Nanomaterials under Biocidal Products Regulation

Nanomaterials are chemical substances or materials that are manufactured and used on a very small scale. Their structures range from approximately 1 to 100 nm in at least one dimension.

Nanomaterials have unique and more pronounced characteristics compared to the same material without nanoscale features. Therefore, the physico-chemical properties of nanomaterials may differ from those of the bulk substance or particles of a larger size.

Nanotechnology is rapidly expanding. A large number of products containing nanomaterials are already on the European market (e.g. batteries, coatings, anti-bacterial clothing, cosmetics, food products). Nanomaterials offer technical and commercial opportunities, but may pose risks to the environment and raise health and safety concerns for humans and animals.

 

 

The Biocidal Products Regulation has specific provisions for nanomaterials. The provisions apply to products and substances that meet the criteria defined in the Biocidal Products Regulation. These definitions are based on the Commission recommendation on the definition of nanomaterials.
 
These provisions apply for active and non-active substances with the following characteristics:
  • 50% or more of the particles have a size of 1-100 nm in at least one dimension
  • Particles are in an unbound state or as an aggregate or agglomerate
The Commission may adapt this definition depending on technical and scientific progress, and it may also, at the request of a Member State, adopt a decision on whether a specific substance is a nanomaterial.
 
According to the BPR, the approval of the active substance does not cover the nanoform of the active substance except where explicitly mentioned. A separate dossier with all data requirements must usually be prepared for nanoforms of active substances.
 
A dedicated risk assessment is needed when the nanoform of the active and non-active substances are used in a biocidal product. The label of the biocidal product must show the name of each nanomaterial followed by the word "nano" in brackets. Products containing nanomaterials are excluded from the simplified authorisation procedure.
 

Monitoring and reporting 

Member States must report on the implementation of the BPR every five years. The reporting must include information on the use of nanomaterials in biocidal products and the potential risks identified. Reports are to be submitted to the Commission by 30 June of the relevant year and will cover the period until 31 December of the year preceding their submission.