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Expiry dates for CoPR Product Approvals – Impact of the new EU Biocides Regulation (EC 528/2012) and Regulation (EU) No 736/2013 to extend the biocide active substance review programme

This page provides information about the impact of the extension of the biocides active substance review program and the requirements of Articles 89 and 95 (approved active substance suppliers) of the EU Biocides Regulation 528/2012 (EU BPR) (as amended) on the expiry dates of approval granted under the Control of Pesticides Regulations (COPR). The information on this page reflects the current text of EU BPR which has been amended by Regulation (EU) No 334/2014.

Introduction

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 and its subsequent amendment by Regulation (EU) No 334/2014, impacts on the expiry dates of COPR-approved products (both new and existing).

Impact of the extension of the biocide active substance review programme on COPR approvals

Publication of Regulation (EU) No 736/2013, extends the deadline for completion of the EU BPR (as amended) biocide active substance review programme from May 2014 to the end of 2024. This will have an impact on new and existing product approvals as follows:

New applications for product approval

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 (as amended), 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 (as amended), 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 3 years from the date of approval of the last active substance in the product).

Existing approvals

Existing products approved under COPR have had expiry dates extended based on the status of the active substance(s) they contain ie either 31 December 2024 or in line with the provisions set out in Article 89 of EU BPR (as amended) (currently up to 3 years from the date of approval of the last active substance in the product).

Impact of the approval of an active substance(s) under EU BPR on COPR approvals

Under EU BPR (as amended), following the approval of the last active substance in a product COPR does not “switch off” as it did under the old Biocidal Products Directive (BPD). Consequently, as COPR continues to apply, there is no need to issue Certificates of Exemption for products.

Once all the active substances in a product approved under COPR have been approved under EU BPR (as amended) for that particular product type, action will  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.

I have submitted an application for product authorisation what will be my product expiry date?

If a product authorisation application is made for a product which is considered equivalent to one that is currently approved under COPR, then a Notice of Approval (amendment) will be issued amending the expiry date of the COPR approval.

The expiry date will be set at a period of time in line with the provisions set out in Article 89 of EU BPR (as amended) (currently up to 3 years from the date of approval of the last active substance in the product).

During this time, you must continue to comply with general chemical legislation such as:

In addition, the General Product Safety (GPS) Regulations may apply. These regulations place a general duty on all suppliers of consumer goods to supply products that are safe in normal or reasonably foreseeable use. The responsibility for the GPS Regulations lies with the Department of Business, Innovation and Skills (BIS).

Specific elements of EU BPR also apply to products before (and after) the product is Authorised under EU BPR, namely:

Provide information to the National Poisons Information Service.

I have submitted an application for product authorisation but it has failed the validation check, what will be my product expiry date?

If after the validation check the product authorisation application is not considered to be complete (after suitable bilateral exchanges with the relevant Applicant), the 365 day phase out period as set out in Article 89 of EU BPR (as amended) will apply from the date of the official letter informing the Applicant of this decision.

The 365 days phase out period for the product is made up of:

  • 180 days for making the product available; and
  • 365 days for its use.

The final expiry date will be set at 365 days from the date of the official letter informing the Applicant of this decision.

NOTE:  The 180 day period for making the product available on the market relates to all making available of the biocidal products from the top of the supply chain (e.g. manufacturer or formulator) down to when the user receives it (e.g. from a distributor or retail store/website).

During this 365 day phase-out period you must continue to comply with general chemical legislation such as:

In addition, the General Product Safety (GPS) Regulations may apply. These regulations place a general duty on all suppliers of consumer goods to supply products that are safe in normal or reasonably foreseeable use. The responsibility for the GPS Regulations lies with the Department of Business, Innovation and Skills (BIS).

Specific elements of EU BPR also apply to products before (and after) the product is Authorised under EU BPR, namely:

I have submitted an application for product authorisation but authorisation isn’t going to be granted, what will be my product expiry date?

If during the evaluation phase of the product authorisation application, it is concluded that a product authorisation cannot be granted (after suitable bilateral exchanges with the relevant Applicant), the 365 day phase out period as set out in Article 89 of EU BPR (as amended) will apply from the date of the official letter informing the Applicant of this decision.

The 365 day phase out period for the product is made up of:

  • 180 days for making the product available; and
  • 365 days for its use.

The final expiry date of the CoPR approval will be set at 365 days from the date of the official letter informing the Applicant that the product cannot be authorised under EU BPR (as amended).

NOTE: The 180 day period for making the product available on the market relates to all making available of the biocidal products from the top of the supply chain (e.g. manufacturer or formulator) down to when the user receives it (e.g. from a distributor or retail store/website).

During this 365 day phase-out period you must continue to comply with general chemical legislation such as:

In addition, the General Product Safety (GPS) Regulations may apply. These regulations place a general duty on all suppliers of consumer goods to supply products that are safe in normal or reasonably foreseeable use. The responsibility for the GPS Regulations lies with the Department of Business, Innovation and Skills (BIS).
Specific elements of EU BPR also apply to products before (and after) the product is Authorised under EU BPR, namely:

I have submitted an application for product authorisation and received an EU BPR authorisation, what will be the expiry date of my product approved under COPR?

