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.