Biocides

This page provides a brief understanding of biocides and the associated legislation in place in Northern Ireland, for the latest news from ECHA and HSE in relation to biocides, please click on the following link:

A biocide is a chemical substance, mixture, or microorganism intended to control any harmful organism in a way that is not purely physical or mechanical.

What are biocidal products?

Biocidal products are used to protect people and animals, preserve goods, stop pests like insects or rodents and control viruses, bacteria and fungi through a chemical or biological action. Common examples are disinfectants, wood preservatives and insect repellents.

Typically a biocidal product will be a mixture of chemicals and will include the 'active substance'. The active substance has the controlling effect on the harmful organism.

Biocidal products can also be:

  • 100% active substance with no other components
  • articles that have been impregnated with the active substance, such as disinfecting wipes
  • bacteria, viruses or other micro-organisms

Biocidal products without an active substance

The active substance could be created when the product is used, either from:

  • Mixing the product with another chemical
  • A reaction with the air or moisture

This is called 'in-situ generation'. It’s still covered by the law, even if no products are supplied and the biocide is generated from everyday things. For example, when a machine generates ozone from oxygen in the air to be used as a disinfectant.

Find out more about in-situ generation via HSE (In situ generation: Active substances vs biocidal products (hse.gov.uk))

Treated articles

A treated article is something which has been treated with, or intentionally includes, one or more biocidal products; for example wood that has been treated with a preservative to protect it from decay, is known as a treated article.

Find out more about treated articles via HSE (Treated articles - Biocides - HSE)

What is the Biocidal Products Regulation and its associated requirements in Northern Ireland?

The EU Biocidal Products Regulation (EU BPR) is applicable in Northern Ireland. However, HSE GB will continue to deliver Competent Authority functions for Northern Ireland in relation to biocides.

All biocidal products supplied in Northern Ireland must comply with the EU BPR e.g.

  • EU BPR Article 95 supplier
  • Advertisement requirements
  • Record keeping requirements

You should also check your duties to classify, label and notify poison centres etc. under general chemical laws (such as the Classification, Labelling and Packaging Regulation, CLP).

The HSE (GB) website has been updated to outline changes to processes and explain how the EU BPR regulations continue to apply in Northern Ireland.

If you wish to make an application for:

  • product authorisation
  • active substance approval
  • inclusion in the EU Article 95 list

Please visit the HSE (GB) website to find out who you need to submit your application to:

To check whether an active substance has been approved under EU BPR, please check the following ECHA link:

To check whether a biocidal product has been authorised under EU BPR, please check the following ECHA link:

Any active substance approval or product authorisations previously granted for the United Kingdom are still valid in Northern Ireland and for the latest updates to the BPR Active Substance List for GB and NI, and the UK Authorised Biocidal Products List, please see the following links:

Authorisation holders must:

  • continue to comply with the terms and conditions for the biocidal products as outlined in their certificate of authorisation and
  • be established in the EU or Northern Ireland

New Union authorisations granted under EU BPR by the EU Commission are applicable in Northern Ireland (but not Great Britain).

Pending Union applications submitted under EU BPR are still valid in Northern Ireland.

For all other pending product authorisation application types (e.g. National Authorisation, Mutual Recognition etc.) please contact HSE at NI.Biocides@hse.gov.uk to confirm you wish to proceed with the application for access to the market in Northern Ireland.

Businesses who wish to supply a biocidal product in Ireland should visit PRCD - Biocides (agriculture.gov.ie) to ensure compliance with the appropriate legislation.

What are the requirements of the Biocidal Products Regulation in Great Britain (GB BPR)?

The existing EU Biocidal Products Regulation (EU BPR) has been copied into GB law and amended to enable it to operate effectively in GB.

This means that most aspects of EU BPR will continue in the same way under the new GB Biocidal Products Regulation (GB BPR) that came into force at 11pm on 31 December 2020.

