General exemptions
Substances and groups of substances which are regulated by special laws are not subject to the provisions of the ChemO (article 1 paragraph 5 and 6 ChemO). This applies:
a) to the transport of substances and preparations by road, rail, water, air or pipelines;
b) to the transit of substances and preparations under customs supervision provided that they do not undergo any processing or transformation;
c) to substances and preparations in the form of finished products ready for supply to the end consumer that fall into the following categories:
a. foodstuffs as defined by article 4 of the Foodstuffs Act of 20 June 2014,
b. medicines as defined by article 4 paragraph 1 letter a and medical devices as defined by article 4 paragraph 1 letter b of the Therapeutic Products Act of 15 December 2000,
c. animal feedstuffs as defined by article 2 paragraph 1 of the Feedstuffs Ordinance of 26 May 1999;
d) to weapons as defined by article 4 paragraph 1 and ammunition as defined by article 4 para-graph 4 of the Weapons Act of 20 June 1997;
e) to substances, preparations and objects which are waste according to article 7 paragraph 6 of the EPA.
f) Articles 57, 62 (storage) and 67 (theft, loss, erroneous placing on the market) apply to imported substances and preparations that are simply relabelled and then exported without alteration. Dangerous substances and preparations that are exported are also governed by the PIC Ordinance of 10 November 2004.
Crop protection producs and biocidal products
New substances that are used exclusively as active ingredients and co-formulants in crop protection products and as active ingredients in biocidal products are not subject to the requirement for notification because they are required to undergo a regulatory approval procedure.
Cosmetic products
For cosmetic products within the meaning of art. 53 par. 1 of the Ordinance of 16 December 2016 on foodstuffs and commodities, in form of finished products which are destined for private or professional users (Art. 1 par. 4 ChemO), only Articles 5-7 (self-regulation, classification) and 81 (review of self-regulation) apply and only with regard to environmental protection and to classification or assessment in relation to risks to the environment.
Exemptions for new substances to which the ChemO applies
Not all new substances to which the ChemO applies are subject to the notification requirement. The exceptions are listed in article 26 ChemO. This article states that notification is not required for:
a. Polymers as well as substances contained therein (monomers or substances chemically bond to the polymer) below 2%. Monomers must be notified!
b. substances placed on the market (in Switzerland) in quantities of less than one ton per year
c. substances placed on the market by a manufacturer:
1. purely for the purposes of product- and process-orientated research
and development
2. limited to the quantities required for the said purposes and
3. for a period not exceeding five years; in justified cases and on request,
the notification authority, after consultation with the evaluation unit, may
extend this period by a further five or ten years;
a. substances used exclusively as raw materials, active ingredients or additives in food, therapeutic products and animal feed;
b. substances acquired in Switzerland;
c. intermediates, provided that they are not monomers;
d. substances listed in Annex IV or V REACH
e. Substances that have been notified already, exported by a manufacturer and imported again by the same manufacturer or another manufacturer of the same supply chain, if he can demonstrate that:
1. the substance is the same
2. he has been provided with the safety data sheet for the substance
in accordance with article 20 ChemO if required by art. 19 ChemO.
Comments
Letter c: This adaptation of the minimum quantity threshold for notification corresponds with that for registration according to the REACH Regulation. Here, the quantity actually placed on the market in Switzerland counts, notwithstanding the place where the substance is manufactured.
Letter g: Intermediate: any substance manufactured and used solely for chemical transformation processes during which it is transformed into one or more chemical substances (article 2, paragraph 2, letter d, ChemO). This definition includes three different types of intermediates introduced in the EU with the REACH Regulation (i.e. non-isolated intermediates, on-site isolated intermediates and transported isolated intermediates). Monomers may also represent intermediates. However, if a new substance is notified in accordance with Article 24 Paragraph 2, monomers are not covered by the exemption for intermediates.
