Home Europe European Commission Commission Implementing Regulation (EU) 2019/1977 of 26 Nove...
Date: 2019-11-29 Category: Not Applicable State: Union Government Country: Europe

Commission Implementing Regulation (EU) 2019/1977 of 26 November 2019 concerning the authorisation of phenylmethanethiol, benzyl methyl sulfide, sec-pentylthiophene, tridec-2-enal, 12-methyltridecanal, 2,5-dimethylphenol, hexa-2(trans),4(trans)-dienal and 2-ethyl-4-hydroxy-5-methyl-3(2H)-furanone as feed additives for cats and dogs (Text with EEA relevance)

Issued by European Commission · Directorate-General for Health and Food Safety

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Executive Summary & Key Takeaways

Executive Summary: Commission Implementing Regulation (EU) 2019/1977 authorises phenylmethanethiol, benzyl methyl sulfide, sec-pentylthiophene, tridec-2-enal, 12-methyltridecanal, 2,5-dimethylphenol, hexa-2-trans,4-trans-dienal, and 2-ethyl-4-hydroxy-5-methyl-3(2H)-furanone as sensory feed additives (flavouring compounds) for cats and dogs. The regulation includes conditions for use, labeling requirements, and safety measures. Transitional measures allow continued use of products produced and labeled under previous rules until specific dates. Key Points / Main Content: Authorisation of Feed Additives: * Authorises the specified substances as feed additives for cats and dogs, classifying them as sensory additives (flavouring compounds). Conditions of Use: * Additives must be incorporated into feed in the form of a premixture. * Directions for use of the additive and premixture must indicate storage conditions and stability to heat treatment. * Specific content recommendations for the active substance should be indicated on the label. Labeling Requirements: * The label must include the recommended maximum content of the active substance in complete feeding stuff. * For premixtures exceeding specified content levels, the label must indicate the functional group, identification number, name, and added amount of the active substance. Safety Measures: * Feed business operators must establish operational procedures and organizational measures to address potential risks from inhalation, dermal contact, or eye contact. * If risks cannot be minimized, personal protective equipment (breathing protection, safety glasses, and gloves) must be used. Transitional Measures: * Substances and premixtures produced and labeled before December 19, 2019, under previous rules may be placed on the market and used until June 19, 2020. * Compound feed and feed materials containing the substances, produced and labeled before December 19, 2019, may be placed on the market and used until existing stocks are exhausted if intended for cats and dogs. Entry into Force: * The regulation came into force on the twentieth day following its publication in the Official Journal of the European Union. Impact Analysis: Feed Additive Manufacturers/Producers: * Impact: Need to comply with the new authorization conditions, including proper incorporation into premixtures, updated labeling requirements, and implementation of safety measures. * Action Required: Update production and labeling processes to align with the regulation; provide safety data sheets and usage guidelines to customers; ensure appropriate protective measures are in place for workers handling the additives. Feed Business Operators: * Impact: Responsible for ensuring the safe handling and use of the feed additives, including establishing operational procedures and organizational measures to address potential risks to users. * Action Required: Develop and implement safety protocols, provide personal protective equipment, and communicate potential hazards to employees. Users of Feed Additives/Animal Feed Producers: * Impact: Need to be aware of the new labeling requirements and recommended maximum content levels for the additives in complete feeding stuff. * Action Required: Follow labeling instructions, adhere to recommended content levels, and use appropriate protective equipment when handling the additives. Cat and Dog Owners: * Impact: Indirectly affected by the regulation of feed additives in pet food. * Action Required: No direct action required, but may benefit from improved safety and quality control in pet food production.

