COMMISSION DIRECTIVE 93/71/EEC of 27 July 1993 amending Council Directive 91/414/EEC concerning the placing of plant protection products on the market

KOMMISSIONENS DIREKTIV 93/71/EOEF af 27. juli 1993 om aendring af Raadets direktiv 91/414/EOEF om markedsfoering af plantebeskyttelsesmidler

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

KOMMISSIONEN FOR DE EUROPAEISKE FAELLESSKABER HAR -

Having regard to the Treaty establishing the European Economic Community,

under henvisning til Traktaten om Oprettelse af Det Europaeiske OEkonomiske Faellesskab,

Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (1), and in particular Article 18 (2) thereof,

under henvisning til Raadets direktiv 91/414/EOEF af 15. juli 1991 om markedsfoering af plantebeskyttelsesmidler (1), saerlig artikel 18, stk. 2, og

Whereas Annexes II and III to Directive 91/414/EEC lay down the requirements for the dossier to be submitted by applicants respectively for the inclusion of an active substance in Annex I and for the authorization of a plant protection product;

ud fra foelgende betragtninger:

Whereas it is necessary to indicate to applicants in Annexes II and III, as precisely as possible, the details of the required information, such as the circumstances, conditions and technical protocols under which certain data have to be generated; whereas these provisions should be introduced as soon as available in order to permit applicants to use them in the preparation of their dossiers;

Bilag II og III til direktiv 91/414/EOEF indeholder kravene til det dossier, ansoegerne skal indsende med henblik paa henholdsvis optagelse af et aktivt stof i bilag I og godkendelse af et plantebeskyttelsesmiddel;

Whereas greater precision can be given at the present time to the general introductionary provisions to Annexes II and III and to the data requirements concerning efficacy testing provided for in Section 6 of Parts A and B of Annex III;

i bilag II og III maa ansoegerne saa praecist som muligt kunne se, hvilke oplysninger der kraeves, saasom en naermere beskrivelse af, under hvilke omstaendigheder og vilkaar og med hvilke tekniske protokoller visse forsoeg skal udfoeres; disse praeciseringer boer gives, saa snart de foreligger, for at give ansoegerne mulighed for at anvende dem ved udarbejdelsen af deres dossierer;

Whereas the introductions to the Annexes II and III currently refer to the application of the principles of good laboratory practice (GLP) for any data requirements; whereas, however, the application of such principles is not considered to be appropriate for efficacy testing and for the testing of certain physico-chemical properties or other information which are not related to data on the properties and/or safety with respect to human or animal health or the environment;

der kan nu foretages en praecisering, hvad angaar de generelle bestemmelser i indledningen til bilag II og III, og hvad angaar datakravene effektivitetsforsoegene i afsnit 6 i del A og B i bilag III;

Whereas moreover it is necessary to provide for a temporary exemption of the application of these principles for certain data requirements to permit the laboratories concerned to adapt themselves to the requirements of GLP;

i indledningen til bilag II og III staar der paa nuvaerende tidspunkt, at alle de kraevede data skal opnaas under anvendelse af principperne for god laboratoriepraksis (GLP); anvendelsen af disse principper betragtes ikke som relevant for effektivitetsforsoegene og for forsoegene vedroerende visse fysisk-kemiske egenskaber eller andre oplysninger, som ikke har tilknytning til data for egenskaber og/eller sikkerhed, hvad angaar menneskers eller dyrs sundhed eller miljoeet;

Whereas the specific European and Mediterranean Plant Protection Organization (EPPO) guidelines constitute for the time being the best available basis for setting the minimum requirements to be applied in all Member States with regard to the guidelines used for efficacy testing, whereas it appears necessary however to proceed urgently to a detailed examination of these guidelines and to provide for higher standards in Directive 91/414/EEC in cases where certain guidelines would appear inadequate for efficacy testing;

der boer desuden fastsaettes en midlertidig undtagelse fra anvendelsen af disse principper for visse datakravs vedkommende for at give laboratorierne mulighed for at tilpasse sig til GLP-kravene;

Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Plant Health,

de specifikke retningslinjer fra Plantebeskyttelsesorganisationen for Europa og Middelhavsomraaderne (EPPO) giver for oejeblikket det bedst foreliggende grundlag for fastsaettelse af de minimumskrav, der boer gaelde i alle medlemsstaterne med hensyn til de retningslinjer, som skal anvendes for effektivitetsforsoegene; det ser dog ud til, at der hurtigt maa foretages en noeje undersoegelse af disse retningslinjer, og at der maa fastlaegges hoejere standarder i naevnte direktiv i tilfaelde, hvor visse retningslinjer forekommer utilstraekkelige til udfoerelsen af effektivitetsforsoegene;

HAS ADOPTED THIS DIRECTIVE:

de i dette direktiv fastsatte foranstaltninger er i overensstemmelse med udtalelse fra Den Staaende Komité for Plantesundhed -

UDSTEDT FOELGENDE DIREKTIV:

Article 1

Directive 91/414/EEC is amended as follows:

Artikel 1

1. the section headed 'Introduction' in Annex II is replaced by Annex I hereto;

I direktiv 91/414/EOEF foretages foelgende aendringer:

2. the section headed 'Introduction' in Annex III is replaced by Annex II hereto,

1) indledningen til bilag II affattes som anfoert i bilag I til naervaerende direktiv

3. Section 6 headed 'Efficacy data' in both Parts A and B of Annex III is replaced by Annex III hereto.

2) indledningen til bilag III affattes som anfoert i bilag II til naervaerende direktiv

3) afsnit 6 »Effektivitetsdata« i del A og B i bilag III affattes som anfoert i bilag III til naervaerende direktiv.

