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. )
Date: 2018-02-15
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: animal feedingstuffs, flavouring, market approval




L_2018053EN.01013401.xml










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).












(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.












(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.












(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.












(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.












(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.




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.

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

(3)  
            EFSA Journal 2014;12(5):3670.




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
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.










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
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.










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.










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.’














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;










—


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.










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).