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: A European Parliament and Council regulation 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. Council Directive 70/524/EEC: A Council Directive concerning additives in feedingstuffs. Standing Committee on Plants, Animals, Food and Feed: A committee that provides opinions on measures proposed by the European Commission related to plant health, animal health, food safety and animal feed. phenylmethanethiol: A substance authorized as feed additives for cats and dogs benzyl methyl sulfide: A substance authorized as feed additives for cats and dogs
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29.11.2019 E N O f f i c i a l J o u r n a l o f t h e E u r o p e a n Union L 308/45 COMMISSION IMPLEMENTING REGULATION (EU) 2019/1977 of 26 November 2019 concerning the authorisation of phenylmethanethiol, benzyl methyl sulfide, sec-pentylthiophene, tridec-2-enal, 12-methyltridecanal, 2,5-dimethylphenol, hexa-2(trans),4(trans)-dienal and 2-ethyl-4- hydroxy-5-methyl-3(2H)-furanone as feed additives for cats and dogs (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. Article 10 of that Regulation provides for the re- evaluation of additives authorised pursuant to Council Directive 70/524/EEC (2). (2) Phenylmethanethiol, benzyl methyl sulfide, sec-pentylthiophene, tridec-2-enal, 12-methyltridecanal, 2,5- dimethylphenol, hexa-2(trans),4(trans)-dienal and 2-ethyl-4-hydroxy-5-methyl-3(2H)-furanone (‘the substances concerned’) were authorised as feed additives for cats and dogs without a time limit in accordance with Directive 70/524/EEC. Those feed additives 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 substances concerned for cats and dogs, requesting those feed additives to be classified in the additive category ‛sensory additives’. The 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 February 2019 (3) that, under the proposed conditions of use, the substances concerned do not have adverse effects on animal health or the environment. It also concluded that hazards for users have been identified. The applicant as required produced a safety data sheet for each compound where hazards for users have been identified. No studies to assess the safety for the user were submitted. Therefore, the EFSA cannot conclude on the safety for the users when handling the additives. The hazards described in the safety data sheet are, in particular, hazards for skin and eye contact were recognised for 2,5-dimethylphenol, 12-methyltridecanal, hexa-2(trans),4(trans)-dienal, phenylmethanethiol, benzyl methyl sulfide, 2-ethyl-4-hydroxy-5-methyl-3(2H)-furanone and sec-pentylthiophene. Hazard for respiratory exposure was recognised for 12-methyltridecanal, benzyl methyl sulfide and 2-pentylthiophene. In the absence of data, the Authority could not conclude on the risk for the users. Therefore, the Commission considers that appropriate protective measures should be taken to prevent effects on human health, in particular as regards the users of the feed additive. For non-food-producing animals Commission Regulation (EC) No 429/2008 (4), exempted additives intended for those animals from the environmental assessment as they do not have a significant environmental effect. Pets are not raised in large groups of animals so their effect on the environment is considered not significant. The Authority further concluded that since the substances concerned are used in food as flavourings and their function in feed is the same as that in food, no further demonstration of efficacy in feed is necessary. (1) OJ L 268, 18.10.2003, p. 29. (2) Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (OJ L 270, 14.12.1970, p. 1). (3) EFSA Journal 2019;17(3):5649. (4) Regulation (EC) No 429/2008 of 25 April 2008 on detailed rules for the implementation of Regulation (EC) No 1831/2003 of the European Parliament and of the Council as regards the preparation and the presentation of applications and the assessment and the authorisation of feed additives (OJ L 133, 22.5.2008, p. 1).L 308/46 E N O f f i c i a l J o u r n a l o f t h e E u r o p e an Union 29.11.2019 (5) The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the reports on the method of analysis in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003. (6) Restrictions and conditions should be provided for to allow for a better control. For the substances concerned 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. (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 for the use in feed. Accordingly, the use of those feed additives 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 1 Authorisation The 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 the Annex. Article 2 Transitional Measures 1. The substances specified in the Annex and premixtures containing those substances, which are produced and labelled before 19 December 2019 in accordance with the rules applicable before 19 December 2019 may continue to be placed on the market and used until 19 June 2020. 