Date: 2022-08-08Category: Not ApplicableState: Union GovernmentCountry: Europe
Commission Implementing Regulation (EU) 2022/1374 of 5 August 2022 concerning the authorisation of potassium diformate as a feed additive for weaned piglets, pigs for fattening and sows, and repealing Implementing Regulation (EU) No 333/2012 (Text with EEA relevance)
Issued by European Commission
· Directorate-General for Health and Food Safety
Executive Summary:
This regulation renews the authorization of potassium diformate as a technological feed additive (preservative) for weaned piglets, pigs for fattening, and sows. It repeals Implementing Regulation (EU) No 333/2012. The regulation includes transitional measures for products produced and labeled before specific dates in 2022, 2023 and 2024 and enters into force on August 28, 2022.
Key Points / Main Content:
* **Authorisation Renewal:**
* Potassium diformate (additive category: technological additives; functional group: preservatives) is re-authorised for use in feed for weaned piglets, pigs for fattening, and sows, as specified in the Annex.
* The authorisation is valid until 28 August 2032.
* **Repeal:**
* Implementing Regulation (EU) No 333/2012, which previously authorised potassium diformate for all animal species, is repealed.
* **Transitional Measures:**
* Substances and premixtures produced and labelled before 28 February 2023, according to pre-existing rules, can continue to be placed on the market and used until stocks are exhausted.
* Compound feed and feed materials for food-producing animals, produced and labelled before 28 August 2023, according to pre-existing rules, can continue to be placed on the market and used until stocks are exhausted.
* Compound feed and feed materials for non-food-producing animals, produced and labelled before 28 August 2024, according to pre-existing rules, can continue to be placed on the market and used until stocks are exhausted.
* **Conditions of Use:**
* Storage conditions must be indicated in the directions for use of the additive and premixtures.
* It is only permitted in raw fish and fish byproducts for feed use with a maximum content of 9 000mg potassium diformate as active substance per kg raw fish.
* Maximum content of potassium diformate shall be 6 000 mg/kg of complete feedingstuff for weaned piglets and pigs for fattening and 12 000 mg/kg for sows (moisture content of 12%).
* The mixture of different sources of formic acid shall not exceed the permitted maximum level in complete feedingstuffs of 10 000 mg/kg complete feedingstuffs for weaned piglets, pigs for fattening and sows.
* The simultaneous use of different organic acids or their salts is contraindicated where one or more of them is used at or near the maximum permitted content.
* Feed business operators must 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, skin and breathing protection.
Impact Analysis:
* **Feed Additive Manufacturers/Producers:**
* Impact: Continued authorization for potassium diformate production, but must adhere to new conditions and update labeling.
* Action Required: Ensure compliance with the specifications in the Annex, including concentration limits, labeling requirements, and safety measures. Update product information and safety protocols.
* **Feed Business Operators:**
* Impact: Continued use of potassium diformate as a feed additive, subject to revised conditions.
* Action Required: Implement operational procedures and organizational measures to address potential risks. Use personal protective equipment where risks cannot be minimised. Ensure correct usage and that maximum content levels are adhered to.
* **Farmers (Pig):**
* Impact: Continued access to feed containing potassium diformate for weaned piglets, pigs for fattening, and sows.
* Action Required: Be aware of the updated regulations and any changes to feeding practices or feed composition.
* **European Food Safety Authority (EFSA):**
* Impact: Its assessment of potassium diformate supported the renewal of authorisation.
* Action Required: Continue to monitor and assess the safety and efficacy of potassium diformate as a feed additive as needed.
Key Entities Referenced
European Union: A political and economic union of member states located primarily in Europe.
European Commission: An institution of the European Union responsible for proposing legislation, implementing decisions, upholding the EU treaties and managing the day-to-day business of the EU.
Regulation (EC) No 1831/2003: A Regulation of the European Parliament and of the Council on additives for use in animal nutrition.
European Parliament: The parliamentary body of the European Union, directly elected by EU citizens.
Council of the European Union: One of the legislative bodies of the European Union
Potassium diformate: A feed additive authorized for use in animal nutrition, specifically for weaned piglets, pigs for fattening and sows.
European Food Safety Authority (EFSA): An agency of the European Union that provides independent scientific advice and communicates on existing and emerging risks associated with the food chain.
Commission Implementing Regulation (EU) No 333/2012: A previous regulation concerning the authorisation of potassium diformate as a feed additive for all animal species, which is repealed by this new regulation.
8.8.2022 EN Official Journal of the European Union L 206/35
COMMISSION IMPLEMENTING REGULATION (EU) 2022/1374
of 5 August 2022
concerning the authorisation of potassium diformate as a feed additive for weaned piglets, pigs for
fattening and sows, and repealing Implementing Regulation (EU) No 333/2012
(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 2003on
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 and renewing such authorisation.
(2) Potassium diformate was authorised for a period of 10 years as a feed additive for all animal species by Commission
Implementing Regulation (EU) No 333/2012(2).
