2000R0451 — EN — 28.08.2002 — 001.001 — 1
This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents
►B COMMISSIONREGULATION(EC)No451/2000
of28February2000
layingdownthe detailed rules for theimplementation ofthe secondandthird stagesofthe work
programme referred toinArticle 8(2)ofCouncilDirective 91/414/EEC
(OJ L 55, 29.2.2000, p. 25)
Amended by:
Official Journal
No page date
►M1Commission Regulation (EC) No 1490/2002 of 14 August 2002 L 224 23 21.8.2002
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COMMISSIONREGULATION(EC)No451/2000
of28February2000
layingdownthedetailedrulesfortheimplementationofthesecond
andthirdstagesoftheworkprogrammereferredtoinArticle8(2)
ofCouncilDirective 91/414/EEC
THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Community,
Having regard to Council Directive 91/414/EEC of 15 July 1991
concerning the placing of plant protection products on the market(1),
as last amended by Commission Directive 1999/80/EC(2), and in parti-
cular Article 8(2), second subparagraph, thereof,
Whereas:
(1)The Commission is to undertake a work programme for the
gradual examination of active substances on the market twoyears after the date of notification of Directive 91/414/EECwithin a period of 12 years. The first stage of the programmewas laid down by Commission Regulation (EEC) No 3600/92
of 11 December 1992 laying down the detailed rules for the
implementation of the first stage of the work programmereferred to in Article 8(2) of Council Directive 91/414/EECconcerning the placing of plant protection products on themarket(
3), as last amended by Regulation (EC) No 1972/
1999(4). The first stage is ongoing. It is necessary to continue
and speed up the examination of the remaining active
substances, taking into account experience from the first stage.
(2)Given the very high number of existing active substances on themarket still to be evaluated, a programme in several phases mustbe established. Experience has shown that the evaluation and
decision-making on an active substance is a time-consuming
process. It is therefore not yet possible to provide for a detailedevaluation of all the existing active substances.
(3)Therefore the second stage will provide for the detailed evalua-tion of a number of active substances comparable to the number
covered in the first stage whilst the third stage will prepare for
the subsequent evaluation of active substances. For certain cate-gories of active substances further harmonisation is requiredconcerning the dossier to be provided and the evaluation to becarried out. Those categories should therefore not be included
in the current proposed work programme but should be covered
by further stages for their evaluation with a view to theirpossible inclusion in Annex I to Directive 91/414/EEC.
(4)For the second stage a selection should be made taking intoaccount, in a balanced manner, suchaspects as h ealthand/or
environmental concern, possibility of leaving residues in treated
products, importance of the preparations containing thesesubstances for agriculture, any manifest data gaps and any simi-larity of chemical or biological properties.
(5)The relationships between producers, Member States and the
Commission and the obligations on each of the parties for the
implementation of the programme should be laid down, takinginto account experience gained during the first stage of theprogramme. Close cooperation between all parties involved isnecessary to increase the efficiency of the programme.
(6)Technical or scientific information about an active substance, inparticular withregard to its potentially dangerous effects or itsresidues, submitted within the relevant time limits by any other2000R0451 — EN — 28.08.2002 — 001.001 — 2
(1) OJ L 230, 19.8.1991, p. 1.
(2) OJ L 210, 10.8.1999, p. 13.
(3) OJ L 366, 15.12.1992, p. 10.
(4) OJ L 244, 16.9.1999, p. 41.
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interested parties should also be taken into consideration in the
evaluations.
(7)A notification procedure should be provided by which interestedproducers have the right to inform the Commission of theirinterest in securing the inclusion of an active substance in AnnexI to Directive 91/414/EEC and of their undertaking to submit all
the required information for a proper evaluation of, and decision
on, that active substance in the light of the criteria for inclusionset out in Article 5 of Directive 91/414/EEC. Therefore theinformation submitted should include information on a limitedrange of representative uses for which the notifier must demon-strate, on the basis of the data submitted, that for one or more
preparations the requirements of Directive 91/414/EEC in rela-
tion to the criteria referred to in its Article 5 can be met.
(8)It is necessary to define the obligations of notifiers with regard
to the formats, periods and recipient authorities for the informa-
tion to be submitted.
(9)The task of evaluation should be distributed among the compe-tent authorities of the Member States. Therefore, for each active
substance a rapporteur Member State should be designated to
examine and evaluate the information submitted and to presentto the Commission the results of the evaluation and a recommen-dation for a decision to be taken withregard to th e activesubstance concerned.
(10)Rapporteur Member States should first examine dossiersreceived, assess the completeness check provided by the notifiersand report to the Commission. It should be established thatMember States should send draft reports of their evaluations to
the Commission generally within 12 months after the dossiers
submitted by notifiers have been considered complete.
(11)The draft reports prepared by the rapporteur Member Statesshould, where necessary, be the subject of preliminary examina-
tion by experts of other Member States within a programme
coordinated by the Commission before they are submitted tothe Standing Committee on Plant Health.
(12)In order to avoid duplication of work, and in particular experi-ments involving vertebrate animals, producers should beencouraged to submit collective dossiers.
(13)The notification and submission of a dossier should not be a
prerequisite for the possibility after inclusion of the active
substance in Annex I to Directive 91/414/EEC to place plantprotection products on the market subject to the provisions ofArticle 13 of Directive 91/414/EEC. Therefore, it should bepossible for operators which have not presented notifications to
be informed at all stages of the possible further requirements
for continued marketing of plant protection products containingan active substance under evaluation.
(14)The procedures provided for in this Regulation should not preju-
dice procedures and actions to be undertaken in the framework
of other Community legislation, in particular, under CouncilDirective 79/117/EEC of 21 December 1978 prohibiting theplacing on the market and use of plant protection productscontaining certain active substances(
1), as last amended by
Commission Directive 91/188/EEC(2), where information
becomes available to the Commission showing that its require-ments may be satisfied.
(15)Directive 91/414/EEC provides in Article 8(2), second subpara-
graph, a 12-year period for the work programme concerning the
evaluation of existing active substances. The 12-year period maybe extended by the Commission subject to the conclusions of a2000R0451 — EN — 28.08.2002 — 001.001 — 3
(1) OJ L 33, 8.2.1979, p. 36.
