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With all these regulatory updates, it can be hard to find your way around ! Let’s see together what are the Swiss regulatory requirements, and what are the main differences with the European regulations. This will let you know :
● How to access the European market when you are a Swiss manufacturer ?
● How to access the Swiss market when you are a European manufacturer ?
Since a few years, the Swiss regulations have tended to align with the European regulations. This is evidenced in particular by the latest Swiss ordinance on foodstuffs and consumer goods 817.0 (cosmetics being part of consumer goods) which now obliges companies to make available to the authorities a PIF containing among other things, a safety report as well as a certificate of compliance with Good Manufacturing Practices.
Regulatory framework :
First of all, it is needed to remind the regulatory and legislative framework regarding cosmetics, their manufacture and their marketing.
● 817.023.31 Ordinance of the FDI on cosmetics
● 817.02 Ordinance on foodstuffs and usual objects
● 817.0 Federal Law on foodstuffs and usual objects
● Lists of substances with references to the annexes of the European Regulation n°1223/2009 on cosmetics and their variations for Switzerland.
Required elements :
Even if it will be necessary to study more the Swiss cosmetic regulatory in details during the development and the marketing of your cosmetics, here is a recap of the main requirements mentioned in the regulatory :
● PIF (Product Information File) :
This is a file containing all the information on cosmetics, it must be realized for each product placed on the market and it must include at least the following 5 chapters :
A description of the cosmetic product, which makes possible to link the cosmetic product to the information file,
The cosmetic products safety report,
A description of the manufacturing method and a statement of compliance with Good Manufacturing Practices (GMP),
Evidence of the effect claimed by the cosmetic product (when the nature or the effect of the product justifies it),
Relative data to animal experiments carried out by the manufacturer, its agents or suppliers, and to the development or the evaluation about the safety of the cosmetics product’ or its ingredients. (Testing on animals is now prohibited.)
The file must be written in one of the official languages of the confederation or in English, and it must be kept for ten years from the date on which the last batch of the product was first placed on the market.
Note : The creation of a product information file can be waived if such a file has already been made abroad (in Europe for exemple) for this cosmetic product and if it corresponds to the requirements detailed in the prescription.
The importer or distributor must be able to provide some proof to the cantonal authorities.
● Safety assessment or safety report :
It is described in Annex 5, Part B of the Swiss Cosmetics Ordinance. It must be carried out by a person holding a diploma or other title attesting to university training in theoretical and practical education in pharmacy, toxicology, medicine or in a similar discipline, or training recognized as equivalent.
The cosmetic product safety report must include, at least, the following elements :
Part A : Information about the cosmetic product safety
1. Quantitive and qualitative formula of the cosmetic product
2. Physical/chemical characteristics and stability of the cosmetic product
3. Microbiological quality
4. Impurities, traces, informations about the packaging material
5. Normal and reasonably foreseeable use
6. Exposure to cosmetic product
7. Exposure to substances
8. Toxicological profile of substances
9. Side effects and serious side effects
10. Cosmetic product information
Part B : Cosmetic product safety assessment
1. Conclusion of the assessment
2. Label warnings and instructions for use
3. Reasoning
4. Reviewer references and part B approval
Note : There is an exception for so-called artisanal cosmetic products sold locally, in a limited setting, such as a school party or a bazaar. These products must nevertheless be safe for health.
● The responsibilities involved :
The manufacturer and/or the importer will act as the responsible person. Therefore, they will have the obligation to ensure that the product being placed on the market complies with the requirements of the legislation on foodstuffs and consumer goods 817.0 (cosmetics being part of consumer goods). They must also keep the updated PIF available to the authorities, for a period of ten years from the date of production of the last batch. The manufacturer and the importer may appoint if necessary, by written mandate, an agent/representative who must be based in Switzerland. This agent will act as a responsible person for them.
Note : The responsible person (manufacturer, importer or appointed agent) must have an address on Swiss territory and will be the referent person to the authorities in case of controls or other.
● Good Manufacturing Practices (GMP) :
In order to guarantee the protection of human health, hygiene and cleanliness requirements must be respected during the manufacture of cosmetics. A new standard is defined for GMPs. This corresponds to the ISO 22716 standard.
Companies must provide an attestation of compliance to the GMPs on authorities request, and this attestation must be included in the PIF of each cosmetic product marketed as well.
Note : The certification isn’t required, only an attestation of compliance to the GMPs is asked.
● Prohibition of cheating :
Since May 1, 2017, the ban of cheat has also been established for cosmetics. Their claims must not be misleading and must follow these six criteria :
1. Compliance with Legislation
2. Veracity
3. Evidence
4. Sincerity
5. Equity
6. Informed choice
Please note : Claims can not mention therapeutic properties (preventive or curative).
WHAT IS THE DIFFERENCE BETWEEN SWISS AND EUROPEAN REGULATIONS ?
Every cosmetic product need to have a complete PIF in Switzerland and in Europe. However some are exception to the rule only in Switzerland : for exemple, artisanal products sold locally (except those intended for children).
HOW TO ACCESS THE SWISS MARKET WHEN YOU ARE A EUROPEAN MANUFACTURER ?
● A manufacturer or importer must be appointed for each product placed on the Swiss market. This person is responsible to ensure the compliance of the Swiss regulations, but they can delegate these obligations to an agent based in Switzerland (a representative).
● It is possible to indicate the address of a responsible person in Europe on the products but the obligations related to the compliance of the products can’t be transferred to it.
HOW TO ACCESS THE EUROPEAN MARKET WHEN YOU ARE A SWISS MANUFACTURER ?
To access the European market, it will be necessary to appoint a responsible person in Europe. Indicate the address of that person on the label so that the authorities can have access to it. Don’t hesitate to contact us, Reguloo can be a « responsible person ».
If your products comply with Swiss legislation, they will comply with European legislation.