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EU BPR Compliance

Background of the EU BPR

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

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 incorporated, one or more biocidal product.

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

Group and product type information of Biocidal   product

 

Category

Group 1

Group 2

Group 3

Group 4

Disinfectant

Preservatives

Pest Control

Other Products

 

 

 

 

 

 

Biocidal product type

PT 1: Human Hygiene

PT 6: Preservatives for products during storage

PT 14: Rodenticides

PT 21: Antifouling products

PT 2: Disinfectants and algaecides not intended for   direct application to humans or animals

PT 7: Film preservatives

PT 15: Avicides

PT 22: Embalming and taxidermist fluids

PT 3: Veterinary hygiene

PT 8: Wood preservatives

PT 16: Molluscicides, vermicides and products to   control other invertebrates

 

PT 4: Food and feed area

PT 9: Fibre, leather, rubber and polymerised materials   preservatives

PT 17: Piscicides

 

PT 5: Drinking water

PT 10: Construction material preservatives

PT 18: Insecticides, acaricides and products to control   other arthropods

 
 

PT 11: Preservatives for liquid-cooling and processing   systems

PT 19: Repellents and attractants

 
 

PT 12: Slimicides

PT 20: Control of other vertebrates

 
 

PT 13: Working or cutting fluid preservatives

  

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

Approved Active Substance List

It is required that 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:

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:

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. 

Obligations

1. Supplier of an active substance

  • Check whether their products are covered by BPR regulation.
  • Check whether their active substances have been approved by ECHA in the EU.
  • Apply for inclusion in Article 95 List.
  • Apply for approval of new active substance (if necessary).

2. Formulator or supplier of biocidal product

  • Check whether the active substances have been approved.
  • Check whether the supplier of the active substance is listed in Article 95.
  • Apply for product authorization.

3. Supplier or manufacturer of an article

  • Check whether the article needs to be treated with a biocidal product; if yes, only use approved active substances 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 (OR) to submit the registration or materials on behalf of them to fulfill the obligations under EU-BPR.

Our Services:

  • Only representative under EU-BPR;
  • Active substance authorization approval;
  • Biocide product authorization approval;
  • Apply for inclusion of suppliers into Article 95.
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