In the midst of the global COVID-19 pandemics, the Belgian government decided in June 2020 to distribute free protective cloth masks to the population. The Luxembourg company Avrox was in charge of supplying 15 million masks for a total amount of EUR 32 million (excl. VAT) to the Federal government. However, according to an analysis conducted by the Belgian institute of public health Sciensano, these masks contain silver and/or titanium dioxide nanoparticles, recognised by the scientific community as a potential health risk.

There is a registry in Belgium, established by the Royal Decree of 27 May 2014 concerning the placing on the market of substances produced in nanoparticulate state, for the registration and notification of nanomaterials. This registry came into effect on 1st January 2016 for substances containing nanomaterials and on 1st January 2018 for mixtures containing such substances. The entry into force of the notification for articles, defined as "an object which is given, during the manufacturing process, a particular shape, surface or design which is more decisive for its function than its chemical composition" is still to be determined.

Companies that import, produce or distribute for professional purposes substances and mixtures considered to be or containing nanomaterials according to the Belgian definition of the term will have to register the substances and mixtures prior to placing them on the market. This registration consists of submitting a certain amount of scientific and commercial information to the Federal Public Service of Health. Registration also requires legal justification for the confidentiality of certain data, in order to preserve the company's commercial or technical secrets. Each company must therefore also implement a monitoring and coordination policy between its suppliers and its own professional customers, including on a contractual level. Registration covers the entire chain of placing nanomaterials on the market, except for sales to consumers.

The question that arises here is whether the cloth masks sold by Avrox should have been subject to any form of traceability specific to the presence of nanomaterials in their composition.

It should be noted that the analysis provided by Sciensano treats the masks distributed by the Belgian government as masks coated with "biocides". The Royal Decree of 27 May 2014 excludes from its scope articles treated with biocides that fall within the scope of Regulation (EU) 528/2012 of the European Parliament and of the Council of 22nd May 2012 concerning the making available on the market and use of biocidal products.

Both biocidal products and articles treated with a biocidal product are subject to a labelling obligation specifically identifying the nanomaterials present. With regard to treated articles, Article 58.3 of Regulation 528/2012 provides that the label shall include "the name of all nanomaterials contained in the biocidal products, followed by the word "nano" in brackets".

Are the masks placed on the market treated articles and does their labelling include the information required by Regulation 528/2012? Not having had these masks in our hands, we cannot pronounce on this subject, but the question is raised.

Although the placing on the market of biocidal products is outside the scope of the Royal Decree of 27 May 2014, this does not mean that its application should be systematically excluded. Indeed, the steps that precede the treatment of the cloth masks with the biocide might have to be taken into consideration and might fall under a registration obligation.

On the other hand, although it is particularly relevant in the case of masks placed on the market, the obligation to notify articles containing nanomaterials has not come into force nearly 7 years after the adoption of the Royal Decree. Does this delay mean that this obligation will never come into effect ? No one knows. If this notification requirement had existed in June 2020, would the placing on the market of the masks has had to be notified ? Surprising as it may be, the answer is no. It calls for a more specific comment.

In principle, according to the planned legal regime, which may one day come into force, cloth masks containing nanoparticles will be considered as articles within the meaning of the Royal Decree of 27 May 2014, requiring notification to the Federal Public Health Service. However, this notification is only mandatory if 4 cumulative conditions are met:

a. one or more substances produced in nanoparticulate state have been incorporated into the article

b. a quantity of more than 100 grams of at least one such substance produced in the nanoparticulate state is placed on the market during the calendar year in which the notification takes place

c. it cannot be excluded that the article will, under appropriate and reasonably foreseeable use, release a fraction of at least one such substance produced in a nanoparticulate state of more than 0.1 percent of the mass originally contained in the article

d. the article is produced by the person placing it on the market or is placed on the market exclusively for professional users.

It seems surprising that this notification obligation only concerns articles placed on the market "exclusively for professional users". Indeed, while the consumer is arguably the primary recipient of an item such as a cloth mask, the exclusion of any notification when consumers are the recipients of the items is somewhat incomprehensible. We can also ask ourselves the question of the legal regime applicable to "mixed" sales, intended for both professionals and consumers, which are very numerous and logically also exempts from notification if we rely on the adverb "exclusively" added to the fourth notification condition.

The conclusion is obvious : masks containing nanomaterials could not be subject to the Belgian nanomaterial register. On the other hand, the question of compliance with European Regulation 528/2012 on biocidal products is relevant and does not fail to raise interrogations about the very effectiveness of the obligation to mention nanomaterials in the labelling of biocidal products and treated articles.

The mask saga that hits Belgium again only highlights the Belgian legislative deficiency in the control of products containing nanoparticles. Indeed, with a notification that is only compulsory in case of sale to professionals and a register that is still non-existent as far as articles are concerned, Belgium seems to have missed the initial objective of the register, even though it was the third Member State of the European Union to adopt such a register, due to the lack of European harmonisation in this matter.

When we were the first to comment on the Belgian nanomaterials register from a legal point of view (see the list of our previous contributions at the bottom of the article), we noted the legal feverishness of the Belgian register – in contrast to the French register, which was adopted on what we considered to be solid foundations. In fact, few lawyers paid attention to the implementation of this regime; more scientists were interested in it.

Almost seven years have passed since the adoption of the legal framework of the Belgian nanomaterials register and scientific studies have multiplied. If the time of law is intrinsically out of step with the pace of innovation and science, one can only expect legislators to be able to anticipate and put in place appropriate legal mechanisms. This is clearly not the case here.

By now, we can only conclude that this register and the general legal framework are inadequate, in a context where the placing on the market of articles containing nanomaterials concerns certain nanomaterials to which risks have been associated.

It is up to the actors concerned by the problem to take a position on the issue.

Our previous contributions on the subject :

Our first article on the Belgian register published on 29 July 2014: https://www.lexgo.be/fr/articles/divers/divers/the-future-belgian-register-for-nanomaterials-what-companies-should-know-about-it,88277.html

Our comparative publication on the Belgian, Danish and French registers, published on 16 March 2015:

 https://chemycal.com/news/73403e63-3194-4295-96a0-740c8b9bbee8/Do_you_need_to_register_your_nanomaterials_in_the_European_Union

Reprint of the article on Nanowerk :

https://www.nanowerk.com/spotlight/spotid=37181.php?utm_source=feedburner&utm_medium=email&utm_campaign=Feed%
3A+nanowerk%2FagWB+%28Nanowerk+Nanotechnology+News%29#ixzz3Cj218uh7

Interview of 1st October 2015 by the Chamber of Commerce and Industry of Wallon Brabant: https://www.ccimag.be/2015/10/01/enregistrement-des-substances-et-produits-chimiques-le-registre-belge-des-nanomateriaux/

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