(2) OJ L 92, 13.4.1991, p. 42.
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progress report, referred to in Article 8(2), third subparagraph,
on the programme to the European Parliament and the Council.On the expiry of the time limit, whether or not it was extended,
Member States will have to withdraw authorisations of plant
protection products containing the active substances which werenot included in Annex I to Directive 91/414/EEC.
The Commission, subject to the conclusions of that report, will
adopt further detailed regulatory provisions serving to finaliseas soon as possible the evaluation and decision making of active
substances for which the provisions of the present Regulation
concerning notification and submission of complete dossiers axesatisfied.
Article 8(2), fourthsubparagraph , of Directive 91/414/EEC
provides for a Commission Decision not to include in Annex Iactive substances in cases where the requirements of Article 5of Directive 91/414/EEC are not satisfied or the requisite infor-
mation and data have not been submitted within the prescribed
time period and for the withdrawal by Member States of author-isations of plant protection products containing suchactivesubstances. However, subject to the conclusions of the saidreport and if necessary, it may be appropriate to re-examine
these provisions for certain uses which are essential and for
which there is no alternative to protect efficiently plants or plantproducts suchas to allow th e development of alternatives repla-cing the use of withdrawn products. The necessity of re-examining those provisions will have to be demonstrated on acase-by-case basis.
(16)If, for a particular active substance, the requirements of thepresent Regulation concerning notification and submission ofcomplete dossiers are not satisfied, interested parties are not
prevented from seeking inclusion of suchactive substances in
Annex I to Directive 91/414/EEC, in accordance withth e proce-dures under Article 6(2) of Directive 91/414/EEC, at a later date.
(17)A third stage of work is envisaged for all the active substances
not covered by the first and second stage of the programme.
Producers wishing to secure the inclusion of such activesubstances in Annex I to Directive 91/414/EEC should providedetailed information relating to the current stage of completenessof their dossiers and on the endpoints, which would be useful forfurther prioritisation of the work programme, and undertake to
provide a full data package. It is also appropriate to indicate
now the time limit for submission of the full data package.
(18)It is necessary to inform the producers as early as possible aboutfuture stages of the re-evaluation programme by publishing the
active substances which will be included in the third stage of
the programme in order to facilitate the submission of collectivedossiers and the preparation of the necessary studies and data.
(19)In order to ensure the proper implementation of this workprogramme, a fee should be paid to the rapporteur MemberStates for the detailed evaluation of notifications and dossiers.The cost structure in the Member States is not the same. It istherefore not possible to harmonise completely the amount ofsuch fees. A fee should also be paid to the authority designated
by the Commission to examine the notifications for the active
substances covered by the third stage.
(20)The measures provided for in this Regulation are in accordancewith the opinion of the Standing Committee on Plant Health,2000R0451 — EN — 28.08.2002 — 001.001 — 4
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HAS ADOPTED THIS REGULATION:
CHAPTER 1
GENERALPROVISIONSANDDEFINITIONS
Article 1
Scope
1. This Regulation lays down detailed rules for the implementation
of the second and third stages of the work programme referred to inArticle 8(2) of Directive 91/414/EEC, hereinafter referred to as ‘theDirective’.
2. The second stage concerns the evaluation of the active substances
listed in Annex I to this Regulation with a view to their possible inclu-sion in Annex I to the Directive.
3. The third stage concerns the reporting of the active substances
referred to in Annex II to this Regulation with a view to their possible
inclusion at a later stage in a subsequent priority list of active
substances with a view to their possible inclusion in Annex I to theDirective.
4. Article 6(2), Article 6(3) and the second subparagraph of Article
6(4) of the Directive shall not apply to a substance listed in Annexes Iand II to this Regulation as long as the procedures provided for in thisRegulation with regard to that substance have not been finalised.
5. This Regulation shall apply without prejudice to:
(a) reviews by Member States in particular pursuant to renewals of
authorisations in accordance with Article 4(4) of the Directive;
(b) reviews by the Commission pursuant to Article 5(5) of the Direc-
tive;
(c) assessments carried out under Directive 79/117/EEC.
Article 2
Definitions
1. For the purpose of this Regulation, plant protection products,
substances, active substances, preparations and authorisations of plant
protection products shall have the meanings defined in Article 2 ofthe Directive.
2. For the purpose of this Regulation, the following definitions shall
also apply:
(a) ‘producer’ means:
— for active substances produced within the Community, the
manufacturer or a person established within the Community
designated by the manufacturer as his sole representative for
the purpose of compliance with this Regulation,
— for active substances produced outside the Community, the
person established within the Community and designated by
the manufacturer as his sole representative within the Commu-nity for the purpose of compliance with this Regulation,
— for active substances for which a joint notification or joint
dossier is submitted, the association of producers establishedwithin the Community and designated by the producers referredto in the first or second indent for the purpose of compliancewithth is Regulation;
(b) ‘manufacturer’ means the person who manufactures the active
substance on his own or who contracts out to another party themanufacturing of the active substance on his behalf;
(c) ‘committee’ means the Standing Committee on Plant Health,
referred to in Article 19 of the Directive.2000R0451 — EN — 28.08.2002 — 001.001 — 5
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Article 3
Member Stateauthority
1. Member States shall allocate responsibility for the implementa-
tion of their obligations under the work programme referred to inArticle 8(2) of the Directive to an authority or authorities.
2. In each Member State one authority, which is referred to in
Annex III, shall coordinate and ensure all necessary contacts withproducers, other Member States and the Commission pursuant to thisRegulation. Each Member State shall inform the Commission and the
designated coordinating authority of each other Member State of any
modifications to the communicated details concerning the designatedcoordinating authority.
CHAPTER 2
SECONDSTAGEOFTHEWORKPROGRAMME
Article 4
Notification
1. Any producer wishing to secure the inclusion of an active
substance referred to in Annex I to this Regulation, or any variantsthereof such as salts, esters or amines, in Annex I to the Directive shall
so notify, for eachactive substance separately, th e rapporteur Member
State designated in Annex I to this Regulation within six months afterthe date of entry into force of this Regulation.
