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  1. Tekst
  2. Originele weergave
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1.

Tekst

STATEMENT OF THE COUNCIL'S REASONS

I. INTRODUCTION

  • 1. 
    On 19 July 2006 the Commission submitted to the Council a proposal for a Regulation of the European Parliament and of the Council concerning the placing of plant protection

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products on the market . The proposal is based on Articles 37(2) and 152(4)(b) of the Treaty.

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  • 2. 
    The European Parliament adopted its opinion at first reading on 23 October 2007 . The Economic and Social Committee and the Committee of the Regions delivered their

opinions on 14 March and 1 February 2007 respectively.

  • 3. 
    On [], the Council adopted its common position in accordance with Article 251 of the Treaty.

II. OBJECTIVES

The proposal replaces Directive 91/414/EEC and aims at achieving -

higher protection of human beings, animals and the environment in the context of authorisation and the placing on the market of plant protection products;

  • - 
    better harmonisation and availability of plant protection products; and
  • - 
    an update and simplification of procedures for the approval of active substances and the authorisation of plant protection products. Its main elements concern in particular: -

the approval of active substances at EU level in accordance with a list of clearer and stricter criteria which will exclude from the market those substances with a very hazardous profile;

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a system of mutual recognition of authorisations between Member States belonging to the same zone, the EU territory being divided into three zones with similar agricultural, climatic and environmental conditions;

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a procedure for low-risk substances and plant protection products;

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the definition of the role of the European Food Safety Authority (EFSA); and

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provisions to avoid unnecessary animal testing.

The Council has introduced new provisions concerning parallel trade, seed treatment and the establishment of national provisional authorisations.

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An amended proposal was submitted on 11 March 2008. 2

14184/07.

III. ANALYSIS OF THE COMMON POSITION

  • 1. 
    GENERAL OBSERVATIONS

The Council has incorporated the following amendments in full: 41, 59, 67, 79, 81, 96,

124, 153, 155, 157, 159, 195, 196, 197, 212, 213, 226, 286 and 301.

It has also included in part or in principle amendments 5, 6, 10, 11, 14, 18 , 22, 29, 31,

32, 33, 34, 39, 43, 45, 46, 54, 62, 64, 66, 77, 78, 80, 82, 84, 87, 89, 95, 97, 109, 121,

122, 126, 130, 134, 136, 141, 143, 149, 163, 169, 175, 176, 177, 180, 181, 183, 185,

188, 189, 190, 201, 206, 248, 251, 296, 300 and 305

Amendments 1, 2, 3, 8, 15-17, 23, 28, 30, 35, 37, 38, 40, 42, 44, 47-48, 52, 55, 58, 68-

69, 70-71, 73-74, 83, 85-86, 88, 91, 101, 103-106, 110-111, 113, 117-118, 120, 127-

129, 132, 135, 137-139, 142, 144, 146-148, 150, 152, 154,158, 161-162, 164-166, 168,

171, 173, 179, 191-192, 194, 198, 202, 204-205, 207-208, 211, 214, 216, 219, 221-222,

226, 228-230, 232, 235-242, 245-246, 249-250, 253, 255, 267, 276, 287, 293, 295, 299,

303 and 304 have not been taken up in the common position, the Council sharing the

same opinion as the Commission.

Amendments 7, 9, 11, 20-21, 24-26, 36, 49-51, 53, 56, 57, 75-76, 92-94, 98-100, 107-

108, 114-116, 119, 131, 133, 140, 145, 156, 160, 167, 170, 184, 199, 203, 215, 217,

218, 220, 224-225, 244, 252, 274 and 297 which were accepted fully or in part by the

Commission, have not been included in the common position, the Council departing

from the Commission's views.

Certain amendments, such as 281 (provisional authorisations), 90 (renewal period for

the approval of active substances), 198 (data protection for the studies necessary for

renewal or review of the authorisation), 210 (confidentiality of names and addresses of

persons involved in testing on vertebrate animals) and 223 (cost recovery by Member

States) were totally or partially incorporated in the common position although they were

not accepted initially by the Commission.

