Europe

This page provides:

Links to European websites relating to biocides legisl'ation:

• Joint Research Centre-Institute for Health and Consumer Protection (JRC-IHCP) web pages with links to the Biocidal Products Directive and related legislation, contact points for EU Competent Authorities, and access to guidance documents for the assessment of biocidal products and their active substances, including the Technical Guidance Document (TGD) separated into chapters, Environmental Emission Scenario Documents (ESDs), and Technical Notes for Guidance (TNsG) on various issues (eg dossier preparation and study evaluation, and human exposure).
• European Union website (Europa) with links to scope documents such as the 'Manual of Decisions', details of the Review Programme and contact details for the EU Competent Authorities.

Details of what happens to applications (for active substance inclusion on Annex I of the BPD) in Europe

Once the Rapporteur Member State (RMS) has completed their evaluation of an active substance, and the Applicant has had 2-4 weeks in which to submit final comments, the process outlined below is followed. This may vary slightly depending upon whether the active substance is ‘new’ or ‘existing’ and the time periods given may change as more experience of active substance assessments is gained (information from Biocides Technical Meeting February 2007).

1. The RMS evaluation is made available for comment

The RMS should send their evaluation to the EU Commission (COM) who place it on their CIRCA (Communication and Information Resource Centre Administrator) website, in a restricted area to which other member states (OMS) have access. The RMS must also:

• send their evaluation to the Applicant at the same time as they send it to the COM; and
• provide a non-confidential version of Document I and II of their evaluation to the COM within one month. This report is then included on the public part of the CIRCA website and can also be found on the EU Commission website.

Once the RMS evaluation has been placed on CIRCA there is a 90-day commenting period in which OMS and the Applicant can submit comments. Industry and the public are also welcome to comment on the non-confidential version within this time. All comments should be sent, in writing, directly to the COM.

2. Handling comments received on a RMS evaluation

All written comments received by the COM will be placed on the restricted part of their CIRCA website, so they are available to the RMS and OMS. Non-confidential comments will also be placed on the public part of the CIRCA website.

Once the commenting period is over, the RMS consolidates all comments received, into a pre-structured commenting table. The RMS then has 1-3 months to add their response to each tabulated comment. During this responding period, the RMS should work with the relevant MSs who have commented to try to resolve as many concerns as possible. This should minimise the discussion needed at a Biocides Technical Meeting (TM).

At the end of the responding period the RMS should:

• send the updated commenting table to COM who place it on the restricted part of CIRCA (so all OMS have access), and to the Applicant;
• send their responses to comments raised by industry or the public on the non-confidential version to COM for inclusion on the public part of the CIRCA website; and
• produce an overview of outstanding issues and identify those that are scientific/technical and should be discussed at the TM and others for which a decision is required at a Competent Authority (CA) meeting.

3. Discussion of RMS evaluation

As the BPD is European legislation, any RMS evaluation needs to be acceptable to the majority of MSs (or the active substance would not pass a vote for inclusion/non-inclusion on to Annex I at the Standing Committee of Biocidal Products). Hence discussions may be required at both Technical and Competent Authority meetings to resolve significant issues.

Once the commenting period is complete, and the review of outstanding issues produced by the RMS has been sent to the COM, the COM will determine whether a discussion at TM is required. If relevant, the COM will place the commenting table (including responses) and the CA report on the agenda of the next available Biocides TM for discussion.

3.1 Discussions at Biocides Technical Meetings

TM discussions on RMS evaluations are intended to focus on outstanding scientific/technical issues from the evaluation, where OMSs commented but did not receive a response from the RMS that satisfied their concerns. The TM meetings are chaired by the Joint Research Centre-Institute for Health and Consumer Protection (JRC-IHCP) web pages who provide scientific and technical support to MSs and the COM. There is insufficient time in TM meetings to discuss minor points (which should have been adequately addressed in the commenting table or by bilateral discussions) or new concerns (which should have been raised during the commenting period).

Detailed discussion, and agreed actions, on specific active substance evaluations are recorded in the commenting table by the RMS, and the updated commenting table is then resent to the COM, who place it on CIRCA, and to the Applicant.

