One Day Seminar on Biocidal Products Regulation – Liverpool, 24 February 2016

This page contains details of recent regulatory decisions and general news relating to the regulation of biocidal products.

Information on significant historical regulatory decisions can be found in our archive.


One Day Seminar on Biocidal Products Regulation: Product Authorisation Overview and Guidance

HSE’s Chemicals Regulation Directorate (CRD) will be holding a one-day seminar to provide an overview and guidance, via a series of presentations and interactive sessions on general aspects of the Biocidal Product Regulation (BPR) EU 528/2012 and the UK National Legislation COPR. The seminar will be held at the Hilton Hotel in Liverpool on Wednesday 24th February, 2016. Registration will begin from 8:30am; the seminar will start at 9:00am and will finish around 4:30pm. The cost per delegate for the seminar will be £430.00 (plus 20% VAT).

Format of the day

On the day delegates will hear from CRD staff responsible for managing and evaluating biocidal product applications. The focus of the sessions will be on how the regulations work in practice, providing advice on common pitfalls, and how to tackle or avoid them as well as practical IT demonstrations. The seminar will also be a good opportunity for delegates to network, share experiences, and make suggestions for improvements.

Topics of discussion

It is proposed that the event will cover topics including:

  • Introduction to COPR
  • Transition to EU BPR
  • Biocidal Products Regulation –  Application types
  • Biocidal Products Regulation – Evaluation Process
  • Biocidal Products Regulation – Common dossier pitfalls and advice
  • Biocidal Products Regulation – Fees
  • EU groups and emerging trends
  • Practical IT Demonstration- FEPA 1 Form, Active substance database, Article 95 list and CIRCA BC

Registrations

If you would like to register for this seminar please complete the application form below and send it to our administration team at events@hse.gsi.gov.uk.
The closing date for applications is Monday 18th January 2016.

Given the nature of the event, places will be limited to a maximum of 60 people, and will be issued on a first-come first-served basis.

Further Information

Final information about the seminar will be sent to you 2 weeks before the event.  A full list of delegates and seminar papers will be supplied on the day.

Should you require any further assistance please telephone: +44 (0)1904 455920 or email: events@hse.gsi.gov.uk.


EU Biocides Regulation 528/2012 (EU BPR) – ECHA’s open invitations following withdrawal of support for Didecyldimethylammonium chloride (DDAC (C8-10)) (product type 5), Performic acid generated from formic acid and hydrogen peroxide (product types 3, 5 and 6), Formic acid (product types 11 and 12) and Silver Copper Zeolite (product type 5) from the biocides active substance review programme

The following active substance/product type combinations are no longer considered to be supported in the biocides active substance review programme:

  • Didecyldimethylammonium chloride (DDAC (C8-10)) (CAS No. 68424-95-3) for product type 5;
  • Performic acid generated from formic acid and hydrogen peroxide for product types 3, 5 and 6;
  • Formic acid (CAS No. 64-18-6) for product types 11 and 12; and
  • Silver Copper Zeolite (CAS No. 130328-19-7) for product type 5.

The European Chemicals Agency (ECHA) has published an open invitation, which allows interested companies to take over the role of participant for the above active substance/product type combinations.

Interested companies should complete the notification procedure in Article 17 of the Review Regulation by the 30 September 2016. Notifications should be submitted to the European Chemicals Agency (ECHA), via R4BP.

If no-one takes over the role of participant, these active substance/product type combinations will be subject to a non-approval decision and products containing them for the affected product types will have to be removed from the market.


EU Biocides Regulation 528/2012 (EU BPR) – ECHA’s open invitations following redefinition of active substances in the biocides active substance review programme

Where the evaluation of an active substance demonstrates that it does not exactly match the identity of the substance as originally included in the Review Programme (Part 1 of Annex II of the biocides Review Regulation), the substance identity will be redefined by the evaluating competent authority (after consultation with the participant). It will be the redefined substance that will then go forward for Approval under the EU BPR, whilst for the ‘original’ substance an opportunity will be made for industry to come forward and take over the role of participant, and so support that ‘original’ substance through the review programme.

The following active substance/product type combinations originally included in the review programme have been so redefined and are therefore no longer considered to be supported in the biocides active substance review programme,

  • Bacillus subtilis for product type 3 (this does not cover does not cover Bacillus amyloquefaciens);
  • Bacillus sphaericus for product type 18 (this does not cover Bacillus sphaericus 2362, strain ABTS-1743); and
  • Bacillus thuringiensis subsp. israelensis, Serotype H14 for product type 18 (this does not cover Bacillus thuringiensis subsp. israelensis, strain SA3A).

