With extensive experience in the field of environmental risk assessment, Peter Fisk Associates offers services relating to compliance with European (EU) legislation on biocides. Biocidal products are categorised into 22 different product types such as wood preservatives, disinfectants, slimicides – see http://echa.europa.eu/regulations/biocidal-products-regulation/product-types.
EU law (Biocides Regulation 528/2012) requires that the active substance(s) i.e. the substance/s in the biocidal product that give it biocidal properties is/are approved and the formulated biocidal product which is placed on the market, is assessed for its claims, efficacy and authorised for all of its applications. A biocidal product authorisation application requires a technical dossier containing information on the properties of the active substance as well as the co-formulants, with risk assessment for all uses. There is obligatory data-sharing to reduce the need for new testing and the introduction of mandatory deadlines for submission of applications for product authorisation depending on active substance.
Applying for authorisation of a biocidal product: planning the process
It is important to understand the regulatory status of the active substance(s).
- Identify the active substance(s) in your product (the ingredient related to biocidal claim) and the end uses of the product.
- Establish efficacy, stability and uses in relation to product claims.
- Establish active substance status in relation to approval per product type – see http://echa.europa.eu/web/guest/information-on-chemicals/biocidal-active-substances. Your supplier should know if it has been approved or is pending approval.
- Have the permission (Letter of Access) to the relevant data on the active substance in your dossier. Your supplier will likely be the data owner themselves, or can advise you.
- Identify the EU countries you will require authorisation in to determine type of authorisation (i.e. whether it is best to authorise in one or a limited set of EU countries or for the whole EU).
The above factors determine how you go about compiling product authorisation dossier(s) and when you need to submit them to the authorities. Product authorisation dossiers require a lot of technical information on the active substance, and the other ingredients in the products, and require a risk assessment. There is also a need to demonstrate that the product is effective and that it is labelled correctly. Doing assessment for product authorisation dossiers takes time and requires detailed information, and can be time consuming and costly.
Taking the time to plan will put you in a better position to understand what you need to do and when. We suggest you look at information from the regulators, and also check with your suppliers on active substance status and what information they can supply to you and at what cost.
PFA expertise is grounded in the know-how in applying the best scientific knowledge to dossier development, which is essential for both regulatory acceptance and cost savings. Our understanding of scientific techniques and practical context enables us to make the best use of existing information, and to ensure that testing programmes are appropriate to the substance being registered. We have expert knowledge of chemistry, degradation in the environment, toxicology and ecotoxicology, and thus can process dossier information correctly and with confidence.
You might find the information below useful:
There is quite a lot of information available from the regulators, particularly
- ECHA (European Chemicals Agency – see http://echa.europa.eu/regulations/biocidal-products-regulation which is the European regulator for biocides.
- national competent authorities – for example HSE (UK) see http://www.hse.gov.uk/biocides/, including clear advice on the process for product authorisation see http://www.hse.gov.uk/biocides/marketing.htm
Please contact us to discuss your needs.