Biocides

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.

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.