ECHA

The Swedish Chemicals Agency (Kemi) has set up a mandatory reporting scheme to obtain information on the quantities and types of nanomaterials used in Sweden. We interviewed Mr Robert Johansson, Head of the Chemical Statistics and Registries Unit at Kemi, about the types of information they will collect and how it will be used.

Gathering information about nanomaterials on the EU market is an ongoing effort. Nanomaterials have been around for decades, but information about how they are used and in what quantities is scarce. Many Member States, such as France, Belgium, Denmark and most recently Sweden, have launched their own mandatory registries to which companies must provide information about the nanomaterials they use.

Robert Johansson. Image: Swedish Chemicals Agency (KEMI).

New reporting requirement

There has been a long-standing requirement in Sweden for companies to annually register the content of their chemical products in Kemi’s products registry. This reporting requirement applies when the manufactured or imported volume of a product is at least 100 kilograms per year.

“The new requirement for nanomaterials means that companies reporting chemical products to be included in the registry must also state whether these contain deliberately added nanomaterials, regardless of their concentration,” says Mr Johansson.

The purpose is to obtain information on the quantities and types of nanomaterials used in Sweden. “This information can then provide a basis for making changes to legislation or taking other measures regarding nanomaterials, in areas such as healthcare, the environment or workplace safety,” Mr Johansson tells.

Who should notify?

Several actors are required to notify in the registry if their products contain nanomaterials, including:

• professional manufacturers or importers of chemical products and biotechnical organisms;
• those who, in their own name, package, repackage or change the names of chemical products or biotechnical organisms for further distribution;
• those who make mixtures of chemical products and biotechnical organisms for further distribution;
• manufacturers or importers of notifiable chemical pesticides; and 
• third parties that report the products on behalf of the manufacturers or importers.

“To support SMEs, companies with turnovers of less than EUR 500 000 per year are also exempt from the reporting requirement,” Mr Johansson explains.

Up to a couple of thousand notifications expected

Kemi expects to receive between 900 and 2 600 notifications, taking into account some exemptions that have been granted to properly evaluate the new requirements. Some of these exemptions cover nanomaterials that occur naturally or are accidentally produced as well as nanomaterials used as pigments.

“These figures are uncertain. They are partly based on a study originally made at EU level, so they might change when applied here in Sweden,” Mr Johansson adds.

If a company has not reported the nanomaterials that are present in their product, Kemi can decide to publish a statement of non-compliance and request the missing information.

Tips for other countries planning to establish a national registry

When setting up a national registry, there has to be a clear purpose and concrete ideas about how it should be used. “The registry should be planned together with different stakeholders, taking into account their views and needs during the entire process,” Mr Johansson suggests.

According to Mr Johansson, many companies have asked whether it would be possible for different registries in the Member States to have a similar design and to be synchronised for easier data access across the EU.

What types of information do companies have to report in the registry? The information that companies have to report in the registry includes:   the classification of the nanomaterial according to the CLP Regulation; the function of the nanomaterial in the specific product; primary particle size of the nanomaterial; the average size of the agglomerate or aggregate for nanomaterials usually found in a product in an agglomerated or aggregated state; the shape of the nanomaterial; crystal structure; and the surface area and surface treatment of the nanomaterial. KEMI's nano registry

Did you know?    ECHA has launched a European Union Observatory for Nanomaterials (EUON). It aims to make use of a variety of information sources, including that collected in different national inventories, to deliver accurate information to the public on nanomaterials in the EU. The EUON: was established in July 2017; brings together information about nanomaterials on the EU market from a wide range of different sources; and aims to compile data from national inventories into a searchable list. EUON

Further information:

SweNanoSafe – the Swedish national platform for nanosafety

Swedish Chemicals Agency – impact assessment of expanded notification obligation for nanomaterials

European Commission – study to assess the impact of possible legislation to increase transparency on nanomaterials on the market

European Union Observatory for Nanomaterials (EUON) – National reporting schemes

KEMI website

KEMI products registry
 

Interview by Adam Elwan

Published on: 17 May 2018

Top image: IStock.com/XtockImages

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