As labelling is not only used to help inform consumers of a product’s intended use and any related warnings, also notify its ingredients, the net quantity of contents, and its place of manufacture or distribution, proper labelling is an important aspect of marketing a cosmetic or personal care product.
Labelling represents an important part of a cosmetic product packaging, from both the regulatory and marketing view. Each country has its own regulatory framework, including specific labelling requirements. Companies that are selling products worldwide have to make sure that their product labels are compliant with labelling requirements of every country they are selling in. Product labelling includes various information, but one of the most important parts of the labelling is definitely an ingredient list, which informs the customers about product composition. Writing a correct and compliant ingredient list is not as easy as one might think, so it is important to know the rules on how to write it.
EU, US, and Canada
EU Product Composition
The first step towards writing a compliant ingredient list is having the exact and complete product composition. Product formula has to include all raw materials (substances or mixtures), which are used in the manufacturing of the cosmetic product. In case the product contains raw materials, which are mixtures, all substances that are part of the mixture, have to be included in the product formula (e.g. preservatives used for preserving raw materials, antioxidants, solvents, etc.).
All ingredients listed in the product formula have to be included in the ingredient list and appear on the product label. There are only the following two exceptions, which do not have to be included:
- Impurities in the raw materials used
- Subsidiary technical materials used in the mixture but not present in the final product.
US Product Composition
In the US, the ingredient list does not have to include incidental ingredients, which are defined as:
- Any processing aid added and removed or converted to a declared ingredient
- Any ingredient of another ingredient or processing aid present at an insignificant level and having no technical or functional effect.
In case the product includes any ‘trade secret ingredients’, which have been accepted by US Food & Drug Administration (FDA) as exempt from public disclosure, they do not have to be listed on the label. In place of their name, it is allowed to use the phrase ‘and other ingredients’ at the end of the ingredient list.
Canada Product Composition
Canada has the same definitions of incidental ingredients as the USA and also does not require them to be included on the label.
EU Nomenclature
Once we have the product formula, we have to make sure that we are using the correct ingredient names. The ingredients have to be listed by their International Nomenclature Cosmetic Ingredient name or INCI name. The list of INCI names can be found in Glossary of Common Ingredient Names published by the European Commission. INCI names can also be accessed via CosIng database, found online on the European Commission website for cosmetics.
For perfume and aromatic compositions, the INCI names ‘parfum’ or ‘aroma’ should be used. Colourants, other than colourants used to colour hair, should be listed by their Colour Index Number (CI). In case a product contains nanomaterials, this has to be clearly indicated by using the word ‘nano’ in brackets next to INCI name of the nanomaterial (e.g. titanium dioxide [nano]).
US Nomenclature
Ingredients have to be written by the name established by the commissioner as specified in section 701.30 of the Title 21 of the Code of Federal Regulations, or by the name adopted in the following publications:
- CTFA Cosmetic Ingredient Dictionary
- United States Pharmacopeia
- National Formulary
- Food Chemical Codex
- USAN and the USP Dictionary of Drug Names.
If the name is still not found, then it is possible to use the name that is generally recognised by consumers or a chemical or technical name or description. Usually, the names given in the above sources are INCI names, so the ingredient list does not differ much from the ingredient list used in the EU.
However, there are certain exceptions:
- Perfumes and flavours have to be listed as ‘fragrance’ and flavour’
- Colour additives should be named by the FDA Colour additive name (e.g. FD&C Yellow No. 5)
- Botanical ingredients should include common names (e.g. Rosmarinus Officinalis (rosemary) extract).
If you want to use one ingredient list for the USA and the EU, it is possible to write both names, e.g. water (aqua).
Canadian Nomenclature
Ingredients have to be listed by their INCI names, and as the EU, Canada also accepts words ‘parfum’ or ‘aroma’ for fragrances or flavours. Botanical ingredients must be listed at a minimum by the genus and species names or by using the complete INCI name. It is important to also check the Schedule of the Cosmetic Regulations (Appendix 1). The names listed there can either be used by their EU trivial name or by the English and French equivalent. It is also allowed to use all three names together.
EU Appearance, Location and Order
The ingredient list has to be preceded by the term ‘ingredients’, followed by the list of ingredients present in the product. It is important that the ingredient list is visible to the consumer at the time of purchase. It can appear on the outer packaging only. If there is no outer packaging, the ingredient list must appear on the container. Where it is impractical to indicate the ingredients on the packaging, the information has to be mentioned on an enclosed or attached leaflet, label, tape, tag, or card and should be referred to by the open book symbol.
US Appearance, Location and Order
Rules on appearance and location are similar to the ones in the EU. It is important that the declaration is clearly visible and easy to be read and understood by ordinary individuals under normal conditions of purchase. Additionally, the font size should not be less than 1/16 inch in height.
If a product has outer and inner packaging, then the ingredient list can appear only on the outer packaging. The list of ingredients can appear on the information panels (side panels of the packaging). Like in the EU, ingredients must be listed in descending order of predominance. Ingredients with a concentration below 1% may be listed in any order after the listing of the ingredients present at more than 1%. Colour additives may be listed in any order after all other ingredients. Trade secret ingredients may be listed at the end of the ingredient list, using the phrase ‘and other ingredients.’
