Commission Implementing Regulation (EU) 2017/56 of 14 December 2016 concerning the authorisation of lactic acid, 4-oxovaleric acid, succinic acid, fumaric acid, ethyl acetoacetate, ethyl lactate, butyl lactate, ethyl 4-oxovalerate, diethyl succinate, diethyl malonate, butyl-O-butyryllactate, hex-3-enyl lactate, hexyl lactate, butyro-1,4-lactone, decano-1,5-lactone, undecano-1,5-lactone, pentano-1,4-lactone, nonano-1,5-lactone, octano-1,5-lactone, heptano-1,4-lactone and hexano-1,4-lactone as feed additives for all animal species (Text with EEA relevance)
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Address https://gelex.eu/eli/EU/regulation/2017/56@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) Lactic acid, 4-oxovaleric acid, succinic acid, fumaric acid, ethyl acetoacetate, ethyl lactate, butyl lactate, ethyl 4-oxovalerate, diethyl succinate, diethyl malonate, butyl-O-butyryllactate, hex-3-enyl lactate, hexyl lactate, butyro-1,4-lactone, decano-1,5-lactone, undecano-1,5-lactone, pentano-1,4-lactone, nonano-1,5-lactone, octano-1,5-lactone, heptano-1,4-lactone and hexano-1,4-lactone (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. 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 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 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 it increases the food smell or palatability. Therefore, that conclusion can be extrapolated for feed. The Authority is not in a position to evaluate the use of the substances concerned 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 and, taking into account the re-evaluation performed by the Authority, recommended contents should be indicated on the label of the additive. Where such contents are exceeded, certain information should be indicated on the label of premixtures, compound feeds and feed materials.
(6) The Authority concluded that the substances concerned are considered as potentially hazardous to the respiratory tract skin, eyes and skin sensitisers. 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.
(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 2b08004 — Lactic acid All animal species — — — 6 February 2027 2b08023 — 4-Oxovaleric acid All animal species — — — 6 February 2027 2b08024 — Succinic acid All animal species — — — 6 February 2027 2b08025 — Fumaric acid All animal species — — — 6 February 2027 2b09402 — Ethyl acetoacetate All animal species — — — 6 February 2027 2b09433 — Ethyl lactate All animal species — — — 6 February 2027 2b09434 — Butyl lactate All animal species — — — 6 February 2027 2b09435 — Ethyl 4-oxovalerate All animal species — — — 6 February 2027 2b09444 — Diethyl succinate All animal species — — — 6 February 2027 2b09490 — Diethyl malonate All animal species — — — 6 February 2027 2b09491 — Butyl-O-butyryllactate All animal species — — — 6 February 2027 2b09545 — Hex-3-enyl lactate All animal species — — — 6 February 2027 2b09580 — Hexyl lactate All animal species — — — 6 February 2027 2b10006 — Butyro-1,4-lactone All animal species — — — 6 February 2027 2b10007 — Decano-1,5-lactone All animal species — — — 6 February 2027 2b10011 — Undecano-1,5-lactone All animal species — — — 6 February 2027 2b10013 — Pentano-1,4-lactone All animal species — — — 6 February 2027 2b10014 — Nonano-1,5-lactone All animal species — — — 6 February 2027 2b10015 — Octano-1,5-lactone All animal species — — — 6 February 2027 2b10020 — Heptano-1,4-lactone All animal species — — — 6 February 2027 2b10021 — Hexano-1,4-lactone All animal species — — — 6 February 2027
Additive composition
Lactic acid
Characterisation of the active substance
Lactic acid Produced by chemical synthesis Purity: min. 95 % Chemical formula: C3H6O3 CAS number 598-82-3 and 50-21-5 for DL-lactic acid 79-33-4 for L-lactic acid FLAVIS No 08.004
Method of analysis
For the determination of lactic 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 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-Oxovaleric acid
Characterisation of the active substance
4-Oxovaleric acid Produced by chemical synthesis Purity: min. 97 % Chemical formula: C5H8O3 CAS number 123-76-2 FLAVIS No 08.023
Method of analysis
For the determination of 4-oxovaleric 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 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
Succinic acid
Characterisation of the active substance
Succinic acid Produced by chemical synthesis Purity: min. 99 % Chemical formula: C4H6O4 CAS number 110-15-6 FLAVIS No 08.024
Method of analysis
For the determination of succinic 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 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
Fumaric acid
Characterisation of the active substance
Fumaric acid Produced by chemical synthesis Purity: min. 99,5 % Chemical formula: C4H4O4 CAS number 110-17-8 FLAVIS No 08.025
Method of analysis
For the determination of fumaric 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 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 acetoacetate
Characterisation of the active substance
Ethyl acetoacetate Produced by chemical synthesis Purity: min. 97,5 % Chemical formula: C6H10O3 CAS number 141-97-9 FLAVIS No 09.402
Method of analysis
For the determination of ethyl acetoacetate 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 lactate
Characterisation of the active substance
Ethyl lactate Produced by chemical synthesis Purity: min. 97 % Chemical formula: C5H10O3 CAS number 97-64-3 FLAVIS No 09.433
Method of analysis
For the determination of ethyl lactate 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
Butyl lactate
Characterisation of the active substance
Butyl lactate Produced by chemical synthesis Purity: min. 95 % Chemical formula: C7H14O3 CAS number 138-22-7 FLAVIS No 09.434
Method of analysis
For the determination of butyl lactate 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 4-oxovalerate
Characterisation of the active substance
Ethyl 4-oxovalerate Produced by chemical synthesis Purity: min. 98 % Chemical formula: C7H12O3 CAS number 539-88-8 FLAVIS No 09.435
