# Official Journal L 53/2018

| | ISSN 1977-0677 |
| --- | --- |
| Official Journal
  of the European Union | L 53 |
| | |
| English edition | Legislation | Volume 6123 February 2018 |

ISSN 1977-0677

Official Journal

of the European Union

L 53

English edition

Legislation

Volume 6123 February 2018

---

| Contents | | II   Non-legislative acts | page |
| --- | --- | --- | --- |
| | | REGULATIONS |
| | * | Commission Implementing Regulation (EU) 2018/238 of 15 February 2018 concerning the authorisation of disodium 5′-ribonucleotides, disodium 5′-guanylate and disodium 5′-inosinate as feed additives for all animal species (
  1
  ) | 1 |
| | * | Commission Implementing Regulation (EU) 2018/239 of 15 February 2018 concerning the authorisation of methyl N-methylanthranilate and methylanthranilate as feed additives for all animal species except avian species (
  1
  ) | 9 |
| | * | Commission Implementing Regulation (EU) 2018/240 of 15 February 2018 concerning the authorisation of trimethylamine, trimethylamine hydrochloride, 3-methylbutylamine for all animal species except laying hens and 2-methoxyethyl benzene, 1,3-dimethoxy-benzene, 1,4-dimethoxy-benzene, 1-isopropyl-2-methoxy-4-methylbenzene as feed additives for all animal species (
  1
  ) | 14 |
| | * | Commission Implementing Regulation (EU) 2018/241 of 15 February 2018 concerning the authorisation of piperine, 3-methylindole, indole, 2-acetylpyrrole and pyrrolidine as feed additives for all animal species (
  1
  ) | 27 |
| | * | Commission Implementing Regulation (EU) 2018/242 of 15 February 2018 concerning the authorisation of hex-3(cis)-en-1-ol, non-6-en-1-ol, oct-3-en-1-ol, non-6(cis)-enal, hex-3(cis)-enal, hept-4-enal, hex-3(cis)-enyl acetate, hex-3(cis)-enyl formate, hex-3-enyl butyrate, hex-3-enyl hexanoate, hex-3(cis)-enyl isobutyrate, citronellol, (-)-3,7-dimethyl-6-octen-1-ol, citronellal, 2,6-dimethylhept-5-enal, citronellic acid, citronellyl acetate, citronellyl butyrate, citronellyl formate, citronellyl propionate, 1-ethoxy-1-(3-hexenyloxy)ethane and hex-3-enyl isovalerate as feed additives for all animal species (
  1
  ) | 36 |
| | * | Commission Implementing Regulation (EU) 2018/243 of 15 February 2018 concerning the authorisation of 3-hydroxybutan-2-one, pentan-2,3-dione, 3,5-dimethyl cyclopentan-1,2-dione, hexan-3,4-dione, sec-butan-3-onyl acetate, 2,6,6-trimethylcyclohex-2-en-1,4-dione and 3-methylnona-2-,4-dione as feed additives for all animal species (
  1
  ) | 69 |
| | * | Commission Implementing Regulation (EU) 2018/244 of 15 February 2018 concerning the authorisation of vanillyl acetone and 4-(4-methoxyphenyl) butan-2-one as feed additives for all animal species and the denial of 1-phenylethan-1-ol (
  1
  ) | 81 |
| | * | Commission Implementing Regulation (EU) 2018/245 of 15 February 2018 concerning the authorisation of menthol, d-carvone, menthyl acetate, d,l-isomenthone, 3-methyl-2-(pent-2(cis)-enyl)cyclopent-2-en-1-one, 3,5,5-trimethylcyclohex-2-en-1-one, d-fenchone, fenchyl alcohol, carvyl acetate, dihydrocarvyl acetate and fenchyl acetate as feed additives for all animal species (
  1
  ) | 87 |
| | * | Commission Implementing Regulation (EU) 2018/246 of 15 February 2018 concerning the authorisation of linalool oxide as a feed additive for all animal species except fish (
  1
  ) | 105 |
| | * | Commission Implementing Regulation (EU) 2018/247 of 15 February 2018 concerning the authorisation of 2,4,5-trimethylthiazole, 2-isobutylthiazole, 5-(2-hydroxyethyl)-4-methylthiazole, 2-acetylthiazole, 2-ethyl-4- methylthiazole, 5,6-dihydro-2,4,6,tris(2-methylpropyl)4H-1,3,5-dithiazine and thiamine hydrochloride as feed additives for all animal species (
  1
  ) | 109 |
| | * | Commission Implementing Regulation (EU) 2018/248 of 15 February 2018 concerning the authorisation of 2,3-diethylpyrazine, 2,5 or 6-methoxy-3-methylpyrazine, 2-acetyl-3-ethylpyrazine, 2,3-diethyl-5-methylpyrazine, 2-(sec-butyl)-3-methoxypyrazine, 2-ethyl-3-methoxypyrazine, 5,6,7,8-tetrahydroquinoxaline, 2-ethylpyrazine and 5-methylquinoxaline as feed additives for all animal species (
  1
  ) | 120 |
| | * | Commission Implementing Regulation (EU) 2018/249 of 15 February 2018 concerning the authorisation of taurine, beta-alanine, L-alanine, L-arginine, L-aspartic acid, L-histidine, D,L-isoleucine, L-leucine, L-phenylalanine, L-proline, D,L-serine, L-tyrosine, L-methionine, L-valine, L-cysteine, glycine, monosodium glutamate and L-glutamic acid as feed additives for all animal species and L-cysteine hydrochloride monohydrate for all species except cats and dogs (
  1
  ) | 134 |
| | * | Commission Implementing Regulation (EU) 2018/250 of 15 February 2018 concerning the authorisation of methyl 2-furoate, bis-(2-methyl-3-furyl) disulfide, furfural, furfuryl alcohol, 2-furanmethanethiol, S-furfuryl acetothioate, difurfuryl disulfide, methyl furfuryl sulfide, 2-methylfuran-3-thiol, methyl furfuryl disulfide, methyl 2-methyl-3-furyl disulfide and furfuryl acetate as feed additives for all animal species (
  1
  ) | 166 |

Contents

II   Non-legislative acts

page

REGULATIONS

*

Commission Implementing Regulation (EU) 2018/238 of 15 February 2018 concerning the authorisation of disodium 5′-ribonucleotides, disodium 5′-guanylate and disodium 5′-inosinate as feed additives for all animal species (
  1
  )

1

1

*

Commission Implementing Regulation (EU) 2018/239 of 15 February 2018 concerning the authorisation of methyl N-methylanthranilate and methylanthranilate as feed additives for all animal species except avian species (
  1
  )

1

9

*

Commission Implementing Regulation (EU) 2018/240 of 15 February 2018 concerning the authorisation of trimethylamine, trimethylamine hydrochloride, 3-methylbutylamine for all animal species except laying hens and 2-methoxyethyl benzene, 1,3-dimethoxy-benzene, 1,4-dimethoxy-benzene, 1-isopropyl-2-methoxy-4-methylbenzene as feed additives for all animal species (
  1
  )

1

14

*

Commission Implementing Regulation (EU) 2018/241 of 15 February 2018 concerning the authorisation of piperine, 3-methylindole, indole, 2-acetylpyrrole and pyrrolidine as feed additives for all animal species (
  1
  )

1

27

*

Commission Implementing Regulation (EU) 2018/242 of 15 February 2018 concerning the authorisation of hex-3(cis)-en-1-ol, non-6-en-1-ol, oct-3-en-1-ol, non-6(cis)-enal, hex-3(cis)-enal, hept-4-enal, hex-3(cis)-enyl acetate, hex-3(cis)-enyl formate, hex-3-enyl butyrate, hex-3-enyl hexanoate, hex-3(cis)-enyl isobutyrate, citronellol, (-)-3,7-dimethyl-6-octen-1-ol, citronellal, 2,6-dimethylhept-5-enal, citronellic acid, citronellyl acetate, citronellyl butyrate, citronellyl formate, citronellyl propionate, 1-ethoxy-1-(3-hexenyloxy)ethane and hex-3-enyl isovalerate as feed additives for all animal species (
  1
  )

1

36

*

Commission Implementing Regulation (EU) 2018/243 of 15 February 2018 concerning the authorisation of 3-hydroxybutan-2-one, pentan-2,3-dione, 3,5-dimethyl cyclopentan-1,2-dione, hexan-3,4-dione, sec-butan-3-onyl acetate, 2,6,6-trimethylcyclohex-2-en-1,4-dione and 3-methylnona-2-,4-dione as feed additives for all animal species (
  1
  )

1

69

*

Commission Implementing Regulation (EU) 2018/244 of 15 February 2018 concerning the authorisation of vanillyl acetone and 4-(4-methoxyphenyl) butan-2-one as feed additives for all animal species and the denial of 1-phenylethan-1-ol (
  1
  )

1

81

*

Commission Implementing Regulation (EU) 2018/245 of 15 February 2018 concerning the authorisation of menthol, d-carvone, menthyl acetate, d,l-isomenthone, 3-methyl-2-(pent-2(cis)-enyl)cyclopent-2-en-1-one, 3,5,5-trimethylcyclohex-2-en-1-one, d-fenchone, fenchyl alcohol, carvyl acetate, dihydrocarvyl acetate and fenchyl acetate as feed additives for all animal species (
  1
  )

1

87

*

Commission Implementing Regulation (EU) 2018/246 of 15 February 2018 concerning the authorisation of linalool oxide as a feed additive for all animal species except fish (
  1
  )

1

105

*

Commission Implementing Regulation (EU) 2018/247 of 15 February 2018 concerning the authorisation of 2,4,5-trimethylthiazole, 2-isobutylthiazole, 5-(2-hydroxyethyl)-4-methylthiazole, 2-acetylthiazole, 2-ethyl-4- methylthiazole, 5,6-dihydro-2,4,6,tris(2-methylpropyl)4H-1,3,5-dithiazine and thiamine hydrochloride as feed additives for all animal species (
  1
  )

1

109

*

Commission Implementing Regulation (EU) 2018/248 of 15 February 2018 concerning the authorisation of 2,3-diethylpyrazine, 2,5 or 6-methoxy-3-methylpyrazine, 2-acetyl-3-ethylpyrazine, 2,3-diethyl-5-methylpyrazine, 2-(sec-butyl)-3-methoxypyrazine, 2-ethyl-3-methoxypyrazine, 5,6,7,8-tetrahydroquinoxaline, 2-ethylpyrazine and 5-methylquinoxaline as feed additives for all animal species (
  1
  )

1

120

*

Commission Implementing Regulation (EU) 2018/249 of 15 February 2018 concerning the authorisation of taurine, beta-alanine, L-alanine, L-arginine, L-aspartic acid, L-histidine, D,L-isoleucine, L-leucine, L-phenylalanine, L-proline, D,L-serine, L-tyrosine, L-methionine, L-valine, L-cysteine, glycine, monosodium glutamate and L-glutamic acid as feed additives for all animal species and L-cysteine hydrochloride monohydrate for all species except cats and dogs (
  1
  )

1

134

*

Commission Implementing Regulation (EU) 2018/250 of 15 February 2018 concerning the authorisation of methyl 2-furoate, bis-(2-methyl-3-furyl) disulfide, furfural, furfuryl alcohol, 2-furanmethanethiol, S-furfuryl acetothioate, difurfuryl disulfide, methyl furfuryl sulfide, 2-methylfuran-3-thiol, methyl furfuryl disulfide, methyl 2-methyl-3-furyl disulfide and furfuryl acetate as feed additives for all animal species (
  1
  )

1

166

| | |
| --- | --- |
| | (1)   Text with EEA relevance. |

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(1)   Text with EEA relevance.

1

| EN | Acts whose titles are printed in light type are those relating to day-to-day management of agricultural matters, and are generally valid for a limited period.
  The titles of all other Acts are printed in bold type and preceded by an asterisk. |
| --- | --- |

EN

Acts whose titles are printed in light type are those relating to day-to-day management of agricultural matters, and are generally valid for a limited period.

The titles of all other Acts are printed in bold type and preceded by an asterisk.

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II Non-legislative acts

REGULATIONS

| 23.2.2018 | EN | Official Journal of the European Union | L 53/1 |
| --- | --- | --- | --- |

23.2.2018

EN

Official Journal of the European Union

L 53/1

---

COMMISSION IMPLEMENTING REGULATION (EU) 2018/238

of 15 February 2018

concerning the authorisation of disodium 5′-ribonucleotides, disodium 5′-guanylate and disodium 5′-inosinate 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). |
| --- | --- |

(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) | Disodium 5′-ribonucleotides, disodium 5′-guanylate and disodium 5′-inosinate (‘substances concerned’) were authorised without a time limit by 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. |
| --- | --- |

(2)

Disodium 5′-ribonucleotides, disodium 5′-guanylate and disodium 5′-inosinate (‘substances concerned’) were authorised without a time limit by 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 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. Lately the applicant withdrew the application for water for drinking. |
| --- | --- |

(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 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. Lately the applicant withdrew the application for water for drinking.

| (4) | The European Food Safety Authority (‘the Authority’) concluded in its opinion of 4 March 2014 (3) that, under the proposed conditions of use the substances concerned do not have adverse effects on animal health, human health or the environment. The Authority further concluded that the function of the substances concerned in feed is similar to that in food. The Authority has already concluded that for food the substances concerned are efficacious, as they increase the food smell or palatability. Therefore, that conclusion can be extrapolated for feed. The applicant withdrew the application for water for drinking. However, the substances concerned can be used within compound feeds which are subsequently administered via water. |
| --- | --- |

(4)

The European Food Safety Authority (‘the Authority’) concluded in its opinion of 4 March 2014 (3) that, under the proposed conditions of use the substances concerned do not have adverse effects on animal health, human health or the environment. The Authority further concluded that the function of the substances concerned in feed is similar to that in food. The Authority has already concluded that for food the substances concerned are efficacious, as they increase the food smell or palatability. Therefore, that conclusion can be extrapolated for feed. The applicant withdrew the application for water for drinking. However, the substances concerned 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 and on the labelling of compound feeds and feed materials. |
| --- | --- |

(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 and on the labelling of compound feeds and feed materials.

| (6) | The Authority also concluded that in the absence of data the substances concerned should be considered as potentially hazardous to workers by skin, eyes and mucous membranes or inhalation exposure. 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. |
| --- | --- |

(6)

The Authority also concluded that in the absence of data the substances concerned should be considered as potentially hazardous to workers by skin, eyes and mucous membranes or inhalation exposure. 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 except for the substances concerned produced by fermentation. The applicant asked for the authorisation of the substances concerned produced by fermentation and RNA hydrolysis. The lack of information on the production strains does not allow to assess the safety of the substances concerned produced by fermentation despite they are ‘per se’ safe. Accordingly, the use of the substances concerned should be authorised as specified in the Annex to this Regulation and the authorisation of those additives produced by fermentation should be denied. |
| --- | --- |

(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 except for the substances concerned produced by fermentation. The applicant asked for the authorisation of the substances concerned produced by fermentation and RNA hydrolysis. The lack of information on the production strains does not allow to assess the safety of the substances concerned produced by fermentation despite they are ‘per se’ safe. Accordingly, the use of the substances concerned should be authorised as specified in the Annex to this Regulation and the authorisation of those additives produced by fermentation should be denied.

| (8) | Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation of 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)

Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation of 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, |
| --- | --- |

(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

Denial

The authorisation of disodium 5′-ribonucleotides, disodium 5′-guanylate and disodium 5′-inosinate produced by fermentation is denied.

Article 3

Transitional measures

1.   The substances specified in the Annex and the substances mentioned in Article 2, and premixtures containing those substances and which are produced and labelled before 15 December 2018 in accordance with the rules applicable before 15 March 2018 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 and the substances mentioned in Article 2 which are produced and labelled before 15 September 2019 in accordance with the rules applicable before 15 March 2018 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 and the substances mentioned in Article 2 which are produced and labelled before 15 September 2020 in accordance with the rules applicable before 15 March 2018 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 4

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.

Official Journal of the European Union

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 15 February 2018.

For the Commission

The President

Jean-Claude JUNCKER

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(1)  
  OJ L 268, 18.10.2003, p. 29.

1

(2)  Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (OJ L 270, 14.12.1970, p. 1).

2

(3)  
  EFSA Journal 2014;12(3):3606.

3

EFSA Journal

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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 % |
| Category: Sensory additives. Functional group: Flavouring compounds |
| 2b635 | — | Disodium 5′-ribonucleotide | Additive composition

  Disodium 5′-ribonucleotides

  Characterisation of the active substance

  Disodium 5′-ribonucleotides: a mixture of disodium 5′-guanylate (GMP) and disodium 5′-inosinate (IMP).
  Produced by RNA hydrolysis
  Purity: min.: 97 % assay
  Chemical formula:






  — | C10H11N4O8P · nH2O |

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 %

Category: Sensory additives. Functional group: Flavouring compounds

2b635

—

Disodium 5′-ribonucleotide

Additive composition

Disodium 5′-ribonucleotides

Characterisation of the active substance

Disodium 5′-ribonucleotides: a mixture of disodium 5′-guanylate (GMP) and disodium 5′-inosinate (IMP).

Produced by RNA hydrolysis

Purity: min.: 97 % assay

Chemical formula:

—

C10H11N4O8P · nH2O

| — | C10H12N5Na2O8P · nH2O |
| --- | --- |

—

C10H12N5Na2O8P · nH2O

Method of analysis
   (1)

For the identification of GMP and IMP in the feed additive:

JECFA monograph, Specifications for food additives: Disodium 5′-Ribonucleotides.

For the determination of GMP and IMP in the feed additive and premixtures of flavourings:

High performance Liquid Chromatography coupled to UV detection (HPLC-UV).

All animal species

—

—

—

| 1. | The additive shall be incorporated into the feed in the form of a premixture. |
| --- | --- |

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. |
| --- | --- |

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 or the combination of disodium 5′-ribonucleotide (2b635), disodium 5′-guanylate (2b627) and disodium 5′-inosinate (2b631) shall be:
  50 mg/kg of complete feedingstuff with a moisture content of 12 %. |
| --- | --- |

3.

The recommended maximum content of the active substance or the combination of disodium 5′-ribonucleotide (2b635), disodium 5′-guanylate (2b627) and disodium 5′-inosinate (2b631) shall be:

50 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 or the combination of disodium 5′-ribonucleotide, disodium 5′-guanylate and disodium 5′-inosinate of complete feedingstuff with a moisture content of 12 %: 50 mg/kg’. |
| --- | --- |

4.

On the label of the additive the following shall be indicated:

‘Recommended maximum content of the active substance or the combination of disodium 5′-ribonucleotide, disodium 5′-guanylate and disodium 5′-inosinate of complete feedingstuff with a moisture content of 12 %: 50 mg/kg’.

| 5. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of premixtures and on the labelling of feed materials and compound feedingstuffs, if the following content of the active substance or the combination of disodium 5′-ribonucleotide, disodium 5′-guanylate and disodium 5′-inosinate in complete feedingstuff with a moisture content of 12 % is exceeded: 50 mg/kg. |
| --- | --- |

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of premixtures and on the labelling of feed materials and compound feedingstuffs, if the following content of the active substance or the combination of disodium 5′-ribonucleotide, disodium 5′-guanylate and disodium 5′-inosinate in complete feedingstuff with a moisture content of 12 % is exceeded: 50 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 inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves. |
| --- | --- |

6.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

15.3.2028

2b627

—

Disodium 5′-guanylate

Additive composition

Disodium 5′-guanylate (GMP)

Characterisation of the active substance

Disodium 5′-guanylate

Produced by RNA hydrolysis

Purity: min.: 97 % assay

Chemical formula: C10H12N5Na2O8P · n H2O

CAS number: 5550-12-9

Method of analysis
   (1)

For the identification of GMP in the feed additive:

JECFA monograph, Specifications for food additives: Disodium 5′-Ribonucleotides.

For the determination of GMP in the feed additive and premixtures of flavourings:

High performance Liquid Chromatography coupled to UV detection (HPLC-UV).

All animal species

—

—

—

| 1. | The additive shall be incorporated into the feed in the form of a premixture. |
| --- | --- |

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. |
| --- | --- |

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 or the combination of disodium 5′-ribonucleotide (2b635), disodium 5′-guanylate (2b627) and disodium 5′-inosinate (2b631) shall be:
  50 mg/kg of complete feedingstuff with a moisture content of 12 %. |
| --- | --- |

3.

The recommended maximum content of the active substance or the combination of disodium 5′-ribonucleotide (2b635), disodium 5′-guanylate (2b627) and disodium 5′-inosinate (2b631) shall be:

50 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 or the combination of disodium 5′-ribonucleotide, disodium 5′-guanylate and disodium 5′-inosinate of complete feedingstuff with a moisture content of 12 %: 50 mg/kg’. |
| --- | --- |

4.

On the label of the additive the following shall be indicated:

‘Recommended maximum content of the active substance or the combination of disodium 5′-ribonucleotide, disodium 5′-guanylate and disodium 5′-inosinate of complete feedingstuff with a moisture content of 12 %: 50 mg/kg’.

| 5. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of premixtures and on the labelling of feed materials and compound feedingstuffs, if the following content of the active substance or the combination of disodium 5′-ribonucleotide disodium 5′-guanylate and disodium 5′-inosinate in complete feedingstuff with a moisture content of 12 % is exceeded: 50 mg/kg. |
| --- | --- |

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of premixtures and on the labelling of feed materials and compound feedingstuffs, if the following content of the active substance or the combination of disodium 5′-ribonucleotide disodium 5′-guanylate and disodium 5′-inosinate in complete feedingstuff with a moisture content of 12 % is exceeded: 50 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 inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves. |
| --- | --- |

6.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

15.3.2028

2b631

—

Disodium 5′-inosinate

Additive composition

Disodium 5′-inosinate (IMP)

Characterisation of the active substance

Disodium 5′-inosinate

Produced by RNA hydrolysis

Purity: min. 97 % assay

Chemical formula: C10H11 N4O8P · nH2O

CAS number 4691-65-0

Method of analysis
   (1)

For the identification of IMP in the feed additive:

JECFA monograph, Specifications for food additives: Disodium 5′-Ribonucleotides.

For the determination of IMP in the feed additive and premixtures of flavourings:

High performance Liquid Chromatography coupled to UV detection (HPLC-UV).

All animal species

—

—

—

| 1. | The additive shall be incorporated into the feed in the form of a premixture. |
| --- | --- |

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. |
| --- | --- |

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 or the combination of disodium 5′-ribonucleotide (2b635), disodium 5′-guanylate (2b627) and disodium 5′-inosinate (2b631) shall be:
  50 mg/kg of complete feedingstuff with a moisture content of 12 %. |
| --- | --- |

3.

The recommended maximum content of the active substance or the combination of disodium 5′-ribonucleotide (2b635), disodium 5′-guanylate (2b627) and disodium 5′-inosinate (2b631) shall be:

50 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 or the combination of disodium 5′-ribonucleotide, disodium 5′-guanylate and disodium 5′-inosinate of complete feedingstuff with a moisture content of 12 %: 50 mg/kg’. |
| --- | --- |

4.

On the label of the additive the following shall be indicated:

‘Recommended maximum content of the active substance or the combination of disodium 5′-ribonucleotide, disodium 5′-guanylate and disodium 5′-inosinate of complete feedingstuff with a moisture content of 12 %: 50 mg/kg’.

| 5. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of premixtures and on the labelling of feed materials and compound feedingstuffs, if the following content of the active substance or the combination of disodium 5′-ribonucleotide, disodium 5′-guanylate and disodium 5′-inosinate in complete feedingstuff with a moisture content of 12 % is exceeded: 50 mg/kg. |
| --- | --- |

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of premixtures and on the labelling of feed materials and compound feedingstuffs, if the following content of the active substance or the combination of disodium 5′-ribonucleotide, disodium 5′-guanylate and disodium 5′-inosinate in complete feedingstuff with a moisture content of 12 % is exceeded: 50 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 inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves. |
| --- | --- |

6.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

15.3.2028

---

(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

---

| 23.2.2018 | EN | Official Journal of the European Union | L 53/9 |
| --- | --- | --- | --- |

23.2.2018

EN

Official Journal of the European Union

L 53/9

---

COMMISSION IMPLEMENTING REGULATION (EU) 2018/239

of 15 February 2018

concerning the authorisation of methyl N-methylanthranilate and methylanthranilate as feed additives for all animal species except avian 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). |
| --- | --- |

(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) | The substances methyl N-methylanthranilate and methylanthranilate were authorised without a time limit in accordance with Directive 70/524/EEC as feeds additives for all animal species. Those substances were subsequently entered in the Register of feed additives as existing products, in accordance with Article 10(1) of Regulation (EC) No 1831/2003. |
| --- | --- |

(2)

The substances methyl N-methylanthranilate and methylanthranilate were authorised without a time limit in accordance with Directive 70/524/EEC as feeds additives for all animal species. Those substances 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 methyl N-methylanthranilate and methylanthranilate as feed additives for all animal species except for avian 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. |
| --- | --- |

(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 methyl N-methylanthranilate and methylanthranilate as feed additives for all animal species except for avian 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 15 November 2011 (3) that, under the proposed conditions of use in feed, methyl N-methylanthranilate and methylanthranilate do not have adverse effects on animal health, human health or the environment. The Authority has concluded that, since methyl N-methylanthranilate and methylanthranilate are efficacious when used in food as flavourings and their function in feed is essentially the same as in food, no further demonstration of efficacy was necessary. Therefore, that conclusion can be extrapolated to feed. The applicant withdrew the application for water for drinking, however, it should be possible to use the substances concerned within compound feeds which are subsequently administered via water. |
| --- | --- |

(4)

The European Food Safety Authority (‘the Authority’) concluded in its opinion of 15 November 2011 (3) that, under the proposed conditions of use in feed, methyl N-methylanthranilate and methylanthranilate do not have adverse effects on animal health, human health or the environment. The Authority has concluded that, since methyl N-methylanthranilate and methylanthranilate are efficacious when used in food as flavourings and their function in feed is essentially the same as in food, no further demonstration of efficacy was necessary. Therefore, that conclusion can be extrapolated to feed. The applicant withdrew the application for water for drinking, however, it should be possible to use the substances concerned 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 and on the labelling of feed materials and compound feed. |
| --- | --- |

(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 and on the labelling of feed materials and compound feed.

| (6) | The Authority concluded that methyl N-methylanthranilate and methylanthranilate are possible eye and respiratory irritants. 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. |
| --- | --- |

(6)

The Authority concluded that methyl N-methylanthranilate and methylanthranilate are possible eye and respiratory irritants. 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 methyl N-methylanthranilate and methylanthranilate 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. |
| --- | --- |

(7)

The assessment of methyl N-methylanthranilate and methylanthranilate shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of those substances should be authorised as specified in the Annex to this Regulation.

| (8) | Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation for methyl N-methylanthranilate and methylanthranilate, it is appropriate to allow a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the authorisation. |
| --- | --- |

(8)

Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation for methyl N-methylanthranilate and methylanthranilate, 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, |
| --- | --- |

(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 15 September 2018 in accordance with the rules applicable before 15 March 2018 may continue to be placed on the market and used until the existing stocks are exhausted.