Canada Appearance, Location and Order
Like in the EU and USA, all cosmetic products require the ingredient list to be present on the label. It has to be listed on the outer packaging or, in case the product does not have an outer packaging, it has to appear on the container label. Products, which are too small or impractical to include the ingredient list on the label, ingredients have to appear on the tag, tape or card affixed to the product.
It is common, although not mandatory that the ingredients are preceded by the term “ingredient” or “ingredients/ingrédients”. Rules on ingredient order are the same as in the EU and the US. In addition to colouring agents, flavouring and fragrance agents may also be listed at the end of the ingredient list.
EU Declaration of Allergens
The presence of any of the 26 allergens listed in Annex III of the Cosmetics Regulation 1223/2009 has to be declared in the ingredient list, but only if their concentration exceeds:
- 0.001% for leave-on products (e.g. face cream)
- 0.01% for rinse-off products (e.g. shower gel)
It is important to add that if any of the 26 allergens are present in different ingredients of a cosmetic product, the concentration of all allergens has to be added up in order to check whether the summed-up concentration of the allergens exceeds the allowed threshold.
US Declaration of Allergens
The FDA does not require allergens to be declared on the label.
Canada Declaration of Allergens
In Canada, it is also not a requirement to list allergens on the label.
EU Decorative Cosmetics
For decorative cosmetics marketed in several shades, it is allowed to use a common ingredient list for the whole colour range. To do so, all colorants used in the range may be listed, provided that they are preceded by the words ‘may contain’ or ‘+/- ‘
US Decorative Cosmetic
Decorative cosmetic products sold in the USA may also share one ingredient list among shades within the same product range. In this case, each shade has the same ingredient list, where the colorants have to be listed and the end of the ingredient list and after the phrase ‘may contain’.
However, it is important to add that all colorants, which appear in all shades, must be listed before ‘may contain’. All the others, which do not appear in all shades, may be listed in ‘may contain’ section. Since one ingredient list is shared among many shades, there is sometimes the case, that there are also ingredients other than colorants, which are not included in all shade formulations. In this case, it has to be written in which shade those ingredients are present, e.g. beeswax in peach shade.
Canada Decorative Cosmetics
For make-up products (e.g. eyeshadow, lipstick), nail polishes and nail enamel, it is allowed to use one ingredient list. The list must include all colouring agents used in the range, preceded by the symbol “+/-” or the phrase “may contain/peut contenir”.
In Canada, all cosmetic products have to be notified to Health Canada, which monitores production and distribution of various types of products, including cosmetics.
Manufacturer, a Canadian importer or a person responsible on their behalf, has to notify Health Canada by submitting a Cosmetic Notification Form (CNF) for each cosmetic product being sold in Canada. Cosmetic registration in Canada is a post-market requirement, meaning that the notification has to be made within 10 days after the cosmetic products are first sold in Canada.
If the products are not notified, they may be denied entry into Canada or removed from sale.
Cosmetic notification form has 9 sections. Information that has to be provided includes the following:
- Brand and name of the product
- Date of the first sale of the product in Canada (actual or predicted)
- Product information (area of application, form, function, ingredients and their concentrations
- Contact information of the notifier
Contact information of the manufacturer and/or Canadian importer (note that at least one of the companies for which contact information is provided has to be based in Canada. If the manufacturer is not from Canada, then the details of the Canadian importer have to be provided as well) Additional documents and pictures (needed only if the product presents an avoidable hazard according to the Cosmetic Regulation or Cosmetic Ingredient Hotlist)
Before notifying your product, it is important to check the Cosmetic Ingredient Hotlist, which contains lists of prohibited and restricted ingredients for use in cosmetics in Canada. If any ingredient you have in your product, requires warning statements, it is important to provide a product’s label (as an additional document) with the notification form.
China has released new cosmetic labelling regulations to combat misleading product information in the fast-growing industry. On May 31, 2021, China’s National Medical Products Association (NMPA) released the Measures for the Administration of Cosmetic Labeling (the “Measures”), which describe how cosmetics companies should label their products.
The new labelling requirements follow a comprehensive series of new regulations governing the cosmetics industry in China, which took effect on January 1, 2021. The Measures act in accordance with this broader regulatory framework and will come into force on May 1, 2022. Cosmetics provided to consumers in the form of free trial, gift, and via coupons or vouchers that can be redeemed are also subject to the Measure.
According to Reed Exhibitions Russia, Russia represents 4% of the global cosmetics market. It is the fourth biggest market in Europe (after Germany, France and UK), while according to per capita consumption of cosmetics, Russia globally comes in 6th place. Russia is, however, also known for its quite burdensome regulations, so getting to know the Russian cosmetics legislation and regulatory requirements is a vital part of preparing yourself to enter this market. The current cosmetics legislation in use in Russia came into force in 2012, and it is called the Technical Regulation on the Safety of Cosmetic Products (CU TR 009/2011).
