French Decree Regarding the Annual Mandatory Reporting of Nanoparticulate Substances Placed on the Market
The French Ministry for Ecology, Sustainable Development, Transportation and Housing (Ministry) published a final decree, entitled “Decree regarding the annual mandatory reporting of nanoparticulate substances placed on the market,” Decree No. 2012-232, on February 17, 2012. The Decree requires companies that manufacture, import, and/or distribute a “substance with nanoparticle status” in an amount of at least 100 grams per year to submit an annual report with substance identity, quantity, and use information. The report will be due by May 1 for information about nanoparticle substances produced/imported/distributed during the prior year. The Decree is effective January 1, 2013, so a report containing 2012 data will be due by May 1, 2013.
The Decree defines “substance with nanoparticle status” as:
[A] substance as that defined in Article 3 of the Regulation (EC) No 1907/2006, 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.
The Decree states that the reporting obligation extends to substances with nanoparticle status “as such or contained in a loose mixture, or of materials intended to release such substances under normal conditions or reasonably foreseeable use.” Available English translations of the Decree vary in precise wording, but the Decree also contains the following definition, which clarifies the “loose mixture” term to the extent that term appears in other translations as “a mixture without being bound”:
"Substance with nanoparticle status contained in a mixture without being bound”: a substance with nanoparticle status intentionally incorporated in a mixture from which it is likely to be extracted or released under normal or reasonably foreseeable conditions of use.
The Decree states that a company subject to reporting may request that the Ministry treat its information as confidential but must provide a detailed justification for the request. Reduced reporting requirements are available for nanoparticle substances manufactured or imported as part of scientific research and development (R&D); according to the Decree, R&D materials are automatically treated as confidential.
The Ministry has published and circulated for comment a draft second decree entitled “Decree relating to the content and submission conditions of annual declarations of substances with nanoparticle status pursuant to articles R. 523-12 and R. 523-13 of the Environmental Code.” The most recent consultation version is dated December 2011. This draft second decree sets out with more specificity the reporting requirements for the annual declarations of substances with nanoparticle status. Comments are due on the December 2011 consultation draft by March 30, 2012.