# L_2007063EN.01000101.xml

| 1.3.2007 | EN | Official Journal of the European Union | L 63/1 |
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1.3.2007

EN

Official Journal of the European Union

L 63/1

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COMMISSION REGULATION (EC) No 184/2007

of 20 February 2007

concerning the authorisation of potassium diformate (Formi LHS) as a feed additive

(text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

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. |
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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.

| (2) | In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of the preparation set out in the Annex. That application was accompanied by the particulars and documents required under Article 7(3) of that Regulation. |
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(2)

In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of the preparation set out in the Annex. That application was accompanied by the particulars and documents required under Article 7(3) of that Regulation.

| (3) | The application concerns authorisation of the preparation of potassium diformate (Formi LHS) as a feed additive for piglets (weaned) and pigs for fattening, to be classified in the additive category ‘zootechnical additives’. |
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(3)

The application concerns authorisation of the preparation of potassium diformate (Formi LHS) as a feed additive for piglets (weaned) and pigs for fattening, to be classified in the additive category ‘zootechnical additives’.

| (4) | The method of analysis included in the application for authorisation in accordance with Article 7(3)(c) of Regulation (EC) No 1831/2003 concerns the determination of the active substance of the feed additive in feed. The method of analysis referred to in the Annex to this Regulation is therefore not to be understood as a Community method of analysis within the meaning of Article 11 of Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules (2). |
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(4)

The method of analysis included in the application for authorisation in accordance with Article 7(3)(c) of Regulation (EC) No 1831/2003 concerns the determination of the active substance of the feed additive in feed. The method of analysis referred to in the Annex to this Regulation is therefore not to be understood as a Community method of analysis within the meaning of Article 11 of Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules (2).

| (5) | The European Food Safety Authority (the Authority) concludes in its opinion of 14 February 2006 (3) that the safety of this additive for the consumer, the user and the environment have already been established and will not be changed by the proposed use. It further concludes, that the use of the preparation does not have an adverse effect on this animal category and that the use of that preparation can improve the zootechnical parameters (average daily intake gain, feed to gain ratio) for piglets (weaned) and pigs for fattening. It considers that the post market monitoring plan provided by the applicant is appropriate. The opinion of the Authority recommends appropriate measures for user safety. This opinion also verifies 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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(5)

The European Food Safety Authority (the Authority) concludes in its opinion of 14 February 2006 (3) that the safety of this additive for the consumer, the user and the environment have already been established and will not be changed by the proposed use. It further concludes, that the use of the preparation does not have an adverse effect on this animal category and that the use of that preparation can improve the zootechnical parameters (average daily intake gain, feed to gain ratio) for piglets (weaned) and pigs for fattening. It considers that the post market monitoring plan provided by the applicant is appropriate. The opinion of the Authority recommends appropriate measures for user safety. This opinion also verifies 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.

| (6) | The assessment of that preparation shows that the conditions for authorisation, provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of that preparation should be authorised, as specified in the Annex to this Regulation. |
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(6)

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

| (7) | Article 1 of Commission Regulation (EC) No 1810/2005 of 4 November 2005 concerning a new authorisation for 10 years of an additive in feedingstuffs, the permanent authorisation of certain additives in feedingstuffs and the provisional authorisation of new uses of certain additives already authorised in feedingstuffs (4) which had provided for an authorisation for that use under the transitional provisions of Regulation (EC) No 1831/2003 should therefore be deleted. |
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(7)

Article 1 of Commission Regulation (EC) No 1810/2005 of 4 November 2005 concerning a new authorisation for 10 years of an additive in feedingstuffs, the permanent authorisation of certain additives in feedingstuffs and the provisional authorisation of new uses of certain additives already authorised in feedingstuffs (4) which had provided for an authorisation for that use under the transitional provisions of Regulation (EC) No 1831/2003 should therefore be deleted.

| (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

The preparation specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘other zootechnical additives’, is authorised as an additive in animal nutrition subject to the conditions laid down in that Annex.

