Commission Regulation (EC) No 1490/2002 of 14 August 2002 laying down further detailed rules for the implementation of the third stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC and amending Regulation (EC) No 451/2000 (Text with EEA relevance)

Article 1

Subject matter and scope

• (a) reviews by Member States of active substances in Annex I in particular pursuant to renewals of authorisations in accordance with Article 4(4) of Directive 91/414/EEC;

• (b) reviews by the Commission pursuant to Article 5(5) of Directive 91/414/EEC;

• (c) assessments carried out under Directive 79/117/EEC.

Article 2

Definitions

For the purpose of this Regulation, the definitions in Directive 91/414/EEC shall apply.

The following definitions shall also apply:

• (a) ‘notifier’ means the natural or legal person who submitted a notification in accordance with the terms specified in Regulation (EC) No 451/2000 as listed in Annex II;

• (b) ‘Committee’ means the Standing Committee on the Food Chain and Animal Health, referred to in Article 19 of Directive 91/414/EEC;

• (c) ‘data list’ means a list of all the data which is available to be submitted in the full data package;

• (d) ‘full data package’ means information and results of studies sufficient to satisfy the requirements of Annexes II and III to Directive 91/414/EEC in relation to a limited range of representative uses of the active substance concerned.

Article 3

Member State authority

Article 4

Measures in case of imbalances

If, during the assessment and evaluation referred to in Articles 9 and 10, it becomes apparent that there is an imbalance in the responsibilities borne and the work to be done or actually done by the Member States as rapporteurs, it may be decided, in accordance with the procedure provided for in Article 19 of Directive 91/414/EEC, to replace a Member State originally designated as rapporteur for a particular active substance by another Member State.

In such cases the original rapporteur Member State shall inform the notifiers concerned and shall transfer to the newly designated rapporteur Member State all correspondence and information which it has received as rapporteur Member State for the active substance concerned. The original Member State shall return to the notifier the fee referred to in Article 17 except for the part referred to in paragraph 2(d) thereof. The newly designated rapporteur Member State shall then require the notifiers to pay the fee referred to in Article 17 except the part referred to in paragraph 2(d) thereof.

Article 5

Withdrawal or replacement of notifier

Article 6

Submission and checking of data lists

Where, for any active substance listed in Annex I, there are several notifications, the notifiers concerned shall take all reasonable steps to submit these data lists collectively.

Where a data list is not submitted by all notifiers concerned, it shall mention the efforts made and the reasons why certain notifiers have not participated.

For active substances notified by more than one notifier those notifiers shall for each study involving vertebrate animals, detail the attempts made to avoid duplication of testing and give, if applicable, the reasons for conducting a duplicate study.

Article 7

Submission of dossiers

Where for any active substance listed in Annex I there are several notifications, the notifiers concerned shall take all reasonable steps to submit these dossiers collectively.

Where a dossier is not submitted by all notifiers concerned, it shall mention the efforts made and the reasons why certain notifiers have not participated.

For active substances notified by more than one notifier, those notifiers shall for each study involving vertebrate animals, detail the attempts made to avoid duplication of testing and give, if applicable, the reasons for conducting a duplicate study.

• (a) a copy of the notification; in the case of a joint application made by several producers, a copy of the notifications made in accordance with Article 10 of Regulation (EC) No 451/2000 and the name of the person designated by the producers concerned as being responsible for the joint dossier and the processing of the dossier in accordance with this Regulation;

• (b) a limited range of representative uses of the active substance, in respect of which the data submitted by the notifier in the dossier shall demonstrate that for one or more preparations, the requirements set out in Article 5 of Directive 91/414/EEC for inclusion of the active substance in Annex I to Directive 91/414/EEC, can be met;

• (c) - (i) for each point of Annex II to Directive 91/414/EEC, the summaries and results of studies and trials, the name of the person or institute that has carried out the trials;
• (ii) for each point of Annex III to Directive 91/414/EEC the summaries and results of studies and trials, the name of the person or institute that has carried out the trials, relevant to the assessment of the criteria referred to in Article 5 of Directive 91/414/EEC for one or more preparations which are representative for the uses referred to in subparagraph (b) taking into account that data gaps in the information of the Annex II dossier resulting from the proposed limited range of representative uses of the active substance may lead to restrictions in the inclusion into Annex I to Directive 91/414/EEC;
• (iii) and for active substances listed in Annex I, part B, for studies not yet fully completed the evidence that these studies have been commissioned as required by Article 10(4) of Regulation (EC) No 451/2000 with an undertaking that they will be submitted at the latest by 31 May 2005;

• (d) a checklist to be filled in by the notifier, demonstrating that the dossier is complete.

Article 8

Submission of information by third parties

Any person wishing to submit information which might contribute to the evaluation, in particular with regard to the potentially dangerous effects of the active substance or its residues on human and animal health and on the environment to the rapporteur Member States shall do so by 30 November 2003 at the latest for substances listed in Annex I, part A, and by 30 November 2004 at the latest for substances listed in Annex I, part B. The rapporteur Member State shall submit any information received to the EFSA.

Article 9

Completeness check of dossiers

The EFSA shall assess the reports submitted to it by the rapporteur Member States and report to the Commission on the completeness of the dossiers.

For those active substances for which one or more dossiers are considered to be complete, the rapporteur Member State shall perform the evaluation as referred to in Article 10, unless the EFSA informs the rapporteur Member State and the Commission, within two months of receipt of the Member State report on completeness, that it does not consider the dossier to be complete.

For those active substances for which the dossier is to be completed, as provided for under Article 7(2)(c)(iii), the report must confirm the date by which the dossier will be completed and by which date the evaluation as referred to in Article 10 will begin.

Article 10

Evaluation by the rapporteur Member State

At the same time, the rapporteur Member State shall make a recommendation to the Commission either:

• — to include the active substance in Annex I to Directive 91/414/EEC, stating the conditions for inclusion, or

• — not to include the active substance in Annex I to Directive 91/414/EEC, stating the reasons for the non-inclusion.

The rapporteur Member State shall in particular include in the draft assessment report a reference to each test and study report, for each point of Annex II and Annex III to Directive 91/414/EEC, relied on for the assessment. This reference shall be made in the form of a list of test and study reports including the title, the author(s), the date of the study or test report and the date of publication, the standard to which the test or study was conducted, the holder's name and, if any, the claim made by the holder or notifier for data protection. It shall also mention for the other notified sources of the active substances for which the dossier was considered not to be complete whether it can be concluded that such active substances are comparable within the meaning of Article 13(5) of Directive 91/414/EEC.

The rapporteur Member State may, from the start of its examination of the dossier, consult with experts from the EFSA and may request additional technical or scientific information from other Member States to assist the evaluation. The rapporteur Member State may perform the evaluation together with a co-rapporteur Member State.

