Do you need to register your nanomaterials in the European Union?

What is the current status of nanomaterials under REACH?

For many years, the European Commission has repeatedly stated that REACH applies to nanomaterials. Although this argument is legally accurate, non-governmental organizations have called for the adoption of specific measures pertaining to the characteristics of chemical substances at the nanoscale. The main argument is that the REACH requirements do not allow to address the health and safety concerns specific to the nanomaterials. Indeed, a material at nanoscale can have different chemical and physical properties due to its greater surface area. Supporters of a special register for nanomaterials consider that information on the nano form of substance is insufficiently collected through the REACH procedure and it would be better with a distinct register.

Why are there national registers instead of an EU nanomaterials register?

As the Member States of the European Union have failed to agree on the creation of a national nanomaterials register, France became in 2012 the first State in the world to adopt such register, effective as of 11^th January 2013. Denmark and Belgium have followed since then, despite the legal uncertainty in relation to the Member States’ discretion when adopting measures pertaining to substances covered by REACH, because the objective of REACH was precisely to harmonize all rules within the limits of the internal market and Member States are normally deprived from their power to regulate at their level what is already regulated at the Union’s level.During the standstill period preceding the entry into force of the three registers, some Member States have submitted comments through the TRIS notification procedure. However, the Commission does not seem to take the view that the adoption of national registers violates REACH. Any addressee who would dispute the compatibility of a national register with EU law would have to raise this issue before national courts which could refer to the Court of Justice of the European Union for preliminary ruling.

The strategic idea behind the multiplication of national nanomaterials registers is to force the Commission to accept the creation of an EU-wide register. It is unsure whether this will be achieved, as none of these registers imposes a marketing authorization scheme and are mainly adopted to provide more information to the public powers about the presence of nanomaterials on the market.

What should companies do to comply with the registration requirements? 

Not all companies are deemed to register their chemical products under the national registration schemes. However, they should check the following and take action when necessary:

• Companies should check if their chemical products fall within the scope of one of the national nanoregisters;

• If they do, the company must collect all information required for the registration of the nanomaterials; an attorney can provide guidance as to the information that should not be disclosed and be considered as confidential pursuant to the applicable law;

• The company must then file its notification with the competent authority in due time; it can be filed by an attorney on behalf of the company;

• The company must also review the contract it has with other companies upstream and downstream the distribution chain, as such contracts should contain a specific reference to the registration number of the product sold pursuant to this contract; otherwise, the company should adapt its terms and conditions;

What is required under the three national nanoregisters (France, Denmark and Belgium)?

To compare the three national nanoregisters, one needs to take into account different criteria that have an impact on the scope of application, enforceability and practicability of each nanoregister

• Nature of legal basis: if the legal basis is legislative (adopted by a parliament) rather than regulatory (adopted by a government), it would take more time to amend the legal text;
• Supervising authority: none of the three nanoregisters is or will be monitored by an independent authority; it is important to know the ministry entrusted with this task and the viewpoint it could adopt when assessing the quality of the registration;
• Entry into force: the date by which the legal text becomes compulsory; it does not equivalent to the deadline;
• Type of control: an ex-post control implies that the registration is made after the nanomaterials have been placed on the market; an ex-ante implies that the nanomaterials must be registered before they are placed on the market;
• Deadline: date before which the registration must be made;
• Scope by product: substances subject to the registration requirements according to the definition of the term “nanomaterial”;
• Exclusion by substance: substances not subject to the registration requirements despite the fact that they match the definition of the term “nanomaterial”;
• Exclusion by application: exclusion of substances from the registration requirements according the use of these substances made;
• Scope by activity: type of activity related to the substances which triggers the registration requirements;
• Activity excluded: type of activity not in the scope of activity;
• Registration threshold: threshold below which no registration of substances must be made;
• Simplified procedure: whether there is or not a simplified version of the registration form for applicants eligible for the simplified registration
• Exemption: whether there is no registration in certain cases, although all registration criteria are met
• Publicity: whether the information communicated to the authority through the registration process is made public or not;
• Protection of confidential information: whether the information deemed confidential (e.g. chemical formula) will be protected or not;
• Penalties: penalties imposed in case of infringement of the registration requirements (not filing, filing false information, filing incomplete information)

The three national nanomaterials have been compared in the light of the above-mentioned criteria:

