The 24 September 2014 edition of the Belgian Official Journal (Le Moniteur Belge) has endorsed the Belgian Royal Decree regarding the Placement on the Market of Substances manufactured at the Nanoscale (Koninklijk besluit betreffende het op de markt brengen van als nanodeeltjes geproduceerde stoffen / Arrêté royal relatif à la mise sur le marché des substances manufacturées à l’état nanoparticulaire); it has been published together with a Report to the King and the opinion of the Council of State.
In the Report to the King, responsible ministers lay down the rationale that has led to the development of the register; they state that this decree will aim at achieving the four following objectives:
- making sure that the evolution of this innovative technology is being done in harmony with the safeguarding of human health
- acquiring better knowledge on the market, on characteristics of nanomaterials, on potential exposure risks, and on the speed and breadth of the development of more complex nanomaterials
- ensuring the traceability and, therefore, the confidence of the public and of workers towards these substances
- putting in place a database that could be necessary to the future regulatory evolution of these substances at the national and European level
Under the scope of this registration requirement are ‘manufactured nanoparticle substances’ which diverge from ‘nanomaterials’ as defined by the European Commission in 2011; in the Belgian legislation, manufactured nanoparticle substances are defined as follows:
‘a substance containing bound particles or forming an aggregate or agglomerate with a proportion of at least 50 % in the distribution of sizes by number, having one or more external dimensions ranging between 1 nm and 100 nm, excluding natural substances which have not been chemically modified and substances where the fraction between 1 nm and 100 nm is a by-product of a human activity. Fullerenes, graphene flakes and single wall carbon nanotubes with one or several external dimensions less than 1 nm will be considered as manufactured nanoparticle substances.’
Such substances (and mixtures containing them) require registration by the Belgian Federal Public Service for Health, Food Chain Safety and the Environment (FPS HFCSE) if at least 100g of the substance or mixture is put on the market during the year covered by the registration, and if the entity putting the substance on the market produced this substance or mixture, or puts it on the market for professional users only. Biocidal products, medicines, food and feed, food contact materials, and pigments are excluded from the scope of this decree.
Registered data on the substances, their exact use, function or application, and the registrant are treated as confidential under the Belgian nano-register (Article 20-1 and 2) .
Under this newly enforced decree, registration will be done through a web-platform which will be set by the FPS HFCSE; the deadline for the registration of substances has been set to 1 January 2016 while mixtures containing them will have to be registered by 1 January 2017. Products containing manufactured nanoparticle substances will be registered at a later stage.
Follow this link to download the decree as published on the Official Journal (in French / Dutch), and this link to read NIA’s previous reporting of the scheme. NIA Members can find out more about the Belgian and French nano registers, and the EC recommended definition, through the NIA Regulatory Monitoring Database.