Scope & Classification

Scope

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”.

Classification

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.

Learn More:

• 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)
• Nanomaterials
• Post-Market Surveillance
• Risks of Non-Compliance

Need assistance with the classification of your cosmetic products? Contact us today!