Commission Implementing Regulation (EU) 2017/59 of 14 December 2016 concerning the authorisation of 1,1-dimethoxy-2-phenylethane, phenethyl formate, phenethyl octanoate, phenethyl isobutyrate, phenethyl 2-methyl-butyrate and phenethyl benzoate as feed additives for all animal species (Text with EEA relevance)
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Address https://gelex.eu/eli/EU/regulation/2017/59@2016-12-14/en
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, 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) 1,1-Dimethoxy-2-phenylethane, phenethyl formate, phenethyl octanoate, phenethyl isobutyrate, phenethyl 2-methyl-butyrate and phenethyl benzoate (the substances concerned) were authorised without a time limit in accordance with Directive 70/524/EEC as feeds 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 substances concerned 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 7 March 2012 that, under the proposed conditions of use in feed, the substances concerned do not have adverse effects on animal health, human health or the environment. The Authority further concluded that the function of the substances concerned in feed is similar to that on food. The Authority has already concluded that for food those substances are efficacious, as they increase the food smell or palatability. Therefore, that conclusion can be extrapolated for feed. As the use of the substances concerned in water for drinking is difficult to control when used simultaneously with feed such use should be excluded. However, those substances can be used within compound feeds which are subsequently administered via water.
(5) Restrictions and conditions should be provided for to allow better control. Since safety reasons do not require the setting of a maximum content and taking into account the re-evaluation performed by the Authority, 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, compound feeds and feed materials.
(6) The Authority concluded that the substances concerned are considered as irritant to eyes and respiratory tract, skin sensitisers and harmful if swallowed. Consequently, appropriate protective measures should be taken. 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 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 Transitional measures
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.
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, 14 December 2016. For the Commission The President Jean-Claude Juncker
ANNEX
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 2b06006 — 1,1-Dimethoxy-2-phenylethane All animal species — — — 6 February 2027 2b09083 — Phenethyl formate All animal species — — — 6 February 2027 2b09262 — Phenethyl octanoate All animal species — — — 6 February 2027 2b09427 — Phenethyl isobutyrate All animal species — — — 6 February 2027 2b09538 — Phenethyl 2-methyl-butyrate All animal species — — — 6 February 2027 2b09774 — Phenethyl benzoate All animal species — — — 6 February 2027
Additive composition
1,1-Dimethoxy-2-phenylethane
Characterisation of the active substance
1,1-Dimethoxy-2-phenylethane Produced by chemical synthesis Purity: min. 95 % Chemical formula: C10H14O2 CAS number 101-48-4 FLAVIS No 06.006
Method of analysis
For the identification of 1,1-dimethoxy-2-phenylethane in the feed additive and flavouring premixtures: Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.
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: 1 mg/kg, and for other species and categories: 1,5 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 %:
1 mg/kg for pigs and poultry;
1,5 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:
1 mg/kg for pigs and poultry;
1,5 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.
Additive composition
Phenethyl formate
Characterisation of the active substance
Phenethyl formate Produced by chemical synthesis Purity: min. 96 % Chemical formula: C9H10O2 CAS number 104-62-1 FLAVIS No 09.083
Method of analysis
For the identification of phenethyl formate in the feed additive and flavouring premixtures: Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.
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: 1 mg/kg, and for other species and categories: 1,5 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 %:
1 mg/kg for pigs and poultry;
1,5 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:
1 mg/kg for pigs and poultry;
1,5 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.
Additive composition
Phenethyl octanoate
Characterisation of the active substance
Phenethyl octanoate Produced by chemical synthesis Purity: min. 98 % Chemical formula: C16H24O2 CAS number 5457-70-5 FLAVIS No 09.262
Method of analysis
For the identification of phenethyl octanoate in the feed additive and flavouring premixtures: Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.
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: 1 mg/kg, and for other species and categories: 1,5 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 %:
1 mg/kg for pigs and poultry;
1,5 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:
1 mg/kg for pigs and poultry;
1,5 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.
Additive composition
Phenethyl isobutyrate
Characterisation of the active substance
Phenethyl isobutyrate Produced by chemical synthesis Purity: min. 98 % Chemical formula: C12H16O2 CAS number 103-48-0 FLAVIS No 09.427
Method of analysis
For the identification of phenethyl isobutyrate in the feed additive and flavouring premixtures: Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.
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: 1 mg/kg, and for other species and categories: 1,5 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 %:
1 mg/kg for pigs and poultry;
1,5 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:
1 mg/kg for pigs and poultry;
1,5 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.
Additive composition
Phenethyl 2-methyl-butyrate
Characterisation of the active substance
Phenethyl 2-methyl-butyrate Produced by chemical synthesis Purity: min. 95 % Chemical formula: C13H18O2 CAS number 24817-51-4 FLAVIS No 09.538
Method of analysis
For the identification of phenethyl 2-methyl-butyrate in the feed additive and flavouring premixtures: Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.
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: 1 mg/kg, and for other species and categories: 1,5 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 %:
1 mg/kg for pigs and poultry;
1,5 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:
1 mg/kg for pigs and poultry;
1,5 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..
Additive composition
Phenethyl benzoate
Characterisation of the active substance
Phenethyl benzoate Produced by chemical synthesis Purity: min. 98 % Chemical formula: C15H14O2 CAS number 94-47-3 FLAVIS No 09.774
Method of analysis
For the identification of phenethyl benzoate in the feed additive and flavouring premixtures: Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.
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: 1 mg/kg, and for other species and categories: 1,5 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 %:
1 mg/kg for pigs and poultry;
1,5 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 content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded:
1 mg/kg for pigs and poultry;
1,5 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.