Common Position (EC) No 25/2008 of 15 September 2008 adopted by the Council, acting in accordance with the procedure referred to in Article 251 of the Treaty establishing the European Community, with a view to the adoption of a Regulation of the European Parliament and of the Council concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC
Date: 2008-09-15
Institutions: Council of the European Union
Subjects: market approval, marketing standard, pharmaceutical product, plant health legislation, plant health product

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III

(Preparatory Acts)

COUNCIL

COMMON POSITION (EC) No 25/2008

adopted by the Council on 15 September 2008

with a view to the adoption of Regulation (EC) No …/2008 of the European Parliament and of the
Council of … concerning the placing of plant protection products on the market and repealing
Council Directives 79/117/EEC and 91/414/EEC

(2008/C 266 E/01)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE
EUROPEAN UNION,

Having regard to the Treaty establishing the European Com-
munity, and in particular Articles 37(2) and 95 thereof,

Having regard to the proposal from the Commission,

Having regard to the opinion of
Committee (1),

the Economic and Social

Having regard to the opinion of
Regions (2),

the Committee of

the

Acting in accordance with the procedure
Article 251 of the Treaty (3),

laid down in

Whereas:

(1)

(2)

(3)

Council Directive 91/414/EEC of 15 July 1991
concerning the placing of plant protection products on
the market (4) provides for rules governing plant protec-
tion products and the active substances contained in
those products.

91/414/EEC,

under Directive

Following the progress report presented by the Commis-
European
sion
Parliament by its Resolution of 30 May 2002 (5) and the
Council in its Conclusions of 12 December 2001 asked
the Commission to review Directive 91/414/EEC and
issues for the Commission to
identified a number of
address.

the

In the light of the experience gained from the application
of Directive 91/414/EEC and of recent scientific and tech-
nical developments, that Directive should be replaced.

(1) OJ C 175, 27.7.2007, p. 44.
(2) OJ C 146, 30.6.2007, p. 48.
(3) Opinion of the European Parliament of 23 October 2007 (OJ C 263 E,
16.10.2008, p. 182), Council Common Position of 15 September
2008 and European Parliament Position of … (not yet published in the
Official Journal).

(4) OJ L 230, 19.8.1991, p. 1.
(5) OJ C 187 E, 7.8.2003, p. 173.

(4)

(5)

(6)

(7)

(8)

By way of simplification, the new act should also repeal
Council Directive 79/117/EEC of 21 December 1978
prohibiting the placing on the market and use of plant
protection
active
substances (6).

containing

products

certain

To simplify application of the new act and to ensure
consistency throughout the Member States, it should take
the form of a Regulation.

Plant production has a very important place in the Com-
munity. One of the most important ways of protecting
plants and plant products against harmful organisms,
including weeds, and of improving agricultural produc-
tion is the use of plant protection products.

can however

Plant protection products
also have
non-beneficial effects on plant production. Their use may
involve risks and hazards for humans, animals and the
environment, especially if placed on the market without
having been officially tested and authorised and if incor-
rectly used.

In order to remove as far as possible obstacles to trade in
plant protection products existing due to the different
levels of protection in the Member States, this Regulation
should lay down harmonised rules for the approval of
active substances and the placing on the market of plant
protection products,
including the rules on the mutual
recognition of authorisations and on parallel trade. The
purpose of this Regulation is thus to increase the free
these
movement of such products and availability of
products in the Member States.

(6) OJ L 33, 8.2.1979, p. 36.

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(9)

(10)

(11)

The purpose of this Regulation is also to ensure a high
level of protection of both human and animal health and
the environment and at the same time to safeguard the
competitiveness of Community agriculture. Particular
attention should be paid to the protection of vulnerable
groups of the population,
including pregnant women,
infants and children. The precautionary principle should
be applied and this Regulation should ensure that
substances or products
that
industry demonstrates
produced or placed on the market do not have any
harmful effect on human or animal health or any unac-
ceptable effects on the environment.

Substances should only be included in plant protection
products where it has been demonstrated that
they
present a clear benefit for plant production and they are
not expected to have any harmful effect on human or
animal health or any unacceptable effects on the environ-
ment. In order to achieve the same level of protection
in all Member States, the decision on acceptability or
non-acceptability of such substances should be taken at
Community level on the basis of harmonised criteria.
These criteria should be applied for the first approval of
an active substance under this Regulation. For active
the criteria should be
substances already approved,
applied at
their
review of
approval.

the time of

renewal or

In the interest of predictability, efficiency and consistency,
a detailed procedure should be laid down for assessing
whether an active substance can be approved. The infor-
mation to be submitted by interested parties for the
purposes of approval of a substance should be specified.
the amount of work connected with the
In view of
approval procedure, it is appropriate that the evaluation
of such information be performed by a Member State
acting as a rapporteur for the Community. To ensure
consistency in evaluation, an independent
scientific
review should be performed by the European Food Safety
Authority established by Regulation (EC) No 178/2002
of the European Parliament and the Council of 28 January
2002 laying down the general principles and require-
ments of food law, establishing the European Food Safety
Authority and laying down procedures in matters of food
safety (1), hereinafter referred to as ‘the Authority’.
It
should be clarified that the Authority performs a risk
assessment whilst the Commission should perform the
risk management and take the final decision on an active
substance. Provisions should be included to ensure trans-
parency of the evaluation process.

(12)

For ethical reasons, the assessment of an active substance
or a plant protection product should not be based on
tests or studies involving the deliberate administration of
to
the active substance or plant protection product

(1) OJ L 31, 1.2.2002, p. 1.

humans with the purpose of determining a human ‘no
observed effect level’ of an active substance. Similarly,
toxicological studies carried out on humans should not
be used to lower the safety margins for active substances
or plant protection products.

(13)

To speed up the approval of active substances, strict dead-
lines should be established for the different procedural
steps.

(14)

In the interest of safety, the approval period for active
substances should be limited in time. The approval
period should be proportional
to the possible risks
inherent in the use of such substances. Experience gained
from the actual use of plant protection products
containing the substances concerned and any develop-
ments in science and technology should be taken into
account when any decision regarding the renewal of an
approval is taken.

(15)

The possibility of amending or withdrawing the approval
of an active substance in cases where the criteria for
approval are no longer satisfied should be provided for.

(16)

(17)

(18)

(19)

The evaluation of an active substance may reveal that it
presents considerably less of a risk than other substances.
In order to favour the inclusion of such a substance in
plant protection products,
it is appropriate to identify
such substances and to facilitate the placing on the
market of plant protection products containing them.

Certain substances which are not predominantly used as
plant protection products may be of value for plant
protection, but
the economic interest of applying for
approval may be limited. Therefore, specific provisions
should ensure that such substances, as far as their risks
are acceptable, may also be approved for plant protection
use.

Some active substances may only be acceptable when
extensive risk mitigation measures are taken. Such
substances should be identified at Community level as
candidates for substitution. Member States should regu-
larly re-examine whether plant protection products
containing such active substances can be replaced by
plant protection products containing active substances
which require less risk mitigation.

In certain Member States non-chemical control or
prevention methods, which are significantly safer for
human, animal health or for the environment, have been
In
established and generally applied for certain uses.
exceptional cases Member States should also be able to
apply the comparative assessment when granting authori-
sation for plant protection products.

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In addition to active
substances, plant protection
products may contain safeners or synergists for which
similar rules should be provided. The technical rules
necessary for the evaluation of such substances should be
established. Substances currently on the market should
only be evaluated after those provisions have been estab-
lished.

(27)

(20)

(21)

(22)

(23)

(24)

(25)

(26)

Plant protection products may also contain co-formu-
lants. It is appropriate to provide a list of co-formulants
which should not be included in plant protection
products.

Plant protection products containing active substances
can be formulated in many ways and used on a variety of
plants and plant products, under different agricultural,
plant health and environmental
(including climatic)
conditions. Authorisations for plant protection products
should therefore be granted by Member States.

The provisions governing authorisation must ensure a
high standard of protection. In particular, when granting
authorisations of plant protection products, the objective
of protecting human or animal health and the environ-
ment should take priority over the objective of improving
plant production. Therefore, it should be demonstrated,
before plant protection products are placed on the
market, that they present a clear benefit for plant produc-
tion and do not have any harmful effect on human or
animal health, including that of vulnerable groups, or any
unacceptable effects on the environment.

In the interest of predictability, efficiency and consistency,
criteria, procedures and conditions for the authorisation
of plant protection products should be harmonised,
account being taken of the general principles of protec-
tion of human and animal health and the environment.

falling under

the responsibility of

In case the decision on approval cannot be finalised
within the period of time provided for due to reasons
not
the applicant,
Member States should be able to grant the provisional
authorisations for a limited period of time in order to
facilitate
approval procedure
provided for under this Regulation. In the light of the
the active
experience gained with the approval of
substances under
the provisions on
this Regulation,
provisional authorisations should cease to apply or be
extended after the period of five years, if necessary.

transition to the

the

The active substances contained in a plant protection
product can be produced by different manufacturing
processes,
leading to differences in specifications. Such
differences may have safety implications. For efficiency
reasons, a harmonised procedure at Community level
should be provided for
those
differences.

assessment of

the

The principle of mutual recognition is one of the means
of ensuring the free movement of goods within the Com-
munity. To avoid any duplication of work, to reduce the
administrative burden for industry and for Member States
and to provide for more harmonised availability of plant
protection products,
authorisations granted by one
Member State should be accepted by other Member
States where agricultural, plant health and environmental
(including climatic) conditions are comparable. Therefore,
the Community should be divided into zones with such
comparable conditions in order to facilitate such mutual
recognition. However,
agricultural
circumstances specific to the territory of a Member State
might require that, on application, Member States recog-
nise an authorisation issued by another Member State,
amend it or refrain from authorising the plant protection
product in their territory, if justified because of specific
agricultural circumstances or if the high level of protec-
tion of both human and animal health and the environ-
ment set out in this Regulation can not be achieved.

environmental or

(28)

The economic incentive for industry to apply for an
authorisation is limited in certain uses. In order to ensure
that diversification of agriculture and horticulture is not
jeopardised by the lack of availability of plant protection
products, specific rules should be established for minor
uses.

(29) When identical plant protection products are authorised
in different Member States, a simplified procedure for
granting a parallel trade permit should be provided for in
this Regulation, in order to facilitate the trade between
Member States of such products.

(30)

(31)

In exceptional cases, Member States should be permitted
to authorise plant protection products not complying
with the conditions provided for
in this Regulation,
where it is necessary to do so because of a danger or
threat to plant production which cannot be combatted
by any other means. Such authorisations should be
reviewed at Community level.

Community seeds legislation provides for free movement
of seeds within the Community but does not contain a
specific provision concerning seeds treated with plant
protection products. Such a provision should therefore be
included in this Regulation. If treated seeds constitute a
serious risk to human or animal health or to the environ-
ment, Member States should have the possibility of
taking the protective measures.

(32)

To promote innovation, special rules should be estab-
lished permitting the use of plant protection products in
experiments
they have not yet been
authorised.

even where

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(33)

(34)

in the

In order to ensure a high level of protection of human
health and the environment, plant protection products
should be used properly having regard to the principles
integrated pest management. The Council should
of
include
requirement
statutory management
referred to in Council Regulation (EC) No 1782/2003 of
29 September 2003 establishing common rules for direct
support schemes under the common agricultural policy
and establishing certain support schemes for farmers (1)
the principles of integrated pest management, including
good plant protection practice.

In addition to this Regulation a thematic strategy on the
sustainable use of pesticides was adopted as well as Direc-
the European Parliament and the
tive 2008/…/EC of
Council of … establishing a framework for Community
action to achieve a sustainable use of pesticides (2). In
order to achieve coherence between these instruments,
the user should know from the product label where,
when and under what circumstances a plant protection
product may be used.

(35) A system of exchange of information should be estab-
lished. Member States should make available to each
other, the Commission and the Authority the particulars
and scientific documentation submitted in connection
with applications for authorisation of plant protection
products.

(36) Adjuvants may be used to increase the efficacy of a plant
protection product. Their placing on the market or use
should be forbidden where they contain a co-formulant
which has been prohibited. The technical rules necessary
for the authorisation should be established.

(37)

Studies represent a major investment. This investment
should be protected in order to stimulate research. For
this reason, studies lodged by one applicant with a
Member State should be protected against use by another
applicant. This protection should, however, be limited in
time in order to allow competition. It should also be
limited to studies which are genuinely necessary for regu-
latory purposes, to avoid applicants artificially extending
the period of protection by submitting new studies which
are not necessary.

(38)

Rules should be laid down to avoid duplication of tests
and studies. In particular, repetition of studies involving
vertebrates should be prohibited. In this context, there
should be an obligation to allow access to studies on
vertebrates on reasonable terms. In order to allow opera-
tors to know what studies have been carried out by

others, Member States should keep a list of such studies
even where they are not covered by the above system of
compulsory access.

(39) As different rules are applied by Member States,

the
Commission and the Authority in relation to access to
and confidentiality of documents,
it is appropriate to
clarify the provisions concerning access to information
contained in the documents in the possession of these
authorities and the confidentiality of these documents.

(40) Directive 1999/45/EC of the European Parliament and of
the Council of 31 May 1999 concerning the approxima-
tion of the laws, regulations and administrative provi-
sions of the Member States relating to the classification,
packaging and labelling of dangerous preparations (3)
applies to the classification, packaging and labelling of
pesticides. However, to further improve the protection of
users of plant protection products, of consumers of
plants and plant products and of
the environment,
further specific rules are appropriate which take account
of
the specific conditions of use of plant protection
products.

(41)

To ensure that advertisements do not mislead users of
plant protection products, it is appropriate to lay down
rules on the advertising of those products.

(42)

(43)

(44)

Provisions on record-keeping and information about the
use of plant protection products should be established in
order to raise the level of protection of human and
animal health and the environment by ensuring the trace-
ability of potential exposure, to increase the efficiency of
monitoring and control and to reduce the costs of moni-
toring water quality.

Provisions on control and inspection arrangements with
regard to the marketing and use of plant protection
products should ensure correct, safe and harmonised
implementation of the requirements laid down in this
Regulation in order to achieve a high level of protection
of both human and animal health and the environment.

the

Regulation (EC) No 882/2004 of
European
Parliament and of the Council of 29 April 2004 on offi-
cial controls performed to ensure the verification of
compliance with feed and food law, animal health and
animal welfare rules (4) provides for control measures for
the use of plant protection products at all stages of the
production of food, including record-keeping on the use

(1) OJ L 270, 21.10.2003, p. 1.
(2) OJ L …

(3) OJ L 200, 30.7.1999, p. 1.
(4) OJ L 165, 30.4.2004, p. 1. Corrected version in OJ L 191, 28.5.2004,

p. 1.

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of plant protection products. Similar rules on monitoring
and controls relating to the storage and use of plant
protection products not covered by Regulation (EC)
No 882/2004 should be adopted by the Commission.

(52)

The measures necessary for the implementation of this
Regulation should be
adopted in accordance with
Council Decision 1999/468/EC of 28 June 1999 laying
down the procedures for the exercise of implementing
powers conferred on the Commission (2).

(45)

coordination should be

ensured with other
Close
Community legislation,
in particular Regulation (EC)
No 396/2005 of the European Parliament and of the
Council of 23 February 2005 on maximum residue levels
of pesticides in or on food and feed of plant and animal
origin (1), and with Community legislation on the protec-
tion of workers
concerned with the
contained use and deliberate release of genetically modi-
fied organisms.

and anyone

(46)

It is necessary to establish procedures for the adoption of
emergency measures in situations where an approved
active substance, a safener, a synergist or a plant protec-
tion product
is likely to constitute a serious risk to
human or animal health or the environment.

(47) Member States should lay down rules on penalties applic-
able to infringements of this Regulation and should take
the measures necessary to ensure that they are imple-
mented.

(53)

In particular, the Commission should be empowered to
adopt Regulations concerning labelling requirements,
controls and rules for adjuvants, establishing a work
programme for safeners and synergists,
including their
data requirements, postponing the expiry of the approval
period, extending the date for provisional authorisations,
setting the information requirements for parallel trade
and on inclusion of co-formulants, as well as amend-
ments to the Regulations on data requirements and on
uniform principles for evaluation and authorisation and
to the Annexes. Since those measures are of general
scope and are designed to amend non-essential elements
inter alia by supplementing it with
of this Regulation,
new non-essential elements, they must be adopted in
accordance with the regulatory procedure with scrutiny
provided for in Article 5a of Decision 1999/468/EC.

(54) On grounds of efficiency, the normal time-limits for the
regulatory procedure with scrutiny should be curtailed
for the adoption of a Regulation postponing the expiry
of the approval period for a period sufficient to examine
the application.

(48) General civil and criminal liability in the Member States
of the manufacturer and, where applicable, of the person
responsible for placing the plant protection product on
the market or using it should remain applicable.

(55)

(49) Member States should have the possibility of recovering
the costs of the procedures associated with the applica-
tion of this Regulation from those seeking to place, or
placing, plant protection products or adjuvants on the
market and from those applying for the approval of
active substances, safeners or synergists.

legal

Furthermore, it is appropriate to transfer certain current
in the Annexes to the Directive
provisions set out
91/414/EEC into separate
to be
adopted by the Commission within 18 months after the
entry into force of this Regulation. Since these current
provisions should be, as a first step, transferred into new
legal
instruments and thus be adopted without any
substantial modification, the advisory procedure is the
most appropriate.

instruments

(50) Member States should designate the necessary national

competent authorities.

(51)

The Commission should facilitate the application of this
Regulation. Therefore, it is appropriate to provide for the
necessary financial
resources and the possibility of
amending certain provisions of this Regulation in the
light of experience or of developing technical notes for
guidance.

