1991L0414 — EN — 01.09.1994 — 001.001 — 1
This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents
►B COUNCILDIRECTIVE
of15July1991
concerningtheplacingofplantprotection productsonthemarket
(91/414/EEC)
(OJ L 230, 19.8.1991, p. 1)
Amended by:
Official Journal
No page date
►M1 Commission Directive 93/71/EEC of 27 July 1993 L 221 27 31.8.1993
►M2 Commission Directive 94/37/EC of 22 July 1994 L 194 65 29.7.1994
►M3 Council Directive 94/43/EC of 27 July 1994 L 227 31 1.9.1994
Corrected by:
►C1 Corrigendum, OJ L 170, 25.6.1992, p. 40 (91/414/EEC)
►C2 Corrigendum, OJ L 4, 6.1.1996, p. 16 (93/71/EEC)
▼B
COUNCILDIRECTIVE
of15July1991
concerningtheplacingofplantprotectionproductsonthemarket
(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 Commu-
nity;
Whereas plant production yields are continually affected by harmful
organisms including weeds; whereas it is absolutely essential to protectplants against these risks to prevent a decline in yields and to help toensure security of supplies;
Whereas one of the most important ways of protecting plants and plant
products and of improving agricultural production is to use plantprotection products;
Whereas these plant protection products can have non-beneficial effects
upon plant production; whereas their use may involve risks and hazardsfor humans, animals and the environment, especially if placed on themarket without having been officially tested and authorized and ifincorrectly used;
Whereas, in view of the hazards, there are rules in most Member States
governing the authorization of plant health products; whereas theserules 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 internalmarket;
Whereas it is therefore desirable to eliminate such barriers by harmo-
nizing the provisions laid down in the Member States;
Whereas uniform rules on the conditions and procedures for the author-
ization 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 offi-cially 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 authoriza-
tion of plant protection products whose risks to health, groundwater
and the environment and human and animal health should take priorityover 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 purposeintended, they are sufficiently effective and have no unacceptableeffect on plants or plant products, no unacceptable influence on theenvironment in general and, in particular, no harmful effect on humanor animal health or on groundwater;1991L0414 — EN — 01.09.1994 — 001.001 — 2
(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.
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Whereas authorization should be limited to plant protection products
containing certain active substances specified at Community level onthe 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 aview 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 plantprotection products containing an active substance not yet entered onthe 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 productscan be expected to satisfy the Community conditions set in regard tothem;
Whereas, in the interests of safety, substances on the Community list
should be reviewed periodically, to take account of developments inscience 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 agricul-tural, plant health and environmental (including climatic) conditionsrelevant 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 MemberStates 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 makeavailable to each other on request the particulars and scientific docu-mentation 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 threa-tening plant production which cannot be countered by other means;whereas such authorization should be reviewed by the Community inclose 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 usersof plant protection products and consumers of plants and plantproducts; whereas it also contributes to the protection of the environ-ment;
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 provi-sions relating to maximum permissible levels for pesticide residuesand will facilitate the adoption of such levels in the Commission;whereas together with the latter provisions it considerably improvesthe protection of consumers of plants and plant products;1991L0414 — EN — 01.09.1994 — 001.001 — 3
▼B
Whereas resources devoted to the conduct of tests on vertebrate
animals should not be dissipated as a result of the differences in thelaws 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 provisionsof the Member States regarding the protection of animals used forexperimental and other scientific purposes (
1) militate against needless
repetition of tests on animals;
Whereas, in order to ensure that the requirements laid down are satis-
fied, Member States must make provision for appropriate control andinspection arrangements with regard to the marketing and use of plant
protection products;
Whereas the procedures provided for by this Directive for the evalua-
tion 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 of23 April 1990 on the deliberate release into the environment of geneti-cally modified organisms (
2); 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, andwhereas the procedure of the Standing Committee on Plant Healthoffers 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 the market and control within theCommunity of active substances intended for a use specified in Article2 (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 theMember States relating to the classification, packaging and labelling ofdangerous preparations (pesticides) (
3), as last amended by Directive
84/291/EEC (4) 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 theapproximation of laws, regulations and administrative provisionsrelating to the classification, packaging and labelling of dangeroussubstances (
5), as last amended by Directive 90/517/EEC (6).
3.This Directive applies to the authorization to place on the market
plant protection products containing or composed of genetically modi-fied 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 Dand 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 notifi-cation of this Directive, a proposal for an amendment with a view to1991L0414 — EN — 01.09.1994 — 001.001 — 4
(1) OJ No L 358, 18.12.1986, p.1.
(2) OJ No L 117, 8.5.1990, p.15.
(3) OJ No L 206, 29.7.1978, p.13.
(4) OJ No L 144, 30.5.1984, p.1.
(5) OJ No 196, 16.8.1967, p.1.
(6) OJ No L 287, 19.10.1990, p.37.
▼B
including in this Directive (1) a specific procedure for evaluating the
risk to the environment analogous to that provided for the Directive90/220/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 theEuropean Parliament and the Council with a report on the operationof the arrangements described in the first and second subparagraphs.
4.This Directive shall apply without prejudice to Council Regula-
tion (EEC) No 1734/88 of 16 June 1988 concerning export from andimport into the Community of certain dangerous chemicals (
2).
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 theuser, intended to:
1.1. protect plants or plant products against all harmful organisms or
prevent the action of such organisms, in so far as such substancesor 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 onpreservatives;
1.4. destroy undesired plants; or1.5. 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 andresulting from the use of a plant protection product, including theirmetabolites and products resulting from their degradation or reac-tion;
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; or4.2. 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’1991L0414 — EN — 01.09.1994 — 001.001 — 5
(1) This Directive was notified to the Member States on 26 July 1991.
(2) OJ No L 155, 22.6.1988, p.2.
▼B
products in the unprocessed state or having undergone only simple
preparation such as milling, drying or pressing, derived fromplants, 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 otherpathogens;
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 theCommunity 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 appli-
cant, 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 interrela-
tionship between them, as well as any relationship with livingorganisms;
13.‘integrated control’
the rational application of a combination of biological, biotechno-
logical, chemical, cultural or plant-breeding measures whereby theuse of chemical plant protection products is limited to the strictminimum necessary to maintain the pest population at levelsbelow 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 haveauthorized the product in accordance with this Directive, except wherethe 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 produc-tion, storage or movement of such products intended for use in anotherMember 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 condi-tions 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 integratedcontrol.
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 Direc-
tive 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 theMember States and to the Commission, in accordance with Article6, with the declaration that the active substance is intended for a1991L0414 — EN — 01.09.1994 — 001.001 — 6
▼B
use specified in Article 2 (1).This condition shall not apply to
active substances intended for a use under Article 22.
Granting,reviewandwithdrawalofauthorizationsofplantprotec-
tionproducts
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 inAnnex III, that when used in accordance with Article 3 (3), andhaving regard to all normal conditions under which it may beused, and to the consequences of its use:
(i) it is sufficiently effective;
(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 ongroundwater;
(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 andgroundwater,
— its impact on non-target species;
(c) the nature and quantity of its active substances and, where appro-
priate, any toxicologically or ecotoxicologically significantimpurities and co-formulants can be determined by appropriatemethods, harmonized according to the procedure provided inArticle 21, or, if not, agreed by the authorities responsible for theauthorization;
(d) its residues, resulting from authorized uses, and which are of toxi-
cological 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 andstorage 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, theCommission shall consider whether the provisional maximumlevels established by the Member State are acceptable, and inaccordance 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 maximumlevels are adopted pursuant to the procedure provided for in thesecond subparagraph of Article 1 (1) of Directive 90/462/EEC (
1)
and in Article 11 of Directive 86/362/EEC (2), as amended by
Directive 88/298/EEC (3).1991L0414 — EN — 01.09.1994 — 001.001 — 7
(1) OJ No L 350, 14.12.1990, p.71.
(2) OJ No L 221, 7.8.1986, p.36.
(3) OJ No L 126, 20.5.1988, p.53.
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In particular:
(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 require-
ments set out in paragraph 1 (b) to (f) is established by official orofficially recognized tests and analyses carried out under agricultural,plant health and environmental conditions relevant to use of the plantprotection product in question and representative of these prevailingwhere 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 condi-tions imposed in paragraph 1 are still satisfied.Renewal may begranted for the period necessary to the competent authorities of theMember States, for such verification, where an application for renewalhas been made.
5.Authorizations may be reviewed at any time if there are indica-
tions 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 fieldof application was granted in accordance with Article 9 to submitfurther information necessary for the review.The authorization may,where necessary, be extended for the period necessary to complete areview 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 begranted 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 immedi-
ately 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 thewithdrawal, without prejudice to any period provided for by decisiontaken under Council Directive 79/117/EEC of 21 December 1978prohibiting the placing on the market and use of plant protection
products containing certain active substances (
1), as last amended by
Directive 90/533/EEC (2), or Article 6 (1) or Article 8 (1) or (2) of
this Directive.1991L0414 — EN — 01.09.1994 — 001.001 — 8
(1) OJ No L 33, 8.2.1979, p.36.
(2) OJ No L 296, 27.10.1990, p.63.
▼B
InclusionofactivesubstancesinAnnexI
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 oranimal health or on groundwater or any unacceptable influence onthe environment, and the said residues, in so far as they are of toxi-
cological 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 environmentas 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 envir-
onment 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 require-ments shall be deemed to be satisfied where this has been establishedfor 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 envir-onmental (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 inclu-
sion 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 areview, where an application has been made for such renewal in suffi-cient time, and in any case not less than two years before the entry isdue 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 satis-
fies 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 adossier which is believed to satisfy the requirements of Annex II isforwarded by the applicant to the other Member States and to theCommission together with a dossier complying with Annex III on at1991L0414 — EN — 01.09.1994 — 001.001 — 9
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least one preparation containing that active substance.The Commission
shall refer the dossier to the Standing Committee on Plant Healthreferred 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 ofreferral to the committee mentioned in Article 19, it shall be estab-lished by the procedure laid down in Article 20 whether the dossierhas 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 theapplicant to submit such information.The applicant or his authorizedrepresentative 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 conformitywith the requirements indicated in Article 5 (1) and (2), or if renewalin accordance with Article 5 (5) is being considered.
5.The procedure concerning the submission and appraisal of appli-
cations for inclusion in Annex I and setting or varying any conditions
for inclusion shall be adopted in accordance with the procedure laiddown in Article 21.
Informationonpotentiallyharmfuleffects
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 compe-
tent authority of all new information on the potentially dangerouseffects of any plant protection product, or of residues of an activesubstance on human or animal health or on groundwater, or theirpotentially 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 theinformation to the committee referred to in Article 19.
Transitionalmeasuresandderogations
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 avail-
able for use in agriculture, authorize, for a provisional period notexceeding three years, the placing on the market of plant protectionproducts containing an active substance not listed in Annex I and notyet available on the market two years after notification of this Direc-tive, provided that:
(a) following application of Article 6 (2) and (3) it is found that the
dossier on the active substance satisfies the requirements ofAnnexes 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 protectionproduct 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 informationprovided 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 inArticle 19, that the active substance does not satisfy the requirements1991L0414 — EN — 01.09.1994 — 001.001 — 10
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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 anactive substance in Annex I, a further period may be ordered by theprocedure referred to in Article 19 to enable a full examination to bemade of the dossier and, where appropriate, of any additional informa-tion requested in accordance with Article 6 (3) and (4).
The provisions of Article 4 (2), (3), (5) and (6) shall apply to authori-
zations granted under the terms of this paragraph without prejudice tothe 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 protectionproducts containing active substances not listed in Annex I that arealready on the market two years after the date of notification of thisDirective.
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 foregoingsubparagraph.This programme may require interested parties to submitall requisite data to the Commission and the Member States within aperiod provided for in the programme.A Regulation, adoptedaccording 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 reporton the programme.Depending upon the conclusions of the report, itmay 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 ofsuch active substance, be decided by the procedure laid down in thatArticle 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 submittedwithin the prescribed period, that such active substance will not beincluded in Annex I.The Member States shall ensure that the relevantauthorizations 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 hastaken place, Member States shall apply the requirements laid down inArticle 4 (1) (b) (i) to (v), and (c) to (f) in accordance with nationalprovisions concerning the data to be provided.
4.By way of further derogation from Article 4, in special circum-
stances a Member State may authorize for a period not exceeding 120days the placing on the market of plant protection products notcomplying with Article 4 for a limited and controlled use if such ameasure 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 theCommission of its action.It shall be decided without delay, in accor-dance with the procedure laid down in Article 19, whether and underwhich conditions the action taken by the Member State may beextended for a given period, repeated, or revoked.1991L0414 — EN — 01.09.1994 — 001.001 — 11
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Applicationforauthorization
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 beplaced on the market.
Official or scientific bodies involved in agricultural activities or profes-
sional agricultural organizations and professional users may requestthat 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 suchan 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 meansof 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 reasonableperiod, provided that it has the necessary scientific and technical struc-tures at its disposal.
5.Member States shall ensure that a file is compiled on each appli-
cation.Each file shall contain at least a copy of the application, arecord of the administrative decisions taken by the Member Stateconcerning the application and concerning the particulars and docu-mentation laid down in Article 13 (1) together with a summary of thelatter.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 neces-sary for full comprehension of applications, and shall where requestedensure that applicants provide a copy of the technical documentationlaid down in Article 13 (1) (a).
Mutualrecognitionofauthorizations
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 theuse 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 activesubstances listed in Annex I, also authorize the placing of thatproduct on the market in its territory, to the extent that agricultural,1991L0414 — EN — 01.09.1994 — 001.001 — 12
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plant health and environmental (including climatic) conditions rele-
vant to the use of the product are comparable in the regionsconcerned.
Authorization may be subject to conditions resulting from the imple-
mentation of other measures in accordance with Community law,relating to the conditions for distribution and use of plant protectionproducts 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 dietarypatterns 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 environ-
mental (including climatic) conditions irrelevant for the purpose ofcomparability.
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 theagricultural, plant health and environmental (including climatic) condi-tions relevant to use of the product in the regions concerned in theMember 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 testwas 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 inthe relevant regions of its territory, the decision as to whether or notcomparability exists shall be taken in accordance with the procedurelaid down in Article 19 and, if the decision is negative, it shall alsospecify 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 delayaccept the tests and analyses or authorize the placing of the plantprotection 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, itmay provisionally restrict or prohibit the use and/or sale of that producton its territory.It shall immediately inform the Commission and theother 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 the procedure laid down in Article 19.
Exchangeofinformation
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 writingof any plant protection products authorized or withdrawn, in accor-dance 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,1991L0414 — EN — 01.09.1994 — 001.001 — 13
▼B
— 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 standar-
dized information system shall be set up to facilitate the application
of paragraphs 1 and 2.
Datarequirements, dataprotectionandconfidentiality
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 knowl-edge, 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 exemptedfrom supplying the information required under paragraph 1 (b) exceptfor that identifying the active substance if the active substance isalready listed in Annex I, taking into account the conditions of inclu-
sion in Annex I, and does not differ significantly in degree of purity
and nature of impurities, from the composition registered in the dossieraccompanying 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 appli-
cants:
(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 notificationof 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 AnnexI, or to vary the conditions for, or to maintain the inclusion of an
active substance in Annex I, which has been taken either to vary
the conditions for, or to maintain, the inclusion of an activesubstance in Annex I, unless the five-year period expires beforethe period provided for in paragraphs 3 (b) and (c), in which casethe period of five years shall be extended so as to expire on thesame date as those periods.1991L0414 — EN — 01.09.1994 — 001.001 — 14
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4.In granting authorizations, Member States shall not make use of
the information referred to in Annex III to the benefit of other appli-cants:
(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 protec-
tion product in any Member State, where authorization follows theinclusion in Annex I of any active substance contained in theproduct; or
(c) for periods not exceeding 10 years and provided for in existing
national rules after the first authorization of the plant protectionproduct in each Member State, where that authorization precedesinclusion in Annex I of any active substance contained in theproduct.
5.Member States, on examination of an application for authoriza-
tion, shall inform the Commission of instances ►
C1where they
consider an active substance as listed ◄in Annex I, which has been
produced by a person or manufacturing process other than those speci-fied in the dossier on the basis of which the active substance was firstincluded in Annex I.They shall transmit to it all data regarding theidentify 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 requirementsas 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 whichthey 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 whichauthorization 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 ofthe holder or holders of previous relevant authorizations and shallat 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 informa-tion 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 ofthis Directive, the competent authorities of the Member State shallencourage data holders to cooperate in the provision of the requesteddata, 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 ofdata, Member States may introduce national measures obliging theapplicant and holders of previous authorizations located within theirterritory to share the data with a view to avoiding duplicative testingon vertebrate animals and determine both the procedure for utilizing1991L0414 — EN — 01.09.1994 — 001.001 — 15
▼B
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 (1), ensure that information submitted
by applicants involving industrial and commercial secrets is treated asconfidential if the applicant wishing to have an active substanceincluded in Annex I or the applicant for authorization of a plant protec-tion 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 andthe 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 acciden-
tial 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 informa-
tion, he shall be required to inform the competent authority
accordingly.
Packagingandlabelling ofplantprotectionproducts
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 require-ments 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 forthe final packaging and labelling or for the final labelling ofthe plant protection product on the market;
►
C1(c) the name and amount of each active substance expressed
as provided for in Article 6 of Directive 78/631/EEC and ◄in
particular paragraph (2) (d) of that Article.1991L0414 — EN — 01.09.1994 — 001.001 — 16
(1) OJ No L 158, 23.6.1990, p.56.
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The name must be as given in the list contained in Annex I to
Directive 67/548/EEC or, if not included therein, its ISOcommon 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 informationon first aid;
(g) the nature of any special risks for humans, animals or the envir-
onment, by means of standard phrases selected as appropriatefrom 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 appro-
priate from those given in Annex V;
(i) the type of action of the plant protection product (e.g. insecti-
cide, 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 author-
ized and any specific agricultural, plant health andenvironmental conditions under which the product may beused 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 appli-
cation 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 orproducts 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 thepackage if the space available on the package is too small.Such aleaflet shall be regarded as part of the label for the purposes of thisDirective.
3.Taking account of the rules in force within their territories regarding
the supply of certain plant protection products to certain categoriesof users, pending Community harmonization, the Member Statesshall 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’, orsimilar indications.However, information to the effect that the plant1991L0414 — EN — 01.09.1994 — 001.001 — 17
▼B
protection product may be used when bees or other non-target
species are active, or when crops or weeds are in flower or othersuch 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 presentsminimal 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 toin 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 theyshall notify the other Member States and the Commission forthwithof each derogation granted and shall forward the additional phraseor 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 justifiedand hence that Annexes IV and V must be amended accordingly, orthat the Member States concerned must no longer require suchphrase(s).The Member State shall be entitled to maintain itsrequirement until such time as a decision has been taken.
Controlmeasures
Article 17
Member States shall make the necessary arrangements for plant protec-
tion products which have been placed on the market and for their useto be officially checked to see whether they comply with the require-ments of this Directive and in particular with the requirements of theauthorization 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.
Administrativeprovisions
Article 18
1.The Council, acting by a qualified majority on a proposal from
the Commission, shall adopt the ‘uniform principles’ referred to inAnnex VI.
2.In accordance with the procedure laid down in Article 19 and
having regard to current scientific and technical knowledge, the neces-sary 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 hisown initiative or at the request of a Member State, to the StandingCommittee on Plant Health, set up by Decision 76/894/EEC (
1), herin-
after 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 itsopinion on the draft within a time limit which the chairman may laydown according to the urgency of the matter.The opinion shall bedelivered by the majority laid down in Article 148 (2) of the Treaty.The votes of the representatives of the Member States within the1991L0414 — EN — 01.09.1994 — 001.001 — 18
(1) OJ No L 340, 9.12.1976, p.25.
▼B
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 beadopted 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 initiativeor 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 itsopinion 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 theCommittee 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, withoutdelay, submit to the Council a proposal relating to the measures to betaken.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 itsopinion 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 theminutes.
The Commission shall take the utmost account of the opinion delivered
by the committee.It shall inform the committee of the manner inwhich its opinion has been taken into account.
