COSMETICS REGULATION IN SWITZERLAND AND PROJECT LARGO

Switzerland is a member of the European Free Trade Association (EFTA) but it is not a participant of the Agreement on the European Economic Area (EEA). In Switzerland, cosmetic products need to be in compliance with the Federal Office for Food Safety and Veterinary Affairs (OSAV).

Project LARGO (2014) was developed as an effort to adjust the legal framework and had as main goals: guarantee food safety (top priority and to match EU safety level); break down trade barriers with the EU; and create conditions to participate in safety systems run by the EU (RASFF, RAPEX, EFSA). Harmonization with the EU Cosmetic Regulation was the central objective of Swiss Regulation changes.

On May 1^st 2017, ordinance on foodstuffs and consumer goods and ordinance on cosmetic products entered into force. These ordinances set up some requirements for cosmetic products similar to the ones present in the European Regulation.

According to the Federal Act on Foodstuffs and Utility Articles (Foodstuffs Act, FSA, 817.0) cosmetics are considered utility articles (and not foodstuffs) which, when used as normally intended, externally come into contact with the body, teeth or mucous membranes. The same act says that it must be possible to trace cosmetics at all levels of production, processing and distribution phases.

HARMONIZATION WITH THE EU REGULATION

The Safety Assessment Report necessary for cosmetic products must obey to the same standards in Switzerland and the EU (European Cosmetics Regulation (EC) No. 1223/22009). It needs to have a part A (information regarding the product and formula) and a part B (safety assessment details such as warnings, conclusions and reasoning, and information about the safety assessor who performed it).

The Federal Council may stipulate further requirements for cosmetic products and recommends following Good Manufacturing Practices (GMP). Cosmetic products must comply with the lists of regulated substances and have a Product Information File (PIF). Advertising, labelling and forbidding deception are also regulated and included in the ordinance. Moreover, if the final formulation or ingredients of cosmetics have been tested in animals, the Federal Council may restrict or prohibit the placing on the market of such cosmetics (in order to comply with foodstuff legislation).

Ingredients present in cosmetic products made available on the Swiss market need to comply with the Annexes of the European Regulation (EC) No. 1223/2009. Nevertheless, the Federal Department of Home Affairs may establish exemptions.

Despite the similarities, Swiss regulation is still different from the EU. For example, artisanal cosmetic products sold locally (which are not intended for children) do not need to have a PIF. Although the address of the EU Responsible Person (RP) may be put on the label, the responsibility to ensure compliance with Swiss Regulation is attributed to the manufacturer/importer (which needs to be designated for each cosmetic product made available on the market and they may not delegate this responsibility to an EU RP or any other legal person abroad).

As part of the harmonization with EU Cosmetic Regulation, several deadlines were set. The obligation to provide a safety assessment report for each cosmetic product, create a Product Information File, and to follow Good Manufacturing Practices (GMP), has come into force since the 30^th of April, 2021. This date represented the last deadline for the harmonization process.

With the LARGO Project and the harmonization of its Regulation with the European Union, Switzerland aims to achieve the same level of protection for consumers as seen in the EU. Cosmetic products made available in the Swiss market must comply with the lists of regulated substances, labelling, and the obligations defined in the EU Cosmetic Regulation. Switzerland also follows the same 6 common criteria set out in the Commission Regulation (EU) No 655/2013 regarding the justification of cosmetic claims.

Compliance with different Regulations can be a challenge and it is important to be up to date. Critical Catalyst is available to help you, wherever you wish to place your cosmetic products. For more information bout Switzerland requirements and other enquiries, feel free to contact us at info@criticalcatalyst.com.

References:

1. Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products.
2. Federal Assembly of the Swiss Confederation – Federal Act on Foodstuffs and Utility Articles (Foodstuffs Act, FSA) of 20 June 2014 (Status as of 1 May 2021)
3. Swiss Federal Council – Ordinance on the Use of Swiss Indications of Source for Cosmetic Products of 23 November 2016 (Status as of 1 January 2017)
4. Conseil Fédéral Suisse – Ordonnance sur les denrées alimentaires et les objets usuels, du 16 décembre 2016 (Etat le 1er juillet 2020)