Once agreement between MSs has been reached on all issues (this may require discussion at more than one TM meeting) then the RMS should:

• finalise the commenting table;
• prepare a revised/final version of their evaluation, to incorporate all changes agreed, within 60 days of agreement on all issues.

and send both documents to the COM for inclusion on the restricted part of CIRCA.

3.2 Discussions at Competent Authority Meetings

CA discussions do not normally occur on scientific/technical aspects of RMS evaluations, although the TM can refer specific technical issues to the CA for a discussion/decision/endorsement. The CA will discuss political issues and ultimately discuss and endorse RMS evaluations that have been agreed by the TM.

4. Preparation for a vote for inclusion on to Annex I

After MSs have agreed on the evaluation of an active substance, the RMS evaluation is finalised. In preparation for a vote on the inclusion of the active substance on to Annex I of the Biocidal Products Directive (BPD):

• The RMS prepares a draft assessment report, based on the template developed by the COM, and the information within Document I of the RMS evaluation on the specific active substance. The final version will become a public document so confidential information in Document I will not be transferred into the assessment report.
• The COM prepares a draft decision for the inclusion/non-inclusion of the active substance on to Annex I, based on the outcome of the evaluation agreed by MSs.

When all three documents (the final evaluation report, the draft assessment report, and the draft decision for inclusion/non-inclusion) are complete the COM will ensure they are placed on the restricted part of CIRCA and inform MS of this. MS must have at least 8 weeks to comment prior to the next TM. At the TM, the TM should:

• approve the final version of the RMS evaluation, including Document I (also called the CA report);
• recommend its endorsement to the CA meeting;
• note the draft assessment report and draft decision.

5. Vote for inclusion/non-inclusion of active substance on to Annex I

The draft decision, along with the draft assessment report, is presented by the COM to:

• the CA for endorsement;
• the Standing Committee on Biocidal Products (SCBP) who make a final decision, by Qualified Majority Voting (QVM) on the draft decision. The decision on whether the active substance should/should not be included on to Annex I of the BPD should be made within 12 months of completion of the evaluation.

If the SCBP agrees to put the active substance on to Annex I then the COM will get the decision translated into the EC official languages. The active substance is included on to Annex I by publication of the decision in the Official Journal of the European Communities (OJEC). The assessment report is not translated into the EC official languages. The EC Commission website includes the current list of the active substances on Annex I and links to both the OJEC published decisions and assessment reports that supported their inclusion.

Annex I listing initially lasts for up to 10 years, but can be reviewed at any time during this period and may be removed if, for example, any new information becomes available regarding the risks or any requirements of the listing fail to be met. Inclusion on to Annex I may be extended on one or more occasions for periods not exceeding 10 years each.

If the SCBP agrees with non-inclusion for the active substance on to Annex I then the COM will get the decision translated into the EC official languages and published in the OJEC. For an existing active substance:

• if non-inclusion is due to the lack of data then the decision will also indicate that the active substance should be removed from the market according to Article 1 of the Fourth Review Regulation (1849/2006). The date of removal will be 12 months after the date of such a decision entering into force, unless otherwise stipulated in the non-inclusion decision.
• if non-inclusion is due to adverse data, then the marketing of the active substance may be restricted/banned under the Marketing and Use Directive or Regulation (EC) No. 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), as it comes into force.

6. The time-scale post-SCBP vote for Annex I inclusion

Following a SCBP vote for inclusion of an active substance on to Annex I, the COM currently submits the SCBP draft decision to the EU Parliament and Council (for regulatory procedures and comment) and the World Trade Organisation (for comment) although this procedure is currently under discussion. After 3-6 months the final decision, written as an Inclusion Directive, in all EC official languages, is then published in the OJEC and includes:

• the date for formal inclusion on to Annex I (2 years after publication in the OJEC);
• the date by which relevant biocidal products must be authorised (2 years after formal inclusion on to Annex I);
• the date of expiry of Annex I listing (10 years after formal inclusion).