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Transition from UK National Legislation to EU Legislation following the Approval of an Active Substance under the EU Biocides Regulation 528/2012 (EU BPR)

This page provides information about how the transitional provisions in Article 89 of EU BPR (as amended) will apply in the UK to biocidal products which are currently available on the UK market (both COPR approved and Non COPR approved). This reflects the current text of Article 89 which has been amended by Regulation 334/2014.

Background

The Biocidal Products Directive 98/8/EC (BPD) was replaced by EU Biocides Regulation 528/2012 (EU BPR) on 1st September 2013. As a result of this change, the transitional arrangements for products currently regulated under the UK Control of Pesticides Regulation (CoPR) to being regulated under the new EU BPR are different to the transitional arrangements which operated when BPD was in force.

In addition, the transitional arrangements will also differ for those products which are currently not regulated under CoPR but will be regulated under EU BPR.

The key change is that for active substances added to the EU BPR Article 9 Union list of Approved active substance after 1 September 2013, Applicants will no longer need Certificates of Exemption to keep products on the UK market following the date of approval of an active substance for use in a particular product type under EU BPR.

NOTE:  a “COPR product” refers to a product that requires and has approval under the COPR (such as wood preservatives, public hygiene insecticides etc); a “Non COPR product” is a product that does not require an approval under COPR), (such as disinfectants repellents applied to human skin etc.) but falls within the scope of EU BPR (as amended)

COPR Products

From 1st September 2013, on the date of approval of an active substance for use in a particular product type under EU BPR (as amended), COPR does not “switch off” as it did under the old BPD, if that active substance is the last one to be approved in a particular product. Instead COPR continues to apply to that product for the period of time 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). However, this period of time will be dependent on whether or not an application for an authorisation under EU BPR for the particular product has been made.

Non COPR Products

Biocidal products not currently regulated under COPR but which fall within the scope of EU BPR (as amended) can continue to be made available on the UK market, subject to any requirements from any other relevant national legislation, for the period of time set out in Article 89 of EU BPR (as amended). This is currently up to 3 years from the date of approval of the last active substance in the product. However, this period of time will be dependent on whether or not an application for an authorisation under EU BPR for the particular product has been made.

How will I know if the active substances in my product have been approved?

The decision to approve an active substance is published by the EU Commission approximately 18 months before the formal approval date. Approval dates can be found in the Implementing Regulation published for that active substance. Links to these can be found on the EU Commissions website .

All companies making biocides available on the UK market should keep themselves up to date with the status of the active substance in their COPR/Non COPR product(s) through the biocides review programme. HSE has produced and regularly updates an active substance database, which contains the active substance approval date and other key dates to apply for product authorisation in the UK.

HSE will alert stakeholders of decisions to approve or not approve an active substance via the news section of this website and via our biocides ebulletin.

When do I need to apply for EU BPR authorisation?

The deadline for applications for authorisation of existing COPR/Non COPR products under EU BPR (as amended) is the date of approval of the last active substance in that product.

You can find the approval date in the Implementing Regulation published for that active substance. Links to these can be found on the EU Commissions website .

HSE has also produced an active substance database which contains the active substance approval date and other key dates for apply for authorisation in the UK.

For further details of the product authorisation processes in the UK please see the product authorisation section of this website.

What will happen to my product if I apply for product authorisation?

If an application for product authorisation is made under EU BPR (as amended), you can continue to make the product available on the UK market for the period of time set out in Article 89 of EU BPR (as amended). This is currently up to 3 years from the date of approval of the last active substance in the product.

For products approved under COPR, the expiry date of the approval will be amended to a date 3 years from the date of approval of the last active substance in the product.

During this time, 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 before (and after) the product is Authorised under EU BPR, namely:

What will happen to my product if I don’t apply for product authorisation?

If no application for product authorisation is made under EU BPR (as amended), the 365 day phase out period as set out in Article 89 of EU BPR (as amended) will apply from the date of approval of the last active substance in the product.

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

For products that hold a COPR approval, the final expiry date will be set at 365 days from the date of approval of the last active substance.

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, 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 before (and after) the product is Authorised under EU BPR, namely:

I have submitted an application for product authorisation for my product but it failed the validation check, what happens now?

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:

For products that hold a COPR approval, the final expiry date will be set at 365 days from the date of approval of the last active substance.

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, 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 before (and after) the product is Authorised under EU BPR, namely:

A decision has been made not to authorise my product what happens now?

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:

For products that hold a COPR approval, 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, 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 before (and after) the product is Authorised under EU BPR, namely:

A decision has been made to authorise my product what happens now?

The original text of the EU BPR did not include a provision to allow a phase out period for existing stocks of biocidal products that didn’t comply with the conditions of authorisation granted under the EU BPR. This meant that existing stocks in the supply chain not labelled in accordance with the EU BPR authorisation would become illegal when the product was authorised under EU BPR.

The UK highlighted the absence of this phase out period to the EU Commission and they decided to take action to remove the anomaly. This has resulted in a 365 days phase out period being included in Article 89 (4) of the EU BPR by amending Regulation 334/2014.

Existing stocks of the product in the supply chain that does not comply with the conditions of authorisation granted under the EU BPR (as amended) can be phased off the UK market. 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 granting the EU BPR authorisation.

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

For products that hold a COPR approval, the final expiry date of the CoPR approval will be set at 365 days from the date of the official letter granting the EU BPR authorisation.

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, 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 before (and after) the product is Authorised under EU BPR, namely:

A non-approval decision has been made for an active substance in my product what happens now?

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:

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:

Updated 2014-10-24