2. Notification must be made on paper and sent by registered mail to
the coordinating authority in the rapporteur Member State, referred toin Annex III to this Regulation, in accordance with the model notifica-tion as shown in Part 1 of Annex IV to this Regulation. A copy of the
notification shall be sent to the European Commission, Health and
Consumer Protection DG, Rue de la Loi/Wetstraat 200, B-1049 Brus-sels.
3. Any producer who has not notified any given active substance
referred to in paragraph 1 within the time limit referred to in that para-graph or whose notification was rejected in accordance with theprovisions of Article 5(2) shall be permitted to participate in thisprogramme only collectively withone or more notifiers of th e active
substance, whose notification was accepted in accordance with Article
5(2), in submitting a joint dossier.
Article 5
Examinationofnotificationsandrequestforsubmissionofdossiers
todesignatedrapporteurMember States
1. For each active substance for which a Member State has been
designated rapporteur, it shall examine the notifications referred to in
Article 4(2) and, at the latest three months after the time limit referred
to in Article 4(1), report to the Commission on the admissibility of thenotifications received taking into account the criteria as referred to inAnnex V, Part 1.
2. The Commission shall refer the reports referred to in paragraph 1
within three months from the receipt thereof to the committee forfurther examination concerning their admissibility, taking into account
the criteria as referred to in Annex V, Part 1.
Following that examination, a regulation shall be adopted in accor-
dance with the procedure laid down in Article 19 of the Directive
establishing the list of active substances, adopted for evaluation with aview to their possible inclusion in Annex I to the Directive. Only activesubstances for which at least one notification was considered admis-sible in accordance with the provisions of the first subparagraph shallbe included in that Regulation.
3. In the list referred to in paragraph 2, certain active substances
with similar structures or chemical properties may be grouped together;2000R0451 — EN — 28.08.2002 — 001.001 — 6
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if an active substance has been notified with different compositions
which may lead to different toxicological properties or have differentenvironmental effects, those compositions may be listed separately.
4. For eachactive substance adopted for assessment, th e Regulation
referred to in paragraph2 sh all specify:
(a) the names and addresses of all notifiers who have made notifica-
tions in accordance with Article 4(1) and (2) and which have beenconsidered to be admissible following their examination in accor-dance withth e first subparagraphof paragraph2;
(b) the name of the Member State designated as rapporteur; this will be
the same Member State as the one designated in Annex I unless an
imbalance has become apparent in the number of active substancesattributed to the different Member States;
(c) the time limit for the submission to the rapporteur Member State of
the dossiers referred to in Article 6, which shall be a period of 12months;
(d) the same time limit for the submission to the rapporteur Member
States by any interested parties of relevant information which may
contribute to the evaluation, in particular with regard to the poten-
tially dangerous effects of the active substance or its residues onhuman and animal health and on the environment.
5. From the time of the adoption of the Regulation referred to in
paragraph2, if a Member State envisages taking action to with drawfrom the market or to restrict severely the use of a plant protectionproduct containing an active substance listed in that Regulation, wherethat action is based on information contained in the dossiers referred toin Article 6 or the report referred to in Article 8, the Member State
shall inform the Commission and the other Members States as soon as
possible, citing the reasons for its intended action.
6. When, during the assessment and evaluation referred to in Arti-
cles 6 and 7, an imbalance becomes apparent in the responsibilities
borne by the Member States as rapporteurs, it may be decided, inaccordance with the procedure laid down in Article 19 of the Directive,to replace a Member State originally designated as rapporteur for aparticular 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 rappor-teur Member State all correspondence and information which it hasreceived as rapporteur Member State for the active substance
concerned. The original Member State shall return the fee referred to
in Article 12, except the part referred to in Article 12(2)(d) to the noti-fiers concerned. The newly designated rapporteur Member State shallthen require the notifiers to pay the fee referred to in Article 12, exceptthe part referred to in Article 12(2)(d).
7. When a notifier decides to end its participation in the work
programme for an active substance, he shall inform at the same timethe rapporteur Member State, the Commission and the other notifiers
for the substance concerned, mentioning the reasons. Where a notifier
ends his participation or fails to fulfil his obligations provided for inthis Regulation, the procedures provided for in Article 7 or Article 8shall not be continued for his dossier.
When a notifier agrees with another producer that the notifier shall be
replaced for the purposes of further participation in the workprogrammes under this Regulation, the notifier and the other producershall inform the rapporteur Member State and the Commission by acommon declaration, agreeing that the other producer shall replace the
original notifier in carrying out the notifier's duties as set out in Arti-
cles 6, 7 and 8; they shall ensure that the other notifiers for thesubstance concerned are informed at the same time. In such a case,the other producer may be liable for any fees remaining payable underthe regime established by the rapporteur Member State pursuant toArticle 12.2000R0451 — EN — 28.08.2002 — 001.001 — 7
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Article 6
Submissionofdossiersbynotifiers
1. Within the time limit referred to in Article 5(4)(c), for each active
substance the notifiers specified in the Regulation referred to in thatArticle shall, individually or collectively, submit to the designatedauthority of the rapporteur Member State for any given active
substance the complete dossier referred to in paragraph 3, including
the summary dossier referred to in paragraph 2.
Where for any substance the Regulation referred to in Article 5 indi-
cates several notifications, the notifiers concerned shall take allreasonable sttif to present collectively the dossiers as referred to in thefirst subparagraph.
Where a dossier was not presented by all notifiers concerned, it shall
mention the efforts made and the reasons why certain producers have
not participated.
