Commission Directive 2008/70/EC of 11 July 2008 amending Council Directive 91/414/EEC to include tritosulfuron as an active substance (Text with EEA relevance)
Date: 2008-07-11
Institutions: European Commission
Subjects: chemical product, market approval, marketing standard, pesticide, pharmaceutical product, plant health control, plant health product

L 185/40

EN

Official Journal of the European Union

12.7.2008

DIRECTIVES

COMMISSION DIRECTIVE 2008/70/EC

of 11 July 2008

amending Council Directive 91/414/EEC to include tritosulfuron as an active substance

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty
Community,

establishing the European

Having regard to Council Directive 91/414/EEC of 15 July 1991
concerning the placing of plant protection products on the
market (1), and in particular Article 6(1) thereof,

Whereas:

(1)

(2)

(3)

in Annex

In accordance with Article 6 (2) of Directive 91/414/EEC
Germany received on 8 June 2001 an application from
BASF AG for the inclusion of the active substance trito­
sulfuron
91/414/EEC.
Commission Decision 2002/268/EC (2) confirmed that
the dossier was ‘complete’ in the sense that it could be
considered as satisfying, in principle, the data and infor­
mation requirements of Annexes II and III to Directive
91/414/EEC.

to Directive

I

For this active substance, the effects on human health
and the environment have been assessed, in accordance
with the provisions of Article 6(2) and (4) of Directive
91/414/EEC, for the uses proposed by the applicant. The
designated rapporteur Member State submitted a draft
assessment report on 5 September 2002.

tritosulfuron the draft assessment

reports were
For
reviewed by the Member States and the Commission
within the Standing Committee on the Food Chain and
Animal Health. The review was finalised on 20 May
2008 in the format of the Commission review report
for tritosulfuron.

(4)

The documents and information on tritosulfuron were
also submitted to the European Food Safety Authority
(EFSA) for separate consultation. The EFSA was invited

(1) OJ L 230, 19.8.1991, p. 1. Directive as

last amended by

Commission Directive 2008/45/EC (OJ L 94, 5.4.2008, p. 21).

(2) OJ L 92, 9.4.2002, p. 34.

tritosulfuron in the context of

to prepare a scientific opinion on the toxicological
relevance of the soil and groundwater metabolite TBSA
of
the human risk
assessment. The EFSA was asked whether, on the basis
the metabolite TBSA shows a
of
the data available,
genotoxic potential or
impaired
fertility and what are the implications for toxicological
reference values for humans.

an indication of

(5)

(6)

In its opinion of 11 December 2007 (3),
the EFSA
concluded that TBSA did not show any clastogenic or
other genotoxic potential and has no direct effect on
fertility and that therefore there is no requirement for
any adjustment of the default safety factor for potential
effect on fertility. That opinion was taken into account.

It has appeared from the various examinations made that
plant protection products containing the active substance
concerned may be expected to satisfy,
in general, the
requirements laid down in Article 5(1)(a) and (b) and
Article 5(3) of Directive 91/414/EEC, in particular with
regard to the uses which were examined and detailed in
the Commission review report. It is therefore appropriate
to include tritosulfuron in Annex I to that Directive, in
order to ensure that in all Member States the authoris­
ations of plant protection products containing these
active substances may be granted in accordance with
the provisions of that Directive.

six months after

in Annex I, Member States

(7) Without prejudice to the obligations defined by Directive
including an active
91/414/EEC as a consequence of
should be
substance
inclusion to
allowed a period of
review existing provisional
authorisations of plant
protection products containing tritosulfuron to ensure
by Directive
that
laid
in its Article 13 and the
91/414/EEC,
relevant conditions set out
in Annex I, are satisfied.
Member States should transform existing provisional
authorisations into full authorisations, amend them or

in particular

requirements

down

the

(3) Scientific Opinion of the Panel on Plant Protection Products and
from the European
their Residues
Commission on the
and
groundwater metabolite TBSA of tritosulfuron in the context of
the human risk assessment. The EFSA Journal (2007) 621, pp. 1-33.

(PPR Panel) on a request
toxicological

relevance of

soil

the

12.7.2008

EN

Official Journal of the European Union

L 185/41

withdraw them in accordance with the provisions of
Directive 91/414/EEC. By derogation from the above
deadline, a longer period should be provided for the
submission and assessment of the complete Annex III
for each
dossier of each plant protection product
intended use in accordance with the uniform principles
laid down in Directive 91/414/EEC.

(8)

(9)

is

It
therefore
91/414/EEC accordingly.

appropriate

to

amend Directive

The measures provided for
accordance with
Committee on the Food Chain and Animal Health,

in this Directive are in
Standing
the

opinion

the

of

HAS ADOPTED THIS DIRECTIVE:

Article 1

exception of those identified in part B of the entry concerning
the active substance, and that the holder of the authorisation
has, or has access to, a dossier satisfying the requirements of
Annex II to that Directive in accordance with the conditions of
Article 13(2) of that Directive.

By way of derogation from paragraph 1,

2.
for each
authorised plant protection product containing tritosulfuron as
either the only active substance or as one of several active
substances all of which were listed in Annex I to Directive
the latest, Member
91/414/EEC by 30 November 2008 at
in accordance with the
States shall re-evaluate the product
to Directive
uniform principles provided for
91/414/EEC, on the basis of
the
requirements of Annex III to that Directive and taking into
account part B of
to that Directive
the entry in Annex I
concerning tritosulfuron. On the basis of that evaluation, they
shall determine whether the product satisfies the conditions set
out in Article 4(1)(b), (c), (d) and (e) of Directive 91/414/EEC.

in Annex VI
a dossier

satisfying

Annex I to Directive 91/414/EEC is amended as set out in the
Annex to this Directive.

Following that determination Member States shall:

Article 2

1. Member States shall adopt and publish by 31 May 2009
at the latest the laws, regulations and administrative provisions
necessary to comply with this Directive. They shall forthwith
communicate to the Commission the text of those provisions
and a correlation table between those provisions and this
Directive.

They shall apply those provisions from 1 June 2009.

When Member States adopt those provisions, they shall contain
a reference to this Directive or shall be accompanied by such a
reference on the occasion of their official publication. Member
States shall determine how such reference is to be made.

2. Member States shall communicate to the Commission the
text of the main provisions of national law which they adopt in
the field covered by this Directive.

Article 3

shall

States

1. Member
in accordance with Directive
91/414/EEC, where necessary, amend or withdraw existing
authorisations for plant protection products containing trito­
sulfuron as active substance by 31 May 2009. By that date,
they shall
in particular verify that the conditions in Annex I
to that Directive relating to tritosulfuron, are met, with the

(a)

in the case of a product containing tritosulfuron as the only
active substance, where necessary, amend or withdraw the
authorisation by 31 May 2010 at the latest; or

active

substances, where necessary,

(b) in the case of a product containing tritosulfuron as one of
amend or
several
withdraw the authorisation by 31 May 2010 or by the
date fixed for such an amendment or withdrawal
in the
respective Directive or Directives which added the relevant
substance
to Directive
91/414/EEC, whichever is the latest.

to Annex

substances

or

I

Article 4

This Directive shall enter into force on 1 December 2008.

Article 5

This Directive is addressed to the Member States.

Done at Brussels, 11 July 2008.

For the Commission

Androulla VASSILIOU
Member of the Commission

L 185/42

EN

Official Journal of the European Union

12.7.2008

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