COUNCIL DIRECTIVE of 15 July 1991 concerning the placing of plant
protection products on the market (91/414/EEC)
THE COUNCIL OF
THE EUROPEAN COMMUNITIES,
Having regard to the Treaty
establishing the European Economic Community, and in particular
Article 43 thereof,
Having regard to the proposal from the
Commission (1),
Having regard to the opinion of the European
Parliament (2),
Having regard to the opinion of the Economic and
Social Committee (3),
Whereas plant production has a very
important place in the Community;
Whereas plant production
yields are continually affected by harmful organisms including
weeds; whereas it is absolutely essential to protect plants against
these risks to prevent a decline in yields and to help to ensure
security of supplies;
Whereas one of the most important ways of
protecting plants and plant products and of improving agricultural
production is to use plant protection products;
Whereas these
plant protection products can have non-beneficial effects upon plant
production; whereas 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 authorized and if
incorrectly used;
Whereas, in view of the hazards, there are
rules in most Member States governing the authorization of plant
health products; whereas these rules present differences which
constitute barriers not only to trade in plant protection products
but also to trade in plant products, and thereby directly affect the
establishment and operation of the internal market;
Whereas it
is therefore desirable to eliminate such barriers by harmonizing the
provisions laid down in the Member States;
Whereas uniform rules
on the conditions and procedures for the authorization of plant
protection products must be applied by the Member States;
Whereas such rules should provide that plant protection products
should not be put on the market or used unless they habe been
officially authorized and should be used properly having regard to
the principles of good plant protection practice and of integrated
pest control;
Whereas the provisions governing authorization
must ensure a high standard of protection, which, in particular,
must prevent the authorization of plant protection products whose
risks to health, groundwater and the environment and human and
animal health should take priority over the objective of improving
plant production;
Whereas it is necessary, at the time when
plant protection products are authorized, to make sure that, when
properly applied for the purpose intended, they are sufficiently
effective and have no unacceptable effect on plants or plant
products, no unacceptable influence on the environment in general
and, in particular, no harmful effect on human or animal health or
on groundwater;
Whereas authorization should be limited to plant
protection products containing certain active substances specified
at Community level on the basis of their toxicological and
ecotoxicological properties;
Whereas it is therefore necessary
to establish a Community list of authorized active substances;
Whereas a Community procedure must be laid down for assessing
whether an active substance can be entered on the Community list;
whereas the information that interested parties must submit with a
view to admission of a substance to the list should be specified;
Whereas the Community procedure should not prevent Member States
from authorizing for use in their territory for a limited period
plant protection products containing an active substance not yet
entered on the Community list, provided that the interested party
has submitted a dossier meeting Community requirements and the
Member State has concluded that the active substance and the plant
protection products can be expected to satisfy the Community
conditions set in regard to them;
Whereas, in the interests of
safety, substances on the Community list should be reviewed
periodically, to take account of developments in science and
technology and of impact studies based on the actual use of plant
protection products containing the said substances;
Whereas it
is in the interests of free movement of plant products as well as of
plant protection products that authorization granted by one Member
State, and tests carried out with a view to authorization, should be
recognized by other Member States, unless certain agricultural,
plant health and environmental (including climatic) conditions
relevant to the use of the products concerned are not comparable in
the regions concerned; whereas to this end there is a need to
harmonize the methods of experimentation and control applied by the
Member States for the purpose of granting authorization;
Whereas
it is therefore desirable that a system for the mutual supply of
information should be established and that Member States should make
available to each other on request the particulars and scientific
documentation submitted in connection with applications for
authorization of plant protection products;
Whereas, however,
Member States must be enabled to authorize plant protection products
not complying with the abovementioned conditions when it is
necessary to do so because of an unforeseeable danger threatening
plant production which cannot be countered by other means; whereas
such authorization should be reviewed by the Community in close
cooperation with the Member States in the framework of the Standing
Committee on Plant Health;
Whereas this Directive complements
Community provisions on the classification, packaging and labelling
of pesticides; whereas together with these provisions it
considerably
improves the protection of users of plant protection
products and consumers of plants and plant products; whereas it also
contributes to the protection of the environment;
Whereas it is
necessary to maintain consistency between this Directive and
Community rules on the residues of plant protection products in
agricultural products and the free movement of the latter in the
Community; whereas this Directive complements Community provisions
relating to maximum permissible levels for pesticide residues and
will facilitate the adoption of such levels in the Commission;
whereas together with the latter provisions it considerably improves
the protection of consumers of plants and plant products;
Whereas resources devoted to the conduct of tests on vertebrate
animals should not be dissipated as a result of the differences in
the laws of the Member States and whereas considerations of public
interest and Council Directive 86/609/EEC of 24 November 1986 on the
approximation of laws, regulations and administrative provisions of
the Member States regarding the protection of animals used for
experimental and other scientific purposes (4) militate against
needless repetition of tests on animals;
Whereas, in order to
ensure that the requirements laid down are satisfied, Member States
must make provision for appropriate control and inspection
arrangements with regard to the marketing and use of plant
protection products;
Whereas the procedures provided for by this
Directive for the evaluation of the risks to the environment
presented by plant protection products containing or composed of
genetically modified organisms correspond in principle to those laid
down in Directive 90/220/EEC of 23 April 1990 on the deliberate
release into the environment of genetically modified organisms (5);
whereas in future however the supply of data in accordance with Part
B of Annexes II and III is likely to be subject to specific
requirements, provision should be made to amend this Directive
accordingly;
Whereas the implementation of this Directive and
the adaptation of its Annexes to advances in technical and
scientific knowledge necessitate close cooperation between the
Commission and the Member States, and whereas the procedure of the
Standing Committee on Plant Health offers a suitable basis for this
cooperation,
HAS ADOPTED THIS DIRECTIVE:
Scope
Article 1
1. This Directive concerns the authorization, placing on the
market, use and control within the Community of plant protection
products in commercial form and the placing on
(; ) OJ No L 358,
18. 12. 1986, p. 1.
($) OJ No L 117, 8. 5. 1990, p. 15.
the
market and control within the Community of active substances
intended for a use specified in Article 2 (1).
2. This Directive
shall apply without prejudice to Council Directive 78/631/EEC of 26
June 1978 on the approximation of the laws of the Member States
relating to the classification, packaging and labelling of dangerous
preparations (pesticides) (; ), as last amended by Directive
84/291/EEC ($) and, where active substances are concerned, without
prejudice to the provisions concerning classification, packaging and
labelling of Council Directive 67/548/EEC of 27 June 1967 on the
approximation of laws, regulations and administrative provisions
relating to the classification, packaging and labelling of dangerous
substances (=), as last amended by Directive 90/517/EEC (%).
3.
This Directive applies to the authorization to place on the market
plant protection products containing or composed of genetically
modified organisms, provided that authorization to release them into
the environment has been granted after the risk to the environment
has been assessed in accordance with the provisions of Parts A, B
and D and the relevant provisions of Part C of Directive 90/220/EEC.
The Commission shall submit to the Council, in sufficient time
for the latter to be able to act not later than two years after the
date of notification of this Directive, a proposal for an amendment
with a view to including in this Directive (& ) a specific
procedure for evaluating the risk to the environment analogous to
that provided for the Directive 90/220/EEC, and enabling this
Directive to be placed on the list provided for in Article 10 (3) of
Directive 90/220/EEC in accordance with the procedure laid down in
the said Article 10.
Within five years of the date of
notification of this Directive, the Commission, on the basis of
experience gained, shall provide the European Parliament and the
Council with a report on the operation of the arrangements described
in the first and second subparagraphs.
4. This Directive shall
apply without prejudice to Council Regulation (EEC) No 1734/88 of 16
June 1988 concerning export from and import into the Community of
certain dangerous chemicals (().
Definitions
Article 2
For the purposes of this Directive the following definitions
shall apply:
1.
'plant protection products'
active
substances and preparations containing one or more active
substances, put up in the form in which they are supplied to the
user, intended to:
(; ) OJ No L 206, 29. 7. 1978, p. 13.
($)
OJ No L 144, 30. 5. 1984, p. 1.
(=) OJ No 196, 16. 8. 1967, p.
1.
(%) OJ No L 287, 19. 10. 1990, p. 37.
(& ) This
Directive was notified to the Member States on 26 July 1991.
(()
OJ No L 155, 22. 6. 1988, p. 2.
1.1.
protect plants or plant
products against all harmful organisms or prevent the action of such
organisms, in so far as such substances or preparations are not
otherwise defined below;
1.2.
influence the life processes
of plants, other than as a nutrient, (e.g. growth regulators);
1.3.
preserve plant products, in so far as such substances
or products are not subject to special Council of Commission
provisions on preservatives;
1.4.
destroy undesired plants;
or
1.5.
destroy parts of plants, check or prevent undesired
growth of plants;
2.
'residues of plant protection
products'
one or more substances present in or on plants or
products of plant origin, edible animal products or elsewhere in the
environment and resulting from the use of a plant protection
product, including their metabolites and products resulting from
their degradation or reaction;
3.
'substances'
chemical
elements and their compounds, as they occur naturally or by
manufacture, including any impurity inevitable resulting from the
manufacturing process;
4.
'active substances'
substances
or micro-organisms including viruses, having general or specific
action:
4.1.
against harmful organisms; or
4.2.
on
plants, parts of plants or plant products;
5.
'preparations'
mixtures or solutions composed of two or more
substances of which at least one is an active substance, intended
for use as plant protection products;
6.
'plants'
live
plants and live parts of plants, including fresh fruit and seeds;
7.
'plant products'
products in the unprocessed state or
having undergone only simple preparation such as milling, drying or
pressing, derived from plants, but excluding plants themselves as
defined in point 6;
8.
'harmful organisms'
pests of
plants or plant products belonging to the animal or plant kingdom,
and also viruses, bacteria and mycoplasmas and other pathogens;
9.
'animals'
animals belonging to species normally fed
and kept or consumed by man;
10.
'placing on the
market'
any supply, whether in return for payment or free of
charge, other than for storage followed by consignment from the
territory of the Community or disposal. Importation of a plant
protection product into the territory of the Community shall be
deemed to constitute placing on the market for the purposes of this
Directive;
11.
'authorization of a plant protection
product'
administrative act by which the competent authority of a
Member State authorizes, following an application submitted by an
applicant, the placing on the market of a plant protection product
in its territory or in a part thereof;
12.
