authority referred to its previous assessment of acetic acid as a pesticide active substance in 2013 (5) in which it concluded that the establishment of an acceptable daily intake (ADI) for acetic acid is not considered necessary. Such conclusion is reached for substances of a very low safety concern and only if there is reliable information for both exposure and toxicity and there is a low probability of adverse health effects in humans at doses that do not induce nutritional imbalance in animals (6). Taking into account the assessment of acetic acid in 2013 and that buffered vinegar dissociates into the acetic anion, a natural constituent of the human diet and of the human body for which extensive data on its biological effects exist, the Authority assessed the safety of buffered vinegar without biological or toxicological data obtained with this food additive and concluded that that there is no safety concern for the use of buffered vinegar as a food additive at the proposed maximum use levels.

| (6) | Part C of Annex II to Regulation (EC) No 1333/2008 defines all groups of additives. Group I of Part C lists food additives, except for colours and sweeteners, for which there is no need for a numerical acceptable daily intake and which are authorised for use in many foods in accordance with the quantum satis principle as defined in Article 3(2), point (h) of that Regulation. The outcome of the safety assessment of buffered vinegar allows its inclusion in Part C, Group I, of Annex II to Regulation (EC) No 1333/2008. |
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(6)

Part C of Annex II to Regulation (EC) No 1333/2008 defines all groups of additives. Group I of Part C lists food additives, except for colours and sweeteners, for which there is no need for a numerical acceptable daily intake and which are authorised for use in many foods in accordance with the quantum satis principle as defined in Article 3(2), point (h) of that Regulation. The outcome of the safety assessment of buffered vinegar allows its inclusion in Part C, Group I, of Annex II to Regulation (EC) No 1333/2008.

| (7) | Buffered vinegar is a liquid or dried product prepared by adding sodium/potassium hydroxides (E 524-525) and sodium/potassium carbonates (E 500-501) to vinegar, which is compliant with European Standard EN 13188:2000 and is exclusively obtained from an agricultural source origin (except wood/cellulose) by a double (alcoholic and acetous) fermentation. Buffered vinegar is intended for use as an alternative to other authorised preservatives or acidity regulators, in particular to acetic acid and its salts (E 260-263). Buffering increases pH and allows the use as a preservative or acidity regulator in many food categories without impacting the quality of foods. |
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(7)

Buffered vinegar is a liquid or dried product prepared by adding sodium/potassium hydroxides (E 524-525) and sodium/potassium carbonates (E 500-501) to vinegar, which is compliant with European Standard EN 13188:2000 and is exclusively obtained from an agricultural source origin (except wood/cellulose) by a double (alcoholic and acetous) fermentation. Buffered vinegar is intended for use as an alternative to other authorised preservatives or acidity regulators, in particular to acetic acid and its salts (E 260-263). Buffering increases pH and allows the use as a preservative or acidity regulator in many food categories without impacting the quality of foods.

| (8) | It is therefore appropriate to authorise the use of buffered vinegar as a food additive and to assign E 267 as the E-number to that additive. |
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(8)

It is therefore appropriate to authorise the use of buffered vinegar as a food additive and to assign E 267 as the E-number to that additive.

| (9) | The specifications for buffered vinegar (E 267) should be included in the Annex to Regulation (EU) No 231/2012 as this additive is included in the Union list of food additives laid down in Annex II to Regulation (EC) No 1333/2008 for the first time. |
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(9)

The specifications for buffered vinegar (E 267) should be included in the Annex to Regulation (EU) No 231/2012 as this additive is included in the Union list of food additives laid down in Annex II to Regulation (EC) No 1333/2008 for the first time.

| (10) | Regulations (EC) No 1333/2008 and (EU) No 231/2012 should therefore be amended accordingly. |
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(10)

Regulations (EC) No 1333/2008 and (EU) No 231/2012 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, |
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(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 Annex I to this Regulation.

Article 2

The Annex to Regulation (EU) No 231/2012 is amended in accordance with Annex II to this Regulation.

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, 28 September 2023.

For the Commission

The President

Ursula VON DER LEYEN

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(1)  
  OJ L 354, 31.12.2008, p. 16.

1

(2)  
  OJ L 354, 31.12.2008, p. 1.

2

(3)  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

(4)  
  EFSA Journal 2022;20(7):7351.

4

EFSA Journal

(5)  
  EFSA Journal 2013;11(1):3060.

