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EN
Official Journal of the European Union
26.10.2012
COMMISSION IMPLEMENTING REGULATION (EU) No 991/2012
of 25 October 2012
concerning the authorisation of zinc chloride hydroxide monohydrate as feed additive for all animal
species
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
that its use may be considered as an effective source of
zinc for all animal species. The Authority does not
Having regard to the Treaty on the Functioning of the European
consider that there is a need for specific requirements
Union,
of post-market monitoring. It also verified the report
on the method of analysis of the feed additive in feed
Having regard to Regulation (EC) No 1831/2003 of the
submitted by the Reference Laboratory set up by Regu
European Parliament and of the Council of 22 September
lation (EC) No 1831/2003.
2003 on additives for use in animal nutrition ( 1 ), and in
particular Article 9(2) thereof,
(5) The
assessment
of
zinc
chloride
hydroxide
monohydrate
shows that the conditions for authorisation, as provided
Whereas:
for in Article 5 of Regulation (EC) No 1831/2003, are
satisfied. Accordingly, the use of this preparation should
(1) Regulation
(EC)
No
1831/2003
provides
for
the
auth
be authorised as specified in the Annex to this Regu
orisation of additives for use in animal nutrition and
lation.
for the grounds and procedures for granting such auth
orisation.
(6) The
measures
provided
for
in
this
Regulation
are
in
accordance with the opinion of the Standing
(2) In
accordance
with
Article
7
of
Regulation
(EC)
No
Committee on the Food Chain and Animal Health,
1831/2003, an application was submitted for the auth
orisation of zinc chloride hydroxide monohydrate. That
application was accompanied by the particulars and
HAS ADOPTED THIS REGULATION:
documents required under Article 7(3) of Regulation
(EC) No 1831/2003.
Article 1
The preparation specified in the Annex, belonging to the
(3) The
application
concerns
the
authorisation
of
zinc additive category ‘nutritional additives’ and to the functional
chloride hydroxide monohydrate as a feed additive for
group ‘compounds of trace elements’, is authorised as an
all animal species, to be classified in the additive
additive in animal nutrition, subject to the conditions laid
category ‘nutritional additives’.
down in that Annex.
(4) The
European
Food
Safety
Authority
(the
Authority)
Article 2
concluded in its opinion of 26 April 2012 ( 2 ) that,
under the proposed conditions of use, zinc chloride
This Regulation shall enter into force on the twentieth day
hydroxide monohydrate does not have an adverse effect
following that of its publication in the Official Journal of the
on animal health, human health or the environment and
European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 25 October 2012.
For the Commission
The President
José Manuel BARROSO
( 1 ) OJ L 268, 18.10.2003, p. 29.
( 2 ) EFSA Journal 2012; 10(5):2672.

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26.10.2012 Off
ANNEX
Minimum
Name of
content
Maximum content
Identification
the
Species or
number of the holder of
Additive Composition,
chemical
formula,
description,
analytical
method
category of Maximum
Other provisions
End of period of
additive
authori
animal
age
Content of element (Zn) in mg/kg of
authorisation
sation
complete feedingstuff with a moisture
EN
content of 12 %

Category of nutritional additives. Functional group: compounds of trace elements
3b609
— zinc
chloride
Characterisation of the additive
All
—
— Pets:
250
(total)
1. For user safety: 15 November
hydroxide
animal
breathing
2022
monohy
Chemical formula: Zn
Fish: 200 (total)

5 (OH) 8 Cl 2 (H 2O)
species
protection,
drate
CAS Number: 12167-79-2
Other species: 150 (total)
safety glasses
and gloves
Purity: min. 84 %
Complete and comple
should be worn
mentary milk replacers:
during handling.
Zinc oxide: max. 9 %
200 (total)
2. The additive
icial
Zinc content: min. 54 %
shall be incor
Jour
Particles < 50 μm: below 1 %
porated into
feed in the form
nal
of a premixture.
Analytical method (1 )
of
the
For the identification of zinc chloride hydroxide crystal form in
the feed additive:
European
— X-ray diffraction (XRD).
For the determination of total zinc in the additive and premix
tures:
Union
— EN 15510: Inductively Coupled Plasma – Atomic Emission
Spectrometry (ICP-AES) or
— CEN/TS 15621: Inductively Coupled Plasma – Atomic
Emission Spectrometry (ICP-AES) after pressure digestion.
For the determination of total zinc in feed materials and
compound feed:
— Atomic Absorption Spectrometry (AAS) or
— EN 15510 or CEN/TS 15621.
(1 ) Details of the analytical methods are available at the following address of the Reference Laboratory: http://irmm.jrc.ec.europa.eu/EURLs/EURL_feed_additives/Pages/index.aspx
L
297/19

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