Commission Implementing Regulation (EU) 2017/54 of 14 December 2016 concerning the authorisation of 2-methylpropan-1-ol, isopentanol, 3,7-dimethyloctan-1-ol, 2-ethylhexan-1-ol, 2-methylpropanal, 3-methylbutanal, 2-methylbutyraldehyde, 3-methylbutyric acid, 2-methylvaleric acid, 2-ethylbutyric acid, 2-methylbutyric acid, 2-methylheptanoic acid, 4-methylnonanoic acid, 4-methyloctanoic acid, isobutyl acetate, isobutyl butyrate, 3-methylbutyl hexanoate, 3-methylbutyl dodecanoate, 3-methylbutyl octanoate, 3-methylbutyl propionate, 3-methylbutyl formate, glyceryl tributyrate, isobutyl isobutyrate, isopentyl isobutyrate, isobutyl isovalerate, isopentyl 2-methylbutyrate, 2-methylbutyl isovalerate and 2-methylbutyl butyrate as feed additives for all animal species (Text with EEA relevance)
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Address https://gelex.eu/eli/EU/regulation/2017/54@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) 2-Methylpropan-1-ol, isopentanol, 3,7-dimethyloctan-1-ol, 2-ethylhexan-1-ol, 2-methylpropanal, 3-methylbutanal, 2-methylbutyraldehyde, 3-methylbutyric acid, 2-methylvaleric acid, 2-ethylbutyric acid, 2-methylbutyric acid, 2-methylheptanoic acid, 4-methylnonanoic acid, 4-methyloctanoic acid, isobutyl acetate, isobutyl butyrate, 3-methylbutyl hexanoate, 3-methylbutyl dodecanoate, 3-methylbutyl octanoate, 3-methylbutyl propionate, 3-methylbutyl formate, glyceryl tributyrate, isobutyl isobutyrate, isopentyl isobutyrate, isobutyl isovalerate, isopentyl 2-methylbutyrate, 2-methylbutyl isovalerate and 2-methylbutyl butyrate, herereinafter referred to as the 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.
(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. This 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 17 October 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 those substances are flavouring agents authorised in food for which the efficacy is demonstrated as the functions of the additive applied for feed use and described for food use are similar.
(5) The Authority concluded that no safety concerns would arise for users provided that appropriate protective measures are 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.
(6) 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. Maximum recommended contents should be set up for those substances. Those substances may be used within a compound feed subsequently administered via water.
(7) 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.
(8) 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 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 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 2b02001 — 2-Methylpropan-1-ol All animal species — — — 6 February 2027 2b02003 — Isopentanol All animal species — — — 6 February 2027 2b02026 — 3,7-Dimethyloctan-1-ol All animal species — — — 6 February 2027 2b02082 — 2-Ethylhexan-1-ol All animal species — — — 6 February 2027 2b05004 — 2-Methylpropanal All animal species — — — 6 February 2027 2b05006 — 3-Methylbutanal All animal species — — — 6 February 2027 2b05049 — 2-Methylbutyraldehyde All animal species — — — 6 February 2027 2b08008 — 3-Methylbutyric acid All animal species — — — 6 February 2027 2b08031 — 2-Methylvaleric acid All animal species — — — 6 February 2027 2b08045 — 2-Ethylbutyric acid All animal species — — — 6 February 2027 2b08046 — 2-Methylbutyric acid All animal species — — — 6 February 2027 2b08047 — 2-Methylheptanoic acid All animal species — — — 6 February 2027 2b08062 — 4-Methylnonanoic acid All animal species — — — 6 February 2027 2b08063 — 4-Methyloctanoic acid All animal species — — — 6 February 2027 2b09005 — Isobutyl acetate All animal species — — — 6 February 2027 2b09043 — Isobutyl butyrate All animal species — — — 6 February 2027 2b09070 — 3-Methylbutyl hexanoate All animal species — — — 6 February 2027 2b09103 — 3-Methylbutyl dodecanoate All animal species — — — 6 February 2027 2b09120 — 3-Methylbutyl octanoate All animal species — — — 6 February 2027 2b09136 — 3-Methylbutyl propionate All animal species — — — 6 February 2027 2b09162 — 3-Methylbutyl formate All animal species — — — 6 February 2027 2b09211 — Glyceryl tributyrate All animal species — — — 6 February 2027 2b09417 — Isobutyl isobutyrate All animal species — — — 6 February 2027 2b09419 — Isopentyl isobutyrate All animal species — — — 6 February 2027 2b09472 — Isobutyl isovalerate All animal species — — — 6 February 2027 2b09530 — Isopentyl 2-methylbutyrate All animal species — — — 6 February 2027 2b09531 — 2-Methylbutyl isovalerate All animal species — — — 6 February 2027 2b09659 — 2-Methylbutyl butyrate All animal species — — — 6 February 2027
Additive composition
2-Methylpropan-1-ol
Characterisation of the active substance
2-Methylpropan-1-ol Produced by chemical synthesis Purity: min. 98 % Chemical formula: C4H10O CAS number 78-83-1 FLAVIS 02.001
Method of analysis
For the determination of 2-Methylpropan-1-ol 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 recommended maximum content of the active substance in complete feed shall be indicated.
5. Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.
6. For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks 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
Isopentanol
Characterisation of the active substance
Isopentanol Produced by chemical synthesis Purity: min. 98 % Chemical formula: C5H12O CAS number 123-51-3 FLAVIS 02.003
Method of analysis
For the determination of Isopentanol 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 recommended maximum content of the active substance in complete feed shall be indicated.
5. Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.
6. For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks 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
3,7-Dimethyloctan-1-ol
Characterisation of the active substance
3,7-Dimethyloctan-1-ol Produced by chemical synthesis Purity: min. 90 % Chemical formula: C10H22O CAS number 106-21-8 FLAVIS 02.026
Method of analysis
For the identification of 3,7-Dimethyloctan-1-ol 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 all 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 recommended maximum content of the active substance in complete feed shall be indicated.
5. Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.
6. For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks 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
2-Ethylhexan-1-ol
Characterisation of the active substance
2-Ethylhexan-1-ol Produced by chemical synthesis Purity: min. 97 % Chemical formula: C8H18O CAS number 104-76-7 FLAVIS 02.082
Method of analysis
For the determination of 2-Ethylhexan-1-ol 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 recommended maximum content of the active substance in complete feed shall be indicated.
5. Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.
6. For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks 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
2-Methylpropanal
Characterisation of the active substance
2-Methylpropanal Produced by chemical synthesis Purity: min. 98 % Chemical formula: C4H8O CAS number 78-84-2 FLAVIS 05.004
Method of analysis
For the determination of 2-Methylpropanal 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 recommended maximum content of the active substance in complete feed shall be indicated.
5. Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.
6. For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks 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
3-Methylbutanal
Characterisation of the active substance
3-Methylbutanal Produced by chemical synthesis Purity: min. 95 % Chemical formula: C5H10O CAS number 590-86-3 FLAVIS 05.006
Method of analysis
For the determination of 3-Methylbutanal 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 recommended maximum content of the active substance in complete feed shall be indicated.
5. Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.
6. For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks 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
2-Methylbutyraldehyde
Characterisation of the active substance
2-Methylbutyraldehyde Produced by chemical synthesis Purity: min. 97 % Chemical formula: C5H10O CAS number 96-17-3 FLAVIS 05.049
Method of analysis
For the determination of 2-Methylbutyraldehyde 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 recommended maximum content of the active substance in complete feed shall be indicated.
5. Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.
6. For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks 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
3-Methylbutyric acid
Characterisation of the active substance
3-Methylbutyric acid Produced by chemical synthesis Purity: min. 99 % Chemical formula: C5H10O2 CAS number 503-74-2 FLAVIS 08.008
Method of analysis
For the determination of 3-Methylbutyric 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. 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 recommended maximum content of the active substance in complete feed shall be indicated.
5. Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.
6. For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks 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
2-Methylvaleric acid
Characterisation of the active substance
2-Methylvaleric acid Produced by chemical synthesis Purity: min. 98 % Chemical formula: C6H12O2 CAS number 97-61-0 FLAVIS 08.031
Method of analysis
For the determination of 2-Methylvaleric 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. 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 recommended maximum content of the active substance in complete feed shall be indicated.
5. Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.
6. For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks 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
2-Ethylbutyric acid
Characterisation of the active substance
2-Ethylbutyric acid Produced by chemical synthesis Purity: min. 98 % Chemical formula: C6H12O2 CAS number 88-09-5 FLAVIS 08.045
Method of analysis
For the determination of 2-Ethylbutyric 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. 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 recommended maximum content of the active substance in complete feed shall be indicated.
5. Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.
6. For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks 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
2-Methylbutyric acid
Characterisation of the active substance
2-Methylbutyric acid Produced by chemical synthesis Purity: min. 98 % Chemical formula: C5H10O2 CAS number 116-53-0 FLAVIS 08.046
Method of analysis
For the determination of 2-Methylbutyric 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. 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 recommended maximum content of the active substance in complete feed shall be indicated.
5. Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.
6. For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks 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
2-Methylheptanoic acid
Characterisation of the active substance
2-Methylheptanoic acid Produced by chemical synthesis Purity: min. 97 % Chemical formula: C8H16O2 CAS number 1188-02-9 FLAVIS 08.047
Method of analysis
For the determination of 2-Methylheptanoic 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. 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 recommended maximum content of the active substance in complete feed shall be indicated.
5. Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.
6. For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks 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
4-Methylnonanoic acid
Characterisation of the active substance
4-Methylnonanoic acid Produced by chemical synthesis Purity: min. 98 % Chemical formula: C10H20O2 CAS number 45019-28-1 FLAVIS 08.062
Method of analysis
For the identification of 4-Methylnonanoic 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: for pigs and poultry: 1 mg/kg, and for all 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 recommended maximum content of the active substance in complete feed shall be indicated.
5. Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.
6. For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks 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
4-Methyloctanoic acid
Characterisation of the active substance
4-Methyloctanoic acid Produced by chemical synthesis Purity: min. 97 % Chemical formula: C9H18O2 CAS number 54947-74-9 FLAVIS 08.063
Method of analysis
For the determination of 4-Methyloctanoic 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. 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 recommended maximum content of the active substance in complete feed shall be indicated.
5. Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.
6. For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks 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
Isobutyl acetate
Characterisation of the active substance
Isobutyl acetate Produced by chemical synthesis Purity: min. 95 % Chemical formula: C6H12O2 CAS number 110-19-0 FLAVIS 09.005
Method of analysis
For the determination of Isobutyl 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 5 mg/kg of complete feedingstuff with a moisture content of 12 %.
4. On the label of the additive, the recommended maximum content of the active substance in complete feed shall be indicated.
5. Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.
6. For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks 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
Isobutyl butyrate
Characterisation of the active substance
Isobutyl butyrate Produced by chemical synthesis Purity: min. 98 % Chemical formula: C8H16O2 CAS number 539-90-2 FLAVIS 09.043
Method of analysis
For the determination of Isobutyl 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 recommended maximum content of the active substance in complete feed shall be indicated.
5. Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.
6. For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks 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
3-Methylbutyl hexanoate
Characterisation of the active substance
3-Methylbutyl hexanoate Produced by chemical synthesis Purity: min. 98 % Chemical formula: C11H22O2 CAS number 2198-61-0 FLAVIS 09.070
Method of analysis
For the identification of 3-Methylbutyl 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 all 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 recommended maximum content of the active substance in complete feed shall be indicated.
5. Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.
6. For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks 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
3-Methylbutyl dodecanoate
Characterisation of the active substance
3-Methylbutyl dodecanoate Produced by chemical synthesis Purity: min. 97 % Chemical formula: C17H34O2 CAS number 6309-51-9 FLAVIS 09.103
Method of analysis
For the identification of 3-Methylbutyl dodecanoate 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 all 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 recommended maximum content of the active substance in complete feed shall be indicated.
5. Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.
