What do you need to think about when introducing a cosmetic to Switzerland?

Swiss Cosmetic Compliance Requirement

Generalities

Switzerland is a small country located in Europe and is not part of the Economic European Community.
It’s a Federation of 26 cantons (districts). Its Capital city is Berne and its biggest city is Zürich.
The population has 8.5 inhabitants in a 41 285 km2 area. The languages spoken are French, German and Italian, while the local currency is the Swiss Franc (CHF): 1 CHF = 0.94045 EUR 1 CHF = 7.28195 CNY.

competent autorities

Federal Office of Food Safety and Veterinary Affairs (FOSV)
The main task of the FSVO is to actively promote the health and well-being of humans and animals. The central pillars of this approach are food safety and healthy eating for humans, and animal health and welfare for animals.

Département Fédéral Intérieur (DFI)
A multifaceted department, the DFI brings together different fields ranging from health and social insurance to statistics and equality between women and men, including culture and meteorology. Two important files currently occupy the DFI: the reform of health and that of the old-age provision.

Cassis-du-Dijon Principle
Name given to the principle of mutual recognition by the Member States of the European Union of their respective regulations, in the absence of Community harmonization.

regulation in force

817.02
Ordonnance sur les denrées alimentaires et les objets usuels (ODAlOUs) / Order on food and usual objects
https://www.admin.ch/opc/fr/classified-compilation/20143388/index.html

CHAPTER 3
Objets usuels/Usual Objects

Section 3
Produits cosmétiques/Cosmetics

Art. 53 – Definition
A cosmetic product is defined as any substance or preparation intended to be brought into contact with certain superficial parts of the human body such as the epidermis, the hair and capillary systems, the nails, the lips, the external genitalia or with the teeth and the oral mucous membranes with a view, exclusively or mainly, to cleaning them, perfuming them, changing their appearance, protecting them, maintaining them in good condition or correcting body odours.

817.023.31
Ordonnance du DFI sur les cosmétiques (OCos) / Order on cosmetics
https://www.admin.ch/opc/fr/classified-compilation/20143407/index.html

Section1: General dispositions
Section 2: Distributor, Importer and Manufacturer’s obligations
Section 3: Safety assessment and Product Information File
Section 4: Prohibited and restricted substances
Section 5: Labelling, Claims and interdiction of fraud
Section 6: Hygiene and Manufacturing
Section 7: Auto-contrôle / Self-checking
Section 8: Annex update
Section 9: Final dispositions
Since 2017: Regulation similar to the European Regulation 1223/2009
Section 7: Auto-contrôle / Self-checking

The information must be able to be provided to the cantonal enforcement authorities for 3 years: a. by the manufacturer, from the date on which the batch of the cosmetic product was placed on the market, and b. by the importer and the distributor, from the date on which the batch of the cosmetic product was supplied.
Anyone who manufactures, processes, stores, transports, places on the market, imports, exports or transits food or everyday objects must ensure that the requirements set by law are met. It is bound by the duty of self-checking.
Official control does not release from the obligation to carry out a self-checking.
The Federal Council defines the procedures for applying and documenting self-checking. It provides for simplified selfchecking and a simplified written documentation procedure for micro-enterprises. It can set the requirements which the persons responsible for self-checking must meet in terms of professional knowledge.

summary of european regualtion 1223/2009 from the official journal of the european union

Main articles:

• Article 2 – 1.a) Definition of cosmectic product
• Article 2 – 1.d) Manufacturer’s definition
• Article 4: Responsible person’s definition
• Article 5: Responsible person’s obligations
• Article 3: Safety of cosmetics
• Article 8: Good Manufacturing Practices
• Article 10: Cosmetic Product Safety Report (CPSR)
• Article 11: Product Information File
• Article 13: Notification (CPNP)
• Article 15: Cancerigen Mutagen Reprotoxic (CMR) substances
• Article 16: Nanomaterial substances
• Article 17: Traces of prohibited substances
• Article 18: Animal testing (prohibited)
• Article 19: Labelling requirements
• Article 20: Claims
• Article 23: Cosmetovigilance

Annexes:

• • I: CPSR (part A & B) template
  • II: Prohibited sustances
  • III: Restricted substances
  • IV: Positive list of coloring agents
  • V: Positive list of preservatives
  • VI: Positive list of UV filters
  • VII: Symbols used on packaging/containers

Each time an Annex is amended, there is a new European Regulation issued.

Swiss specificities

In Switzerland, safety is the responsibility of OFSP: its role is to take up the opinions of the SCCS and adapt the list of authorised and prohibited substances.
These lists are the same as EU, here is a difference:

Furocoumarines
– Prohibited substances (Annexe II) in EU regulation
– Restricted substances in Swiss regulation: “In cosmetics, with the exception of perfumes, eaux de toilette and eaux de Cologne, the furocoumarin content in the final product must be less than 1 mg/kg and natural essences must be dosed accordingly where the cosmetic product, used under normal or reasonably foreseeable conditions of use, – a. remains on the skin, and – b. can be exposed to direct sunlight”.

The “Volatile Organic Compounds” (VOC) Incentive Tax
since 1 January 2003, the rate of the tax has been 3 Swiss francs per kg of VOC, provided that the product contains at least 3% VOCs.
The following substances may, by way of derogation, be marketed under the Order until 30 April 2021 if a safety report is drawn up in accordance with Article 4, even if the conditions laid down in Articles 5 and 12 are not met; in the absence of a safety report, these substances may still be used under the old law until 30 April 2021:

• • • Kojic acid (CAS No 501-30-4)
    • Essential oils and their components in products intended to remain on the skin (with the exception of perfumes and eaux de toilette)
    • Alpha-hydroxy-acids in peeling products
    • Retinal, retinaldehyde (CAS No. 116-31-4)

Labelling

Similar to European regulations concerning:

• • • The list of ingredients on the label (in descending weight order)
    • The intended use of the product
    • The name and address of the manufacturer, importer and distributor
    • The DDM, the PAO, the conservation conditions
    • The manufacturing batch number or product reference number
    • The precautions of use

Claims

Similar to European regulations concerning 6 common criteria:

• • • Legal compliance
    • Truthfulness
    • Evidential support
    • Honesty
    • Fairness
    • Informed decision-making

Swiss law is stricter than many EU states regarding claims, especially regarding borderline cosmetics and the delimitation between a cosmetic and a therapeutic product. Some products can therefore not be imported if they do not meet the claim standards.

Prohibition if the final formulation or ingredients have been tested on animals.