Practical information about applications for exemption for substances listed in Annex 1.17 ORRChem
Requesting exemptions for substances listed in Annex 1.17 ORRChem (Annex XIV REACH) can now be done directly in RPC using a dedicated form.
Product register for chemicals (admin.ch)
Applications are accepted only after entry in Annex 1.17 ORRChem. They shall be submitted 18 months at the latest before the end of the transitional period.
The Notification Authority grants a reasonable extension to the deadline if 18 months at the latest before the end of the transitional period if it is satisfied that the required documents cannot be produced within the stipulated time.
The IUCLID format (Substance export file, not write protected) used in the EU should preferably be used for preparing the application, PDF files otherwise https://iuclid6.echa.europa.eu/de/.
The application must be submitted to the Notification Authority for Chemicals using RPC.
3. Contents of the dossier
Information pursuant to Article 62 paragraphs 4-6 REACH shall be submitted in electronic form (IUCLID and/or PDF):
a) Identity of the substance
b) Name and contact details of the applicant
c) Application for authorisation with indications of the use(s) for which the authorisation is requested.
d) Chemical safety report
e) Analysis of the alternatives
f) if suitable alternatives are available, substitution plan incl. timetable for action.
The application may comprise the following:
a) a socio-economic analysis according to Annex XVI REACH;
The socio-economic analysis must be tailored to Swiss conditions. Useful EU guidelines for this are:
- “Guidelines for preparing socio-economic analyses” from ECHA
b) A justification as to why risks for human health and the environment from one of the following sources are not taken into consideration:
i) emissions of a substance from an authorised facility that has been authorised according to RL 96/61/EC on integrated avoidance and reduction of environmental pollution;
ii) discharges of a substance from a point source governed by the requirements of the water framework Directive 2000/60/EC.
For uses, whose authorisation was refused by the European Commission supported by Article 60 paragraph 1 REACH, an application may still be submitted pursuant to paragraph 4 within 3 months of the refusal. In addition to the documents according to paragraph 4 letter a, the following are to be appended to such an application:
a) the original application for authorisation made to the European Commission;
b) the decision for rejection made by the European Commission.
4. Consultation, Publication
The Notification Authority, in accordance with Article 73 ChemO (confidential data), publishes information on its website on the proposed uses of the substances. Before documents are published, the applicant is consulted and requested
- to check the documents for justifiable, confidential details
- to submit a version intended for publication (substance safety report with uses, exposure assessment, risk description)
- to release versions and parts of the application (uses in the substance safety report) for publication
This sets a deadline for the interested parties, who may transmit information on alternative substances or technologies up to the end of the deadline. In the context of this public consultation the Notification Authority will publish the uses, as are documented in the substance safety report.
5. Authorisation, Period of Validity
The Notification Authority can authorise a temporary exemption from the prohibitions pursuant to number 1 Annex 1.17 ORRChem by allocating an approval number. It publishes in digital form a publicly accessible register of the granted authorisations.
The fees are listed in accordance with ChemFO , III. The fees specified in the Chemical Risk Reduction Ordinance of 18 May 2005 are as follows:
Processing an application for an exemption pursuant to Annex 1.17 number 2 paragraph 4
- Basic fee for one substance and one use: 10 000 – 40 000
- Additional fee for one additional substance of one substance group pursuant to Annex XI section 1.5 REACH 1 000 – 10 000
- Additional fee for one additional use: 1 000 – 10 000
Fees are calculated depending on the expenditure of time.