'environment'
water, air, land, wild species of fauna and
flora, and any interrelationship between them, as well as any
relationship with living organisms;
13.
'integrated
control'
the rational application of a combination of biological,
biotechnological, chemical, cultural or plant-breeding measures
whereby the use of chemical plant protection products is limited to
the strict minimum necessary to maintain the pest population at
levels below those causing economically unacceptable damage or loss.
General provisions
Article 3
1. Member States shall
prescribe that plant protection products may not be placed on the
market and used in their territory unless they have authorized the
product in accordance with this Directive, except where the intended
use is covered by Article 22.
2. Member States shall not, on the
grounds that a plant protection product is not authorized for use in
their territory, impede the production, storage or movement of such
products intended for use in another Member State, provided that:
- the product is authorized in another Member State, and
-
the inspection requirements laid down by the Member States in order
to ensure compliance with paragraph 1 are satisfied.
3. Member
States shall prescribe that plant protection products must be used
properly. Proper use shall include compliance with the conditions
established in accordance with Article 4 and specified on the
labelling, and the application of the principles of good plant
protection practice as well as, whenever possible, the principles of
integrated control.
4. Member States shall prescribe that active
substances may not be placed on the market unless:
- they are
classified, packaged and labelled in accordance with Directive
67/548/EEC, and
- where the active substance was not on the
market two years after notification of this Directive, a dossier has
been forwarded to the Member States and to the Commission, in
accordance with Article 6, with the declaration that the active
substance is intended for a use specified in Article 2 (1). This
condition shall not apply to active substances intended for a use
under Article 22.
Granting, review and withdrawal of
authorizations of plant protection products
Article 4
1.
Member States shall ensure that a plant protection product is not
authorized unless:
(a) its active substances are listed in Annex
I and any conditions laid down therein are fulfilled,
and, with
regard to the following points (b), (c), (d) and (e), pursuant to
the uniform principles provided for in Annex VI, unless:
(b)
it is established, in the light of current scientific and
technical kowledge and shown from appraisal of the dossier provided
for in Annex III, that when used in accordance with Article 3 (3),
and having regard to all normal conditions under which it may be
used, and to the consequences of its use:
ii(i) it is
sufficiently effective;
i(ii)
it has no unacceptable effect
on plants or plant products;
(iii)
it does not cause
unnecessary suffering and pain to vertebrates to be controlled;
(iv)
it has no harmful effect on human or animal health,
directly or indirectly (e.g. through drinking water, food or feed)
or on groundwater;
i(v)
it has no unacceptable influence on
the environment, having particular regard to the following
considerations:
- its fate and distribution in the environment,
particularly contamination of water including drinking water and
groundwater,
- its impact on non-target species;
(c)
the
nature and quantity of its active substances
and, where
appropriate, any toxicologically or ecotoxicologically significant
impurities and co-formulants can be determined by appropriate
methods, harmonized according to the procedure provided in Article
21, or, if not, agreed by the authorities responsible for the
authorization;
(d)
its residues, resulting from authorized
uses, and which are of toxicological or environmental significance,
can be determined by appropriate methods in general use;
(e)
its physical and chemical properties have been determined
and deemed acceptable for the purposes of the appropriate use and
storage of the product;
(f)
maximum residue levels in the
agricultural products referred to in the authorization have been
provisionally established by the Member State and notified to the
Commission in accordance with Article 12; within three months of the
said notification, the Commission shall consider whether the
provisional maximum levels established by the Member State are
acceptable, and in accordance with the procedure laid down in
Article 19 it shall establish provisional maximum levels throughout
the Community and these shall remain in force until the
corresponding maximum levels are adopted pursuant to the procedure
provided for in the second subparagraph of Article 1 (1) of
Directive 90/462/EEC (; ) and in Article 11 of Directive 86/362/EEC
($), as amended by Directive 88/298/EEC (=).
In particular:
i(i) Member States may not prohibit or impede the introduction
into their territory of products containing pesticide residues
provided the residue level does not exceed the provisional maximum
levels set in accordance with the first subparagraph;
(ii)
Member States must ensure that the conditions for
approval are applied in such a way that the provisional maximum
levels are not exceeded.
2. The authorization must stipulate the
requirements relating to the placing on the market and use of the
product or at least those aimed at ensuring compliance with the
provisions of paragraph 1 (b).
3. Member States shall ensure
that compliance with the requirements set out in paragraph 1 (b) to
(f) is established by
(; ) OJ No L 350, 14. 12. 1990, p. 71.
($) OJ No L 221, 7. 8. 1986, p. 36.
(=) OJ No L 126, 20. 5.
1988, p. 53.
official or officially recognized tests and
analyses carried out under agricultural, plant health and
environmental conditions relevant to use of the plant protection
product in question and representative of these prevailing where the
product is intended to be used, within the territory of the Member
State concerned.
4. Without prejudice to paragraphs 5 and 6,
authorizations shall be granted for a fixed period of up to 10 years
only, determined by the Member States; they may be renewed after
verification that the conditions imposed in paragraph 1 are still
satisfied. Renewal may be granted for the period necessary to the
competent authorities of the Member States, for such verification,
where an application for renewal has been made.
5.
Authorizations may be reviewed at any time if there are indications
that any of the requirements referred to in paragraph 1 are no
longer satisfied. In such instances the Member States may require
the applicant for authorization or party to whom an extension of the
field of application was granted in accordance with Article 9 to
submit further information necessary for the review. The
authorization may, where necessary, be extended for the period
necessary to complete a review and provide such further information.
6. Without prejudice to Decisions already taken pursuant to
Article 10, an authorization shall be cancelled if it is established
that:
(a) the requirements for obtaining the authorization are
not or are no longer satisfied;
(b)
false or misleading
particulars were supplied concerning the facts on the basis of which
the authorization was granted;
or modified if it is established
that:
(c)
on the basis of developments in scientific and
technical knowledge the manner of use and amounts used can be
modified.
It may also be cancelled or modified at the request of
the holder of the authorization, who shall state the reasons
therefor; amendments can be granted only if it is established that
the requirements of Article 4 (1) continue to be satisfied.
Where a Member State withdraws an authorization, it shall
immediately inform the holder of the authorization; moreover, it may
grant a period of grace for the disposal, storage, placing on the
market and use of existing stocks, of a length in accordance with
the reason for the withdrawal, without prejudice to any period
provided for by decision taken under Council Directive 79/117/EEC of
21 December 1978 prohibiting the placing on the market and use of
plant protection products containing certain active substances (%),
as last amended by Directive 90/335/EEC (& ), or Article 6 (1)
or Article 8 (1) or (2) of this Directive.
(%) OJ No L 33, 8. 2.
1979, p. 36.
(& ) OJ No L 162, 28. 6. 1990, p. 37.
Inclusion of active substances in Annex I
Article 5
1.
In the light of current scientific and technical knowledge, an
active substance shall be included in Annex I for an initial period
not exceeding 10 years, if it may be expected that plant protection
products containing the active substance will fulfil the following
conditions:
(a) their residues, consequent on application
consistent with good plant protection practice, do not have any
harmful effects on human or animal health or on groundwater or any
unacceptable influence on the environment, and the said residues, in
so far as they are of toxicological or environmental significance,
can be measured by methods in general use;
(b) their use,
consequent on application consistent with good plant protection
practice, does not have any harmful effects on human or animal
health or any anacceptable influence on the environment as provided
for in Article 4 (1) (b) (iv) and (v).
2. For inclusion of an
active substance in Annex I, the following shall be taken into
particular account:
(a) where relevant, an acceptable daily
intake (ADI) for man;
(b)
an acceptable operator exposure
level if necessary;
(c)
where relevant, an estimate of its
fate and distribution in the environment as well as its impact on
non-target species.
3. For the first inclusion of an active
substance which was not yet on the market two years after
notification of this Directive, the requirements shall be deemed to
be satisfied where this has been established for at least one
preparation containging the said active substance.
4. Inclusion
of an active substance in Annex I may be subject to requirements
such as:
- the minimum degree of purity of the active substance,
- the nature and maximum content of certain impurities,
-
restrictions arising from evaluation of the information referred to
in Article 6, taking account of the agricultural, plant health and
environmental (including climatic) conditions in question,
-
type of preparation,
- manner of use.
5. On request, the
inclusion of a substance in Annex I may be renewed once or more for
periods not exceeding 10 years; such inclusion may be reviewed at
any time if there are
indications that the criteria referred to
in paragraphs 1 and 2 are no longer satisfied. Renewal shall be
granted for the period necessary to complete a review, where an
application has been made for such renewal in sufficient time, and
in any case not less than two years before the entry is due to
lapse, and shall be granted for the period necessary to provide
information requested in accordance with Article 6 (4).
Article 6
1. Inclusion of an active substance in Annex I
shall be decided in accordance with the procedure laid down in
Article 19.
The following shall also be decided in accordance
with that procedure:
- any conditions for inclusion,
-
amendements to Annex I, where necessary,
- removal of an active
substance form Annex I if it no longer satisfies the requirements of
Article 5 (1) and (2).
2. A Member State receiving an
application for the inclusion of an active substance in Annex I
shall without undue delay ensure that a dossier which is believed to
satisfy the requirements of Annex II is forwarded by the applicant
to the other Member States and to the Commission together with a
dossier complying with Annex III on at least one preparation
containing that active substance. The Commission shall refer the
dossier to the Standing Committee on Plant Health referred to in
Article 19 for examination.
3. Without prejudice to the
provisions of paragraph 4, at the request of a Member State, and
within three to six months after the date of referral to the
committee mentioned in Article 19, it shall be established by the
procedure laid down in Article 20 whether the dossier has been
submitted in accordance with the requirements of Annexes II and III.
4. If the assessment of the dossier referred to in paragraph 2
shows that further information is necessary, the Commission may ask
the applicant to submit such information. The applicant or his
authorized representative may be asked by the Commission to submit
his remarks to it, in particular whenever an unfavourable decision
is envisaged.
These provisions shall also apply if, after
inclusion of an active substance in Annex I, facts emerge that cast
doubt on its conformity with the requirements indicated in Article 5
(1) and (2), or if renewal in accordance with Article 5 (5) is being
considered.
5. The procedure concerning the submission and
appraisal of applications for inclusion in Annex I and setting or
varying any conditions for inclusion shall be adopted in accordance
with the procedure laid down in Article 21.
