Cosmetics

International Nomenclature of Cosmetic Ingredients (INCI) names are standardized and used globally for cosmetic ingredients on product labels. 

When a new cosmetic ingredient is developed, companies register it with the Personal Care Products Council (PCPC) to obtain an official INCI name.

Your product must comply with Regulation (EC) No 1223/2009.

Key things to check:

• Safe ingredients (compliance with Annexes II-VI of the Regulation)
• Good Manufacturing Practices (GMP) — based on ISO 22716 guideline
• Clear labelling and legal claims
• No animal testing (only validated alternative methods allowed)

Mandatory: Each product must have a Responsible Person based in the EU.

The RP is legally responsible for:

• Ensuring product compliance
• Keeping technical documentation (PIF)
• Reporting serious undesirable effects
• The RP can be the manufacturer, importer, or a third party.

A Product Information File (PIF) must be created before placing the product on the market.

It includes:

• Product Description
• Cosmetic Product Safety Report (CPSR )
• Method of manufacturing (GMP evidence)
• Proof of claims made 
• Data on animal testing (confirming compliance with bans)

The Cosmetic Product Safety Report (CPSR) must be prepared by a qualified Safety Assessor and is part of the PIF.

CPSR includes:

• Toxicological profile of ingredients
• Exposure assessment
• Margin of safety calculations
• Safety conclusion for intended use

The product should be notified via the Cosmetic Products Notification Portal (CPNP).

No product can be legally sold without CPNP notification.

Information uploaded:

• Product category
• Formula composition
• Label and packaging images
• Contact details of the Responsible Person

Your product labels must include:

• Name and address of the Responsible Person
• Country of origin (for products imported into the EU)
• Nominal content (weight/volume)
• Date of minimum durability (or PAO — Period After Opening)
• Precautions for use
• Batch number
• Product function (unless clear from presentation)
• Ingredients (INCI format)

After launch:

• Serious Undesirable Effects (SUEs) should be monitored and reported,  if necessary
• Responsiveness to competent authority requests during inspections or audits
• PIF to be kept and updated for 10 years after the last batch is placed on the market