The rapporteur Member State shall request the notifiers to submit an updated summary dossier to the EFSA, the other Member States and on request to the Commission at the same time as the rapporteur's draft assessment report is sent to the EFSA.

The Member States, the Commission or the EFSA may request through the rapporteur Member State that notifiers also send them an updated complete dossier or parts thereof.

Article 11

Receipt of and access to the draft assessment report

In exceptional cases where the draft assessment report clearly does not fulfil the requirements concerning the format recommended by the Commission, the Commission shall agree with the EFSA and the rapporteur Member State on a period for resubmission of an amended report. This period shall not exceed two months.

It shall collate the comments it receives, including available comments from the EFSA, and forward them to the Commission, Member States and the notifiers.

• (a) the draft assessment report except the elements thereof which have been accepted as confidential in accordance with Article 14 of Directive 91/414/EEC;

• (b) the list of any data required for the evaluation in view of the possible inclusion of the active substance in Annex I to that Directive as finalised by the EFSA where it has finalised such a list.

Article 11a

Examination of the draft assessment report

The Commission shall, without delay, examine the draft assessment report and the recommendation by the rapporteur Member State and the comments received from other Member States, the EFSA and from the notifiers in accordance with Article 11(2).

Article 11b

Active substance with clear indications that they do not have any harmful effects

If there are clear indications that it may be expected that the active substance does not have any harmful effects on human or animal health or on groundwater or any unacceptable influence on the environment, as set out in Annex V, Article 12(1)(a) and (2)(a) shall apply.

Article 11c

Consultation of the EFSA

Where the Commission requests the EFSA to carry out a full peer review, the EFSA shall deliver its conclusion at the latest six months after the request. Where the Commission does not request a full peer review, but only a conclusion on specific points, the period shall be reduced to three months. The submission of the conclusions shall in any event be no later than 30 September 2008.

The Commission may take a Decision as referred to in Article 11f.

Article 11d

Submission of additional information after the draft assessment report has been submitted to the EFSA

The rapporteur Member State shall, within one month after the receipt of such information, evaluate the information received and send its evaluation to the EFSA.

Where the rapporteur Member State, pursuant to paragraph 1 or to the first subparagraph of this paragraph, refuses to take into account studies or information received from the notifier, it shall inform the Commission and the EFSA and indicate the reasons for such refusal.

Article 11e

Withdrawal by notifier

Where Article 11b does not apply, the notifier may withdraw his support of the inclusion of the active substance in Annex I to Directive 91/414/EEC within two months from receipt of the draft assessment report referred to in Article 11(2).

Article 11f

Active substance for which there are clear indications of harmful effects

If there are clear indications that it may be expected that the active substance has harmful effects on human or animal health or on groundwater as set out in Annex VI, the Commission shall take a Decision on the non-inclusion of the active substance in Annex I to Directive 91/414/EEC, in accordance with Article 12(1)(a) and (2)(b) of this Regulation.

Article 12

Presentation of a draft directive or draft decision

• (a) receipt of the draft assessment report where Article 11b or Article 11f applies;

• (b) receipt of the conclusion established by the EFSA where Article 11c applies;

• (c) receipt of a written withdrawal of the notifier’s support where Article 11e applies.

• (a) a draft directive including the active substance in Annex I to Directive 91/414/EEC, setting out where appropriate the conditions, including the time limit, for such inclusion; or

• (b) a draft decision addressed to the Member States requiring them to withdraw, within six months, the authorisations of plant protection products containing the active substance, pursuant to the fourth subparagraph of Article 8(2) of Directive 91/414/EEC, whereby that active substance is not included in Annex I to that Directive, mentioning the reasons for the non-inclusion.

The Directive or Decision shall be adopted in accordance with the procedure referred to in Article 19(2) of Directive 91/414/EEC.

Article 12a

View by the EFSA

Where an active substance is included in Annex I to Directive 91/414/EEC pursuant to Article 11b of this Regulation, the Commission shall request the EFSA to deliver its view on the draft review report by 31 December 2010 at the latest. Member States and notifiers shall cooperate with the EFSA and the Commission.

In order to facilitate the planning of the work, the Commission and the EFSA shall agree on a schedule for the delivery of the view of the EFSA on the draft review report and on the format in which that view is submitted.

Article 13

Finalised review report

Where the Commission submits a draft directive or a draft decision in accordance with Article 12, it shall at the same time submit the conclusions of the Committee's examination in the format of a finalised review report to be noted in the summary record of the meeting. The finalised review report, excluding any parts which refer to confidential information contained in the dossiers and determined as such in accordance with Article 14 of Directive 91/414/EEC, shall be made available for public consultation.

Article 14

Suspension of time limits

Where, in respect of a substance listed in Annex I, the Commission submits a proposal for a total prohibition under Directive 79/117/EEC, the time limits provided for in this Regulation shall be suspended until a decision on that proposal has been taken. Where the Council decides on the total prohibition of the substance in the Annex to Directive 79/117/EEC, the procedure under this Regulation shall be terminated.

Article 15

Measures taken by Member States

Any Member State which, on the basis of information contained in the dossiers referred to in Article 7 or in the report concerning an active substance referred to in Article 10, envisages taking action to withdraw from the market or to restrict severely the use of a plant-protection product containing that substance, shall, as soon as possible, inform the Commission, the EFSA, the other Members States and the notifiers giving the reasons for its intended action.

Article 16

Interim progress report

All Member States shall provide to the Commission and the EFSA a report of their progress on the evaluation of the active substances for which they are rapporteur. Such report shall be made by 30 November 2004 for the active substances mentioned in Annex I, part A, and by 30 November 2005 for those of Annex I, part B.

Article 17

Fees

• (a) require the payment of a fee or charge for each submission of a dossier;

• (b) ensure that the amount of the fee or charge shall be established in a transparent manner with the view to correspond to the real cost of the examination and administrative treatment of a dossier; however this does not exclude that Member States provide for a scale of fixed charges based on average costs for the calculation of the total fee;

• (c) ensure that the fee or charge is received in accordance with the instructions given by the organisation in each Member State listed in Annex IV and that the income from the fee or charge is used to finance exclusively the costs actually incurred by the Member State for the evaluation and administrative treatment of the dossiers for which that Member State is rapporteur or to finance general activities of the Member States resulting from Articles 9, 10 or 11;

• (d) require that a first part of the fee or charge, covering the costs of the rapporteur Member State's obligations resulting from Article 6 and Article 9 is paid at the time of the submission of the data lists referred to in Article 6; this part will not be refundable under any circumstance.

