Opinion of the European Economic and Social Committee on the Proposal for a Regulation of the European Parliament and of the Council concerning the placing of plant protection products on the market COM(2006) 388 final — 2006/0136 COD
Date: 2007-05-31
Institutions: European Economic and Social Committee
Subjects: consumer protection, environmental protection, exchange of information, marketing, marketing standard, pharmaceutical product, plant health product

C 175/44

EN

Official Journal of the European Union

27.7.2007

Opinion of the European Economic and Social Committee on the ‘Proposal for a Regulation of the
European Parliament and of the Council concerning the placing of plant protection products on the
market’

COM(2006) 388 final — 2006/0136 COD

(2007/C 175/12)

On 15 September 2006, the Council decided to consult the European Economic and Social Committee,
under Articles 37(2) and 152(4)(b) of the Treaty establishing the European Community, on the abovemen-
tioned proposal.

The Section for Agriculture, Rural Development and the Environment, which was responsible for preparing
the Committee's work on the subject, adopted its opinion on 8 May 2007. The rapporteur was
Mr Van Oorschot.

At its 436th plenary session, held on 30-31 May 2007 (meeting of 31 May 2007), the European Economic
and Social Committee adopted the following opinion by 65 votes to one, with one abstention.

1. Summary of the conclusions and the recommendations

the

The

EESC welcomes

1.1
European Commission's
proposal to introduce a new Regulation on the placing of plant
protection products on the market
insecticides,
herbicides and similar products for use in agriculture and
horticulture).

(fungicides,

In addition to the goal of ensuring that

the plant
1.2
protection products placed on the market are effective and safe,
a further top priority objective is to ensure that these products
are used in a sustainable and safe way. The EESC therefore
welcomes the fact that the European Commission is presenting,
together with the proposal for a Regulation under review, a
proposal for a Directive regulating the sustainable use of plant
protection products.

The EESC notes that in the preamble to the proposal for
1.3
a Regulation, strong emphasis is placed on preventing and
limiting harmful consequences for humans and the environment
arising from the use of plant protection products. It is, in the
to prevent harmful consequences for the
EESC's view, vital
environment and human beings arising from the use of plant
protection products. The EESC does, however, draw attention to
the fact that, one aspect of an approach geared to ensuring
sustainability is that, economic considerations, too, must carry
equal weight. In addition to the growing level of interest in
organic farming products,
the vast majority of present-day
consumers is interested mainly in being provided with high-
quality products which are, furthermore, available throughout
the year and at an acceptable price. The safety of products for
consumers is an absolute prerequisite in this context. This
requires considerable efforts to be made in the agricultural
production value chain. The availability of adequate supplies of
good, safe plant protection products is,
in this connection,
indispensable.

fails to meet one criterion, whilst representing an improvement
vis-à-vis all the other criteria, being denied approval. The EESC
calls for a risk assessment to be carried out which takes greater
account of actual use and exposure.

1.5
The EESC takes the view that the proposed introduction
of zonal authorisation and mutual recognition represents a first
step along the road towards complete harmonisation of authori-
sations in Europe. The EESC proposes that mutual recognition
of authorisations also be made possible on a cross-zonal basis,
in the case of (neighbouring) states where similar climatic and
agricultural conditions prevail.

plant

protection

assessments

The EESC supports

the principle of
of

carrying out
1.6
comparative
products
containing substances that are candidates for substitution. The
EESC does, however, call for evaluations to be carried out at less
frequent intervals and for the normal period of data protection
to be applied in the case of the abovementioned substances in
in these
order to maintain a degree of readiness to invest
substances on the part of industry and thereby prevent bottle-
necks in the agricultural sector.

The EESC considers that the proposal for a Regulation
1.7
the authorisation of plant
contains too few incentives for
protection products
for minor uses. The EESC proposes
two measures for improving this situation. Firstly, a system
could be introduced under which the initial applicant would be
the greater the
granted a longer period of data protection,
number of minor uses that are included. Secondly, the EESC
asks the European Commission to facilitate the drawing-up of
an up-to-date list for the benefit of the Member States, setting
out all the authorised (minor) uses.

