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Posted: Feb 26, 2018
Back to the future: Belgian nanomaterials register retroactively amended
(Nanowerk Spotlight) In Alice’s Adventures in Wonderland, the White Rabbit keeps saying "Oh dear! Oh dear! I shall be too late." The same could have been said by the Belgian federal government when it adopted the Royal Decree of 22nd December 2017, published in the annexes of the Belgian Official Gazette of 15th January 2018 (“Amending Royal Decree”), whose main provisions retroactively enter into force on 31st December 2016. The Amending Royal Decree modifies the Royal Decree of 27 May 2014 (“Nanoregister Royal Decree”). In the meantime, from a strict legal viewpoint, the date as from which mixtures containing nanomaterials placed on the Belgian market had to be registered was still 1st January 2017.
The Belgian federal government unnecessarily delayed the adoption of the Amending Royal Decree until December 2017 and published it only mid-January 2018. It creates legal uncertainty where it should have been avoided. The Belgian nanomaterials register (which we commented here when it was adopted) symbolizes a Belgian exceptionalism in the small world of national nanomaterials registers. Unlike France, Denmark and Sweden, Belgium decided from the very beginning to have three different deadlines for substances, mixtures and articles.
In an already fragmented regulatory landscape (with 4 EU Member States having their own national nanomaterials register and 24 EU Member States which do not have such registration requirements), the confusion around the deadline for the registration of mixtures in Belgium does not allow the addressees of the legal obligations to comply with them.
The Royal Decree amends the Nanoregister Royal Decree in four ways:
1. Cosmetics are now officially of the scope of the Nanoregister Royal Decree. Though it was not necessary, again from a strict legal viewpoint, to insert the exemption because the primacy of EU law, which gives precedence to the Cosmetics Regulation (which fully harmonizes registration requirements of cosmetics) over Belgian law (including the Nanomaterials Royal Decree), that clarification is particularly welcome.
2. The entry into force of articles 3 to 10 of the Nanoregister Royal Decree is changed from 1st January 2017 to 1st January 2018 insofar these apply to mixtures containing nanomaterials.
3. The mixture already placed on the market have to be registered by 1st January 2018
4. The annual reporting for mixtures has been made by 31st March 2019
We can regret that the Belgian federal government has not taken any decision yet about the entry into force of the provisions of the Nanoregister Royal Decree relating to the registration of articles. The addressees of these provisions do not know when they will have to comply with these obligations.
At the same time, it is difficult to understand the exact purpose of the Belgian nanomaterials register as it currently exists. Like all other national nanomaterials registers, it is not based on the “no data, no market” principle underlying REACH.
Even though failure to properly register substances – and now mixtures – within the Belgian nanomaterials register exposes the addressees of the obligation to criminal penalties, the function of the register remains purely informational.
The data collected through the registration was meant to be used to identify the presence of manufactured nanomaterials on the Belgian market, with the implicit objective of regulating the exposure of workers and consumers to these nanomaterials. The absence of entry into force of the provisions relating to the registration of articles is therefore incoherent and should question the relevance of the whole Belgian registration system.
In the meantime, manufacturers, importers and distributors have to face compliance costs and legal uncertainties about the applicability of the requirements to their own substances and mixtures.
By Anthony Bochon ([email protected]). Attorney at the Brussels Bar, Senior associate at Squire Patton Boggs (UK) LLP Brussels office, Associate lecturer at the Université libre de Bruxelles and expert in the Horizon 2020 project EC4SafeNano.