Commission Directive 2003/81/EC of 5 September 2003 amending Council Directive 91/414/EEC to include molinate, thiram and ziram as active substances (Text with EEA relevance)
Date: 2003-09-05
Institutions: European Commission
Subjects: market approval, marketing standard, plant health product

6.9.2003

EN

Official Journal of the European Union

L 224/29

COMMISSION DIRECTIVE 2003/81/EC

of 5 September 2003

amending Council Directive 91/414/EEC to include molinate, thiram and ziram as active substances

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European
Community,

Having regard to Council Directive 91/414/EEC of 15 July
1991 concerning the placing of plant protection products on
the market (1), as last amended by Commission Directive 2003/
79/EC (2), and in particular Article 6(1) thereof,

Whereas:

(1)

(2)

Commission Regulation (EEC) No 3600/92 of 11
December 1992 laying down the detailed rules for the
implementation of the first stage of the programme of
work referred to in Article 8(2) of Council Directive 91/
414/EEC concerning the placing of plant protection
products on the market (3), as last amended by Regula-
tion (EC) No 2266/2000 (4), establishes a list of active
substances to be assessed, with a view to their possible
inclusion in Annex I to Directive 91/414/EEC. That list
includes molinate, thiram and ziram.

For those active substances the effects on human health
and the environment have been assessed in accordance
with the provisions laid down in Regulation (EEC) No
3600/92 for a range of uses proposed by the notifiers.
By Commission Regulation (EC) No 933/94 of 27 April
1994 laying down the active substances of plant protec-
tion products and designating the rapporteur Member
State for the implementation of Commission Regulation
(EEC) No 3600/92 (5), as last amended by Regulation
(EC) No 2230/95 (6), the following rapporteur Member
States were designated, which in turn submitted the rele-
vant assessment reports and recommendations to the
Commission in accordance with Article 7(1)(c) of Regu-
lation (EEC) No 3600/92. For molinate the rapporteur
Member State was Portugal, and all relevant information
was submitted on 30 November 1998. For thiram the
Rapporteur Member State was Belgium, and the relevant
information was submitted on 15 January 1998. For
ziram the rapporteur Member State was Belgium and the
relevant information was submitted on 9 June 1998.

(4)

(5)

(6)

(7)

(8)

(9)

(10)

The reviews of all active substances were finalised on 4
the Commission review
July 2003 in the format of
reports for molinate, thiram and ziram.

The reviews of molinate, thiram and ziram did not reveal
any open questions or concerns, which would have
required a consultation of the Scientific Committee on
Plants.

It has appeared from the various examinations made that
plant protection products containing molinate, thiram or
ziram may be expected to satisfy, in general, the require-
ments laid down in Article 5(1)(a) and (b) 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 these active
substances in Annex I,
in order to ensure that in all
Member States the authorisations of plant protection
products containing these active substances can be
granted in accordance with the provisions of that Direc-
tive.

A reasonable period should be allowed to elapse before
an active substance is included in Annex I in order to
permit Member States and the interested parties to
prepare themselves to meet the new requirements which
will resulting from the inclusion.

After inclusion, Member States should be allowed a
reasonable period within which to implement the provi-
sions of Directive 91/414/EEC as regards plant protec-
tion products containing molinate, thiram or ziram, and
in particular, to review existing authorisations to ensure
that the conditions regarding those active substances set
out in Annex I to Directive 91/414/EEC are satisfied. A
longer period should be provided for the submission and
assessment of the complete dossier of each plant protec-
tion product in accordance with the uniform principles
laid down in Directive 91/414/EEC.

It is therefore appropriate to amend Directive 91/414/
EEC accordingly.

The measures provided for in this Directive are in accor-
dance with the opinion of the Standing Committee on
the Food Chain and Animal Health,

(3)

Those assessment reports have been reviewed by the
Member States and the Commission within the Standing
Committee on the Food Chain and Animal Health.

HAS ADOPTED THIS DIRECTIVE:

(1) OJ L 230, 19.8.1991, p. 1.
(2) OJ L 205, 14.8.2003, p. 16.
(3) OJ L 366, 15.12.1992, p. 10.
(4) OJ L 259, 13.10.2000, p. 27.
(5) OJ L 107, 28.4.1994, p. 8.
(6) OJ L 225, 22.9.1995, p. 1.

