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Document 32017R0056
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. )
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. )
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. )
C/2016/8215
OJ L 13, 17.1.2017, p. 129–152
(BG, ES, CS, DA, DE, ET, EL, EN, FR, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
In force
17.1.2017 |
EN |
Official Journal of the European Union |
L 13/129 |
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)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (1), and in particular Article 9(2) thereof,
Whereas:
(1) |
Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such authorisation. Article 10 of that Regulation provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC (2). |
(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 (3) 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
(1) OJ L 268, 18.10.2003, p. 29.
(2) Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (OJ L 270, 14.12.1970, p. 1).
(3) EFSA Journal 2012;10(10):2928.
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 |
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 (1) 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. |
All animal species |
— |
— |
— |
|
6 February 2027 |
||||||||||||
2b08023 |
— |
4-Oxovaleric acid |
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 (1) 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. |
All animal species |
— |
— |
— |
|
6 February 2027 |
||||||||||||
2b08024 |
— |
Succinic acid |
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 (1) 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. |
All animal species |
— |
— |
— |
|
6 February 2027 |
||||||||||||
2b08025 |
— |
Fumaric acid |
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 (1) 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. |
All animal species |
— |
— |
— |
|
6 February 2027 |
||||||||||||
2b09402 |
— |
Ethyl acetoacetate |
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 (1) 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. |
All animal species |
— |
— |
— |
|
6 February 2027 |
||||||||||||
2b09433 |
— |
Ethyl lactate |
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 (1) 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. |
All animal species |
— |
— |
— |
|
6 February 2027 |
||||||||||||
2b09434 |
— |
Butyl lactate |
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 (1) 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. |
All animal species |
— |
— |
— |
|
6 February 2027 |
||||||||||||
2b09435 |
— |
Ethyl 4-oxovalerate |
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 (1) 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. |
All animal species |
— |
— |
— |
|
6 February 2027 |
||||||||||||
2b09444 |
— |
Diethyl succinate |
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 (1) 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. |
All animal species |
— |
— |
— |
|
6 February 2027 |
||||||||||||
2b09490 |
— |
Diethyl malonate |
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 (1) 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. |
All animal species |
— |
— |
— |
|
6 February 2027 |
||||||||||||
2b09491 |
— |
Butyl-O-butyryllactate |
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 (1) 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. |
All animal species |
— |
— |
— |
|
6 February 2027 |
||||||||||||
2b09545 |
— |
Hex-3-enyl lactate |
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 (1) 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. |
All animal species |
— |
— |
— |
|
6 February 2027 |
||||||||||||
2b09580 |
— |
Hexyl lactate |
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 (1) 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. |
All animal species |
— |
— |
— |
|
6 February 2027 |
||||||||||||
2b10006 |
— |
Butyro-1,4-lactone |
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 (1) 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. |
All animal species |
— |
— |
— |
|
6 February 2027 |
||||||||||||
2b10007 |
— |
Decano-1,5-lactone |
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 (1) 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. |
All animal species |
— |
— |
— |
|
6 February 2027 |
||||||||||||
2b10011 |
— |
Undecano-1,5-lactone |
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 (1) 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. |
All animal species |
— |
— |
— |
|
6 February 2027 |
||||||||||||
2b10013 |
— |
Pentano-1,4-lactone |
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 (1) 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. |
All animal species |
— |
— |
— |
|
6 February 2027 |
||||||||||||
2b10014 |
— |
Nonano-1,5-lactone |
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 (1) 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. |
All animal species |
— |
— |
— |
|
6 February 2027 |
||||||||||||
2b10015 |
— |
Octano-1,5-lactone |
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 (1) 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. |
All animal species |
— |
— |
— |
|
6 February 2027 |
||||||||||||
2b10020 |
— |
Heptano-1,4-lactone |
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 (1) 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. |
All animal species |
— |
— |
— |
|
6 February 2027 |
||||||||||||
2b10021 |
— |
Hexano-1,4-lactone |
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 (1) 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. |
All animal species |
— |
— |
— |
|
6 February 2027 |
(1) Details of the analytical methods are available at the following address of the Reference Laboratory: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports