Date: 2018-07-12Category: Not ApplicableState: Union GovernmentCountry: Europe
Commission Implementing Regulation (EU) 2018/983 of 11 July 2018 concerning the authorisation of benzoic acid as a feed additive for minor porcine species for fattening and for reproduction (holder of authorisation DSM Nutritional Products Sp. z o. o.) (Text with EEA relevance.)
Issued by European Commission
· Directorate-General for Health and Food Safety
Executive Summary:
This document is Commission Implementing Regulation (EU) 2018/983, authorising the use of benzoic acid as a zootechnical feed additive for minor porcine species for fattening and reproduction. The authorisation is granted to DSM Nutritional Products Sp. z o. o. and is valid until 1 August 2028. The regulation specifies conditions of use, labelling requirements, and analytical methods.
Key Points / Main Content:
Authorisation:
* Benzoic acid is authorised as a feed additive for minor porcine species for fattening and reproduction.
* The additive category is zootechnical additives, functional group: other zootechnical additives (urinary pH decrease).
* The holder of authorisation is DSM Nutritional Products Sp. z o. o.
* Identification number: 4d210
Conditions of Use:
* Minimum and maximum content of benzoic acid in complete feedingstuff: 5 000 mg/kg.
* The additive shall not be used with other sources of benzoic acid or benzoates.
* Complementary feedingstuffs containing benzoic acid shall not be fed as such.
Labelling Requirements:
* The directions for use of the additive and premixtures, the storage conditions, and stability to heat treatment shall be indicated.
* Complementary feedingstuffs for sows shall be thoroughly mixed with other feed materials.
Quality and Safety:
* Additive composition: Benzoic acid 99,9 %.
* Maximum level of impurities: Phthalic acid: 100 mg/kg, Biphenyl: 100 mg/kg.
* Feed business operators shall establish operational procedures and organisational measures to address potential risks.
* Where risks cannot be eliminated or reduced, personal protective equipment (eyes and skin protection) shall be used.
Validity:
* The authorisation is valid until 1 August 2028.
Analytical Methods:
* For quantification of benzoic acid in the feed additive: titration with sodium hydroxide (European Pharmacopoeia monograph 0066).
* For quantification of benzoic acid in premixtures and feedingstuffs: reversed-phase liquid chromatography with UV detection (RPHPLC-UV) method based on ISO 9231:2008.
Impact Analysis:
DSM Nutritional Products Sp. z o. o.:
* Impact: Granted authorisation to market benzoic acid as a feed additive for minor porcine species.
* Action Required: Comply with the conditions of use and labelling requirements specified in the Annex.
Feed Business Operators (Manufacturers of Additives/Premixtures/Feedingstuffs):
* Impact: Required to ensure the additive is used according to the specified conditions, and that labelling requirements are met.
* Action Required: Establish operational procedures and organisational measures to address potential risks, use personal protective equipment if risks cannot be minimised, and follow the specified analytical methods for quantification.
Users of the Additive (Farmers/Animal Feeders):
* Impact: Can use benzoic acid as a feed additive for minor porcine species for fattening and reproduction, adhering to the specified conditions.
* Action Required: Follow the directions for use and safety measures indicated on the label and ensure proper mixing of complementary feedingstuffs.
European Food Safety Authority:
* Impact: Their assessment of benzoic acid formed the basis for this regulation.
* Action Required: No specific action required based on this document.
Reference Laboratory:
* Impact: Provides the analytical methods for benzoic acid quantification.
* Action Required: Maintain and update the analytical methods 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: 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.
benzoic acid: A feed additive for minor porcine species for fattening and for reproduction.
DSM Nutritional Products Sp. z o. o.: Holder of authorisation of benzoic acid as a feed additive for minor porcine species.
Standing Committee on Plants, Animals, Food and Feed: A committee providing opinions related to measures concerning plants, animals, food and feed.
Brussels: The location where the regulation was adopted.
12.7.2018 EN Official Journal of the European Union L 176/17
COMMISSION IMPLEMENTING REGULATION (EU) 2018/983
of 11 July 2018
concerning the authorisation of benzoic acid as a feed additive for minor porcine species for
fattening and for reproduction (holder of authorisation DSM Nutritional Products Sp. z o. o.)