2. Introduction

2.1 General observations

1.4
The EESC expresses its concern over the introduction of
criteria for the approval of plant protection products based on
the intrinsic properties of the active substances and the conse-
quences which this measure may have with regard to innovation
in respect of new and better plant protection products. Rigid
application of these criteria may result in a substance which

2.1.1
Plant protection products are used to afford protection
and to promote plant health. They enable farmers to increase
their yield and to make their production methods more flexible.
This ensures
safe (food)
reliable production of affordable,
products in local regions.

27.7.2007

EN

Official Journal of the European Union

C 175/45

2.1.2
The vast majority of European consumers is becoming
ever more demanding with regard to the quality of food and its
availability throughout the year; food safety is regarded as an
in this
absolute prerequisite and a self-evident requirement
respect. As a result, the agricultural production chain is facing
major challenges.
it is to be in a position to satisfy the
exacting demands of this large group of consumers, it must be
able to have available a sufficiently broad package of good, safe
plant protection products.

If

2.1.3
On the other hand, a number of other factors need to
be taken into consideration: the use of plant protection products
may have an impact on agro-ecosystems; these products may
pose risks to the health of users; and they may have an impact
on food quality and harmful effects on the health of consumers,
particularly in cases where harmful residues of plant protection
products remain in food products, as a result of inappropriate
use of plant protection products
in
accordance with good practice).

(uses which are not

2.2 Regulatory framework

The proposal for a Regulation under review involves
2.2.1
replacing the currently applicable Directive 91/414/EEC on the
marketing of plant protection products. This Directive seeks to
take action at source in order to preclude risks by making provi-
sion for the application of a very comprehensive risk-assessment
procedure in respect of each active substance and the products
which contain these substances, before these products may be
marketed and used.

The proposal under review also involves repealing the
2.2.2
current Directive 79/117/EEC prohibiting the placing on the
market and the use of plant protection products containing
certain active substances.

The EU's regulatory framework for plant protection
2.2.3
products also includes Regulation (EC) 396/2005 of
the
European Parliament and of the Council on maximum residue
levels of pesticides in or on food and feed of plant and animal
origin and amending Council Directive 91/414/EEC which sets
maximum residue levels (MRLs) of active substances in agri-
cultural products.

Together with the proposal

for a Regulation under
2.2.4
is also presented for a Directive of
review, a proposal
the European Parliament and of
the Council establishing a
framework for Community action to achieve a sustainable use
of pesticides (COM(2006) 373 final). The aim of this Directive
is to regulate the use and distribution of pesticides insofar as
these phases are not addressed in the proposal for a Regulation.

2.3 Background to the proposal for a Regulation

In connection with the European Commission's evalua-
2.3.1
tion of Directive 91/414/EEC, the European Parliament and the
Council called, in 2001, for the Directive to be amended with a
view to:

— establishing criteria for the approval of active substances;

— tightening up criteria for the approval of substances with a

high risk profile;

— introducing a simplified procedure for substances with a low

risk profile;

— introducing the principle of applying comparative assess-

ment and substitution;

— improving mutual

recognition by introducing product

authorisation zones for plant protection products.

2.3.2
Following an extensive period of consultation (lasting
five years) with all stakeholders and the establishment of an
impact assessment, the Commission presented its proposal for
amending Directive 91/414/EEC in July 2006. The Commission
decided to replace the Directive by a Regulation with a view to
achieving simplification and further harmonising legislation in
the EU Member States.

2.4 Short summary of the proposal for a Regulation

2.4.1
A positive list of active substances is to be drawn up at
EU level by the Standing Committee on the Food Chain and
Animal Health. Approval of the active substances is to be based
on a set of clear criteria which will seek to ensure a high level
of protection for human beings, animals and the environment.

2.4.2 When active substances are being assessed, there must,
as a minimum requirement, be at least one use which is safe for
both the user of the product and the consumer and there must
not be any unacceptable impact on the environment. Clear
deadlines are laid down for the various stages of the assessment
and in respect of decision-making on the approval of active
substances.

2.4.3 Member States, themselves, will continue to be respon-
the authorisation of plant protection products at
sible for
national
these products must be based on active
level;
substances included in the list of approved active substances.