(56)

It is also appropriate to use the advisory procedure to
adopt some purely technical measures, in particular tech-
nical guidelines in view of their non-binding character.

(57)

Certain provisions of Directive 91/414/EEC should
remain applicable during the transitional period,

(1) OJ L 70, 16.3.2005, p. 1.

(2) OJ L 184, 17.7.1999, p. 23.

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HAVE ADOPTED THIS REGULATION:

CHAPTER I

GENERAL PROVISIONS

Article 1

3.

This Regulation shall apply to the following:

Subject matter

This Regulation lays down rules for the authorisation of plant
protection products in commercial form and for their placing
on the market, use and control within the Community.

This Regulation lays down both rules for the approval of active
substances,
safeners and synergists, which plant protection
products contain or consist of, and rules for adjuvants and
co-formulants.

Article 2

Scope

This Regulation shall apply to products,

1.
in the form in
which they are supplied to the user, consisting of or containing
active substances, safeners or synergists, and intended for one of
the following uses:

(a) protecting plants or plant products against all harmful
organisms or preventing the action of such organisms,
unless the main purpose of these products is considered to
be for reasons of hygiene rather than for the protection of
plants or plant products;

(a) substances or preparations which are added to a plant
protection product to eliminate or reduce phytotoxic effects
of the plant protection product on certain plants, hereinafter
referred to as ‘safeners’;

(b) substances or preparations which, while showing no or only
weak activity as referred to in paragraph 1, can give
in a plant
enhanced activity to the active substance(s)
protection product, hereinafter referred to as ‘synergists’;

(c) substances or preparations which are used or intended to be
used in a plant protection product or adjuvant, but are
neither active substances nor safeners or synergists, herein-
after referred to as ‘co-formulants’;

(d) substances or preparations which consist of co-formulants
or preparations containing one or more co-formulants, in
the form in which they are supplied to the user and placed
on the market to be mixed by the user with a plant protec-
tion product and which enhance its effectiveness or other
pesticidal properties, hereinafter referred to as ‘adjuvants’.

Article 3

Definitions

(b) influencing the life processes of plants, such as substances

influencing their growth, other than as a nutrient;

For the purposes of this Regulation, the following definitions
shall apply:

(c) preserving plant products,

insofar as such substances or
products are not subject to special Community provisions
on preservatives;

(d) destroying undesired plants or parts of plants, except algae
unless the products are applied on soil or water to protect
plants;

1) ‘residues’

One or more substances present in or on plants or plant
products, edible animal products, drinking water or else-
where in the environment and resulting from the use of a
plant protection product, including their metabolites, break-
down or reaction products;

(e) checking or preventing undesired growth of plants except
algae unless the products are applied on soil or water to
protect plants.

2) ‘substances’

These products are referred to hereinafter as ‘plant protection
products’.

Chemical elements and their compounds, as they occur
naturally or by manufacture, including any impurity inevi-
tably resulting from the manufacturing process;

This Regulation shall apply to substances, including micro-
2.
organisms having general or specific action against harmful
organisms or on plants, parts of plants or plant products, here-
inafter referred to as ‘active substances’.

3) ‘preparations’

Mixtures composed of two or more substances intended for
use as a plant protection product or as an adjuvant;

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4) ‘substance of concern’

Any substance which has an inherent capacity to cause an
adverse effect on humans, animals or the environment and
is present or is produced in a plant protection product in
sufficient concentration to present risks of such an effect.

Such substances include, but are not limited to, substances
meeting the criteria to be classified as dangerous in accord-
ance with Council Directive 67/548/EEC of 27 June 1967
on the approximation of laws, regulations and administra-
tive provisions relating to the classification, packaging and
labelling of dangerous substances (1), and present in the
plant protection product at a concentration leading the
product to be regarded as dangerous within the meaning of
Article 3 of Directive 1999/45/EC;

adjuvants on his own, or who contracts this manufacturing
to another party, or a person designated by the manufac-
turer as his sole representative for the purpose of compli-
ance with this Regulation;

11) ‘letter of access’

An original document by which the owner of data
protected under this Regulation agrees to the use of such
data under the specific terms and conditions by the compe-
tent authority for the purpose of granting an authorisation
of a plant protection product or an approval of an active
substance, synergist or safener for the benefit of another
applicant;

5) ‘plants’

12) ‘environment’

Live plants and live parts of plants, including fresh fruit,
vegetables and seeds;

Waters (including ground, surface, transitional, coastal and
marine), sediment, soil, air, land, wild species of fauna and
flora, and any interrelationship between them, and any rela-
tionship with other living organisms;

6) ‘plant products’

13) ‘micro-organisms’

Products of plant origin in unprocessed state or having
undergone only simple preparation, such as milling, drying
or pressing, but excluding plants;

Any microbiological entity,
fungi and
viruses, cellular or non-cellular, capable of replication or of
transferring genetic material;

including lower

7) ‘harmful organisms’

14) ‘genetically modified organisms’

Any species, strain or biotype belonging to the animal
kingdom or plant kingdom or pathogenic agent injurious
to plants or plant products;

8) ‘placing on the market’

The holding for the purpose of sale within the Community,
including offering for sale or any other form of transfer,
whether free of charge or not, and the sale, distribution,
and other forms of transfer themselves, but not the return
to the previous seller. Release for free circulation into the
territory of the Community shall constitute placing on the
market for the purposes of this Regulation;

9) ‘authorisation of a plant protection product’

Administrative act by which the competent authority of a
Member State authorises the placing on the market of a
plant protection product in its territory;

10) ‘producer’

A person who manufactures plant protection products,
active substances, safeners, synergists, co-formulants or

Organisms in which the genetic material has been altered
within the meaning of Article 2(2) of Directive 2001/18/EC
of the European Parliament and of the Council of 12 March
2001 on the deliberate release into the environment of
genetically modified organisms (2);

15) ‘zone’

Group of Member States as defined in Annex I.

For the purpose of use in greenhouses, as post-harvest
treatment, for treatment of empty storage rooms and for
seed treatment the zone means all zones defined in Annex I;

16) ‘good plant protection practice’

Practice whereby the treatments with plant protection
products applied to given plants or plant products,
in
conformity with the conditions of their authorised uses, are
selected, dosed and timed to ensure acceptable efficacy with
the minimum quantity necessary, taking due account of
local conditions and of the possibilities for cultural and
biological control;

(1) OJ 196, 16.8.1967, p. 1.

(2) OJ L 106, 17.4.2001, p. 1.

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17) ‘good laboratory practice’

production of mushrooms or witloof) are also considered
as greenhouses;

Practice as defined in point 2.1 of Annex I to Directive
2004/10/EC of the European Parliament and of the Council
of 11 February 2004 on the harmonisation of laws, regula-
tions and administrative provisions relating to the applica-
tion of the principles of good laboratory practice and the
tests on chemical
verification of
substances (codified version) (1);

their applications for

24) ‘post-harvest treatment’

Treatment of plants or plant products after harvest in an
isolated space where no run-off is possible, for example in
a warehouse;

18) ‘good experimental practice’

25) ‘biodiversity’

Practice in accordance with the provisions of European and
Mediterranean Plant Protection Organisation (EPPO) Guide-
lines 181 and 152;

19) ‘data protection’

sources,
Variability among living organisms
including terrestrial, marine and other aquatic ecosystems
and the ecological complexes of which they are part; this
variability may include diversity within species, between
species and of ecosystems;

from all

The temporary right of the owner of a test or study report
to prevent it being used for the benefit of another appli-
cant;

26) ‘competent authority’

20) ‘authorisation holder’

Any authority or authorities of a Member State responsible
for carrying out the tasks established under this Regulation;

Any natural or legal person holding an authorisation of a
plant protection product;

27) ‘advertisement’

21) ‘professional user’

Professional user as defined in Article 3(1) of Directive
2008/…/EC;

A means of promoting the sale or use of plant protection
products (to anyone other than the authorisation holder,
the person placing the plant protection product on the
market and their agents) by printed or electronic media;

22) ‘minor use’

28) ‘metabolite’

Use of a plant protection product in a particular Member
State on plants or plant products which are:

(a) not widely grown in that Member State; or

(b) widely grown to meet an exceptional plant protection

need;

23) ‘greenhouse’

A walk-in, static, closed place of crop production with a
usually translucent outer shell, which allows controlled
exchange of material and energy with the surroundings and
prevents release of plant protection products into the envir-
onment.

For the purpose of this Regulation, closed places of plant
production where the outer shell is not translucent (e.g. for

(1) OJ L 50, 20.2.2004, p. 44.

Any metabolite or a degradation product of an active
substance, safener or synergist, formed either in organisms
or in the environment.

A metabolite is deemed relevant if there is a reason to
assume that it has comparable intrinsic properties as the
parent substance in terms of its biological target activity, or
that it poses a higher or comparable risk to organisms than
the parent substance or that it has certain toxicological
properties that are considered unacceptable. Such a meta-
bolite is relevant for the overall approval decision or for the
definition of risk mitigation measures;

29) ‘impurity’

than the pure active substance
Any component other
and/or variant which is present in the technical material
(including originating from the manufacturing process or
from degradation during storage);

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ACTIVE SUBSTANCES, SAFENERS, SYNERGISTS AND CO-FORMULANTS

CHAPTER II

SECTION 1

Active substances

Subsection 1

(taking into account substances resulting from water treat-
ment), food, feed or air, or consequences in the workplace
or through other indirect effects, taking into account known
cumulative and synergistic effects where the methods to
assess such effects are agreed; or on groundwater;

(c) it shall not have any unacceptable effects on plants or plant

products;

Requirements and conditions for approval

Article 4

(d) it shall not cause unnecessary suffering and pain to verte-

brates to be controlled;

Approval criteria for active substances

(e) it shall have no unacceptable effects on the environment,
having particular regard to the following considerations:

An active substance shall be approved in accordance with
1.
Annex II if it may be expected, in the light of current scientific
and technical knowledge, that, taking into account the approval
criteria set out in points 2 and 3 of that Annex, plant protection
products containing that active substance meet the requirements
provided for in paragraphs 2 and 3.

the active substance shall

The assessment of
first establish
whether the approval criteria set out in points 3.6.2 to 3.6.4
and 3.7 of Annex II are satisfied. If these criteria are satisfied the
assessment
the other
shall continue to establish whether
approval criteria set out in points 2 and 3 of Annex II are satis-
fied.

(i) its fate and distribution in the environment, particularly
including estuarine

contamination of surface waters,
and coastal waters, groundwater, air and soil;

(ii) its impact on non-target species;

(iii) its impact on biodiversity.

4.
The requirements of paragraphs 2 and 3 shall be evaluated
in the light of uniform principles as referred to in Article 29(6).

2.
The residues of the plant protection products, consequent
on application consistent with good plant protection practice
and having regard to realistic conditions of use, shall meet the
following requirements:

5.
For approval of an active substance, paragraphs 1, 2 and 3
shall be deemed to be satisfied where this has been established
with respect to one or more representative uses of at least one
plant protection product containing that active substance.

(a) they shall not have any harmful effects on human health,
including vulnerable groups, or animal health, taking into
account known cumulative and synergistic effects where the
methods to assess such effects are agreed, or on ground-
water;

(b) they shall not have any unacceptable effect on the environ-

ment.

For residues which are of toxicological, ecotoxicological, envir-
onmental or drinking water relevance, there shall be methods in
general use for measuring them. Analytical standards shall be
commonly available.

3.
A plant protection product, consequent on application
consistent with good plant protection practice and having
regard to realistic conditions of use, shall meet the following
requirements:

6.
In relation to human health, no data collected on humans
shall be used to lower the safety margins resulting from tests or
studies on animals.

By way of derogation from paragraph 1, where on the
7.
basis of documented evidence an active substance is necessary
to control a serious danger to plant health which cannot be
contained by other available means, such active substance may
be approved for a time limited period not exceeding five years
even if it does not satisfy the criteria set out in points 3.6.3,
3.6.4, 3.6.5 or 3.8.2 of Annex II, provided that the use of the
active substance is subject to risk mitigation measures to ensure
that exposure of humans and the environment is minimised. For
such substances maximum residue levels shall be set in accord-
ance with Regulation (EC) No 396/2005.

(a) it shall be sufficiently effective;

(b) it shall have no immediate or delayed harmful effect on
human or animal health, directly or through drinking water

This derogation shall not apply to active substances which are
or have
classified in accordance with Directive
67/548/EEC, as carcinogenic category 1 or toxic for reproduc-
tion category 1.

to be

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Article 5

First approval

First approval shall be for a period not exceeding ten years.

strating that the active substance fulfils the approval criteria
provided for in Article 4.

A joint application may be submitted by an association of
producers designated by the producers for
the purpose of
compliance with this Regulation.

Article 6

Conditions and restrictions

The application shall be examined by the Member State
proposed by the applicant, unless another Member State agrees
to examine it.

Approval may be
including:

subject

to conditions

and restrictions

(a) the minimum degree of purity of the active substance;

(b) the nature and maximum content of certain impurities;

(c) restrictions arising from the evaluation of the information
referred to in Article 8 taking account of the agricultural,
plant health and environmental, including climatic, condi-
tions in question;

(d) type of preparation;

(e) manner and conditions of application;

(f) submission of further confirmatory information to Member
the Commission and the European Food Safety
States,
‘the Authority’,
referred to as
Authority, hereinafter
where new requirements are established during the evalua-
tion process or as a result of new scientific and technical
knowledge;

(g) designation of categories of users, such as professional and

non-professional;

(h) designation of areas where the use of plant protection
products containing the active substance may not be
authorised or where the use may be authorised under
specific conditions;

(i) the need to impose risk mitigation measures and monitoring

after use;

(j) any other particular conditions that result from the evalua-
tion of information made available in the context of this
Regulation.

Subsection 2

Approval procedure

Article 7

Application

1.
An application for the approval of an active substance or
for an amendment to the conditions of an approval shall be
submitted by the producer of the active substance to a Member
referred to as ‘rapporteur Member State’,
State, hereinafter
together with a summary and a complete dossier as provided
for in Article 8(1) and (2) or a scientifically reasoned justifica-
tion for not providing certain parts of those dossiers, demon-

the applicant may
2. When submitting his application,
pursuant to Article 63 request certain information,
including
certain parts of dossier, to be kept confidential and shall physi-
cally separate that information.

Member States shall assess the confidentiality requests. Upon a
request for access to information, the rapporteur Member State
shall decide what information is to be kept confidential.

3. When submitting his application the applicant shall at the
same time join a complete list of tests and studies submitted
pursuant to Article 8(2) and a list of any claims for data protec-
tion pursuant to Article 59.

4. When assessing the application the rapporteur Member
State may at any time consult the Authority.

Article 8

Dossiers

1.

The summary dossier shall include the following:

(a) information with respect to one or more representative uses
on a widely grown crop in each zone of at least one plant
protection product containing the active substance, demon-
strating that the approval criteria provided for in Article 4
are met; where the information submitted does not cover all
zones or concern a crop which is not widely grown, justifi-
cation for this approach;

(b) for each point of

the data requirements for the active
substance, the summaries and results of tests and studies,
the name of their owner and of the person or institute that
has carried out the tests and studies;

(c) for each point of the data requirements for the plant protec-
tion product, the summaries and results of tests and studies,
the name of their owner and of the person or institute that
carried out the tests and studies, relevant to the assessment
of the criteria provided for in Article 4(2) and (3) for one or
more plant protection products which are representative of
the uses referred to in point (a), taking into account the fact
that data gaps in the dossier, as provided for in paragraph 2
of this Article, resulting from the proposed limited range of
representative uses of
the active substance, may lead to
restrictions in the approval;

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(d) a checklist demonstrating that the dossier provided for in
paragraph 2 of this Article is complete in view of the uses
applied for;

A new application for the same substance may be submitted at
any time.

(e) the reasons why the test and study reports submitted are
necessary for first approval of the active substance or for
amendments to the conditions of the approval;

(f) where relevant a copy of an application for a maximum
residue level as referred to in Article 7 of Regulation (EC)
No 396/2005 or a justification for not supplying such infor-
mation;

(g) an assessment of all information submitted.

The complete dossier shall contain the full text of the indi-
2.
vidual test and study reports concerning all the information
referred to in points (b) and (c) of paragraph 1. It shall not
contain any reports of tests or studies involving the deliberate
administration of the active substance or the plant protection
product to humans.

The format of

3.
the summary dossier and the complete
dossier shall be established in accordance with the advisory
procedure referred to in Article 79(2).

4.
The data requirements referred to in paragraphs 1 and 2
shall contain the requirements for active substances and plant
protection products as
to
Directive 91/414/EEC and laid down in Regulations adopted
in accordance with the advisory procedure referred to in
Article 79(2) without any substantial modifications. Subsequent
amendments to these Regulations shall be adopted in accord-
ance with Article 78(1)(b).

in Annexes II and III

set out

Article 9

Admissibility of the application

the

receiving

application,

1. Within 45 days of
the
rapporteur Member State shall send the applicant a written
acknowledgement, stating the date of receipt and check whether
the dossier submitted with the application contain all
the
elements provided for in Article 8, using the checklist referred
to in point (d) of Article 8(1). It shall also check the requests for
confidentiality referred to in Article 7(2) and the complete lists
of tests and studies submitted pursuant to Article 8(2).

the elements provided for in Article 8,

3. Where the dossiers submitted with the application contain
the rapporteur
all
Member State shall notify the applicant,
the other Member
States, the Commission and the Authority of the admissibility of
the application and start assessing the active substance.

