2008/937/EC: Commission Decision of 5 December 2008 concerning the non-inclusion of sulphuric acid in Annex I to Council Directive 91/414/EEC and the withdrawal of authorisations for plant protection products containing that substance (notified under document number C(2008) 7612) (Text with EEA relevance)
Date: 2008-12-05
Institutions: European Commission
Subjects: animal health, health legislation, marketing restriction, pharmaceutical product, plant health product, withdrawal from the market

L 334/88

EN

Official Journal of the European Union

12.12.2008

COMMISSION DECISION

of 5 December 2008

concerning the non-inclusion of sulphuric acid in Annex I to Council Directive 91/414/EEC and the
withdrawal of authorisations for plant protection products containing that substance

(notified under document number C(2008) 7612)

(Text with EEA relevance)

(2008/937/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

sulphuric acid the rapporteur Member State was France
and all relevant information was submitted in October
2007.

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
fourth subparagraph of
Article 8(2) thereof,

the

Whereas:

(1)

(2)

(3)

Article 8(2) of Directive 91/414/EEC provides that a
Member State may, during a period of 12 years
that Directive, authorise
following the notification of
the placing on the market of plant protection products
containing active substances not listed in Annex I to that
Directive that are already on the market two years after
the date of notification, while those substances are
gradually being examined within the framework of a
programme of work.

Commission Regulations (EC) No 1112/2002 (2) and (EC)
No 2229/2004 (3) lay down the detailed rules for the
implementation of the fourth stage of the programme
of work referred to in Article 8(2) of Directive
91/414/EEC and establish a list of active substances to
be assessed with a view to their possible inclusion in
Annex I
includes
sulphuric acid.

to Directive 91/414/EEC. That

list

For sulphuric acid the effects on human health and the
environment have been assessed in accordance with the
provisions laid down in Regulations (EC) No 1112/2002
and (EC) No 2229/2004 for a range of uses proposed by
the notifier. Moreover, those Regulations designate the
rapporteur Member States which have to submit
the
relevant assessment
reports and recommendations to
the European Food Safety Authority (EFSA) in accordance
with Article 20 of Regulation (EC) No 2229/2004. For

(1) OJ L 230, 19.8.1991, p. 1.
(2) OJ L 168, 27.6.2002, p. 14.
(3) OJ L 379, 24.12.2004, p. 13.

(4)

(5)

(6)

(7)

(8)

The Commission examined sulphuric acid in accordance
with Article 24a of Regulation (EC) No 2229/2004. A
draft review report for that substance was reviewed by
the Member States and the Commission within the
Standing Committee on the Food Chain and Animal
Health and finalised on 26 September 2008 in the
format of the Commission review report.

is not

it was
received from Member States,

During the examination of this active substance by the
taking into account
Committee,
concluded,
the
comments
existing evidence
the
consumer risk assessment and to set a reliable Acceptable
(AOEL) and such value is
Operator Exposure Level
necessary to conduct
risk assessment.
Moreover, other concerns which were identified by the
rapporteur Member State in its assessment report are
included in the review report for the substance.

that
to finalise

the operator

sufficient

to submit

submitted its

The Commission invited the notifier
its
comments on the results of the peer review and on its
intention or not to further support the substance. The
notifier
comments which have been
carefully examined. However, despite the arguments put
forward by the notifier, the concerns identified could not
be eliminated, and assessments made on the basis of the
information submitted have not demonstrated that
it
may be expected that, under the proposed conditions
of use, plant protection products containing sulphuric
acid satisfy in general the requirements laid down in
Article 5(1)(a) and (b) of Directive 91/414/EEC.

Sulphuric acid should therefore not be included in Annex
I to Directive 91/414/EEC.

for

plant

Measures should be taken to ensure that authorisations
granted
containing
sulphuric acid are withdrawn within a fixed period of
time and are not renewed and that no new authorisations
for such products are granted.

protection products

12.12.2008

EN

Official Journal of the European Union

L 334/89

(9)

(10)

(11)

Any period of grace granted by a Member State for the
disposal, storage, placing on the market and use of
existing stocks of plant protection products containing
sulphuric acid should be limited to 12 months in order
to allow existing stocks to be used in one further
growing season, which ensures that plant protection
products containing sulphuric acid remain available to
farmers
this
Decision.

from the adoption of

for 18 months

sulphuric

This Decision does not prejudice the submission of an
application for
acid in accordance with
Article 6(2) of Directive 91/414/EEC and Commission
Regulation (EC) No 33/2008 of 17 January 2008
application of
laying down detailed rules
Council Directive 91/414/EEC as regards a regular and
an accelerated procedure for the assessment of active
substances which were part of the programme of work
referred to in Article 8(2) of that Directive but have not
been included into its Annex I (1), in view of a possible
inclusion in its Annex I.

the

for

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

in this Decision are in
Standing
the

opinion

the

of

Article 2

Member States shall ensure that:

(a) authorisations

for plant protection products containing

sulphuric acid are withdrawn by 5 June 2009;

(b) no authorisations for plant protection products containing
sulphuric acid are granted or renewed from the date of
publication of this Decision.

Article 3

Any period of grace granted by Member States in accordance
with the provisions of Article 4(6) of Directive 91/414/EEC,
shall be as short as possible and shall expire on 5 June 2010
at the latest.

Article 4

This Decision is addressed to the Member States.

Done at Brussels, 5 December 2008.

HAS ADOPTED THIS DECISION:

Article 1

Sulphuric acid shall not be included as active substance in
Annex I to Directive 91/414/EEC.

For the Commission

Androulla VASSILIOU
Member of the Commission

(1) OJ L 15, 18.1.2008, p. 5.