Tag Archives: R-Nano.fr; Declaration of Nanomaterials

France’s nanomaterial declaration

I stumbled across a rather brief May 13, 2013 announcement on the ICON (International Council on Nanotechnology) website about a French nanomaterial initiative,

France Extends Deadline for Reporting Nanomaterials (NOECT Blog)

Further investigation landed me on the R-Nano.fr; Declaration of Nanomaterials website,

Welcome to the website for declaring substances with nanoparticle status: “r-nano”. On these pages you can declare the substances with nanoparticle status that you produce, import, distribute, or formulate, as required by Articles L. 523-1 to L. 523-5 of the French Environmental Code.

At the deadline of 30 April 2013, 457 companies have made 1991 declarations. These initial results shows a satisfactory mobilization of stakeholders.

The Ministry of Ecology, Sustainable Development and Energy, considering the diversity of actors covered by the declaration requirement, and at the request of several industries, decided, for the first reporting year, to grant two more months to complete the declarations. Thereby, exceptionally, new declarations can be initiated and submitted until 30 June 2013.

There’s a little more explanation of the site’s raison d’être on the Help/FAQs page,

Q : 1/ Why is there a system for declaring substances with nanoparticle status ?

Because of the advantages offered by their specific properties, substances with nanoparticle status are used in a number of sectors: foodstuffs, aeronautics, cosmetics, alternative energies, pneumatics, health, sport and others. The properties in question are such as to create potential hazards for humans and the environment. As emphasised in the European Commission Communication of 3 October 2012, a substance can present different hazards depending on whether it has bulk status or nanoparticle status.

For a better understanding of the issues, it seems necessary to acquire an improved knowledge of the market, including the substances marketed in France, their uses, the sectors in which they are used, the quantities involved, etc.

With the help of this information, it will be possible to estimate exposures more accurately and produce risk assessments for these substances. It is for this purpose that France has decided to introduce mandatory declaration of substances with nanoparticle status, whether in that form, in mixtures or within certain materials.

Q : 2/ How must declarations be made? Is there a special form ?

A web site has been set up on which the various companies concerned can each create an account and submit their declarations. The address of the declaration web site is www.r-nano.fr

Regarding declarations for which applicants wish to make use of the waiver concerning the availability of information to the public provided for activities related to national defence, the declaration will first be made online and then finalised on paper.

Q : 3/ At what date does the system come into force ?

The system comes into force on 1 January 2013: the first declarations will concern substances in nanoparticle status produced, imported and/or distributed during 2012.

Q : 5/ If a substance with nanoparticle status is indicated on the packaging (case of biocides and cosmetics in 2013), is it still necessary to submit a declaration ?

Yes: the labelling and the declaration system do not have the same purpose.

Q : 6/ Is France the only country in Europe with this kind of declaration system ?

Yes, though Italy, Belgium and Denmark are considering the introduction of similar measures.

Q : 7/ Which players are concerned by the declaration ? (UPDATED)

All national participants in the distribution chain in France covered by the requirement to declare substances with nanoparticle status must complete a declaration if they produce, import into France from another Member State of the European Union or from any other country or distribute any substance, mixture or “article” (article, see Question 18) covered by the definitions laid down in Article R. 523-12 and in quantities exceeding 100 grams/year and per substance.

Q : 38/ How will the information supplied be used ?

The information supplied for declarations enables the authorities to estimate the flows of substances with nanoparticle status in France, which will be a “first” for Europe. The knowledge acquired concerning substances and their uses, the production and usage sectors, or the quantities sold, will provide insight into the dissemination of these substances and their actual use.

To help them undertake health risk assessments, authorities will be allowed to request supplementary information from declarers, when available, especially concerning toxicological and ecotoxicological data, as well as data concerning exposure.

I have two comments. First, there are over 40 questions in the FAQs but none concern the issue of how this requirement will be enforced. Second, I gather that after abysmal results elsewhere the French concluded that voluntary reporting does not work.

It’s good to see at least [one*] government making an attempt to gather the information openly. The Canadian scheme was managed in a more clandestine fashion. I finally tracked down some information about it in an OECD (Organization for Economic Cooperation and Development) document and featured some of the data from the Canadian nanomaterial reporting scheme (as reported to the OECD)  in my April 12, 2010 posting.

* ETA May 17, 2013: I added the word ‘one’.