Commission Regulation (EC) No 1972/1999 of 15 September 1999 amending Regulation (EEC) No 3600/92 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
Date: 1999-09-15
Institutions: European Commission
Subjects: exchange of information, marketing, marketing standard, pharmaceutical product, plant health product, standing committee (EU)

16. 9. 1999

EN

Official Journal of the European Communities

L 244/41

COMMISSION REGULATION (EC) No 1972/1999

of 15 September 1999

amending Regulation (EEC) No 3600/92 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

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 1999/
1/EC (2), and in particular Article 8(2) thereof,

(1) Whereas the re-evaluation of active substances already
on the market two years after notification of Directive
91/414/EEC under Article 8(2) of that Directive is orga-
nised by the Commission in a collaborative and coordi-
nated programme established in Commission Regulation
(EEC) No 3600/92 (3), as last amended by Regulation
(EC) No 1199/97 (4), within which Member States
undertake specific tasks contributing to the scientific and
technical assessment which are the basis for regulatory
decisions taken at Community level;

(2) Whereas it is necessary that any interested parties have
access as early as possible to updated information
concerning tests and studies on which claims for data
protection have been presented as well as concerning
tests and studies which may be required at a later stage
in order to finalise the evaluation and decision making
on the active substance concerned; whereas this infor-
mation should be made available by the rapporteur
Member State;

(3) Whereas Commission Regulation (EEC) No 3600/92
should therefore be amended to ensure access to such
information to any interested parties;

(4) Whereas the measures provided for in this Regulation
are in accordance with the opinion of the Standing
Committee on Plant Health,

HAS ADOPTED THIS REGULATION:

Article 1

The second sentence of the second subparagraph of Article 7(3)
of Regulation (EEC) No 3600/92 is amended as follows:

‘The Rapporteur Member State shall make available at
specific request or keep available for consultation by inter-
ested parties the following:
— the information referred to in point (d) of paragraph 1,
except the elements thereof which have been accepted
as confidential
in accordance with Article 14 of the
Directive;

— the name of the active substance;
— the content of the pure active substance in the manu-

factured material;

— the list of any data required for consideration of the
possible inclusion of the active substance into Annex I
to the Directive, first as contained in the rapporteur's
report and secondly as finalised after the consultation
by the Commission of the experts referred to in the
next subparagraph.’

This Regulation shall enter into force on 1 October 1999.

Article 2

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 15 September 1999.

For the Commission

Franz FISCHLER

Member of the Commission

(1) OJ L 230, 9.8.1991, p. 1.
(2) OJ L 21, 28.1.1999, p. 21.
(3) OJ L 366, 15.12.1992, p. 10.
(4) OJ L 170, 28.6.1997, p. 19.