eu-picolinafen-2002, Wikileaks, Compleat Wikileaks Archive, Misc
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EUROPEAN COMMISSION
HEALTH & CONSUMER PROTECTION DIRECTORATE-GENERAL
Directorate E – Food Safety: plant health, animal health and welfare, international questions
E1 - Plant health
Picolinafen
SANCO/1418/2001-rev. 5
18 April 2002
EU RESTRICTED
COMMISSION WORKING DOCUMENT - DOES NOT NECESSARILY REPRESENT
THE VIEWS OF THE COMMISSION SERVICES
DRAFT
Review report for the active substance
picolinafen
Finalised in the Standing Committee on the Food Chain and Animal Health at its meeting on
19 April 2002 in view of the inclusion of picolinafen in Annex I of Directive 91/414/EEC.
1.
Procedure followed for the evaluation process
This review report has been established as a result of the evaluation of the new active substance
picolinafen, made in the context of the work provided for in Articles 5 and 6 of Directive
91/414/EEC concerning the placing of plant protection products on the market, with a view to
the possible inclusion of this substance in Annex I to the Directive.
In accordance with the provisions of Article 6(2) of Directive 91/414/EEC, the German
authorities received on
10 May 1999
an application from
BASF (formerly Cyanamid), hereafter
referred to as the applicant, for the inclusion of the active substance picolinafen in Annex I to
the Directive. German
authorities indicated to the Commission on 3 June 1999 the results of a
first examination of the completeness of the dossier, with regard to the data and information
requirements provided for in Annex II and, for at least one plant protection product containing
the active substance concerned, in Annex III to the Directive. Subsequently, and in accordance
with the requirements of Article 6(2), a dossier on picolinafen was distributed to the Member
States and the Commission.
The Commission referred the dossier to the Standing Committee on Plant Health in the meeting
of the working group ‘legislation’ thereof on
10 June 1999, during which the Member States
confirmed the receipt of the dossier.
In accordance with the provisions of Article 6(3), which requires the confirmation at
Community level that the dossier is to be considered as satisfying, in principle, the data and
information requirements provided for in Annex II and, for at least one plant protection product
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containing the active substance concerned, in Annex III to the Directive and in accordance with
the procedure laid down in Article 20 of the Directive, the Commission confirmed in its
Decision 1999/555/EC
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of 2 July 1999 that these requirements were satisfied.
Within the framework of that decision and with a view to the further organisation of the works
related to the detailed examination of the dossier provided for in Article 6(2) and (4) of
Directive 91/414/EEC, it was agreed between the Member States and the Commission that
Germany, as rapporteur Member State would carry out the detailed examination of the dossier
and report the conclusions of the examination accompanied by any recommendations on the
inclusion or non-inclusion and any conditions relating thereto, to the Commission as soon as
possible and at the latest within a period of one year.
Germany submitted to the Commission on
21 December 2000 the report of its detailed scientific
examination, hereafter referred to as the draft assessment report, including, as required, a
recommendation concerning the possible inclusion of picolinafen in Annex I to the Directive.
On receipt of the draft assessment report, the Commission forwarded it for consultation to all
the Member States on 15 November 2000 as well as to BASF being the sole applicant on
21
December 2000.
Further discussion between the Rapporteur Member State and the United Kingdom acting as
Co-rapporteur Member State were organised, to review the draft assessment report and the
comments received thereon in particular on each of the following disciplines :
-
identity and physical /chemical properties ;
-
fate and behaviour in the environment ;
-
ecotoxicology ;
-
mammalian toxicology ;
-
residues and analytical methods ;
-
regulatory questions.
The report of this peer review (i.e. the Reporting Table) was circulated, for further consultation,
to Member States and the sole applicant on 30 August 2001
.
The dossier, revised draft assessment report and the peer review report (i.e. Reporting Table)
including in particular an outline resumé of the remaining technical questions, were referred to
the Standing Committee on Plant Health, and specialised working groups of this Committee, for
final examination, with participation of experts from the 15 Member States. This final
examination took place from October 2002 to December 2002, and was finalised in the meeting
of the Standing Committee on 19 April 2002.
The present review report contains the conclusions of this final examination; given the
importance of the revised draft assessment report, the peer review report (i.e. Reporting Table)
and the comments and clarifications submitted after the revision of the draft assessment report
as basic information for the final examination process, these documents are considered
respectively as background documents A, B and C to this review report and are part of it.
1
OJ No L210, 10.08 1999, p.22.
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The review did not reveal any open questions, which would have required a consultation of the
Scientific Committee on Plants.
2.
Purposes of this review report
This review report, including the background documents and appendices thereto, have been
developed and finalised in support of the Directive
../../00 EEC
concerning the inclusion of
picolinafen in Annex I to Directive 91/414/EEC, and to assist the Member States in decisions
on individual plant protection products containing picolinafen they have to take in accordance
with the provisions of that Directive, and in particular the provisions of article 4(1) and the
uniform principles laid down in Annex VI.