2.   Feed materials and compound feed containing the substances specified in the Annex which are produced and labelled before 15 March 2019 in accordance with the rules applicable before 15 March 2018 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.   Feed materials and compound feed containing the substances specified in the Annex which are produced and labelled before 15 March 2020 in accordance with the rules applicable before 15 March 2018 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.

Official Journal of the European Union

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 15 February 2018.

For the Commission

The President

Jean-Claude JUNCKER

---

(1)  
  OJ L 268, 18.10.2003, p. 29.

1

(2)  Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (OJ L 270, 14.12.1970, p. 1).

2

(3)  EFSA Journal 2011; 9(12):2441

3

---

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 % |
| Category: Sensory additives. Functional group: Flavouring compounds |
| 2b09781 | — | Methyl N-methylanthranilate | Additive composition

  Methyl N-methylanthranilate

  Characterisation of the active substance

  Methyl N-methylanthranilate
  Produced by chemical synthesis
  Purity: min. 98 %
  Chemical formula: C9H11O2N
  CAS number: 85-91-6
  FLAVIS No 09.781

  Method of analysis
   (1)

  For the identification of methyl N-methylanthranilate in the feed additive and flavouring premixtures:
  Gas chromatography mass spectrometry with retention time locking GC-MS-RTL. | All species except avian species | — | — | — | 1. | The additive shall be incorporated into the feed in the form of a premixture. |

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 %

Category: Sensory additives. Functional group: Flavouring compounds

2b09781

—

Methyl N-methylanthranilate

Additive composition

Methyl N-methylanthranilate

Characterisation of the active substance

Methyl N-methylanthranilate

Produced by chemical synthesis

Purity: min. 98 %

Chemical formula: C9H11O2N

CAS number: 85-91-6

FLAVIS No 09.781

Method of analysis
   (1)

For the identification of methyl N-methylanthranilate in the feed additive and flavouring premixtures:

Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

All species except avian species

—

—

—

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. |
| --- | --- |

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: 4 mg/kg of complete feedingstuff with a moisture content of 12 %. |
| --- | --- |

3.

The recommended maximum content of the active substance shall be: 4 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 %: 4 mg/kg’. |
| --- | --- |

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 %: 4 mg/kg’.

| 5. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds: 4 mg/kg. |
| --- | --- |

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds: 4 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 inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves. |
| --- | --- |

6.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

15.3.2028

2b09715

—

Methylanthranilate

Additive composition

Methylanthranilate

Characterisation of the active substance

Methylanthranilate

Produced by chemical synthesis

Purity: min. 98 %

Chemical formula: C8H9O2N

CAS number: 134-20-3

FLAVIS No 09.715

Method of analysis
   (1)

For the identification of methylanthranilate in the feed additive and flavouring premixtures:

Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

All species except avian species

—

—

—

| 1. | The additive shall be incorporated into the feed in the form of a premixture. |
| --- | --- |

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. |
| --- | --- |

2.

In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.

| 3. | The recommended maximum content of the active substance shall be: 25 mg/kg of complete feedingstuff with a moisture content of 12 %. |
| --- | --- |

3.

The recommended maximum content of the active substance shall be: 25 mg/kg of complete feedingstuff with a moisture content of 12 %.

| 4. | On the label of the additive the following shall be indicated:
  ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 25 mg/kg’. |
| --- | --- |

4.

On the label of the additive the following shall be indicated:

‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 25 mg/kg’.

| 5. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds: 25 mg/kg. |
| --- | --- |

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds: 25 mg/kg.

| 6. | For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves. |
| --- | --- |

6.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

15.3.2028

---

(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

---

| 23.2.2018 | EN | Official Journal of the European Union | L 53/14 |
| --- | --- | --- | --- |

23.2.2018

EN

Official Journal of the European Union

L 53/14

---

COMMISSION IMPLEMENTING REGULATION (EU) 2018/240

of 15 February 2018

concerning the authorisation of trimethylamine, trimethylamine hydrochloride, 3-methylbutylamine for all animal species except laying hens and 2-methoxyethyl benzene, 1,3-dimethoxy-benzene, 1,4-dimethoxy-benzene, 1-isopropyl-2-methoxy-4-methylbenzene 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). |
| --- | --- |

(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) | The substances trimethylamine, trimethylamine hydrochloride, 3-methylbutylamine for all animal species, except laying hens and 2-methoxyethyl benzene, 1,3-dimethoxy-benzene, 1,4-dimethoxy-benzene, 1-isopropyl-2-methoxy-4-methylbenzene for all animal species (‘the substances concerned’) were authorised without a time limit by Directive 70/524/EEC as feed additives for all animal species. Those substances were subsequently entered in the Register of feed additives as existing products, in accordance with Article 10 (1) of Regulation (EC) No 1831/2003. |
| --- | --- |

(2)

The substances trimethylamine, trimethylamine hydrochloride, 3-methylbutylamine for all animal species, except laying hens and 2-methoxyethyl benzene, 1,3-dimethoxy-benzene, 1,4-dimethoxy-benzene, 1-isopropyl-2-methoxy-4-methylbenzene for all animal species (‘the substances concerned’) were authorised without a time limit by Directive 70/524/EEC as feed additives for all animal species. Those substances 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 as feed additives of trimethylamine, trimethylamine hydrochloride, 3-methylbutylamine for all animal species, except laying hens and 2-methoxyethyl benzene, 1,3-dimethoxy-benzene, 1,4-dimethoxy-benzene, 1-isopropyl-2-methoxy-4-methylbenzene 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. |
| --- | --- |

(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 as feed additives of trimethylamine, trimethylamine hydrochloride, 3-methylbutylamine for all animal species, except laying hens and 2-methoxyethyl benzene, 1,3-dimethoxy-benzene, 1,4-dimethoxy-benzene, 1-isopropyl-2-methoxy-4-methylbenzene 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 opinions of 25 April 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 has concluded that, since the substances concerned are efficacious when used in food as flavourings and their function in feed is essentially the same as in food, no further demonstration of efficacy was necessary. Therefore, that conclusion can be extrapolated to feed. The applicant withdrew the application for water for drinking, however, it should be possible to use the substances concerned within compound feeds which are subsequently administered via water. |
| --- | --- |

(4)

The European Food Safety Authority (‘the Authority’) concluded in its opinions of 25 April 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 has concluded that, since the substances concerned are efficacious when used in food as flavourings and their function in feed is essentially the same as in food, no further demonstration of efficacy was necessary. Therefore, that conclusion can be extrapolated to feed. The applicant withdrew the application for water for drinking, however, it should be possible to use the substances concerned 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 and on the labelling of feed materials and compound feed. |
| --- | --- |

(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 and on the labelling of feed materials and compound feed.

| (6) | The Authority noted that trimethylamine, trimethylamine hydrochloride, 3-methylbutylamineare recognised as being corrosive to the eye, strongly irritant or corrosive to the skin and irritant to respiratory tract. Asthma like symptoms may occur after inhalation. For 2-methoxyethyl benzene, 1,3-dimethoxy-benzene, 1,4-dimethoxy-benzene, 1-isopropyl-2-methoxy-4-methylbenzene potential hazards for skin and eye contact and respiratory exposure are recognised. 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. |
| --- | --- |

(6)

The Authority noted that trimethylamine, trimethylamine hydrochloride, 3-methylbutylamineare recognised as being corrosive to the eye, strongly irritant or corrosive to the skin and irritant to respiratory tract. Asthma like symptoms may occur after inhalation. For 2-methoxyethyl benzene, 1,3-dimethoxy-benzene, 1,4-dimethoxy-benzene, 1-isopropyl-2-methoxy-4-methylbenzene potential hazards for skin and eye contact and respiratory exposure are recognised. Consequently, appropriate protective measures should be taken. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additives in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

| (7) | The assessment of the substances concerned shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of those substances should be authorised as specified in the Annex to this Regulation. |
| --- | --- |

(7)

The assessment of the substances concerned shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of those substances should be authorised as specified in the Annex to this Regulation.

| (8) | Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation for the substances concerned, it is appropriate to allow a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the authorisation. |
| --- | --- |

(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, |
| --- | --- |

(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 15 September 2018 in accordance with the rules applicable before 15 March 2018 may continue to be placed on the market and used until the existing stocks are exhausted.

2.   Feed materials and compound feed containing the substances specified in the Annex which are produced and labelled before 15 March 2019 in accordance with the rules applicable before 15 March 2018 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.   Feed materials and compound feed containing the substances specified in the Annex which are produced and labelled before 15 March 2020 in accordance with the rules applicable before 15 March 2018 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.

Official Journal of the European Union

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 15 February 2018.

For the Commission

The President

Jean-Claude JUNCKER

---

(1)  
  OJ L 268, 18.10.2003, p. 29.

1

(2)  Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (OJ L 270, 14.12.1970, p. 1).

2

(3)  
  EFSA Journal 2012;10(5):2678 and EFSA Journal 2012;10(5):2679.

3

EFSA Journal

---

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 % |
| Category: Sensory additives. Functional group: Flavouring compounds |
| 2b11009 | — | Trimethylamine | Additive composition

  Trimethylamine

  Characterisation of the active substance

  Trimethylamine
  Produced by chemical synthesis
  Purity: min. 98 %
  Chemical formula: C3H9N
  CAS number: 75-50-3
  FLAVIS No: 11.009

  Method of analysis
   (1)

  For the determination of trimethylamine in the feed additive and in feed flavouring premixtures:
  Gas chromatography mass spectrometry with retention time locking GC-MS-RTL. | All animal species except laying hens | — | — | — | 1. | The additive shall be incorporated into the feed in the form of a premixture. |

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 %

Category: Sensory additives. Functional group: Flavouring compounds

2b11009

—

Trimethylamine

Additive composition

Trimethylamine

Characterisation of the active substance

Trimethylamine

Produced by chemical synthesis

Purity: min. 98 %

Chemical formula: C3H9N

CAS number: 75-50-3

FLAVIS No: 11.009

Method of analysis
   (1)

For the determination of trimethylamine in the feed additive and in feed flavouring premixtures:

Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

All animal species except laying hens

—

—

—

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. |
| --- | --- |

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 %. |
| --- | --- |

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’. |
| --- | --- |

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 label of the premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds: 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 label of the premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds: 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 inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves. |
| --- | --- |

6.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

15.3.2028

2b11024

—

Trimethylamine hydrochloride

Additive composition

Trimethylamine hydrochloride

Characterisation of the active substance

Trimethylamine hydrochloride

Produced by chemical synthesis

Purity: min. 98.5 %

Chemical formula: C3H9N · HCl

CAS number: 593-81-7

FLAVIS No: 11.024

Method of analysis
   (1)

For the determination of trimethylamine hydrochloride in the feed additive and in feed flavouring premixtures:

Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

All animal species except laying hens

—

—

—

| 1. | The additive shall be incorporated into the feed in the form of a premixture. |
| --- | --- |

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. |
| --- | --- |

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 %. |
| --- | --- |

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’. |
| --- | --- |

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 label of premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds: 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 label of premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds: 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 inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves. |
| --- | --- |

6.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

15.3.2028

2b11001

—

3-Methylbutylamine

Additive composition

3-Methylbutylamine

Characterisation of the active substance

3-Methylbutylamine

Produced by chemical synthesis

Purity: min. 98 %

Chemical formula: C5H13N

CAS number: 107-85-7

FLAVIS No:11.001

Method of analysis
   (1)

For the determination of 3-methylbutylamine in the feed additive and in feed flavouring premixtures:

Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

All animal species except laying hens

—

—

—

| 1. | The additive shall be incorporated into the feed in the form of a premixture. |
| --- | --- |

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. |
| --- | --- |

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 of complete feedingstuff with a moisture content of 12 % shall be:






  — | 1 mg/kg for pigs and poultry, except laying hens; |
| --- | --- | --- |

3.

The recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 % shall be:

—

1 mg/kg for pigs and poultry, except laying hens;

| — | 1,5 mg/kg for other species and categories. |
| --- | --- |

—

1,5 mg/kg for other species and categories.

| 4. | On the label of the additive the following shall be indicated:
  ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %:






  — | 1 mg/kg for pigs and poultry, except laying hens; |
| --- | --- | --- |

4.

On the label of the additive the following shall be indicated:

‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %:

—

1 mg/kg for pigs and poultry, except laying hens;

| — | 1,5 mg/kg for other species and categories’. |
| --- | --- |

—

1,5 mg/kg for other species and categories’.

| 5. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds:






  — | 1 mg/kg for pigs and poultry, except laying hens; |
| --- | --- | --- |

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds:

—

1 mg/kg for pigs and poultry, except laying hens;

| — | 1,5 mg/kg for other species and categories. |
| --- | --- |

—

1,5 mg/kg for other species and categories.

| 6. | For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves. |
| --- | --- |

6.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

15.3.2028

2b03006

—

2-Methoxyethyl benzene

Additive composition

2-Methoxyethyl benzene

Characterisation of the active substance

2-Methoxyethyl benzene

Produced by chemical synthesis

Purity: min. 99 %

Chemical formula: C9H12O

CAS number: 3558-60-9

FLAVIS No: 03.006

Method of analysis
   (1)

For the determination of 2-methoxyethyl benzene in the feed additive and in feed flavouring premixtures:

Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

All animal species

—

—

—

| 1. | The additive shall be incorporated into the feed in the form of a premixture. |
| --- | --- |

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. |
| --- | --- |

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 of complete feedingstuff with a moisture content of 12 % shall be:






  — | 0,3 mg/kg for pigs and poultry; |
| --- | --- | --- |

3.

The recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 % shall be:

—

0,3 mg/kg for pigs and poultry;

| — | 0,5 mg/kg for other species and categories. |
| --- | --- |

—

0,5 mg/kg for other species and categories.

| 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 %:






  — | 0,3 mg/kg for pigs and poultry; |
| --- | --- | --- |

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 %:

—

0,3 mg/kg for pigs and poultry;

| — | 0,5 mg/kg for other species and categories.’. |
| --- | --- |

—

0,5 mg/kg for other species and categories.’.

| 5. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds:






  — | 0,3 mg/kg for pigs and poultry; |
| --- | --- | --- |

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds:

—

0,3 mg/kg for pigs and poultry;

| — | 0,5 mg/kg for other species and categories. |
| --- | --- |

—

0,5 mg/kg for other species and categories.

| 6. | For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves. |
| --- | --- |

6.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

15.3.2028

2b04016

—

1,3-Dimethoxy-benzene

Additive composition

1,3-Dimethoxy-benzene

Characterisation of the active substance

1,3-Dimethoxy-benzene

Produced by chemical synthesis

Purity: min. 98 %

Chemical formula: C8H10O2

CAS number: 151-10-0

FLAVIS No: 04.016

Method of analysis
   (1)

For the determination of 1,3-dimethoxy-benzene in the feed additive and in feed flavouring premixtures:

Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

All animal species

—

—

—

| 1. | The additive shall be incorporated into the feed in the form of a premixture. |
| --- | --- |

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. |
| --- | --- |

2.

In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.

| 3. | The recommended maximum content of the active substance shall be: 1 mg/kg of complete feedingstuff with a moisture content of 12 %. |
| --- | --- |

3.

The recommended maximum content of the active substance shall be: 1 mg/kg of complete feedingstuff with a moisture content of 12 %.

| 4. | On the label of the additive the following shall be indicated:
  ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 1 mg/kg’. |
| --- | --- |

4.

On the label of the additive the following shall be indicated:

‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 1 mg/kg’.

| 5. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds: 1 mg/kg. |
| --- | --- |

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds: 1 mg/kg.

| 6. | For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves. |
| --- | --- |

6.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

15.3.2028

2b04034

—

1,4-Dimethoxy-benzene

Additive composition

1,4-Dimethoxy-benzene

Characterisation of the active substance

1,4-Dimethoxy-benzene

Produced by chemical synthesis

Purity: min. 98 %

Chemical formula: C8H10O2

CAS number: 150-78-7

FLAVIS No: 04.034

Method of analysis
   (1)

For the determination of 1,4-dimethoxy-benzene in the feed additive and in feed flavouring premixtures:

Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

All animal species

—

—

—

| 1. | The additive shall be incorporated into the feed in the form of a premixture. |
| --- | --- |

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. |
| --- | --- |

2.

In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.

| 3. | The recommended maximum content of the active substance shall be: 1 mg/kg of complete feedingstuff with a moisture content of 12 %. |
| --- | --- |

3.

The recommended maximum content of the active substance shall be: 1 mg/kg of complete feedingstuff with a moisture content of 12 %.

| 4. | On the label of the additive the following shall be indicated:
  ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 1 mg/kg’. |
| --- | --- |

4.

On the label of the additive the following shall be indicated:

‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 1 mg/kg’.

| 5. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds: 1 mg/kg. |
| --- | --- |

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds: 1 mg/kg.

| 6. | For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves. |
| --- | --- |

6.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

15.3.2028

2b04043

—

1-Isopropyl-2-methoxy-4-methylbenzene

Additive composition

1-Isopropyl-2-methoxy-4-methylbenzene

Characterisation of the active substance

1-Isopropyl-2-methoxy-4-methylbenzene

Produced by chemical synthesis

Purity: min. 98 %

Chemical formula: C11H16O

CAS number: 1076-56-8

FLAVIS No: 04.043

Method of analysis
   (1)

For the determination of 1-isopropyl-2-methoxy-4-methylbenzene in the feed additive and in feed flavouring premixtures:

Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

All animal species

—

—

—

| 1. | The additive shall be incorporated into the feed in the form of a premixture. |
| --- | --- |

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. |
| --- | --- |

2.

In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.

| 3. | The recommended maximum content of the active substance shall be: 1 mg/kg of complete feedingstuff with a moisture content of 12 %. |
| --- | --- |

3.

The recommended maximum content of the active substance shall be: 1 mg/kg of complete feedingstuff with a moisture content of 12 %.

| 4. | On the label of the additive the following shall be indicated:
  ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 1 mg/kg’. |
| --- | --- |

4.

On the label of the additive the following shall be indicated:

‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 1 mg/kg’.

| 5. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds: 1 mg/kg. |
| --- | --- |

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds: 1 mg/kg.

| 6. | For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves. |
| --- | --- |

6.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

15.3.2028

---

(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

---

| 23.2.2018 | EN | Official Journal of the European Union | L 53/27 |
| --- | --- | --- | --- |

23.2.2018

EN

Official Journal of the European Union

L 53/27

---

COMMISSION IMPLEMENTING REGULATION (EU) 2018/241

of 15 February 2018

concerning the authorisation of piperine, 3-methylindole, indole, 2-acetylpyrrole and pyrrolidine 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). |
| --- | --- |

(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) | The substances piperine, 3-methylindole, indole, 2-acetylpyrrole and pyrrolidine, (‘the substances concerned’) were authorised without a time limit by Directive 70/524/EEC as feeds additives for all animal species. Those substances were subsequently entered in the Register of feed additives as existing products, in accordance with Article 10(1) of Regulation (EC) No 1831/2003. |
| --- | --- |

(2)

The substances piperine, 3-methylindole, indole, 2-acetylpyrrole and pyrrolidine, (‘the substances concerned’) were authorised without a time limit by Directive 70/524/EEC as feeds additives for all animal species. Those substances 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 that those additives 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. |
| --- | --- |

(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 that those additives 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 26 January 2016 (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 has concluded that, since the substances concerned are efficacious when used in food as flavourings and their function in feed is essentially the same as in food, no further demonstration of efficacy was necessary. Therefore, that conclusion can be extrapolated to feed. The applicant withdrew the application for water for drinking. However, it should be possible to use the substances concerned within compound feeds which are subsequently administered via water. |
| --- | --- |

(4)

The European Food Safety Authority (‘the Authority’) concluded in its opinion of 26 January 2016 (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 has concluded that, since the substances concerned are efficacious when used in food as flavourings and their function in feed is essentially the same as in food, no further demonstration of efficacy was necessary. Therefore, that conclusion can be extrapolated to feed. The applicant withdrew the application for water for drinking. However, it should be possible to use the substances concerned 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 and on the labelling of feed materials and compound feed. |
| --- | --- |

(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 and on the labelling of feed materials and compound feed.

| (6) | The Authority noted that for the substances concerned potential hazards for skin and eye contact and respiratory exposure are recognised. Most are classified as irritating to the respiratory system. 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. |
| --- | --- |

(6)

The Authority noted that for the substances concerned potential hazards for skin and eye contact and respiratory exposure are recognised. Most are classified as irritating to the respiratory system. Consequently, appropriate protective measures should be taken. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additives in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

| (7) | The assessment of the substances concerned shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of those substances should be authorised as specified in the Annex to this Regulation. |
| --- | --- |

(7)

The assessment of the substances concerned shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of those substances should be authorised as specified in the Annex to this Regulation.

| (8) | Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation for the substances concerned, it is appropriate to allow a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the authorisation. |
| --- | --- |

(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, |
| --- | --- |

(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 15 September 2018 in accordance with the rules applicable before 15 March 2018 may continue to be placed on the market and used until the existing stocks are exhausted.

2.   Feed materials and compound feed containing the substances specified in the Annex which are produced and labelled before 15 March 2019 in accordance with the rules applicable before 15 March 2018 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.   Feed materials and compound feed containing the substances specified in the Annex which are produced and labelled before 15 March 2020 in accordance with the rules applicable before 15 March 2018 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.

Official Journal of the European Union

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 15 February 2018.

For the Commission

The President

Jean-Claude JUNCKER

---

(1)  
  OJ L 268, 18.10.2003, p. 29.

1

(2)  Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (OJ L 270, 14.12.1970, p. 1).

2

(3)  
  EFSA Journal 2016;14(2):4390

3

EFSA Journal

---

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 % |
| Category: Sensory additives. Functional group: Flavouring compounds |
| 2b14003 | — | Piperine | Additive composition

  Piperine

  Characterisation of the active substance

  Piperine
  Produced by chemical synthesis
  Purity: min. 95 %
  Chemical formula: C17H19O3N
  CAS number: 94-62-2
  FLAVIS No: 14.003

  Method of analysis
   (1)

  For the determination of piperine in the feed additive and in feed flavouring premixtures:
  Gas chromatography coupled to a Flame Ionisation Detector (GC-FID). | All animal species | — | — | — | 1. | The additive shall be incorporated into the feed in the form of a premixture. |

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 %

Category: Sensory additives. Functional group: Flavouring compounds

2b14003

—

Piperine

Additive composition

Piperine

Characterisation of the active substance

Piperine

Produced by chemical synthesis

Purity: min. 95 %

Chemical formula: C17H19O3N

CAS number: 94-62-2

FLAVIS No: 14.003

Method of analysis
   (1)

For the determination of piperine in the feed additive and in feed flavouring premixtures:

Gas chromatography coupled to a Flame Ionisation Detector (GC-FID).

All animal species

—

—

—

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. |
| --- | --- |

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: 0,5 mg/kg of complete feedingstuff with a moisture content of 12 %. |
| --- | --- |

3.

The recommended maximum content of the active substance shall be: 0,5 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 %: 0,5 mg/kg’. |
| --- | --- |

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 %: 0,5 mg/kg’.

| 5. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds: 0,5 mg/kg. |
| --- | --- |

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds: 0,5 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 inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves. |
| --- | --- |

6.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

15.3.2028

2b14004

—

3-Methylindole

Additive composition

3-Methylindole

Characterisation of the active substance

3-Methylindole

Produced by chemical synthesis

Purity: min. 97 %

Chemical formula: C9H9N

CAS number: 83-34-1

FLAVIS No:14.004

Method of analysis
   (1)

For the identification of 3-methylindole in the feed additive and flavouring premixtures:

Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

All animal species

—

—

—

| 1. | The additive shall be incorporated into the feed in the form of a premixture. |
| --- | --- |

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. |
| --- | --- |

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: 0,5 mg/kg of complete feedingstuff with a moisture content of 12 %. |
| --- | --- |

3.

The recommended maximum content of the active substance shall be: 0,5 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 %: 0,5 mg/kg’. |
| --- | --- |

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 %: 0,5 mg/kg’.

| 5. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds: 0,5 mg/kg. |
| --- | --- |

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds: 0,5 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 inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves. |
| --- | --- |

6.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

15.3.2028

2b14007

—

Indole

Additive composition

Indole

Characterisation of the active substance

Indole

Produced by chemical synthesis

Purity: min. 97 %

Chemical formula: C8H7N

CAS number: 120-72-9

FLAVIS No: 14.007

Method of analysis
   (1)

For the determination of indole in the feed additive and in feed flavouring premixtures:

Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

All animal species

—

—

—

| 1. | The additive shall be incorporated into the feed in the form of a premixture. |
| --- | --- |

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. |
| --- | --- |

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: 0,5 mg/kg of complete feedingstuff with a moisture content of 12 %. |
| --- | --- |

3.

The recommended maximum content of the active substance shall be: 0,5 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 %: 0,5 mg/kg’. |
| --- | --- |

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 %: 0,5 mg/kg’.

| 5. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds: 0,5 mg/kg. |
| --- | --- |

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds: 0,5 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 inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves. |
| --- | --- |

6.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

15.3.2028

2b14047

—

2-Acetylpyrrole

Additive composition

2-Acetylpyrrole

Characterisation of the active substance

2-Acetylpyrrole

Produced by chemical synthesis

Purity: min. 97 %

Chemical formula: C6H7ON

CAS number 1072-83-9

FLAVIS No: 14.047

Method of analysis
   (1)

For the determination of 2-acetylpyrrole in the feed additive and in feed flavouring premixtures:

Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

All animal species

—

—

—

| 1. | The additive shall be incorporated into the feed in the form of a premixture. |
| --- | --- |

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. |
| --- | --- |

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: 0,5 mg/kg of complete feedingstuff with a moisture content of 12 %. |
| --- | --- |

3.

The recommended maximum content of the active substance shall be: 0,5 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 %: 0,5 mg/kg’. |
| --- | --- |

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 %: 0,5 mg/kg’.

| 5. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds: 0,5 mg/kg. |
| --- | --- |

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds: 0,5 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 inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves. |
| --- | --- |

6.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

15.3.2028

2b14064

—

Pyrrolidine

Additive composition

Pyrrolidine

Characterisation of the active substance

Pyrrolidine

Produced by chemical synthesis

Purity: min. 95 %

Chemical formula: C4H9N

CAS number 123-75-1

FLAVIS No: 14.064

Method of analysis
   (1)

For the determination of pyrrolidine the feed additive and in feed flavouring premixtures:

Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

All animal species

—

—

—

| 1. | The additive shall be incorporated into the feed in the form of a premixture. |
| --- | --- |

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. |
| --- | --- |

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 of complete feedingstuff with a moisture content of 12 %.shall be:






  — | 0,3 mg/kg for pigs and poultry, |
| --- | --- | --- |

3.

The recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %.shall be:

—

0,3 mg/kg for pigs and poultry,

| — | 0,5 mg/kg for other species and categories. |
| --- | --- |

—

0,5 mg/kg for other species and categories.

| 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 %:






  — | 0,3 mg/kg for pigs and poultry, |
| --- | --- | --- |

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 %:

—

0,3 mg/kg for pigs and poultry,

| — | 0,5 mg/kg for other species and categories.’ |
| --- | --- |

—

0,5 mg/kg for other species and categories.’

| 5. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds:






  — | 0,3 mg/kg for pigs and poultry, |
| --- | --- | --- |

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds:

—

0,3 mg/kg for pigs and poultry,

| — | 0,5 mg/kg for other species and categories. |
| --- | --- |

—

0,5 mg/kg for other species and categories.

| 6. | For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves. |
| --- | --- |

6.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

15.3.2028

---

(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

---

| 23.2.2018 | EN | Official Journal of the European Union | L 53/36 |
| --- | --- | --- | --- |

23.2.2018

EN

Official Journal of the European Union

L 53/36

---

COMMISSION IMPLEMENTING REGULATION (EU) 2018/242

of 15 February 2018

concerning the authorisation of hex-3(cis)-en-1-ol, non-6-en-1-ol, oct-3-en-1-ol, non-6(cis)-enal, hex-3(cis)-enal, hept-4-enal, hex-3(cis)-enyl acetate, hex-3(cis)-enyl formate, hex-3-enyl butyrate, hex-3-enyl hexanoate, hex-3(cis)-enyl isobutyrate, citronellol, (-)-3,7-dimethyl-6-octen-1-ol, citronellal, 2,6-dimethylhept-5-enal, citronellic acid, citronellyl acetate, citronellyl butyrate, citronellyl formate, citronellyl propionate, 1-ethoxy-1-(3-hexenyloxy)ethane and hex-3-enyl isovalerate 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). |
| --- | --- |

(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) | The substances, hex-3(cis)-en-1-ol, non-6-en-1-ol, oct-3-en-1-ol, non-6(cis)-enal, hex-3(cis)-enal, hept-4-enal, hex-3(cis)-enyl acetate, hex-3(cis)-enyl formate, hex-3-enyl butyrate, hex-3-enyl hexanoate, hex-3(cis)-enyl isobutyrate, citronellol, (-)-3,7-dimethyl-6-octen-1-ol, citronellal, 2,6-dimethylhept-5-enal, citronellic acid, citronellyl acetate, citronellyl butyrate, citronellyl formate, citronellyl propionate, 1-ethoxy-1-(3-hexenyloxy)ethane and hex-3-enyl isovalerate (‘substances concerned’) were authorised without a time limit by Directive 70/524/EEC as feed additives for all animal species. Those substances were subsequently entered in the Register of feed additives as existing products, in accordance with Article 10(1) of Regulation (EC) No 1831/2003. |
| --- | --- |

(2)

The substances, hex-3(cis)-en-1-ol, non-6-en-1-ol, oct-3-en-1-ol, non-6(cis)-enal, hex-3(cis)-enal, hept-4-enal, hex-3(cis)-enyl acetate, hex-3(cis)-enyl formate, hex-3-enyl butyrate, hex-3-enyl hexanoate, hex-3(cis)-enyl isobutyrate, citronellol, (-)-3,7-dimethyl-6-octen-1-ol, citronellal, 2,6-dimethylhept-5-enal, citronellic acid, citronellyl acetate, citronellyl butyrate, citronellyl formate, citronellyl propionate, 1-ethoxy-1-(3-hexenyloxy)ethane and hex-3-enyl isovalerate (‘substances concerned’) were authorised without a time limit by Directive 70/524/EEC as feed additives for all animal species. Those substances 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 that those additives be classified in the additive category ‘sensory additives’. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003. |
| --- | --- |

(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 that those additives be classified in the additive category ‘sensory additives’. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

| (4) | The European Food Safety Authority (‘the Authority’) concluded in its opinion of 12 July 2016 (3) that, under the proposed conditions of use the substances concerned do not have adverse effects on animal health, human health or the environment. The Authority has concluded that, since the substances concerned are efficacious when used in food as flavourings and their function in feed is essentially the same as in food, no further demonstration of efficacy was necessary. Therefore, that conclusion can be extrapolated to feed. The applicant withdrew the application for water for drinking. However, it should be possible to use the substances concerned within compound feeds which are subsequently administered via water. |
| --- | --- |

(4)

The European Food Safety Authority (‘the Authority’) concluded in its opinion of 12 July 2016 (3) that, under the proposed conditions of use the substances concerned do not have adverse effects on animal health, human health or the environment. The Authority has concluded that, since the substances concerned are efficacious when used in food as flavourings and their function in feed is essentially the same as in food, no further demonstration of efficacy was necessary. Therefore, that conclusion can be extrapolated to feed. The applicant withdrew the application for water for drinking. However, it should be possible to use the substances concerned 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, a recommended content should be indicated on the label of the additive. Where such content is exceeded, certain information should be indicated on the label of premixtures, and on the labelling of feed materials and compound feed. |
| --- | --- |

(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, a recommended content should be indicated on the label of the additive. Where such content is exceeded, certain information should be indicated on the label of premixtures, and on the labelling of feed materials and compound feed.

| (6) | The Authority concluded that hazards for the skin, eye contact and respiratory exposure are recognised. Most substances are classified as irritating to the respiratory system. 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. |
| --- | --- |

(6)

The Authority concluded that hazards for the skin, eye contact and respiratory exposure are recognised. Most substances are classified as irritating to the respiratory system. Consequently, appropriate protective measures should be taken. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additives in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

| (7) | The assessment of the substances concerned shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of those substances should be authorised as specified in the Annex to this Regulation. |
| --- | --- |

(7)

The assessment of the substances concerned shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of those substances should be authorised as specified in the Annex to this Regulation.

| (8) | Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation for the substances concerned, it is appropriate to allow a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the authorisation. |
| --- | --- |

(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, |
| --- | --- |

(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 15 September 2018 in accordance with the rules applicable before 15 March 2018 may continue to be placed on the market and used until the existing stocks are exhausted.

2.   Feed materials and compound feed containing the substances as specified in the Annex which are produced and labelled before 15 March 2019 in accordance with the rules applicable before 15 March 2018 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.   Feed materials and compound containing the substances as specified in the Annex which are produced and labelled before 15 March 2020 in accordance with the rules applicable before 15 March 2018 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.

Official Journal of the European Union

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 15 February 2018.

For the Commission

The President

Jean-Claude JUNCKER

---

(1)  
  OJ L 268, 18.10.2003, p. 29.

1

(2)  Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (OJ L 270, 14.12.1970, p. 1).

2

(3)  
  EFSA Journal 2016;14(8):4559.

3

EFSA Journal

---

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 % |
| Category: Sensory additives. Functional group: Flavouring compounds |
| 2b02056 | — | Hex-3(cis)-en-1-ol | Additive composition

  Hex-3(cis)-en-1-ol

  Characterisation of the active substance

  Hex-3(cis)-en-1-ol
  Produced by chemical synthesis
  Purity: min. 98 % assay as sum of (Z)- and (E)-isomers; min. 92 % of (Z)-isomer
  Chemical formula: C6H12O
  CAS number: 928-96-1
  FLAVIS No: 02.056

  Method of analysis
   (1)

  For the determination of hex-3(cis)-en-1-ol in the feed additive and in feed flavouring premixtures:
  Gas chromatography mass spectrometry with retention time locking GC-MS-RTL | All animal species | — | — | — | 1. | The additive shall be incorporated into the feed in the form of a premixture. |

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 %

Category: Sensory additives. Functional group: Flavouring compounds

2b02056

—

Hex-3(cis)-en-1-ol

Additive composition

Hex-3(cis)-en-1-ol

Characterisation of the active substance

Hex-3(cis)-en-1-ol

Produced by chemical synthesis

Purity: min. 98 % assay as sum of (Z)- and (E)-isomers; min. 92 % of (Z)-isomer

Chemical formula: C6H12O

CAS number: 928-96-1

FLAVIS No: 02.056

Method of analysis
   (1)

For the determination of hex-3(cis)-en-1-ol in the feed additive and in feed flavouring premixtures:

Gas chromatography mass spectrometry with retention time locking GC-MS-RTL

All animal species

—

—

—

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. |
| --- | --- |

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 %. |
| --- | --- |

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.’ |
| --- | --- |

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 label of the premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds: 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 label of the premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds: 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 inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves. |
| --- | --- |

6.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

15.3.2028

2b02093

—

Non-6-en-1-ol

Additive composition

Non-6-en-1-ol

Characterisation of the active substance

Non-6-en-1-ol

Produced by chemical synthesis

Purity: min. 98 % assay

Chemical formula: C9H18O

CAS number: 35854-86-5

FLAVIS No: 02.093

Method of analysis
   (1)

For the determination of non-6-en-1-ol in the feed additive and in feed flavouring premixtures:

Gas chromatography mass spectrometry with retention time locking GC-MS-RTL

All animal species

—

—

—

| 1. | The additive shall be incorporated into the feed in the form of a premixture. |
| --- | --- |

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. |
| --- | --- |

2.

In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.

| 3. | The recommended maximum content of the active substance shall be 1 mg/kg of complete feedingstuff with a moisture content of 12 %. |
| --- | --- |

3.

The recommended maximum content of the active substance shall be 1 mg/kg of complete feedingstuff with a moisture content of 12 %.

| 4. | On the label of the additive the following shall be indicated:
  ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 1 mg/kg.’ |
| --- | --- |

4.

On the label of the additive the following shall be indicated:

‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 1 mg/kg.’

| 5. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds: 1 mg/kg. |
| --- | --- |

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds: 1 mg/kg.

| 6. | For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves. |
| --- | --- |

6.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

15.3.2028

2b02094

—

Oct-3-en-1-ol

Additive composition

Oct-3-en-1-ol

Characterisation of the active substance

Oct-3-en-1-ol

Produced by chemical synthesis

Purity: min. 96 % assay, as (Z)- isomer.

Chemical formula: C8H16O

CAS number: 20125-84-2

FLAVIS No: 02.094

Method of analysis
   (1)

For the determination oct-3-en-1-ol in the feed additive and in feed flavouring premixtures:

Gas chromatography mass spectrometry with retention time locking GC-MS-RTL

All animal species

—

—

—

| 1. | The additive shall be incorporated into the feed in the form of a premixture. |
| --- | --- |

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. |
| --- | --- |

2.

In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.

| 3. | The recommended maximum content of the active substance shall be 1 mg/kg of complete feedingstuff with a moisture content of 12 %. |
| --- | --- |

3.

The recommended maximum content of the active substance shall be 1 mg/kg of complete feedingstuff with a moisture content of 12 %.

| 4. | On the label of the additive the following shall be indicated:
  ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 1 mg/kg.’ |
| --- | --- |

4.

On the label of the additive the following shall be indicated:

‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 1 mg/kg.’

| 5. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds: 1 mg/kg. |
| --- | --- |

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds: 1 mg/kg.

| 6. | For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves. |
| --- | --- |

6.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

15.3.2028

2b05059

—

Non-6(cis)-enal

Additive composition

Non-6(cis)-enal

Characterisation of the active substance

Non-6(cis)-enal

Produced by chemical synthesis

Purity: min. 96 % assay; secondary component 6–9 % trans-6-nonenal

Chemical formula: C9H16O

CAS number: 2277-19-2

FLAVIS No: 05.059

Method of analysis
   (1)

For the determination non-6(cis)-enal in the feed additive and in feed flavouring premixtures:

Gas chromatography mass spectrometry with retention time locking GC-MS-RTL

All animal species

—

—

—

| 1. | The additive shall be incorporated into the feed in the form of a premixture. |
| --- | --- |

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. |
| --- | --- |

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 %. |
| --- | --- |

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.’ |
| --- | --- |

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 label of the premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds: 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 label of the premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds: 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 inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves. |
| --- | --- |

6.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

15.3.2028

2b05075

—

Hex-3(cis)-enal

Additive composition

Hex-3(cis)-enal

Characterisation of the active substance

Hex-3(cis)-enal

Produced by chemical synthesis

Purity: min. 97 % assay

Chemical formula: C6H10O

CAS number: 6789-80-6

FLAVIS No: 05.075

Method of analysis
   (1)

For the determination of hex-3(cis)-enal in the feed additive and in feed flavouring premixtures:

Gas chromatography mass spectrometry with retention time locking GC-MS-RTL

All animal species

—

—

—

| 1. | The additive shall be incorporated into the feed in the form of a premixture. |
| --- | --- |

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. |
| --- | --- |

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 %. |
| --- | --- |

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.’ |
| --- | --- |

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 label of the premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds: 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 label of the premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds: 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 inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves. |
| --- | --- |

6.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

15.3.2028

2b05085

—

Hept-4-enal

Additive composition

Hept-4-enal

Characterisation of the active substance

Hept-4-enal

Produced by chemical synthesis

Purity: min. 98 % as sum of (Z)- and (E)-isomers; min. 93 % of (Z)-isomer; secondary component: 2-5 % (E)- isomer.

Chemical formula: C7H12O

CAS number: 6728-31-0

FLAVIS No: 05.085

Method of analysis
   (1)

For the determination of hept-4-enal in the feed additive and in feed flavouring premixtures:

Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

All animal species

—

—

—

| 1. | The additive shall be incorporated into the feed in the form of a premixture. |
| --- | --- |

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. |
| --- | --- |

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 %. |
| --- | --- |

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.’ |
| --- | --- |

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 label of the premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds: 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 label of the premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds: 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 inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves. |
| --- | --- |

6.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

15.3.2028

2b09197

—

Hex-3(cis)-enyl acetate

Additive composition

Hex-3(cis)-enyl acetate

Characterisation of the active substance

Hex-3(cis)-enyl acetate

Produced by chemical synthesis

Purity: min. 98 % assay as sum of (Z)- and (E)-isomers; min. 92 % of (Z)-isomer

Chemical formula: C8H14O2

CAS number: 3681-71-8

FLAVIS No: 09.197

Method of analysis
   (1)

For the determination of hex-3(cis)-enyl acetate in the feed additive and in feed flavouring premixtures:

Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

All animal species

—

—

—

| 1. | The additive shall be incorporated into the feed in the form of a premixture. |
| --- | --- |

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. |
| --- | --- |

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 %. |
| --- | --- |

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.’ |
| --- | --- |

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 label of the premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds: 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 label of the premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds: 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 inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves. |
| --- | --- |

6.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

15.3.2028

2b09240

—

Hex-3(cis)-enyl formate

Additive composition

Hex-3(cis)-enyl formate

Characterisation of the active substance

Hex-3(cis)-enyl formate

Produced by chemical synthesis

Purity: min. 95 % assay

Chemical formula: C7H12O2

CAS number: 33467-73-1

FLAVIS No: 09.240

Method of analysis
   (1)

For the determination of hex-3(cis)-enyl formate in the feed additive and in feed flavouring premixtures:

Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

All animal species

—

—

—

| 1. | The additive shall be incorporated into the feed in the form of a premixture. |
| --- | --- |

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. |
| --- | --- |

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 %. |
| --- | --- |

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.’ |
| --- | --- |

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 label of the premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds: 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 label of the premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds: 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 inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves. |
| --- | --- |

6.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

15.3.2028

2b09270

—

Hex-3-enyl butyrate

Additive composition

Hex-3-enyl butyrate

Characterisation of the active substance

Hex-3-enyl butyrate

Produced by chemical synthesis

Purity: min. 95 % assay

Chemical formula: C10H18O2

CAS number: 16491-36-4

FLAVIS No: 09.270

Method of analysis
   (1)

For the determination of hex-3-enyl butyrate in the feed additive and in feed flavouring premixtures:

Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

All animal species

—

—

—

| 1. | The additive shall be incorporated into the feed in the form of a premixture. |
| --- | --- |

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. |
| --- | --- |

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 %. |
| --- | --- |

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.’ |
| --- | --- |

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 label of the premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds: 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 label of the premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds: 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 inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves. |
| --- | --- |

6.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

15.3.2028

2b09271

—

Hex-3-enyl hexanoate

Additive composition

Hex-3-enyl hexanoate

Characterisation of the active substance

Hex-3-enyl hexanoate

Produced by chemical synthesis

Purity: min. 96 % assay

Chemical formula: C12H22O2

CAS number: 31501-11-8

FLAVIS No: 09.271

Method of analysis
   (1)

For the determination of hex-3-enyl hexanoate in the feed additive and in feed flavouring premixtures:

Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

All animal species

—

—

—

| 1. | The additive shall be incorporated into the feed in the form of a premixture. |
| --- | --- |

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. |
| --- | --- |

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 %. |
| --- | --- |

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.’ |
| --- | --- |

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 label of the premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds: 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 label of the premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds: 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 inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves. |
| --- | --- |

6.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

15.3.2028

2b09563

—

Hex-3(cis)-enyl isobutyrate

Additive composition

Hex-3(cis)-enyl isobutyrate

Characterisation of the active substance

Hex-3(cis)-enyl isobutyrate

Produced by chemical synthesis

Purity: min. 98 % assay

Chemical formula: C10H18O2

CAS number: 41519-23-7

FLAVIS No: 09.563

Method of analysis
   (1)

For the determination of hex-3(cis)-enyl isobutyrate in the feed additive and in feed flavouring premixtures:

Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

All animal species

—

—

—

| 1. | The additive shall be incorporated into the feed in the form of a premixture. |
| --- | --- |

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. |
| --- | --- |

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 %. |
| --- | --- |

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.’ |
| --- | --- |

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 label of the premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds: 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 label of the premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds: 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 inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves. |
| --- | --- |

6.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

15.3.2028

2b02011

—

Citronellol

Additive composition

Citronellol

Characterisation of the active substance

Citronellol

Produced by chemical synthesis

Purity: min. 90 % assay; racemate; other constituents: diunsaturated and saturated C10 alcohols, citronellyl acetate and citronellal

Chemical formula: C10H20O

CAS number: 106-22-9

FLAVIS No: 02.011

Method of analysis
   (1)

For the determination of citronellol in the feed additive and in feed flavouring premixtures:

Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

All animal species

—

—

—

| 1. | The additive shall be incorporated into the feed in the form of a premixture. |
| --- | --- |

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. |
| --- | --- |

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 of complete feedingstuff with a moisture content of 12 % shall be:






  — | 1 mg/kg for cats |
| --- | --- | --- |

3.

The recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 % shall be:

—

1 mg/kg for cats

| — | 5 mg/kg for other species and categories. |
| --- | --- |

—

5 mg/kg for other species and categories.

| 4. | On the label of the additive the following shall be indicated:
  ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %:






  — | 1 mg/kg for cats |
| --- | --- | --- |

4.

On the label of the additive the following shall be indicated:

‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %:

—

1 mg/kg for cats

| — | 5 mg/kg for other species and categories’. |
| --- | --- |

—

5 mg/kg for other species and categories’.

| 5. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds:






  — | 1 mg/kg for cats |
| --- | --- | --- |

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds:

—

1 mg/kg for cats

| — | 5 mg/kg for other species and categories. |
| --- | --- |

—

5 mg/kg for other species and categories.

| 6. | For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves. |
| --- | --- |

6.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

15.3.2028

2b02229

—

(-)-3,7-Dimethyl-6-octen-1-ol

Additive composition

(-)-3,7-Dimethyl-6-octen-1-ol

Characterisation of the active substance

(-)-3,7-Dimethyl-6-octen-1-ol

Produced by chemical synthesis or derived by fractional distillation of essential oils and saponification of extracts

Purity: min. 90 % assay

Chemical formula: C10H20O

CAS number: 7540-51-4

FLAVIS No: 02.229

Method of analysis
   (1)

For the determination of (-)-3,7-dimethyl-6-octen-1-ol in the feed additive and in feed flavouring premixtures:

Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

All animal species

—

—

—

| 1. | The additive shall be incorporated into the feed in the form of a premixture. |
| --- | --- |

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. |
| --- | --- |

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 of complete feedingstuff with a moisture content of 12 % shall be:






  — | 1 mg/kg for cats |
| --- | --- | --- |

3.

The recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 % shall be:

—

1 mg/kg for cats

| — | 5 mg/kg for other species and categories. |
| --- | --- |

—

5 mg/kg for other species and categories.

| 4. | On the label of the additive the following shall be indicated:
  ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %:






  — | 1 mg/kg for cats |
| --- | --- | --- |

4.

On the label of the additive the following shall be indicated:

‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %:

—

1 mg/kg for cats

| — | 5 mg/kg for other species and categories’. |
| --- | --- |

—

5 mg/kg for other species and categories’.

| 5. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds:






  — | 1 mg/kg for cats |
| --- | --- | --- |

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds:

—

1 mg/kg for cats

| — | 5 mg/kg for other species and categories. |
| --- | --- |

—

5 mg/kg for other species and categories.

| 6. | For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves. |
| --- | --- |

6.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

15.3.2028

2b05021

—

Citronellal

Additive composition

Citronellal

Characterisation of the active substance

Citronellal

Produced by chemical synthesis

Purity: min. 85 % assay.

Chemical formula: C10H18O

CAS number: 106-23-0

FLAVIS No: 05.021

Method of analysis
   (1)

For the determination of citronellal in the feed additive and in feed flavouring premixtures:

Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

All animal species

—

—

—

| 1. | The additive shall be incorporated into the feed in the form of a premixture. |
| --- | --- |

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. |
| --- | --- |

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 of complete feedingstuff with a moisture content of 12 % shall be:






  — | 1 mg/kg for cats |
| --- | --- | --- |

3.

The recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 % shall be:

—

1 mg/kg for cats

| — | 5 mg/kg for other species and categories. |
| --- | --- |

—

5 mg/kg for other species and categories.

| 4. | On the label of the additive the following shall be indicated:
  ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %:






  — | 1 mg/kg for cats |
| --- | --- | --- |

4.

On the label of the additive the following shall be indicated:

‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %:

—

1 mg/kg for cats

| — | 5 mg/kg for other species and categories’ |
| --- | --- |

—

5 mg/kg for other species and categories’

| 5. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds:






  — | 1 mg/kg for cats |
| --- | --- | --- |

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds:

—

1 mg/kg for cats

| — | 5 mg/kg for other species and categories. |
| --- | --- |

—

5 mg/kg for other species and categories.

| 6. | For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves. |
| --- | --- |

6.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

15.3.2028

2b05074

—

2,6-Dimethylhept-5-enal

Additive composition

2,6-Dimethylhept-5-enal

Characterisation of the active substance

2,6-Dimethylhept-5-enal

Produced by chemical synthesis

Purity: min. 85 % assay

Chemical formula: C9H16O

CAS number: 106-72-9

FLAVIS No: 05.074

Method of analysis
   (1)

For the determination of 2,6-dimethylhept-5-enal in the feed additive and in feed flavouring premixtures:

Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

All animal species

—

—

—

| 1. | The additive shall be incorporated into the feed in the form of a premixture. |
| --- | --- |

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. |
| --- | --- |

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 of complete feedingstuff with a moisture content of 12 % shall be:






  — | 1 mg/kg for cats |
| --- | --- | --- |

3.

The recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 % shall be:

—

1 mg/kg for cats

| — | 5 mg/kg for other species and categories. |
| --- | --- |

—

5 mg/kg for other species and categories.

| 4. | On the label of the additive the following shall be indicated:
  ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %:






  — | 1 mg/kg for cats |
| --- | --- | --- |

4.

On the label of the additive the following shall be indicated:

‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %:

—

1 mg/kg for cats

| — | 5 mg/kg for other species and categories’. |
| --- | --- |

—

5 mg/kg for other species and categories’.

| 5. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds:






  — | 1 mg/kg for cats |
| --- | --- | --- |

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds:

—

1 mg/kg for cats

| — | 5 mg/kg for other species and categories. |
| --- | --- |

—

5 mg/kg for other species and categories.

| 6. | For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves. |
| --- | --- |

6.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

15.3.2028

2b08036

—

Citronellic acid

Additive composition

Citronellic acid

Characterisation of the active substance

Citronellic acid

Produced by chemical synthesis

Purity: min. 90 % assay

Chemical formula: C10H18O2

CAS number: 502-47-6

FLAVIS No: 08.036

Method of analysis
   (1)

For the determination of citronellic acid in the feed additive and in feed flavouring premixtures:

Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

All animal species

—

—

—

| 1. | The additive shall be incorporated into the feed in the form of a premixture. |
| --- | --- |

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. |
| --- | --- |

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 of complete feedingstuff with a moisture content of 12 % shall be:






  — | 1 mg/kg for cats |
| --- | --- | --- |

3.

The recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 % shall be:

—

1 mg/kg for cats

| — | 5 mg/kg for other species and categories. |
| --- | --- |

—

5 mg/kg for other species and categories.

| 4. | On the label of the additive the following shall be indicated:
  ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %:






  — | 1 mg/kg for cats |
| --- | --- | --- |

4.

On the label of the additive the following shall be indicated:

‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %:

—

1 mg/kg for cats

| — | 5 mg/kg for other species and categories’. |
| --- | --- |

—

5 mg/kg for other species and categories’.

| 5. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds:






  — | 1 mg/kg for cats |
| --- | --- | --- |

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds:

—

1 mg/kg for cats

| — | 5 mg/kg for other species and categories. |
| --- | --- |

—

5 mg/kg for other species and categories.

| 6. | For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves. |
| --- | --- |

6.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

15.3.2028

2b09012

—

Citronellyl acetate

Additive composition

Citronellyl acetate

Characterisation of the active substance

Citronellyl acetate

Produced by chemical synthesis

Purity: min. 92 % assay

Chemical formula: C11H22O2

CAS number: 150-84-5

FLAVIS No: 09.012

Method of analysis
   (1)

For the determination of citronellyl acetate in the feed additive and in feed flavouring premixtures:

Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

All animal species

—

—

—

| 1. | The additive shall be incorporated into the feed in the form of a premixture. |
| --- | --- |

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. |
| --- | --- |

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 of complete feedingstuff with a moisture content of 12 % shall be:






  — | 1 mg/kg for cats |
| --- | --- | --- |

3.

The recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 % shall be:

—

1 mg/kg for cats

| — | 5 mg/kg for other species and categories. |
| --- | --- |

—

5 mg/kg for other species and categories.

| 4. | On the label of the additive the following shall be indicated:
  ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %:






  — | 1 mg/kg for cats |
| --- | --- | --- |

4.

On the label of the additive the following shall be indicated:

‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %:

—

1 mg/kg for cats

| — | 5 mg/kg for other species and categories’. |
| --- | --- |

—

5 mg/kg for other species and categories’.

| 5. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds:






  — | 1 mg/kg for cats |
| --- | --- | --- |

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds:

—

1 mg/kg for cats

| — | 5 mg/kg for other species and categories. |
| --- | --- |

—

5 mg/kg for other species and categories.

| 6. | For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves. |
| --- | --- |

6.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

15.3.2028

2b09049

—

Citronellyl butyrate

Additive composition

Citronellyl butyrate

Characterisation of the active substance

Citronellyl butyrate

Produced by chemical synthesis

Purity: min. 90 % assay

Chemical formula: C14H26O2

CAS number: 141-16-2

FLAVIS No: 09.049

Method of analysis
   (1)

For the determination of citronellyl butyrate in the feed additive and in feed flavouring premixtures:

Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

All animal species

—

—

—

| 1. | The additive shall be incorporated into the feed in the form of a premixture. |
| --- | --- |

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. |
| --- | --- |

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 of complete feedingstuff with a moisture content of 12 % shall be:






  — | 1 mg/kg for cats |
| --- | --- | --- |

3.

The recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 % shall be:

—

1 mg/kg for cats

| — | 5 mg/kg for other species and categories. |
| --- | --- |

—

5 mg/kg for other species and categories.

| 4. | On the label of the additive the following shall be indicated:
  ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %:






  — | 1 mg/kg for cats |
| --- | --- | --- |

4.

On the label of the additive the following shall be indicated:

‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %:

—

1 mg/kg for cats

| — | 5 mg/kg for other species and categories’. |
| --- | --- |

—

5 mg/kg for other species and categories’.

| 5. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds:






  — | 1 mg/kg for cats |
| --- | --- | --- |

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds:

—

1 mg/kg for cats

| — | 5 mg/kg for other species and categories. |
| --- | --- |

—

5 mg/kg for other species and categories.

| 6. | For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves. |
| --- | --- |

6.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

15.3.2028

2b09078

—

Citronellyl formate

Additive composition

Citronellyl formate

Characterisation of the active substance

Citronellyl formate

Produced by chemical synthesis

Purity: min. 90 % assay.

Chemical formula: C11H20O2

CAS number: 105-85-1

FLAVIS No: 09.078

Method of analysis
   (1)

For the determination of citronellyl formate in the feed additive and in feed flavouring premixtures:

Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

All animal species

—

—

—

| 1. | The additive shall be incorporated into the feed in the form of a premixture. |
| --- | --- |

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. |
| --- | --- |

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 of complete feedingstuff with a moisture content of 12 % shall be:






  — | 1 mg/kg for cats |
| --- | --- | --- |

3.

The recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 % shall be:

—

1 mg/kg for cats

| — | 5 mg/kg for other species and categories. |
| --- | --- |

—

5 mg/kg for other species and categories.

| 4. | On the label of the additive the following shall be indicated:
  ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %:






  — | 1 mg/kg for cats |
| --- | --- | --- |

4.

On the label of the additive the following shall be indicated:

‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %:

—

1 mg/kg for cats

| — | 5 mg/kg for other species and categories’. |
| --- | --- |

—

5 mg/kg for other species and categories’.

| 5. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds:






  — | 1 mg/kg for cats |
| --- | --- | --- |

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds:

—

1 mg/kg for cats

| — | 5 mg/kg for other species and categories. |
| --- | --- |

—

5 mg/kg for other species and categories.

| 6. | For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves. |
| --- | --- |

6.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

15.3.2028

2b09129

—

Citronellyl propionate

Additive composition

Citronellyl propionate

Characterisation of the active substance

Citronellyl propionate

Produced by chemical synthesis

Purity: min. 95 % assay

Chemical formula: C13H24O2

CAS number: 141-14-0

FLAVIS No: 09.129

Method of analysis
   (1)

For the determination of citronellyl propionate in the feed additive and in feed flavouring premixtures:

Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

All animal species

—

—

—

| 1. | The additive shall be incorporated into the feed in the form of a premixture. |
| --- | --- |

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. |
| --- | --- |

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 of complete feedingstuff with a moisture content of 12 % shall be:






  — | 1 mg/kg for cats |
| --- | --- | --- |

3.

The recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 % shall be:

—

1 mg/kg for cats

| — | 5 mg/kg for other species and categories. |
| --- | --- |

—

5 mg/kg for other species and categories.

| 4. | On the label of the additive the following shall be indicated:
  ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %:






  — | 1 mg/kg for cats |
| --- | --- | --- |

4.

On the label of the additive the following shall be indicated:

‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %:

—

1 mg/kg for cats

| — | 5 mg/kg for other species and categories’. |
| --- | --- |

—

5 mg/kg for other species and categories’.

| 5. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds:






  — | 1 mg/kg for cats |
| --- | --- | --- |

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds:

—

1 mg/kg for cats

| — | 5 mg/kg for other species and categories. |
| --- | --- |

—

5 mg/kg for other species and categories.

| 6. | For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves. |
| --- | --- |

6.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

15.3.2028

2b06081

—

1-Ethoxy-1-(3-hexenyloxy)ethane

Additive composition

1-Ethoxy-1-(3-hexenyloxy)ethane

Characterisation of the active substance

1-Ethoxy-1-(3-hexenyloxy)ethane

Produced by chemical synthesis

Purity: min. 97 % assay

Chemical formula: C10H20O2

CAS number: 28069-74-1

FLAVIS No: 06.081

Method of analysis
   (1)

For the determination of 1-ethoxy-1-(3-hexenyloxy)ethane in the feed additive and in feed flavouring premixtures:

Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

All animal species

—

—

—

| 1. | The additive shall be incorporated into the feed in the form of a premixture. |
| --- | --- |

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. |
| --- | --- |

2.

In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.

| 3. | The recommended maximum content of the active substance shall be 1 mg/kg of complete feedingstuff with a moisture content of 12 %. |
| --- | --- |

3.

The recommended maximum content of the active substance shall be 1 mg/kg of complete feedingstuff with a moisture content of 12 %.

| 4. | On the label of the additive the following shall be indicated:
  ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 1 mg/kg.’ |
| --- | --- |

4.

On the label of the additive the following shall be indicated:

‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 1 mg/kg.’

| 5. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds: 1 mg/kg. |
| --- | --- |

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds: 1 mg/kg.

| 6. | For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves. |
| --- | --- |

6.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

15.3.2028

2b09505

—

Hex-3-enyl isovalerate

Additive composition

Hex-3-enyl isovalerate

Characterisation of the active substance

Hex-3-enyl isovalerate

Produced by chemical synthesis

Purity: min. 95 % assay

Chemical formula: C11H20O2

CAS number: 10032-11-8

FLAVIS No: 09.505

Method of analysis
   (1)

For the determination of hex-3-enyl isovalerate in the feed additive and in feed flavouring premixtures:

Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

All animal species

—

—

—

| 1. | The additive shall be incorporated into the feed in the form of a premixture. |
| --- | --- |

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. |
| --- | --- |

2.

In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.

| 3. | The recommended maximum content of the active substance shall be 1 mg/kg of complete feedingstuff with a moisture content of 12 %. |
| --- | --- |

3.

The recommended maximum content of the active substance shall be 1 mg/kg of complete feedingstuff with a moisture content of 12 %.

| 4. | On the label of the additive the following shall be indicated:
  ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 1 mg/kg.’ |
| --- | --- |

4.

On the label of the additive the following shall be indicated:

‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 1 mg/kg.’

| 5. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds: 1 mg/kg. |
| --- | --- |

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds: 1 mg/kg.

| 6. | For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves. |
| --- | --- |

6.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

15.3.2028

---

(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.

---

| 23.2.2018 | EN | Official Journal of the European Union | L 53/69 |
| --- | --- | --- | --- |

23.2.2018

EN

Official Journal of the European Union

L 53/69

---

COMMISSION IMPLEMENTING REGULATION (EU) 2018/243

of 15 February 2018

concerning the authorisation of 3-hydroxybutan-2-one, pentan-2,3-dione, 3,5-dimethyl cyclopentan-1,2-dione, hexan-3,4-dione, sec-butan-3-onyl acetate, 2,6,6-trimethylcyclohex-2-en-1,4-dione and 3-methylnona-2-,4-dione 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). |
| --- | --- |

(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) | The substances 3-hydroxybutan-2-one, pentan-2,3-dione, 3,5-dimethyl cyclopentan-1,2-dione, hexan-3,4-dione, sec-butan-3-onyl acetate, 2,6,6-trimethylcyclohex-2-en-1,4-dione and 3-methylnona-2-,4-dione (‘substances concerned’) were authorised without a time limit by Directive 70/524/EEC as feed additives for all animal species. Those substances were subsequently entered in the Register of feed additives as existing products, in accordance with Article 10(1) of Regulation (EC) No 1831/2003. |
| --- | --- |

(2)

The substances 3-hydroxybutan-2-one, pentan-2,3-dione, 3,5-dimethyl cyclopentan-1,2-dione, hexan-3,4-dione, sec-butan-3-onyl acetate, 2,6,6-trimethylcyclohex-2-en-1,4-dione and 3-methylnona-2-,4-dione (‘substances concerned’) were authorised without a time limit by Directive 70/524/EEC as feed additives for all animal species. Those substances 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 that those additives be classified in the additive category ‘sensory additives’. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003. |
| --- | --- |

(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 that those additives be classified in the additive category ‘sensory additives’. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

| (4) | The European Food Safety Authority (‘the Authority’) concluded in its opinion of 19 October 2016 (3) that, under the proposed conditions of use the substances concerned do not have adverse effects on animal health, human health or the environment. The Authority has concluded that, since the substances concerned are efficacious when used in food as flavourings and their function in feed is essentially the same as in food, no further demonstration of efficacy was necessary. Therefore, that conclusion can be extrapolated to feed. The applicant withdrew the application for water for drinking, however, it should be possible to use the substances concerned within compound feeds which are subsequently administered via water. |
| --- | --- |

(4)

The European Food Safety Authority (‘the Authority’) concluded in its opinion of 19 October 2016 (3) that, under the proposed conditions of use the substances concerned do not have adverse effects on animal health, human health or the environment. The Authority has concluded that, since the substances concerned are efficacious when used in food as flavourings and their function in feed is essentially the same as in food, no further demonstration of efficacy was necessary. Therefore, that conclusion can be extrapolated to feed. The applicant withdrew the application for water for drinking, however, it should be possible to use the substances concerned 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, a recommended content should be indicated on the label of the additive. Where such content is exceeded, certain information should be indicated on the label of premixtures, and on the labelling of feed materials and compound feed. |
| --- | --- |

(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, a recommended content should be indicated on the label of the additive. Where such content is exceeded, certain information should be indicated on the label of premixtures, and on the labelling of feed materials and compound feed.

| (6) | The Authority noted that hazards for the skin, eye contact and respiratory exposure are recognised. Most substances are classified as irritating to the respiratory system. 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. |
| --- | --- |

(6)

The Authority noted that hazards for the skin, eye contact and respiratory exposure are recognised. Most substances are classified as irritating to the respiratory system. Consequently, appropriate protective measures should be taken. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additives in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

| (7) | The assessment of the substances concerned shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of those substances should be authorised as specified in the Annex to this Regulation. |
| --- | --- |

(7)

The assessment of the substances concerned shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of those substances should be authorised as specified in the Annex to this Regulation.

| (8) | Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation for the substances concerned, it is appropriate to allow a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the authorisation. |
| --- | --- |

(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, |
| --- | --- |

(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 15 September 2018 in accordance with the rules applicable before 15 March 2018 may continue to be placed on the market and used until the existing stocks are exhausted.

2.   Feed materials and compound feed containing the substances as specified in the Annex which are produced and labelled before 15 March 2019 in accordance with the rules applicable before 15 March 2018 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.   Feed materials and compound feed containing the substances as specified in the Annex which are produced and labelled before 15 March 2020 in accordance with the rules applicable before 15 March 2018 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.

Official Journal of the European Union

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 15 February 2018.

For the Commission

The President

Jean-Claude JUNCKER

---

(1)  
  OJ L 268, 18.10.2003, p. 29.

1

(2)  Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (OJ L 270, 14.12.1970, p. 1).

2

(3)  
  EFSA Journal 2016;14(11):4618.

3

EFSA Journal

---

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 % |
| Category: Sensory additives. Functional group: Flavouring compounds |
| 2b07051 | — | 3-Hydroxybutan-2-one | Additive composition

  3-Hydroxybutan-2-one

  Characterisation of the active substance

  3-Hydroxybutan-2-one
  Produced by chemical synthesis
  Purity: min. 96 % assay
  Chemical formula: C4H8O2

  CAS number: 513-86-0
  FLAVIS No: 07.051

  Method of analysis
   (1)

  For the determination of 3-hydroxybutan-2-one in the feed additive and in feed flavouring premixtures:
  Gas chromatography mass spectrometry with retention time locking GC-MS-RTL. | All animal species | — | — | — | 1. | The additive shall be incorporated into the feed in the form of a premixture. |

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 %

Category: Sensory additives. Functional group: Flavouring compounds

2b07051

—

3-Hydroxybutan-2-one

Additive composition

3-Hydroxybutan-2-one

Characterisation of the active substance

3-Hydroxybutan-2-one

Produced by chemical synthesis

Purity: min. 96 % assay

Chemical formula: C4H8O2

CAS number: 513-86-0

FLAVIS No: 07.051

Method of analysis
   (1)

For the determination of 3-hydroxybutan-2-one in the feed additive and in feed flavouring premixtures:

Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

All animal species

—

—

—

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. |
| --- | --- |

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 %. |
| --- | --- |

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.’ |
| --- | --- |

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 label of the premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds: 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 label of the premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds: 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 inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves. |
| --- | --- |

6.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

15.3.2028

2b07060

—

Pentan-2,3-dione

Additive composition

Pentan-2,3-dione

Characterisation of the active substance

Pentan-2,3-dione

Produced by chemical synthesis

Purity: min. 93 % assay

Chemical formula: C5H8O2

CAS number: 600-14-6

FLAVIS No: 07.060

Method of analysis
   (1)

For the determination of pentan-2,3-dione in the feed additive and in feed flavouring premixtures:

Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

All animal species

—

—

—

| 1. | The additive shall be incorporated into the feed in the form of a premixture. |
| --- | --- |

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. |
| --- | --- |

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 %. |
| --- | --- |

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.’ |
| --- | --- |

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 label of the premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds: 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 label of the premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds: 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 inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves. |
| --- | --- |

6.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

15.3.2028

2b07076

—

3,5-Dimethyl cyclopentan-1,2-dione

Additive composition

3,5-dimethyl cyclopentan-1,2-dione

Characterisation of the active substance

3,5-dimethyl cyclopentan-1,2-dione

Produced by chemical synthesis

Purity: min. 97 % assay

Chemical formula: C7H10O2

CAS number: 13494-07-0

FLAVIS No: 07.076

Method of analysis
   (1)

For the determination of 3,5-dimethyl cyclopentan-1,2-dione in the feed additive and in feed flavouring premixtures:

Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

All animal species

—

—

—

| 1. | The additive shall be incorporated into the feed in the form of a premixture. |
| --- | --- |

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. |
| --- | --- |

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 0,5 mg/kg of complete feedingstuff with a moisture content of 12 %. |
| --- | --- |

3.

The recommended maximum content of the active substance shall be 0,5 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 %: 0,5 mg/kg.’ |
| --- | --- |

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 %: 0,5 mg/kg.’

| 5. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds: 0,5 mg/kg. |
| --- | --- |

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds: 0,5 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 inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves. |
| --- | --- |

6.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

15.3.2028

2b07077

—

Hexan-3,4-dione

Additive composition

Hexan-3,4-dione

Characterisation of the active substance

Hexan-3,4-dione

Produced by chemical synthesis

Purity: min. 97 % assay

Chemical formula: C6H10O2

CAS number: 4437-51-8

FLAVIS No: 07.077

Method of analysis
   (1)

For the determination of hexan-3,4-dione in the feed additive and in feed flavouring premixtures:

Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

All animal species

—

—

—

| 1. | The additive shall be incorporated into the feed in the form of a premixture. |
| --- | --- |

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. |
| --- | --- |

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 %. |
| --- | --- |

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.’ |
| --- | --- |

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 label of the premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds: 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 label of the premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds: 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 inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves. |
| --- | --- |

6.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

15.3.2028

2b09186

—

Sec-butan-3-onyl acetate

Additive composition

Sec-butan-3-onyl acetate

Characterisation of the active substance

Sec-butan-3-onyl acetate

Produced by chemical synthesis

Purity: min. 98 % assay

Chemical formula: C6H10O3

CAS number: 4906-24-5

FLAVIS No: 09.186

Method of analysis
   (1)

For the determination of sec-butan-3-onyl acetate in the feed additive and in feed flavouring premixtures:

Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

All animal species

—

—

—

| 1. | The additive shall be incorporated into the feed in the form of a premixture. |
| --- | --- |

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. |
| --- | --- |

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 %. |
| --- | --- |

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.’ |
| --- | --- |

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 label of the premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds: 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 label of the premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds: 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 inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves. |
| --- | --- |

6.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

15.3.2028

2b07109

—

2,6,6-Trimethylcyclohex-2-en-1,4-dione

Additive composition

2,6,6-Trimethylcyclohex-2-en-1,4-dione

Characterisation of the active substance

2,6,6-Trimethylcyclohex-2-en-1,4-dione

Produced by chemical synthesis

Purity: min. 98 % assay

Chemical formula: C9H12O2

CAS number: 1125-21-9

FLAVIS No: 07.109

Method of analysis
   (1)

For the determination of 2,6,6-trimethylcyclohex-2-en-1,4-dione in the feed additive and in feed flavouring premixtures:

Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

All animal species

—

—

—

| 1. | The additive shall be incorporated into the feed in the form of a premixture. |
| --- | --- |

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. |
| --- | --- |

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 of complete feedingstuff with a moisture content of 12 % shall be:






  — | 0,3 mg/kg for pigs and poultry; |
| --- | --- | --- |

3.

The recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 % shall be:

—

0,3 mg/kg for pigs and poultry;

| — | 0,5 mg/kg for other species and categories. |
| --- | --- |

—

0,5 mg/kg for other species and categories.

| 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 %:






  — | 0,3 mg/kg for pigs and poultry; |
| --- | --- | --- |

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 %:

—

0,3 mg/kg for pigs and poultry;

| — | 0,5 mg/kg for other species and categories’. |
| --- | --- |

—

0,5 mg/kg for other species and categories’.

| 5. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds:






  — | 0,3 mg/kg for pigs and poultry; |
| --- | --- | --- |

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds:

—

0,3 mg/kg for pigs and poultry;

| — | 0,5 mg/kg for other species and categories. |
| --- | --- |

—

0,5 mg/kg for other species and categories.

| 6. | For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves. |
| --- | --- |

6.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

15.3.2028

2b07184

—

3-Methylnona-2-,4-dione

Additive composition

3-Methylnona-2-,4-dione

Characterisation of the active substance

3-Methylnona-2-,4-dione

Produced by chemical synthesis

Purity: min. 97 % assay

Chemical formula: C10H18O2

CAS number: 113486-29-6

FLAVIS No: 07.184

Method of analysis
   (1)

For the determination of 3-methylnona-2-,4-dione in the feed additive and in feed flavouring premixtures:

Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

All animal species

—

—

—

| 1. | The additive shall be incorporated into the feed in the form of a premixture. |
| --- | --- |

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. |
| --- | --- |

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 of complete feedingstuff with a moisture content of 12 % shall be:






  — | 0,3 mg/kg for pigs and poultry; |
| --- | --- | --- |

3.

The recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 % shall be:

—

0,3 mg/kg for pigs and poultry;

| — | 0,5 mg/kg for other species and categories. |
| --- | --- |

—

0,5 mg/kg for other species and categories.

| 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 %:






  — | 0,3 mg/kg for pigs and poultry; |
| --- | --- | --- |

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 %:

—

0,3 mg/kg for pigs and poultry;

| — | 0,5 mg/kg for other species and categories’. |
| --- | --- |

—

0,5 mg/kg for other species and categories’.

| 5. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds:






  — | 0,3 mg/kg for pigs and poultry; |
| --- | --- | --- |

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds:

—

0,3 mg/kg for pigs and poultry;

| — | 0,5 mg/kg for other species and categories. |
| --- | --- |

—

0,5 mg/kg for other species and categories.

| 6. | For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves. |
| --- | --- |

6.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

15.3.2028

---

(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.

---

| 23.2.2018 | EN | Official Journal of the European Union | L 53/81 |
| --- | --- | --- | --- |

23.2.2018

EN

Official Journal of the European Union

L 53/81

---

COMMISSION IMPLEMENTING REGULATION (EU) 2018/244

of 15 February 2018

concerning the authorisation of vanillyl acetone and 4-(4-methoxyphenyl) butan-2-one as feed additives for all animal species and the denial of 1-phenylethan-1-ol

(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). |
| --- | --- |

(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).

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

Denial

The authorisation of 1-phenylethan-1-ol, as additive belonging to the additive category ‘sensory additives’ and to the functional group ‘flavouring compounds’ is denied.

Article 3

Transitional measures

1.   Vanillyl acetone, 4-(4-methoxyphenyl) butan-2-one and 1-phenylethan-1-ol and premixtures containing those substances, which are produced and labelled before 15 September 2018 in accordance with the rules applicable before 15 March 2018 may continue to be placed on the market and used until the existing stocks are exhausted.

2.   Feed materials and compound feed containing vanillyl acetone, 4-(4-methoxyphenyl) butan-2-one and 1-phenylethan-1-ol which are produced and labelled before 15 March 2019 in accordance with the rules applicable before 15 March 2018 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.   Feed materials and compound feed containing vanillyl acetone, 4-(4-methoxyphenyl) butan-2-one and 1-phenylethan-1-ol which are produced and labelled before 15 March 2020 in accordance with the rules applicable before 15 March 2018 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 4

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.

Official Journal of the European Union

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 15 February 2018.

For the Commission

The President

Jean-Claude JUNCKER

---

(1)  
  OJ L 268, 18.10.2003, p. 29.

1

(2)  Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (OJ L 270, 14.12.1970, p. 1).

2

(3)  
  EFSA Journal 2016;14(8):4557.

3

EFSA Journal

---

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 % |
| Category: Sensory additives. Functional group: Flavouring compounds |
| 2b07005 | — | Vanillyl acetone | Additive composition

  Vanillyl acetone

  Characterisation of the active substance

  Vanillyl acetone
  Produced by chemical synthesis
  Purity: min. 95 % assay
  Chemical formula: C11H14O3

  CAS number: 122-48-5
  FLAVIS No: 07.005

  Method of analysis
   (1)

  For the determination of vanillyl acetone in the feed additive and in feed flavouring premixtures:
  Gas chromatography mass spectrometry with retention time locking GC-MS-RTL. | All animal species | — | — | — | 1. | The additive shall be incorporated into the feed in the form of a premixture. |

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 %

Category: Sensory additives. Functional group: Flavouring compounds

2b07005

—

Vanillyl acetone

Additive composition

Vanillyl acetone

Characterisation of the active substance

Vanillyl acetone

Produced by chemical synthesis

Purity: min. 95 % assay

Chemical formula: C11H14O3

CAS number: 122-48-5

FLAVIS No: 07.005

Method of analysis
   (1)

For the determination of vanillyl acetone in the feed additive and in feed flavouring premixtures:

Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

All animal species

—

—

—

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. |
| --- | --- |

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 %. |
| --- | --- |

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.’ |
| --- | --- |

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 label of the premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds: 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 label of the premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds: 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 inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves. |
| --- | --- |

6.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

15.3.2028

2b07029

—

4-(4-Methoxyphenyl) butan-2-one

Additive composition

4-(4-Methoxyphenyl) butan-2-one

Characterisation of the active substance

4-(4-Methoxyphenyl) butan-2-one

Produced by chemical synthesis

Purity: min. 96 % assay

Chemical formula: C11H14O2

CAS number 104-20-1

FLAVIS No 07.029

Method of analysis
   (1)

For the determination of 4-(4-methoxyphenyl) butan-2-one in the feed additive and in feed flavouring premixtures:

Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

All animal species

—

—

—

| 1. | The additive shall be incorporated into the feed in the form of a premixture. |
| --- | --- |

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. |
| --- | --- |

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 %. |
| --- | --- |

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.’ |
| --- | --- |

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 label of the premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds: 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 label of the premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds: 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 inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves. |
| --- | --- |

6.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

15.3.2028

---

(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.

---

| 23.2.2018 | EN | Official Journal of the European Union | L 53/87 |
| --- | --- | --- | --- |

23.2.2018

EN

Official Journal of the European Union

L 53/87

---

COMMISSION IMPLEMENTING REGULATION (EU) 2018/245

of 15 February 2018

concerning the authorisation of menthol, d-carvone, menthyl acetate, d,l-isomenthone, 3-methyl-2-(pent-2(cis)-enyl)cyclopent-2-en-1-one, 3,5,5-trimethylcyclohex-2-en-1-one, d-fenchone, fenchyl alcohol, carvyl acetate, dihydrocarvyl acetate and fenchyl acetate 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). |
| --- | --- |

(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) | The substances menthol, d-carvone, menthyl acetate, d,l-isomenthone, 3-methyl-2-(pent-2(cis)-enyl)cyclopent-2-en-1-one, 3,5,5-trimethylcyclohex-2-en-1-one, d-fenchone, fenchyl alcohol, carvyl acetate, dihydrocarvyl acetate and fenchyl acetate (‘substances concerned’) were authorised without a time limit by Directive 70/524/EEC as feed additives for all animal species. Those substances were subsequently entered in the Register of feed additives as existing products, in accordance with Article 10(1) of Regulation (EC) No 1831/2003. |
| --- | --- |

(2)

The substances menthol, d-carvone, menthyl acetate, d,l-isomenthone, 3-methyl-2-(pent-2(cis)-enyl)cyclopent-2-en-1-one, 3,5,5-trimethylcyclohex-2-en-1-one, d-fenchone, fenchyl alcohol, carvyl acetate, dihydrocarvyl acetate and fenchyl acetate (‘substances concerned’) were authorised without a time limit by Directive 70/524/EEC as feed additives for all animal species. Those substances 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 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. |
| --- | --- |

(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 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 20 April 2016 (3) that, under the proposed conditions of use the substances concerned do not have adverse effects on animal health, human health or the environment. The Authority has concluded that, since the substances concerned are efficacious when used in food as flavourings and their function in feed is essentially the same as in food, no further demonstration of efficacy is necessary. Therefore, that conclusion can be extrapolated to feed. The applicant withdrew the application for the use of the substances concerned in water for drinking. |
| --- | --- |

(4)

The European Food Safety Authority (‘the Authority’) concluded in its opinion of 20 April 2016 (3) that, under the proposed conditions of use the substances concerned do not have adverse effects on animal health, human health or the environment. The Authority has concluded that, since the substances concerned are efficacious when used in food as flavourings and their function in feed is essentially the same as in food, no further demonstration of efficacy is necessary. Therefore, that conclusion can be extrapolated to feed. The applicant withdrew the application for the use of the substances concerned in water for drinking.

| (5) | The Authority further noted that hazards for the skin, eye contact and respiratory exposure are recognised. Most substances are classified as irritating to the respiratory system. 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. |
| --- | --- |

(5)

The Authority further noted that hazards for the skin, eye contact and respiratory exposure are recognised. Most substances are classified as irritating to the respiratory system. 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.

| (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. |
| --- | --- |

(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.

| (7) | The applicant proposed use levels for the substances concerned to the Authority. Having regard to that proposal, the Authority considered that certain use levels are safe (‘levels considered by the Authority’). For the purpose of official controls along the food chain, certain labelling requirements should be provided for. In particular, where the use levels exceed the levels considered by the Authority, it is appropriate to require that the label of premixtures and the labelling of feed materials and compound feed containing the substances concerned include certain information including reference to the levels considered by the Authority. |
| --- | --- |

(7)

The applicant proposed use levels for the substances concerned to the Authority. Having regard to that proposal, the Authority considered that certain use levels are safe (‘levels considered by the Authority’). For the purpose of official controls along the food chain, certain labelling requirements should be provided for. In particular, where the use levels exceed the levels considered by the Authority, it is appropriate to require that the label of premixtures and the labelling of feed materials and compound feed containing the substances concerned include certain information including reference to the levels considered by the Authority.

| (8) | The fact that the use of the substances concerned in water for drinking is not authorised does not preclude their use in compound feed which is administered via water. |
| --- | --- |

(8)

The fact that the use of the substances concerned in water for drinking is not authorised does not preclude their use in compound feed which is administered via water.

| (9) | 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)

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.

| (10) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
| --- | --- |

(10)

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 15 September 2018 in accordance with the rules applicable before 15 March 2018 may continue to be placed on the market and used until the existing stocks are exhausted.

