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I. INTRODUCTION
At its meeting on 28 February and 1 March 2007, the Working Party on Agricultural
Questions (Pesticides/Plant Protection Products) finalized its first reading of the above
proposal. The discussion focussed on Chapters V and VI and the Annexes.
The outcome of this examination is summarized hereafter in Chapter II.
II. MAIN ITEMS OF DISCUSSION
A. CHAPTER V - Data Protection and Data Sharing
In general, Delegations supported the proposal. They considered it a major step forward
towards achieving simpler and more transparent data protection provisions.
However, a number of Delegations asked the Commission for further clarifications and the
inclusion of additional details.
The Commission representative accepted to take on board some of these suggestions. In some
cases, he asked for time for reflection. This reflection would take into account the overall
objective of fair competition and simplification.
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1.Article 56 (Data Protection)
A large number of Delegations wanted to delete the words "in order to allow the use on
another crop" from para 1(a). They considered them too restrictive.
Numerous Delegations feared that the idea of not protecting studies and tests necessary for the
renewal or review of an authorisation would discourage industry from investing in research
and would reduce the number of products available.
Some Delegations highlighted the need to specify that both data provided for the approval of
the active substance and for the authorisation of the plant protection product were included in
this Article.
Another Member State was apprehensive about a possible chain reaction related to the zonal
system which would allow some holders to overextend the cover of data protection.
Some Delegations requested that, in order to encourage companies to submit applications for
minor uses, additional data protection should be offered as an incentive.
A proposal for the inclusion of a compensatory mechanism similar to the one in REACH was
put forward.
One Delegation wanted consistency in the use of the terms "reasons" and "justification".
Questions were raised on the status of data protection in the following cases:
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-following mutual recognition, - if authorisation is not granted, if it expires or if it is withdrawn before it expires, - if other data is submitted to comply with national law, - during the transitional period, and - for tests other than GLP and GEP.
The Commission representative offered an explanation on these issues.
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2.Article 57 (List of test and study reports)
Several Delegations expressed concerns about the administrative burdens and practical
difficulties of keeping the lists mentioned in this Article and also wondered whether it was not
more appropriate for the Commission than for Member States to make these lists available to
the public.
The establishment of a centralised system was proposed to facilitate the distribution of the
lists. The Commission representative acknowledged the merit of this concept but reminded
Member States that it would still be their task to elaborate these lists. He insisted that any
system should be as simple as possible and avoid duplication or confusion.
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3.Article 58 (General rules on avoidance of duplicative testing)
The basic idea of having no duplicative testing found broad support among Member States.
However, a number of Delegations asked for the simplification of the procedure envisaged by
the Commission and offered written contributions. Some of them believed there was no
reason why Member States had to be involved, in particular when information on authorised
plant protection products had to be made available pursuant to article 54.
On comparability, one Delegation thought it was necessary to provide the full composition of
the plant protection product and not just data related to the active substance in order for the
equivalence to be assessed.
One Delegation wanted to clarify the precise role of the authorities and the exact meaning of
"reasonable steps".
Another Delegation thought it should be compulsory to share all data providing financial
compensation.
Doubts were raised about the legal obligation of the prospective applicant to provide evidence
that he intends to apply for an authorisation.
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4.Article 59 (Sharing of tests and studies involving vertebrate animals)
The need to avoid repeating test and studies in vertebrates was widely accepted.
The main concerns expressed related to the consequences of not reaching agreement between
the parties on sharing of tests. Some Member States required clarifications on types of courts
and jurisdiction. One Delegation asked for the possibility of arbitration to be included. This
was accepted by the Commission.
Some Delegations asked for the market share criterion to be taken into account. Another
Delegation wondered whether the applicant had to share the costs for each application in each
Member State.
B. CHAPTER VI - Public access to information - Article 60 (Confidentiality)
A number of Delegations considered the provisions included in REACH to be more
appropriate so as to prevent conflict with Regulation (EC) 1049/2001 and Member States'
internal laws. They requested the Council Legal Service representative's advice. The latter
explained that DELETED.
In order to avoid future problems, one Delegation recommended the inclusion of a
comprehensive lists of elements covered by confidentiality. Another Delegation asked for the
inclusion of the names of the persons carrying out the tests and studies and the location of the
facilities so as to prevent attacks from activists.
One Delegation suggested that the first words of para 2(a) should be replaced by "the
specification of profile of the impurities of the active substance ...".
C. ANNEX I (Definition of zones for the authorisation of plant protection products)
In his presentation of Annex I, the Commission Representative announced that new Member
States Romania and Bulgaria would join Zone B and Zone C respectively.
The scientific criteria followed for the definition of the zones was questioned by some
delegations. The number and size of zones was also discussed, in particular whether it was
better to have 4 zones instead of 3, following the classification established by EPPO.