The European Chemicals Agency (ECHA) has published an open invitation, which allows interested companies to take over the role of participant for the above active substance/product type combinations.

Interested companies should complete the notification procedure in Article 17 of the Review Regulation by the 30 September 2016. Notifications should be submitted to the European Chemicals Agency (ECHA), via R4BP.

If no-one takes over the role of participant, these active substance/product type combinations will be subject to a non-approval decision and products containing them for the affected product types will have to be removed from the market.


Biocides Manual of Decisions (MoD) becomes obsolete – European Court of Justice decision on products with indirect effects on the target organism and scope of EU BPR – first step deadline 1 October 2016

Under the Biocidal Products Directive (BPD) where the scope of the legislation was unclear, issues were discussed at the EU level. When the EU Commission finalised decisions on scope issues, these are included in the BPD Manual of Decisions (MoD).

However as the EU Biocides Regulation (EU BPR) has repealed and replaced the BPD, the guidance provided in the MoD is now obsolete.

The EU Commission confirmed in their paper “New authoritative guidance in the meaning of Article 15 of Regulation (EU) No 1062/2014” that the MoD is obsolete as of 1 October 2015.

If you have relied on the guidance previously provided by the MoD to conclude that your product(s) were out of the scope of the biocides legislation, but your product might now be within the scope of the EU BPR, there is an opportunity to support the relevant active substance/product type combination. The EU Commission has specifically identified the issue of products that only work by indirect means on the target organism, which were previously considered to be outside the scope of the old BPD. Due to a decision by the European Court of Justice, that position has had to be reconsidered, and such products may now be within the scope of the EU BPR and therefore the active substances will need to be supported,  The EU Commission note provides information about the process to follow and further information on the European Court of Justice decision. Additional information on the declaration, notification, submission processes can be found on the European Chemicals Agency website. Please note the deadline for the first step in the process to support the relevant active substance/product type combination is 1 October 2016

If you are unsure if your product now falls within the scope of the EU BPR please contact your National helpdesk or the ECHA helpdesk. Please note HSE are able to deal with enquiries that are relevant to our role as the UK Competent Authority (CA). If you do not have products on the UK market (or are not about to put them on the UK market) and you are based in another EU Member State (MS) we advise you to contact the CA in your MS.

Published 23 October 2015


EU Biocides Regulation 528/2012 (EU BPR) – 30 October 2015 deadline

A number of active substance/product type combinations are no longer considered to be in the biocides active substance review programme. Details can be found in Part 2 of Annex II (page 28 to 33) of the Review Regulation of the EU Biocides Regulation which is the “withdrawal notice” for these active substance/product type combinations.

Anyone wishing to take over the role of participant of these active substance/product type combinations should complete the notification procedure in Article 17 of the Review Regulation by 30 October 2015Notifications should be submitted to the European Chemicals Agency (ECHA), via R4BP.

If no-one takes over the role of participant these active substance/product type combinations will be subject to a non approval decision, and products in these product types containing these active substances will have to be removed from the market.

Published 29 September 2015


EU Biocides Regulation 528/2012 (EU BPR) – 14 October 2015 deadline for dialuminium chloride pentahydroxide

As the scope of the EU Biocides Regulation 528/2012 (EU BPR) is different in some aspects from the Biocidal Products Directive (BPD), the EU BPR Review Regulation allows for affected active substances to be included into the review programme.

This process only applies to active substances that weren’t included in the review programme previously for certain specific reasons:

  • due to incorrect advice from the EU Commission or Competent Authority (CA);
  • it benefited from a food and feed derogation in the Fifth Review Regulation; and/or
  • due to change of the scope of the product type.

The first step in the process has been completed for dialuminium chloride pentahydroxide (CAS 12042-91-0) in product type 2 as a declaration to notify was submitted and accepted by the European Chemicals Agency (ECHA).

For the next step, interest companies have until 14 October 2015 to complete the notification procedure in Article 17 of the Review Regulation. Notifications should be submitted to the ECHA, via R4BP.

If the notification is accepted the EU Commission will include dialuminium chloride pentahydroxide (CAS 12042-91-0) in the review programme for product type 2.

