PLANT PROTECTION PRODUCTS (11755/06)
Letter from the Chairman to Lord Rooker,
Minister of State for Sustainable Food and Farming, Department
for Environment, Food and Rural Affairs
At its meeting on 25 October 2006 Sub-Committee
D considered the above document and your accompanying Explanatory
Memorandum dated 2 October 2006.
The Committee supports the principle of the
legislation and believes that, broadly speaking, it will contribute
to a simplification of the existing regulatory regime and may
well render the authorisation process more efficient.
Your EM, however, highlights a number of concerns,
many of which we share. In particular, we would like to see a
greater clarity on how the proposed zonal arrangements for authorisations
will function in practice and we urge you to seek improved wording
in this matter in the text.
The Committee was also concerned to note that
a number of important products may not be authorised under the
proposed new system and would appreciate further information from
you as regards the products affected and whether it would be possible
to amend the proposals in such a way as to allow authorisation
of existing important products while maintaining a high level
of consumer protection.
We would also appreciate the Government's thoughts
on the proposed transitional measures between the current regulatory
framework and the revised one.
We propose to retain this item under scrutiny
pending information on your ongoing consultations with Stakeholders
and clarification on the matters we have raised.
2 November 2006
Letter from Jeff Rooker MP to the Chairman
Thank you for your letter of 2 November seeking
further information on three aspects of the Commission's proposal
for a Regulation of the European Parliament and of the Council
concerning the placing of plant protection products on the market.
You note that the Committee would like to see
greater clarity on how the proposed zonal arrangements for authorisation
will function in practice. The current system under Directive
91/414/EEC is based around each Member State issuing authorisations
for individual products. Directive 91/414/EEC provides for "mutual
recognition" of products designed to encourage the same approvals
in different Member States but this has had limited impact. The
Commission is now proposing a major simplification involving a
system of up to 3 different zonal authorisations for a particular
product instead of up to 25 different national authorisations
as at present. As the Explanatory Memorandum notes, the proposed
zonal arrangements for authorisation would have important benefits,
including speeding up decision making and ensuring a level playing
field within the zone in terms of pesticide availability to farmers
and growers. However, the details given in the Commission's proposal
are limited and there are a number of issues that would have to
be resolved for a zonal system to work satisfactorily. These include
making allowances for differences in climate or diet and harmonising
the way Member States conduct risk assessments. As you request,
we will endeavour to seek improved wording in the text, with further
clarification in supplementary legislation or guidance documents
if necessary, to ensure that the benefits of zonal arrangements
can be realised in practice.
The Committee was also concerned about important
products that may not be authorised under the proposed new system.
The proposal includes new criteria for approval of active substances
including toxicity and environmental `hazard triggers' for CMR
substances (i.e. those that are carcinogenic mutagenic or toxic
for reproduction), substances that are considered to have endocrine
disrupting properties, PBT substances (persistent, bioaccumulative
or toxic) and vPvB substances (very persistent or very bio-accumulative).
The crop protection industry estimates that as currently drafted
between 12-35% of active substances could be caught by the toxicity
hazard triggers. The environmental triggers as drafted would have
only a small impact. We believe that any hazard triggers should
be clear and set realistically and have already suggested refined
criteria which would reduce the impact of the toxicity hazard
triggers.
The Committee has also asked about the proposed
transitional measures between the current regulatory framework
and the revised one. A key issue will be the transition to the
new review arrangements. Under the current system there is a rolling
review programme under which active substance approvals and product
authorisations are renewed on their tenth anniversary. Under the
new proposals approvals and authorisations will be renewed once
then granted for an unlimited period with the provision that Member
States may withdraw or amend them at any time if necessary. Chapter
XI of the Commission's proposal includes suitable transitional
provisions for issuing approvals and authorisations for active
substances and plant protection products. This Chapter also details
supplementary regulations, one of which will list active substances
approved when the Regulation is published while the others will
specify data requirements and risk assessment and labelling provisions.
We have already indicated our concerns that the list of active
substances should specify appropriate expiry dates and that the
other supplementary regulations are issued earlier than the Commission
proposes to allow an appropriate lead in time. Other details may
need to be clarified in relation to whatever new regime emerges,
particularly the arrangements for zonal authorisations.
I note that the Committee proposes to retain
this item under scrutiny pending information on our consultation
with Stakeholders. Responses to this are due by mid-December and
I will endeavour to provide you with a summary of responses in
January.
14 November 2006
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