The Biocidal Product Regulation (BPR)
Biocidal products are those designed to control harmful or unwanted organisms such as bacteria, pests, and viruses through the action of the active substance. Examples of biocidal products include disinfectants, alcohol hand washes or sanitisers, and insect repellents.
The Biocidal Product Regulation aims to improve regulation of these products due to their potential dangers to humans, animals, and the environment. This is achieved by requiring the registration of active substances and finished products. Biocidal products may only contain active substances that have previously been approved. (Ref suppliers Article 95).
In the UK, the Health and Safety Executive (HSE) are the Competent Authority for Biocides while the European Chemicals Agency (ECHA) is responsible for driving the legislation forward. Both can be consulted for advice on complying with this regulation.
The Biocidal Products Regulation – we are here to help.
What is a biocidal product?
A biocidal product as defined by the Biocidal Products Directive is “a substance intending to destroy, deter, render harmless, prevent the action of, or exert a controlling effect on any harmful organism by any means other than mere physical or mechanical action”. These products surround us in everyday life, from our places of work, education, or the home. However, the industry for a long time has remained largely unregulated and there is little the consumer can do to ensure what they are using is safe, ethical and fit for the intended purpose. This is where regulation (EU) No. 528/2012 or the BPR comes in. The BPR has separated these products into 22 product types and is helping regulate the market making it clearer for the end user to be certain of what they are using.
What is the Biocidal Products Regulation?
The Biocidal Products Regulation (BPR) is a piece of EU legislation released in 2012 replacing the Biocidal Product Directive. This was done to improve the functioning of the internal market in biocidal products without reducing the protection provided by these products. This legislation makes it illegal to sell a product which does not meet the requirements in the UK and European market.
The key changes from the old regulations to the new include treated articles being classed as biocides, the ability to share data, strict data requirements for products and streamlining the Union Authorisation system. These changes also encourage a reduction in animal testing across Europe by creating this obligation to share data.
The rules of BPR apply to the products in the form in which they are supplied to the user and not to the manufacturer or distributor, e.g. raw materials used in the manufacture of a biocidal product.
How does the Biocidal Product Regulation affect your Products?
The BPR requires the manufacturer to prove that everything claimed about a product is accurate including its lifespan, its effectiveness in use and its contents. They must also ensure a product is safe to use and make all this information clear and easy to interpret for the end user on the label. A product must make claims suitable to its purpose and area of use and have evidence in the form of testing to back up these claims. This requires extensive research and development from the manufacturer, as without the correct testing or reaching the minimum requirements for its intended purpose, whilst remaining safe to use and stable, then a product could be removed from the market in both the UK and Europe once its deadline has passed. This means a clock has already started ticking and failing to get your range ready in time may mean being blocked from huge parts of your market.
How we can help with your progress through the Biocidal Product Regulation
As a microbiological laboratory that offers a wide range of testing and regulatory services for organisations worldwide, we can act as your experts throughout BPR to ensure your products remain available to your markets in a cost-effective and timely manner. The majority of our biocides testing, including virology testing, is accredited by UKAS 4045 to ISO/IEC 17025:2017 standards.
We cover the entire range of biocidal product types, including disinfectants and preservatives. Additionally, we offer consultation services and technical support that you may need during the process, tailoring our services to your needs and unique requirements.
For more information about the Biocidal Product Regulation, please contact us.
Useful references
• https://echa.europa.eu/regulations/biocidal-products-regulation/legislation
• https://echa.europa.eu/regulations/biocidal-products-regulation/understanding-bpr
• https://echa.europa.eu/documents/10162/21742587/pg_on_bpr_en.pdf
• https://echa.europa.eu/regulations/biocidal-products-regulation/product-types