| Legal Compliance Tool |
Determining legal compliance
Via this screen, you can access a decision tree for determining legal compliance related to the manufacturing, transport or use of a product incorporating nanomaterials.
Main question: Is manufacturing, trade, use or waste processing of nanomaterials or products incorporating nanomaterials legal in the countries it is produced, transported through, or used? |
Does manufacturing the nanomaterial comply with existing legislation in the countries where it is produced, will be used, and transported through?
This question assists the users to self-assess their awareness of legal compliance of the nanomaterial. If the answer is no, the nanomaterial is not legal in one or more countries and their intended manufacturing, trade or use cannot proceed.
Are you a subscriber to the NIA regulatory monitoring database?
The Nanotechnology Industries Association offers a continuously updated database monitoring changes in legal requirements governing nanomaterials, but only to members. If the answer is no, use open access information.
After checking the NIA regulatory monitoring database, does manufacturing the nanomaterial comply with existing legislation in the countries where it is produced, will be used, and transported through?
If the answer is no, the nanomaterial is not legal in one or more countries and their intended manufacturing, trade or use cannot proceed.
Will the nanomaterial be manufactured, used or transported through an EU-Member State?
The scope of the tool is limited to the EU and its member states. If the intended activities will take place outside the EU, the user should contact the authorities of the country or countries to check compliance.
If relevant, the user should check compliance with the EU regulations collected by the EU Observatory for Nanomaterials:
https://euon.echa.europa.eu/home
Is it or does it contain a chemical substance which should be registered under REACH/CLP?
Chemical substances are subject to the REACH / CLP regulations. If not applicable, the user should move to the next question.
Is the nanomaterial already registered under REACH/CLP?
Is it a biocidal product?
Does the product comply with the BPR?
Is it a Food or Food Contact Material covered by EU regulations?
Does the product comply with the EU regulations?
Is it a cosmetic subject to EU cosmetics legislation?
Does it comply with EU cosmetics legislation?
Is it a medical device?
Does it comply with EU legislation for medical devices?
Are workers involved in manufacturing, transport, use of waste processing of the nanomaterial or product?
Does the manufacturing, transport and professional use comply with Worker protection legislation?
Will the nanomaterial be produced, transported, used or subject to waste processing in France, Belgium, Denmark, Norway or Sweden?
These countries require national reporting of some nanomaterials and nano-enabled products.
If no activities will take place in any of these countries, the user can go to the end of the checklist.
Is national reporting required?
Is the nanomaterial already reported?
**This work project has received funding from European Union Horizon 2020 Programme (H2020) via RiskGONE project under grant agreement nÂș 814425