# L_2015253EN.01000301.xml

| 30.9.2015 | EN | Official Journal of the European Union | L 253/3 |
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30.9.2015

EN

Official Journal of the European Union

L 253/3

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COMMISSION REGULATION (EU) 2015/1739

of 28 September 2015

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 the iron tartrate as an anti-caking agent in salt and its substitutes

(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 food 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 food and their conditions of use.

| (2) | 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. |
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(2)

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.

| (3) | 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. |
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(3)

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.

| (4) | On 18 January 2012, an application was submitted for the authorisation of the use of iron tartrate as an anti-caking agent in salt and its substitutes. The application was made available to the Member States pursuant to Article 4 of Regulation (EC) No 1331/2008. |
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(4)

On 18 January 2012, an application was submitted for the authorisation of the use of iron tartrate as an anti-caking agent in salt and its substitutes. The application was made available to the Member States pursuant to Article 4 of Regulation (EC) No 1331/2008.

| (5) | The European Food Safety Authority evaluated the safety of iron tartrate, which is a complexation product of sodium tartrate and iron (III) chloride, as a food additive and in its opinion (4) of 9 December 2014 concluded that, taking into account toxicological data and the conservative assumptions included in the exposure assessment, there is no safety concern for its use as an anti-caking agent in salt and its substitutes at the level of use proposed. |
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(5)

The European Food Safety Authority evaluated the safety of iron tartrate, which is a complexation product of sodium tartrate and iron (III) chloride, as a food additive and in its opinion (4) of 9 December 2014 concluded that, taking into account toxicological data and the conservative assumptions included in the exposure assessment, there is no safety concern for its use as an anti-caking agent in salt and its substitutes at the level of use proposed.

| (6) | Addition of an anti-caking agent to salt and its substitutes is considered necessary in order to improve flow properties and to avoid the formation of hardened agglomerates when exposed to moisture and during storage. The use of iron tartrate can serve as an alternative to other currently authorised additives, such as ferrocyanides (E 535-538) and silicon dioxide silicates (E 551-553). It is therefore appropriate to authorise the use of iron tartrate as an anti-caking agent in salt and its substitutes and to assign E 534 as E-number to that additive. |
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(6)

Addition of an anti-caking agent to salt and its substitutes is considered necessary in order to improve flow properties and to avoid the formation of hardened agglomerates when exposed to moisture and during storage. The use of iron tartrate can serve as an alternative to other currently authorised additives, such as ferrocyanides (E 535-538) and silicon dioxide silicates (E 551-553). It is therefore appropriate to authorise the use of iron tartrate as an anti-caking agent in salt and its substitutes and to assign E 534 as E-number to that additive.

| (7) | The specifications for iron tartrate (E 534) should be included in Regulation (EU) No 231/2012 when it 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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(7)

The specifications for iron tartrate (E 534) should be included in Regulation (EU) No 231/2012 when it is included in the Union list of food additives laid down in Annex II to Regulation (EC) No 1333/2008 for the first time.

| (8) | Regulations (EC) No 1333/2008 and (EU) No 231/2012 should therefore be amended accordingly. |
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(8)

Regulations (EC) No 1333/2008 and (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, |
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(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 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 2015.

For the Commission

The President

Jean-Claude JUNCKER

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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 2015;13(1):3980

4

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ANNEX I

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

| (1) | In Part B, point 3 ‘Additives other than colours and sweeteners’, the following new entry is inserted after the entry for food additive E 530:






  ‘E 534 | Iron tartrate’ |
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(1)

In Part B, point 3 ‘Additives other than colours and sweeteners’, the following new entry is inserted after the entry for food additive E 530:

‘E 534

Iron tartrate’

| (2) | In Part E is amended as follows:






  (a) | in category 12.1.1 ‘Salt’:






  (i) | the following new entry is inserted after the entry for food additive E 530: | ‘E 534 | Iron tartrate | 110 | (92)’ | |
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(2)

In Part E is amended as follows:

(a)

in category 12.1.1 ‘Salt’:

(i)

the following new entry is inserted after the entry for food additive E 530:

‘E 534

Iron tartrate

110

(92)’

| (ii) | the following footnote is added: | | ‘(92): Expressed on dry matter’ |
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(ii)

the following footnote is added:

‘(92): Expressed on dry matter’

| (b) | in category 12.1.2 ‘Salt substitutes’:






  (i) | the following new entry is inserted after the entry for for food additive E 338-452: | ‘E 534 | Iron tartrate | 110 | (92)’ | |
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(b)

in category 12.1.2 ‘Salt substitutes’:

(i)

the following new entry is inserted after the entry for for food additive E 338-452:

‘E 534

Iron tartrate

110

(92)’

| (ii) | the following footnote is added: | | ‘(92): Expressed on dry matter’ |
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(ii)

the following footnote is added:

‘(92): Expressed on dry matter’

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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 530:

| ‘E 534 IRON TARTRATE |
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| Synonyms | Iron meso-tartrate; complexation product of sodium tartrate with iron(III) chloride |
| Definition | Iron tartrate is manufactured by the isomerisation of L-tartrate to an equilibrium mixture of D-, L- and meso-tartrate followed by addition of iron(III) chloride. |
| CAS number | 1280193-05-9 |
| Chemical name | Iron(III) complexation product of D(+)-, L(-)- and meso-2,3 dihydroxybutanedioic acids |
| Chemical formula | Fe(OH)2 C4H4O6Na |
| Molecular weight | 261,93 |
| Assay |
| meso-tartrate | > 28 %, expressed as the anion on dry basis |
| D(-)- and L(+)-tartrate | > 10 %, expressed as the anion on dry basis |
| Iron(III) | > 8 %, expressed as the anion on dry basis |
| Description | Dark green aqueous solution typically comprising ca 35 % by weight complexation products |
| Identification | Highly soluble in water |
| | Positive tests for tartrate and iron |
| | pH of a 35 % aqueous solution of complexation products between 3,5 and 3,9 |
| Purity |
| Chloride | Not more than 25 % |
| Sodium | Not more than 23 % |
| Arsenic | Not more than 3 mg/kg |
| Lead | Not more than 2 mg/kg |
| Mercury | Not more than 1 mg/kg |
| Oxalate | Not more than 1,5 % expressed as oxalate on dry basis’ |

‘E 534 IRON TARTRATE

Synonyms

Iron meso-tartrate; complexation product of sodium tartrate with iron(III) chloride

Definition

Iron tartrate is manufactured by the isomerisation of L-tartrate to an equilibrium mixture of D-, L- and meso-tartrate followed by addition of iron(III) chloride.

CAS number

1280193-05-9

Chemical name

Iron(III) complexation product of D(+)-, L(-)- and meso-2,3 dihydroxybutanedioic acids

Chemical formula

Fe(OH)2 C4H4O6Na

Molecular weight

261,93

Assay

meso-tartrate

> 28 %, expressed as the anion on dry basis

D(-)- and L(+)-tartrate

> 10 %, expressed as the anion on dry basis

Iron(III)

> 8 %, expressed as the anion on dry basis

Description

Dark green aqueous solution typically comprising ca 35 % by weight complexation products

Identification

Highly soluble in water

Positive tests for tartrate and iron

pH of a 35 % aqueous solution of complexation products between 3,5 and 3,9

Purity

Chloride

Not more than 25 %

Sodium

Not more than 23 %

Arsenic

Not more than 3 mg/kg

Lead

Not more than 2 mg/kg

Mercury

Not more than 1 mg/kg

Oxalate

Not more than 1,5 % expressed as oxalate on dry basis’

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