(3) In accordance with Article 14(1) of Regulation (EC) No 1831/2003, an application was submitted for the renewal of
the authorisation of potassium diformate as a feed additive for all animal species, requesting the additive to be
classified in the additive category ‘technological additives’. That application was accompanied by the particulars and
documents required under Article 14(2) of that Regulation. The applicant has later withdrawn the application for all
animal species except for weaned piglets, pigs for fattening and sows.
(4) The European Food Safety Authority (‘the Authority’) concluded in its opinion of 27 January 2022(3) that the
applicant had provided evidence that the additive complies with the conditions of authorisation. The Authority
further concluded that potassium diformate does not have adverse effects on animal health, consumer safety or the
environment. It also concluded that the additive is an eye irritant, but it could not conclude on the potential of the
additive to be an irritant to the skin or a respiratory or skin sensitiser. 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 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 authorisation of that additive should be renewed.
(6) As a consequence of the renewal of the authorisation of potassium diformate as a feed additive, Implementing
Regulation (EU) No 333/2012 should be repealed.
(7) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on
Plants, Animals, Food and Feed,
(1) OJ L 268, 18.10.2003, p. 29.
(2) Commission Implementing Regulation (EU) No 333/2012 of 19 April 2012 concerning the authorisation of a preparation of
potassium diformate as a feed additive for all animal species and amending Regulation (EC) No 492/2006 (OJ L 108, 20.4.2012, p. 3).
(3) EFSA Journal 2022;20(3):7167.L 206/36 EN Official Journal of the European Union 8.8.2022
HAS ADOPTED THIS REGULATION:
Article 1
The authorisation of the substance specified in the Annex, belonging to the additive category ‘technological additives’ and
to the functional group ‘preservatives’, is renewed subject to the conditions laid down in that Annex.
Article 2
Implementing Regulation (EU) No 333/2012 is repealed.
Article 3
Transitional measures
1. The substance specified in the Annex and premixtures containing this substance, which are produced and labelled
before 28 February 2023in accordance with the rules applicable before 28 August 2022may continue to be placed on the
market and used until the existing stocks are exhausted.
2. Compound feed and feed materials containing the substance as specified in the Annex which are produced and
labelled before 28 August 2023in accordance with the rules applicable before 28 August 2022may continue to be placed
on the market and used until the existing stocks are exhausted if they are intended for food-producing animals.
3. Compound feed and feed materials containing the substance as specified in the Annex which are produced and
labelled before 28 August 2024in accordance with the rules applicable before 28 August 2022may continue to be placed
on the market and used until the existing stocks are exhausted if they are intended for non-food-producing animals.
Article 4
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, 5 August 2022.
For the Commission
The President
Ursula VON DER LEYENANNEX
Minimum Maximum
content content
Identification
Composition, chemical formula, Species or category End of period of
number of the Additive Maximum age Other provisions
description, analytical method of animal mg active substance/kg of authorisation
additive
complete feedingstuff with a
moisture content of 12 %
Category: technological additives. Functional group: preservatives.
1a237a Potassium diformate Additive composition: Sows - 12 000 1. In the directions for use of the 28.8.2032
additive and premixtures, the sto
Potassium diformate: 50 ± 5 % Weaned piglets - 6 000
rage conditions shall be indicated.
and
Liquid form (50:50 diluted in water) 2. Only permitted in raw fish and
pigs for fattening
fish by-products for feed use with
Characterisation of the active
a maximum content of 9 000mg
substance:
potassium diformate as active
Potassium diformate substance per kg raw fish.
3. The maximum content of potas
C H O K
2 3 4 sium diformate shall be 6 000
CAS number: 20642-05-1 mg/kg of complete feedingstuff
with a moisture content of 12 %
Einecs number: 243-934-6 for weaned piglets and pigs for
Produced by chemical synthesis fattening and 12 000 mg/kg of
complete feedingstuff with a
Analytical method(1): moisture content of 12 % for
sows, whether used alone as a
For the determination of potassium
preservative or used in
diformate (as total formic acid) in
combination with other sources
the feed additive, premixture,
of potassium diformate.
feedingstuffs:
4. The mixture of different sources
— Ion chromatography with con of formic acid shall not exceed the
ductivity detection (IC-CD) – permitted maximum level in
EN 17294; complete feedingstuffs of 10 000
mg/kg complete feedingstuffs for
For the determination of potassium
weaned piglets, pigs for fattening
in the feed additive:
and sows.
— Atomic absorption spectrome
try (AAS) – EN ISO 6869; or
8.8.2022
EN
Official
Journal
of
the
European
Union
L
206/37— Inductively coupled plasma- 5. Indicate in the instructions of use
atomic emission spectrometry of the additive, premixture and
(ICP-AES) – EN15510. related feedingstuffs for food-pro
ducing animals:
‘The simultaneous use of different
organic acids or their salts is con
traindicated where one or more of
them is used at or near the max
imum permitted content’.
6. For users of the additive and pre
mixtures, feed business operators
shall establish operational proce
dures and organisational mea
sures to address potential risks re
sulting from its use. Where those
risks cannot be eliminated or re
duced to a minimum by such pro
cedures and measures, the addi
tive and premixtures shall be
used with personal protective
equipment, including eyes, skin
and breathing protection.
(1) Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-
reports_en
L
206/38
EN
Official
Journal
of
the
European
Union
8.8.2022