Commission Implementing Regulation (EU) 2019/900 of 29 May 2019 concerning the authorisation of 8-mercapto-p-menthan-3-one and p-menth-1-ene-8-thiol as feed additives for all animal species (Text with EEA relevance.)
Commission Implementing Regulation (EU) 2019/900of 29 May 2019concerning the authorisation of 8-mercapto-p-menthan-3-one and p-menth-1-ene-8-thiol as feed additives for all animal species(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 nutritionOJ L 268, 18.10.2003, p. 29., 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. Article 10 of that Regulation provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EECCouncil Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (OJ L 270, 14.12.1970, p. 1)..(2)8-mercapto-p-menthan-3-one and p-menth-1-ene-8-thiol were authorised without a time limit in accordance with Directive 70/524/EEC as feed additives for all animal species. Those products were subsequently entered in the Register of feed additives as existing products, in accordance with Article 10(1) of Regulation (EC) No 1831/2003.(3)In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 thereof, an application was submitted for the re-evaluation of the 8-mercapto-p-menthan-3-one and p-menth-1-ene-8-thiol as feed additives for all animal species. The applicant requested those additives to be classified in the additive category "sensory additives". That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.(4)The European Food Safety Authority ("the Authority") concluded in its opinion of 27 November 2018EFSA Journal 2019;17(1):5530. that, under the proposed conditions of use in feed 8-mercapto-p-menthan-3-one and p-menth-1-ene-8-thiol do not have adverse effects on animal health, consumer safety or the environment. It also concluded that both compounds are irritant to the respiratory tract and no conclusions can be drawn for skin sensitisation potential. Therefore, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on human heath, in particular, as regards the users of the additive. The Authority further concluded that since the two substances are used in food and their function in feed is the same as that in food, no further demonstration of efficacy in feed is necessary.(5)Restrictions and conditions should be provided for to allow for a better control. For 8-mercapto-p-menthan-3-one and p-menth-1-ene-8-thiol recommended contents should be indicated on the label of the additive. Where such contents are exceeded, certain information should be indicated on the label of premixtures and in the labelling compound feeds and feed materials.(6)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 additives in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.(7)The assessment of the substances concerned shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of those substances should be authorised as specified in the Annex to this Regulation.(8)Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation for the substances concerned it is appropriate to allow a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the authorisation.(9)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 1AuthorisationThe substances specified in the Annex, belonging to the additive category "sensory additives" and to the functional group "flavouring compounds", are authorised as feed additives in animal nutrition subject to the conditions laid down in that Annex.
Article 2Transitional Measures1.The substances specified in the Annex and premixtures containing those substances, which are produced and labelled before 23 December 2019 in accordance with the rules applicable before 23 June 2019 may continue to be placed on the market and used until the existing stocks are exhausted.2.Compound feed and feed materials containing the substances as specified in the Annex which are produced and labelled before 23 June 2020 in accordance with the rules applicable before 23 June 2019 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for food-producing animals.3.Compound feed and feed materials containing the substances as specified in the Annex which are produced and labelled before 23 June 2021 in accordance with the rules applicable before 23 June 2019 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for non-food-producing animals.
Article 3Entry into ForceThis 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, 29 May 2019.For the CommissionThe PresidentJean-Claude JunckerANNEX
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-reportsCategory: Sensory additives. Functional group: Flavouring compounds
Identification number of the additiveName of the holder of authorisationAdditiveComposition, chemical formula, description, analytical methodSpecies or category of animalMaximum ageMinimum contentMaximum contentOther provisionsEnd of period of authorisation
mg of active substance/kg of complete feedingstuff with a moisture content of 12 %
2b12038—8-mercapto-p-menthan-3-oneAdditive composition8-mercapto-p-menthan-3-oneCharacterisation of the active substance8-mercapto-p-menthan-3-oneProduced by chemical synthesisPurity: min. 97 %Chemical formula: C10H18OSCAS number 38462-22-5FLAVIS 12.038Method of analysisFor the determination of 8-mercapto-p-menthan-3-one in the feed additive and in feed flavouring premixtures:Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.All animal species———1.The additive shall be incorporated into the feed in the form of a premixture.2.In the directions for use of the additive and premixture, the storage conditions, the stability to heat treatment shall be indicated.3.On the label of the additive the following shall be indicated:"Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 0,05 mg/kg"4.The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures and on the labelling of feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 0,05 mg/kg.5.For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.23 June 2029
2b12085—p-menth-1-ene-8-thiolAdditive compositionp-menth-1-ene-8-thiolCharacterisation of the active substancep-menth-1-ene-8-thiolProduced by chemical synthesisPurity: min. 98 %Chemical formula: C10H18OSCAS number 71159-90-5FLAVIS 12.085Method of analysisFor the determination of p-menth-1-ene-8-thiol in the feed additive and in feed flavouring premixtures:Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.All animal species———1.The additive shall be incorporated into the feed in the form of a premixture.2.In the directions for use of the additive and premixture, the storage conditions, the stability to heat treatment shall be indicated.3.On the label of the additive the following shall be indicated:"Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 0,05 mg/kg"4.The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures and on the labelling of feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 0,05 mg/kg.5.For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection safety glasses and gloves.23 June 2029