Commission Implementing Regulation (EU) 2017/57 of 14 December 2016 concerning the authorisation of 1,8-cineole, 3,4-dihydrocoumarin and 2-(2-methylprop-1-enyl)-4-methyltetrahydropyran as feed additives for all animal species (Text with EEA relevance. )

Authorisation

Article 1

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 that Annex.

Transitional measures

Article 2

1.   The substances as specified in the Annex and premixtures containing those substances, which are produced and labelled before 6 August 2017 in accordance with the rules applicable before 6 February 2017 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 6 February 2018 in accordance with the rules applicable before 6 February 2017 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 6 February 2019 in accordance with the rules applicable before 6 February 2017 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.

Entry into force

Article 3

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .

ANNEXSupplementary provisions

ANNEX Identification number of the additive Name of the holder of authorisation Additive 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 of active substance/kg of complete feedingstuff with a moisture content of 12 % (1) (2) (3) (4) (5) (6) (7) (8) (9) Category: Sensory additives. Functional group: Flavouring compounds 2b03001 — 1,8-Cineole Additive composition 1,8-Cineole Characterisation of the active substance 1,8-Cineole Produced by distillation from Eucalyptus globulus Purity: min. 98 % Chemical formula: C 10 H 18 O CAS number 470-82-6 FLAVIS No 03.001 Method of analysis  ( 1 ) For the determination of 1,8-cineole 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 premixtures, the storage and stability conditions shall be indicated. 3. The recommended maximum content of the active substance shall be: 5 mg/kg of complete feedingstuff with a moisture content of 12 %. 4. 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 %: 5 mg/kg’. 5. The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 5 mg/kg. 6. 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. 6 February 2027 2b13009 — 3,4-Dihydrocoumarin Additive composition 3,4-Dihydrocoumarin Characterisation of the active substance 3,4-Dihydrocoumarin Produced by chemical synthesis Purity: min. 99 % Chemical formula: C 9 H 8 O 2 CAS number 119-84-6 FLAVIS No 13.009 Method of analysis  ( 1 ) For the determination of 3,4-dihydrocoumarin 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 premixtures, the storage and stability conditions shall be indicated. 3. The recommended maximum content of the active substance shall be: 5 mg/kg of complete feedingstuff with a moisture content of 12 %. 4. 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 %: 5 mg/kg’ 5. The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 5 mg/kg. 6. 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. 6 February 2027 2b13037 — 2-(2-Methylprop-1-enyl)-4-methyltetrahydropyran Additive composition 2-(2-Methylprop-1-enyl)-4-methyltetrahydropyran Characterisation of the active substance 2-(2-Methylprop-1-enyl)-4-methyltetrahydropyran Produced by chemical synthesis Purity: min. 99 % Chemical formula: C 10 H 18 O CAS number 16409-43-1 FLAVIS No 13.037 Method of analysis  ( 1 ) For the identification of 2-(2-methylprop-1-enyl)-4-methyltetrahydropyran in the feed additive and 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 premixtures, the storage and stability conditions shall be indicated. 3. The recommended maximum content of the active substance shall be: For pigs and poultry: 0,5 mg/kg, and for other species and categories: 0,3 mg/kg of complete feedingstuff with a moisture content of 12 %. 4. 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 %: — 0,5 mg/kg for pigs and poultry; — 0,3 mg/kg for other species and categories.’ 5. The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compound feedingstuffs, if the following contents of the active substance in complete feedingstuff with a moisture content of 12 % are exceeded: — 0,5 mg/kg for pigs and poultry; — 0,3 mg/kg for other species and categories. 6. 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. 6 February 2027 ( 1 )   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-reports