Information on
potentially harmful effects
Article 7
Member States shall
prescribe that the holder of an authorization or those to whom an
extension of the field of application has been granted in accordance
with Article 9 (1) must immediately notify the competent authority
of all new information on the potentially dangerous effects of any
plant protection product, or of residues of an active substance on
human or animal health or on groundwater, or their potentially
dangerous effects on the environment. Member States shall ensure
that the parties concerned immediately notify this information to
the other Member States and to the Commission, which shall refer the
information to the committee referred to in Article 19.
Transitional measures and derogations
Article 8
1.
By way of derogation from Article 4, a Member State may, to enable a
gradual assessment to be made of the properties of new active
substances and to make it easier for new preparations to be made
available for use in agriculture, authorize, for a provisional
period not exceeding three years, the placing on the market of plant
protection products containing an active substance not listed in
Annex I and not yet available on the market two years after
notification of this Directive, provided that:
(a) following
application of Article 6 (2) and (3) it is found that the dossier on
the active substance satisfies the requirements of Annexes II and
III in relation to the projected uses;
(b) the Member State
establishes that the active substance can satisfy the requirements
of Article 5 (1) and that the plant protection product may be
expected to satisfy the requirements of Article 4 (1) (b) to (f).
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 authorization, giving at least the
information provided for in Article 12 (1).
Following the
evaluation of the dossier as provided for in Article 6 (3), it may
be decided, in accordance with the procedure laid down in Article
19, that the active substance does not satisfy the requirements
specified in Article 5 (1). In such cases the Member States shall
ensure that the authorizations must be withdrawn.
By way of
derogation from Article 6, if, on expiry of the three-year period, a
decision has not been taken concerning the inclusion of an active
substance in Annex I, a further period may be ordered by the
procedure referred to in Article 19 to enable a full examination to
be made of the dossier and, where appropriate, of any additional
information requested in accordance with Article 6 (3) and (4).
The provisions of Article 4 (2), (3), (5) and (6) shall apply to
authorizations granted under the terms of this paragraph without
prejudice to the foregoing subparagraphs.
2. By way of
derogation from Article 4 and without prejudice to paragraph 3 or to
Directive 79/117/EEC, a Member State may, during a period of 12
years following the notification of this Directive, authorize the
placing on the market in its territory of plant protection products
containing active substances not listed in Annex I that are already
on the market two years after the date of notification of this
Directive.
After the adoption of this Directive, the
Commission
shall commence a programme of work for the gradual
examination of these active substances within the 12-year period
referred to in the foregoing subparagraph. This programme may
require interested parties to submit all requisite data to the
Commission and the Member States within a period provided for in the
programme. A Regulation, adopted according to the procedure laid
down in Article 19, will set out all the provisions necessary for
the implementation of the programme.
Ten years following
notification of this Directive the Commission shall present to the
European Parliament and the Council a progress report on the
programme. Depending upon the conclusions of the report, it may be
decided, according to the procedure laid down in Article 19,
whether, for certain substances, the 12-year period referred to in
the first subparagraph is to be extended for a period to be
determined.
During the 12-year period referred to in the first
subparagraph it may, following examination by the Committee referred
to in Article 19 of such active substance, be decided by the
procedure laid down in that Article that the substance can be
included in Annex I and under which conditions, or, in cases where
the requirements of Article 5 are not satisfied or the requisite
information and data have not been submitted within the prescribed
period, that such active substance will not be included in Annex I.
The Member States shall ensure that the relevant authorizations are
granted, withdrawn or varied, as appropriate, within a prescribed
period.
3. Where they review plant protection products
containing an active substance in accordance with paragraph 2, and
before such review has taken place, Member States shall apply the
requirements laid down in Article 4 (1) (b) (i) to (v), and (c) to
(f) in accordance with national provisions concerning the data to be
provided.
4. By way of further derogation from Article 4, in
special circumstances a Member State may authorize for a period not
exceeding 120 days the placing on the market of plant protection
products not complying with Article 4 for a limited and controlled
use if such a measure appears necessary because of an unforeseeable
danger which cannot be contained by other means. In this case, the
Member State concerned shall immediately inform the other Member
States
and the Commission of its action. It shall be decided
without delay, in accordance with the procedure laid down in Article
19, whether and under which conditions the action taken by the
Member State may be extended for a given period, repeated, or
revoked.
Application for authorization
Article 9
1.
Application for authorization of a plant protection product shall be
made by or on behalf of the person responsible for first placing it
on the market in a Member State to the competent authorities of each
Member State where the plant protection product is intended to be
placed on the market.
Official or scientific bodies involved in
agricultural activities or professional agricultural organizations
and professional users may request that the field of application of
a plant protection product already authorized in the Member State in
question be extended to purposes other than those covered by this
authorization.
Member States shall grant an extension of the
field of application of an authorized plant protection product and
shall be obliged to grant such an extension when it is in the public
interest to the extent that:
- the documentation and information
to support an extension of the field of application has been
submitted by the applicant,
- they have established that the
conditions referred to in Article 4 (1) (b) (iii), (iv) and (v) are
satisfied,
- the intended use is minor in nature,
- users
are fully and specifically informed as to instructions for use, by
means of an addition to the labelling or, failing that, by means of
an official publication.
2. Every applicant shall be required to
have a permanent office within the Community.
3. Member States
may require that applications for authorization be submitted in
their national or official languages or one of those languages. They
may also require that samples of the preparation and of its
ingredients be provided.
4. Each Member State shall agree to
consider any application for authorization made to it and shall
decide thereon within a reasonable period, provided that it has the
necessary scientific and technical structures at its disposal.
5. Member States shall ensure that a file is compiled on each
application. Each file shall contain at least a copy of
the
application, a record of the administrative decisions taken
by the Member State concerning the application and concerning the
particulars and documentation laid down in Article 13 (1) together
with a summary of the latter. Member States shall on request make
available to the other Member States and to the Commission the files
provided for in this paragraph; they shall supply to them on request
all information necessary for full comprehension of applications,
and shall where requested ensure that applicants provide a copy of
the technical documentation laid down in Article 13 (1) (a).
Mutual recognition of authorizations
Article 10
1.
At the request of the applicant, who must substantiate the claim to
comparability with documentary evidence, a Member State to which an
application is made for the authorization of a plant protection
product already authorized in another Member State must:
-
refrain from requiring the repetition of tests and analyses already
carried out in connection with the authorization of the product in
that Member State, and to the extent that agricultural, plant health
and environmental (including climatic) conditions relevant to the
use of the product are comparable in the regions concerned, and
-
to the extent that the uniform principles have been adopted in
accordance with Article 23, where the product contains only active
substances listed in Annex I, also authorize the placing of that
product on the market in its territory, to the extent that
agricultural, plant health and environmental (including climatic)
conditions relevant to the use of the product are comparable in the
regions concerned.
Authorization may be subject to conditions
resulting from the implementation of other measures in accordance
with Community law, relating to the conditions for distribution and
use of plant protection products intended to protect the health of
the distributors, users and workers concerned.
Subject to
compliance with the Treaty, authorization may also be accompanied by
restrictions on use arising from differences in dietary patterns and
necessary in order to avoid exposure of consumers of treated
products to the risks of dietary contamination in excess of the
acceptable daily intake of the residues concerned.
Authorization
may be subject, with the agreement of the applicant, to changes in
the conditions of use in order to render, in the regions concerned,
any non-comparable agricultural, plant health or environmental
(including climatic) conditions irrelevant for the purpose of
comparability.
2. Member States shall inform the Commission of
cases where they have required repetition of a test and of cases
where they have refused to authorize a plant protection product
already authorized in another Member State, in respect of which the
applicant had claimed that the agricultural, plant health and
environmental (including climatic) conditions relevant to use of the
product in the regions concerned in the Member State where the test
was carried out or for which authorization was granted were
comparable to those in their own territory. They shall notify the
Commission of the grounds on which repetition of the test was
required or authorization was refused.
3. Without prejudice to
Article 23, in cases where a Member State refuses to recognize
comparability and accept tests and analyses or authorize the placing
on the market of a plant protection product in the relevant regions
of its territory, the decision as to whether or not comparability
exists shall be taken in accordance with the procedure laid down in
Article 19 and, if the decision is negative, it shall also specify
the conditions of use under which the non-comparability may be
deemed irrelevant. In this procedure account shall be taken, inter
alia, of the serious ecological vulnerability problems that may
arise in certain Community regions or zones thereby requiring, if
they do arise, specific protection measures. The Member State shall
without delay accept the tests and analyses or authorize the placing
of the plant protection product on the market, subject in the latter
case to any terms which the above decision may set.
Article
11
1. Where a Member State has valid reasons to consider that a
product which it has authorized or is bound to authorize under
Article 10 constitutes a risk to human or animal health or the
environment, it may provisionally restrict or prohibit the use
and/or sale of that product on its territory. It shall immediately
inform the Commission and the other Member States of such action and
give reasons for its decision.
2. A decision shall be taken on
the matter within three months in accordance with theprocedure laid
down in Article 19.
Exchange of information
Article 12
1. Within a period of one month at the end of each quarter at
least, Member States shall inform each other and the Commission in
writing of any plant protection products
authorized or withdrawn,
in accordance with the provisions of this Directive, indicating at
least:
- the name or business name of the holder of the
authorization,
- the trade name of the plant protection product,
- the type of preparation,
- the name and amount of each
active substance which it contains,
- the use or uses for which
it is intended,
- the maximum residue levels provisionally
established where they have not already been set by Community rules,
- where relevant, the reasons for withdrawal of an
authorization,
- the dossier needed for the evaluation of the
maximum residue levels provisionally established.
2. Each Member
State shall draw up an annual list of the plant protection products
authorized in its territory and shall communicate that list to the
other Member States and the Commission.
In accordance with the
procedure laid down in Article 21 a standardized information system
shall be set up to facilitate the application of paragraphs 1 and 2.
Data requirements, data protection and confidentiality
Article 13
1. Without prejudice to Article 10, Member States
shall require that applicants for authorization of a plant
protection product submit with their application:
(a) a dossier
satisfying, in the light of current scientific and technical
knowledge, the requirements set out in Annex III; and
(b) for
each active substance in the plant protection product, a dossier
satisfying, in the light of current scientific and technical
knowledge, the requirements set out in Annex II.
