How do you ensure labeling compliance with your cosmetic?

The product label is the first information displayed to the consumer. That is why cosmetic labels follow specific rules, for example in Europe (EU) or the United States (USA). It is designed to protect consumers and to help them to make an informed choice.

European labeling requirements for cosmetics

EU labelling requirements for cosmetics are established by the cosmetic Regulation (CE) n°1223/2009 governed by Article 19 of Regulation. The required information must be on the packaging in indelible, easily readable, and visible characters. The following statements are mandatory:

• Contact details of the Responsible Person (RP) : any natural or legal person established within the EU who ensures the compliance of the product to the regulation ;
• Country of origin for imported products 
• The nominal content, that is, the amount (by weight or volume) of the product contained in the package. Products containing less than 5 g or 5 ml, samples and unidoses are exempt
• Minimum sustainability date or PAO  
• Particular precautions and/or warnings necessary to safely use cosmetic products 
• The reference for identifying the cosmetic product (batch number or equivalent) to ensure traceability 
• The function of the product (unless it is clearly identifiable by the presentation)
• The list of ingredients (see below), preceded by the term "Ingredients."

Minimum sustainability date and PAO   The date of minimal durability (DMD) shall be the date until which the cosmetic product retains its specific properties when properly stored, and is safe to use. DMD is evaluated by stability testing. When it last less than 30 months, it is indicated by the hourglass symbol, with a date (month/day/year or month/year), and sometimes with storage recommandations     If the DMD is evaluated to more than 30 months, it's not indicated on the packaging, but the period after opening (PAO) replaces it (unless PAO is irrelevant). PAO is the durability after opening, the time during which the product keep its properties and is safe to use. PAO is indicated by the « open jar » symbol, with a period in months (M) or years (Y)

All required information is written in the language of the member country of origin. In the case of export, the function of the product and the precautions of use must be translated. Please note that if exported to France, Austria, Bulgaria, Portugal, Poland or Slovakia, the entire labeling must be translated. However, in order to bring a cosmetic product to the U.S. market, the English translation of the label is not sufficient, it is necessary to follow the specific rules issued by the FDA (Food and Drug Administration)

FDA cosmetic labeling requirements

Cosmetics labeling in the United States is regulated by the Federal Food, Drug & Cosmetics (FD&C) Act and the Fair Packaging and Labelling (FP&L) Act, and must comply with the Cosmetic Labelling Guide. Please note that in the United States, these rules also apply to any text, image, or drawing that appears on the product or that accompanies it. The required information must be in English.

U.S. law distinguishes two parts for labeling, which the required information differs.

- the « principal display panel » (PDP) : it's the part that the consumer sees when the product is displayed for retail sale. It's more likely the front panel of the packaging ;

- the « information panel » (IP) : the other sides of the product, like the sides or the back of the secondary packaging.

The PDP requirements are:

• The name of the product
• The identity statement: a name or an illustration that describes the nature and the use of the product
• The warning "warning - the safety of this product has not been determined." when the safety of the product cannot be completely substantiated (for example in the case of the lack of data for an ingredient, or unongoing studies at the time of the launch
• The net quantity, in terms of weight, measure (with the mention "Net wt. " or "Net contents") or numerical count.

The other information requested in the "information panels" are:

• Directions for safe use 
• Warnings: they can be specific to the category of product. They are necessary if the product or its misuse can be unsafe for the consumer 
• Name and place of business: manufacturer, distributor, or packer. This mention may come with "manufactured for…" or " distributed by…" if the manufacturer and the distributor are not the same 
• The ingredient list (or ingredient declaration): it should be visible. Its minimal size and the condition of its visibility are indicated in the Cosmetic Labelling Guide 
• Any other information necessary for the safe use of the product

Cosmetic product labelling requirements in the United States have a number of subtleties, such as net quantity reporting units, its size relative to PDP, or specific warnings depending on the type of product. It is therefore essential to follow the guidelines of the Cosmetic Labelling Guide on this subject.

Cosmetic ingredient labelling requirements: the ingredients list

In Europe or the United States, ingredients are reported in descending order of concentration in the product, except for ingredients present at less than 1%. The dyes are listed at the end of the ingredient list (except in the case of hair-coloring ingredients in Europe). In the case of products with different colors, therefore compositions that vary only by dyes in the same range, all the dyes used in the range can be listed at the end of the list after the word "may contain" or the sign "+/-" (Europe), or the word "may contain" (United States). In Europe, the list of ingredients must also declare cosmetic allergens under certain conditions (put allergens article link).

The name of the ingredients to be used is specified by each regulation. For Europe, it is the Glossary of common denominations of ingredients. In the United States, this is the one established by the Commissioner as specified in Section 701.30 of the Code of Federal Regulations (Title 21), or by other publications specified in the Cosmetic Labelling Guide, such as the CTFA's Dictionary of Cosmetic Ingredients or the Pharmacopoeia of the United States. In fact, it is the NOMENCLATURE INCI (International Nomenclature of Cosmetic Ingredients) that is mainly used but with some specificities .

 

Differences between the ingredients list in Europe and the United States (not exhaustive)

	European Union	USA
Fragrance	« parfum » or « aroma »	« fragrance » or « flavor »
Color additives	CI (Color Index) name	FDA name (for example FD&C Yellow n°5)
Botanical ingredients	Latin name	Common name
Water	aqua	water
Honey	mel	honey

One of the peculiarities of labeling in the United States is trade secrecy. It is not possible to mention one or more ingredients by adding the words "and other ingredients". However, this is only possible after declaring the composition of the ingredient/raw material to the FDA via the Voluntary Cosmetic Registration Program and the FDA granting trade secret status, which is extremely rare.

Conclusion

In both Europe and the United States, cosmetic product labeling is under strict regulations. In order not to avoid sanction from the authorities, it is essential to master the subtleties, or to ask for help. The first contact with the consumer is on the shelf, but the packaging is also the first to display the cosmetic claims which are very much regulated by cosmetic regulations.

More info - Cosmetic Labelling Guide .https://www.fda.gov/cosmetics/cosmetics-labeling-regulations/cosmetics-labeling-guide#clgc