PRODUCT INFORMATION FILE (PIF)
The product information file (PIF) as described in Article 11 of Regulation 1223/2009 is a major milestone in placing a legal cosmetic on the European and UK market. Its construction requires a significant understanding of the regulations and related toxicology of the product. The PIF contains the most important information about the finished product, ingredients, packaging, manufacturing process and product labelling, covering its safety and efficacy. The PIF for the product must be retained for a period of ten years following the date on which the last batch of the cosmetic product was placed on the market.
According to the Cosmetics Regulation, the responsible person must keep the PIF at the address specified on the product label, readily accessible (Electronic or other format) for the competent authority of the EU member state where the responsible person is established and in a language easily understood by the competent authority where the PIF is retained. The address must be only a single address within the EU even if the product is to be sold in different EU countries (One PIF even if sold in France, Spain and the UK).
According to Article 11 in addition to the CPSR the PIF must contain:
A specific description of the cosmetic product which enables the PIF to be clearly attributed to the cosmetic product; A description of the method of manufacturing and either a good manufacturing practice certificate or a statement on compliance with good manufacturing practice (the GMP standard which must be followed in the EU is standard ISO 22716)
Where justified, a proof of the effect claimed for the cosmetic product
Any data on animal testing performed by the manufacturer, agents or suppliers, relating to the development or safety assessment of the cosmetic product or its ingredients, including any animal testing performed to meet the legislative or regulatory requirements of third countries outside the EEA.
The product information file should also contain product labelling
The PIF must also include the “Physical and chemical characteristics of the substances or mixtures, as well as of the cosmetic product.” which is covered in the raw materials’ MSDS sheets.
Legal Cosmetics® can help construct you company and product specific PIF so that where requested all legal requirements are in place as Article 22 of the Cosmetic regulations require Member States to monitor compliance and where found wanting to implement sanctions.
WARNING: Please note the regulation is updated on average every 12 weeks and thus you PIF may become outdated. You must update your PIF to take into consideration any changes that impact the formation. This can also include labelling or ingredient sourcing, manufacture etc.