5

EFSA Journal

(6)  
  EFSA Journal 2014;12(6):3697; Statement on a conceptual framework for the risk assessment of certain food additives re-evaluated under Commission Regulation (EU) No 257/2010.

6

EFSA Journal

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ANNEX I

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

| (a) | in Part B, point 3 ‘Additives other than colours and sweeteners’, the following new entry is inserted after the entry for food additive E 263, Calcium acetate:






  ‘E 267 | Buffered vinegar’ |
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(a)

in Part B, point 3 ‘Additives other than colours and sweeteners’, the following new entry is inserted after the entry for food additive E 263, Calcium acetate:

‘E 267

Buffered vinegar’

| (b) | in Part C, Group I, the entry for E 267 is inserted after the entry for E 263, Calcium acetate:







  ‘E 267 | Buffered vinegar | quantum satis’ |
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(b)

in Part C, Group I, the entry for E 267 is inserted after the entry for E 263, Calcium acetate:

‘E 267

Buffered vinegar

quantum satis’

| (c) | Part E is amended as follows:






  (1) | in category 01.7.1 (Unripened cheese excluding products falling in category 16), the entry for E 267 (Buffered vinegar) is inserted after the entry for E 260, Acetic acid: | ‘E 267 | Buffered vinegar | quantum satis | | only mozzarella’ |
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(c)

Part E is amended as follows:

(1)

in category 01.7.1 (Unripened cheese excluding products falling in category 16), the entry for E 267 (Buffered vinegar) is inserted after the entry for E 260, Acetic acid:

‘E 267

Buffered vinegar

quantum satis

only mozzarella’

| (2) | in category 01.7.4 (Whey cheese), the entry for E 267 (Buffered vinegar) is inserted after the entry for E 260, Acetic acid: | ‘E 267 | Buffered vinegar | quantum satis’ | | |
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(2)

in category 01.7.4 (Whey cheese), the entry for E 267 (Buffered vinegar) is inserted after the entry for E 260, Acetic acid:

‘E 267

Buffered vinegar

quantum satis’

| (3) | in category 04.2.3 (Canned or bottled fruit and vegetables), the entry for E 267 (Buffered vinegar) is inserted after the entry for E 263, Calcium acetate: | ‘E 267 | Buffered vinegar | quantum satis’ | | |
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(3)

in category 04.2.3 (Canned or bottled fruit and vegetables), the entry for E 267 (Buffered vinegar) is inserted after the entry for E 263, Calcium acetate:

‘E 267

Buffered vinegar

quantum satis’

| (4) | in category 06.4.1 (Fresh pasta), the entry for E 267 (Buffered vinegar) is inserted before the entry for E 270, Lactic acid: | ‘E 267 | Buffered vinegar | quantum satis’ | | |
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(4)

in category 06.4.1 (Fresh pasta), the entry for E 267 (Buffered vinegar) is inserted before the entry for E 270, Lactic acid:

‘E 267

Buffered vinegar

quantum satis’

| (5) | in category 06.4.3 (Fresh pre-cooked pasta), the entry for E 267 (Buffered vinegar) is inserted before the entry for E 270, Lactic acid: | ‘E 267 | Buffered vinegar | quantum satis’ | | |
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(5)

in category 06.4.3 (Fresh pre-cooked pasta), the entry for E 267 (Buffered vinegar) is inserted before the entry for E 270, Lactic acid:

‘E 267

Buffered vinegar

quantum satis’

| (6) | in category 06.4.4 (Potato Gnocchi), the entry for E 267 (Buffered vinegar) is inserted after the entry for E 200-202, Sorbic acid-potassium acid: | ‘E 267 | Buffered vinegar | quantum satis | | only fresh refrigerated potato gnocchi’ |
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(6)

in category 06.4.4 (Potato Gnocchi), the entry for E 267 (Buffered vinegar) is inserted after the entry for E 200-202, Sorbic acid-potassium acid:

‘E 267

Buffered vinegar

quantum satis

only fresh refrigerated potato gnocchi’

| (7) | in category 07.1.1 (Bread prepared solely with the following ingredients: wheat flour, water, yeast or leaven, salt), the entry for E 267 (Buffered vinegar) is inserted after the entry for E 263, Calcium acetate: | ‘E 267 | Buffered vinegar | quantum satis’ | | | |
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(7)

in category 07.1.1 (Bread prepared solely with the following ingredients: wheat flour, water, yeast or leaven, salt), the entry for E 267 (Buffered vinegar) is inserted after the entry for E 263, Calcium acetate:

