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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 nutritionnote, 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.
(2)In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of L-cysteine, L-cysteine hydrochloride monohydrate and L-cysteine hydrochloride. The application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.
(3)That application concerns the authorisation of L-cysteine, L-cysteine hydrochloride monohydrate and L-cysteine hydrochloride, requesting those additives to be classified in the additive category ‘nutritional additives’ and the functional group ‘amino acids, their salts and analogues’ and in the additive category ‘sensory additives’ and the functional group ‘flavouring compounds’. The applicant requested the additives to be authorised for use also in water for drinking. However, Regulation (EC) No 1831/2003 does not allow the authorisation of flavouring compounds for use in water for drinking. Therefore, the use of those additives in water for drinking should not be allowed insofar as they are classified in the functional group ‘flavouring compounds’. The applicant later withdrew the application for the authorisation of L-cysteine, L-cysteine hydrochloride monohydrate and L-cysteine hydrochloride in the additive category ‘nutritional additives’ and the functional group ‘amino acids, their salts and analogues’.
(4)The European Food Safety Authority (‘the Authority’) concluded in its opinion of 17 September 2025note that, under the proposed conditions of use, L-cysteine, L-cysteine hydrochloride monohydrate and L-cysteine hydrochloride are safe for all animal species as well as for consumers and the environment. The Authority also concluded that L-cysteine is not considered a skin and eye irritant nor a skin sensitiser. The substances L-cysteine, L-cysteine hydrochloride monohydrate and L-cysteine hydrochloride are considered to be corrosive to eyes and respiratory tract, but no conclusion could be reached on their skin irritation potential. The Authority further concluded that, as L-cysteine, L-cysteine hydrochloride, and L-cysteine hydrochloride monohydrate are used in food as flavouring compounds, it is expected that they can provide a similar function in feed and no further demonstration of their efficacy is necessary. The Authority did not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.
(5)In view of the above, the Commission considers that L-cysteine, L-cysteine hydrochloride monohydrate and L-cysteine hydrochloride satisfy the conditions provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the use of those substances should be authorised for all animal species. In addition, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on the health of the users of the additives.
(6)The Commission considers that safety reasons do not require the setting of maximum contents for L-cysteine, L-cysteine hydrochloride monohydrate and L-cysteine hydrochloride. In order to allow better control, the recommended maximum content should be indicated on the label of the additives. Where the recommended maximum content is exceeded, certain information should be indicated on the label of the premixtures concerned.
(7)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 1Authorisation#
The substances specified in the Annex, belonging to the additive category ‘sensory additives’ and to the functional group ‘flavouring compounds’, are authorised as additives in animal nutrition, subject to the conditions laid down in that Annex.
Article 2Entry 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.
| Identification number of the additive | Name of the 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/kg of complete feed with a moisture content of 12 % | ||||||||
| Category: Sensory additives. Functional group: Flavouring compounds | ||||||||
| 2b92457 | L-cysteine | Additive compositionL-cysteineSolid formCharacterisation of the active substanceL-cysteinePurity: minimum 98 % on a dry matter basisProduced by electrochemical reduction of L-cystine (produced with Escherichia coli DSM 34232)IUPAC name: (2R)-2-amino-3-sulfanylpropanoic acidChemical formula:C3H7NO2SCAS number: 52-90-4FLAVIS number: 17.033Analytical methodsnoteFor the identification of L-cysteine monohydrochloride in the feed additive:Food Chemical Codex L-cysteine monohydrochloride monographFor the determination of cysteine in the feed additive:Ion-exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS/FLD)For the determination of cysteine in premixtures:Ion-exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS) – Commission Regulation (EC) No 152/2009 | 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 conditions and the stability to heat treatment shall be indicated.3. On the label of the additive the following shall be indicated: Recommended maximum content of the active substance per kg of complete feedingstuff with a moisture content of 12 %: 25mg.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 on the label of the premixture would result in exceeding the content referred to in point 3. | 28 May 2036 |
| Identification number of the additive | Name of the 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/kg of complete feed with a moisture content of 12 % | ||||||||
| Category: Sensory additives. Functional group: Flavouring compounds | ||||||||
| 2b17032 | L-cysteine hydrochloride | Additive compositionL-cysteine hydrochlorideSolid formCharacterisation of the active substanceL-cysteine hydrochloridePurity: minimum 98,5 % on a dry matter basisProduced by electrochemical reduction of L-cystine (produced with Escherichia coli DSM 34232)IUPAC name: (2R)-2-amino-3- sulfanylpropanoic acid; hydrochlorideChemical formula:C3H8ClNO2SCAS number: 52-89-1FLAVIS number: 17.032Analytical methodsnoteFor the identification of L-cysteine monohydrochloride in the feed additive:Food Chemical Codex L-cysteine monohydrochloride monographFor the determination of cysteine in the feed additive:Ion-exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS/FLD)For the determination of cysteine in premixtures:Ion-exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS) – Commission Regulation (EC) No 152/2009 | 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 conditions and the stability to heat treatment shall be indicated.3. On the label of the additive the following shall be indicated: Recommended maximum content of the active substance per kg of complete feedingstuff with a moisture content of 12 %: 25 mg.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 on the label of the premixture would result in exceeding the content referred to in point 3.5. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal skin, eye and breathing protective equipment. | 28 May 2036 |
| Identification number of the additive | Name of the 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/kg of complete feed with a moisture content of 12 % | ||||||||
| Category: Sensory additives. Functional group: Flavouring compounds | ||||||||
| 2b920i | L-cysteine hydrochloride monohydrate | Additive compositionL-cysteine hydrochloride monohydrate Solid formCharacterisation of the active substanceL-cysteine hydrochloride monohydratePurity: minimum 98,5 % on a dry matter basisProduced by electrochemical reduction of L-cystine (produced with Escherichia coli DSM 34232).IUPAC name: (2R)-2-amino-3- sulfanylpropanoic acid; hydrate; hydrochloride;Chemical formula:C3H8ClNO2S·H2OCAS number: 7048-04-6FLAVIS number: 17.032Analytical methodsnoteFor the identification of L-cysteine monohydrochloride in the feed additive:Food Chemical Codex L-cysteine monohydrochloride monographFor the determination of cysteine in the feed additive:Ion-exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS/FLD)For the determination of cysteine in premixtures:Ion-exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS) – Commission Regulation (EC) No 152/2009 | 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 conditions and the stability to heat treatment shall be indicated.3. On the label of the additive the following shall be indicated: Recommended maximum content of the active substance per kg of complete feedingstuff with a moisture content of 12 %: 25 mg.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 on the label of the premixture would result in exceeding the content referred to in point 3.5. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal skin, eye and breathing protective equipment. | 28 May 2036 |
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