Commission Regulation (EC) No 1334/2001 of 2 July 2001 concerning the provisional authorisation of a new additive in feedingstuffs (Text with EEA relevance)
Date: 2001-07-02
Institutions: European Commission
Subjects: animal nutrition, food additive, foodstuffs legislation, hormone, market approval, swine

L 180/18

EN

Official Journal of the European Communities

3.7.2001

COMMISSION REGULATION (EC) No 1334/2001

of 2 July 2001

concerning the provisional authorisation of a new additive in feedingstuffs

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(5)

Having regard to the Treaty establishing the European
Community,

Having regard to Council Directive 70/524/EEC of 23
November 1970 concerning additives in feedingstuffs (1), as last
amended by Commission Regulation (EC) No 2697/2000 (2),
and in particular Article 4 thereof,

Whereas:

(1)

(2)

(3)

(4)

Directive 70/524/EEC provides that new additives may
be authorised following the review of an application
made in accordance with Article 4 of the Directive.

Article 9e(1) of the Directive provides that provisional
authorisation of a new additive may be given if the
conditions of Article 3a(b) to (e) of the Directive are
satisfied and if it is reasonable to assume, in view of the
available results, that when used in animal nutrition it
has one of the effects referred to in Article 2(a). Such
provisional authorisation may be given for a period up
to four years in the case of additives referred to in Part II
of Annex C to the Directive,
including growth
promoters.

Article 2(aaa) of Directive 70/524/EEC requires author-
isations for growth promoters to be linked to the person
responsible for putting them into circulation

The assessment of the dossier submitted in respect of the
authorisation of potassium diformate belonging to the
group of ‘Growth promoters’ described in the Annex
shows that it satisfies the abovementioned conditions
and may therefore be authorised on a provisional basis
for a four-year period.

The assessment of the dossier shows that certain proced-
ures may be required to protect workers from exposure
to the additive. Such protection should however be
assured by the application of Council Directive 89/
391/EEC of 12 June 1989 on the introduction of meas-
ures to encourage improvements in the safety and health
of workers at work (3).

(6)

(7)

The Scientific Committee for Animal Nutrition has deliv-
ered a favourable opinion with regard to the safety for
animals, users, consumers and the environment of the
growth promoter under the conditions described in the
said Annex.

The measures provided for in this Regulation are in
accordance with the opinion of the Standing Committee
for Feedingstuffs,

HAS ADOPTED THIS REGULATION:

Article 1

The additive belonging to the group ‘Growth promoters’ listed
in the Annex to the present Regulation is provisionally author-
ised for use as an additive in animal nutrition under the condi-
tions laid down in that Annex.

Article 2

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

It shall apply from 1 July 2001.

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

Done at Brussels, 2 July 2001.

For the Commission

David BYRNE

Member of the Commission

(1) OJ L 270, 14.12.1970, p. 1.
(2) OJ L 319, 16.12.2000, p. 1.

(3) OJ L 183, 29.6.1989, p. 1.

Registration
number
of additive

Name and registration
number of person
responsible for putting
additive into circulation

Additive
(trade name)

Composition, chemical formula,
description

Species or category
of animal

Maximum
age

Minimum
content

Maximum
content

(mg of active substance /kg
of complete feedingstuff)

Other
provisions

End of
period of
authorisation

ANNEX

1

Norsk Hydro Ltd

Potassium diformate
(FormiTM LHS)

Growth promoters

Additive composition:

Piglets

2 months

6 000

6 000

—

30.6.2005

Potassium diformate, solid 98 g/
100 g,
Silicate 1,5 g/100 g,
Water 0,5 g/100 g

Active substance:

Pigs for fattening

—

6 000

6 000

—

30.6.2005

Potassium diformate, solid
KH(COOH)
2
CAS No 20642-05-1

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