The EU Biocidal Products Regulation 528/2012 (BPR) concerns market access and use of biocidal active substances and products in the European Union. The regulation covers a very diverse group of product types including disinfectants, preservatives, pest control, anti-fouling and embalming products.
The BPR came into force in September 2013 revising and replacing the BPD (Directive 98/8/EC) and lays down the rules and procedures for supplying active substances and placing biocidal products onto the market within the EU.
The Regulation sets out comprehensive guidance and approval criteria for active substances at the EU level and procedures for biocidal product assessment via a Union or National Authorisation framework. It also provides the basis for the renewal of existing approved active substances. Whilst the approval of active substances is done at EU level, the authorisation of biocidal products is done at EU Member State level, except for Union Authorisations. Despite ongoing efforts at harmonisation and mutual recognition procedures, some Member States maintain different administrative or data requirements. These requirements and their constant change represent a challenge for companies wishing to place their biocidal products on the EU market.
TSG can help
- Our multidisciplinary team of scientists and registration specialists has years of proven experience gaining approvals for biocidal active substances and product authorisations or registrations for biocidal products across the EU
- We work with both major chemical companies and small suppliers, targeting services to each company’s specific needs
- We have wide-ranging expertise from working in industry, regulatory authorities, and research facilities
- We believe that proactive project management is essential to ensure that our clients’ needs are identified and met in a timely manner
- We have a comprehensive pan-European infrastructure to meet those challenges presented by differing requirements across the European Union with offices in France, Spain, Germany, and the UK offering focused, local registration support
- We have been actively assessing the impact that the differing Brexit scenarios will have on biocides regulations following the UK’s decision to leave the EU. We are in a strong position to advise clients on the actions they may need to take in order to secure and maintain product authorisations and manage the impact on active substance evaluations, approvals and approved suppliers
- We can provide support for non-EU European countries including Switzerland and Norway
- We have experience of preparing Union Authorisation submissions and have successfully managed these through the Member State evaluation and peer review processes including Biocidal Product Committee (BPC) meetings
- We can help with understanding the new biocidal product family guidance and can build your product family and ensure there are robust justifications in place for your product family strategy
- We can support clients with endocrine disruptor data searches, collation of published and regulatory data, and a full assessment according to the ECHA/EFSA guidance of June 2018
TSG provides companies with high-quality regulatory and scientific consulting services. We aim to understand our clients' goals and objectives, learn the scientific and technical aspects of projects and anticipate compliance challenges to plan a strategic path forward. TSG's team of experts is deadline-focused, responsive and committed to professionalism. We have the utmost respect for the confidentiality of our work, strong project management skills, and take great measure to cultivate long-term partnerships with clients.
TSG has a team of specialized consultants drawn from industry, regulatory authorities and contract research who manage all aspects of biocidal active substance approval, biocidal product authorisation/registration and strategic planning. Led by Amy Burrows, Head of Biocides & Cosmetics, key professionals working in the sector include Samantha Walker and Philippa O’Donovan.
Frequently asked questions
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.