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The Swedish Chemicals Agency is introducing a reporting requirement for nanomaterials

News 12/5/2017

The Swedish Chemicals Agency is introducing a new requirement whereby companies reporting products to the Agency’s Products Register must also state whether these products contain nanomaterials. The new regulations come into force on 1 January 2018. This means that information on nanomaterials will be reported for the first time in the Products Register in February 2019.

There has been a long-standing requirement in Sweden for companies to register the content of their chemical products in the Swedish Chemicals Agency’s Products Register. The new regulations mean that companies reporting products to the Products Register must also state whether these products contain nanomaterials that have been deliberately added.

The purpose of the new reporting requirement is to obtain information on the quantities and types of nanomaterials used in Sweden. This information can provide a basis on which to make changes to legislation or take other measures in the future regarding nanomaterials. 

The new regulations on nanomaterials are based on a report produced by the Swedish Chemicals Agency on behalf of the Government in 2015. Companies with a turnover of less than SEK 5 million per year are exempted from the new reporting requirement on nanomaterials. The new rules are being incorporated in the Swedish Chemicals Agency’s new basic regulations (KIFS 2017:7) on Chemical Products and Biotechnical Organisms, which as of the start of the New Year will replace the old basic regulations KIFS 2008:2.

The new reporting requirement is being introduced in connection with the decision taken by the Swedish Chemicals Agency on two new basic regulations: KIFS 2017:7 and KIFS 2017:8. The purpose of the new basic regulations is to achieve greater clarity in terms of both a systematic approach and language. The Swedish Chemicals Agency has also decided on the amendment regulations to KIFS 2008:3. Examples of new content in the regulations apart from the registration requirement for nanomaterials are as follows:

  • The new regulations are based on the old ones but are divided differently in terms of chapters and annexes.
  • References are being introduced at the start of each chapter, explaining the way in which the regulations relate to other regulations (EU laws, Swedish laws and ordinances).
  • Existing regulations on the flammability and chemical properties of toys are being removed to form their own body of regulations (KIFS 2017:8).
  • The regulations on the documentation requirement for handling mercury and regulations on exemption from the threshold values for heavy metals in packaging material are being abolished.
  • Regulations on wood treated with wood preservative are being transferred to the Swedish Chemicals Agency’s regulations on pesticides (KIFS 2008:3).
  • The amendments will come into force on 1 January 2018.

For more information, please feel free to contact:

Christophe Kellner, Legal Officer, +46 8 519 41 399

The Swedish Chemicals Agency’s press service, +46 8 519 41 200, press@kemi.se

E-mail addresses of the Swedish Chemicals Agency’s employees are written as follows: firstname.surname@kemi.se

Facts: Nanomaterials are extremely tiny materials

Nanomaterials are minute materials which are only a few atoms in size.  Their extremely tiny size means that a substance may assume completely different properties in nano size to those in its normal size. Nanomaterials can be used in many different products such as paints, cosmetics, textiles, sports equipment and electronic goods.

The special properties nanomaterials have may pose a greater risk to human health and the environment. Not only technical properties but also hazardous properties can change. Nanomaterials can be absorbed, spread and act in the body and the environment in a way they do not do when of normal size.

The Swedish Chemicals Agency is monitoring developments and seeking to provide more knowledge about the risks associated with nanomaterials. The Agency is also taking steps within the EU and at international level to draw up rules for protecting human health and the environment.

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