The regulation on cosmetic products Regulation (EC) No 1223/2009 states that upon the entry of a specific product to market in EU, the Responsible Person must maintain a PIF.
PIF should be kept for at least 10 years from the date of the sale of the last batch of the product. Any changes on the product require immediate updates to the PIF.
A PIF should include:
1- Description of the cosmetic product
A detailed overview of the cosmetic product, outlining its intended use, target market, and unique features.
2- Cosmetic product safety report (CPSR)
An assessment conducted by a qualified safety assessor, evaluating the safety of the product based on its formulation and intended use.
3- Identification of manufacturer/ contract manufacturer and responsible person
Clear identification of all parties involved in the production and marketing of the product, ensuring accountability.
4- GMP certificate of the manufacturer
Certification that the manufacturer adheres to Good Manufacturing Practices, ensuring consistent quality in production.
5- Method of manufacture
Detailed documentation of the manufacturing process, which ensures that the product is made in accordance with established standards.
6- Quantitative and qualitative formulation
A complete list outlining the ingredients in both the quantitative (percentage breakdown of each ingredient) and qualitative (trade names of the raw materials, ingredients and functions ) aspects.
7- Raw material specifications
Technical data sheet (TDS). Safety data sheet (SDS) and Certificate of Analysis (CoA) of each raw material. IFRA certificate and allergens list with the % of the allergens for any fragrance and/or botanical essential oils.
8- Physico-chemical and microbiological specifications of the final product
Documentation of the physical and chemical properties, as well as microbiological safety, ensuring the product is safe for consumer use.
9- Reports of tests performed on the cosmetic product
Microbiological test – Results from tests that identify any microbial contaminants in the product, which is vital for safety, Preservative efficacy (challenge) test – Evidence showing the effectiveness of preservatives in the formulation to prevent microbial growth over the product’s shelf life, Stability test – Stability studies demonstrating that the product maintains its intended performance and safety throughout its shelf life. Compatibility test report – In the Compatibility Test, the possible interaction between the product and the packaging is studied. It can also be run along the stability test. Evidence that the product is compatible with its packaging; this ensures that there are no adverse reactions between the product and container (the one that is in direct contact with the product).
10- Detailed packaging specifications
Information on the materials and design of the packaging, ensuring it is suitable for the product and compliant with regulations.
11- Labelling
Label and box artwork of each size (ml, g) of the product and prospectus if available
12- Proof of the claimed effect
Information (document / analysis report / scientific articles) which can support the marketing claims of the product.
13- Data on undesirable effects or serious undesirable effects
Information regarding any adverse effects reported by consumers, which is critical for ongoing safety assessments.
14- Compliance Statements
Final product declarations stating that the product complies with EU regulations, such as animal testing, presence of nanomaterials, presence of CMRs, purity and compatibility of colorants used in the product.
Format and Language
The PIF should be organized in a clear and logical format (electronic or paper-based), using a language that is easily understood by regulatory authorities.
It is recommended that documentation be provided in one of the national languages of the EU Member States in which the product is marketed or in the official language of the country where the PIF is located.
Check out our Product Information File (PIF) Review service to prepare a fully compliant PIF for your cosmetics!