2.   Feed materials and compound feed containing the substances as specified in the Annex which are produced and labelled before 15 March 2019 in accordance with the rules applicable before 15 March 2018 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.   Feed materials and compound feed containing the substances as specified in the Annex which are produced and labelled before 15 March 2020 in accordance with the rules applicable before 15 March 2018 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.

Official Journal of the European Union

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 15 February 2018.

For the Commission

The President

Jean-Claude JUNCKER

---

(1)  
  OJ L 268, 18.10.2003, p. 29.

1

(2)  Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (OJ L 270, 14.12.1970, p. 1).

2

(3)  
  EFSA Journal 2016;14(6):4475.

3

EFSA Journal

---

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 % |
| Category: Sensory additives. Functional group: Flavouring compounds |
| 2b02015 | — | Menthol | Additive composition

  Menthol

  Characterisation of the active substance

  Menthol
  Produced by chemical synthesis
  Purity: min. 95 % assay
  Chemical formula: C10H20O
  CAS number: 89-78-1
  FLAVIS No: 02.015

  Method of analysis
   (1)

  For the determination of menthol in the feed additive and in feed flavouring premixtures:
  Gas chromatography mass spectrometry with retention time locking GC-MS-RTL. | All animal species | — | — | — | 1. | The additive shall be incorporated into the feed in the form of a premixture. |

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 %

Category: Sensory additives. Functional group: Flavouring compounds

2b02015

—

Menthol

Additive composition

Menthol

Characterisation of the active substance

Menthol

Produced by chemical synthesis

Purity: min. 95 % assay

Chemical formula: C10H20O

CAS number: 89-78-1

FLAVIS No: 02.015

Method of analysis
   (1)

For the determination of menthol in the feed additive and in feed flavouring premixtures:

Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

All animal species

—

—

—

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. |
| --- | --- |

2.

In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.

| 3. | On the label of the additive the following shall be indicated:
  ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 25 mg/kg.’ |
| --- | --- |

3.

On the label of the additive the following shall be indicated:

‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 25 mg/kg.’

| 4. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3 |
| --- | --- |

4.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3

| 5. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 25 mg/kg |
| --- | --- |

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 25 mg/kg

| 6. | For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves. |
| --- | --- |

6.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

15.3.2028

2b07146

—

d-Carvone

Additive composition

d-Carvone

Characterisation of the active substance

d-Carvone

Produced by chemical synthesis

Purity: min. 95 % assay

Chemical formula: C10H14O

CAS number: 2244-16-8

FLAVIS No: 07.146

Method of analysis
   (1)

For the determination of d-carvone in the feed additive and in feed flavouring premixtures:

Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

All animal species

—

—

—

| 1. | The additive shall be incorporated into the feed in the form of a premixture. |
| --- | --- |

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. |
| --- | --- |

2.

In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.

| 3. | 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.’ |
| --- | --- |

3.

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.’

| 4. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3 |
| --- | --- |

4.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3

| 5. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 5 mg/kg |
| --- | --- |

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 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 inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves. |
| --- | --- |

6.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

15.3.2028

2b09016

—

Menthyl acetate

Additive composition

Menthyl acetate

Characterisation of the active substance

Menthyl acetate

Produced by chemical synthesis

Purity: min. 97 % assay

Chemical formula: C12H22O2

CAS number: 29066-34-0

FLAVIS No: 09.016

Method of analysis
   (1)

For the determination of menthyl acetate in the feed additive and in feed flavouring premixtures:

Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

All animal species

—

—

—

| 1. | The additive shall be incorporated into the feed in the form of a premixture. |
| --- | --- |

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. |
| --- | --- |

2.

In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.

| 3. | 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.’ |
| --- | --- |

3.

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.’

| 4. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3 |
| --- | --- |

4.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3

| 5. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 5 mg/kg |
| --- | --- |

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 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 inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves. |
| --- | --- |

6.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

15.3.2028

2b07078

—

d,l-Isomenthone

Additive composition

d,l-Isomenthone

Characterisation of the active substance

d,l-Isomenthone

Produced by chemical synthesis

Purity: min. 98 % assay

Chemical formula: C10H18O

CAS number: 491-07-6

FLAVIS No: 07.078

Method of analysis
   (1)

For the determination of d,l-isomenthone in the feed additive and in feed flavouring premixtures:

Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

All animal species

—

—

—

| 1. | The additive shall be incorporated into the feed in the form of a premixture. |
| --- | --- |

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. |
| --- | --- |

2.

In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.

| 3. | 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 %:






  — | 0,3 mg/kg for pigs and poultry; |
| --- | --- | --- |

3.

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 %:

—

0,3 mg/kg for pigs and poultry;

| — | 0,5 mg/kg for other species and categories.’ |
| --- | --- |

—

0,5 mg/kg for other species and categories.’

| 4. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level suggested on the label of the premixture would result in exceeding the levels referred to in point 3 |
| --- | --- |

4.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level suggested on the label of the premixture would result in exceeding the levels referred to in point 3

| 5. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds:






  — | 0,3 mg/kg for pigs and poultry; |
| --- | --- | --- |

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds:

—

0,3 mg/kg for pigs and poultry;

| — | 0,5 mg/kg for other species and categories |
| --- | --- |

—

0,5 mg/kg for other species and categories

| 6. | For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves. |
| --- | --- |

6.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

15.3.2028

2b07094

—

3-Methyl-2-(pent-2(cis)-enyl)cyclopent-2-en-1-one

Additive composition

3-Methyl-2-(pent-2(cis)-enyl)cyclopent-2-en-1-one

Characterisation of the active substance

3-Methyl-2-(pent-2(cis)-enyl)cyclopent-2-en-1-one

Produced by chemical synthesis

Purity: min. 98 % assay

Chemical formula: C11H16O

CAS number: 488-10-8

FLAVIS No: 07.094

Method of analysis
   (1)

For the determination of 3-methyl-2-(pent-2(cis)-enyl)cyclopent-2-en-1-one in the feed additive and in feed flavouring premixtures:

Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

All animal species

—

—

—

| 1. | The additive shall be incorporated into the feed in the form of a premixture. |
| --- | --- |

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. |
| --- | --- |

2.

In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.

| 3. | 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 %:






  — | 0,3 mg/kg for pigs and poultry; |
| --- | --- | --- |

3.

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 %:

—

0,3 mg/kg for pigs and poultry;

| — | 0,5 mg/kg for other species and categories.’ |
| --- | --- |

—

0,5 mg/kg for other species and categories.’

| 4. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level suggested on the label of the premixture would result in exceeding the levels referred to in point 3 |
| --- | --- |

4.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level suggested on the label of the premixture would result in exceeding the levels referred to in point 3

| 5. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds:






  — | 0,3 mg/kg for pigs and poultry; |
| --- | --- | --- |

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds:

—

0,3 mg/kg for pigs and poultry;

| — | 0,5 mg/kg for other species and categories. |
| --- | --- |

—

0,5 mg/kg for other species and categories.

| 6. | For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves. |
| --- | --- |

6.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

15.3.2028

2b07126

—

3,5,5-Trimethylcyclohex-2-en-1-one

Additive composition

3,5,5-Trimethylcyclohex-2-en-1-one

Characterisation of the active substance

3,5,5-Trimethylcyclohex-2-en-1-one

Produced by chemical synthesis

Purity: min. 98 % assay

Chemical formula: C9H14O

CAS number: 78-59-1

FLAVIS No: 07.126

Method of analysis
   (1)

For the determination of 3,5,5-trimethylcyclohex-2-en-1-one in the feed additive and in feed flavouring premixtures:

Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

All animal species

—

—

—

| 1. | The additive shall be incorporated into the feed in the form of a premixture. |
| --- | --- |

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. |
| --- | --- |

2.

In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.

| 3. | 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 %:






  — | 0,3 mg/kg for pigs and poultry; |
| --- | --- | --- |

3.

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 %:

—

0,3 mg/kg for pigs and poultry;

| — | 0,5 mg/kg for other species and categories.’ |
| --- | --- |

—

0,5 mg/kg for other species and categories.’

| 4. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level suggested on the label of the premixture would result in exceeding the levels referred to in point 3. |
| --- | --- |

4.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level suggested on the label of the premixture would result in exceeding the levels referred to in point 3.

| 5. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds:






  — | 0,3 mg/kg for pigs and poultry; |
| --- | --- | --- |

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds:

—

0,3 mg/kg for pigs and poultry;

| — | 0,5 mg/kg for other species and categories |
| --- | --- |

—

0,5 mg/kg for other species and categories

| 6. | For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and glove. |
| --- | --- |

6.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and glove.

15.3.2028

2b07159

—

d-Fenchone

Additive composition

d-Fenchone

Characterisation of the active substance

d-Fenchone

Produced by chemical synthesis

Purity: min. 97 % assay

Chemical formula: C10H16O

CAS number: 4695-62-9

FLAVIS No: 07.159

Method of analysis
   (1)

For the determination of d-fenchone in the feed additive and in feed flavouring premixtures:

Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

All animal species

—

—

—

| 1. | The additive shall be incorporated into the feed in the form of a premixture. |
| --- | --- |

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. |
| --- | --- |

2.

In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.

| 3. | 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 %:






  — | 0,3 mg/kg for pigs and poultry; |
| --- | --- | --- |

3.

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 %:

—

0,3 mg/kg for pigs and poultry;

| — | 0,5 mg/kg for other species and categories.’ |
| --- | --- |

—

0,5 mg/kg for other species and categories.’

| 4. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level suggested on the label of the premixture would result in exceeding the levels referred to in point 3 |
| --- | --- |

4.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level suggested on the label of the premixture would result in exceeding the levels referred to in point 3

| 5. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds:






  — | 0,3 mg/kg for pigs and poultry; |
| --- | --- | --- |

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds:

—

0,3 mg/kg for pigs and poultry;

| — | 0,5 mg/kg for other species and categories |
| --- | --- |

—

0,5 mg/kg for other species and categories

| 6. | For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves |
| --- | --- |

6.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves

15.3.2028

2b02038

—

Fenchyl alcohol

Additive composition

Fenchyl alcohol

Characterisation of the active substance

Fenchyl alcohol

Produced by chemical synthesis

Purity: min. 97 % assay

Chemical formula: C10H18O

CAS number: 1632-73-1

FLAVIS No: 02.038

Method of analysis
   (1)

For the determination of fenchyl alcohol in the feed additive and in feed flavouring premixtures:

Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

All animal species

—

—

—

| 1. | The additive shall be incorporated into the feed in the form of a premixture. |
| --- | --- |

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. |
| --- | --- |

2.

In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.

| 3. | On the label of the additive the following shall be indicated:
  ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 1 mg/kg.’ |
| --- | --- |

3.

On the label of the additive the following shall be indicated:

‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 1 mg/kg.’

| 4. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3 |
| --- | --- |

4.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3

| 5. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 1 mg/kg |
| --- | --- |

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 1 mg/kg

| 6. | For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves. |
| --- | --- |

6.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

15.3.2028

2b09215

—

Carvyl acetate

Additive composition

Carvyl acetate

Characterisation of the active substance

Carvyl acetate

Produced by chemical synthesis

Purity: min. 98 % assay

Chemical formula: C12H18O2

CAS number: 97-42-7

FLAVIS No: 09.215

Method of analysis
   (1)

For the determination of carvyl acetate in the feed additive and in feed flavouring premixtures:

Gas chromatography mass spectrometry with retention time locking GC-MS-RTL

All animal species

—

—

—

| 1. | The additive shall be incorporated into the feed in the form of a premixture. |
| --- | --- |

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. |
| --- | --- |

2.

In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.

| 3. | On the label of the additive the following shall be indicated:
  ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 1 mg/kg.’ |
| --- | --- |

3.

On the label of the additive the following shall be indicated:

‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 1 mg/kg.’

| 4. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3 |
| --- | --- |

4.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3

| 5. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 1 mg/kg. |
| --- | --- |

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 1 mg/kg.

| 6. | For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves. |
| --- | --- |

6.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

15.3.2028

2b09216

—

Dihydrocarvyl acetate

Additive composition

Dihydrocarvyl acetate

Characterisation of the active substance

Dihydrocarvyl acetate

Produced by chemical synthesis

Purity: min. 97 % assay

Chemical formula: C12H20O2

CAS number: 20777-49-5

FLAVIS No: 09.216

Method of analysis
   (1)

For the determination of dihydrocarvyl acetate in the feed additive and in feed flavouring premixtures:

Gas chromatography mass spectrometry with retention time locking GC-MS-RTL

All animal species

—

—

—

| 1. | The additive shall be incorporated into the feed in the form of a premixture. |
| --- | --- |

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. |
| --- | --- |

2.

In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.

| 3. | On the label of the additive the following shall be indicated:
  ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 1 mg/kg.’ |
| --- | --- |

3.

On the label of the additive the following shall be indicated:

‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 1 mg/kg.’

| 4. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3 |
| --- | --- |

4.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3

| 5. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 1 mg/kg |
| --- | --- |

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 1 mg/kg

| 6. | For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves. |
| --- | --- |

6.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

15.3.2028

2b09269

—

Fenchyl acetate

Additive composition

Fenchyl acetate

Characterisation of the active substance

Fenchyl acetate

Produced by chemical synthesis

Purity: min. 98 % assay

Chemical formula: C12H20O2

CAS number: 13851-11-1

FLAVIS No: 09.269

Method of analysis
   (1)

For the determination of fenchyl acetate in the feed additive and in feed flavouring premixtures:

Gas chromatography mass spectrometry with retention time locking GC-MS-RTL

All animal species

—

—

—

| 1. | The additive shall be incorporated into the feed in the form of a premixture. |
| --- | --- |

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. |
| --- | --- |

2.

In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.

| 3. | On the label of the additive the following shall be indicated:
  ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 1 mg/kg.’ |
| --- | --- |

3.

On the label of the additive the following shall be indicated:

‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 1 mg/kg.’

| 4. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3 |
| --- | --- |

4.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3

| 5. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 1 mg/kg |
| --- | --- |

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 1 mg/kg

| 6. | For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves. |
| --- | --- |

6.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

15.3.2028

---

(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

---

| 23.2.2018 | EN | Official Journal of the European Union | L 53/105 |
| --- | --- | --- | --- |

23.2.2018

EN

Official Journal of the European Union

L 53/105

---

COMMISSION IMPLEMENTING REGULATION (EU) 2018/246

of 15 February 2018

concerning the authorisation of linalool oxide as a feed additive for all animal species except fish

(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). |
| --- | --- |

(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) | The substance linalool oxide was authorised by Directive 70/524/EEC as a feed additive for all animal species. That substance was subsequently entered in the Register of feed additives as existing product, in accordance with Article 10(1) of Regulation (EC) No 1831/2003. |
| --- | --- |

(2)

The substance linalool oxide was authorised by Directive 70/524/EEC as a feed additive for all animal species. That substance was subsequently entered in the Register of feed additives as existing product, 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 linalool oxide as a feed additive for all animal species except fish. The applicant requested that this additive 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. |
| --- | --- |

(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 linalool oxide as a feed additive for all animal species except fish. The applicant requested that this additive be classified in the additive category ‘sensory additives’. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

| (4) | The European Food Safety Authority (‘the Authority’) concluded in its opinion of 13 June 2012 (3) that, under the proposed conditions of use, linalool oxide does not have adverse effects on animal health, human health or the environment. In addition, as regards consumer safety, the conclusions of the opinion adopted on 5 March 2014 (4) are applicable to linalool oxide since linalool oxide belongs to the same chemical group as the substances examined in that opinion. The terminal metabolism of this additive through glucuronidation among mammals, birds and fish allows the conjugates of the additive to be rapidly excreted. The Authority has concluded that, since linalool is used in food as flavouring and its function in feed is essentially the same as in food, no further demonstration of efficacy is necessary. Therefore, that conclusion can be extrapolated to feed. The applicant withdrew the application for use of linalool in water for drinking. |
| --- | --- |

(4)

The European Food Safety Authority (‘the Authority’) concluded in its opinion of 13 June 2012 (3) that, under the proposed conditions of use, linalool oxide does not have adverse effects on animal health, human health or the environment. In addition, as regards consumer safety, the conclusions of the opinion adopted on 5 March 2014 (4) are applicable to linalool oxide since linalool oxide belongs to the same chemical group as the substances examined in that opinion. The terminal metabolism of this additive through glucuronidation among mammals, birds and fish allows the conjugates of the additive to be rapidly excreted. The Authority has concluded that, since linalool is used in food as flavouring and its function in feed is essentially the same as in food, no further demonstration of efficacy is necessary. Therefore, that conclusion can be extrapolated to feed. The applicant withdrew the application for use of linalool in water for drinking.

| (5) | The Authority further concluded that, linalool oxide should be treated as potentially hazardous to the respiratory tract, skin and eyes and also as irritating to the skin. 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 additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003. |
| --- | --- |

(5)

The Authority further concluded that, linalool oxide should be treated as potentially hazardous to the respiratory tract, skin and eyes and also as irritating to the skin. 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 additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

| (6) | The assessment of linalool oxide shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of that substance should be authorised as specified in the Annex to this Regulation. |
| --- | --- |

(6)

The assessment of linalool oxide shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of that substance should be authorised as specified in the Annex to this Regulation.

| (7) | The applicant proposed use levels for linalool oxide to the Authority. Having regard to that proposal, the Authority considered that certain use levels are safe (‘levels considered by the Authority’). For the purpose of official controls along the food chain, certain labelling requirements should be provided for. In particular, where the use levels exceed the levels considered by the Authority, it is appropriate to require that the label of premixtures and the labelling of feed materials and compound feed containing the substances concerned include certain information including reference to the levels considered by the Authority. |
| --- | --- |

(7)

The applicant proposed use levels for linalool oxide to the Authority. Having regard to that proposal, the Authority considered that certain use levels are safe (‘levels considered by the Authority’). For the purpose of official controls along the food chain, certain labelling requirements should be provided for. In particular, where the use levels exceed the levels considered by the Authority, it is appropriate to require that the label of premixtures and the labelling of feed materials and compound feed containing the substances concerned include certain information including reference to the levels considered by the Authority.

| (8) | The fact that the use of the substance concerned in water for drinking is not authorised does not preclude its use in compound feed which is administered via water. |
| --- | --- |

(8)

The fact that the use of the substance concerned in water for drinking is not authorised does not preclude its use in compound feed which is administered via water.

| (9) | Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation for linalool oxide, it is appropriate to allow a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the authorisation. |
| --- | --- |

(9)

Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation for linalool oxide, it is appropriate to allow a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the authorisation.

| (10) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
| --- | --- |

(10)

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 substance specified in the Annex, belonging to the additive category ‘sensory additives’ and to the functional group ‘flavouring compounds’, is authorised as a feed additive in animal nutrition subject to the conditions laid down in that Annex.

Article 2

Transitional measures

1.   The substance specified in the Annex and premixtures containing that substance, which are produced and labelled before 15 September 2018 in accordance with the rules applicable before 15 March 2018 may continue to be placed on the market and used until the existing stocks are exhausted.

2.   Feed materials and compound feed containing the substance as specified in the Annex which are produced and labelled before 15 March 2019 in accordance with the rules applicable before 15 March 2018 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.   Feed materials and compound feed containing the substance as specified in the Annex which are produced and labelled before 15 March 2020 in accordance with the rules applicable before 15 March 2018 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.

Official Journal of the European Union

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 15 February 2018.

For the Commission

The President

Jean-Claude JUNCKER

---

(1)  
  OJ L 268, 18.10.2003, p. 29.

1

(2)  Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (OJ L 270, 14.12.1970, p. 1).

2

(3)  
  EFSA Journal 2012;10(7):2786.

3

EFSA Journal

(4)  
  EFSA Journal 2014:12(3):3608.

4

EFSA Journal

---

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 % |
| Category: Sensory additives. Functional group: Flavouring compounds |
| 2b13140 | — | Linalool oxide | Additive composition

  Linalool oxide

  Characterisation of the active substance

  Produced by chemical synthesis
  Purity: min. 95 % assay
  Chemical formula: C10H18O2

  CAS number: 1365-19-1
  FLAVIS No: 13.140

  Method of analysis
   (1)

  For the determination of linalool oxide in the feed additive and in feed flavouring premixtures:
  Gas chromatography mass spectrometry with retention time locking GC-MS-RTL. | All animal species except fish | — | — | — | 1. | The additive shall be incorporated into the feed in the form of a premixture. |

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 %

Category: Sensory additives. Functional group: Flavouring compounds

2b13140

—

Linalool oxide

Additive composition

Linalool oxide

Characterisation of the active substance

Produced by chemical synthesis

Purity: min. 95 % assay

Chemical formula: C10H18O2

CAS number: 1365-19-1

FLAVIS No: 13.140

Method of analysis
   (1)

For the determination of linalool oxide in the feed additive and in feed flavouring premixtures:

Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

All animal species except fish

—

—

—

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. |
| --- | --- |

2.

In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.

| 3. | 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 %:






  — | 0,3 mg/kg for pigs and poultry, |
| --- | --- | --- |

3.

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 %:

—

0,3 mg/kg for pigs and poultry,

| — | 0,5 mg/kg for other species and categories except fish.’ |
| --- | --- |

—

0,5 mg/kg for other species and categories except fish.’

| 4. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use levels suggested on the label of the premixture would result in exceeding the levels referred to in point 3. |
| --- | --- |

4.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use levels suggested on the label of the premixture would result in exceeding the levels referred to in point 3.

| 5. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds:






  — | 0,3 mg/kg for pigs and poultry, |
| --- | --- | --- |

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds:

—

0,3 mg/kg for pigs and poultry,

| — | 0,5 mg/kg for other species and categories except fish. |
| --- | --- |

—

0,5 mg/kg for other species and categories except fish.

| 6. | For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves. |
| --- | --- |

6.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

15.3.2028

---

(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

---

| 23.2.2018 | EN | Official Journal of the European Union | L 53/109 |
| --- | --- | --- | --- |

23.2.2018

EN

Official Journal of the European Union

L 53/109

---

COMMISSION IMPLEMENTING REGULATION (EU) 2018/247

of 15 February 2018

concerning the authorisation of 2,4,5-trimethylthiazole, 2-isobutylthiazole, 5-(2-hydroxyethyl)-4-methylthiazole, 2-acetylthiazole, 2-ethyl-4- methylthiazole, 5,6-dihydro-2,4,6,tris(2-methylpropyl)4H-1,3,5-dithiazine and thiamine hydrochloride 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). |
| --- | --- |

(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) | The substances 2,4,5-trimethylthiazole, 2-isobutylthiazole, 5-(2-hydroxyethyl)-4-methylthiazole, 2-acetylthiazole, 2-ethyl-4- methylthiazole, 5,6-dihydro-2,4,6,tris(2-methylpropyl)4H-1,3,5-dithiazine and thiamine hydrochloride (‘substances concerned’) were authorised without a time limit by 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. |
| --- | --- |

(2)

The substances 2,4,5-trimethylthiazole, 2-isobutylthiazole, 5-(2-hydroxyethyl)-4-methylthiazole, 2-acetylthiazole, 2-ethyl-4- methylthiazole, 5,6-dihydro-2,4,6,tris(2-methylpropyl)4H-1,3,5-dithiazine and thiamine hydrochloride (‘substances concerned’) were authorised without a time limit by 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 that those additives be classified in the additive category ‘sensory additives’. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003. |
| --- | --- |

(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 that those additives be classified in the additive category ‘sensory additives’. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

| (4) | The European Food Safety Authority (‘the Authority’) concluded in its opinion of 13 April 2016 (3) that, under the proposed conditions of use, the substances concerned do not have adverse effects on animal health, human health or the environment. The Authority has concluded that, since the substances concerned are used in food as flavourings and their function in feed is essentially the same as in food, no further demonstration of efficacy is necessary. Therefore, that conclusion can be extrapolated to feed. The applicant withdrew the application for use of the substances concerned in water for drinking. |
| --- | --- |

(4)

The European Food Safety Authority (‘the Authority’) concluded in its opinion of 13 April 2016 (3) that, under the proposed conditions of use, the substances concerned do not have adverse effects on animal health, human health or the environment. The Authority has concluded that, since the substances concerned are used in food as flavourings and their function in feed is essentially the same as in food, no further demonstration of efficacy is necessary. Therefore, that conclusion can be extrapolated to feed. The applicant withdrew the application for use of the substances concerned in water for drinking.

| (5) | The Authority further noted that for the substances concerned hazards for the skin, eye contact and respiratory exposure are recognised. Most substances are classified as irritating to the respiratory system. 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. |
| --- | --- |

(5)

The Authority further noted that for the substances concerned hazards for the skin, eye contact and respiratory exposure are recognised. Most substances are classified as irritating to the respiratory system. 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.

| (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. |
| --- | --- |

(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.

| (7) | The applicant proposed use levels for the substances concerned to the Authority. Having regard to that proposal, the Authority considered that certain use levels are safe (‘levels considered by the Authority’). For the purpose of official controls along the food chain, certain labelling requirements should be provided for. In particular, where the use levels exceed the levels considered by the Authority, it is appropriate to require that the label of premixtures, and the labelling of feed materials and compound feed containing the substances concerned include certain information including reference to the levels considered by the Authority. |
| --- | --- |

(7)

The applicant proposed use levels for the substances concerned to the Authority. Having regard to that proposal, the Authority considered that certain use levels are safe (‘levels considered by the Authority’). For the purpose of official controls along the food chain, certain labelling requirements should be provided for. In particular, where the use levels exceed the levels considered by the Authority, it is appropriate to require that the label of premixtures, and the labelling of feed materials and compound feed containing the substances concerned include certain information including reference to the levels considered by the Authority.

| (8) | The fact that the use of the substance concerned in water for drinking is not authorised does not preclude its use in compound feed which is administered via water. |
| --- | --- |

(8)

The fact that the use of the substance concerned in water for drinking is not authorised does not preclude its use in compound feed which is administered via water.

| (9) | 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)

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.

| (10) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
| --- | --- |

(10)

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 belonging to the additive category ‘sensory additives’ and to the functional group ‘flavouring compounds’ which are produced and labelled before 15 September 2018 in accordance with the rules applicable before 15 March 2018 may continue to be placed on the market and used until the existing stocks are exhausted.

2.   Feed materials and compound feed containing the substances belonging to, the additive category ‘sensory additives’ and to the functional group ‘flavouring compounds’ as specified in the Annex which are produced and labelled before 15 March 2019 in accordance with the rules applicable before 15 March 2018 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.   Feed materials and compound feed containing the substances belonging to, the additive category ‘sensory additives’ and to the functional group ‘flavouring compounds’ as specified in the Annex which are produced and labelled before 15 March 2020 in accordance with the rules applicable before 15 March 2018 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.

