Substances of very high concern which are prohibited in the EU may also not be placed on the market or used in Switzerland. The aim behind the implementation of the provisions of Regulation (EC) 1907/2006 (REACH) in Annex 1.17 to the Chemical Risk Reduction Ordinance (ORRChem) is to ensure that human beings and the environment receive the same level of protection in Switzerland as they do in the EU.
1. Basic principles
In the EU, in accordance with Regulation (EC) No. 1907/2006 (REACH), certain substances that are carcinogenic, mutagenic or toxic for reproduction (CMR substances), substances that are persistently bio-accumulative and toxic (PBT substances), and substances that are very persistent and very bio-accumulative (vPvB substances) are classified as substances of very high concern and are thus candidates for inclusion in Annex XIV to REACH. Substances listed in this Annex are prohibited, though they may be declared exempt under certain circumstances: manufacturers, importers and/or downstream users may apply for exemption from the ban for a limited period of time.
In Switzerland, the European list (i.e. list of candidate substances) of classified substances of very high concern is incorporated into Annex 3 to the Federal Chemicals Ordinance (SR 813.11), while the provisions governing the approval requirement in the EU for substances of very high concern are laid down in Annex 1.17 to the Ordinance on Chemical Risk Reduction (ORRChem). It is prohibited to place on the market and use substances listed in Annex 1.17 ORRChem. Authorisations granted by the EU Commission take the form of exemptions from the prohibition, as long as the substance concerned is placed on the market and used in accordance with the terms of the EU authorisation. Furthermore, the provisions of Annex 1.17 ORRChem stipulate that the Chemicals Registration Authority may, upon application, grant additional exemptions for limited periods of time, upon consultation with the Federal Office for the Environment (FOEN), the Federal Office of Public Health (FOPH) and the State Secretariat for Economic Affairs (SECO), for placing prohibited substances on the market and using them in Switzerland. The Federal Council has also authorised the FOEN to adapt the list of substances upon consultation with the FOPH and SECO and to add substances to the list that were previously included in Annex 3 (list of candidate substances) to the Chemicals Ordinance and in Annex XIV to REACH.
It is essentially prohibited to place on the market for use substances that are listed in Annex 1.17, section 5, ORRChem, or preparations containing such substances. It is also prohibited to use such substances or preparations on a professional or commercial basis..
The following concentrations of substances of very high concern are tolerated in substances and preparations:
- PBT and vPvB substances, and substances giving rise to concern on account of similar or endocrine-disrupting properties: up to 0.1%
- CMR substances: concentrations below the limit levels specified in Annex I, paragraph 220.127.116.11. of Regulation (EC) No. 1272/2008 (CLP Regulation), which result in the classification of the preparation (mixture) as dangerous.
Provided that use is not restricted by other legislation, the specified prohibitions do not apply to use:
- as an intermediate product as defined in Article 2, paragraph 2i of the Chemicals Ordinance
- in medicinal products
- in foodstuffs or feeding stuffs
- in plant protection products or biocide products
- as a motor fuel or combustible
- in cosmetic products or in food contact materials and articles, provided that the substance has been included in the list under section 5 solely on the basis of the intrinsic properties "carcinogenic", "mutagenic", "toxic to reproduction" or "other serious effects to human health"
- in scientific research and development
In addition, a prohibition does not apply:
- in cases where authorisations have been granted by the European Commission in accordance with Article 60 paragraph 1 of REACH
- to those uses of the substance in question for which an application for authorisation was made, within the specified deadline, in accordance with Article 62 of REACH, on which a decision has not yet been taken
- if the Chemicals Registration Authority has granted additional exemptions upon substantiated application
Authorisations granted by the EU Commission are recognised unilaterally as exemptions from the prohibition as long as the substance concerned is placed on the market and used in Switzerland as described in the application for approval. These exemptions may be granted without the need for an application to be submitted to a Swiss authority for recognition of EU approval.
4. Reporting requirements
Manufacturers and importers are subject to reporting requirements in accordance with Article 48 of the Chemicals Ordinance. In addition, in accordance with Annex 1.17 ORRChem, the requirement to submit a report to the Chemicals Registration Authority also applies to anyone who obtains a substance as such or as a constituent of a preparation, from a Swiss manufacturer, importer or dealer and uses it on a professional or commercial basis.
5. Update regarding Annex 1.17 ORRChem
As noted above, the FOEN is authorised to adapt the list of substances upon consultation with the FOPH and SECO, and to add substances to the list that were previously included in Annex 3 (list of candidate substances) and in Annex XIV to REACH. When a substance is added to Annex 1.17, section 5, ORRChem, a transitional period and any exempted uses are specified. The transitional period specifies the date until the substance may continue to be placed on the market and used in Switzerland. Applications must be submitted to the Chemicals Registration Authority by not later than 18 months prior to the expiry of the specified transitional period. The transitional period in accordance with ORRChem may be (but does not have to be) identical to the "sunset date" as per Annex XIV to REACH.
In order to identify the impacts for the industry as well as for the authorities associated with the inclusion of a substance in section 5, Annex 1.17 ORRChem, the FOEN contacts the corresponding industry associations at an early stage. The document below lists those substances that are included in Annex XIV to REACH, but not yet in Annex 1.17, section 5, ORRChem:
Stoffe mit Zulassungspflicht (PDF, 294 kB, 09.10.2018)(available in German and French)
- It is also specified in Annex 1.17 that, if so requested, the Chemicals Registration Authority may, with the agreement of the FOEN, FOPH and SECO, grant further temporary exemptions from the prohibitions for placing on the market and use in Switzerland. This option is primarily intended for cases in which a given substance is only used in Switzerland. The requirements for such a request are in principle the same as those specified in the EU. Accordingly, the submitted information should include:
o a chemical safety report
o an analysis of the alternatives
o if appropriate, a socioeconomic analysis.
- The Chemicals Registration Authority may in some cases decide it does not need to receive all the cited information.
- Fees apply for the processing of applications. Exemptions granted by the Chemicals Registration Authority are only valid in Switzerland and only for licence holders and their customers.
Last modification 09.10.2018