European Observatory for Nanomaterials

• REACH registrations: Since 1 January 2020, Regulation (EC) No 1907/2006 (the REACH Regulation) requires concerned companies to submit data on nanoforms of substances as part of a REACH registration dossier (following Commission Regulation (EU) 2018/1881 of 3 December 2018 amending Regulation (EC) No 1907/2006). The search retrieves registrations from ECHA’s chemicals database that include at least one nanoform.
• French national inventory: In 2013, France established a requirement that nanomaterials on the French market need to be notified. The notifications need to be updated by companies or public laboratories on a yearly basis. The definition of a nanomaterial for the French scheme is derived from the European Commission’s recommendation for the definition of a nanomaterial, and the threshold for notifying is 100 grams, i.e., below the one tonne/year threshold that would require registration under the REACH Regulation. Note that the tonnages reported in the French inventory reflect only the tonnage of the nanomaterial, while the REACH Regulation is based on the the total tonnage of the substance imported or produced on the EU market, including both the non-nanoforms and the nanoforms of the substance.
• Belgian national inventory: In Belgium, a national requirement to submit notifications regarding nanomaterials entered into force in 2016. The requirement covers substances produced in a nanoparticular state and placed on the Belgian market above 100 grams per year. The definition of a nanomaterial for the Belgian scheme is nearly identical to that of the European Commission’s recommendation for the definition of a nanomaterial. Note that the Belgian inventory excludes natural, non-chemically modified substances, and substances where the nanomaterial particles are considered a by-product of human activity. Concretely, the Belgian inventory requires registration of substances and mixtures containing nanomaterials. Additionally, articles and complex objects containing one or more nanomaterials need to be notified - although the entry into force of the notification of articles and complex objects has not yet entered into force. There are several exemptions in place, such as for pigments, cosmetics and biocides. Companies must update their information on a yearly basis.
• EU cosmetics inventory: Regulation EC 1223/2009 has specific rules on the use of nanomaterials in cosmetics products, although it does not use the European Commission’s recommendation for the definition of a nanomaterial. Nanomaterials are defined as “an insoluble or biopersistant and intentionally manufactured material with one or more external dimensions, or an internal structure, on the scale from 1 to 100 nm”. A prior authorisation before their use in cosmetic products is required for products such as colourants, preservatives, and UV filters. The European Commission publishes a catalogue of cosmetic products using nanomaterials, and updates it regularly based on data submitted through the Cosmetic Product Notification Portal (CPNP).

Due to differences in defining nanomaterials, existence of specific exemptions, and tonnage reporting thresholds, the presence of a nanomaterial in any single data source does not mean that it is present in all of them. Nanomaterials notified to the French or Belgian inventories, or through the Cosmetic Product Notification Portal, do not automatically mean that the substance must be registered as a nanoform under the REACH Regulation and vice versa.

As the contributing sources have differing reporting rules and scopes, it is not always possible to match a substance reported in one of them with the substance in ECHA’s chemicals database. Where no match is possible, the substance in the original source is not reported in the EUON search for nanomaterials tool. Companies notifying nanomaterials to the French and Belgian national inventories may also be different from those that have registration obligations under the REACH Regulation.

In many cases, a substance can be manufactured as either a nanoform or a non-nanoform. Therefore, it is possible that a particular substance is notified as a nanoform by one company, but not manufactured in nanoforms by other companies. These differences can result in a substance appearing as a nanoform in one source, but not in others.