2.4.4 When assessing the dossiers submitted in connection
with applications for authorisation, the Member States should
apply harmonised criteria, if such criteria are available, and take
account of national circumstances.

In the case of substances with a low or normal risk
2.4.5
the Commission is introducing a system involving
profile,
mandatory mutual
for plant
recognition of authorisations
protection products within ‘authorisation zones’. Under this
system,
the three proposed climate zones (the
Commission divides the EU into three zones), a Member State
takes a decision on a national authorisation for a given product
and the product is to be authorised only in those Member States
where the producer has also applied for mutual recognition of
the authorisation in question.

in any of

C 175/46

EN

Official Journal of the European Union

27.7.2007

3. General observations

4.2 Extending zonal authorisation and mutual recognition

3.1 The importance of plant protection products to the supply of

high-quality food to the EU

3.1.1
In the preamble to the Directive the recitals are listed
which led to the drawing-up of the proposal for a Regulation.
Express mention should also be made,
in this preamble, of
the importance,
in respect of the reliable supply of safe and
high-quality food to demanding European consumers, of having
available adequate quantities of plant protection products.

3.2 Making provision for provisional authorisations subject to certain

conditions

3.2.1
The Directive makes no provision for Member States to
issue provisional national authorisations. This can delay the
marketing of substances which update and improve those
currently available. The Commission is endeavouring to tackle
this situation by applying shorter deadlines designed to lead to
the more rapid inclusion of new substances on the positive list.

The EESC proposes that the Regulation still provides
3.2.2
for provisional authorisations to be granted at national level in
cases where the set deadlines have been exceeded because of
administrative delays and where the obligation in respect of
maximum residue levels (MRLs), set out under Regulation (EC)
396/2005, has been complied with.

The EESC believes that the system of zonal authorisa-
4.2.1
tion and mutual recognition represents an important step on
the
completely harmonised
road towards
European system for
the marketing of plant protection
products.

establishing

a

Introduction of compulsory mutual

4.2.2
recognition of
authorisations in the Member States in respect of same authori-
sation zone, alongside the standard authorisation procedure at
national
the duplication of work in the
Member States and make innovatory, environmentally-friendly
plant protection products available more quickly.

level, will prevent

4.2.3
The EESC proposes that provision be made for mutual
recognition of authorisations also on a cross-zonal basis, in the
case of neighbouring countries having comparable conditions of
production.

In the case of the use of plant protection products in
4.2.4
greenhouses and in the case of post-harvest
the
Commission proposes that provision be made for compulsory
mutual recognition by all
the Member States in all zones
(Article 39). The EESC takes the view that seed treatment, one
of the cornerstones of integrated plant protection (IPS), should
also be included under this regime.

treatment,

4. Specific observations

4.3 Adjustments to the comparative assessment procedure

4.1 Risk assessments in connection with the application of the criteria

for approving active substances

4.1.1
Article 4 of the proposal for a Regulation deals with
the approval criteria for active substances, with reference to
Annex II. Strict application of these criteria would result in
active substances being denied approval already on the basis of
a single property since all the requirements must always be met.

4.1.2
The application of such approval criteria for plant
protection products, based solely on the intrinsic properties of
their active substances without taking account of actual use and
levels of exposure, would undermine the principle that decisions
are to be taken on the basis of risk assessments. This situation
will result in the gradual disappearance from the market of a
number of existing products/applications, which may well be
required in order to meet the need to have a broad range of
products available.

In this way, Article 4 will prevent the marketing of
4.1.3
innovative products which bring about improvements in respect
of all criteria but fail to fulfil the requirements in respect of just
one criterion. The EESC cannot endorse these provisions since
they would unnecessarily curtail innovation in respect of new
and better products. It takes the view that the intrinsic approval
criteria for active substances should only be used to identify
candidates for substitution and not to reject products in advance
without carrying out a thorough evaluation.

4.3.1
In the case of plant protection products based on more
critical substances (candidates for substitution), Member States
are to carry out a comparative assessment within a period of
four years from the authorisation of the product (Article 48).
This assessment is to be carried out with a view to finding an
alternative substance, thereby making it possible to replace the
more harmful substances, except in cases where the substance
in question continues to be necessary in order to provide
ongoing protection in the event of
the development of
resistance.