2. Compound feed and feed materials containing the substances as specified in the Annex which are produced and labelled before 19 December 2021 in accordance with the rules applicable before 19 December 2019 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for cats and dogs. Article 3 Entry into Force 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, 26 November 2019. For the Commission The President Jean- Claude JUNCKERANNEX Minimum Maximum content content Identification Name of the Species or End of period Composition, chemical formula, number of the holder of Additive category of Maximum age Other provisions of description, analytical method mg of active substance/kg of additive authorisation animal authorisation complete feedingstuff with a moisture content of 12 % Category: Sensory additives. Functional group: Flavouring compounds 2b5169 - 12-Methyl­ Additive composition: Cats and - - - 1. The additive shall be incorpo­ 19.12.2029 tridecanal 12-Methyltridecanal dogs rated into the feed in the form of a premixture. Characterisation of the active substance: 2. In the directions for use of the 12-Methyltridecanal additive and premixture, the Produced by chemical synthesis storage conditions, the stabi­ Purity: min. 97 % lity to heat treatment shall be Chemical formula: C H O 14 28 indicated. CAS number: 75853-49-5 3. On the label of the additive FLAVIS: 05.169 the following shall be indi­ Method of analysis (1): cated: For the determination of ‘Recommended maximum 12-methyltridecanal content of the active sub­ in the feed additive and in feed fla­ stance of complete feeding­ vouring premixtures: stuff with a moisture content Gas chromatography mass spectrome­ of 12 %: 0,5 mg/kg’ try with retention time locking GC-MS- 4. The functional group, the RTL. identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures, if the fol­ lowing content of the active substance in complete fee­ dingstuff with a moisture content of 12 % is exceeded: 0,5 mg/kg. 5. For users of the additive and premixtures, feed business operators shall establish op­ erational procedures and or­ ganisational measures to ad­ dress potential risks by 29.11.2019 E N O f f i c i a l J o u r n a l o f t h e E u r o p e a n Union L 308/47Minimum Maximum content content Identification Name of the Species or End of period Composition, chemical formula, number of the holder of Additive category of Maximum age Other provisions of description, analytical method mg of active substance/kg of additive authorisation animal authorisation complete feedingstuff with a moisture content of 12 % inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and mea­ sures, the additive and pre­ mixtures shall be used with personal protective equip­ ment, including breathing protection, safety glasses and gloves. 2b5057 - Hexa-2 Additive composition: Cats and - - - 1. The additive shall be incorpo­ 19.12.2029 (trans),4 Hexa-2(trans),4(trans)-dienal dogs rated into the feed in the form (trans)-die­ of a premixture. Characterisation of the active substance: nal 2. In the directions for use of the Hexa-2(trans),4(trans)-dienal additive and premixture, the Produced by chemical synthesis storage conditions, the stabi­ Purity: min. 97 % lity to heat treatment shall be Chemical formula: C H O 6 8 indicated. CAS number: 142-83-6 3. On the label of the additive FLAVIS: 05.057 the following shall be indi­ Method of analysis (1): cated: For the determination of hexa-2 ‘Recommended maximum (trans),4(trans)-dienal in the feed addi­ content of the active sub­ tive and in feed flavouring premixtures: stance of complete feeding­ Gas chromatography mass spectrome­ stuff with a moisture content try with retention time locking GC-MS- of 12 %: 1,5 mg/kg’ RTL. 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, if the fol­ lowing content of the active substance in complete fee­ dingstuff with a moisture content of 12 % is exceeded: 1,5 mg/kg. L 308/48 E N O f f i c i a l J o u r n a l o f t h e E u r o p e an Union 29.11.2019Minimum Maximum content content Identification Name of the Species or End of period Composition, chemical formula, number of the holder of Additive category of Maximum age Other provisions of description, analytical method mg of active substance/kg of additive authorisation animal authorisation complete feedingstuff with a moisture content of 12 % 5. For users of the additive and premixtures, feed business operators shall establish op­ erational procedures and or­ ganisational measures to ad­ dress potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and mea­ sures, the additive and pre­ mixtures shall be used with personal protective equip­ ment, including breathing protection safety glasses and gloves. 2b5078 - Tridec-2- Additive composition: Cats and - - - 1. The additive shall be incorpo­ 19.12.2029 enal Tridec-2-enal dogs rated into the feed in the form of a premixture. Characterisation of the active substance: 2. In the directions for use of the Tridec-2-enal additive and premixture, the Produced by chemical synthesis storage conditions, the stabi­ Purity: min. 92 % lity to heat treatment shall be Chemical formula: C H O 13 24 indicated. CAS number: 7774-82-5 3. On the label of the additive FLAVIS: 05.078 the following shall be indi­ Method of analysis (1): cated: For the determination of tridec-2-enal in the feed additive and in feed fla­ vouring premixtures: Gas chromatography mass spectrome­ try with retention time locking GC-MS- RTL. 29.11.2019 E N O f f i c i a l J o u r n a l o f t h e E u r o p e a n Union L 308/49Minimum Maximum content content Identification Name of the Species or End of period Composition, chemical formula, number of the holder of Additive category of Maximum age Other provisions of description, analytical method mg of active substance/kg of additive authorisation animal authorisation complete feedingstuff with a moisture content of 12 % ‘Recommended maximum content of the active sub­ stance of complete feeding­ stuff with a moisture content of 12 %: 0,5 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, if the fol­ lowing content of the active substance