Need guidance building your biocide product family strategy?

ECHA defines a biocide as:

“- any substance or mixture, in the form in which it is supplied to the user, consisting of, containing or generating one or more active substances, with the intention of destroying, deterring, rendering harmless, preventing the action of, or otherwise exerting a controlling effect on, any harmful organism by any means other than mere physical or mechanical action,

- any substance or mixture, generated from substances or mixtures which do not themselves fall under the first indent, to be used with the intention of destroying, deterring, rendering harmless, preventing the action of, or otherwise exerting a controlling effect on, any harmful organism by any means other than mere physical or mechanical action.”

The Biocidal Products Regulation (528/2012) classifies biocides into 22 product types (‘PTs’). They are divided into four main groups:

Group 1 – Disinfectants (human hygiene; disinfectants and algaecides not intended for direct application to humans or animals; veterinary hygiene; food and feed areas; drinking water)

Group 2 – Preservatives (preservatives for products during storage; film preservatives; wood preservatives; fibre, leather, rubber and polymerised materials preservatives; construction material preservatives; preservatives for liquid-cooling and processing systems; slimicides; working or cutting fluid preservatives)

Group 3 – Pest control (rodenticides; avicides; molluscicides, vermicides and products to control other vertebrates; piscicides; insecticides, acaricides and products to control other arthropods; repellents or attractants; control of other vertebrates)

Group 4 – Other biocidal products (antifouling products; embalming or taxidermist fluids)

No, a notification, registration or authorisation of the biocidal product is usually needed in every country in which you wish to market the product.

The data requirements that are needed for product registration/authorisation are dependent on factors such as the proposed product type (PT), specific product uses, intended user (professional/non-professional) and country. The formulation type and active ingredient(s) of the proposed product will also impact the type of data required. There are many ways the data requirements can be addressed such as data references, waivers and lab generation. TSG can provide a list of data requirements specific to your proposed product through a product strategy assessment document and/or a data gap analysis.

Article 3 of the Regulation (EU) No 528/2012 (EU BPR) defines a treated article as “any substance, mixture or article which has been treated with, or intentionally incorporates, one or more biocidal products."

Where the primary function of a treated article is biocidal, the treated article will be treated as a biocidal product rather than a treated article.

Treated Articles must comply with the requirements in Article 58 of EU Biocides Regulation 528/2012.

Potentially, yes. A biocidal product family can be submitted if there are similar formula compositions, uses and levels of risk and efficacy across all the products. There is new guidance (CA-July19-Doc.4.2: Note for Guidance agreed in July 2019) on product families which details exactly what conditions need to be met. TSG can help with assessing if your products can fit into a product family and ensure there is robust justification for your product family strategy.

Under the BPR, certain biocidal products can be authorised at Union level, allowing companies to place their biocidal products on the market throughout the entire European Union, without the need to obtain a specific national authorisation in each country.

Union authorisation will give the same rights and obligations in all the Members States as those provided by national authorisations.

Union authorisation can be granted to biocidal products with similar conditions of use across the Union, although there are certain exclusions.

TSG Consulting can advise on which active substances can be included in a Union authorisation application, as well as support clients in preparing Union authorisation submissions, managing them through the Member State evaluation and peer review processes.

Companies planning to sell biocidal products in one EU Member State must apply for product authorisation in that country (national authorisation). If a company wishes to extend the national product authorisation to other markets within the EU, it can ask other Member States to recognise it through a process called mutual recognition. Applications for mutual recognition can either be made in sequence, or in parallel. TSG Consulting can advise on the most appropriate route for your company to take, as well as support you through the mutual recognition process.

Endocrine disruptors are chemicals which under certain conditions can impact on the hormonal system of humans and animals. An endocrine disrupter assessment is required for every single active substance and co-formulant in biocidal products placed on the EU market. Guidance on how to carry out assessments of biocides (and plant protection products) for endocrine disruptors was published by the European Chemicals Agency (ECHA) and the European Food Safety Authority (EFSA) in June 2018. Whilst the document aimed to help users comply with their obligations under the BPR, many questions remain as to what exactly is required of companies, and the process is far from simple as the European competent authorities are taking different approaches to the assessment process. TSG Consulting supports companies in navigating the many nuances of biocides product legislation, providing endocrine disruptor data searches, collation of data from published sources and from regulatory studies and a detailed analysis and weight-of-evidence report according to the ECHA/EFSA guidance of June 2018.