Purpose
1. This note gives you important information on the requirements of the first EC Review Regulation for the Biocidal Products Directive (98/8/EC, Biocidal Products Directive). If you are a supplier of either active substances used in biocides, or of biocidal products, you need to be aware of this. There are important obligations placed on you. If you do not meet them, then your active substances, and their products, will no longer be able to be placed on the EU market. The definition of existing active substance is given in the Review Regulation (copy attached to this note). Placing on the market means supply, whether in return for payment or not, within the European Community, including importation into the European Community; or any subsequent storage, other than a supply for storage followed by consignment from the customs territory of the European Community. Annex I etc refers to Annex I, IA or IB of Biocidal Products Directive.
Background
2. When the Biocidal Products Directive entered into force on 14 May 2000 it had little immediate effect on the supply of existing active substances and their biocidal products. This is because existing national controls on such actives substances and their products can continue until the active substances are reviewed. Following review, if the active substance is considered acceptable for inclusion on Annex I etc of Biocidal Products Directive, then authorisation of individual products containing that active substance can occur under Biocidal Products Directive. If inclusion in Annex I etc is not possible, then products containing that active substance will have to be withdrawn from the EU market. The processes and timetable for undertaking such reviews are to be established by one or more EC Review Regulations. The first of these has now been published.
3. This first Review Regulation establishes the processes and the timetable which you must follow if the active substance(s) you currently supply or include in your products is/are to be included in the review programme. Essentially, it requires that you Identify existing active substances and Notify those which you wish to have evaluated for possible inclusion in Annex I etc. For active substances used in Product Types (PT) 8 (Wood Preservatives) and 14 (Rodenticides) it also sets the deadline for the submission of full dossiers in support of applications for inclusion in Annex I etc. The key actions, together with their deadlines, are set out below. The consequences to you if you do not comply are highlighted. Whilst Biocidal Products Directive is implemented in British legislation by the Biocidal Products Regulations, this EC Review Regulation is directly implemented in British legislation and came into force on 28 September 2000.
4. A subsequent Review Regulation, likely to be published in approximately two years time, will list all Identified and Notified active substances. It will also give the deadline for final withdrawal from the EU market, for use in biocidal products, of all active substances not on those lists.
This first Review Regulation requires that you tell the EC what you intend to do about the active substance(s) you currently supply for use in biocidal products. This will be by either Identification or Notification as explained further below. If you do not tell the EC, then action will be taken such that your active substance(s) can no longer be placed on the EU market for use in biocidal products. The deadlines for these actions will be given in a subsequent Review Regulation.
Your obligations
Identification (Article 3)
5. If you are a producer of an active substance or a product formulator (see definitions in the Review Regulation, Article 2), and wish to continue to supply, you need to Identify that active substance by supplying the information specified in Annex I of the Review Regulation.
6. Identification information must be presented using a special software package, available via the European Chemicals Bureau (ECB) Webpage (see end of document for address) and must be received by ECB no later than 28 March 2002.
7. The only exemptions from identifying are:
- if you intend to Notify the active substance (see Para 8 below); or,
- you consider the substance to be a basic substance and you intend to Notify it as such (see Para 19 below)
8. After 28 March 2002 the EC will draw up a list of existing active substances which have been identified in accordance with the Review Regulation. This list will be published in a subsequent Review Regulation.
Warning: If your active substance is not on this list of identified existing actives substances then it, and all products containing it, must be withdrawn from the EU market. The deadline for this withdrawal will be given in a subsequent Review Regulation.
If your active substance is on this list, but is not notified (see Para 8), then it, and all products containing it, must be withdrawn from the EU market. The deadline for this withdrawal will be given in a subsequent Review Regulation.
Notification (Article 4)
8. If you are a producer of an active substance or a product formulator, and wish to support your active substance for review and continue to supply, then you need to ensure that your active substance is Notified. Notification will be by supplying the information specified in Annex II of the Review Regulation.
Notification information must be presented using special software, available free on a CD-ROM, from the ECB (see end of document for address) and must be received by ECB no later than 28 March 2002.
9. It is necessary for there to be at least one notification for each product type in which the active substance is to remain on the EU market. The active substance will have to be withdrawn from the EU market for use in any product type(s) in which it is not notified. Whenever you are aware that there may be other potential notifiers of the active substance, then you should try to agree to present a single notification. Thus, whilst individual producers or formulators do not need to present separate notifications, it is essential that you ensure that the product type(s) in which you wish the active substance to be used ha(s/ve) been notified.
10. The EC will check your notification(s). If one is found to be deficient in some way you will be given 30 days to correct or complete your notification. If you are unable to do this, then the EC will not accept it.
11. After 28 March 2002 the EC will draw up a list of existing active substances for which they have accepted notifications and the product types for which they were notified. This list will be published in a subsequent Review Regulation.
Warning: If your active substance is not on the list of notified existing active substances then it, and all products containing it, must be withdrawn from the EU market. If it is on the list but not for (a) particular product type(s) then all products in that/those product types must be withdrawn from the EU market. The deadline for withdrawal will be given in a subsequent Review Regulation.
