5. What information on substances and preparations has to be reported?

The requirements for reporting of substances and preparations are specified in Art. 49 ChemO and additionally, for the extended report for preparations, in Art. 50 ChemO.
To be included in all reports are:
the name and address of the manufacturer in Switzerland.¹⁷

In general, substances and already reported preparations can be selected from a list in the RPC. If a substance does not appear in the list, please contact the Notification Authority.

¹⁷To be included, in addition, is the name of the person responsible for placing on the market in the EEA, as specified in Article 17 paragraph 1 letter a of the CLP Regulation, if the manufacturer’s name is not mentioned on the labelling. This only applies if, in accordance with Art. 10 para. 3bis, the substances or preparations:
a. are not intended for distribution to private users; or
b. are supplied to private users, are contained in an inner packaging in portions of no more than 125 ml or g and are marked on the outer packaging with the name, address and telephone number of the manufacturer.

5.1 Specific information on substances

	Legal requirements under Art. 49 para. 1 let. c ChemO	Notes
1	The chemical name in accordance with Article 18 paragraph 2 letters a–d of the CLP Regulation	The product identifier for a substance shall consist of at least the following: a. if the substance is included in Part 3 of Annex VI to the CLP Regulation (list of harmonised classification and labelling), a name and an identification number as given therein, b. if the substance is not included in Part 3 of Annex VI to the CLP Regulation, but appears in the ECHA classification and labelling inventory, a name and an identification number as given therein, c. if the substance is not included in Part 3 of Annex VI nor in the classification and labelling inventory, the number provided by the CAS (hereinafter referred to as “the CAS number”), together with the name set out in the nomenclature provided by the IUPAC (hereinafter referred to as “the IUPAC Nomenclature”), or the CAS number together with another international chemical name(s); or d. if the CAS number is not available, the name set out in the IUPAC Nomenclature or another international chemical name(s). If in doubt, please contact the Notification Authority, particularly if the substance does not appear in the RPC list.
2	The CAS number
3	The EC number
4	The classification and   labelling	Hazard class, hazard category and the associated hazard statements (H-phrases) Hazard pictogram, signal word, hazard statements (H-phrases), appropriate precautionary statements (P-phrases) and EUH-phrases
5	The intended uses	The various categories of intended uses are available in a picklist in the RPC.
6	In the case of substances dangerous to the environment: the quantity likely to be placed on the market annually according to one of the following categories: less than 1 tonne, 1–10 tonnes, 10–100 tonnes, more than 100 tonnes
7	In the case of nanomaterials: a. the composition, particle form and mean particle size and, where available, the number size distribution, specific surface area by volume, crystal structure, aggregation status, surface coating and surface functionalisation, and b. the quantity expected to be placed on the market annually according to one of the following categories: less than 1 kilogramme, 1–10 kilogrammes, 10–100 kilogrammes, 100–1000 kilogrammes, 1–10 tonnes, 10–100 tonnes, more than 100 tonnes
8	An indication of whether the substance is considered to be PBT or vPvB	If a substance is considered to be PBT or vPvB, this property must be indicated in addition to the classification, as it does not necessarily lead to special labelling.
9	The chemical safety report available in the EEA, provided that it can be obtained by the manufacturer with reasonable effort	The chemical safety report contains important information on the hazardous properties, exposure assessment and risk reduction measures. For existing substances, the preparation of such a report may be highly demanding and require considerable resources. If a substance is imported from the EU and a report has been compiled for this substance, the Swiss importer should enquire whether it is possible to obtain the report.

