The Regulatory Framework

Regulatory watch to ensure the appropriate compliance of our products

Based on a life cycle approach, the development of products is subject to regulatory control at every stage. The European chemical industry is well regulated, with the European Union legal framework for chemicals recognized as one of the most advanced worldwide. However, nanomaterials raise a number of safety and regulatory questions. Nanocyl did not wait government focus and is committed to the safe and sustainable development of NC7000™ and NC7000™ formulated products by generating safety knowledge. By sharing those results with authorities Nanocyl contributes to development of specific regulatory framework.

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Nanocyl is active in the follow up of new regulatory developments related to product safety.

Although there are no explicit requirements for nanomaterials under REACH (Registration, Evaluation, Authorisation and restriction of Chemicals) or CLP (Classification Labeling and Packaging), they meet the regulations’ substance definition and therefore the provisions apply. In 2011, the European Commission released a specific recommendation on the definition of a nanomaterial. The recommendation should be used in different European regulations, including REACH and CLP.

Like the EU, most of the industrial countries have put systems in place to register chemical substances and to require toxicological and eco-toxicological data before authorizing the marketing of substances on their territory. Worldwide, the requirements are similar to those of REACH in Europe and dossier should be submitted and analyzed by the authorities in order to get the authorization. The main difference compare to EU is the fact that each company should submit a dossier while in the EU joint submission is recommended.

NC7000™ compliance

Nanocyl is active in the follow up of new regulatory developments related to product safety. These can be those resulting from the REACH (Registration, Evaluation, Authorisation and restriction of Chemicals) regulation or CLP (Classification Labeling and Packaging) in Europe. Nanocyl is committed to comply with EU-REACH, the US-TSCA (Toxic Substances Control Act), the Canada-CEPA (Canadian Environmental Protection Act) regulations requirements and any other countries regulations where we plan to do business.

  • Reach-EU
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  • RoHS2

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Specific regulatory dossiers were established based on data generated on our NC7000™. For all dossiers no specific CAS number was provided to the authorities and our product was registered under the chemical name “short tangled multi-walled carbon nanotubes obtained by chemical vapour deposition”. The following registrations numbers were obtained worldwide:

  • EUROPE: REACH registration number : 01-2119879048-26-0001
  • US: PMN (Pre-Manufacture Notice) registration number: P09-0417
  • CANADA: NSN (New Substance Notification) Schedule 5 – registration number : 16037


Open science-based dialogue with all stakeholders

To ensure access to prime state-of-the-art information on our product in the field, we are adopting a very open and collaborative attitude notably through several international collaborations with various stakeholders:

  • Academics and research centers: scientific experts by collaborating inside collaborative funded projects (e.g. FP-7, H2020 programs,…)
  • Authorities: US-EPA, Environment & Health Canada,…
  • Industrial Associations: CEFIC, FEB, NIA…