- January 25, 2014
- UK - HSE
Biocidal products on the UK market: HSE clarifies how to apply for an "Essential Use Authorisation"
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:
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- 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.
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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