5.2 Specific information on preparations

	Legal requirements under Art. 49 para. 1 let. d ChemO	Notes
1	The trade name
1a	In the case of preparations classified as dangerous because of the physical or health hazards they pose: the unique formula identifier (UFI)18	The UFI allows the composition to be unequivocally determined by Tox Info Suisse19 in an emergency. Inclusion of a UFI is to become obligatory as follows: • from 1.1.2022: for preparations newly placed on the market from this date which are intended for private users; • from 1.1.2022: for preparations which already have a UFI. This category includes in particular products imported from the EEA. The requirement that products for which a UFI is available must also be reported is designed to ensure that, with the aid of the UFI, Tox Info Suisse can find the formulation in the RPC; • from 1.1.2026: for all other preparations classified as dangerous because of the physical or health hazards they pose. On the ECHA website20 companies established in the EEA can generate a UFI. For preparations which are imported to Switzerland from the EEA or exported from Switzerland to the EEA, this UFI can also be reported in Switzerland and indicated (or left) on the label.21 The Swiss Notification Authority has made available an online UFI generator for preparations which are only placed on the market in Switzerland.22
2	Data relating to the constituents in accordance with the provisions concerning the safety data sheet	All dangerous constituents are to be listed from the specific or generic concentration limits set for the hazard class to which they are assigned (if appropriate, taking the M-factors into consideration and, for PBT and vPvB substances, 0.1%). In order to simplify the reporting of preparations in accordance with Articles 48–54 ChemO, using the RPC, it has no longer been necessary since 1.7.2015 to report the classification of each individual constituent; instead, it is sufficient to indicate the classification and labelling of the preparation as a whole. Listed in the RPC are all EINECS substances and notified substances, as well as all reported preparations. It is recommended that substances should be searched for by CAS or EC number, if possible. If a substance is not listed, please contact the Notification Authority. Data concerning the constituents of a preparation is defined in Section 3 of Annex II to the REACH Regulation, to which reference is made in Annex 2 Number 3 ChemO. In subsection 3.2.4, it is specified that the EC number of each substance concerned is to be given, if available. The substances in the preparation, which have to be indicated on the label, i.e. declared, are to be marked. The substances to be declared are those substances contained in the preparation that contribute to its classification “as regards acute toxicity, skin corrosion or serious eye damage, germ cell mutagenicity, carcinogenicity, reproductive toxicity, respiratory or skin sensitisation, specific target organ toxicity (STOT) or aspiration hazard (Art. 10 para. 1 let. a ChemO in conjunction with Art. 18 para. 3 CLP Regulation). Where that requirement leads to the provision of multiple chemical names, a maximum of four chemical names shall suffice, unless more than four names are needed to reflect the nature and the severity of the hazards (Art. 10 para. 1 let. a ChemO in conjunction with Art. 18 para. 3 CLP Regulation). The chemical names selected shall identify the substances primarily responsible for the major health hazards which have given rise to the classification and the choice of the corresponding hazard statements.”
3	The classification and labelling	Hazard class, hazard category and the associated hazard statements (H-phrases) Hazard pictogram, signal word, hazard statements (H-phrases), appropriate precautionary statements (P-phrases)
4	The intended uses	The various categories of intended uses are available in a picklist in the RPC.
5	The physical state
6	In the case of preparations dangerous to the environment: the quantity likely to be placed on the market annually, according to one of the following categories: less than 1 tonne, 1–10 tonnes, 10–100 tonnes, more than 100 tonnes
7	In the case of preparations containing nanomaterials that must be specified in the safety data sheet: the composition of the nanomaterials, their particle form and mean particle size and, where available, the number size distribution, specific surface area by volume, crystal structure, aggregation status, surface coating and surface functionalisation.

¹⁸While the UFI is only obligatory for preparations classified as dangerous because of the physical or health hazards they pose, the Swiss authorities recommend that, for all preparations, a UFI should be printed on the label and reported, so that the poisons information centre (Tox Info Suisse) can provide appropriate recommendations and unnecessary treatments are avoided.
¹⁹Tox Info Suisse, as specified in Art. 79 ChemO, is the poisons information centre providing medical advice, round the clock and free of charge, in cases of poisoning or suspected poisoning. http://toxinfo.ch; Tel. 145
²⁰https://poisoncentres.echa.europa.eu/ufi-generator
²¹According to the ECHA guidance document, the UFI can also be indicated elsewhere, with the other label elements (see https://echa.europa.eu/documents/10162/17235/guidance_on_annex_viii_to_clp_en.pdf/412c5874-f8ec-cf52-fe1e-2fbe08fe2d11?t=1651484042203).
²²https://www.anmeldestelle.admin.ch/chem/en/home/themen/pflicht-hersteller/selbstkontrolle/kennzeichnung/ufi-eindeutiger-rezepturidentifikator.html