6. For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks 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
3-Methylbutyl octanoate
Characterisation of the active substance
3-Methylbutyl octanoate Produced by chemical synthesis Purity: min. 98 % Chemical formula: C13H26O2 CAS number 2035-99-6 FLAVIS 09.120
Method of analysis
For the identification of 3-Methylbutyl 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 all 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 recommended maximum content of the active substance in complete feed shall be indicated.
5. Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.
6. For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks 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
3-Methylbutyl propionate
Characterisation of the active substance
3-Methylbutyl propionate Produced by chemical synthesis Purity: min. 98 % Chemical formula: C8H16O2 CAS number 105-68-0 FLAVIS 09.136
Method of analysis
For the determination of 3-Methylbutyl 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 5 mg/kg of complete feedingstuff with a moisture content of 12 %.
4. On the label of the additive, the recommended maximum content of the active substance in complete feed shall be indicated.
5. Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.
6. For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks 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
3-Methylbutyl formate
Characterisation of the active substance
3-Methylbutyl formate Produced by chemical synthesis Purity: min. 92 % Chemical formula: C6H12O2 CAS number 110-45-2 FLAVIS 09.162
Method of analysis
For the determination of 3-Methylbutyl 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 recommended maximum content of the active substance in complete feed shall be indicated.
5. Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.
6. For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks 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
Glyceryl tributyrate
Characterisation of the active substance
Glyceryl tributyrate Produced by chemical synthesis Purity: min. 99 % Chemical formula: C15H26O6 CAS number 60-01-5 FLAVIS 09.211
Method of analysis
For the determination of Glyceryl tributyrate 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 recommended maximum content of the active substance in complete feed shall be indicated.
5. Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.
6. For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks 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
Isobutyl isobutyrate
Characterisation of the active substance
Isobutyl isobutyrate Produced by chemical synthesis Purity: min. 98 % Chemical formula: C8H16O2 CAS number 97-85-8 FLAVIS 09.417
Method of analysis
For the determination of Isobutyl 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 recommended maximum content of the active substance in complete feed shall be indicated.
5. Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.
6. For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks 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
Isopentyl isobutyrate
Characterisation of the active substance
Isopentyl isobutyrate Produced by chemical synthesis Purity: min. 98 % Chemical formula: C9H18O2 CAS number 2050-01-3 FLAVIS 09.419
Method of analysis
For the determination of Isopentyl 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 recommended maximum content of the active substance in complete feed shall be indicated.
5. Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.
6. For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks 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
Isobutyl isovalerate
Characterisation of the active substance
Isobutyl isovalerate Produced by chemical synthesis Purity: min. 98 % Chemical formula: C9H18O2 CAS number 589-59-3 FLAVIS 09.472
Method of analysis
For the determination of Isobutyl 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 recommended maximum content of the active substance in complete feed shall be indicated.
5. Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.
6. For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks 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
Isopentyl 2-methylbutyrate
Characterisation of the active substance
Isopentyl 2-methylbutyrate Produced by chemical synthesis Purity: min. 95 % Chemical formula: C10H20O2 CAS number 27625-35-0 FLAVIS 09.530
Method of analysis
For the determination of Isopentyl 2-methylbutyrate 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 recommended maximum content of the active substance in complete feed shall be indicated.
5. Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.
6. For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks 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
2-Methylbutyl isovalerate
Characterisation of the active substance
2-Methylbutyl isovalerate Produced by chemical synthesis Purity: min. 98 % Chemical formula: C10H20O2 CAS number 2445-77-4 FLAVIS 09.531
Method of analysis
For the determination of 2-Methylbutyl 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 recommended maximum content of the active substance in complete feed shall be indicated.
5. Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.
6. For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks 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
2-Methylbutyl butyrate
Characterisation of the active substance
2-Methylbutyl butyrate Produced by chemical synthesis Purity: min. 95 % Chemical formula: C9H18O2 CAS number 51115-64-1 FLAVIS 09.659
Method of analysis
For the determination of 2-Methylbutyl 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 recommended maximum content of the active substance in complete feed shall be indicated.
5. Where the maximum recommended content is exceeded; the name of the functional group, the name of the additive, the identification number and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compounds feedingstuff.
6. For users of the additive and premixtures, feed business operators, shall establish operational procedures and appropriate organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment