EU Biocidal Products Registration (BPR) Compliance

Background of EU BPR

The Biocidal Products Regulation (BPR) refers to Regulation (EU) 528/2012 concerning the placing on the market and use of biocidal products, which came into force on September 1st 2013. The regulation covers the responsibilities of biocidal products manufacturers and importers and article producers who use biocidal products to treat their products. .

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Definition of EU-BPR

1. Active substance: A substance or a micro-organism that has an effect or action on or against harmful organisms.
2. Biocidal product: 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.
3. Treated article: Articles that have been treated with, or intentionally incorporating, one or more biocidal products.

Under EU-BPR Regulation, there are 4 main groups and 22 product types for the classification of Biocidal products, which are listed in the table below:

*Note: A treated article that has a primary biocidal function should be considered as a biocidal product.

Approved Active Substance List

It is required that only biocidal products that contain 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 product 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 a provisional authorisation 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 list is to make sure that the total costs of acquiring the data on active substances are fairly shared. Only after suppliers of active substances or biocidal products have applied and submitted required information for inclusion in the active substances supplier list will be included in Article 95 list.

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

• Article 95 List - ECHA
  

Treated Article 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 the 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 CLP regulation and the additional requirements in the EU-BPR.

Obligations

1. Supplier of active substance

• Check if their products are covered by BPR regulation or not.
• Check if their active substances have been approved or not by ECHA in EU.
• Apply for the inclusion in the Article 95 List.
• Apply for approval of new active substance if necessary

2. Formulator or supplier of biocidal product

• Check if the active substances have been approved or not.
• Check if the supplier of the active substance is listed in the Article 95 or not.
• Apply for product authorization.
• Apply for inclusion in the Article 95 list.

3. Supplier or manufacturer of article

• Check if the article needs to be treated with biocidal product or not; if yes, only use approved active substance to treat articles.
• Check if any claim is made regarding the biocidal properties or functions of the treated article; if yes, label the treated article accordingly.
• Provide information on the biocidal treatment of the article to the downstream users.

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 Only Representative to submit the registration or materials on behalf of them to fulfill the obligations under EU-BPR.

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