Special form of fulfilment of the obligation to report
To ensure that the submitter only has to contact the Notification Authority once for a given chemical, the obligation to report preparations is deemed to be fulfilled if a request to use an alternative chemical name²³ (Art. 15) has been submitted and the Notification Authority has the information which is required when a report of this kind is submitted (i.e. the information specified in Art. 49 para. 1 let. a, b and d and, if appropriate, in Art. 50).

²³https://www.anmeldestelle.admin.ch/chem/en/home/themen/pflicht-hersteller/selbstkontrolle/kennzeichnung/chemische-bezeichnung-art-15.html
 

5.3 Extended report for dangerous preparations sold to private users

In the case of dangerous preparations²⁴ sold to private users, the full composition is to be reported (Art. 50 ChemO), so that in cases of poisoning (particularly in children) Tox Info Suisse can recommend the best possible treatment. Constituents which are not deemed to be dangerous under Article 3 may be designated by a name that identifies the most important functional groups. For certain constituents, it is appropriate to indicate the molar mass. Example: aliphatic alcohol, molar mass between 200 and 300. For pragmatic reasons, it is accepted by the Notification Authority that non-classified constituents with a total concentration below 1% are not generally reported. Similar provisions are to be found in Part B Section 3.3 of Annex VIII to the CLP Regulation.

²⁴Dangerous within the meaning of Art. 3, i.e. the preparation is classified as dangerous and to be labelled accordingly.

5.4 Concentration ranges applicable to constituents of a preparation

It is desirable that a specific concentration should be reported for each constituent. If necessary, however, concentration ranges may be indicated. The ChemO does not contain any provisions concerning the concentration ranges that may be submitted when the constituents of a preparation are reported. In the interests of harmonisation of data requirements with the EU, the Swiss authorities recommend application of the rules given in Part B Section 3.4 of Annex VIII to the CLP Regulation:

Note: The highest concentration within each range determines the classification of the preparation.

Concentration ranges applicable to hazardous components of major concern for emergency health response²⁵

Concentration ranges applicable to other hazardous components and components not classified as hazardous.

²⁵Of major concern for emergency health response are substances classified as follows:
• Acute toxicity, Category 1, 2 or 3,
• Specific target organ toxicity – Single exposure, Category 1 or 2,
• Specific target organ toxicity – Repeated exposure, Category 1 or 2,
• Skin corrosion, category 1, 1A, 1B or 1C,
• Serious eye damage, Category 1.

5.5 Colorants and perfumes

For perfumes and fragrances with a total concentration not exceeding 5% by weight and for colorants with a total concentration not exceeding 25% by weight, generic product identifiers may be indicated in the RPC:

- perfume (PAID : 380880-21)
- colorant (PAID : 807554-11)

Substances of very high concern included in Annex 3 ChemO are, however, to be indicated separately. These are to be found in Section 3.2 of the safety data sheet of the fragrance or colorant. Unlike in the EU, this provision is applicable in Switzerland not only for colouring agents, but also for colorants. Colorants are defined as substances and preparations that primarily contain colouring agents, colour pigments and effect-producing pigments which are added solely for the purpose of colouring or producing effects (Art. 2 para. 2 let. r ChemO). The Swiss authorities recommend that a safety data sheet should be submitted for the colouring agents and fragrances, with fragrances not classified as dangerous being indicated if possible.