After receiving that notification, the applicant shall immediately
forward the dossiers as provided for in Article 8 to the other
Member States, the Commission and the Authority,
including
the information for which parts of the dossiers' confidentiality
has been requested as referred to in Article 7(2).

Article 10

Access to the summary dossier

The Authority shall without delay make the summary dossier
referred to in Article 8(1) available to the public, excluding any
information for which confidential treatment has been requested
and justified pursuant to Article 63, unless there is an overriding
public interest in its disclosure.

Article 11

Draft assessment report

the date of

the notification
1. Within twelve months of
the
provided for in the first subparagraph of Article 9(3),
rapporteur Member State shall prepare and submit
to the
Commission, with a copy to the Authority a report, hereinafter
referred to as ‘draft assessment report’, assessing whether the
active substance can be expected to meet the approval criteria
provided for in Article 4.

2.
The draft assessment report shall also include where rele-
vant, a proposal to set maximum residue levels. In such a case
the rapporteur Member State shall forward the application, the
evaluation report and the supporting dossier referred to in
Article 9 of Regulation (EC) No 396/2005 to the Commission
no later than six months after the date of
the notification
provided for in the first subparagraph of Article 9(3) of this
Regulation.

2. Where one or more of
the elements provided for in
Article 8 are missing, the rapporteur Member State shall inform
the applicant, setting a time period for their submission. Such
time period shall be a maximum of three months.

The rapporteur Member State shall make an independent, objec-
tive and transparent assessment in the light of current scientific
and technical knowledge.

the end of

the applicant has not
that period,
Where at
submitted the missing elements, the rapporteur Member State
shall
inform the applicant, the other Member States and the
Commission that the application is inadmissible.

If, pursuant to Article 4(1), the assessment establishes that the
approval criteria set out in points 3.6.2 to 3.6.4 and 3.7 of
Annex II are not satisfied, the draft assessment report shall be
limited to these parts of the assessment.

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3. Where the rapporteur Member State needs additional
studies or information, it shall set a time period for the appli-
cant to supply it. In that case, the twelve-month period shall be
extended by the additional time period granted by the rappor-
teur Member State. The additional time period shall be of a
maximum of six months and shall cease at the moment when
received by the rapporteur
the additional
Member State.
inform the Commission and the
Authority accordingly.

information is
It

shall

Where at the end of the additional period, the applicant has not
submitted the additional studies or information, the rapporteur
Member State shall inform the applicant, the Commission and
the Authority and shall state the missing elements in the assess-
ment included in the draft assessment report.

The rapporteur Member State shall assess the additional infor-
mation and submit it to the Authority without delay and at the
latest within 60 days after receipt of the additional information.
In that case the 120-day period provided for in paragraph 2
shall be extended by a period which shall cease at the moment
when the additional assessment is received by the Authority.

The Authority may ask the Commission to consult a Com-
munity reference laboratory, designated pursuant to Regulation
(EC) No 882/2004 for the purposes of verifying whether the
analytical method for
residues
proposed by the applicant is satisfactory and meets the require-
ments in point (f) of Article 29(1) of this Regulation. The appli-
cant shall, if requested by the Community reference laboratory,
provide samples and analytical standards.

the determination of

the

The format of the draft assessment report shall be estab-
4.
lished in accordance with the advisory procedure referred to in
Article 79(2).

4.
The conclusion of the Authority shall include details on
the procedure of the evaluation and the properties of the active
substance concerned.

Article 12

Conclusion by the Authority

1.
The Authority shall circulate the draft assessment report
received from the rapporteur Member State to the applicant and
the other Member States at the latest 30 days after its receipt. It
shall ask the applicant to circulate an update of the dossier
where applicable to the Member States, the Commission and the
Authority.

The Authority shall make the draft assessment report available
to the public, after giving the applicant two weeks to request,
pursuant to Article 63, that certain parts of the draft assessment
report be kept confidential.

The Authority shall allow a period of 60 days for the submis-
sion of written comments.

The Authority, where appropriate shall organise a consul-
from the rapporteur

including experts

2.
tation of experts,
Member State.

Within 120 days of the end of the period provided for the
submission of written comments, the Authority shall adopt a
conclusion in the light of current scientific and technical
knowledge using guidance documents available at the time of
application on whether the active substance can be expected to
meet the approval criteria provided for in Article 4 and shall
communicate it to the applicant, the Member States and the
Commission and shall make it available to the public.

Where appropriate, the Authority shall address in its conclusion
the risk mitigation options identified in the draft assessment
report.

5.
The Authority shall establish the format for its conclusion
which shall include details on the procedure of the evaluation
and the properties of the active substance concerned.

6.
The time limits for the Authority's opinion on applications
concerning maximum residue levels set out in Article 11 and
for decisions on applications concerning maximum residue
levels set out in Article 14 of Regulation (EC) No 396/2005
shall be without prejudice to the time limits laid down in this
Regulation

Article 13

Approval Regulation

1. Within six months of receiving the conclusion from the
Authority, the Commission shall present a report, hereinafter
referred to as ‘the review report’, and a draft Regulation to the
Committee referred to in Article 79(1), taking into account the
draft assessment report by the rapporteur Member State and the
conclusion of the Authority.

The applicant shall be given the possibility to submit comments
on the review report.

On the basis of the review report, other factors legitimate
2.
to the matter under consideration and the precautionary prin-
ciple where the conditions laid down in Article 7(1) of Regu-
lation (EC) No 178/2002 are relevant, a Regulation shall be
adopted in accordance with the regulatory procedure referred to
in Article 79(3), providing that:

(a) an active substance is approved, subject to conditions and
restrictions, as referred to in Article 6, where appropriate;

3. Where the Authority needs additional information, it shall
set a time period of a maximum of 90 days for the applicant to
supply it
the Commission and the
Authority.

to the Member States,

(b) an active substance is not approved; or

(c) the conditions of the approval are amended.

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In case the approval provides for

3.
the submission of
further confirmatory information as referred to in point (f) of
Article 6, the Regulation shall provide the time limit to submit
the information to the Member States, the Commission and the
Authority.

The applicant shall
identify, giving reasons, the parts of the
information submitted that he requests to be kept confidential
in accordance with Article 63 and at the same time any data
protection claims pursuant to Article 59.

The rapporteur Member State shall assess the additional infor-
mation and submit its assessment to the other Member States,
the Commission and the Authority without delay and at the
latest six months after the receipt of the additional information.

Article 16

Access to the information for renewal

Approved active substances shall be included in the Regu-
4.
lation referred to in Article 78(3) containing the list of active
substances already approved. The Commission shall maintain a
list of approved active substances electronically available to the
public.

The Authority shall, without delay, make available to the public
the information provided by the applicant under Article 15,
excluding any information for which confidential treatment has
been requested and justified pursuant to Article 63, unless there
is an overriding public interest in its disclosure.

Subsection 3

Renewal and review

Article 14

Renewal of approval

1.
On application the approval of an active substance shall
be renewed where it is established that the approval criteria
provided for in Article 4 are satisfied.

Article 4 shall be deemed to be satisfied where this has been
established with respect to one or more representative uses of at
least one plant protection product containing that active
substance.

Such renewal of
restrictions, as referred to in Article 6.

the approval may include conditions and

2.
The renewal of the approval shall be for a period not
exceeding fifteen years. The renewal of approval of active
substances covered by Article 4(7) shall be for a period not
exceeding five years.

Article 15

Application for renewal

The application provided for

1.
in Article 14 shall be
submitted by a producer of the active substance to a Member
State, with a copy to the other Member States, the Commission
and the Authority, no later than three years before the expiry of
the first approval.

2. When applying for renewal, the applicant shall
identify
new data he intends to submit and demonstrate that they are
necessary, because of data requirements or criteria which were
not applicable on first approval of
the active substance or
because his request is for an amended approval. He shall at the
same time submit a timetable of any new and ongoing studies.

Article 17

Extension of approval period for the duration of

the

procedure

Where for reasons beyond the control of the applicant it appears
that the approval is likely to expire before a decision has been
taken on renewal, a decision shall be adopted in accordance
with the regulatory procedure referred to in Article 79(3), post-
poning the expiry of the approval period for that applicant for a
period sufficient to examine the application.

A Regulation postponing the expiry for a period sufficient to
examine the application shall be adopted in accordance with the
regulatory procedure with scrutiny referred to in Article 79(5)
where an applicant could not give the three years' notice
required under Article 15(1) because the active substance was
included in Annex I to Directive 91/414/EEC for a duration
which expired before … (*).

The length of that period shall be established on the basis of the
following:

(a) the time needed to provide the information requested;

(b) the time needed to complete the procedure;

(c) where appropriate, the need to ensure the establishment of
a coherent work programme, as provided for in Article 18.

Article 18

Work programme

The Commission may establish a work programme grouping
together similar active substances setting priorities on the basis
of safety concerns for human and animal health or the environ-
ment and taking into account, as far as possible, the need for an
effective control and resistance management of target pest. The
programme may require interested parties to submit all the
necessary data to the Member States, the Commission and the
Authority within a period provided for in the programme.

(*) 54 months from the date of entry into force of this Regulation.

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The programme shall include the following:

Article 21

(a) the procedures concerning the submission and assessment

of applications for renewal of approvals;

Review of approval

(b) the necessary data to be submitted;

(c) the time periods for submission of such data;

(d) rules on the submission of new information;

(e) time period for assessment and decision making;

(f) the allocation of evaluation of active substances to Member
States, taking into account a balance in the responsibilities
and work to be done among Member States acting as
rapporteurs.

Article 19

Implementing measures

1.
The Commission may review the approval of an active
substance at any time. It may take into account the request of a
Member State to review the approval of an active substance.

Where, in the light of new scientific and technical knowledge it
considers that there are indications that the substance no longer
satisfies the approval criteria provided for in Article 4, or
further information required in accordance with point (f) of
Article 6 has not been provided, it shall
inform the Member
States, the Authority and the producer of the active substance,
setting a time period for the producer to submit its comments.

2.
The Commission may ask the Member States and the
Authority for an opinion, or for scientific or technical assistance.
to the
The Member States may provide their comments
Commission within three months
from the request. The
Authority shall provide its opinion or the results of its work to
the Commission within three months of the request.

A Regulation, adopted in accordance with the regulatory proce-
dure referred to in Article 79(3), shall set out the provisions
necessary for the implementation of
the renewal procedure,
the implementation of a work
including, where relevant,
programme, as provided for in Article 18.

3. Where the Commission concludes
the approval
criteria provided for in Article 4 are no longer satisfied, or the
further information required in accordance with point (f) of
Article 6 has not been provided, a Regulation to withdraw or
amend the approval shall be adopted in accordance with the
regulatory procedure referred to in Article 79(3).

that

Article 13(4) and Article 20(2) shall apply.

Article 20

Renewal Regulation

1.
A Regulation shall be adopted in accordance with the
regulatory procedure referred to in Article 79(3), providing that:

(a) the approval of an active substance is renewed, subject to

conditions and restrictions where appropriate; or

(b) the approval of an active substance is not renewed.

2. Where the reasons for not renewing the approval permit
it, the Regulation referred to in paragraph 1 shall provide for a
grace period not exceeding one year for the placing on the
market and in addition a maximum of one year for the disposal,
storage, and use of existing stocks of
the plant protection
products concerned.

In the case of a withdrawal of the approval or if the approval is
not renewed because of the immediate concerns for human
health or animal health or the environment, the plant protection
products concerned shall be withdrawn from the market imme-
diately.

3.

Article 13(4) shall apply.

Subsection 4

Derogations

Article 22

Low-risk active substances

1.
An active substance complying with the criteria provided
for in Article 4 shall be approved for a period not exceeding
15 years by way of derogation from Article 5, where it is
considered a low-risk active substance and where it may be
expected that plant protection products
containing that
substance will pose only a low risk to human and animal health
and the environment as provided for in Article 47(1).

2.
Articles 4 and 6 to 21 and Section 5 of Annex II shall
apply. Low-risk active substances shall be listed separately in the
Regulation referred to in Article 13(4).

3.
The Commission may review and if necessary specify new
criteria for approving an active substance as low-risk active
substance in accordance with Article 78(1)(a).

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Article 23

Approval criteria for basic substances

The Commission shall ask the Authority for an opinion, or for
scientific or technical assistance. The Authority shall provide its
opinion or the results of its work to the Commission within
three months of the request.

1.
Basic substances shall be approved in accordance with
paragraphs 2 to 6. By way of derogation from Article 5, the
approval shall be for an unlimited period of time.

Where the Commission concludes that the criteria referred to in
paragraph 1 are no longer satisfied, a Regulation to withdraw or
amend the approval shall be adopted in accordance with the
regulatory procedure referred to in Article 79(3).

For the purpose of paragraphs 2 to 6 of this Article, a basic
substance is an active substance which:

(a) is not a substance of concern; and

(b) is not predominantly used for plant protection purposes but
nevertheless is useful in plant protection either directly or in
a product consisting of the substance and a simple diluent;
and

(c) is not placed on the market as a plant protection product.

2.
By way of derogation from Article 4, a basic substance
shall be approved where any relevant evaluations, carried out in
accordance with other Community legislation regulating the use
of that substance for purposes other than for a plant protection
product, show that the substance has neither an immediate or
delayed harmful effect on human or animal health nor an unac-
ceptable effect on the environment.

3.
By way of derogation from Article 7 an application for the
approval of a basic substance shall be submitted by a Member
State or by any interested party to the Commission.

Article 24

Candidates for substitution

An active substance complying with the criteria provided
1.
for in Article 4 shall be approved as a candidate for substitution
if it meets one or more of the additional criteria laid down in
point 4 of Annex II. By way of derogation from Article 14(2),
the approval may be renewed once or more for a period not
exceeding ten years.

2. Without prejudice to paragraph 1, Articles 4 to 21 shall
apply. Candidates for substitution shall be listed separately in
the Regulation referred to in Article 13(4).

SECTION 2

Safeners and synergists

Article 25

The application shall be accompanied by the following informa-
tion:

Approval of safeners and synergists

(a) any evaluations of its possible effects on human or animal
health or the environment carried out in accordance with
other Community legislation regulating the use of
the
substance; and

(b) other relevant information on its possible effects on human

or animal health or the environment.

4.
The Commission shall ask the Authority for an opinion,
or for scientific or technical assistance. The Authority shall
provide its opinion or the results of its work to the Commission
within three months of the request.

A safener or synergist shall be approved, where it complies

1.
with Article 4.

2.

Articles 5 to 21 shall apply.

requirements

Similar data

referred to in
3.
Article 8(4) shall be defined for safeners and synergists in
accordance with the regulatory procedure with scrutiny referred
to in Article 79(4).

to those

Article 26

Articles 6 and 13 shall apply. Basic substances shall be

5.
listed separately in the Regulation referred to in Article 13(4).

Safeners and synergists already on the market

6.
The Commission may review the approval of a basic
substance at any time. It may take into account the request of a
Member State to review the approval.

Where the Commission considers that there are indications that
the substance no longer satisfies the criteria provided for in
paragraphs 1 to 3 it shall
the
Authority and the interested party, setting a time period for
their comments to be submitted.

inform the Member States,

By … (*), a Regulation shall be adopted in accordance with the
regulatory procedure with scrutiny referred to in Article 79(4)
establishing a work programme for the gradual review of syner-
gists and safeners on the market when that Regulation enters
into force. The Regulation shall include notification, evaluation,
assessment and decision-making procedures.
It shall require
interested parties to submit all
the necessary data to the
Member States, the Commission and the Authority within a
specified time period.

(*) 60 months from the date of entry into force of this Regulation.

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SECTION 3

Unacceptable co-formulants

Article 27

Co-formulants

A co-formulant shall not be accepted for inclusion in a

1.
plant protection product where it has been established that:

(a) its residues, consequent on application consistent with good
plant protection practice, and having regard to realistic
conditions of use, have a harmful effect on human or
animal health or on groundwater or an unacceptable effect
on the environment; or

(b) its use, consequent on application consistent with good
plant protection practice and having regard to realistic

conditions of use, has a harmful effect on human or animal
health or an unacceptable effect on plants, plant products or
the environment.

2.
Co-formulants which shall not be accepted for inclusion
in a plant protection product pursuant to paragraph 1 shall be
included in Annex III in accordance with the regulatory proce-
dure with scrutiny referred to in Article 79(4).

The Commission may review co-formulants at any time. It
information provided by

relevant

3.
may take into account
Member States.

4.

Article 81(2) shall apply.

5.
Detailed rules for the implementation of this Article may
be established in accordance with the regulatory procedure
referred to in Article 79(3).

CHAPTER III

PLANT PROTECTION PRODUCTS

Article 29

SECTION 1

Authorisation

Subsection 1

Requirements and contents

Article 28

Authorisation for placing on the market and use

1.
A plant protection product shall not be placed on the
market or used unless it has been authorised in the Member
State concerned in accordance with this Regulation.

By way of derogation from paragraph 1, no authorisation

2.
shall be required in the following cases:

(a) use of products containing exclusively one or more basic

substances;

(b) placing on the market and use of plant protection products
for research or development purposes in accordance with
Article 54;

(c) production, storage or movement of a plant protection
product intended for use in another Member State, provided
that the product is authorised in that Member State and that
the Member State of production, storage or movement has
put
in place inspection requirements to ensure that the
plant protection product is not used in its territory;

(d) production, storage or movement of a plant protection
product intended for use in a third country provided that
the Member State of production, storage or movement has
put
in place inspection requirements to ensure that the
plant protection product is exported from its territory;

(e) placing on the market and use of plant protection products
for which a parallel trade permit has been granted in accord-
ance with Article 52.