Researchanddevelopment
Article 22
1.The Member States shall prescribe that any experiment or test for
research or development purposes involving the release into the envir-onment of an unauthorized plant protection product may only becarried out after authorization for trial purposes has been granted andunder controlled conditions and for limited quantities and areas.1991L0414 — EN — 01.09.1994 — 001.001 — 19
▼C1
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▼B
2.The persons concerned shall submit an application to the compe-
tent authority of the Member State in whose territory the experiment ortest 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 bemade of possible effects on human or animal health or the possibleimpact 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 tosuch conditions as it considers necessary to prevent those conse-quences.
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 parti-
cular the maximum quantities of pesticides that may be releasedduring experiments covered by paragraph 1, and the minimum data tobe submitted in accordance with paragraph 2, shall be adopted inaccordance 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.
ImplementationoftheDirective
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 immediatelyinform the Commission thereof.The uniform principles shall beadopted one year after the date of notification.
When Member States adopt these measures, they shall contain a refer-
ence to this Directive or shall be accompanied by such reference on theoccasion 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 implementingArticle 10 (1), second indent, until one year at the latest followingadoption of the uniform principles, and only in relation to the require-ments 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.1991L0414 — EN — 01.09.1994 — 001.001 — 20
▼B
ANNEX I
ACTIVE SUBSTANCES AUTHORIZEDFOR INCORPORATION IN
PLANTPROTECTIONPRODUCTS1991L0414 — EN — 01.09.1994 — 001.001 — 21
▼B
ANNEX II
REQUIREMENTS FOR THE DOSSIER TO BE SUBMITTED FOR THE
INCLUSIONOFANACTIVESUBSTANCEINANNEXI
INTRODUCTION
The information required shall:
1.1. include a technical dossier supplying the information necessary for
evaluating the foreseeable risks, whether immediate or delayed, which
the substance may entail for humans, animals and the environment and
containing at least the information and results of the studies referred to
below;
1.2. where relevant, be generated using test guidelines referred to or
described in this Annex, in the case of studies initiated before the adop-
tion of the modification of this Annex, the information shall be
generated using suitable internationally or nationally validated test
guidelines or, in the absence thereof, test guidelines accepted by the
competent authority;
1.3. in the event of a test guideline being inappropriate or not described, or
where another one than those referred to in this Annex has been used,
inlcude a justification, which is acceptable to the competent authority
for the guidelines used;
1.4. include, when required by the competent authority, a full description of
test guidelines used, except if they are referred to or described in this
Annex, and a full description of any deviations from them including a
justification, which is acceptable to the competent authority, for these
deviations;
1.5. include a full and unbiased report of the studies conducted as well as
full description of them or a justification, which is acceptable to the
competent authority where:
— particular data and information which would not be necessary owing
to the nature of the product or its proposed uses, are not provided,
or
— it is not scientifically necessary, or technically possible to supply
information and data;
1.6. where relevant, have been generated in accordance with the require-
ments of Directive 86/609/EEC.
2.1. Tests and analyses must be conducted in accordance with the principles
laid down in Directive 87/18/EEC (1) where testing is done to obtain
data on the properties and/or safety with respect to human or animal
health or the environment.
2.2. By way of derogation from point 2.1, tests and analyses done to obtain
data on the properties and/or safety with respect to honeybees and bene-
ficial arthropods other than bees may have been conducted by official
or officially recognized testing facilities or organizations which satisfy
at least the requirements as set out under points 2.2 and 2.3 of the intro-
duction to Annex III.
This derogation expires on 31 December 1999.
PART A
Chemicalsubstances (2)
1.Identity of the active substance
The information provided must be sufficient to identify with precision
each active substance, to define it in terms of its specification and to1991L0414 — EN — 01.09.1994 — 001.001 — 22
(1) OJ No L 15, 17.1.1987, p.29.
(2) Substance within the meaning of the definition of Article 2, point 3.▼M1
▼B
▼M2
▼M2
characterize it as to its nature.The information and data referred to,
unless otherwise specified, are required for all active substances.
1.1. Applicant (name, address, etc.)
The name and address of the applicant (permanent Community address)
must be provided as must the name, position, telephone and telefax
number of the appropriate person to contact.
Where, in addition, the applicant has an office, agent or representative
in the Member State to which the application for inclusion in Annex I
is submitted, and if different, in the Rapporteur Member State
appointed by the Commission, the name and address of the local office,
agent or representative must be provided, as must the name, position,
telephone and telefax number of the appropriate person to contact.
1.2. Manufacturer (name, address, including location of plant)
The name and address of the manufacturer or manufacturers of the
active substance must be provided as must the name and address of
each manufacturing plant in which the active substance is manufac-
tured.A contact point (preferably a central contact point, to include
name, telephone and telefax number) must be provided, with a view to
providing updating information and responding to queries arising,
regarding manufacturing technology, processes and the quality of
product (including where relevant, individual batches).Where following
inclusion of the active substances in Annex I, there are changes in the
location or number of manufacturers, the information required must
again be notified to the Commission and the Member States.
1.3. Common name proposed or ISO-accepted, and synonyms
The ISO common name, or proposed ISO common name and where
relevant, other proposed or accepted common names (synonyms),
including the name (title) of the nomenclature authority concerned,
must be provided.
1.4. Chemical name (IUPAC and CA nomenclature)
The Chemical name as given in Annex I to Directive 67/548/EEC, or, if
not included in this Directive, in accordance with both IUPAC and CA
nomenclature, must be provided.
1.5. Manufacturer's development code number(s)
Code numbers used to identify the active substance, and where avail-
able, formulations containing the active substance, during development
work, must be reported.For each code number reported, the material to
which it relates, the period for which it was used, and the Member
States or other countries in which it was used and is being used, must
be stated.
1.6. CAS, EEC and CIPAC numbers (if available)
Chemical Abstracts, EEC (EINECS or ELINCS), and CIPAC numbers,
where they exist, must be reported.
1.7. Molecular and structural formula, molecular mass
The molecular formula, molecular mass and structural formula of the
active substance, and where relevant, the structural formula of each
stereo and optical isomer present in the active substance, must be
provided.
1.8. Method of manufacture (synthesis pathway) of the active
substance
The method of manufacture, in terms of the identity of the starting
materials, the chemical pathways involved, and the identity of by-
products and impurities present in the final product, must be provided,
for each manufacturing plant.Generally process engineering informa-
tion is not required.
Where the information provided relates to a pilot plant production
system, the information required must again be provided once industrial
scale production methods and procedures have stabilized.
1.9. Specification of purity of the active substance in g/kg
The minimum content in g/kg of pure active substance (excluding inac-
tive isomers) in the manufactured material used for production of
formulated products, must be reported.1991L0414 — EN — 01.09.1994 — 001.001 — 23
▼M2
Where the information provided relates to a pilot plant production
system, the information required must again be provided to the
Commission and the Member States once industrial scale production
methods and procedures have stabilized, if production changes result
in a changed specification of purity.
1.10. Identity of isomers, impurities and additives (e.g. stabili-
zers), together with the structural formula and the content
expressed as g/kg
The maximum content in g/kg of inactive isomers as well as the ratio of
the content of isomers/diastereo-isomers, where relevant, must be
provided.In addition, the maximum content in g/kg of each further
component other than additives, including by-products, and impurities,
must be provided.In the case of additives the content in g/kg must be
provided.
For each component, present in quantities of 1 g/kg or more, the
following information, where relevant, must be provided:
— chemical name according to IUPAC and CA nomenclature,
— ISO common name or proposed common name if available,
— CAS number, EEC (EINECS or ELINCS) number, and CIPAC
number if available,
— molecular and structural formula,
— molecular mass, and— maximum content in g/kg.
Where the manufacturing process is such that impurities and by-
products which are particularly undesirable because of their toxicolo-
gical, ecotoxicological or environmental properties could be present in
the active substance, the content of each such compound must be deter-
mined and reported.In such cases, the analytical methods used and the
limits of determination, which must be sufficiently low, for each
compound of concern, must be reported.Additionally the following
information, where relevant, must be provided:
— chemical name according to IUPAC and CA nomenclature,
— ISO common name or proposed common name if available,
— CAS number, EEC (EINECS or ELINCS) number, and CIPAC
number if available,
— molecular and structural formula,
— molecular mass, and— maximum content in g/kg.
Where the information provided relates to a pilot plant production
system, the information required must again be provided once industrial
scale production methods and procedures have stabilized, if production
changes result in a changed specification of purity.
Where the information provided does not fully identify a component
viz.condensates, detailed information on the composition must be
provided for each such component.
The trade name of components added to the active substance, prior to
manufacture of formulated product, to preserve stability and facilitate
ease of handling, where they are used, must also be provided.Addition-
ally the following information, where relevant, must be provided for
such additives:
— chemical name according to IUPAC and CA nomenclature,
— ISO common name or proposed common name if available,
— CAS number, EEC (EINECS or ELINCS) number, and CIPAC
number if available,
— molecular and structural formula,
— molecular mass, and
— maximum content in g/kg.
For added components, other than active substance and other than
impurities resulting from the manufacturing process, the function of
the component (additive) must be given:
— antifoaming agent,
— antifreeze,— binder,
— other (specify),
— buffer,
— dispersing agent,1991L0414 — EN — 01.09.1994 — 001.001 — 24
▼M2
— stabilizer.
1.11. Analytical profile of batches
Representative samples of the active substance must be analysed for
content of pure active substance, inactive isomers, impurities and addi-
tives, as appropriate.The analytical results reported must include
quantitative data, in terms of g/kg content, for all components present
in quantities of more than 1 g/kg and typically should account for at
least 98 % of the material analysed.The actual content of components
which are particularly undesirable because of their toxicological,
ecotoxicological or environmental properties, must be determined and
reported.Data reported must include the results of the analysis of indi-
vidual samples and a summary of that data, to show the minimum or
maximum and typical content of each relevant component, as appro-
priate.
Where an active substance is produced in different plants this informa-
tion must be provided for each of the plants separately.
In addition, where available and relevant, samples of the active
substance produced in laboratory scale or pilot production systems,
must be analyzed, if such material was used in generating toxicologicalor ecotoxicological data.
2.Physical and chemical properties of the active substance
(i) The information provided, must describe the physical and chemical
properties of active substances and together with relevant informa-
tion, must serve to characterize them.In particular, the information
provided must permit:
— physical, chemical, and technical hazards associated with
active substances, to be identified,
— classification of active substance as to harzard,
— appropriate restrictions and conditions to be associated with
inclusions in Annex I to be selected, and
— appropriate risk and safety phrases to be specified.
The information and data referred to are required for all active
substances, except where otherwise specified.
(ii) The information provided, taken together with that provided for
relevant preparations, must permit the physical, chemical hazards
associated with preparations, to be identified, permit preparations
to be classified, and permit establishment that preparations can be
used without unnecessary difficulty, and be such that exposure of
man, animals, and the environment is minimized, taking account of
manner of use.
(iii) The extent to wich active substances of which inclusion in Annex I
is sought, comply with relevant FAO specifications, must be
stated.Divergences from FAO specifications must be described in
detail, and justified.
(iv) In certain specified instances, tests must be conducted using puri-
fied active substance of stated specification.In such cases the
principles of the method(s) of purification must be reported.The
purity of such test material, which must be as high as can be
achieved using the best available technology, must be reported.A
reasoned justification must be provided in cases where the degree
of purity achieved is less than 980 g/kg.
Such justification must demonstrate that all technically feasible
and reasonable possibilities for the production of the pure active
substance have been exhausted.
2.1. Melting point and boiling point
2.1.1. The melting point or where appropriate the freezing or solidification
point of purified active substance must be determined and reported
according to EEC method A 1.Measurements should be taken up to
360 ºC.
2.1.2. Where appropriate the boiling point of purified active substances must
be determined and reported according to EEC method A 2.Measure-
ments should be taken up to 360 ºC.
2.1.3. Where melting point and/or boiling point cannot be determined because
of decomposition or sublimation, the temperature at which decomposi-
tion or sublimation occurs, must be reported.1991L0414 — EN — 01.09.1994 — 001.001 — 25
▼M2
2.2. Relative density
In the case of active substances which are liquids or solids, the relative
density of the purified active substance must be determined and
reported according to EEC method A 3.
2.3. Vapour pressure (in Pa), volatility (e.g. Henry's law
constant)
2.3.1. The vapour pressure of purified active substance must be reported
according to EEC method A 4.Where vapour pressure is less than 10−
5Pa, the vapour pressure at 20 or 25 ºC may be estimated by a vapour
pressure curve.
2.3.2. In the case of active substances which are solids or liquids, volatility
(Henry's law constant) of purified active substance must be determined
or calculated from its water solubility and vapour pressure and be
reported (in Pa × m3× mol−1).
2.4. Appearance (physical state, colour and odour; if known)
2.4.1. A description of both the colour, if any, and the physical state of both
the active substance as manufactured and purified active substance,
must be provided.
2.4.2. A description of any odour associated with the active substance as
manufactured and purfied active substance, noted when handling the
materials in laboratories or production plants, must be reported.
2.5. Spectra (UV/VIS, IR, NMR, MS), molecular extinction at
relevant wavelengths
2.5.1. The following specta including a table of signal characteristica needed
for interpretation must be determined and reported: Ultraviolet/Visible
(UV/VIS), infrared (R), nuclear magnetic resonance (NMR), and mass
spectra (MS) of purified active substance and molecular extinction at
relevant wavelengths, must be determined and reported.
The wavelengths at which UV/visible molecular extinction occurs are to
be determined and reported and must include where appropriate a
wavelength at the highest absorption value above 290 nm.
In the case of active substances which are resolved optical isomers their
optical purity must be measured and reported.
2.5.2. The UV/visible absorption spectra, IR, NMR and MS spectra, where
necessary for the identification of the impurities considered to be of
toxicological, ecotoxicological or environmental significance must be
determined and reported.
2.6. Solubility in water including effect of pH (4 to 10) on solu-
bility
The water solubility of purified active substances under atmospheric
pressure must be determined and reported according to EEC method A
6.These water solubility determinations must be made in the neutral
range (i.e. in distilled water in equilibrium with atmospheric carbon
dioxide).Where the active substance is capable of forming ions, deter-
minations must also be made in the acidic range (pH 4 to 6) and in the
alkaline range (pH 8 to 10), and be reported.Where the stability of the
active substance in aqueous media is such that water solubility cannot
be determined, a justification based on test data must be provided.
2.7. Solubility in organic solvents
The solubility of the active substances as manufactured in the following
organic solvents at 15 to 25 ºC must be determined and reported if less
than 250 g/kg; the temperature applied must be specified:
— Aliphatic hydrocarbon: preferably n-heptane,
— Aromatic hydrocarbon: preferably xylene,— Halogenated hydrocarbon: preferably 1,2-dichlorethane,
— Alcohol: preferably methanol or isopropyl alcohol,
— Ketone: preferably acetone,— Ester: preferably ethyl acetate.
If for a particular active substance, one or more of these solvents is
unsuitable (e.g. reacts with test material), alternative solvents can be
used instead.In such cases, choices made must be justified in terms of
their structure and polarity.1991L0414 — EN — 01.09.1994 — 001.001 — 26
▼M2
2.8. Partition coefficient n-octanol/water including effect of pH
(4 to 10)
The n-octanol/water partition coefficient of purified active substance
must be determined and reported according to EEC method A 8.The
effect of pH (4 to 10) must be investigated when the substance is acidic
or basic as defined by its pKa value (< 12 for acids, > 2 for bases).
2.9. Stability in water, hydrolysis rate, photochemical degrada-
tion, quantum yield and identity of breakdown product(s),
dissociation constant including effect of pH (4 to 9)
2.9.1. The hydrolysis rate of purified active substances (usually radiolabelled
active substance, > 95 % purity), for each of the pH values 4, 7 and 9,
under sterile conditions, in the absence of light, must be determined and
report according to EEC method C 7.For substances with a low rate of
hydrolysis, the rate can be determined at 50 ºC, or another appropriate
temperature.
If degradation is observed at 50 ºC, degradation rate at another tempera-
ture must be determined, and an Arrhenius plot must be constructed to
permit an estimate to be made of hydrolysis at 20 ºC.The identity of
hydrolysis products formed and the rate constantly observed, must be
reported.The estimated DT 50 value must also be reported.
2.9.2. For compounds with a molar (decadic) absorption coefficient ( ε)>1 0
(1 × mol−1×c m−1) at a wavelength λ≥290 nm, direct phototrans-
formation in purified (e.g. distilled) water at 20 to 25 ºC, of purified
active substance usually radio labelled using artificial light under sterile
conditions, if necessary using a solubilizer, must be determined and
reported.Sensitizers such as acetone must not be used as a cosolvent
or solubilizer.The light source must simulate sunlight and be equipped
with filters to exclude radiation at wavelengths λ< 290 nm.The iden-
tity of breakdown products formed which at any time during the study
are present in quantities ≥10 % of the active substance added, a mass
balance to account for at least 90 % of the applied radioactivity, as well
as photochemical halflife must be reported.
2.9.3. Where necessary to investigate direct phototrans-formation, the
quantum yield of direct photodegradation in water must be determined
and reported, together with calculations to estimate theoretical lifetime
of the active substance in the top layer of aqueous systems and the real
lifetime of the substance.
The method is described in the FAO Revised Guidelines on Environ-
mental Criteria for the Registration of Pesticides.
2.9.4. Where dissociation in water occurs, the dissociation constant(s) (pKa
values) of the purified active substance must be determined and
reported according to OECD Test Guideline 112.The identity of the
dissociated species formed, based on theoretical considerations, must
be reported.If the active, substance is a salt, the pKa value of the active
principle must be given.
2.10. Stability in air, photochemical degradation, identity of
breakdown product(s)
An estimation of the photochemical oxidative degradation (indirect
hototransformation) of the active substance, must be submitted.
2.11. Flammability including auto-flammability2.11.1. The flammability of active substances as manufactured, which are
solids, gases, or are substances which evolve highly flammable gases,
must be determined and reported according to EEC method A 10, A
11 or A 12 as as appropriate.
2.11.2. The auto-flamability of active substances as manufactured must be
determined and reported according to EEC method A 15 or A 16 as
appropriate, and/or, where necessary according to the UN-Bowes-
Cameron-Cage-Test (UN-Recommendations on the Transport of
Dangerous Goods, Chapter 14, No 14.3.4).
2.12. Flash point
The flash point of active substances as manufactured with a melting
point below 40 ºC, must be determined and reported according to EEC
method A 9; only closed cup methods should be used.1991L0414 — EN — 01.09.1994 — 001.001 — 27
▼M2
2.13. Explosive properties
The explosive properties of active substances as manufactured, must be
determined and reported according to EEC method A 14 where neces-
sary.
2.14. Surface tension
The surface tension has to be determined and reported according to
EEC method A 5.
2.15 Oxidizing properties
The oxidizing properties of active substances as manufactured, must be
determined and reported according to EEC method A 17, except where
examination of its sturctural formula, establishes beyond reasonable
doubt that the active substance is incapable of reacting exothermically
with a combustible material.In such cases, it is sufficient to provide
that information as justification for not determining the oxidizing prop-
erties of the substance.
3.Further information on the active substance
(i) The information provided must describe the intended purposes for
which preparations containing the active substance are used, or are
to be used and the dose and manner of their use or proposed use.
(ii) The information provided must specify the normal methods and
precautions to be followed, in the handling, storage and transport
of the active substance.
(iii) The studies, data and information submitted, together with other
relevant studies, data and information, must both specify and
justify the methods and precautions to be followed in the event offire.The possible products of combustion in the event of fire
should be estimated, based on the chemical structure and the
chemical and physical properties of the active substance.
(iv) The studies, data and information submitted, together with other
relevant studies, data and information, must demonstrate the suit-
ability of measures proposed for use in emergency situations.
(v) The informaton and data referred to are reqired for all active
substances, except where otherwise specified.
