Cosmetic Directive and EU Cosmetics Regulation
The EU Cosmetic Directive 76/768/EEC has been replaced by Regulation (EC) No 1223/2009 on cosmetic products, which has applied since 11 July 2013. Doruksistem helps manufacturers, importers and brand owners meet EU and Turkish cosmetics requirements, from safety assessment and product information files to notification and labelling.
From the Cosmetic Directive to Regulation (EC) No 1223/2009
For more than three decades, cosmetic products in the EU were governed by the Cosmetic Directive 76/768/EEC, which each Member State had to transpose into national law. To remove differences between national rules and strengthen product safety, the EU recast the Cosmetic Directive as Regulation (EC) No 1223/2009.
Adopted on 30 November 2009, the Regulation entered into force on 11 January 2010 and has applied since 11 July 2013; its CMR provisions (Article 15(1) and (2)) already applied from 1 December 2010. As a regulation, it is directly applicable in all EU Member States without national transposition, and it also applies in Iceland, Liechtenstein and Norway under the EEA Agreement.
The Responsible Person
Only cosmetic products for which a responsible person established in the EU has been designated may be placed on the EU market (Article 4). The manufacturer, the importer or a person mandated in writing can act as the responsible person, who is accountable for the product’s compliance with the Regulation.
Safety Assessment, PIF and GMP
- Safety assessment (Article 10): Before a product is placed on the market, a qualified safety assessor must prepare a cosmetic product safety report (CPSR) in line with Annex I.
- Product information file (Article 11): The responsible person keeps a PIF for each product for ten years after the last batch was placed on the market.
- Good manufacturing practice (Article 8): Products must be manufactured in line with GMP; compliance with the harmonised standard EN ISO 22716 gives a presumption of conformity.
Product Notification (CPNP)
Before a cosmetic product is placed on the market, the responsible person must notify it electronically to the European Commission through the Cosmetic Products Notification Portal (CPNP) (Article 13). The notification includes, among other things, the product category and name, the responsible person, the country of origin for imported products, the Member State where the product is placed on the market, the presence of nanomaterials and of CMR substances of category 1A or 1B, the frame formulation and the original labelling.
Distributors that make an already notified product available in another Member State and translate any element of its labelling must also submit certain information through the CPNP.
Prohibited and Restricted Substances
The Annexes to the Regulation determine which substances may be used in cosmetic products (Article 14):
- Annex II: substances prohibited in cosmetic products
- Annex III: substances that may be used only under the restrictions and conditions laid down
- Annex IV: permitted colorants
- Annex V: permitted preservatives
- Annex VI: permitted UV filters
Colorants (other than hair dyes), preservatives and UV filters may be used only if they are listed in the relevant Annex and used in line with its conditions. Because the Annexes are amended regularly, formulations should be checked against the current consolidated text.
Nanomaterials
Cosmetic products containing nanomaterials must be notified to the European Commission six months before they are placed on the market (Article 16), in addition to the standard product notification. This does not apply to nanomaterials used as colourants, preservatives or UV filters that are listed in the Annexes of the Regulation.
In the list of ingredients, the name of each nanomaterial must be followed by the word “nano” in brackets (Article 19).
Product Claims
Claims on labels and in advertising must not attribute characteristics or functions to a product that it does not have (Article 20). Commission Regulation (EU) No 655/2013 sets six common criteria for cosmetic claims:
- legal compliance
- truthfulness
- evidential support
- honesty
- fairness
- informed decision-making
Labelling Requirements
Cosmetic products may be made available on the market only if the container and packaging bear the following information in indelible, easily legible and visible lettering (Article 19):
- name or registered name and address of the responsible person
- country of origin for imported products
- nominal content (weight or volume)
- date of minimum durability for products that last 30 months or less, or the period after opening (PAO) for products with a minimum durability of more than 30 months
- particular precautions for use
- batch number or reference for identification
- function of the product, unless it is clear from its presentation
- list of ingredients, with nanomaterials followed by the word “nano” in brackets
CMR Substances
Substances classified as carcinogenic, mutagenic or toxic for reproduction (CMR) are subject to strict rules under Article 15:
- CMR category 1A and 1B: prohibited, with limited exceptions where strict conditions are met and the Scientific Committee on Consumer Safety (SCCS) has found the use safe.
- CMR category 2: may be used only if the SCCS has evaluated the substance and found it acceptable for use in cosmetic products.
The Annexes of the Regulation are amended regularly to reflect new CMR classifications, so formulations need continuous monitoring.
Animal Testing Ban
The Regulation prohibits animal testing of finished cosmetic products and their ingredients in the EU. Since 11 March 2013, a full marketing ban also applies: cosmetic products whose final formulation or ingredients have been tested on animals to meet the Regulation’s requirements cannot be placed on the EU market (Article 18).
Serious Undesirable Effects and Market Surveillance
The responsible person and distributors must notify serious undesirable effects without delay to the competent authority of the Member State where they occurred, including the product concerned and any corrective measures taken (Article 23). The competent authority forwards this information to the authorities of the other Member States.
Member States carry out in-market controls through the product information file and, where appropriate, physical and laboratory checks (Article 22). Where a product presents or could present a serious risk to human health, authorities can take provisional measures to withdraw, recall or restrict it (Article 27).
Cosmetic Products in Türkiye
In Türkiye, cosmetic products are regulated by Cosmetics Law No. 5324 and the Cosmetic Products Regulation published in Official Gazette No. 32184 (repeated issue) of 8 May 2023, which is aligned with Regulation (EC) No 1223/2009. The competent authority is the Turkish Medicines and Medical Devices Agency (TİTCK).
There is no pre-market approval for cosmetics in Türkiye. Before placing a product on the market, however, companies must complete a product safety assessment, prepare a product information file and notify the product through the Product Tracking System (ÜTS). More details are available on our Turkish cosmetic products page.
How Doruksistem Supports You
Doruksistem supports cosmetic companies with:
- Responsible Technical Staff service in Türkiye
- Product information file (PIF) preparation and product safety assessment
- Cosmetic testing, including microbiological, preservative efficacy, stability and heavy metal tests, and in vitro and in vivo tests to support claims
- Formula and label compliance checks
- GMP compliance audits
- Product notification and ÜTS company registration
- Support with export certificate applications
For an overview of EU cosmetics rules, see the EU summary Safer cosmetics for people in the EU. Contact us for EU and Turkish cosmetics compliance support.