Article 18

Other charges, taxes, levies or fees

Article 17 is without prejudice to Member States' rights to maintain or introduce, to the extent permitted under the Treaty, charges, taxes, levies or fees with regard to authorisation, placing on the market, use and control of active substances and plant-protection products other than the fee provided for in Article 17.

Article 19

Temporary measures

If necessary and on a case-by-case basis, the Commission may take appropriate temporary measures as provided for by the third subparagraph of Article 8(2) of Directive 91/414/EEC for uses for which additional technical evidence has been provided demonstrating the essential need for further use of the active substance and that there is no efficient alternative.

Article 20

Amendment to Regulation (EC) No 451/2000

Regulation (EC) No 451/2000 is amended as follows:

• 1. Article 8 is replaced by the following: ‘Article 8 Evaluation of dossiers by rapporteur Member States and the EFSA

At the same time, the rapporteur Member State shall make a recommendation to the Commission either: - — to include the active substance in Annex I to the Directive, stating the conditions for inclusion, or - — not to include the active substance in Annex I to the Directive, stating the reasons for the non-inclusion. The rapporteur Member State shall in particular include in the draft assessment report a reference to each test and study report, for each point of Annex II and Annex III to the Directive, relied on for the assessment. This reference shall be made in the form of a list of test and study reports including the title, the author(s), the date of the study or test report and the date of publication, the standard to which the test or study was conducted, the holder's name and, if any, the claim made by the holder or notifier for data protection. It shall also mention for the other notified sources of the active substances for which the dossier was considered not to be complete whether it can be concluded that such active substances are comparable within the meaning of Article 13(5) of the Directive.

The rapporteur Member State may, from the start of this examination, consult with experts from the EFSA and may request additional technical or scientific information from other Member States to assist the evaluation. The rapporteur Member State may perform the evaluation together with a co-rapporteur Member State. The rapporteur Member State shall request the notifiers to submit an updated summary dossier to the EFSA, the other Member States and on request to the Commission at the same time as the rapporteur's draft assessment report is sent to the EFSA. The Member States, the EFSA or the Commission may request through the rapporteur Member State that notifiers also send them the updated complete dossiers or parts thereof.

Without prejudice to Article 7 of the Directive, submission of new studies shall not be accepted. The rapporteur Member State, with the agreement of the EFSA, may request the notifiers to submit within specified periods further data considered by the rapporteur member state of the EFSA necessary to clarify the dossier.

(a) the information referred to in the last subparagraph of paragraph 1, except the elements thereof which have been accepted as confidential in accordance with Article 14 of the Directive; (b) the name of the active substance; (c) the content of the pure active substance in the manufactured material; (d) the list of any data required for consideration of the possible inclusion of the active substance into Annex I to the Directive, first as contained in the rapporteur's report and secondly as finalised by the EFSA; (e) the draft assessment report, except the elements thereof which have been accepted as confidential in accordance with Article 14 of the Directive.

(a) a draft directive to include the active substance in Annex I to the Directive, setting out where appropriate the conditions, including the time limit, for such inclusion, or (b) a draft decision addressed to the Member States to withdraw the authorisations of plant-protection products containing the active substance, pursuant to the fourth subparagraph of Article 8(2) of the Directive, whereby that active substance is not included in Annex I to the Directive, mentioning the reasons for the non-inclusion. The directive or decision shall be adopted in accordance with the procedure provided for in Article 19 of the Directive.

The finalised review report, excluding any parts which refer to confidential information contained in the dossiers and determined as such in accordance with Article 14 of the Directive, shall be made available for public consultation.’

• 1. In Article 10(4), the first sentence is replaced by the following: ‘The time limit for the submission of a list of available studies shall be 23 May 2003. A full data package shall be available on 23 May 2003 at the latest.’

• 1. In Article 11(2), the second sentence is replaced by the following: ‘Member States shall withdraw by 25 July 2003 authorisations of plant-protection products containing active substances for which no admissible notification has been submitted. Authorisations of plant-protection products containing active substances for which no list of available studies has been submitted or for which no full data package is available shall be withdrawn by the deadline referred to in the Decision on the non-inclusion of the active substance concerned.’

• 1. In Annex I, part A, in relation to the active substance Tolclofos-methyl ‘The Netherlands’ is replaced by ‘Sweden’.

Article 21

Entry into force

This Regulation shall enter into force on the seventh day following its publication in the Official Journal of the European Communities.

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

ANNEX I

List of active substances (column A), rapporteur Member States (column B) and notifying producers (code identification) (column C)

PART A

A	B	C
Name	Rapporteur Member State	Notifiers
Abamectin	Netherlands	IBE-ES
Abamectin	Netherlands	PRO-ES
Abamectin	Netherlands	SNO-FR
Abamectin	Netherlands	SYN-GB
Acetochlor	Spain	DAS-GB
Acetochlor	Spain	MON-BE
Acetochlor	Spain	RIV-IE
Amidosulfuron	Austria	AVS-DE
Benfluralin	Belgium	DAS-GB
Benfluralin	Belgium	MAK-BE
Bifenox	Belgium	FSG-DE
Bifenthrin	France	FMC-BE
Bitertanol	United Kingdom	BAY-DE
Bromuconazole	Belgium	AVS-FR
Buprofezin	Finland	NIH-GB
Butralin	France	CFP-FR
Carbetamide	France	FSG-DE
Chlorflurenol	Germany	SCC-DE
Chloridazon	Germany	BAS-DE
Chloropicrin	Italy	EBR-NL
Chloropicrin	Italy	RIV-IE
Chlorthal-dimethyl	Greece	AMV-GB
Cinosulfuron	Italy	SYN-GB
Clethodim	Netherlands	TOM-FR
Clofentezine	United Kingdom	MAK-BE
Clomazone	Denmark	FMC-BE
Coppercompounds	France	EUC-GB
Cresylic acid	Netherlands	ASP-NL
Cyanamide	Germany	DUS-DE
Cycloxydim	Austria	BAS-DE
Dichlorophen	Ireland	CCD-GB
Diclofop	France	AVS-DE
Diclofop	France	PPC-ES
Dicloran	Spain	MAI-PT
Diflubenzuron	Sweden	UNI-NL
Diflufenican	United Kingdom	AVS-DE
Diflufenican	United Kingdom	HRM-BE
Diflufenican	United Kingdom	MAK-BE
Dimethipin	Greece	CRO-GB
Dithianon	Greece	BAS-BE
Dithianon	Greece	HRM-BE
Epoxiconazole	Germany	BAS-DE
Epoxiconazole	Germany	MAK-BE
Etofenprox	Italy	LKC-UK
Fenazaquin	Greece	DAS-GB
Fenbuconazole	United Kingdom	DAS-GB
Fenoxaprop-P	Austria	AVS-DE
Fenpropidin	Sweden	SYN-GB
Fenpropimorph	Germany	BAS-DE
Fenpyroximate	Germany	NIH-GB
Fluazifop-P	France	SYN-GB
Fluazinam	Austria	ISK-BE
Fludioxonyl	Denmark	SYN-GB
Fluometuron	Greece	MAK-BE
Fluometuron	Greece	NLI-AT
Fluquinconazole	Ireland	AVS-FR
Flurenol	Germany	SCC-DE
Flutolanil	Finland	NIH-GB
Fuberidazole	United Kingdom	BAY-DE
Hexaflumuron	Portugal	DAS-GB
Hexythiazox	Finland	NPS-DE
Imidacloprid	Germany	BAY-DE
Kasugamycin	Netherlands	LAI-ES
Mefluidide	Ireland	MKC-BE
Mepiquat	United Kingdom	BAS-DE
Metaldehyde	Austria	LON-DE
Metazachlor	United Kingdom	BAS-DE
Metazachlor	United Kingdom	FSG-DE
Metazachlor	United Kingdom	MAK-BE
Methyl bromide	United Kingdom	EBR-NL
Myclobutanil	Belgium	DAS-GB
Napropamide	Denmark	UPL-GB
Nicosulfuron	United Kingdom	ISK-BE
Nuarimol	Portugal	DAS-GB
Pencycuron	Netherlands	BAY-DE
Polyoxin	Spain	LAI-ES
Pretilachlor	Italy	SYN-GB
Propaquizafop	Italy	MAK-BE
Prosulfocarb	Sweden	SYN-GB
Pyriproxyfen	Netherlands	SUM-FR
Quinoclamine	Sweden	AKA-DE
Streptomycine	Netherlands	DSM-NL
Tebufenozide	Germany	DAS-GB
—————	—————	—————
Tetraconazole	Italy	ISA-IT
Thiobencarb	Spain	KCI-GB
Tralkoxydim	United Kingdom	SYN-GB
Triadimefon	United Kingdom	BAY-DE
Triadimenol	United Kingdom	BAY-DE
Triadimenol	United Kingdom	MAK-BE
Tridemorph	Germany	BAS-DE
Triflumizole	Netherlands	CRE-NL
Triflumuron	Italy	BAY-DE
Triflusulfuron	France	DPD-FR
Zeta-Cypermethrin	Belgium	FMC-BE