Article 2

Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive within twelve months following notification thereof. They shall immediately inform the Commission thereof.

Artikel 2

When Member States adopt these measures, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States.

Medlemsstaterne saetter de noedvendige love og administrative bestemmelser i kraft for at efterkomme dette direktiv inden for en frist paa tolv maaneder fra dets meddelelse. De underretter straks Kommissionen herom.

Naar medlemsstaterne vedtager disse bestemmelser, henvises der deri til dette direktiv, eller de ledsages ved offentliggoerelsen af en saadan henvisning. De naermere regler for denne henvisning fastsaettes af medlemsstaterne.

Article 3

This Directive is addressed to the Member States.

Artikel 3

Done at Brussels, 27 July 1993.

Dette direktiv er rettet til medlemsstaterne.

For the Commission

Udfaerdiget i Bruxelles, den 27. juli 1993.

René STEICHEN

Paa Kommissionens vegne

Member of the Commission

René STEICHEN

Medlem af Kommissionen

(1) OJ No L 230, 19. 8. 1991, p. 1.

(1) EFT nr. L 230 af 19. 8. 1991, s. 1.

ANNEX I

'INTRODUCTION

BILAG I

The information required shall:

»INDLEDNING

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;

De kraevede oplysninger:

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;

1.1. skal omfatte et teknisk dossier med de oplysninger, som er noedvendige for at vurdere de forudselige - oejeblikkelige eller senere forekommende - risici, som stoffet kan frembyde for mennesker, for dyr og for miljoeet, og mindst indeholde de nedenfor omhandlede oplysninger og undersoegelsesresultater

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;

1.2. skal, hvis det er relevant, udfoeres efter de i dette bilag naevnte eller beskrevne retningslinjer, naar der er tale om undersoegelser, som er ivaerksat inden vedtagelsen af aendringen af dette bilag, skal undersoegelserne udfoeres under anvendelse af egnede internationalt eller nationalt anerkendte retningslinjer eller, hvis saadanne retningslinjer ikke foreligger, under anvendelse af reretningslinjer, som er accepteret af den kompetente myndighed.

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;

1.3. skal, hvis en retningslinje ikke er egnet eller ikke er beskrevet, eller hvis der er anvendt andre retningslinjer end dem, der er naevnt i dette bilag, omfatte en begrundelse for den anvendte retningslinje, som den kompetente myndighed kan acceptere

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:

1.4. skal, naar den kompetente myndighed kraever det, omfatte en detaljeret beskrivelse af de anvendte retningslinjer, medmindre de er naevnt eller beskrevet i dette bilag, og en detaljeret beskrivelse af eventuelle fravigelser fra dem, herunder en begrundelse for disse fravigelser, som den kompetente myndighed kan acceptere

- particular data and information which would not be necessary owing to the nature of the product or its proposed uses, are not provided,

1.5. skal omfatte en udfoerlig og objektiv rapport om de foretagne undersoegelser tillige med en detaljeret beskrivelse af dem eller en begrundelse, som den kompetente myndighed kan acceptere, hvis:

- visse data og oplysninger, som ikke er noedvendige som foelge af stoffets art eller det paataenkte anvendelsesformaal, ikke forelaegges, eller

- it is not scientifically necessary, or technically possible to supply information and data;

- det ikke er videnskabeligt paakraevet eller teknisk muligt at forelaegge visse data og oplysninger

1.6. where relevant, have been generated in accordance with the requirements of Directive 86/609/EEC.

1.6. skal i givet fald vaere udfoert i overensstemmelse med kravene i direktiv 86/609/EOEF.

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.

2.1. Forsoeg og analyser skal gennemfoeres i overensstemmelse med principperne i direktiv 87/18/EOEF (1), hvis forsoegene gennemfoeres for at opnaa data for egenskaber og/eller sikkerhed, hvad angaar menneskers eller dyrs sundhed eller miljoeet.

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 beneficial 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 introduction to Annex III.

2.2. Som undtagelse fra punkt 2.1 kan proever og analyser, der udfoeres for at opnaa data for egenskaber og/eller sikkerhed med hensyn til honningbier og andre nytte-leddyr, udfoeres af officielle eller officielt anerkendte forsoegsenheder eller organisationer, der mindst opfylder kravene i punkt 2.2 og 2.3 i indledningen til bilag III.

This derogation expires on 31 December 1999.

Denne undtagelsesbestemmelser udloeber den 31. december 1999.

(1) OJ No L 15, 17. 1. 1987, p. 29.'

