Date: 2018-07-12Category: Not ApplicableState: Union GovernmentCountry: Europe
Commission Implementing Regulation (EU) 2018/982 of 11 July 2018 concerning the authorisation of the preparation of benzoic acid, calcium formate and fumaric acid as feed additive for chickens for fattening and chickens reared for laying (holder of the authorisation Novus Europe N.A./S.V.) (Text with EEA relevance.)
Issued by European Commission
· Directorate-General for Health and Food Safety
Executive Summary:
Commission Implementing Regulation (EU) 2018/982 authorises the use of benzoic acid, calcium formate, and fumaric acid as a zootechnical feed additive for chickens for fattening and chickens reared for laying. The authorisation, held by Novus Europe N.A.S.V., is valid until August 1, 2028. The regulation specifies conditions of use, including post-market monitoring requirements.
Key Points / Main Content:
* **Authorisation:**
* The preparation of benzoic acid, calcium formate, and fumaric acid is authorised as a feed additive for chickens for fattening and chickens reared for laying.
* The additive falls under the "zootechnical additives" category, specifically "other zootechnical additives" for improving zootechnical performance.
* **Composition and Specifications:**
* The additive consists of benzoic acid, calcium formate, and fumaric acid in granulated form.
* Minimum and maximum content levels of the additive in complete feedingstuff with a moisture content of 12% are specified (500-1000 mg/kg).
* Minimum content requirements for each component are: Benzoic acid: 42.5-50.5%; Calcium formate: 2.5-3.5%; Fumaric acid: 0.8-1.2%.
* **Conditions of Use:**
* Directions for use, storage conditions, and stability to heat treatment must be indicated on the additive and premixture packaging.
* The additive should not be used with other sources of benzoic acid or benzoates, calcium formate or formate, and fumaric acid.
* Feed business operators must establish procedures and measures to address potential risks.
* Personal protective equipment, including breathing protection, is required if risks cannot be eliminated or minimised.
* **Analytical Methods:**
* Specific analytical methods for determining benzoic acid, calcium formate, fumaric acid, and total calcium are provided, referencing HPLC-UV, AAS, ICP-AES, and ion-exclusion HPLC-UV/RI.
* Details are available at the European Union Reference Laboratory.
* **Validity:**
* The authorisation is valid until August 1, 2028.
Impact Analysis:
* **Novus Europe N.A.S.V.:**
* Impact: As the authorisation holder, they are permitted to market the specified feed additive.
* Action Required: Comply with all conditions outlined in the Annex, including proper labeling, storage guidelines, and risk management procedures.
* **Feed Business Operators:**
* Impact: Need to incorporate the authorised additive into feed formulations according to the specified conditions.
* Action Required: Implement operational procedures and organisational measures to address potential risks associated with the additive's use, ensuring worker safety and compliance.
* **Chickens for Fattening and Chickens Reared for Laying:**
* Impact: Improved zootechnical performance with the use of the feed additive.
* Action Required: No direct action required.
* **European Food Safety Authority (EFSA):**
* Impact: Their scientific opinions formed the basis for the authorisation.
* Action Required: No direct action required, but may be involved in future reviews or monitoring activities.
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 Food Safety Authority: An agency of the European Union that provides independent scientific advice and communicates on existing and emerging risks associated with the food chain.
Novus Europe N.A.S.V.: The holder of the authorisation for the feed additive.
benzoic acid, calcium formate and fumaric acid: A preparation authorised as a feed additive for chickens for fattening and chickens reared for laying.
Brussels: The city where the regulation was done.
Standing Committee on Plants, Animals, Food and Feed: A committee providing opinion on measures of the European Commission.
12.7.2018 EN Official Journal of the European Union L 176/13
COMMISSION IMPLEMENTING REGULATION (EU) 2018/982
of 11 July 2018
concerning the authorisation of the preparation of benzoic acid, calcium formate and fumaric acid
as feed additive for chickens for fattening and chickens reared for laying (holder of the
authorisation Novus Europe N.A./S.V.)
(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.
(2) In accordance with Article 7 of Regulation (EC) No 1831/2003 an application was submitted for the authorisa
tion of the preparation of benzoic acid, calcium formate and fumaric acid as a feed additive for chickens for
fattening, chickens reared for laying, minor avian species for fattening and reared for laying. That application was
accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.
(3) That application concerns the authorisation of the preparation of benzoic acid, calcium formate and fumaric acid
as a feed additive for chickens for fattening, chickens reared for laying, minor avian species for fattening and
reared for laying, to be classified in the additive category ‘zootechnical additives’.
(4) The European Food Safety Authority (‘the Authority’) concluded in its opinions of 2 December 2014 (2) and
28 September 2017 (3) that, under the proposed conditions of use, the preparation of benzoic acid, calcium
formate and fumaric acid does not have an adverse effect on animal health, human health or the environment.
The Authority also concluded that it has the potential to improve the performance of chickens for fattening and
this conclusion can be extended to chickens reared for laying. However, since no conclusions can be drawn on
the margin of safety of the additive for major target species, the conclusions on safety cannot be extrapolated to
minor avian species for fattening and to minor avian species reared for laying. 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 Reference Laboratory set up by Regulation (EC)
No 1831/2003.
(5) The assessment of the preparation of benzoic acid, calcium formate and fumaric acid 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 preparation 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 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.
(1) OJ L 268, 18.10.2003, p. 29.
(2) EFSA Journal 2015;13(5):3794.
(3) EFSA Journal 2017;15(10):5025.L 176/14 EN Official Journal of the European Union 12.7.2018
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, 11 July 2018.
For the Commission
The President
Jean-Claude JUNCKERANNEX
Minimum Maximum
content content
Identification Name of the Species or End of
Composition, chemical formula, Maximum
number of holder of Additive category of mg of additive/kg of Other provisions period of
description, analytical method age
the additive authorisation animal complete feedingstuff authorisation
with a moisture
content of 12 %
Category of zootechnical additives. Functional group: other zootechnical additives (improving zootechnical performance)
4d14 Novus Europe Preparation of Additive composition Chickens for — 500 1 000 1. In the directions for use of 1 August
N.A./S.V. benzoic acid, fattening the additive and premixtures, 2028
calcium formate Preparation of benzoic acid, cal the storage conditions and
and fumaric acid cium formate and fumaric acid Chickens stability to heat treatment
having a minimum content of: reared for shall be indicated.
laying
Benzoic acid: 42,5-50 % 2. The additive shall not be
used with other sources of
Calcium formate: 2,5-3,5 %
benzoic acid or benzoates,
calcium formate or formate
Fumaric acid: 0,8-1,2 %
and fumaric acid.
Granulated form
3. For users of the additive and
premixtures, feed business
Characterisation of the active sub
operators shall establish
stance
operational procedures and
benzoic acid CAS number: organisational measures to
65-85-0 (≥ 99,0 % purity); address potential risks con
C H O cerning their use. Where
7 6 2 those risks cannot be elimin
calcium formate: CAS number ated or reduced to a mini
544-17-2; C H O Ca; mum by such procedures
2 2 4
and measures, the additive
fumaric acid (≥ 99,5 % purity): and premixtures shall be
CAS number 110-17-8; C H O used with personal protective
4 4 4.
equipment, including breath
Analytical method(1) ing protection.
For the determination of ben
zoic acid, calcium formate and
fumaric acid in the feed additive:
— high performance liquid
chromatography with UV
detection (HPLC-UV)
12.7.2018
EN
Official
Journal
of
the
European
Union
L
176/15Minimum Maximum
content content
Identification Name of the Species or End of
Composition, chemical formula, Maximum
number of holder of Additive category of mg of additive/kg of Other provisions period of
description, analytical method age
the additive authorisation animal complete feedingstuff authorisation
with a moisture
content of 12 %
For the determination of total
calcium in the feed additive:
— atomic absorption spec
trometry (AAS) – EN
ISO 6869; or
— inductively coupled plasma
atomic emission spec
trometry (ICP-AES) –
EN 15510
For the determination of ben
zoic acid in premixtures and
feedingstuffs:
— high performance liquid
chromatography with UV
detection (HPLC-UV)
For the determination of cal
cium formate and fumaric acid
in premixtures:
— ion-exclusion high perform
ance liquid chromatography
with UV or refractive index
detection (HPLC-UV/RI)
(1) 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
L
176/16
EN
Official
Journal
of
the
European
Union
12.7.2018