End of the transition period for companies facing cosmetics regulation in Switzerland
Swiss cosmetics regulation: the changes
The Swiss cosmetics regulation has been in line with the European regulation for some years. The new ordinance 817.023.331 in place is based on the Federal Law on Foodstuffs and Consumer Goods 817.0 (cosmetics are part of Consumer Goods).
As part of its alignment with the EU regulation, several deadlines were set. The last one was 30th April 2021, and concerned the obligation for companies to provide a safety report on cosmetic ingredients and a PIF (Product Information File) but also to comply with Good Manufacturing Practices (GMPs).
In the PIF, there is a part A which provides information about the product and the formula, such as:
- The quantitative and qualitative formula
- Chemical characteristics and stability
- The toxicological profile of ingredients
Part B, on the other hand, deals with the safety assessment of the product, and provides information such as:
- The conclusion of the product safety assessment
- Warnings and instructions for use on the label
- The reasoning
- References of the Responsible Person for the safety assessment
For consumers, these changes are not significant and allow them to consume safely.
For manufacturers, this implies numerous administrative procedures and investments, especially for small companies. Indeed, this does not normally represent a major change for large companies as they already had to comply with the European regulation in order to sell outside Switzerland.
The LARGO project: a progressive alignment with the EU
Since June 2014, the Swiss LARGO project aims at introducing numerous changes to the regulations in order to align with those of the EU, in particular with regard to cosmetics, compliance with the lists of regulated substances, labelling, the obligation to keep a PIF, compliance with good manufacturing practices and the ban on animal testing.
The cosmetic regulation in place before these changes was already very similar in terms of labelling and restricted substances, but it relied more on the self-regulation of companies.
According to Article 54 of the Ordinance on Foodstuffs and Utility Articles (ODAIOUs), all cosmetic products must therefore comply with the annexes of Regulation EC 1223/2009, whether it be for prohibited ingredients or for colourings and preservatives.
Among the various changes, we also note that, for cosmetic claims, Switzerland now follows the 6 common criteria from the EU regulation: legal compliance, truthfulness of evidence, honesty, fairness and informed decision making.
Different transitional periods were foreseen to allow time for companies to adapt:
- 1st May 2018 to appoint a Responsible Person based in Switzerland to stop animal testing
- 31st December 2018 to comply with the list of ingredients in good standing
- 30th April 2021 to draft the PIF and comply with GMP (Good Manufacturing Practices)
However, some elements of the Swiss regulation are still not the same as in the EU.
For example, a manufacturer or importer must be designated for each cosmetic product placed on the Swiss market and not in Europe. This person is responsible for ensuring compliance with Swiss regulations, but they may delegate these obligations to an agent located in Switzerland.
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 product cannot be transferred to them.
Furthermore, although all cosmetic products need to have a full PIF, some are exceptions to the rule: for example, locally sold handicrafts (except those intended for children).
Wish to know more about the compliance of cosmetic products ?
For more information, do not hesitate to contact Nataliya Muller or one of our experts!
Swiss cosmetics regulation: the changes
The Swiss cosmetics regulation has been in line with the European regulation for some years. The new ordinance 817.023.331 in place is based on the Federal Law on Foodstuffs and Consumer Goods 817.0 (cosmetics are part of Consumer Goods).
As part of its alignment with the EU regulation, several deadlines were set. The last one was 30th April 2021, and concerned the obligation for companies to provide a safety report on cosmetic ingredients and a PIF (Product Information File) but also to comply with Good Manufacturing Practices (GMPs).
In the PIF, there is a part A which provides information about the product and the formula, such as:
- The quantitative and qualitative formula
- Chemical characteristics and stability
- The toxicological profile of ingredients
Part B, on the other hand, deals with the safety assessment of the product, and provides information such as:
- The conclusion of the product safety assessment
- Warnings and instructions for use on the label
- The reasoning
- References of the Responsible Person for the safety assessment
For consumers, these changes are not significant and allow them to consume safely.
For manufacturers, this implies numerous administrative procedures and investments, especially for small companies. Indeed, this does not normally represent a major change for large companies as they already had to comply with the European regulation in order to sell outside Switzerland.
The LARGO project: a progressive alignment with the EU
Since June 2014, the Swiss LARGO project aims at introducing numerous changes to the regulations in order to align with those of the EU, in particular with regard to cosmetics, compliance with the lists of regulated substances, labelling, the obligation to keep a PIF, compliance with good manufacturing practices and the ban on animal testing.
The cosmetic regulation in place before these changes was already very similar in terms of labelling and restricted substances, but it relied more on the self-regulation of companies.
According to Article 54 of the Ordinance on Foodstuffs and Utility Articles (ODAIOUs), all cosmetic products must therefore comply with the annexes of Regulation EC 1223/2009, whether it be for prohibited ingredients or for colourings and preservatives.
Among the various changes, we also note that, for cosmetic claims, Switzerland now follows the 6 common criteria from the EU regulation: legal compliance, truthfulness of evidence, honesty, fairness and informed decision making.
Different transitional periods were foreseen to allow time for companies to adapt:
- 1st May 2018 to appoint a Responsible Person based in Switzerland to stop animal testing
- 31st December 2018 to comply with the list of ingredients in good standing
- 30th April 2021 to draft the PIF and comply with GMP (Good Manufacturing Practices)
However, some elements of the Swiss regulation are still not the same as in the EU.
For example, a manufacturer or importer must be designated for each cosmetic product placed on the Swiss market and not in Europe. This person is responsible for ensuring compliance with Swiss regulations, but they may delegate these obligations to an agent located in Switzerland.
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 product cannot be transferred to them.
Furthermore, although all cosmetic products need to have a full PIF, some are exceptions to the rule: for example, locally sold handicrafts (except those intended for children).
Wish to know more about the compliance of cosmetic products ?
For more information, do not hesitate to contact Nataliya Muller or one of our experts!
