Cosmetic product documentation - what you need before entering the EU market

Regulation (EC) No 1223/2009 of the European Parliament and of the Council requires every person or company placing a cosmetic on the market in the European Union to hold a complete Product Information File (PIF) before the product is first made available to consumers. The PIF is a set of documents confirming safety, composition and regulatory compliance - missing or incomplete documentation risks the product being withdrawn from the market and administrative sanctions. The PIF is the responsibility of the Responsible Person (RP) - an entity established in the EU that is legally liable for every cosmetic placed on the Community market.

It's worth noting that the PIF must be kept up to date throughout the product's life cycle and for three years after its last sale. This means documentation isn't a one-off obligation but an ongoing product management requirement. Below we outline the elements that make up a properly compiled PIF.

Elements of the Product Information File (PIF)

1. Cosmetic product description - the full INCI composition with the function of each ingredient, the product's intended use, target groups (including whether the product is intended for children under 3), conditions of use and warnings. The INCI composition must be listed in descending order of concentration down to 1%; below 1%, ingredients may be listed in any order.
2. Safety assessment (Cosmetic Product Safety Report - CPSR) - a document prepared exclusively by a qualified Safety Assessor holding an appropriate qualification (pharmacy, toxicology, dermatology or a related field). The CPSR consists of two parts: an assessment of ingredient safety and an assessment of the finished product's safety. Without a signed CPSR, a product cannot be placed on the market.
3. Description of the manufacturing method - a description of the production process confirming compliance with Good Manufacturing Practice (GMP), i.e. the ISO 22716:2007 standard. For production at MG Evolution, we provide manufacturing documentation (batch records) ready to be included in the client's PIF.
4. Proof of claimed effect - if a product carries a performance claim (e.g. "reduces wrinkles by 30%", "hydrates for 24 hours"), it must be backed by reliable evidence - instrumental, consumer or clinical testing. Unsubstantiated claims are one of the most common reasons for regulatory scrutiny of cosmetics.
5. Animal testing data - a declaration of compliance with the EU ban on animal testing of cosmetics and their ingredients, in force since 2013. For ingredients tested on animals outside the EU before the cut-off date, a relevant statement must be attached.
6. Ingredient toxicological data - a compilation of toxicological data for every ingredient in the formula, including NOAEL values, safety profiles and toxicological study results in line with current SCCS (Scientific Committee on Consumer Safety) guidelines. This data is the basis on which the Safety Assessor issues their opinion.

CPNP - mandatory notification before market entry

The Cosmetic Products Notification Portal (CPNP) is a European Commission platform through which the Responsible Person must notify every cosmetic before it's placed on the EU market. The notification covers, among other things, the product category, INCI composition, country of manufacture and the Responsible Person's details. The portal makes this information available to market surveillance authorities and poison control centers in the member states.

Only an entity established in the EU acting as the Responsible Person can submit a CPNP notification. Brands based outside the EU (e.g. in the US, Australia or Japan) must appoint an RP established in one of the member states - without this, selling within the Union is not possible. It's worth remembering that after Brexit, the CPNP no longer covers the UK - a separate SCPN notification system applies there.

How MG Evolution supports clients with documentation

As part of our production cooperation, we support clients at every stage of compiling PIF documentation. We provide full manufacturing documentation (batch records), raw material Certificates of Analysis (CoA), product specifications and a description of the production process compliant with ISO 22716. We can point you to proven Safety Assessors and coordinate the safety assessment process. For clients who don't yet have a Responsible Person established in the EU, we can recommend suitable entities that provide this service - so your brand can enter the European market without unnecessary regulatory delays.