Requirements for the authorisation for placing on the
market

1. Without prejudice to Article 50 a plant protection product
shall only be authorised where following the uniform principles
referred to in paragraph 6 it complies with the following
requirements:

(a) its active substances, safeners and synergists have been

approved;

(b) where its active substance, safener or synergist is produced
by a different source, or by the same source with a change
in the manufacturing process and/or manufacturing loca-
tion:

(i) the specification, pursuant

to Article 38, does not
deviate significantly from the specification included in
the Regulation approving that substance, safener or
synergist; and

(ii) the active substance, safener or synergist has no more
harmful effects within the meaning of Article 4(2) and
(3) due to its impurities than if it had been produced in
accordance with the manufacturing process specified in
the dossier that supported the approval;

(c) its co-formulants are not included in Annex III;

(d) in the light of current scientific and technical knowledge, it
complies with the requirements provided for in Article 4(3);

and, where

(e) the nature and quantity of its active substances, safeners and
any toxicologically,
synergists
ecotoxicologically or environmentally relevant
impurities
and co-formulants can be determined by appropriate
methods;

appropriate,

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(f) its residues, resulting from authorised uses, and which are of
toxicological, ecotoxicological or environmental relevance,
can be determined by appropriate methods in general use;

(g) its physical and chemical properties have been determined
and deemed acceptable for the purposes of the appropriate
use and storage of the product;

(h) for plant or plant products to be used as feed or food,
where appropriate, the maximum residue levels for the agri-
cultural products affected by the use referred to in the
authorisation have been set or modified in accordance with
Regulation (EC) No 396/2005.

The applicant shall demonstrate that

2.
provided for in points (a) to (g) of paragraph 1 are met.

the requirements

3.
Compliance with the requirements set out in point (b) and
points (d) to (g) of paragraph 1 shall be established by official or
officially recognised tests and analyses carried out under agri-
cultural, plant health and environmental conditions relevant to
the use of the plant protection product in question and repre-
sentative of the conditions prevailing in the zone where the
product is intended to be used.

4. With respect to point (e) of paragraph 1, harmonised
methods may be adopted in accordance with the regulatory
procedure referred to in Article 79(3).

5.

Article 81 shall apply.

6.
Uniform principles for evaluation and authorisation of
plant protection products shall contain the requirements set out
in Annex VI to Directive 91/414/EEC and shall be laid down in
Regulations adopted in accordance with the advisory procedure
referred to in Article 79(2) without any substantial modifica-
tions. Subsequent amendments to these Regulations shall be
adopted in accordance with Article 78(1)(c).

Article 30

Provisional authorisations

1.
By way of derogation from Article 29(1)(a), Member States
may authorise for a provisional period not exceeding three
years, the placing on the market of plant protection products
containing an active substance not yet approved, provided that:

(a) the decision on approval could not be finalised within a
time period of 30 months from the date of admissibility of
the application, extended with any additional time period
in accordance with Article 9(2), Article 11(3) or
set
Article 12(3); and

plant protection product may be expected to satisfy the
requirements of points (b) to (g) of Article 29(1); and

(d) maximum residue levels have been established in accordance

with Regulation (EC) No 396/2005.

2.
In such cases the Member State shall immediately inform
the other Member States and the Commission of its assessment
of the dossier and of the terms of the authorisation, giving at
least the information provided for in Article 57(1).

3.
The provisions set in paragraphs 1 and 2 shall apply
until … (*). If necessary, that time limit may be extended in
accordance with the regulatory procedure with scrutiny referred
to in Article 79(4).

Article 31

Contents of authorisations

1.
The authorisation shall define plants or plant products
and non-agricultural areas (e.g. railways, public areas, storage
rooms) on which and the purposes for which the plant protec-
tion product may be used.

The authorisation shall set out the requirements relating to
2.
the placing on the market and use of
the plant protection
product. Those requirements shall as a minimum include the
conditions of use necessary to comply with the conditions and
requirements provided for in the Regulation approving the
active substances, safeners and synergists.

include a classification of

The authorisation shall
the plant
protection product for the purpose of Directive 1999/45/EC.
Member States may provide that authorisation holders shall clas-
sify or update the label without undue delay following any
change to the classification and labelling of the plant protection
product in accordance with Directive 1999/45/EC. In such case,
they shall immediately inform the competent authority thereof.

The requirements referred to in paragraph 2 may include

3.
among others the following:

(a) a restriction with respect to the distribution and use of the
plant protection product taking into consideration require-
ments imposed by other community provisions in order to
protect the health of the distributors, users, bystanders and
workers concerned and the environment; such restriction
shall be indicated on the label;

(b) the obligation before the product is used to inform any
neighbours who could be exposed to the spray drift and
who have requested to be informed;

(c) designation of categories of users, such as professional and

non-professional;

(b) pursuant to Article 9 the dossier on the active substance is

(d) the approved label;

admissible in relation to the proposed uses; and

(c) the Member State concludes that the active substance can
satisfy the requirements of Article 4(2) and (3) and that the

(*) 78 months from the date of entry into force of this Regulation.

(e) the maximum dose per hectare in each application;

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(f) the maximum number of applications per year and interval

between applications;

(g) the period between the last application and consumption of

the plant product where applicable;

(h) the pre-harvest interval, where applicable;

(i) the re-entry interval;

(j) the packaging size and material.

Article 32

Duration

The period of authorisation shall be laid down in the

1.
authorisation.

Without prejudice to Article 44 the duration of an authorisation
shall be set for a period not exceeding one year from the date of
expiry of the approval of the active substances, safeners and
synergists contained in the plant protection product and there-
after for as long as the active substances, safeners and synergists
contained in the plant protection product are approved.

This period shall allow the examination as provided for in
Article 43 to be carried out.

Authorisations may be granted for shorter periods to
2.
synchronise the re-evaluation of
the
purposes of a comparative assessment of products containing
candidates for substitution as provided for in Article 50.

similar products

for

Subsection 2

Procedure

Article 33

Application for

authorisation or
authorisation

amendment of

an

1.
An applicant who wishes to place a plant protection
product on the market shall apply for an authorisation or
amendment of an authorisation himself, or through a represen-
tative, to each Member State where the plant protection product
is intended to be placed on the market.

2.

The application shall include the following:

(a) a list of intended uses in each zone as indicated in Annex I
and the Member States where the applicant has made or
intends to make an application;

(b) a proposal as to which Member State the applicant expects
to evaluate the application in the zone concerned. In case of
an application for use in greenhouses, as post-harvest treat-
ment, for treatment of empty storage rooms and for seed
treatment only one Member State shall be proposed, which

evaluates the application considering all zones. In this case
the applicant shall send the summary or complete dossier as
referred to in Article 8 to other Member States on request;

(c) where relevant, a copy of any authorisations already granted

for that plant protection product in a Member State;

(d) where relevant, a copy of any conclusion of the Member
State assessing equivalence as referred to in Article 38(2).

3.

The application shall be accompanied by the following:

(a) for the plant protection product concerned, a complete and
a summary dossier for each point of the data requirements
of the plant protection product;

(b) for each active substance, safener and synergist contained in
the plant protection product, a complete and a summary
dossier for each point of the data requirements of the active
substance, safener and synergist;

(c) for each test or study involving vertebrate animals, a justifi-

cation of the steps taken to avoid unnecessary testing;

(d) the reasons why the test and study reports submitted are
necessary for first authorisation or for amendments to the
conditions of the authorisation;

(e) where relevant a copy of the application for a maximum
residue level as referred to in Article 7 of Regulation (EC)
No 396/2005 or a justification for not supplying such infor-
mation;

(f) where relevant for an amendment of an authorisation an
assessment of all information submitted in accordance with
point (g) of Article 8(1);

(g) a draft label.

4. When submitting his application,
the applicant may
pursuant to Article 63, request certain information, including
certain parts of the dossier, to be kept confidential and shall
physically separate the information.

He shall at the same time submit the complete list of studies
submitted pursuant to Article 8(2) and a list of test and study
reports for which any claims for data protection pursuant to
Article 59 are requested.

Upon a request for access to information the Member State
examining the application shall decide what information is to be
kept confidential.

5. Where requested by the Member State the applicant shall
submit his application in the national or official languages of
that Member State or one of those languages.

6.
On request, the applicant shall provide the Member State
with samples of the plant protection product and analytical
standards of its ingredients.

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Article 34

Exemption from the submission of studies

1.
Applicants shall be exempted from supplying the test and
study reports referred to in Article 33(3) where the Member
State to which an application is made has the test and study
reports concerned and the applicants demonstrate that they
have been granted access in accordance with Article 59, 61
or 62 or that any data protection period has expired.

However, applicants to whom paragraph 1 applies shall

2.
provide the following information:

(a) all necessary data for the identification of the plant protec-
tion product including its complete composition as well as a
declaration that no unacceptable co-formulants are used;

(b) the information needed to identify the active substance,
safener or synergist, where they have been approved, and to
establish whether the conditions for approval are met and
comply with point (b) of Article 29(1), where appropriate;

(c) on the request of the concerned Member State, the data
needed to demonstrate that the plant protection product has
comparable effects to the plant protection product
for
which they show access to the protected data.

Article 35

Member State examining the application

The application shall be examined by the Member State
proposed by the applicant, unless another Member State in the
same zone agrees to examine it. The Member State which will
examine the application shall inform the applicant.

At the request of the Member State examining the application,
the other Member States in the same zone to which an applica-
tion has been submitted shall cooperate to ensure a fair division
of the workload.

The other Member States within the zone to which an applica-
tion has been submitted shall refrain from proceeding with the
file pending assessment by the Member State examining the
application.

In case an application has been made in more than one zone,
Member States evaluating the application shall agree on the
evaluation of data which are not related to the environmental
and agricultural conditions.

Article 36

Examination for authorisation

1.
The Member State examining the application shall make
an independent, objective and transparent assessment in the
scientific and technical knowledge using
light of current
guidance documents available at the time of application. It shall
give all Member States in the same zone the opportunity to
submit comments to be considered in the assessment.

It shall apply the uniform principles for evaluation and authori-
sation of plant protection products, referred to in Article 29(6),
to establish, as far as possible, whether the plant protection
product meets the requirements provided for in Article 29 in
the same zone, where used in accordance with Article 55, and
under realistic conditions of use.

The Member State examining the application shall make avail-
able its assessment to the other Member States within the same
zone. The format of the assessment report shall be established
in accordance with the advisory procedure referred to in
Article 79(2).

The Member States concerned shall grant or refuse author-
2.
isations accordingly on the basis of
the
assessment of the Member State examining the application as
provided for in Articles 31 and 32.

the conclusions of

3.
By way of derogation from paragraph 2 and subject to
Community law, appropriate conditions may be imposed with
respect to the requirements referred to in points (a) and (b) of
Article 31(3) and other risk mitigation measures deriving from
specific conditions of use.

Where the concerns of a Member State related to human or
animal health or the environment cannot be controlled by the
establishment of national risk mitigation measures referred to in
the first subparagraph, a Member State may as a last resort
refuse authorisation of the plant protection product in its terri-
tory if, due to its very specific environmental or agricultural
circumstances, it has substantiated reasons to consider that the
product in question poses a serious risk to human or animal
health or the environment.

It shall immediately inform the applicant and the Commission
of its decision and provide a technical or scientific justification
therefore.

Member States shall provide for a possibility to challenge deci-
sion refusing the authorisation of such product before the
national courts or other instances of appeal.

Article 37

Time period for examination

The Member State examining the application shall decide
1.
within twelve months of receiving it whether the requirements
for authorisation are met.

Where the Member State needs additional information, it shall
set a time period for the applicant to supply it. In that case, the
twelve-month period shall be extended by the additional time
period granted by the Member State. The additional time period
shall be at maximum six months and shall cease at the moment
information is received by the Member
when the additional
State. Where at the end of that period the applicant has not
submitted the missing elements, the Member State shall inform
the applicant that the application is inadmissible.

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The time-limits provided for in paragraph 1 shall be

2.
suspended while applying the procedure set out in Article 38.

3.
For an application for authorisation of a plant protection
product containing an active substance not yet approved, the
Member State examining the application shall start the evalua-
tion as soon as it has received the draft assessment report
referred to in Article 12(1). In case the application concerns the
same plant protection product and the same uses as contained
in the dossier referred to in Article 8, the Member State shall
decide on the application at the latest within six months of the
active substance being approved.

4.
The other Member States concerned shall at the latest
within 90 days of the receipt of the assessment report and
the copy of the authorisation of the Member State examining
the application decide on the application as referred to in
Article 36(2) and (3).

4. Where the Member States concerned do not reach agree-
ment within 45 days the Member State assessing equivalence
shall submit the matter to the Commission. A decision on
whether the conditions referred to in point (b) of Article 29(1)
are complied with shall be adopted in accordance with the regu-
latory procedure referred to in Article 79(3). The 45-day period
begins on the date on which the Member State examining the
application for authorisation informed the rapporteur Member
State or vice versa that it does not agree with the conclusion of
the latter, in accordance with paragraph 3.

Before such a decision is adopted, the Commission may ask the
Authority for an opinion, or for scientific or technical assistance
which shall be provided within three months of the request.

Detailed rules and procedures for the implementation of
5.
paragraphs 1 to 4 may be established in accordance with the
regulatory procedure referred to in Article 79(3), after consulta-
tion of the Authority.

Article 38

Article 39

Assessment of equivalence under point (b) of Article 29(1)

Reporting and exchange of information on applications for
authorisation

1. Where it is necessary to establish for an active substance,
safener or synergist whether a different source or, for the same
source a change of the manufacturing process and/or manufac-
turing location complies with point (b) of Article 29(1), this
shall be assessed by the Member State which acted as rapporteur
for the active substance, safener or synergist as referred to in
Article 7(1) unless the Member State examining the application
as referred to in Article 35 agrees to assess the equivalence. The
applicant shall submit all necessary data to the Member State
assessing equivalence.

2.
After giving the applicant the opportunity to submit his
comments, which the applicant shall also communicate to the
rapporteur Member State or the Member State examining the
application as the case may be, the Member State assessing
equivalence shall prepare a report on equivalence within 60 days
from receiving the application and shall communicate the
report to the Commission, the other Member States and the
applicant.

In case of a positive conclusion on equivalence and where
3.
no objection to this conclusion has been raised, point (b) of
Article 29(1) shall be considered to be complied with. However,
where a Member State examining the application does not agree
with the conclusion of the rapporteur Member State or vice
versa, it shall inform the applicant, the other Member States and
the Commission stating its reasons.

1. Member States shall compile a file on each application.
Each file shall contain the following:

(a) a copy of the application;

(b) a report containing information on the evaluation of and
decision on the plant protection product; the format of the
report shall be established in accordance with the advisory
procedure referred to in Article 79(2);

(c) a record of

the administrative decisions taken by the
Member State concerning the application and of the docu-
mentation provided for in Article 33(3) and Article 34
together with a summary of the latter;

(d) the approved label, where applicable.

2.
On request, Member States shall, without delay, make
available to the other Member States, the Commission and the
Authority a file containing the documentation provided for in
points (a) to (d) of paragraph 1.

3.
On request, applicants shall provide a copy of the docu-
mentation to be submitted with an application pursuant to
Article 33(3) and Article 34 to Member States, the Commission
and the Authority.

The concerned Member States shall try to reach agreement on
whether point (b) of Article 29(1) is complied with. They shall
provide the applicant with an opportunity to submit his
comments.

4.
Detailed rules for the implementation of paragraphs 2
and 3 may be established in accordance with the regulatory
procedure referred to in Article 79(3).

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Subsection 3

(a) an authorisation under point

(b) of Article 40(1) was

applied for;

Mutual recognition of author isations

(b) it contains a candidate of substitution;

Article 40

Mutual recognition

(c) Article 30 has been applied; or

(d) it contains a substance approved in accordance with

Article 4(7).

1.
The holder of an authorisation granted in accordance with
Article 29 may apply for an authorisation for the same plant
protection product, the same use and under the comparable
agricultural practices in another Member State under the mutual
recognition procedure, provided for in this subsection,
in the
following cases:

(a) the authorisation was granted by a Member State (reference

Member State) which belongs to the same zone;

(b) the authorisation was granted by a Member State (reference
Member State) which belongs to a different zone provided
that the authorisation for which the application was made is
not used for the purpose of mutual recognition in another
Member State within the same zone;

(c) the authorisation was granted by a Member State for use in
greenhouses, or as post-harvest treatment, or for treatment
of empty rooms or containers used for storing plant or
plant products, or for seed treatment, regardless of the zone
to which the reference Member State belongs.

2. Where a plant protection product is not authorised in a
Member State because no application for an authorisation has
been submitted in that Member State, official or scientific bodies
involved in agricultural activities or professional agricultural
organizations may apply, with the consent of the authorisation
holder,
the same plant protection
product, the same use and under the same agricultural practices
in that Member State under the mutual recognition procedure
referred to in paragraph 1. In that case the applicant has to
demonstrate that the use of such a plant protection product is
of general interest for the Member State of introduction.

for an authorisation for

In case the authorisation holder refuses its consent, the compe-
tent authority of the Member State concerned may accept the
application, on grounds of public interest.

Article 41

Authorisation

The Member State

to which an application under
1.
Article 40 is submitted shall authorise the plant protection
product concerned under the same conditions as the Member
State examining the application except where Article 36(3)
applies.

Article 42

Procedure

1.

The application shall be accompanied by the following:

(a) a copy of

the authorisation granted by the reference
Member State as well as a translation of the authorisation
into an official language of the Member State receiving the
application;

(b) a formal statement that the plant protection product is iden-
tical to that authorised by the reference Member State;

(c) a complete or summary dossier as required in Article 33(3)

when requested by the Member State;

(d) an assessment

the reference Member State
containing information on the evaluation and decision on
the plant protection product.

report of

The Member State

2.
to which an application under
Article 40 is submitted shall decide on the application within
90 days.