PART B

A	B	C
Name	Rapporteur Member State	Notifiers
8-Hydroxyquinoline	Spain	ASU-DE
8-Hydroxyquinoline	Spain	PRO-ES
Aclonifen	Germany	AVS-DE
Acrinathrin	France	AVS-DE
Aluminium phosphide	Germany	DET-DE
Ammonium sulphamate	Ireland	DAP-GB
Asulam	United Kingdom	AVS-DE
Azocyclotin	Italy	CRX-FR
Bensulfuron	Italy	DPD-FR
Bupirimate	Netherlands	MAK-BE
Calcium phosphide	Germany	CFW-DE
Carboxin	United Kingdom	CRO-GB
Chlorate	France	ATO-FR
Chlormequat	United Kingdom	BCL-IE
Chlormequat	United Kingdom	CTF-AT
Chlormequat	United Kingdom	FSG-DE
Chlormequat	United Kingdom	PUS-FR
Chlorsulfuron	Greece	DPD-FR
Cyhexatin	Italy	CRX-FR
Cyhexatin	Italy	OXO-IT
Cymoxanil	Austria	CAL-FR
Cymoxanil	Austria	DPD-FR
Cymoxanil	Austria	OXO-IT
Cymoxanil	Austria	PUS-FR
Cyproconazole	Ireland	SYN-GB
Cyromazine	Greece	SYN-GB
Dazomet	Belgium	BAS-DE
Dicamba	Denmark	GHA-GB
Dicamba	Denmark	SYN-GB
Dichlobenil	Netherlands	UNI-NL
Dichlorobenzoic acid methylester	Germany	ASU-DE
Dicofol	Spain	DAS-GB
Dicofol	Spain	MAK-BE
Diethofencarb	France	SUM-FR
Difenoconazole	Sweden	SYN-GB
Dimethachlor	Germany	SYN-GB
Diniconazole	France	SUM-FR
Diphenylamine	Ireland	CRX-FR
Diphenylamine	Ireland	CSI-UK
Dodemorph	Netherlands	BAS-DE
Dodine	Portugal	CAG-BE
Dodine	Portugal	OXO-IT
Ethalfluralin	Greece	DAS-GB
Etridiazole	Netherlands	UNI-NL
Fenbutatin oxide	Belgium	BAS-BE
Fenbutatin oxide	Belgium	CRX-FR
Fenoxycarb	Netherlands	SYN-GB
Flamprop-M	Sweden	BAS-BE
Flufenoxuron	France	BAS-BE
Flurochloridone	Spain	MAK-BE
Flurprimidole	Finland	DAS-GB
Flutriafol	United Kingdom	CHE-DK
Guazatine	United Kingdom	MAK-BE
Hexaconazole	Italy	IQV-ES
Hexaconazole	Italy	SYN-GB
Hymexazol	Finland	TSG-GB
Imazamethabenz	United Kingdom	BAS-BE
Imazaquin	Belgium	BAS-BE
Imazethapyr	Italy	BAS-BE
Isoxaben	Sweden	DAS-GB
Lenacil	Belgium	HRM-BE
Lenacil	Belgium	SCH-DE
Lufenuron	Portugal	SYN-GB
Magnesium phosphide	Germany	DET-DE
Metam	Belgium	FMF-ES
Metam	Belgium	LAI-ES
Metam	Belgium	MAK-BE
Metam	Belgium	UCB-BE
Metamitron	United Kingdom	BAY-DE
Metamitron	United Kingdom	BCL-IE
Metamitron	United Kingdom	EXC-BE
Metamitron	United Kingdom	FSG-DE
Metamitron	United Kingdom	HRM-BE
Metamitron	United Kingdom	MAK-BE
Metamitron	United Kingdom	PUS-FR
Metamitron	United Kingdom	UPL-GB
Methabenzthiazuron	Sweden	PUS-FR
Metosulam	France	BAY-DE
Monocarbamide-dihydrogensulphate	Spain	AGX-GB
Oryzalin	France	DAS-GB
Oxadiazon	Italy	AVS-DE
Oxyfluorfen	Spain	DAS-GB
Oxyfluorfen	Spain	MAK-BE
Oxyfluorfen	Spain	PPC-ES
Paclobutrazol	United Kingdom	SYN-GB
Penconazole	Germany	SYN-GB
Picloram	United Kingdom	DAS-GB
Primisulfuron	Austria	SYN-GB
Prochloraz	Ireland	AVS-FR
Prochloraz	Ireland	BCL-IE
Prochloraz	Ireland	MAK-BE
Prochloraz	Ireland	PUS-FR
Prochloraz	Ireland	SPC-FR
Propachlor	Netherlands	MAK-BE
Propachlor	Netherlands	MON-BE
Propanil	Italy	DAS-GB
Propanil	Italy	MAK-BE
Propanil	Italy	RCO-PT
Propargite	France	CRO-GB
Propargite	France	PPC-ES
Pyridaben	Netherlands	NCI-DE
Quinclorac	Portugal	BAS-DE
Quinmerac	United Kingdom	BAS-DE
Quizalofop-P	Finland	CRO-GB
Quizalofop-P	Finland	MAK-BE
Quizalofop-P	Finland	NCI-DE
Sintofen	France	DPD-FR
Sodium 5-nitroguaiacolate	Greece	CAL-FR
Sodium o-nitrophenolate	Greece	CAL-FR
Sodium p-nitrophenolate	Greece	CAL-FR
Sodium tetrathiocarbonate	Spain	AGX-GB
Sulcotrione	Germany	BAY-DE
Tau-fluvalinate	Denmark	MAK-BE
Tebuconazole	Denmark	BAY-DE
Tebuconazole	Denmark	MAK-BE
Tebufenpyrad	Germany	BAS-BE
Teflubenzuron	United Kingdom	BAS-BE
Tefluthrin	Germany	SYN-GB
Terbuthylazine	United Kingdom	MAK-BE
Terbuthylazine	United Kingdom	OXO-IT
Terbuthylazine	United Kingdom	SYN-GB
Thidiazuron	Spain	AVS-FR
Tri-allate	United Kingdom	MON-BE
Triazoxide	United Kingdom	BAY-DE
Tricyclazole	France	DAS-GB