Article 2

Article 1 of Regulation (EC) No 1810/2005 is deleted.

Article 3

This Regulation shall enter into force on the 20th day following 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, 20 February 2007.

For the Commission

Markos KYPRIANOU

Member of the Commission

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(1)  
  OJ L 268, 18.10.2003, p. 29. Regulation as amended by Commission Regulation (EC) No 378/2005 (OJ L 59, 5.3.2005, p. 8).

1

(2)  
  OJ L 165, 30.4.2004, p. 1, corrected by OJ L 191, 28.5.2004, p. 1. Regulation as last amended by Regulation (EC) No 1791/2006 (OJ L 363, 20.12.2006, p. 1).

2

(3)  Opinion of the Scientific Panel on Additives and products or Substances used in Animal Feed on the safety and efficacy of the product ‘Formi LHS’ as a feed additive for weaned piglets and pigs for fattening in accordance with Regulation (EC) No 1831/2003. Adopted on 14 February 2006. The EFSA Journal (2006) 325, 1-16.

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(4)  
  OJ L 291, 5.11.2005, p. 8.

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ANNEX

| Identification number of the additive | Name of the holder of authorisation | Additive (trade name) | 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/kg of complete feedingstuff with a moisture content of 12 % |
| Category of zootechnical additive. Functional group: other zootechnical additives (improvement of performance parameters: weight gain or feed gain ratio) |
| 4d800 | BASF Aktiengesellschaft | Potassium diformate
  (Formi LHS) | Additive composition

  Potassium diformate: min. 98 %
  Silicate: max. 1,5  %
  Water: Max. 0,5  %

  Active substance

  Potassium diformate, solid CAS No20642-05-1

  Analytical method
   (1)

  Ion chromatography with conductivity detection | Piglets (weaned) | | 6 000 | 18 000 | To be used until approx. 35 kg.
  The mixture of different sources of potassium diformate must not exceed the permitted maximum level in complete feedingstuff of 18 000 mg/kg of complete feedingstuff.
  The additive shall be incorporated in compound feedingstuff in form of a premixture.
  This product can produce risk of serious damage to the eye. Measures to protect workers shall be adopted. | 21.3.2017 |
| | | | | Pigs for fattening | | 6 000 | 12 000 | The mixture of different sources of potassium diformate must not exceed the permitted maximum level in complete feedingstuff of 12 000 mg per complete feedingstuff.
  The additive shall be incorporated in compound feedingstuff in form of a premixture.
  This product can produce risk of serious damage to the eye. Measures to protect workers shall be adopted. | 21.3.2017 |

Identification number of the additive

Name of the holder of authorisation

Additive (trade name)

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/kg of complete feedingstuff with a moisture content of 12 %

Category of zootechnical additive. Functional group: other zootechnical additives (improvement of performance parameters: weight gain or feed gain ratio)

4d800

BASF Aktiengesellschaft

Potassium diformate

(Formi LHS)

Additive composition

Potassium diformate: min. 98 %

Silicate: max. 1,5  %

Water: Max. 0,5  %

Active substance

Potassium diformate, solid CAS No20642-05-1

Analytical method
   (1)

Ion chromatography with conductivity detection

Piglets (weaned)

6 000

18 000

To be used until approx. 35 kg.

The mixture of different sources of potassium diformate must not exceed the permitted maximum level in complete feedingstuff of 18 000 mg/kg of complete feedingstuff.

The additive shall be incorporated in compound feedingstuff in form of a premixture.

This product can produce risk of serious damage to the eye. Measures to protect workers shall be adopted.

21.3.2017

Pigs for fattening

6 000

12 000

The mixture of different sources of potassium diformate must not exceed the permitted maximum level in complete feedingstuff of 12 000 mg per complete feedingstuff.

The additive shall be incorporated in compound feedingstuff in form of a premixture.

This product can produce risk of serious damage to the eye. Measures to protect workers shall be adopted.

21.3.2017

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(1)  Details of the analytical method are available at the following address of the Community Reference Laboratory: www.irmm.jrc.be/html/crlfaa/

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