3.1. Function, e.g. fungicide, herbicide, insecticide, repellant,
growth regulator
The function must be specified from among the following:
— acaricide
— bactericide— fungicide— herbicide— insecticide— molluscicide— nematicide— plant growth regulator— repellant— rodenticide
— semio-chemicals
— talpicide— viricide— other (must be specified)
3.2. Effects on harmful organisms, e.g. contact poison, inhala-
tion poison, stomach poison, fungitoxic, etc.systematic or
not in plants
3.2.1. The nature of the effects on harmful organisms must be stated:
— contact action
— stomach action— inhalation action— fungitoxic action— fungistatic action— desiccant— reproduction inhibitor— other (must be specified)1991L0414 — EN — 01.09.1994 — 001.001 — 28
▼M2
3.2.2. It must be stated whether or not the active substance is translocated in
plants and where relevant whether such translocation is apoplastic,
symplastic or both.
3.3. Field of use envisaged, e.g. field, protected crops, storage
of plant products, home gardening
The field(s) of use, existing and proposed, for preparations containing
the active substance must be specified from among the following:
— Field use, such as agriculture, horticulture, forestry and viticulture
— Protected crops— Amenity— Weed control on non-cultivated areas— Home gardening— House plants— Plant products storage practice— Other (specify)
3.4. Harmful organisms controlled and crops or products
protected or treated
3.4.1. Details of existing and the intended use in terms of crops, groups of
crops, plants, or plant products treated and where relevant protected,
must be provided.
3.4.2. Where relevant, details of harmful organisms against which protection
is afforded, must be provided.
3.4.3 Where relevant, effects achieved e.g. sprout suppression, retardation of
ripening, reduction in stem length, enhanced fertilization etc., must be
reported.
3.5. Mode of action
3.5.1. To the extent that is has elucidated, a statement must be provided as to
the mode of action of the active substance in terms, where relevant, of
the biochemical and physiological mechanism(s) and biochemical path-
way(s) involved.Where availble, the results of relevant experimental
studies must be reported.
3.5.2. Where it is known that to exert its intended effect, the active substance
must be converted to a metabolite or degradation product following
application or use of preparations containing it, the following informa-
tion, cross referenced to and drawing on information provided in the
context of paragraphs 5.6, 5.11, 6.1, 6.2, 6.7, 7.1, 7.2 and 9, where rele-
vant, must be provided for active metabolite or degradation product:
— chemical name according to IUPAC and CA nomenclature,
— ISO common name or porposed common name,— CAS EEC-number EEC (EINECS or ELINCS) number, and CIPAC
number if available,
— empirical and structural formula, and— molecular mass.
3.5.3. Available information relating to the formation of active metabolites
and degradation products, must be provided, to include:
— the processes, mechanisms and reactions involved,
— kinetic and other data concerning the rate of conversion and if
known the rate limiting step,
— environmental and other factors effecting the rate and extent of
conversion.
3.6. Information on the occurrence or possible occurrence of the
development of resistance and appropriate management
strategies
Where available information on possible occurrence of the development
of resistance or cross-resistance must be provided.
3.7. Recommended methods and precautions concerning hand-
ling, storage, transport or fire
A safety data sheet pursuant to Article 27 of Council Directive 65/548/
EEC (
1) must be provided for all active substances.1991L0414 — EN — 01.09.1994 — 001.001 — 29
(1) OJ No L 196, 16.8.1967, p.1.
▼M2
3.8. Procedures for destruction or decontamination
3.8.1. Controlled incineration
In many cases the preferred or sole means to safely dispose of active
substances, contaminated materials, or contaminated packaging, is
through controlled incineration in a licensed incinerator.
Where the content of halogens of the active substance is greater than
60 %, the pyrolytic behaviour of the active substance under controlled
conditions (including where relevant supply of oxygen and defined resi-
dence time), at 800 ºC and the content of polyhalogenated dibenzo-p-
dioxins and dibenzo-furans in the products of pyrolysis must be
reported.The application must provide detailed instructions for safe
disposal.
3.8.2. Others
Other methods to dispose of the active substance, contaminated packa-
ging and contaminated materials, where proposed, must be fully
described.Data must be provided for such methods, to establish their
effectiveness and safety.
3.9. Emergency measures in case of an accident
Procedures for the decontamination of water in case of an accident must
be provided.
4.Analytical methods
4.1. Analytical methods for the determination of pure active substance and,
where appropriate, for relevant breakdown products, isomers and impu-
rities 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. Soil4.2.3. 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. Percutaneous5.1.3. Inhalation
5.1.4. Intraperitoneal
5.1.5. Skin and where appropriate eye irritation
5.1.6. Skin sensitization
5.2. Short-term toxicity5.2.1. 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 percutaneous1991L0414 — EN — 01.09.1994 — 001.001 — 30
▼B
▼B
5.5.2. Multigeneration studies in mammals (at least two generations)
5.6. Metabolism studies in mammals5.6.1. Absorption, distribution and excretion studies — following both oral
and percutaneous administration
5.6.2. Elucidation of metabolic pathways5.7. Neurotoxicity studies — including where appropriate delayed neuro-
toxicity 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 pets5.10. Medical data
5.10.1. Medical surveillance on manufacturing plant personnel
5.10.2. Direct observation, e.g. clinical cases and poisoning incidents5.10.3. Health records, both from industry and agriculture
5.10.4. Observations on exposure of the general population and epidemiolo-
gical 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 poisoning5.11. 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 soil7.1.1. 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.1991L0414 — EN — 01.09.1994 — 001.001 — 31
▼B
7.1.2. Adsorption and desorption in at least three soil types and where rele-
vant 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 residues7.2. 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 toxicity8.1.2. Short-term toxicity — eight-day dietary study in at least one species
(other than chicken)
8.1.3. Effects on reproduction8.2. Effects on aquatic organisms8.2.1. Acute toxicity to fish
8.2.2. Chronic toxicity to fish
8.2.3. Effects on fish reproduction and growth rate8.2.4. Bioaccumulation in fish8.2.5. Acute toxicity for Daphnia magna
8.2.6.Daphnia magna reproduction and growth rate
8.2.7. Effects on algal growth8.3. Effects on other non-target organisms8.3.1. Acute toxicity to honeybees and other beneficial arthropods (e.g. preda-
tors)
8.3.2. Toxicity to earthworms and to other soil non-target macro-organisms8.3.3. 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 product1991L0414 — EN — 01.09.1994 — 001.001 — 32
▼B
PART B
Micro-organismsandviruses
(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 taxo-
nomic 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 geogra-
phical 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.Persis-
tence 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 envir-
onmental conditions of proposed use
2.7. Presence, absence or production of toxins as well as their nature, iden-
tity, chemical structure (if appropriate) and stability
3.Further information on the organism
3.1. Function, e.g. fungicide, herbicide, insecticide, repellant, growth regu-
lator
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 agricul-
tural, 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 stock3.8. Recommended methods and precautions concerning handling, storage,
transport or fire
3.9. Possibility of rendering the organism uninfective1991L0414 — EN — 01.09.1994 — 001.001 — 33
▼B
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 dose5.1.1.2. 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 dose5.1.1.5. Intraperitoneal single dose
5.1.1.6. Skin and, where necessary, eye irritation
5.1.1.7. Skin sensitization5.1.2. 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 studies5.1.3.4. 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 neurotoxi-
city tests in adult hens
5.1.3.7. Immunotoxicity, e.g. allergenicity
5.1.3.8. Pathogenicity and infectivity under immunosuppression5.2. 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 pets1991L0414 — EN — 01.09.1994 — 001.001 — 34
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5.4. Medical data
5.4.1. Medical surveillance on manufacturing plant personnel5.4.2. Health records, both from industry and agriculture
5.4.3. Observations on exposure of the general population and epidemiolo-
gical 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 infec-
tivity 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 chains7.3. 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 infectivity8.3. 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 infectivity8.7. 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 81991L0414 — EN — 01.09.1994 — 001.001 — 35
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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.1991L0414 — EN — 01.09.1994 — 001.001 — 36
▼B
ANNEX III
REQUIREMENTS FOR THE DOSSIER TO BE SUBMITTED FOR THE
AUTHORIZATIONOFAPLANTPROTECTIONPRODUCT
INTRODUCTION
The information required shall:
1.1. 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,
animals and the environment and containing at least the information
and results of the studies referred to below;
1.2. where relevant, be generated using test guidelines referred to or
described in this Annex; in the case of studies initiated before the
adoption of the modification of this Annex, the information shall be
generated using suitable internationally or nationally validated test
guidelines or, in the absence thereof, test guidelines accepted by the
competent authority;
1.3. in the event of a test guideline being inappropriate or not described, or
where another one than those referred to in this Annex has been used,
include a justification, which is acceptable to the competent authority
for the guidelines used;
1.4. include when required by the competent authority, a full description of
test guidelines used, except if they are referred to or described in this
Annex, and a full description of any deviations from them including a
justification, which is acceptable to the competent authority, for these
deviations;
1.5. include a full and unbiased report of the studies conducted as well as a
full description of them or a justification, which is acceptable to the
competent authority where:
— particular data and information which would not be necessary
owing to the nature of the product or its proposed uses, are not
provided,
or
— it is not scientifically necessary, or technically possible to supply
information and data.
1.6. where relevant, have been generated in accordance with the require-
ments of Directive 86/609/EEC.
2.1. Tests and analyses must be conducted in accordance with the princi-
ples laid down in Directive 87/18/EEC where testing is done to
obtain data on the properties and/or safety with respect to human or
animal health or the environment.
2.2. Tests and analyses, required under the provisions of Section 6 points
6.2 to 6.7 of this Annex, shall be conducted by official or officially
recognized testing facilites or organizations which satisfy at least the
following requirements:
— have at their disposal sufficient scientific and technical staff,
having the necessary education, training, technical knowledge and
experience for their assigned functions,
— have at their disposal suitable items of equipment required for
correct performance of the tests and measurements which it claims
to be competent to carry out.This equipment shall be properly
maintained and calibrated where appropriate before being put into
service and thereafter according to an established programme,
— have at their disposal appropriate experimental fields and, where
necessary glasshouses, growth cabinets or storage rooms.The
environment in which the tests are undertaken shall not invalide
its results or adversely effect the required accuracy of measure-
ment,
— make available to all relevant personnel operating procedures and
protocols used for the trials,1991L0414 — EN — 01.09.1994 — 001.001 — 37
▼M1
▼M1
— make available, where requested by the competent authority, prior
to the commencement of a test, detailed information on it,
containing at least its location and the plant protection products
included in it,
— ensure that the quality of the work performed is appropriate to its
type, range, volume and intended purpose,
—►C2maintain records of all original observations, calculations
and derived data, ◄calibration records and the final test report
as long as the product concerned authorized in the Community.
2.3. Member States shall require that officially recognized testing facilities
and organizations, and, where requested, official facilities and organi-
zations:
— report to the relevant national authority all detailed information
necessary to demonstrate that they can satisfy the requirements
provided for in point 2.2,
— accept at any time the inspections, which each Member State shall
regularly organize on its territory in order to verify the compliance
with the requirement as laid down in point 2.2.
2.4. By way of derogation from point 2.1 the provisions of points 2.2 and
2.3 also apply until 31 December 1999 for the tests and analyses done
to obtain data on the properties and/or safety with respect to honey-
bees and beneficial arthropods other than bees.
3.The information required shall include the proposed classification and
labelling of the plant protection product in accordance with relevant
Community Directives.
4.In individial cases it may be necessary to require certain information
as provided for in Annex II, Part A, for formulants.Before such infor-
mation will be required and before possible new studies have to be
performed, all information on the formulant, made available to the
competent authority, will be considered, in particular when:
— the use of the formulant is permitted in food, animal feeding stuffs,
medicines or cosmetics in accordance with Community legislation,
or
— a safety data sheet has been submitted for the formulant in accor-
dance with Council Directive 67/548/EEC.
PART A
Chemicalpreparations
1. Identity of the plant protection product
The information provided, taken together with that provided for the
active substance(s), must be sufficient to precisely identify prepara-
tions and define them in terms of their specification and nature.The
information and data referred to, unless otherwise specified, are
required for all plant protection products.
1.1. Applicant (name and address, etc.)
The name and address of the applicant (permanent community
address) must be provided as must the name, position, telephone and
telefax number of the appropriate person to contact.
Where in addition, the applicant has an office, agent or representative
in the Member State in which the authorization is being sought, the
name and address of the local office agent or representative should
be provided, as should the name, position, telephone and telefax
number of the appropriate person to contact.
1.2. Manufacturer of the preparation and the active
substance(s) (names and addresses etc.including location
of plants)
The name and address of the manufacturer of the preparation and of
each active substance in the preparation must be provided as must
the name and address of each manufacturing plant in which the
preparation and active substance are manufactured.
A contact point (preferable a central contact point, to include name,
telephone and telefax numbers) must be provided for each.1991L0414 — EN — 01.09.1994 — 001.001 — 38
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▼M2
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If the active substance originates from a manufacturer from which data
according to Annex II had not been submitted previously, a statement
of purity and detailed information on the impurities in Annex II have
to be provided.
1.3. Trade name or proposed trade name, and manufacturer's
development code number of the preparation if appropriate
All former and current trade names and proposed trade names and
development code numbers of the preparation as well as the current
names and numbers must be provided.Where trade names and code
numbers referred to, relate to similar but different preparations
(possibly absolete), full details of the differences, must be provided.
(The proposed trade name may not give rise to confusion with the
trade name of already registered plant protection products.)
1.4. Detailed quantitative and qualitative information on the
composition of the preparation (active substance(s), and
formulants)
1.4.1. For preparations the following information must be reported:
— the content of both technical active substance(s) and pure active
substance(s);
— the content of formulants.
The concentrations should be expressed in terms as provided for in
Article 6 (2) of Directive 78/631/EEC.
1.4.2. For active substances their ISO common names or proposed ISO
common names and their CIPAC numbers, and, where available, the
EEC (EINECS or ELINCS) numbers must be provided.Where rele-
vant it must be stated which salt, ester, anion or cation is present.
1.4.3. Formulants must where possible, be identified both by their chemical
name as given in Annex I to Directive 67/548/EEC, or, if not included
in this Directive, in accordance with both IUPAC and CA nomencla-
ture.Their structure or structural formula must be provided.For each
component of the formulants the relevant EEC (EINECS or ELINCS)
number and CAS number where they exist, must be provided.Where
the information provided does not fully identify a formulant, an appro-
priate specification must be provided.The trade name of formulants,
where they exist, must also be provided.
1.4.4. For formulants the function must be given:
— adhesive (sticker),
— antifoaming agent,
— antifreeze,— binder,— buffer,
— carrier,
— deodorant,— dispersing agent,— dye,
— emetic,
— emulsifier,— fertilizer,
— preservative,
— odourant,— perfume,— propellant,
— repellent,
— safener,— solvent,— stabilizer,
— synergist,
— thickener,— wetting agent,
— miscellaneous (specify).1991L0414 — EN — 01.09.1994 — 001.001 — 39
▼M2
1.5. Physical state and nature of the preparation (emulsifiable
concentrate, wettable powder, solution etc).
1.5.1. The type and code of preparation must be designated according to the
‘Catalogue of pesticide formulation types and international coding
system (GIFAP Technical Monograph No 2.1989)’.
Where a particular preparation is not defined precisely in this publica-
tion a full description of the physical nature and state of the
preparation must be provided, together with a proposal for a suitable
description of the type of preparation and a proposal for its definition.
1.6. Function (herbicide, insecticide, etc.)
The function must be specified from among the following:
— acaricide,
— bactericide,
— fungicide,
— herbicide— insecticide,— molluscicide,
— nematicide,
— plant growth regulator,— repellant,— rodenticide,— semio-chemicals,
— talpicide,
— viricide,— other (must be specified).
2. Physical, chemical and technical properties of the plant protection
product
The extent to which plant protection products for which authorization
is sought, comply with relevant FAO specifications as agreed by the
Group of Experts on Pesticide Specifications, of the FAO Panel of
Experts on Pesticide Specifications, Registration Requirements and
Application Standards, must be stated.Divergences from FAO specifi-
cations must be described in detail, and justified.
2.1. Appearance (colour and odour)
A description of both the colour and odour, if any, and the physical
state of the preparation, must be provided.
2.2. Explosivity and oxidizing properties2.2.1. The explosive properties of preparations must be reported according to
EEC method A 14.Where available thermodynamic information
establishes beyond reasonable doubt that the preparation is incapable
of exothermic reaction, it is sufficient to provide that information as
a justification for not determining the explosive properties of the
preparation.
2.2.2. Oxidizing properties of preparations which are solids must be deter-
mined and exported according to EEC method A 17.For other
preparations the method used must be justified.The oxidizing proper-
ties do not have to be determined if it can be shown without
reasonable doubt on the basis of thermodynamic information, that the
preparation is incapable of reacting exothermically with combustible
materials.
2.3. Flash point and other indications of flammability or spon-
taneous ignition
The flash point of liquids which contain flammable solvents, must be
determined and reported according to EEC Method A 9.The flamm-
ability of solid preparations and gases must be determined and
reported according to EEC methods A 10, A 11 and A 12 as appro-
priate.The auto-flammability of preparations must be determined and
reported in accordance with EEC methods A 15 or A 16 as appro-
priate, and or, where necessary, according to the UN-Bowes-
Cameron-Cage-Test (UN-Recommendations on the Transport of
Dangerous Goods, Chapter 14, No 14.3.4).1991L0414 — EN — 01.09.1994 — 001.001 — 40
▼M2
2.4. Acidity/alkalinity and if necessary pH value
2.4.1. In the case of preparations which are acidic (pH < 4) or alkaline (pH
> 10) the acidity or alkalinity and the pH value must be determined
and reported according to CIPAC Method MT 31 and MT 75 respec-
tively.
2.4.2. Where relevant (if to be applied as aqueous dilution) the pH of a 1 %
aqueous dilution, emulsion or dispersion of the preparation, must be
determined and reported according to CIPAC Method MT 75.
2.5. Viscosity and surface tension
2.5.1. In the case of liquid preparations for Ultra Low Volume use (ULV)
the kinematic viscosity must be determined and reported according to
OECD Test Guideline 114.
2.5.2. For non newtonian liquids the viscosity must be determined and
reported together with the test conditions.
2.5.3. In the case of liquid preparations the surface tension has to be deter-
mined and reported according to EEC method A 5.
2.6. Relative density and bulk density2.6.1. The relative density of liquid preparations must be determined and
reported according to EEC Method A 3.
2.6.2. The bulk (tap) density of preparations which are powders or granules,
must be determined and reported according to CIPAC Methods MT
33, MT 159 or MT 169 as appropriate.
2.7. Storage — stability and shelf-life: Effects of light,
temperature and humidity on technical characteristics of
the plant protection product
2.7.1. The stability of the preparation after storage for 14 days at 54 ºC must
be determined and reported according to CIPAC Method MT 46.
Other times and/or temperatures may be needed (e.g. eight weeks at
40 ºC or 12 weeks at 35 ºC or 18 weeks at 30 ºC) if the preparation
is heat sensitive.
If the active substance content after the heat stability test has
decreased by more than 5 % of the initially found content, the
minimum content shall be declared and information on the degradation
products shall be supplied.
2.7.2. Additionally in the case of liquid preparations, the effect of low
temperatures on stability, must be determined and reported according
to CIPAC Methods MT 39, MT 48, MT 51 or MT 54 as appropriate.
2.7.3. The shelf life of the preparation at ambient temperature must be
reported.Where shelf life is less than two years, the shelf life in
months, with appropriate temperature specifications, must be reported.
Useful information is given in GIFAP Monograph No.17.
2.8. Technical characteristics of the plant protection product
The technical characteristics of the preparation must be determined to
permit a decision to be made as to its acceptability.
2.8.1. Wettability
The wettability of solid preparations which are diluted for use (e.g.
wettable powders, water soluble powders, water soluble granules and
water dispersible granules), must be determined and reported
according to CIPAC Method MT 53.3.
2.8.2. Persistent foaming
The persistence of foaming of preparations to be diluted with water,
must be determined and reported according to CIPAC Method MT 47.
2.8.3. Suspensibility and suspension stability
— The suspensibility of water dispersible products (e.g. wettable
powders, water dispersible granules, suspension concentrates)
must be determined and reported according to CIPAC Method
MT 15, MT 161 or MT 168 as appropriate.