Comparison between the national nano registers
Criteria	FRANCE	DENMARK	BELGIUM
Nature of legal basis	Legislative and regulatory	Legislative	Regulatory
Supervising authority	Ministry of Environment	Ministry of Employment Ministry of Environment	Ministry of Health
Entry into force	11st January 2013	18th June 2014	1st January 2016 (substances) 1st January 2017 (mixtures)
Type of control	Ex-post	Ex-post	Ex-ante
Deadline	Notifications must be made by 1st May of each year for Year-1 The first notifications for 2012 had to be made by 1st July 2013	Notifications must be made by 30th August of each year for the period from 20th June of Year-1 until 20th June of the Year (2?) The first notifications will be due by 30th August 2015	Before the product is placed on the market
Scope by product	Substance at nanoscale intentionally produced	Mixtures and articles containing nanomaterials (natural, incidental or manufactured)	Manufactured nanoparticle substance as such or as part of a mixture
Exclusions by substance	NO	NO	Natural substances By-products of human activity Carbon black Synthetic amorphous silica Precipitated calcium carbonate
Exclusions by application	YES	YES	YES
Scope by activity	Production Importation Distribution to professional users	Production Importation Distribution to the general public	Production Importation Distribution to professional users
Activity excluded	Distribution to consumers	Distribution to professionals	Distribution to consumers
Registration threshold	100 grams/year	No threshold	100 grams/year
Simplified procedures	YES Simplified notification for R&D	YES If some information cannot be obtained or would be too expensive to obtain	YES Simplified notification for R&D   Notification with another foreign authority with whom Belgian has an agreement Previous notification
Exemption	YES For Defence	NO	NO
Publicity	Non-confidential information is made public every year within 6 months of the declaration deadline   Other agencies have access to the information for risk assessment purposes	Non-confidential information is made public every year about notifications for the previous period   Other agencies have access to the information for risk assessment purposes	Other agencies have access to the information for risk assessment purposes
Protection of confidential information	Some information are deemed confidential / Other information can be treated as confidential upon a duly justified request
Penalties	Fine up to EUR 3.000 Daily penalty of EUR 300	Fines (undetermined)	8 days – 1 year jail EUR 312 – EUR 720.000
Other specific requirements			Information to the Health & Safety Committee

It is important to stress that this mere comparison does not reflect all the specific requirements laid down in the domestic legislation of each Member State.

What does this mean in practice?

Companies do not only need to comply with the REACH requirements in France, Denmark and Belgium but also have to comply with the specific requirements applicable in these countries to the manufacturing, importation and distribution of nanomaterials.  The following non-exhaustive examples illustrate how the national registers can affect companies active in the EU:

Example 1      A company manufactures in the United States objects containing nanomaterials that are used by consumers. These objects are then exported to France, Belgium and Denmark. If all registration criteria laid down in the legislation of the Member State are met, the French and Danish importer must register the nanomaterials with its national authority. The Belgian importer must currently not register the nanomaterials when they are contained in articles. It is indifferent whether the importer is related or not to the US company manufacturing the objects.

There is currently no agreement at the Belgian governmental level as to the applicability of the register to articles containing nanomaterials.

Example 2      A French company already manufactures substances at nanoscale. It sells more than 100 grams per year of these substances to professional users based in Belgium. Although the French company notifies the production of the nanomaterials to the French authority, it does not file any notification to the Belgian Ministry of Health before 1^st January 2016. It however distributes more than 100 grams of the nanomaterials to professional users and they notify the nanomaterials to the Belgian Ministry of Health, by complaining that there is a lack of information due to the absence of notification made by the French company. On 30^th August 2016, the Belgian Ministry of Health sends a letter to the French company stating that it infringed Belgian law and proposes to settle for an amount of 100.000 EUR.

Please note that the Belgian government has not issued yet the guidance documents relating to the register. It is currently unclear whether a Belgian company buying nanomaterials from another EU company and which distributes them to consumers would be subject to the notification requirements or if the EU-based seller is subject to these obligations.

Example 3      A Chinese company has a subsidiary in France, Denmark and Belgium. Each local subsidiary imports chemicals products from the Chinese mother company and these products contain natural nanomaterials. While the French and Belgian subsidiaries must not notify the importation to their national authority, the Danish importer must file an application with the Danish authority.

Although the Danish domestic market is small, the impact of the Danish register could be more important in terms of notifications filed, as naturally or incidentally produced nanomaterials are covered by the definition laid down in the legislation.

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Author: 

Anthony Bochon is a Belgium-qualified lawyer. He focuses his practice on European law and Belgian Economic Law. Since his bar admission, he has gained experience in advising international clients in a range of business sectors including chemicals, energy, telecommunications, fast-moving consumer goods, automotive, healthcare, raw materials and media. He has also assisted governments and public authorities on EU law matters. He has contributed to the representation of clients before Belgian judicial and regulatory authorities, as well as before European courts. 

He has significant and recognized expertise on the emerging regulation of nanotechnologies, being regularly asked to contribute at conferences and in the media. He is a part-time university lecturer on EU and Economic law (Université libre de Bruxelles and Brussels Business Institute) and fellow at the Transatlantic Technology Law Forum of Stanford Law School. He often publishes on various EU law, Economic law and Technology law topics. He is the secretary of the European Consumer Law Journal.