The EESC takes the view that (a) the stipulation that
4.3.2
comparative assessments are to take place within four years of
the granting of authorisation and (b) the seven-year period of
data protection afforded to candidates for substitution do not
provide the industry with adequate security and will lead to the
early withdrawal of such products from the market, with
possible damaging consequences as regards the availability of
satisfactory products in the case of resistance and minor uses.

4.3.3
The EESC calls for comparative assessments to be
carried out at less frequent intervals and for the application of
the normal period of data protection in the case of candidates
for substitution in order to maintain a degree of readiness to
thereby
invest
preventing bottlenecks in agricultural production and bottle-
necks further on in the value chain in the direction of the
consumer.

in such substances on the part of

industry,

27.7.2007

EN

Official Journal of the European Union

C 175/47

4.4 Inadequate incentives for minor uses

4.5 Provision of information

4.4.1
Article 49 entitles, amongst others, professional users
and professional agricultural organisations to request that the
authorisation of a plant protection product be extended to cover
minor uses. Under this article, Member States are also to esta-
blish and regularly update a list of minor uses.

The EESC welcomes this article but notes that it does
4.4.2
not provide holders of authorisations, themselves, with sufficient
incentives to seek to bring about extensions of authorisations
for minor uses.

The EESC proposes that holders of authorisations be
4.4.3
given a bonus in the form of an extension of the period of data
protection in cases where, following the granting of an authori-
sation, they are the first applicants to request several extensions
of authorisations to include minor uses.

The EESC proposes that

4.4.4
the European Commission
facilitates the drawing-up of a centralised European list of minor
uses and makes such a list available for inspection by the
Member States, in place of the proposed lists to be drawn up by
individual Member States under Article 49(6).

4.5.1
Under the proposal for a Regulation, it is possible to
make it obligatory to inform any neighbours who have
requested to be informed and who could be exposed to the
spray drift; such neighbours are to be informed before the
product is used (Article 30).

4.5.2 Whilst the EESC believes that transparency with regard
to the use of plant protection products makes very good sense,
it does, however, take the view that the proposed obligation to
provide information would undermine the confidence in the
law, on which the marketing of plant protection products is
based. We are, after all, dealing here with the use of products
which are deemed to be safe and imposing an obligation to
inform neighbours could convey the opposite assumption.

4.5.3
The EESC believes that implementation of this article is
not conducive to mutual understanding between users of plant
protection products and their neighbours;
it may, on the
contrary, upset social cohesion in rural communities since
making it obligatory to inform neighbours may give rise to the
impression that the products being used are unsafe. This provi-
sion would, in this sense, be counterproductive.

Brussels, 31 May 2007.

The President

of the European Economic and Social Committee

Dimitris DIMITRIADIS

Opinion of the European Economic and Social Committee on the ‘Proposal for a Directive of the
European Parliament and of the Council amending Directive 2003/87/EC so as to include aviation
activities in the scheme for greenhouse gas emission allowance trading within the Community’

COM(2006) 818 final — 2006/0304 (COD)

(2007/C 175/13)

On 8 February 2007 the Council decided to consult the European Economic and Social Committee, under
Article 175 (1) of the Treaty establishing the European Community, on the abovementioned proposal.

The Section for Agriculture, Rural Development and the Environment, which was responsible for preparing
the Committee's work on the subject, adopted its opinion on 8 May 2007. The rapporteur was Mr Adams.

At its 436th plenary session, held on 30-31 May 2007 (meeting of 31 May), the European Economic and
Social Committee adopted the following opinion by 50 votes to 8 with 4 abstentions.

1. Conclusions and recommendations

strengthened and made more robust as the pre-eminent model
for tackling CO2 emissions at a global level.

1.1
The Committee welcomes the proposed Directive which
offers a carefully considered and pragmatic approach to
moderating and compensating for the rapidly growing volume
of greenhouse gases emitted by the aviation industry.

1.2
By bringing aviation within the remit of the European
Emissions Trading Scheme (ETS) the scheme is itself potentially

The proposal

1.3
is realistic. It recognises the strength of
political, economic and consumer pressures for the continuing
development of air travel and transport whilst using the market