Official Journal of the European Union

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 15 February 2018.

For the Commission

The President

Jean-Claude JUNCKER

---

(1)  
  OJ L 268, 18.10.2003, p. 29.

1

(2)  Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (OJ L 270, 14.12.1970, p. 1).

2

(3)  
  EFSA Journal 2016;14(4):4441.

3

EFSA Journal

---

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 % |
| Category: Sensory additives. Functional group: Flavouring compounds |
| 2b15019 | — | 2,4,5-Trimethylthiazole | Additive composition

  2,4,5-Trimethylthiazole

  Characterisation of the active substance

  Produced by chemical synthesis
  Purity: min. 97 % assay
  Chemical formula: C6H9NS
  CAS number: 13623-11-5
  FLAVIS No: 15.019

  Method of analysis
   (1)

  For the determination of 2,4,5-trimethylthiazole in the feed additive and in feed flavouring premixtures:
  Gas chromatography mass spectrometry with retention time locking GC-MS-RTL. | All animal species | — | — | — | 1. | The additive shall be incorporated into the feed in the form of a premixture. |

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 %

Category: Sensory additives. Functional group: Flavouring compounds

2b15019

—

2,4,5-Trimethylthiazole

Additive composition

2,4,5-Trimethylthiazole

Characterisation of the active substance

Produced by chemical synthesis

Purity: min. 97 % assay

Chemical formula: C6H9NS

CAS number: 13623-11-5

FLAVIS No: 15.019

Method of analysis
   (1)

For the determination of 2,4,5-trimethylthiazole in the feed additive and in feed flavouring premixtures:

Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

All animal species

—

—

—

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. |
| --- | --- |

2.

In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.

| 3. | 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 %: 0,05 mg/kg.’ |
| --- | --- |

3.

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 %: 0,05 mg/kg.’

| 4. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3. |
| --- | --- |

4.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3.

| 5. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 0,05 mg/kg. |
| --- | --- |

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 0,05 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 inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves. |
| --- | --- |

6.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

15.3.2028

2b15013

—

2-Isobutylthiazole

Additive composition

2-Isobutylthiazole

Characterisation of the active substance

2-Isobutylthiazole

Produced by chemical synthesis

Purity: min. 96 % assay

Chemical formula: C7H11NS

CAS number: 18640-74-9

FLAVIS No: 15.013

Method of analysis
   (1)

For the determination of 2-isobutylthiazole in the feed additive and in feed flavouring premixtures:

Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

All animal species

—

—

—

| 1. | The additive shall be incorporated into the feed in the form of a premixture. |
| --- | --- |

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. |
| --- | --- |

2.

In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.

| 3. | 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 %: 0,05 mg/kg.’ |
| --- | --- |

3.

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 %: 0,05 mg/kg.’

| 4. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3. |
| --- | --- |

4.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3.

| 5. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 0,05 mg/kg. |
| --- | --- |

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 0,05 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 inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves. |
| --- | --- |

6.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

15.3.2028

2b15014

—

5-(2-Hydroxyethyl)-4-methylthiazole

Additive composition

5-(2-Hydroxyethyl)-4-methylthiazole

Characterisation of the active substance

5-(2-Hydroxyethyl)-4-methylthiazole

Produced by chemical synthesis

Purity: min. 96 % assay

Chemical formula: C6H9ONS

CAS number: 137-00-8

FLAVIS No: 15.014

Method of analysis
   (1)

For the determination of 5-(2-hydroxyethyl)-4-methylthiazole in the feed additive and in feed flavouring premixtures:

Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

All animal species

—

—

—

| 1. | The additive shall be incorporated into the feed in the form of a premixture. |
| --- | --- |

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. |
| --- | --- |

2.

In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.

| 3. | 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 %: 0,05 mg/kg.’ |
| --- | --- |

3.

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 %: 0,05 mg/kg.’

| 4. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3. |
| --- | --- |

4.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3.

| 5. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 0,05 mg/kg. |
| --- | --- |

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 0,05 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 inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves. |
| --- | --- |

6.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

15.3.2028

2b15020

—

2-Acetylthiazole

Additive composition

2-Acetylthiazole

Characterisation of the active substance

2-Acetylthiazole

Produced by chemical synthesis

Purity: min. 97 % assay

Chemical formula: C5H5ONS

CAS number: 24295-03-2

FLAVIS No: 15.020

Method of analysis
   (1)

For the determination of 2-acetylthiazole in the feed additive and in feed flavouring premixtures:

Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

All animal species

—

—

—

| 1. | The additive shall be incorporated into the feed in the form of a premixture. |
| --- | --- |

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. |
| --- | --- |

2.

In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.

| 3. | 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 %: 0,05 mg/kg.’ |
| --- | --- |

3.

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 %: 0,05 mg/kg.’

| 4. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3. |
| --- | --- |

4.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3.

| 5. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 0,05 mg/kg. |
| --- | --- |

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 0,05 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 inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves. |
| --- | --- |

6.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

15.3.2028

2b15033

—

2-Ethyl-4- methylthiazole

Additive composition

2-Ethyl-4- methylthiazole

Characterisation of the active substance

2-Ethyl-4- methylthiazole

Produced by chemical synthesis

Purity: min. 97 % assay

Chemical formula: C6H9NS

CAS number:15679-12-6

FLAVIS No: 15.033

Method of analysis
   (1)

For the determination of 2-ethyl-4- methylthiazole in the feed additive and in feed flavouring premixtures:

Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

All animal species

—

—

—

| 1. | The additive shall be incorporated into the feed in the form of a premixture. |
| --- | --- |

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. |
| --- | --- |

2.

In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.

| 3. | 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 %: 0,05 mg/kg.’ |
| --- | --- |

3.

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 %: 0,05 mg/kg.’

| 4. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3. |
| --- | --- |

4.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3.

| 5. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 0,05 mg/kg. |
| --- | --- |

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 0,05 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 inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves. |
| --- | --- |

6.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

15.3.2028

2b15113

—

5,6-Dihydro-2,4,6,tris(2-methylpropyl)4H-1,3,5-dithiazine

Additive composition

5,6-Dihydro-2,4,6,tris(2-methylpropyl)4H-1,3,5-dithiazine

Characterisation of the active substance

5,6-Dihydro-2,4,6,tris(2-methylpropyl)4H-1,3,5-dithiazine

Produced by chemical synthesis

Purity: min. 87 % assay

Chemical formula: C15H31NS2

CAS number: 74595-94-1

FLAVIS No: 15.113

Method of analysis
   (1)

For the determination of 5,6-dihydro-2,4,6,tris(2-methylpropyl)4H-1,3,5-dithiazine in the feed additive and in feed flavouring premixtures:

Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

All animal species

—

—

—

| 1. | The additive shall be incorporated into the feed in the form of a premixture. |
| --- | --- |

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. |
| --- | --- |

2.

In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.

| 3. | 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 %: 0,05 mg/kg.’ |
| --- | --- |

3.

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 %: 0,05 mg/kg.’

| 4. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3. |
| --- | --- |

4.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3.

| 5. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 0,05 mg/kg. |
| --- | --- |

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 0,05 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 inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves. |
| --- | --- |

6.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

15.3.2028

2b16027

—

Thiamine hydrochloride

Additive composition

Thiamine hydrochloride

Characterisation of the active substance

Thiamine hydrochloride

Produced by chemical synthesis

Purity: min.98 % assay

Chemical formula: C12H17ClN4OS · HCl

CAS number: 67-03-8

FLAVIS No: 16.027

Method of analysis
   (1)

For the determination of thiamine hydrochloride in the feed additive and in feed flavouring premixtures:

High-Performance Liquid Chromatography (HPLC) European Pharmacopeia (Ph. Eur. 6.0, method 01/2008:0303)

All animal species

—

—

—

| 1. | The additive shall be incorporated into the feed in the form of a premixture. |
| --- | --- |

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. |
| --- | --- |

2.

In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.

| 3. | 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 %: 0,05 mg/kg.’ |
| --- | --- |

3.

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 %: 0,05 mg/kg.’

| 4. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3. |
| --- | --- |

4.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3.

| 5. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 0,05 mg/kg. |
| --- | --- |

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 0,05 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 inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves. |
| --- | --- |

6.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

15.3.2028

---

(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

---

| 23.2.2018 | EN | Official Journal of the European Union | L 53/120 |
| --- | --- | --- | --- |

23.2.2018

EN

Official Journal of the European Union

L 53/120

---

COMMISSION IMPLEMENTING REGULATION (EU) 2018/248

of 15 February 2018

concerning the authorisation of 2,3-diethylpyrazine, 2,5 or 6-methoxy-3-methylpyrazine, 2-acetyl-3-ethylpyrazine, 2,3-diethyl-5-methylpyrazine, 2-(sec-butyl)-3-methoxypyrazine, 2-ethyl-3-methoxypyrazine, 5,6,7,8-tetrahydroquinoxaline, 2-ethylpyrazine and 5-methylquinoxaline 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). |
| --- | --- |

(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) | The substances 2,3-diethylpyrazine, 2,5 or 6-methoxy-3-methylpyrazine, 2-acetyl-3-ethylpyrazine, 2,3-diethyl-5-methylpyrazine, 2-(sec-butyl)-3-methoxypyrazine, 2-ethyl-3-methoxypyrazine, 5,6,7,8-tetrahydroquinoxaline, 2-ethylpyrazine and 5-methylquinoxaline (‘substances concerned’) were authorised without a time limit by Directive 70/524/EEC as feed additives for all animal species. Those substances were subsequently entered in the Register of feed additives as existing products, in accordance with Article 10(1) of Regulation (EC) No 1831/2003. |
| --- | --- |

(2)

The substances 2,3-diethylpyrazine, 2,5 or 6-methoxy-3-methylpyrazine, 2-acetyl-3-ethylpyrazine, 2,3-diethyl-5-methylpyrazine, 2-(sec-butyl)-3-methoxypyrazine, 2-ethyl-3-methoxypyrazine, 5,6,7,8-tetrahydroquinoxaline, 2-ethylpyrazine and 5-methylquinoxaline (‘substances concerned’) were authorised without a time limit by Directive 70/524/EEC as feed additives for all animal species. Those substances 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 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. |
| --- | --- |

(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 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 6 December 2016 (3) that, under the proposed conditions of use the substances concerned do not have adverse effects on animal health, human health or the environment. These substances increase the food smell or palatability. The Authority has concluded that since the substances concerned are used in food as flavourings and their function in feed is essentially the same as in food, no further demonstration of efficacy is necessary. Therefore, that conclusion can be extrapolated for feed. The applicant withdrew the application for use of the substances concerned in water for drinking. |
| --- | --- |

(4)

The European Food Safety Authority (‘the Authority’) concluded in its opinion of 6 December 2016 (3) that, under the proposed conditions of use the substances concerned do not have adverse effects on animal health, human health or the environment. These substances increase the food smell or palatability. The Authority has concluded that since the substances concerned are used in food as flavourings and their function in feed is essentially the same as in food, no further demonstration of efficacy is necessary. Therefore, that conclusion can be extrapolated for feed. The applicant withdrew the application for use of the substances concerned in water for drinking.

| (5) | The Authority further noted that for the substances concerned hazards for the skin, eye contact and respiratory exposure are recognised. Most substances are classified as irritating to the respiratory system. 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. |
| --- | --- |

(5)

The Authority further noted that for the substances concerned hazards for the skin, eye contact and respiratory exposure are recognised. Most substances are classified as irritating to the respiratory system. 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.

| (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. |
| --- | --- |

(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.

| (7) | The applicant proposed use levels for the substances concerned to the Authority. Having regard to that proposal, the Authority considered that certain use levels are safe (‘levels considered by the Authority’). For the purpose of official controls along the food chain, certain labelling requirements should be provided for. In particular, where the use levels exceed the levels considered by the Authority, it is appropriate to require that the label of premixtures and the labelling of feed materials and compound feed containing the substances concerned include certain information including reference to the levels considered by the Authority. |
| --- | --- |

(7)

The applicant proposed use levels for the substances concerned to the Authority. Having regard to that proposal, the Authority considered that certain use levels are safe (‘levels considered by the Authority’). For the purpose of official controls along the food chain, certain labelling requirements should be provided for. In particular, where the use levels exceed the levels considered by the Authority, it is appropriate to require that the label of premixtures and the labelling of feed materials and compound feed containing the substances concerned include certain information including reference to the levels considered by the Authority.

| (8) | The fact that the use of the substances concerned in water for drinking is not authorised does not preclude their use in compound feed which is administered via water. |
| --- | --- |

(8)

The fact that the use of the substances concerned in water for drinking is not authorised does not preclude their use in compound feed which is administered via water.

| (9) | 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)

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.

| (10) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
| --- | --- |

(10)

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 15 September 2018 in accordance with the rules applicable before 15 March 2018 may continue to be placed on the market and used until the existing stocks are exhausted.

2.   Feed materials and compound feed containing the substances as specified in the Annex which are produced and labelled before 15 March 2019 in accordance with the rules applicable before 15 March 2018 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.   Feed materials and compound feed containing the substances as specified in the Annex which are produced and labelled before 15 March 2020 in accordance with the rules applicable before 15 March 2018 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.

Official Journal of the European Union

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 15 February 2018.

For the Commission

The President

Jean-Claude JUNCKER

---

(1)  
  OJ L 268, 18.10.2003, p. 29.

1

(2)  Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (OJ L 270, 14.12.1970, p. 1).

2

(3)  
  EFSA Journal 2016;15(2):4671.

3

EFSA Journal

---

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 % |
| Category: Sensory additives. Functional group: Flavouring compounds |
| 2b14005 | — | 2,3-Diethylpyrazine | Additive composition

  2,3-Diethylpyrazine

  Characterisation of the active substance

  2,3-Diethylpyrazine
  Produced by chemical synthesis
  Purity: min. 97 % assay
  Chemical formula: C8H12N2

  CAS number: 15707-24-1
  FLAVIS No: 14.005

  Method of analysis
   (1)

  For the determination of 2,3-diethylpyrazine in the feed additive and in feed flavouring premixtures:
  Gas chromatography mass spectrometry with retention time locking GC-MS-RTL. | All animal species | — | — | — | 1. | The additive shall be incorporated into the feed in the form of a premixture. |

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 %

Category: Sensory additives. Functional group: Flavouring compounds

2b14005

—

2,3-Diethylpyrazine

Additive composition

2,3-Diethylpyrazine

Characterisation of the active substance

2,3-Diethylpyrazine

Produced by chemical synthesis

Purity: min. 97 % assay

Chemical formula: C8H12N2

CAS number: 15707-24-1

FLAVIS No: 14.005

Method of analysis
   (1)

For the determination of 2,3-diethylpyrazine in the feed additive and in feed flavouring premixtures:

Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

All animal species

—

—

—

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. |
| --- | --- |

2.

In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.

| 3. | 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 %:






  — | 0,1 mg/kg for pigs and poultry. |
| --- | --- | --- |

3.

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 %:

—

0,1 mg/kg for pigs and poultry.

| — | 0,5 mg/kg for other species and categories’. |
| --- | --- |

—

0,5 mg/kg for other species and categories’.

| 4. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use levels suggested on the label of the premixture would result in exceeding the levels referred to in point 3. |
| --- | --- |

4.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use levels suggested on the label of the premixture would result in exceeding the levels referred to in point 3.

| 5. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds:






  — | 0,1 mg/kg for pigs and poultry. |
| --- | --- | --- |

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds:

—

0,1 mg/kg for pigs and poultry.

| — | 0,5 mg/kg for other species and categories |
| --- | --- |

—

0,5 mg/kg for other species and categories

| 6. | For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves. |
| --- | --- |

6.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

15.3.2028

2b14025

—

2,5 or 6-Methoxy-3-methylpyrazine

Additive composition

2,5 or 6-Methoxy-3-methylpyrazine

Characterisation of the active substance

2,5 or 6-Methoxy-3-methylpyrazine

Produced by chemical synthesis

Purity: min. 97 % assay

Chemical formula: C6H8ON2

CAS number: 63450-30-6

FLAVIS No: 14.025

Method of analysis
   (1)

For the determination of 2,5 or 6-methoxy-3-methylpyrazine in the feed additive and in feed flavouring premixtures:

Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

All animal species

—

—

—

| 1. | The additive shall be incorporated into the feed in the form of a premixture. |
| --- | --- |

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. |
| --- | --- |

2.

In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.

| 3. | 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 %:






  — | 0,1 mg/kg for pigs and poultry. |
| --- | --- | --- |

3.

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 %:

—

0,1 mg/kg for pigs and poultry.

| — | 0,5 mg/kg for other species and categories’. |
| --- | --- |

—

0,5 mg/kg for other species and categories’.

| 4. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use levels suggested on the label of the premixture would result in exceeding the levels referred to in point 3. |
| --- | --- |

4.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use levels suggested on the label of the premixture would result in exceeding the levels referred to in point 3.

| 5. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds:






  — | 0,1 mg/kg for pigs and poultry. |
| --- | --- | --- |

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds:

—

0,1 mg/kg for pigs and poultry.

| — | 0,5 mg/kg for other species and categories |
| --- | --- |

—

0,5 mg/kg for other species and categories

| 6. | For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves. |
| --- | --- |

6.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

15.3.2028

2b14049

—

2-Acetyl-3-ethylpyrazine

Additive composition

2-Acetyl-3-ethylpyrazine

Characterisation of the active substance

2-Acetyl-3-ethylpyrazine

Produced by chemical synthesis

Purity: min. 98 % assay

Chemical formula: C8H10ON2

CAS number: 32974-92-8

FLAVIS No: 14.049

Method of analysis
   (1)

For the determination of 2-acetyl-3-ethylpyrazine in the feed additive and in feed flavouring premixtures:

Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

All animal species

—

—

—

| 1. | The additive shall be incorporated into the feed in the form of a premixture. |
| --- | --- |

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. |
| --- | --- |

2.

In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.

| 3. | 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 %:






  — | 0,1 mg/kg for pigs and poultry. |
| --- | --- | --- |

3.

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 %:

—

0,1 mg/kg for pigs and poultry.

| — | 0,5 mg/kg for other species and categories’. |
| --- | --- |

—

0,5 mg/kg for other species and categories’.

| 4. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use levels suggested on the label of the premixture would result in exceeding the levels referred to in point 3. |
| --- | --- |

4.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use levels suggested on the label of the premixture would result in exceeding the levels referred to in point 3.

| 5. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds:






  — | 0,1 mg/kg for pigs and poultry. |
| --- | --- | --- |

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds:

—

0,1 mg/kg for pigs and poultry.

| — | 0,5 mg/kg for other species and categories |
| --- | --- |

—

0,5 mg/kg for other species and categories

| 6. | For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves. |
| --- | --- |

6.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

15.3.2028

2b14056

—

2,3-Diethyl-5-methylpyrazine

Additive composition

2,3-Diethyl-5-methylpyrazine

Characterisation of the active substance

2,3-Diethyl-5-methylpyrazine

Produced by chemical synthesis

Purity: min. 98 % assay

Chemical formula: C9H14N2

CAS number: 18138-04-0

FLAVIS No: 14.056

Method of analysis
   (1)

For the determination of 2,3-diethyl-5-methylpyrazine alcohol in the feed additive and in feed flavouring premixtures:

Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

All animal species

—

—

—

| 1. | The additive shall be incorporated into the feed in the form of a premixture. |
| --- | --- |

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. |
| --- | --- |

2.

In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.

| 3. | 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 %:






  — | 0,1 mg/kg for pigs and poultry. |
| --- | --- | --- |

3.

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 %:

—

0,1 mg/kg for pigs and poultry.

| — | 0,5 mg/kg for other species and categories’. |
| --- | --- |

—

0,5 mg/kg for other species and categories’.

| 4. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use levels suggested on the label of the premixture would result in exceeding the levels referred to in point 3. |
| --- | --- |

4.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use levels suggested on the label of the premixture would result in exceeding the levels referred to in point 3.

| 5. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds:






  — | 0,1 mg/kg for pigs and poultry. |
| --- | --- | --- |

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds:

—

0,1 mg/kg for pigs and poultry.

| — | 0,5 mg/kg for other species and categories |
| --- | --- |

—

0,5 mg/kg for other species and categories

| 6. | For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves. |
| --- | --- |

6.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

15.3.2028

2b14062

—

2-(sec-Butyl)-3-methoxypyrazine

Additive composition

2-(sec-Butyl)-3-methoxypyrazine

Characterisation of the active substance

2-(sec-Butyl)-3-methoxypyrazine

Produced by chemical synthesis

Purity: min. 99 % assay

Chemical formula: C9H14ON2

CAS number: 24168-70-5

FLAVIS No: 14.062

Method of analysis
   (1)

For the determination of 2-(sec-butyl)-3-methoxypyrazine in the feed additive and in feed flavouring premixtures:

Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

All animal species

—

—

—

| 1. | The additive shall be incorporated into the feed in the form of a premixture. |
| --- | --- |

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. |
| --- | --- |

2.

In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.

| 3. | 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 %:






  — | 0,1 mg/kg for pigs and poultry. |
| --- | --- | --- |

3.

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 %:

—

0,1 mg/kg for pigs and poultry.

| — | 0,5 mg/kg for other species and categories’. |
| --- | --- |

—

0,5 mg/kg for other species and categories’.

| 4. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use levels suggested on the label of the premixture would result in exceeding the levels referred to in point 3. |
| --- | --- |

4.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use levels suggested on the label of the premixture would result in exceeding the levels referred to in point 3.

| 5. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds:






  — | 0,1 mg/kg for pigs and poultry. |
| --- | --- | --- |

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds:

—

0,1 mg/kg for pigs and poultry.

| — | 0,5 mg/kg for other species and categories |
| --- | --- |

—

0,5 mg/kg for other species and categories

| 6. | For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves. |
| --- | --- |

6.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

15.3.2028

2b14112

—

2-Ethyl-3-methoxypyrazine

Additive composition

2-Ethyl-3-methoxypyrazine

Characterisation of the active substance

2-Ethyl-3-methoxypyrazine

Produced by chemical synthesis

Purity: min. 99 % assay

Chemical formula: C7H10N2O

CAS number: 25680-58-4

FLAVIS No: 14.112

Method of analysis
   (1)

For the determination of 2-ethyl-3-methoxypyrazine in the feed additive and in feed flavouring premixtures:

Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

All animal species

—

—

—

| 1. | The additive shall be incorporated into the feed in the form of a premixture. |
| --- | --- |

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. |
| --- | --- |

2.

In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.

| 3. | 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 %:






  — | 0,1 mg/kg for pigs and poultry |
| --- | --- | --- |

3.

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 %:

—

0,1 mg/kg for pigs and poultry

| — | 0,5 mg/kg for other species and categories’. |
| --- | --- |

—

0,5 mg/kg for other species and categories’.

| 4. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use levels suggested on the label of the premixture would result in exceeding the levels referred to in point 3. |
| --- | --- |

4.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use levels suggested on the label of the premixture would result in exceeding the levels referred to in point 3.

| 5. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds:






  — | 0,1 mg/kg for pigs and poultry. |
| --- | --- | --- |

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds:

—

0,1 mg/kg for pigs and poultry.

| — | 0,5 mg/kg for other species and categories |
| --- | --- |

—

0,5 mg/kg for other species and categories

| 6. | For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves. |
| --- | --- |

6.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

15.3.2028

2b14015

—

5,6,7,8-Tetrahydroquinoxaline

Additive composition

5,6,7,8-Tetrahydroquinoxaline

Characterisation of the active substance

5,6,7,8-Tetrahydroquinoxaline

Produced by chemical synthesis

Purity: min. 98 % assay

Chemical formula: C8H10N2

CAS number: 34413-35-9

FLAVIS No: 14.015

Method of analysis
   (1)

For the determination of 5,6,7,8-tetrahydroquinoxaline in the feed additive and in feed flavouring premixtures:

Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

All animal species

—

—

—

| 1. | The additive shall be incorporated into the feed in the form of a premixture. |
| --- | --- |

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. |
| --- | --- |

2.

In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.

| 3. | 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 %:






  — | 0,1 mg/kg for pigs and poultry. |
| --- | --- | --- |

3.

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 %:

—

0,1 mg/kg for pigs and poultry.

| — | 0,5 mg/kg for other species and categories’. |
| --- | --- |

—

0,5 mg/kg for other species and categories’.

| 4. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use levels suggested on the label of the premixture would result in exceeding the levels referred to in point 3. |
| --- | --- |

4.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use levels suggested on the label of the premixture would result in exceeding the levels referred to in point 3.

| 5. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds:






  — | 0,1 mg/kg for pigs and poultry. |
| --- | --- | --- |

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds:

—

0,1 mg/kg for pigs and poultry.

| — | 0,5 mg/kg for other species and categories |
| --- | --- |

—

0,5 mg/kg for other species and categories

| 6. | For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves. |
| --- | --- |

6.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

15.3.2028

2b14022

—

2-Ethylpyrazine

Additive composition

2-Ethylpyrazine

Characterisation of the active substance

2-Ethylpyrazine

Produced by chemical synthesis

Purity: min. 98 % assay

Chemical formula: C6H8N2

CAS number: 13925-00-3

FLAVIS No: 14.022

Method of analysis
   (1)

For the determination of 2-ethylpyrazine in the feed additive and in feed flavouring premixtures:

Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

All animal species

—

—

—

| 1. | The additive shall be incorporated into the feed in the form of a premixture. |
| --- | --- |

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. |
| --- | --- |

2.

In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.

| 3. | 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 %:






  — | 0,1 mg/kg for pigs and poultry. |
| --- | --- | --- |

3.

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 %:

—

0,1 mg/kg for pigs and poultry.

| — | 0,5 mg/kg for other species and categories’. |
| --- | --- |

—

0,5 mg/kg for other species and categories’.

| 4. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use levels suggested on the label of the premixture would result in exceeding the levels referred to in point 3. |
| --- | --- |

4.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use levels suggested on the label of the premixture would result in exceeding the levels referred to in point 3.

| 5. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds:






  — | 0,1 mg/kg for pigs and poultry. |
| --- | --- | --- |

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds:

—

0,1 mg/kg for pigs and poultry.

| — | 0,5 mg/kg for other species and categories |
| --- | --- |

—

0,5 mg/kg for other species and categories

| 6. | For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves. |
| --- | --- |

6.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

15.3.2028

2b14028

—

5-Methylquinoxaline

Additive composition

5-Methylquinoxaline

Characterisation of the active substance

5-Methylquinoxaline

Produced by chemical synthesis

Purity: min. 98 % assay

Chemical formula: C9H8N2

CAS number: 13708-12-8

FLAVIS No: 14.028

Method of analysis
   (1)

For the determination of 5-methylquinoxaline in the feed additive and in feed flavouring premixtures:

Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

All animal species

—

—

—

| 1. | The additive shall be incorporated into the feed in the form of a premixture. |
| --- | --- |

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. |
| --- | --- |

2.

In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.

| 3. | 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 %:






  — | 0,05 mg/kg for pigs and poultry |
| --- | --- | --- |

3.

