Gelex

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)

In forceVersion 2018-02-15from 2018-03-15
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Contents
  1. Preamble
    1. Article 1 Authorisation
    2. Article 2 Transitional measures
    3. Article 3 Entry into force
  3. ANNEX
  4. ANNEX 1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.
  5. ANNEX Additive composition
  6. ANNEX 1.2.3.4.5.6.7. Additive composition
  7. ANNEX 1.2.3.4.5.6.7.1.2.3.4.5.6.7. Additive composition
  8. ANNEX 1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7. Additive composition
  9. ANNEX 1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7. Additive composition
  10. ANNEX 1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7. Additive composition
  11. ANNEX 1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7. Additive composition
  12. ANNEX 1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7. Additive composition
  13. ANNEX 1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7. Additive composition
  14. ANNEX 1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7. Additive composition
  15. ANNEX 1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7. Additive composition
  16. ANNEX 1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7. Additive composition
  17. ANNEX 1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7. Additive composition
  18. ANNEX 1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7. Additive composition
  19. ANNEX 1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7. Additive composition
  20. ANNEX 1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7. Additive composition
  21. ANNEX 1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7. Additive composition
  22. ANNEX 1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7. Additive composition
  23. ANNEX 1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7. Additive composition

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition, and in particular Article 9(2) thereof,

Whereas:

(1) Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such authorisation. Article 10 of that Regulation provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC.

(2) 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 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

ANNEX

ANNEX 1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.

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 All animal species — — — The additive shall be incorporated into the feed in the form of a premixture. In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated. On the label 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. 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. 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 additives produced from hydrolysis of animal protein, the animal species shall be indicated on the label of the additive and premixtures. 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 All animal species — — — The additive shall be incorporated into the feed in the form of a premixture. In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated. On the label 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. 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. 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 additives produced from hydrolysis of animal protein, the animal species shall be indicated on the label of the additive and premixtures. 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 All animal species — — — The additive shall be incorporated into the feed in the form of a premixture. In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated. On the label 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. 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. 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 additives produced from hydrolysis of animal protein, the animal species shall be indicated on the label of the additive and premixtures. 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 All animal species — — — The additive shall be incorporated into the feed in the form of a premixture. In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated. On the label 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. 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. 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 additives produced from hydrolysis of animal protein, the animal species shall be indicated on the label of the additive and premixtures. 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 All animal species — — — The additive shall be incorporated into the feed in the form of a premixture. In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated. On the label 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. 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. 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 additives produced from hydrolysis of animal protein, the animal species shall be indicated on the label of the additive and premixtures. 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 All animal species — — — The additive shall be incorporated into the feed in the form of a premixture. In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated. On the label 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. 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. 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 additives produced from hydrolysis of animal protein, the animal species shall be indicated on the label of the additive and premixtures. 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 All animal species — — — The additive shall be incorporated into the feed in the form of a premixture. In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated. On the label 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. 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. 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 additives produced from hydrolysis of animal protein, the animal species shall be indicated on the label of the additive and premixtures. 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 All animal species — — — The additive shall be incorporated into the feed in the form of a premixture. In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated. On the label 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. 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. 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 additives produced from hydrolysis of animal protein, the animal species shall be indicated on the label of the additive and premixtures. 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 All animal species — — — The additive shall be incorporated into the feed in the form of a premixture. In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated. On the label 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. 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. 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 additives produced from hydrolysis of animal protein, the animal species shall be indicated on the label of the additive and premixtures. 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 All animal species — — — The additive shall be incorporated into the feed in the form of a premixture. In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated. On the label 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. 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. 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 additives produced from hydrolysis of animal protein, the animal species shall be indicated on the label of the additive and premixtures. 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 All animal species — — — The additive shall be incorporated into the feed in the form of a premixture. In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated. On the label 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. 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. 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 additives produced from hydrolysis of animal protein, the animal species shall be indicated on the label of the additive and premixtures. 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 All animal species — — — The additive shall be incorporated into the feed in the form of a premixture. In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated. On the label 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. 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. 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 additives produced from hydrolysis of animal protein, the animal species shall be indicated on the label of the additive and premixtures. 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 All animal species — — — The additive shall be incorporated into the feed in the form of a premixture. In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated. On the label 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. 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. 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 additives produced from hydrolysis of animal protein, the animal species shall be indicated on the label of the additive and premixtures. 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 All animal species — — — The additive shall be incorporated into the feed in the form of a premixture. In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated. On the label 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. 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. 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 additives produced from hydrolysis of animal protein, the animal species shall be indicated on the label of the additive and premixtures. 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 All animal species — — — The additive shall be incorporated into the feed in the form of a premixture. In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated. On the label 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. 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. 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 additives produced from hydrolysis of animal protein, the animal species shall be indicated on the label of the additive and premixtures. 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 All animal species except cats and dogs — — — The additive shall be incorporated into the feed in the form of a premixture. In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated. On the label 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. 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. 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. For additives produced from hydrolysis of animal protein, the animal species shall be indicated on the label of the additive and premixtures. 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 All animal species — — — The additive shall be incorporated into the feed in the form of a premixture. In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated. On the label of the additive the following shall be indicated: Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 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. 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: For additives produced from hydrolysis of animal protein, the animal species shall be indicated on the label of the additive and premixtures. 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 All animal species — — — The additive shall be incorporated into the feed in the form of a premixture. In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated. On the label 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. 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. 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 additives produced from hydrolysis of animal protein, the animal species shall be indicated on the label of the additive and premixtures. 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 All animal species — — — The additive shall be incorporated into the feed in the form of a premixture. In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated. On the label 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. 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. 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 additives produced from hydrolysis of animal protein, the animal species shall be indicated on the label of the additive and premixtures. 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

ANNEX 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

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 (Annex III, part F).

ANNEX 1.2.3.4.5.6.7. 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

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).

ANNEX 1.2.3.4.5.6.7.1.2.3.4.5.6.7. 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

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).

ANNEX 1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7. 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

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).

ANNEX 1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7. 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

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).

ANNEX 1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7. 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

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).

ANNEX 1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7. 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

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).

ANNEX 1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7. 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

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).

ANNEX 1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7. 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

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).

ANNEX 1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7. 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

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).

ANNEX 1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7. 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

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).

ANNEX 1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7. 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

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).

ANNEX 1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7. 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

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).

ANNEX 1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7. 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

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).

ANNEX 1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7. 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

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).

ANNEX 1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7. 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

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).

ANNEX 1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7. 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

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).

20 g/kg for cats and dogs;

25 g/kg for other species and categories.

20 g/kg for cats and dogs;

25 g/kg for other species and categories.

ANNEX 1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7. 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

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).

ANNEX 1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7.1.2.3.4.5.6.7. 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

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).

Versions

  1. 2018-02-15

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