2. The summary dossier shall include the following:
(a) a copy of the notification; in the case of a joint application made
by several producers, a copy of the notifications made in accor-
dance with Article 4 and the name of the person designated bythe producers concerned as being responsible for the joint dossierand the processing of the dossier in accordance with this Regula-tion;
(b) a limited range of representative uses of the active substance for
which it has to be demonstrated by the notifier, on the basis ofthe data submitted, that for one or more preparations the require-ments of the Directive in relation to the criteria referred to inArticle 5 thereof can be met;
(c) — for each point of Annex II to the Directive, the summaries and
results of studies and trials, and the name of the person or insti-tute that has carried out the trials,
— the same information for each point of Annex III to the Direc-
tive relevant to the assessment of the criteria referred to inArticle 5 of the Directive for one or more preparations whichare representative for the uses referred to in subparagraph (b)taking into account the fact that data gaps in the informationof the Annex II dossier resulting from the proposed limited
range of representative uses of the active substance may lead
to restrictions in the inclusion in Annex I to the Directive,
— for studies not yet fully completed, the evidence that these
studies have been commissioned at the latest three months afterthe entry into force of this Regulation with an undertaking thatthey will be submitted at the latest within 12 months after thetime limit referred to in Article 5(4)(c);
(d) a check by the notifier of the completeness of the dossier.
3. The complete dossier shall contain physically the individual test
and study reports concerning all the information referred to in para-
graph 2(c), or the protocols and the undertakings referred to inparagraph2(c) wh ere work is in progress.
4. Member States shall determine the number of copies and the
format of the dossiers referred to to in paragraphs 2 and 3 to besubmitted by the notifiers. In determining the format of the dossier,Member States shall take the utmost account of the recommendations
made by the Commission in the framework of the Standing Committee
on Plant Health.
5. Where, for any given active substance, the dossiers referred to in
paragraph 1 are not sent within the time limit referred to in Article 5(4)(c), the rapporteur Member State shall inform the Commission at thelatest within three months, giving the reasons pleaded by the notifiers.
6. On the basis of the report of the rapporteur Member State referred
to in paragraph 5, a new time limit shall only be established in accor-dance with the procedure laid down in Article 19 of the Directive in2000R0451 — EN — 28.08.2002 — 001.001 — 8
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the Regulation referred to in Article 5 for the submission of a dossier
fulfilling the requirements of paragraphs 2 and 3 where the delay isdemonstrated to have been caused by force majeure .
7. After that examination, the Commission shall decide, as provided
for in Article 8(2), fourth subparagraph, of the Directive, not to includein Annex I to the Directive an active substance for which no notifica-tion or no dossier has been submitted within the prescribed time limit
mentioning the reasons for the non-inclusion. Member States shall
withdraw by 25 July 2003 authorisations of plant protection productscontaining those active substances.
Article 7
Completenesscheckofdossiers
1. For each active substance for which it has been designated
rapporteur, the Member State shall:
(a) examine the dossiers referred to in Article 6(2) and (3) and assess
the completeness check(s) provided by the notifiers;
(b) at the latest six months after the receipt of all dossiers for an active
substance, report to the Commission on the completeness of the
dossiers; for those active substances for which one or more dossiersare considered to be complete within the meaning of Article 6(2)and (3), the rapporteur Member State shall perform the evaluationas referred to in Article 8, unless the Commission informs therapporteur Member State within two months that the dossier is not
to be considered complete. For those active substances for which
the dossier is to be completed, as provided for under Article6(2)(c), third indent, the report must confirm the date by whichthe dossier is to be completed and from which the evaluation asreferred to in Article 8 will begin.
2. For those active substances for which a rapporteur Member State
or the Commission consider that no dossier is complete within themeaning of Article 6(2) and (3), the Commission shall, within threemonths after the receipt of the report of the rapporteur Member Statereferred to in paragraph (1)(b), refer that report to the committee. In
accordance with the procedure laid down in Article 19 of the Directive
it shall be decided whether a dossier is considered complete within themeaning of Article 6(2) and (3). Where the dossier is consideredcomplete, the rapporteur Member State shall perform the evaluationreferred to in Article 8.
3. After that examination, the Commission shall decide, as provided
for in Article 8(2), fourth subparagraph, of the Directive, not to includein Annex I to the Directive active substances for which no completedossier has been submitted within the prescribed time limit mentioningthe reasons for the non-inclusion. Member States shall withdraw by 25
July 2003 authorisations of plant protection products containing those
active substances.
Article 8
EvaluationofdossiersbyrapporteurMemberStatesandtheEFSA1. The rapporteur Member State shall evaluate and report only on
those active substances for which at least one dossier has been deter-
mined to be complete in accordance withArticle 6(2) and (3). For
such active substances it shall evaluate and report only on the completedossiers and for the other dossiers it shall check the identity and impu-rities of the active substance. The rapporteur Member State shall takeinto consideration the information available on potentially dangerous
effects in the other dossiers submitted by any notifier or by any third
party in accordance with the provisions of Article 5(4)(d). It shallsend a draft report of its assessment of the dossier to the EuropeanFood Safety Authority (EFSA) as quickly as possible, and at the latest12 months after the dossier was determined to be complete. The draftassessment report shall be submitted in the format recommended in2000R0451 — EN — 28.08.2002 — 001.001 — 9
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accordance with the procedure provided for in Article 19 of the Direc-
tive.
At the same time, the rapporteur Member State shall make a recom-
mendation 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 eachtest and study report, for each
point of Annex II and Annex III to the Directive, relied on for theassessment. This reference shall be made in the form of a list of testand study reports including the title, the author(s), the date of the studyor 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 forthe other notified sources of the active substances for which the dossierwas considered not to be complete whether it can be concluded thatsuch active substances are comparable within the meaning of Article13(5) of the Directive.
2. Without prejudice to Article 7 of the Directive, submission of
new studies shall not be accepted, except for the studies as referred to
in Article 6(2)(c), third indent. The rapporteur Member State may
request the notifiers to submit further data which are necessary toclarify the dossier. When doing so the rapporteur Member State shallset a time limit within which the information should be provided; thistime limit shall not affect the time limit for the submission of the
report referred to in paragraph1.
The rapporteur Member State may, from the start of this examination,
consult with experts from the EFSA and may request additional tech-
nical or scientific information from other Member States to assist theevaluation. The rapporteur Member State may perform the evaluationtogether 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 andon request to the Commission at the same time as the rapporteur's draftassessment 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.
