The Swiss federal public health office is revising its regulation for the notification of nanomaterials. It will include a “specific notification for the nanoform of a substance,” according to Olivier Depallens, from Bundesamt für Gesundheit’s (BAG) chemicals division.
REACH says that information on the nanoform of a bulk substance should be included in the same registration dossier as the bulk substance.
But with only one dossier, “it is never clear which form was tested (bulk or nano) and the declaration of the manufacturer saying the nanoform has the same toxicological properties as the bulk form is subject to long discussions,” Mr Depallens told Chemical Watch.
The Swiss chemicals Ordinance (ChemO) regulates:
- the notification of new substances;
- identification of SVHCs; and
- the classification, labelling and safety data sheet of substances and mixtures.
For most of the nanomaterial substances (where the bulk form is registered as a phase-in substance under REACH) ChemO will require a notification of the nanoform only, according to Mr Depallens. And the dossier should “be the same as under REACH after adaptation of the REACH annexes”.
The current revision is based on two decisions of the federal council. The first, in December 2014, extended the implementation phase of its action plan for synthetic nanomaterials to 2019. A September 2015 decision launched a ‘modernisation’ of the national chemicals legislation.
These decisions gave BAG the order to prepare a revision of the legal requirements. Following this, it undertook an impact assessment from November 2015 to April 2016 and opened discussions with stakeholders.
Eye on the EU
BAG is aiming to begin a formal consultation of stakeholders, cantonal authorities and political parties early next year.
Meanwhile, Mr Depallens said the federal office is monitoring the result of the EU decision on nanomaterials-specific information for registration and adaptation of REACH annexes.
It will also use the 2018 REACH registration phase to clarify how many unregistered substances are on the Swiss market in quantities of more than 1 tonne/year and could be submitted for notification in the country.
Based on the results, BAG will propose splitting the revision into two phases to the federal council, according to Mr Depallens.
Phase one will take place in 2017 with some revision elements, including communication of all nanomaterials on the Swiss market.
Phase two will probably take place from 2019 to 2020, he says. It will include the introduction of the notification requirements for nanomaterials, as well as substances not registered under REACH (1t/y or more on the Swiss market).
Mr Depallens said that BAG expects Echa to publish the list of all REACH registered substances and annexes introducing nano-specific information in the second half of 2018: “We will need this information to prepare the second phase of the revision at the end of 2018.”
Notification of both measures correspond to registration under REACH, Mr Depallens said. The difference being that “every dossier should be evaluated by the authority – under REACH the registration dossier is not systematically checked for compliance by an authority”.