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January 25, 2017

KEMI Consulting on Draft Nano Register Regulation

Lynn L. Bergeson Carla N. Hutton

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 to the Swedish products register by February 28, 2019.  According to KEMI, the proposal is the same as presented in its 2015 report.  Although the report is in Swedish, it includes an English summary on page 8, which states:

The Swedish Chemicals Agency proposes 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.  The proposal covers nanomaterials which have been intentionally added to the product, regardless of concentration.  Nanomaterials are defined in accordance with the recommended definition of the European Commission.  Although, this proposal does not cover nanomaterials that are naturally occurring or unintentionally produced.

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 report states that KEMI does not propose any reporting requirements for nanomaterials in articles.  Comments are due March 24, 2017.  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 regulation.