Commission Directive 98/19/EC of 18 March 1998 amending Council Directive 70/524/EEC concerning additives in feedingstuffs (Text with EEA relevance)
Date: 1998-03-18
Institutions: European Commission
Subjects: animal nutrition, antibiotic, food additive, food chemistry, foodstuffs legislation, veterinary drug

28. 3. 98

‹

EN

‹

Official Journal of the European Communities

L 96/39

COMMISSION DIRECTIVE 98/19/EC

of 18 March 1998

amending Council Directive 70/524/EEC concerning additives in feedingstuffs

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

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 Directive 97/72/EC (2),
and in particular Article 11 thereof,

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 were adopted, has detailed grounds
for establishing that the use of one of the additives listed
in Annex I constitutes a danger to animal or human
health or the environment may temporarily suspend the
authorization to use that additive;

Whereas Germany prohibited the use on its territory of
ronidazole in turkey feed on 19 January 1996; whereas in
accordance with Directive 70/524/EEC, on 15 April 1996
Germany notified the other Member States and the
Commission of the reasons for its decision, duly substan-
tiated by detailed arguments;

Whereas Germany argued in its notification that
it
suspected ronidazole of mutagenic, carcinogenic and
genotoxic properties and, in view of this worrying situ-
ation for the health of consumers, this Member State took
the view that its use in animal feed should be banned at
Community level;

Whereas in its reasoned argument Germany concluded
that the use of ronidazole in animal feed resulted in some
residues remaining in animal tissue, even with a six-day
withdrawal period in accordance with the rules; whereas
in view of the carcinogenic and mutagenic properties that
ronidazole as the parent substance might have and the
possibility that
its nitroimidazole structure might be
released from bound residues, a risk to consumer health
cannot be ruled out, even where the withdrawal period is
complied with;

concluded, in the opinion expressed on 26 September
1997 and reinforced on 5 November 1997, that, while
ronidazole clearly shows a mutagenic effect on prokary-
otic cells, there are no data on its possible genotoxic effect
on eukaryotic cells; whereas it was not possible to evaluate
conclusively the carcinogenic mechanism because raw
data on the experiments into carciongenisis were not
available; whereas it is therefore impossible to evaluate the
risk to consumers; whereas the data on metronidazole
cannot be used to make inferences about ronidazole since
chemical substances belonging to the same family may
have totally different
toxicological properties; whereas
information is lacking on the metabolic fate of ronidazole
in turkeys, such as the nature of the faecal metabolites, or
its presence in various tissues after the withdrawal period;
whereas it should be noted, however, that the substantial
information available on pigs could be reasonably applied
to turkeys, where justified; whereas, on the other hand, the
limited amount of data that does exist on the presence of
trace quantities of a nitroimidazole compound released
chemically from these bound residues is strongly sug-
gestive of analytical artefact;

Whereas the Scientific Committee on Animal Nutrition
has finally concluded that, while not all the scientific
arguments submitted by Germany to prohibit ronidazole
can be accepted, some important issues have not been
resolved and, in the absence of the additional data, an
acceptable daily dose of ronidazole residues cannot be
established to ensure consumer safety;

Whereas, in view of the uncertainty still surrounding the
safety of ronidazole, its use as an additive in turkey feed
should be prohibited to protect consumer health;

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

HAS ADOPTED THIS DIRECTIVE:

Whereas the Commission has consulted the Scientific
Committee
after
thoroughly examining the situation, that Committee has

on Animal Nutrition; whereas,

Article 1

(1) OJ L 270, 14. 12. 1970, p. 1.
(2) OJ L 351, 23. 12. 1997, p. 55.

Annex I to Directive 70/524/EEC is hereby amended as
set out in the Annex hereto.

L 96/40

‹

EN

‹

Official Journal of the European Communities

28. 3. 98

Article 2

Article 3

1. Member States shall bring into force the laws, regu-
lations or administrative provisions necessary to comply
with this Directive by 31 May 1998. They shall immedi-
ately inform the Commission thereof.

They shall apply the measures from 1 June 1998.

When Member States adopt these measures, they shall
contain a reference to this Directive or shall be accom-
panied by such reference at the time of their official
publication. The procedure for such reference shall be
adopted by Member States.

2. Member States shall communicate to the Commis-
sion the text of the main provisions of domestic law
which they adopt in the field governed by this Directive.

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

Article 4

This Directive is addressed to the Member States,

Done at Brussels, 18 March 1998.

For the Commission

Franz FISCHLER

Member of the Commission

ANNEX

In Annex I to Directive 70/524/EEC, Part D:
‘Coccidiostats and other medicinal substances’, item E 759,
‘Ronidazole’ and all references to it (chemical formula, description, species or category of animal, maximum
age, minimum content, maximum content, other provisions) are hereby deleted.