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EU Cosmetics : Regulation (EC) N° 1223/2009 & Subsequent amendments [V_01.05.2020]
Brief Summary
Regulation (EC) N° 1223/2009 on cosmetic products is the main regulatory framework for finished cosmetic products when placed on the EU market.
It strengthens the safety of cosmetic products and streamlines the framework for all operators in the sector.
The regulation simplifies procedures to the extent that the internal market of cosmetic products is now a reality.
In full force since 11 July 2013, Regulation (EC) N° 1223/2009 replaces Directive 76/768/EC, which was adopted in 1976 and had been substantially revised on numerous occasions.
Providing a robust, internationally recognised regime, which reinforces product safety while taking into consideration the latest technological developments, including the possible use of nanomaterials.
Terminology under EU Cosmetics
Cosmetic product :
Means any 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.
Note: A substance or mixture intended to be ingested, inhaled, injected or implanted into the human body shall not be considered to be a cosmetic product.
Substance :
Means a chemical element and its compounds in the natural state or obtained by any manufacturing process, including any additive necessary to preserve its stability and any impurity deriving from the process used but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition.
Frame formulation :
Means a formulation which lists the category or function of ingredients and their maximum concentration in the cosmetic product or gives relevant quantitative and qualitative information whenever a cosmetic product is not covered or only partially covered by such a formulation. The Commission shall provide indications for the establishment of the frame formulation and adapt them regularly to technical and scientific progress.
Manufacturer :
Means any natural or legal person who manufactures a cosmetic product or has such a product designed or manufactured, and markets that cosmetic product under his name or trademark.
Importer :
Means any natural or legal person established within the Community, who places a cosmetic product from a third country on the Community market.
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.
End user :
Means either a consumer or professional using the cosmetic product.
Preservatives :
Means substances which are exclusively or mainly intended to inhibit the development of micro-organisms in the cosmetic product.
Colorants :
Means substances which are exclusively or mainly intended to colour the cosmetic product, the body as a whole or certain parts thereof, by absorption or reflection of visible light; in addition, precursors of oxidative hair colorants shall be deemed colorants.
UV-filters :
Means substances which are exclusively or mainly intended to protect the skin against certain UV radiation by absorbing, reflecting or scattering UV radiation.
Nanomaterial :
Means an insoluble or biopersistant and intentionally manufactured material with one or more external dimensions, or an internal structure, on the scale from 1 to 100 nm.
Note:
In view of the various definitions of nanomaterials published by different bodies and the constant technical and scientific developments in the field of nanotechnologies, the Commission shall adjust and adapt this current definition to technical and scientific progress and to definitions subsequently agreed at international level.
Making available on the market :
Means any supply of a cosmetic product for distribution, consumption or use on the Community market in the course of a commercial activity, whether in return for payment or free of charge.
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.
Serious undesirable effect :
Means an undesirable effect which results in temporary or permanent functional incapacity, disability, hospitalisation, congenital anomalies or an immediate vital risk or death.
More definitions ...
Our Regulatory Services on EU Cosmetics
Step 0: Products pre-assessment [Free of charges]
- ¤ Product portfolio pre-assessment
- ¤ Review of product formulations
- ¤ Review of product labels
- ¤ Review of marketing materials
Step 1: [optional] Administrative assignment of the service provider as “Responsible Person”
- ¤ The scope of proxy services legaly provided by a “Reponsible Person” includes:
- • Notification of Cosmetic Product [Article 13]
- • Authoring of a Product Information File [Article 11]
- Note :
- • The “Responsible Person” ensures compliance of the products with the rules set out in the Regulation.
- • In particular, the compliance with requirements relating to human health, safety and consumer information.
Step 2: Generation of EU Compliant PIF Dossier
- ¤ Make available Checklists and templates for Product Information File (PIF) building
- ¤ Collect of testing data
- ¤ PIF filling completed
Step 3: Generation of the Cosmetic Product Safety Report (CPSR) and the regulatory content briefs
- ¤ Regulatory check and the safety assessment
- ¤ The Cosmetic Product Safety Report (CPSR) is built by our team of toxicologists and chemists
- ¤ Issuing of the regulatory content briefs
Step 4: Labels and claims review
- ¤ Review of regulatory content briefs for labels and claims including the INCI ingredients listing
- ¤ Review of artwork design and marketing materials to avoid post-launch relabeling and/or costly reworks
Step 5: Cosmetic products notifications in CPNP (EU cosmetic products portal)
- ¤ Notification of products via the EU CPNP, last short step towards EU market readiness
- ¤ Note:
- • Products can be notified through the Responsible Person status, or in assisting you to notify under your own company name