Commission Implementing Regulation (EU) 2017/63 of 14 December 2016 concerning the authorisation of benzyl alcohol, 4-isopropylbenzyl alcohol, benzaldehyde, 4-isopropylbenzaldehyde, salicylaldehyde, p-tolualdehyde, 2-methoxybenzaldehyde, benzoic acid, benzyl acetate, benzyl butyrate, benzyl formate, benzyl propionate, benzyl hexanoate, benzyl isobutyrate, benzyl isovalerate, hexyl salicylate, benzyl phenylacetate, methyl benzoate, ethyl benzoate, isopentyl benzoate, pentyl salicylate and isobutyl benzoate as feed additives for all animal a species and of veratraldehyde and gallic acid as feed additives for certain animal species (Text with EEA relevance)
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Address https://gelex.eu/eli/EU/regulation/2017/63@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) Benzyl alcohol, 4-isopropylbenzyl alcohol, benzaldehyde, veratraldehyde, 4-isopropylbenzaldehyde, salicylaldehyde, p-tolualdehyde, 2-methoxybenzaldehyde, benzoic acid, gallic acid, benzyl acetate, benzyl butyrate, benzyl formate, benzyl propionate, benzyl hexanoate, benzyl isobutyrate, benzyl isovalerate, hexyl salicylate, benzyl phenylacetate, methyl benzoate, ethyl benzoate, isopentyl benzoate, pentyl salicylate and isobutyl benzoate (substances concerned) 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. Veratraldehyde for poultry and fish and gallic acid for fish will not be re-authorised as they were withdrawn by the applicant.
(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 benzyl alcohol, 4-isopropylbenzyl alcohol, benzaldehyde, 4-isopropylbenzaldehyde, salicylaldehyde, p-tolualdehyde, 2-methoxybenzaldehyde, benzoic acid, benzyl acetate, benzyl butyrate, benzyl formate, benzyl propionate, benzyl hexanoate, benzyl isobutyrate, benzyl isovalerate, hexyl salicylate, benzyl phenylacetate, methyl benzoate, ethyl benzoate, isopentyl benzoate, pentyl salicylate and isobutyl benzoate as feed additives for all animal a species and of veratraldehyde and gallic acid as feed additives for certain animal species. The applicant requested those additives 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 13 June 2012 that, under the proposed conditions of use 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 the substances concerned are efficacious, as they increase the food smell or palatability. Therefore, that conclusion can be extrapolated for feed. The Authority cannot conclude on the safety of the concerned substances in water for drinking. 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, except for benzoic acid, 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 in the absence of data the substances concerned should be considered as potentially hazardous to the respiratory tract, skin and eyes, 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 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 2b02010 — Benzyl alcohol All animal species — — — 6 February 2027 2b02039 — 4-Isopropylbenzyl alcohol All animal species — — — 6 February 2027 2b05013 — Benzaldehyde All animal species — — — 6 February 2027 2b05017 — Veratraldehyde All animal species except poultry and fish — — — 6 February 2027 2b05022 — 4-Isopropylbenzaldehyde All animal species — — 6 February 2027 2b05055 — Salicylaldehyde All animal species — — — 6 February 2027 2b05029 — p-Tolualdehyde All animal species — — — 6 February 2027 2b05129 — 2-Methoxybenzaldehyde All animal species — — — 6 February 2027 2b08021 — Benzoic acid All animal species — — 125 6 February 2027 2b08080 — Gallic acid All animal species except fish — — — 6 February 2027 2b09014 — Benzyl acetate All animal species — — — 6 February 2027 2b09051 — Benzyl butyrate All animal species — — — 6 February 2027 2b09077 — Benzyl formate All animal species — — — 6 February 2027 2b09132 — Benzyl propionate All animal species — — — 6 February 2027 2b09316 Benzyl hexanoate All animal species — — — 6 February 2027 2b09426 — Benzyl isobutyrate All animal species — — — 6 February 2027 2b09458 — Benzyl isovalerate All animal species — — — 6 February 2027 2b09581 — Hexyl salicylate All animal species — — — 6 February 2027 2b09705 — Benzyl phenylacetate All animal species — — — 6 February 2027 2b09725 — Methyl benzoate All animal species — — — 6 February 2027 2b09726 — Ethyl benzoate All animal species — — 6 February 2027 2b09755 — Isopentyl benzoate All animal species — — — 6 February 2027 2b09762 — Pentyl salicylate All animal species — — — 6 February 2027 2b09757 — Isobutyl benzoate All animal species — — — 6 February 2027
Additive composition
Benzyl alcohol
Characterisation of the active substance
Benzyl alcohol Produced by chemical synthesis Purity: min. 98 % Chemical formula: C7H8O CAS number 100-51-6 FLAVIS No 02.010
Method of analysis
For the determination of benzyl alcohol in the feed additive and in feed 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: 125 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 %: 125 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: 125 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 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 safety glasses and gloves.