ANNEX II

List of notifiers' code identification, names and addresses

Code identification	Name	Address
AGX-GB	Agrilex UK Ltd	PO Box 31 Robertsbridge TN32 5ZL United Kingdom Tel. (44-1580) 88 20 59 Fax (44-1580) 88 20 57
AKA-DE	Agro-Kanesho Co., Ltd, European Branch	Stader Elbstraße D-21683 Stade Tel. (49-41) 41 40 83 88 Fax (49-41) 41 40 83 90
AMV-GB	Amvac Chemical UK Ltd	Surrey Technology Centre, 40 Occam Rd The Surrey Research Park Guildford, Surrey GU2 5YG United Kingdom Tel. (44-1483) 29 57 80 Fax (44-1483) 29 57 81
ASP-NL	Asepta BV	Cyclotronweg 1 / P.O. Box 33 2600 AA Delft Nederland Tel. (31-15) 256 92 10 Fax (31-15) 257 19 01
ASU-DE	Stähler Agrochemie GmbH & Co. KG	Postfach 2047 D-21680 Stade Tel. (49-41) 41 92 04-0 Fax (49-41) 41 92 04-10
ATO-FR	Atofina	4-8, cours Michelet F-92800 Puteaux Tel. (33-1) 49 00 80 80 Fax (33-1) 49 00 88 80
AVS-DE	Aventis CropScience GmbH	Industriepark Höchst Gebäude K 607 D-65926 Frankfurt am Main Tel. (49-69) 305 66 99 Fax (49-69) 305 176 69
AVS-FR	Aventis CropScience SA	14-20, rue Pierre Baizet BP 9163 F-69263 Lyon Cedex 09 Tel. (33-4) 72 85 25 25 Fax (33-4) 72 85 30 81
BAS-BE	BASF (Belgium)	Global Regulatory Affairs — APD/RF Avenue Hamoir, 14 B-1180 Bruxelles Tel. (32-2) 373 27 11 Fax (32-2) 373 27 00
BAS-DE	BASF AG (Deutschland)	Agricultural Center PO Box 120 D-67114 Limburgerhof Tel. (49-621) 60-0 Fax (49-621) 60-27701
BAY-DE	Bayer AG	Business Group Crop Protection Agricultural Centre Monheim D-51368 Leverkusen Tel. (49-2173) 38 49 28 Fax (49-2173) 38 37 35
BCL-IE	Barclay Chemicals Ltd	Tyrellstown Way Damastown Industrial Park Mulhuddart Dublin 15 Ireland Tel. (353-18) 42 57 55 Fax (353-18) 42 53 81
CAG-BE	Chimac-Agriphar SA	26, rue de Renory B-4102 Ougrée Tel. (32-4) 385 97 46 Fax (32-4) 385 97 49
CAL-FR	Calliope SAS	Route d'Artix BP 80 F-64150 Noguères Tel. (33-5) 59 60 92 92 Fax (33-5) 59 60 92 19
CCD-GB	Coalite Chemicals Division	PO Box 152 Buttermilk Lane Bolsover Chesterfield Derbyshire S44 6AZ United Kingdom Tel. (44-1246) 82 68 16 Fax (44-1246) 24 03 09
CFP-FR	CFPI Nufarm	Regulatory Affairs Dept. 28, boulevard Camélinat F-92230 Gennevilliers Tel. (33-1) 40 85 50 20 Fax (33-1) 40 85 51 56
CFW-DE	Chemische Fabrik Wülfel GmbH & Co. KG	Hildesheimer Straße 305 D-30519 Hannover Tel. (49-511) 98 49 60 Fax (49-511) 984 96 40
CHE-DK	Cheminova A/S	Thyborønvej 76-78 DK-7673 Harboøre Tel. (45) 96 90 96 90 Fax (45) 96 90 96 91
CRE-NL	Certis Europe BV	Straatweg 30B PO Box 1180 3600 BD Maarssen Nederland Tel. (31-346) 55 24 00 Fax (31-346) 55 42 74
CRO-GB	Crompton Europe Ltd	Registration Department Kennet House 4 Langley Quay Slough Berkshire SL3 6EH United Kingdom Tel. (44-17) 53 60 30 00 Fax (44-17) 53 60 30 77
CRX-FR	Cerexagri	Registration Department 1, rue des Frères Lumière F-78370 Plaisir Tel. (33-1) 30 81 73 00 Fax (33-1) 30 81 72 51
CSI-UK	CSI-Europe	Pentlands Science Park Penicuik Edinburgh EH26 0PZ United Kingdom Tel. (44-131) 445 60 82 Fax (44-131) 445 60 85
CTF-AT	CCC Task Force	c/o Nufarm GmbH & Co KG St.-Peter-Straße 25 A-4021 Linz Tel. (43-732) 69 18 23 13 Fax (43-732) 69 18 20 04
DAP-GB	Dax Products Ltd	76 Cyprus Road Nottingham NG3 5ED United Kingdom Tel. (44-11) 59 26 9996 Fax (44-11) 59 66 1173
DAS-GB	Dow AgroSciences	Letcombe Laboratory Letcombe Regis Wantage Oxon OX12 9JT United Kingdom Tel. (49-69) 78 99 60 Fax (49-69) 97 84 24 77
DET-DE	Detia Freyberg GmbH	Dr.-Werner-Freyberg-Straße 11 D-69514 Laudenbach Tel. (49-6201) 70 80 Fax (49-6201) 70 84 27
DPD-FR	DuPont de Nemours (France) SAS	Crop Protection Products 137, rue de l'Université F-75334 Paris Cedex 07 Tel. (33-1) 45 50 65 50 Fax (33-1) 45 50 60 05
DSM-NL	DSM Food Specialties, Agri Ingredients	Alexander Fleminglaan 1 PO Box 1 2600 MA Delft Nederland Tel. (31-15) 279 91 11 Fax (31-15) 279 34 82
DUS-DE	Degussa AG	Dr.-Albert-Frank-Straße 32 D-83308 Trostberg Tel. (49-8621) 86-0 Fax (49-8621) 86 22 52
EBR-NL	Eurobrom BV	Regulatory Affairs Department Verrijn Stuartlaan 1c 2288 EK Rijswijk Nederland Tel. (31-70) 3 408 408 Fax (31-70) 3 999 035
EUC-GB	European Union Copper Task Force	c/o TSGE Conyngham Hall Knaresborough North Yorkshire HG5 9AY United Kingdom Tel. (44-1423) 79 91 51 Fax (44-1423) 79 91 55
EXC-BE	Excel Industries Ltd	Luithagen Haven 9 B-2030 Antwerpen Tel. (32-3) 239 82 24 Fax (32-3) 239 82 69
FMC-BE	FMC Chemical SPRL	Agricultural Products Group Boulevard de la Plaine 9/3 B-1050 Bruxelles Tel. (32-2) 645 95 84 Fax (32-2) 645 96 55
FMF-ES	FMC Foret SA	Córcega 293 E-08008 Barcelona Tel. (34) 934 16 75 17 Fax (34) 934 16 74 13
FSG-DE	Feinchemie Schwebda GmbH	Straßburger Straße 5 D-37269 Eschwege Tel. (49-221) 94 98 14-0 Fax (49-221) 94 98 14 15
GHA-GB	Gharda Chemicals Ltd Europe	Holbrook House 72 Lower Addiscombe Road Croydon CR9 6AD United Kingdom Tel. (44-2086) 55 41 03 Fax (44-2086) 55 41 02