For the final step the notifier must then submit the dossier for approval under EU BPR or for inclusion in Annex I to EU BPR for active substance/product type combination within two years of the acceptance of the notification in step 2.

If no-one submits a notification for dialuminium chloride pentahydroxide (CAS 12042-91-0) for product type 2 by 14 October 2015 it will not be included in the review programme and cannot be used as an active substance in biocidal products made available on the EU market. 

For further details of the UK CAs understanding of the declaration and notification process under Articles 15 to 19 of the EU Review Regulation are outline on our website.

Published 29 September 2015


European Chemicals Agency (ECHA) – Biocides Stakeholders’ Day – 1 September 2015

The European Chemicals Agency (ECHA) held its Biocides Stakeholders’ Day on 1 September 2015 in Helsinki.

Details of the programme, copies of the presentations and a video recording of the event can be found on the ECHA website.

Published 29 September 2015


Withdrawal of the General Industry Charge

Legislation enables HSE to collect fees and charges from those placing biocidal products on the market. This is to recover costs that arise from work it does under the EU Biocidal Products Regulation No 528/2012.  Until April 2015, this was done under the Biocidal Products (Fees and Charges) Regulations 2013. However, these regulations have been revoked and the costs are now dealt with under the Health and Safety and Nuclear (Fees) Regulations 2015. 

When HSE consulted on the Fees and Charges regulations in 2013, we set out our intention to review the requirement in those Regulations for an Annual Charge (commonly known as the General Industry Charge or GIC).

The review led to a decision to withdraw the GIC and the legal changes to bring this about were made through the Health and Safety and Nuclear (Fees) Regulations 2015.  As a result:

  • the GIC will not be collected from 2015 onwards
  • with immediate effect, companies no longer need to notify HSE of their liability to pay the GIC

The final year in which HSE collected the GIC was 2014 (for the period 1st April 2013 to 31 March 2014).

In Northern Ireland similar arrangements will apply.  Here HSE has collected the GIC on behalf of HSENI and changes enabling withdrawal of the GIC are also being made.

Please note: Activities for which a fee is payable remain unchanged.

If you have any questions about this change please email: chemicalsconsultation@hse.gsi.gov.uk

Published 20 August 2015


Use of biocidal products affected by the 1 September 2015 deadline

It has been brought to HSE attention that the prohibition in Article 95 is causing some confusion. 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 have 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 about the requirement of Article 95 can be found on the ECHA website
Further information about the Article 95 requirements in the UK.

Published 6 August 2015


HSE Biological Agent e-bulletin

Some companies may have recently received HSE Biological Agent e-bulletin, which highlights the upcoming Article 95 deadline. The e-bulletin was targeted at the disinfectant industry and as such specifically mentioned that disinfectants cannot be made available on the market after the 1 September 2015 if the supplier isn’t included in the Article 95 list. HSE biocides team would like to remind the industry that the 1 September 2015 deadline applies to all biocidal products made available on the EU market not just disinfectants.

Published 6 August 2015


HSE’s Chemicals Regulation Directorate workshop on the Chemistry Data Requirements for Biocides Regulated Under Regulation 528-2012

HSE’s Chemicals Regulation Directorate will be holding two identical one day workshops which will provide an introduction and detailed presentation on the chemistry risk assessment for biocides regulated under regulation 528/2012. Further information can be found on CRD’s website.

Published 30 July 2015


HSE’s Chemicals Regulation Directorate workshop on Non Dietary Human Exposure Assessment of Biocide Products

HSE’s Chemicals Regulation Directorate (CRD) will be holding a one day workshop on technical aspects of the human health non dietary exposure assessment of biocide products. Further information can be found on CRD’s website.

Published 30 July 2015


Government agrees high level principles for stewardship regime for rodenticides – 23 July 2015

Pest rodents can threaten public and animal health and the UK infrastructure – controlling problem rodents is socially and economically important and, in some situations, may be required by law. A wide range of rodent control measures exist, including use of rodenticides (‘poisons’) which are valuable because they are effective and suitable for use in a variety of situations where other techniques would not work.

Regulatory environmental risk assessments have concluded that the use of First and Second Generation Anticoagulant Rodenticides (FGARs and SGARs) outdoors present a higher level of risk to non-target animals (such as predatory birds and mammals) than would normally be considered acceptable. As a result, outdoor use of these rodenticides would normally be banned. However the Government recognises that, despite carrying these risks, outdoor use of FGARs and SGARs is sometimes necessary as part of properly managed rodent control strategies.

