HSEP News Bulletin by Gert Melis, SH&E Regulatory Affairs Manager at Agfa Gevaert and member of ESMA HSEP Committee.
Substances in nano scaleNanomaterials are substances, mixtures or materials that are manufactured in the range of 1 to 100 nm in at least one dimension. Nanomaterials have unique characteristics compared to the same material without nanoscale features. Therefore, the physico-chemical properties of nanomaterials may differ from those of the bulk substance or particles of a larger size.
In Europe, nanomaterials are covered by REACH and CLP. ECHA says they are able to carry out their tasks within the various REACH and CLP processes for nanoforms as it would for any other form of a substance. As a result, in 2016 the European Commission has rejected the idea of an EU nano registry. Instead ECHA will set up a website that will be named “nano observatory”. It will collect, analyse and review available information from a wide range of sources.
France
Before Europe has decided not to create an EU nano registry, France has adopted a nano registry that became effective in January 2013. Companies producing, distributing and importing 100 grams or more annually of a substance at nanoscale or a substance at nanoscale contained in a mixture without being linked to it, have to register. Substances at nanoscale that are used to manufacture UV inks could be pigments or additives. It is not likely that these products are extracted or released under normal or reasonably foreseeable conditions of use thus it could be stated that they are linked to the mixture. As a result UV inks would not have to be registered in France.
Belgium
The Belgian nano registry came into force January 2016 for substances. The registration of mixtures is postponed until January 2018. Companies manufacturing, distributing and importing 100 grams or more annually of a nanoparticle substance as such or as part of a mixture have to register. Pigments, when placed on the market in a mixture, an article or a complex object are exempt. UV inks do not need to be registered in Belgium if the pigments are the only nano substance in the ink.
Other countries
Denmark has a nano registry that applies to consumer goods. Distribution to professionals is exempted. In addition, as of the 1st of April 2017, it is obligatory to register nano content in chemicals to the Danish Product Registry.
In Norway, since June 2015, companies producing or importing hazardous chemicals in quantities of 100 kilograms or more annually must continue declaring these to the Norwegian Product Registry. In case a chemical product contains substances in nano form, this must be specified in the declaration form.
Notification to the Swedish product registry is coming up. The first registrations would concern manufactured and imported products during 2018, to be reported by 28 February 2019.
Further updates on the European and global nanomaterial legislation will be discussed at the next Health, Safety and Environment Protection Committee meeting on 17 November 2017 in Venice. All ESMA members are welcome to participate in the committee meetings and benefit from sharing information, knowledge and working together to manage complex regulatory issues. Please contact us at This email address is being protected from spambots. You need JavaScript enabled to view it. to register your attendance.
