Here are questions our clients frequently ask about cosmetic safety and regulation.

In imported cosmetic products it is necessary to indicate the country of origin?

The container and packaging of cosmetic products should bear the following information in indelible, easily legible and visible lettering:

The name or registered name and the address of the Responsible Person. Such information may be abbreviated in so far as the abbreviation makes it possible to identify that person and his address. If several addresses are indicated, the one where the responsible person makes readily available the product information file shall be highlighted.

The country of origin shall be specified for imported cosmetic products.

Why should we conduct a Challenge test?

The Challenge test is mandatory for all cosmetic products, according to Regulation EC 1223/2009. Challenge test is essential to justify the effectiveness of the preservation system and justify the shelf life and period after opening of cosmetics in terms of safety.

Water-based cosmetic products provide a perfect environment for microbial growth, and the products’ additional components can serve as nutrients for these microorganisms. It should be kept in mind that a contaminated product (which may show no visible signs of contamination) is much more dangerous for users than preservatives.

The reasons for microbial preservation of cosmetics are:

  • to ensure the microbial safety for the consumers
  • to maintain the intended quality and specifications
  • to preserve the image and the reputation of your company

When should the Durability be indicated and when the PAO (Period After Opening)?

The indication of the Durability Date is obligatory for all cosmetic products which the minimum durability date does not exceed the 30 months.

For cosmetic products which the minimum durability date exceed the 30 months an indication of the time after opening the package in which the product can be used without endangering the health of consumers, is called PAO.

For single use products the indication of PAO is not obligatory.

What is withdrawal and recall of a cosmetic product?

Withdrawal means any measure aimed at preventing the making available on the market of a cosmetic product in the supply chain.

Recall means any measure aimed at achieving the return of a cosmetic product that has already been made available to the end user.

What are the obligations of the distributor?

‘Distributor’ means any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a cosmetic product available on the Community market. This includes wholesalers, retailers, shops, beauty or hair salons, telesales, outlets and internet selling.

Before making a cosmetic product available on the market distributors shall verify that:

  • The mandatory labeling information is present.
  • The language requirements are fulfilled.
  • The date of minimum durability specified, where applicable, has not passed.
  • Distributors shall ensure that, while a product is under their responsibility, storage or transport conditions do not jeopardize its compliance with the requirements set out in the Cosmetics Regulation.

Where distributors consider or have reason to believe that:

A cosmetic product is not in conformity with the requirements laid down in the Cosmetics Regulation, they shall not make the product available on the market until it has been brought into conformity with the applicable requirements.

Do products containing only natural ingredients need a Safety Assessment?

A safety assessment is required for all cosmetic products, regardless of the origin of the materials they contain. It does not matter whether a cosmetic product is made up of all natural or all synthetic ingredients – the legislation does not distinguish between the origins of an ingredient.

Whether an ingredient is synthetic or natural has no bearing on whether an ingredient is safe to use. The Annexes of the EU Cosmetics Regulations include many natural materials, as well as many man-made materials, that are prohibited from use in cosmetics for reasons of safety.

Is my product vegan?

There is no legal definition of a vegan cosmetic product. Responsible persons may include claims that the product does not contain any animal-derived ingredients or is ‘suitable for vegans’. Such claims are acceptable, but it is a legal requirement that all claims can be substantiated and are not misleading to the consumer. It should therefore be clear to the consumer what criteria are being applied.

It must be remembered that certification by a commercial organization of either ingredients and/or a final cosmetic product is optional, while compliance with the EU Cosmetics Regulations is mandatory.

Does my product labeling have to be reviewed or approved?

There is no legal requirement for labeling to be reviewed or approved by a third party.

However, as mistakes can be costly to rectify and can have a reputational impact, it is recommended that the artwork is checked by a specialist experienced with the EU Cosmetics Regulation.

What information needs to be printed on the label of a cosmetic product?

The labeling requirements for cosmetic products are detailed under Article 19 of the EU Cosmetics Regulation.

The container and packaging of cosmetic products should bear the following information in indelible, easily legible and visible lettering

  1. Name and address of the EU Responsible Person.
  2. The nominal content at the time of packaging, given by weight or by volume
  3. Period after Opening or date of minimum durability where relevant
  4. Warning statements and precautionary information;
  5. The batch number of manufacture
  6. The function of the cosmetic product, unless it is clear from its presentation
  7. Declaration of ingredients. The list shall be preceded by the term ‘ingredients’
  8. Country of origin for imported products.