Scope & Classification
According to the Cosmetics Regulation:
“Cosmetic product means any substance or mixture intended to be placed in contact with 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 odors.” (Art. 2, p.1a) Cosmetic products shall be safe for human health, “under normal or reasonably foreseeable conditions of use” (Preamble).
Site of application:
(✓) External parts of the human body
(✓) Oral cavities
EC 1223/2009 Recital 2: “products containing substances or preparations intended to be ingested, inhaled, injected or implanted in the human body do not come under the field of cosmetics”.
Intended main function:
(✓) Cleaning, perfuming, changing appearance, correcting body odours, protecting, keeping in good condition.
Not applicable, e.g.:
(✗) Repellents (mosquitoes, lice)
(✗) Soaps with primary biocide function
(✗) Products for muscles, joints
The main function is exerted on the specified application sites: “with a view… to cleaning them, perfuming them, changing their appearance, protecting them or keeping them in good condition”.
In order to ensure that a product is indeed a cosmetic product, the product formulation, characteristics, claims as well as the sites of application and intended functions need to match the definition of a cosmetic product as defined in the Scope of the EC 1223/2009.
Once the product has been found to match the definition of a cosmetic product, the cosmetic product categories listed in the regulation 1223/2009/EC preamble 7 need to be considered.
- The Regulation: EC 1223/2009
- EU Responsible Person
- Product Information File
- Good Manufacturing Practices
- Cosmetic Product Safety Report (CPSR) - Part A & B
- Mandatory Safety Testing
- EU Labeling
- Pre-Market Notification: Cosmetic Product Notification Portal (CPNP)
- Post-Market Surveillance
- Risks of Non-Compliance
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