3. When requested by the Member State the applicant shall
submit his application in the national or official languages of
that Member State or one of those languages.

Subsection 4

Renewal, withdrawal and amendment

Article 43

Renewal of authorisation

An authorisation shall be renewed upon application by
1.
the authorisation holder, provided that the requirements referred
to in Article 29 are still met.

2. Within three months from the renewal of the approval of
an active substance, safener or synergist contained in the plant
protection product, the applicant shall submit the following
information:

(a) a copy of the authorisation of the plant protection product;

By way of derogation from paragraph 1, the Member State

2.
may authorise the plant protection product where:

(b) any new information required as a result of amendments in

data requirements or criteria;

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(c) evidence that the new data submitted are the result of data
requirements or criteria which were not in force when the
authorisation of the plant protection product was granted
or necessary to amend the conditions of approval;

(d) any information required to demonstrate that

the plant
protection product meets the requirements set out in the
Regulation on the renewal of the approval of the active
substance, safener or synergist contained in it;

(e) a report on the monitoring information, where the authori-

sation was subject to monitoring.

3. Member States shall check compliance of all plant protec-
tion products containing the active substance, safener or syner-
gist concerned with any conditions and restrictions provided for
in the Regulation renewing the approval under Article 20.

The Member State referred to in Article 35 within each zone
shall coordinate the compliance check and assessment of the
information submitted for all Member States within that zone.

4.
Guidelines on the authorisation of compliance checks may
be established in accordance with the advisory procedure
referred to in Article 79(2).

5. Member States shall decide on the renewal of the authori-
sation of a plant protection product at the latest twelve months
after the renewal of the approval of the active substance, safener
or synergist contained in it.

6. Where, for reasons beyond the control of the holder of
the authorisation, no decision is taken on the renewal of the
authorisation before its expiry, the Member State in question
shall extend the authorisation for
the period necessary to
complete the examination and adopt a decision on the renewal.

Article 44

Withdrawal or amendment of an authorisation

1. Member States may review an authorisation at any time
where there are indications that a requirement referred to in
Article 29 is no longer satisfied.

review an authorisation where it
A Member State shall
concludes that the objectives of Article 4(1)(a)(iv) and (b)(i) and
Article 7(2) and (3) of Directive 2000/60/EC of the European
Parliament and of the Council of 23 October 2000 establishing
a framework for Community action in the field of water
policy (1) may not be achieved.

The Member State shall withdraw or amend the authorisa-

3.
tion, as appropriate, where:

(a) the requirements referred to in Article 29 are not or are no

longer satisfied;

(b) false or misleading information was supplied concerning the
facts on the basis of which the authorisation was granted;

(c) a condition included in the authorisation has not been met;

or

(d) the authorisation holder fails to comply with his obligations

resulting from this Regulation.

it shall

the authorisation,

4. Where a Member State withdraws or amends an authorisa-
immediately
tion in accordance with paragraph 3,
inform the holder of
the other Member
States, the Commission and the Authority. The other Member
States belonging to the same zone shall withdraw or amend the
authorisation accordingly taking into account national condi-
tions and risk mitigation measures except
for cases where
second to fourth subparagraphs of Article 36(3) have been
applied. Article 46 shall apply where appropriate.

Article 45

Withdrawal or amendment of an authorisation at

the

request of the authorisation holder

An authorisation may be withdrawn or amended at the
1.
request of the holder of the authorisation, who shall state the
reasons for his request.

Amendments may only be granted where it is established
2.
that the requirements referred to in Article 29 continue to be
met.

3.

Article 46 shall apply where appropriate.

Article 46

Grace period

Where a Member State withdraws or amends an authorisation
or does not renew it,
it may grant a grace period for the
disposal, storage, placing on the market and use of existing
stocks.

2. Where a Member State intends to withdraw or amend an
authorisation, it shall inform the authorisation holder and give
him the possibility to submit comments or further information.

(1) OJ L 327, 22.12.2000, p. 1.

Where the reasons for withdrawal, amendment or not renewing
the authorisation permit it the grace period shall be limited and
not exceed six months for the placing on the market and an
additional maximum of one year for the disposal, storage, and
use of existing stocks of
the plant protection products
concerned.

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Subsection 5

Special cases

Article 47

Unless otherwise specified, all provisions

4.
authorisations under this Regulation shall apply.

relating to

Article 48

Placing on the market of

low-risk plant protection

products

Placing on the market and use of plant protection products
containing a genetically modified organism

1. Where all
the active substances contained in a plant
protection product are low-risk active substances as referred to
in Article 22, that product shall be authorised as a low-risk
plant protection product provided no specific risk mitigation
measures are needed following a risk assessment. This plant
protection product shall also meet the following requirements:

(a) the low-risk active substances,

safeners and synergists

contained in it have been approved under Chapter II;

(b) it does not contain a substance of concern;

(c) it is sufficiently effective;

1.
A plant protection product which contains an organism
falling within the scope of Directive 2001/18/EC shall be exam-
ined in respect of the genetic modification in accordance with
that Directive, in addition to the assessment under this Chapter.

An authorisation under this Regulation shall not be granted for
such a plant protection product unless written consent, as
referred to in Article 19 of Directive 2001/18/EC, has been
granted for it.

Unless otherwise specified, all provisions

2.
authorisations under this Regulation shall apply.

relating to

(d) it does not cause unnecessary pain and suffering to verte-

brates to be controlled;

Article 49

(e) it complies with points (b), (c) and (e) to (h) of Article 29(1).

Placing on the market of treated seeds

These products are referred to hereinafter as ‘low-risk plant
protection products’.

2.
An applicant for authorisation of a low-risk plant protec-
tion product shall demonstrate that the requirements set out in
paragraph 1 are met and shall accompany the application with a
the data
complete and summary dossier for each point of
requirements of the active substance and the plant protection
product.

The Member State shall decide within 120 days on
to approve an application for authorisation of a

3.
whether
low-risk plant protection product.

1. Member States shall not prohibit placing on the market
and use of
treated with plant protection products
authorised for that use in at least one Member State.

seeds

2. Where there are substantial concerns that treated seeds as
referred to in paragraph 1 are likely to constitute a serious risk
to human or animal health or to the environment and that such
risk cannot be contained satisfactorily by means of measures
taken by the Member State(s) concerned, measures to restrict or
prohibit the use and/or sale of such treated seeds shall be taken
immediately in accordance with the regulatory procedure
referred to in Article 79(3). Before taking such measures the
Commission shall examine the evidence and may request an
opinion from the Authority. The Commission may set a time
limit within which such an opinion shall be provided.

Where the Member State needs additional information, it shall
set a time limit for the applicant to supply it. In that case, the
period specified shall be extended by the additional time limit
granted by the Member State.

3.

Articles 70 and 71 shall apply.

The additional
time period shall be of a maximum of six
months and shall cease at the moment when the additional
information is received by the Member State. Where at the end
of
that period the applicant has not submitted the missing
elements, the Member State shall inform the applicant that the
application is inadmissible.

to other Community

legislation
4. Without prejudice
concerning the labeling of seeds,
the label and documents
accompanying the treated seeds shall include the name of the
plant protection product with which the seeds were treated, the
in that product, standard
the active substance(s)
name(s) of
phrases for safety precautions as provided for
in Directive
1999/45/EC and risk mitigation measures set out in the authori-
sation for that product where appropriate.

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Article 50

amendment shall take effect five years after the decision of the
Member State or at the end of the approval period of the candi-
date for substitution where that period ends earlier.

Comparative assessment of plant protection products
containing candidates for substitution

A comparative assessment shall be performed by Member
1.
States when evaluating an application for authorisation for a
plant protection product
substance
approved as a candidate for substitution. Member States shall
not authorise or shall restrict the use of a plant protection
product containing a candidate for substitution where the
comparative assessment weighing up the risks and benefits, as
set out in Annex IV, demonstrates that:

containing an active

(a) for the uses specified in the application an authorised plant
protection product, or a non-chemical control or prevention
method, already exists which is significantly safer for human
or animal health or the environment; and

(b) the plant protection product or non-chemical control or
prevention method referred to in point (a) does not present
significant economic or practical disadvantages; and

(c) the chemical diversity of the active substances is adequate to
target

the occurrence of

resistance

in the

minimize
organism; and

(d) the consequences on minor use authorisations are taken

into account.

2.
By way of derogation from Article 36(2) Member States
may in exceptional cases also apply the provisions of paragraph
1 of this Article when evaluating an application for authorisa-
tion of a plant protection product not containing a candidate
for substitution or a low-risk active substance, if a non-chemical
control or prevention method exists for the same use and it is
in general use in that Member State.

Unless otherwise specified, all provisions

6.
authorisations under this Regulation shall apply.

relating to

Article 51

Extension of authorisations for minor uses

The authorisation holder, official or

1.
scientific bodies
involved in agricultural activities, professional agricultural orga-
nisations or professional users may ask for the authorisation of
a plant protection product already authorised in the Member
State concerned to be extended to minor uses not yet covered
by that authorisation.

2. Member States shall extend the authorisation provided
that:

(a) the intended use is minor in nature;

(b) the conditions referred to in points (b),

(d) and (e) of

Article 4(3) and point (h) of Article 29(1) are satisfied;

(c) the extension is in the public interest; and

(d) the documentation and information to support the exten-
sion of use has been submitted by the persons or bodies
referred to in paragraph 1, especially data on the magnitude
of residues and where necessary on the risk assessment to
the operator, worker and bystander.

containing a candidate for

By way of derogation from paragraph 1, a plant protection
3.
substitution shall be
product
authorised without comparative assessment in cases where it is
necessary to acquire experience first through using that product
in practice.

3.
The extension may take the form of an amendment to the
in
existing authorisation or may be a separate authorisation,
accordance with the administrative procedures of the Member
State concerned.

Such authorisations shall be granted for a period not exceeding
five years.

4. When Member States grant an extension of authorisation
for a minor use, they shall inform if necessary the authorisation
holder and request him to change the labelling accordingly.

For plant protection products containing a candidate for
4.
substitution Member States
shall perform the comparative
assessment provided for in paragraph 1 regularly and at the
latest at renewal or amendment of the authorisation.

Where the authorisation holder declines, the Member States
shall ensure that users are fully and specifically informed as to
instructions for use, by means of an official publication or an
official website.

Based on the results of that comparative assessment, Member
States shall maintain, withdraw or amend the authorisation.

5. Where a Member State decides to withdraw or amend an
that withdrawal or
authorisation pursuant

to paragraph 4,

The official publication or where applicable the label shall
include a reference to the liability of the person using the plant
protection product with respect to failures on the efficacy or to
phytotoxicity of
for which the minor use was
granted. The minor use extension shall be separately identified
in the label.

the product

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5.
The applicants referred to in paragraph 1 may also apply
for authorisation of a plant protection product for minor uses
in accordance with Article 40(1) provided that a plant protec-
tion product concerned is authorised in that Member State.
Member States shall authorise such uses in accordance with the
provisions of Article 41 provided that the uses are considered
also minor in the Member States of application.

The application for a parallel trade permit shall include the

4.
following information:

(a) the name and registration number of the plant protection

product in the Member State of origin;

6. Member States shall establish and regularly update a list of
minor uses.

Unless otherwise specified, all provisions

7.
authorisations under this Regulation shall apply.

relating to

Article 52

Parallel trade

that

A plant protection product

is authorised in one
1.
Member State (Member State of origin) may, subject to granting
a parallel trade permit, be introduced, placed on the market or
used in another Member State (Member State of introduction), if
this Member State determines that the plant protection product
is identical in composition to a plant protection product already
authorised in its territory (reference product). The application
shall be submitted to the competent authority of the Member
State of introduction.

From receiving a complete application a parallel

trade
2.
permit
shall be granted in a simplified procedure within
45 working days if the plant protection product to be intro-
duced is identical in terms of paragraph 3. Member States shall
on request provide each other with the information necessary to
assess whether the products are identical within 10 working
days of receiving the request. The procedure for granting a
parallel trade permit is interrupted from the day the request for
information is sent to the competent authority of the Member
State of origin until the complete information required is deliv-
ered to the competent authority of the Member State of intro-
duction.

Plant protection products shall be considered as identical

3.
to the reference products if:

(a) they have been manufactured by the same company or by
an associated undertaking or under licence in accordance
with the same manufacturing process;

(b) they are identical in specification and content of the active
substances, safeners and synergists, and in the type of
formulation; and

(c) they are either the same or equivalent in the co-formulants
present and the packaging size, material or form, in terms
of the potential adverse impact on the safety of the product
with regard to human or animal health or the environment.

(b) the Member State of origin;

(c) the name and address of the authorisation holder in the

Member State of origin;

(d) the original label and instructions for use with which the
plant protection product to be introduced is distributed in
the Member State of origin if it is considered as necessary
the
for the examination by the competent authority of
introduction. This competent authority
Member State of
may require a translation of
the
original instructions for use;

the relevant parts of

(e) the name and address of the applicant;

(f) the name to be given to the plant protection product to be

distributed in the Member State of introduction;

(g) a draft label for the product intended to be placed on the

market;

(h) a sample of the product which is intended to be introduced
if it is considered as necessary by the competent authority
of the Member State of introduction;

(i) the name and registration number of the reference product.

The information requirements may be amended or completed
and further details and specific requirements shall be established
in case of application for a plant protection product for which a
parallel trade permit has already been granted and in case of an
application for a plant protection product for a personal use in
accordance with the regulatory procedure with scrutiny referred
to in Article 79(4).

for which a parallel

A plant protection product

5.
trade
permit has been issued shall be placed on the market and used
only in accordance with the provisions of the authorisation of
the reference product. To facilitate monitoring and controls the
Commission shall set out specific control requirements for the
product
to be introduced in a Regulation referred to in
Article 68.

the reference product.

The parallel trade permit shall be valid for the duration of
6.
authorisation of
the authorisation
holder of the reference product applies for a withdrawal of
authorisation in accordance with Article 45(1) and the require-
ments of Article 29 are still fulfilled, the validity of the parallel
trade permit shall expire by the date on which the authorisation
of the reference product would normally have expired.

If

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7. Without prejudice to specific provisions in this Article,
Articles 44, 45, 46, and 55 and Article 56(4) and Chapters VI
to X shall apply to parallel traded plant protection products
correspondingly.

4.
Paragraphs 1 to 3 shall not apply to plant protection
products containing or composed of genetically modified
organisms unless such release has been accepted in accordance
with Directive 2001/18/EC.

8. Without prejudice to Article 44 a parallel trade permit
may be withdrawn if the authorisation of the introduced plant
protection product is withdrawn in the Member State of origin
because of safety or efficacy reasons.

9. Where the product is not identical in terms of paragraph
3 to the reference product, the Member State of introduction
may only grant the authorisation required for placing on the
market and use in accordance with Article 29.

10.
The provisions of this Article shall not apply to plant
protection products which are authorised in the Member State
of origin in accordance with Article 53 or 54.

Subsection 6

Derogations

Article 53

Emergency situations in plant protection

By way of derogation from Article 28, in special circum-
1.
stances a Member State may authorise,
for a period not
exceeding 120 days, the placing on the market of plant protec-
tion products, for limited and controlled use, where such a
measure appears necessary because of a danger which cannot be
contained by any other reasonable means.

immediately inform the
The Member State concerned shall
other Member States and the Commission of the measure taken,
providing detailed information about
the situation and any
measures taken to ensure consumer safety.

The Commission may ask the Authority for an opinion, or

2.
for scientific or technical assistance.

The Authority shall provide its opinion or the results of its
work to the Commission within one month of the request.

If necessary, a decision shall be taken, in accordance with
3.
the regulatory procedure referred to in Article 79(3), as to when
and under what conditions the Member State:

(a) may or may not extend the duration of the measure or

repeat it; or

(b) shall withdraw or amend its measure.

Article 54

Research and development

1.
By way of derogation from Article 28, experiments or
tests for research or development purposes involving the release
into the environment of an unauthorised plant protection
product or
involving unauthorised use of plant protection
product may be carried out if the Member State in whose terri-
tory the experiment or test is to be carried out has assessed the
available data and granted a permit for trial purposes. The
permit may limit the quantities to be used and the areas to be
treated and may impose further conditions to prevent any
harmful effects on human or animal health or any unacceptable
adverse effect on the environment, such as the need to prevent
entry into the food chain of feed and food containing residues
unless a relevant provision has already been established under
Regulation (EC) No 396/2005.

The Member State may authorise a programme of experiments
or tests in advance or require a permit for each experiment or
test.

An application shall be submitted to the Member State in
2.
is to be conducted,
whose territory the experiment or test
together with a dossier containing all
the available data to
permit an assessment of possible effects on human or animal
health or the possible impact on the environment.

3.
Permit for trial purposes shall not be granted for experi-
ments or tests involving the release into environment of a
genetically modified organism unless such release has been
accepted under Directive 2001/18/EC.

Paragraph 2 shall not apply if

the Member State has
4.
granted the person concerned the right to undertake certain
experiments and tests and has determined the conditions under
which the experiments and tests have to be undertaken.

5.
Detailed rules for the application of this Article, in particu-
lar the maximum quantities of plant protection products that
may be released during experiments or tests and the minimum
data to be submitted in accordance with paragraph 2, may be
adopted in accordance with the regulatory procedure referred to
in Article 79(3).

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SECTION 2

Use and information

Article 55

Use of plant protection products

Plant protection products shall be used properly.

