Dag Kappes

International Chemical Regulatory and Law Review, Volume 6 (2023), Issue 2, Page 60 - 67

The latest revision to the Swiss Chemicals Ordinance, enforced in May 2022, brought about substantial changes to the definition of existing substances. Since then, the definition of existing substances in Switzerland depends upon the registration status of the substance in question under EU-REACH regulation. All substances that do not meet the definition of existing substances are considered new substances and are in principle subject to notification before they are placed on the Swiss market. Exemptions are coherent with those of REACH, e.g., for quantities of less than one tonne per year. A notification requires the submission of a data set corresponding to the one for a registration under REACH. Substances already on the market before the entry into force of the revision, which became new substances according to the modification, will have to be notified under the transitional provisions in order to continue to be placed on the market. On the contrary, the notifiers of already notified substances, which are now existing substances, are exempt from their obligation to provide information and updates. This revision also amended the language requirements for labelling and introduced facilitations for the reporting of preparations.

Dag Kappes

International Chemical Regulatory and Law Review, Volume 4 (2021), Issue 2, Page 53 - 60

The Swiss Chemicals Ordinance will be revised, amending mainly two issues: Currently, the Chemicals Ordinance requires labelling of certain chemicals in at least two official languages. In consequence, products are legally on the market namely in the Italian-speaking parts of Switzerland not being labelled in Italian. With the planned revision, the language of the place of supply will be decisive for the labelling of all chemicals including biocides, fertilisers and plant protection products. Furthermore, manufacturers and importers have to notify new substances, which are not listed on a static existing substances list, by submitting a data set to the notification authority before placing them on the market. In future, all substances not registered in the EU, but placed on the market in Switzerland will be subject to notification. The public consultation on this revision project is open until 16 July 2021.

Dag Kappes, Brunhilde Kolp Buchs

International Chemical Regulatory and Law Review, Volume 2 (2019), Issue 2, Page 52 - 60

The Swiss Ordinance on Biocidal Products is technically equivalent to the Biocidal Products Regulation (BPR) of the EU. As a result, the requirements concerning the harmonised authorisation procedures and the lists of active substances in the EU and Switzerland are identical. Therefore, in 2015 both parties renewed the existing chapter on ‘Biocidal Products’ in the EU-CH Mutual Recognition Agreement, which until 2013 had been based on the Biocidal Products Directive. Due to mutual recognition of authorisations of biocidal products, technical barriers to trade are avoided while maintaining the high level of protection. Furthermore, Switzerland participates in several BPR expert groups on EU level. This international exchange of knowledge and experience offers the opportunity to continuously improve the assessment techniques and to contribute to its harmonised development. Switzerland has to comply with the acquis. Consequently its room for manoeuvre concerning pragmatic solutions, eg for niche products, is therefore limited. The population benefits from the high level of protection. On the one hand, industry benefits from the same requirements and the possibility of mutual recognition of authorisations. On the other hand, small and medium enterprises operating only on the relatively small Swiss market suffer under the costs for the dossier preparation and the fees. Overall, the positive effects are likely to predominate due to the high level of protection.

Dag Kappes, Olivier Depallens

International Chemical Regulatory and Law Review, Volume 1 (2018), Issue 2, Page 64 - 73

Switzerland is a follower of the EU chemicals legislation due to its close trade relations and interest in a high level of protection for human health and the environment. However, Switzerland as a non-EEA member needs to find solutions for elements of REACH that cannot reasonably be introduced by a small country, such as a comprehensive registration scheme for substances, as is possible for the EU with its 28 member states and half a billion inhabitants. In addition, Switzerland's own registrations and decisions would inevitably lead to trade barriers. The rapid development of the EU chemicals legislation requires smart solutions and fast autonomous adaptations. Switzerland plans to introduce the ‘no data - no market’ principle for substances on the Swiss market that are not registered under REACH. The envisaged solution is a pragmatic compromise that requires data only for substances for which the necessary data for self-regulation by the manufacturer may not be available. With this approach, comparatively few resources can ensure a high level of protection and prevent trade barriers.