Belgium will be the second country in the European Union (France being the first) to enact a mandatory register for nanomaterials. A Sept. 3, 2014 Nanowerk Spotlight article by Anthony Bochon (Attorney at the Brussels Bar, Associate at Squire Patton Boggs (UK) LLP Brussels office, Associate lecturer at the Université libre de Bruxelles and fellow at Stanford Law School) provides details (Note: A link has been removed),

On 7th February 2014, the Belgian federal government issued a press release declaring that the draft Royal Decree creating a Belgian register for nanomaterials has been approved. Although its not been formally enacted yet, its content has been disclosed to the European Commission on 19th February 2014. The Royal Decree would enter into force on 1st January 2016 for substances manufactured at the nanoscale and on 1st January 2017 for preparations containing a substance or substances manufactured at the nanoscale. [emphases mine]

…

The scope of the Belgian nano register is twofold with the scopes by product and by activity that delineate the cases when a declaration or notification would be filled with the Ministry of Health.

Scope by product

The registration requirements will apply to products which are or which include substances manufactured at nanoscale. The central issue with the registration requirements was and remains the definition of the so-called “substance manufactured at nanoscale”. In absence of any common compulsory definition in EU law, the Belgian government has decided to adopt the definition proposed by the European Commission in its recommendation of 18th October 2011. The Royal Decree defines the “substance manufactured at nanoscale” as “a substance containing unbound particles or particles in the form of an aggregate or agglomerate, of which a minimum proportion of at least fifty per cent of the size distribution, by number, have one or more external dimensions within the range of one nanometre and one hundred nanometres, excluding chemically unmodified natural substances, accidentally produced substances and substances whose fraction between one nanometre and one hundred nanometres is a by-product of human activity. Fullerenes, graphene flakes and single-wall carbon nanotubes with one or more external dimensions below one nanometre shall be treated as substances manufactured at the nanoscale.”
Companies will have to determine with their counsel if their products fall within the product scope of application of the Belgian nano register. The choice of such definition has already faced some serious criticism during the preparatory phase of the Royal Decree. It is unsure whether this definition would survive a legality test or whether the federal government will not broaden the product scope of application. Unlike the Commission recommendation of 18th October 2011, the Belgian definition of nanomaterials does not encompass materials with a specific surface area by volume of the material greater than 60 m2/cm3 but which does not meet the 50% size distribution requirement.

A certain number of products will be excluded from the notification or declaration requirements set out in the Royal Decree:

Cosmetics products which have been notified in accordance with Regulation 1223/2009 on cosmetic products;

Biocides falling within the scope of Regulation 528/2012 (the Biocides Regulation) and which have been registered or authorized in accordance with the Royal Decree of 22 May 2003 concerning the placing on the market and use of biocides;

Medicines for human and veterinary use falling within the scope of Regulation 726/2004 or the Royal Decree of 14 December 2006 on medicinal products for human and veterinary use

Foodstuffs and materials and objects intended to come into contact with foodstuffs referred to in Article 1, 1° and 2°, b) of the Law of 24 January 1977 on the protection of consumer health in regard to foodstuffs and other products

Animal feed, as defined in Article 3 of Regulation 178/2002

Medicines and medicated animal feed falling within the scope of the Law of 21 June 1983 on medicated animal feed;

Processing aids and other products which may be used in processing organically produced agricultural ingredients, mentioned in Part B of Annex VIII to Commission Regulation (EC) No 889/2008

Pigments, defined as substances which are insoluble in typical suspension media, used for their optical properties in a preparation or article.

It is important to point out that complex articles containing carbon black, amorphous synthetic silica or precipitated calcium carbonate, used as fillers, are excluded from the notification requirements laid down by the Royal Decree.

It’s fascinating to note the materials being excluded from this registry. I expect most of those materials/products are already covered under other regulations or decrees as are, for example, cosmetics, since the EU requires cosmetics companies to label (and, presumably, to register) products containing nanomaterials.

There’s a lot more to the article than the bits I have excerpted here so I encourage anyone interested in regulatory matters to read the piece in its entirety.

The author, Anthony Bochon, was last mentioned here in an Aug. 15, 2014 posting, about his forthcoming 2015 book, Nanotechnology Law & Guidelines: A Practical Guide for the Nanotechnology Industries in Europe.

For anyone interested here’s the Belgium’s Feb. 7, 2014 press release by Sarah Delafortrie and Christophe Springael. You will need your French language skills to read it.