(1) EFT nr. L 15 af 17. 1. 1987, s. 29.«

ANNEX II

BILAG II

'INTRODUCTION

»INDLEDNING

The information required shall:

De kraevede oplysninger:

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;

1.2. skal, hvis det er relevant udfoeres efter de i dette bilag naevnte eller beskrevne retningslinjer; naar der er tale om undersoegelser, som er ivaerksat inden vedtagelsen af aendringen af dette bilag, skal undersoegelserne udfoeres under anvendelse af egnede internationalt eller nationalt anerkendte retningslinjer, eller, hvis saadanne retningslinjer ikke foreligger, under anvendelse af retningslinjer, som er accepteret af den kompetente myndighed

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:

1.5. skal omfatte en udfoerlig og objektiv rapport om de foretagne undersoegelser tillige med en detaljeret beskrivelse af dem eller en begrundelse, som den kompetente myndighed kan acceptere, hvis:

- particular data and information which would not be necessary owing to the nature of the product or its proposed uses, are not provided,

- visse data og oplysninger, som ikke er noedvendige som foelge af stoffets art eller dets paataenkte anvendelsesformaal, ikke forelaegges, eller

- det ikke er videnskabeligt paakraevet eller teknisk muligt at forelaegge visse data og oplysninger

- it is not scientifically necessary, or technically possible to supply information and data.

1.6. skal i givet fald vaere udfoert i overensstemmelse med kravene i direktiv 86/609/EOEF.

1.6. where relevant, have been generated in accordance with the requirements of Directive 86/609/EEC.

2.1. Forsoeg og analyser skal gennemfoeres i overensstemmelse med principperne i direktiv 87/18/EOEF, hvis forsoegene gennemfoeres for at opnaa data for egenskaber og/eller sikkerhed, hvad angaar menneskers eller dyrs sundhed eller miljoeet.

2.1. Tests and analyses must be conducted in accordance with the principles 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. Proever og analyser, der kraeves i henhold til afsnit 6, punkt 6.2 til 6.7, i dette bilag, skal udfoeres af officielle eller officielt anerkendte forsoegsenheder eller organisationer, der mindst opfylder foelgende krav:

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:

- de skal have et tilstraekkeligt stort videnskabeligt og teknisk personale med den noedvendige uddannelse, oplaering, tekniske viden og erfaring til at varetage de opgaver, der overdrages det

- have at their disposal sufficient scientific and technical staff, having the necessary education, training, technical knowledge and experience for their assigned functions,

- de skal raade over det udstyr, der kraeves til korrekt udfoerelse af de proever eller maalinger, de haevder at vaere kompetente til at udfoere. dette udstyr skal vedligeholdes ordentligt og i givet fald kalibreres, inden det tages i brug, og derefter efter et naermere fastlagt program

- 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,

- de skal raade over egnede forsoegsmarker og om noedvendigt vaeksthuse, vaekstkabiner eller oplagringsrum. Det miljoe, hvori forsoegene udfoeres, maa ikke svaekke resultaterne eller forringe den praecision, maalingerne kraeves udfoert med

- 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 measurement,

- de skal give det relevante personale adgang til standardforskrifter og protokoller for forsoegene

- make available to all relevant personnel operating procedures and protocols used for the trials,

- de skal, naar den kompetente myndighed ammoder herom, inden et forsoeg paabegyndes, forelaegge den detaljerede oplysninger om forsoeget, som mindst omfatter stedet for forsoegets udfoerelse og de plantebeskyttelsesmidler, der indgaar i forsoeget

- 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,

- de skal sikre, at kvaliteten af det udfoerte arbejde svarer til dets art, omfang og formaal

- ensure that the quality of the work performed is appropriate to its type, range, volume and intended purpose,

- de skal opbevare alle originale observationer, beregninger og afledte data, kalibreringsjournaler og den endelige forsoegsrapport, saa laenge det paagaeldende middel er godkendt i Faellesskabet.

- calibration records and the final test report as long as the product concerned authorized in the Community.

2.3. Medlemsstaterne skal kraeve, at officielt anerkendte forsoegsenheder og organisationer eller, hvis der anmodes herom, officielle institutioner og organisationer:

2.3. Member States shall require that officially recognized testing facilities and organizations, and, where requested, official facilities and organizations:

- forelaegger den relevante nationale myndighed alle de oplysninger, der er noedvendige for at dokumentere, at de kan opfylde kravene i punkt 2.2

- report to the relevant national authority all detailed information necessary to demonstrate that they can satisfy the requirements provided for in point 2.2,

- paa ethvert tidspunkt accepterer de inspektioner, som de enkelte medlemsstater skal gennemfoere paa deres omraade med regelmaessige mellemrum for at kontrollere, at kravene i punkt 2.2 er opfyldt.

- 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. Som undtagelse fra punkt 2.1 er bestemmelserne i punkt 2.2 og 2.3 ogsaa gaeldende indtil den 31. december 1999 for proever og analyser, der udfoeres for at opnaa data for egenskaber og/eller sikkerhed med hensyn til honningbier og andre nytte-leddyr.

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 honeybees and beneficial arthropods other than bees.

3. De kraevede oplysninger skal omfatte den foreslaaede klassificering og etikettering af plantebeskyttelsesmidlet i overensstemmelse med de relevante faellesskabsdirektiver.

3. The information required shall include the proposed classification and labelling of the plant protection product in accordance with relevant Community Directives.