— The spontaneity of dispersion of water dispersible products (e.g.
suspension concentrates and water dispersible granules) must be
determined and reported according to CIPAC Methods MT 160 or
MT 174 as appropriate.1991L0414 — EN — 01.09.1994 — 001.001 — 41
▼M2
2.8.4. Dilution stability
The dilution stability of water soluble products must be determined
and reported according to CIPAC Method MT 41.
2.8.5. Dry sieve test and wet sieve test
In order to ensure that dustable powders have a suitable particle size
distribution for ease of application, a dry sieve test must be conducted
and reported according to CIPAC Method MT 59.1.
In the case of water dispersible products, a wet sieve test must be
conducted and reported according to CIPAC Method MT 59.3 or MT
167 as appropriate.
2.8.6. Particle size distribution (dustable and wettable powders,
granules), content of dust/fines (granules), attrition and
friability (granules)
2.8.6.1. The size distribution of particles in the case of powders, must be
determined and reported according to OECD Method 110.
The nominal size range of granules for direct application must be
determined and reported in accordance with CIPAC MT 58.3, for
water dispersible granules in accordance with CIPAC MT 170.
2.8.6.2. The dust content of granular preparations, must be determined and
reported according CIPAC Method MT 171.If relevant for operator
exposure the particle size of dust must be determined and reported
according to OECD Method 110.
2.8.6.3. The friability and attrition characteristics of granules, must be deter-
mined and reported once internationally agreed methods are
available.Where already data are available they must be reported
together with the method used.
2.8.7. Emulsifiability, Re-emulsifiability, emulsion stability
2.8.7.1. The emulsifiability, emulsion stability and re-emul-sifiability of
preparations which form emulsions, must be determined and reported
according to CIPAC Methods MT 36 or MT 173 as appropriate.
2.8.7.2. The stability of dilute emulsions and of preparations which are emul-
sions, must be determined and reported according to CIPAC Method
MT 20 or MT 173.
2.8.8. Flowability, pourability (rinsability) and dustability2.8.8.1. The flowability of granular preparations must be determined and
reported according to CIPAC Mehtod MT 172.
2.8.8.2. The pourability (including rinsed residue) of suspensions (e.g. suspen-
sion concentrates, suspo-emulsions), must be determined and reported
according to CIPAC Method MT 148.
2.8.8.3. The dustability of dustable powders following accelerated storage
according 2.7.1 must be determined and reported according to CIPAC
Method MT 34 or another suitable method.
2.9. Physical and chemical compatibility with other products
including plant protection products with which its use is
to be authorized
2.9.1. The physical compatibility of tank mixes must be reported based on
in-house test methods.A practical test would be an acceptable alterna-
tive.
2.9.2. The chemical compatibility of tank mixes must be determined and
reported except where examination of the individual properties of the
preparations would establish beyond reasonable doubt that there is no
possibility of reaction taking place.In such cases it is sufficient to
provide that information as justification for not practically determining
the chemical compatibility.
2.10. Adherence and distribution to seeds
In the case of preparations for seed treatment, both distribution and
adhesion must be investigated and reported; in the case of distribution
according to CIPAC Method MT 175.
2.11. Summary and evaluation of data presented under points
2.1. to 2.101991L0414 — EN — 01.09.1994 — 001.001 — 42
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3. Data on application
3.1. Field of use envisaged, e.g. field, protected crops, storage
of plant products, home gardening
The field(s) of use, existing and proposed, for preparations containing
the active substance must be specified from among the following:
— field use, such as agriculture, horticulture, forestry and viticulture,
— protected crops,— amenity,— weed control on non-cultivated areas,
— home gardening,
— house plants,— plant products storage practice,— other (specify).
3.2. Effects on harmful organisms, e.g. contact, inhalation or
stomach poison, fungitoxic or fungistatic, etc., systemic
or not in plants
The nature of the effects on harmful organisms must be stated:
— contact action,
— stomach action,
— inhalation action,
— fungitoxic action,— fungistatic action,— desiccant,— reproduction inhibitor,— other (must be specified).
It must be stated whether or not the product is translocated in plants.
3.3. Details of intended use e.g. types of harmful organisms
controlled and/or plants or plant products to be protected
Details of the intended use must be provided.Where relevant, effects achieved e.g. sprout suppression, retardation of
ripening, reduction in stem length, enhanced fertilization etc.must be
reported.
3.4. Application rate
For each method of application and each use, the rate of application
per unit (ha, m
2,m3) treated, in terms of g or kg of both preparation
and active substance, must be provided.
Application rates shall normally be expressed in g or kg/ha or in kg/m3
and where appropriate in g or kg/tonne; for protected crops and home
gardening use rates shall be expressed in g or kg/100 m2or g or kg/m3.
3.5. Concentration of active substance in material used (e.g. in
the diluted spray, baits or treated seed)
The content of active substance shall be reported, as appropriate, in g/
l, g/kg, mg/kg or in g/tonne.
3.6. Method of application
The method of application proposed must be described fully, indi-
cating the type of equipment to be used, if any, as well as the type
and volume of diluent to be used per unit of area or volume.
3 .7 . N u m b e ra n dt i m i n go fa p p l i c a t i o n sa n dd u r a t i o no fp r o t e c -
tion
The maximum number of applications to be used and their timing,
must be reported.Where relevant the growth stages of the crop or
plants to be protected and the development stages of the harmful
organisms, must be indicated.Where possible the interval between
applications, in days, must be stated.
The duration of protection afforded both by each application and by
the maximum number of applications to be used, must be indicated.
3.8. Necessary waiting periods or other precautions to avoid
phytotoxic effects on succeeding crops
Where relevant, minimum waiting periods between last application
and sowing or planting of succeeding crops, which are necessary to1991L0414 — EN — 01.09.1994 — 001.001 — 43
▼M2
avoid phytotoxic effects on succeeding crops, must be stated, and
follow from the data provided under paragraph 6.6.
Limitations on choice of succeeding crops, if any, must be stated.
3.9. Proposed instructions for use
The proposed instructions for use of the preparation, to be printed on
labels and leaflets, must be provided.
4. Further information on the plant protection product
4.1. Packaging (type, materials, size etc.), compatibility of the
preparation with proposed packaging materials
4.1.1. Packaging to be used must be fully described and specified in terms of
the materials used, manner of construction (e.g. extruded, welded etc.),
size and capacity, size of opening, type of closure and seals.It must be
designed in accordance with the criteria and guidelines specified in the
FAO ‘Guidelines for the Packaging of Pesticides’.
4.1.2. The suitability of the packaging, including closures, in terms of its
strength, leakproofness and resistance to normal transport and hand-
ling, must be determined and reported according to ADR Methods
3552, 3553, 3560, 3554, 3555, 3556 3558, or appropriate ADR
Methods for intermediate bulk containers, and, where for the prepara-
tion child-resistant closures are required, according to ISO standards
8317.
4.1.3. The resistance of the packaging material to its contents must be
reported according to GIFAP Monograph No 17.
4.2. Procedures for cleaning application equipment
Cleaning procedures for both application equipment and protective
clothing must be described in detail.The effectiveness of the cleaning
procedure, must be fully investigated and reported.
4.3. Re-entry periods, necessary waiting periods or other
precautions to protect man, livestock and the environment
The information provided must follow from and be supported by the
data provided for the active substance(s) and that provided under
sections 7 and 8.
4.3.1. Where relevant pre-harvest intervals, re-entry periods or withholding
periods necessary to minimize the presence of residues in or on crops,
plants and plant products, or in treated areas or spaces, with a view to
protecting man or livestock, must be specified e.g.:
— pre-harvest interval (in days) for each relevant crop,
— re-entry period (in days) for livestock, to areas to be grazed,— re-entry period (in hours or days) for man to crops, buildings or
spaces treated,
— withholding period (in days) for animal feedingstuffs,— waiting period (in days), between application and handling treated
products, or
— waiting period (in days), between last application and sowing or
planting succeeding crops.
4.3.2. Where necessary, in the light of the test results, information on any
specific agricultural, plant health or environmental conditions under
which the preparation may or may not be used must be provided.
4.4. Recommended methods and precautions concerning: hand-
ling, storage, transport or fire
The recommended methods and precautions concerning handling
procedures (detailed) for the storage, at both warehouse and user level
of plant protection products, for their transport and in the event of fire
must be provided.Where available information on combustion
products must be provided.The risks likely to arise and the methods
and procedures to minimize the hazards arising, must be specified.
Procedures to preclude or minimize the generation of waste or left-
overs must be provided.
Where relevant assessment has to be done according to ISO — TR
9122.
Where appropriate the nature and characteristics of protective clothing
and equipment proposed must be provided.The data provided must be1991L0414 — EN — 01.09.1994 — 001.001 — 44
▼M2
sufficient to evaluate the suitability and effectiveness under realistic
conditions of use (e.g. field or glasshouse circumstances).
4.5. Emergency measures in the case of an accident
Whether arising during transport, storage or use, detailed procedures to
be followed in the event of an emergency, must be provided; and
include:
— containment of spillages,
— decontamination of areas, vehicles and buildings,
— disposal of damaged packaging, adsorbents and other materials,— protection of emergency workers and bystanders,— first aid measures.
4.6. Procedures for destruction or decontamination of the plant
protection product and its packaging
Procedures for destruction and decontamination must be developed for
both small quantities (user level) and large quantities (warehouse
level).The procedures must be consistent with provisions in place
relating to the disposal of waste and of toxic waste.The means of
disposal proposed should be without unacceptable influence on the
environment and be the most cost effective and practical means of
disposal feasible.
4.6.1. Possibility of neutralization
Neutralization procedures (e.g by reaction with alkali to form less
toxic compounds) for use in the event of accidental spillages, must
where they are feasible, be described.The products produced after
neutralization should be practically or theoretically evaluated and
reported.
4.6.2. Controlled incineration
In many cases the preferred or sole means to safely dispose of active
substances as well as plant protection products containing it, contami-
nated materials, or contaminated packaging, is through controlled
incineration in a lincensed incinerator.
Where the content of halogens of the active substance(s) in the
preparation is greater than 60 %, the pyrolytic behaviour of the active
substance under controlled conditions (including where relevant supply
of oxygen and defined residence time) at 800 ºC and the content of
polyhalogenated dibenzo-p-dioxins and dibenzo-furans in the products
of pyrolysis must be reported.The applicant must provide detailed
instructions for safe disposal.
4.6.3. Others
Other methods to dispose of plant protection products, packaging and
contaminated materials, where proposed, must be fully described.Data
must be provided for such methods, to establish their effectiveness and
safety.
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, feedingstuffs5.2.2. Soil
5.2.3. Water (including drinking water)
5.2.4. Air5.2.5. Animal and human body fluids and tissues1991L0414 — EN — 01.09.1994 — 001.001 — 45
▼B
▼M1
6. Efficacy data
GeneralThe data supplied must be sufficient to permit an evaluation of the
plant protection product to be made.In particular it must be possible
to evaluate the nature and extent of benefits that accrue following use
of the preparation, where they exist in comparison to suitable refer-
ence products and damage thresholds, and to define its conditions of
use.
The number of trials to be conducted and reported depends mainly on
factors such as the extent to which the properties of the actieve
substance(s) it contains are known and on the range of conditions
that arise, including variability in plant health conditions, climatic
differences, the range of agriculral practices, the uniformity of the
crops, the mode of application the type of harmful organism and the
type of plant protection product.
Sufficient data must be generated and submitted to confirm that
patterns determined hold for the regions and the range of conditions,
likely to be encountered in the regions concerned, for which its use
is to be recommended.Where an applicant claims that tests in one or
more of the proposed regions of use are unnecessary because condi-tions are comparable with those in other regions where tests have
been carried out, the applicant must substantiate the claim for compar-
ability with documentary evidence.
In order to assess seasonal differences, if any, sufficient data must be
generated and submitted to confirm the performance of the plant
protection product in each agronomically and climatically different
region for each particular crop (or commodity)/harmful organism
combination.Normally trials on effectiveness or phytotoxicity, where
relevant, in at least two growing seasons must be reported.
If to the opinion of the applicant the trials from the first season
adequately confirm the validity of claims made on the basis of extra-
polation of results from other crops, commodities or situations or from
tests with closely similar preparations, a justification, which is accep-
table to the competent authority for not carrying out a second seaons's
work must be provided.Conversely, where, because of climatic or
plant health conditions or other reasons the data obtained in any parti-
cular season are of limited value for the assessment of performance,
trials in one or more further seasons must be conducted and reported.
6.1. Preliminary tests
Reports in summary form of preliminary tests, including glasshouse
and field studies, used to assess the biological activity and dose range
finding of the plant protection product and of the active substance(s) it
contains, must be submitted when requested by the competent
authority.These reports will provide additional information for the
competent authority when it evaluates the plant production product.
Where this information is not submitted a justification which is accep-
table to the competent authority must be provided.
6.2. Testing effectiveness
Aim of the testsThe tests shall provide sufficient data to permit an evaluation of the
level, duration and consistency of control or protection or other
intended effects of the plant protection product in comparison to
suitable reference products, where they exist.
Test conditionsNormally a trial consists of three components: test product, reference
product and untreated control.
The performance of the plant protection product must be investigated
in relation to suitable reference products, where they exist.A suitable
reference product is defined as an authorized plant protection product
which has proved a sufficient performance in practice under the agri-
cultural, plant health and environmental (including climatic)
conditions in the area of proposed use.In general, formulation type,
effects on the harmful organisms, working spectrum and method of
application should be close to those of the tested plant protection
product.
Plant protection products must be tested in circumstances where the
target harmful organism has been shown to have been present at a1991L0414 — EN — 01.09.1994 — 001.001 — 46
▼M1
level causing or known to cause adverse effects (yield, quality, opera-
tional benefit) on an unprotected crop or area or on plants or plant
products which have not been treated or where the harmful organism
is present at such a level that an evaluation of the plant protection
product can be made.
Trials to provide data on plant protection products for control of
harmful organisms must show the level of control of the species of
harmful organisms concerned or of species representative of groups
for which claims are made.Trials must include the different stages of
growth of life cycle of the harmful species, where this is relevant and
the different strains or races, where these are likely to show different
degrees of susceptibility.
Similarly, trials to provide data on plant protection products which are
plant growth regulators, must how the level of effects on the species to
be treated, and include investigation of differences in the response of a
representative sample of the range of cultivars on which its use is
proposed.
In order to clarify the dose response, dose rates lower than the recom-
mended one must be included in some trials in order to enable to
assess whether the recommended rate is the minimum necessary toachieve the desired effect.
The duration of the effects of treatment must be investigated in rela-
tion to the control of the target organism or effect on the treated plants
or plant products, as appropriate.When more than one application is
recommended, trials must be reported which establish the duration of
the effects of an application, the number of applications necessary and
the desired intervals between them.
Evidence must be submitted to show that the dose, timing and
medthod of application recommended give adequate control, protec-
tion or have the intended effect in the range of circumstances likely
to be encountered in practical use.
Unless there are clear indications that the performance of the plant
protection production is unlikely to be affected to a significant degree
by environemental factors, such as temperature or rain, an investiga-
tion of the effects of such factors on performace must be carried out
and reported, particularly where it is known that the performance of
chemically related products os so affected.
Where proposed label claims include recommendations for the use of
the plant protection product with other plant protection product(s) or
adjuvant(s) information on the performance of the mixture must be
provided.
Test guidelineTrials must be designed to investigate specified issues, to minimize the
effects of random variation between different parts of each site and to
enable statistical analysis to be applied to results amenable to such
analysis.The design, analysis and reporting of trials must be in accor-
dance with European and Mediterranean Plant Protection Organization
(EPPO) guidelines 152 and 181.The report shall include a detailed
and critical assessment of the data.
The trials must be carried out in accordance to specific EPPO guide-
lines, where available, or when a requires so and when the test is
carried out on the territory of this, with guidelines satisfying at least
the requirements of the corresponding EPPO guideline.
A statistical analysis of results amenable to such analysis must be
carried out; where necessary the test guideline used must be adapted
to enable such analysis.
6.3. Information on the occurrence or possible occurrence of
the development of resistance
Laboratory data and where it exists, field information relating to the
occurrence and development of resistance or cross-resistance in popu-
lations of harmful organisms to the active substance(s), or to related
actived substances, must be provided.Where such information is not
directly relevant to the uses for which authorization is ought or to be
renewed (different species of harmful organism or different crops), it
must, if available, nevertheless be provided, as it may provide and
indication of the likelihood of resistance developing in the target
population.1991L0414 — EN — 01.09.1994 — 001.001 — 47
▼M1
Where there is evidence or information to suggest that, in commercial
use, the development of resistance is likely, evidence must be gener-
ated and submitted as to the sensitivity of the population of the
harmful organism concerned to the plant protection product.In such
cases a management strategy designed to minimize the likelihood of
resistance or cross-resistance developing in target species must be
provided.
6.4. Effects on the yield of treated plants or plant products in
terms of quantity and/or quality
6.4.1. Effects on the quality of plants or plant product
Aim of the tests
The tests shall provide sufficient data to permit an evaluation of the
possible occurrence of taint or odour or other quality aspects of plants
or plant products after treatment with the plant protection product.
Circumstances in which requiredThe possibility of the occurrence of taint or odour in food crops must
be investigated and be reported where:
— the nature of the products or its use is such that a risk of occur-
rence of taint or odour might be expected,
or
— other products based on the same or a closely similar active ingre-
dient have been shown to present a risk of occurrence of taint or
odour.
The effects of plant protection products on other quality aspects of
treated plants or plant products must be investigated and reported
where:
— the nature of the plant protection product or it use could have an
adverse influence on other quality aspects (for example in the case
of use of plant growth regulators close or harvest), or
— other products based on the same or a closely similar active ingre-
dient have been shown to have an adverse influence on the quality.
Testing should be conducted initially on the main crops on which the
plant protection product is to be used, at twice the normal rates of
application and using, where relevant, the main methods of processing.
Where effects are observed it is necessary to perform testing at the
normal rate of application.
The extent of investigation necessary on other crops will depend on
their degree of similarity of the main crops already tested, the quantity
and quality of data available on those main crops and how far the
manner of use of the plant protection product and methods of proces-
sing the crops, are similar.It is generally sufficient to perform the test
with the main formulation type to be authorized.
6.4.2. Effects on transformation processes
Aim of the testsThe tests shall provide sufficient data to permit an evaluation of the
possible occurrence of adverse effects after treatment with the plant
protection product on transformation processes or on the quality of
their products.
Circumstances in which requiredWhen the treated plants or plant products are normally intended for
use in transformation process such as wine making, brewing or bread
making and when at harvest significant residues are present, the possi-
bility of the occurrence of adverse effects must be investigated and
reported where:
— there are indications that the use of the plant protection product
could have an influence on the processes involved (for example
in the case of use of plant growth regulators or fungicides close
to harvest),
or
— other products based on the same or a closely similar active ingre-
dient have been shown to have an adverse influence on these
processes or its products.
It is generally sufficient to perform the test with the main formulation
type to be authorized.1991L0414 — EN — 01.09.1994 — 001.001 — 48
▼M1
6.4.3. Effects on the yield of treated plants or plant products
Aim of the testsThe test shall provide sufficient data to permit an evaluation of the
performance of the plant protection product and of possible occurrence
of yield reduction or loss in storage of treated plants or plant products.
Circumstances in which requiredThe effects of plant protection products on the yield or yield compo-
nents of treated plant products must be determined where relevant.
When treated plants or plant products are likely to be stored the effect
on the yield after storage, including data on starage life must be deter-
mined where relevant.
This information will normally be available from the tests required
under the provisions of point 6.2.
6.5. Phytotoxicity to target plants (including different culti-
vars), or to target plant products
Aim of the testsThe test shall provide sufficient data to permit an evaluation of the
performance of the plant protection product and of the possible occur-
rence of phytotoxicity after treatment with the plant protection
product.