3. As soon as it becomes evident to a rapporteur Member State that
it will be unable to comply withth e time limit specified in paragraph1for the submission of the draft assessment report to the EFSA, it shallinform the Commission and the EFSA and give the reasons for thedelay. All Member States shall provide to the Commission and theEFSA a report of their progress on the evaluation of the active
substances for which they are rapporteur. Such report has to be made
by 30 April 2003.
4. After receiving the updated summary dossier and the draft assess-
ment report referred to in paragraph 1, the EFSA shall, within 30 days,acknowledge receipt of the report to the rapporteur Member State. Inexceptional cases where the draft assessment report clearly does notfulfil 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 amendedreport. This period shall not exceed four months.
5. The EFSA shall circulate the rapporteur's draft assessment report
to the Member States and may organise a consultation of expertsincluding the rapporteur Member State. The EFSA may consult someor all of the notifiers of active substances specified in Annex I on thereport or parts of the report on the relevant active substance.2000R0451 — EN — 28.08.2002 — 001.001 — 10
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Without prejudice to Article 7 of the Directive, submission of new
studies shall not be accepted. The rapporteur Member State, with theagreement 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.
6. The EFSA shall make available at specific request or keep avail-
able for consultation by any person the following:
(a) the information referred to in the last subparagraph of paragraph 1,
except the elements thereof which have been accepted as confiden-tial in accordance withArticle 14 of th e Directive;
(b) the name of the active substance;
(c) the content of the pure active substance in the manufactured mate-
rial;
(d) the list of any data required for consideration of the possible inclu-
sion of the active substance into Annex I to the Directive, first ascontained in the rapporteur's report and secondly as finalised by theEFSA;
(e) the draft assessment report, except the elements thereof which have
been accepted as confidential in accordance withArticle 14 of th eDirective.
7. The EFSA shall evaluate the rapporteur's draft assessment report
and deliver its opinion on whether the active substance can be expectedto meet the safety requirements of the Directive to the Commission at
the latest one year after receipt of the rapporteur Member State draft
assessment report. Where appropriate, the EFSA shall give its opinionon the available options claimed to meet the safety requirements. TheCommission and the EFSA shall agree on a schedule for the delivery ofthe opinions in order to facilitate the planning of the work. TheCommission and the EFSA shall agree on the format in which the
opinion of the EFSA is submitted.
8. At the latest six months after receipt of the EFSA opinion
referred to in paragraph 7, the Commission shall submit the draftreview report. Without prejudice to any proposal it may submit with aview to amending the Annex to Directive 79/117/EEC, and on the basisof the finalised review report it shall submit to the Committee:
(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 activesubstance, 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-inclu-sion.
The directive or decision shall be adopted in accordance with the
procedure provided for in Article 19 of the Directive.
9. Where the Commission submits a draft directive or a draft deci-
sion in accordance with paragraph 8, it shall at the same time submitthe conclusions of the Committee's examination in the format of a fina-
lised review report to be noted in the summary record of the meeting.
The finalised review report, excluding any parts which refer to confi-
dential information contained in the dossiers and determined as suchin accordance with Article 14 of the Directive, shall be made availablefor public consultation.
Article 9
Suspensionofevaluation
Where, in respect of a substance mentioned in Annex I to this Regula-
tion, the Commission presents a proposal for a total prohibition underDirective 79/117/EEC, the time limits provided for in this Regulation2000R0451 — EN — 28.08.2002 — 001.001 — 11
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shall be suspended until a decision on that proposal has been taken.
Where the Council decides on the total prohibition of the substanceunder Directive 79/117/EEC, the procedure under this Regulation shall
be terminated.
CHAPTER 3
THIRDSTAGEOFTHEWORKPROGRAMME
Article 10
Notification
1. Any producer wishing to secure the inclusion of an active
substance referred to in Annex II to this Regulation, in Annex I to theDirective shall so notify the body referred to in Annex VII to thisRegulation. The Commission shall give regular follow-up of the tasksmentioned in Annex VII to this Regulation entrusted to the body
referred to in that Annex. In accordance with the procedure laid down
in Article 19 of the Directive it may be decided to designate anotherbody if it appears that the tasks are not adequately performed.
2. Notifications shall be submitted for each active substance sepa-
rately, as follows:
(a) within three months of the date of entry into force of this Regula-
tion, a first notification in accordance withSection 1 of th e modelnotification as shown in Annex IV, Part 2 hereto;
and
(b) within nine months of the date of entry into force of this Regula-
tion, a second notification in accordance withSections 1 and 2 ofthe model notification as shown in Annex IV, Part 2 hereto,including a written commitment to present a complete dossier.
3. Detailed provisions concerning the submission of such dossiers,
the time limit(s) for their submission and the fee regime for the activesubstances concerned shall be established by the Commission in a
Regulation to be adopted in accordance withArticle 8(2), second
subparagraph, of the Directive.
4.►
M1The time limit for the submission of a list of available
studies shall be 23 May 2003. A full data package shall be availableon 23 May 2003 at the latest. ◄The full data package shall contain
physically the individual test and study reports concerning all the infor-mation referred to in Article 6(2)(c), first and second indents.Nevertheless, in the Regulation referred to in paragraph 3, a later time
limit may be established in exceptional cases for the results of long-
term studies, not expected to be fully completed by that date, providedthat the data package contains:
— evidence that such studies have been commissioned at the latest
within 12 months of the date of the entry into force of this Regula-
tion,
— a due scientific justification,
— the protocol and a progress report of the study.
5. Any producer who has not notified any given active substance
referred to in paragraph 1 within the time limits referred to in para-graph2 or wh ose notification was rejected in accordance withArticle11 will be permitted to participate in the review programme onlycollectively with one or more notifiers of the active substance, whosenotification was considered admissible in accordance withArticle 11,
in submitting a joint dossier.
Article 11
Examinationofnotifications
1. The Commission shall, within three months after the time limit
referred to in Article 10(2)(b), inform the committee of the notifica-tions received in time. At the latest eight months after the receipt ofthe notifications, the commission will report to the Committee for2000R0451 — EN — 28.08.2002 — 001.001 — 12
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further examination on the admissibility of the notifications received
taking into account the criteria as referred to in Annex V, Part 2.
