2017/0227/S
EC/EFTA
SE Suède
  • C00C - PRODUITS CHIMIQUES
2017-09-08
2017-06-19
Chemical products

Regulations amending the Swedish Chemicals Agency’s regulations (KIFS 2017:5) on chemical products and biotechnological organisms

There are currently certain information requirements for those who notify products to the Swedish Chemicals Agency’s product register. The notified draft in question concerns the introduction of a requirement that the notifier – in addition to the information presently registered – also provide information on nanomaterial(s) contained in the product. It is proposed that this shall apply to nanomaterials which have been intentionally added to the product, regardless of the concentration of the nanomaterial(s).

It is proposed that the definition of nanomaterial shall reflect the European Commission’s recommended definition. Under this draft, however, nanomaterials that are natural or incidental shall not be notified to the product register. Exemption from the notification obligation is proposed for nanopigments and for entities with an annual turnover of less than SEK 5 million. Those covered by the exemption shall only provide information as to whether or not a component is a nanomaterial. Other information may be provided on a voluntary basis. It is proposed that these exceptions shall be valid for an evaluation period of three years. Under this draft, those product groups which are already exempt from the required registration in the product register will remain exempt. This is the case for waste, foodstuffs and animal feed, medicinal products, cosmetics and tattoo inks. The draft does not entail a registration obligation for nanomaterials in goods.