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Reporting Schemes for Nanomaterials

Reporting Schemes _200Several countries have introduced national-level mandatory reporting schemes in order to gather available information on nanomaterials and gain an insight into levels of production, importation and distribution on the market. 

The first of these schemes was launched in France during 2013.  This was closely followed by a comparable scheme finalised by the Danish Environmental Protection Agency (EPA), which had a deadline of 30th August 2015 for the first round of registration.  The Danish EPA has since published a report assessing the administrative burdens on businesses with an obligation to report to this scheme.   The Belgian Council of Ministers has also set up a national nanomaterial reporting scheme, which became operational from January 2016.  The key requirements of these registries are summarised in the table below, including links to further information on the relevant government websites.

A number of other European countries are considering introducing mandatory reporting schemes, including Norway, Sweden, and Italy.  Details of these schemes will be included here as they become available. 

At a European level, following an impact assessment to identify and develop the most adequate means to increase transparency and ensure regulatory oversight on nanomaterials, the European Commission concluded that an EU-wide mandatory registry would be too costly for both industry and authorities. Instead, an EU observatory for nanomaterials is currently being developed by ECHA. The observatory will not result in new data, but will collate together information that is already available on nanomaterials and present it in an easily understandable way. Information sources for the observatory will include data generated by various pieces of EU legislation regulating the safe use of nanomaterials (e.g. REACH, biocides, cosmetics), from national inventories, research projects, and market studies. The observatory will be developed in three phases. The first phase, which will describe what nanomaterials are, how they are used, and identify relevant safety issues – including links to relevant research projects – is set to go live in summer 2017. Later phases will include search functionalities and more detailed product information.

In the United States, the Toxic Substances Control Act (TSCA) contains a requirement under section 8(a) to report the manufacture or processing of nanoscale materials within one year of the final effective date of the ruling. This includes activities in the three years prior to the ruling.

Summary of reporting scheme requirements:

Reporting scheme Registrants Main exceptions Key information requirements Annual reporting
France - National Decree for Mandatory Reporting of Nanomaterials Manufacturers or importers of nanomaterials (on their own or included in a mixture or another material) in quantities of 100g/year or above The amount manufactured, imported or distributed is less than 100g/year;
The substance is sold directly to consumers (general public).
Identity of the declarant;
Identity of the nanomaterial (including physico-chemical data);
Annual tonnage;
Uses of the substance;
Identity of the professional users.
1st May (from 2013 onwards)
Belgium - Royal Decree on the placing on the market of substances manufactured in the nanoparticle form Companies that place substances and mixtures containing nanomaterials on the Belgian market in quantities of >100g/year The amount placed on the market is less than 100g/year;
Products already subject to regulations concerning nanomaterials (e.g.  biocides, foodstuffs, etc.)
Registrant’s identity;
Characteristics of the substance;
Quantity of nanomaterials placed on the market;
Identity of professional purchasers and users.
1st January (from 2015 onwards)
Denmark - Order on the Register of Mixtures and Products Containing Nanomaterials Manufacturers or importers of mixtures and articles incorporating nanomaterials that are intended for sale to the Danish general public Foods and FCMs;
Animal feed;
Medicinal products;
Medical devices;
Registrant’s identity;
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).
30th August (from 2015 onwards)
USA - Chemicals under the Toxic Substances Control Act (TSCA) Section 8(a) Manufacturers or processors of nanoscale forms, including aggregates and agglomerates, with at least one dimension in the size range 1- 100nm as defined in section 3 of TSCA (including those with intention to manufacture or process). Persons that manufacture or process, or intend to manufacture or process these chemical substances as part of articles, as impurities, or in small quantities solely for research. Chemical identity; actual or anticipated production volume; methods of manufacture and processing; use; exposure and release information; and available health and safety information. One time reporting within one year of the final effective date of the ruling (14th August 2017)