National reporting schemes
Several Member States have taken national initiatives to request more information on nanomaterials from industry. These national regulations vary in scope, but also in terms of what information is actually requested from companies, exemptions, and information available to the public. Belgium, France, and Denmark have stand-alone inventories for nanomaterials, whereas Norway and Sweden have included a section for nanomaterials in their already-existing product registers.
The data collected from French and Belgian national inventories is also incorporated into the Search for Nanomaterials database to enable easy search for the information, and linking to information on the substance(s) and nanoform(s) collected under the REACH regulation.
To learn more about National nano registers in Europe and how they came about, visit the open-access Chapter 21 “Nanoregisters in Europe” by Abdelqader Sumrein which is part of the book “Particle Technology and Textiles: Review of Applications”.
EUON which is funded by the European Commission has financed the chapter’s availability to a broader public.
|National initiative||Registrants||Main exceptions||Information requirements||Reporting|
Notification Scheme - National Decree for Mandatory Reporting of Nanomaterials
Manufacturers, importers and distributors of a substance, mixture or article containing nanomaterials in quantities of 100 g/year or above.
Definition used is different from EU Recommendation and refers to “intentionally manufactured”.
The declaration applies to the entire national territory to the exclusion of New Caledonia, the French Polynesia, Wallis and Futuna and the French Southern and Antarctic Lands.
The quantity imported or distributed by a legal entity is less than 100 g/year per substance;
The substance as such or contained in a mixture or as articles intented to reject such substance, are sold directly to consumers (the general public).
Info of the nanomaterial (including physico-chemical data) and available info on (eco)toxicological properties;
Identity of the professional users.
Registry - Royal Decree on the placing on the market of substances manufactured in the nanoparticle form
Manufacturers and importers that put nanomaterials or mixtures containing nanomaterials on the Belgian market in Belgian territory in quantities of >100 g/year.
Distributors that put nanomaterials or mixtures containing nanomaterials on the Belgian market in Belgian territory in quantities of >100 g/year exclusively to professional users (companies or a persons who acquire and use the product in the framework of their economic activities).
Definition based on EU Recommendation, but makes excemption for naturally occurring, non-chemical modified.
Natural, non-chemically modified substances.
Pigments when placed on the market in a mixture, an article or a complex object.
Company and user info;
Mixture and composition of the mixture;
Chemical name and formula of the substance;
(from 2015 onwards)
Product Registry - Order on the Register of Mixtures and Products Containing Nanomaterials
Manufacturers or importers of mixtures and articles containing nanomaterials intended to be sold to the general public on the Danish market.
The EU Recommendation for a nanomaterial is used.
|Foodstuff and food contact materials;
Mixtures and articles in which the nanomaterial is the nanoscale of substances listed in Annex IV or V to Regulation (EC) No 1907/2006 of the European Parliament and of the Council (REACH);
Mixtures and articles containing naturally occuring nanomaterials;
Articles in which the nanomaterial is part of a fixed matrix unless wear, tear, washing, breaking and similar normal use of the article leads to a release of free nanomaterials;
Articles on which the nanomaterial is used as ink directly on the article or on labels on the article, including newspapers, periodicals, magazines, packaging that is not coloured in the mass or dyed;
Textiles where nanomaterial is used as ink or for dyeing of textiles;
Paint, wood preservative, glue and filler containing pigment on the nanoscale where the pigment is added solely for the purpose of colouring the mixture;
Articles of rubber or rubber parts of articles that contain the nanomaterials carbon black or silocon dioxide;
Mixtures and articles produced or imported by individuals for their own, non-commercial use.
Product information (including name, quantity; professional uses, applications);
Information on nanomaterial (including REACH registration status);
Chemical information on nanomaterial (including CAS/EU number and chemical formula).
(from 2015 onwards)
Product Registry – Order on mandatory declaration of chemicals to the national product registry
General requirement to all manufacturers and importers to report on chemicals that are classified under Article 3 of CLP and placed on the market 100kg or more per year. If the chemical contains nanomaterials, it should be noted in the declaration.
The EU Recommendation for a nanomaterial is used.
|Products that are not chemicals
Chemicals that are imported or produced less than 100kg per year
Certain chemicals which are exempt under regulations:
medical devices (which include certain disinfectants);
plant protection products;
|Information that is already known by the producer/manufacturer should be reported. In addition, the function fulfilled by the nanomaterial should be reported.||Compulsory from March 2013 onwards|
|Manufacturers and importers of common chemicals and biocides containing nanomaterials exceeding 100kg per product per year that are placed on the market in Sweden.||Chemicals that are handled by a private person in a "hobby sized" environment less than 100kg per year||Info of the nanomaterial (including physico-chemical data) and available info on (eco)toxicological properties.
If such information cannot be provided an applicant should explain the reason.
For pigments it only needs to be stated that the material is a pigment without providing any additional information on numbers.
|Entry into force on
1 January 2018.
Ref: Kemikalieinspektionens foreskrifter (KIFS) 2017:7
- Jean Cornier and Franz Pursche "Particle Technology and Textiles: Review of Applications", Berlin, Boston: De Gruyter, 2023 (in English)
- Chapter 21 “Nanoregisters in Europe” by Abdelqader Sumrein (from the book by Jean Cornier and Franz Pursche "Particle Technology and Textiles: Review of Applications", Berlin, Boston: De Gruyter, 2023) (in English)
- Report on the notifications of nanoparticle substances produced, imported or distributed in France during the year 2016 (in French), French Ministry for an ecological and solidary transition
- Study of the scope of a Belgian national register for nanomaterials and products containing nanomaterials (in English), Federal Public Service Health, Food Chain Safety and Environment, Belgium
- Assessment of the administrative consequences for companies to report to a Danish nano product database, Environmental Protection Agency, Denmark (in Danish, summary in English)
- Assessment of options to reduce the administrative burdens connected to reporting to the Danish nano product database, Environmental Protection Agency, Denmark (in Danish, summary in English)
- Assessment of impacts of a European register of products containing nanomaterials, Federal Environment Agency, Germany (in English, summary in German)