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Impact of the Article 95 alternative suppliers of active substance list on biocidal products made available on the UK market

Link to European Chemicals Agency - Application details

This page provides information about the impact of Article 95 of the EU Biocides Regulation 528/2012 (EU BPR), alternative suppliers of active substance, on biocidal products made available on the UK market. For information on the process to be included on the Article 95 alternative suppliers of active substance list please see the information on the European Chemicals Agency (ECHA) website .

Introduction

The objective of Article 95 of the EU Biocides Regulation 528/2012 (EU BPR) is to ensure that the costs of generating data and supporting active substances are shared fairly.

Companies that have not already submitted their own dossier on an active substance under the old Biocidal Products Directive (BPD) or the EU BPR can either submit a dossier, a letter of access, or if all data protection periods have expired, a reference to an existing dossier, to ECHA when they apply to be included in the Article 95 alternative suppliers of active substance list. In addition to manufacturers and importers, the amending Regulation (EU) No 334/2014 allows product suppliers (e.g. formulators) to apply to be included in the Article 95 alternative suppliers of active substance list.

Please note the provisions/requirement of Article 95 of the EU BPR are managed and implemented by ECHA. For information on the process to be included on the Article 95 alternative suppliers of active substance list please see the information on the ECHA website.  Any questions about the process to be included, amendments/corrections to the list, costs involved etc should be sent to ECHA  not HSE.

Impact of the Article 95 list on biocidal products made available on the UK market

By 1 September 2015, all companies making biocidal products available on the UK market must be able to demonstrate that their active substance supplier is included in the Article 95 list. This could include written confirmation of the source of the active substance formulated within the product and a link to the source’s entry on ECHA’s Article 95 list.

HSE does not intend to be prescriptive as to exactly what that evidence should comprise as we believe industry should have a degree of flexibility on this issue, but you should be able to demonstrate a clear, auditable trail showing the supply of the active substance used in your product is from a specific Article 95 listed company – for example that could be a Letter of Intent to Supply or a similar document from the Article 95 listed company; copies of paperwork such a contract between the companies for the supply of that substance; or invoices/delivery notices etc. If a company is making the biocidal product available on the market and is also the Article 95 listed company for the active substance in the product, a simple written confirmation of the fact that they will only be using their own source of the active substance will suffice.

The requirements of Article 95 of the EU BPR apply to all biocidal products made available on the EU market whether they have authorisation under the EU BPR, in the process of obtaining EU BPR authorisation or regulated under existing National legislation in the EU Member State. In the UK many product types covered under the EU BPR are currently regulated under legislation called the Control of Pesticides Regulations 1986 (COPR). The following information outlines how COPR approval holders and EU BPR authorisation holders, including prospective authorisation holders, can demonstrate their compliance with the requirements of Article 95 of the EU BPR.

Control of Pesticides Regulations (COPR)

All COPR Approval Holders need to submit evidence to HSE to prove that the supplier of the active substance in their product(s) or the product supplier is included in the Article 95 list. Have you submitted your evidence yet? If you haven’t send it to our usual address.

If HSE does not receive this information on your product(s) by 1 September 2015, the approval consents relating to the advertisement, sale and supply of your product(s) will expire/be revoked.

No phase out period for the advertisement, sale and supply of your product(s) on the UK market can be granted.

The approval consents relating to the storage, use and disposal of your product(s) will continue subject to the provisions of Article 89(2), 3(b) and 4(b) of EU BPR. So in practice this will mean storage and use continue under COPR until the review of the active substances in the product are completed and action is required to authorise the product under the BPR or to remove the COPR approval. This is the process that happens to all products where the actives are under review – national legislation such as COPR in the UK continue to regulate the products until action is required when the reviews are completed.

If the review of an active substance in the product ends in a decision not to approve the active substance, then the COPR storage and use consent will expire 18 months after the date of decision of non-approval. If all the active substances in the product gain positive approval decisions then an application for product authorisation under BPR has to have been made by the latest date of approval for the active substances in the product – as the companies who own the product are unlikely to make those applications as they have already decided to stop marketing the product due to Article 95, storage and use under COPR will therefore expire 365 days after the latest date of approval for active substances in the product.

To demonstrate this with some ‘worked examples’:

As action is taken for COPR products affected by Article 95 of the EU BPR, details of the relevant expiry dates for advertisement, sale, supply, storage and use will be included in the on-line databases. In some cases the final dates for storage and use will not yet be known as the active substance may still be under review – as in the example above for tetramethrin – so once the approval decision for tetramethrin is taken, the relevant dates in the database will be update.

Biocidal products authorised or being evaluated under the EU BPR

HSE will check the details provided to obtain authorisation to confirm the supplier of the active substance in the product(s) or the product supplier is included in the Article 95 list and may requested additional information to confirm compliance.

Other biocidal products

All other companies making biocidal products available on the UK market, which don't require approval under COPR or authorisation under the EU BPR at this time, must be able to demonstrate that their supplier is included in the Article 95 list and must provide it to HSE or Enforcement Authorities if requested.

Use of biocidal products affected by the 1 September 2015 deadline

Article 95 (as amended) of the EU BPR states that a biocidal product “shall not be made available on the market” if the product or active supplier isn’t included in the Article 95 list. However, Article 95 (as amended) of the EU BPR does not prohibit use of stocks of products that had already been supplied before 1 September 2015. The original text of Article 95 of the EU BPR did prohibit the use of biocidal products affected by 1 September 2015 deadline but this prohibition was removed when the requirements of Article 95 where updated via Regulation (EU) No 334/2014 which entered into force on 25 April 2014. Therefore, use of the biocidal products can continue after 1 September 2015.

Therefore, after 1 September 2015 use of biocidal products affected by the 1 September 2015 deadline can continue until an approval decision (positive or negative) is taken for active substance(s) in the product, at which point the relevant phase out periods in Article 89(2), 3(b) and 4(b) of EU BPR (as amended) will apply. If the biocidal product has approval under COPR the conditions of approval relating to storage and use continue to apply during this time and until the end of the Article 89 phase out period.

Further information

The ECHA website provided more information about the provisions/requirement of Article 95 of the EU BPR including information on

Updated 2016-05-10