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 %:

—

0,05 mg/kg for pigs and poultry

| — | 0,08 mg/kg for other species and categories.’ |
| --- | --- |

—

0,08 mg/kg for other species and categories.’

| 4. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use levels suggested on the label of the premixture would result in exceeding the levels referred to in point 3. |
| --- | --- |

4.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use levels suggested on the label of the premixture would result in exceeding the levels referred to in point 3.

| 5. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds:






  — | 0,05 mg/kg for pigs and poultry. |
| --- | --- | --- |

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds:

—

0,05 mg/kg for pigs and poultry.

| — | 0,08 mg/kg for other species and categories |
| --- | --- |

—

0,08 mg/kg for other species and categories

| 6. | For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves. |
| --- | --- |

6.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

15.3.2028

---

(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

---

| 23.2.2018 | EN | Official Journal of the European Union | L 53/134 |
| --- | --- | --- | --- |

23.2.2018

EN

Official Journal of the European Union

L 53/134

---

COMMISSION IMPLEMENTING REGULATION (EU) 2018/249

of 15 February 2018

concerning the authorisation of taurine, beta-alanine, L-alanine, L-arginine, L-aspartic acid, L-histidine, D,L-isoleucine, L-leucine, L-phenylalanine, L-proline, D,L-serine, L-tyrosine, L-methionine, L-valine, L-cysteine, glycine, monosodium glutamate and L-glutamic acid as feed additives for all animal species and L-cysteine hydrochloride monohydrate for all species except cats and dogs

(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). |
| --- | --- |

(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) | The substances taurine, beta-alanine, L-alanine, L-arginine, L-aspartic acid, L-histidine, D,L-isoleucine, L-leucine, L-phenylalanine, L-proline, D,L-serine, L-tyrosine, L-methionine, L-valine, L-cysteine, L-cysteine hydrochloride monohydrate, glycine, monosodium glutamate and L-glutamic acid (‘substances concerned’) were authorised without a time limit by Directive 70/524/EEC as feed additives for all animal species. Those substances were subsequently entered in the Register of feed additives as existing products, in accordance with Article 10(1) of Regulation (EC) No 1831/2003. |
| --- | --- |

(2)

The substances taurine, beta-alanine, L-alanine, L-arginine, L-aspartic acid, L-histidine, D,L-isoleucine, L-leucine, L-phenylalanine, L-proline, D,L-serine, L-tyrosine, L-methionine, L-valine, L-cysteine, L-cysteine hydrochloride monohydrate, glycine, monosodium glutamate and L-glutamic acid (‘substances concerned’) were authorised without a time limit by Directive 70/524/EEC as feed additives for all animal species. Those substances 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 produced by fermentation, protein hydrolysis and chemical synthesis as feed additives for all animal species. The applicant requested those additives be classified in the additive category ‘sensory additives’. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003. |
| --- | --- |

(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 produced by fermentation, protein hydrolysis and chemical synthesis as feed additives for all animal species. The applicant requested those additives be classified in the additive category ‘sensory additives’. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

| (4) | The European Food Safety Authority (‘the Authority’) concluded in its opinion of 9 April 2014 (3) that, under the proposed conditions of use the substances concerned do not have adverse effects on animal health, human health or the environment. The lack of information on the production strains does not allow concluding on the substances concerned produced by fermentation. The Authority has concluded that, since the substances concerned are efficacious when used in food as flavourings and their function in feed is essentially the same as in food, no further demonstration of efficacy is necessary. Therefore, that conclusion can be extrapolated to feed. The applicant withdrew the application for the use of the substances concerned in water for drinking. |
| --- | --- |

(4)

The European Food Safety Authority (‘the Authority’) concluded in its opinion of 9 April 2014 (3) that, under the proposed conditions of use the substances concerned do not have adverse effects on animal health, human health or the environment. The lack of information on the production strains does not allow concluding on the substances concerned produced by fermentation. The Authority has concluded that, since the substances concerned are efficacious when used in food as flavourings and their function in feed is essentially the same as in food, no further demonstration of efficacy is necessary. Therefore, that conclusion can be extrapolated to feed. The applicant withdrew the application for the use of the substances concerned in water for drinking.

| (5) | The Authority further concluded that, in the absence of data, the substances concerned should be considered as irritating to skin and eyes and as skin sensitisers. The Authority also considered that the substances concerned are irritating to the respiratory system and have the potential to produce hazardous dust. 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. |
| --- | --- |

(5)

The Authority further concluded that, in the absence of data, the substances concerned should be considered as irritating to skin and eyes and as skin sensitisers. The Authority also considered that the substances concerned are irritating to the respiratory system and have the potential to produce hazardous dust. 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.

| (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 except for the substances concerned produced by fermentation. The lack of information on the production strains does not allow assessing their safety. Accordingly, the use of the substances concerned produced by chemical synthesis and protein hydrolysis should be authorised as specified in the Annex to this Regulation. |
| --- | --- |

(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 except for the substances concerned produced by fermentation. The lack of information on the production strains does not allow assessing their safety. Accordingly, the use of the substances concerned produced by chemical synthesis and protein hydrolysis should be authorised as specified in the Annex to this Regulation.

| (7) | The applicant proposed use levels for the substances concerned to the Authority. Having regard to that proposal, the Authority considered that certain use levels are safe (‘levels considered by the Authority’). For the purpose of official controls along the food chain, certain labelling requirements should be provided for. In particular, where the use levels exceed the levels considered by the Authority, it is appropriate to require that the label of premixtures and the labelling of feed materials and compound feed containing the substances concerned include certain information including reference to the levels considered by the Authority. |
| --- | --- |

(7)

The applicant proposed use levels for the substances concerned to the Authority. Having regard to that proposal, the Authority considered that certain use levels are safe (‘levels considered by the Authority’). For the purpose of official controls along the food chain, certain labelling requirements should be provided for. In particular, where the use levels exceed the levels considered by the Authority, it is appropriate to require that the label of premixtures and the labelling of feed materials and compound feed containing the substances concerned include certain information including reference to the levels considered by the Authority.

| (8) | The fact that the use of the substances concerned in water for drinking is not authorised does not preclude their use in compound feed which is administered via water. |
| --- | --- |

(8)

The fact that the use of the substances concerned in water for drinking is not authorised does not preclude their use in compound feed which is administered via water.

| (9) | 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)

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.

| (10) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
| --- | --- |

(10)

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 taurine, beta-alanine, L-alanine, L-arginine, L-aspartic acid, L-histidine, D,L-isoleucine, L-leucine, L-phenylalanine, L-proline, D,L-serine, L-tyrosine, L-methionine, L-valine, L-cysteine, L-cysteine hydrochloride monohydrate, glycine, monosodium glutamate and L-glutamic acid, belonging to the additive category ‘sensory additives’ and to the functional group ‘flavouring compounds’, and premixtures containing those substances, which are produced and labelled before 15 December 2018 in accordance with the rules applicable before 15 March 2018 may continue to be placed on the market and used until the existing stocks are exhausted.

2.   Feed materials and compound feed containing the substances referred to in paragraph 1 which are produced and labelled before 15 September 2019 in accordance with the rules applicable before 15 March 2018 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.   Feed materials and compound feed containing the substances referred to in paragraph 1 which are produced and labelled before 15 September 2020 in accordance with the rules applicable before 15 March 2018 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.

Official Journal of the European Union

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 15 February 2018.

For the Commission

The President

Jean-Claude JUNCKER

---

(1)  
  OJ L 268, 18.10.2003, p. 29.

1

(2)  Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (OJ L 270, 14.12.1970, p. 1).

2

(3)  
  EFSA Journal 2014;12(5):3670.

3

EFSA Journal

---

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 % |
| Category: Sensory additives. Functional group: Flavouring compounds |
| 2b16056 | — | Taurine | Additive composition

  Taurine

  Characterisation of the active substance

  Taurine
  Produced by chemical synthesis or protein hydrolysis
  Purity: min. 98 % assay
  Chemical formula: C2H7O3NS
  CAS number 107-35-7
  FLAVIS No 16.056

  Method of analysis
   (1)

  For identification of taurine in premixtures of flavourings: Ion-exchange chromatography with post column ninhydrin derivatisation (Ph.Eur. 6.6-2.2.56-Method 1).
  For the determination of taurine in premixtures: Ion-exchange chromatography with post column ninhydrin derivatisation and photometric detection: based on Commission Regulation (EC) No 152/2009 (2) (Annex III, part F). | All animal species | — | — | — | 1. | The additive shall be incorporated into the feed in the form of a premixture. |

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 %

Category: Sensory additives. Functional group: Flavouring compounds

2b16056

—

Taurine

Additive composition

Taurine

Characterisation of the active substance

Taurine

Produced by chemical synthesis or protein hydrolysis

Purity: min. 98 % assay

Chemical formula: C2H7O3NS

CAS number 107-35-7

FLAVIS No 16.056

Method of analysis
   (1)

For identification of taurine in premixtures of flavourings: Ion-exchange chromatography with post column ninhydrin derivatisation (Ph.Eur. 6.6-2.2.56-Method 1).

For the determination of taurine in premixtures: Ion-exchange chromatography with post column ninhydrin derivatisation and photometric detection: based on Commission Regulation (EC) No 152/2009 (2) (Annex III, part F).

All animal species

—

—

—

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. |
| --- | --- |

2.

In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.

| 3. | On the label of the additive the following shall be indicated:
  ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 25 mg/kg.’ |
| --- | --- |

3.

On the label of the additive the following shall be indicated:

‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 25 mg/kg.’

| 4. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3. |
| --- | --- |

4.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3.

| 5. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 25 mg/kg. |
| --- | --- |

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 25 mg/kg.

| 6. | For additives produced from hydrolysis of animal protein, the animal species shall be indicated on the label of the additive and premixtures. |
| --- | --- |

6.

For additives produced from hydrolysis of animal protein, the animal species shall be indicated on the label of the additive and premixtures.

| 7. | For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves. |
| --- | --- |

7.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

15.3.2028

2b17001

—

Beta-alanine

Additive composition

Beta-alanine

Characterisation of the active substance

Beta-alanine

Produced by chemical synthesis or protein hydrolysis

Purity: min. 97 % assay

Chemical formula: C3H7O2N

CAS number 107-95-9

FLAVIS No 17.001

Method of analysis
   (1)

For identification of beta-alanine in premixtures of flavourings: Ion-exchange chromatography with post column ninhydrin derivatisation (Ph.Eur. 6.6-2.2.56-Method 1).

For the determination of beta-alanine in premixtures: Ion-exchange chromatography with post column ninhydrin derivatisation and photometric detection: based on Regulation (EC) No 152/2009 (Annex III, part F).

All animal species

—

—

—

| 1. | The additive shall be incorporated into the feed in the form of a premixture. |
| --- | --- |

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. |
| --- | --- |

2.

In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.

| 3. | On the label of the additive the following shall be indicated:
  ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 25 mg/kg.’ |
| --- | --- |

3.

On the label of the additive the following shall be indicated:

‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 25 mg/kg.’

| 4. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3. |
| --- | --- |

4.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3.

| 5. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 25 mg/kg. |
| --- | --- |

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 25 mg/kg.

| 6. | For additives produced from hydrolysis of animal protein, the animal species shall be indicated on the label of the additive and premixtures. |
| --- | --- |

6.

For additives produced from hydrolysis of animal protein, the animal species shall be indicated on the label of the additive and premixtures.

| 7. | For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves. |
| --- | --- |

7.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

15.3.2028

2b17002

—

L-Alanine

Additive composition

L-Alanine

Characterisation of the active substance

L-Alanine

Produced by chemical synthesis or protein hydrolysis

Purity: min. 98,5 % assay

Chemical formula: C3H7NO2

CAS number 56-41-7

FLAVIS No 17.002

Method of analysis
   (1)

For identification of L-Alanine in premixtures of flavourings: Ion-exchange chromatography with post column ninhydrin derivatisation (Ph.Eur. 6.6-2.2.56-Method 1).

For the determination of L-alanine in premixtures: Ion-exchange chromatography with post column ninhydrin derivatisation and photometric detection: based on Regulation (EC) No 152/2009 (Annex III, part F).

All animal species

—

—

—

| 1. | The additive shall be incorporated into the feed in the form of a premixture. |
| --- | --- |

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. |
| --- | --- |

2.

In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.

| 3. | On the label of the additive the following shall be indicated:
  ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 25 mg/kg.’ |
| --- | --- |

3.

On the label of the additive the following shall be indicated:

‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 25 mg/kg.’

| 4. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3. |
| --- | --- |

4.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3.

| 5. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 25 mg/kg. |
| --- | --- |

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 25 mg/kg.

| 6. | For additives produced from hydrolysis of animal protein, the animal species shall be indicated on the label of the additive and premixtures. |
| --- | --- |

6.

For additives produced from hydrolysis of animal protein, the animal species shall be indicated on the label of the additive and premixtures.

| 7. | For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves. |
| --- | --- |

7.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

15.3.2028

2b17003

—

L-Arginine

Additive composition

L-Arginine

Characterisation of the active substance

L-Arginine

Produced by chemical synthesis or protein hydrolysis

Purity: min. 98 % assay

Chemical formula: C6H14O2N4

CAS number 74-79-3

FLAVIS No 17.003

Method of analysis
   (1)

For identification of L-arginine in premixtures of flavourings: Ion-exchange chromatography with post column ninhydrin derivatisation (Ph.Eur. 6.6-2.2.56-Method 1).

For the determination of L-arginine in premixtures: Ion-exchange chromatography with post column ninhydrin derivatisation and photometric detection: based on Regulation (EC) No 152/2009 (Annex III, part F).

All animal species

—

—

—

| 1. | The additive shall be incorporated into the feed in the form of a premixture. |
| --- | --- |

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. |
| --- | --- |

2.

In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.

| 3. | On the label of the additive the following shall be indicated:
  ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 25 mg/kg.’ |
| --- | --- |

3.

On the label of the additive the following shall be indicated:

‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 25 mg/kg.’

| 4. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3. |
| --- | --- |

4.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3.

| 5. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 25 mg/kg. |
| --- | --- |

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 25 mg/kg.

| 6. | For additives produced from hydrolysis of animal protein, the animal species shall be indicated on the label of the additive and premixtures. |
| --- | --- |

6.

For additives produced from hydrolysis of animal protein, the animal species shall be indicated on the label of the additive and premixtures.

| 7. | For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves. |
| --- | --- |

7.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

15.3.2028

2b17005

—

L-Aspartic acid

Additive composition

L-Aspartic acid

Characterisation of the active substance

L-Aspartic acid

Produced by chemical synthesis or protein hydrolysis

Purity: min. 98 % assay

Chemical formula: C4H7O4N

CAS number 56-84-8

FLAVIS No 17.005

Method of analysis
   (1)

For identification of L-aspartic acid in premixtures of flavourings: Ion-exchange chromatography with post column ninhydrin derivatisation (Ph.Eur. 6.6-2.2.56-Method 1).

For the determination of L-aspartic acid in premixtures: Ion-exchange chromatography with post column ninhydrin derivatisation and photometric detection: based on Regulation (EC) No 152/2009 (Annex III, part F).

All animal species

—

—

—

| 1. | The additive shall be incorporated into the feed in the form of a premixture. |
| --- | --- |

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. |
| --- | --- |

2.

In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.

| 3. | On the label of the additive the following shall be indicated:
  ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 25 mg/kg.’ |
| --- | --- |

3.

On the label of the additive the following shall be indicated:

‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 25 mg/kg.’

| 4. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3. |
| --- | --- |

4.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3.

| 5. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 25 mg/kg. |
| --- | --- |

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 25 mg/kg.

| 6. | For additives produced from hydrolysis of animal protein, the animal species shall be indicated on the label of the additive and premixtures. |
| --- | --- |

6.

For additives produced from hydrolysis of animal protein, the animal species shall be indicated on the label of the additive and premixtures.

| 7. | For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves. |
| --- | --- |

7.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

15.3.2028

2b17008

—

L-Histidine

Additive composition

L-Histidine

Characterisation of the active substance

L-Histidine

Produced by chemical synthesis or protein hydrolysis

Purity: min. 98 % assay

Chemical formula: C6H9O2N3

CAS number 71-00-1

FLAVIS No 17.008

Method of analysis
   (1)

For identification of L-histidine in premixtures of flavourings: Ion-exchange chromatography with post column ninhydrin derivatisation (Ph.Eur. 6.6-2.2.56-Method 1).

For the determination of L-histidine in premixtures: Ion-exchange chromatography with post column ninhydrin derivatisation and photometric detection: based on Regulation (EC) No 152/2009 (Annex III, part F).

All animal species

—

—

—

| 1. | The additive shall be incorporated into the feed in the form of a premixture. |
| --- | --- |

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. |
| --- | --- |

2.

In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.

| 3. | On the label of the additive the following shall be indicated:
  ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 25 mg/kg.’ |
| --- | --- |

3.

On the label of the additive the following shall be indicated:

‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 25 mg/kg.’

| 4. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3. |
| --- | --- |

4.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3.

| 5. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 25 mg/kg. |
| --- | --- |

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 25 mg/kg.

| 6. | For additives produced from hydrolysis of animal protein, the animal species shall be indicated on the label of the additive and premixtures. |
| --- | --- |

6.

For additives produced from hydrolysis of animal protein, the animal species shall be indicated on the label of the additive and premixtures.

| 7. | For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves. |
| --- | --- |

7.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

15.3.2028

2b17010

—

D,L-Isoleucine

Additive composition

D,L-Isoleucine

Characterisation of the active substance

D,L-Isoleucine

Produced by chemical synthesis or protein hydrolysis

Purity: min. 98 % assay

Chemical formula: C6H13O2N

CAS number 443-79-8

FLAVIS No 17.010

Method of analysis
   (1)

For identification of D,L-isoleucine in premixtures of flavourings: Ion-exchange chromatography with post column ninhydrin derivatisation (Ph.Eur. 6.6-2.2.56-Method 1).

For the determination of D, L-isoleucine in premixtures: Ion-exchange chromatography with post column ninhydrin derivatisation and photometric detection: based on Regulation (EC) No 152/2009 (Annex III, part F).

All animal species

—

—

—

| 1. | The additive shall be incorporated into the feed in the form of a premixture. |
| --- | --- |

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. |
| --- | --- |

2.

In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.

| 3. | On the label of the additive the following shall be indicated:
  ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 25 mg/kg.’ |
| --- | --- |

3.

On the label of the additive the following shall be indicated:

‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 25 mg/kg.’

| 4. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3. |
| --- | --- |

4.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3.

| 5. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 25 mg/kg. |
| --- | --- |

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 25 mg/kg.

| 6. | For additives produced from hydrolysis of animal protein, the animal species shall be indicated on the label of the additive and premixtures. |
| --- | --- |

6.

For additives produced from hydrolysis of animal protein, the animal species shall be indicated on the label of the additive and premixtures.

| 7. | For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves. |
| --- | --- |

7.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

15.3.2028

2b17012

—

L-Leucine

Additive composition

L-Leucine

Characterisation of the active substance

L-Leucine

Produced by chemical synthesis or protein hydrolysis

Purity: min. 98 % assay

Chemical formula: C6H13O2N

CAS number 61-90-5

FLAVIS No 17.012

Method of analysis
   (1)

For identification of L-leucine in premixtures of flavourings: Ion-exchange chromatography with post column ninhydrin derivatisation (Ph.Eur. 6.6-2.2.56-Method 1).

For the determination of L-leucine in premixtures: Ion-exchange chromatography with post column ninhydrin derivatisation and photometric detection: based on Regulation (EC) No 152/2009 (Annex III, part F).

All animal species

—

—

—

| 1. | The additive shall be incorporated into the feed in the form of a premixture. |
| --- | --- |

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. |
| --- | --- |

2.

In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.

| 3. | On the label of the additive the following shall be indicated:
  ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 25 mg/kg.’ |
| --- | --- |

3.

On the label of the additive the following shall be indicated:

‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 25 mg/kg.’

| 4. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3. |
| --- | --- |

4.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3.

| 5. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 25 mg/kg. |
| --- | --- |

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 25 mg/kg.

| 6. | For additives produced from hydrolysis of animal protein, the animal species shall be indicated on the label of the additive and premixtures. |
| --- | --- |

6.

For additives produced from hydrolysis of animal protein, the animal species shall be indicated on the label of the additive and premixtures.

| 7. | For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves. |
| --- | --- |

7.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

15.3.2028

2b17018

—

L-Phenylalanine

Additive composition

L-Phenylalanine

Characterisation of the active substance

L-Phenylalanine

Produced by chemical synthesis or protein hydrolysis

Purity: min. 98 % assay

Chemical formula: C9H11O2N

CAS number 63-91-2

FLAVIS No 17.018

Method of analysis
   (1)

For identification of L-phenylalanine in premixtures of flavourings: Ion-exchange chromatography with post column ninhydrin derivatisation (Ph.Eur. 6.6-2.2.56-Method 1).

For the determination of L-phenylalanine in premixtures: Ion-exchange chromatography with post column ninhydrin derivatisation and photometric detection: based on Regulation (EC) No 152/2009 (Annex III, part F).

All animal species

—

—

—

| 1. | The additive shall be incorporated into the feed in the form of a premixture. |
| --- | --- |

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. |
| --- | --- |

2.

In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.

| 3. | On the label of the additive the following shall be indicated:
  ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 25 mg/kg.’ |
| --- | --- |

3.

On the label of the additive the following shall be indicated:

‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 25 mg/kg.’

| 4. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3. |
| --- | --- |

4.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3.

| 5. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 25 mg/kg. |
| --- | --- |

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 25 mg/kg.

| 6. | For additives produced from hydrolysis of animal protein, the animal species shall be indicated on the label of the additive and premixtures. |
| --- | --- |

6.

For additives produced from hydrolysis of animal protein, the animal species shall be indicated on the label of the additive and premixtures.

| 7. | For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves. |
| --- | --- |

7.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

15.3.2028

2b17019

—

L-Proline

Additive composition

L-Proline

Characterisation of the active substance

L-Proline

Produced by chemical synthesis or protein hydrolysis

Purity: min. 98 % assay

Chemical formula: C5H9O2N

CAS number 147-85-3

FLAVIS No 17.019

Method of analysis
   (1)

For identification of L-proline in premixtures of flavourings: Ion-exchange chromatography with post column ninhydrin derivatisation (Ph.Eur. 6.6-2.2.56-Method 1).

For the determination of L-proline in premixtures: Ion-exchange chromatography with post column ninhydrin derivatisation and photometric detection: based on Regulation (EC) No 152/2009 (Annex III, part F).

All animal species

—

—

—

| 1. | The additive shall be incorporated into the feed in the form of a premixture. |
| --- | --- |

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. |
| --- | --- |

2.

In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.

| 3. | On the label of the additive the following shall be indicated:
  ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 25 mg/kg.’ |
| --- | --- |

3.

On the label of the additive the following shall be indicated:

‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 25 mg/kg.’

| 4. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3. |
| --- | --- |

4.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3.

| 5. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 25 mg/kg. |
| --- | --- |

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 25 mg/kg.

| 6. | For additives produced from hydrolysis of animal protein, the animal species shall be indicated on the label of the additive and premixtures. |
| --- | --- |

6.

For additives produced from hydrolysis of animal protein, the animal species shall be indicated on the label of the additive and premixtures.

| 7. | For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves. |
| --- | --- |

7.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

15.3.2028

2b17020

—

D,L-Serine

Additive composition

D,L-Serine

Characterisation of the active substance

D,L-Serine

Produced by chemical synthesis or protein hydrolysis

Purity: min. 95 % assay

Chemical formula: C3H7NO3

CAS number 302-84-1

FLAVIS No 17.020

Method of analysis
   (1)

For identification of D,L-serine in premixtures of flavourings: Ion-exchange chromatography with post column ninhydrin derivatisation (Ph.Eur. 6.6-2.2.56-Method 1).

For the determination of D, L-serine in premixtures: Ion-exchange chromatography with post column ninhydrin derivatisation and photometric detection: based on Regulation (EC) No 152/2009 (Annex III, part F).

All animal species

—

—

—

| 1. | The additive shall be incorporated into the feed in the form of a premixture. |
| --- | --- |

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. |
| --- | --- |

2.

In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.

| 3. | On the label of the additive the following shall be indicated:
  ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 25 mg/kg.’ |
| --- | --- |

3.

On the label of the additive the following shall be indicated:

‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 25 mg/kg.’

| 4. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3. |
| --- | --- |

4.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3.

| 5. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 25 mg/kg. |
| --- | --- |

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 25 mg/kg.

| 6. | For additives produced from hydrolysis of animal protein, the animal species shall be indicated on the label of the additive and premixtures. |
| --- | --- |

6.

For additives produced from hydrolysis of animal protein, the animal species shall be indicated on the label of the additive and premixtures.

| 7. | For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves. |
| --- | --- |

7.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

15.3.2028

2b17022

—

L-Tyrosine

Additive composition

L-Tyrosine

Characterisation of the active substance

L-Tyrosine

Produced by chemical synthesis or protein hydrolysis

Purity: min. 98 % assay

Chemical formula: C9H11O3N

CAS number 60-18-4

FLAVIS No 17.022

Method of analysis
   (1)

For identification of L-tyrosine in premixtures of flavourings: Ion-exchange chromatography with post column ninhydrin derivatisation (Ph.Eur. 6.6-2.2.56-Method 1).

For the determination of L-tyrosine in premixtures: Ion-exchange chromatography with post column ninhydrin derivatisation and photometric detection: based on Regulation (EC) No 152/2009 (Annex III, part F).

All animal species

—

—

—

| 1. | The additive shall be incorporated into the feed in the form of a premixture. |
| --- | --- |

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. |
| --- | --- |

2.

In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.

| 3. | On the label of the additive the following shall be indicated:
  ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 25 mg/kg.’ |
| --- | --- |

3.

On the label of the additive the following shall be indicated:

‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 25 mg/kg.’

| 4. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3. |
| --- | --- |

4.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3.

| 5. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 25 mg/kg. |
| --- | --- |

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 25 mg/kg.

| 6. | For additives produced from hydrolysis of animal protein, the animal species shall be indicated on the label of the additive and premixtures. |
| --- | --- |

6.

For additives produced from hydrolysis of animal protein, the animal species shall be indicated on the label of the additive and premixtures.

| 7. | For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves. |
| --- | --- |

7.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

15.3.2028

2b17027

—

L-Methionine

Additive composition

L-Methionine

Characterisation of the active substance

L-Methionine

Produced by chemical synthesis or protein hydrolysis

Purity: min. 98,5 % assay

Chemical formula: C5H11NO2S

CAS number 63-68-3

FLAVIS No 17.027

Method of analysis
   (1)

For identification of L-methionine in premixtures of flavourings: Ion-exchange chromatography with post column ninhydrin derivatisation (Ph.Eur. 6.6-2.2.56-Method 1).

For the determination of L-methionine in premixtures: Ion-exchange chromatography with post column ninhydrin derivatisation and photometric detection: based on Regulation (EC) No 152/2009 (Annex III, part F).

All animal species

—

—

—

| 1. | The additive shall be incorporated into the feed in the form of a premixture. |
| --- | --- |

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. |
| --- | --- |

2.

In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.

| 3. | On the label of the additive the following shall be indicated:
  ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 25 mg/kg.’ |
| --- | --- |

3.

On the label of the additive the following shall be indicated:

‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 25 mg/kg.’

| 4. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3. |
| --- | --- |

4.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3.

| 5. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 25 mg/kg. |
| --- | --- |

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 25 mg/kg.

| 6. | For additives produced from hydrolysis of animal protein, the animal species shall be indicated on the label of the additive and premixtures. |
| --- | --- |

6.