2. By way of
derogation from paragraph 1, and without prejudice to the provisions
of paragraphs 3 and 4, applicants shall be exempted from supplying
the information required under paragraph 1 (b) except for that
identifying the active substance if the active substance is already
listed in Annex I, taking into account the conditions of inclusion
in Annex I, and does not differ significantly in degree of purity
and nature of impurities, from the composition registered in the
dossier accompanying the original application.
3. In granting
authorizations, Member States shall not make use of the information
referred to in Annex II for the benefit of other applicants:
(a)
unless the applicant has agreed with the first applicant that use
may be made of such information; or
(b)
for a period of 10
years from first inclusion in Annex I of an active substance not on
the market two years after the date of notification of this
Directive; or
(c)
for periods not exceeding 10 years from the
date of the decision in each Member State and provided for in
existing national rules, concerning an active substance on the
market two years after the date of notification of this Directive;
and
(d)
for a period of five years from the date of a
decision, following receipt of further information necessary for
first inclusion in Annex I, which has been taken either to vary the
conditions for, or to maintain, the inclusion of an active substance
in Annex I, unless the five-year period expires before the period
provided for in paragraphs 3 (b) and (c), in which case the period
of five years shall be extended so as to expire on the same date as
those periods.
4. In granting authorizations, Member States
shall not make use of the information referred to in Annex III to
the benefit of other applicants:
(a) unless the applicant has
agreed with the first applicant that use may be made of such
information; or
(b)
for a period of 10 years from first
authorization of the plant protection product in any Member State,
where authorization follows the inclusion in Annex I of any active
substance contained in the product; or
(c)
for periods not
exceeding 10 years and provided for in existing national rules after
the first authorization of the plant protection product in each
Member State, where that authorization precedes inclusion in Annex I
of any active substance contained in the product.
5. Member
States, on examination of an application for authorization, shall
inform the Commission of instances where they consider an active
substance to be listed in Annex I, which has been produced by a
person or manufacturing process other than those specified in the
dossier on the basis of which the active substance was first
included in Annex I. They shall transmit to it all data regarding
the identify and impurities of the active substance.
6. By way
of derogation from paragraph 1, for active substances already on the
market two years after notification of this Directive, Member States
may, with due regard for the provisions of the Treaty, continue to
apply previous national rules concerning data requirements as long
as such substances are not included in Annex I.
7.
Notwithstanding paragraph 1, and without prejudice to Article 10,
where the active substance is listed in Annex I:
(a) applicants
for authorization of plant protection products shall, before
carrying out experiments involving vertebrate animals, enquire of
the competent authority of the Member State to which they intend
making application:
- whether the plant protection product for
which an application is to be made is the same as a plant protection
product for which authorization has been granted, and
- as to the
name and address of the holder or holders of the authorization or
authorizations.
The enquiry shall be supported by evidence that
the prospective applicant intends to apply for authorization on his
own behalf and that the other information specified in paragraph 1
is available;
(b) the competent authority of the Member State,
if satisfied that the applicant intends to apply, shall provide the
name and address of the holder or holders of previous relevant
authorizations and shall at the time inform the holders of the
authorizations of the name and address of the applicant.
The
holder or holders of previous authorizations and the applicant shall
take all reasonable steps to reach agreement on the sharing of
information so as to avoid the duplication of testing on vertebrate
animals.
Where data is requested with a view to inclusion in
Annex I of an active substance already on the market two years after
notification of this Directive, the competent authorities of the
Member State shall encourage data holders to cooperate in the
provision of the requested data, with a view to limiting the
duplication of testing on vertebrate animals.
If, nevertheless,
the applicant and holders of previous authorizations of the same
product can still not reach an agreement on the sharing of data,
Member States may introduce national measures obliging the applicant
and holders of previous authorizations located within their
territory to share the data with a view to avoiding duplicative
testing on vertebrate animals and determine both the procedure for
utilizing information, and the reasonable balance of the interests
of the parties concerned.
Article 14
Member States and
the Commission shall, without prejudice to Council Directive
90/313/EEC of 7 June 1990 on the freedom of access to information on
the environment (6), ensure that information submitted by applicants
involving industrial and commercial secrets is treated as
confidential if the applicant wishing to have an active substance
included in Annex I or the applicant for authorization of a plant
protection product so requests, and if the Member State or the
Commission accepts that the applicant's request is warranted.
Confidentiality shall not apply to:
- the names and content
of the active substance or substances and the name of the plant
protection product,
- the name of other substances which are
regarded as dangerous under Directives 67/548/EEC and 78/631/EEC,
- physico-chemical data concerning the active substance and
plant protection product,
- any ways of rendering the active
substance or plant protection product harmless,
- a summary of
the results of the tests to establish the substance's or product's
efficacy and harmlessness to humans, animals, plants and the
environment,
- recommended methods and precautions to reduce
handling, storage, transport, fire or other hazards,
- methods
of analysis referred to in Articles 4 (1) (c) and (d) and 5 (1),
- methods of disposal of the product and of its packaging,
-
decontamination procedures to be followed in the case of accidential
spillage or leakage,
- first aid and medical treatment to be
given in the case of injury to persons.
If the applicant
subsequently discloses previously confidential information, he shall
be required to inform the competent authority accordingly.
Packaging and labelling of plant protection products
Article 15
Article 5
(1) of Directive 78/631/EEC
shall apply to all plant protection products not covered by
Directive 78/631/EEC.
Article 16
Member States shall
take all necessary measures to ensure that the packaging of plant
protection products satisfies the following requirements as to
labelling.
1. All packaging must show clearly and indelibly the
following:
(a) the trade name or designation of the plant
protection product;
(b)
the name and address of the holder of
the authorization and the authorization number of the plant
protection product and, if different, the name
and address of the
person responsible for the final packaging and labelling or for the
final labelling of the plant protection product on the market;
(c)
the name and amount of each active substance expressed as
provided for in Article 6 of Directive 67/548/EEC and in particular
paragraph (2) (d) of that Article.
The name must be as given in
the list contained in Annex I to Directive 67/548/EEC or, if not
included therein, its ISO common name. If the latter is not
available, the active substance shall be designated by its chemical
designation according to IUPAC rules;
(d)
the net quantity of
plant protection product given in legal units of measurement;
(e)
the formulation batch number or some means of identifying
it;
(f)
the particulars required under Article 6 of Directive
78/631/EEC, in particular those mentioned in paragraph 2 (d), (g),
(h) and (i), and paragraphs 3 and 4 of that Article and information
on first aid;
(g)
the nature of any special risks for humans,
animals or the environment, by means of standard phrases selected as
appropriate from those given in Annex IV;
(h)
safety
precautions for the protection of humans, animals or the
environment, in the form of standard phrases selected as appropriate
from those given in Annex V;
(i)
the type of action of the
plant protection product (e.g. insecticide, growth regulator,
weedkiller, etc.);
(j)
the type of preparation (e.g. wettable
powder, emulsifiable concentrate, etc.);
(k)
the uses for
which the plant protection product has been authorized and any
specific agricultural, plant health and environmental conditions
under which the product may be used or should not be used;
(l)
directions for use and the dose rate, expressed in metric
units, for each use provided for under the terms of the
authorization;
(m)
where necessary, the safety interval for
each use between application and:
- sowing or planting of the
crop to be protected,
- sowing or planting of succeeding crops,
- access by humans or animals,
- harvesting,
- use or
consumption;
(n)
particulars of possible phytotoxicity,
varietal susceptibility, and any other direct or indirect
adverse
side effects on plants or products of plant origin together with the
intervals to be observed between application and sowing or planting
of:
- the crop in question, or
- subsequent crops;
(o)
if accompanied by a leaflet, as provided for in paragraph
2, the sentence 'Read accompanying instructions before use';
(p)
directions for safe disposal of the plant protection
product and of the packaging; and
(q)
the expiry date relevant
to normal conditions of storage where the shelf life of the product
is limited to less than two years.
2. Member States may permit
the requirements in paragraph 1 (l), (m) and (n) to be indicated on
a separate leaflet accompanying the package if the space available
on the package is too small. Such a leaflet shall be regarded as
part of the label for the purposes of this Directive.
3. Taking
account of the rules in force within their territories regarding the
supply of certain plant protection products to certain categories of
users, pending Community harmonization, the Member States shall
require that it be indicated on the label whether a product is
restricted to certain categories of users.
4. In no
circumstances may the label of the packaging of a plant protection
product bear the indications 'non-toxic', 'harmless', or similar
indications. However, information to the effect that the plant
protection product may be used when bees or other non-target species
are active, or when crops or weeds are in flower or other such
phrases to protect bees or other non-target species may be given on
the label, if the authorization relates explicitly to use during the
season for bees or other specified organisms and presents minimal
hazard to them.
5. Member States may make the placing of plant
protection products on the market in their territories subject to
their being labelled in their national language or languages, and
may require that samples, models or drafts of the packaging,
labelling and leaflets referred to in this Article be submitted.
By way of derogation from paragraph 1 (g) and (h), Member States
may require additional phrases to be clearly and indelibly marked on
packaging where they are deemed to be necessary for the protection
of human beings, animals or the environment; in that event they
shall notify the other Member States and the
Commission forthwith
of each derogation granted and shall forward the additional phrase
or phrases and the reasons for these requirements.
In accordance
with the procedure laid down in Article 19, a decision shall be
taken that the additional phrase or phrases is or are justified and
hence that Annexes IV and V must be amended accordingly, or that the
Member States concerned must no longer require such phrase(s). The
Member State shall be entitled to maintain its requirement until
such time as a decision has been taken.
Control measures
Article 17
Member States shall make the necessary
arrangements for plant protection products which have been placed on
the market and for their use to be officially checked to see whether
they comply with the requirements of this Directive and in
particular with the requirements of the authorization and
information appearing on the label.
The Member States shall
report annually before 1 August to the other Member States and the
Commission on the results of the inspection measures taken in the
previous year.
Administrative provisions
Article 18
1. The Council, acting by a qualified majority on a proposal
from the Commission, shall adopt the 'uniform principles' referred
to in Annex VI.
2. In accordance with the procedure laid down in
Article 19 and having regard to current scientific and technical
knowledge, the necessary amendments to Annexes II, III, IV, V and VI
shall be adopted.
Article 19
Where the procedure laid
down in this Article is to be followed, matters shall be referred
without delay by the chairman, either on his own initiative or at
the request of a Member State, to the Standing Committee on Plant
Health, set up by Decision 76/894/EEC (7), herinafter referred to as
'the Committee'.