Proper use shall
include the application of the principles of
good plant protection practice and compliance with the condi-
tions established in accordance with Article 31 and specified on
the labelling. It shall also comply with the provisions of Direc-
tive 2008/…/EC and,
in particular, with general principles of
integrated pest management, as referred to in Article 13 and in
Annex III to that Directive, which shall apply at the latest by
1 January 2014.

3. Without prejudice to the right of Member States to adopt
interim protective measures
the Member State which first
granted an authorisation within each zone shall evaluate the
information received and inform the other Member States,
belonging to the same zone, where it decides to withdraw or
amend the authorisation under Article 44.

It shall inform the other Member States and the Commission
where it considers that the conditions of the approval of the
active substance, safener or synergist contained in the plant
protection product are no longer fulfilled or whether in the case
it has been considered unacceptable and
of a co-formulant
propose that
the approval be withdrawn or the conditions
amended.

The holder of an authorisation for a plant protection
4.
product shall report annually to the competent authorities of
the Member States which authorised his plant protection
product if he has any information available relating to the lack
of expected efficacy, the development of resistance and to any
unexpected effect on plants, plant products or the environment.

Article 56

Article 57

Information on potentially harmful or unacceptable effects

Obligation to keep information available

1.
The holder of an authorisation for a plant protection
product shall immediately notify the Member States that granted
an authorisation of any new information concerning that plant
protection product,
its metabolites, a
the active substance,
safener, synergist or co-formulant contained in the plant protec-
tion product, which suggests that the plant protection product
no longer complies with the criteria set out in Articles 29 and 4
respectively.

In particular, potentially harmful effects of that plant protection
product, or of residues of an active substance, its metabolites, a
safener, synergist or co-formulant contained in it, on human or
animal health or on groundwater, or their potentially unaccep-
table effects on plants or plant products or the environment
shall be notified.

To this end the authorisation holder shall record and report all
suspected adverse reactions in humans related to the use of the
plant protection product.

The obligation to notify shall include relevant information on
decisions or assessments by international authorisation or by
public bodies which authorise plant protection products or
active substances in third countries.

The notification shall

2.
include an assessment of whether
and how the new information means that the plant protection
its metabolites, a safener,
product or
or synergist or co-formulant no longer comply with the require-
ments set out
in Article 29 and Article 4 or Article 27,
respectively.

the active substance,

1. Member States shall keep information electronically avail-
able to the public on plant protection products authorised or
withdrawn in accordance with this Regulation, containing at
least:

(a) the name or business name of the holder of the authorisa-

tion and the authorisation number;

(b) the trade name of the product;

(c) the type of preparation;

(d) the name and amount of each active substance, safener or

synergist which it contains;

(e) the classification, risk and safety phrases in accordance to
Directive 1999/45/EC and to the Regulation referred to in
Article 65;

(f) the use or uses for which it is authorised;

(g) the reasons for withdrawal of an authorisation if they are

related to safety concerns.

The information referred to in paragraph 1 shall be readily

2.
accessible and updated at least once every three months.

In accordance with the regulatory procedure referred to in
3.
Article 79(3), an authorisation information system may be set
up to facilitate the application of paragraphs 1 and 2 of this
Article.

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CHAPTER IV

ADJUVANTS

Article 58

Placing on the market and use of adjuvants

1.
An adjuvant shall not be placed on the market or used
unless it has been authorised in the Member State concerned in
accordance with the conditions established in the Regulation
referred to in paragraph 2.

2.
Detailed rules for the authorisation of adjuvants, including
data requirements, notification, evaluation, assessment and deci-
sion making procedure shall be set out in a Regulation to be
adopted in accordance with the regulatory procedure with scru-
tiny referred to in Article 79(4).

3.

Article 81(3) shall apply.

CHAPTER V

DATA PROTECTION AND DATA SHARING

Article 59

Data protection

The same data protection rules as for the first authorisation
shall also apply to test and study reports submitted by third
parties for the purpose of extension of authorisation for minor
uses as referred to in Article 51(1).

Test and study reports shall benefit from data protection

1.
under the conditions laid down in this Article.

A study shall also be protected if
it was necessary for the
renewal or review of an authorisation. The period for data
protection shall be 30 months. The first
to fourth sub-
paragraphs shall apply with due changes.

The protection shall apply to test and study reports concerning
the active substance, safener or synergist, adjuvants and the
plant protection product as referred to in Article 8(2) when they
are submitted to a Member State by an applicant for authorisa-
tion under this Regulation, hereinafter referred to as ‘the first
applicant’, provided that those test and study reports were:

2.

Paragraph 1 shall not apply:

(a) to test and study reports for which the applicant has

submitted a letter of access; or

(a) necessary for the authorisation or an amendment of an
authorisation in order to allow the use on another crop; and

(b) where any period of data protection granted for the test and
study reports concerned in relation to another plant protec-
tion product has expired.

(b) certified as compliant with the principles of good laboratory

practice or of good experimental practice.

Where a report is protected, it may not be used, by the Member
State which received it for the benefit of other applicants for
authorisation of plant protection products, safeners or synergists
and adjuvants, except as provided in paragraph 2 of this Article,
in Article 62 or in Article 80.

The period of data protection is ten years starting at the date of
first authorisation in that Member State, except as provided in
paragraph 2 of this Article or in Article 62. That period is
extended to 13 years for plant protection products covered by
Article 47.

Those periods shall be extended by three months for each exten-
sion of authorisation for minor uses as defined in Article 51(1),
except where the extension of authorisation is based on extrapo-
lation, if the applications for such authorisations are made by
the authorisation holder at the latest five years after the date of
the first authorisation in that Member State. The total period of
data protection may in no case exceed 13 years. For plant
protection products covered by Article 47 the total period of
data protection may in no case exceed 15 years.

Data protection under paragraph 1 shall only be granted
3.
where the first applicant has claimed data protection for test
and study reports concerning the active substance, safener or
synergist, adjuvant and the plant protection product at the time
of submitting the dossier and has provided to the Member State
concerned for each test or study report the information referred
to in point (e) of Article 8(1) and in point (d) of Article 33(3) as
well as confirmation that a period of data protection has never
been granted for the test or study report or that any period
granted has not expired.

Article 60

List of test and study reports

1.
For each active substance, safener and synergist and adju-
vant, rapporteur Member States shall prepare a list of the test
and study reports necessary for first approval, amendment of
approval conditions or renewal of the approval and make it
available to the Member States and the Commission.

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2.
For each plant protection product which they authorise,
Member States shall keep and make available to any interested
party upon request:

Article 62

(a) a list of the test and study reports concerning the active
substance, safener or synergist, adjuvant and the plant
protection product necessary for first authorisation, amend-
the
ment of
authorisation; and

the authorisation conditions or renewal of

(b) a list of test and study reports for which the applicant
claimed data protection under Article 59 and any reasons
submitted in accordance with that Article.

The lists provided for in paragraphs 1 and 2 shall include
3.
information on whether those test and study reports were certi-
fied as compliant with the principles of good laboratory practice
or of good experimental practice.

Sharing of tests and studies involving vertebrate animals

1. Member States shall not accept repeated test and studies
involving vertebrate animals or those initiated where conven-
tional methods described in Annex II to Directive 1999/45/EC
could reasonably have been used, in support of applications for
authorisations. Any person intending to perform tests and
studies involving vertebrate animals shall take the necessary
measures to verify that those tests and studies have not already
been performed or initiated.

Article 61

General rules on avoidance of duplicative testing

2.
The prospective applicant and the holder or holders of the
relevant authorisations shall make every effort to ensure that
they share tests and studies involving vertebrate animals. The
costs of sharing the test and study reports shall be determined
in a fair, transparent and non-discriminatory way. The prospec-
tive applicant is only required to share in the costs of informa-
tion he is required to submit to meet the authorisation require-
ments.

1.
In order to avoid duplicate testing, any persons intending
to seek an authorisation for a plant protection product shall,
before carrying out tests or studies, consult the information
referred to in Article 57 to find out if and to whom an authori-
sation has already been granted for a plant protection product
containing the same active substance, safener or synergist or for
an adjuvant. The competent authority shall on request from the
applicant provide him with the list of test and study reports
prepared in accordance with Article 60 for that product.

The prospective applicant shall submit all data regarding the
identity and impurities of the active substance he proposes to
use. The enquiry shall be supported by evidence that
the
prospective applicant intends to apply for an authorisation.

the prospective applicant

2.
The competent authority of the Member State, where satis-
intends to apply for an
fied that
authorisation, shall provide him with the name and address of
the holder or holders of previous relevant authorisations and
shall at the same time inform the holders of the authorisations
of the name and address of the applicant.

3.
The prospective applicant for the authorisation and the
holder or holders of relevant authorisations shall take all reason-
able steps to reach agreement on the sharing of any test and
study reports protected under Article 59 that are required by
the applicant for authorisation of a plant protection product.

3. Where the prospective applicant and the holder or holders
of
the relevant authorisations of plant protection products
containing the same active substance, safener or synergist, or of
adjuvant cannot reach agreement on the sharing of test and
study reports involving vertebrate animals,
the prospective
applicant shall inform the competent authority of the Member
State mentioned in Article 61(1).

The failure to reach agreement, as provided in paragraph 2, shall
not prevent the competent authority of that Member State from
using the test and study reports involving vertebrate animals for
the purpose of the application of the prospective applicant.

4.
The holder or holders of the relevant authorisation shall
have a claim on the prospective applicant for an equal share of
the costs incurred by him. The competent authority of
the
Member State may direct the parties involved to resolve the
matter by formal and binding arbitration administered under
national
law. Otherwise the parties may resolve the matter
through litigation in the courts of the Member States. Awards
from arbitration or litigation shall have regard to the principles
determined in paragraph 2 and shall be enforceable in the
courts of the Member States.

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CHAPTER VI

PUBLIC ACCESS TO INFORMATION

Article 63

Confidentiality

A person requesting that information submitted under this
1.
Regulation is to be treated as confidential shall provide verifiable
evidence to show that the disclosure of the information might
undermine his commercial
interests, or in the protection of
privacy and the integrity of the individual.

2.
Disclosure of the following information shall normally be
deemed to undermine the protection of the commercial interests
or of privacy and the integrity of the individuals concerned:

(a) the method of manufacture;

(c) results of production batches of

the active substance

including impurities;

(d) methods of analysis for impurities in the active substance as
manufactured except for methods for impurities that are
considered to be toxicologically, ecotoxicologically or envir-
onmentally relevant;

(e) links between a producer or importer and the applicant or

the authorisation holder;

(f) information on the complete composition of a plant protec-

tion product;

(g) names and addresses of persons involved in testing on verte-

brate animals.

(b) the specification of impurity of the active substance except
for the impurities that are considered to be toxicologically,
ecotoxicologically or environmentally relevant;

This Article is without prejudice to Directive 2003/4/EC
3.
of the European Parliament and of the Council of 28 January
2003 on public access to environmental information (1).

PACKAGING, LABELLING AND ADVERTISING OF PLANT PROTECTION PRODUCTS AND ADJUVANTS

CHAPTER VII

Article 64

Packaging and presentation

1.
Plant protection products and adjuvants that may be
mistaken for food, drink or feed shall be packaged in such a
way as to minimise the likelihood of such a mistake being
made.

2.
Plant protection products and adjuvants available to the
general public that may be mistaken for food, drink or feed
shall contain components
their
consumption.

to discourage or prevent

3.
Article 9 of Directive 1999/45/EC shall also apply to plant
protection products and adjuvants not covered by that Directive.

text of Article 16 and the text of the Annexes IV and V to Direc-
tive 91/414/EEC with any necessary modifications.

2. Member States may require samples or mock-ups of the
packaging and drafts of
labels and leaflets to be submitted
before the authorisation is granted.

3. Where a Member State considers that additional phrases
are necessary to protect human or animal health or the environ-
ment, it shall notify the other Member States and the Commis-
forward the additional phrase or
sion forthwith and shall
phrases and the reasons for these requirements.

Such phrases shall be considered for inclusion in the Regulation
referred to in paragraph 1.

Pending that inclusion, the Member State may require the use of
the additional phrase or phrases.

Article 65

Labelling

1.
The labelling of plant protection products shall include the
classification, labelling and packaging requirements of Directive
1999/45/EC and shall comply with the requirements set out in
a Regulation adopted in accordance with the regulatory proce-
dure with scrutiny referred to in Article 79(4).

That Regulation shall also contain standard phrases for special
risks and safety precautions which supplement
the phrases
provided for by Directive 1999/45/EC. It shall incorporate the

Article 66

Advertising

1.
Plant protection products which are not authorised shall
not be advertised. Every advertisement for a plant protection
product shall be accompanied by the sentences ‘Use plant
protection products safely. Always read the label and product
information before use’. These sentences shall be easily legible
and clearly distinguishable in relation to the whole advertise-
ment. The words ‘plant protection products’ may be replaced by
a more precise description of the product-type, such as fungi-
cide, insecticide or herbicide.

(1) OJ L 41, 14.2.2003, p. 26.

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2.
The advertisement shall not include information in text or
graphic form which could be misleading as regards possible
risks to human or animal health or to the environment, such as
the terms ‘low risk’, ‘non-toxic’ or ‘harmless’.

Only in the case of low-risk plant protection products the term
‘authorised as low-risk plant protection product in accordance
with Regulation (EC) No …/2008’ shall be allowed in the adver-
tisement. It can not be used as a claim on the label of the plant
protection product.

All statements used in advertising shall be technically justi-

3.
fiable.

Advertisements shall not contain any visual representation
4.
of potentially dangerous practices, such as mixing or application
without sufficient protective clothing, not any use near food or
use by or in the vicinity of children.

Advertising or promotional material shall draw attention
5.
to the appropriate warning phrases and symbols as laid down in
the labelling.

CHAPTER VIII

CONTROLS

Article 67

Record-keeping

Producers, suppliers, distributors, importers, exporters and
1.
professional users of plant protection products
shall keep
records of the plant protection products they produce, import,
export, store, use or place on the market for at least three years.

They shall make the relevant information contained in these
records available to the competent authority on request. Third
parties such as the drinking water industry may request access
to this information by addressing the competent authority.

2.
Authorisation holders shall provide the competent autho-
rities of the Member States with all data relating to the volume
of sales of plant protection products in accordance with Regu-
lation (EC) No …/2008 of the European Parliament and the
Council of … concerning statistics on plant protection
products (1).

3.
Implementing measures to ensure the uniform application
of paragraphs 1 and 2 may be adopted in accordance with the
regulatory procedure referred to in Article 79(3).

Article 68

Monitoring and controls

Member States shall carry out official controls in order to
enforce compliance with this Regulation. They shall finalise and
transmit to the Commission a report on the scope and the
results of these controls within six months of the end of the
year to which the reports relate.

Commission experts shall carry out general and specific audits
in the Member States for purposes of verifying the official
controls carried out by the Member States.

A Regulation, adopted in accordance with the regulatory proce-
dure with scrutiny referred to in Article 79(4), shall set out
provisions for the controls,
in particular on the production,
packaging, labelling, storage, transport, marketing, formulation,
parallel trade and use of plant protection products. It shall also
contain provisions concerning the collection of information and
reporting on suspected poisonings.

CHAPTER IX

EMERGENCIES

Article 69

the Authority. The Commission may set a time limit within
which such an opinion shall be provided.

Emergency measures

Article 70

Where it is clear that an approved substance, safener, synergist
or co-formulant or a plant protection product which has been
authorised in accordance with this Regulation is likely to consti-
tute a serious risk to human or animal health or the environ-
ment, and that such risk cannot be contained satisfactorily by
means of measures taken by the Member State(s) concerned,
measures to restrict or prohibit the use and/or sale of that
substance or product shall be taken immediately in accordance
with the regulatory procedure referred to in Article 79(3), either
at the own initiative of the Commission or at the request of a
Member State. Before taking such measures the Commission
shall examine the evidence and may request an opinion from

(1) OJ L …

Emergency measures in cases of extreme urgency

By way of derogation from Article 69, the Commission may in
cases of
emergency
extreme urgency provisionally adopt
measures after consulting the Member State or Member States
concerned and informing the other Member States.

As soon as possible, and at the latest after ten working days,
those measures
revoked or
extended in accordance with the regulatory procedure referred
to in Article 79(3).

shall be confirmed, amended,

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Article 71

Other emergency measures

1. Where a Member State officially informs the Commission
of the need to take emergency measures, and no action has
been taken in accordance with Article 69 or 70, the Member
State may adopt interim protective measures. In this event, it
immediately inform the other Member States and the
shall
Commission.

2. Within 30 working days,
the Commission shall put
the matter before the Committee referred to in Article 79(1)
in accordance with the regulatory procedure referred to in
Article 79(3) with a view to the extension, amendment or abro-
gation of the national interim protective measure.

The Member State may maintain its national

3.
interim
protective measures until Community measures have been
adopted.

CHAPTER X

ADMINISTRATIVE AND FINANCIAL PROVISIONS

Article 72

Penalties

The Member States shall lay down the rules on penalties applic-
able to infringements of
take the
measures necessary to ensure that they are implemented. The
penalties provided for must be effective, proportionate and
dissuasive.

this Regulation and shall

The Member States shall notify those rules and any subsequent
amendment to the Commission without delay.

Article 73

Civil and criminal liability

The granting of authorisation and any other measures in confor-
mity with this Regulation shall be without prejudice to general
civil and criminal liability in the Member States of the producer
and, where applicable, of the person responsible for placing the
plant protection product on the market or using it.

2.
Each Member State shall designate a coordinating national
authority to coordinate and ensure all the necessary contacts
with applicants, other Member States, the Commission and the
Authority.

