# L_2012257EN.01000701.xml

| 25.9.2012 | EN | Official Journal of the European Union | L 257/7 |
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25.9.2012

EN

Official Journal of the European Union

L 257/7

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COMMISSION IMPLEMENTING REGULATION (EU) No 869/2012

of 24 September 2012

concerning the authorisation of thaumatin as a feed additive for all animal species

(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 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (1), and in particular Article 9(2) thereof,

Whereas:

| (1) | Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such authorisation. Article 10 of that Regulation provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC (2). |
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(1)

Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such authorisation. Article 10 of that Regulation provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC (2).

| (2) | Thaumatin was authorised without a time limit in accordance with Directive 70/524/EEC as a feed additive for use on all animal species. That feed additive was subsequently entered in the Community Register of feed additives as an existing product, in accordance with Article 10(1) of Regulation (EC) No 1831/2003. |
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(2)

Thaumatin was authorised without a time limit in accordance with Directive 70/524/EEC as a feed additive for use on all animal species. That feed additive was subsequently entered in the Community Register of feed additives as an existing product, in accordance with Article 10(1) of Regulation (EC) No 1831/2003.

| (3) | In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 thereof, an application was submitted for the re-evaluation of thaumatin as a feed additive for all animal species, requesting that additive to be classified in the additive category ‘sensory additives’. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003. |
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(3)

In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 thereof, an application was submitted for the re-evaluation of thaumatin as a feed additive for all animal species, requesting that additive to be classified in the additive category ‘sensory additives’. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

| (4) | The European Food Safety Authority (‘the Authority’) concluded in its opinion of 6 September 2011 (3) that, under the proposed conditions of use, thaumatin does not have an adverse effect on animal health, human health or the environment, and that it is effective as flavouring. It concluded that no safety concerns would arise for users provided that appropriate protective measures are taken. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additive in feed submitted by the Community Reference Laboratory set up by Regulation (EC) No 1831/2003. |
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(4)

The European Food Safety Authority (‘the Authority’) concluded in its opinion of 6 September 2011 (3) that, under the proposed conditions of use, thaumatin does not have an adverse effect on animal health, human health or the environment, and that it is effective as flavouring. It concluded that no safety concerns would arise for users provided that appropriate protective measures are taken. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additive in feed submitted by the Community Reference Laboratory set up by Regulation (EC) No 1831/2003.

| (5) | The assessment of thaumatin shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of that substance should be authorised as specified in the Annex to this Regulation. |
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(5)

The assessment of thaumatin shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of that substance should be authorised as specified in the Annex to this Regulation.

| (6) | Since modifications to the conditions of authorisation of thaumatin are introduced and as there are no direct immediate effects on safety, a reasonable period should be allowed to elapse before authorisation in order to allow the interested parties to prepare themselves to meet the new requirements resulting from the authorisation. In addition, it is appropriate to allow a transitional period for the disposal of existing stocks of thaumatin, as authorised in accordance with Directive 70/524/EEC and of feed containing thaumatin. |
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(6)

Since modifications to the conditions of authorisation of thaumatin are introduced and as there are no direct immediate effects on safety, a reasonable period should be allowed to elapse before authorisation in order to allow the interested parties to prepare themselves to meet the new requirements resulting from the authorisation. In addition, it is appropriate to allow a transitional period for the disposal of existing stocks of thaumatin, as authorised in accordance with Directive 70/524/EEC and of feed containing thaumatin.

| (7) | It is disproportionately complex for operators to adapt repeatedly and from one day to the other labels of feed containing different additives which have been successively authorised according to the procedure laid down in Article 10(2) of Regulation (EC) No 1831/2003 and for which new labelling rules are to be complied with. It is therefore appropriate to reduce the administrative burden on the operators by providing a period of time allowing a smooth conversion of labelling. |
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(7)

It is disproportionately complex for operators to adapt repeatedly and from one day to the other labels of feed containing different additives which have been successively authorised according to the procedure laid down in Article 10(2) of Regulation (EC) No 1831/2003 and for which new labelling rules are to be complied with. It is therefore appropriate to reduce the administrative burden on the operators by providing a period of time allowing a smooth conversion of labelling.

| (8) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, |
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(8)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

HAS ADOPTED THIS REGULATION:

Article 1

Authorisation

The substance thaumatin specified in the Annex, belonging to the additive category ‘sensory additives’ and to the functional group ‘flavouring compounds’ is authorised as an additive in animal nutrition subject to the conditions laid down in that Annex.

