HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 186/4
EN
Official Journal of the European Union
5.7.2013
COMMISSION IMPLEMENTING REGULATION (EU) No 642/2013
of 4 July 2013
concerning the authorisation of niacin and niacinamide as feed additives for all animal species
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
consumer health, and are not expected to pose additional
risk for the environment. The Authority does not
consider that there is a need for specific requirements
Having regard to the Treaty on the Functioning of the European
of post-market monitoring. The Authority also
Union,
concluded that no safety concerns would arise for users
provided that appropriate protective measures are taken.
It also verified the report on the method of analysis of
Having regard to Regulation (EC) No 1831/2003 of the
the feed additive in feed submitted by the Reference
European Parliament and of the Council of 22 September
Laboratory set up by Regulation (EC) No 1831/2003.
2003 on additives for use in animal nutrition ( 1 ), and in
particular Article 9(2) thereof,
(5) The
assessment
of
niacin
and
niacinamide
shows
that
the
conditions for authorisation, as provided for in Article 5
Whereas:
of Regulation (EC) No 1831/2003, are satisfied. Accord
ingly, the use of those additives should be authorised as
specified in the Annex to this Regulation.
(1) Regulation
(EC)
No
1831/2003
provides
for
the
auth
orisation of additives for use in animal nutrition and
for the grounds and procedures for granting such auth
orisation. Article 10 of that Regulation provides for the
(6)
Since safety reasons do not require the immediate appli
re-evaluation of additives authorised pursuant to Council
cation of the modifications to the conditions of auth
Directive 70/524/EEC (
orisation, it is appropriate to allow a transitional period

2 ).
for the disposal of existing stocks of the additive, pre-
mixtures and compound feed containing it, as authorised
by Directive 70/524/EEC.
(2) Niacin
(nicotinic
acid)
and
niacinamide
(nicotinamide)
were authorised without a time limit in accordance
with Directive 70/524/EEC as feed additives for use on
all animal species as part of the group ‘Vitamins, pro-
(7) The
measures
provided
for
in
this
Regulation
are
in
vitamins and chemically well-defined substances having
accordance with the opinion of the Standing
similar effect’. Those feed additives were subsequently
Committee on the Food Chain and Animal Health,
entered in the Community Register of feed additives as
existing products, in accordance with Article 10(1) of
Regulation (EC) No 1831/2003.
HAS ADOPTED THIS REGULATION:
(3) In
accordance
with
Article
10(2)
of
Regulation
(EC)
No
1831/2003 in conjunction with Article 7 thereof, five
Article 1
applications were submitted for the re-evaluation of
The substances specified in the Annex, belonging to the additive
niacin and niacinamide, as a feed additive for all
category ‘nutritional additives’ and to the functional group ‘vit
animal species, requesting those additives to be classified
amins, pro-vitamins and chemically well-defined substances
in the additive category ‘nutritional additives’. Those
having similar effect’, are authorised as an additive in animal
applications were accompanied by the particulars and
nutrition subject to the conditions laid down in that Annex.
documents required under Article 7(3) of Regulation
(EC) No 1831/2003.
Article 2
(4) The
European
Food
Safety
Authority
(‘the
Authority’) The substances specified in the Annex and feed containing
concluded in its opinions of 22 May 2012 ( 3 ), 14 June
those substances, which are produced and labelled before
2012 ( 4 ) ( 5 ) ( 6 ), and 12 September 2012 ( 7 ) that, under
25 January 2014 in accordance with the rules applicable
the proposed conditions of use in feed, niacin and niaci
before 25 July 2013 may continue to be placed on the
namide do not have an adverse effect on animal and
market and used until the existing stocks are exhausted.
( 1 ) OJ L 268, 18.10.2003, p. 29.
( 2 ) OJ L 270, 14.12.1970, p. 1.
( 3 ) EFSA Journal 2012; 10(6):2731.
Article 3
( 4 ) EFSA Journal 2012; 10(7):2781.
This Regulation shall enter into force on the twentieth day
( 5 ) EFSA Journal 2012; 10(7):2788.
( 6 ) EFSA Journal 2012; 10(7):2789.
following that of its publication in the Official Journal of the
( 7 ) EFSA Journal 2012; 10(10):2885.
European Union.

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EN
5.7.2013 Official
Journal
of
the
European
Union L
186/5
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 4 July 2013.
For the Commission
The President
José Manuel BARROSO

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L 186/6
ANNEX
Minimum Maximum
content
content
Identifi
cation
Name of
Species or
End of period
number of the holder
Additive Composition,
chemical
formula,
description,
analytical
method
category of Maximum
mg of active
Other provisions
of
the
of authori
animal
age
substance/kg of
authorisation
EN
additive
sation
complete feedingstuff

with a moisture
content of 12 %
Category of nutritional additives. Functional group: vitamins, provitamins and chemically well defined substances having a similar effect
3a314
— Niacin Additive
composition
All
—
—
— 1.
In
the
directions
for
use
of
the 25 July
Niacin, not less than 99 %
animal
additive and premixture,
2023
species
indicate the storage conditions.
Characterisation of the active substance
2. Niacin may be used also via
Chemical names: niacin, nicotinic acid
water for drinking.
Off
Chemical formula: C 6H 5NO 2
3. For safety: breathing, eye and
icial
CAS number: 59-67-6
skin protection shall be used
Einecs 200-441-0
during handling.
Jour
Method of Analysis (1 )
nal
— For the determination of niacin (nicotinic acid) in the feed additive:
of
Titration with sodium hydroxide; European Pharmacopoeia method
the
(Ph. Eur. 6th Edition, monograph 0459)
European
— For the determination of niacin (nicotinic acid) in premixtures,
feedingstuffs and water: Ion-pair Reversed Phase High Performance
Liquid Chromatography coupled to UV detector (RP-HPLC-UV)
Union
3a315
— Niacinamide Additive
composition
All
—
—
— 1.
In
the
directions
for
use
of
the
Niacinamide, not less than 99 %
animal
additive and premixture,
species
indicate the storage conditions.
Characterisation of the active substance
2. Niacinamide may be used also
Chemical name: niacinamide, nicotinamide
via water for drinking.
Chemical formula: C 6H 6N 2O
3. For safety: breathing, eye and
CAS number: 98-92-0
skin protection shall be used
Einecs number: 202-7134
during handling.
Method of Analysis (1 )
— For the determination of niacinamide (nicotinamide) in the feed
additive: Titration with perchloric acid; European Pharmacopoeia
method (Ph. Eur. 6th Edition, monograph 0047)
— For the determination of niacinamide (nicotinamide) in premixtures,
feedingstuffs and water: Ion-pair Reversed Phase High Performance
Liquid Chromatography coupled to UV detector (RP-HPLC-UV)
5.7.2013
(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

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Document Outline

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