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Document af2dceea-ecc4-11e8-b690-01aa75ed71a1

Consolidated text: 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)Text with EEA relevance

02018R0249 — EN — 15.03.2018 — 001.001


This text is meant purely as a documentation tool and has no legal effect. The Union's institutions do not assume any liability for its contents. The authentic versions of the relevant acts, including their preambles, are those published in the Official Journal of the European Union and available in EUR-Lex. Those official texts are directly accessible through the links embedded in this document

►B

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)

(OJ L 053 23.2.2018, p. 134)

Amended by:

 

 

Official Journal

  No

page

date

►M1

COMMISSION IMPLEMENTING REGULATION (EU) 2018/1567 of 18 October 2018

  L 262

31

19.10.2018




▼B

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)



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.

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




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.

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.’

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.

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.

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.

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.’

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.

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.

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.

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.’

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.

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.

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.

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.’

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.

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.

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.

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.’

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.

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.

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.

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.’

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.

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.

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.

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.’

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.

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.

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.

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.’

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.

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.

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.

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.’

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.

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.

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.

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.’

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.

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.

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.

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.’

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.

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.

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.

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.’

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.

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.

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.

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.’

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.

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.

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.

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.’

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.

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.

15.3.2028

2b17033

L-Cysteine

Additive composition

L-Cysteine

Characterisation of the active substance

L-Cysteine

►M1  Produced by chemical synthesis or hydrolysis of animal or vegetal protein ◄

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.

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.’

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.

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.

15.3.2028

2b920

L-Cysteine hydrochloride monohydrate

Additive composition

L-Cysteine hydrochloride monohydrate

Characterisation of the active substance

L-Cysteine hydrochloride monohydrate

►M1  Produced by chemical synthesis or hydrolysis of animal or vegetal proteins ◄

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.

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’.

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.

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.

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.
2.  In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated. ►M1  
3.  On the label of the additive the following shall be indicated: ‘Recommended maximum content of the active substance of complete feeding stuff with a moisture content of 12 %:

— 20 g/kg for cats and dogs;

— 25 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. ►M1  
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 feeding stuff with a moisture content of 12 % exceeds:

— 20 g/kg for cats and dogs;

— 25 mg/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.
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.

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.’

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.

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.

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.

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.’

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.

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.

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).

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