/ EUROPEAN COMMISSION
DIRECTORATE-GENERAL
ENVIRONMENT
Directorate D - Water, Chemicals & Biotechnology
ENV.D.3 - Chemicals &Nanomaterials

39thmeeting of representatives of Members States Competent Authorities for the implementation of Directive 98/8/EC concerning the placing of biocidal products on the market

Participant withdrawalfrom the review programme after the completeness check

Purpose

  1. The purpose of this note is to update the line to take in situations where all participants to the review programme for a given substance/product type (hereinafter 'PT') combination withdraw their support for the inclusion in the course of the evaluation. Itcomplements and – where relevant – overrides the guidance documenton the same subject tabled in the competent authority (hereinafter 'CA') meeting of November2007 (CANov07Doc.3.2.1) as well as the guidance document on Non inclusion fast track procedure (CA-Nov07-Doc.6.2) also tabled in the competent authority meeting of November2007.

Background

  1. The withdrawal of participants is regulated in Articles11 and 12 of Regulation1451/2007. According to Article11(2) and Article12(1), where all the participants for a given substance/PT combination have withdrawn from the review programme, the Commission shall publish a withdrawal notice, thereby giving other companies the opportunity to take over the role of participant. However, pursuant to Article12(4), a given substance/PT combination may only be taken over once. Pursuant to Article12(5) of Regulation1451/2007, the Commission shall take a non inclusion decision if no one indicates an interest to take over the substance/PT combination in question.
  2. In the abovementioned guidance document CA-Nov07-Doc.3.2.1, the Commission concluded that the latter provision is meant to apply only in situations where the last applicant withdraws before a complete dossier has been submitted. This was because Regulation1451/2007 cannot extend the grounds to take a non inclusion decision beyond what is stipulated in the Directive that the Regulation implements, i.e. Directive98/8/EC (hereinafter referred to as 'BPD'). The second subparagraph of Article16(2)of the BPD limits non inclusion decisions for substances included in the review programme to cases where either the requirements of Article10 of the BPD are not satisfied, orthe requisite information or data have not been submitted within the prescribed period. The conclusion drawn in the guidance document was that, if a complete dossier has been submitted, the CA of the rapporteur member state (hereinafter 'RMS')has to continue the evaluation process in order to allow the Commission to verify whether the requirements of Article 10 of the BPD are satisfied and decide whether to include the substance in Annex I, IA or IB to the BPD.

Reasons for the policy development

  1. There are reasons to revisit the approach of guidance document CANov07Doc.3.2.1 in the light of the experience gained since it was drafted.The document stipulates that the evaluation should be finalised if "a complete dossier has been submitted", which could be perceived as meaning that the evaluation should be finalised whenever the last applicant withdraws after the completeness check.
  2. However, the guidance was drafted having in mind real cases where the participant had withdrawn its support at a very late stage of the evaluation, when the EU level technical peer review had been finalised and there was not much work left for the RMS CA. Since then, there have been other cases where the last participant has withdrawn at an earlier stage of the evaluation, albeit after the RMS CA declared the dossier complete.
  3. If there is no longer a participant supporting the inclusion, the RMS CA is no longer in a position to obtain any data necessary for the evaluation, and can therefore not be requested to continue the evaluation. This will certainly be the caseif the participant withdraws before the submission of all the data requested for a positive outcome of the completeness check, which already follows from the 2007 guidance. However, experience has shown that participants are often requested to submit additional data even after a positive completeness check.
  4. Therefore, even if it is only after a successful completeness check that the last participant for a given substance/PT combination withdraws, it is not certain that the RMS CA will have all the data necessary to evaluate whether the substance/PT combination fulfils the requirements for inclusion in AnnexI, IA or IB to BPD.
  5. Furthermore, there are Member States in which the full evaluation fee is either only due at the end of the complete evaluation, or partially reimbursed if the evaluation is interrupted. In such cases, the RMS CA may not have the budget to finance the finalisation of the evaluation.

Suggested line to take when additional data is required

  1. If additional data is required when the only remaining participant for a given substance/PT combination withdraws, the evaluation cannot be finalised without the participation of a new participant. In the interest of transparency and harmonisation, and in the light of experience, it is proposed to presume that further data will be required if the participant withdraws any time before the CA meeting discussion on the first draft assessment report.
  2. If the substance/PT combination has not yet been taken over, Article11(2) of Regulation1451/2007 requests that a withdrawal notice is published.According to Article12(2) of Regulation1451/2007, any person wishing to take over the role of participant shall provide evidence of having begun its work within three months.
  3. If no response to the withdrawal notice is received, or if the substance/PT combination has already been taken over once, a non inclusion decision should be taken based on Article12(5) of the Regulation.Since – even if the dossier has formally been declared complete at some stage – in reality some of the requisite data has not been and will not be submitted, such a non inclusion decision will also be compatible with the second subparagraph of Article16(2)BPD.
  4. The withdrawal from the review programme does not deprive a company from its data protection. In consequence, if the role of participant is taken over, Article12BPD will prevent the RMS CA from making use of the data submitted by one of the first participants for the benefit of the new participant, unless the new participant has a letter of access to it. The new participant will therefore have to negotiate data access or – as a last resort – generate its own data in order to be considered to have access to a complete dossier.In the former case, the dossier submitted by the first participant(s) will be complemented by the data submitted by the new participant for the purpose of the evaluation. In the latter case, in analogy with the policy relating to evaluation of "multiple dossiers",[1] the RMS can prepare a CA report on the basis of all the information available to it, independent of which dossier the information is presented in.

