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In the know on...the French decree

French decree for mandatory reporting of nanomaterials

Objectives and scope...

In February this year, following an extensive consultation process (Grenelles de l’environment), the French Government introduced a national decree for mandatory reporting of nanomaterials (Décret n° 2012-232 du 17 février 2012), the first of its kind to be introduced in Europe. Its objectives are to gather available information on nanomaterials (properties, applications, toxicological and eco-toxicological data) and gain insight on their level of production, importation and distribution on the market, as well as to ensure a better traceability. 
The decree defines "Substance à l'état nanoparticulaire” as engineered substances at the nanometric scale containing primary particles or aggregates or agglomerates. This definition also includes fullerenes, graphene flakes and carbon nanotubes, similarly to the definition of the term nanomaterial adopted by the European Commission in 2011 (2011/696/EU). The decree applies to nanomaterials on their own or included in a mixture or another material, and requires an annual declaration to be submitted to the French National Agency for Food Safety, Environment and Labor (ANSES) in May of each year, commencing from May 2013. This declaration is mandatory as soon as 100 g of nanoscale substance has been produced, distributed or imported over the previous year. Non-compliance to this mandatory registration scheme would lead to financial penalties.

Reporting requirements...

The information that is to be submitted to ANSES on an annual basis, as published in August 2012 (Arrete Aout 2012), is divided into five sections:
1. Identity of the declarant
Information about the declarant, their role in the supply chain (producer, distributor or importer) and sector of activity must be specified. When the declarant is undertaking research and development activities, they must declare if the substance is put on the market.
2. Identity of the “substance a l’etat nanoparticulaire”
Information about the properties of the nanomaterial produced, used and distributed, including:
  • Chemical identification of the substance. The declarant must specify if the substance is: on its own; or included in a mixture or incorporated into a material and potentially extracted or released upon use;
  • The physical state (solid, liquid, gas or powder) of any mixture; 
  • Commercial name (where applicable);
  • Mean particle size and method used to quantify this parameter;
  • Particle number size distribution and method used to quantify this parameter;
  • Degree of aggregation and/or agglomeration;
  • Particle shape and method used to determine this parameter;
  • Description of substance coating (if applicable);
  • REACH Registration number (if the substance has already been registered);
  • Contaminants level (if applicable);
  • Crystalline structure (if applicable);
  • Surface area and method used to determine this parameter;
  • Surface charge (zeta-potential and associated pH).
3. Annual tonnage
Information of the quantity of the substance produced, distributed or imported over the year prior to reporting.
4. Uses of the substance
The declarant must specify all the foreseen uses of the substance. Where the substance is put on the market, the commercial name must be mentioned. Optionally, the properties claimed for the use of the substance may also be indicated.
5. Identity of the professional users to whom the declarant transferred the substance
All information reported, except the identity of the declarant and the chemical name of the substance, will automatically be treated as confidential. Additional confidentiality measures can be claimed to protect intellectual properties and adverse impacts on business where nanomaterials are used as part of research and development activities.

In summary…

The first national-level mandatory reporting for nanomaterials being adopted in France, which becomes effective in 2013, may be the forerunner to similar reporting initiatives and the development of harmonised databases understood to be in preparation in Belgium and Italy (Working with Nanomaterials, 2011). Ideally, this concerted activity would lead to the availability of a dataset to allow better understanding of the level of development of nanotechnologies in Europe and also complement registrations under REACH.
Scoping of regulatory requirements and obligations are provided as part of SAFENANO Scientific Services. For further enquiries, please contact Dr Steve Hankin.

References

Décret n° 2012-232 du 17 février 2012 relatif à la déclaration annuelle des substances à l'état nanoparticulaire pris en application de l'article L. 523-4 du code de l'environnement (in French). 

Working With Nanomaterials – A seminar on policy, practice and the role of public authorities in dealing with uncertain risks. Brussels November 29th 2011

2011/696/EU: Commission Recommendation of 18 October 2011 on the definition of nanomaterial - 2011/696/EU, published on the OJ L 275/38 of 20.10.2011

Did you know?

100 nm is the size below which the EU recommendation of the definition of nanomaterials applies.