Commission Directive 2000/50/EC of 26 July 2000 including an active substance (prohexadione-calcium) in Annex I to Council Directive 91/414/EEC concerning the placing of plant protection products on the market
Date: 2000-07-26
Institutions: European Commission
Subjects: marketing, pharmaceutical product, plant health product

4.8.2000

EN

Official Journal of the European Communities

L 198/39

COMMISSION DIRECTIVE 2000/50/EC

of 26 July 2000

including an active substance (prohexadione-calcium) in Annex I to Council Directive 91/414/EEC
concerning the placing of plant protection products on the market

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 2000/
10/EC (2), hereafter referred to as ‘the Directive’, and in partic-
ular Article 6(1) thereof,

Whereas:

(1)

(2)

(3)

(4)

(5)

In accordance with Article 6(2) of the Directive, on 10
February 1994, France received an application from
BASF AG, hereafter referred to as ‘the applicant’, for the
inclusion of the active substance prohexadione-calcium
in Annex I to the Directive.

In accordance with the provisions of Article 6(3) of the
Directive the Commission confirmed in its Decision 96/
520/EC (3) that the dossier submitted for prohexadione-
calcium could be considered as satisfying, in principle,
the data and information requirements of Annex II and
for a plant protection product containing this active
substance, of Annex III to the Directive.

In accordance with Article 5(1) of the Directive, an
active substance should be included in Annex I for a
period not exceeding 10 years if it may be expected that
neither the use of, or residues from, plant protection
products containing the active substance will have any
harmful effects on human or animal health or on
groundwater or any unacceptable influence on the envir-
onment.

For prohexadione-calcium, the effects on human health
and the environment have been assessed, in accordance
the
with the provisions of Article 6(2) and (4) of
Directive, for the uses proposed by the applicant. France
acting
State,
submitted to the Commission on 9 June 1998 the draft
assessment report concerned.

rapporteur Member

nominated

as

The submitted report has been reviewed by the Member
States
and the Commission within the Standing
Committee on Plant Health. This review was finalised on
16 June 2000 in the format of the Commission review
report for prohexadione-calcium. It may be necessary to
update this report
technical and
scientific developments. In such case the conditions for
the inclusion of prohexadione-calcium in Annex I to the
Directive will also need to be amended pursuant to
Article 6(1) of that Directive.

to take account of

(6)

(7)

(8)

(9)

(10)

The dossier and the information from the review were
also submitted to the Scientific Committee for Plants for
opinion on 26 November 1999. This Committee gave
its opinion on 6 June 2000.

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), (b)
and (3) of the Directive, in particular with regard to the
uses which were examined and detailed in the Commis-
sion review report. It is therefore appropriate to include
the active substance concerned in Annex I, in order to
ensure that in all Member States the authorisations of
plant
active
substance concerned can be granted in accordance with
the provisions of the said Directive.

containing

protection

products

the

After inclusion, a reasonable period is necessary to
permit Member States to implement the provisions of
the Directive on plant protection products containing
prohexadione-calcium and in particular to review, within
this period, existing provisional authorisations or to
grant, by the end of this period at the latest, new author-
isations
the
Directive. A longer period may also be required for plant
protection products containing prohexadione-calcium
and other active substances included in Annex I.

in accordance with the provisions of

(except

It is appropriate to provide that the finalised review
report
information in the
meaning of Article 14 of the Directive) is kept available
or made available by the Member States for consultation
by any interested parties.

for confidential

The review report is required for the proper imple-
mentation by the Member States, of several sections of
the uniform principles laid down in Annex VI to the
Directive, where these principles refer to the evaluation
of the Annex II data which were submitted for the
purpose of
the active substance in
Annex I to the Directive.

the inclusion of

(11)

The measures provided for in this Directive are in
accordance with the opinion of the Standing Committee
on Plant Health delivered on 16 June 2000,

HAS ADOPTED THIS DIRECTIVE:

Article 1

(1) OJ L 230, 19.8.1991, p. 1.
(2) OJ L 57, 2.3.2000, p. 28.
(3) OJ L 220, 30.8.1996, p. 19.

Prohexadione-calcium is hereby designated as
an active
substance in Annex I to Directive 91/414/EEC, as set out in the
Annex hereto.

L 198/40

EN

Official Journal of the European Communities

4.8.2000

Article 2

1. Member States shall bring into force the laws, regulations
and administrative provisions necessary to comply with this
Directive, at the latest by 1 January 2001.

However, with regard to evaluation and decision-making
2.
pursuant to the uniform principles provided for in Annex VI to
Directive 91/414/EEC, on the basis of a dossier satisfying the
requirements of Annex III thereto, the period laid down in the
first paragraph is extended for existing provisional author-
isations of plant protection products containing prohexadione-
calcium to 1 January 2002.

However

for plant protection products

3.
containing
prohexadione-calcium together with another active substance
which is in Annex I
the period
referred to in paragraph 1 is extended to the extent that a
longer implementation period is provided for by the provisions
laid down in the Directive concerning the inclusion of this
other active substance in Annex I to Directive 91/414/EEC.

to Directive 91/414/EEC,

4. Member States shall keep available the review report
(except for confidential information in the meaning of Article

14 of the Directive) for consultation by any interested parties
or shall make it available to them on specific request.

5. When Member States adopt the measures, these shall
contain a reference to this Directive or shall be accompanied by
such reference at the time of their official publication. The
Member States shall lay down the procedure for such reference.

This Directive shall enter into force on 1 October 2000.

Article 3

This Directive is addressed to the Member States.

Article 4

Done at Brussels, 26 July 2000.

For the Commission

David BYRNE

Member of the Commission

ANNEX

1. Prohexadione-calcium

1.

2.

Identity: (IUPAC) Calcium 3,5-dioxo-4-propionylcyclohexanecarboxylate

Particular conditions to be fulfilled:

2.1. The active substance shall have a minimum purity of 890 g/kg.

2.2. Only uses as plant growth regulator may be authorised.

2.3. For the implementation of the uniform principles of Annex VI, the conclusions of the review report on
prohexadione-calcium, and in particular the Appendices I and II thereof, as finalised in the Standing Committee
on Plant Health on 16 June 2000 shall be taken into account.

3.

Expiry date of the inclusion: 1 October 2010.