Circumstances in which requiredFor herbicides and for other plant protection products for which
adverse effects, however transitory, are seen during the trials,
performed in accordance to point 6.2, the margins of selectivity on
target crops must be established, using twice the recommended rate
of application.Where serious phytotoxic effects are seen, an inter-
mediate application rate must also be investigated.
Where adverse effects occur, but are claimed to be unimportant in
comparison with the benefits of use or transient, evidence to support
this claim is required.If necessary yield measurement must be
submitted.
The safety of a plant protection product to the main cultivars of the
main crops for which it is recommended must be demonstrated,
including effects of crop growh stage, vigour, and other factors which
may influence suspectibility to damage or injury.
The extent of investigation necessary on other crops will depend on
their degree of similarity to the main crops already tested, the quantity
and quality of data available on those main crops and how far the
manner of use of the plant protection product, if relevant, is similar.
It is generally sufficient to perform the test with the main formulation
type to be authorized.
Where proposed label claims include recommendations for the use of
the plant protection product with other plant protection product(s), the
provisions of the previous paragraphs apply for the mixture.
Test guidelineObservations concerning phytotoxicity must be performed in the tests
provided for under point 6.2.
Where phytotoxic effects are seen, they must be accurately assessed
and recorded in accordance with EPPO guideline 135 or when a
Member State requires so and when the test is carried out on the terri-
tory of this Member State, with guidelines satisfying at least the
requirements of this EPPO guideline.
A statistical analysis of results amenable to such analysis must be
carried out, where necessary the test guideline used must be adapted
to enable such analysis.1991L0414 — EN — 01.09.1994 — 001.001 — 49
▼M1
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)
6.6.1. Impact on succeeding crops
Aim of the information requiredSufficient data must be reported to permit an evaluation of possible
adverse effects of a treatment with the plant protection product on
succeeding crops.
Circumstances in which requiredWhere data, generated in accordance with Section 9, point 9.1, shows
that signification residues of the active substance, its metabolites or
degradation products, which have or may have biological activity on
succeeding crops, remain in soil or in plant materials, such as straw
or organic material up to sowing or planting time of possible
succeeding crops, observations must be submitted on effects on the
normal range of succeedings crops.
6.6.2. Impact on other plants, including adjacent crops
Aim of the information requiredSufficient data must be reported to permit an evaluation of possible
adverse effects of a treatment with the plant protection product on
other plants, including adjacent crops.
Circumstances in which required
Observations must be submitted on adverse effects on other plants,
including the normal range of adjacent crops, when there are indica-
tions that the plant protection product could affect these plants via
vapour drift.
6.6.3. Impact on treated plants or plant products to be used for
propagation
Aim of the information requiredSufficient data must be reported to permit an evaluation of possible
adverse effects of a treatment with the plant protection product on
plants or plant products ot be used for propagation.
Circumstances in which requiredObservations must be submitted on the impact of plant protection
products on plant parts used for propagation except where the
proposed uses preclude use on crops intended for production of seeds,
cuttings, runners or tubers for planting, as appropriate.
(i) for seeds — viability, germination and vigour;
(ii) cuttings — rooting and growth rates;
(iii) runners — establishment and growth rates;
(iv) tubers — sprouting and normal growth.
Test guidelineSeeds testing shall be done according to ISTA Methods (
1).
6.6.4. Effects on beneficial and other non-target organisms
Any effects, positive or negative, on the incidence of other harmful
organisms, observed in the tests performed in accordance with the
requirements of this section, shall be reported.Any observed environ-
mental effects must also be reported, especially effects on wildlife
and/or beneficial organisms.
6.7. Summary and evaluation of data presented under 6.1 to 6.6
A summary of all data and informations provided under points 6.1 to
6.6 must be provided, together with a detailed and a critical assess-
ment of the data, with particular reference to the benefits that the
plant protection product offers, adverse effects that do or may arise
and measures necessary to avoid or minimize adverse effects.1991L0414 — EN — 01.09.1994 — 001.001 — 50
(1) International rules for seed testing, 1985.Proceedings of the International Seed Testing
Association, Seed Science and Technology , Volume 13, No 2, 1985.
▼B
7. Toxicological studies
7.1. Acute toxicity
7.1.1. Oral7.1.2. Percutaneous7.1.3. Inhalation7.1.4. 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 exposure7.2.1. Dermal absorption7.2.2. Likely operator exposure under field conditions, including where rele-
vant 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, rele-
vant 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 live-
stock referred to in Annex II, Part A, point 6.5
8.5. Residue data in succeeding or rotational crops where presence of resi-
dues 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 conditions10.1.3. If appropriate, studies on acceptance of bait, granules, or treated seeds
by birds1991L0414 — EN — 01.09.1994 — 001.001 — 51
▼B
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 persis-
tent in water) to assess risks to aquatic organisms under field
conditions
10.2.4. In case of application in/at surface waters10.2.4.1. 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 birds10.3.2. Toxicity to honey-bees10.3.3. 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 countries12.2. 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
Preparationsofmicro-organismsorviruses
(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.)1991L0414 — EN — 01.09.1994 — 001.001 — 52
▼B
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 preparation2.4.1. Wettability2.4.2. Persistent foaming
2.4.3 Suspensibility and suspension stability
2.4.4. Wet sieve test and dry sieve test2.4.5. Particle size distribution, content of dust/fines, attrition and friability2.4.6. In the case of granules, sieve test and indications of weight distribu-
tion 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 dustability2.5. 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 agricul-
tural, 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. % concentra-
tion in the diluted spray)
3.6. Method of application3.7. Number and timing of applications3.8. 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 equipment4.3. 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 packaging1991L0414 — EN — 01.09.1994 — 001.001 — 53
▼B
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
GeneralThe data supplied must be sufficient to permit an evaluation of the
plant protection product to be made.In particular it must be possible
to evaluate the nature and extent of benefits that accrue following use
of the preparation, where they exist in comparison to suitable refer-
ence products and damage thresholds, and to define its conditions of
use.
The number of trials to be conducted and reported depends mainly on
factors such as the extent to which the properties of the actieve
substance(s) it contains are known and on the range of conditions
that arise, including variability in plant health conditions, climatic
differences, the range of agriculral practices, the uniformity of the
crops, the mode of application the type of harmful organism and the
type of plant protection product.
Sufficient data must be generated and submitted to confirm that
patterns determined hold for the regions and the range of conditions,
likely to be encountered in the regions concerned, for which its use
is to be recommended.Where an applicant claims that tests in one or
more of the proposed regions of use are unnecessary because condi-
tions are comparable with those in other regions where tests have
been carried out, the applicant must substantiate the claim for compar-
ability with documentary evidence.
In order to assess seasonal differences, if any, sufficient data must be
generated and submitted to confirm the performance of the plant
protection product in each agronomically and climatically different
region for each particular crop (or commodity)/harmful organism
combination.Normally trials on effectiveness or phytotoxicity, where
relevant, in at least two growing seasons must be reported.
If to the opinion of the applicant the trials from the first season
adequately confirm the validity of claims made on the basis of extra-
polation of results from other crops, commodities or situations or from
tests with closely similar preparations, a justification, which is accep-
table to the competent authority for not carrying out a second seaons's
work must be provided.Conversely, where, because of climatic or
plant health conditions or other reasons the data obtained in any parti-
cular season are of limited value for the assessment of performance,
trials in one or more further seasons must be conducted and reported.
6.1. Preliminary tests
Reports in summary form of preliminary tests, including glasshouse
and field studies, used to assess the biological activity and dose range
finding of the plant protection product and of the active substance(s) it
contains, must be submitted when requested by the competent
authority.These reports will provide additional information for the
competent authority when it evaluates the plant production product.
Where this information is not submitted a justification which is accep-
table to the competent authority must be provided.
6.2. Testing effectiveness
Aim of the testsThe tests shall provide sufficient data to permit an evaluation of the
level, duration and consistency of control or protection or other1991L0414 — EN — 01.09.1994 — 001.001 — 54
▼M1
▼M1
intended effects of the plant protection product in comparison to
suitable reference products, where they exist.
Test conditions
Normally a trial consists of three components: test product, reference
product and untreated control.
The performance of the plant protection product must be investigated
in relation to suitable reference products, where they exist.A suitable
reference product is defined as an authorized plant protection product
which has proved a sufficient performance in practice under the agri-
cultural, plant health and environmental (including climatic)
conditions in the area of proposed use.In general, formulation type,
effects on the harmful organisms, working spectrum and method of
application should be close to those of the tested plant protection
product.
Plant protection products must be tested in circumstances where the
target harmful organism has been shown to have been present at a
level causing or known to cause adverse effects (yield, quality, opera-
tional benefit) on an unprotected crop or area or on plants or plant
products which have not been treated or where the harmful organism
is present at such a level that an evaluation of the plant protection
product can be made.
Trials to provide data on plant protection products for control of
harmful organisms must show the level of control of the species of
harmful organisms concerned or of species representative of groups
for which claims are made.Trials must include the different stages of
growth of life cycle of the harmful species, where this is relevant and
the different strains or races, where these are likely to show different
degrees of susceptibility.
Similarly, trials to provide data on plant protection products which are
plant growth regulators, must how the level of effects on the species to
be treated, and include investigation of differences in the response of a
representative sample of the range of cultivars on which its use is
proposed.
In order to clarify the dose response, dose rates lower than the recom-
mended one must be included in some trials in order to enable to
assess whether the recommended rate is the minimum necessary to
achieve the desired effect.
The duration of the effects of treatment must be investigated in rela-
tion to the control of the target organism or effect on the treated plants
or plant products, as appropriate.When more than one application is
recommended, trials must be reported which establish the duration of
the effects of an application, the number of applications necessary and
the desired intervals between them.
Evidence must be submitted to show that the dose, timing and
medthod of application recommended give adequate control, protec-
tion or have the intended effect in the range of circumstances likely
to be encountered in practical use.
Unless there are clear indications that the performance of the plant
protection production is unlikely to be affected to a significant degree
by environemental factors, such as temperature or rain, an investiga-
tion of the effects of such factors on performace must be carried out
and reported, particularly where it is known that the performance of
chemically related products os so affected.
Where proposed label claims include recommendations for the use of
the plant protection product with other plant protection product(s) or
adjuvant(s) information on the performance of the mixture must be
provided.
Test guideline
Trials must be designed to investigate specified issues, to minimize the
effects of random variation between different parts of each site and to
enable statistical analysis to be applied to results amenable to such
analysis.The design, analysis and reporting of trials must be in accor-
dance with European and Mediterranean Plant Protection Organization
(EPPO) guidelines 152 and 181.The report shall include a detailed
and critical assessment of the data.
The trials must be carried out in accordance to specific EPPO guide-
lines, where available, or when a requires so and when the test is1991L0414 — EN — 01.09.1994 — 001.001 — 55
▼M1
carried out on the territory of this, with guidelines satisfying at least
the requirements of the corresponding EPPO guideline.
A statistical analysis of results amenable to such analysis must be
carried out; where necessary the test guideline used must be adapted
to enable such analysis.
6.3. Information on the occurrence or possible occurrence of
the development of resistance
Laboratory data and where it exists, field information relating to the
occurrence and development of resistance or cross-resistance in popu-
lations of harmful organisms to the active substance(s), or to related
actived substances, must be provided.Where such information is not
directly relevant to the uses for which authorization is ought or to be
renewed (different species of harmful organism or different crops), it
must, if available, nevertheless be provided, as it may provide and
indication of the likelihood of resistance developing in the target
population.
Where there is evidence or information to suggest that, in commercial
use, the development of resistance is likely, evidence must be gener-
ated and submitted as to the sensitivity of the population of the
harmful organism concerned to the plant protection product.In such
cases a management strategy designed to minimize the likelihood of
resistance or cross-resistance developing in target species must be
provided.
6.4. Effects on the yield of treated plants or plant products in
terms of quantity and/or quality
6.4.1. Effects on the quality of plants or plant product
Aim of the testsThe tests shall provide sufficient data to permit an evaluation of the
possible occurrence of taint or odour or other quality aspects of plants
or plant products after treatment with the plant protection product.
Circumstances in which requiredThe possibility of the occurrence of taint or odour in food crops must
be investigated and be reported where:
— the nature of the products or its use is such that a risk of occur-
rence of taint or odour might be expected,
or
— other products based on the same or a closely similar active ingre-
dient have been shown to present a risk of occurrence of taint or
odour.
The effects of plant protection products on other quality aspects of
treated plants or plant products must be investigated and reported
where:
— the nature of the plant protection product or it use could have an
adverse influence on other quality aspects (for example in the case
of use of plant growth regulators close or harvest), or
— other products based on the same or a closely similar active ingre-
dient have been shown to have an adverse influence on the quality.
Testing should be conducted initially on the main crops on which the
plant protection product is to be used, at twice the normal rates of
application and using, where relevant, the main methods of processing.
Where effects are observed it is necessary to perform testing at the
normal rate of application.
The extent of investigation necessary on other crops will depend on
their degree of similarity of the main crops already tested, the quantity
and quality of data available on those main crops and how far the
manner of use of the plant protection product and methods of proces-
sing the crops, are similar.It is generally sufficient to perform the test
with the main formulation type to be authorized.
6.4.2. Effects on transformation processes
Aim of the testsThe tests shall provide sufficient data to permit an evaluation of the
possible occurrence of adverse effects after treatment with the plant
protection product on transformation processes or on the quality of
their products.1991L0414 — EN — 01.09.1994 — 001.001 — 56
▼M1
Circumstances in which required
When the treated plants or plant products are normally intended for
use in transformation process such as wine making, brewing or bread
making and when at harvest significant residues are present, the possi-
bility of the occurrence of adverse effects must be investigated and
reported where:
— there are indications that the use of the plant protection product
could have an influence on the processes involved (for example
in the case of use of plant growth regulators or fungicides close
to harvest),
or
— other products based on the same or a closely similar active ingre-
dient have been shown to have an adverse influence on these
processes or its products.
It is generally sufficient to perform the test with the main formulation
type to be authorized.
6.4.3. Effects on the yield of treated plants or plant products
Aim of the testsThe test shall provide sufficient data to permit an evaluation of the
performance of the plant protection product and of possible occurrence
of yield reduction or loss in storage of treated plants or plant products.
Circumstances in which required
The effects of plant protection products on the yield or yield compo-
nents of treated plant products must be determined where relevant.
When treated plants or plant products are likely to be stored the effect
on the yield after storage, including data on starage life must be deter-
mined where relevant.
This information will normally be available from the tests required
under the provisions of point 6.2.
6.5. Phytotoxicity to target plants (including different culti-
vars), or to target plant products
Aim of the tests
The test shall provide sufficient data to permit an evaluation of the
performance of the plant protection product and of the possible occur-
rence of phytotoxicity after treatment with the plant protection
product.
Circumstances in which requiredFor herbicides and for other plant protection products for which
adverse effects, however transitory, are seen during the trials,
performed in accordance to point 6.2, the margins of selectivity on
target crops must be established, using twice the recommended rate
of application.Where serious phytotoxic effects are seen, an inter-
mediate application rate must also be investigated.
Where adverse effects occur, but are claimed to be unimportant in
comparison with the benefits of use or transient, evidence to support
this claim is required.If necessary yield measurement must be
submitted.
The safety of a plant protection product to the main cultivars of the
main crops for which it is recommended must be demonstrated,
including effects of crop growh stage, vigour, and other factors which
may influence suspectibility to damage or injury.
The extent of investigation necessary on other crops will depend on
their degree of similarity to the main crops already tested, the quantity
and quality of data available on those main crops and how far the
manner of use of the plant protection product, if relevant, is similar.
It is generally sufficient to perform the test with the main formulation
type to be authorized.
Where proposed label claims include recommendations for the use of
the plant protection product with other plant protection product(s), theprovisions of the previous paragraphs apply for the mixture.
Test guidelineObservations concerning phytotoxicity must be performed in the tests
provided for under point 6.2.1991L0414 — EN — 01.09.1994 — 001.001 — 57
▼M1
Where phytotoxic effects are seen, they must be accurately assessed
and recorded in accordance with EPPO guideline 135 or when a
Member State requires so and when the test is carried out on the terri-
tory of this Member State, with guidelines satisfying at least the
requirements of this EPPO guideline.
A statistical analysis of results amenable to such analysis must be
carried out, where necessary the test guideline used must be adapted
to enable such analysis.
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)
6.6.1. Impact on succeeding crops
Aim of the information requiredSufficient data must be reported to permit an evaluation of possible
adverse effects of a treatment with the plant protection product on
succeeding crops.
Circumstances in which requiredWhere data, generated in accordance with Section 9, point 9.1, shows
that signification residues of the active substance, its metabolites or
degradation products, which have or may have biological activity on
succeeding crops, remain in soil or in plant materials, such as straw
or organic material up to sowing or planting time of possible
succeeding crops, observations must be submitted on effects on the
normal range of succeedings crops.
6.6.2. Impact on other plants, including adjacent crops
Aim of the information required
Sufficient data must be reported to permit an evaluation of possible
adverse effects of a treatment with the plant protection product on
other plants, including adjacent crops.
Circumstances in which requiredObservations must be submitted on adverse effects on other plants,
including the normal range of adjacent crops, when there are indica-
tions that the plant protection product could affect these plants via
vapour drift.
6.6.3. Impact on treated plants or plant products to be used for
propagation
Aim of the information requiredSufficient data must be reported to permit an evaluation of possible
adverse effects of a treatment with the plant protection product on
plants or plant products ot be used for propagation.
Circumstances in which requiredObservations must be submitted on the impact of plant protection
products on plant parts used for propagation except where the
proposed uses preclude use on crops intended for production of seeds,
cuttings, runners or tubers for planting, as appropriate.
(i) for seeds — viability, germination and vigour;
(ii) cuttings — rooting and growth rates;
(iii) runners — establishment and growth rates;
(iv) tubers — sprouting and normal growth.
Test guidelineSeeds testing shall be done according to ISTA Methods (
1).
6.6.4. Effects on beneficial and other non-target organisms
Any effects, positive or negative, on the incidence of other harmful
organisms, observed in the tests performed in accordance with the
requirements of this section, shall be reported.Any observed environ-1991L0414 — EN — 01.09.1994 — 001.001 — 58
(1) International rules for seed testing, 1985.Proceedings of the International Seed Testing
Association, Seed Science and Technology , Volume 13, No 2, 1985.
▼M1
mental effects must also be reported, especially effects on wildlife
and/or beneficial organisms.
6.7. Summary and evaluation of data presented under 6.1 to 6.6
A summary of all data and informations provided under points 6.1 to
6.6 must be provided, together with a detailed and a critical assess-
ment of the data, with particular reference to the benefits that the
plant protection product offers, adverse effects that do or may arise
and measures necessary to avoid or minimize adverse effects.
7. Toxicity and/or pathogenicity and infectivity studies
7.1. Oral single dose
7.2. Percutaneous single dose
7.3. Inhalation7.4. Skin and where relevant eye irritation7.5. Skin sensitization
7.6. Available toxicological data relating to non-active substances
7.7. Operator exposure7.7.1. Percutaneous absorption7.7.2. Likely operator exposure under field conditions, including where rele-
vant 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 resi-
dues 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. Fish10.1.2. Studies in Daphnia magna and in species closely related to the target
organisms
10.1.3. Studies in aquatic micro-organisms10.2. Effects on beneficial and other non-target organisms10.2.1. Effects on honey-bees, if appropriate1991L0414 — EN — 01.09.1994 — 001.001 — 59
▼B
▼B
10.2.2. Effects on other beneficial organisms
10.2.3. Effects on earthworms
10.2.4. Effects on other soil fauna10.2.5. 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 packaging1991L0414 — EN — 01.09.1994 — 001.001 — 60
▼B
ANNEX IV
RISKPHRASES1991L0414 — EN — 01.09.1994 — 001.001 — 61
▼B
ANNEX V
SAFETYPHRASES1991L0414 — EN — 01.09.1994 — 001.001 — 62
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ANNEX VI
UNIFORM PRINCIPLES FOR EVALUATION ANDAUTHORIZATION
OFPLANTPRODUCTIONPRODUCTS
CONTENTS
A.INTRODUCTION
B.EVALUATION
1.Generalprinciples
2.Specificprinciples
2.1.Efficacy
2.2.Absence of unacceptable effects on plants or plant products
2.3.Impact on vertebrates to be controlled
2.4.Impact on human or animal health
2.4.1. arising from the plant protection product2.4.2. arising from residues
2.5.Influence on the environment
2.5.1. Fate and distribution in the environment2.5.2. Impact on non-target species
2.6.Analytical methods
2.7.Physical and chemical properties
C.DECISION-MAKING
1.Generalprinciples
2.Specificprinciples
2.1.Efficacy
2.2.Absence of unacceptable effects on plants or plant products
2.3.Impact on vertebrates to be controlled
2.4.Impact on human or animal health
2.4.1. arising from the plant protection product
2.4.2. arising from residues2.5.Influence on the environment
2.5.1. Fate and distribution in the environment
2.5.2. Impact on non-target species2.6.Analytical methods
2.7.Physical and chemical properties1991L0414 — EN — 01.09.1994 — 001.001 — 63
▼M3
A.INTRODUCTION
1.The principles developed in this Annex aim to ensure that evaluations and
decisions with regard to authorization of plant protection products, provided
they are chemical preparations, result in the implementation of the require-
ments of Article 4 (1) (b), (c), (d) and (e) of this Directive by all the
Member States at the high level of protection of human and animal health
and the environment.
