What is EU Biocidal Products Regulation?
The EU Biocidal Products Regulation (EU BPR, Regulation (EU) 528/2012) regulates the marketing and use of biocidal products, which are used to protect humans, animals, materials, or articles from harmful organisms such as pests or bacteria through the action of active ingredients in the biocidal product. This regulation intends to improve the functioning of the EU’s biocidal products market while also assuring a high degree of human and environmental protection.
The text had been in effect since September 1, 2013, with certain parts having a transitional period. The Biocidal Products Directive (Directive 98/8/EC) will be repealed.
How to Comply with EU Biocidal Products Regulation?
The three key aspects of the EU BPR compliance level are iocidal active substances, biocidal products and treated articles.
Biocidal active substances (AS)
The active substance is defined as
‘Active Substance’ (AS) refers to a substance or microbe that has an effect on or against hazardous organisms, such as ethanol, calcium hypochlorite, and oxygen-derived ozone.
The active substance that is currently in use and the new active substance
Existing active substances and novel active substances are the two types of active substances that can be found.
Existing active chemicals are those that were on the market as an active substance in a biocidal product on May 14, 2000. (for purposes other than scientific or product and process-orientated research and development). The Review Programme included a list of existing active compounds that had been identified as such and for which a notice had been approved. Article 89 of Regulation (EU) No 528/2012 contains transitional provisions that allow biocidal products containing an active substance included in the Review Programme (for a given product-type) to be made available on the market and used until three years after their approval date, subject to national rules (shorter timeframes apply in case of non-approval).
The term “new active substances” refers to substances that are not listed in the Review Program for a particular product class. Before new active substances with the product-type can be placed on the EU market, they must be approved.
Approval of active substances
Companies must submit a dossier to ECHA to request approval of an active substance. The dossier contains studies on phytochemicals, efficacy, human health, ecotoxicology, environmental fate and behavior, and so forth. Following ECHA’s validation check, the evaluating competent authority conducts a completeness check and an evaluation within one year. The evaluation’s findings are sent to the ECHA’s Biocidal Products Committee, which issues an opinion within 270 days. The opinion serves as a foundation for the European Commission’s and Member States’ decision-making. An active substance’s authorisation is granted for a set period of time, not to exceed ten years.
To summarize, active substance approval necessitates more evidence and time. The review judgment will be issued three years after the submission date.
Article 95 listing
After the first company submits an application for active substance approval, it will be automatically added to the Art 95 list. Other companies must either split costs with the first company or submit an application for inclusion in Article 95’s list.
Only a legal business established within the EU can apply to be added to the list of active ingredient providers (Article 95 list). For the purposes of Article 95, non-EU corporations can be represented by an EU representative, who will be included next to their EU representation on the list.
Biocidal Product (BP)
‘Biocidal Product’ is defined 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 purpose of destroying, deterring, rendering harmless, preventing the action of, or otherwise exerting a controlling effect on, any harmful organism by any means other than physical or mechanical action,
Any substance or mixture, derived from substances or mixtures that do not themselves fall under the first indent, that is intended to be used for the purpose of destroying, deterring, rendering harmless, preventing the action of, or otherwise exerting a controlling effect on any harmful organism by means other than physical or mechanical action.
A biocidal product is a treated material that performs a principal biocidal function.
Authorisation of biocidal products
Before a biocidal product can be put on the market, it must first obtain approval. Depending on their product and the number of countries in which they desire to sell it, businesses can pick from a number of different processes. Companies who want to apply for an EU-wide permission in one go, for example, could choose Union authorisation. If the product will only be sold in one country, national approval from that country is sufficient. A corporation can apply for mutual recognition for product authorisation if it wants to sell its product in multiple countries.
Biocidal product authorization has data requirements that are identical to those for active chemicals.
National regulations govern registration and notification
Biocidal products using active chemicals under the Review Program can be put on the market and used (according to national legislation) while the active substance is awaiting approval (and up to 3 years after).
National registration/notification is less complicated and takes less time than biocidal product authorization.
Technical equivalence (TE)
When there has been a change in the source of the active susbtance, the technical equivalence of the active substance must be examined in the context of biocidal product authorisation. If the substances produced from a source other than the reference source or from the reference source but after a change in the manufacturing process and/or manufacturing location are compared to the substance of the reference source for which the initial risk assessment was conducted, technical equivalence should be used if the chemical composition and hazard profile are similar.
Treated Article (TA)
Any substance, mixture, or article that has been treated with, or purposely integrates, one or more biocidal products is referred to as a “treated article.”
Requirements for treated articles’ compliance
Articles can only be treated with biocidal products containing active ingredients approved in the EU, according to the legislation.
Manufacturers and importers of treated articles must ensure that products are labeled in accordance with both the Classification, Labelling, and Packaging Regulation and the Biocidal Products Regulation’s extra requirements.
Companies must also be prepared to educate customers about the biocidal treatment of the product they are offering. If a customer wants information regarding a treated product, the provider must respond within 45 days and supply it free of charge.
To summarize, all biocidal goods require biocidal product authorisations before they may be sold, and the active ingredients in those biocidal products must have been authorised earlier. However, there are a few exceptions to this rule. When a provisional authorisation is given, products containing new active ingredients that are still being evaluated may be allowed on the market.
Different organizations must adopt the most appropriate compliance plan based on their actual situations and requirements, based on the standards and flexibility of EU BPR.