The identification of a substance as a nanomaterial impacts various regulatory requirements under the REACH, Cosmetics and Biocidal Products Regulations. The Chemical Compliance Coach has experience with the characterisation and identification of nanomaterials, and can help you to test and register your products.
Nanomaterials and REACH
Substances may be manufactured as nanomaterials and non-nanomaterials. Furthermore, for a given substance that is manufactured as a nanomaterial, multiple ‘nanoforms’ may be produced. In such case, the different materials have a composition giving them the same substance identity, yet they may differ from each other in a variety of other parameters, most notably:
- Particle size
- Particle shape
- Surface chemisty
Nanoforms and non-nanoforms may be registered under one REACH registration. Registrants of nanomaterials must characterise their products using a so-called ‘nanoform composition record’ in their registration dossier. Depending on the substance, it may be necessary to report of refine additional elements (i.e. specific size ranges, specific shapes, etc.) where these impact substance properties as determined in the data collected/generated to fulfil information requirements. The Chemical Compliance Coach has experience with the registration of nanomaterials, and can help you to adequately characterise your products.
Nanomaterials in biocidal products
The approval of an active substance does not cover the nanoform of that substance, except where explicitly mentioned. Similarly, where nanomaterials are used in biocidal products, the risk to human health, animal health and the environment has to be assessed separately prior to authorisation. As a consequence, biocidal products containing nanomaterials are not eligible for the simplified authorisation procedure described in BPR article 25.
When test methods are applied to nanomaterials for the purpose of active substance approval or biocidal product authorisation, the scientific appropriateness of the test for nanomaterials must be demonstrated. Any technical adaptations or adjustments that were made in order to respond to the specific characteristics of the nanomaterials must be explained.
When biocidal products or treated articles are placed on the market, the name of all nanomaterials contained in these products or articles products must be listed on the label, followed by the word ‘nano’ in brackets. If any specific related risks were identified these must be shown of the label of biocidal products as well.
For more information, visit our webpage on BPR services.