The French Ministry has recently adopted a decree which will introduce a mandatory reporting scheme for nanomaterials in 2013.
The French Ministry for Ecology, Sustainable Development, Transportation and Housing has recently published a final decree regarding the mandatory reporting of nanomaterials. The decree, which was signed in February 2012 and will be applicable from January 2013, requires companies that manufacture, import, distribute nanomaterials in quantities of ≥ 100g to submit to the authorities an annual declaration containing the quantity and use information.
The aims of the decree are to:
- have a better understanding of nanomaterials and their use;
- enable better traceability;
- have a better knowledge of the market and volume of nanomaterials involved;
- collect available information on toxicology and ecotoxicology of nanomaterials.
This decree applies to importers, producers, distributors of nanomaterials, as well as “professional users” and research laboratories located in France. On the 1st May annually, information will have to be sent to the Minister of the Environment and the data collected will be managed by the French National Agency for Food Safety, Environment and Labour (ANSES). Thus, a report containing 2012 data will be due by the 1st May 2013. Special confidentiality terms are applicable for research and development (R&D) and businesses upon justification.
The Decree defines "substance with nanoparticle status" as:
substance as that defined in Article 3 of the Regulation (EC) No 1907/2006 (REACH), intentionally manufactured to a nanometric scale and containing particles in an unbound state or as an aggregate or as an agglomerate and where, for a minimum proportion threshold of the particles in the number size distribution, one or more external dimensions is in the size range 1 nm-100 nm.
In specific cases and where warranted by concerns for the environment, health, safety or competitiveness the minimum proportion of number size distribution threshold can be reduced.
The Decree clarifies that fullerenes, graphene flakes, and single wall carbon nanotubes with one or more external dimensions less than one nanometer are included in this definition, and is applicable to nanomaterials as such, contained loose in a mixture or incorporated into other composites and potentially released during use.
Importantly, this decree introduces the first mandatory reporting scheme for nanomaterials in Europe.
The full text of the decree is available to download here [available in French only].