4. Which substances and preparations have to be reported?

4.1 Reportable substances and preparations under Art. 48 ChemO

Under Art. 48 para. 1 ChemO, manufacturers must report the following substances and preparations within 3 months after first placing them on the market:

a. the substances and preparations specified in Article 19, irrespective of whether a safety data sheet has to be compiled for them;
b. nanomaterials, other than those referred to in letter a, which specifically contain biopersistent⁹ fibres or tubes exceeding 5 μm in length.¹⁰

The substances and preparations specified in Article 19 are as follows:

a. dangerous substances and preparations (Article 3 ChemO);
b. PBT¹¹ or vPvB¹² substances;
c. substances listed in Annex 3 to ChemO¹³;
d. preparations which are not dangerous within the meaning of Article 3 and contain at least one of the following substances:

1. a substance that is dangerous to health or to the environment in an individual concentration of ≥1.0 per cent by weight (non-gaseous preparations) or ≥0.2 per cent by volume (gaseous preparations),
2. a category 2 carcinogenic substance, a category 1A, 1B or 2 toxic for reproduction substance, a category 1 skin allergen, a category 1 inhalation allergen, a substance having effects on or through lactation, or a PBT or vPvB substance in an individual concentration of ≥0.1 per cent by weight,
3. a substance listed in Annex 3 to ChemO in an individual concentration of ≥0.1 per cent by weight,
4. a substance for which an occupational exposure limit value has been laid down in Directives 2000/39/EC, 2006/15/EC, 2009/161/EU or (EU) 2017/164 or (EU) 2019/1831.

In the Ordinance, no provision is made for trivial quantities, below which a substance or preparation does not have to be reported, except in the case of intermediates and preparations intended exclusively for professional users. For these two exemptions, a threshold of 100 kg per year is specified.

If a preparation is to be labelled exclusively with one or more EU hazard statements (e.g. EUH208 Contains <name of sensitising substance>. May produce an allergic reaction.), then the chemical is not deemed to be dangerous under the Chemicals Ordinance. However, if the preparation contains a substance specified in Art. 19 let. d ChemO above the concentration limit, then the product must be reported and a safety data sheet is to be compiled for professional users.

Notes on substances
Under Art. 26 para. 3 ChemO, new substances that are exempt from notification requirements must be reported (see guidelines on reporting and notifying new substances¹⁴) if they

• are dangerous within the meaning of Art. 3 ChemO and/or
• have PBT and/or vPvB properties as specified in Art. 4 ChemO.

Intermediates are substances according to the definition given in Art. 2 para. 2 let. j ChemO. Intermediates are exempt from reporting requirements if they

• are placed on the market in quantities less than 100 kg per year,
• are not supplied to third parties, or
• do not leave the manufacturing site.

If they are subject to reporting requirements, they must be specifically declared as intermediates by the manufacturer.
When reported, nanomaterials must be specifically declared as such. A nanomaterial may be a multi-constituent substance or a mono-constituent substance (i.e. with one main constituent present at a concentration of at least 80%). This also applies to preparations containing nanomaterials. For nanomaterials, the Swiss authorities apply, by analogy, the ECHA Guidance “How to prepare registration dossiers that cover nanoforms: best practices”.¹⁵ Also subject to reporting requirements, as well as those nanomaterials classified as dangerous, are those, which contain, by design, biopersistent fibres or tubes exceeding 5 μm in length.

⁹Biopersistent materials are those with a water solubility of less than 100 mg per litre or with a half-life of 40 days or more in the lungs.
¹⁰These criteria were derived from the WHO definition of respirable fibres and from the standard definition of high aspect ratio nanomaterials. To be subject to reporting requirements, the material must, however, also meet the definition of a nanomaterial given in Art. 2 para. 2 let. q.
¹¹Substances are considered persistent, bioaccumulative and toxic (PBT) if they fulfil the criteria defined in Sections 1.1.1–1.1.3 of Annex XIII to the REACH Regulation.
¹²Substances are considered very persistent and very bioaccumulative (vPvB) if they fulfil the criteria defined in Sections 1.2.1 and 1.2.2 of Annex XIII to the REACH Regulation.
¹³List of substances of very high concern (SVHC), taken from the Candidate List of the European Chemicals Agency (ECHA) (Article 59 of the REACH Regulation); https://www.anmeldestelle.admin.ch/chem/en/home/themen/recht-wegleitungen/chemikalienrecht/chemikalienverordnung.html
¹⁴See https://www.anmeldestelle.admin.ch/chem/en/home/themen/pflicht-hersteller/stoffe/neuer-stoff/stoffe-anmeldepflicht-ausgenommen.html
¹⁵https://op.europa.eu/en/publication-detail/-/publication/6dc3d254-6c2c-11e7-b2f2-01aa75ed71a1/language-en

