The cosmetic product information file
The cosmetic product information file brings together the safety and technical information needed to document an EU cosmetic product. Its preparation involves the Responsible Person, a qualified safety assessor and the writers compiling the material.
Regulatory framework
Regulation (EC) No 1223/2009 applied from 11 July 2013, replacing Cosmetics Directive 76/768/EEC. It strengthened safety requirements and required preparation of a product safety report before a product was placed on the market. It also introduced the Responsible Person, centralised product notification, reporting of serious undesirable effects and new rules for nanomaterials. Animal testing of cosmetic products remained prohibited in the EU.
Responsibility for the file
The Responsible Person ensures compliance with the regulation, including human health, safety and consumer-information requirements, and maintains a product information file accessible to public authorities. This role includes ensuring compliant labelling under Article 19 and the applicable language requirements. If a product is non-compliant, the Responsible Person must take steps to bring it into compliance, withdraw it or recall it, and must inform competent authorities when it presents a risk to human health.
For imported products, the Responsible Person may be the importer or a designated third party; a distributor placing its own name on a product must take the role. Distributors and other supply-chain participants must be recorded for three years after the batch is made available to the distributor. A distributor suspecting non-compliance must stop making the product available and ensure corrective measures; a risk to human health must be reported to the Responsible Person and competent authorities.
Safety and technical information
The product information file (PIF), also called a product information pack, compiles safety and stability information. Safety-assessment material includes the following.
- All active substances and subcomponents, including antioxidants, preservatives and additives.
- Ingredient toxicological profiles and the formulation with exact raw-material percentages.
- Physico-chemical and microbiological characteristics of ingredients and the finished product.
- Analysis certificates and material safety data sheets for each raw material.
- Technical data available from toxicological databases.
- Preservative challenge and stability-test data; a finished product may not need preservative challenge testing if its environment can be shown not to support microbiological growth.
Further information includes the manufacturing method, filling and packaging process, packaging materials, and tests performed on the finished product, including human-subject and other efficacy tests.
A safety assessor examines the information on behalf of the Responsible Person. The assessor must have formal qualifications from theoretical and practical university study in pharmacy, toxicology, medicine or a similar discipline, or a course recognised as equivalent by a member state.
Notification and safety follow-up
The Responsible Person notifies each cosmetic product through the Cosmetic Products Notification Portal (CPNP), where a notification number is allocated. Central notification means the manufacturer notifies a product only once. The portal also handles nanomaterial notification.
Cosmetovigilance records undesirable health-related effects of cosmetic products. The records are evaluated regularly to support safety reassessment and decisions about further action, such as withdrawal.
Writing the documentation
Writers with pharmaceutical clinical and regulatory experience are well placed to compile PIFs because they already present information and key messages clearly, completely and consistently. Experienced writers can reduce preparation time and minimise questions and delays.