For additives produced from hydrolysis of animal protein, the animal species shall be indicated on the label of the additive and premixtures.

| 7. | For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves. |
| --- | --- |

7.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

15.3.2028

2b17028

—

L-Valine

Additive composition

L-Valine

Characterisation of the active substance

L-Valine

Produced by chemical synthesis or protein hydrolysis

Purity: min. 98,5 % assay

Chemical formula: C5H11NO2

CAS number 72-18-4

FLAVIS No 17.028

Method of analysis
   (1)

For identification of L-valine in premixtures of flavourings: Ion-exchange chromatography with post column ninhydrin derivatisation (Ph.Eur. 6.6-2.2.56-Method 1).

For the determination of L-valine in premixtures: Ion-exchange chromatography with post column ninhydrin derivatisation and photometric detection: based on Regulation (EC) No 152/2009 (Annex III, part F).

All animal species

—

—

—

| 1. | The additive shall be incorporated into the feed in the form of a premixture. |
| --- | --- |

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. |
| --- | --- |

2.

In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.

| 3. | On the label of the additive the following shall be indicated:
  ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 25 mg/kg.’ |
| --- | --- |

3.

On the label of the additive the following shall be indicated:

‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 25 mg/kg.’

| 4. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3. |
| --- | --- |

4.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3.

| 5. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 25 mg/kg. |
| --- | --- |

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 25 mg/kg.

| 6. | For additives produced from hydrolysis of animal protein, the animal species shall be indicated on the label of the additive and premixtures. |
| --- | --- |

6.

For additives produced from hydrolysis of animal protein, the animal species shall be indicated on the label of the additive and premixtures.

| 7. | For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves. |
| --- | --- |

7.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

15.3.2028

2b17033

—

L-Cysteine

Additive composition

L-Cysteine

Characterisation of the active substance

L-Cysteine

Produced by chemical synthesis or protein hydrolysis

Purity: min. 98 % assay

Chemical formula: C3H7O2NS

CAS number 52-90-4

FLAVIS No 17.033

Method of analysis
   (1)

For identification of L-cysteine in premixtures of flavourings: Ion-exchange chromatography with post column ninhydrin derivatisation (Ph.Eur. 6.6-2.2.56-Method 1).

For the determination of L-cysteine in premixtures: Ion-exchange chromatography with post column ninhydrin derivatisation and photometric detection: based on Regulation (EC) No 152/2009 (Annex III, part F).

All animal species

—

—

—

| 1. | The additive shall be incorporated into the feed in the form of a premixture. |
| --- | --- |

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. |
| --- | --- |

2.

In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.

| 3. | On the label of the additive the following shall be indicated:
  ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 25 mg/kg.’ |
| --- | --- |

3.

On the label of the additive the following shall be indicated:

‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 25 mg/kg.’

| 4. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3. |
| --- | --- |

4.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3.

| 5. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 25 mg/kg. |
| --- | --- |

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 25 mg/kg.

| 6. | For additives produced from hydrolysis of animal protein, the animal species shall be indicated on the label of the additive and premixtures. |
| --- | --- |

6.

For additives produced from hydrolysis of animal protein, the animal species shall be indicated on the label of the additive and premixtures.

| 7. | For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves. |
| --- | --- |

7.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

15.3.2028

2b920

—

L-Cysteine hydrochloride monohydrate

Additive composition

L-Cysteine hydrochloride monohydrate

Characterisation of the active substance

L-Cysteine hydrochloride monohydrate

Produced by chemical synthesis or protein hydrolysis

Purity: min. 98,5 % assay

Chemical formula: C3H8ClNO2S · H2O

CAS number 7048-04-6

Method of analysis
   (1)

For identification of L-cysteine hydrochloride monohydrate in premixtures of flavourings: Ion-exchange chromatography with post column ninhydrin derivatisation (Ph.Eur. 6.6-2.2.56-Method 1).

For the determination of L-cysteine hydrochloride monohydrate in premixtures: Ion-exchange chromatography with post column ninhydrin derivatisation and photometric detection: based on Regulation (EC) No 152/2009 (Annex III, part F).

All animal species except cats and dogs

—

—

—

| 1. | The additive shall be incorporated into the feed in the form of a premixture. |
| --- | --- |

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. |
| --- | --- |

2.

In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.

| 3. | On the label of the additive the following shall be indicated:
  ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 25 mg/kg for all species except cats and dogs’. |
| --- | --- |

3.

On the label of the additive the following shall be indicated:

‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 25 mg/kg for all species except cats and dogs’.

| 4. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3. |
| --- | --- |

4.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3.

| 5. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 25 mg/kg for all species except cats and dogs. |
| --- | --- |

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 25 mg/kg for all species except cats and dogs.

| 6. | For additives produced from hydrolysis of animal protein, the animal species shall be indicated on the label of the additive and premixtures. |
| --- | --- |

6.

For additives produced from hydrolysis of animal protein, the animal species shall be indicated on the label of the additive and premixtures.

| 7. | For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves. |
| --- | --- |

7.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

15.3.2028

2b17034

—

Glycine

Additive composition

Glycine

Characterisation of the active substance

Glycine

Produced by chemical synthesis or protein hydrolysis

Purity: min. 98 % assay

Chemical formula: C2H5O2N

CAS number 56-40-6

FLAVIS No 17.034

Method of analysis
   (1)

For identification of glycine in premixtures of flavourings: Ion-exchange chromatography with post column ninhydrin derivatisation (Ph.Eur. 6.6-2.2.56-Method 1).

For the determination of glycine in premixtures: Ion-exchange chromatography with post column ninhydrin derivatisation and photometric detection: based on Regulation (EC) No 152/2009 (Annex III, part F).

All animal species

—

—

—

| 1. | The additive shall be incorporated into the feed in the form of a premixture. |
| --- | --- |

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. |
| --- | --- |

2.

In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.

| 3. | 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 %:






  — | 20 g/kg for cats and dogs; |
| --- | --- | --- |

3.

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 %:

—

20 g/kg for cats and dogs;

| — | 25 g/kg for other species and categories.’ |
| --- | --- |

—

25 g/kg for other species and categories.’

| 4. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level suggested on the label of the premixture would result in exceeding the levels referred to in point 3. |
| --- | --- |

4.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level suggested on the label of the premixture would result in exceeding the levels referred to in point 3.

| 5. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds:






  — | 20 g/kg for cats and dogs; |
| --- | --- | --- |

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds:

—

20 g/kg for cats and dogs;

| — | 25 g/kg for other species and categories. |
| --- | --- |

—

25 g/kg for other species and categories.

| 6. | For additives produced from hydrolysis of animal protein, the animal species shall be indicated on the label of the additive and premixtures. |
| --- | --- |

6.

For additives produced from hydrolysis of animal protein, the animal species shall be indicated on the label of the additive and premixtures.

| 7. | For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves. |
| --- | --- |

7.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

15.3.2028

2b621

—

Monosodium glutamate

Additive composition

Monosodium glutamate

Characterisation of the active substance

Monosodium glutamate

Produced by chemical synthesis or protein hydrolysis

Purity: min. 99 % assay

Chemical formula: C5H8 NaNO4 · H2O

CAS number 142-47-2

Method of analysis
   (1)

For identification of monosodium glutamate in premixtures of flavourings: Ion-exchange chromatography with post column ninhydrin derivatisation (Ph.Eur. 6.6-2.2.56-Method 1).

For the determination of monosodium glutamate in premixtures: Ion-exchange chromatography with post column ninhydrin derivatisation and photometric detection: based on Regulation (EC) No 152/2009 (Annex III, part F).

All animal species

—

—

—

| 1. | The additive shall be incorporated into the feed in the form of a premixture. |
| --- | --- |

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. |
| --- | --- |

2.

In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.

| 3. | On the label of the additive the following shall be indicated:
  ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 25 mg/kg.’ |
| --- | --- |

3.

On the label of the additive the following shall be indicated:

‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 25 mg/kg.’

| 4. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3. |
| --- | --- |

4.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3.

| 5. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 25 mg/kg. |
| --- | --- |

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 25 mg/kg.

| 6. | For additives produced from hydrolysis of animal protein, the animal species shall be indicated on the label of the additive and premixtures. |
| --- | --- |

6.

For additives produced from hydrolysis of animal protein, the animal species shall be indicated on the label of the additive and premixtures.

| 7. | For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves. |
| --- | --- |

7.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

15.3.2028

2b620

—

L-Glutamic acid

Additive composition

L-Glutamic acid

Characterisation of the active substance

L-Glutamic acid

Produced by chemical synthesis or protein hydrolysis

Purity: min. 98 % assay

Chemical formula: C5H9O4N

CAS number 56-86-0

Method of analysis
   (1)

For identification of L-glutamic acid in premixtures of flavourings: Ion-exchange chromatography with post column ninhydrin derivatisation (Ph.Eur. 6.6-2.2.56-Method 1).

For the determination of L-glutamic acid in premixtures: Ion-exchange chromatography with post column ninhydrin derivatisation and photometric detection: based on Regulation (EC) No 152/2009 (Annex III, part F).

All animal species

—

—

—

| 1. | The additive shall be incorporated into the feed in the form of a premixture. |
| --- | --- |

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. |
| --- | --- |

2.

In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.

| 3. | On the label of the additive the following shall be indicated:
  ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 25 mg/kg.’ |
| --- | --- |

3.

On the label of the additive the following shall be indicated:

‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 25 mg/kg.’

| 4. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3. |
| --- | --- |

4.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3.

| 5. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 25 mg/kg. |
| --- | --- |

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 25 mg/kg.

| 6. | For additives produced from hydrolysis of animal protein, the animal species shall be indicated on the label of the additive and premixtures. |
| --- | --- |

6.

For additives produced from hydrolysis of animal protein, the animal species shall be indicated on the label of the additive and premixtures.

| 7. | For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves. |
| --- | --- |

7.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

15.3.2028

---

(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

(2)  Commission Regulation (EC) No 152/2009 of 27 January 2009 laying down the methods of sampling and analysis for the official control of feed (OJ L 54, 26.2.2009, p. 1).

---

| 23.2.2018 | EN | Official Journal of the European Union | L 53/166 |
| --- | --- | --- | --- |

23.2.2018

EN

Official Journal of the European Union

L 53/166

---

COMMISSION IMPLEMENTING REGULATION (EU) 2018/250

of 15 February 2018

concerning the authorisation of methyl 2-furoate, bis-(2-methyl-3-furyl) disulfide, furfural, furfuryl alcohol, 2-furanmethanethiol, S-furfuryl acetothioate, difurfuryl disulfide, methyl furfuryl sulfide, 2-methylfuran-3-thiol, methyl furfuryl disulfide, methyl 2-methyl-3-furyl disulfide and furfuryl acetate 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). |
| --- | --- |

(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) | The substances methyl 2-furoate, bis-(2-methyl-3-furyl) disulfide, furfural, furfuryl alcohol, 2-furanmethanethiol, S-furfuryl acetothioate, difurfuryl disulfide, methyl furfuryl sulfide, 2-methylfuran-3-thiol, methyl furfuryl disulfide, methyl 2-methyl-3-furyl disulfide and furfuryl acetate (‘substances concerned’) were authorised without a time limit by 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. |
| --- | --- |

(2)

The substances methyl 2-furoate, bis-(2-methyl-3-furyl) disulfide, furfural, furfuryl alcohol, 2-furanmethanethiol, S-furfuryl acetothioate, difurfuryl disulfide, methyl furfuryl sulfide, 2-methylfuran-3-thiol, methyl furfuryl disulfide, methyl 2-methyl-3-furyl disulfide and furfuryl acetate (‘substances concerned’) were authorised without a time limit by 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 that those additives be classified in the additive category ‘sensory additives’. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003. |
| --- | --- |

(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 that those additives be classified in the additive category ‘sensory additives’. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

| (4) | The European Food Safety Authority (‘the Authority’) concluded in its opinion of 26 January 2016 (3) that under the proposed conditions of use the substances concerned do not have adverse effects on animal health, human health or the environment. These substances increase the food smell or palatability. The Authority has concluded that since the substances concerned are used in food as flavourings and their function in feed is essentially the same as in food no further demonstration of efficacy is necessary. Therefore, that conclusion can be extrapolated for feed. The applicant withdrew the application for use of the substances concerned in water for drinking. |
| --- | --- |

(4)

The European Food Safety Authority (‘the Authority’) concluded in its opinion of 26 January 2016 (3) that under the proposed conditions of use the substances concerned do not have adverse effects on animal health, human health or the environment. These substances increase the food smell or palatability. The Authority has concluded that since the substances concerned are used in food as flavourings and their function in feed is essentially the same as in food no further demonstration of efficacy is necessary. Therefore, that conclusion can be extrapolated for feed. The applicant withdrew the application for use of the substances concerned in water for drinking.

| (5) | The Authority further noted that for the substances concerned hazards for the skin, eye contact and respiratory exposure are recognised. Most substances are classified as irritating to the respiratory system. 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. |
| --- | --- |

(5)

The Authority further noted that for the substances concerned hazards for the skin, eye contact and respiratory exposure are recognised. Most substances are classified as irritating to the respiratory system. 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.

| (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. |
| --- | --- |

(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.

| (7) | The applicant proposed use levels for the substances concerned to the Authority. Having regard to that proposal, the Authority considered that certain use levels are safe (‘levels considered by the Authority’). For the purpose of official controls along the food chain, certain labelling requirements should be provided for. In particular, where the use levels exceed the levels considered by the Authority, it is appropriate to require that the label of premixtures and the labelling of feed materials and compound feed containing the substances concerned include certain information including reference to the levels considered by the Authority. |
| --- | --- |

(7)

The applicant proposed use levels for the substances concerned to the Authority. Having regard to that proposal, the Authority considered that certain use levels are safe (‘levels considered by the Authority’). For the purpose of official controls along the food chain, certain labelling requirements should be provided for. In particular, where the use levels exceed the levels considered by the Authority, it is appropriate to require that the label of premixtures and the labelling of feed materials and compound feed containing the substances concerned include certain information including reference to the levels considered by the Authority.

| (8) | The fact that the use of the substance concerned in water for drinking is not authorised does not preclude its use in compound feed which is administered via water. |
| --- | --- |

(8)

The fact that the use of the substance concerned in water for drinking is not authorised does not preclude its use in compound feed which is administered via water.

| (9) | 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)

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.

| (10) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
| --- | --- |

(10)

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 15 September 2018 in accordance with the rules applicable before 15 March 2018 may continue to be placed on the market and used until the existing stocks are exhausted.

2.   Feed materials and compound feed containing the substances as specified in the Annex which are produced and labelled before 15 March 2019 in accordance with the rules applicable before 15 March 2018 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.   Feed materials and compound feed containing the substances as specified in the Annex which are produced and labelled before 15 March 2020 in accordance with the rules applicable before 15 March 2018 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.

Official Journal of the European Union

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 15 February 2018.

For the Commission

The President

Jean-Claude JUNCKER

---

(1)  
  OJ L 268, 18.10.2003, p. 29.

1

(2)  Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (OJ L 270, 14.12.1970, p. 1).

2

(3)  
  EFSA Journal 2016;14(2):4389.

3

EFSA Journal

---

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 % |
| Category: Sensory additives. Functional group: Flavouring compounds |
| 2b13002 | — | Methyl 2-furoate | Additive composition

  Methyl 2-furoate

  Characterisation of the active substance

  Methyl 2-furoate
  Produced by chemical synthesis
  Purity: min. 98 % assay
  Chemical formula: C6H6O3

  CAS number: 611-13-2
  FLAVIS No: 13.002

  Method of analysis
   (1)

  For the determination of methyl 2-furoate in the feed additive and in feed flavouring premixtures:
  Gas chromatography mass spectrometry with retention time locking GC-MS-RTL | All animal species | — | — | — | 1. | The additive shall be incorporated into the feed in the form of a premixture. |

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 %

Category: Sensory additives. Functional group: Flavouring compounds

2b13002

—

Methyl 2-furoate

Additive composition

Methyl 2-furoate

Characterisation of the active substance

Methyl 2-furoate

Produced by chemical synthesis

Purity: min. 98 % assay

Chemical formula: C6H6O3

CAS number: 611-13-2

FLAVIS No: 13.002

Method of analysis
   (1)

For the determination of methyl 2-furoate in the feed additive and in feed flavouring premixtures:

Gas chromatography mass spectrometry with retention time locking GC-MS-RTL

All animal species

—

—

—

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. |
| --- | --- |

2.

In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.

| 3. | 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 %: 0,5 mg/kg.’ |
| --- | --- |

3.

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 %: 0,5 mg/kg.’

| 4. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3. |
| --- | --- |

4.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3.

| 5. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 0,5 mg/kg. |
| --- | --- |

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 0,5 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 inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves. |
| --- | --- |

6.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

15.3.2028

2b13016

—

Bis-(2-methyl-3-furyl) disulfide

Additive composition

Bis-(2-methyl-3-furyl) disulfide

Characterisation of the active substance

Bis-(2-methyl-3-furyl) disulfide

Produced by chemical synthesis

Purity: min. 98 % assay

Chemical formula: C10H10O2 S2

CAS number: 28588-75-2

FLAVIS No: 13.016

Method of analysis
   (1)

For the determination of bis-(2-methyl-3-furyl) disulfide in the feed additive and in feed flavouring premixtures:

Gas chromatography mass spectrometry with retention time locking GC-MS-RTL

All animal species

—

—

—

| 1. | The additive shall be incorporated into the feed in the form of a premixture. |
| --- | --- |

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. |
| --- | --- |

2.

In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.

| 3. | 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 %: 0,05 mg/kg.’ |
| --- | --- |

3.

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 %: 0,05 mg/kg.’

| 4. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3. |
| --- | --- |

4.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3.

| 5. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 0,05 mg/kg. |
| --- | --- |

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 0,05 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 inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves. |
| --- | --- |

6.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

15.3.2028

2b13018

—

Furfural

Additive composition

Furfural

Characterisation of the active substance

Furfural

Produced by chemical synthesis

Purity: min. 95 % assay

Chemical formula: C5H4O2

CAS number: 98-01-1

FLAVIS No: 13.018

Method of analysis
   (1)

For the determination of furfural in the feed additive and in feed flavouring premixtures:

Gas chromatography mass spectrometry with retention time locking GC-MS-RTL

All animal species

—

—

—

| 1. | The additive shall be incorporated into the feed in the form of a premixture. |
| --- | --- |

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. |
| --- | --- |

2.

In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.

| 3. | 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.’ |
| --- | --- |

3.

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.’

| 4. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3. |
| --- | --- |

4.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3.

| 5. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 5 mg/kg. |
| --- | --- |

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 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 inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves. |
| --- | --- |

6.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

15.3.2028

2b13019

—

Furfuryl alcohol

Additive composition

Furfuryl alcohol

Characterisation of the active substance

Furfuryl alcohol

Produced by chemical synthesis

Purity: min. 97 % assay

Chemical formula: C5H6O2

CAS number: 98-00-0

FLAVIS No: 13.019

Method of analysis
   (1)

For the determination of furfuryl alcohol in the feed additive and in feed flavouring premixtures:

Gas chromatography mass spectrometry with retention time locking GC-MS-RTL

All animal species

—

—

—

| 1. | The additive shall be incorporated into the feed in the form of a premixture. |
| --- | --- |

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. |
| --- | --- |

2.

In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.

| 3. | 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.’ |
| --- | --- |

3.

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.’

| 4. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3. |
| --- | --- |

4.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3.

| 5. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 5 mg/kg. |
| --- | --- |

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 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 inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves. |
| --- | --- |

6.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

15.3.2028

2b13026

—

2-Furanmethanethiol

Additive composition

2-Furanmethanethiol

Characterisation of the active substance

2-Furanmethanethiol

Produced by chemical synthesis

Purity: min. 97 % assay

Chemical formula: C5H6OS

CAS number: 98-02-2

FLAVIS No: 13.026

Method of analysis
   (1)

For the determination of 2-furanmethanethiol in the feed additive and in feed flavouring premixtures:

Gas chromatography mass spectrometry with retention time locking GC-MS-RTL

All animal species

—

—

—

| 1. | The additive shall be incorporated into the feed in the form of a premixture. |
| --- | --- |

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. |
| --- | --- |

2.

In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.

| 3. | 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 %: 0,05 mg/kg.’ |
| --- | --- |

3.

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 %: 0,05 mg/kg.’

| 4. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3. |
| --- | --- |

4.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3.

| 5. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 0,05 mg/kg. |
| --- | --- |

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 0,05 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 inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves. |
| --- | --- |

6.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

15.3.2028

2b13033

—

S-Furfuryl acetothioate

Additive composition

S-furfuryl acetothioate

Characterisation of the active substance

S-furfuryl acetothioate

Produced by chemical synthesis

Purity: min. 95 % assay

Chemical formula: C7H8O2S

CAS number: 13678-68-7

FLAVIS No: 13.033

Method of analysis
   (1)

For the determination of S-furfuryl acetothioate in the feed additive and in feed flavouring premixtures:

Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

All animal species

—

—

—

| 1. | The additive shall be incorporated into the feed in the form of a premixture. |
| --- | --- |

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. |
| --- | --- |

2.

In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.

| 3. | 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 %: 0,05 mg/kg.’ |
| --- | --- |

3.

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 %: 0,05 mg/kg.’

| 4. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3. |
| --- | --- |

4.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3.

| 5. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 0,05 mg/kg. |
| --- | --- |

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 0,05 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 inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves. |
| --- | --- |

6.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

15.3.2028

2b13050

—

Difurfuryl disulfide

Additive composition

Difurfuryl disulfide

Characterisation of the active substance

Difurfuryl disulfide

Produced by chemical synthesis

Purity: min. 96 % assay

Chemical formula: C10H10O2S2

CAS number: 4437-20-1

FLAVIS No: 13.050

Method of analysis
   (1)

For the determination of difurfuryl disulfide in the feed additive and in feed flavouring premixtures:

Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

All animal species

—

—

—

| 1. | The additive shall be incorporated into the feed in the form of a premixture. |
| --- | --- |

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. |
| --- | --- |

2.

In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.

| 3. | 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 %: 0,05 mg/kg.’ |
| --- | --- |

3.

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 %: 0,05 mg/kg.’

| 4. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3. |
| --- | --- |

4.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3.

| 5. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 0,05 mg/kg. |
| --- | --- |

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 0,05 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 inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves. |
| --- | --- |

6.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

15.3.2028

2b13053

—

Methyl furfuryl sulfide

Additive composition

Methyl furfuryl sulfide

Characterisation of the active substance

Methyl furfuryl sulfide

Produced by chemical synthesis

Purity: min. 97 % assay

Chemical formula: C6H8OS

CAS number: 1438-91-1

FLAVIS No: 13.053

Method of analysis
   (1)

For the determination of methyl furfuryl sulfide in the feed additive and in feed flavouring premixtures:

Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

All animal species

—

—

—

| 1. | The additive shall be incorporated into the feed in the form of a premixture. |
| --- | --- |

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. |
| --- | --- |

2.

In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.

| 3. | 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 %: 0,05 mg/kg.’ |
| --- | --- |

3.

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 %: 0,05 mg/kg.’

| 4. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3. |
| --- | --- |

4.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3.

| 5. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 0,05 mg/kg. |
| --- | --- |

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 0,05 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 inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves. |
| --- | --- |

6.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

15.3.2028

2b13055

—

2-Methylfuran-3-thiol

Additive composition

2-Methylfuran-3-thiol

Characterisation of the active substance

2-Methylfuran-3-thiol

Produced by chemical synthesis

Purity: min. 95 % assay

Chemical formula: C5H6OS

CAS number: 28588-74-1

FLAVIS No: 13.055

Method of analysis
   (1)

For the determination of 2-methylfuran-3-thiol in the feed additive and in feed flavouring premixtures:

Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

All animal species

—

—

—

| 1. | The additive shall be incorporated into the feed in the form of a premixture. |
| --- | --- |

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. |
| --- | --- |

2.

In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.

| 3. | 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 %: 0,05 mg/kg.’ |
| --- | --- |

3.

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 %: 0,05 mg/kg.’

| 4. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3. |
| --- | --- |

4.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3.

| 5. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 0,05 mg/kg. |
| --- | --- |

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 0,05 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 inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves. |
| --- | --- |

6.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

15.3.2028

2b13064

—

Methyl furfuryl disulfide

Additive composition

Methyl furfuryl disulfide

Characterisation of the active substance

Methyl furfuryl disulfide

Produced by chemical synthesis

Purity: min. 95 % assay

Chemical formula: C6H8OS2

CAS number: 57500-00-2

FLAVIS No: 13.064

Method of analysis
   (1)

For the determination of methyl furfuryl disulfide in the feed additive and in feed flavouring premixtures:

Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

All animal species

—

—

—

| 1. | The additive shall be incorporated into the feed in the form of a premixture. |
| --- | --- |

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. |
| --- | --- |

2.

In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.

| 3. | 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 %: 0,05 mg/kg.’ |
| --- | --- |

3.

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 %: 0,05 mg/kg.’

| 4. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3. |
| --- | --- |

4.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3.

| 5. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 0,05 mg/kg. |
| --- | --- |

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 0,05 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 inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves. |
| --- | --- |

6.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

15.3.2028

2b13079

—

Methyl 2-methyl-3-furyl disulfide

Additive composition

Methyl 2-methyl-3-furyl disulfide

Characterisation of the active substance

Methyl 2-methyl-3-furyl disulfide

Produced by chemical synthesis

Purity: min. 97 % assay

Chemical formula: C6H8OS2

CAS number: 65505-17-1

FLAVIS No: 13.079

Method of analysis
   (1)

For the determination of methyl 2-methyl-3-furyl disulfide in the feed additive and in feed flavouring premixtures:

Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

All animal species

—

—

—

| 1. | The additive shall be incorporated into the feed in the form of a premixture. |
| --- | --- |

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. |
| --- | --- |

2.

In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.

| 3. | 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 %: 0,05 mg/kg.’ |
| --- | --- |

3.

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 %: 0,05 mg/kg.’

| 4. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3. |
| --- | --- |

4.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3.

| 5. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 0,05 mg/kg. |
| --- | --- |

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 0,05 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 inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves. |
| --- | --- |

6.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

15.3.2028

2b13128

—

Furfuryl acetate

Additive composition

Furfuryl acetate

Characterisation of the active substance

Furfuryl acetate

Produced by chemical synthesis

Purity: min. 97 % assay

Chemical formula: C7H8O3

CAS number: 623-17-6

FLAVIS No: 13.128

Method of analysis
   (1)

For the determination of furfuryl acetate in the feed additive and in feed flavouring premixtures:

Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

All animal species

—

—

—

| 1. | The additive shall be incorporated into the feed in the form of a premixture. |
| --- | --- |

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. |
| --- | --- |

2.

In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.

| 3. | 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 %: 0,5 mg/kg.’ |
| --- | --- |

3.

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 %: 0,5 mg/kg.’

| 4. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3. |
| --- | --- |

4.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3.

| 5. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 0,5 mg/kg. |
| --- | --- |

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 0,5 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 inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves. |
| --- | --- |

6.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

15.3.2028

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(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

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