HRM-BE	Hermoo Belgium NV	Zepperenweg 257 B-3800 Sint-Truiden Tel. (32-11) 68 68 66 Fax (32-11) 70 74 84
IBE-ES	Iberotam SA	Muntaner, 322, 12a E-08021 Barcelona Tel. (34) 934 54 34 64 Fax (34) 934 54 89 21
IQV-ES	Industrias Químicas del Vallés SA	Av. Rafael Casanova 81 E-08100 Mollet del Vallès ( Barcelona) Tel. (34) 935 79 66 77 Fax (34) 935 93 80 11
ISA-IT	Isagro SPA	Registration Department Centro Uffici San Siro Fabbricato D ala 3 Via Caldera, 21 I-20153 Milano Tel. (39-02) 40 90 11 Fax (39-02) 40 90 12 87
ISK-BE	ISK Biosciences Europe SA	Tour ITT Avenue Louise 480 bte 12 B-1050 Bruxelles Tel. (32-2) 627 86 11 Fax (32-2) 627 86 00
KCI-GB	Kumiai Chemical Industry Co., Ltd	London Liaison Office 35 Piccadilly London W1J 0DW United Kingdom Tel. (44-2077) 34 72 82 Fax (44-2077) 34 45 61
LAI-ES	Lainco, SA	Polígono Can Jardí Av. Bizet 8-12 E-08191 Rubí ( Barcelona) Tel. (34) 935 86 20 15 Fax (34) 935 86 20 16
LKC-UK	Landis Kane Consulting	PO Box 383 Cheltenham Gloucestershire GL52 6WD United Kingdom Tel. (44-4161) 906 85 04 Fax (44-4161) 906 85 09
LON-DE	Lonza GmbH	Morianstraße 32 Postfach 13 14 53 D-42041 Wuppertal Tel. (49-202) 245 38-0 Fax (49-202) 245 38 10
MAI-PT	Margarita Internacional	Comércio e Serviços, Limitada Rua do Bom Jesus, 18-3.o Esq.o P-9050-028 Funchal Tel. (351-291) 23 24 84
MAK-BE	Makhteshim Agan	International Coordination Center (MAICC) Avenue Louise 283 B-1050 Bruxelles Tel. (32-2) 646 86 06 Fax (32-2) 646 91 52
MKC-BE	McKenna & Cuneo, L.L.P.	56, rue des Colonies, Box 14 B-1000 Bruxelles Tel. (32-2) 278 12 11 Fax (32-2) 278 12 00
MON-BE	Monsanto Europe SA	Regulatory Department Avenue de Tervuren 270-272 B-1150 Bruxelles Tel. (32-10) 49 42 11 Fax (32-10) 49 42 42
NCI-DE	Nissan Chemical Europe GmbH	Deutsch-Japanisches Center Immermannstraße 45 D-40210 Düsseldorf Tel. (49-211) 17 22 70 Fax (49-211) 16 22 43
NIH-GB	Nihon Nohyaku Co., Ltd	8 Cork Street Mayfair London W1S 3LJ United Kingdom Tel. (44-2074) 34 00 33 Fax (44-2072) 87 13 35
NLI-AT	Nufarm GmbH & Co KG	St.-Peter-Straße 25 A-4021 Linz Tel. (43-73) 26 91 80 Fax (43-73) 26 91 82 004
NPS-DE	Nisso Chemical Europe GmbH	Berliner Allee 29/Ecke Steinstraße D-40212 Düsseldorf Tel. (49-211) 323 01 35 Fax (49-211) 32 82 31
OXO-IT	Oxon Italia SpA	Via Sempione, 195 I-20016 Pero( MI) Tel. (39-02) 35 37 81 Fax (39-02) 339 02 75
PPC-ES	Proplan-Plant Protection Company, SL	Vía de las dos Castillas 11. Bloque 3, 1o C. E-28224 Pozuelo de Alarcón ( Madrid) Tel. (34) 913 52 29 60 Fax (34) 913 52 72 82
PRO-ES	Probelte, SA	Ctra. Madrid Km. 384.6 Polígono Industrial El Tiro E-30100 Espinardo ( Murcia) Tel. (34) 968 30 72 50 Fax (34) 968 30 54 32
PUS-FR	Phytorus SA	Parc d'Ariane, Bât B 11, boulevard de la grande Thumine F-13090 Aix-en-Provence Tel. (33-1) 60 27 26 26 Fax (33-4) 42 52 68 52
RCO-PT	Rice Madeira Company Europe	Comércio Internacional e Serviços, Sociedade Unipessoal Lda. Rua 31 de Janeiro n.o 81-A, 5.o E PT-9050-011 Funchal ( Madeira) Tel. (351-291) 22 77 44 Fax (351-291) 22 66 31
RIV-IE	Rivendell Consulting Ltd	Rivendell House Stamullen County Meath Ireland Tel. (353-18) 41 52 95 Fax (353-18) 41 47 68
SCC-DE	SCC Scientific Consulting Company GmbH	Mikroforum Ring 1 D-55234 Wendelsheim Tel. (49-67) 34 91 90 Fax (49-67) 34 91 91 91
SCH-DE	Dr. Schirm AG	Kipper Straße 9-11 D-44147 Dortmund Tel. (49-392) 845 63 02 Fax (49-392) 845 63 00
SNO-FR	SINON EU Corporation	170, boulevard Haussmann F-75008 Paris Tel. (33-5) 59 60 92 92 Fax (33-5) 59 60 92 19
SPC-FR	Sipcam-Phyteurop	Courcellor 2 35, rue d'Alsace F-92531 Levallois-Perret Cedex Tel. (33-1) 47 59 77 00 Fax (33-1) 47 37 54 52
SUM-FR	Sumitomo Chemical Agro Europe SA	2, rue Claude Chappe F-69370 Saint-Didier-au-Mont-d'Or Tel. (33-4) 78 64 32 60 Fax (33-4) 78 47 70 05
SYN-DE	Syngenta Agro GmbH	Am Technologiepark 1-5 Postfach 110353 D-63477 Maintal Tel. (49-6971) 55-0 Fax (49-6971) 55-319
SYN-GB	Syngenta Europe Ltd	European Regional Centre Priestley Road Surrey Research Park Guildford Surrey GU2 7YH United Kingdom Tel. (44-1483) 26 00 00 Fax (44-1483) 26 00 19
TOM-FR	Tomen France	18, avenue de l'Opéra F-75001 Paris Tel. (33-1) 42 96 14 56 Fax (33-1) 42 97 52 91
TSG-GB	Sankyo Company Ltd	C/o TSGE Conyngham Hall Knaresborough North Yorkshire HG5 9AY United Kingdom Tel. (44-1423) 79 91 51 Fax (44-1423) 79 91 55
UCB-BE	UCB Chemicals NV	Allée de la Recherche 60 B-1070 Bruxelles Tel. (32-2) 559 99 99 Fax (32-2) 559 99 00
UNI-NL	Uniroyal Chemical Europe BV	Registration Department Ankerweg 18 1041 AT Amsterdam Nederland Tel. (31-20) 587 18 60 Fax (31-20) 587 18 68
UPL-GB	United Phosphorus Ltd	Chadwick House Birchwood Park Warrington Cheshire WA3 6AE United Kingdom Tel. (44-1925) 81 99 99 Fax (44-1925) 81 74 25

