2007/322/EC: Commission Decision of 4 May 2007 laying down protective measures concerning uses of plant protection products containing tolylfluanid leading to the contamination of drinking water (notified under document number C(2007) 1865) (Text with EEA relevance)
Date: 2007-05-04
Institutions: European Commission
Subjects: chemical compound, drinking water, health control, health risk, pharmaceutical product, plant health product, water pollution

9.5.2007

EN

Official Journal of the European Union

L 119/49

COMMISSION DECISION

of 4 May 2007

laying down protective measures concerning uses of plant protection products containing
tolylfluanid leading to the contamination of drinking water

(notified under document number C(2007) 1865)

(Text with EEA relevance)

(2007/322/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(5)

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 11(2) thereof,

Whereas:

(1)

(2)

(3)

(4)

Tolylfluanid is an active substance included in Annex I to
Directive
Commission Directive
by
2006/6/EC (2).

91/414/EEC

23

February

informed

2007 Germany

On
the
Commission that it has recently been discovered that
tolylfluanid can have an unexpected effect on drinking
water. Specifically, the use of a certain plant protection
‘Eurparen M WG’ which contains tolylfluanid,
product,
leads to the formation of a metabolite of tolylfluanid,
namely dimethylsulfamide, which is likely to be found
in the soil, and in groundwater and surface water. By a
(ozon-
standard drinking water preparation process
isation) this metabolite is converted into a nitrosamine
(NDMA) which is harmful to health.

active

substances with a

Other
similar molecular
structure as tolylfluanid could undergo the same degra-
dation path.

Nitrosamines are suspected or proven genotoxic and
carcinogenic substances and their presence in drinking
water should therefore be avoided.

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

last amended by

Commission Directive 2007/25/EC (OJ L 106, 24.4.2007, p. 34).

(2) OJ L 12, 18.1.2006, p. 21.

(6)

(7)

(8)

(9)

Article 11(1) of Directive 91/414/EEC provides that if a
Member State has valid reasons to consider
that a
is bound to
product which it has authorised or
authorise under Article 10 constitutes a risk to human
or animal health or
it may pro-
visionally restrict or prohibit the use and/or sale of that
product on its territory. It shall immediately inform the
Commission and the other Member States of such action
and give reasons for its decision.

the environment,

Ireland, Spain,

According to information received, the Czech Republic,
Germany,
Italy, Luxembourg, Austria,
Poland, Sweden and the United Kingdom, have already
suspended the outdoor use of products containing tolyl-
fluanid.

Article 11(2) of Directive 91/414/EEC provides that a
decision is to be taken on the matter at Community
level.
In this case, urgent measures are needed to
ensure that uses of plant protection products containing
tolylfluanid do not lead to drinking water contamination.
The problem is not limited to a single Member State,
contamination of groundwater or drinking
because
water could have effects across national borders. As set
out in its ninth recital, Directive 91/414/EEC aims for a
high level of protection of health, groundwater and the
environment. The fifth recital to Directive 91/414/EEC
it also aims at preventing unnecessary
shows
barriers to trade. Unilateral measures by Member States
could lead to differing levels of protection, and also
hinder trade in plant protection products. As a conse-
quence, it is necessary to adopt measures at Community
level.

that

In the present case, warning through labelling is not
sufficient to protect human health.

Additional information should be collected to allow the
Commission to review if necessary Directive 91/414/EEC
as regards tolylfluanid.
It should also be investigated
whether
the same problems could arise with other
substances currently being assessed or already assessed
at Community level. As a consequence, each Member
State which has been appointed as a rapporteur for
assessing
under Directive
91/414/EEC should investigate without delay whether
the use of plant protection products containing that
substance could lead to similar concerns.

substance

active

an

L 119/50

EN

Official Journal of the European Union

9.5.2007

(10)

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

in this Decision are in
Standing
the

opinion

the

of

Member State within three months from the date of notification
of this Decision studies on:

HAS ADOPTED THIS DECISION:

(a)

the leaching behaviour of this active substance; and

Article 1

(b) the conditions in which the formation of nitrosamines can

be excluded.

Member States in which ozone is used for treatment of drinking
water shall vary or withdraw authorisations of plant protection
products containing tolylfluanid by prohibiting any uses which
may lead to contamination of groundwater or surface water by
tolylfluanid or its metabolites, which results in contamination of
drinking water by nitrosamines during the ozonisation process.

Article 2

Member States shall, for the active substances for which they
are rapporteur,
investigate without delay whether the use of
plant protection products containing such substances could
lead to similar concerns. If the Member States referred to in
Article 1 have indications that nitrosamines are formed and
contaminate drinking water they shall take similar measures
as those provided for in Article 1.

Article 3

The Member States referred to in Article 1 shall ensure that the
notifiers, at whose request tolylfluanid has been included in
Annex I to Directive 91/414/EEC, submit to the rapporteur

Article 4

Member States concerned by Articles 1 and 2 shall immediately
inform the Commission on the measures taken. Within three
months from the date of notification of this Decision, they shall
also provide to the Commission an overview of actions they
have taken as a result of this Decision.

Article 5

This Decision is addressed to the Member States.

Done at Brussels, 4 May 2007.

For the Commission

Markos KYPRIANOU
Member of the Commission