Biocidal Products Regulation BPR (EU) No. 528/2012 of 22 May 2012 concerning the making available on the market and use of biocidal products.
Biocidal Product authorization
Different to REACH under BPR formulators of biocidal products have to prepare and submit dossiers to the national authorities e.g. CtgB in the Netherlands, BAuA in Germany, ANSES in France, HSE in United Kingdom, etc. to remain compliant on the market. The submission period ends when the respective active substance is listed for the first time on the Union list.
The product dossiers must contain data relating to the active substance (by purchasing a Letter of Access), provide evidence of efficacy studies following relevant EN test procedures and include a risk assessment. Applications for authorizations contain, similar to those under REACH, substance-related data, toxicological and eco-toxicological data as well as information on the intended applications of the products supported by relevant efficiency tests.
Applications are separated into 22 different product types (PTs) covering disinfection (PT 1-5), preservation (PT 6 – 13), pest control (PT 14 – 20) and other applications (PT 21-22).
Most active substances are marketed as formulations, such as 80% ethanol/water solutions for hand disinfection. These formulations which are supplied directly to the end users are biocidal products.
European national authorities responsible for the implementation of the BPR often require notifications or even authorizations of biocidal products. During the transitional period (time of dossier evaluation) biocidal products need to have these notification numbers on the label accompanied by use and disposal instructions, dosage recommendations and shelf life mentioned on the product label.
There are substances that are commonly used as biocidal products without formulation or dilution. Peracetic acids in the food industry, sodium hypochlorite used in swimming pools or chlorine dioxide in the form of Clorious2 are just some examples. These products intended for biocidal use also have to be placed on the market with biocide labelling.
How does Brenntag support you under the BPR?
- Since 1 September 2015 biocidal products have to be formulated with active substances sourced from suppliers on the Article 95 list. Brenntag is able to ensure compliant supply from listed sources to ensure compliant production of your biocidal products for more than 30 active substances. Written confirmations are available on request.
- Brenntag’s own listing on the Article 95 list for ethanol, isopropanol and sodium hypochlorite
- Ensure compliant biocidal products under national authorizations supported with product dossiers once the active substance is on the Union list in cooperation with suppliers
- In exceptional cases by submitting own dossiers (e.g. isopropanol for PT 1, 2, 4)
- Support of your branded products by On-Boarding for isopropanol, glutaraldehyde, hydrogen peroxide, peracetic acid, sodium hypochlorite etc.
- Offering of letters of access (LoA) to support customer dossiers
- Support of customer enquiries
- Acceptation the responsibility for maintaining communications with suppliers and customers
- Communication with authorities to support you in the best way
Please contact your sales contact for questions and additional details!
All products that have a biocidal effect, i.e. are suitable for controlling microorganisms, are regulated under the Biocidal Products Regulation that came into effect on 1 September 2013.
These include not only established substances such as glutaraldehyde and CMIT/MIT but also generic chemicals that are used due to their antimicrobial effect, such as:
ethanol, isopropanol, n-propanol, hydrogen peroxide, peracetic acid, sodium hypochlorite, formic acid or formaldehyde.
Active substance approval
By 2024 at the latest the authorities have to review the active substance dossiers. Subsequently, all other member states will likewise have to grant their approval. Once it is granted, a joint deadline will be set for when the substance will be placed on the “Union list”. This Union list will name all active substances for biocidal applications approved in the EU. No other substances are admitted for biocidal applications.
Manufacturers active substances are not obliged to submit a dossier.
However, all enterprises that participate or participated in the preparation of the dossier will be published in the Article 95 list. In this context, the enterprises listed are registered sources for the production of biocidal products. The article 95 list details which company has applied for approval for which active substance and for which PTs.
The list is available on the ECHA’s website where it is updated on a monthly basis.