Biocidal Products Directive/Regulations (BPD/R)

The Directive has three main objectives:

• to harmonise the European market for biocidal products and their active substances such that product authorisation in one Member State can be recognised in other Member States;
• to provide a high level of protection for people, animals and the environment (from the use of biocidal products) through risk assessment. This requires the submission and evaluation of data relating to substances’ chemistry, toxicity to humans, and toxicity and fate in the environment;
• to ensure products are sufficiently effective against the target species.

The Directive is going to achieve its aims by reviewing notified existing active substances that were on the market when the directive came into force, via a 10-year review programme and evaluate new active substances prior to their marketing. This regulatory scheme will ultimately require all biocidal products to be authorised before they can be placed on the EU market and authorisation may be subject to certain conditions in order to minimise any risk to people, animals or the environment.

The Directive is implemented in Great Britain through the Biocidal Products Regulations 2001 (as amended) and in Northern Ireland through the Biocidal Products Regulations [Northern Ireland] 2001 (as amended). The Health and Safety Executive (HSE) acts as the Competent Authority (CA) to carry out the work under the BPD on behalf of UK Ministers. The BPR is enforced by both HSE and local authority inspectors and trading standards officers.

From time to time the Directive is amended, for example when a new or existing active substance is including onto Annex I of the Directive. These amendments are then automatically transposed/implemented into UK law.

The BPD has a specific definition for biocidal products. Despite the name a biocide does not actually have to kill, it may instead make harmless, repel or control harmful organisms by chemical or biological means.

Uses

There are 23 different biocidal product types covering disinfectants, preservatives, pest control and speciality biocides such as antifouling products and embalming and taxidermist fluids.

• Establish whether your product falls under the scope of the BPD.
• Check whether the active substance in your product is supported for review in the appropriate product types under the BPD review programme.

If the active substance in your product is supported:

• Ensure the product is marketed subject to existing national rules.
• Provide the National Poisons Information Service with product-specific safety information.
  All companies who place biocidal products on to the market in the UK are required to provide this information.
• Check your liability to pay the General Industry Charge, an industry-wide annual charge to cover the costs for general activity carried out by the UK authorities in operating the regulatory framework.

If the active substance in your product is not supported:

• Withdraw your product from the EU market. All products containing active substances which are not being supported through the review programme should have been withdrawn from the market before 01 September 2006.
• Decide whether to apply for an active substance to be evaluated. It remains the case that any biocidal products containing this active substance (where it has not been supported in an appropriate product type) need to be removed from the EU market until the substance has been evaluated and a positive recommendation for Annex I has been made. At this stage a provisional/product authorisation can be applied for.

If the active substance in your product was once, but is no longer supported:

If all participants for a given active substance/product type combination inform the EU Commission that they are withdrawing from the review programme, or where no dossier is received by a specified deadline then:

• the Commission gives public notice of this;
• within three months of this publication, producers, formulators, associations or other persons wishing to take over the role of participants for the active substance/product type combination concerned should inform the Commission;
• if the role of participant is taken over, products of this active substance/product type combination can remain on the market subject to the requirements for supported active substances above;
• if the role of participant is not taken over, products of this active substance/product type combination should be removed from the EU market within 12 months of the active substance being withdrawn/excluded from the review programme.

For example, products containing Notified active substances where no dossier was submitted for product types 16, 18, 19 and 21, these products need to be removed from the EU market by 22 August 2008.