In order to be able to authorise these rodenticides for use outdoors, the Government must be assured that the risks arising from such use will be properly managed. One way of providing that assurance is through a rodenticide stewardship regime. In April 2013, a Government Oversight Group, consisting of officials from HSE, HSE NI, DEFRA, Public Health England, Natural England, the Welsh and Scottish Governments and an independent scientific adviser, asked industry to explore ways to improve and spread good practice and to self-police professional use of FGARs and SGARs via an industry-led, voluntary ‘stewardship’ regime. The Government Oversight Group has agreed a set of high-level principles to assist industry in developing stewardship regimes. ( High-level principles for Rodenticide Regime(s) )

The new regime, managed by the Campaign for Responsible Rodenticide Use, will shortly be launched and will adhere to the high level principles. This will help to provide robust assurance that the continued use of FGARs and SGARs will use a hierarchy of risk controls for rodents, promoting responsible use and good practice by all suppliers and professional users.

High-level principles for Rodenticide Regime(s)

Any Rodenticide Stewardship Regime is built on:

  • using Integrated Pest Management, including use of rodenticides, involving a hierarchy of risk controls for rodents
  • using rodenticides responsibly, when demonstrated they are needed, because of their potential threat to human, animal health and the environment
  • being applicable to all suppliers, handlers and professional users of rodenticides approved under stewardship to address these risks
  • being robust, effective and workable, while remaining as simple as possible
  • covering the whole life-cycle of the rodenticide products: manufacture, supply chain, end-use, disposal and environmental fate
  • enabling good practice in the control of rodent populations as part of an integrated pest management system, while minimising resistance build-up and secondary poisoning in non-target species

Delivering key benefits such as:

  • governance of the supply chain, which gives governance over and provides the driver for later stages
  • a competent workforce capable of delivering stewardship standards and of demonstrating an appropriate understanding and attitude toward case-specific control of rodents and use of rodenticides
  • monitoring compliance with the regime and its environmental impacts, and if possible of the level of conflict reduction – ie an assessment of whether rodenticides and stewardship together are actually tackling the problems

Published 23 July 2015


EU Biocides Regulation 528/2012 – Active Substance(s) Approval(s)

The following active substance(s) have been evaluated under the EU Biocides Regulation 528/2012 (EU BPR) and will be approved for use in biocidal products placed on the EU market on 1 September 2015. Biocidal products containing these active substances will therefore need to obtain EU BPR authorisation if they are to remain on the market.

All affected companies are reminded that they must apply for UK product authorisation by 1 September 2015 in order to keep their biocidal products on the UK market after the active substance approval date, 1 September 2015. Please note if your biocidal product contains more than one active substance the date by which you have to apply for product authorisation will be the date the last active substance in the product is approved.

If no application for product authorisation in the UK is made by 1 September 2015 for a biocidal product containing these active substances, the biocidal product shall no longer be made available on the UK market after 28 February 2016. Disposal and use of existing stocks of the biocidal product may continue until 31 August 2016.  If the biocidal product has approval under the UK Control of Pesticides Regulations (COPR) its approval will be revoked.

Guidance for applying for product authorisation in the UK can be found in our EU BPR product authorisation section of the HSE biocides website. Guidance is also available there on the transitional arrangements for existing biocidal products on the UK market including products currently regulated under the COPR, which are effected by the approval of the above active substance(s). 

The full Union list of approved biocidal active substances, including links to the approval decisions and assessment reports can be found on the EU Commission’s website.

Published 21 May 2015


EU Biocides Regulation 528/2012 – Active Substance Amending Approval.

The EU Commission has published an EU Biocides Regulation (EU BPR) Implementing Regulation amending the approval of the following active substance to include its use as a curative/remedial algaecide treatment for construction materials: 

This use falls under PT2 of the EU BPR but would previously have been considered a PT10 use under the old Biocidal Products Directive. Please note this also amends the date of Approval for Nonanoic Acid for PT2. All affected companies are reminded that they must apply for UK product authorisation by 1 October 2015 in order to keep their biocidal products on the UK market after the active substance approval date, 1 October 2015. Please note if your biocidal product contains more than one active substance the date by which you have to apply for product authorisation will be the date the last active substance in the product is approved.