12. After this time, and using the information provided in the notifications, the EC will also draw up priority lists of active substances for evaluation for possible inclusion in Annex I etc (with the exception of those used in PT 8 and 14 - see Para 14 below). These lists, together with the name of the rapporteur Member State will be published in a subsequent Review Regulation.
13. Making a Notification does commit you to supporting the active substance during the next phase of the review programme. In this next phase you will be required to provide a full dossier of all the data and other information needed for the evaluation of the active substance for possible inclusion on Annex I. If you do not provide the full dossier at the appropriate time, without good reason, then it is likely that the active substance will have to be withdrawan from the EU market within a short time period.
Active substances used in Product Types 8 (Wood Preservatives) and 14 (Rodenticides) (Article 7)
14. The EC has decided that active substances used in these product types should be evaluated first for possible inclusion in Annex I etc. If you are a producer or formulator of active substances in these product types and wish to continue to supply, you need to notify as described in Para 8 above.
However, the date for submission of the full dossier of all the data and other information for PT 8 and 14 has already been determined. It must be submitted to the rapporteur Member State by 28 March 2004.
15. The name of the appointed rapporteur Member State will be given in a subsequent Review Regulation. A fee will be charged for this work (likely to be approx £60,000-£100,000 in the UK).
Warning:
- If you do not notify your active substance for use in PT 8 or 14, then products in PT 8 and 14 containing it must be withdrawn from the EU market. The deadline for withdrawal will be given in a subsequent Review Regulation.
- If you do not submit the full dossier by 28 March 2004 then the EC will take action to ensure that the active substance is withdrawn from the EU market for use in PT8 and 14 within a short period of time.
16. When preparing your submission dossier you should, in the first instance, consult the draft EC Technical Note for Guidance: Guidance on Data Requirements for Active Substances and Biocidal Products. If you need further advice about the minimum necessary data requirements in order to carry out an adequate risk assessment, then you should approach the rapporteur Member State. Whenever you are aware that there are other notifiers of the active substance, then you should try to agree to present a single dossier. If you are unable to reach such agreement, then the efforts made and the reasons why certain parties have not participated must be given.
17. The EC is currently drafting guidance on the format for the presentation of dossiers and software may be available for the dossier to be submitted electronically. Again, you should consult the rapporteur Member State for further details.
18. Also, in order to gain experience of the costs to you in complying with the requirements of Biocidal Products Directive, you are invited to prepare and present with your dossier a breakdown of the costs of the respective actions and studies you carried out.
Basic substances (Article 8)
19. If you consider that your active substance is a basic substance (a substance whose major use is non-pesticidal but has a minor use as a biocidal product) and you intend to apply for it to be included in Annex IB in (a) specific product type(s), then you must Notify that basic substance by supplying the information specified in Annex II of the Review Regulation.
Notification information for basic substances must be presented using special software, available free, on a CD-ROM, from ECB (see end of document for address) and must be received by ECB no later than 28 March 2002.
20. It is necessary for there to be at least one notification for each product type in which the basic substance is to remain on the EU market. Whenever you are aware that there may be other potential notifiers of the basic substance, then you should try to agree to present a single notification. Thus, whilst individual producers or formulators do not need to present separate notifications, it is essential that you ensure that the product type(s) in which you wish the basic substance to be used ha(s/ve) been notified.
21. The EC will check your notification(s). If one is found to be deficient in some way you will be given 30 days to correct or complete your notification. If you are unable to do this, then the EC will not accept it.
22. After 28 March 2002 the EC will draw up a list of existing basic substances for which they have accepted notifications and the product types for which they were notified. This list will be published in a subsequent Review Regulation.
Warning: If your basic substance is not on the list of notified basic substances then it must be withdrawn from the EU market. If it is on the list but not for (a) particular product type(s) then it must be withdrawn from the EU market for use in that/those product type(s). The deadline for withdrawal will be given in a subsequent Review Regulation.
23. The procedures for the evaluation of basic substances will be given in a subsequent Review Regulation.
24. Making a Notification does commit you to supporting the basic substance during the next phase of the review programme. In this next phase you will be required to provide all the data and other information needed for the evaluation of the active substance for possible inclusion on Annex IB. If you do not provide the data and information at the appropriate time, without good reason, then it is likely that the active substance will have to be withdrawn from the EU market within a short time period.
25. If you need further information on this regulation, or clarification of anything in this note, please contact us at the address given below:
Chemicals Assessment Schemes Unit (CASU)Health & Safety Executive
Building 1, 3rd Floor
Redgrave Court
Merton Road
Bootle
Merseyside L20 7HS
e-mail: biocides@hse.gsi.gov.uk
26. Address for the European Chemicals Bureau (Paras 5, 8 and 19):
European CommissionJoint Research Centre
Institute for Health and Consumer Protection
European Chemicals Bureau
TP 280, ISPRA (VA)
21020, ITALY
Internet: http://ecb.jrc.it/biocides/
HSE BPU September 2000