2. The Commission shall decide, as provided for in Article 8(2),
fourth subparagraph of the Directive, not to include in Annex I to theDirective active substances referred to in Annex II to this Regulation
for which no admissible notification or no full data package has been
submitted within the prescribed time limit mentioning the reasons forthe non-inclusion. ►
M1Member States shall withdraw by 25 July
2003 authorisations of plant-protection products containing activesubstances 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 deadlinereferred to in the Decision on the non-inclusion of the active substanceconcerned. ◄
CHAPTER 4
FEES
Article 12
Feesforthesecondprioritylist
1. Member States shall establish a regime obliging the notifiers to
pay a fee for the administrative treatment and the evaluation of notifi-cations as well as the dossiers related thereto, which have beensubmitted to them in accordance with Article 4 or Article 6 in eachcase where the Member State has been designated as the rapporteur
Member State.
2. For this purpose, the Member States shall:
(a) require the payment of a fee for each notification, whether intro-
duced by one notifier or collectively by several interestednotifiers, as well as for eachsubmission of a dossier related
thereto;
(b) ensure that the amount of the fee is established in a transparent
manner with a view to corresponding to the real cost of the exam-ination and administrative treatment of a notification and a dossier;however, Member States may provide for a scale of fixed chargesbased on average costs for the calculation of the total fee;
(c) ensure that the fee is received in accordance with the instructions
given by the organisation in each Member State listed in AnnexVI and that the income from the fee is used to finance exclusivelythe costs actually incurred by the rapporteur Member State for theevaluation and administrative treatment of the notifications and thedossiers for which that Member State is rapporteur or to finance
general actions for the implementation of its obligations as rappor-
teur Member State resulting from Article 7 or Article 8;
(d) require that a first part of the fee, covering the costs of the rappor-
teur Member State's obligations resulting from Article 5(1) andArticle 7, is paid at the time of the submission of the notificationreferred to in Article 4; this part shall not be refundable under any
circumstances.
Article 13
FeesforthenotificationforthethirdstageoftheworkprogrammeAny producers submitting a notification in accordance withArticle 10
shall at the time of the submission of their first notification, as referredto in Article 10(2)(a), pay a fee of EUR 5 000 for eachactive substanceto the body referred to in Annex VII. The fee shall be used to financeexclusively the costs actually incurred for the tasks referred to inAnnex VII.2000R0451 — EN — 28.08.2002 — 001.001 — 13
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Article 14
Othercharges,levies orfees
Articles 12 and 13 are without prejudice to Member States' rights to
maintain or introduce, in accordance with the Treaty, charges, levies
or fees with regard to the authorisation, placing on the market, use
and control of active substances and plant protection products otherthan the fee provided for in Articles 12 and 13.
CHAPTER 5
FINALPROVISIONS
Article 15
Temporarymeasures
The Commission shall report to the committee on the conclusions of its
progress report, referred to in Article 8(2), third subparagraph, of theDirective.
If necessary and on a case-by-case basis, the Commission may take
appropriate temporary measures as provided for by Article 8(2), third
subparagraph, of the Directive for uses for which additional technicalevidence has been provided demonstrating the essential need for furtheruse of the active substance and that there is no efficient alternative.
Article 16
Entryintoforce
This Regulation shall enter into force on 1 March 2000.
This Regulation shall be binding in its entirety and directly applicable
in all Member States.2000R0451 — EN — 28.08.2002 — 001.001 — 14
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ANNEX I
List of active substances to be covered by the second stage of the work
programmeprovidedforinArticle8(2)oftheDirectivewiththedesignated
rapporteurMemberState
Name
PART A: ANTICHOLINESTERASE ACTIVE SUBSTANCES
Organophosphates Rapporteur Member State
Azamethiphos United Kingdom
Ampropylfos Sweden
Bromophos Austria
Bromophos-ethyl Austria
Cadusafos Greece
Carbophenothion Luxembourg
Chlorfenvinphos Italy
Tetrachlorvinphos Italy
Chlormephos Spain
Chlorthiophos Spain
Demeton-S-methyl France
Demeton-S-methyl-sulphone France
Oxydemeton-methyl France
Dialifos France
Diazinon Portugal
Dichlofenthion The NetherlandsDichlorvos Italy
Dicrotophos Italy
Monocrotophos Italy
Dimefox Germany
Dimethoate United Kingdom
Omethoate United Kingdom
Formothion United Kingdom
Dioxathion France
Disulfoton Greece
Ditalimfos Austria
Ethephon The Netherlands
Ethion France
Ethoate-methyl Italy
Ethoprophos United Kingdom
Etrimfos United Kingdom
Fenamiphos The Netherlands
Fenitrothion Denmark
Fonofos Ireland
Isazofos France
Isoxathion Spain
Heptenophos AustriaIdofenphos France
Isofenphos Austria
Malathion Finland
Mecarbam Spain2000R0451 — EN — 28.08.2002 — 001.001 — 15
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Organophosphates Rapporteur Member State
Mephosfolan Ireland
Methidathion Portugal
Mevinphos Sweden
Naled France
Phorate United Kingdom
Phosalone Austria
Phosmet Spain
Phosphamidon Germany
Phoxim Belgium
Pirimiphos-ethyl United Kingdom
Pirimiphos-methyl United Kingdom
Profenofos Germany
Propetamphos Luxembourg
Prothiofos Spain
Prothoate Greece
Pyraclofos Spain
Pyridaphenthion Italy
Quinalphos FranceSulprofos Spain
Sulfotep Finland
Temephos Ireland
Terbufos Austria
Thiometon The Netherlands
Thionazin Italy
Tolclofos-methyl ►
M1Sweden◄
Triazophos Greece
Trichlorfon Portugal
Trichloronat Finland
Vamidothion Portugal
Carbamates Rapporteur Member State
Bendiocarb United KingdomBenfuracarb Belgium
Carbofuran Belgium
Carbosulfan Belgium
Furathiocarb Belgium
Butocarboxim Germany
Butoxycarboxim Germany
Carbaryl Spain
Dioxacarb Denmark
Ethiofencarb Germany
Formetanate Italy
Methiocarb GermanyMethomyl United Kingdom
Thiodicarb United Kingdom
Oxamyl Ireland
Pirimicarb Portugal2000R0451 — EN — 28.08.2002 — 001.001 — 16
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Carbamates Rapporteur Member State
Promecarb Portugal
Propamocarb Sweden
Prothiocarb Sweden
Propoxur Belgium
Thiofanox France
Triazamate United Kingdom
PART B
1,3-dichloropropene Spain
