Regulations of Swiss Cosmetics
The cosmetic regulations of Switzerland are very similar to the regulations of the European Union. However, there are certain differences between the two. Switzerland hasn't signed the European Economic Area Agreement (EEA) but it is a European Free Trade Association (EFTA) member.
The cosmetic products made for the Switzerland market have to comply with the Federal Office for Food Safety and Veterinary Affairs (FSVO). Such products are also categorized as Utility Products.
According to Article 5 (Food and Utility Federal Act), things defined as objects have the product categories as follows:
Cosmetics, preparations as well as substances, which is used as per directions, come in contact with the mucous membranes, teeth and body.
Inks and tools used for tattooing as well as for make-up.
Aerosol dispensers which have foodstuff or some other utility articles.
Here is a product list that can be considered as cosmetics according to the Cosmetic Products Ordinance Annex I.
Lotions, oils and gels as well as creams and emulsions for skin care.
Foundations in the form of powder, liquid or paste.
Powders used for makeup and personal hygiene.
Deodorant and toilet soaps.
Perfumes and cologne
Bath and shower preparations (oils, salts, gels and foam)
Antiperspirants and deodorants
Products for hair care such as hair bleach and dyes; hair cleaning (powders, lotions and shampoos, creams and oils); styling products such as gels and foams.
Makeup as well as makeup removal products
Lip care products
Oral care hygiene products
Intimate care products
Products used for tanning
Skin whitening as well as products for anti-wrinkle
This Ordinance has also specified general requirements regarding the following:
Restricted or prohibited substances
Advertising, labelling and forbidding deception
Hygiene and manufacturing criteria
The defined responsibilities of the importer, manufacturer and distributor
The following regulatory texts should be referred to for marketing cosmetics in Switzerland:
The Utility and Foodstuffs Ordinance articles
Aerosol Dispensers Ordinance
The incentive tax on volatile organic compounds Ordinance
Protection of the Environment Federal Act
A product information file has to be written before placing the product in the market. It has to be written in the confederation official language or in the English language. Here is a list of information that definitely has to be included in the documentation:
Cosmetic product description along with a link to the product information file.
Safety report about the cosmetic item.
Explanation of the method adopted for manufacturing along with a compliance declaration that is in alignment with the manufacturing process.
Solid evidence of what the product actually claims to do which has to be justified by the effect or nature of the cosmetic item.
Relevant data pertaining to the animal tests which are done by the manufacturers, suppliers and agents along with the tests related to safety or development of cosmetics or its ingredients.
Furthermore, the file has to be preserved for ten years starting from the date when the last batch of cosmetics was launched in the market.
Part B includes an assessment of the safety process. This has to be done by someone who holds proof of a formal qualification or diploma. The training could be in fields such as toxicology, pharmacy, or medicine.
The safety report required for cosmetic products that are launched in the Switzerland market is the same as that of the European Cosmetics Regulations (EC) No.1223/2009. Following are the norms:
The part A needs to have information pertaining to cosmetic product safety. This includes physiochemical data, traces, information about packaging material, quality of the microbiology, profile of how toxic the substances are, data related to cosmetovigilance and the likes.
Part B comprises safety assessment details like warnings, conclusion, and reasoning along with the reference of who assessed the safety.
The ODAIOUS article 54 (paragraph 1-6) states that the substances present in the Switzerland cosmetic products have to comply with the Annex to European Regulation pertaining to (EC) No.1233/2009. (It includes prohibited as well as restricted substances, preservatives, colourants and UV filters.) Moreover, Article 54 also mentions that the Federal Department of Home Affairs can establish exemptions from paragraph 1-6. These details are mentioned in Section 4. It is named as Prohibited and Restricted Substances of the Ocos SR 817.023.31. So far the only difference from the EU annexes is Furocoumarins and Hydrogen Peroxide.
The article doesn’t cover a nanomaterial that is found in the cosmetic product. However, here is the additional information that the safety report should have:
Nanomaterial identification along with the nomenclature as well as its chemical name.
Specifics of the nanomaterial and it is chemical/physical properties and particle size.
An approximation of the nanomaterials contained in cosmetics that are launched in the Switzerland market each year.
Toxicological profile of the nanomaterial.
Data related to the safety of nanomaterial-related to the cosmetic.
Exposure conditions that are reasonably estimated.
The ordinance has regulated the incentive tax on the volatile organic compounds (OCOV, 814.018). The cross-cutting regulations pertain to the cosmetic products and include a list of substances that get a tax of CHF 3 for each kg of VOC.
The idea of border products is absent in the regulations of the confederation. However, the essential oil concentration can cause a change in the product status.
Thus, products with a concentration equal to or less than 3% are categorized as either cosmetics or class I medical devices. If the essential oil concentration exceeds 3% then the products are categorized as drugs or medical devices (class III).
In the EU, the labelling has to be written in the language of the destination. However, in Switzerland, either French, Italian or German language can be used. As per the safety regulations, it is obligatory to have all the three official languages.
As far as contact details are concerned, irrespective of the address and name of the person responsible, the contact details of the importer, manufacturer, distributor in the EU is also necessary.
The following details are mandatory and should be placed such that they are easily visible:
What the product function is unless it is obvious from the way it is presented.
The name, business name as well as the address of the importer, distributor, manufacturer or the responsible person present in the EU.
The durability date if it is within 30 months. This should be indicated in the MM.DD Format or MM.DD.YY format for the reference of consumers. This date should be mentioned after showing a pictogram like an hourglass or writing the words “Preferably to be used before the end”.
If the minimum durability happens to be greater than 30 months then PAO has to be mentioned. It can be avoided if the postponing duration is not valid for the said product. Thus, “open jar” symbol has to be used which can be succeeded by the usage duration mentioned in years or months.
List of all the ingredients used. (Same as EU)
Batch number and capacity
Precautions to be used
Instructions about how to use and conditions for storage as and where applicable.
If there is an aerosol present then the relevant indication has to be added.
The EU Common Criteria is written in Annex 6 OCos and have to be respected. However, the claims which are permitted are different.
Claiming antimicrobial activity is prohibited unless it is for products which are related to oral and dental care.
The animal tests can be claimed if they are verified.
Hygiene and Manufacturing Criteria
The cosmetic products have to be manufactured such that they meet the cleanliness as well as hygiene requirements to protect the health of the consumer. The manufacturer also has to comply with the best practices in the cosmetic industry. The cosmetic ordinance has administered ISO 22716 on GMP for cosmetics.
Notification/ FSC/ Registration
Switzerland follows self-monitoring rules as per which the importer, distributor, as well as the importer, have to ensure that their cosmetics comply with the legal requirements. Cosmetics which meet the legal requirements don’t need any prior authorization from cantonal inspection or the OSAV. There is no notification norm.
However, a product information file must be kept that contains the elements which are the same as the European Regulation requirements. Similarly, the distributor or the importer must provide the execution proof to the cantonal authorities. The authorities regularly check whether your cosmetic product conforms to the Switzerland market. There is not any need for a free sale certificate.
Responsibilities of Importer, Manufacturer and Importer
The importer and manufacturer need to make sure that the cosmetics launched in the market are compliant with the food legislation. It is a good idea to appoint an agent who stays in Switzerland.
The distributor has to be vigilant while selling the product under her/his name. The conformity to standards should be kept in mind if any modifications are made while rebranding. Before selling the product, the labelling, as well as durability date, has to be checked. Same goes with the transport and storage conditions as they should not be compromised under any situation.
Cosmetics in Switzerland have a VAT of 8% and are duty-free.