Article 2

Labelling requirements

Feed containing thaumatin shall be labelled in accordance with this Regulation at the latest by 25 May 2013.

However, feed containing thaumatin which has been labelled in accordance with Directive 70/524/EEC before 25 May 2013 may continue to be placed on the market until stocks are exhausted.

Article 3

Transitional measures

Existing stocks of thaumatin and of feed containing thaumatin at the date of entry into force of this Regulation may continue to be placed on the market and used under the conditions of Directive 70/524/EEC until they are exhausted.

Article 4

Entry into force

This Regulation shall enter into force 25 November 2012.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 24 September 2012.

For the Commission

The President

José Manuel BARROSO

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(1)  
  OJ L 268, 18.10.2003, p. 29.

1

(2)  
  OJ L 270, 14.12.1970, p. 1.

2

(3)  
  EFSA Journal 2011; 9(9):2354.

3

EFSA Journal 2011

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ANNEX

| Identification number of the additive | Name of the holder of authorisation | Additive | Composition, chemical formula, description, analytical method | Species or category of animal | Maximum age | Minimum content | Maximum content | Other provisions | End of period of authorisation |
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| mg of active substance/kg of complete feedingstuff with a moisture content of 12 % |
| Category of sensory additives. Functional group: flavouring compounds |
| 2b957 | — | Thaumatin | | Additive composition

  Thaumatin |

Identification number of the additive

Name of the holder of authorisation

Additive

Composition, chemical formula, description, analytical method

Species or category of animal

Maximum age

Minimum content

Maximum content

Other provisions

End of period of authorisation

mg of active substance/kg of complete feedingstuff with a moisture content of 12 %

Category of sensory additives. Functional group: flavouring compounds

2b957

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Thaumatin

Additive composition

Thaumatin

| | Characterisation of the active substance

  Proteins thaumatin I and thaumatin II extracted from the arils of the fruit of the natural strain of Thaumatococcus daniellii (Benth)






  1. | Einecs: 258-822-2 |
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Characterisation of the active substance

Proteins thaumatin I and thaumatin II extracted from the arils of the fruit of the natural strain of Thaumatococcus daniellii (Benth)

1.

Einecs: 258-822-2

| 2. | Chemical formula: Polypeptide of 207 aminoacids |
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2.

Chemical formula: Polypeptide of 207 aminoacids

| 3. | Relative molecular mass: Thaumatin I: 22209, Thaumatin II: 22293 |
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3.

Relative molecular mass: Thaumatin I: 22209, Thaumatin II: 22293

| 4. | Assay: min. 16 % nitrogen on the dried basis equivalent to not less than 94 % protein |
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4.

Assay: min. 16 % nitrogen on the dried basis equivalent to not less than 94 % protein

| 5. | Purity:






  5.1. | Carbohydrates: not more than 3 % expressed on dry weight basis |
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5.

Purity:

5.1.

Carbohydrates: not more than 3 % expressed on dry weight basis

| 5.2. | Sulphated ash: not more than 2 % expressed on dry weight basis |
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5.2.

Sulphated ash: not more than 2 % expressed on dry weight basis

| 5.3. | Aluminium: not more than 100 mg/kg expressed on dry weight basis |
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5.3.

Aluminium: not more than 100 mg/kg expressed on dry weight basis

| | Method of Analysis
   (1)

  Identification of the thaumatin in the feed additive: Nitrogen content in the food additive Kjeldahl method (JECFA Monograph on Thaumatin. 2006. Thaumatin. Specification Monograph). |
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Method of Analysis
   (1)

Identification of the thaumatin in the feed additive: Nitrogen content in the food additive Kjeldahl method (JECFA Monograph on Thaumatin. 2006. Thaumatin. Specification Monograph).

All animal species

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| 1. | In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting. |
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1.

In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting.

| 2. | Recommended use up to 5 mg/kg complete feedingstuff. |
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2.

Recommended use up to 5 mg/kg complete feedingstuff.

| 3. | For safety: breathing, eye and skin protection shall be used during handling. |
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3.

For safety: breathing, eye and skin protection shall be used during handling.

25 November 2022

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(1)  Details of the analytical methods are available at the following address of the Reference Laboratory: http://irmm.jrc.ec.europa.eu/EURLs/EURL_feed_additives/Pages/index.aspx

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