1,3-dichloropropene (cis) SpainCaptan Italy
Folpet Italy
Clodinafop The Netherlands
Clopyralid Finland
Cyanazine Sweden
Cyprodinil France
Dichlorprop Denmark
Dichlorprop-P Denmark
Dimethenamid Germany
Dimethomorph Germany
Diuron Denmark
Fipronil France
Fosetyl France
Glufosinate Sweden
Haloxyfop Denmark
Haloxyfop-R Denmark
Metconazole Belgium
Methoxychlor Italy
Metolachlor BelgiumMetribuzin Germany
Prometryn Greece
Pyrimethanil Portugal
Rimsulfuron Germany
Terbutryne Germany
Tolylfluanid Finland
Tribenuron Sweden
Triclopyr Ireland
Trifluralin Greece
Trinexapac The Netherlands
Triticonazole Austria
PART C
Barban Belgium
Bromocyclen Denmark
Bronopol Germany
Chloral-semi-acetal Germany2000R0451 — EN — 28.08.2002 — 001.001 — 17
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Chloral-bis-acylal Germany
Chlorfenprop Greece
Chlorobenzilate Spain
Chloroxuron Spain
P-chloronitrobenzene Spain
DADZ(Zinc-diethyldithiocarbamate) France
Di-allate France
Difenoxuron Ireland
(2-dithiocyanomethylthio)ben-
zothiazolItaly
Fluorodifen Italy
Furfural Luxembourg
Isocarbamide The Netherlands
Naphthylacetic acid hydrazide Austria
Noruron Portugal
Pentachlorophenol Finland
4-t-pentylphenol SwedenPropazine United Kingdom
Sodium diacetoneketogulonate United Kingdom
Sodium dimethyldithiocarbamate United Kingdom
2,4,5-T France2000R0451 — EN — 28.08.2002 — 001.001 — 18
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ANNEX II
Active substances covered by the third stage of the work programme
providedforinArticle 8(2)oftheDirective
All active substances (including any variants thereof such as salts, esters or
amines) that were on the market before 25 July 1993 with the exception of the
following active substances:
1. the active substances listed in the Annex to Regulation (EEC) No 3600/92;
2. the active substances listed in Annex I to this Regulation;3. active substances which are micro-organisms including viruses;4. active substances of which the use is authorised in human foodstuffs or
animal feeding stuffs in accordance withEU legislation;
5. active substances which are plant extracts;
6. active substances which are animal products or derived thereof by simple
processing;
7. active substances which are or will be exclusively used as attractants or
repellants (including pheromones). Active substances which are or will be
exclusively used in traps and/or dispenses, in conformity withCouncil
Regulation (EEC) No 2092/91(
1) concerning organic farming;
8. active substances which are or will be exclusively used as rodenticides;9. active substances which are or will exclusively be used on stored plants or
plant products;
10. the following commodity substances:
aluminium sulphate
calcium chlorideCO
2
EDTA and salts thereofethanolgrease (bands, fruit trees)
fatty alcohols
iron sulphatelime phosphatelime sulphur
nitrogen
paraffin oilpetroleum oils
potassium permanganate
propionic acidresins and polymerssodium chloride
sodium hydroxide
sulphur and sulphur dioxidesulphuric acidwaxes.2000R0451 — EN — 28.08.2002 — 001.001 — 19
(1) OJ L 36, 10.2.1998, p. 16.
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ANNEX III
CoordinatingauthorityintheMemberStates
AUSTRIA
Bundesamt und Forschungszentrum für Landwirtschaft
Spargelfeldstraße 191A-1226 Wien
BELGIUM
Ministère des classes moyennes et de l'agriculture,
Service ‘Qualité des matières premières et analyses’WTC 3, 8
eétage
Boulevard Simon Bolivar 30B-1000 Bruxelles
Ministerie van Middenstand en Landbouw
Dienst Kwaliteit van de grondstoffen en analysesWTC 3, 8
everdieping
Simon Bolivarlaan 30B-1000 Brussel
DENMARK
Ministry of Environment and Energy
DanishEnvironmental Protection AgencyPesticide DivisionStrandgade 29DK-1401 Copenhagen K
GERMANY
Biologische Bundesanstalt für Land- und Forstwirtschaft (BBA)
Abteilung für Pflanzenschutzmittel und Anwendungstechnik (AP)Messeweg 11-12D-38104 Braunschweig
GREECE
Hellenic Republic
Ministry of AgricultureGeneral Directorate of Plant ProduceDirectorate of Plant Produce ProtectionDepartment of Pesticides3-4 Hippokratous StreetGR-10164 Athens
SPAIN
Ministerio de Agricultura, Pesca y Alimentación
Dirección General de AgriculturaSubdirección General de Medios de Producción Agrícolasc/Ciudad de Barcelona, 118-120
E-28007 Madrid
FINLAND
Plant Production Inspection Centre
Pesticide DivisionP.O. BOX 42
FIN-00501 Helsinki
FRANCE
Ministère de l'agriculture
Service de la protection des végétaux251, rue de Vaugirard
F-75732 Paris Cedex 152000R0451 — EN — 28.08.2002 — 001.001 — 20
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IRELAND
Pesticide Control Service
Department of Agriculture, Food and Rural Development
Abbotstown Laboratory Complex
Abbotstown, Castleknock
Dublin 15
Ireland
ITALY
Ministero della Sanità
Dipartimento degli Alimenti, Nutrizione e Sanità Pubblica Veterinaria
Ufficio XIV
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-2780-155 Oeiras
SWEDEN
Kemikalieinspektionen
Box 1384
S-171 27 Solna
UNITED KINGDOM
Pesticides Safety Directorate
Ministry of Agriculture, Fisheries and Food
Mallard House
Kings Pool
3 Peasholme Green,
York YO1 7PX
United Kingdom2000R0451 — EN — 28.08.2002 — 001.001 — 21
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ANNEX IV
PART1
Notificationofanactive substanceaccordingtoArticle4
2000R0451 — EN — 28.08.2002 — 001.001 — 22
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PART2
NotificationofanactivesubstanceaccordingtoArticle 10
2000R0451 — EN — 28.08.2002 — 001.001 — 23
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2000R0451 — EN — 28.08.2002 — 001.001 — 24
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2000R0451 — EN — 28.08.2002 — 001.001 — 25
▼B
2000R0451 — EN — 28.08.2002 — 001.001 — 26
▼B
2000R0451 — EN — 28.08.2002 — 001.001 — 27
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2000R0451 — EN — 28.08.2002 — 001.001 — 28
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2000R0451 — EN — 28.08.2002 — 001.001 — 29
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2000R0451 — EN — 28.08.2002 — 001.001 — 30
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ANNEX V
PART1
Criteriafortheadmissibilityofnotificationsreferred toinArticle 4
A notification will only be considered admissible if the following conditions are
satisfied:
1. it is presented within the time limit referred to in Article 4(1);
2. it is introduced by a notifier who is a producer as defined in Article 2(2)(a)
for an active substance as defined by the Directive;
3. it is presented in the format as provided for in Annex IV, Part 1;
4. a fee as referred to in Article 12(2)(d) has been paid.