Article 1

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

L 224/30

EN

Official Journal of the European Union

6.9.2003

Article 2

Member States shall adopt and publish by 31 January 2005 at
the latest the laws, regulations and administrative provisions
necessary to comply with this Directive. They shall forthwith
inform the Commission thereof.

They shall apply those provisions from 1 February 2005.

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

Article 3

1. Member States shall review the authorisation for each
plant protection product containing molinate, thiram or ziram
to ensure that the conditions relating to those active substances
set out in Annex I to Directive 91/414/EEC are complied with.
Where necessary and by 31 January 2005 at the latest, they
shall amend or withdraw the authorisation.

2. Member States shall, for each authorised plant protection
product containing molinate, thiram or ziram as either the only
active substance or as one of several active substances all of
which were listed in Annex I to Directive 91/414/EEC by 31

July 2004 at the latest, re-evaluate the product in accordance
with the uniform principles provided for in Annex VI to Direc-
tive 91/414/EEC, on the basis of a dossier satisfying the
requirements of Annex III to that Directive. 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 Direc-
tive 91/414/EEC. Where necessary and by 31 July 2008 at the
latest, they shall amend or withdraw the authorisation.

Article 4

This Directive shall enter into force on 1 August 2004.

Article 5

This Directive is addressed to the Member States.

Done at Brussels, 5 September 2003.

For the Commission

David BYRNE

Member of the Commission

The following entries shall be added at the end of the table in Annex I to Directive 91/414/EEC

ANNEX

IUPAC name

Purity (1)

Entry into force

Expiration of inclusion

Specific provisions

.

.

6
9
2
0
0
3

No

Common name, iden-
tification numbers

‘72

Molinate
CAS No 2212-67-1
CIPAC No 235

950 g/kg

1 August 2004

31 July 2014

azepane-1-

S-ethyl
carbothioate;
S-ethyl
pine-1-carbothioate;
S-ethyl
pine-1-thiocarboxilate

perhydroaze-

perhydroaze-

73

Thiram
CAS No 137-26-8
CIPAC No 24

tetramethylthiuram
disulfide;
bis (dimethylthiocarba-
moyl)-disulfide

960 g/kg

1 August 2004

31 July 2014

74

Ziram
CAS No 137-30-4
CIPAC No 31

Zinc bis (dimethyl-
dithiocarbamate)

(FAO-

950 g/kg
specification)
Arsenic:
maximum
250 mg/kg
Water: maximum
1,5 %

1 August 2004

31 July 2014

(1) Further details on identity and specification of active substance are provided in the review report.’

Only uses as herbicide may be authorised.
For the implementation of the uniform principles of Annex VI, the conclu-
sions of the review report on molinate, and in particular Appendices I and II
thereof, as finalised in the Standing Committee on the Food Chain and
Animal Health on 4 July 2003 shall be taken into account. In this overall
assessment:
— Member States should pay particular attention to the potential

for
groundwater contamination, when the active substance is applied in
regions with vulnerable soil and/or climatic conditions. Conditions of
authorisation should include risk mitigation measures, where appro-
priate,

— Member States should pay particular attention to the possibility of short-

range transport of the active substance in air.

Only uses as fungicide or as repellent may be authorised.
For the implementation of the uniform principles of Annex VI, the conclu-
sions of the review report on thiram, and in particular Appendices I and II
thereof, as finalised in the Standing Committee on the Food Chain and
Animal Health on 4 July 2003 shall be taken into account. In this overall
assessment:
— Member States should pay particular attention to the protection of
aquatic organisms. Risk mitigation measures should be applied, where
appropriate,

— Member States should pay particular attention to the protection of small
mammals and birds when the substance is used as a seed treatment in
spring uses. Risk mitigation measures should be applied, where appro-
priate.

Only uses as fungicide or as repellent may be authorised.
For the implementation of the uniform principles of Annex VI, the conclu-
sions of the review report on ziram, and in particular Appendices I and II
thereof, as finalised in the Standing Committee on the Food Chain and
Animal Health on 4 July 2003 shall be taken into account. In this overall
assessment:
— Member States should pay particular attention to the protection of non-
target arthropods and aquatic organisms. Risk mitigation measures
should be applied, where appropriate,

— Member States should observe the acute dietary exposure situation of

consumers in view of future revisions of Maximum Residue Levels.

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