4. I de enkelte tilfaelde kan det vaere noedvendigt at kraeve visse oplysninger som omhandlet i bilag II, del A, naar det gaelder hjaelpestoffer. Inden saadanne oplysninger kraeves, og inden eventuelle nye undersoegelser maa foretages, tages alle oplysninger om hjaelpestoffet, som den kompetente myndighed har faaet forelagt, i betragtning, isaer naar:

4. In individial cases it may be necessary to require certain information as provided for in Annex II, Part A, for formulants. Before such information 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:

- det er tilladt at anvende hjaelpestoffet i levnedsmidler, foder, medicin eller kosmetik i henhold til faellesskabslovgivningen, eller

- the use of the formulant is permitted in food, animal feeding stuffs, medicines or cosmetics in accordance with Community legislation,

- der er forelagt et sikkerhedsdatablad for hjaelpestoffet i overensstemmelse med Raadets direktiv 67/548/EOEF«

- a safety data sheet has been submitted for the formulant in accordance with Council Directive 67/548/EEC.'

BILAG III

»6. Effektivitetsdata

ANNEX III

Generelt

'6. Efficacy data

De forelagte data skal vaere tilstraekkelige til at goere det muligt at foretage en evaluering af plantebeskyttelsesmidlet. Det skal navnlig vaere muligt at evaluere, hvilke og hvor store fordele der er forbundet med at anvende praeparatet i forhold til egnede referenceprodukter og skadetaerskler, og at fastlaegge bestingelserne for dets anvendelse.

General

Antallet af forsoeg, der skal udfoeres og indberettes, afhaenger hovedsagelig af faktorer saasom kendskabet til de egenskaber, der knytter sig til det eller de aktive stoffer, midlet indeholder, og de forskellige forhold, der goer sig gaeldende, herunder variabilitet i plantesundhedsforhold, klimaforskelle, de forskellige former for landbrugspraksis, afgroedernes ensartethed, udbringningsmetode, skadegoererens art og plantebeskyttelsesmidlets art.

The 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 reference products and damage thresholds, and to define its conditions of use.

Der skal fremskaffes og forelaegges tilstraekkelige data til, at det kan bekraeftes, at de konstaterede effekter holder stik for de paagaeldende omraader og de forskellige forhold, der kan forventes at goere sig gaeldende i de omraader, hvortil midlet anbefales. Hvis en ansoeger haevder, at forsoeg i et eller flere af de omraader, hvor midlet paataenkes anvendt, er unoedvendige, fordi forholdene kan sammenlignes med forholdene i andre omraader, hvor der er udfoert undersoegelser maa ansoegeren ved hjaelp af dokumentation underbygge paastanden om sammenlignelighed.

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.

For at goere det muligt at vurdere eventuelle forskelle fra vaekstsaeson til vaekstsaeson maa der fremskaffes og forelaegges tilstraekkelige data til, at plantebeskyttelsesmidlernes virkning kan bekraeftes i hvert enkelt agronomisk og klimatisk omraade for hver enkelt kombination af afgroede (eller planteprodukt)/skadegoerer. Normalt maa der gives indberetning om forsoeg vedroerende effektivitet eller fytotoksicitet, hvis det er relevant, i mindst to vaekstsaesoner.

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 conditions are comparable with those in other regions where tests have been carried out, the applicant must substantiate the claim for comparability with documentary evidence.

Hvis ansoegeren mener, at forsoegene fra den foerste vaekstsaeson giver en tilstraekkeligt solid bekraeftelse af de forventede virkninger, der er forudsagt paa grundlag af en ekstrapolering af resultaterne fra andre afgroeder, planteprodukter eller situationer eller fra forsoeg med naert beslaegtede praeparater, maa der gives en begrundelse, som kan accepteres af den kompetente myndighed, for, at arbejdet ikke viderefoeres i endnu en vaekstsaeson. Omvendt maa der, hvis de data, der er opnaaet i en bestemt vaekstsaeson, er af begraenset vaerdi for vurderingen af virkningen paa grund af klimaforhold eller plantesundhedsforhold eller andet, udfoeres og gives indberetning om forsoeg i en eller flere yderligere vaekstsaesoner.

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.

6.1. Indledende forsoeg

If to the opinion of the applicant the trials from the first season adequately confirm the validity of claims made on the basis of extrapolation of results from other crops, commodities or situations or from tests with closely similar preparations, a justification, which is acceptable 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 particular season are of limited value for the assessment of performance, trials in one or more further seasons must be conducted and reported.

Efter anmodning fra den kompetente myndighed skal der forelaegges kortfattede rapporter om indledende forsoeg, herunder vaeksthusforsoeg og markforsoeg, der er udfoert for at vurdere den biologiske aktivitet og doseringsintervallet af plantebeskyttelsesmidlet og det eller de aktive stoffer, det indeholder. Disse rapporter giver den kompetente myndighed yderligere oplysninger til brug for dens evaluering af plantebeskyttelsesmidlet. Hvis disse oplysninger ikke forelaegges, maa der gives en begrundelse som kan accepteres af den kompetente myndighed.

6.1. Preliminary tests

6.2. Effektivitetsforsoeg

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 acceptable to the competent authority must be provided.

Formaalet med forsoegene

6.2. Testing effectiveness

Forsoegene skal give tilstraekkelige data til at goere det muligt at evaluere niveauet for og varigheden og konsekvensen af bekaempelsen eller beskyttelsen eller eventuelle andre tiltaenkte virkninger af plantebeskyttelsesmidlet sammenlignet med egnede referenceprodukter, hvis saadanne findes.

Aim of the tests

Forsoegsbetingelser

The 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.

Normalt bestaar et forsoeg af tre komponenter: forsoegsprodukt, referenceprodukt og ubehandlet kontrol.

