Expiry dates for CoPR Product Approvals – Impact of the new EU Biocides Regulation (EC 528/2012) and Regulation (EU 736/2013) to extend the biocide active substance review programme
The publication of Regulation (EU) No 736/2013 extending the biocide active substance review programme and the implementation of the new EU Biocides Regulation 528/2012 (EU BPR) on 1 September 2013, will have a significant impact on the expiry dates of COPR-approved products (both new and existing).
The European Commission has published Regulation (EU) No 736/2013 , which extends the deadline for completion of the biocide active substance review programme from May 2014 to the end of 2024. This will have an impact on new and existing product approvals:
- If a new application is submitted for a product approval under CoPR and all the active substances contained within that product do not have an agreed approval date under EU BPR, then the expiry date for that COPR product approval will be set at 31 December 2024.
- If a new application is submitted for a product approval under CoPR and all the active substances contained within that product have an agreed approval date under EU BPR, then the expiry date for that COPR product approval will initially be set in line with the provisions set out in Article 89 of EU BPR (currently up to 2 years, but likely to be up to 3 years if proposed amendments to EU BPR are agreed, after the latest active substance approval date).
- For existing products, if all the active substances contained within a particular product do not have an agreed approval date under EU BPR, then the expiry date for that product approval will be set at 31 December 2024.
- For existing products, if all the active substances contained within a particular product have an agreed approval date under EU BPR, then the expiry date for that product approval will initially be set in line with the provisions set out in Article 89 of EU BPR (currently up to 2 years, but likely to be up to 3 years if proposed amendments to EU BPR are agreed, after the latest active substance approval date).
For products containing active substance(s) that have EU BPR approval dates later than 1 September 2013, COPR will not “switch off/expire” on the date of approval of the last active substance(s) under EU BPR.
- This is different to the old system under the Biocidal Products Directive (BPD) and ‘Certificates of Exemption’ will no longer be issued for such products whilst they are being assessed for authorisation under EU BPR, as COPR will still apply to these products.
- Once all the active substances in a product approved under COPR have been approved under EU BPR for that particular product type, action may need to be taken to amend the expiry dates of this product. This will be dependent on whether or not an application for authorisation of an equivalent product under EU BPR has been made.
If no application is made under EU BPR for a product which is equivalent to one that is currently approved under COPR, then the COPR approval will be revoked with a 12 month phase out period, made up of 6 months for making the product available and 6 months for its use/disposal.
- The final expiry date of the COPR approval will be set at 12 months from the date of the approval of the relevant active substance in that product type under EU BPR. These periods are in-line with the provisions of Article 89 of EU BPR.
Article 95 of EU BPR introduces an approved active substance supplier list. Article 95 of EU BPR applies to all products that are approved under the Control of Pesticides Regulations (COPR).
- Article 95 (3) of EU BPR states “as of 1 September 2015, a biocidal product shall not be made available on the market if the manufacturer or importer of the active substance(s) contained in the product, or where relevant, the importer of the biocidal product, is not included in the list” of approved active substance suppliers.
- By 1 September 2015, COPR Approval Holders will need to show they have access to active substance data from an approved supplier on the Article 95 list to support their COPR product approval.
Source: HSE