Today, the Swedish Chemical Agency (KEMI) has proposed an approach to registering nanomaterials to the Swedish Government. KEMI had been tasked with this report in January 2015.
The report [in Swedish, summary in English p.8] outlines a plan for a registry in Sweden under the existing Swedish Products Register that already gathers ‘information on chemicals and biotechnical organisms that are manufactured in or transferred or imported into Sweden’.
In this report, KEMI proposes that nanomaterials, defined according to the European Commission Recommendation for a Definition of Nanomaterial (2011/696) but excluding naturally occurring and unintentionally produced nanomaterials, would have to be registered as a specific category under the Products Register.
‘Alternative modes of action’ are proposed by KEMI; these are based either on the Norwegian registration scheme (1.a and 1.b) or on the French nanomaterial register (2.a. and 2.b)
At the moment, KEMI forseens a number of exemptions from this potential registration schem:
- Companies with a turnover of less than 5 million Swedish Krona (SEK) per year would be exempted during a ‘period of evaluation’, and,
- Product groups which are already exempted from reporting under the Products Register would not need to be registered (i.e. waste, food and animal feed, pharmaceuticals, cosmetics and tattoo ink), and,
- In a first period, articles would also be exempted from the proposed register.
According to this report, Swedish authorities intend to use data from this registration ‘as the basis for future regulatory development within environment, health and safety’. KEMI also suggests that data could be used ‘to monitor trends, fulfillment of environmental objectives, development of indicators and research’.
KEMI finally proposes further investigation and lists the legal modifications that the Swedish authorities would have to apply to enforce this new requirement.
Please follow this link to read the full press release of the Swedish Chemicals Agency.