The representative of the Commission shall
submit to the committee a draft of the measures to be taken. The
committee shall deliver its opinion on the draft within a time limit
which the chairman may lay down according to the urgency of the
matter. The opinion shall be delivered by the
majority laid down
in Article 148 (2) of the Treaty. The votes of the representatives
of the Member States within the committee shall be weighted in the
manner set out in that Article. The chairman shall not vote.
The
Commission shall adopt the measures envisaged if they are in
accordance with the opinion of the committee.
If the measures
envisaged are not in accordance with the opinion of the committee,
or if no opinion is delivered, the Commission shall, without delay,
submit to the Council a proposal relating to the measures to be
taken. The Council shall act by a qualified majority.
If, on the
expiry of a period of three months from the date of referral to the
Council, the Council has not acted, the proposed measures shall be
adopted by the Commission.
Article 20
Where the
procedure laid down in this Article is to be followed, matters shall
be referred by the chairman, either on his own initiative or at the
request of a Member State, to the committee.
The representative
of the Commission shall submit to the Committee a draft of the
measures to be taken. The committee shall deliver its opinion on the
draft, within a time limit which the chairman may lay down according
to the urgency of the matter, if necessary by taking a vote.
The
Commission shall adopt the measures envisaged if they are in
accordance with the opinion of the committee.
If the measures
envisaged are not in accordance with the opinion of the committee,
or if no opinion is delivered, the Commission shall, without delay,
submit to the Council a proposal relating to the measures to be
taken. The Council shall act by a qualified majority.
If, on the
expiry of a period of 15 days from the date of referral to the
Council, the Council has not acted, the proposed measures shall be
adopted by the Commission.
Article 21
Where the
procedure laid down in this Article is to be followed, matters shall
be referred by the Chairman, either on his own initiative or at the
request of a Member State, to the committee.
The representative
of the Commission shall submit to the committee a draft of the
measures to be taken. The
committee shall deliver its opinion on
the draft, within a time limit which the chairman may lay down
according to the urgency of the matter, if necessary by taking a
vote.
The opinion shall be recorded in the minutes; in addition,
each Member State shall have the right to ask to have its position
recorded in the minutes.
The Commission shall take the utmost
account of the opinion delivered by the committee. It shall inform
the committee of the manner in which its opinion has been taken into
account.
Research and development
Article 22
1. The
Member States shall prescribe that any experiment or test for
research or development purposes involving the release into the
environment of an unauthorized plant protection product may only be
carried out after authorization for trial purposes has been granted
and under controlled conditions and for limited quantities and
areas.
2. The persons concerned shall submit an application to
the competent authority of the Member State in whose territory the
experiment or test is to be conducted, within time periods
prescribed by the Member State before the commencement of the
experiment or test, together with a dossier containing all the
available data to permit an assessment to be made of possible
effects on human or animal health or the possible impact on the
environment.
If the proposed experiments or tests referred to in
paragraph 1 are liable to have harmful effects on human or animal
health or to have an unacceptable adverse influence on the
environment, the Member State concerned may either prohibit them or
permit them subject to such conditions as it considers necessary to
prevent those consequences.
3. Paragraph 2 shall not apply if
the Member State has 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.
4. Common conditions for the application of this
Article, in particular the maximum quantities of pesticides that may
be released during experiments covered by paragraph 1, and the
minimum data to be submitted in accordance with paragraph 2, shall
be adopted in accordance with the procedure laid down in Article 19.
5. This Article shall not apply to experiments or tests covered
by Part B of Directive 90/220/EEC.
Implementation of the
Directive
Article 23
1. Member States shall bring into force
the laws, regulations and administrative provisions necessary to
comply with this Directive within two years following notification
thereof. They shall immediately inform the Commission thereof. The
uniform principles shall be adopted one year after the date of
notification.
When Member States adopt these measures, they
shall contain a reference to this Directive or shall be accompanied
by such reference on the occasion of their official publication. The
methods of making such a reference shall be laid down by the Member
States.
2. Paragraph 1 notwithstanding, Member States need not
bring into force laws, regulations and administrative
provisions
implementing Article 10 (1), second indent, until one year at the
latest following adoption of the uniform principles, and only in
relation to the requirements of Article 4 (1) (b) to (e) which are
covered by the uniform principles thus adopted.
Article 24
This Directive is addressed to the Member States.
Done at
Brussels, 15 July 1991.
For the Council
The President
P.
BUKMAN
(1) OJ No C 89, 10. 4. 1989, p. 22.(2) OJ No C 72, 18.
3. 1991, p. 33.(3) OJ No C 56, 7. 3. 1990, p. 3.(4) OJ No L 158, 23.
6. 1990, p. 56.(5) OJ No L 340, 9. 12. 1976, p. 25.
ANNEX I
ACTIVE SUBSTANCES AUTHORIZED FOR INCORPORATION IN PLANT
PROTECTION PRODUCTS
ANNEX II
REQUIREMENTS FOR THE DOSSIER TO
BE SUBMITTED FOR THE INCLUSION OF AN ACTIVE SUBSTANCE IN ANNEX I
INTRODUCTION The information shall include:
- a technical
dossier supplying the information necessary for evaluating the
foreseeable risks, whether immediate or delayed, which the substance
may entail for humans and the environment and containing at least
the information and results of the studies referred to below,
together with a detailed and full description of the studies
conducted and of the methods used or a bibliographical reference to
them,
- the proposed classification and labelling of the
substance in accordance with Directive 67/548/EEC.
However,
certain pieces of information which would not be necessary owing to
the nature of the substance or of its proposed uses need not be
supplied. In such cases, or where it is not scientifically necessary
or technically possible to supply information, a justification which
is acceptable to the Commission in accordance with Article 6 must be
submitted.
Tests must be conducted according to the methods
described in Annex V to Directive 79/831/EEC or, in the event of a
method being inappropriate or not described, other methods used must
be justified. Tests must be conducted in accordance with the
requirements of Directive 86/609/EEC and the principles laid down in
Directive 87/18/EEC (; ).
PART A
Chemical substances
($)
1.
Identity of the active substance
1.1.
Applicant
(name, address, etc.)
1.2.
Manufacturer (name, address,
including location of plant)
1.3.
Common name proposed or
ISO-accepted, and synonyms
1.4.
Chemical name (IUPAC
nomenclature)
1.5.
Manufacturer's development code
number(s)
1.6.
CAS and EEC numbers (if available)
1.7.
Empirical and structural formula, molecular mass
1.8.
Method of manufacture (synthesis pathway) of the active
substance
1.9.
Specification of purity of the active
substance in g/kg or g/l as appropriate
1.10.
Identity of
isomers, impurities and additives (e.g. stabilizers), together with
the structural formula and the possible range expressed as g/kg or
g/l as appropriate
(; ) OJ No L 15, 17. 1. 1987, p. 29.
($)
Substance within the meaning of the definition of Article 2, point
3.
2.
Physical and chemical properties of the active
substance
2.1.
Melting point, boiling point, relative density
(; )
2.2.
Vapour pressure (in Pa) at 20 oC, volatility (e.g.
Henry's law constant) (; )
2.3.
Appearance (physical state,
colour and odour; if appropriate, threshold concentrations for
substances with intense odour or taste in water) ($)
2.4.
Absorption spectra (UV/VIS, IR, NMR, MS), molecular extinction
at relevant wavelengths (; )
2.5.
Solubility in water
including effect of pH (5 to 9) and temperature on solubility (;
)
2.6.
Solubility in organic solvents including effect of
temperature on solubility (; )
2.7.
Partition coefficient
N-octanol/water including effect of pH (5 to 9) and temperature (;
)
2.8.
Stability in water, hydrolysis rate, photochemical
degradation, quantum yield and identity of breakdown product(s),
dissociation constant including effect of pH (5 to 9) (; )
2.9.
Stability in air, photochemical degradation, identity of
breakdown product(s) ($)
2.10.
Stability in organic solvents
used in preparations ($)
2.11.
Thermal stability, identity of
breakdown products
2.12.
Flammability including
auto-flammability and identity of combustion products
2.13.
Flash point
2.14.
Surface tension
2.15.
Explosive
properties
2.16.
Oxidizing properties
2.17.
Reactivity
towards container material
3.
Further information on the
active substance
3.1.
Function, e.g. fungicide, herbicide,
insecticide, repellant, growth regulator
3.2.
Effects on
harmful organisms, e.g. contact poison, inhalation poison, stomach
poison, fungitoxic or fungistatic, etc., systemic or not in
plants
3.3.
Field of use envisaged, e.g. field, glasshouse,
food or feed storage, home garden
3.4.
Where necessary, in
the light of the test results, any specific agricultural, plant
health or environmental conditions under which the active substance
may or may not be used.
3.5.
Harmful organisms controlled
and crops or products protected or treated
3.6.
Mode of
action
3.7.
Information on the occurrence or possible
occurrence of the development of resistance and appropriate
management strategies
3.8.
Recommended methods and
precautions concerning handling, storage, transport or fire
3.9.
In case of fire, nature of reaction product, combustion gases,
etc.
(; ) These data must be submitted for the purified active
substance of stated specification.
($) These data must be
submitted for the active substance and the purified active substance
of stated specification.
3.10.
Emergency measures in the
case of an accident
3.10.1.
Procedures for destruction or
decontamination of the active substance
3.10.2.
Possibility
of recovery
3.10.3.
Possibility of neutralization
3.10.4.
Controlled discharge
3.10.5.
Controlled
incineration
3.10.6.
Water purification
3.10.7.
Others
4.
Analytical methods
4.1.
Analytical
methods for the determination of pure active substance and, where
appropriate, for relevant breakdown products, isomers and impurities
of the active substance and additives (e.g. stabilizers)
4.2.
Analytical methods including recovery rates and the limits of
determination for residues in, and where relevant on, the following:
4.2.1.
Treated plants, plant products, foodstuffs,
feedingstuffs
4.2.2.
Soil
4.2.3.
Water (including
drinking water)
4.2.4.
Air
4.2.5.
Animal and human
body fluids and tissues
5.
Toxicological and metabolism
studies on the active substance
5.1.
Acute toxicity
5.1.1.
Oral
5.1.2.
Percutaneous
5.1.3.
Inhalation
5.1.4.
Intraperitoneal
5.1.5.
Skin and
where appropriate eye irritation
5.1.6.
Skin
sensitization
5.2.
Short-term toxicity
5.2.1.