Test conditions

Plantebeskyttelsesmidlets virkning skal undersoeges i forhold til egnede referenceprodukter, hvis saadanne findes. Et egnet referenceprodukt defineres som et godkendt plantebeskyttelsesmiddel, der har udvist tilstraekkelig virkning i praksis under de landbrugsmaessige, plantesundhedsmaessige og miljoemaessige (herunder klimatiske) forhold i det omraade, hvor midlet paataenkes anvendt. Generelt boer formuleringstype, virkninger paa skadegoererne, virkningsspektrum og udbringningsmetode ligge taet op ad det testede plantebeskyttelsesmiddels.

Normally a trial consists of three components: test product, reference product and untreated control.

Plantebeskyttelsesmidler skal testes under forhold, hvor maalgruppen af skadegoerere har vist sig at vaere til stede i et omfang, der fremkalder eller vides at fremkalde skadelige virkninger (udbytte, kvalitet, hoestbesvaer mv.) paa en ubehandlet afgroede eller et ubehandlet areal eller paa planter eller planteprodukter, som ikke er blevet behandlet, eller hvor skadegoereren er til stede i et saadant omfang, at der kan foretages en evaluering af plantebeskyttelsesmidlet.

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 agricultural, 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.

Forsoeg med henblik paa fremskaffelse af data for plantebeskyttelsesmidler til bekaempelse af skadegoerere skal vise, hvor effektivt midlerne bekaemper de paagaeldende skadegoerere eller arter, der er repraesentative for grupper, som midlerne haevdes at tage sigte paa. Forsoegene skal omfatte de forskellige stadier af skadegoerernes vaekst- eller livscyklus, hvis dette er relevant, og de forskellige stammer eller racer, hvis disse kan forventes at udvise forskellige grader af modtagelighed.

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, operational 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.

Tilsvarende skal forsoeg med henblik paa fremskaffelse af data for plantebeskyttelsesmidler, der er vaekstreguleringsmidler, vise, hvor store virkninger midlerne har paa de arter, der skal behandles, og omfatte en undersoegelse af virkningen paa et repraesentativt udsnit af de forskellige sorter, som midlerne paataenkes anvendt paa.

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.

For at skaffe klarhed over doseringsresponset maa lavere doser end den anbefalede dosis indgaa i nogle forsoeg, saaledes at det kan vurderes, om den anbefalede dosis er den mindst mulige, der kraeves for at opnaa den oenskede virkning.

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.

Varigheden af behandlingens virkninger skal undersoeges i forhold til henholdsvis bekaempelsen af de oenskede skadegoerere eller virkningen paa de behandlede planter eller planteprodukter. Hvis mere end en enkelt behandling anbefales, skal der gives indberetning om forsoeg, der fastlaar varigheden af virkningerne af en behandling, det paakraevede antal behandlinger og de oenskede intervaller mellem dem.

In order to clarify the dose response, dose rates lower than the recommended 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.

Der skal forelaegges bevis for, at den anbefalede dosis, sproejtetidspunkt og udbringningsmetode resulterer i tilstraekkelig bekaempelse eller beskyttelse eller har den tilsigtede virkning under en raekke forskellige forhold, der kan forventes at optraede ved anvendelsen i praksis.

The duration of the effects of treatment must be investigated in relation 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.

Medmindre der er tydelige tegn paa, at et plantebeskyttelsesmiddels virkning naeppe i saerlig grad vil blive paavirket af faktorer i miljoeet, saasom temperatur eller regn, skal der foretages undersoegelser og gives indberetning om effekter af saadanne faktorer paa virkningen, navnlig i tilfaelde af, at man ved, at kemisk beslaegtede midlers virkning paavirkes paa en saadan maade.

Evidence must be submitted to show that the dose, timing and medthod of application recommended give adequate control, protection or have the intended effect in the range of circumstances likely to be encountered in practical use.

Hvis foreslaaede angivelser paa etiketten omfatter anvisninger paa brugen af plantebeskyttelsesmidlet sammen med et eller flere andre plantebeskyttelsesmidler eller adjuvanter, skal der gives oplysninger om blandingens virkning.

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 investigation 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.

Retningslinje for forsoeg

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.

Forsoeg skal vaere tilrettelagt med henblik paa at undersoege bestemte spoergsmaal, mest muligt at reducere virkningerne af tilfaeldig variation mellem forskellige dele af hver enkel forsoegslokalitet og at goere det muligt at foretage en statistisk analyse af de resultater, som kan underkastes en saadan analyse. Udformningen, analysen og indberetningen af forsoeg skal vaere i overensstemmelse med retningslinje 152 og 181 fra Plantebeskyttelsesorganisationen for Europa og Middelhavsomraaderne (EPPO). Rapporten skal omfatte en detaljeret og kritisk vurdering af dataene.

Test guideline

Forsoegene skal udfoeres i overensstemmelse med specifikke EPPO-retningslinjer, hvis saadanne foreligger, eller, hvis en medlemsstat kraever det, og forsoeget udfoeres paa denne medlemsstats omraade, med retningslinjer, der mindst opfylder kravene i den tilsvarende EPPO-retningslinje.

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 accordance with European and Mediterranean Plant Protection Organization (EPPO) guidelines 152 and 181. The report shall include a detailed and critical assessment of the data.

