# L_2022023EN.01002201.xml

| 2.2.2022 | EN | Official Journal of the European Union | L 23/22 |
| --- | --- | --- | --- |

2.2.2022

EN

Official Journal of the European Union

L 23/22

---

COMMISSION REGULATION (EU) 2022/141

of 21 January 2022

amending Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of the Council as regards the use of sodium carbonates (E 500) and potassium carbonates (E 501) in unprocessed cephalopods

(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. |
| --- | --- |

(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 by a Member State or by an interested party. |
| --- | --- |

(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 by a Member State or by an interested party.

| (3) | Pursuant to Annex II to Regulation (EC) No 1333/2008, sodium carbonates (E 500) and potassium carbonates (E 501) are authorised for use as food additives in a wide variety of foods at quantum satis levels. Among others, they are authorised for use in food category 9.2. ‘Processed fish and fishery products including molluscs and crustaceans’. |
| --- | --- |

(3)

Pursuant to Annex II to Regulation (EC) No 1333/2008, sodium carbonates (E 500) and potassium carbonates (E 501) are authorised for use as food additives in a wide variety of foods at quantum satis levels. Among others, they are authorised for use in food category 9.2. ‘Processed fish and fishery products including molluscs and crustaceans’.

| (4) | On 9 September 2020, the Commission received an application for the authorisation of the use of sodium carbonates (E 500) and potassium carbonates (E 501) in unprocessed cephalopods. |
| --- | --- |

(4)

On 9 September 2020, the Commission received an application for the authorisation of the use of sodium carbonates (E 500) and potassium carbonates (E 501) in unprocessed cephalopods.

| (5) | Carbonates have similar effect as phosphoric acid — phosphates — di-, tri- and polyphosphates (E 338-452), currently authorized in frozen and deep-frozen molluscs and crustaceans, as regard the appearance of cephalopods. The manufacturing process for cephalopods involves an immersion treatment in baths containing a dissolution of salt, citrates and carbonates at a maximum concentration of 3 % to regulate the acidity of the bath for 2-3 days. The result being hydration, a change in the consistency and texture of the product as well as keeping the colour. After steaming, cephalopods treated with carbonates and citrates have better organoleptic properties such as softer flesh, better taste and lighter colour than cephalopods treated only with citrates. It results from the sensorial evaluation performed by the applicant that the proposed use of sodium carbonates (E 500) and potassium carbonates (E 501) as acidity regulators in alternative to phosphates, improves the organoleptic properties of cephalopods and consumer’s perception of it. |
| --- | --- |

(5)

Carbonates have similar effect as phosphoric acid — phosphates — di-, tri- and polyphosphates (E 338-452), currently authorized in frozen and deep-frozen molluscs and crustaceans, as regard the appearance of cephalopods. The manufacturing process for cephalopods involves an immersion treatment in baths containing a dissolution of salt, citrates and carbonates at a maximum concentration of 3 % to regulate the acidity of the bath for 2-3 days. The result being hydration, a change in the consistency and texture of the product as well as keeping the colour. After steaming, cephalopods treated with carbonates and citrates have better organoleptic properties such as softer flesh, better taste and lighter colour than cephalopods treated only with citrates. It results from the sensorial evaluation performed by the applicant that the proposed use of sodium carbonates (E 500) and potassium carbonates (E 501) as acidity regulators in alternative to phosphates, improves the organoleptic properties of cephalopods and consumer’s perception of it.

| (6) | 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. |
| --- | --- |

(6)

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.

| (7) | The safety of sodium carbonate (E 500) and potassium carbonate (E 501) was evaluated in 1990 by the Scientific Committee for Food, which established its Acceptable daily intake (ADI) as ‘not specified’ (3). The term ‘not specified’ means that, on the basis of the available toxicological, biochemical and clinical data, the total daily intake of the substance, arising from its natural occurrence and its present use or uses in food at the levels necessary to achieve the desired technological effect, does not present a hazard to health. In view of that and in the absence of specific priorities for the re-evaluation of sodium carbonates (E 500) and potassium carbonates (E 501) under the programme for the re-evaluation of food additives laid down in Commission Regulation (EU) No 257/2010 (4), the Commission considers that the authorisation of use of sodium carbonates (E 500) and potassium carbonates (E 501) as acidity regulators on unprocessed cephalopods constitutes an update of that list which is not liable to have an effect on human health and therefore it is not necessary to seek the opinion of the Authority. |
| --- | --- |