in complete fee­ dingstuff with a moisture content of 12 % is exceeded: 0,5 mg/kg. 5. For users of the additive and premixtures, feed business operators shall establish op­ erational procedures and or­ ganisational measures to ad­ dress potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and mea­ sures, the additive and pre­ mixtures shall be used with personal protective equip­ ment, including breathing protection, safety glasses and gloves. L 308/50 E N O f f i c i a l J o u r n a l o f t h e E u r o p e an Union 29.11.2019Minimum Maximum content content Identification Name of the Species or End of period Composition, chemical formula, number of the holder of Additive category of Maximum age Other provisions of description, analytical method mg of active substance/kg of additive authorisation animal authorisation complete feedingstuff with a moisture content of 12 % 2b13084 2-Ethyl-4- Additive composition: Cats and 1. The additive shall be incorpo­ 19.12.2029 hydroxy-5- 2-Ethyl-4-hydroxy-5-methyl-3 (2H)- dogs rated into the feed in the form methyl-3 furanone of a premixture. (2H)-fura­ 2. In the directions for use of the Characterisation of the active substance: none additive and premixture, the 2-Ethyl-4-hydroxy-5-methyl-3 (2H)- storage conditions, the stabi­ furanone lity to heat treatment shall be Produced by chemical synthesis indicated. Purity: min. 97 % 3. On the label of the additive Chemical formula: C H O 7 10 3 the following shall be indi­ CAS number: 27538-09-6 cated: FLAVIS: 13.084 ‘Recommended maximum Method of analysis (1): content of the active sub­ For the determination of stance of complete feeding­ 2-ethyl-4-hydroxy-5-methyl-3 (2H)- stuff with a moisture content furanone in the feed additive and in feed of 12 %: 2,25 mg/kg’ flavouring premixtures: 4. The functional group, the Gas chromatography mass spectrome­ identification number, the try with retention time locking GC-MS- name and the added amount RTL. of the active substance shall be indicated on the label of the premixtures, if the fol­ lowing content of the active substance in complete fee­ dingstuff with a moisture content of 12 % is exceeded: 2,25 mg/kg. 5. For users of the additive and premixtures, feed business operators shall establish op­ erational procedures and or­ ganisational measures to ad­ dress potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and mea­ 29.11.2019 E N O f f i c i a l J o u r n a l o f t h e E u r o p e a n Union L 308/51Minimum Maximum content content Identification Name of the Species or End of period Composition, chemical formula, number of the holder of Additive category of Maximum age Other provisions of description, analytical method mg of active substance/kg of additive authorisation animal authorisation complete feedingstuff with a moisture content of 12 % sures, the additive and pre­ mixtures shall be used with personal protective equip­ ment, including breathing protection, safety glasses and gloves. 2b12005 - Phenylme­ Additive composition: Cats and - - - 1. The additive shall be incorpo­ 19.12.2029 thanethiol Phenylmethanethiol dogs rated into the feed in the form of a premixture. Characterisation of the active substance: 2. In the directions for use of the Phenylmethanethiol additive and premixture, the Produced by chemical synthesis storage conditions, the stabi­ Purity: min. 99 % lity to heat treatment shall be Chemical formula: C H S 7 8 indicated. CAS number: 100-53-8 3. On the label of the additive FLAVIS: 12.005 the following shall be indi­ Method of analysis (1): cated: For the determination of phenyl­ ‘Recommended maximum methanethiol in the feed additive and in content of the active sub­ feed flavouring premixtures: stance of complete feeding­ Gas chromatography mass spectrome­ stuff with a moisture content try with retention time locking GC-MS- of 12 %: 0,05 mg/kg’ RTL. 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, if the fol­ lowing content of the active substance in complete fee­ dingstuff with a moisture content of 12 % is exceeded: 0,05 mg/kg. L 308/52 E N O f f i c i a l J o u r n a l o f t h e E u r o p e an Union 29.11.2019Minimum Maximum content content Identification Name of the Species or End of period Composition, chemical formula, number of the holder of Additive category of Maximum age Other provisions of description, analytical method mg of active substance/kg of additive authorisation animal authorisation complete feedingstuff with a moisture content of 12 % 5. For users of the additive and premixtures, feed business operators shall establish op­ erational procedures and or­ ganisational measures to ad­ dress potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and mea­ sures, the additive and pre­ mixtures shall be used with personal protective equip­ ment, including breathing protection, safety glasses and gloves. 