Commission Regulation (EC) No 244/2007 of 7 March 2007 concerning the authorisation of L-histidine monohydrochloride monohydrate as a feed additive (Text with EEA relevance)
Date: 2007-03-07
Institutions: European Commission
Subjects: animal nutrition, fish, food additive, organic acid, veterinary legislation

L 73/6

EN

Official Journal of the European Union

13.3.2007

COMMISSION REGULATION (EC) No 244/2007

of 7 March 2007

concerning the authorisation of L-histidine monohydrochloride monohydrate as a feed additive

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(6)

Having regard to the Treaty establishing the European Commu-
nity,

the
Having regard to Regulation (EC) No 1831/2003 of
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 authorisa-
tion of additives for use in animal nutrition and for the
grounds and procedures for granting such authorisation.

It

of

5(2)

with

the environment.

The European Food Safety Authority (the Authority)
concluded in its opinions of 2 March 2005 (3) and of
18 October 2006 (4) that L-histidine monohydrochloride
monohydrate does not have an adverse effect on animal
health, human health or
further
concluded that L-histidine monohydrochloride monohy-
in
drate does not present any other risk which would,
accordance
Regulation
Article
(EC) No 1831/2003, exclude authorisation. According to
that opinion, it is an essential amino acid also for fish, and
the use of that preparation has been shown to prevent
cataracts under farming conditions for salmonids. The
opinion of the Authority recommends appropriate mea-
sures for user safety. It does not consider that there is a need
for specific requirements of post market monitoring. The
report on the method of analysis of the feed additive in feed
was submitted by the Community Reference Laboratory set
up by Regulation (EC) No 1831/2003 to the Authority. The
assessment of that preparation shows that the conditions
for authorisation, provided for in Article 5 of Regulation
(EC) No 1831/2003, are satisfied. Accordingly, the use of
that preparation should be authorised, as specified in the
Annex to this Regulation.

(2) An application for authorisation has been submitted for L-
histidine monohydrochloride monohydrate as an amino
acid.

(7)

in this Regulation are in
The measures provided for
accordance with the opinion of the Standing Committee on
the Food Chain and Animal Health,

(3) As the application for authorisation was submitted before
the date of application of Regulation (EC) No 1831/2003, it
was submitted under Council Directive 82/471/EEC of
30 June 1982 concerning certain products used in animal
nutrition (2). As from 18 October 2004, amino acids, their
salts and analogues fall under the scope of Regulation (EC)
No 1831/2003. The application is
therefore to be
considered as an application under Article 7 of Regulation
(EC) No 1831/2003.

HAS ADOPTED THIS REGULATION:

Article 1

The preparation specified in the Annex, belonging to the additive
category ‘nutritional additives’ and to the functional group
is authorised as an
‘amino acids, their salts and analogues’,
additive in animal nutrition subject to the conditions laid down
in that Annex.

(4)

(5)

In order to comply with the requirements laid down in
Article 7 of Regulation (EC) No 1831/2003, additional
information was submitted in support of the application.

Article 2

This Regulation shall enter into force on the 20th day following
its publication in the Official Journal of the European Union.

The application concerns authorisation of L-histidine
monohydrochloride monohydrate as a feed additive for
salmonids,
to be classified in the additive category
‘nutritional additives’ and the functional group ‘amino
acids, their salts and analogues’.

(1) OJ L 268, 18.10.2003, p. 29. Regulation as amended by
Commission Regulation (EC) No 378/2005 (OJ L 59, 5.3.2005, p. 8).
(2) OJ L 213, 21.7.1982, p. 8. Directive as last amended by Commission

Directive 2004/116/EC (OJ L 379, 24.12.2004, p. 81).

(3) Opinion of

the Scientific Panel on Additives and Products or
Substances used in Animal Feed on the safety and the bioavailability
of product L-Histidine monohydrochloride monohydrate
for
salmonids. Adopted on 2 March 2005. The EFSA Journal (2005)
195, p. 1.
(4) Opinion of

the Scientific Panel on Additives and Products or
Substances used in Animal Feed under Regulation (EC) 1831/2003
on L-Histidine monohydrochloride monohydrate as feed additive for
use in salmonids. Adopted on 18 October 2006. The EFSA Journal
(2006) 407, p. 1.

13.3.2007

EN

Official Journal of the European Union

L 73/7

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

Done at Brussels, 7 March 2007.

For the Commission

Markos KYPRIANOU

Member of the Commission

ANNEX

Species or
category of
animal

Maximum
age

Minimum
content

Maximum
content

Maximum content in mg/kg
of complete feedingstuff

Other provisions

End of period of
authorisation

Salmonids

—

—

—

—

2.4.2017

Identification
number of the
additive

Name of the holder of
authorisation

Additive

Composition, chemical formula, description,
analytical method

Category of nutritional additives. Functional group: amino acids, their salts and analogues

3c3.5.1

—

L-histidine mono-
hydrochloride
monohydrate

Characterisation of the additive
L-histidine monohydrochloride monohy-
drate 98 %
produced by Escherichia coli (ATCC 9637)
C3H3N2-CH2-CH(NH2)-COOH· HCl· H2O
Analytical method
Community method for the determina-
tion of aminoacids (Commission Direc-
tive 98/64/EC amending Directive 71/
393/EEC (1)

(1) OJ L 257, 19.9.1998, p. 14

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