Biocides

Biocides

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 that are grouped in 4 main areas – see http://echa.europa.eu/regulations/biocidal-products-regulation/product-types.

The EU Biocides Regulation 528/2012 (BPR) requires that the active substance(s) i.e. the substance/s in the biocidal product that give it biocidal properties is/are approved at Union level and the formulated biocidal product which is placed on the market, is assessed for its claims, its safety and efficacy and authorised for all of its applications at Member State level or at Union level in case of a Union authorisation dossier. A biocidal product authorisation application requires a technical dossier containing information on the properties of the active substance as well as the co-formulants, information on the properties and uses of the product, its efficacy and stability as well as a risk assessment for all uses. There is a mandatory data-sharing of data on vertebrates and a mandatory data sharing of all toxicological and environment data for the approved suppliers listing in order to reduce the need for new testing and to make sure the costs of data are fairly shared.

Under the BPR, biocidal product authorisation application must be made by the date of approval of the active substance otherwise the product must be removed from the market within 180 days of the active substance approval date. The use of existing stocks of that product may continue until 1 year after the approval date. A product authorisation application can also be made at a later date but until it is granted the products must be removed from the market.

Applying for authorisation of a biocidal product: planning the process

 It is important to understand the regulatory status of the active substance(s) and whether it is an existing active substance or a new active substance. 

An existing active substance (AS): An AS which was already available on the market in biocidal products on 14 May 2000 and which has been notified for the correct product type and is currently part of the review programme and under evaluation. An AS is regarded as “existing” only for the product-types for which it is being evaluated in the review programme.
A new active substance: An AS which was not on the EU market before or by 14 May 2000 and/or is not notified, e.g. is not currently being supported in the review programme for an appropriate product type.

  1. Identify the active substance(s) in your product (the ingredient related to biocidal claim) and the end uses of the product.
  1. Establish efficacy, stability and uses in relation to product claims.
  1. 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.
  1. 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.
  1. 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

Please contact us to discuss your needs.