Existing stocks of a product approved under COPR in the supply chain that do not comply with the conditions of authorisation granted under the EU BPR (as amended) can be phased off the UK market in line with the provisions set out in Article 89 of EU BPR (as amended). The COPR approval will be revoked with a 365 day phase out period.

The 365 days phase out period for the product is made up of:

  • 180 days for making the product available; and
  • 365 days for its use.

The final expiry date of the COPR approval will be set at 365 days from the date of the official letter informing the Applicant that the product is authorised under EU BPR (as amended).

NOTE: The 180 day period for making the product available on the market relates to all making available of the biocidal products from the top of the supply chain (e.g. manufacturer or formulator) down to when the user receives it (e.g. from a distributor or retail store/website).

During this 365 days phase-out period you must continue to comply with general chemical legislation such as:

In addition, the General Product Safety (GPS) Regulations may apply. These regulations place a general duty on all suppliers of consumer goods to supply products that are safe in normal or reasonably foreseeable use. The responsibility for the GPS Regulations lies with the Department of Business, Innovation and Skills (BIS).

Specific elements of EU BPR also apply to products before (and after) the product is Authorised under EU BPR, namely:

I have NOT submitted an application for product authorisation, what will be my product expiry date?

If NO application is made under EU BPR for a product which is considered equivalent to one that is currently approved under COPR, then the COPR approval will be revoked with a 365 day phase out period.

The 365 days phase out period for the product is made up of:

  • 180 days for making the product available; and
  • 365 days for its use.

The final expiry date of the COPR approval will be set at 365 days from the date of approval of the last active substance under EU BPR (as amended).

NOTE: The 180 day period for making the product available on the market relates to all making available of the biocidal products from the top of the supply chain (e.g. manufacturer or formulator) down to when the user receives it (e.g. from a distributor or retail store/website).

During this 365 days phase-out period you must continue to comply with general chemical legislation such as:

In addition, the General Product Safety (GPS) Regulations may apply. These regulations place a general duty on all suppliers of consumer goods to supply products that are safe in normal or reasonably foreseeable use. The responsibility for the GPS Regulations lies with the Department of Business, Innovation and Skills (BIS).

Specific elements of EU BPR also apply to products before (and after) the product is Authorised under EU BPR, namely:

Impact of the non-approval of an active substance(s) under EU BPR

The decision not to approve an active substance under EU BPR (as amended) is published by the EU Commission in an Implementing Decision.

Biocidal products containing active substances for which a non-approval decision has been taken shall be removed from the market within the deadlines published in the decision; this will normally be:

  • 12 months from the date of the decision for making the product available; and
  • 18 months from the date of the decision for its use.

NOTE: The 12 months period for making the product available on the market relates to all making available of the biocidal products from the top of the supply chain (e.g. manufacturer or formulator) down to when the user receives it (e.g. from a distributor or retail store/website).

The EU Commission’s website provides a list of active substances for which a non-approval decision under EU BPR (as amended) has been adopted. This list also contains the dates by which products containing these active substances shall no longer be made available on the market and used for the relevant product-types.

For products that hold a COPR approval, the final expiry date of the CoPR approval will be set in line with the non-approval decision.

During the phase-out period, for both COPR and Non COPR approved products, you must continue to comply with general chemical legislation such as:

In addition, the General Product Safety (GPS) Regulations may apply. These regulations place a general duty on all suppliers of consumer goods to supply products that are safe in normal or reasonably foreseeable use. The responsibility for the GPS Regulations lies with the Department of Business, Innovation and Skills (BIS).

Specific elements of EU BPR also apply to products, namely:

Where can I find out more about the Article 89 transitional provisions of EU BPR?

Further information about the Article 89 transitional provisions of EU BPR (as amended) and how they apply in the UK can be found on our transfer from UK law page.

Where can I find out more information about the EU BPR product authorisation process?

Further information about the product authorisation process in the UK can be found in our EU BPR products authorisation pages.

Impact of Article 95 on COPR approvals

Article 95 of EU BPR (as amended) 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 (2) of EU BPR (as amended) states “As of 1 September 2015, a biocidal product consisting of, containing or generating a relevant substance, included in the list referred to in paragraph 1, shall not be made available on the market unless either the substance supplier or the product supplier is included in the list referred to in paragraph 1 for the product-type(s) to which the product belongs.”

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.

What information does HSE need?

This information should comprise written confirmation of the source of the active substance formulated within the COPR product approval and a link to that’s source’s entry on ECHA’s list of approved suppliers.

Where can I find the list of approved active substance suppliers?

Article 95 (1) states that ECHA “shall make publically available and shall regularly update a list of …” approved active substance suppliers. The list is published on the ECHA website and updated as required by ECHA.

Where should I send the information?

Information should be sent to our usual address

If I supply the information what will happen to my COPR approval?

If information is submitted to HSE to show that the approval is in compliance with Article 95 of EU BPR (as amended), no further action will be taken at this point.

If I don’t supply the information what will happen to my COPR approval?

If NO information is submitted to HSE, by 1 September 2015, to show that the approval is in compliance with Article 95 of EU BPR (as amended), the COPR approval will be revoked on 1 September 2015 and NO phase out period for making the product available on the UK market can be granted.

Where can I find out more information about the requirements of Article 95?

More information on the requirements of Article 95 including how to apply to become an approved supplier can be found in our EU BPR Approved Active substance suppliers’ page.

Updated 2014-10-24