3. Member States shall ensure that competent authorities
have a sufficient number of suitable qualified and experienced
staff so that the obligations as defined in this Regulation shall
be carried out efficiently and effectively.

Each Member State shall give the details concerning its
4.
national competent authority or authorities to the Commission,
the Authority and the coordinating national authorities of the
other Member States and inform them of any modifications
thereof.

5.
The Commission shall publish and keep updated on its
website a list of the authorities referred to in paragraphs 1
and 2.

Article 74

Fees and charges

Article 76

Expenditure by the Commission

1. Member States may recover the costs associated with any
work they carry out within the scope of this Regulation, by
means of fees or charges.

2. Member States shall ensure that
referred to in paragraph 1:

the fees or charges

(a) are established in a transparent manner; and

(b) correspond to the actual cost of the work involved except if

it is in public interest to lower the fees or charges.

The fees or charges may include a scale of fixed charges based
on average costs for the work referred to in paragraph 1.

Article 75

Competent authority

1.
The Commission may incur expenditure for activities
contributing to the aims of this Regulation including the organi-
sation of the following:

(a) development of a harmonised system, including an appro-
priate database, for gathering and storing all
information
concerning active substances, safeners, synergists, co-formu-
lants, plant protection products and adjuvants and for
making such information available to the Member States,
producers and other interested parties;

(b) performance of studies needed to prepare and develop
further legislation on the placing on the market and use of
plant protection products and adjuvants;

(c) performance of studies needed to harmonise procedures,

decision-making criteria and data requirements;

1.
Each Member State shall designate a competent authority
or authorities to carry out the obligations of the Member States
as defined in this Regulation.

(d) coordination, if necessary by electronic means, of coopera-
the Commission and the

tion between Member States,
Authority and measures to facilitate work sharing;

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(e) development and maintenance of a coordinated electronic
submission and evaluation system aimed at promoting elec-
tronic document exchange and work sharing between the
the Commission and the
applicants, the Member States,
Authority;

(f) a Regulation establishing a work program for safeners and

synergists referred to in Article 26;

(g) inclusion of co-formulants in Annex III, as referred to in

Article 27(2);

(f) development of guidance to facilitate the day-to-day imple-

mentation of this Regulation;

(h) extension of the date of application of this Regulation to
provisional authorisations, as referred to in Article 30(3);

(g) travel and subsistence expenses that Member States' experts
incur as a result of the Commission appointing them to
assist its experts in the framework of control activities laid
down under Article 68;

(i) information requirements for parallel trade, as referred to in

Article 52(4);

(j) detailed rules for adjuvants, as referred to in Article 58(2);

(h) training of control staff;

(i) financing of other measures needed to ensure application of

the Regulation adopted under Article 68.

2.
The appropriations required under paragraph 1 shall be
subject to authorisation by the budgetary authority each finan-
cial year.

Article 77

Guidance documents

The Commission may, in accordance with the advisory proce-
dure referred to in Article 79(2), adopt or amend technical and
other guidance documents for the implementation of this Regu-
lation. The Commission may ask the Authority to prepare or to
contribute to such guidance documents.

Article 78

Amendments and implementing measures

1.
The following measures designed to amend non-essential
elements of this Regulation inter alia by supplementing it shall
be adopted in accordance with the regulatory procedure with
scrutiny referred to in Article 79(4):

(a) amendments to the Annexes, taking into account current

scientific and technical knowledge;

(b) amendments to the Regulations on data requirements for
active substances and for plant protection products, as
referred to in points (b) and (c) of Article 8(1), taking into
account current scientific and technical knowledge;

(c) amendments to the Regulation on uniform principles for
evaluation and authorisation of plant protection products,
as referred to in Article 29(6), taking into account current
scientific and technical knowledge;

(d) a Regulation postponing the expiry of the approval period

referred to in the second subparagraph of Article 17;

(e) a Regulation on data requirements for safeners and syner-

gists referred to in Article 25(3);

(k) a Regulation containing the requirements of the labelling of
plant protection products, as referred to in Article 65(1);

(l) a Regulation on controls, as referred to in the third sub-

paragraph of Article 68.

2.
Any further measures necessary for the implementation of
this Regulation may be adopted in accordance with the regula-
tory procedure referred to in Article 79(3).

3.
In accordance with the advisory procedure referred to in
Article 79(2), a Regulation shall be adopted containing the list of
active substances included in Annex I to Directive 91/414/EEC.
Those substances shall be deemed to have been approved under
this Regulation.

Article 79

Committee procedure

1.
The Commission shall be assisted by the Standing
Committee on the Food Chain and Animal Health, as estab-
lished by Article 58 of Regulation (EC) No 178/2002.

2. Where reference is made to this paragraph, Articles 3
and 7 of Decision 1999/468/EC shall apply, having regard to
the provisions of Article 8 thereof.

3. Where reference is made to this paragraph, Articles 5
and 7 of Decision 1999/468/EC shall apply, having regard to
the provisions of Article 8 thereof.

The period laid down in Article 5(6) of Decision 1999/468/EC
shall be set at three months.

4. Where reference is made to this paragraph, Article 5a(1)
to (4) and Article 7 of Decision 1999/468/EC shall apply,
having regard to the provisions of Article 8 thereof.

5. Where reference is made to this paragraph, Article 5a(1)
to (4) and (5)(b) and Article 7 of Decision 1999/468/EC shall
apply, having regard to the provisions of Article 8 thereof.

The time-limits laid down in Article 5a(3)(c) and (4)(b) and (e)
of Decision 1999/468/EC shall be set at
two months, one
month and two months respectively.

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CHAPTER XI

TRANSITIONAL AND FINAL PROVISIONS

Article 80

Transitional measures

Directive 91/414/EEC shall continue to apply, with respect

1.
to the procedure and the conditions for approval:

(a) to active substances for which a decision has been adopted
in accordance with Article 6(3) of Directive 91/414/EEC
before … (*); or

(b) to active substances listed in Annex I to Regulation (EC)

No 737/2007 (1); or

(c) to active substances for which completeness has been estab-
lished in accordance with Article 16 of Regulation (EC)
No 33/2008 (2); or

(d) to active substances for which completeness has been estab-
lished in accordance with Article 6 of Regulation (EC)
No 33/2008 before … (*).

On the basis of the examination carried out under Directive
91/414/EEC, a Regulation on the approval of such a substance
shall be adopted in accordance with Article 13(2) of this Regu-
lation. For active substances mentioned in point (b) of this para-
graph that approval shall not be considered as the renewal of
approval referred to in Article 14 of this Regulation.

Article 13(1) to (4) and Annexes II and III to Directive
2.
91/414/EEC shall continue to apply with respect
to active
substances included in Annex I to that Directive and to active
substances approved in accordance with paragraph 1 of this
Article:

(a) for a period of five years from the date of their inclusion or
approval, for active substances covered by Article 8(2) of
Directive 91/414/EEC;

(b) for a period of ten years from the date of their inclusion or
for active substances which were not on the

approval,
market on 26 July 1993;

renewal of
inclusion in Annex I

(c) for a period of five years from the date of the renewal of
for active
the inclusion or
substances whose
to Directive
91/414/EEC expires by … (**). This provision shall only
apply to data necessary for the renewal of the approval and
which were certified as compliant with the principles of
good laboratory practice by that date.

the approval,

3. Where Article 13 of Directive 91/414/EEC applies by
virtue of paragraph 1 or paragraph 2 of this Article, it shall be
subject to any special rules concerning Directive 91/414/EEC
laid down in the Act of Accession by which a Member State
joined the Community.

4.
For active substances for which the first approval expires
by … (***), the application provided for in Article 14 shall be

(*) 18 months from the date of entry into force of this Regulation.
(1) OJ L 169, 29.6.2003, p. 10.
(2) OJ L 15, 18.1.2008, p. 5.
(**) 24 months after the date of publication of this Regulation.
(***) 36 months from the date of entry into force of this Regulation.

submitted by a producer of the active substance to a Member
State, with a copy to the other Member States, the Commission
and the Authority, no later than two years before the expiry of
the first approval.

Applications

5.
products:

for

authorisations of plant protection

(a) under Article 4 of Directive 91/414/EEC which are pending

in the Member States; or

(b) which are due to be amended or withdrawn following an
inclusion in Annex I to Directive 91/414/EEC or following
an approval in accordance with paragraph 1 of this Article,

on … (*) shall be decided on the basis of national law in force
before that date.

After that decision, this Regulation shall apply.

6.
Products labeled in accordance with Article 16 of Directive
91/414/EEC may continue to be placed on the market
until … (****).

By … (*****),

7.
the Commission shall establish a list of
substances included in Annex I of Directive 91/414/EEC which
satisfy the criteria set out in point 4 of Annex II to this Regu-
lation and to which the provisions of Article 50 of this Regu-
lation shall apply.

Article 81

Derogation for safeners and synergists, co-formulants and
adjuvants

1.
By way of derogation from Article 28(1), a Member State
may, for a period of five years following the adoption of the
programme referred to in Article 26, authorise the placing on
the market
territory of plant protection products
containing safeners and synergists, which have not been
approved, where they are included in that programme.

in its

2.
By way of derogation from Article 27 and without preju-
dice to Community law, Member States may apply national
provisions
included in Annex III
for
until … (*****).

co-formulants not

Where, after … (*****), a Member State has serious grounds for
considering that a co-formulant not included in Annex III is
likely to constitute a serious risk to human or animal health or
the environment,
it may temporarily prohibit or restrict the
application of a co-formulant in question within its territory. It
shall
immediately inform the other Member States and the
Commission thereof and give reasons for its decision. Article 71
shall apply.

(****) 66 months from the date of entry into force of this Regulation.
(*****) 78 months from the date of entry into force of this Regulation.

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3.
By way of derogation from Article 58(1) Member States
may apply national provisions for authorisation of adjuvants
until the adoption of detailed rules referred to in Article 58(2).

Article 82

Review clause

to the
By … (*), The Commission shall present a report
European Parliament and the Council on the functioning of
mutual recognition of authorisations and in particular on the
application by the Member States of the provisions referred to
in Article 36(3) and Article 50(2), the division of the Com-
munity into three zones and on the application of the criteria
for the approval of active substances, safeners and synergists as
set out in Annex II and the impact thereof on the diversification
and competitiveness of agriculture as well as on human health
and on the environment. The report may be accompanied, if
necessary, by the appropriate legislative proposals to amend
those provisions.

Article 83

Repeal

Without prejudice to Article 80, Directives 79/117/EEC and
91/414/EEC, as amended by the acts listed in Annex V, are
repealed with effect from … (**), without prejudice to the obli-
gations of the Member States relating to the time-limits for
transposition into national law and application of the Directives
set out in that Annex.

References to the repealed Directives shall be construed as refer-
ences to this Regulation. In particular, references in other Com-
munity legislation, such as Regulation (EC) No 1782/2003, to
Article 3 of Directive 91/414/EEC shall be construed as refer-
ences to Article 55 of this Regulation.

Article 84

Entry into force and application

This Regulation shall enter into force on the twentieth day
following that of its publication in the Official
Journal of the
European Union.

By … (**), the Commission shall adopt the following:

(a) a Regulation containing the list of the active substances
already approved at the moment of adoption of that Regu-
lation;

(b) a Regulation on data requirements for active substances, as

referred to in Article 8(1)(b);

(c) a Regulation on data requirements for plant protection

products, as referred to in Article 8(1)(c);

(d) a Regulation on uniform principles for risk assessment for

plant protection products, as referred to in Article 36;

(e) a Regulation containing the requirements of the labelling of
plant protection products, as referred to in Article 65(1).

This Regulation shall apply from … (**).

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at …

For the European Parliament

The President

…

For the Council

The President

…

(*) 60 months from the date of entry into force of this Regulation.
(**) 18 months from the date of entry into force of this Regulation.

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Definition of zones for the authorisation of plant protection products as referred to in Article 3(15)

ANNEX I

The following Member States belong to this zone:

Denmark, Estonia, Latvia, Lithuania, Finland, Sweden

Zone A — North

Zone B — Centre

The following Member States belong to this zone:

Belgium, Czech Republic, Germany, Ireland, Luxembourg, Hungary, Netherlands, Austria, Poland, Romania, Slovenia,
Slovakia, United Kingdom

The following Member States belong to this zone:

Bulgaria, Greece, Spain, France, Italy, Cyprus, Malta, Portugal

Zone C — South

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Procedure and criteria for the approval of active substances, safeners and synergists pursuant to Chapter II

ANNEX II

1. Evaluation

1.1. During the process of evaluation and decision-making provided for in Articles 4 to 21, the rapporteur Member
State and the Authority shall cooperate with applicants to resolve any questions on the dossier quickly or to iden-
tify at an early stage any further explanations or additional studies necessary for the evaluation of the dossier,
including information to eliminate the need for a restriction of the approval, or to amend any proposed condi-
tions for the use of the plant protection product or to modify its nature or its composition in order to ensure full
satisfaction of the requirements of this Regulation.

1.2. The evaluation by the Authority and the rapporteur Member State must be based on scientific principles and be

made with the benefit of expert advice.

1.3. During the process of evaluation and decision-making provided for in Articles 4 to 21, Member States and the
Authority shall take into consideration any further guidance developed in the framework of the Standing
Committee on the Food Chain and Animal Health for the purposes of refining, where relevant, the risk assess-
ments.

2. General decision-making criteria

2.1. Article 4 shall only be considered as complied with, where, on the basis of the dossier submitted, authorisation in
at least one Member State is expected to be possible for at least one plant protection product containing that
active substance for at least one of the representative uses.

2.2. Submission of further information

In principle an active substance, safener or synergist shall only be approved where a complete dossier is
submitted.

In exceptional cases an active substance, safener or synergist may be approved even though certain information is
still to be submitted where:

(a) the data requirements have been amended or refined after the submission of the dossier; or,

(b) the information is considered to be confirmatory in nature, as required to increase the confidence in the

decision.

2.3. Restrictions on approval

Where necessary, the approval may be subject to conditions and restrictions as referred to in Article 6.

Where the rapporteur Member State considers that the dossier provided lacks certain information, to the effect
that the active substance could only be approved subject to restrictions, it shall contact the applicant at an early
stage to obtain more information which may possibly enable these restrictions to be removed.

3. Criteria for the approval of an active substance

3.1. Dossier

The dossiers submitted pursuant to Article 7(1) shall contain the information needed to establish, where rele-
vant, Acceptable Daily Intake (ADI), Acceptable Operator Exposure Level (AOEL) and Acute Reference Dose
(ARfD).

In the case of an active substance, safener or synergist for which one or more representative uses includes use on
feed or food crops or leads indirectly to residues in food or feed, the dossier submitted pursuant to Article 7(1)
shall contain the information necessary to carry out a risk assessment and for enforcement purposes.

The dossier shall in particular:

(a) permit any residue of concern to be defined;

(b) reliably predict the residues in food and feed, including succeeding crops;

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(c) reliably predict, where relevant, the corresponding residue level reflecting the effects of processing and/or

mixing;

(d) permit a maximum residue level to be defined and to be determined by appropriate methods in general use
for the commodity and, where appropriate, for products of animal origin where the commodity or parts of
it is fed to animals;

(e) permit, where relevant, concentration or dilution factors due to processing and/or mixing to be defined.

The dossier submitted pursuant to Article 7(1) shall be sufficient to permit, where relevant, an estimate of the
fate and distribution of the active substance in the environment, and its impact on non-target species.

3.2.

Efficacy

An active substance alone or associated with a safener or synergist shall only be approved where it has been
established for one or more representative uses that the plant protection product, consequent on application
consistent with good plant protection practice and having regard to realistic conditions of use is sufficiently
effective. This requirement shall be evaluated in accordance with the uniform principles for evaluation and
authorisation of plant protection products referred to in Article 29(6).

3.3. Relevance of metabolites

Where applicable the documentation submitted shall be sufficient to permit the establishment of the toxicolo-
gical, ecotoxicological or environmental relevance of metabolites.

3.4. Composition of the active substance, safener or synergist

3.4.1. The specification shall define the minimum degree of purity, the identity and maximum content of impu-
rities and, where relevant, of isomers/diastereo-isomers and additives, and the content of impurities of
toxicological, ecotoxicological or environmental concern within acceptable limits.

3.4.2. The specification shall be in compliance with the relevant Food and Agriculture Organisation specification
as appropriate, where such specification exists. However, where necessary for reasons of protection of
human or animal health or the environment, stricter specifications may be adopted.

3.5. Methods of analysis

3.5.1. The methods of analysis of

the active substance, safener or synergist as manufactured and of
determination of impurities of toxicological, ecotoxicological or environmental concern or which are
present in quantities greater than 1 g/kg in the active substance, safener or synergist as manufactured,
shall have been validated and shown to be sufficiently specific, correctly calibrated, accurate and precise.

3.5.2. The methods of residue analysis for the active substance and relevant metabolites in plant, animal and
environmental matrices and drinking water, as appropriate, shall have been validated and shown to be
sufficiently sensitive with respect to the levels of concern.

3.5.3. The evaluation has been carried out in accordance with the uniform principles for evaluation and authori-

sation of plant protection products referred to in Article 29(6).

3.6.

Impact on human health

3.6.1. Where relevant, an ADI, AOEL and ARfD shall be established. When establishing such values an appro-
priate safety margin of at least 100 shall be ensured taking into account the type and severity of effects
and the vulnerability of specific groups of the population.

3.6.2. An active substance, safener or synergist shall only be approved if, on the basis of assessment of higher
tier genotoxicity testing carried out in accordance with the data requirements for the active substances,
safeners or synergists and other available data and information, including a review of the scientific litera-
ture, reviewed by the Authority, it is not or has not to be classified, in accordance with the provisions of
Directive 67/548/EEC, as mutagen category 1 or 2.