ANNEX III

Coordinating authority in the Member States (more details are available at the following website: http://www.europa.eu.int/comm/food/fs/ph_ps/pro/index_en.htm)

AUSTRIA

Bundesamt für Ernährungssicherheit

Landwirtschaftliche Untersuchungen und Forschung Wein

Spargelfeldstraße 191

A-1220 Wien

BELGIUM

Ministère des classes moyennes et de l'agriculture

Service Qualité des matières premières et analyses

WTC 3, 8^e étage

Boulevard S. Bolivar 30

B-1000 Bruxelles

DENMARK

Ministry of Environment and Energy

Danish Environmental Protection Agency

Pesticide Division

Strandgade 29

DK-1401 Copenhagen K

GERMANY

Biologische Bundesanstalt für Land- und Forstwirtschaft (BBA)

Abteilung für Pflanzenschutzmittel und Anwendungstechnik (AP)

Messeweg 11-12

D-38104 Braunschweig

GREECE

Hellenic Republic

Ministry of Agriculture

General Directorate of Plant Produce

Directorate of Plant Produce Protection

Department of Pesticides

3-4 Hippokratous Street

GR-10164 Athens

SPAIN

Ministerio de Agricultura, Pesca y Alimentación

Dirección General de Agricultura

Subdirección General de Medios de Producción Agrícolas

Ciudad de Barcelona, 118-120

E-28007 Madrid

FINLAND

Kasvintuotannon tarkastuskeskus

Torjunta-aineet

PL 42

FIN-00501 Helsinki

FRANCE

Ministère de l'agriculture, de l'alimentation, de la pêche et des affaires rurales

Sous-direction de la qualité et de la protection des végétaux

Bureau de la réglementation et de la mise sur le marché des intrants

251, rue de Vaugirard

F-75732 Paris Cedex 15

IRELAND

Pesticide Control Service

Department of Agriculture and Food

Abbotstown Laboratory Complex

Abbotstown, Castleknock

Dublin 15

Ireland

ITALY

Ministero della Salute

Direzione generale della Sanità pubblica veterinaria degli alimenti e della nutrizione

Piazza G. Marconi, 25

I-00144 Roma

LUXEMBOURG

Administration des services techniques de l'agriculture

Service de la protection des végétaux

Boîte postale 1904

16, route d'Esch

L-1019 Luxembourg

NETHERLANDS

College voor de Toelating van Bestrijdingsmiddelen

Postbus 217

6700 AE Wageningen

Nederland

PORTUGAL

Direcção-Geral de Protecção das Culturas

Quinta do Marquês

P-2780 Oeiras

SWEDEN

Kemikalieinspektionen

Box 1384

S-17127 Solna

UNITED KINGDOM

Pesticides Safety Directorate

Department for Environment, Food and Rural Affairs

Mallard House

Kings Pool

3 Peasholme Green

York YO1 7PX

United Kingdom

ANNEX IV

Organisations in the Member States to be contacted concerning further details on the payment of the fees referred to in Article 17 and to which such fees have to be paid

AUSTRIA

Bundesamt für Ernährungssicherheit

Landwirtschaftliche Untersuchungen und Forschung Wein

Spargelfeldstraße 191

A-1220 Wien

BELGIUM

Fonds budgétaire des matières premières

Ministère des classes moyennes et de l'agriculture

Inspection générale des matières premières et produits transformés, WTC 3

Boulevard S. Bolivar 30

B-1000 Bruxelles

Account number 679-2005985-25 (Banque de la Poste)