Oral
cumulative toxicity (28-day study)
5.2.2.
Oral administration
- two species, one rodent (preferably rat) and one non-rodent,
usually 90-day study
5.2.3.
Other routes (inhalation,
percutaneous as appropriate)
5.3.
Chronic toxicity
5.3.1.
Oral long-term toxicity and carcinogenicity (rat and other
mammalian species) - other routes as appropriate
5.4.
Mutagenicity - test battery to assess gene mutations,
chromosomal aberrations and DNA perturbations
5.5.
Reproductive toxicity
5.5.1.
Teratogenicity studies -
rabbit and one rodent species, oral and when appropriate
percutaneous
5.5.2.
Multigeneration studies in mammals (at
least two generations)
5.6.
Metabolism studies in
mammals
5.6.1.
Absorption, distribution and excretion studies
- following both oral and percutaneous administration
5.6.2.
Elucidation of metabolic pathways
5.7.
Neurotoxicity
studies - including where appropriate delayed neurotoxicity tests in
adult hens
5.8.
Supplementary studies
5.8.1.
Toxic
effects of metabolites from treated plants in cases where different
from those identified in animal studies
5.8.2.
Any
mechanistic studies needed to clarify effects reported in toxicity
studies
5.9.
Toxic effects on livestock and pets
5.10.
Medical data
5.10.1.
Medical surveillance on
manufacturing plant personnel
5.10.2.
Direct observation,
e.g. clinical cases and poisoning incidents
5.10.3.
Health
records, both from industry and agriculture
5.10.4.
Observations on exposure of the general population and
epidemiological studies if appropriate
5.10.5.
Diagnosis of
poisoning (determination of active substance, metabolites), specific
signs of poisoning, clinical tests
5.10.6.
Sensitization/allergenicity observations
5.10.7.
Proposed
treatment: first aid measures, antidotes, medical
treatment
5.10.8.
Prognosis of expected effects of
poisoning
5.11.
Summary of mammalian toxicology and
conclusions (including no observable adverse effect level (NOAEL),
no observable effect level (NOEL), acceptable daily intake (ADI).
Overall evaluation with regard to all toxicological data, and other
information concerning the active substance
6.
Residues in or
on treated products, food and feed
6.1.
Identification of
breakdown and reaction products and of metabolites in treated plants
or products
6.2.
Behaviour of residue of the active substance
and its metabolites from the time of application until harvest or
outloading of stored products - uptake and distribution in, and
where relevant on, plants, kinetics of disappearance, binding to
plant constituents, etc.
6.3.
Overall material balance for
the active substance. Sufficient residue data from supervised trials
to demonstrate that residues likely to arise from the proposed
treatments would not be of concern for human and animal
health
6.4.
Estimation of the potential and actual exposure
through diet and other means, such as residue monitoring data for
products in the distribution chain, or such as data concerning
exposure via air, water, etc.
6.5.
Feeding and metabolism
studies in livestock (if residues remain in or on crops or parts of
crops used for feed) to permit evaluation of residues in foodstuffs
of animal origin
6.6.
Effects of industrial processing and/or
household preparation on the nature and magnitude of
residues
6.7.
Summary and evaluation of residue behaviour
resulting from data submitted pursuant to points 6.1 to 6.6
7.
Fate and behaviour in the environment
7.1.
Fate and
behavoir in soil
7.1.1.
Rate and route of degradation (to 90
per cent degradation) including identification of the processes
involved and identification of metabolites and breakdown products in
at least three soil types under appropriate conditions.
7.1.2.
Adsorption and desorption in at least three soil types and where
relevant adsorption and desorption of metabolites and breakdown
products
7.1.3.
Mobility in at least three soil types and
where relevant mobility of metabolites and breakdown
products
7.1.4.
Extent and nature of bound residues
7.2.
fate and behaviour in water and air
7.2.1.
Rate and route
of degradation in aquatic systems - biodegradation, hydrolysis,
photolysis (as far as not covered by point 2.8), including
identification of metabolites and breakdown products
7.2.2.
Adsorption and desorption in water (sedimentation) and where
relevant adsorption and desorption of metabolites and breakdown
products
7.2.3.
Rate and route of degradation in air (for
fumigants and other volatile active substances) (as far as not
covered by point 2.9)
8.
Ecotoxicological studies on the
active substance
8.1.
Effects on birds
8.1.1.
Acute
oral toxicity
8.1.2.
Short-term toxicity - eight-day dietary
study in at least one species (other than chicken)
8.1.3.
Effects on reproduction
8.2.
Effects on aquatic
organisms
8.2.1.
Acute toxicity to fish
8.2.2.
Chronic
toxicity to fish
8.2.3.
Effects on fish reproduction and
growth rate
8.2.4.
Bioaccumulation in fish
8.2.5.
Acute toxicity for Daphnia magna
8.2.6.
Daphnia magna
reproduction and growth rate
8.2.7.
Effects on algal
growth
8.3.
Effects on other non-target organisms
8.3.1.
Acute toxicity to honeybees and other beneficial arthropods
(e.g. predators)
8.3.2.
Toxicity to earthworms and to other
soil non-target macro-organisms
8.3.3.
Effects on soil
non-target micro organisms
8.3.4.
Effects on other non-target
organisms (flora and fauna) believed to be at risk
8.3.5.
Effects on biological methods for sewage treatment
9.
Summary and evaluation of points 7 and 8
10.
Proposals
including justification for the proposals for the classification and
labelling of the active substance according to Council Directive
67/548/EEC
- Hazard symbol(s)
- Indications of danger
-
Risk phrases
- Safety phrases
11.
A dossier as referred to
in Annex III, part A, for a representative plant protection
product
PART B Micro-organisms and viruses (this part does not
apply to GMOs where points come under Directive 90/220/EEC)
1.
Identity of the organism
1.1.
Applicant (name, address,
etc.)
1.2.
Manufacturer (name, address, including location of
plant)
1.3.
Common name or alternative and superseded
names
1.4.
Taxonomic name and strain for bacteria, protozoa
and fungi, indication whether it is a stock variant or a mutant
strain; for viruses the taxonomic designation of the agent,
serotype, strain or mutant
1.5.
Collection and culture
reference number where the culture is deposited
1.6.
The
appropriate test procedures and criteria used for identification
(e.g. morphology, biochemistry, serology)
1.7.
Composition -
microbiological purity, nature, identity, properties, content of any
impurities and extraneous organisms
2.
Biological properties
of the organism
2.1.
Target organism. Pathogenicity or kind
of antagonism to host, infective dose, transmissibility and
information on mode of action
2.2.
History of the organism
and its uses. Natural occurrence and geographical
distribution
2.3.
Host specificity range and effects on
species other than the target harmful organism including species
most closely related to the target species - to include infectivity,
pathogenicity and transmissibility
2.4.
Infectivity and
physical stability when used according to the proposed method.
Effect of temperature, exposure to air radiation, etc. Persistence
under the likely environmental conditions of use
2.5.
Whether
the organism is closely related to a plant pathogen or to a pathogen
of a vertebrate species or a non-target invertebrate species
2.6.
Laboratory evidence of genetic stability (i.e. mutation rate)
under environmental conditions of proposed use
2.7.
Presence,
absence or production of toxins as well as their nature, identity,
chemical structure (if appropriate) and stability
3.
Further
information on the organism
3.1.
Function, e.g. fungicide,
herbicide, insecticide, repellant, growth regulator
3.2.
Effects on harmful organisms, e.g. contact poison, inhalation
poison, stomach poison, fungitoxic or fungistatic, etc., systemic or
not in plants
3.3.
Field of use envisaged, e.g. field,
glasshouse, food or feed storage, home garden
3.4.
Where
necessary, in the light of the test results, any specific
agricultural, plant health or environmental conditions under which
the active substance may or may not be used
3.5.
Harmful
organisms controlled and crops or products protected or
treated
3.6.
Method of production with descriptions of the
techniques used to ensure a uniform product and of assay methods for
its standardization. In the case of a mutant, detailed information
should be provided on its production and isolation, together with
all known differences between the mutant and the parent wild
strains
3.7.
Methods to prevent loss of virulence of seed
stock
3.8.
Recommended methods and precautions concerning
handling, storage, transport or fire
3.9.
Possibility of
rendering the organism uninfective
4.
Analytical
methods
4.1.
Methods for establishing the identity and purity
of seed stock from which batches are produced and results obtained,
including information on variability
4.2.
Methods to show
microbiological purity of the final product and showing that
contaminants have been controlled to an acceptable level, results
obtained and information on variability
4.3.
Methods used to
show that there are no human or other mammalian pathogens as
contaminants in the active agent, including in the case of protozoa
and fungi, the effects of temperature (35 oC and other relevant
temperatures)
4.4.
Methods to determine viable and non-viable
(e.g. toxins) residues in or on treated products, foodstuffs,
feedingstuffs, animal and human body fluids and tissues, soil, water
and air, where relevant
5.
Toxicological, pathogenicity and
infectivity studies
5.1.
Bacteria, fungi, protozoa and
mycoplasma
5.1.1.
Toxicity and/or pathogenicity and
infectivity
5.1.1.1.
Oral single dose
5.1.1.2.
In
cases where a single dose is not appropriate to assess
pathogenicity, a set of range-finding texts must be carried out to
reveal highly toxic agents and infectivity
5.1.1.3.
Percutaneous single dose
5.1.1.4.
Inhalation single
dose
5.1.1.5.
Intraperitoneal single dose
5.1.1.6.
Skin and, where necessary, eye irritation
5.1.1.7.
Skin
sensitization
5.1.2.
Short-term toxicity (90 days
exposure)
5.1.2.1.
Oral administration
5.1.2.2.
Other
routes (inhalation, percutaneous as appropriate)
5.1.3.
Supplementary toxicological and/or pathogenicity and infectivity
studies
5.1.3.1.
Oral long-term toxicity and
carcinogenicity
5.1.3.2.
Mutagenicity - (tests as referred to
under point 5.4 of part A)
5.1.3.3.
Teratogenicity
studies
5.1.3.4.
Multigeneration study in mammals (at least
two generations)
5.1.3.5.
Metabolic studies - absorption,
distribution and excretion in mammals including elucidation of
metabolic pathways
5.1.3.6.
Neurotoxicity studies, including
where appropriate delayed neurotoxicity tests in adult
hens
5.1.3.7.
Immunotoxicity, e.g. allergenicity
5.1.3.8.
