Commission Implementing Regulation (EU) 2018/244 of 15 February 2018 concerning the authorisation of vanillyl acetone and 4-(4-methoxyphenyl) butan-2-one as feed additives for all animal species and the denial of 1-phenylethan-1-ol (Text with EEA relevance. )
Date: 2018-02-15
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: animal feedingstuffs, flavouring, market approval




L_2018053EN.01008101.xml










23.2.2018   


EN


Official Journal of the European Union


L 53/81








            COMMISSION IMPLEMENTING REGULATION (EU) 2018/244
of 15 February 2018
         
concerning the authorisation of vanillyl acetone and 4-(4-methoxyphenyl) butan-2-one as feed additives for all animal species and the denial of 1-phenylethan-1-ol
(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).





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 that Annex.


Article 2

Denial

The authorisation of 1-phenylethan-1-ol, as additive belonging to the additive category ‘sensory additives’ and to the functional group ‘flavouring compounds’ is denied.


Article 3

Transitional measures


1.   Vanillyl acetone, 4-(4-methoxyphenyl) butan-2-one and 1-phenylethan-1-ol and premixtures containing those substances, which are produced and labelled before 15 September 2018 in accordance with the rules applicable before 15 March 2018 may continue to be placed on the market and used until the existing stocks are exhausted.


2.   Feed materials and compound feed containing vanillyl acetone, 4-(4-methoxyphenyl) butan-2-one and 1-phenylethan-1-ol which are produced and labelled before 15 March 2019 in accordance with the rules applicable before 15 March 2018 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.   Feed materials and compound feed containing vanillyl acetone, 4-(4-methoxyphenyl) butan-2-one and 1-phenylethan-1-ol which are produced and labelled before 15 March 2020 in accordance with the rules applicable before 15 March 2018 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 4

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, 15 February 2018.


For the Commission


The President

Jean-Claude JUNCKER
            





(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 2016;14(8):4557.




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 %





Category: Sensory additives. Functional group: Flavouring compounds






2b07005


—


Vanillyl acetone



Additive composition

Vanillyl acetone

Characterisation of the active substance

Vanillyl acetone
Produced by chemical synthesis
Purity: min. 95 % assay
Chemical formula: C11H14O3

CAS number: 122-48-5
FLAVIS No: 07.005

Method of analysis
 (1)

For the determination of vanillyl acetone 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 label of the premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds: 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.






15.3.2028




2b07029


—


4-(4-Methoxyphenyl) butan-2-one



Additive composition

4-(4-Methoxyphenyl) butan-2-one

Characterisation of the active substance

4-(4-Methoxyphenyl) butan-2-one
Produced by chemical synthesis
Purity: min. 96 % assay
Chemical formula: C11H14O2

CAS number 104-20-1
FLAVIS No 07.029

Method of analysis
 (1)

For the determination of 4-(4-methoxyphenyl) butan-2-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 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 label of the premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds: 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.






15.3.2028






(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.