Statement on the safety and efficacy of the product Rosemary extract liquid of natural origin as a technological feed additive for dogs and cats 1

Transcription

1 EFSA Journal 2012;10(1):2526 SCIENTIFIC OPINION Statement on the safety and efficacy of the product Rosemary extract liquid of natural origin as a technological feed additive for dogs and cats 1 EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) 2 ABSTRACT European Food Safety Authority (EFSA), Parma, Italy The additive rosemary extract liquid of natural origin is intended to be used as a technological additive (antioxidant) in feed for dogs and cats. The FEEDAP Panel assessed the data provided by the applicant in the technical dossier. During the course of the assessment, the need for additional information in order to be able to deliver an opinion on the safety and efficacy of this additive was identified and notified to the applicant. The information requested covered several aspects of the characterisation of the additive, the safety of the additive for the target species and its efficacy. The applicant has failed to provide the additional information even after several requests by EFSA. Therefore, considering the data provided in the original dossier and the absence of response from the applicant to the requests from EFSA, the FEEDAP Panel is not in a position to deliver an opinion on the safety and efficacy of the additive rosemary extract liquid of natural origin as a technological additive for dogs and cats. European Food Safety Authority, 2012 KEY WORDS Rosemary extract liquid of natural origin, safety, efficacy, dogs, cats 1 On request from the European Commission, Question No EFSA-Q , adopted on 13 December 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 Suggested citation: EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP); Statement on the safety and efficacy of the product Rosemary extract liquid of natural origin as a technological feed additive for dogs and cats. EFSA Journal 2012;10(1):2526. [7 pp.] doi: /j.efsa Available online: European Food Safety Authority, 2012

2 SUMMARY Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of the product rosemary extract liquid of natural origin as a technological additive (antioxidant) in feed for dogs and cats. The FEEDAP Panel assessed the data provided by the applicant in the technical dossier. During the course of the assessment, the need for additional information in order to be able to deliver an opinion on the safety and efficacy of this additive was identified and notified to the applicant. The information requested covered several aspects of the characterisation of the additive, the safety of the additive for the target species and its efficacy. The applicant has failed to provide the additional information even after several requests by EFSA. Therefore, considering the data provided in the original dossier and the absence of response from the applicant to the requests from EFSA, the FEEDAP Panel is not in a position to deliver an opinion on the safety and efficacy of the additive rosemary extract liquid of natural origin as a technological additive for dogs and cats. EFSA Journal 2012;10(1):2526 2

3 TABLE OF CONTENTS Abstract... 1 Summary... 2 Table of contents... 3 Background... 4 Terms of reference Introduction The application and dossier Conclusions... 7 EFSA Journal 2012;10(1):2526 3

4 BACKGROUND Regulation (EC) No 1831/ establishes the rules governing the Community authorisation of additives for use in animal nutrition. In particular, Article 4(1) of that Regulation lays down that any person seeking authorisation for a feed additive or for a new use of a feed additive shall submit an application in accordance with Article 7. The European Commission received a request from the company Kemin Europe NV 4 for authorisation of the product Rosemary extract liquid of natural origin to be used as a feed additive (category: technological additives; functional group: antioxidants) for dogs and cats 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 4(1) (authorisation of a feed additive or new use of a feed additive). EFSA received directly from the applicant the technical dossier in support of this application. 5 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 application were considered valid by EFSA as of 1 April This product has not been previously authorised as a technological feed additive for use in animal nutrition in the European Union. 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 animal(s), consumer, user and the environment and the efficacy of the product Rosemary extract liquid of natural origin, when used under the conditions described in Table 1. 3 Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition. OJ L 268, , p Kemin Europa N.V. Nutrisurance Division. Atealaan 4N, 2200 Herentals, Belgium. 5 EFSA Dossier reference: FAD EFSA Journal 2012;10(1):2526 4

5 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 Rosemary extract liquid of natural origin - Technological additives Antioxidants Composition, description Carnosic acid ( %) Sunflower oil ( %) Other rosemary compounds (max 9.0 %) Chemical formula C 20 H 28 O 4 Description Purity criteria Method of analysis A high performance liquid chromatography (HPLC) method was used to quantify the carnosic acid in Rosemary Extract. The method used a Zorbax XDB-C8 column and a gradient elution consisting of acetonitrile and water. HPLC conditions were determined which permitted the separation and measurement of the phenolic diterpenes by absorbance detection at 280 nm with a suitable detector. The method was validated following the International Conference on Harmonisation (ICH) guidelines. In addition limits of quantification and resolution were calculated. Trade name Name of the holder of authorisation Rosemary Extract Liquid of Natural Origin KEMIN EUROPE NV, NUTRISURANCE Division Species or category of animal Maximum Age Conditions of use Minimum content Maximum content Withdrawal period mg/kg of complete feedingstuffs Dogs and cats N/A N/A Specific conditions or restrictions for use Specific conditions or restrictions for handling Other provisions and additional requirements for the labeling Rosemary Extract liquid is added to the complete feedingstuff via a topical fat which makes up 5 to 10 % of the total formulation. For a diet containing 10 % fat, a treatment of 5000 mg/kg to the fat added to the diet would provide the typical 500 mg/kg treatment level for the diet. N/A EFSA Journal 2012;10(1):2526 5

6 Post-market monitoring Specific conditions for use in complementary feedingstuffs N/A N/A Marker residue Maximum Residue Limit (MRL) Species or category of animal Target tissue(s) or food products Maximum content in tissues N/A N/A N/A N/A EFSA Journal 2012;10(1):2526 6

7 1. Introduction Rosemary extract for dogs and cats The present application concerns the product Rosemary extract liquid of natural origin to be used as an antioxidant in petfood for dogs and cats. It is extracted from rosemary leaves, and its antioxidant activity is attributed to the compounds carnosic acid, carnosol and rosmarinic acid. 2. The application and dossier The European Commission received an application for the use of this product in feedingstuffs for dogs and cats on 13 December This application was received by the European Food Safety Authority (EFSA) on 23 December EFSA immediately started the verification of the dossier to check whether all the documents and particulars requested in Article 7(3) of Regulation (EC) No 18318/2003 were provided. The dossier was considered valid for the start of the assessment on 1 April The scientific evaluation of the technical dossier started immediately. During the course of the assessment, the working group of the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) identified the need for additional information in order to be able to deliver an opinion on the safety and efficacy of this additive. The information request was sent to the applicant on 31 May 2005 and covered several aspects of the characterisation of the additive, the safety of the additive for the target species and its efficacy. In several occasions the applicant requested extensions of the deadline to provide the information, which was eventually set to 1 October Since then, the applicant had been asked several times to answer EFSA s request but the data was never provided. Therefore, on 5 October 2011, EFSA notified the applicant its intention to finalise the assessment regarding the dossier of reference.. The European Union Reference Laboratory delivered its report on the methods of analysis for this dossier Conclusions Considering the data provided in the original dossier and the absence of response from the applicant to the requests from EFSA for additional information, the FEEDAP Panel is not in a position to deliver an opinion on the safety and efficacy of the additive Rosemary extract liquid of natural origin as a technological additive for dogs and cats. DOCUMENTATION PROVIDED TO EFSA 1. Dossier on Rosemary extract liquid of natural origin as an antioxidant for pet food. November Submitted by Kemin Europa N.V. Nutrisurance Division. 2. Evaluation report of the European Union Reference Laboratory for Feed Additives on the methods(s) of analysis for Rosemary extract liquid of natural origin. 3. Comments from Member States received through the ScienceNet. 6 The full report is available on the EURL website: pdf EFSA Journal 2012;10(1):2526 7