4.2 Exemptions

Provision is made for general exemptions from the obligation to report substances and preparations (Art. 1 para. 5–6 and Art. 54 ChemO). The Ordinance does not apply to:

• the transport of substances and preparations by road, rail, water, air or pipelines;
• the transit of substances and preparations under customs supervision, provided that this does not involve any processing or transformation;
• substances and preparations which are placed on the market solely for the purposes of analysis, research or development;
• substances which are placed on the market solely for training purposes;
• substances and preparations in the form of the following categories of finished products ready for supply to private and professional users:
  o foodstuffs as defined by Article 4 of the Foodstuffs Act of 20 June 2014 (FoodA),
  o medicinal products 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 (TPA),
  o animal feedingstuffs as defined by Article 3 paragraph 1 of the Feedstuffs Ordinance of 26 October 2011 (SR 916.307);
• weapons and ammunition as defined by Article 4 paragraphs 1 and 5 of the Weapons Act of 20 June 1997 (WA);
• substances, preparations and objects which are waste according to Article 7 paragraph 6 of the Environmental Protection Act (EPA);
• cosmetic products (within the meaning of Art. 53 of the Ordinance on Foodstuffs and Utility Articles (SR 817.02);
• products imported for private purposes;
• substances and preparations to be used exclusively as raw materials for foodstuffs, therapeutic products or animal feedingstuffs;
• gas mixtures consisting exclusively of reported gases;
• gases and gas mixtures that are classified in the “gases under pressure” hazard category;
• chemicals subject to authorisation requirements: plant protection products; biocidal products; substances and fertilisers subject to authorisation and notification requirements; explosives and pyrotechnic devices;
• preparations not deemed to be dangerous under Article 3 ChemO which are in packages containing no more than 200 ml, if they are manufactured in Switzerland and supplied directly to professional or private users;
• preparations placed on the market in quantities of less than 100 kg per year and intended exclusively for professional users;
• substances obtained in Switzerland,
• preparations obtained in Switzerland and supplied in packaging other than that provided by the original manufacturer, provided that:
  o the trade name, composition, the unique formula identifier (UFI)¹⁶ and intended use are unchanged, and
  o the name of the original manufacturer is also indicated;
• imported substances and preparations that are simply relabelled and then exported without alteration;
• intermediates that:
  1. are not supplied to third parties,
  2. do not leave the manufacturing site, or
  3. are placed on the market in quantities less than 100 kg per year;
  not exempted from reporting requirements (or notification requirements) are intermediates in the form of monomers which are new substances;
• paints formulated on demand in limited quantities for an individual consumer or professional user at the point of sale by tinting or mixing colours, provided that:
  1. the requirements of Article 25 paragraph 8 of the CLP Regulation are complied with, or
  2. the potentially hazardous colorants are indicated in the notification of the base colour in the maximum concentration in which they are added; in this case, the product must be labelled with the UFI of the base colour;
• concrete, plaster and cement that conform with any of the standard formulas specified in Part D of Annex VIII to the CLP Regulation and that bear the UFI required by the Notification Authority.
  

If certain preparations have a UFI, they must be reported even if they fall under an exemption, so that emergency health care can be ensured and Tox Info Suisse does not lose unnecessary time in establishing that no prescription is filed for the UFI. This applies to the following preparations:

• preparations which are placed on the market solely for the purposes of analysis, research or development;
• preparations used exclusively for foodstuffs, therapeutic products or animal feedingstuffs;
•  preparations not deemed to be dangerous under Article 3 which are in packages containing no more than 200 ml, if they are manufactured in Switzerland and supplied directly to professional or private users;
• preparations placed on the market in quantities of less than 100 kg per year and intended exclusively for professional users;
• gas mixtures consisting exclusively of reported gases;

¹⁶Cf. https://www.anmeldestelle.admin.ch/chem/en/home/themen/pflicht-hersteller/selbstkontrolle/kennzeichnung/ufi-eindeutiger-rezepturidentifikator.html

Last modification 14.04.2023