Der skal foretages en statistisk analyse af de resultater, som kan underkastes en saadan analyse. Om noedvendigt maa den anvendte retningslinje tilpasses, saa det bliver muligt at foretage en saadan analyse.

The trials must be carried out in accordance to specific EPPO guidelines, 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.

6.3. Oplysninger om udvikling eller mulig udvikling af resistens

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.

Der skal fremskaffes laboratoriedata, hvis der forefindes oplysninger fra marken om forekomst og udvikling af resistens eller krydsresistens i skadegoererpopulationer over for det eller de aktive stoffer eller over for beslaegtede aktive stoffer. Selv om disse oplysninger ikke direkte er relevante for de anvendelsesformaal, for hvilke der ansoeges om godkendelse eller fornyelse af godkendelse (andre skadegoerere eller andre afgroeder), skal de ikke desto mindre fremlaegges, hvis de foreligger, da de kan sige noget om sansynligheden af, at der udvikler sig resistens i maalproduktionen.

6.3. Information on the occurrence or possible occurrence of the development of resistance

Hvis det er bevist, eller der foreligger oplysninger, som tyder paa, at det kan forventes, at der udvikles resistens ved kommerciel anvendelse, skal der fremskaffes og forelaegges bevis med hensyn til den paagaeldende skadegoererpopulations foelsomhed over for plantebeskyttelsesmidlet. I disse tilfaeldet skal der fastlaegges en bekaempelsesstrategi, hvorved risikoen for, at der udvikles resistens eller krydsresistens hos maalarterne, reduceres mest muligt

Laboratory data and where it exists, field information relating to the occurrence and development of resistance or cross-resistance in populations 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.

6.4. Virkninger paa udbyttet af behandlede planter eller planteprodukter i henseende til maengde og/eller kvalitet

Where there is evidence or information to suggest that, in commercial use, the development of resistance is likely, evidence must be generated 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.

6.4.1. Virkninger paa planters eller planteprodukters kvalitet

6.4. Effects on the yield of treated plants or plant products in terms of quantity and/or quality

Formaalet med forsoegene

6.4.1. Effects on the quality of plants or plant product

Forsoegene skal give tilstraekkelige data til, at der kan foretages en evaluering af den mulige forekomst af afsmag eller lugt eller andre kvalitetsaspekter hos planter eller planteprodukter efter behandling med plantebeskyttelsesmidlet.

Aim of the tests

Omstaendigheder, hvorunder forsoegene kraeves

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.

Muligheden for forekomst af afsmag eller lugt hos konsumafgroeder skal undersoeges og indberettes, hvis:

Circumstances in which required

- midlets art eller anvendelse bevirker, at der kan vaere risiko for forekomst af afsmag eller lugt

The possibility of the occurrence of taint or odour in food crops must be investigated and be reported where:

- andre midler, der er baseret paa samme aktive stof eller et naert beslaegtet aktivt stof, har vist sig at indebaere risiko for forekomst af afsmag eller lugt.

- the nature of the products or its use is such that a risk of occurrence of taint or odour might be expected,

Plantebeskyttelsesmidlernes virkninger paa andre aspekter af behandlede planters eller planteprodukters kvalitet skal undersoeges og indberettes, hvis:

- plantebeskyttelsesmidlets art eller anvendelse kan have skadelig indfyldelse paa andre kvalitetsaspekter (f.eks. hvis der benyttes vaekstregulatorer taet paa hoesten), eller

- other products based on the same or a closely similar active ingredient have been shown to present a risk of occurrence of taint or odour.

- andre midler baseret paa samme aktive stof eller et naert beslaegtet aktivt stof, har vist sig at have skadelig indfyldelse paa kvaliteten.

The effects of plant protection products on other quality aspects of treated plants or plant products must be investigated and reported where:

Forsoegene boer i foerste omgang udfoeres paa hovedafgroederne, som plantebeskyttelsesmidlet skal anvendes paa, med dobbelt saa stor dosis som normalt og, hvis det er relevant, under anvendelse af de vigtigste forarbejdningsmetoder. Hvis der observeres virkninger, skal forsoeget udfoeres med den normale dosis.

- 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

Omfanget af paakraevede forsoeg paa andre afgroeder afhaenger af, i hvor hoej grad de er beslaegtet med de allerede testede hovedafgroeder, maengden og kvaliteten af de data, der foreligger for disse hovedafgroeder, og af, i hvor hoej grad anvendelsesmetoderne for plantebeskyttelsesmidlet og metoderne til forarbejdning af afgroederne, hvis det er relevant, ligner hinanden. Det er normalt tilstraekkeligt at udfoere forsoeget med den vigtigste formuleringstype, der skal godkendes.

- other products based on the same or a closely similar active ingredient have been shown to have an adverse influence on the quality.

6.4.2. Virkninger paa forarbejdningsprocesserne

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.

Formaalet med forsoegene

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 processing the crops, are similar. It is generally sufficient to perform the test with the main formulation type to be authorized.

Forsoegene skal give tilstraekkelige data til, at der kan foretages en evaluering af den mulige forekomst af skadelige virkninger efter behandling med plantebeskyttelsesmidlet paa forarbejdningsprocesserne eller paa kvaliteten af de forarbejdede produkter.