PART2
Criteria fortheadmissibilityofnotificationsreferred toinArticle 10
A notification will only be considered admissible if the following conditions are
satisfied:
1. it is presented within the time limit referred to in Article 10(2);
2. it is introduced by a notifier who is a producer as defined in Article 2(2)(a)
for an active substance as defined by the Directive;
3. it is presented in the format as provided for in Annex IV, Part 2;4. it appears from the completeness check that the dossier currently available is
sufficiently complete or a time plan to complete it is proposed;
5. the list of endpoints is sufficiently complete;6. a fee as referred to in Article 13 has been paid.2000R0451 — EN — 28.08.2002 — 001.001 — 31
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ANNEX VI
Organisations in the Member States to be contacted concerning further
details on the payment of the fees referred to in Article 12 and to which
suchfeeshavetobepaid
AUSTRIA
Bundesamt und Forschungszentrum für Landwirtschaft
Spargelfeldstraße 191
A-1226 Wien
BELGIUM
Fonds budgétaire des matières premières
Ministère des classes moyennes et de l'agriculture
Inspection générale des matières premières et produits transformés, WTC 3Boulevard Simon Bolivar 30B-1000 Bruxelles
Account number 679-2005985-25 (Banque de la Poste)Begrotingsfonds voor de grondstoffen
Ministerie van Middenstand en LandbouwInspectie-generaal Grondstoffen en verwerkte producten, WTC 3Simon Bolivarlaan 30B-1000 Brussel
Account number 679-2005985-25 (Bank van De Post)
DENMARK
Ministry of Environment and Energy
DanishEnvironmental Protection Agency
Strandgade 29
DK-1401 Copenhagen K
GERMANY
Biologische Bundesanstalt für Land- und Forstwirtschaft
Abteilung für Pflanzenschutzmittel und Anwendungstechnik
Messeweg 11-12D-38104 Braunschweig
GREECE
Hellenic Republic
Ministry of AgricultureGeneral Directorate of Plant ProduceDirectorate of Plant Produce ProtectionDepartment of Pesticides3-4 Hippokratous StreetGR-10164 Athens
SPAIN
Ministerio de Agricultura, Pesca y Alimentación
Dirección General de Agricultura
Subdirección General de Medios de Producción Agrícolas
c/Ciudad de Barcelona, 118-120ES-28007 Madrid
FINLAND
Plant Production Inspection Centre
Pesticide DivisionP.O. Box 42FIN-00501 Helsinki
Bank and account:
Leonia Bank plcPSP BFIHH800015-189822000R0451 — EN — 28.08.2002 — 001.001 — 32
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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 n. 11281011
LUXEMBOURG
Administration des services techniques de l'agriculture
Boîte postale 1904
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-2780-155 Oeiras
Account number: 003505840003800793097
Bank: Caixa Geral de Depósitos
SWEDEN
Kemikalieinspektionen
Box 1384
S-171 27 Solna
National Giro Account: 4465054-7
UNITED KINGDOM
Pesticides Safety Directorate
Ministry of Agriculture, Fisheries and Food
Mallard House
Kings Pool
3 Peasholme Green,
York YO1 7PX
United Kingdom2000R0451 — EN — 28.08.2002 — 001.001 — 33
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ANNEX VII
Designatedbodyreferred toinArticle 10
The following body is designated to perform on behalf of the Commission the
tasks referred to in Article 11: Biologische Bundesanstalt für Land und
Forstwirtschaft (RENDER PROJECT), Messeweg 11-12 D-38104 Braunschweig
(Internet: http://www.bba.de/english/render.htm or e-mail: render@bba.de). The
fee referred to in Article 13 has to be paid to account No 250 010 00, BLZ
250 000 00, Landeszentralbank Hannover (reference ‘BBA-RENDER’mentioning the reference number of the notification).
This body will:
1. examine the notifications referred to in Article 10;
2. make available to the notifiers the format of the notification referred to in
Article 10(2);
3. examine the notifications and consult with experts from other Member States
in the light of the acceptability criteria referred to in Annex V, Part 2;
4. report to the Commission within six months from the time limit referred to in
Article 10(2)(b) on the acceptability of the notifications received;
5. make available to the Commission the notifications received;
6. make a detailed account available to the Commission;
7. if the total amount of fees paid by all notifiers exceeds the real cost of the
examination and administrative treatment of all notifications, refund the
balance to the notifiers in equal shares.2000R0451 — EN — 28.08.2002 — 001.001 — 34