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Swedish nano product register under consultation

Date: 26/1/2017

The Swedish Chemicals Agency (KEMI) is in the process of consulting with stakeholders on a draft regulation that would require companies to provide information on nanomaterials in chemical products.

There has been a long-standing requirement in Sweden for companies to register the content of their chemical products to KEMI’s Products Register, but no special mention of nanomaterials has been required. The proposed regulation means that companies reporting products to the Products Register must also state whether these products contain nanomaterials.

According to the consultation document [pdf, in Swedish] from KEMI, the proposal is the same as outlined in its 2015 report with the following key features:

  • that those who report chemical products to the products register shall, in addition to the information that is currently reported, also provide further information regarding any nanomaterials contained in the product;
  • nanomaterials are defined in accordance with the recommended definition of the European Commission;
  • the proposal covers nanomaterials which have been intentionally added to the product, regardless of concentration;
  • exemptions from the reporting requirements are proposed for companies with a turnover of less than SEK 5 million per year during a period of evaluation.  These companies should only need to tick a box if they believe that their products contain nanomaterials;
  • during the period of evaluation, the same exemption should also apply to nanomaterials in the form of pigment;
  • the product groups, which are already exempt from the reporting requirements in the Products Register, will remain exempt for any purposes of this proposal.  Those product groups are waste, food and animal feed, pharmaceuticals, cosmetics and tattoo ink.

The 2015 report states that KEMI does not propose any reporting requirements for nanomaterials in articles. It is understood that a first reporting deadline of 28th February 2019 has been proposed.  

The draft regulation is open for comments until 24th March 2017. Comments should be submitted by email to kemi@kemi.se with the reference ‘4.7-H16-07940’.

Following the consultation, KEMI will review the responses and consider whether any revisions are necessary.  Once KEMI prepares a final draft, it will notify the European Commission of the new regulation.

Source: KEMI

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MWCNT-7 is classified by IARC as ‘possibly carcinogenic to humans’ (Group 2B).