Pathogenicity and infectivity under immunosuppression
5.2.
Viruses, viroids
5.2.1.
Acute toxicity and/or
pathogenicity and infectivity. Data as outlined under point 5.1.1
and cell culture studies using purified infective virus and primary
cell cultures of mammalian, avian and fish cells
5.2.2.
Short-term toxicity
Data as outlined under point 5.1.2 and
tests for infectivity carried out by bio-assay or on a suitable cell
culture at least seven days after the last administration to the
test animals
5.2.3.
Supplementary toxicological and/or
pathogenicity and infectivity studies as outlined under point
5.1.3
5.3.
Toxic effects on livestock and pets
5.4.
Medical data
5.4.1.
Medical surveillance on manufacturing
plant personnel
5.4.2.
Health records, both from industry and
agriculture
5.4.3.
Observations on exposure of the general
population and epidemiological data, if appropriate
5.4.4.
Diagnosis of poisoning, specific signs of poisoning, clinical
tests, if appropriate
5.4.5.
Sensitization/allergenicity
observations, if appropriate
5.4.6.
Proposed treatment: first
aid measures, antidotes, medical treatment, if appropriate
5.4.7.
Prognosis of expected effects of poisoning, if
appropriate
5.5.
Summary of mammalian toxicology and
conclusions (including NOAEL, NOEL and ADI, if appropriate). Overall
evaluation with regard to all toxicological pathogenicity and
infectivity data, and infectivity and other information concerning
the active substance
6.
Residues in or on treated products,
food and feed
6.1.
Identification of viable and non-viable
(e.g. toxins) residues in or on treated plants or products, the
viable residue by culture or bio-assay and the non-viable by
appropriate techniques
6.2.
Likelihood of multiplication of
the active substance in or on crops or food together with a report
on any effect on food quality
6.3.
In cases where residues of
toxins remain in or on an edible plant product, data as outlined
under points 4.2.1 and 6 of part A are required
6.4.
Summary
and evaluation of residue behaviour resulting from data submitted
under points 6.1 to 6.3
7.
Fate and behaviour in the
environment
7.1.
Spread, mobility, multiplication and
persistence in air, water, soil
7.2.
Information concerning
possible fate in food chains
7.3.
In cases where toxins are
produced, data as outlined under part A, point 7 are required, where
relevant
8.
Ecotoxicological studies
8.1.
Birds -
acute oral toxicity and/or pathogenicity and infectivity
8.2.
Fish - acute toxicity and/or pathogenicity and
infectivity
8.3.
Toxicity - Daphnia magna (if
appropriate)
8.4.
Effects on algal growth
8.5.
Important parasites and predators of target species; acute
toxicity and/or pathogenicity and infectivity
8.6.
Honey-bees: acute toxicity and/or pathogenicity and
infectivity
8.7.
Earthworms: acute toxicity and/or
pathogenicity and infectivity
8.8.
Other non-target organisms
believed to be at risk: acute toxicity and/or pathogenicity and
infectivity
8.9.
Extent of indirect contamination on adjacent
non-target crops, wild plants, soil and water
8.10.
Effects
on other flora and fauna
8.11.
In cases where toxins are
produced, data as outlined under Part A, points 8.1.2, 8.1.3, 8.2.2,
8.2.3, 8.2.4, 8.2.5, 8.2.6, 8.2.7 and 8.3.3 are required, where
relevant
9.
Summary and evaluation of points 7 and 8
10.
Proposals including justification of the proposals for the
classification and labelling of the active substance in accordance
with Directive 67/548/EEC
- Hazard symbol(s)
- Indications of
danger
- Risk phrases
- Safety phrases
11.
A dossier as
referred to in Annex III, part B, for a representative plant
protection product.
ANNEX III
REQUIREMENTS FOR THE
DOSSIER TO BE SUBMITTED FOR THE AUTHORIZATION OF A PLANT PROTECTION
PRODUCT INTRODUCTION
The information required shall include:
- a technical dossier supplying the information necessary for
evaluating efficacy and the foreseeable risks, whether immediate or
delayed, which the plant protection product may entail for humans
and the environment and containing at least the information and
results of the studies referred to below, together with a detailed
and full description of the studies conducted and of the methods
used or a bibliographical reference to them,
- the proposed
classification and labelling of the plant protection product in
accordance with relevant Community Directives.
In individual
cases it may be necessary to require information as provided for in
Annex II, Part A, for formulants (e.g. solvents and synergists).
However, certain pieces of information which would not be
necessary owing to the nature of the product or of its proposed uses
need not be supplied. In such cases, or where it is not
scientifically necessary, or technically possible to supply
information, a justification which is acceptable to the competent
authorities must be submitted.
Tests must be conducted according
to the methods described in Annex V to Directive 79/831/EEC or, in
the event of a method being inappropriate or not described, other
methods used must be justified. Tests must be conducted in
accordance with the requirements of Directive 86/609/EEC and the
principles laid down in Directive 87/18/EEC.
PART A Chemical
preparations 1.
Identity of the plant protection product
1.1.
Applicant (name and address, etc.)
1.2.
Manufacturer of
the preparation and the active substance(s) (names and addresses,
etc. including location of plants)
1.3.
Trade name or
proposed trade name, and manufacturer's development code number for
the preparation, if appropriate
1.4.
Detailed quantitative
and qualitative information on the composition of the preparation
(active substance(s)), impurities, adjuvants, inert components,
etc.)
1.5.
Physical state and nature of the preparation
(emulsifiable concentrate, wettable powder, solution etc.)
1.6.
Use category (herbicide, insecticide, etc.)
2.
Physical,
chemical and technical properties of the plant protection
product
2.1.
Appearance (colour and odour)
2.2.
Explosivity and oxidizing properties
2.3.
Flash point and
other indications of flammability or spontaneous ignition
2.4.
Acidity/alkalinity and if necessary pH value (1 % in
water)
2.5.
Viscosity, surface tension
2.6.
Relative
density
2.7.
Storage stability - stability and shelf-life.
Effects of light, temperature and humidity on technical
characteristics of the plant protection product
2.8.
Technical characteristics of the plant health product
2.8.1.
Wettability
2.8.2.
Persistent foaming
2.8.3.
Suspensibility and suspension stability
2.8.4.
Wet sieve
test and dry sieve test
2.8.5.
Particle size distribution,
content of dust/fines, attrition and friability
2.8.6.
In the
case of granules: sieve test and indication of weight distribution
of the granules, at least of the fraction with particle sizes bigger
than 1 mm
2.8.7.
Content of active substance in or on bait
particles, granules or treated seed
2.8.8.
Emulsifiability,
re-emulsifiability, emulsion stability
2.8.9.
Flowability,
pourability and dustability
2.9.
Physical and chemical
compatibility with other products including plant protection
products with which its use is to be authorized
2.10.
Wetting, adherence and distribution to target plants
3.
Data on application
3.1.
Field of use, e.g. field,
glasshouse, food or feed storage, home garden
3.2.
Effects on
harmful organisms, e.g. contact poison, inhalation poison or stomach
poison, fungitoxic or fungistatic, etc., systemic or not in
plants
3.3.
Details of intended use, e.g. types of harmful
organisms controlled and/or plants or plant products to be
protected
3.4.
Where necessary, in the light of the test
results, any specific agricultural, plant health and/or
environmental conditions under which the organism may or may not be
used
3.5.
Application rate
3.6.
Concentration of
active substance in material used (e.g. in the diluted spray, bait
or treated seed)
3.7.
Method of application
3.8.
Number and timing of applications and duration of
protection
3.9.
Necessary waiting periods or other
precautions to avoid phytotoxic effects on succeeding crops
3.10.
Proposed instructions for use
4.
Further information on
the plant protection product
4.1.
Packaging (type, materials,
size, etc.), compatibility of the preparation with proposed
packaging materials
4.2.
Procedures for cleaning application
equipment
4.3.
Re-entry periods, necessary waiting periods or
other precautions to protect humans and animals
4.4.
Recommended methods and precautions concerning handling,
storage, transport or fire
4.5.
Emergency measures in case of
an accident
4.6.
Identity of combustion products relevant to
cases of fire
4.7.
Procedures for destruction or
decontamination of the plant protection product and its
packaging
4.7.1.
Possibility of neutralization
4.7.2.
Controlled discharge
4.7.3.
Controlled
incineration
4.7.4.
Water purification
4.7.5.
Others
5.
Analytical methods
5.1.
Analytical
methods for determining the composition of the plant protection
product
5.2.
In so far as not covered by Annex II, Part A,
point 4.2, analytical methods including recovery rates and the
limits of determination for residues in and where relevant on, the
following;
5.2.1.
Treated plants, plant products,
foodstuffs, feedingstuffs
5.2.2.
Soil
5.2.3.
Water
(including drinking water)
5.2.4.
Air
5.2.5.
Animal
and human body fluids and tissues
6.
Efficacy data
6.1.
Preliminary range-finding tests
6.2.
Field
experimentation
6.3.
Information on the possible occurrence
of the development of resistance
6.4.
Effects on the quality
and where appropriate on the yield of treated plants or effects on
the quality of treated plant products
6.5.
Phytotoxicity to
target plants (including different cultivars), or to target plant
products
6.6.
Observations on undesirable or unintended
side-effects, e.g. on beneficial and other non-target organisms, on
succeeding crops, other plants or parts of treated plants used for
propagating purposes (e.g. seeds, cuttings, runners)
6.7.
Summary and evaluation of data presented under points 6.1 to
6.6
7.
Toxicological studies
7.1.
Acute
toxicity
7.1.1.
Oral
7.1.2.
Percutaneous
7.1.3.
Inhalation
7.1.4.
Skin and, where relevant, eye
irritation
7.1.5.
Skin sensitization
7.1.6.
Where
appropriate, acute dermal toxicity, skin and eye irritation for
combinations of plant protection products for which authorization is
sought for use in such combinations
7.2.
Operator
exposure
7.2.1.
Dermal absorption
7.2.2.
Likely
operator exposure under field conditions, including where relevant
quantitative analysis of operator exposure
7.2.3.
Available
toxicological data relating to non-active substances
8.
Residues in or on treated products, food and feed
8.1.
Data from supervised trials in crops, food or feedingstuffs, for
which authorized use is sought, giving all experimental conditions
and details, including residue data concerning the active substance,
relevant metabolites and relevant other constituents of the plant
protection product, from time of application until harvest, or in
the case of post-harvest treatment, breakdown of residues during
storage and levels of residues at time of release from storage for
marketing. Data should be available for the range of climatic and
agronomic conditions likely to be encountered in the proposed area
of use
8.2.
