Nanoforms are regulated in many countries because of their unique properties and impact on health and the environment. Standards have been established by organizations such as the Organization for Economic Cooperation and Development (OECD) and the European Commission to standardize regulations across countries.
In Europe, nanoforms are regulated under the REACH (Registration, Evaluation, Authorization and Restriction of Chemicals) regulation. This regulation requires that all substances, including nanoforms, be registered and evaluated for safety before being placed on the market.
Definition of a nanoform
In January 2022, the European Chemical Agency (ECHA) published version 2 of its "Appendix on Nanoforms for Guidance on Registration and Identification of Substances". The changes made by this revision emphasize the information on joint submission of data and on data per nanoform/group of nanoforms.
The following information summarizes the key points to keep in mind regarding the revised definition of a nanoform.
Annex VI of the European REACH Regulation defines a nanoform as "a form of a natural or manufactured substance containing free particles, in aggregate or agglomerate form, in which at least 50% of the particles, in numerical size distribution, have one or more external dimensions between 1 nm and 100 nm, including by way of derogation fullerenes, graphene flakes and single-walled carbon nanotubes with one or more external dimensions smaller than 1 nm".
Some parameters define the different nanoforms of the substances, as follows:
- Granulometric
- Distribution
- Shape (and other morphological characteristics)
- Surface treatment
- Specific surface of the particles
Thus, it is possible for the same substance to have one or more nanoforms. The characterization of the nanoform must be done in accordance with Annex VI, section 2.4 of the REACH Regulation.
Groups of nanoforms can be formed if, as a result of the manufacturing process, nanoforms have almost identical characterization elements.
EcoMundo proposes to accompany you for the identification and characterization of your nanoforms, and the creation of a group for your nanoforms. The declaration of information on the shape of a single nanoform by a registrant requires specific knowledge. Pioneer of REACH since 2007, EcoMundo has the necessary chemical knowledge for the constitution of nanoform dossiers.
How to declare nanoforms?
Registrants are responsible for registering the nanoforms they manufacture or import. As mentioned above, the registration must consist of data on the specific characteristics and hazards for each nanoform or group of nanoforms.
The submission of the information required in Annex VI must be made separately by each registrant. For the information required in Annexes VII to X, co-registrants may submit the information independently or by relying on the lead registrant to form a joint submission. However, it is mandatory in both cases to establish the links between each nanoform (nanoform alone or by group).
Thus, nanoforms should be characterized individually except in cases where it is possible to form groups of nanoforms (e.g. if it is possible to do hazard, exposure and risk assessments for all nanoforms).
Concerning the registration process, it is quite similar to the registration of any other substance, details are available on the technical guide: registration.
There are exemptions for the registration of nanoforms, in the same way as any other substance under REACH. There are, for example, naturally occurring substances such as minerals, ores, etc.
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