2.In evaluating applications and granting authorizations Member States shall:
(a) — ensure that the dossier supplied is in accordance with the require-
ments of Annex III, at the latest at the time of finalization of the
evaluation for the purpose of decision-making without prejudice,
where relevant, to the provisions of Article 13 (1) (a), (4) and (6)
of this Directive,
— ensure that the data submitted are acceptable in terms of quantity,
quality, consistency and reliability and sufficient to permit a proper
evaluation of the dossier,
— evaluate, where relevant, justifications submitted by the applicant for
not supplying certain data;
(b) take into account the Annex II data concerning the active substance in
the plant protection product, submitted for the purpose of inclusion of
the active substance concerned in Annex I, and the results of the evalua-
tion of those data, without prejudice, where relevant, to the provisions of
Article 13 (1) (b), (2), (3) and (6) of this Directive;
(c) take into consideration other relevant technical or scientific information
they can reasonably possess with regard to the performance of the plant
protection product or to the potentially adverse effects of the plant
protection product, its components or its residues.
3.Where in the specific principles on evaluation reference is made to Annex II
data, this shall be understood as being the data referred to in point 2 (b).
4.Where the data and information provided are sufficient to permit completion
of the evaluation for one of the proposed uses, applications must be evalu-
ated and a decision made for the proposed use.
Taking account of justifications provided and with the benefit of any subse-
quent clarifications, Member States shall reject applications for which the
data gaps are such that it is not possible to finalize the evaluation and to
make a reliable decision for at least one of the proposed uses.
5.During the process of evaluation and decision-making, Member States shall
cooperate with the applicants in order to resolve any questions on the dossier
quickly or to identify at an early stage any additional studies necessary for a
proper evaluation of the dossier, or to amend any proposed conditions for the
use of the plant protection product or to modify its nature or its composition
in order to ensure full satisfaction of the requirements of this Annex or of
this Directive.
Member States shall normally come to a reasoned decision within 12 months
of receiving a technically complete dossier.A technically complete dossier is
one that satisfies all the requirements of Annex III.
6.The judgments made by the competent authorities of the Member States
during the evaluation and decision-making process must be based on scien-
tific principles, preferably recognized at international level (for example, by
the EPPO), and be made with the benefit of expert advice.
B.EVALUATION
1.General principles
1.Having regard to current scientific and technical knowledge, Member
States shall evaluate the information referred to in Part A, point 2, and
in particular:
(a) assess the performance in terms of efficacy and phytotoxicity of the
plant protection product for each use for which authorization is
sought; and
(b) identify the hazards arising, assess their significance and make a
judgment as to the likely risks to humans, animals or the environ-
ment.
2.In accordance with the terms of Article 4 of this Directive, which inter
alia specifies that Member States shall have regard to all normal condi-1991L0414 — EN — 01.09.1994 — 001.001 — 64
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tions under which the plant protection product may be used, and to the
consequences of its use, Member States shall ensure that evaluations
carried out have regard to the proposed practical conditions of use and
in particular to the purpose of use, the dose, the manner, frequency and
timing of applications, and the nature and composition of the preparation.
Whenever possible Memeber States shall also take into account the prin-
ciples of integrated control.
3.In the evaluation of applications submitted, Member States shall have
regard to the agricultural, plant health or environmental (including
climatic) conditions in the areas of use.
4.In interpreting the results of evaluations, Member States shall take into
consideration possible elements of uncertainty in the information obtained
during the evaluation, in order to ensure that the chances of failing to
detect adverse effects or of under-estimating their importance are reduced
to a minimum.The decision-making process shall be examined to identify
critical decision points or items of data for which uncertainties could lead
to a false classification of risk.
The first evaluation made shall be based on the best available data or esti-
mates reflecting the realistic conditions of use of the plant protection
product.
This should be followed by a repeat evaluation, taking account of poten-
tial uncertainties in the critical data and of a range of use conditions that
are likely to occur and resulting in a realistic worst-case approach, to
determine whether it is possible that the initial evaluation could have
been significantly different.
5.Where specific principles of Section 2 provide for the use of calculation
models in the evaluation of a plant protection product, those models shall:
— make a best possible estimation of all relevant processes involved
taking into account realistic parameters and assumptions,
— be submitted to an analysis as referred to in B, point 1.4,
— be reliably validated with measurements carried out under circum-
stances relevant for the use of the model,
— be relevant to the conditions in the area of use.
6.Where metabolites, degradation or reaction products are referred to in the
specific principles, only those that are relevant for the proposed criterion
shall be taken into consideration.
2.Specific principles
Member States shall, for the evaluation of the data and information
submitted in support of applications, and without prejudice to the general
principles of Section 1, implement the following principles.
2.1.Efficacy
2.1.1. Where the proposed use concerns the control of or protection
against an organism, Member States shall evaluate the possibility
that this organism could be harmful under the agricultural, plant
health and environmental (including climatic) conditions in the area
of the proposed use.
2.1.2. Where the proposed use concerns an effect other than the control of
or protection against an organism, Member States shall evaluate
whether significant damage, loss or inconvenience could occur
under the agricultural, plant health and environmental (including
climatic) conditions in the area of proposed use if the plant protec-
tion product were not used.
2.1.3. Member States shall evaluate the efficacy data on the plant protec-
tion product as provided for in Annex III having regard to the
degree of control or the extent of the effect desired and having
regard to the relevant experimental conditions such as:
— the choice of the crop or cultivar,
— the agricultural and environmental (including climatic) condi-
tions,
— the presence and density of the harmful organism,
— the development stage of crop and organism,
— the amount of the plant protection product used,
— if required on the label, the amount of adjuvant added,— the frequency and timing of the applications,1991L0414 — EN — 01.09.1994 — 001.001 — 65
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— the type of application equipment.
2.1.4. Member States shall evaluate the performance of the plant protec-
tion product in a range of agricultural, plant health and
environmental (including climatic) conditions likely to be encoun-
tered in practice in the area of proposed use and in particular:
(i) the level, consistency and duration of the effect sought in rela-
tion to the dose in comparison with a suitable reference product
or products and an untreated control,
(ii) where relevant, effect on yield or reduction of loss in storage, in
terms of quantity and/or quality, in comparison with a suitable
reference product or products and an untreated control.
Where no suitable reference product exists, Member States shall
evaluate the performance of the plant protection product to deter-
mine whether there is a consistent and defined benefit under the
agricultural, plant health and environmental (including climatic)
conditions in the area of proposed use.
2.1.5. Where the product label includes requirements for use of the plant
protection product with other plant protection products and/or with
adjuvants as a tank mix, Member States shall make the evaluations
referred to in points 2.1.1 to 2.1.4 in relation to the information
supplied for the tank mix.
Where the product label includes recommendations for use of the
plant protection product with other plant protection products and/or
with adjuvants as a tank mix, Member States shall evaluate the
appropriateness of the mix and of its conditions of use.
2.2.Absence of unacceptable effects on plants or plant products
2.2.1. Member States shall evaluate the degree of adverse effects on the
treated crop after use of the plant protection product according to
the proposed conditions of use in comparison, where relevant, with
suitable reference product or products, where they exist, and/or an
untreated control.
(a) This evaluation will take into consideration the following infor-
mation:
(i) the efficacy data provided for in Annex III;
(ii) other relevant information on the plant protection product
such as nature of the preparation, dose, method of applica-
tion, number and timing of applications;
(iii) all relevant information on the active substance as provided
for in Annex II, including mode of action, vapour pressure,
volatility and water solubility.
(b) This evaluation will include:
(i) the nature, frequency, level and duration of observed
phytotoxic effects and the agricultural, plant health and
environmental (including climatic) conditions that affect
these;
(ii) the differences between main cultivars with regard to their
sensitivity to phytotoxic effects;
(iii) the part of the treated crop or plant products where phyto-
toxic effects are observed;
(iv) the adverse impact on the yield of the treated crop or plant
products in terms of quantity and/or quality;
(v) the adverse impact on treated plants or plant products to be
used for propagation, in terms of viability, germination,
sprouting, rooting and establishment;
(vi) where volatile products are concerned, the adverse impact
on adjacent crops.
2.2.2. Where the available data indicate that the active substance or signif-
icant metabolites, degradation and reaction products persist in soils
and/or in or on plant substances in significant quantities after use of
the plant protection product according to the proposed conditions of
use, Member States shall evaluate the degree of adverse effects on
subsequent crops.This evaluation will be carried out as specified in
point 2.2.1.
2.2.3. Where the product label includes requirements for use of the plant
protection product with other plant protection products or with adju-
vants as a tank mix, the evaluation as specified in point 2.2.1 will be
carried out in relation to the information supplied for the tank mix.1991L0414 — EN — 01.09.1994 — 001.001 — 66
▼M3
2.3.Impact on vertebrates to be controlled
Where the proposed use of the plant protection product aims to have
an effect on vertebrates, Member States shall evaluate the
mechanism by which this effect is obtained and the observed effects
on the behaviour and health of the target animals; when the intended
effect is to kill the target animal they shall evaluate the time neces-
sary to obtain the death of the animal and the conditions under
which death occurs.
This evaluation will take into consideration the following informa-
tion:
(i) all relevant information as provided for in Annex II and the
results of the evaluation thereof, including the toxicological
and metabolism studies;
(ii) all relevant information on the plant protection product as
provided for in Annex III, including toxicological studies and
efficacy data.
2.4.Impact on human or animal health
2.4.1. Arising from the plant protection product
2.4.1.1. Member States shall evaluate operator exposure to active substance
and/or to toxicologically relevant compounds in the plant protection
product likely to occur under the proposed conditions of use
(including in particular dose, application method and climatic condi-
tions) using by preference realistic data on exposure and, if such
data are not available, as suitable, validated calculation model.
(a) This evaluation will take into consideration the following infor-
mation:
(i) the toxicological and metabolism studies as provided for in
Annex II and the results of the evaluation thereof including
the acceptable operator exposure level (AOEL).The accep-
table operator exposure level is the maximum amount of
active substance to which the operator may be exposed
without any adverse health effects.The AOEL is expressed
as milligrams of the chemical per kilogram body weight of
the operator.The AOEL is based on the highest level at
which no adverse effect is observed in tests in the most
sensitive relevant animal species or, if appropriate data are
available, in humans;
(ii) other relevant information on the active substances such as
physical and chemical properties;
(iii) the toxicological studies provided for in Annex III,
including where appropriate dermal absorption studies;
(iv) other relevant information as provided for in Annex III
such as:
— composition of the preparation,
— nature of the preparation,— size, design and type of packaging,— field of use and nature of crop or target,— method of application including handling, loading and
mixing of product,
— exposure reduction measures recommended,— protective clothing recommendations,— maximum application rate,— minimum spray application volume stated on the label,— number and timing of applications.
(b) This evaluation shall be made for each type of application
method and application equipment proposed for use of the plant
protection product as well as for the different types and sizes of
containers to be used, taking account of mixing, loading opera-
tions, application of the plant protection product and cleaning
and routine maintenance of application equipment.
2.4.1.2. Member States shall examine information relating to the nature and
characteristics of the packaging proposed with particular reference
to the following aspects:
— the type of packaging,
— its dimensions and capacity,— the size of the opening,1991L0414 — EN — 01.09.1994 — 001.001 — 67
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— the type of closure,
— its strength, leakproofness and resistance to normal transport and
handling,
— its resistance to and compatibility with the contents.
2.4.1.3. Member States shall examine the nature and characteristics of the
protective clothing and equipment proposed with particular refer-
ence to the following aspects:
— obtainability and suitability,
— ease of wearing taking into account physical stress and climatic
conditions.
2.4.1.4. Member States shall evaluate the possibility of exposure of other
humans (bystanders or workers exposed after the application of the
plant protection product) or animals to the active substance and/or to
other toxicologically relevant compounds in the plant protection
product under the proposed conditions of use.
This evaluation will take into consideration the following informa-
tion:
(i) the toxicological and metabolism studies on the active
substance as provided for in Annex II and the results of the
evaluation thereof, including the acceptable operator exposure
level,
(ii) the toxicological studies provided for in Annex III, including
where appropriate dermal absorption studies,
(iii) other relevant information on the plant protection product as
provided for in Annex III such as:
— re-entry periods, necessary waiting periods or other precau-
tions to protect humans and animals,
— method of application, in particular spraying,— maximum application rate,
— maximum spray application volume,
— composition of the preparation,— excess remaining on plants and plant products after treat-
ment,
— further activities whereby workers are exposed.
2.4.2. Arising from residues2.4.2.1. Member States shall evaluate the specific information on toxicology
as provided for in Annex II and in particular:
— the determination of an acceptable daily intake (ADI),
— the identification of metabolites, degradation and reaction
products in treated plants or plant products,
— behaviour of residues of the active substance and its metabolites
from the time of application until harvest, or in the case of post-
harvest uses, until outloading of stored plant products.
2.4.2.2. Prior to evaluating the residue levels in the reported trials or in
products of animal origin Member States shall examine the
following information:
— data on the proposed good agricultural practice, including data
on application as provided for in Annex III and proposed pre-
harvest intervals for envisaged uses, or withholding periods or
storage periods, in case of post-harvest uses,
— nature of preparation,— analytical methods and the residue definition.
2.4.2.3. On the basis of suitable statistical models Member States shall eval-
uate the residue levels observed in the reported trials.This
evaluation shall be made for each proposed use and shall take into
consideration:
(i) the proposed conditions of use of the plant protection product;
(ii) the specific information on residues in or on treated plants,
plant products, food and feed as provided for in Annex III and
the distribution of residues between edible and non-edible
parts;
(iii) the specific information on residues in or on treated plants,
plant products, food and feed as provided for in Annex II and
the results of the evaluation thereof;
(iv) the realistic possibilities of extrapolating data from one crop to
another.1991L0414 — EN — 01.09.1994 — 001.001 — 68
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2.4.2.4. Member States shall evaluate the residue levels observed in products
of animal origin, taking into consideration the information provided
for in Annex III, Part A, point 8.4 and residues resulting from other
uses.
2.4.2.5. Member States shall estimate the potential exposure of consumers
through diet and, where relevant, other ways of exposure, using as
suitable calculation model.This evaluation will take account, where
relevant, of other sources of information such as other authorized
uses of plant protection products containing the same active
substance or which give rise to the same residues.
2.4.2.6. Member States shall, where relevant, estimate the exposure of
animals, taking into account residue levels observed in treated plants
or plant products intended to be fed to animals.
2.5.Influence on the environment
2.5.1. Fate and distribution in the environment
In the evaluation of the fate and distribution of the plant protection
product in the environment, Member States shall have regard to all
aspects of the environment, including biota, and in particular to the
following:
2.5.1.1. Member States shall evaluate the possibility of the plant protection
product reaching the soil under the proposed conditions of use; if
this possibility exists they shall estimate the rate and the route of
degradation in the soil, the mobility in the soil and the change in
the total concentration (extractable and non-extractable (*)) of the
active substance and of relevant metabolites, degradation and reac-
tion products that could be expected in the soil in the area of
envisaged use after use of the plant protection product according to
the proposed conditions of use.
This evaluation will take into consideration the following informa-
tion:
(i) the specific information on fate and behaviour in soil as
provided for in Annex II and the results of the evaluation
thereof;
(ii) other relevant information on the active substance such as:
— molecular weight,
— solubility in water,— octanol/water partition coefficient,— vapour pressure,
— volatilization rate,
— dissociation constant,— photodegradation rate and identity of breakdown products,— hydrolysis rate in relation to pH and identity of breakdown
products;
(iii) all information on the plant protection product as provided for
in Annex III, including the information on distribution and
dissipation in soil;
(iv) where relevant, other authorized uses of plant protection
products in the area of proposed use containing the same active
substance or which give rise to the same residues.
2.5.1.2. Member States shall evaluate the possibility of the plant protection
product reaching the groundwater intended to produce drinking
water under the proposed conditions of use; if this possibility exists,
they shall estimate, using a suitable calculation model validated at
Community level, the concentration of the active substance and of
relevant metabolites, degradation and reaction products that could
be expected in the groundwater in the area of envisaged use after
use of the plant protection product according to the proposed condi-
tions of use.
If there is no validated Community calculation model, Member
States shall base their evaluation especially on the results of mobi-1991L0414 — EN — 01.09.1994 — 001.001 — 69
(*) Non-extractable residues (sometimes referred to as ‘bound’ or ‘non-extracted’ resi-
dues) in plants and soils are defined as chemical species originating from pesticidesused according to good agricultural practice that cannot be extracted by methodswhich do not significantly change the chemical nature of these residues.These non-extractable residues are not considered to include fragments through metabolic path-
ways leading to natural products.
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lity and persistence in soil studies as provided for in Annexes II and
III.
This evaluation will also take into consideration the following infor-
mation:
(i) the specific information on fate and behaviour in soil and
water as provided for in Annex II and the results of the evalua-
tion thereof;
(ii) other relevant information on the active substance such as:
— molecular weight,
— solubility in water,
— octanol/water partition coefficient,— vapour pressure,— volatilization rate,— hydrolysis rate in relation to pH and identity of breakdown
products,
— dissociation constant;
(iii) all information on the plant protection product as provided for
in Annex III, including the information on distribution and
dissipation in soil and water;
(iv) where relevant, other authorized uses of plant protection
products in the area of envisaged use containing the same
active substance or which give rise to the same residues;
(v) where relevant, data on dissipation including transformation
and sorption in the saturated zone;
(vi) where relevant, data on the procedures for drinking water
abstraction and treatment in the area of envisaged use;
(vii) where relevant, monitoring data on the presence or absence of
the active substance in groundwater as a result of previous use
of plant protection products containing the same active
substance or which give rise to the same residues.
2.5.1.3. Member States shall evaluate the possibility of the plant protection
product reaching surface water under the proposed conditions of
use; if this possibility exists they shall estimate, using a suitable
calculation model validated at Community level, the short-term and
long-term predicted concentration of the active substance and of
metabolites, degradation and reaction products that could be
expected in the surface water in the area of envisaged use after use
of the plant protection product according to the proposed conditions
of use.
If there is no validated Community calculation model, Member
States shall base their evaluation especially on the results of mobi-
lity and persistence in soil studies and the information on run-off
and drift as provided for in Annexes II and III.This evaluation
will also take into consideration the following information:
(i) the specific information on fate and behaviour in soil and water
as provided for in Annex II and the results of the evaluation
thereof;
(ii) other relevant information on the active substance such as:
— molecular weight,
— solubility in water,— octanol/water partition coefficient,
— vapour pressure,
— volatilization rate,— hydrolysis rate in relation to pH and identity of breakdown
products,
— dissociation constant;
(iii) all relevant information on the plant protection product as
provided for in Annex III, including the information on distri-
bution and dissipation in soil and water;
(iv) possible routes of exposure:
— drift,
— run-off,— overspray,— discharge via drains,— leaching,— deposit in the atmosphere;1991L0414 — EN — 01.09.1994 — 001.001 — 70
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(v) where relevant, other authorized uses of plant protection
products in the area of envisaged use containing the same
active substance or which give rise to the same residues;
(vi) where relevant, data on the procedures for drinking water
abstraction and treatment in the area of envisaged use.