DENMARK

Ministry of Environment and Energy

Danish Environmental Protection Agency

Strandgade 29

DK-1401 Copenhagen K

GERMANY

Biologische Bundesanstalt für Land- und Forstwirtschaft

Abteilung für Pflanzenschutzmittel und Anwendungstechnik

Messeweg 11-12

D-38104 Braunschweig

GREECE

Hellenic Republic

Ministry of Agriculture

General Directorate of Plant Produce

Directorate of Plant Produce Protection

Department of Pesticides

3-4 Hippokratous Street

GR-10164 Athens

SPAIN

Ministerio de Agricultura, Pesca y Alimentación

Dirección General de Agricultura

Subdirección General de Medios de Producción Agrícolas

Ciudad de Barcelona, 118-120

E-28007 Madrid

FINLAND

Kasvintuotannon tarkastuskeskus

Torjunta-aineet

PL 42

FIN-00501 Helsinki

Bank and account:

LEONIA BANK PLC

PSP BFIHH

800015-18982

FRANCE

Ministère de l'agriculture et de la pêche

Bureau de la réglementation des produits antiparasitaires

251, rue de Vaugirard

F-75732 Paris Cedex 15

IRELAND

Pesticide Control Service

Department of Agriculture, Food and Rural Development

Abbotstown Laboratory Complex

Abbotstown, Castleknock

Dublin 15

Ireland

ITALY

Tesoreria provinciale dello Stato di Viterbo

Post current account number: 11281011

LUXEMBOURG

Administration des services techniques de l'agriculture

Boîte postale 1904

L-1019 Luxembourg

THE NETHERLANDS

College voor de Toelating van Bestrijdingsmiddelen

Postbus 217

6700 AE Wageningen

Nederland

PORTUGAL

Direcção-Geral de Protecção das Culturas

Quinta do Marquês

P-2780 Oeiras

Account number: 003505840003800793097

Bank: Caixa Geral de Depósitos

SWEDEN

Kemikalieinspektionen

Box 1384

S-17127 Solna

National Giro Account: 4465054-7

UNITED KINGDOM

Pesticides Safety Directorate

Department for Environment, Food and Rural Affairs

Mallard House

Kings Pool

3 Peasholme Green

York YO1 7PX

United Kingdom

ANNEX V

Criteria for clear indications of no harmful effects

An active substance shall be considered as fulfilling the requirement, as referred to in Article 11b, of there being clear indications that it may be expected that it does not have any harmful effects on human or animal health or on groundwater or any unacceptable influence on the environment if all the criteria set out in points 1 and 2 are met.

• 1. The active substance satisfies the following criteria:

• (a) it is not classified or proposed for classification as C (carcinogenic effects) M (mutagenic effects) R (toxic to reproduction) in categories 1, 2 or 3 in accordance with Directive 67/548/EEC;

• (b) either not requested or, if required, an ADI (Acceptable Daily Intake), AOEL (Acceptable Operator Exposure Level) and ARfD (Acute Reference Dose) can be established on the basis of the standard assessment factor of 100;

• (c) it is not considered to have the potential to meet the criteria of a persistent organic pollutant set out in Regulation (EC) No 850/2004 of the European Parliament and of the Council ([^E0010]);

• (d) it is not considered to have the potential to meet the criteria set out in Annex XIII to the Regulation (EC) No 1907/2006 of the European Parliament and of the Council ([^E0011]).

• 1. At least one supported representative use of the active substance satisfies all of the following criteria:

• (a) operator exposure is less than or equal to 75 % of the AOEL in modelled scenarios, considered relevant for the intended use and where the use of such modelling is appropriate to the supported use and at maximum using gloves as personal protective equipment (PPE);

• (b) bystander exposure and worker exposure is less than or equal to 75 % AOEL in modelled scenarios, considered relevant for the intended use and where the use of such modelling is appropriate to the supported use and without the use of PPE;

• (c) consumer exposure is less than or equal to 75 % of the ADI or ARfD (where such a value is necessarily established) in all available EU consumer diets on the basis of the MRLs (Maximum Residues Level) proposed for the active substance (without special refinements);

• (d) leaching to groundwater is below 0,1 μg/l in at least half of the scenarios considered relevant for the intended use, or in relevant lysimeter/field studies, for both the parent substance and relevant metabolites;

• (e) buffer zones for the protection of the environment do not exceed 30m without any further risk mitigation measures (e.g. drift reducing nozzles);

• (f) the risk to non-target organisms is acceptable based on standard refinements.

ANNEX VI

Criteria for clear indications of harmful effects

An active substance shall be considered as fulfilling the requirement, as referred to in Article 11f, of there being clear indications that on the basis on the available data, and which are evaluated in accordance with the provisions of Article 11d, it may be expected that it has harmful effects on human or animal health or on groundwater if either the criterion in point 1 or one of the criteria in point 2 is met.

• 1. As regards the active substance, the existing evidence is not sufficient to allow the establishment of an ADI, ARfD or an AOEL and such values are necessary to conduct a consumer and operator risk assessment.

• 1. As regards each supported representative use, at least one of the following criteria is met:

• (a) operator exposure is greater than 100 % AOEL in all modelled scenarios with the use of PPE/RPE (Personal Protective Equipment/Respiratory Protective Equipment), where the use of such modelling is appropriate to the supported use, and where actual exposure data, if available, also indicate that the AOEL will be exceeded under normal conditions of use;

• (b) bystander exposure and worker exposure is greater than 100 % AOEL in modelled scenarios, where the use of such modelling is appropriate to the supported use, and where actual exposure data, if available, indicate that the AOEL will be exceeded for these groups under normal conditions of use;

• (c) consumer exposure is greater than 100 % of the ADI or ARfD (where such a value is required) in at least one of the available EU consumer diets on the basis of the MRLs (Maximum Residues Level) proposed for the active substance;

• (d) leaching to groundwater is equal to or above 0,1 μg/l in all modelled scenarios either for the parent substance or for relevant metabolites.

OJ L 230, 9.8.1991, p. 1.

OJ L 148, 6.6.2002, p. 19.

OJ L 366, 15.12.1992, p. 10.

OJ L 259, 13.10.2000, p. 27.

OJ L 55, 29.2.2000, p. 25.

OJ L 31, 1.2.2002, p. 1.

OJ L 33, 8.2.1979, p. 36.

[^E0008]: (⁸) Opinion of the Scientific Steering Committee of 28 May 1999 on anti-microbial resistance.

[^E0009]: OJ L 15, 18.1.2008, p. 5.

[^E0010]: OJ L 158, 30.4.2004, p. 7; corrected by OJ L 229, 29.6.2004, p. 5.

[^E0011]: OJ L 396, 30.12.2006, p. 1; corrected by OJ L 136, 29.5.2007, p. 3.