2b12077 - Benzyl Additive composition: Cats and - - - 1. The additive shall be incorpo­ 19.12.2029 methyl sul­ Benzyl methyl sulfide dogs rated into the feed in the form fide of a premixture. Characterisation of the active substance: 2. In the directions for use of the Benzyl methyl sulfide additive and premixture, the Produced by chemical synthesis storage conditions, the stabi­ Purity: min. 99 % lity to heat treatment shall be Chemical formula: C H S 8 10 indicated. CAS number: 766-92-7 3. On the label of the additive FLAVIS: 12.077 the following shall be indi­ Method of analysis (1): cated: For the determination of benzyl methyl sulfide in the feed additive and in feed ‘Recommended maximum flavouring premixtures: content of the active sub­ Gas chromatography mass spectrome­ stance of complete feeding­ try with retention time locking GC-MS- stuff with a moisture content RTL. of 12 %: 0,05 mg/kg’ 29.11.2019 E N O f f i c i a l J o u r n a l o f t h e E u r o p e a n Union L 308/53Minimum Maximum content content Identification Name of the Species or End of period Composition, chemical formula, number of the holder of Additive category of Maximum age Other provisions of description, analytical method mg of active substance/kg of additive authorisation animal authorisation complete feedingstuff with a moisture content of 12 % 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, if the fol­ lowing content of the active substance in complete fee­ dingstuff 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 op­ erational procedures and or­ ganisational measures to ad­ dress potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and mea­ sures, the additive and pre­ mixtures shall be used with personal protective equip­ ment, including breathing protection, safety glasses and gloves. 2b4019 - 2,5-Di­ Additive composition: Cats and - - - 1. The additive shall be incorpo­ 19.12.2029 methylphe­ 2,5-Dimethylphenol dogs rated into the feed in the form nol of a premixture. Characterisation of the active substance: 2,5-Dimethylphenol Produced by chemical synthesis Purity: min. 99 % Chemical formula: C H O 8 10 L 308/54 E N O f f i c i a l J o u r n a l o f t h e E u r o p e an Union 29.11.2019Minimum Maximum content content Identification Name of the Species or End of period Composition, chemical formula, number of the holder of Additive category of Maximum age Other provisions of description, analytical method mg of active substance/kg of additive authorisation animal authorisation complete feedingstuff with a moisture content of 12 % CAS number: 95-87-4 2. In the directions for use of the FLAVIS: 04.019 additive and premixture, the storage conditions, the stabi­ Method of analysis (1): lity to heat treatment shall be For the determination of indicated. 2,5-dimethylphenol in the feed additive 3. On the label of the additive and in feed flavouring premixtures: the following shall be indi­ Gas chromatography mass spectrome­ cated: try with retention time locking GC-MS- RTL. ‘Recommended maximum content of the active sub­ stance of complete feeding­ stuff with a moisture content of 12 %: 1 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, if the fol­ lowing content of the active substance in complete fee­ dingstuff with a moisture content of 12 % is exceeded: 1 mg/kg. 5. For users of the additive and premixtures, feed business operators shall establish op­ erational procedures and or­ ganisational measures to ad­ dress potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and mea­ 29.11.2019 E N O f f i c i a l J o u r n a l o f t h e E u r o p e a n Union L 308/55Minimum Maximum content content Identification Name of the Species or End of period Composition, chemical formula, number of the holder of Additive category of Maximum age Other provisions of description, analytical method mg of active substance/kg of additive authorisation animal authorisation complete feedingstuff with a moisture content of 12 % sures, the additive and pre­ mixtures shall be used with personal protective equip­ ment, including breathing protection, safety glasses and gloves. 2b15096 - sec-Pen­ Additive composition: Cats and - - - 1. The additive shall be incorpo­ 19.12.2029 tylthio­ sec-Pentylthiophene dogs rated into the feed in the form phene of a premixture. Characterisation of the active substance: 2. In the directions for use of the sec-Pentylthiophene additive and premixture, the Produced by chemical synthesis storage conditions, the stabi­ Purity: min. 98 % lity to heat treatment shall be Chemical formula: C H S 9 14 indicated. CAS number: 4861-58-9 3. On the label of the additive FLAVIS: 15.096 the following shall be indi­ Method of analysis (1): cated: For the determination of sec- ‘Recommended maximum -pentylthiophene in the feed additive content of the active sub­ and in feed flavouring premixtures: stance of complete feeding­ Gas chromatography mass spectrome­ stuff with a moisture content try with retention time locking GC-MS- of 12 %: 0,1 mg/kg’ RTL. 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, if the fol­ lowing content of the active substance in complete fee­ dingstuff with a moisture content of 12 % is exceeded: 0,1 mg/kg. L 308/56 E N O f f i c i a l J o u r n a l o f t h e E u r o p e an Union 29.11.2019Minimum Maximum content content Identification Name of the Species or End of period Composition, chemical formula, number of the holder of Additive category of Maximum age Other provisions of description, analytical method mg of active substance/kg of additive authorisation animal authorisation complete feedingstuff with a moisture content of 12 % 5. For users of the additive and premixtures, feed business operators shall establish op­ erational procedures and or­ ganisational measures to ad­ dress potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and mea­ sures, the additive and pre­ mixtures shall be used with personal protective equip­ ment, including breathing protection, safety glasses and gloves. (1) Details of the methods of analysis are available at the following address of the Reference Laboratory: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports. 29.11.2019 E N O f f i c i a l J o u r n a l o f t h e E u r o p e a n Union L 308/57

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