2.5.1.4. Member States shall evaluate the possibility of the plant protection
product being dissipated in the air under the proposed conditions of
use; if this possibility exists they shall make the best possible esti-
mation, using where appropriate a suitable, validated calculation
model, of the concentration of the active substance and of relevant
metabolites, degradation and reaction products that could be
expected in the air after use of the plant protection product
according to the proposed conditions of use.
This evaluation will take into consideration the following informa-
tion:
(i) the specific information on fate and behaviour in soil, water
and air as provided for in Annex II and the results of the
evaluation thereof;
(ii) other relevant information on the active substance such as:
— vapour pressure,
— solubility in water,— hydrolysis rate in relation to pH and identity of breakdown
products,
— photochemical degradation in water and air and identity of
breakdown products,
— octanol/water partition coefficient;
(iii) all relevant information on the plant protection product as
provided for in Annex III, including the information on distri-
bution and dissipation in air.
2.5.1.5. Member States shall evaluate the procedures for destruction or
decontamination of the plant protection product and its packaging.
2.5.2. Impact on non-target species
When calculating toxicity/exposure ratios Member States shall take
into consideration toxicity to the most sensitive relevant organism
used in the tests.
2.5.2.1. Member States shall evaluate the possibility of exposure of birds
and other terrestrial vertebrates to the plant protection product under
the proposed conditions of use; if this possibility exists they shall
evaluate the extent of the short-term and long-term risk to be
expected for these organisms, including their reproduction, after
use of the plant protection product according to the proposed condi-
tions of use.
(a) This evaluation will take into consideration the following infor-
mation:
(i) the specific information relating to toxicological studies on
mammals and to the effects on birds and other non-target
terrestrial vertebrates, including effects on reproduction,
and other relevant information concerning the active
substance as provided for in Annex II and the results of
the evaluation thereof;
(ii) all relevant information on the plant protection product as
provided for in Annex III, including the information on
effects on birds and other non-target terrestrial vertebrates;
(iii) where relevant, other authorized uses of plant protection
products in the area of envisaged use containing the same
active substance or which give rise in the same residues.
(b) This evaluation will include:
(i) the fate and distribution, including persistence and biocon-
dition, of the active substance and of relevant metabolites,
breakdown and reaction products in the various parts of the
environment after application of the plant protection
product;
(ii) the estimated exposure of the species likely to be exposed
at the time of application or during the period that residues
are present, taking into account all relevant routes of expo-
sure such as ingestion of the formulated product or treated
food, predation on invertebrates, feeding on vertebrate
prey, contact by overspraying or with treated vegetation;1991L0414 — EN — 01.09.1994 — 001.001 — 71
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(iii) a calculation of the acute, short-term and, where necessary,
long-term toxicity/exposure ratio.The toxicity/exposure
ratios are defined as respectively the quotient of LD50,
LC50or NOEC expressed on an active substance basis and
the estimated exposure expressed in mg/kg body weight.
2.5.2.2. Member States shall evaluate the possibility of exposure of aquatic
organisms to the plant protection product under the proposed condi-
tions of use; if this possibility exists that shall evaluate the degree of
short-term and long-term risk to be expected for aquatic organisms
after use of the plant protection product according to the proposed
conditions of use.
(a) This evaluation will take into consideration the following infor-
mation:
(i) the specific information relating to the effects on aquatic
organisms as provided for in Annex II and the results of
the evaluation thereof;
(ii) other relevant information on the active substance such as:
— solubility in water,
— octanol/water partition coefficient,
— vapour pressure,— volatilization rate,
— KOC,
— biodegradation in aquatic systems and in particular the
ready biodegradability,
— photodegradation rate and identity of breakdown
products,
— hydrolysis rate in relation to pH and identity of break-
down products;
(iii) all relevant information on the plant protection product as
provided for in Annex III and in particular the effects on
aquatic organisms;
(iv) where relevant, other authorized uses of plant protection
products in the area of envisaged use, containing the same
active substance or which give rise to the same residues.
(b) This evaluation will include:
(i) the fate and distribution of residues of the active substance
and of relevant metabolites, breakdown and reaction
products in water, sediment or fish;
(ii) a calculation of the acute toxicity/exposure ratio for fish
and Daphnia.This ratio is defined as the quotient of
respectively acute LC
50or EC50and the predicted short-
term environmental concentration;
(iii) a calculation of the algal growth inhibition/exposure ratio
for algae.This ratio is defined as the quotient of the EC50and the predicted short-term environmental concentration;
(iv) a calculation of the long-term toxicity/exposure ratio for
fish and Daphnia.The long-term toxicity/exposure ratio is
defined as the quotient of the NOEC and the predicted
long-term environmental concentration;
(v) where relevant, the bioconcentration in fish and possible
exposure of predators of fish, including humans;
(vi) if the plant protection product is to be applied directly to
surface water, the effect on the change of surface water
quality, such as pH or dissolved oxygen content.
2.5.2.3. Member States shall evaluate the possibility of exposure of honey-
bees to the plant protection product under the proposed conditions
of use; if this possibility exists they shall evaluate the short-term
and long-term risk to be expected for honeybees after use of the
plant protection product according to the proposed conditions of use.
(a) This evaluation will take into consideration the following infor-
mation:
(i) the specific information on toxicity to honeybees as
provided for in Annex II and the results of the evaluation
thereof;
(ii) other relevant information on the active substance such as:
— solubility in water,
— octanol/water partition coefficient,— vapour pressure,1991L0414 — EN — 01.09.1994 — 001.001 — 72
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— photodegradation rate and identity of breakdown
products,
— mode of action (e.g. insect growth regulating activity);
(iii) all relevant information on the plant protection product as
provided for in Annex III, including the toxicity to honey-
bees;
(iv) where relevant, other authorized uses of plant protection
products in the area of envisaged use, containing the same
active substance or which give rise to the same residues.
(b) This evaluation will include:
(i) the ratio between the maximum application rate expressed
in grammes of active substance per hectare and the contact
and oral LD50expressed in µg of active substance per bee
(hazard quotients) and where necessary the persistence of
residues on or, where relevant, in the treated plants;
(ii) where relevant, the effects of honeybee larvae, honeybee
behaviour, colony survival and development after use of
the plant protection product according to the proposed
conditions of use.
2.5.2.4. Member States shall evaluate the possibility of exposure of benefi-
cial arthropods other than honeybees to the plant protection product
under the proposed conditions of use; if this possibility exists they
will assess the lethal and sublethal effects on these organisms to be
expected and the reduction in their activity after use of the plant
protection product according to the proposed conditions of use.
This evaluation will take into consideration the following informa-
tion:
(i) the specific information on toxicity to honeybees and other
beneficial arthropods as provided for in Annex II and the
results of the evaluation thereof:
(ii) other relevant information on the active substance such as:
— solubility in water,
— octanol/water partition coefficient,— vapour pressure,
— photodegradation rate and identity of breakdown products,
— mode of action (e.g. insect growth regulating activity);
(iii) all relevant information on the plant protection product as
provided for in Annex III such as:
— effects on beneficial arthropods other than bees,
— toxicity to honeybees,— available data from biological primary screening,
— maximum application rate,
— maximum number and timetable of applications.
(iv) where relevant, other authorized uses of plant protection
products in the area of envisaged use, containing the same
active substance or which give rise to the same residues.
2.5.2.5. Member States shall evaluate the possibility of exposure of earth-
worms and other non-target soil macro-organisms to the plant
protection product under the proposed conditions of use; if this
possibility exists they shall evaluate the degree of short-term and
long-term risk to be expected to these organisms after use of the
plant protection product according to the proposed conditions of use.
(a) This evaluation will take into consideration the following infor-
mation:
(i) the specific information relating to the toxicity of the active
substance to earthworms and to other non-target soil
macro-organisms as provided for in Annex II and the
results of the evaluation thereof;
(ii) other relevant information on the active substance such as:
— solubility in water,
— octanol/water partition coefficient,
— Kd for adsorption,
— vapour pressure,— hydrolysis rate in relation to pH and identity of break-
down products,
— photodegradation rate and identity of breakdown
products,1991L0414 — EN — 01.09.1994 — 001.001 — 73
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—D T50and DT90for degradation in the soil;
(iii) all relevant information on the plant protection product as
provided for in Annex III, including the effects on earth-
worms and other non-target soil macro-organisms;
(iv) where relevant, other authorized uses of plant protection
product in the area of envisaged use, containing the same
active substance or which give rise to the same residues.
(b) This evaluation will include:
(i) the lethal and sublethal effects;
(ii) the predicted initial and long-term environmental concen-
tration;
(iii) a calculation of the acute toxicity/exposure ratio (defined
as the quotient of LC50and predicted initial environmental
concentration) and of the long-term toxicity/exposure ratio
(defined as the quotient of the NOEC and predicted long-
term environmental concentration);
(iv) where relevant, the bioconcentration and persistence of
residues in earthworms.
2.5.2.6. Member States shall, where the evaluation carried out under Part B,
point 2.5.1.1, does not exclude the possibility of the plant protection
product reaching the soil under the proposed conditions of use, eval-
uate the impact on microbial activity such as the impact on nitrogen
and carbon mineralization processes in the soil after use of the plant
protection product according to the proposed conditions of use.
This evaluation will take into consideration the following informa-
tion:
(i) all relevant information on the active substance, including the
specific information relating to the effects on non-target soil
micro-organisms as provided for in Annex II and the results of
the evaluation thereof;
(ii) all relevant information on the plant protection product as
provided for in Annex III, including the effects on non-target
soil micro-organisms;
(iii) where relevant, other authorized uses of plant protection
products in the area of proposed use, containing the same
active substance or which give rise to the same residues;
(iv) all available information from biological primary screening.
2.6.Analytical methods
Member States shall evaluate the analytical methods proposed for
post-registration control and monitoring purposes, to determine:
2.6.1. for formulation analysis:
the nature and quantity of the active substance(s) in the plant protec-
tion product and, where appropriate, any toxicologically,
ecotoxicologically or environmentally significant impurities and co-
formulants.
This evaluation will take into consideration the following informa-
tion:
(i) the data on analytical methods as provided for in Annex II and
the results of the evaluation thereof;
(ii) the data on analytical methods as provided for in Annex III and
in particular:
— the specificity and linearity of the proposed methods,
— the importance of interferences,
— the precision of the proposed methods (intra-laboratory
repeatability and inter-laboratory reproducibility);
(iii) the limit of detection and determination of the proposed
methods for impurities;
2.6.2. for residue analysis:
the residues of the active substance, metabolites, breakdown or reac-
tion products resulting from authorized uses of the plant protection
product and which are of toxicological, ecotoxicological or environ-
mental significance.1991L0414 — EN — 01.09.1994 — 001.001 — 74
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This evaluation will take into consideration the following informa-
tion:
(i) the data on analytical methods as provided for in Annex II and
the results of the evaluation thereof;
(ii) the data on analytical methods as provided for in Annex III and
in particular:
— the specificity of the proposed methods,
— the precision of the proposed methods (intra-laboratory
repeatability and inter-laboratory reproducibility),
— the recovery rate of the proposed methods at appropriate
concentrations;
(iii) the limit of detection of the proposed methods;
(iv) the limit of determination of the proposed methods.
2.7.Physical and chemical properties
2.7.1. Member States shall evaluate the actual active substance content of
the plant protection product and its stability during storage.
2.7.2. Member States shall evaluate the physical and chemical properties
of the plant protection product and in particular:
— where a suitable FAO specification exists, the physical and
chemical properties addressed in that specification,
— where no suitable FAO specification exists, all the relevant
physical and chemical properties for the formulation as referred
to in the ‘Manual on the development and use of FAO specifica-
tions for plant protection products’.
This evaluation will take into consideration the following informa-
tion:
(i) the data on the physical and chemical properties of the active
substance as provided for in Annex II and the results of the
evaluation thereof;
(ii) the data on the physical and chemical properties of the plant
protection product as provided for in Annex III.
2.7.3. Where proposed label claims include requirements or recommenda-
tions for use of the plant protection product with other plant
protection products or adjuvants as a tank mix, the physical and
chemical compatibility of the products in the mixture must be eval-
uated.
C.DECISION-MAKING
1.General principles
1.Where appropriate, Member States shall impose conditions or restrictions
with the authorizations they grant.The nature and severity of these
measures must be selected on the basis of, and be appropriate to, the
nature and extent of the expected advantages and the risks likely to arise.
2.Member States shall ensure that, where necessary, decisions taken with
respect to the granting of authorizations take account of the agricultural,
plant health or environmental (including climatic) conditions in the areas
of envisaged use.Such considerations may result in specific conditions
and restrictions of use, and, where necessary, in authorization being
granted for some but not other areas within the Member State in question.
3.Member States shall ensure that the authorized amounts, in terms of rates
and number of applications, are the minimum necessary to achieve the
desired effect even where higher amounts would not result in unaccep-
table risks to human or animal health or to the environment.The
authorized amounts must be differentiated according to, and be appro-
priate to the agricultural, plant health or environmental (including
climatic) conditions in the various areas for which an authorization is
granted.However, the rates and the number of applications may not giverise to undesirable effects such as the development of resistance.
4.Member States shall ensure that decisions respect the principles of inte-
grated control if the product is intended to be used in conditions where
these principles are relied on.
5.Since the evaluation is to be based on data concerning a limited number
of representative species, Member States shall ensure that use of plant
protection products does not have any long-term repercussions for the
abundance and diversity of non-target species.1991L0414 — EN — 01.09.1994 — 001.001 — 75
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6.Before issuing an authorization, Member States shall ensure that the label
of the product:
— fulfils the requirements of Article 16 of this Directive,
— also contains the information on protection of users required by
Community legislation on worker protection,
— specifies in particular the conditions or restrictions under which the
plant protection product may or may not be used as referred to in
points 1, 2, 3, 4 and 5.
The authorization shall mention the particulars indicated in Article 6 (2)
(g) and (h), (3) and (4) of 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 (pesti-
cides) (1) and in Article 16 (g) and (h) of Directive 91/414/EEC.
7.Before issuing authorizations, Member States shall:
(a) ensure that the proposed packaging is in accordance with the provi-
sions of Directive 78/631/EEC;
(b) ensure that:
— the procedures for destruction of the plant protection product,
— the procedures for neutralizaton of the adverse effects of the
product if it is accidentally dispersed,
— the procedures for the decontamination and destruction of the
packagings,
are in accordance with the relevant regulatory provisions.
8.No authorization shall be granted unless all the requirements referred to
in Section 2 are satisfied.However:
(a) when one or more of the specific decision-making requirements
referred to in Part C, points 2.1, 2.2, 2.3 or 2.7, are not fully satisfied,
authorizations shall be granted only when the advantages of the use
of the plant protection product under the proposed conditions of use
outweigh the possible adverse effects of its use.Any restrictions on
use of the product relating to non-compliance with some of the afore-
mentioned requirements must be mentioned on the label, and non-
compliance with the requirements referred to in point 2.7 must not
compromise proper use of the product.These advantages can be interms of:
— advantages for and compatibility with integrated control measures
or organic farming,
— facilitating strategies to minimize the risk of development of
resistance,
— the need for a greater diversity of types of active substances or
biochemical modes of action, e.g. for use in strategies to avoid
accelerated breakdown in the soil,
— reduced risk for operators and consumers,— reduced contamination of the environment and reduced impact on
non-target species;
(b) where the criteria referred to in Part C, point 2.6, are not fully satis-
fied because of limitations in current analytical science and
technology, authorization shall be granted for a limited period if the
methods submitted prove adequate for the purposes intended.In this
case the applicant shall be given a time limit in which to develop and
submit analytical methods that are in accordance with the criteria
referred to above.The authorization will be reviewed on expiry of
the time limit accorded to the applicant;
(c) where the reproducibility of the submitted analytical methods referred
to in Part C, point 2.6, has only been verified in two laboratories, an
authorization shall be granted for one year to permit the applicant to
demonstrate the reproducibility of those methods in accordance with
agreed criteria.1991L0414 — EN — 01.09.1994 — 001.001 — 76
(1) OJ No L 206, 29.7.1978, p.13.Directive as last amended by Directive 92/32/EEC
(OJ No L 154, 5.6.1992, p.1).
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9.Where an authorization has been granted according to the requirements
provided for in this Annex, Member States may, by virtue of Article 4
(6):
(a) define, where possible, preferably in close cooperation with the appli-
cant, measures to improve the performance of the plant protection
product; and/or
(b) define, where possible, in close cooperation with the applicant,
measures to reduce further the exposure that could occur during and
after use of the plant protection product.
Member States shall inform the applicants of any measures identified
under (a) or (b) and shall invite applicants to provide any supplementary
data and information necessary to demonstrate performance or potential
risks arising under the changed conditions.
2.Specific principles
The specific principles shall apply without prejudice to the general principles
referred to in Section 1.
2.1.Efficacy
2.1.1. Where the proposed uses include recommendations for the control
of or protection against organisms which are not considered to be
harmful on the basis of experience acquired or scientific evidence
under normal agricultural, plant health and environmental (including
climatic) conditions in the areas of proposed use or where the other
intended effects are not considered to be beneficial under those
conditions, no authorization shall be granted for those uses.
2.1.2. The level, consistency and duration of control or protection or other
intended effects must be similar to those resulting from the use of
suitable reference products.If no suitable reference product exists,
the plant protection product must be shown to give a defined benefit
in terms of the level, consistency and duration of control or protec-
tion or other intended effects under the agricultural, plant health and
environmental (including climatic) conditions in the area of
proposed use.
2.1.3. Where relevant, yield response when the product is used and reduc-
tion of loss in storage must be quantitatively and/or qualitatively
similar to those resulting from the use of suitable reference
products.If no suitable reference product exists, the plant protection
product must be shown to give a consistent and defined quantitative
and/or qualitative benefit in terms of yield response and reduction of
loss in storage under the agricultural, plant health and environmental
(including climatic) conditions in the area of proposed use.
2.1.4. Conclusions as to the performance of the preparation must be valid
for all areas of the Member State in which it is to be authorized, and
must hold for all conditions under which its use is proposed, except
where the proposed label specifies that the preparation is intended
for use in certain specified circumstances (e.g. light infestations,
particular soil types or particular growing conditions).
2.1.5. Where proposed label claims include requirements for use of the
preparation with other specified plant protection products or adju-
vants as a tank mix, the mixture must achieve the desired effect
and comply with the principles referred to in points 2.1.1 and 2.1.4.
Where proposed label claims include recommendations for use of
the preparation with other specified plant protection products or
adjuvants as a tankmix, Member States shall not accept the recom-
mendations unless they are justified.
2.2.Absence of unacceptable effects on plants or plant products
2.2.1. There must be no relevant phytotoxic effects on treated plants or
plant products except where the proposed label indicates appropriate
limitations of use.
2.2.2. There must be no reduction of yield at harvest due to phytotoxic
effects below that which could be obtained without the use of the
plant protection product, unless this reduction is compensated for
by other advantages such as an enhancement of the quality of the
treated plants or plant products.1991L0414 — EN — 01.09.1994 — 001.001 — 77
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2.2.3. There must be no unacceptable adverse effects on the quality of
treated plants or plant products, except in the case of adverse effects
on processing where proposed label claims specify that the prepara-
tion should not be applied to crops to be used for processing
purposes.
2.2.4. There must be no unacceptable adverse effects on treated plants or
plant products used for propagation or reproduction, such as effects
on viability, germination, sprouting, rooting and establishment,
except where proposed label claims specify that the preparation
should not be applied to plants or plant products to be used for
propagation or reproduction.
2.2.5. There must be no unacceptable impact on succeeding crops, except
where proposed label claims specify that particular crops, which
would be affected, should not be grown following the treated crop.
2.2.6. There must be no unacceptable impact on adjacent crops, except
where proposed label claims specify that the preparation should not
be applied when particular sensitive adjacent crops are present.
