EU Biocidal Products Regulation (BPR)

In EU, biocidal products are regulated by the EU Biocidal Products Regulation (BPR) Regulation (EU) 528/2012 concerning the placing on the market and use of biocidal products, which came into force on September 1, 2013. Before any biocidal products can be placed on the EU market, they must receive authorization first. The regulation establishes a two-tier system: active substances must first be approved at the EU level, and then individual biocidal products containing these substances require authorization either nationally or through a Union authorization procedure. 

Definition of Biocidal Products in EU

A biocidal product is defined as any substance or mixture, 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. It does not include any pesticide used for crop protection, which is governed by Regulation (EC) No 1107/2009 (PPP regulation).

Under the EU BPR, there are four main groups and 22 product types of biocidal products, which are listed in the table below:

*Note: EU BPR also regulates treated articles.

• Treated article: Articles that have been treated with, or intentionally incorporated, one or more biocidal product.

• A treated article that has a primary biocidal function should be considered a biocidal product.

Approved Active Substance List

Only biocidal products that contain an approved active substance can be sold and used on the EU market. The approved active substance list can be found in the below link:

• Approved active substance list – ECHA

There are two special conditions that allow companies to put biocidal products containing active substances that are not listed in the Approved active substance list on the EU market:

• The transitional provisions laid down in Article 89 of Regulation (EU) No 528/2012 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, subject to national rules, until three years after the date of their approval (shorter timeframes apply in case of non-approval).
• Biocidal products containing new active substances that are still under assessment may also be allowed to be put on the EU market where provisional authorization is granted.

Article 95 List – Active Substance Supplier List

A biocidal product is not able to be placed on the EU market if the active substance supplier or product supplier is not listed in the active substances suppliers list, which is also called Article 95 list.

The purpose of Article 95 is to make sure that the total costs of acquiring the data on active substances are shared fairly. Suppliers of active substances or biocidal products will only be included in Article 95 after they have applied and submitted the required information for inclusion in the active substances supplier list. 

ECHA will update Article 95 periodically. Non-EU companies can appoint an EU-based representative to apply for inclusion in Article 95. The list can be found in the below link:

• Article 95 List – ECHA 

Technical Equivalence Assessment of Active Substances

In EU, application of technical equivalence (TE) assessment is the easiest way to gain market access for your biocidal active substances. If the new source (i.e., your product) has the same or less harmful effects due to its impurities compared to the reference source of an approved technical material, then the new source can be considered (eco)toxicologically equivalent to the reference source. More info about the technical equivalence assessment can be found here.

Product Authorization - Mutual Recognition and Union Authorization

Usually, product authorization can be done at the Member State level or EU level. To facilitate market access, the BPR provides for mutual recognition of authorizations between member states with similar conditions of use. For products intended for the entire EU market, a Union authorization procedure allows for centralized approval, creating efficiencies for both regulators and industry.

Treated Articles and Labeling

The BPR requires that articles only be treated with biocidal products containing active substances that have been approved in the EU. This also applies to imported articles. Companies are also required to provide consumers with information about the biocidal treatment of the article they are selling in the EU market. If a consumer requests information about a treated article, the supplier must provide it free of charge within 45 days.

The BPR requires manufacturers and importers of treated articles to label the treated articles when:

• a claim that the treated article has biocidal properties is made.

• it is required in the conditions of the approval of the active substance contained in the biocidal product used to treat the article.

The labeling of treated articles must be done according to both the Classification, Labeling and Packaging of Substances and Mixtures (CLP) regulation and the additional requirements in the EU BPR.

Only Representative

If a non-EU manufacturer or supplier of the active substance or biocidal product can not get the support of EU BPR compliance from their EU importers, they can appoint an EU-based Only Representative (OR) to submit the registration or materials on behalf of them to fulfill the obligations under EU BPR.

Our EU Biocidal Product Regulatory Services

Our experienced team at CIRS Group can help you navigate the complex biocidal product regulatory barriers in the EU and bring your biocidal products to the EU market efficiently and compliantly.

Our services include:

• Application of Technical Equivalence

• Application of Article 95 List

• Biocidal Product Authorization

• Data Gap Analysis

• GLP Study Monitoring Services

• Dossier Preparation and Submission

• Only Representative Services

For more information on how we can assist with your pesticide registration needs in EU, contact us today via Email: service@cirs-group.com.