Cosmetic labelling: What is the key difference between US and EU?

US and EU require for cosmetic companies who intend to distribute on the market to comply with cosmetic labeling requirements. 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. Cosmereg LLC discusses

US FDA Cosmetic Labeling Requirements

US FDA does not approve cosmetic labeling however FDA does provide guidance documents for labeling. cosmetic manufacturers must ensure to comply with cosmetic labeling.

Cosmetic labelling consists of two parts:

  • Principal display panel
  • Information panel.

The requirements for the Principal Display Panel (PDP) are:

The Principal Display Panel (PDP) is the part of the label most likely displayed or examined under customary conditions of display for sale.

  • Name of product
  • Identity statement: An identity statement indicating the nature and use of the cosmetic product, by means of either the common or usual name, a descriptive name or illustration
  • Net quantity: An accurate statement of the net quantity of contents of the cosmetic in the package in terms of weight, measure, numerical count, or a combination of numerical count and weight or measure
  • Warning: If the cosmetic product contains an ingredient for which adequate substantiation of safety has not been obtained, a warning must be placed on the PDP like “Warning – the safety of this product has not been determined”

The requirements for the Information Panel (IP) are:

The Information Panel (IP) refers to a panel other than the PDP that can inform cosmetic information where the consumer is likely to see it.

  • Name and place of business: This may be the manufacturer, packer, or distributor
  • Language: All label or labeling statements required by law or regulation must be in English. If the label contains any foreign language representation, all statements required by regulation must also appear on the label in foreign language
  • Distributor statement: If the name and address are not those of the manufacturer, the label must say “Manufactured for…” or “Distributed by…”
  • Cosmetic Warning and Caution Statements: Cosmetics which may be hazardous to consumers when misused must bear appropriate label warnings and adequate directions for safe use. Flammable cosmetics such as aerosols, feminine deodorant sprays, and children’s bubble bath products are an example of products that require specific warnings
  • Ingredients declaration: The ingredient declaration must be conspicuous so that it is likely to be read and understood by at the time of purchase. You must use an appropriate information panel and make sure that the letters are not less than 1/6 inches in height and without obscuring design, vignettes, or crowding. If you do not have sufficient space for such declaration, the declaration may appear on a firmly affixed tag, tape, or card
  • Ingredient name: You may use the International Nomenclature of Cosmetic Ingredients (INCI) name. or in absence, you should use the name given by the United States Pharmacopeia, National Formulary, Food Chemical Codex, USAN, and the USP dictionary of drugs names
  • Ingredient listing: The ingredients must be listed in descending order of predominance. Exceptions are active drug ingredients, ingredients with less than 1% concentration, and colour additives. Fragrance and flavor compounds may be declared in descending order of predominance as fragrance and flavour
  • Material facts: You should reveal material facts (e.g.: directions for safe use if a cosmetic product has the potential to be misused), or your product will be considered as misbranded or adulterated.

As labeling is used to help inform consumers, failure to comply with labeling regulations cause you FDA detentions, distribution, and marketing problem.

EU cosmetic labelling requirements

EU requires for the cosmetic companies who intend to place a cosmetic product on the EU market to comply with EU cosmetic regulations. Article 19 of the EU cosmetic regulation explains the rules for a compliant cosmetic label.

Mandatory information for a cosmetic label

The container and the outer packaging of the cosmetic labeling must be indelible, easily legible and visible lettering.

  • The name and address of the Responsible Person: The European regulation EC No. 1223/2009 defines the Responsible Person as a legal or natural person based in the EU who will act as the unique representative throughout the European Union. If you’re outside the EU, you must designate a Responsible Person (RP) based in Europe to be able to market products on the EU market
  • The country of origin: If the product is made in Europe, such mention is not mandatory. But if the product is imported from countries outside of the EU, you should mention the country of origin
  • The nominal content: the nominal content of the product at the time of packaging, given by weight or volume
  • Date of minimum durability and period after opening: You should use “hour-glass symbol” to illustrate the Date of Minimum Durability (DOMD) when equal to or below 30 months. The DOMD is defined by the stability test. If the DOMD exceeds 30 months, You can use the “open-jar symbol” which indicates the period after opening. “PAO” defined by the combination of the stability test and challenge test
  • Precautions for use: Particular precautions of use and warnings are mandatory in certain cases depending on the type of cosmetic product
  • Batch number: Batch number of manufacture or the reference for identifying the cosmetic product. The batch number is mandatory
  • Product function: The function of a product must be clearly indicated to prevent any misuse
  • List of ingredients: In decreasing order of weight, except for ingredients below 1%.

What items should be translated on a cosmetic label?

  • Product function: You must translate the function of the product into the native language of each country the product is being introduced to
  • Precautions for use: These also must be translated into the native language of each country the product is being introduced to. In case it is not possible to include this information, it should be included on the product’s packaging or on an enclosed leaflet. To do this, the product must be marked with ‘The hand-in-book symbol’.

Cosmetics labeling requirements can be complicated and confusing. We can review your current labels and verify if your labeling meets US FDA and EU cosmetic labelling requirements.

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