This review report provides also for the evaluation required under Section A.2.(b) of the above
mentioned uniform principles, as well as under several specific sections of part B of these
principles. In these sections it is provided that Member States, in evaluating applications and
granting authorisations, shall take into account the information concerning the active substance
in Annex II of the directive, submitted for the purpose of inclusion of the active substance in
Annex I, as well as the result of the evaluation of those data.
In parallel with the provisions of Article 7(6) of Regulation 3600/92 for existing active
substances, the Commission and the Member States will keep available or make available this
review report for consultation by any interested parties or will make it available to them on their
specific request. Moreover the Commission will send a copy of this review report (not including
the background documents) to the applicant.
The information in this review report is, at least partly, based on information which is
confidential and/or protected under the provisions of Directive 91/414/EEC. It is therefore
recommended that this review report would not be accepted to support any registration outside
the context of Directive 91/414/EEC, e.g. in third countries, for which the applicant has not
demonstrated possession of regulatory access to the information on which this review report is
based.
3.
Overall conclusion in the context of Directive 91/414/EEC
The overall conclusion from the evaluation is that it may be expected that plant protection
products containing picolinafen will fulfil the safety requirements laid down in Article 5(1)(a)
and (b) of Directive 91/414/EEC. This conclusion is however subject to compliance with the
particular requirements in sections 4, 5, 6 and 7 of this report, as well as to the implementation
of the provisions of Article 4(1) and the uniform principles laid down in Annex VI of Directive
91/414/EEC, for each picolinafen containing plant protection product for which Member States
will grant or review the authorisation.
Furthermore, these conclusions were reached within the framework of the following uses which
were proposed and supported by the sole submitter:
-
herbicide in winter cereals with a application rate up to 0.1 kg a.s./ha
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Extension of the use pattern beyond those described above will require an evaluation at Member
State level in order to establish whether the proposed extensions of use can satisfy the
requirements of Article 4(1) and of the uniform principles laid down in Annex VI of Directive
91/414/EEC.
4.
Specific conclusions which are highlighted in this evaluation
4.1 Residues of picolinafen in foodstuffs
The review has established that the residues arising from the proposed uses, consequent on
application consistent with good plant protection practice, have no harmful effects on human or
animal health. The Theoretical Maximum Daily Intake (TMDI) for a 60 kg adult is
11
% of the
Acceptable Daily Intake (ADI), based on the FAO/WHO European Diet (August 1994). This
low intake value reflects the current limited use pattern for this active substance.
4.2 Exposure of operators, workers and bystanders
The review has identified acceptable exposure scenarios for operators, workers and bystanders,
which require, however, confirmation for each plant protection product in accordance with the
relevant sections of the above mentioned uniform principles.
4.3 Ecotoxicology
The review has also concluded that under the proposed and supported conditions of use there
are no unacceptable effects on the environment, as provided for in Article 4 (1) (b) (iv) and (v)
of Directive 91/414/EEC, provided that certain conditions are taken into account as detailed in
section 7 of this report.
5.
Identity and Physical/chemical properties
The main identity and the physical/chemical properties of picolinafen are given in Appendix I.
The active substance shall have a minimum purity of
>
970
g/kg technical product.
The review has established that for the active substance notified by the applicant (BASF), none
of the manufacturing impurities considered are, on the basis of information currently available,
of toxicological or environmental concern.
6.
Endpoints and related information
In order to facilitate Member States, in granting or reviewing authorisations, to apply adequately
the provisions of Article 4(1) of Directive 91/414/EEC and the uniform principles laid down in
Annex VI of that Directive, the most important endpoints as identified during the evaluation
process are listed in Appendix II.
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7. Particular conditions to be taken into account on short term basis by Member
States in relation to the granting of authorisations of plant protection products containing
picolinafen
On the basis of the proposed and supported uses (max. application rate of 0.1 kg a.s./ha), the
following particular issues have been identified as requiring particular and short term (within 12
months at the latest) attention from the Member States, in the framework of any authorisations
to be granted, varied or withdrawn, as appropriate:
-
Particular attention should be paid to the protection of aquatic organisms. Conditions of
authorisation should include risk mitigation measures, where appropriate.
8.
List of studies to be generated
No further studies were identified which were considered at this stage, and under the current
inclusion conditions necessary in relation to the inclusion of picolinafen in Annex I.
When granting authorisations Member States may also require additional information to ensure
protection of surface water bodies. Also a refined assessment of dermal absorption may be
required to ensure protection of operators.
9.
Updating of this review report
The technical information in this report may require periodic updating to take account of
technical and scientific developments as well as of the results of the examination of any
information referred to the Commission in the framework of Articles 7, 10 or 11 of Directive
91/414/EEC. Such adaptations will be examined and finalised in the Standing Committee on the
Food Chain and Animal Health, in connection with any amendment of the inclusion conditions
for picolinafen in Annex I of the Directive.
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