Additive composition
4-Isopropylbenzyl alcohol
Characterisation of the active substance
4-Isopropylbenzyl alcohol Produced by chemical synthesis Purity: min. 97 % Chemical formula: C10H14O CAS number 536-60-7 FLAVIS No 02.039
Method of analysis
For the determination of 4-isopropylbenzyl alcohol in the feed additive and in feed 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: 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 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 safety glasses and gloves.
Additive composition
Benzaldehyde
Characterisation of the active substance
Benzaldehyde Produced by chemical synthesis Purity: min. 98 % Chemical formula: C7H6O CAS number 100-52-7 FLAVIS No 05.013
Method of analysis
For the determination of benzaldehyde in the feed additive and in feed 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: 25 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 %: 25 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: 25 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 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 safety glasses and gloves.
Additive composition
Veratraldehyde
Characterisation of the active substance
Veratraldehyde Produced by chemical synthesis Purity: min. 95 % Chemical formula: C9H10O3 CAS number 120-14-9 FLAVIS No 05.017
Method of analysis
For the identification of veratraldehyde 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: 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 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 safety glasses and gloves.
Additive composition
4-Isopropylbenzaldehyde
Characterisation of the active substance
4-Isopropylbenzaldehyde Produced by chemical synthesis Purity: min. 95 % Chemical formula: C10H12O CAS number 122-03-2 FLAVIS No 05.022
Method of analysis
For the determination of 4-isopropylbenzaldehyde in the feed additive and in feed 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: 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 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 safety glasses and gloves.
Additive composition
Salicylaldehyde
Characterisation of the active substance
Salicylaldehyde Produced by chemical synthesis Purity: min. 95 % Chemical formula: C7H6O2 CAS number 90-02-8 FLAVIS No 05.055
Method of analysis
For the identification of salicylaldehyde 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: 1 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.
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.
6. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by 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 safety glasses and gloves.
Additive composition
p-Tolualdehyde
Characterisation of the active substance
p-Tolualdehyde Produced by chemical synthesis Purity: min. 97 % Chemical formula: C8H8O CAS number 104-87-0 FLAVIS No 05.029
Method of analysis
For the determination of p-tolualdehyde in the feed additive and in feed 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: 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 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 safety glasses and gloves.
Additive composition
2-Methoxybenzaldehyde
Characterisation of the active substance
2-Methoxybenzaldehyde Produced by chemical synthesis Purity: min. 97 % Chemical formula: C8H8O2 CAS number 135-02-4 FLAVIS No 05.129
Method of analysis
For the identification of 2-methoxybenzaldehyde 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: 1 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.
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.
6. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by 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 safety glasses and gloves.
Additive composition
Benzoic acid
Characterisation of the active substance
Benzenecarboxylic acid, phenylcarboxylic acid Produced by chemical synthesis Purity: min. 99 % Chemical formula: C7H6O2 CAS number 65-85-0 FLAVIS No 08.021 Maximum level of impurities Phthalic acid: ≤ 100 mg/kg; Biphenyl: ≤ 100 mg/kg
Method of analysis
For the determination of benzoic acid in the feed additive and in feed 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. For users of the additive and premixtures in a feed business, operational procedures and appropriate organisational measures shall be established to address hazards by inhalation, dermal contact or eyes contact. Where the dermal, inhalatory or eyes exposure cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment.
Additive composition
Gallic acid
Characterisation of the active substance
Gallic acid Produced by chemical synthesis Purity: min. 95 % Chemical formula: C7H6O5 CAS number 149-91-7 FLAVIS No 08.080
Method of analysis
For the identification of gallic acid 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: 25 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 %: 25 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: 25 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 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 safety glasses and gloves.
Additive composition
Benzyl acetate
Characterisation of the active substance
Benzyl acetate Produced by chemical synthesis Purity: min. 98 % Chemical formula: C9H10O2 CAS number 140-11-4 FLAVIS No 09.014
Method of analysis
For the determination of benzyl acetate in the feed additive and in feed 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: 125 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 %: 125 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: 125 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 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 safety glasses and gloves.
