HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"EN
20.4.2012 Official
Journal
of
the
European
Union L
108/3
COMMISSION IMPLEMENTING REGULATION (EU) No 333/2012
of 19 April 2012
concerning the authorisation of a preparation of potassium diformate as a feed additive for all
animal species and amending Regulation (EC) No 492/2006
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
protective measures are taken. It also verified the report
on the method of analysis of the feed additive in feed
submitted by the Reference Laboratory set up by Regu
Having regard to the Treaty on the Functioning of the European
lation (EC) No 1831/2003.
Union,
Having regard to Regulation (EC) No 1831/2003 of the
(5) The
assessment
of
potassium
diformate
shows
that
the
European Parliament and of the Council of 22 September
conditions for authorisation, as provided for in Article 5
2003 on additives for use in animal nutrition (
of Regulation (EC) No 1831/2003, are satisfied. Accord

1 ), and in
particular Article 9(2) thereof,
ingly, the use of that substance should be authorised as
specified in the Annex to this Regulation.
Whereas:
(6)
As a consequence of a new authorisation being granted
by this Regulation, Article 3 of Regulation (EC) No
(1) Regulation
(EC)
No
1831/2003
provides
for
the
auth
492/2006 and Annex III thereto should be deleted.
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
re-evaluation of additives authorised pursuant to Council
(7)
Since the modifications to the conditions of authorisation
of the feed additive are not related to safety reasons, it is
Directive 70/524/EEC ( 2 ).
appropriate to allow a transitional period for the disposal
of existing stocks of pre-mixtures and compound feed
containing this preparation, as authorised by Regulation
(2) Potassium
diformate,
CAS
number
20642-05-1,
was
(EC) No 492/2006.
authorised without a time limit in accordance with
Directive 70/524/EEC as a feed additive for use on all
animal species by Commission Regulation (EC) No
492/2006 ( 3 ). That additive was subsequently entered in
(8) The
measures
provided
for
in
this
Regulation
are
in
the Community Register of feed additives as an existing
accordance with the opinion of the Standing
product, in accordance with Article 10(1) of Regulation
Committee on the Food Chain and Animal Health,
(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, an
application was submitted for the re-evaluation of
potassium diformate as a feed additive for all animal
Article 1
species, requesting that additive to be classified in the
additive category ‘technological additives’. That appli
The preparation specified in the Annex, belonging to the
cation was accompanied by the particulars and
additive category ‘technological additives’ and to the functional
documents required under Article 7(3) of Regulation
group ‘preservatives’ is authorised as an additive in animal
(EC) No 1831/2003.
nutrition subject to the conditions laid down in that Annex.

(4) The
European
Food
Safety
Authority
(‘the
Authority’)
Article 2
concluded in its opinion of 13 December 2011 ( 4 ) that,
under the proposed conditions of use, potassium
Article 3 of Regulation (EC) No 492/2006 and Annex III
diformate does not have an adverse effect on animal
thereto are deleted.
health, consumer health or the environment, and that
it is effective in increasing the storage time of raw fish
and fish by-products. It concluded that no safety
Article 3
concerns would arise for users provided that appropriate
Premixtures and compound feed labelled in accordance with
Directive 70/524/EEC before the entry into force of this Regu
( 1 ) OJ L 268, 18.10.2003, p. 29.
lation and containing potassium diformate, as authorised by
( 2 ) OJ L 270, 14.12.1970, p. 1.
( 3 ) OJ L 89, 28.3.2006, p. 6.
Regulation (EC) No 492/2006, may continue to be placed on
( 4 ) EFSA Journal 2012; 10(1):2530.
the market and used until the existing stocks are exhausted.

---

L 108/4
EN
Official Journal of the European Union
20.4.2012
Article 4
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 April 2012.
For the Commission
The President
José Manuel BARROSO

---

20.4.2012 Off
ANNEX
Minimum
Maximum
content
content
Identification Name of the
number of the
holder of
Additive
Composition, chemical formula, description,
Species or category of
mg of active substance/kg
Other provisions
End of period of
additive
authorisation
analytical method
animal
Maximum age
authorisation
of complete feedingstuff
EN
with a moisture content of

12 %
Category of technological additives. Functional group: preservatives
1a237a
— Potassium
Additive composition
All animal species
—
—
— 1.
Only
permitted
in
raw
fish
and
11 May 2022
diformate
fish by-products for feed use
Potassium diformate: 50 ± 5 %,
with a maximum content of
Water: 50 ± 5 %.
9 000 mg potassium diformate
as active substance per kg raw
Characterisation of the active substance
fish.
Potassium diformate
2. For use in feed for pigs, the
icial
mixture of different sources of
CAS No 20642-05-1
potassium diformate shall not
Jour
C
exceed the permitted maximum

nal
2H 3O 4K
level in complete feedingstuff of
Produced by chemical synthesis
18 000 mg per kg complete feed
of
ingstuff for weaned piglets and
the
Method of Analysis (1 )
12 000 mg per kg complete feed
European
Determination of potassium in the feed
ingstuff for sows and pigs for
additive:
fattening.
EN ISO 6869: atomic absorption spec
3. Indicate in the instructions for
Union
trometry (AAS) or EN 15510: induc
use:
tively coupled plasma atomic emission
‘The simultaneous use of other
spectrometry (ICP-AES)
organic acids at the maximum
Determination of total formate in the
permitted doses is contraindi
feed additive: EN 15909: reverse
cated’.
phase HPLC-UV
4. ‘For safety: breathing protection,
For the determination of total formate
eye protection and gloves shall
in premixtures and feedingstuffs:
be used during handling’.
Ion-exclusion high performance liquid
chromatography with UV or refractive
index detection (HPLC-UV/RI) or ion
chromatography method equipped
with electrical conductivity detection
(IC-ECD).
L
(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
108/5

---

Document Outline

• �

---