Effects of industrial processing and/or household
preparation on the nature and magnitude of residues
8.3.
Effects on taint, odour, taste or other quality aspects due to
residues in or on fresh or processed products
8.4.
Estimation
of residues in products of animal origin resulting from ingestion of
feedingstuffs or resulting from contact with bedding, on the basis
of residue data referred to in point 8.1 and studies in livestock
referred to in Annex II, Part A, point 6.5
8.5.
Residue data
in succeeding or rotational crops where presence of residues might
be expected
8.6.
Proposed pre-harvest intervals for envisaged
uses, or witholding periods or storage periods, in the case of
post-harvest uses.
8.7.
Proposed maximum residue levels
(MRLs) and justification of the acceptability of these
residues
8.8.
Summary and evaluation of the residue behaviour
on the basis of the data submitted under points 8.1 to 8.7
9.
Fate and behaviour in the environment
The information
provided must, where relevant, include that referred to in Annex II,
part A, point 7, and
9.1.
Testing for distribution and
dissipation in soil
9.2.
Testing for distribution and
dissipation in water
9.3.
Testing for distribution and
dissipation in air
10.
Ecotoxicological studies
10.1.
Effects on birds
10.1.1.
Acute oral toxicity
10.1.2.
Supervised trials to assess risks to avian species under field
conditions
10.1.3.
If appropriate, studies on acceptance of
bait, granules, or treated seeds by birds
10.2.
Effects on
aquatic organisms
10.2.1.
Acute toxicity to fish
10.2.2.
Acute toxicity to Daphnia magna
10.2.3.
Overspray study
(if toxic to fish or other aquatic organisms and persistent in
water) to assess risks to aquatic organisms under field
conditions
10.2.4.
In case of application in/at surface
waters
10.2.4.1.
Particular studies with fish and other
aquatic organisms
10.2.4.2.
Residue data in fish concerning
the active substance and including toxicologically relevant
metabolites
10.2.5.
The studies referred to in Annex II, Part
A points 8.2.2, 8.2.3, 8.2.4, 8.2.6, and 8.2.7 may be required for
particular plant protection products
10.3.
Effects on other
non-target organisms
10.3.1.
Effects on terrestrial
vertebrates other than birds
10.3.2.
Toxicity to
honey-bees
10.3.3.
Toxicity to foraging bees under field
conditions
10.3.4.
Effects on beneficial arthropods other
than bees
10.3.5.
Effects on earthworms and other soil
non-target macro-organisms, believed to be at risk
10.3.6.
Effects on soil non-target micro-organisms
10.3.7.
Available data from biological primary screening in summary
form
11.
Summary and evaluation of points 9 and 10
12.
Further information
12.1.
Information on authorizations
in other countries
12.2.
Information on established maximum
residue limits (MRL) in other countries
12.3.
Proposals
including justification for the classification and labelling
proposed in accordance with Directive 67/548/EEC and Directive
78/631/EEC
- Hazard symbol(s)
- Indications of danger
-
Risk phrases
- Safety phrases
12.4.
Proposals for risk and
safety phrases in accordance with Article 15 (1), (g) and (h) and
proposed label
12.5.
Specimens of proposed
packaging
PART B Preparations of micro-organisms or viruses
(this part does not apply to GMOs where points come under Directive
90/220/EEC)
1.
Identity of the plant protection
product
1.1.
Applicant (name, address, etc.)
1.2.
Manufacturer of the preparation and the active agent(s) (names,
addresses, etc., including location of plants)
1.3.
Trade
name or proposed trade name and manufacturer's development code
number/or the plant protection product, if appropriate
1.4.
Detailed quantitative and qualitative information on the
composition of the plant protection product (active organism(s),
inert components, extraneous organisms, etc.)
1.5.
Physical
state and nature of the plant protection product (emulsifiable
concentrate, wettable powder, etc.)
1.6.
Use category
(insecticide, fungicide, etc.).
2.
Technical properties of
the plant protection product
2.1.
Appearance (colour and
odour)
2.2.
Storage stabilitiy - stability and shelf-life.
Effects of temperature, method of packaging and storage, etc. on
retention of biological activity
2.3.
Methods for
establishing storage and shelf-life stability
2.4.
Technical
characteristics of the preparation
2.4.1.
Wettability
2.4.2.
Persistent
foaming
2.4.3
Suspensibility and suspension
stability
2.4.4.
Wet sieve test and dry sieve test
2.4.5.
Particle size distribution, content of dust/fines, attrition and
friability
2.4.6.
In the case of granules, sieve test and
indications of weight distribution of the granules, at least of the
fraction with particle sizes bigger than 1 mm
2.4.7.
Content
of active substance in or on bait particles, granules or treated
seed
2.4.8.
Emulsifiability, re-emulsifiability, emulsion
stability
2.4.9.
Flowability, pourability and
dustability
2.5.
Physical and chemical compatibility with
other products including plant protection products with which its
use is to be authorized
2.6.
Wetting, adherence and
distribution to target plants
3.
Data on application
3.1.
Field of use, e.g. field, glasshouse, food or feed storage, home
garden
3.2.
Details of intended use, e.g. types of harmful
organism controlled and/or plants or plant products to be
protected
3.3.
Application rate
3.4.
Where necessary,
in the light of the test results, any specific agricultural, plant
health and/or environmental conditions under which the product may
or may not be used.
3.5.
Concentration of active substance
in material used (e.g. % concentration in the diluted spray)
3.6.
Method of application
3.7.
Number and timing of
applications
3.8.
Phytopathogenicity
3.9.
Proposed
instructions for use
4.
Further information on the
preparation
4.1.
Packaging (type, materials, size, etc.),
compatibility of the preparation with proposed packaging
materials
4.2.
Procedures for cleaning application
equipment
4.3.
Re-entry periods, necessary waiting periods or
other precautions to protect humans and animals
4.4.
Recommended methods and precautions concerning handling,
storage, transport
4.5.
Emergency measures in case of an
accident
4.6.
Procedures for destruction or decontamination
of the plant protection product and its packaging
5.
Analytical methods
5.1.
Analytical methods for
determining the composition of the plant protection product
5.2.
Methods for determining residues in or on treated plants or in
or on plant products (e.g. biotest)
5.3.
Methods used to show
microbiological purity of the plant protection product
5.4.
Methods used to show the plant protection product to be free
from any human and other mammalian pathogens or, if need be, from
honey-bee pathogens
5.5.
Techniques used to ensure a uniform
product and assay methods for its standardization
6.
Efficacy
data
6.1.
Preliminary range-finding tests
6.2.
Field
experimentation
6.3.
Information on the possible occurrence
of the development of resistance
6.4.
Effects on the quality
and where appropriate on the yield of treated plants or effects on
the quality of treated plant products
6.5.
Phytotoxicity to
target plants (including different cultivars), or to target plant
products
6.6.
Observations concerning undesirable or
unintended side-effects, e.g. on beneficial and other non-target
organisms, on succeeding crops, other plants or parts of treated
plants used for propagation purposes (e.g. seeds, cuttings,
runners)
6.7.
Summary and evaluation of data presented under
points 6.1 to 6.6
7.
Toxicity and/or pathogenicity and
infectivity studies
7.1.
Oral single dose
7.2.
Percutaneous single dose
7.3.
Inhalation
7.4.
Skin
and where relevant eye irritation
7.5.
Skin
sensitization
7.6.
Available toxicological data relating to
non-active substances
7.7.
Operator exposure
7.7.1.
Percutaneous absorption
7.7.2.
Likely operator exposure
under field conditions, including where relevant quantitative
analysis of operator exposure.
8.
Residues in or on treated
products, food and feed
8.1.
Residue data concerning the
active substance including data from supervised trials in crops,
food or feedingstuffs for which authorization for use is sought,
giving all experimental conditions and details. Data should be
available for the range of different climatic and agronomic
conditions encountered in the proposed area of use. It is also
necessary to identify viable and non-viable residues in treated
crops
8.2.
Effects of industrial processing and/or household
preparation on the nature and magnitude of residues, if
appropriate
8.3.
Effects on taint, odour, taste or other
quality aspects due to residues on or in fresh or processed
products, if appropriate
8.4.
Residue data in products of
animal origin resulting from ingestion of feedingstuffs or contact
with bedding, if appropriate
8.5.
Residue data in succeeding
or rotational crops where presence of residues might be
expected
8.6.
Proposed pre-harvest intervals for envisaged
uses or witholding periods, or storage periods, in the case of
post-harvest uses
8.7.
Proposed maximum residue levels (MRLs)
and the justification of the acceptability of these levels (for
toxins), if appropriate
8.8.
Summary and evaluation of the
residue behaviour on the basis of the data submitted under points
8.1 to 8.7
9.
Fate and behaviour in the environment
9.1.
In cases where toxins are produced, data as outlined under Part
A, point 9 are required, if appropriate
10.
Ecotoxicological
studies
10.1.
Effects on aquatic organisms
10.1.1.
Fish
10.1.2.
Studies in Daphnia magna and in species
closely related to the target organisms
10.1.3.
Studies in
aquatic micro-organisms
10.2.
Effects on beneficial and other
non-target organisms
10.2.1.
Effects on honey-bees, if
appropriate
10.2.2.
Effects on other beneficial
organisms
10.2.3.
Effects on earthworms
10.2.4.
Effects on other soil fauna
10.2.5.
Effects on other
non-target organisms believed to be at risk
10.2.6.
Effects
on soil microflora
11.
Summary and evaluation of points 9 and
10
12.
Further information
12.1.
Information on
authorizations in other countries
12.2.
Information on
established maximum residue limits (MRLs) in other
countries
12.3.
Proposals including justification for the
classification and labelling proposed in accordance with Directives
67/548/EEC and 78/631/EEC
- Hazard symbol(s)
- Indications of
danger
- Risk phrases
- Safety phrases
12.4.
Proposals
for risk and safety phrases in accordance with Article 15(1)(g) and
(h) and proposed label
12.5.
Specimens of proposed
packaging
ANNEX IV
RISK PHRASES
ANNEX V
SAFETY
PHRASES
ANNEX VI
UNIFORM PRINCIPLES FOR THE EVALUATION OF
PLANT PROTECTION PRODUCTS