LegalizeCommission Implementing Regulation (EU) 2021/2092 of 29 November 2021 concerning the authorisation of potassium diformate as a feed additive for pigs for fattening and weaned piglets (Text with EEA relevance)
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| 30.11.2021 | EN | Official Journal of the European Union | L 427/166 |
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 an authorisation.
- (2) In accordance with Article 7 of Regulation (EC) No 1831/2003 an application was submitted for the authorisation of potassium diformate. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.
- (3) The application concerns the authorisation of potassium diformate as a feed additive for pigs for fattening and weaned piglets, to be classified in the category ‘technological additives’.
- (4) The European Food Safety Authority (‘the Authority’) concluded in its opinion of 5 May 2021 2 that, under the proposed conditions of use, potassium diformate does not have adverse effects on animal health, consumer safety or the environment. It also concluded that the substance does not raise concerns regarding the effects on the respiratory system and the skin but is an eye irritant. Therefore, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on human health, in particular as regards the users of the additive. The Authority also concluded that the substance has the potential to be efficacious as a technological additive in feedingstuffs. It also verified the report on the methods of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.
- (5) The assessment of potassium diformate 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) 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 substance specified in the Annex, belonging to the additive category ‘technological additives’ and to the functional group ‘acidity regulators’, is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex.
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, 29 November 2021.
For the Commission
The President
Ursula VON DER LEYEN
EFSA Journal 2021;19(5):6617.
ANNEX
| Identification number of the additive | 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 |
|---|---|---|---|---|---|---|---|---|
| Identification number of the additive | Additive | Composition, chemical formula, description, analytical method | Species or category of animal | Maximum age | mg/kg of complete feedingstuff with a moisture content of 12 % | mg/kg of complete feedingstuff with a moisture content of 12 % | Other provisions | End of period of authorisation |
| Category of technological additives Functional group: acidity regulators | Category of technological additives Functional group: acidity regulators | Category of technological additives Functional group: acidity regulators | Category of technological additives Functional group: acidity regulators | Category of technological additives Functional group: acidity regulators | Category of technological additives Functional group: acidity regulators | Category of technological additives Functional group: acidity regulators | Category of technological additives Functional group: acidity regulators | Category of technological additives Functional group: acidity regulators |
| 1j001 | Potassium diformate | Additive composition: Potassium diformate ≥ 98 % | Pigs for fattening Weaned piglets | - | - | 6 000 | 1. In the directions for use of the additive and premixtures, the storage conditions shall be indicated. 2. The maximum content of potassium diformate shall be 6 000 mg/kg of complete feedingstuff with a moisture content of 12 %, whether used alone as an acidity regulator or used in combination with other sources of potassium diformate. 3. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from its use. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including eyes protection. | 20 December 2031 |
| 1j001 | Potassium diformate | Characterisation of the active substance: Potassium diformate CAS No: 20642-05-1 Einecs No: 243-934-6 C2H3O4K | Pigs for fattening Weaned piglets | - | - | 6 000 | 1. In the directions for use of the additive and premixtures, the storage conditions shall be indicated. 2. The maximum content of potassium diformate shall be 6 000 mg/kg of complete feedingstuff with a moisture content of 12 %, whether used alone as an acidity regulator or used in combination with other sources of potassium diformate. 3. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from its use. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including eyes protection. | 20 December 2031 |
| 1j001 | Potassium diformate | Analytical method 3 For the determination of potassium diformate (as total formic acid) in the feed additive, premixture, feedingstuffs: — Ion chromatography with conductivity detection (IC-CD) – EN 17294; For the determination of potassium in the feed additive: — Atomic absorption spectrometry (AAS) – EN ISO 6869; or — Inductively coupled plasma-atomic emission spectrometry (ICP-AES) – EN15510. | Pigs for fattening Weaned piglets | - | - | 6 000 | 1. In the directions for use of the additive and premixtures, the storage conditions shall be indicated. 2. The maximum content of potassium diformate shall be 6 000 mg/kg of complete feedingstuff with a moisture content of 12 %, whether used alone as an acidity regulator or used in combination with other sources of potassium diformate. 3. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from its use. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including eyes protection. | 20 December 2031 |
Details of the analytical methods are available at the following address of the Reference Laboratory: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports.
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