Additive composition
Benzyl butyrate
Characterisation of the active substance
Benzyl butyrate Produced by chemical synthesis Purity: min. 98 % Chemical formula: C11H14O2 CAS number 103-37-7 FLAVIS No 09.051
Method of analysis
For the determination of benzyl butyrate in the feed additive and in feed 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: 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 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 safety glasses and gloves.
Additive composition
Benzyl formate
Characterisation of the active substance
Benzyl formate Produced by chemical synthesis Purity: min. 95 % Chemical formula: C8H8O2 CAS number 104-57-4 FLAVIS No 09.077
Method of analysis
For the determination of benzyl formate in the feed additive and in feed 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: 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 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 safety glasses and gloves.
Additive composition
Benzyl propionate
Characterisation of the active substance
Benzyl propionate Produced by chemical synthesis Purity: min. 98 % Chemical formula: C10H12O2 CAS number 122-63-4 FLAVIS No 09.132
Method of analysis
For the determination of benzyl propionate in the feed additive and in feed 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: 25 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 %: 25 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: 25 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 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 safety glasses and gloves.
Additive composition
Benzyl hexanoate
Characterisation of the active substance
Benzyl hexanoate Produced by chemical synthesis Purity: min. 99 % Chemical formula: C13H18O2 CAS number 6938-45-0 FLAVIS No 09.316
Method of analysis
For the identification of benzyl hexanoate 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 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 safety glasses and gloves.
Additive composition
Benzyl isobutyrate
Characterisation of the active substance
Benzyl isobutyrate Produced by chemical synthesis Purity: min. 97 % Chemical formula: C11H14O2 CAS number 103-28-6 FLAVIS No 09.426
Method of analysis
For the determination of benzyl isobutyrate in the feed additive and in feed 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: 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 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 safety glasses and gloves.
Additive composition
Benzyl isovalerate
Characterisation of the active substance
Benzyl isovalerate Produced by chemical synthesis Purity: min. 98 % Chemical formula: C12H16O2 CAS number 103-38-8 FLAVIS No 09.458
Method of analysis
For the determination of benzyl isovalerate in the feed additive and in feed 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: 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 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 safety glasses and gloves.
Additive composition
Hexyl salicylate
Characterisation of the active substance
Hexyl salicylate Produced by chemical synthesis Purity: min. 99 % Chemical formula: C13H18O3 CAS number 6259-76-3 FLAVIS No 09.581
Method of analysis
For the identification of hexyl salicylate 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: 1 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.
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.
6. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by 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 safety glasses and gloves.
Additive composition
Benzyl phenylacetate
Characterisation of the active substance
Benzyl phenylacetate Produced by chemical synthesis Purity: min. 98 % Chemical formula: C15H14O2 CAS number 102-16-9 FLAVIS No 09.705
Method of analysis
For the determination of benzyl phenylacetate in the feed additive and in feed 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: 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 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 safety glasses and gloves.
Additive composition
Methyl benzoate
Characterisation of the active substance
Methyl benzoate Produced by chemical synthesis Purity: min. 98 % Chemical formula: C8H8O2 CAS number 93-58-3 FLAVIS No 09.725
Method of analysis
For the determination of methyl benzoate in the feed additive and in feed 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: 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 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 safety glasses and gloves.
Additive composition
Ethyl benzoate
Characterisation of the active substance
Ethyl benzoate Produced by chemical synthesis Purity: min. 98 % Chemical formula: C9H10O2 CAS number 93-89-0 FLAVIS No 09.726
Method of analysis
For the determination of ethyl benzoate in the feed additive and in feed 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: 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 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 safety glasses and gloves.
Additive composition
Isopentyl benzoate
Characterisation of the active substance
Isopentyl benzoate Produced by chemical synthesis Purity: min. 98 % Chemical formula: C12H16O2 CAS number 94-46-2 FLAVIS No 09.755
Method of analysis
For the determination of isopentyl benzoate in the feed additive and in feed 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: 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 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 safety glasses and gloves.
Additive composition
Pentyl salicylate
Characterisation of the active substance
Pentyl salicylate Produced by chemical synthesis Purity: min. 95 % Chemical formula C12H16O3 CAS number 2050-08-0 FLAVIS No 09.762
Method of analysis
For the identification of pentyl salicylate 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: 1 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.
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.
6. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by 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 safety glasses and gloves.
Additive composition
Isobutyl benzoate
Characterisation of the active substance
Isobutyl benzoate Produced by chemical synthesis Purity: min. 98 % Chemical formula: C11H14O2 CAS number 120-50-3 FLAVIS No 09.757
Method of analysis
For the determination of isobutyl benzoate in the feed additive and in feed 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: 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 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 safety glasses and gloves.