Cosmetic Product Regulation (EC) No. 1223/2009

Regulation (EC) No. 1223/2009 on cosmetic products of 30 November 2009 is the main regulatory framework for finished cosmetic products when made available on the EU market.

Regulation (EC) No. 1223/2009 sets out the rules to be applied to any cosmetic product made available on the European market to ensure its functioning and a high level of health protection.

Only products that fully comply with the requirements of the Cosmetic Product Regulation (EC) No. 1223/2009 may be placed on the European market.

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The following products are covered by Regulation (EC) No. 1223/2009:

  • creams, emulsions, lotions, gels and skin oils

  • facial masks

  • foundations (liquids, pastes, powders)

  • perfumes, eau de toilette, eau de cologne

  • bath and shower products (salts, foams, oils, gels)

  • hygienic talcum powder

  • toilet soaps, deodorant soaps

  • depilatory products, deodorants and antiperspirants

  • hair dyes, curling, straightening and fixative agents, hairstyling products

  • lotions, talc, cleansing shampoos, hair conditioners

  • lotions, sprays, hair care products

  • lotions for make-up and make-up removal

  • lotions for lips

  • oral care products

  • nail care and manicure products

  • tanning products, tanning lotions

  • skin whitening and anti-wrinkle products

  • shaving products (creams, foams, lotions)

  • Intimate hygiene products for external use.

Regulation (EC) No. 1223/2009 does not apply to:

  • Pharmaceutical products

  • Medicinal products (drugs)

  • Biocidal products

Cosmetic Product Information File according to Regulation (EC) No. 1223/2009

On the market of cosmetic products, it is the responsible person who shall maintain product data.

Product data should contain the following information and data to be updated:

  • a description of the cosmetic product that allows to clearly determine that the data relate to the product(s) in question

  • a safety assessment of the cosmetic products

  • a description of production methods

  • data on animal testing performed by the manufacturer, its agents or suppliers relating to the development or safety evaluation of cosmetic products or their ingredients, including animal tests performed in order to comply with legislative or regulatory requirements of third countries

The responsible person shall make product data available in electronic and other forms to the authorities of the EC Member State in which the data is stored, at its address on the label.

The information containing the product data shall be available in a language which can be easily understood by the authorities of the Member State concerned.

Product data shall be kept for a period of ten years following the date on which the last batch of cosmetic products was placed on the market.

Cosmetic Product Safety Report according to Regulation (EC) No. 1223/2009

The Cosmetic Product Safety Report (CPRS) shall contain the following:

  • Qualitative and quantitative indicators of cosmetic products, including chemical signatures of substances and their intended use

  • The physical/chemical characteristics and stability of cosmetic products

  • Physical and chemical characteristics of substances or mixtures and cosmetic products

  • Sustainability of cosmetic products under normally foreseeable storage conditions

  • Microbiological characteristics of substances or mixtures and of cosmetic products in general

  • Preservation test results

  • All relevant toxicological absorption methods should be considered, systemic effects and safety margins assessed

  • All available data on undesirable and serious adverse effects of cosmetic products or, where applicable, other cosmetic products. This includes statistical data

  • Information on cosmetic products

  • Other relevant information, e.g. existing risk assessment studies conducted by individuals who have voluntarily made these commitments, or duly validated and substantiated risk assessments conducted in other similar industries

Product conformity assessment procedure according to the Cosmetic Product Regulation (EC) No. 1223/2009:

Before placing cosmetic products on the European market, the responsible person shall submit the below information to the European Commission in electronic form:

  • the category of the cosmetic product and its name or names for its identification

  • the name and address of the responsible person who makes the product data available

  • the country of origin of the product (in case of import)

  • the EU Member State in which the cosmetic product is to be made available

  • the contact details of an individual who can be contacted if required

  • the presence of nanomaterials and their identifying features, including their chemical name

When making available a cosmetic product on the market, the responsible person shall inform the European Commission of its authentic labelling and provide its photograph, for more clarity.

The European Commission shall grant access to the information without delay. This information may only be used by competent authorities for the purposes of market surveillance, market analysis, evaluation, and consumer information.

If any of the information changes, the responsible person or the distributor shall ensure that it is updated without delay.

Labelling according to Cosmetic Product Regulation (EC) No. 1223/2009

CE marking of cosmetic products is not required; cosmetic products may only be placed on the market if the following indelible, legible and highly visible information is affixed to their packaging:

  • the name or trade name and address of the responsible person

  • mass or volume

  • the date until which a cosmetic product which is stored in conformity with the relevant conditions remains in use

  • the date of expiry of the minimum shelf life

  • the specific precautions to be observed during use

  • manufacturer's serial number or reference information allowing the identification of the cosmetic product

  • the intended use of the products, unless this can be clearly seen from the product description

  • list of ingredients

  • impurities used in raw materials

Responsible Person

Only cosmetic products for which a legal or natural person is designated as a “Responsible Person” (RP) can be placed on the EU market. The RP is fully responsible for safety and legal compliance of cosmetic products made available on the European market. Usually, on the cosmetics market the manufacturer, importer or distributor of cosmetic products act as RP.

All inspections will always be carried out at the address of the Responsible Person, as stated on the product label. The Responsible Person is the one in contact with the supervisory authorities of the European Union.

If a manufacturer is located outside the European Union, he must appoint a Responsible Person in the European Union to place the cosmetic product on the market of the EU Member State(s).

In addition to providing a complete range of services with regards to safety and conformity assessment of cosmetic products according to Regulation (EC) No. 1223/2009 CCIS-EXPERTISE also delivers the service of a Responsible Person registered in the European Union.

Statutory reference

In full effect since 11 July 2013, Regulation (EC) No. 1223/2009 replaces Directive 76/768/EC, which was adopted on 27 July 1976 and had been substantially revised on numerous occasions. The new Regulation (EC) No. 1223/2009 reinforces product safety while taking into consideration the latest technological developments, including the possible use of nanomaterials.

The purpose of the Regulation is to guarantee the safety of cosmetic products for human use. This safety relates to composition, packaging, and information. The responsibility for safety rests entirely with the manufacturer or importer in the EU, who is responsible for the correct distribution of the product on the market.

Full text of the Cosmetic Product Regulation (EC) No. 1223/2009

CCIS-EXPERTISE specialists will help you to:

  • identify your products within the scope of Regulation (EC)

  • prepare and evaluate the technical file

  • translate all relevant documentation and labels

  • determine the cost of certification work

  • carry out all procedures of the European conformity assessment process

  • conduct tests of any complexity in accredited European and national laboratories

  • provide a responsible person for your company in the EU