If no application for product authorisation in the UK is made by 1 October 2015 for a biocidal product containing this active substance, the biocidal product shall no longer be made available on the UK market after 29 March 2016. Disposal and use of existing stocks of the biocidal product may continue until 30 September 2016.  If the biocidal product has approval under the UK Control of Pesticides Regulations (COPR) its approval will be revoked.

Guidance for applying for product authorisation in the UK can be found in our EU BPR product authorisation section of the HSE biocides website. Guidance is also available there on the transitional arrangements for existing biocidal products on the UK market including products currently regulated under the COPR, which are effected by the approval of the above active substance(s). 

The full Union list of approved biocidal active substances, including links to the approval decisions and assessment reports can be found on the EU Commission’s website.

Published 21 May 2015


EU Biocides Regulation 528/2012 (EU BPR) – European Chemicals Agency – Biocides Stakeholders’ Day – 1 September 2015

The European Chemicals Agency (ECHA) will be holding a Biocides Stakeholders’ Day on 1 September 2015 in Helsinki.

The conference presents information about the BPR including available tools and support for companies. Its focus is on case studies and experiences from companies on the various aspects of the regulation.

The day is open to all and the content will be of particular relevance to European and national trade associations, SMEs, large companies, alternative suppliers and environmental as well as health NGOs.

Details of the programme, how to register and how to follow via web streaming can be found on ECHA’s website. For any enquiries relating to this event please contact ECHA.

Published 21 May 2015


EU Biocides Regulation 528/2012 – July 2015 Active Substances Approvals

The following active substances have been evaluated under the EU Biocides Regulation 528/2012 (EU BPR) and will be approved for use in biocidal products placed on the EU market on 1 July 2015. Biocidal products containing these active substances will therefore need to obtain EU BPR authorisation if they are to remain on the market:

All affected companies are reminded that they must apply for UK product authorisation by 1 July 2015 in order to keep their biocidal products on the UK market after the active substance approval date, 1 July 2015. Please note if your biocidal product contains more than one active substance the date by which you have to apply for product authorisation will be the date the last active substance in the product is approved.

  • If no application for product authorisation in the UK is made by 1 July 2015 for a biocidal product containing these active substances:
  • the biocidal product shall no longer be made available on the UK market after 28 December 2015; and
    use of existing stocks of the biocidal product may continue until 30 June 2016.

If the biocidal product has approval under the UK Control of Pesticides Regulations (COPR) its approval will be revoked.

Guidance for applying for product authorisation in the UK can be found in our EU BPR product authorisation section of the HSE biocides website. Guidance is also available there on the transitional arrangements for existing biocidal products on the UK market including products currently regulated under the COPR, which are effected by the approval of the above active substance(s).

The full Union list of approved biocidal active substances, including links to the approval decisions and assessment reports can be found on the EU Commission’s website.

Published 21 April 2015


ECHA publishes list of pending Article 95 applications

To increase transparency ahead of the 1 September 2015 deadline for compliance with Article 95 of the EU Biocides Regulation (EU BPR), the European Chemicals Agency (ECHA) has published a list of all pending Article 95 applications

The list which contains applications for which ECHA has not yet taken a decision will be updated regularly and its publication will be synchronised with the list of active substances and suppliers (the “Article 95 list”).

Further information about the requirement of Article 95 can be found on the ECHA website
Further information about the Article 95 requirements in the UK.

Published 21 April 2015


EU Biocides Regulation 528/2012 – Active Substance Non-Approval Implementing Decision Reminder

The EU Commission published in the Official Journal of the European Union

It was decided not to approval the active substances listed in this decision because all the participants have discontinued their participation from the biocides active substance review programme, or no complete dossier was received within the time period specified in Articles 9 and 12(3) of Regulation (EC) No 1451/2007 (Fifth Review Regulation).

All affected companies are reminded that biocidal products containing the active substances in the list product type:

  • shall no longer be made available on the market after 15 May 2015; and
  • use of existing stocks of the biocidal product may only continue until 14 November 2015.

Companies must manage the supply of the affected product to ensure there will be none remaining in the EU supply chain by 15 May 2015.

If the biocidal product was approval under the UK Control of Pesticides Regulations (COPR), affected companies will have received a certificate to revoke the COPR approval in line with the above dates.

Published 21 April 2015


EU Biocides Regulation 528/2012 – May and June 2015 Active Substance(s) Approval(s)

The following active substance(s) have been evaluated under the EU Biocides Regulation 528/2012 (EU BPR):

Chlorfenapyr will be approved for use in biocidal products placed on the EU market on 1 May 2015 and Propiconazole and Cypermethrin on 1 June 2015. Biocidal products containing these active substance(s) will therefore need to obtain EU BPR authorisation if they are to remain on the market.

