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Posted: Sep 03, 2014

The future Belgian register for nanomaterials: challenges ahead for the nanotechnology community

(Nanowerk Spotlight) 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. We provide here an overview of this future Belgian nano register and some suggestions to be ready for the 2016 and 2017 deadlines.
Background
In the European Union, REACH is the core regulation for chemicals. With the growing concerns in the civil society about the specificity of nanomaterials, voices have called for a revision of REACH to address the alleged issues that would be particular to nanomaterials. In 2012, France became the first member State to adopt a special register for nanomaterials. Belgium and Denmark have now followed, with the latter having already formally enacted the register in its domestic legal system.
Is the Belgian Royal Decree compatible with EU law and Belgian administrative law?
The adoption of third national nano register clearly calls into question the compatibility of such initiative with EU law and adds some pressure towards the adoption of an EU-wide nano register, as the existence of some national nano registers could illegally restrict the free movement of goods within the EU internal market.
Furthermore, it is unsure whether the Federal Government could implement a nano register, as it did, on the basis of the law of 21 December 1998 on product standards aimed at promoting sustainable production and consumption, environmental protection and health and safety. That leaves the question of the compatibility of the register with Belgian law entirely open.
Scope of the Belgian nano register
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.
    Scope by activity
    Notification and declarations requirements are triggered when there is a “placement on the market” as defined in article 2,3° of the Law of 21 December 1998.
    The delineation of the scope by activity is further specified in the Royal Decree by the provisions on the declaration or notification of products. In fact, the Belgian nano register will apply to the production, import and distribution of products containing substances at nanoscale provided that a transfer occurs on the Belgian territory between professional users. It applies neither to the sale of the products to a consumer end-user, nor to products in transit on the Belgian territory.
    Declaration of substances manufactured at the nanoscale and preparations containing a substance or substances manufactured at the nanoscale
    Some products will only be legally place on the market upon the filing of a declaration to the SPF Santé publique, Sécurité de la Chaîne Alimentaire et Environnement (hereafter “the Ministry of Health”). The products concerned by the declaration requirements are substances manufactured at the nanoscale and preparations containing a substance or substances manufactured at the nanoscale. They must be declared only if the three following cumulative conditions are met:
    1) The products are placed on the market as such or as part of a mixture;
    2) A total quantity of more than 100 g of the substance is placed on the market by the company concerned during the calendar year covered by the registration;
    3) The person who places the substance or mixture on the market produced the substance or mixture him or herself, or places the substance or mixture on the market exclusively for use by professional users.
    The information to be provided is described in annex nr. 1 to the Royal Decree. The declaration can be filled out by or on behalf of the person responsible for placing the product on the market.
    Notification of articles and complex objects incorporating one or more substances manufactured at the nanoscale
    Other products must be registered through a notification made to the Ministry of Health and can only be placed on the market upon such registration. The products concerned by the notification requirements are complex articles or objects meeting the four following cumulative criteria:
    1) One or more manufactured nanoparticle substances have been incorporated into an article or complex object during any stage of its production;
    2) A quantity of more than 100 grams of one or more of these manufactured nanoparticle substances is placed on the market during the calendar year in which the notification takes place;
    3) It cannot be excluded that the article or complex object emits, in the context of its appropriate use and which is reasonably foreseeable, a fraction of one or more of these manufactured nanoparticle substances of more than 0.1 per cent of the amount originally contained in the article (there are exceptions to this threshold laid down by the Royal Decree)
    4) The article or complex object is produced by the person who places it on the market or it is placed on the market exclusively for professional users.
    The information to be provided to the Ministry of Health is detailed in annex nr. 5 to the Royal Decree.
    How will this declaration/notification system work?
    The Ministry of Health will likely launch an online portal to submit declarations and notification. A short declaration or notification based on Annex nr. 6 to the Royal Decree can be filled out upon respect of certain conditions. When applicable, declarers and notifiers will also have to update the information they have provided to the Ministry of Health every year before 31th March. Declarers and notifiers selling the registered products to professional users will have to provide them with certain information set out in the Royal Decree, notably the registration number of the products in the Belgian nano register.
    Enforcement and sanctions for infringement of the provisions
    The declaration or notification can be used by the Ministry of Health for further information request if there is evidence of potential risks constituted by a manufactured nanoparticle substance. Some information contained in the declarations and notifications will be treated as confidential pursuant to the rules set out by the Royal Decree.
    The Royal Decree will be enforced by agents of the Ministry of Health entitled to conduct inspections at the enterprise’s premises and related premises, as well as to order analyses of samples of the products or seize the products which are allegedly infringing the provisions of the Royal Decree. Administrative fines, criminal fines and jail penalties can be imposed on the enterprises violating the Royal Decree.
    Information duties to workers
    Employers will be obliged to inform their Committee for Health and Safety in the workplace about the products that have been registered by the employer in the nano register or about the products for which the employer received a nano register registration number.
    This information duty also extends to products which have been registered in accordance with other regulations because of the presence of nanomaterials in it and which are excluded from the scope of application of this Royal Decree. This currently applies to cosmetics and biocides.
    For further details on the above, please contact the author.
    By Anthony Bochon (anthony.bochon@squirepb.com). 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
     

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