Suggested line to take when no additional data is required

  1. If the RMS CAis confident that it has all the data necessary to conclude whether the substance/PT combination fulfils the requirements for inclusion in Annex I, IA or IB to BPD, and that no further assistance from the participant is necessary in the course of the remaining evaluation or discussion, it could still be questioned whether the assessment should be finalised. This situation will presumably mostly occur if the participant withdraws at a very late stage of theRMS's evaluation, or in the course of the EU level technical peer review or the CA meeting discussions.
  2. On the one hand, it can be seen as a waste of resources to spend time finalising the assessment in case the commercial interest in using the substance is limited enough to make the participant withdraw its support.
  3. Furthermore, in those cases where the full fees are paid only at the end of the evaluation, or partially reimbursed in the case of a withdrawal, the RMS may not have the budget to finalise the evaluation, even if it has all the necessary data. Article25 of BPDlays down the principle that applicants shall bear the costs of the procedures established by the Directive. It can arguably be considered to follow from this provision that an evaluation can be stopped if the fees required to finance it are not fully paid. In case the evaluation is stopped for this reason, it cannot be concluded that the requirements of Article10 BPD are satisfied, and a non inclusion decision can thus arguably be taken in conformity with the second subparagraph of Article16(2) of BPD.
  4. On the other hand, there may be a public interest in finalising the evaluation even if the participant has withdrawn its support: If the reportwill show an unacceptable risk, it can be in the public interest to have it finalised and published even if the substance in question is no longer to be used in biocidal products. Furthermore, in such a situation, the question whether the non-inclusion decision is based on the assessment report or on the withdrawal of the applicant is of relevance for the purpose of the Rotterdam Convention on the Prior Informed Consent Procedure (PIC) for certain hazardous chemicals and pesticides in international trade.
  5. If the report will not show an unacceptable risk, it can be of public interest to have the substance included in AnnexI even if the commercial interest for the participant is limited or nonexistent. This applies in particular if there are no or few alternatives to that substance in that PT.
  6. It is therefore suggested that, in case a substance/PT combination is withdrawn at a stage where clearly enough data has been submitted to enable the assessment to be concluded, the RMS CA decides whether the finalisation of its work on the assessment can be financed through the fees already paid by and not reimbursable to the participant. If there is a strong public interest in finalising the assessment report, or if there is very little work left for the RMS CA to finalise the assessment, there is also nothing preventing it from financing the remaining work by other means.
  7. If the remaining part of the RMSs work on the assessment cannot be financed, the assessment has to stop, and the procedure set out in paragraph10-11 above should be followed. If, on the other hand, the remaining part of the RMS's work on the assessment can be financed, either through the fees already paid by the former participant or through other means that the RMS chooses to spend in the public interest, the assessment should be brought to an end, and the non inclusion decision or inclusion directive should be based on the assessment report.

Conclusion

  1. In conclusion, in cases where all participants for a given substance/PT combination withdraw after the completeness check but before a decision has been taken whether to include the substance/PT combination in AnnexI, IA or IB to BPD, the RMS CA is invited to indicate to the Commission whether it has all the data necessary to evaluate whether the substance/PT combination fulfils the requirements for inclusion.In cases where the participant withdraws any time before the CA meeting discussion on the first draft assessment report, data gaps can be presumed.
  2. If the RMS CAdoes not have all the data or has not received all the fees necessary to evaluate whether the substance/PT combination fulfils the requirements for inclusion in AnnexI, IA or IB to BPD, and the substance/PT combination has not yet been taken over, the Commission will publish a withdrawal notice, and – in case a person indicates an interest to take over the role of participant – verify that work has begun in accordance with the second subparagraph of Article12 Regulation(EC) No1451/2007. If no response to this notice is received, or if the substance/PT combination has already been taken over once, the Commission will take a non inclusion decision.
  3. If the RMS CA has all the data necessary to evaluate whether the substance/PT combination fulfils the requirements for inclusion in AnnexI, IA or IB to BPD, and if the remaining part of the RMS's work on the assessment can been fully financed through the charges already paid by the former participantor additional means spent by the RMS in the public interest, the evaluation should go on according to the normal evaluation procedure.

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[1]CA-Dec09-Doc.8.3