Low-risk biocidal products
In the Biocidal Products Regulation, the term low-risk biocidal products does not appear as such, but for products with a more beneficial environmental, human or animal health profile,the simplified authorisation procedure applies.
A biocidal product is eligible for this simplified authorisation procedure if all of the following conditions are met:
- all active substances in the biocidal products are listed in Annex I of the Biocidal Products Regulation and comply with every restriction specified in that Annex;
- the biocidal product does not contain any substances of concern;
- the biocidal product does not contain nanomaterials;
- the biocidal product is sufficiently effective; and
- personal protective equipment is not required for handling the product and using it as intended.
If a biocidal product complies with these conditions, an application for a simplified authorisation can submitted. The application must be submitted to ECHA (via R4BP); the application must specify which Member State will conduct the assessment. If you are considering having the Netherlands (Ctgb) conduct the assessment, then contact the account manager for biocidal products, Cindy van der Meer, of the Ctgb.
The authorisation will be issued by the reporting Member State. If the authorisation holder also wants to place the biocidal product concerned on the market in other Member States, these Member States must be informed by means of a notification (notification via R4BP). If the Ctgb conducts the assessment, the fee will be approximately €4000 (advance payment, invoice based on subsequent costing). If the biocidal product is placed on the market in the Netherlands by means of a notification, a fee of €230 is charged.
To have a new active substance included in Annex I of the Biocidal Products Regulation, a specific procedure must be followed. This procedure is specified by the European Commission in a separate Regulation. Briefly summarised, the reporting Member State, based on the submitted dossier, will assess whether this substance is indeed not a substance of concern. If it is not a substance of concern, then it can be included in Annex I of the Regulation, possibly with restrictions on its use.
See also Practical guide on Biocidal Products Regulation
78 Simplified authorisation (ECHA)