The common position also includes other changes, not envisaged by the European

Parliament, which address a number of concerns expressed by the Member States in the

course of the negotiations. A number of technical and editorial amendments were also

introduced to define the scope of some provisions, to make the wording of the

Regulation more explicit and also to guarantee legal certainty or to increase its

consistency with other Community instruments.

The Commission has accepted the common position agreed by the Council.

  • 2. 
    SPECIFIC COMMENTS
  • a) 
    Provisions included in the original proposal

· Legal basis

The Council considered that, as the main purpose of the Regulation was to ensure the

effective functioning of the internal market in plant protection products, Article 95 was

the correct legal basis. The Council, however, decided to adopt a dual legal basis

including Article 37(2) as a gesture towards the Commission.

· Definitions

The Council took up those amendments which provide appropriate clarifications of the

text of the definitions or which were essential because new provisions were introduced

in the text (e.g. amendments 41, 45, 46). However, in some cases, the Council preferred

to place the new definitions within the Articles containing the provisions on those areas

(e.g. definitions of parallel trade, identical, rapporteur Member State or low-risk). The

Council has deleted the definition of Integrated Pest Management from the

Commission's proposal and has instead inserted a link to the Directive on sustainable

use of pesticides in Article 52. The Council could not incorporate amendment 53 as it

considered that priority to non-chemical methods was not an essential element of good

plant protection practice.

The Council has also inserted a number of additional definitions such as "authorisation

holder", "professional user", "minor use", "greenhouse", "post-harvest treatment",

"biodiversity", "competent authority", "advertisement", "relevant metabolite" and

"impurity". It deleted the definitions of "animals" and "integrated pest management".

· Approval of active substances

The Council inserted in Article 4 a sequential approach in the evaluation of the criteria

set out in Annex II whereby points 3.6.2 to 3.6.4 and 3.7 of that Annex should be

verified first before examining the rest of the criteria.

The Council, like Parliament, strongly believes that strict criteria for the approval of

active substances need to be listed in order to protect human health and the

environment.

The Council has introduced in point 3.6 of Annex II a clear definition of negligible

exposure to carcinogenic, endocrine disrupting or toxic for reproduction substances and

has established that mutagenic category 1 or 2 active substances should be banned even

if human contact with those substances was negligible. It nevertheless thought it

necessary to introduce, for exceptional cases, a derogation clause limited in time for

those substances which are essential for the protection of a crop even if they do not meet

the criteria.

The Council could not agree with the European Parliament's view that active substances

with neurotoxic or immunotoxic properties should be excluded but it agreed to consider

them as candidates for substitution.

Like the Parliament, the Council opposed the unlimited renewal of approval of active

substances as proposed by the Commission but established a maximum period of 15

years instead of 10 as requested by the Parliament in amendment 90.

· Procedures

The Council has endeavoured to further streamline the procedures for approval of active

substances and authorisation of plant protection products. It has paid particular attention

to tightening the deadlines and defining more precisely the roles of the various players

involved (Member States, the Commission, the European Food Safety Authority

(EFSA)). The Council has thus accepted in full or in part a number of European

Parliament amendments that tend in this direction and rejected others which might

either cause unnecessary delays, such as part of amendment 141, or not allow enough

time for the adequate completion of some stages of the procedures (e.g. amendment 86).

· Low-risk active substances

The Council, like the Parliament, thought it useful to further explain the concept of "low

risk" but instead of adding a definition in Article 3 or extra clarifications in Article 22 as

proposed by the European Parliament (amendments 43 and 301) it has inserted more

detailed criteria in Annex II.

Regarding data protection for low-risk plant protection products, the Council has

extended the period of protection to a maximum of 13 years instead of 15 as proposed

by the European Parliament (amendment 287). In case the authorisation of a low-risk

plant protection product is extended to minor uses the data protection period could then

be extended to up to 15 years.

· Candidates for substitution

The Council has also clarified the criteria for active substances to be identified as

candidates for substitution. The Council felt it was necessary to extend the period of

approval from seven to ten years and has therefore not accepted amendment 106.