5.6 Identical preparations containing different colorants and fragrances

The ChemO does not contain any provisions for the notification of a preparation indicating several color shades or fragrances (in the sense of a group reporting). Furthermore, the RPC is not designed to potentially represent several compositions within one report.
However, since the management and administration of products that have a color or fragrance palette and differ only by colorants or fragrances can be very time-consuming, the Notification Authority accepts the pragmatic form of group reporting under the following conditions in the interest of proportionality:

• ToxInfo Suisse can quickly and easily identify the preparation and its ingredients based on the message in the RPC;
• The main identifier is identical, except for the color/fragrance information;
• The complete main identifier including all color/fragrance information is listed in the report (if necessary, under additional trade names, e.g., product red, product blue, etc.);
• The products of the different color shades or fragrances must not differ in classification and labelling or contain additional substances which may lead to further regulatory obligations;
• The compositions of the products must be identical, except for colorants, which may be a maximum of 25%, or fragrances, which may be a maximum of 5%, i.e., when the reported concentration or concentration range is the same for each ingredient; and
• All other data for reporting (Art. 49 and 50 ChemO) are identical.

The submission of a safety data sheet for each color shade or fragrance note in the RPC (under Documents) is recommended.
Regarding the UFI, the Notification Authority will accept a report and a UFI provided that all necessary requirements are fulfilled (cf. point 3.2.3 of Part B of Annex VII EU CLP Regulation).²⁶

²⁶Further Information from 5.3.3 in general. Point 5.4 for perfume under https://echa.europa.eu/documents/10162/13643/guidance_on_annex_viii_to_clp_de.pdf/1a231979-2ba0-a1b5-d25e-4310e3650176

5.7 Paints formulated on demand (bespoke paints)

Exempted from the reporting requirements are paints formulated on demand (bespoke paints) in limited quantities for an individual consumer or professional user at the point of sale by tinting or mixing colours, provided that:

• the UFIs of the added colorants subject to UFI requirements are indicated on the label of the base colour, if they constitute more than 0.1% of the final product; if the concentration exceeds 5%, they are also to be listed as a constituent (this corresponds to Art. 25 para. 8 of the CLP Regulation); or
• the colorants are indicated in the notification of the base colour in the maximum concentration in which they are added; in this case, the paint may be sold with the label of the base colour.

5.8 Concrete, plaster and cement

Concrete, plaster and cement are exempted from the reporting requirements if the following two conditions are met:

1. they conform with any of the standard formulas specified in Part D of Annex VIII to the CLP Regulation and
2. they bear the UFI required by the Notification Authority.

All the standard formulas specified in Part D of Annex VIII to the CLP Regulation have been recorded in the RPC by the Notification Authority:

1. Cement standard formula – 1 to 20 with EU UFIs kindly provided by an association in the EU. This is designed to ensure that the UFI does not need to be changed if a border is crossed from or into a neighbouring country. In the RPC (www.rpc.admin.ch), search for: “Cement standard formula – 1” to 20
2. Concrete standard formulas 1 and 2: in the RPC, “Ready mixed concrete standard formula 1” and “Ready mixed concrete standard formula 2”, The UFIs have been kindly provided by an association in the EU. Mortars that comply with the concrete standard formulations can also benefit from the exemption, provided that the product is equipped with the corresponding UFI specified by the Notification Authority.
3. Gypsum binder standard formula: in the RPC, “Gypsum binder standard formula” It was not possible to obtain an EU UFI for gypsum. Therefore, it is a Swiss UFI that may only be used in Switzerland.²⁷

With regard to preparations that have been already reported to the Chemicals Product Register (RPC) and that comply with the standard formulations, either

• add the UFI specified by the notification authority for chemicals to the reporting, or
• contact the Notification Authority at [e-mail] to have the reporting cancelled. Other UFIs that have already been generated for the preparation would no longer be marketable.

²⁷Cf. https://www.anmeldestelle.admin.ch/chem/en/home/themen/pflicht-hersteller/selbstkontrolle/kennzeichnung/ufi-eindeutiger-rezepturidentifikator.html

Last modification 14.04.2023