EFSA Journal 2011;9(12):2443 SCIENTIFIC OPINION Scientific Opinion on the modification of the terms of authorisation of Protural (sodium benzoate) as a feed additive for weaned piglets 1 EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) 2,3 European Food Safety Authority (EFSA), Parma, Italy ABSTRACT The product Protural is a feed additive (zootechnical; other zootechnical additives) authorised for use in weaned piglets at a dose of 4000 mg active substance per kg complete feed. The applicant proposes a modification of the terms of the authorisation, reducing the minimum concentration of sodium benzoate from 99.9 % to 99.0 %. No change in the method of production is involved. The analysis of three batches of Protural showed a mean concentration of benzoic acid of 100 % (and water concentration of 1 %) compliant with the proposed specification. Concentrations of arsenic and heavy metals (as Pb) are < 3 mg/kg and 10 mg/kg, respectively. The FEEDAP Panel concludes that the additive Protural (sodium benzoate) with a minimum content of 99.0 % is as safe for the target species, consumer, user and the environment and efficacious as the previous formulation, under the same conditions of use. European Food Safety Authority, 2011 KEY WORDS Sodium benzoate, weaned piglets, modification of specification 1 On request from European Commission, Question No EFSA-Q-2011-00964, adopted on 15 November 2011. 2 Panel members: Gabriele Aquilina, Georges Bories, Andrew Chesson, Pier Sandro Cocconcelli, Joop de Knecht, Noël Albert Dierick, Mikolaj Antoni Gralak, Jürgen Gropp, Ingrid Halle, Christer Hogstrand, Reinhard Kroker, Lubomir Leng, Secundino López Puente, Anne-Katrine Lundebye Haldorsen, Alberto Mantovani, Giovanna Martelli, Miklós Mézes, Derek Renshaw, Maria Saarela, Kristen Sejrsen and Johannes Westendorf. Correspondence: FEEDAP@efsa.europa.eu 3 Acknowledgement: The Panel wishes to thank the members of the Working Group on Organic Acids, including Atte von Wright and Pieter Wester for the preparatory work on this scientific opinion. Suggested citation: EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP); Scientific Opinion on the modification of the terms of authorisation of Protural (sodium benzoate) as a feed additive for weaned piglets. EFSA Journal 2011;9(12):2443. [7 pp.] doi:10.2903/j.efsa.2011.2443. Available online: www.efsa.europa.eu/efsajournal European Food Safety Authority, 2011
SUMMARY The product Protural is a feed additive (zootechnical; other zootechnical additives) authorised for use in weaned piglets at a dose of 4000 mg active substance per kg complete feed. The applicant proposes a modification of the terms of the authorisation, reducing the minimum concentration of sodium benzoate from 99.9 % to 99.0 %. Following a request from European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on whether this modification would affect the safety and efficacy when used under the same conditions. No change in the method of production is involved. The analysis of three batches of Protural showed a mean concentration of benzoic acid of 100 % (and water concentration of < 1 %) compliant with the proposed specification. Concentrations of arsenic and heavy metals (as Pb) are < 3 mg/kg and < 10 mg/kg, respectively. The FEEDAP Panel concludes that the additive Protural (sodium benzoate) with a minimum content of 99.0 % is as safe for the target species, consumer, user and the environment and efficacious as the previous formulation, under the same conditions of use.. EFSA Journal 2011;9(12):2443 2
TABLE OF CONTENTS Abstract... 1 Summary... 2 Table of contents... 3 Background... 4 Terms of reference... 4 Assessment... 6 1. Introduction... 6 2. Characterisation of the additive... 6 3. Evaluation of the analytical methods by the European Union Reference Laboratory (EURL)... 6 4. Safety and efficacy... 6 Conclusions... 6 Documentation provided to EFSA... 6 References... 7 EFSA Journal 2011;9(12):2443 3
BACKGROUND Regulation (EC) No 1831/2003 4 establishes the rules governing the Community authorisation of additives for use in animal nutrition. In particular, Article 13(3) of that Regulation lays down that if the holder of an authorisation proposes changing the terms of the authorisation by submitting an application to the Commission, accompanied by the relevant data supporting the request for the change, the Authority shall transmit its opinion on the proposal to the Commission and the Member States. The European Commission received a request from the company Kemira Oyj 5 for authorisation of the product Protural (sodium benzoate) when used as a feed additive for weaned piglets (category: zootechnical additives; functional group: other zootechnical additives) under the conditions mentioned in Table 1. According to Article 7(1) of Regulation (EC) No 1831/2003, the Commission forwarded the application to the European Food Safety Authority (EFSA) as an application under Article 13(3) (modification of the authorisation of a feed additive). EFSA received directly from the applicant the technical dossier in support of this application. 