Published on 25 April 2023
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.
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.htmlSpecial 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
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.
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.
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.
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).2626Further 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
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.
Concrete, plaster and cement are exempted from the reporting requirements if the following two conditions are met:
- they conform with any of the standard formulas specified in Part D of Annex VIII to the CLP Regulation and
- 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:
- 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
- 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.
- 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 cheminfo@bag.admin.ch to have the reporting cancelled. Other UFIs that have already been generated for the preparation would no longer be marketable.