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.
(2)
In accordance with Article 7 of Regulation (EC) No 1831/2003 an
application was submitted for the authorisation of DL-methionyl-DL-methionine as
a feed additive. That 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 DL-methionyl-DL-methionine
as a feed additive for all aquatic animal species, to be classified in the
additive category ‘nutritional additives’.
(4)
The European Food Safety Authority (‘the Authority’) concluded in its
opinion of 27 January 2015 (2) that, under the proposed conditions of use,
DL-methionyl-DL-methionine does not have an adverse effect on animal health,
human health or the environment and that it may be considered an efficacious
source of the amino acid L-methionine for fish and crustacean species. The
Authority does not consider that there is a need for specific requirements of
post-market monitoring. It also verified the report on the method of analysis of
the feed additive in feed submitted by the Reference Laboratory set up by
Regulation (EC) No 1831/2003.
(5)
The assessment of DL-methionyl-DL-methionine shows that the conditions
for authorisation, provided for in Article 5 of Regulation (EC) No 1831/2003,
are satisfied. Accordingly, the use of that substance should be authorised as
specified in the Annex to this Regulation.
(6)
The 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
The substance specified in the Annex, belonging to the additive category
‘nutritional additives’ and to the functional group ‘amino acids, their salts
and analogues’, is authorised as an additive in animal nutrition, subject to the
conditions laid down in that Annex.
Article 2
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, 19 August 2015.
For the Commission
The President
Jean-Claude JUNCKER
(1) OJ L 268, 18.10.2003, p. 29.
(2) EFSA Journal 2015;13(2):4012.
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/kg of complete feed with a moisture content of 12 %
|
|
Category of nutritional additives. Functional group: amino acids, their salts
and analogues
|
|
3c306
|
—
|
DL-methionyl-DL-methionine
|
Additive composition
Crystalline powder from chemical synthesis with a minimum of 93 %
DL-methionyl-DL-methionine, a maximum of 3 % DL-methionine and a maximum of 3 %
sodium sulphate (on a dry matter basis)
Characterisation of the active substance
DL-methionyl-DL-methionine
(2-[(2-amino-4-methylsulfanylbutanoyl)amino]-4-methylsulfanylbutanoic acid)
Chemical formula: C10H20N2O3S2
CAS number: 52715-93-2
Analytical method (1)
For the quantification of DL-methionyl-DL-methionine in the feed additive:
reversed-phase high performance liquid chromatography coupled to photometric
detection at 205 nm (RP-HPLC-UV).
For the quantification of DL-methionyl-DL-methionine in premixtures, compound
feed and feed materials: ion exchange chromatography coupled with post-column
derivatisation and photometric detection at 570 nm (IEC-UV).
|
Fish and crustaceans
|
—
|
|
|
The moisture content shall be indicated on the labelling.
|
9 September 2025
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