Selling cosmetics in the EU: CPNP notification and the responsible person

Regulation (EC) 1223/2009 is the single standard for the entire European Union: there is no prior health registry or product-by-product authorisation. Instead, the responsibility falls entirely on the company. Before introducing the product to the market, 4 blocks must be fulfilled: designated responsible person (article 4), safety assessment and product information file (articles 10 and 11), compliant labelling (article 19) and electronic notification on the CPNP portal (article 13).

The CPNP notification is unique for the whole EU: once the product is notified, you do not have to repeat the procedure in each country. However, notifying does not mean the authority has approved the product: the AEMPS and other authorities conduct market control retrospectively and can request the PIF, order corrections or withdraw the product.

In Spain, a specific requirement is added: anyone who manufactures cosmetics in national territory or imports them from outside the EU must first submit a responsible declaration of activities to the AEMPS under Real Decreto 85/2018 (the Royal Decree on cosmetics). Managora identifies which obligations apply to your specific case and processes them for you.

Only cosmetics that have an assigned responsible person, natural or legal, established in the Union can be sold in the EU. By default, this is the manufacturer established in the EU, or the importer when the product comes from a third country. Both can designate a third party established in the EU through a written mandate, which the designated party must also accept in writing. A distributor becomes a responsible person if they market the product under their own brand or modify it in a way that affects compliance.

The responsible person guarantees compliance with the entire Regulation: manufacturing according to good practices (article 8), prior safety assessment (article 10), custody of the PIF (article 11), composition within the annexes, labelling, CPNP notification and immediate communication of serious undesirable effects to the competent authority (article 23). Their name and address must appear on the product label.

If you manufacture outside the EU and want to sell here, you obligatorily need an importer or a designated responsible person in the Union. Managora advises you on the designation, drafts the mandate and leaves the distribution of obligations documented.

The PIF is the dossier that the responsible person must have available, at the address indicated on the label, for when the authority requires it. It contains the product description, the safety report, the manufacturing method and the declaration of conformity with good practices, proof of the claimed effect and data on animal testing. It must be kept for 10 years following the introduction of the last batch to the market.

The central piece is the safety report of annex I, with its part A (safety information: quantitative formula, specifications, stability, microbiological quality, impurities, exposure, toxicological profile) and its part B (the signed assessment). It can only be signed by an assessor with a university diploma in pharmacy, toxicology, medicine or a similar discipline; the AEMPS also admits other graduates with accredited toxicological training.

To prepare this report, real product data is needed: qualitative and quantitative formula, raw material data sheets and supporting tests (stability, compatibility with the packaging and, in susceptible products, a challenge test for preservatives). A generic certificate from the supplier does not replace the report. Managora coordinates the complete assembly of the PIF with a qualified assessor.

The CPNP (Cosmetic Products Notification Portal) is the European Commission portal where the responsible person notifies each product before introducing it to the market. The use of the portal is free: there is no tasa (official fee) to notify. It is accessed with an EU Login account and a responsible person profile.

The notification declares the category and name of the product, the responsible person and a contact person, the country of origin if imported, the Member State of first commercialisation, the presence of nanomaterials and CMR substances, the formula (usually through a predefined frame formula), the original labelling and a photograph of the packaging when reasonably legible.

Products containing nanomaterials also have a specific notification under article 16, in addition to that of article 13: it must be submitted 6 months before the product is introduced to the market (article 16.3). And the distributor who translates the labelling of a product already marketed in another EU country on their own must make their own distributor notification on the portal.

The AEMPS is the competent authority in Spain for the control of the cosmetics market: it can inspect, require the PIF, order the withdrawal of products and manages cosmetovigilance (serious undesirable effects are communicated to it).

Furthermore, Real Decreto 85/2018 obliges anyone who manufactures, conditions, packages or labels cosmetics in Spain and anyone who imports them from countries outside the EU to submit a responsible declaration of activities to the AEMPS before starting the activity. It is submitted electronically (COSMET2_DR application of the electronic headquarters) and accrues a tasa; if you declare both activities at the same time, manufacturing and importing, a single tasa is paid, the one with the highest amount (the manufacturing one). It requires having qualified personnel and adequate facilities in accordance with good manufacturing practices.

Anyone who only buys a product already marketed in another EU country is not an importer for these purposes and does not submit this declaration: they act as a distributor, with their own obligations (verifying labelling in Spanish, batch, responsible person on the label). Managora determines if your activity requires the responsible declaration and submits it for you.

The most frequent ones we detect: believing that the CPNP notification is a health approval (it is not: the responsibility remains yours); selling with a generic safety report from the Asian manufacturer, without specific product data or the signature of a qualified assessor; and trusting that the product "is already notified" by another company, when each responsible person must have their own notification and their own PIF.

In importing from Asia: introducing a product without a responsible person established in the EU or an address on the label, not submitting the responsible declaration of import to the AEMPS, and not checking the formula against the annexes of the Regulation, which change several times a year (retinol, kojic acid or the TPO in semi-permanent nail polishes are recent examples of restricted or prohibited substances).

In labelling: lack of mentions in Spanish, absence of a batch number or period after opening (PAO), an ingredient list that does not follow the INCI nomenclature and medicinal claims ("treats", "cures"), which take the product out of the cosmetic category. Managora reviews the formula and label before notifying, so that the product goes to market without open fronts.