6.4.2. Effects on transformation processes

Omstaendigheder, hvorunder forsoegene kraeves

Aim of the tests

Naar de behandlede planter eller planteprodukter normalt er bestemt til at indgaa i en forarbejdningsproces saasom vinfremstilling, brygning eller broedbagning, og naar der forekommer betydende restkoncentrationer ved hoesten, skal muligheden for forekomst af skadelige virkninger undersoeges og indberettes, hvis:

The 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.

- det tyder paa, at anvendelsen af plantebeskyttelsesmidlet kan have indflydelse paa de paagaeldende processer (f.eks. naar der anvendes vaekstregulatorer eller fungicider taet paa hoesten), eller

Circumstances in which required

- andre midler baseret paa samme aktive stof eller et naert beslaegtet aktivt stof har vist sig at have ugunstig indflydelse paa disse processer eller de forarbejdede produkter.

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 possibility of the occurrence of adverse effects must be investigated and reported where:

Det er normalt tilstraekkeligt at udfoere forsoeget med den vigtigste formuleringstype, der skal godkendes.

- 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),

6.4.3. Virkninger paa udbyttet af behandlede planter eller planteprodukter

Formaalet med forsoegene

- other products based on the same or a closely similar active ingredient have been shown to have an adverse influence on these processes or its products.

Forsoegene skal give tilstraekkelige data til, at der kan foretages en evaluering af plantebeskyttelsesmidlets virkning og af muligheden for et fald i udbytte eller tab ved oplagring af behandlede planter eller planteprodukter.

It is generally sufficient to perform the test with the main formulation type to be authorized.

Omstaendigheder, hvorunder forsoegene kraeves

6.4.3. Effects on the yield of treated plants or plant products

Plantebeskyttelsesmidlernes virkninger paa udbytte eller udbyttekomponenter, naar det gaelder behandlede planter eller planteprodukter, skal bestemmes, hvis det er relevant. Naar det kan forventes, at behandlede planter eller planteprodukter skal oplagres, skal virkningen paa udbytte efter oplagring, herunder data for holdbarhed, fastslaas, hvis det er relevant.

Aim of the tests

Disse oplysninger vil normalt i de forsoeg, der skal udfoeres i henhold til punkt 6.2.

The 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.

6.5. Fytotoksicitet for maalgruppen af planter (herunder forskellige sorter) eller for maalgruppen af planteprodukter

Circumstances in which required

Formaalet med forsoegene

The effects of plant protection products on the yield or yield components 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 determined where relevant.

Forsoegene skal give tilstraekkelige data til, at der kan foretages en evaluering af plantebeskyttelsesmidlets virkning og af muligheden for forekomst af fytotoksicitet efter behandling med plantebeskyttelsesmidlet.

This information will normally be available from the tests required under the provisions of point 6.2.

Omstaendigheder, hvorunder forsoegene kraeves

6.5. Phytotoxicity to target plants (including different cultivars), or to target plant products

For herbicider og andre plantebeskyttelsesmidler, hvorom det under de i henhold til punkt 6.2 udfoerte forsoeg konstateres, at de har skadelige virkninger, omend disse virkninger er forbigaaende, skal selektiviteten for maalgruppen af afgroeder fastslaas under anvendelse af to gange den anbefalede dosis. En intermediaer dosis maa ogsaa undersoeges, hvis der konstateres alvorlige fytotoksiske virkninger.

Aim of the tests

Naar der forekommer skadelige virkninger, men disse virkninger haevdes at vaere betydningsloese sammenlignet med fordelene ved anvendelsen eller haevdes at vaere forbigaaende, kraeves der dokumentation for denne paastand. Om noedvendigt maa der fremlaegges udbyttemaalinger.

The test shall provide sufficient data to permit an evaluation of the performance of the plant protection product and of the possible occurrence of phytotoxicity after treatment with the plant protection product.

Det skal paavises, at et plantebeskyttelsesmiddel uden risiko kan anvendes paa de vigtigste sorter af de hovedafgroeder, det anbefales til, herunder virkningen paa afgroedens udviklingsstadium, frodighed og andre faktorer, som kan paavirke modtageligheden over for skade eller beskadigelse.

Circumstances in which required

Omfanget af paakraevede forsoeg paa andre afgroeder afhaenger af, i hvor hoej grad de er beslaegtet med de allerede testede hovedafgroeder, maengden og kvaliteten af de data, der foreligger for disse hovedafgroeder, og af, i hvor hoej grad anvendelsesmetoderne for plantebeskyttelsesmidlet, hvis dette er relevant, ligner hinanden. Det er normalt tilstraekkeligt at udfoere proeven med den vigtigste formuleringstype, der skal godkendes.

For 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 intermediate application rate must also be investigated.

Hvis foreslaaede angivelser paa etiketten omfatter anvisninger paa brugen af plantebeskyttelsesmidlet sammen med et eller flere andre plantebeskyttelsesmidler eller adjuvanter, gaelder bestemmelserne i de forudgaaende afsnit for blandingen.

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.

Retningslinje for forsoegene

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.

Observationer vedroerende fytotoksicitet skal finde sted i de forsoeg, der er fastsat i punkt 6.2.

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.

Hvis der konstateres fytotoksiske virkninger, skal de vurderes og registreres korrekt i overensstemmelse med EPPO-retningslinje 135, eller, hvis en medlemsstat kraever det, og proeven udfoeres paa denne medlemsstats omraade, med retningslinjer, der mindst opfylder kravene i denne EPPO-retningslinje.

