# L_2020182EN.01000801.xml

| 10.6.2020 | EN | Official Journal of the European Union | L 182/8 |
| --- | --- | --- | --- |

10.6.2020

EN

Official Journal of the European Union

L 182/8

---

COMMISSION REGULATION (EU) 2020/763

of 9 June 2020

amending the Annex to Regulation (EU) No 231/2012 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 as regards specifications for tricalcium phosphate (E 341 (iii))

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

(1)

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

| (2) | Those specifications 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. |
| --- | --- |

(2)

Those specifications 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) | On 28 September 2018, an application was submitted for the amendment of specifications concerning the food additive tricalcium phosphate (E 341(iii)). The application was made available to the Member States pursuant to Article 4 of Regulation (EC) No 1331/2008. |
| --- | --- |

(3)

On 28 September 2018, an application was submitted for the amendment of specifications concerning the food additive tricalcium phosphate (E 341(iii)). The application was made available to the Member States pursuant to Article 4 of Regulation (EC) No 1331/2008.

| (4) | The current Union specifications lay down that tricalcium phosphate (E 341(iii)) is obtained from neutralisation of phosphoric acid with calcium hydroxide. The applicant requests that neutralisation with calcium carbonate is included as an alternative. |
| --- | --- |

(4)

The current Union specifications lay down that tricalcium phosphate (E 341(iii)) is obtained from neutralisation of phosphoric acid with calcium hydroxide. The applicant requests that neutralisation with calcium carbonate is included as an alternative.

| (5) | According to the applicant, calcium hydroxide is produced via calcination of calcium carbonate, which could be avoided if calcium carbonate was used directly as a starting material. The applicant claims that the main advantage of using calcium carbonate directly is the reduction of production energy needed, resulting in a more sustainable production process. According to the applicant, both production processes lead to the same final product, tricalcium phosphate (E 341(iii)), i.e. containing no other impurities than those specified in Regulation (EU) No 231/2012. |
| --- | --- |

(5)

According to the applicant, calcium hydroxide is produced via calcination of calcium carbonate, which could be avoided if calcium carbonate was used directly as a starting material. The applicant claims that the main advantage of using calcium carbonate directly is the reduction of production energy needed, resulting in a more sustainable production process. According to the applicant, both production processes lead to the same final product, tricalcium phosphate (E 341(iii)), i.e. containing no other impurities than those specified in Regulation (EU) No 231/2012.

| (6) | The application was discussed by the Working Party of Governmental Experts on Additives. Taking into account the information provided by the applicant and the feedback received from that Working Party the Commission considered that the proposed amendment of the specifications for tricalcium phosphate (E 341(iii)) is not liable to have an effect on human health. |
| --- | --- |

(6)

The application was discussed by the Working Party of Governmental Experts on Additives. Taking into account the information provided by the applicant and the feedback received from that Working Party the Commission considered that the proposed amendment of the specifications for tricalcium phosphate (E 341(iii)) is not liable to have an effect on human health.

| (7) | Since the use of calcium carbonate as an alternative to calcium hydroxide in the production process of tricalcium phosphate (E 341(iii)) constitutes an update of the Union list, which is not liable to have an effect on human health, it is not necessary to seek the opinion of the European Food Safely Authority in accordance with Article 3(2) of Regulation (EC) No 1331/2008 and the specifications should be amended. |
| --- | --- |

(7)

Since the use of calcium carbonate as an alternative to calcium hydroxide in the production process of tricalcium phosphate (E 341(iii)) constitutes an update of the Union list, which is not liable to have an effect on human health, it is not necessary to seek the opinion of the European Food Safely Authority in accordance with Article 3(2) of Regulation (EC) No 1331/2008 and the specifications should be amended.

| (8) | The Annex to Regulation (EU) No 231/2012 should therefore be amended accordingly. |
| --- | --- |

(8)

The Annex to Regulation (EU) No 231/2012 should therefore be amended 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, |
| --- | --- |

(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

The Annex to Regulation (EU) No 231/2012 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, 9 June 2020.

For the Commission

The President

Ursula VON DER LEYEN

---

(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

---

ANNEX

In the Annex to Regulation (EU) No 231/2012, in the entry for ‘E 341 (iii) tricalcium phosphate’ the definition is replaced by the following:

| ‘Definition | Tricalcium phosphate consists of a variable mixture of calcium phosphates obtained from neutralisation of phosphoric acid with calcium hydroxide or calcium carbonate and having the approximate composition of 10CaΟ·3P2O5·Η2O’ |
| --- | --- |

‘Definition

Tricalcium phosphate consists of a variable mixture of calcium phosphates obtained from neutralisation of phosphoric acid with calcium hydroxide or calcium carbonate and having the approximate composition of 10CaΟ·3P2O5·Η2O’

---