All affected companies are reminded that they must apply for UK product authorisation by 1 May 2015 (Chlorfenapyr) and 1 June 2015 (Propiconazole and Cypermethrin) in order to keep their biocidal products on the UK market after the active substance approval date, 1 May 2015 (Chlorfenapyr) and 1 June 2015 (Propiconazole and Cypermethrin). Please note if your biocidal product contains more than one active substance or more than one product type the date by which you have to apply for product authorisation will be the date the last active substance in the product is approved.

If no application for product authorisation in the UK is made by 1 May 2015 (Chlorfenapyr) or 1 June 2015 (Propiconazole and Cypermethrin) for a biocidal product containing these active substance(s), the biocidal product shall no longer be made available on the UK market after 28 October 2015 (Chlorfenapyr) or 28 November 2015 (Propiconazole and Cypermethrin). Disposal and use of existing stocks of the biocidal product may continue until 30 April 2016 (Chlorfenapyr) or 31 May 2016 (Propiconazole and Cypermethrin).  If the biocidal product has approval under the UK Control of Pesticides Regulations (COPR) its approval will be revoked.

Guidance for applying for product authorisation in the UK can be found in our EU BPR product authorisation section of the HSE biocides website. Guidance is also available there on the transitional arrangements for existing biocidal products on the UK market including products currently regulated under the COPR, which are effected by the approval of the above active substance(s). 

The full Union list of approved biocidal active substances, including links to the approval decisions and assessment reports can be found on the European Chemicals Agency (ECHA) website.

Published 22 January 2015


EU Biocides Regulation 528/2012 (EU BPR) – New Review Regulation Published

The Review Regulation (Regulation EU No. 1062/2014) of the EU Biocides Regulation 528/2012 (EU BPR) was published in the Official Journal of the European Union on 10 October 2014 and entered into force on 30 October 2014.

Details of the key aspects of the EU BPR Review Regulation.

Published 30 October 2014


EU Biocides Regulation 528/2012 (EU BPR) – Withdrawal notice

A number of active substance/product type combinations are no longer considered to be in the biocides active substance review programme. Details can be found in Part 2 of Annex II (page 28 to 33) of the Review Regulation (Regulation EU No. 1062/2014) of the EU Biocides Regulation 528/2012 (EU BPR) and this is the “withdrawal notice” for these active substance/product type combinations.

Anyone wishing to take over the role of participant of these active substance/product type combinations should complete the notification procedure in Article 17 of the Review Regulation by 30 October 2015. If no-one takes over the role of participant, products in these product types containing these active substances will have to be removed from the market.

Published 23 October 2014


EU Biocides Regulation (EU BPR) – Active Substance Approval

The following active substance has been evaluated under the EU Biocides Regulation 528/2012 (EU BPR) and the EU Commission has decided to approve it for use in biocidal products placed on the EU market. Biocidal products containing this active substance will therefore need to obtain EU BPR authorisation if they are to remain on the market.

This substances will be added to the Union list of approved active substances (formerly Annex I of Directive 98/8/EC) for use in biocidal products and treated articles on 1 May 2016. Companies wishing to place biocidal products on the EU market containing it in the relevant product type must apply for product authorisation by 1 May 2016. Please note if your biocidal product contains more than one active substance the date by which you have to apply for product authorisation will be the date the last active substance in the product is approved.

If no application for product authorisation in the UK is made by 1 May 2016, the biocidal product shall no longer be made available on the UK market after 28 October 2016; use of existing stocks of the biocidal product may continue until 1 May 2017.

Guidance for applying for product authorisation in the UK can be found in our EU BPR product authorisation section of this website. Guidance is also available there on the transitional arrangements for existing biocidal products on the UK market including products currently regulated under the UK Control of Pesticides Regulations (COPR), which are effected by the approval of the above active substance(s). 

The full Union list of approved biocidal active substances, including links to the approval decisions and assessment reports can be found on the EU Commission’s website.

Published 23 October 2014


Publication of the 6th ATP to the CLP Regulation (EC 1272/2008) Effect on biocidal products

The 6th ATP to the CLP Regulation (EC 1272/2008) was published in the Official Journal of the European Commission on 6th June 2014 as Commission Regulation (EU) No. 605/2014 .