2.2.7. Where proposed label claims include requirements for use of the
preparation with other plant protection product or adjuvants, as a
tank mix, the mixture must comply with the principles referred to
in points 2.2.1 to 2.2.6.
2.2.8. The proposed instructions for cleaning the application equipment
must be both practical and effective so that they can be applied
with ease so as to ensure the removal of residual traces of the plant
protection product which could subsequently cause damage.
2.3.Impact on vertebrates to be controlled
An authorization for a plant protection product intended to eliminate
vertebrates shall be granted only when:
— death is synchronous with the extinction of consciousness, or
— death occurs immediately, or— vital functions are reduced gradually without signs of obvious
suffering.
For repellant products, the intended effect shall be obtained without
unnecessary suffering and pain for the target animals.
2.4.Impact on human or animal health
2.4.1. Arising from the plant protection product2.4.1.1. No authorization shall be granted if the extent of operator exposure
in handling and using the plant protection product under the
proposed conditions of use, including dose and application method,
exceeds the acceptable operator exposure level (AOEL).
Moreover, the conditions of the authorization shall be in compliance
with the limit value established for the active substance and/or toxi-
cologically relevant compound(s) of the product in accordance with
Council Directive 80/1107/EEC of 27 November 1980 on the
protection of workers from the risks related to exposure to chemical,
physical and biological agents at work (
1) and in accordance with
Council Directive 90/394/EEC of 28 June 1990 on the protection
of workers from the risks related to exposure to carcinogens at
work (2).
2.4.1.2. Where the proposed conditions of use require use of items of protec-
tive clothing and equipment, no authorization shall be granted unless
those items are effective and in accordance with the relevant
Community provisions and are readily obtainable by the user and
unless it is feasible to use them under the circumstances of use of
the plant protection product, taking into account climatic conditions
in particular.
2.4.1.3. Plant protection products which because of particular properties or if
mishandled or misused could lead to a high degree of risk must be
subject to particular restrictions such as restrictions on the size of
packaging, formulation type, distribution, use or manner of use.1991L0414 — EN — 01.09.1994 — 001.001 — 78
(1) OJ No L 327, 3.12.1980, p.8.Directive as last amended by Directive 88/642/EEC
(OJ No L 356, 24.12.1988, p.74).
(2) OJ No L 196, 26.7.1990, p.1.
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Moreover, plant protection products which are classified as very
toxic may not be authorized for use by non-professional users.
2.4.1.4. Waiting and re-entry safety periods or other precautions must be
such that the exposure of bystanders or workers exposed after the
application of the plant protection product does not exceed the
AOEL levels established for the active substance or toxicologically
relevant compound(s) in the plant protection product nor any limit
values established for those compounds in accordance with the
Community provisions referred to in point 2.4.1.1.
2.4.1.5. Waiting and re-entry safety periods or other precautions must be
established in such a way that no adverse impact on animals occurs.
2.4.1.6. Waiting and re-entry periods or other precautions to ensure that the
AOEL levels and limit values are respected must be realistic; if
necessary special precautionary measures must be prescribed.
2.4.2. Arising from residues2.4.2.1. Authorizations must ensure that residues occurring reflect the
minimum quantities of the plant protection product necessary to
achieve adequate control corresponding to good agricultural prac-
tice, applied in such a manner (including pre-harvest intervals or
withholding periods or storage periods) that the residues at harvest,
slaughter or after storage, as appropriate, are reduced to a minimum.
2.4.2.2. Where no Community MRL (*) or provisional MRL (at national or
at Community level) exists, Member States shall establish a provi-
sional MRL in accordance with Article 4 (1) (f) of this Directive;
conclusions as to the levels fixed must be valid for all circumstances
which could influence the residue levels in the crop such as timing
of application, application rate and frequency or manner of use.
2.4.2.3. Where the new circumstances under which the plant protection
product is to be used do not correspond to those under which a
provisional MRL (at national or at Community level) was estab-
lished previously, Member States shall not grant an authorization
for the plant protection product unless the applicant can provide
evidence that its recommended use will not exceed that MRL or
unless a new provisional MRL has been established by the Member
State or the Commission in accordance with Article 4 (1) (f) of this
Directive.
2.4.2.4. Where a Community MRL exists Member States shall not grant an
authorization for the plant protection product unless the applicant
can provide evidence that its recommended use will not exceed
that MRL, or unless a new Community MRL has been established
in accordance with the procedures provided for in the relevant
Community legislation.
2.4.2.5. In the cases referred to in points 2.4.2.2 and 2.4.2.3, each applica-
tion for an authorization must be accompanied by a risk assessment
taking into account worst-case potential exposure of consumers in
the Member State concerned on the basis of good agricultural prac-
tice.1991L0414 — EN — 01.09.1994 — 001.001 — 79
(*) A Community MRL will mean an MRL established pursuant to Council Directive 76/
895/EEC of 23 November 1976 relating to the fixing of maximum levels for pesticideresidues in and on fruit and vegetables (
1), Council Directive 86/362/EEC of 24 July
1986 on the fixing of maximum levels for pesticide residues in and on cereals (2),
Council Directive 86/363/EEC of 24 July 1986 on the fixing of maximum levels for
pesticide residues in and on foodstuffs of animal origin (3), Council Regulation (EEC)
No 2377/90 of 26 June 1990 laying down a Community procedure for the establish-ment of maximum residue limits of veterinary medicinal products in foodstuffs ofanimal origin (
4), Council Directive 90/642/EEC of 27 November 1990 on the fixing
of maximum levels for pesticide residues in and on certain products of plant origin,
including fruit and vegetables (5) or Council Directive 91/132/EEC of 4 March 1991
amending Directive 74/63/EEC on undesirable substances and products in feeding-stuffs (
6).
(1) OJ No L 340, 9.12.1976, p.26.Directive as last amended by Directive 93/58/
EEC (OJ No L 211, 23.8.1993, p.6).
(2) OJ No L 221, 7.8.1986, p.37.Directive as last amended by Directive 93/57/EEC
(OJ No L 211, 23.8.1993, p.1).
(3) OJ No L 221, 7.8.1986, p.43.Directive as last amended by Directive 93/57/EEC
(OJ No L 211, 23.8.1993, p.1).
(4) OJ No L 224, 18.8.1990, p.1.Regulation as last amended by Commission Regu-
lation (EEC) No 955/94 (OJ No L 108, 29.4.1994, p.8).
(5) OJ No L 350, 14.12.1990, p.71.Directive as last amended by Directive 93/58/
EEC (OJ No L 211, 23.8.1993, p.6).
(6) OJ No L 66, 13.3.1991, p.16.
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Taking into account all registered uses, the proposed use cannot be
authorized if the best possible estimate of dietary exposure exceeds
the acceptable daily intake (ADI).
2.4.2.6. Where the nature of residues is affected during processing, a sepa-
rate risk assessment may need to be carried out under the conditions
provided for in point 2.4.2.5.
2.4.2.7. Where the treated plants or plant products are intended to be fed to
animals, residues occurring shall not have an adverse effect on
animal health.
2.5.Influence on the environment
2.5.1. Fate and distribution in the environment2.5.1.1. No authorization shall be granted if the active substance and, where
they are of significance from the toxicological, ecotoxicological or
environmental point of view, metabolites and breakdown or reactionproducts, after use of the plant protection product under the
proposed conditions of use:
— during tests in the field, persist in soil for more than one year
(i.e. DT
90> 1 year and DT50> 3 months), or
— during laboratory tests, form not extractable residues in amounts
exceeding 70% of the initial dose after 100 days with a minera-
lization rate of less than 5 % in 100 days,
unless it is scientifically demonstrated that under field conditions
there is no accumulation in soil at such levels that unacceptable resi-
dues in succeeding crops occur and/or that unacceptable phytotoxic
effects on succeeding crops occur and/or that there is an unaccep-
table impact on the environment, according to the relevant
requirements provided for in points 2.5.1.2, 2.5.1.3, 2.5.1.4 and
2.5.2.
2.5.1.2. (a) An authorization shall be granted only in the following cases:
(1) where adequate monitoring data relevant to the proposed
conditions of use of the plant protection product are not
available and on the basis of the evaluation it appears that,
after use of the plant protection product under the condi-
tions proposed, the foreseeable concentration of the active
substance or of relevant metabolites or breakdown or reac-
tion products in groundwater intended for the production of
drinking water does not exceed the lower of the following
concentrations:
(i) the maximum permissible concentration laid down by
Council Directive 80/778/EEC of 15 July 1980 relating
to the quality of water intended for human consump-
tion (1);
or
(ii) the maximum conncentration laid down by the
Commission when including the active substance in
Annex I, on the basis of appropriate data, in particular
toxicological data, or, where that concentration has not
been laid down, the concentration corresponding to one
tenth of the ADI laid down when the active substance
was included in Annex I;
(2) where adequate monitoring data relevant to the proposed
conditions of use of the plant protection product are avail-
able and support the conclusion that in practice, after use
of the plant protection product under the conditions
proposed, the concentration of the active substance or of
relevant metabolites or breakdown or reaction products in
groundwater intended for the production of drinking water
has not exceeded or no longer exceeds and is not in danger
of exceeding the appropriate maximum concentration as
referred to in (1) above.
(b) Irrespective of the provisions in (a) above, where the concentra-
tion referred to in (a) (1) (ii) is greater than that referred to in
(a) (1) (i), a conditional authorization, which is not an authoriza-
tion within the meaning of Article 10 (1) of this Directive and1991L0414 — EN — 01.09.1994 — 001.001 — 80
(1) OJ No L 229, 30.8.1980, p.11.Directive as last amended by Directive 91/692/EEC
(OJ No L 377, 31.12.1991, p.48).
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which is for a limited period of not more than five years, may
be issued only in those cases in which the conditions specified
in (1) or (2) below are fulfilled:
(1) where adequate monitoring data relevant to the proposed
conditions of use of the plant protection product are not
available, every conditional authorization issued shall be
subject to the following requirements:
(i) it appearing on the basis of the evaluation that, after
use of the plant protection product under the conditions
proposed, the foreseeable concentration of the active
substance of relevant metabolites or breakdown or
reaction products in groundwater intended for the
production of drinking water does not exceed the
maximum concentration referred to in (a) (1) (ii)
above; and
(ii) it being ensured that an adequate monitoring
programme covering areas liable to be contaminated is
introduced or continued in the Member State, using
suitable methods of sampling and analysis, so that it
can be estimated whether the maximum concentration
referred to in (a) (1) (i) above will be exceeded; it is
for the Member States to decide who is to bear the
cost of that monitoring programme;
(iii) where appropriate, attaching to the authorization of the
conditions for or restrictions on the use of the product
concerned, to appear on the label, having regard to
agricultural plant health, and environmental (including
climatic) conditions in the envisaged area of use;
(iv) if necessary, amendment or withdrawal of the condi-
tional authorization, in accordance with Article 4 (5)
and (6), where monitoring results show that, despite
the imposing of the conditions or restrictions referred
to in (iii) above, after use of the plant protection
product under the conditions proposed, the concentra-
tion of the active substance or of relevant metabolites
or breakdown or reaction products in groundwater
intended for the production of drinking water will
exceed the concentration referred to in (a) (1) (i)
above;
(2) where adequate monitoring data relevant to the conditions
of use of the plant protection product are available and
support the conclusion that in practice, after use of the plant
protection product under the conditions proposed, there is
no risk that the concentration of the active substance or of
relevant metabolites or breakdown or reaction products in
groundwater intended for the production of drinking water
will exceed the maximum concentration referred to in (a)
(1) (ii) above, every conditional authorization issued shall
be subject to the following requirements:
(i) prior investigation of the significance of the risk of the
maximum concentration referred to in (a) (1) (i) being
exceeded and of the factors involved;
(ii) it being ensured that an adequate programme, consisting
of measures referred to in (b) (1) (ii), (iii) and (iv)
above, is introduced or continued in the Member State
so as to make sure that in practice the concentration
does not exceed the maximum permissible concentra-
tion referred to in (a) (1) (i) above.
(c) If, upon expiry of the conditional authorization, monitoring
results show that in practice the concentration of the active
substance or of relevant metabolites or breakdown or reaction
products, as a result of the use of the plant protection product
under the proposed conditions of use, in groundwater intended
for the production of drinking water has been reduced to a level
approaching the maximum permissible concentration referred to
in (a) (1) (i) above and if other amendments to the proposed
conditions of use could be expected to ensure that the foresee-
able concentration will be reduced below that maximum
concentration, a further conditional authorization including those
new amendments may be issued for a single period of not more
than five years.
(d) A Member State may at any time introduce appropriate condi-
tions for or restrictions on the product's use, having regard to
local agricultural, plant health and environmental (including1991L0414 — EN — 01.09.1994 — 001.001 — 81
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climatic) conditions, in order to comply with the concentration
referred to in (a) (1) (i) above in water intended for human
consumption, in accordance with Directive 80/778/EEC.
2.5.1.3. No authorization shall be granted if the concentration of the active
substance or of relevant metabolites, breakdown or reaction products
to be expected after use of the plant protection product under
proposed conditions of use in surface water:
— exceeds, where the surface water in or from the area of envi-
saged use is intended for the abstraction of drinking water, the
values fixed by Council Directive 75/440/EEC of 16 June 1975
concerning the quality required of surface water intended for the
abstraction of drinking water in the Member States (1), or
— has an impact deemed unacceptable on non-target species,
including animals, according to the relevant requirements
provided for in point 2.5.2.
The proposed instructions for use of the plant protection product,
including procedures for cleaning application equipment, must be
such that the likelihood of accidental contamination of surface water
is reduced to a minimum.
2.5.1.4. No authorization shall be granted if the airborne concentration of the
active substance under the proposed conditions of use is such that
either the AOEL or the limit values for operators, bystanders or
workers as referred to in Part C, point 2.4.1, are exceeded.
2.5.2. Impact on non-target species2.5.2.1. Where there is a possibility of birds and other non-target terrestrial
vertebrates being exposed, no authorization shall be granted if:
— the acute and short-term toxicity/exposure ratio for birds and
other non-target terrestrial vertebrates is less than 10 on the basis
of LD
50or the long-term toxicity/exposure ratio is less than 5,
unless it is clearly established through an appropriate risk assess-
ment that under field conditions no unacceptable impact occurs
after use of the plant protection product according to the
proposed conditions of use,
— the bioconcentration factor (BCF, related to fat tissue) is greater
than 1, unless it is clearly established through an appropriate risk
assessment that under field conditions no unacceptable effects
occur — directly or indirectly — after use of the plant protec-
tion product according to the proposed conditions of use.
2.5.2.2. Where there is a possibility of aquatic organisms being exposed, no
authorization shall be granted if:
— the toxicity/exposure ratio for fish and Daphnia is less than 100
for acute exposure and less than 10 for long-term exposure, or
— the algal growth inhibition/exposure ratio is less than 10, or
— the maximum bioconcentration factor (BCF) is greater than
1 000 for plant protection products containing active substances
which are readily biodegradable or greater than 100 for those
which are not readily biodegradable, unless it is clearly estab-
lished through an appropriate risk assessment that under field
conditions no unacceptable impact on the viability of exposed
species (predators) occurs — directly or indirectly — after use
of the plant protection product according to the proposed condi-
tions of use.
2.5.2.3. Where there is a possibility of honeybees being exposed, no author-
ization shall be granted if the hazard quotients for oral or contact
exposure of honeybees are greater than 50, unless it is clearly estab-lished through an appropriate risk assessment that under field
conditions there are no unacceptable effects on honeybee larvae,
honeybee behaviour, or colony survival and development after use
of the plant protection product according to the proposed conditions
of use.
2.5.2.4. Where there is a possibility of beneficial arthropods other than
honeybees being exposed, no authorization shall be granted if more
than 30 % of the test-organisms are affected in lethal or sublethal
laboratory tests conducted at the maximum proposed application
rate, unless it is clearly established through an appropriate risk1991L0414 — EN — 01.09.1994 — 001.001 — 82
(1) OJ No L 194, 25.7.1975, p.34.Directive as last amended by Directive 91/692/EEC
(OJ No L 377, 31.12.1991, p.48).
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assessment that under field conditions there is no unacceptable
impact on those organisms after use of the plant protection product
according to the proposed conditions of use.Any claims for selec-
tivity and proposals for use in integrated pest management systems
shall be substantiated by appropriate data.
2.5.2.5. Where there is a possibility of earthworms being exposed, no
authorization shall be granted if the acute toxicity/exposure ratio
for earthworms is less than 10 or the long-term toxicity/exposure
ratio is less than 5, unless it is clearly established through an appro-
priate risk assessment that under field conditions earthworm
populations are not at risk after use of the plant protection product
according to the proposed conditions of use.
2.5.2.6. Where there is a possibility of non-target soil micro-organisms
being exposed, no authorization shall be granted if the nitrogen or
carbon mineralization processes in laboratory studies are affected
by more than 25 % after 100 days, unless it is clearly established
through an appropriate risk assessment that under field conditions
there is no unacceptable impact on microbial activity after use of
the plant protection product according to the proposed conditions
of use, taking account of the ability of micro-organisms to multiply.
2.6.Analytical methods
The methods proposed must reflect the state of the art.The
following criteria must be met in order to permit validation of the
analytical methods proposed for post-registration control and moni-
toring purposes:
2.6.1. for formulation analysis:
the method must be able to determine and to identify the active
substance(s) and where appropriate any toxicologically, ecotoxicolo-
gically or environmentally significant impurities and co-formulants;
2.6.2. for residue analysis:
(i) the method must be able to determine and confirm residues of
toxicological, ecotoxicological or environmental significance;
(ii) the mean recovery rates should be between 70 % and 110 %
with a relative standard deviation of ≤20 %;
(iii) the repeatability must be less than the following values for resi-
dues in foodstuffs:
Residue levelmg/kg Differencemg/kg Differencein %
0,01 0,005 50
0,1 0,025 251 0,125 12,5
> 1 12,5
Intermediate values are determined by interpolation from a log-
log graph;
(iv) the reproducibility must be less than the following values for
residues in foodstuffs:
Residue levelmg/kg Differencemg/kg Differencein %
0,01 0,01 100
0,1 0,05 50
1 0,25 25
>1 2 5
Intermediate values are determined by interpolation from a log-
log graph;1991L0414 — EN — 01.09.1994 — 001.001 — 83
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(v) in the case of residue analysis in treated plants, plant products,
foodstuffs, feedingstuffs or products of animal origin, except
where the MRL or the proposed MRL is at the limit of deter-
mination, the sensitivity of the methods proposed must satisfy
the following criteria:
Limit of determination in relation to the proposed provisional
or Community MRL:
MRL(mg/kg) Limit of determination(mg/kg)
> 0,5 0,1
0,5—0,05 0,1—0,02
< 0,05 MRL × 0,5
2.7.Physical and chemical properties
2.7.1. Where an appropriate FAO specification exists, that specification
must be met.
2.7.2. Where no appropriate FAO specification exists, the physical and
chemical properties of the product must meet the following require-
ments:
(a) Chemical properties:
Throughout the shelf-life period, the difference between the
stated and the actual content of the active substance in the plant
protection product must not exceed the following values:
Declared content in g/kg or g/l at 20 ºC Tolerance
up to 25 ± 15 % homogeneous formulation
± 25 % non-homogeneous formulation
more than 25 up to 100 ± 10 %
more than 100 up to 250 ± 6 %
more than 250 up to 500 ± 5 %
more than 500 ± 25 g/kg or ± 25 g/l
(b) Physical properties:
The plant protection product must fulfil the physical criteria
(including storage stability) specified for the relevant formula-
tion type in the ‘Manual on the development and use of FAO
specifications for plant protection products’.
2.7.3. Where the proposed label claims include requirements or recom-
mendations for use of the preparation with other plant protection
products or adjuvants as a tank mix and/or where the proposed label
includes indications on the compatibility of the preparation with
other plant protection products as a tank mix, those products or
adjuvants must be physically and chemically compatible in the tank
mix.1991L0414 — EN — 01.09.1994 — 001.001 — 84