Fascicolo informativo sui prodotti cosmetici secondo il regolamento UE 112328 ottobre 2019 2021-11-12 15:53
Cosmetics Product Information File According to 1123 EU Regulation
Fascicolo informativo sui prodotti cosmetici secondo il regolamento UE 1123
Cosmetic products placed in the EU market must have a compiled Product Information File (PIF). In this article, QSE Academy explains all the important details for your company to prepare a File informativo sul prodotto.
Remember that the EU Regulation 1123/2009 also applies to the EFTA nations. Even so, the PIF must be fully compliant with the provisions of the regulation before you can perform the notification.
Regulation 1123/2009 Article 11.1 states, “When a cosmetic product is placed on the market, the responsible person shall keep a product information file for it. The product information file shall be kept for ten years following the date on which the last batch of the cosmetic product was placed on the market.”
Thus, the responsible person must preserve the PIF. It should be one responsible person per product.
Tasks of the Responsible Person
- Make the PIF readily accessible in electronic or other formats to the competent authorities of the Member State, in which the PIF is kept.
- Indicate his address on the product label.
- Make the PIF available in a language that can be easily understood by the competent authorities of the Member State where the responsible person is established.
- Make the PIF accessible at a single address with the EU.
Contents of the Product Information File
The Product Information File must include the following details:
- A description of the cosmetic product enabling the PIF to be attributed to the product.
- Cosmetic product safety report.
- A description of the method of manufacturing.
- A statement on Good Manufacturing Practice compliance.
- If relevant, proof of the effect claimed for the product.
- Data on animal testing performed by the manufacturer or suppliers.
What is a Cosmetic Product Safety Report?
A Cosmetic Product Safety Report is a document required by the EU Regulation 1123/2009. This allows your company to legally sell cosmetic products in the EU market.
It has two sections: Part A and Part B, as specified by Regulation EU 1223/2009. This came into effect in July 2013 across the whole EU.
Part A: Safety Information
This consists of information about the foreseeable use of a cosmetic product. This may include:
- Product specifications
- Specifiche di imballaggio
- Product test results
Moreover, safety information covers:
- The product’s quantitative and qualitative compositions
- Microbiological quality
- The cosmetic product’s chemical/physical characteristics and stability
- The packaging material’s trace and impurities
- Normal and reasonably foreseeable use
- Exposure to the substances
- Exposure to the cosmetic product
- Toxicological profile of the substances
- Undesirable effects
Part B: Safety Assessment
Safety assessment is the most crucial part of the Product Information File. This guarantees compliance of the cosmetic product with the EU Cosmetics Regulation 1223/2009.
A qualified safety assessor conducts Part B based on the Safety Information. This part covers:
- Assessment conclusion whether the product is safe and confirms with the EU Cosmetics Regulation or not.
- Labeled warnings, precautions, and instructions of use.
- Assessor’s credentials and approval of part B.
Cosmetic Product Safety Assessor
Article 10 of the EU Cosmetics Regulation states requirements for the safety assessor qualifications.
Only a qualified safety assessor can conduct a safety assessment. He or she must have a university degree in pharmacy, toxicology, medicine or a similar discipline.
In some cases, the assessor must have taken a course recognized as equivalent by a Member State.