Regulations on Nanomaterials in EU and Nano Register 2016

Little Pro on 2016-04-28

Nanomaterials are chemical substances or materials that are manufactured and used at a very small scale (1-100nm). In EU, nanomaterials are regulated by REACH regulation and CLP regulation because they are covered by the definition of a chemical "substance" in both Regulations.

However, some EU member states are concerned with the safety of nanomaterials and have issued their own regulations requiring companies to notify nanomaterials or products containing nanomaterials to their national products register or nano register. In this article, we have summarized the latest updates of nanomaterial regulations in EU and the main nano register in the EU member states.

EU Nano Register

According to recent news from Chemical Watch, the European Commission has rejected the idea of creating a nano register for the whole European Community. Echa will develop the website or “observatory”, providing existing information on nanomaterials. ECHA's REACH guidance for information requirement for nanomaterials will also be revised.

Sweden Nano Register

The Swedish Chemicals Agency, Kemi, is drafting a regulation for companies to provide information on nanomaterials in chemical products and articles to the Swedish products register, by 28 February 2019. Reference

France Nano Register

Mandatory?	Yes
Regulation	Articles L. 523-1 to L. 523-5 of the French Environmental Code
Registry Target	Substance with nanoparticle status with volume >100g per calendar year
Who	Manufacturer/importer/B2B distributor
When	Entry into force: 1 Jan 2013; All declarations must be updated before 1 May each year.
What	Identity of registrant; Substance identity(name, particle size, state, form, etc); Quantity and uses; Identities of professional users.
How	https://www.r-nano.fr/?locale=en
FAQ	https://www.r-nano.fr/?locale=en#help

Belgium Nano Register

Mandatory?	Yes
Regulation	Royal Decree of 27 May 2014
Registry Target	Substance with nanoparticle state with volume >100g per calendar year
Who	Manufacturer/importer/B2B distributor
When	Before 1 January 2016: existing substances produced in nanoparticle state that are already on the Belgian market; Before 1 January 2017: mixtures containing existing substances produced in nanoparticle state that are already on the Belgian market; New substances in nanoparticle state: must be registered prior to being placed on the market; Annual updates: Before 31 March per year.
What	Identity of registrant; Substance identity(name, particle size, state, form, etc); Quantity and uses; Identities of professional users.
How	http://www.nanoregistration.be
FAQ	http://www.health.belgium.be/nanofaq

Danmark Nanoproducts Register

Mandatory?	Yes
National Regulation	Statutory Order no. 644 of 13/06/2014 concerning nanoproducts register
Registry Target	Mixtures and articles that contain nanomaterials
Who	Manufacturer/importer
When	Entry into force: 18 June 2014; First deadline:30 Aug 2015; Annual reporting needed.
What	Identity of registrant; Product description and composition; Identity and uses of nanomaterials; Quantity.
How	https://indberet.virk.dk
FAQ	http://www2.mst.dk/nanoguidance

Norway Products Register

Mandatory?	Yes
National Regulation	Regulations relating to the declaration of chemicals to the Product Register
Registry Target	>=100kg/y hazardous chemical products that contain nanomaterials
Who	Manufacturer/importer
When	Deadline: 31 Dec 2013;
What	Identity of registrant; Product name and composition; The content, identity and function of nanomaterials; Quantity.
How	http://www.miljodirektoratet.no/products-register
FAQ	http://www.miljodirektoratet.no/what

Congratulations!

You have learned the latest updates of nanomaterial regulations in EU and the main nano registers in EU. Please note that some products (i.e, food, medicine) are out the scope of nano registry. Please always read the FAQ first before making any registration.

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