‘E 267

Buffered vinegar

quantum satis’

| (8) | in category 07.1.2 (Pain courant français; Friss búzakenyér, fehér és félbarna kenyerek), the entry for E 267 (Buffered vinegar) is inserted after the entry for E 263, Calcium acetate: | ‘E 267 | Buffered vinegar | quantum satis’ | | |
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(8)

in category 07.1.2 (Pain courant français; Friss búzakenyér, fehér és félbarna kenyerek), the entry for E 267 (Buffered vinegar) is inserted after the entry for E 263, Calcium acetate:

‘E 267

Buffered vinegar

quantum satis’

| (9) | in category 08.2 (Meat preparations as defined by Regulation (EC) No 853/2004), the entry for E 267 (Buffered vinegar) is inserted after the entry for E 263, Calcium acetate: | ‘E 267 | Buffered vinegar | quantum satis | | only prepacked preparations of fresh minced meat and meat preparations to which other ingredients than additives or salt have been added’ |
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(9)

in category 08.2 (Meat preparations as defined by Regulation (EC) No 853/2004), the entry for E 267 (Buffered vinegar) is inserted after the entry for E 263, Calcium acetate:

‘E 267

Buffered vinegar

quantum satis

only prepacked preparations of fresh minced meat and meat preparations to which other ingredients than additives or salt have been added’

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ANNEX II

In the Annex to Regulation (EU) No 231/2012, the following new entry is inserted after the entry for food additive E 263 CALCIUM ACETATE:

| ‘E 267 BUFFERED VINEGAR |
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| Synonyms | Buffered vinegar (liquid); buffered vinegar (powder) |
| Definition | Buffered vinegar is a liquid or dried product prepared by adding buffering agents to vinegar. The buffering agents used are sodium/potassium hydroxides (E 524 to E 525) and sodium/potassium carbonates (E 500 to E 501). The vinegar is compliant with the European Standard EN 13188:2000 and is exclusively obtained from an agricultural source origin (except wood/cellulose) by double fermentation, alcoholic and acetous. The primary constituents of buffered vinegar are acetic acid and its salts. |
| Assay | Liquid: 15–40 % (w/w) acetic acid equivalents |
| Powder: 55–75 % (w/w) acetic acid equivalents |
| 2 to 20 % (w/w) free acetic acid |
| Description | Liquid: colourless to brown viscous liquid |
| Powder: white to creamy-white crystalline powder |
| Identification | Liquid: pH 4,75–7,5 |
| Powder: pH 4,75–6,75 (10 % aqueous solution) |
| Purity |
| Cations | Liquid: Not more than 10 % sodium and 30 % potassium |
| Powder: Not more than 30 % sodium and 40 % potassium |
| Water content | Powder: Not more than 18 % (Karl Fischer Method) |
| Ethanol | Not more than 0,5 % w/w |
| Arsenic | Not more than 0,05 mg/kg |
| Lead | Not more than 0,05 mg/kg |
| Cadmium | Not more than 0,05 mg/kg |
| Mercury | Not more than 0,05 mg/kg’ |

‘E 267 BUFFERED VINEGAR

Synonyms

Buffered vinegar (liquid); buffered vinegar (powder)

Definition

Buffered vinegar is a liquid or dried product prepared by adding buffering agents to vinegar. The buffering agents used are sodium/potassium hydroxides (E 524 to E 525) and sodium/potassium carbonates (E 500 to E 501). The vinegar is compliant with the European Standard EN 13188:2000 and is exclusively obtained from an agricultural source origin (except wood/cellulose) by double fermentation, alcoholic and acetous. The primary constituents of buffered vinegar are acetic acid and its salts.

Assay

Liquid: 15–40 % (w/w) acetic acid equivalents

Powder: 55–75 % (w/w) acetic acid equivalents

2 to 20 % (w/w) free acetic acid

Description

Liquid: colourless to brown viscous liquid

Powder: white to creamy-white crystalline powder

Identification

Liquid: pH 4,75–7,5

Powder: pH 4,75–6,75 (10 % aqueous solution)

Purity

Cations

Liquid: Not more than 10 % sodium and 30 % potassium

Powder: Not more than 30 % sodium and 40 % potassium

Water content

Powder: Not more than 18 % (Karl Fischer Method)

Ethanol

Not more than 0,5 % w/w

Arsenic

Not more than 0,05 mg/kg

Lead

Not more than 0,05 mg/kg

Cadmium

Not more than 0,05 mg/kg

Mercury

Not more than 0,05 mg/kg’

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