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 guideline

6.6 Observerede, uoenskede eller utilsigtede, f.eks. paa nytte- og andre organismer uden for maalgruppen, paa efterfoelgende afgroeder, andre planter eller dele af behandlede planter, som anvendes til formering (f.eks. froe, stiklinger, udloebere)

Observations concerning phytotoxicity must be performed in the tests provided for under point 6.2.

6.6.1 Virkning paa efterfoelgende afgroeder

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 territory of this Member State, with guidelines satisfying at least the requirements of this EPPO guideline.

Formaalet med de kraevede oplysninger

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.

Der skal fremlaegges tilstraekkelige data til, at der kan foretages en evaluering af eventuelle skadelige virkninger paa efterfoelgende afgroeder af en behandling med plantebeskyttelsesmidlet.

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)

Omstaendigheder, hvorunder oplysningerne kraeves

6.6.1. Impact on succeeding crops

Hvis data, der er fremskaffet i overensstemmelse med afsnit 9, punkt 9.1, viser tilstedevaerelse af betydende restkoncentrationer af det aktive stof, dets metabolitter eller nedbrydningsprodukter, som har eller kan have biologisk aktivitet i efterfoelgende afgroeder, i jorden eller i plantemateriale saasom halm eller organisk materiale op til saanings- eller udplantningstidspunktet for eventuelle efterfoelgende afgroeder, skal der fremlaegges observationer om virkningerne paa det normale spektrum af efterfoelgende afgroeder.

Aim of the information required

6.6.2. Virkning paa andre planter, herunder naboafgroeder

Sufficient data must be reported to permit an evaluation of possible adverse effects of a treatment with the plant protection product on succeeding crops.

Formaalet med de kraevede oplysninger

Circumstances in which required

Der skal fremlaegges tilstraekkelige data til, at der kan foretages en evaluering af de eventuelle skadelige virkninger af en behandling med plantebeskyttelsesmidlet paa andre planter, herunder naboafgroeder.

Where 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.

Omstaendigheder, hvorunder oplysningerne kraeves

6.6.2. Impact on other plants, including adjacent crops

Der skal forelaegges observationer vedroerende skadelige virkninger paa andre planter, herunder det normale spektrum af naboafgroeder, naar der er tegn paa, at plantebeskyttelsesmidlet kan paavirke disse planter via afdrift i forbindelse med fordampning.

Aim of the information required

6.6.3 Virkning paa behandlede planter eller planteprodukter, som anvendes til formering

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.

Formaalet med de kraevede oplysninger

Circumstances in which required

Der skal fremlaegges tilstraekkelige data til, at der kan foretages en evaluering af eventuelle skadelige virkninger af en behandling med plantebeskyttelsesmidlet paa planter eller planteprodukter, som anvendes til formering.

Observations must be submitted on adverse effects on other plants, including the normal range of adjacent crops, when there are indications that the plant protection product could affect these plants via vapour drift.

Omstaendigheder, hvorunder oplysningerne kraeves

6.6.3. Impact on treated plants or plant products to be used for propagation

Der skal fremlaegges observationer vedroerende plantebeskyttelsesmidlernes virkning paa plantedele, som anvendes til formering, medmindre de paataenkte anvendelsesformaal udelukker anvendelse paa afgroeder, som er bestemt til produktion af froe, stiklinger, udloebere eller knolde:

Aim of the information required

i) froe: vitalitet, spireevne og vigoer

Sufficient 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.

ii) stiklinger: rodvaekst og tilvaekst

Circumstances in which required

iii) udloebere: etablering og tilvaekst

Observations 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.

iv) knolde: brydning og normal vaekst.

(i) for seeds - viability, germination and vigour;

Retningslinje for proeverne

(ii) cuttings - rooting and growth rates;

Naar det gaelder froe, skal proeverne udfoeres efter ISTA-metoder (1).

(iii) runners - establishment and growth rates;

6.6.4. Virkninger paa nyttige og andre organismer uden for maalgruppen

(iv) tubers - sprouting and normal growth.

Eventuelle positive eller negative virkninger paa forekomsten af andre skadegoerere, der er observeret under de proever, som udfoeres i henhold til kravene i dette afsnit, indberettes. Der skal ogsaa gives indberetning om observerede virkninger paa miljoeet, isaer virkninger paa flora og fauna og/eller nyttige organismer.

Test guideline

6.7. Sammendrag og evaluering i dataene i punkt 6.1 til 6.6

Seeds testing shall be done according to ISTA Methods (1).

Der skal forelaegges et sammendrag af alle data og oplysninger, der omhandles i punkt 6.1 til 6.6, sammen med en detaljeret og kritisk vurdering af dataene, saerlig med henvisning til de fordele, plantebeskyttelsesmidlet frembyder, skadelige virkninger, der forekommer eller kan opstaa, og foranstaltninger, der er noedvendige for at undgaa eller reducere ugunstige virkninger mest mulig.«

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 environmental effects must also be reported, especially effects on wildlife and/or beneficial organisms.

(1) International Rules for Seed Testing, 1985. Proceedings of the International Seed Testing Association, Seed Science and Technology, Volume 13, Number 2, 1985.

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 assessment 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.'

(1) International rules for seed testing, 1985. Proceedings of the International Seed Testing Association, Seed Science and Technology, Volume 13, No 2, 1985.

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