Switzerland’s federal public health office is modifying its proposals to revise the regulation for the notification of nanomaterials. The move comes after it received a deluge of negative feedback from industry. The proposed changes, which include an update on the definition of nanomaterials and a request for communication of all those on the Swiss market, were put to stakeholders in a consultation that ended in May. Two thirds of the 103 responses received were from industry, said Olivier Depallens from the chemicals division of the Bundesamt für Gesundheit (BAG). Most of these “criticised the new communication requirements, asking to cancel them or at least to reduce them to a limited situation or criteria”. Companies and industry associations also asked for a delay in the definition until EU measures are put in place, so as to align the Swiss criteria with those of the EU, Mr Depallens said. “We are now evaluating how to adapt our proposal regarding nano regulation and other proposed modifications,” he told Chemical Watch, adding the discussions are ongoing. A summary of the comments submitted to the consultation will be published in October. A final decision on the modifications is expected in December after several ministries have given their approval BAG’s revision of the legal requirements follows on from the Swiss federal council’s action plan for synthetic nanomaterials. This is to be implemented by 2019. In 2015, the federal council also launched a ‘modernisation’ of the national chemicals legislation.
BAG has split the proposed revision into two phases. The consultation this year referred to phase 1 proposals including:
- introduction of a communication for dangerous intermediates (some data from material data safety sheets to be introduced directly into an electronic product register);
- introduction of a communication for all nanomaterials (currently only dangerous nanomaterials are subject to this);
- introduction of a communication for nanomaterials used by industry in production processes;
- some simplification concerning labelling (language and imported small packaging), but also introduction of a unique formula identifier (UFI) [similar to Annex VIII of CLP]; and
- electronic publication of the list of SVHCs.
The second phase is expected to take place from 2019 to 2020 and will include the notification of substances not registered under REACH (1t/y or more on the Swiss market). The country’s chemicals Ordinance regulates the notification of new substances, identification of SVHCs, and the classification, labelling and safety data sheets of substances and mixtures. For most of the nanomaterial substances (where the bulk form is registered as a phase-in substance under REACH), the chemicals Ordinance will require notification of the nanoform only. Currently there is no EU register on nanomaterials, but several member states including Belgium, Denmark and France, have taken the initiative to require companies to report such information to their national inventories.
The European Commission is also discussing a revision of REACH annexes to take account of substances with nanoforms.
Chemical Watch, 2 August 2017 ; http://chemicalwatch.com