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 (Text with EEA relevance)
Grade B
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Address https://gelex.eu/eli/EU/regulation/2007/1138@2007-10-01/en
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, 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 authorisation of the preparation set out in the Annex to this Regulation. 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 a new use the preparation benzoic acid (VevoVitall) as a feed additive for pigs for fattening, to be classified in the additive category zootechnical additives.
(4) The use of the preparation of benzoic acid (VevoVitall) was authorised for weaned piglets by Commission Regulation (EC) No 1730/2006.
(5) New data were submitted in support of an application for authorisation for pigs for fattening. The European Food Safety Authority (the Authority) concluded in its opinion of 7 March 2007 that benzoic acid (VevoVitall) does not have an adverse effect on animal health, human health or the environment. It further concluded that benzoic acid (VevoVitall) does not present any other risk which would, in accordance with Article 5(2) of Regulation (EC) No 1831/2003, exclude authorisation. According to that opinion, the use of that preparation does not have an adverse effect on this additional animal. The opinion of the Authority recommends appropriate measures for user safety. It does not consider that there is a need for specific requirements of post market monitoring. 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.
(7) 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
This Regulation shall enter into force on the 20th 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, 1 October 2007. For the Commission Markos Kyprianou Member of the Commission
ANNEX
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 mg/kg of complete feedingstuff with a moisture content of 12 % Category of zootechnical additives. Functional group: other zootechnical additives (urinary pH decrease) 4d210 DSM Special Products Benzoic acid (VevoVitall) Pigs for fattening — 5000 10000 The directions for use shall indicate the following: 22.10.2017
Additive composition: Benzoic acid (≥ 99,9 %)
Characterisation of the active substance: Benzenecarboxylic acid, phenylcarboxylic acid, C7H6O2 CAS number 65-85-0 Maximum level in: Phthalic acid: ≤ 100 mg/kg Biphenyl: ≤ 100 mg/kg Heavy metals: ≤ 10 mg/kg Arsenic: ≤ 2 mg/kg
Analytical method: Reversed Phase HPLC coupled with Diode Array Detection (DAD) detection
Complementary feedingstuffs containing benzoic acid shall not be fed to pigs for fattening as such.
Complementary feedingstuffs for pigs for fattening should be thoroughly mixed with other feed materials of the daily ration.
For user safety: measures should be taken to minimize the production of breathable dust from this additive. Material safety data sheets (MSDS) available.
Versions
Cited by
- 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 Product Sp. z o. o.) (Text with EEA relevance) Regulation · Grade B
That additive was already authorised as a feed additive for use in weaned piglets by Commission Regulation (EC) No 1730/2006 and in pigs for fattening by Commission Regulation (EC) No 1138/2007.
- Commission Implementing Regulation (EU) No 863/2014 of 7 August 2014 amending Regulations (EC) No 1730/2006 and (EC) No 1138/2007 as regards the name of the holder of the authorisation of the feed additive benzoic acid (VevoVitall) (Text with EEA relevance) Regulation · Grade B
In the second column of the Annex to Regulation (EC) No 1138/2007, the words Emerald Kalama Chemical BV are replaced by DSM Nutritional Products Ltd.
- Commission Implementing Regulation (EU) No 226/2012 of 15 March 2012 amending Regulation (EC) No 1730/2006 as regards the conditions of use of benzoic acid (holder of authorisation Emerald Kalama Chemical BV) (Text with EEA relevance) Regulation · Grade B
The preparation benzoic acid, belonging to the additive category of zootechnical additives, was authorised for 10 years as a feed additive for use in weaned piglets by Commission Regulation (EC) No 1730/2006 and for use in pigs for fattening by Commission Regulation (EC) No 1138/2007.
- Commission Implementing Regulation (EU) No 226/2012 of 15 March 2012 amending Regulation (EC) No 1730/2006 as regards the conditions of use of benzoic acid (holder of authorisation Emerald Kalama Chemical BV) (Text with EEA relevance) Regulation · Grade B
The Authority concluded in its opinion of 6 September 2011 that there is no reason to continue to restrict the inclusion of the preparation benzoic acid to compound feed via premixtures. It considered the restrictions on the use of the additive in complementary feed established by Regulation (EC) No 1138/2007 as being sufficient and applicable to weaned piglets.
- Commission Implementing Regulation (EU) No 1190/2011 of 18 November 2011 amending Regulations (EC) No 1730/2006 and (EC) No 1138/2007 as regards the name of the holder of the authorisation of the feed additive benzoic acid (VevoVitall) (Text with EEA relevance) Regulation · Grade B
Emerald Kalama Chemical BV has submitted applications under Article 13(3) of Regulation (EC) No 1831/2003 proposing to change the name of the holder of the authorisation as regards Commission Regulation (EC) No 1730/2006 of 23 November 2006 concerning the authorisation of benzoic acid (VevoVitall) as a feed additive and as regards 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.
- Commission Implementing Regulation (EU) No 1190/2011 of 18 November 2011 amending Regulations (EC) No 1730/2006 and (EC) No 1138/2007 as regards the name of the holder of the authorisation of the feed additive benzoic acid (VevoVitall) (Text with EEA relevance) Regulation · Grade B
In column 2 of the Table of the Annex to Regulation (EC) No 1138/2007, the words DSM Special Products are replaced by Emerald Kalama Chemical BV.
- 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) Regulation · Grade B
That additive was already authorised as a feed additive for use in weaned piglets by Commission Regulation (EC) No 1730/2006, in pigs for fattening by Commission Regulation (EC) No 1138/2007 and in sows by Commission Implementing Regulation (EU) 2016/900.
- Commission Implementing Regulation (EU) 2018/1550 of 16 October 2018 concerning the renewal of the authorisation of benzoic acid as a feed additive for weaned piglets and pigs for fattening and repealing Regulations (EC) No 1730/2006 and (EC) No 1138/2007 (holder of authorisation DSM Nutritional Products Ltd) (Text with EEA relevance) Regulation · Grade B
Benzoic acid was authorised for 10 years as a feed additive for weaned piglets by Commission Regulation (EC) No 1730/2006, and for pigs for fattening by Commission Regulation (EC) No 1138/2007.