Subdividing zone B into two zones was another possibility put forward by Delegations.
A number of Delegations expressed the need for more flexibility between zones and
supported the concept of voluntary mutual recognition between them. Others questioned the
suitability of having mandatory recognition inside the zones.
One Delegation asked for the possibility of having exceptions for minor uses.
One Delegation mentioned the difficulties for some countries of being classified in one zone
because of differences in climatic conditions between regions and asked the Commission
about the situation of the EU territories outside the European continent.
One Delegation entered a general reservation on this point until the aspects of mutual
recognition are clarified.
The Commission representative agreed to reflect on the need for more flexibility but stressed
the necessity to avoid the risk of making one voluntary recognition compulsory for the rest of
the zone. He undertook to reflect on the number of zones but pointed out that a division into
too many zones would jeopardise the aim of having a better harmonization between Member
States.
D. ANNEX II (Procedure and criteria for the approval of active substances, safeners and synergists pursuant to Chapter II)
Delegations welcomed the cooperation between Member States and EFSA on evaluation but
underlined that their respective roles should be clearly defined.
One Delegation suggested the addition of a sentence at the end of para 1.3 in order to make
sure that there was no retroactive implementation of guidance documents.
Another Delegation believed that a reference to the uniform principles referred to in
Article 29.6 should be added, and that Annex VI of Directive 91/414 should be directly
transposed to this Regulation.
The general decision-making criteria found broad support among Delegations. Minor changes
were suggested to add coherence to the text.
On the criteria for the approval of an active substance, one Delegation disagreed with the
reference to FAO specifications.
Some Delegations suggested adding references to methods of general use, methods of
analysis of residues in animals and crops, of residues in drinking water, food and feed and
methods to identify additives mentioned in para 3.4.1.
Some Delegations were of the opinion that additional guidelines were needed on the impact
on human health. A few Delegations saw merit in a more risk-based approach, whilst most
supported the Commission's proposal. They also wanted clear definitions of terms such as
"safety margin" and "negligible". Some Delegations demanded the inclusion of a reference to
vulnerable groups of population. There was also a discussion of the link to the substitution
principle. The Presidency floated the idea of organising an informal exchange of views on
these issues.
Responding to questions by Delegations about the criteria for approval as a candidate for
substitution, the Commission representative offered the following clarifications:
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-substitution can only take place if another product meeting the criteria of Annex IV is available, and
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-meeting one criteria is enough to be a candidate for substitution.
He also said he would welcome written contributions by Delegations.
Other comments on Annex II concerned the interpretation of some terms, drafting comments
and the coherence of the text both internally and in relation with REACH and the Biocides
Directive.
E. ANNEX III (List of co-formulants which are not accepted for inclusion in plant protection product)
Delegations discussed whether a positive or a negative list should be established. Most
preferred a list containing the co-formulants which should be prohibited in agreement with
article 27 and pointed out that more precise inclusion criteria should be established.
The possibility of using lists which already exist in other pieces of legislation such as
Directive 79/119/EEC or lists in the U.S. was put forward.
F. ANNEX IV (Comparative assessment pursuant to Article 48)
The Commission representative was satisfied with the support shown by Delegations. He
explained that Annex IV was based on the Biocides Directive.
One Delegation highlighted the need to clarify that the substitute could also be a non-
chemical method or technique. Another Delegation underlined the importance of taking
financial disadvantages into account.
G. ANNEX V (Repealed Directives and their successive amendments)
This list will be completed in the future.
III. OTHER ITEMS AND CONCLUSION
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1.As a second point on the agenda, the Presidency presented the results of the expert discussion on parallel imports which took place on 20 February 2007. Delegations welcomed
the outcome of this meeting as reflected in doc. 6618/07. The Presidency announced that a
second expert discussion was going to take place on 13 March 2007 in order to prepare draft
provisions on parallel imports which could be incorporated into the examined regulation.
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2.The Swedish representative reminded Delegations about the workshop on the "substitution principle" which will take place in Brussels on Tuesday 8 May 2007 and asked
them to submit contributions. She said that a discussion paper will be ready by the end of
March and that invitations will be sent in April.
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3.The Presidency announced that a workshop on "mutual recognition, zonal authorisation and possibilities for better cooperation" will take place in Braunschweig (Germany) on 14 and
15 June 2007.
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4.The Presidency confirmed that the next meeting of the Working Group will take place on 26 and 27 April and will focus on the coherence between the different legislative proposals
on pesticides. She asked Member States for comments to be sent before 8 March and
informed the Delegations that a compromise text will be available and discussed in a meeting
of the Working Group in May (date to be confirmed).
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