Commission Regulation (EC) No 2788/98 of 22 December 1998 amending Council Directive 70/524/EEC concerning additives in feedingstuffs as regards the withdrawal of authorisation for certain growth promoters
Date: 1998-12-22
Institutions: European Commission
Subjects: animal nutrition, approval, food additive, health risk, public health, veterinary drug

23. 12. 98

EN

Official Journal of the European Communities

L 347/31

COMMISSION REGULATION (EC) No 2788/98

of 22 December 1998

amending Council Directive 70/524/EEC concerning additives in feedingstuffs as
regards the withdrawal of authorisation for certain growth promoters

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

in view of its conditions of use, it has an adverse effect on
human or animal health;

Having regard to the Treaty establishing the European
Community,

Having regard to the Act of Accession of Austria, Finland
and Sweden, and in particular Article 151 in conjunction
with Annex XV, Title VII(E)(4) thereof, and to the amend-
ments to the Treaties on which the European Union is
founded,

Having regard to Council Directive 70/524/EEC of 23
November 1970 concerning additives in feedingstuffs (1),
as last amended by Commission Directive 98/19/EC (2),
and in particular Article 11(3) thereof,

Whereas Sweden was authorised under Annex XV to the
Act of Accession to maintain its legislation in force before
accession until 31 December 1998 with regard to the
prohibition of
the use in feedingstuffs of additives
belonging to the groups of growth promoters; whereas on
10 April 1997 and 2 February 1998 it submitted applica-
tions
carbadox and
olaquindox, accompanied by detailed scientific reasoning;
whereas the Commission is required to take a decision on
the adjustment applications submitted by Sweden not
later than 31 December 1998;

in respect of

adjustments

for

Whereas, pursuant to Article 11 of Directive 70/524/EEC,
a Member State which, as a result of new information or
of a reassessment of existing information made since the
provisions in question wee adopted, has detailed grounds
for establishing that the use of one of the additives listed
in the Directive constitutes a danger to animal or human
health or the environment may temporarily suspend the
authorisation to use that additive;

Whereas the Kingdom of the Netherlands prohibited the
use on its territory of carbadox in feedingstuffs on 6
September 1997; whereas it communicated the detailed
grounds for that decision to the other Member States and
the Commission on 18 July 1997;

Whereas by virtue of Article 3a(b) of Directive 70/
524/EEC authorisation of a substance is not to be given if,

(1) OJ L 270, 14. 12. 1970, p. 1.
(2) OJ L 96, 28. 3. 1998, p. 39.

Whereas the Commission has consulted the Scientific
Committee on Animal Nutrition (SCAN) on whether,
based on the information given to the Commission, use
of the quinoxaline-N-dioxides carbadox and olaquindox
presented a risk to consumers, to operators or to the
animal itself;

Whereas, having studied the information supplied to the
Commission, SCAN noted in its opinion issued on 10
July 1998 that it was maintaining its previous opinions
on the
the quinoxaline-N-dioxides
carbadox and olaquindox, within their previously defined
conditions of use;

acceptability of

Whereas, however, SCAN has acknowledged that neither
of these two substances has had an ideal safety profile in
laboratory animal tests and that it is unlikely that other
additives with such genotoxic properties will be devel-
oped in future;

Whereas SCAN acknowledged that carbadox was geno-
toxic and carcinogenic for rodents and that olaquindox
was genotoxic and tumorigenic for rodents;

that

Whereas SCAN notes, and the Commission for its part
the possible exposure of workers is
fully agrees,
undoubtedly a risk, since they are exposed to the parent
molecules; whereas individuals changing air filter mats in
feed plants are at special genotoxic or carcinogenic risk
following possible exposure through the skin or by in-
halation; whereas the possibility of absorbing the parent
substance by individuals exposed to the additives in the
factory or on farm exists;

Whereas SCAN is aware that many conditions must be
met before these substances can be safely used; whereas
SCAN would like to know if these conditions are met in
practice; whereas SCAN recommends in particular that
exposure to carbadox and olaquindox in the workplace be
re-evaluated and that epidemiological
the
health status of additive-exposed workers be carried out;

studies of

L 347/32

EN

Official Journal of the European Communities

23. 12. 98

Whereas the Commission, for its part, believes that it is
not possible to set a threshold for a genotoxic additive
below which it presents no risk to the consumer, since
even a small quantity of residues of the additive can
provoke a tumour-inducing mutation; whereas a time
limit
that will ensure consumer safety
for withdrawal
cannot therefore be fixed;

Whereas the Commission believes that precise descrip-
tion of the composition of the preparations and recom-
mendations to wear masks and protective clothing are not
sufficient to guarantee the protection of operators at plant
or farm level; whereas cases have indeed been reported to
the Commission of livestock farmers who, lacking protec-
tion, have been exposed through inhalation or skin
contact
to the genotoxic and potentially carcinogenic
parent substances;

their possible adverse effect on
Whereas,
growth
for
authorisations
human health,
promoters carbadox and olaquindox should be withdrawn;

in view of
the

the

Whereas the measures provided for in this Directive are
in accordance with the opinion of
the Standing
Committee on Feedingstuffs,

HAS ADOPTED THIS REGULATION:

Article 1

The entries in Annex B to Directive 70/524/EEC for the
following growth promoters are deleted:

‘— Carbadox,
— Olaquindox'.

Article 2

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

This Regulation shall apply from 1 January 1999.

However,
in case a Member State has not banned
conforming to the Community law at the date of the
entering into force of this Regulation one or more of the
growth promoters referred to in Article 1 of this Regula-
tion, this or these growth promoters remain authorised in
this Member State until 31 August 1999.

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

Done at Brussels, 22 December 1998.

For the Commission

Franz FISCHLER

Member of the Commission