In particular, stakeholders should be aware that included in this regulation is the harmonised classification for some substances used in biocidal products, for example 3-iodo-2-propynyl butylcarbamate (IPBC) (CAS No. 55406-53-6), Formaldehyde (CAS 50-00-0). Please see the Regulation for the full list of substances.

Companies placing biocidal products on the EU market (including Approval Holders under the UK Control of Pesticides Regulation (COPR) and UK Authorisation Holders under EU Biocides Regulation (EU BPR)) will need to take these classifications into account when labelling biocidal products.

With specific regard to IPBC, it is now classified as a skin sensitiser. Consequently, consideration will need to be given as to whether the use of COPR approved biocidal products containing IPBC by non-professionals can continue. HSE will be contacting all affected COPR Approval Holders/EU BPR Authorisation holders regarding this issue over the coming weeks.

Published 27 June 2014


EU Biocides Regulation 528/2012 (EU BPR) – New active substance approvals

The following active substance(s) have been evaluated under the EU Biocides Regulation 528/2012 (EU BPR) and the EU Commission has decided to approve them for use in biocidal product placed on the EU market. Biocidal products containing these active substance(s) will therefore need to obtain EU BPR authorisation if they are to remain on the market. 

These substance(s) will be added to the Union list of approved active substances (formerly Annex I of Directive 98/8/EC) for use in biocidal products and treated articles on 1 September 2015 with the exception of Zineb which will be added on 1 January 2016. Companies wishing to place biocidal products on the EU market containing these active substance(s) in the relevant product type must apply for product authorisation by 1 September 2015 (1 January 2016 for Zineb). Please note if your biocidal product contains more than one active substance the date by which you have to apply for product authorisation will be the date the last active substance in the product is approved.

If no application for product authorisation in the UK is made by 1 September 2015 (1 January 2016 for Zineb) for a biocidal product containing the above active substance(s), the biocidal product shall no longer be made available on the UK after 28 February 2016 (30 June for Zineb) and disposal and use of existing stocks of the biocidal product may continue until 31 August 2016 (31 December 2016 for Zineb).

Guidance for applying for product authorisation in the UK can be found in our EU BPR product authorisation section of this website. Guidance is also available there on the transitional arrangements for existing biocidal products on the UK market including products currently regulated under the UK Control of Pesticides Regulations (COPR), which are effected by the approval of the above active substance(s).

The full Union list of approved biocidal active substances, including links to the approval decisions and assessment reports can be found on the EU Commission’s website.

Published 4 April 2014


EU Biocides Regulation 528/2012 (EU BPR) – Simplified actives substances (substances of low concern) procedure for amending Annex I

One of the measures introduced in the EU Biocides Regulation 528/2012 (EU BPR) was the simplified authorisation procedures for products that have a more favourable environmental or human or animal health profile. Such products can only be placed on the EU market (following authorisation) if they contain active substances that are listed in Annex I of the EU BPR.

The EU Commission has published an Implementing Regulation (Regulation (EU) No. 88/2014 ), which specifies the procedure for adding to and amending the substances listed in Annex I of the EU BPR.

The HSE website provides further information on simplified actives substances (substances of low concern) and the simplified product authorisation process.

Published 4 April 2014


New EU Biocides Regulation Active Substance Approval Implementing Regulations

The EU Commission has published EU Biocides Regulation (EU BPR) Implementing Regulation approving the following active substance:

These active substances will be added to the EU BPR Article 9 list of Approved Active Substances. Applications for product authorisation or mutual recognition in parallel must be submitted by 1 July 2015.

  • The EU Commission has also published an EU Biocides Regulation (EU BPR) Implementing Regulation amending the approval of Nonanoic Acid for use in Product Type 2  to include its use as a curative/remedial algaecide treatment for construction materials. This use falls under PT2 of the EU BPR but would previously have been considered a PT10 use under the old Biocidal Products Directive. Please note this also amends the date of Approval for Nonanoic Acid for PT2 and applications for product authorisation or mutual recognition in parallel must now be submitted by 1 October 2015.

Links to previous Annex I/IA Inclusion Decisions and Implementing Regulations can be found on the EU Commission’s website .

  • Guidance on applying for UK product authorisation.
  • Guidance on the transitional arrangements including guidance for products currently regulated under the UK Control of Pesticides Regulations (COPR). 

Published 6 December 2013


Article source: http://www.hse.gov.uk/biocides/news.htm