On 7 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 the Royal Decree has not yet been published in the Belgian Official Gazette, its content has been disclosed under the TRIS notification system. The comments provided here are based on the documents notified to the European Commission on 19th February 2014, with a standstill dated extended to 20th August 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. This Belgian nano register will be the third national register adopted in an EU member State after the entry into force of the French R-nano register on 11st January 2013 and the Danish nano register. We provide here an overview of this future Belgian nano register and some suggestions to be ready for the 2016 and 2017 deadlines.
1. Background
With its upcoming register for nanomaterials, Belgium will be the third EU member State – and the third State in the world – to adopt a special register for nanomaterials. 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. As no action has been undertaken at the EU level after several years of debate, France has been the first member State to adapt a special register for nanomaterials. Belgium and Denmark followed, with the latter having already formally enacted the register in its domestic legal system.
2. 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. The answer to this question about the compatibility of the national register with EU law is left open but should be taken seriously by stakeholders and especially members of the industry. There is no need to say that measures obliging companies to file declarations or notifications to the competent authority in Belgium will restrict the free movement of goods within the EU internal market.
It must also be pointed out that the Belgian government has adopted this Royal Decree as an execution measure based on the law of 21 December 1998 on product standards aimed at promoting sustainable production and consumption, environmental protection and health and safety (“the Law of 21 December 1998”). This creates a notable difference with the legality of the French nano register under French administrative law because the French government had amended the legislative part of the Code of the Environment to provide a legal basis for the execution measures. Here, the Belgian Federal government has relied on an existing law to adopt restrictive measures that impede the proper movement of goods to and from Belgium.
If it was found that the Belgian register was compatible with EU freedom of movement and other provisions from the Treaty on the Functioning of the European Union, the legality of the Royal Decree under Belgian administrative law would however remain open. It is unsure whether the Federal Government could implement a nano register 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.
3. 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.
a) 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. For members of the industry, this definition has a “catch-all” effect and will trigger declaration and notification requirements more often than expected. For some non-governmental organizations such as trade unions and environmental associations, this definition is unsatisfactory as regards its size distribution requirement of at least 50%. 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.
b) 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. A product covered by the notification and declaration requirements will be considered as placed on the market when it is:
- introduced on the market
- imported to Belgium
- hold in view of the sale or the disposal to a third party
- offered for sale
- sold
- offered for rent
- rented
- transferred for free or with compensation
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 occurrs on the Belgian territory between professional users. The sale of the products to a consumer end-user is therefore excluded from the scope of application of this Royal Decree. Although this is not explicated by the Royal Decree, it also does not apply to products in transit on the Belgian territory.
4. Declaration of substances manufactured at the nanoscale and preparations containing a substance or substances manufactured at the nanoscale
Some products must be registered through a declaration made to the SPF Santé publique, Sécurité de la Chaîne Alimentaire et Environnement (hereafter “the Ministry of Health”) and can only be placed on the market upon such registration. 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. The Ministry of Health will likely launch an online portal to submit declarations. A short declaration based on Annex nr. 6 to the Royal Decree can be filled out upon respect of certain conditions. When applicable, declarers will also have to update the information they have provided to the Ministry of Health every year before 31March. Declarers 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.
5. 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 that 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. A short declaration based on Annex nr. 6 to the Royal Decree can be filled out upon respect of certain conditions. When applicable, declarers will also have to update the information they have provided to the Ministry of Health every year before 31 March. Declarers 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.
6. 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. Enterprises infringing the provisions of the Royal Decree can be condemned to a jail penalty between 8 days and 1 year and/or to a fine penalty of an amount between EUR 312 and EUR 720.000. In the first stage, the civil servant of the Ministry of Health in charge of the administrative enforcement of the Royal Decree will submit its process-verbal to the author of the infringement. The latter can offer to pay an administrative fine which will be between EUR 312 and EUR 36.000. If the author of the infringement does not offer such payment, then it will be exposed to the jail and fine penalties as the case will be referred to the competent Prosecutor of the Ministry of Justice.
7. Information duties to workers
Employers will be obliged to inform the 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.
8. Entry into force
To this day, the Federal government has not yet determined when products subject to the notification requirements will have to be notified.
Manufactured nanoparticle substances subject to declaration requirements must be registered by 1st January 2016 if they are already on the market by this date. From then, all substances concerned must be registered before their placement on the market.
Preparations subject to declaration requirements must be registered by 1st January 2017 if they are already on the market by this date. From then, all mixtures concerned must be registered before their placement on the market.
For further details on the above, please contact the author.
