Cosmetic Products Regulation (EC) No 1223/2009

Regulation (EC) No 1223/2009 is the EU law on cosmetic products. Its aim is a high level of protection of human health for every cosmetic product made available on the market. Cosmetic products do not carry the CE marking.

For cosmetic product compliance and notification, apply to CE Danışmanı (CE Consultant); we manage the whole process for you.

What is a cosmetic product?

A cosmetic product is a substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity, with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours.

The responsible person

A cosmetic product can be placed on the market only if a legal or natural person established in that market is designated as the responsible person. For a product made locally this is normally the manufacturer; for an imported product it is the importer, unless another person is mandated in writing. The responsible person ensures compliance with the rules on safety, good manufacturing practice, the safety assessment, the product information file, notification, restricted substances, labelling, claims and the reporting of serious undesirable effects.

Safety assessment

Before placing a product on the market, the responsible person has a cosmetic product safety report drawn up. The safety assessment is carried out by a person holding a qualification in pharmacy, toxicology, medicine or a similar discipline.

Product information file

The responsible person keeps a product information file for each product for 10 years after the last batch was placed on the market. It contains:

• A description of the product
• The cosmetic product safety report
• A description of the method of manufacturing and a statement of compliance with good manufacturing practice
• Proof of the effect claimed for the product, where justified
• Data on any animal testing performed

Notification

Before the product is placed on the market, the responsible person notifies it electronically: in the EU through the Cosmetic Products Notification Portal (CPNP). The notification includes the category and name of the product, the name and address of the responsible person, the country of origin for imports, a contact person, the presence of substances in the form of nanomaterials, and the frame formulation.

Restrictions on substances

• Prohibited substances must not be present.
• Restricted substances may be used only within the stated limits and conditions.
• Colorants, preservatives and UV filters may be used only if they are on the respective positive lists.
• Substances classified as carcinogenic, mutagenic or toxic for reproduction (CMR) are prohibited, with narrowly defined exemptions.
• Nanomaterials: a high level of protection of human health must be ensured for every product containing them, and they are identified in the list of ingredients.

Animal testing

The Regulation prohibits the testing of finished cosmetic products and of ingredients on animals in order to meet its requirements, and the placing on the market of products and ingredients tested on animals for that purpose.

Labelling

The container and the packaging bear, in indelible, easily legible and visible lettering:

• Name or registered name and address of the responsible person; country of origin for imported products
• Nominal content
• Date of minimum durability or, where applicable, the period after opening
• Particular precautions for use
• Batch number or reference for identifying the product
• Function of the product, unless clear from its presentation
• List of ingredients, with nanomaterials marked as such

Distributors

Before making a product available, the distributor verifies that the labelling information is present, that the language requirements are met and that the date of minimum durability has not passed.

Serious undesirable effects

The responsible person and distributors notify the competent authority without delay of all serious undesirable effects known to them, the name of the product concerned and any corrective measures taken.

Cosmetics in Turkey

Turkey has its own Cosmetic Products Regulation, last renewed in 2023 and aligned with (EC) No 1223/2009. The competent authority is the Turkish Medicines and Medical Devices Agency (TITCK). For foreign brands the practical points are:

• A responsible person established in Turkey must be designated.
• The product is notified to the Agency through the national electronic database before it is placed on the market; a Turkish label and packaging image are added where the original label is not in Turkish.
• A notification in the EU does not replace the Turkish notification, and the reverse is also true.