The Council was unable to agree with amendments 170,. 171, 173, all of 251 and 253

extending, in particular, comparative assessment to all plant protection products. The

text of Article 48 has nevertheless been redrafted in order to give Member States the

option, in exceptional cases, of not authorising or of restricting the use of a plant

protection product which does not contain a candidate for substitution or a low-risk

substance if a non-chemical method exists.

· Mutual recognition of authorisations

The Council was not able to accept those amendments relating to the zonal authorisation

and mutual recognition (in particular amendments 15, 19, 52, 137, 138, 139, 147, 148,

152, 166 and 230) . On the contrary, the Council has confirmed the division into

authorisation zones as proposed by the Commission and the system of compulsory

mutual recognition of authorisations as it believes it is a good way to ensure the

reduction of administrative burdens and the quick and wider availability for European

farmers of plant protection products. The Council has extended this system to plant

protection products for minor uses and has provided additional flexibility (e.g. the

recognition of authorisations between Member States belonging to different zones or the

possibility for a professional organisation to apply for an authorisation).

The Council introduced provisions establishing that Member States impose additional

risk mitigation measures relevant to their territory and, exceptionally, can refuse

authorisations granted in another Member State in order to protect human or animal

health or the environment. The Council has also inserted a review clause whereby a

report is to be drawn up by the Commission within five years of the Regulation's entry

into force.

· National Provisional Authorisations (Article 29a)

Member States decided to bring back the provisional authorisations as a transitional

measure as they feared delays in the authorisation of plant protection products. They

thought the new system needed to be tested first to check if deadlines could be met.

National provisional authorisations will only be granted for a limited period of time

(three years) and under certain circumstances. The Council and the Parliament's views

substantially converge on this issue (amendment 281).

· Animal testing

The Council has taken note of the European Parliament particular interest in avoiding or

minimising animal testing (amendments 6, 9, 23, 24, 55, 66, 75, 92, 108, 130, 208 and

  • 225) 
    and has incorporate them, where possible, in the text of the common position.

· Comitology

The Council has modified the Commission's proposal to bring it into line with the new

Comitology Decision 2006/512/EC amending Decision 1999/468/EC and introducing

the new regulatory procedure with scrutiny. The Council could accept amendments 109

and part of 141 but amendments 93, 94, 99, 100, 119, 120, 142, 158, 184, 219, 224, 226,

227 were not taken on board. In some cases the Council could not accept the regulatory

procedure with scrutiny if the measures to be taken were of a purely implementational

nature. In cases concerning the simple transfer of the requirements already contained in

the Annexes to Directive 91/414/EC to the new Regulation or the adoption of non-

binding guidelines, the Council was of the opinion that the advisory committee

procedure was more appropriate.

Concerning amendments 108, 221 and 225 the Council did not agree with the procedure

proposed (Article 251 of the Treaty). It thought instead that the most appropriate

comitology procedure would be that of "regulatory with scrutiny" as the Regulations to

be adopted following the provisions laid down in those articles would supplement the

basic act by adding new non-essential elements.

  • b) 
    New provisions included in the common position

Following discussions in Council, provisions regarding the following areas were added

to the text of the common position:

· Treated seeds (Article 47a)

Delegations considered that it was necessary to insert provisions on this area so as to

protect the free movement of seeds treated with plant protection products in the EU

unless they might pose a serious threat for human or animal health or the environment..

· Parallel trade

The provisions concerning parallel trade were added by the Council following an almost

unanimous request by Member States. The Council has thus incorporated amendment

286 and has adapted the provisions on parallel trade to the most recent jurisprudence. It

has also introduced the requirement of official controls in this area.

· Adjuvants

The Council has inserted provisions establishing that detailed rules for the authorisation

of adjuvants should be set out following a comitology procedure.

IV. CONCLUSIONS

The Council considers that its common position represents a balanced and realistic solution

for a number of concerns expressed on the Commission's proposal and looks forward to a

constructive discussion with the European Parliament with a view to reaching a workable

agreement on this Regulation.

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2.

Originele weergave

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3.

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