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Biocidal products on the UK market: HSE clarifies how to apply for an "Essential Use Authorisation"


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In accordance with article 5 of EU Regulation (EC) 1451/2007 Member States may apply to the Commission for an extension of the deadline for the removal from the market of active substances which have been made subject to a decision not approving them for use in biocidal products (referred to below as an “essential use derogation”).


Member States are able to do this only where they consider that continued use of such a substance is essential for reasons of health, safety, protection of cultural heritage or is critical for the functioning of society, and where there are no available technically and economically feasible alternatives or substitutes that are acceptable from the standpoint of environment and health.

If the European Commission grants an active substance an essential use derogation, companies wishing to place a biocidal product/ or family of such products on the UK market must apply for an Essential Use Authorisation to HSE (UK Competent Authority for biocides), which will then be evaluated and a decision made as regards authorisation.

Any active substance essential use derogation granted by the European Commission will only be available for a specified, limited time and is subject to certain conditions, including that the active substance/s in question can only be used if:
  • it is reasonable to assume there are no unacceptable effects on human or animal health or on the environment;
  • it is subject to appropriate risk reduction measures;
  • the holder of the authorisation is seeking alternatives for such uses, or a dossier for the active substance is being prepared for submission.

Failure to comply with any conditions of the active substance essential use derogation or the essential use product authorisation, including failure to submit the active substance dossier by the stated deadline, may result in the withdrawal of the essential use authorisation. In such a case continuing to place the product on the market would constitute an offence and may lead to enforcement action, including the possibility of prosecution, under the relevant UK Regulations.


Related Links:

- EU Regulation 1451/2007 concerning the placing of biocidal products on the market
- EU Commission - Biocidal Product Regulation
- ECHA - Biocidal Product Regulation
- Regulation 13 of the Biocidal Products and Chemicals (Appointment of Authorities and Enforcement) Regulations 2013;
- Regulation 12 of the Biocidal Products and Chemicals (Appointment of Authorities and Enforcement) Regulations (Northern Ireland) 2013

Source internet page: UK HSE - Essential use authorisation
                   

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