6 According to Article 8 of that Regulation, EFSA, after verifying the particulars and documents submitted by the applicant, shall undertake an assessment in order to determine whether the feed additive complies with the conditions laid down in Article 5. The particulars and documents in support of the application were considered valid by EFSA as of 14 September 2011. The additive Protural consists of sodium benzoate without carrier material. This product is authorised in the EU for use in weaned piglets (4d5) (until 10 June 2021) 7 at the maximum content of 4000 mg/kg. EFSA issued an opinion on the safety and efficacy of Protural for weaned piglets (EFSA, 2011). TERMS OF REFERENCE According to Article 8 of Regulation (EC) No 1831/2003, EFSA shall determine whether the feed additive complies with the conditions laid down in Article 5. EFSA shall deliver an opinion on the safety for the target animals, consumer, user and the environment and the efficacy of the product Protural (sodium benzoate), following the proposed change of formulation of the additive (Table 1). 4 5 6 OJ L 268, 18.10.2003, p. 29. Kemira Oyj, Porkkalankatu 3, 00101 Helsinki, Finland. EFSA Dossier reference: FAD-2011-0027. 7 OJ L 134/9, 20.5.2011, p. 9. EFSA Journal 2011;9(12):2443 4
Table 1: Description and conditions of use of the additive as proposed by the applicant Additive Registration number/ec No/No Category(ies) of additive Functional group(s) of additive Sodium benzoate Zootechnical additive Other zootechnical additive Composition, description Sodium benzoate min. 99.0% Chemical formula C7H5O2Na Description Purity criteria Method of analysis Trade name Name of the holder of authorisation (if appropriate) Protural Kemira Oyj Species or category of animal Conditions of use Maximum Age Minimum content Maximum content Withdrawal period mg or Units of activity or CFU/kg of complete feedingstuffs (select what applicable) Piglets (weaned) 120d 4 000 Specific conditions or restrictions for use (if appropriate) Other provisions and additional requirements for the labelling Specific conditions or restrictions for handling Post-market monitoring Specific conditions for use in complementary feedingstuffs The additive shall not be mixed with other sources of benzoic acid or benzoates. For piglets (weaned) up to 35kg. Recommended minimum dosage 4 000 mg/kg. For safety: breathing protection, glasses and gloves shall be used during handling. Complementary feed containing sodium benzoate may not be fed to piglets as such. Marker residue Maximum Residue Limit (MRL) Species or category Target tissue(s) or food products of animal Maximum content in tissues EFSA Journal 2011;9(12):2443 5
ASSESSMENT 1. Introduction The product Protural is a feed additive (zootechnical; other zootechnical additives) authorised for use in weaned piglets at a dose of 4000 mg active substance per kg complete feed. 8 The applicant proposes a modification of the terms of the authorisation, reducing the minimum concentration of sodium benzoate from 99.9 % to 99.0 %. EFSA issued an opinion on the safety and efficacy of Protural for weaned piglets (EFSA, 2011). 2. Characterisation of the additive No change in the method of production is involved. The analysis of three batches 9 of Protural showed a mean concentration of benzoic acid of 100 % (and water concentration of < 1 %) compliant with the proposed specification. Concentrations of arsenic and heavy metals (as Pb) are < 3 mg/kg and < 10 mg/kg, respectively. One batch showed a concentration of sulphate of < 25 mg/kg, while the other two were 100 mg/kg. One batch showed a concentration of chloride of < 100 mg/kg, while the other two were 50 mg/kg. 3. Evaluation of the analytical methods by the European Union Reference Laboratory (EURL) The EURL considered that the conclusions and recommendations reached in the previous assessment are valid and applicable for the current application. 10 4. Safety and efficacy The proposed minor change in the specification of the additive would not affect the conclusions of the FEEDAP Panel on the safety and efficacy based on the product with a higher minimum content of the active substance (EFSA, 2011). CONCLUSIONS The FEEDAP Panel concludes that the additive Protural (sodium benzoate) with a minimum content of 99.0 % is as safe for the target species, consumer, user and the environment and efficacious as the previous formulation, under the same conditions of use. DOCUMENTATION PROVIDED TO EFSA 1. Protural (sodium benzoate) for weaned piglets. June 2011. Submitted by Kemira Oyj. 2. Comments from Member States received through the ScienceNet. 8 OJ L 134/9, 20.5.2011, p. 9. 9 Technical dossier/section II/Protural CoA 10 The full report is available on the EURL website: http://irmm.jrc.ec.europa.eu/sitecollectiondocuments/finrep-fad- 2009-0005.pdf EFSA Journal 2011;9(12):2443 6
REFERENCES EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP), 2011. Safety and efficacy of Protural (sodium benzoate) as feed additive for weaned piglets. EFSA Journal, 9(2):2005. EFSA Journal 2011;9(12):2443 7