Simplification of the registration application procedure for preparations
To simplify the registration application for preparations according to the articles 48 to 54 ChemO, from now on it is no longer mandatory to enter the classification of each constituent, but only the classification and labelling of the preparation.
This simplification does not apply to biocide products and to plant protection products, which must obtain an authorization.
All other requirements remain unchanged, notably relating to the declaration of dangerous substances in preparations (annex 1 number 4 ChemO) and to the safety data sheet.
The registrant (manufacturer or importer) must be domiciled in Switzerland or with a registered office or branch in Switzerland.
Preparations must be reported within 3 months after first placing them on the market.
The manufacturer or importer must register the following preparations placed on the market (art. 3, 19 and 48 ChemO), if the assessment under the self-regulation has shown that they fall into one of the following categories:
- dangerous preparations (Art. 3 ChemO);
- preparations which are not dangerous within the meaning of Article 3 and contain at least one of the following substances:
- a substance that is dangerous to health or to the environment in an individual concentration of ³1.0 per cent by weight (non-gaseous preparations) or ³0.2 per cent by volume (gaseous preparations),
- a PBT or vPvB substance in an individual concentration of ³0.1 per cent by weight,
- a substance listed in Annex 3 in an individual concentration of ³0.1 per cent by weight,
- a substance for which an occupational exposure limit value has been laid down in Directives 2000/39/EC, 2006/15/EC or 2009/161/EU.
The ChemO has provided some exemptions from the obligation to register the preparations (art. 1 para. 5-6 and art. 54 ChemO):
- the transport of substances and preparations by road, rail, water, air or pipelines, with the exception of Article 10 paragraph 1 letter b;
- the transit of substances and preparations under customs supervision, provided that this does not involve any processing or transformation;
- preparations which are placed on the market solely for purposes of analysis, research or education, or which are subject to research and development;
- preparations in the form of finished products ready for supply to the final user that fall into the following categories;
- foodstuffs as defined by Article 3 of the Foodstuffs Act of 9 October 1992,
- 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,
- animal feedingstuffs as defined by Article 3 paragraph 1 of the Feedstuffs Ordinance of 26 October 2011;
- weapons as defined by Article 4 paragraph 1 and ammunition as defined by Article 4 paragraph 5 of the Weapons Act of 20 June 1997;
- preparations and objects which are waste according to Article 7 paragraph 6 of the Environmental Protection Act, EPA;
- cosmetic products;
- product import for private purpose;
- preparations used exclusively for foodstuffs, therapeutic products or animal feedingstuffs;
- gas mixtures consisting exclusively of registered gases;
- chemicals subject to authorization / notification: Plant protection products ; Biocidal products; fertilisers; explosives and pyrotechnic devices;
- 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;
- preparations obtained in Switzerland and supplied in packaging other than that intended by the original manufacturer, provided that:
- the trade name, composition and intended use are unchanged, and
- the name of the original manufacturer is also indicated.
- Only Article 13 applies to dangerous substances and preparations that are imported, relabelled and then exported.
The registration application of a preparation must contain the following data (art. 49 and 50 ChemO):
- the manufacturer's name and address,
- the name of the person responsible for placing the preparation on the market in the EEA in accordance with Article 17 paragraph 1 letter a of the CLP Regulation1, if the manufacturer's identity is not mentioned on the label;
- the trade name,
- data relating to the constituents in accordance with the provisions concerning the safety data sheet,
- the classification and labelling,
- the intended uses,
- the physical state.
- 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,
- in the case of nanomaterials: 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,
- if the classification is based on the TGM (Treuhänder-Gutachten-Modell) or A.I.S.E. models according to the Directive 1999/45/EC, a note in the remarks field must be specified..
In the case of dangerous preparations sold to private users, the Notification Authority must be informed of the full composition. Constituents which are not deemed to be dangerous under Article 3 may be designated in accordance with Article 15 either by a name that identifies the most important functional groups or by an alternative name.
Any modifications to the information specified in Articles 49 and 50 must be reported within 3 months.
If the quantity of substances and preparations dangerous to the environment actually supplied in a year is outside the registered category of quantities placed on the market, the quantity placed on the market in the previous year must be reported by 31 March of the following year in accordance with the categories specified as: less than 1 tonne, 1-10 tonnes, 10-100 tonnes, more than 100 tonnes.
Transitional Provisions (art. 93 ChemO):
For preparations that were packaged and labelled in accordance with Articles 35-50 of the Chemicals Ordinance of 18 May 20051 before the commencement of this Ordinance apply the transitional provisions according to article 93 ChemO.