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3.6.3. An active substance, safener or synergist shall only be approved, if, on the basis of assessment of carcino-
genicity testing carried out in accordance with the data requirements for the active substances, safener or
synergist and other available data and information, including a review of the scientific literature, reviewed
by the Authority, it is not or has not to be classified, in accordance with the provisions of Directive
67/548/EEC, as carcinogen category 1 or 2, unless the exposure of humans to that active substance,
safener or synergist in a plant protection product, under realistic proposed conditions of use, is negligible,
i.e. the product is used in closed systems or in other conditions excluding contact with humans and
where residues of the active substance, safener or synergist concerned on food and feed do not exceed
the default value set in accordance with point (b) of Article 18(1) of Regulation (EC) No 396/2005.

3.6.4. An active substance, safener or synergist shall only be approved if, on the basis of assessment of repro-
ductive toxicity testing carried out in accordance with the data requirements for the active substances,
safeners or synergists and other available data and information, including a review of the scientific litera-
ture, reviewed by the Authority, it is not or has not to be classified, in accordance with the provisions of
Directive 67/548/EEC, as toxic for reproduction category 1 or 2, unless the exposure of humans to that
active substance, safener or synergist in a plant protection product, under realistic proposed conditions of
use, is negligible, i.e. the product is used in closed systems or in other conditions excluding contact with
humans and where residues of the active substance, safener or synergist concerned on food and feed
do not exceed the default value set in accordance with point (b) of Article 18(1) of Regulation (EC)
No 396/2005.

3.6.5. An active substance, safener or synergist shall only be approved if, on the basis of the assessment of
Community or internationally agreed test guidelines or other available data and information, including a
it is not considered to have endocrine
review of the scientific literature, reviewed by the Authority,
disrupting properties that may cause adverse effect in humans, unless the exposure of humans to that
active substance, safener or synergist in a plant protection product, under realistic proposed conditions of
use, is negligible, i.e. the product is used in closed systems or in other conditions excluding contact with
humans and where residues of the active substance, safener or synergist concerned on food and feed
do not exceed the default value set in accordance with point (b) of Article 18(1) of Regulation (EC)
No 396/2005.

3.7.

Fate and behaviour in the environment

3.7.1. An active substance, safener or synergist shall only be approved where it is not considered to be a persis-

tent organic pollutant (POP).

A substance that fulfils all three of the criteria of the sections below is a POP.

3.7.1.1. P er s iste nce

An active substance, safener or synergist fulfils the persistence criterion where there is evidence
that the time it takes for a degradation of 50 % (DT50) in water is greater than two months, or
that its DT50 in soil is greater than six months, or that its DT50 in sediment is greater than
six months.

3.7.1.2. Bioa c cu mulat ion

An active substance, safener or synergist fulfils the bioaccumulation criterion where there is:

— evidence that

its bio-concentration factor or bioaccumulation factor in aquatic species
the partition coefficient

in the absence of such data,

that

is greater than 5 000 or,
n-octanol/water (log Ko/w) is greater than 5; or

— evidence that the active substance, safener or synergist present other reasons for concern,

such as high bioaccumulation in other non-target species, high toxicity or ecotoxicity.

3.7.1.3. Pote ntial for long-range enviro nment a l t ran sp o r t

An active substance, safener or synergist fulfils the potential for long-range environmental trans-
port criterion where:

— measured levels of the active substance, safener or synergist in locations distant from the

sources of its release are of potential concern; or

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— monitoring data show that long-range environmental transport of the active substance,
safener or synergist, with the potential for transfer to a receiving environment, may have
occurred via air, water or migratory species; or

— environmental fate properties and/or model results demonstrate that the active substance,
safener or synergist has a potential for long-range environmental transport through air, water
or migratory species, with the potential for transfer to a receiving environment in locations
distant from the sources of its release. For an active substance safener or synergist that
migrates significantly through the air, its DT50 in air is to be greater than two days.

3.7.2. An active substance, safener or synergist shall only be approved if it is not considered to be a persistent,

bioaccumulative and toxic (PBT) substance.

A substance that fulfils all three of the criteria of the sections below is a PBT substance.

3.7.2.1. P er s iste nce

An active substance, safener or synergist fulfils the persistence criterion where:

— the half-life in marine water is higher than 60 days, or

— the half-life in fresh or estuarine water is higher than 40 days, or

— the half-life in marine sediment is higher than 180 days, or

— the half-life in fresh or estuarine water sediment is higher than 120 days, or

— the half-life in soil is higher than 120 days.

Assessment of persistency in the environment shall be based on available half-life data collected
under appropriate conditions, which shall be described by the applicant.

3.7.2.2. Bioa c c umu lat ion

An active substance, safener or synergist fulfils the bioaccumulation criterion where the biocon-
centration factor is higher than 2 000.

Assessment of bioaccumulation shall be based on measured data on bioconcentration in aquatic
species. Data from both freshwater and marine water species can be used.

3.7.2.3. Toxic ity

An active substance, safener or synergist fulfils the toxicity criterion where:

— the long-term no-observed effect concentration for marine or freshwater organisms is less

than 0,01 mg/l, or

— the substance is classified as carcinogenic (category 1 or 2), mutagenic (category 1 or 2), or

toxic for reproduction (category 1, 2, or 3), or

— there is other evidence of chronic toxicity, as identified by the classifications: T, R48 or Xn,

R48 pursuant to Directive 67/548/EEC.

3.7.3. An active substance, safener or synergist shall only be approved if it is not considered to be a very persis-

tent and very bioaccumulative substance (vPvB).

A substance that fulfils both of the criteria of the sections below is a vPvB substance.

3.7.3.1. P er s iste nce

An active substance, safener or synergist fulfils the ‘very persistent’ criterion where:

— the half-life in marine, fresh or estuarine water is higher than 60 days, or

— the half-life in marine, fresh or estuarine water sediment is higher than 180 days, or

— the half-life in soil is higher than 180 days.

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3.7.3.2. Bioa c c umu lat io n

An active substance, safener or synergist fulfils the ‘very bioaccumulative’ criterion where the
bioconcentration factor is greater than 5 000.

3.8.

Ecotoxicology

3.8.1. An active substance, safener or synergist shall only be approved if the risk assessment demonstrates risks
to be acceptable in accordance with the criteria laid down in the uniform principles for evaluation and
authorisation of plant protection products referred to in Article 29(6) under realistic proposed conditions
of use of a plant protection product containing the active substance safener or synergist. The assessment
must take into account the severity of effects, the uncertainty of the data, and the number of organism
groups which the active substance safener or synergist is expected to affect adversely by the intended use.

3.8.2. An active substance, safener or synergist shall only be approved if, on the basis of the assessment of
Community or internationally agreed test guidelines, it is not considered to have endocrine disrupting
properties that may cause adverse effects on non-target organisms unless the exposure of non-target
organisms to that active substance in a plant protection product under realistic proposed conditions of
use is negligible.

3.9. Residue definition

An active substance, safener or synergist shall only be approved if, where relevant, a residue definition can be
established for the purposes of risk assessment and for enforcement purposes.

3.10. Fate and behaviour concerning groundwater

An active substance shall only be approved where it has been established for one or more representative uses,
that consequently after application of the plant protection product consistent with realistic conditions on use,
the predicted concentration of the active substance or of metabolites, degradation or reaction products in
groundwater complies with the respective criteria of the uniform principles for evaluation and authorisation of
plant protection products referred to in Article 29(6).

4. Candidate for substitution

An active substance shall be approved as a candidate for substitution pursuant to Article 24 where any of the following
conditions are met:

— its ADI, ARfD or AOEL is significantly lower than those of the majority of the approved active substances within

groups of substances/use categories,

— it meets two of the criteria to be considered as a PBT substance,

— there are reasons for concern linked to the nature of the critical effects (such as developmental neurotoxic or
immunotoxic effects) which, in combination with the use/exposure patterns, amount to situations of use that could
still cause concern, e.g. high potential of risk to groundwater; even with very restrictive risk management measures
(such as extensive personal protective equipment or very large buffer zones),

— it contains a significant proportion of non-active isomers,

— it is or is to be classified, in accordance with the provisions of Directive 67/548/EEC, as carcinogen category 1 or 2,

in case the substance has not been excluded in accordance with the criteria laid down in point 3.6.3,

— it is or is to be classified, in accordance with the provisions of Directive 67/548/EEC, as toxic for reproduction cate-
gory 1 or 2 in case the substance has not been excluded in accordance with the criteria laid down in point 3.6.4,

— if, on the basis of the assessment of Community or internationally agreed test guidelines or other available data
and information, reviewed by the Authority, it is considered to have endocrine disrupting properties that may
cause adverse effect in humans in case the substance has not been excluded in accordance with the criteria laid
down in point 3.6.5.

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5. Low-risk active substances

An active substance shall not be considered of low risk where it is or has to be classified in accordance with Directive
67/548/EEC as at least one of the following:

— carcinogenic,

— mutagenic,

— toxic to reproduction,

— sensitising,

— very toxic or toxic,

— explosive,

— corrosive.

It shall also not be considered as of low risk if:

— persistent (half life in soil is more than 60 days), or

— bioconcentration factor is higher than 100, or

— it is deemed to be an endocrine disrupter.

List of co-formulants which are not accepted for inclusion in plant protection products as referred to in
Article 27

ANNEX III

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ANNEX IV

Comparative assessment pursuant to Article 50

1. Conditions for comparative assessment

Where refusal or withdrawal of an authorisation of a plant protection product in favour of an alternative plant protec-
tion product or a non-chemical control or prevention method is considered, hereinafter referred to as ‘substitution’,
the alternative must, in the light of scientific and technical knowledge, show significantly lower risk to health or the
environment. An assessment of the alternative shall be performed to demonstrate whether it can be used with similar
effect on the target organism and without significant economic and practical disadvantages to the user or not.

Further conditions for refusal or withdrawal of an authorisation are:

(a) substitution shall be applied only where other methods or the chemical diversity of the active substances is suffi-

cient to minimise the occurrence of resistance in the target organism; and

(b) substitution shall be applied only to plant protection products where their use presents a significantly higher level

of risk to human health or the environment; and

(c) substitution shall be applied only after allowing for the possibility, where necessary, of acquiring experience from

use in practice, where not already available.

2. Significant difference in risk

A significant difference in risk shall be identified on a case-by-case basis by the competent authorities. The properties
of the active substance and plant protection product, and the possibility of exposure of different population subgroups
(professional or non-professional users, bystanders, workers, residents, specific vulnerable groups or consumers)
directly or indirectly through food, feed, drinking water or the environment shall be taken into account. Other factors
such as the stringency of imposed restrictions on use and prescribed personal protective equipment shall also be
considered.

For the environment, if relevant, a factor of at least 10 for the toxicity/exposure ratio (TER) of different plant protec-
tion products is considered a significant difference in risk.

3. Significant practical or economic disadvantages

Significant practical or economic disadvantage to the user is defined as a major quantifiable impairment of working
practices or business activity leading to inability to maintain sufficient control of the target organism. Such a major
impairment might be, for example, where no technical facilities for the use of the alternative are available or economic-
ally feasible.

Where a comparative assessment indicates that restrictions on and/or prohibitions of use of a plant protection product
could cause such disadvantage, then this shall be taken into account in the decision-making process. This situation
shall be substantiated.

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ANNEX V

Repealed Directives and their successive amendments as referred to in Article 83

A. Directive 91/414/EEC

Acts amending Directive 91/414/EEC

Deadline for transposition

Directive 93/71/EEC

Directive 94/37/EC

Directive 94/79/EC

Directive 95/35/EC

Directive 95/36/EC

Directive 96/12/EC

Directive 96/46/EC

Directive 96/68/EC

Directive 97/57/EC

Directive 2000/80/EC

Directive 2001/21/EC

Directive 2001/28/EC

Directive 2001/36/EC

Directive 2001/47/EC

Directive 2001/49/EC

Directive 2001/87/EC

Directive 2001/99/EC

Directive 2001/103/EC

Directive 2002/18/EC

Directive 2002/37/EC

Directive 2002/48/EC

Directive 2002/64/EC

Directive 2002/81/EC

Directive 2003/5/EC

Directive 2003/23/EC

Directive 2003/31/EC

Directive 2003/39/EC

Directive 2003/68/EC

Directive 2003/70/EC

Directive 2003/79/EC

Directive 2003/81/EC

3 August 1994

31 July 1995

31 January 1996

30 June 1996

30 April 1996

31 March 1997

30 April 1997

30 November 1997

1 October 1997

1 July 2002

1 July 2002

1 August 2001

1 May 2002

31 December 2001

31 December 2001

31 March 2002

1 January 2003

1 April 2003

30 June 2003

31 August 2003

31 December 2002

31 March 2003

30 June 2003

30 April 2004

31 December 2003

30 June 2004

30 September 2004

31 March 2004

30 November 2004

30 June 2004

31 January 2005

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Acts amending Directive 91/414/EEC

Deadline for transposition

Directive 2003/82/EC

Directive 2003/84/EC

Directive 2003/112/EC

Directive 2003/119/EC

Regulation (EC) No 806/2003

Directive 2004/20/EC

Directive 2004/30/EC

Directive 2004/58/EC

Directive 2004/60/EC

Directive 2004/62/EC

Directive 2004/66/EC

Directive 2004/71/EC

Directive 2004/99/EC

Directive 2005/2/EC

Directive 2005/3/EC

Directive 2005/25/EC

Directive 2005/34/EC

Directive 2005/53/EC

Directive 2005/54/EC

Directive 2005/57/EC

Directive 2005/58/EC

Directive 2005/72/EC

Directive 2006/5/EC

Directive 2006/6/EC

Directive 2006/10/EC

Directive 2006/16/EC

Directive 2006/19/EC

Directive 2006/39/EC

Directive 2006/41/EC

Directive 2006/45/EC

Directive 2006/64/EC

Directive 2006/74/EC

Directive 2006/75/EC

Directive 2006/85/EC

30 July 2004

30 June 2004

30 April 2005

30 September 2004

—

31 July 2005

30 November 2004

31 August 2005

28 February 2005

31 March 2005

1 May 2004

31 March 2005

30 June 2005

30 September 2005

30 September 2005

28 May 2006

30 November 2005

31 August 2006

31 August 2006

31 October 2006

31 May 2006

31 December 2006

31 March 2007

31 March 2007

30 September 2006

31 January 2007

30 September 2006

31 July 2007

31 January 2007

18 September 2006

31 October 2007

30 November 2007

31 March 2007

31 January 2008

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Acts amending Directive 91/414/EEC

Deadline for transposition

Directive 2006/104/EC

Directive 2006/131/EC

Directive 2006/132/EC

Directive 2006/133/EC

Directive 2006/134/EC

Directive 2006/135/EC

Directive 2006/136/EC

Directive 2007/5/EC

Directive 2007/6/EC

Directive 2007/21/EC

Directive 2007/25/EC

Directive 2007/31/EC

Directive 2007/50/EC

Directive 2007/52/EC

Directive 2007/76/EC

Directive 2008/40/EC

Directive 2008/41/EC

Directive 2008/45/EC

Directive 2008/66/EC

1 January 2007

30 June 2007

30 June 2007

30 June 2007

30 June 2007

30 June 2007

30 June 2007

31 March 2008

31 July 2007

12 December 2007

31 March 2008

1 September 2007

31 May 2008

31 March 2008

30 April 2009

30 April 2009

30 June 2009

8 August 2008

30 June 2009

B. Directive 79/117/EEC

Acts amending Directive 79/117/EEC

Deadline for transposition

Directive 83/131/EEC

Directive 85/298/EEC

Directive 86/214/EEC

Directive 86/355/EEC

Directive 87/181/EEC

Directive 87/477/EEC

Directive 89/365/EEC

Directive 90/335/EEC

Directive 90/533/EEC

Directive 91/118/EEC

Regulation (EC) No 807/2003

Regulation (EC) No 850/2004

1 October 1984

1 January 1986

—

1 July 1987

1 January 1988 and 1 January 1989

1 January 1988

31 December 1989

1 January 1991

31 December 1990 and 30 September 1990

31 March 1992

—

—

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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 products on the
market (1). The proposal is based on Articles 37(2) and 152(4)(b) of the Treaty.

2. The European Parliament adopted its opinion at first reading on 23 October 2007 (2). The Economic
and Social Committee and the Committee of the Regions delivered their opinions on 14 March and
1 February 2007 respectively.

3. On 15 September 2008, 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 authorisa-

tion 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;

— 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 environ-
mental conditions;

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

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

— provisions to avoid unnecessary animal testing.

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

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.

(1) An amended proposal was submitted on 11 March 2008.
(2) 14184/07.

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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 verte-
brate 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’,
‘competent
authority’,
It deleted the definitions of
‘animals’ and ‘integrated pest management’.

‘relevant metabolite’ and ‘impurity’.

‘post-harvest treatment’,

‘advertisement’,

‘biodiversity’,

‘greenhouse’,

‘minor use’,

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,
substances need to be listed in order to protect human health and the environment.

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

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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 tigh-
the various players involved
tening the deadlines and defining more precisely the roles of
(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 amend-
ment 141, or not allow enough time for the adequate completion of some stages of the proce-
dures (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 candi-
date 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).

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The Council introduced provisions establishing that Member States impose additional risk mitiga-
tion 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 mini-
mising 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 Comi-
tology Decision 2006/512/EC amending Decision 1999/468/EC and introducing the new regula-
tory 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 unani-
mous 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 adju-
vants should be set out following a comitology procedure.

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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.