HSE (GB)'s biocides website has been updated and contains details of the GB BPR requirements for biocidal products in GB.

HSE (GB)'s updated Brexit guidance highlights the main differences between EU BPR and GB BPR as well as the things that are unchanged.

Product Application Forms

New combined Great Britain (GB) and Northern Ireland (NI) product application forms are now available online.

A single form now allows businesses to submit:

  • a GB only application
  • a NI only application or
  • a joint GB and NI application

For more information on the different product application types please visit the HSE (GB) website at:

Are your contact details up to date?

Businesses that hold product authorisations and approvals in Great Britain and Northern Ireland under the GB and EU Biocidal Products Regulations (GB BPR and EU BPR) or the Control of Pesticides Regulations (COPR) should make sure HSE (GB) has the right contact details.

If the details they hold are out of date, you may not receive important information about your product authorisation or approval.

Enquiries regarding applications under the Control of Pesticides Regulations (COPR): pa.copr@hse.gov.uk

Enquiries regarding applications under the EU Biocides Products Regulations (EU BPR) and GB BPR: biocidesapplications@hse.gov.uk

Other Biocides Enquiries: biocidesenquiries@hse.gov.uk

What is the Control of Pesticides Regulations (COPR)?

The Control of Pesticides Regulations (COPR) is an additional law that controls biocides in Great Britain (GB) and Northern Ireland (NI). COPR is an older law that only applies to some types of biocidal products.

EU BPR and GB BPR apply to a wider range of biocidal products so to help companies with the change, some products can continue to be regulated under COPR while the active substance is still being evaluated under GB or EU BPR.

Eventually, COPR will become redundant and all relevant biocidal products (those in the scope of COPR and those that are not in the scope of COPR) will have moved over to be regulated under EU or GB BPR.

Please visit the following link to learn more abut COPR and which biocidal products require COPR approval from HSE before they can be advertised, sold, supplied, stored or used in NI and GB.

Biocidal product and active substance fact sheets

HSE have published a series of fact sheets for businesses that want to gain, or maintain, access to the GB market after EU exit.

The fact sheets provide information which will be useful to those who may be impacted by the changes, such as:

  • Current UK biocides authorisation holders
  • New and ongoing product authorisation applications
  • Companies supporting active substance(s) for approval
  • Article 95 suppliers

Each fact sheet provides guidance on what action you need to take and when you need to do it.

GB application forms and IT systems

HSE can no longer access data and information in the EU databases and IT systems.

Applications for GB product authorisation, active substance approval and GB Article 95 suppliers should be made direct to HSE (not via R4BP) using their application forms and systems.

Details of each of the application processes including application forms and supporting documents can be found on the following sections of HSE's website:

A list of all the GB BPR application forms and templates can be found on HSE (GB)'s resources webpage.

HSE will accept the EU version of the applicable supporting document e.g. the draft Product Assessment Report (PAR), Summary of Product Characteristics (SPC) (including meta SPC) and active substance draft Risk Assessment Report (RAR) for applications that need to be resubmitted in GB.

GB fees

HSE continues to charge fees for processing and evaluating applications.

The fee levels are the same under GB BPR as they were under EU BPR.

HSE will not charge for receiving and handling the resubmission of data or applications due to loss of access to EU databases and IT systems. Fees to evaluate the resubmitted data or application will be applied as normal.

 

Stakeholder webinar recording available

HSE and the Department for Environment, Food and Rural Affairs (DEFRA) hosted a virtual stakeholder event on 20 January.

The webinar covered actions organisations need to take to keep their business moving now that the UK Transition period has ended and how the new GB regulatory regimes for chemicals impacts their work.

You can watch the session on biocides at the link below:

Keep up-to-date

If you want to keep up-to-date with news in relation to chemicals in the UK or any other subjects, please register on the HSE (GB) website at the following link:

During registration you can select which topics are relevant to you, such as REACH, Chemicals, Biocides, PIC and many others.

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