Method of analysis
For the determination of ethyl 4-oxovalerate 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
Diethyl succinate
Characterisation of the active substance
Diethyl succinate Produced by chemical synthesis Purity: min. 98 % Chemical formula: C8H14O4 CAS number 123-25-1 FLAVIS No 09.444
Method of analysis
For the determination of diethyl succinate 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
Diethyl malonate
Characterisation of the active substance
Diethyl malonate Produced by chemical synthesis Purity: min. 97 % Chemical formula: C7H12O4 CAS number 105-53-3 FLAVIS No 09.490
Method of analysis
For the determination of diethyl malonate 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
Butyl-O-butyryllactate
Characterisation of the active substance
Butyl-O-butyryllactate Produced by chemical synthesis Purity: min. 95 % Chemical formula: C11H20O4 CAS number 7492-70-8 FLAVIS No 09.491
Method of analysis
For the determination of butyl-O-butyryllactate 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
Hex-3-enyl lactate
Characterisation of the active substance
Hex-3-enyl lactate Produced by chemical synthesis Purity: min. 96 % Chemical formula: C9H16O3 CAS number 61931-81-5 FLAVIS No 09.545
Method of analysis
For the determination of hex-3-enyl lactate 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 lactate
Characterisation of the active substance
Hexyl lactate Produced by chemical synthesis Purity: min. 95 % Chemical formula: C9H18O3 CAS number 20279-51-0 FLAVIS No 09.580
Method of analysis
For the determination of hexyl lactate 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
Butyro-1,4-lactone
Characterisation of the active substance
Butyro-1,4-lactone Produced by chemical synthesis Purity: min. 98 % Chemical formula: C4H6O2 CAS number 96-48-0 FLAVIS No 10.006
Method of analysis
For the determination of butyro-1,4-lactone 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
Decano-1,5-lactone
Characterisation of the active substance
Decano-1,5-lactone Produced by chemical synthesis Purity: min. 98 % Chemical formula: C10H18O2 CAS number 705-86-2 FLAVIS No 10.007
Method of analysis
For the determination of decano-1,5-lactone 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
Undecano-1,5-lactone
Characterisation of the active substance
Undecano-1,5-lactone Produced by chemical synthesis Purity: min. 98 % Chemical formula: C11H20O2 CAS number 710-04-3 FLAVIS No 10.011
Method of analysis
For the determination of undecano-1,5-lactone 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
Pentano-1,4-lactone
Characterisation of the active substance
Pentano-1,4-lactone Produced by chemical synthesis Purity: min. 95 % Chemical formula: C5H8O2 CAS number 108-29-2 FLAVIS No 10.013
Method of analysis
For the determination of pentano-1,4-lactone 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
Nonano-1,5-lactone
Characterisation of the active substance
Nonano-1,5-lactone Produced by chemical synthesis Purity: min. 98 % Chemical formula: C9H16O2 CAS number 3301-94-8 FLAVIS No 10.014
Method of analysis
For the determination of nonano-1,5-lactone 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
Octano-1,5-lactone
Characterisation of the active substance
Octano-1,5-lactone Produced by chemical synthesis Purity: min. 98 % Chemical formula: C8H14O2 CAS number 698-76-0 FLAVIS No 10.015
Method of analysis
For the determination of octano-1,5-lactone 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
Heptano-1,4-lactone
Characterisation of the active substance
Heptano-1,4-lactone Produced by chemical synthesis Purity: min. 98 % Chemical formula: C7H12O2 CAS number 105-21-5 FLAVIS No 10.020
Method of analysis
For the determination of heptano-1,4-lactone 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
Hexano-1,4-lactone
Characterisation of the active substance
Hexano-1,4-lactone Produced by chemical synthesis Purity: min. 98 % Chemical formula: C6H10O2 CAS number 695-06-7 FLAVIS No 10.021
Method of analysis
For the determination of hexano-1,4-lactone 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.
Versions
Cited by
- Commission Implementing Regulation (EU) 2026/171 of 26 January 2026 concerning the renewal of the authorisation of fumaric acid as a feed additive for all terrestrial animal species, repealing Implementing Regulation (EU) No 1078/2013 and amending Implementing Regulation (EU) 2017/56 (Text with EEA relevance) Regulation · Grade B
Fumaric acid was authorised for a period of 10 years for all animal species as a feed additive in the functional group preservatives by Commission Implementing Regulation (EU) No 1078/2013, and in the functional group flavouring compounds by Commission Implementing Regulation (EU) 2017/56.
- Commission Implementing Regulation (EU) 2026/171 of 26 January 2026 concerning the renewal of the authorisation of fumaric acid as a feed additive for all terrestrial animal species, repealing Implementing Regulation (EU) No 1078/2013 and amending Implementing Regulation (EU) 2017/56 (Text with EEA relevance) Regulation · Grade B
As a consequence of the renewal of the authorisation of fumaric acid as a feed additive for terrestrial animals, Implementing Regulation (EU) No 1078/2013 should be repealed and Implementing Regulation (EU) 2017/56 should be amended to maintain the authorisation of the additive only for the use for animal species which are not the subject of the renewal of the authorisation.
- Commission Implementing Regulation (EU) 2026/171 of 26 January 2026 concerning the renewal of the authorisation of fumaric acid as a feed additive for all terrestrial animal species, repealing Implementing Regulation (EU) No 1078/2013 and amending Implementing Regulation (EU) 2017/56 (Text with EEA relevance) Regulation · Grade B
In the fifth column of the entry 2b08025 of the Annex to Implementing Regulation (EU) 2017/56, the words All animal species are replaced by the words Aquatic animal species.