(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 authoris
ation of benzoic acid as a feed additive for minor porcine species for fattening and for reproduction. 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 benzoic acid as a feed additive for minor porcine species for
fattening and for reproduction, to be classified in the additive category ‘zootechnical additives’.
(4) That additive was already authorised as a feed additive for use in weaned piglets by Commission Regulation (EC)
No 1730/2006 (2), in pigs for fattening by Commission Regulation (EC) No 1138/2007 (3) and in sows by
Commission Implementing Regulation (EU) 2016/900 (4).
(5) The European Food Safety Authority (‘the Authority’) concluded in its opinion of 28 September 2017 (5) that,
under the proposed conditions of use, the benzoic acid does not have an adverse effect on human health or the
environment, and that it has a potential to decrease urinary pH in minor porcine species. However, due to the
lack of margin of safety in weaned major piglets, the Authority could not extrapolate the conclusion on the safety
to weaned minor porcine species. Therefore it was established the additive is safe for minor porcine species for
fattening and for reproduction. 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.
(6) The assessment of the benzoic 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.
(7) 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 additive 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) Commission Regulation (EC) No 1730/2006 of 23 November 2006 concerning the authorisation of benzoic acid (VevoVitall) as a feed
additive (OJ L 325, 24.11.2006, p. 9).
(3) Commission Regulation (EC) No 1138/2007 of 1 October 2007 concerning the authorisation of a new use of benzoic acid (VevoVitall)
as a feed additive (OJ L 256, 2.10.2007, p. 8).
(4) Commission Implementing Regulation (EU) 2016/900 of 8 June 2016 concerning the authorisation of benzoic acid as a feed additive for
sows (holder of authorisation DSM Nutritional Products Ltd) (OJ L 152, 9.6.2016, p. 18).
(5) EFSA Journal 2017;15(10):5026.L 176/18 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
Identi
Name of the Species or End of period
fication Composition, chemical formula, Maximum
holder of Additive category of mg of active substance/kg Other provisions of autho
number of description, analytical method age
authorisation animal of complete feedingstuff risation the additive
with a moisture content of
12 %
Category of zootechnical additives. Functional group: other zootechnical additives (urinary pH decrease).
4d210 DSM Benzoic acid Additive composition: Minor porcine — 5 000 5 000 1. In the directions for use of the 1 August
Nutritional species for additive and premixtures, the 2028
Products fattening and storage conditions and stabil
Benzoic acid (≥ 99,9 %)
Sp. z o. o. for ity to heat treatment shall be
reproduction indicated..
Characterisation of the active sub
stance:
2. The additive shall not be used
with other sources of benzoic
Benzenecarboxylic acid, phenyl acid or benzoates.
carboxylic acid,
3. The directions of use shall be
C H O indicated the following in
7 6 2 complementary feed: ‘Comp
lementary feedingstuffs con
CAS number 65-85-0
taining benzoic acid shall not
be fed to minor porcine spe
Maximum level of the impurities: cies for fattening and for re
production as such'. Comp
Phthalic acid: ≤ 100 mg/kg lementary feedingstuffs for
sows shall be thoroughly
mixed with other feed mate
Biphenyl: ≤ 100 mg/kg
rials of the daily ration’.
Analytical method(1)
For the quantification of benzoic
acid in the feed additive:
— titration with sodium hydro
xide (European Pharmacopoeia
monograph 0066)
12.7.2018
EN
Official
Journal
of
the
European
Union
L
176/19Minimum Maximum
content content
Identi
Name of the Species or End of period
fication Composition, chemical formula, Maximum
holder of Additive category of mg of active substance/kg Other provisions of autho
number of description, analytical method age
authorisation animal of complete feedingstuff risation
the additive
with a moisture content of
12 %
For the quantification of the ben 4. For users of the additive and
zoic acid in the premixtures and premixtures, feed business op
feedingstuffs: erators shall establish opera
tional procedures and organi
sational measures to address
— reversed phase liquid chroma
potential risks concerning
tography with UV detection
their use. Where those risks
(RP-HPLC/UV) — method
cannot be eliminated or re
based on ISO9231:2008
duced to a minimum by such
procedures and measures, the
additive and premixtures shall
be used with personal protec
tive equipment, including eyes
and skin protection.
(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
176/20
EN
Official
Journal
of
the
European
Union
12.7.2018