(7)

The safety of sodium carbonate (E 500) and potassium carbonate (E 501) was evaluated in 1990 by the Scientific Committee for Food, which established its Acceptable daily intake (ADI) as ‘not specified’ (3). The term ‘not specified’ means that, on the basis of the available toxicological, biochemical and clinical data, the total daily intake of the substance, arising from its natural occurrence and its present use or uses in food at the levels necessary to achieve the desired technological effect, does not present a hazard to health. In view of that and in the absence of specific priorities for the re-evaluation of sodium carbonates (E 500) and potassium carbonates (E 501) under the programme for the re-evaluation of food additives laid down in Commission Regulation (EU) No 257/2010 (4), the Commission considers that the authorisation of use of sodium carbonates (E 500) and potassium carbonates (E 501) as acidity regulators on unprocessed cephalopods constitutes an update of that list which is not liable to have an effect on human health and therefore it is not necessary to seek the opinion of the Authority.

| (8) | Thus, it is appropriate to authorise the use of sodium carbonates (E 500) and potassium carbonates (E 501) as acidity regulators in the food category ‘09.1.2 ‘Unprocessed molluscs and crustaceans’’ in Annex II to Regulation (EC) No 1333/2008 at quantum satis for cephalopods. For the reasons of the restriction of use of phosphates to frozen and deep-frozen molluscs and crustaceans, the use of sodium carbonates (E 500) and potassium carbonates (E 501) in alternative to phosphates in unprocessed cephalopods should be restricted to frozen and deep-frozen cephalopods not treated with phosphoric acid — phosphates — di-, tri- and polyphosphates (E 338-452). |
| --- | --- |

(8)

Thus, it is appropriate to authorise the use of sodium carbonates (E 500) and potassium carbonates (E 501) as acidity regulators in the food category ‘09.1.2 ‘Unprocessed molluscs and crustaceans’’ in Annex II to Regulation (EC) No 1333/2008 at quantum satis for cephalopods. For the reasons of the restriction of use of phosphates to frozen and deep-frozen molluscs and crustaceans, the use of sodium carbonates (E 500) and potassium carbonates (E 501) in alternative to phosphates in unprocessed cephalopods should be restricted to frozen and deep-frozen cephalopods not treated with phosphoric acid — phosphates — di-, tri- and polyphosphates (E 338-452).

| (9) | Annex II to Regulation (EC) No 1333/2008 should therefore be amended accordingly. |
| --- | --- |

(9)

Annex II to Regulation (EC) No 1333/2008 should therefore be amended accordingly.

| (10) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
| --- | --- |

(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, 21 January 2022.

For the Commission

The President

Ursula VON DER LEYEN

---

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

1

(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, 31.12.2008, p. 1).

2

(3)  Reports of the Scientific Committee for Food, Twenty-fifth series, 1991, p. 13 (https://ec.europa.eu/food/system/files/2020-12/sci-com_scf_reports_25.pdf).

3

(4)  Commission Regulation (EU) No 257/2010 of 25 March 2010 setting up a programme 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

---

ANNEX

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

| (i) | in food category 09.1.2 ‘Unprocessed molluscs and crustaceans’ the following entries are inserted after the entry for E 385, Calcium disodium ethylene diamine tetra-acetate (Calcium disodium EDTA):









  ‘E 500 | Sodium carbonates | quantum satis | (95) | only frozen and deep-frozen cephalopods |
| --- | --- | --- | --- | --- | --- |
| E 501 | Potassium carbonates | quantum satis | (95) | only frozen and deep-frozen cephalopods’ |

(i)

in food category 09.1.2 ‘Unprocessed molluscs and crustaceans’ the following entries are inserted after the entry for E 385, Calcium disodium ethylene diamine tetra-acetate (Calcium disodium EDTA):

‘E 500

Sodium carbonates

quantum satis

(95)

only frozen and deep-frozen cephalopods

E 501

Potassium carbonates

quantum satis

(95)

only frozen and deep-frozen cephalopods’

| (ii) | the following footnote (95) is added after footnote (90):






  ‘(95): | may not be used in combination with Phosphoric acid — phosphates — di-, tri- and polyphosphates (E 338-452)’ |
| --- | --- | --- |

(ii)

the following footnote (95) is added after footnote (90):

‘(95):

may not be used in combination with Phosphoric acid — phosphates — di-, tri- and polyphosphates (E 338-452)’

---