Responsible Person
An entity established within the EU (or UK for the GB market) who is legally responsible for ensuring a cosmetic product complies with the Cosmetics Regulation. The Responsible Person maintains the PIF, submits CPNP/SCPN notifications, and reports serious undesirable effects.
The Responsible Person (RP) is a key legal concept in the EU and UK cosmetics regulatory framework. Article 4 of EC 1223/2009 requires that every cosmetic product placed on the EU market has a designated Responsible Person who must be established (have a legal presence) within the EU.
The Responsible Person is determined by a hierarchy defined in the regulation: for products manufactured in the EU, the RP is the EU manufacturer; for imported products, the RP is the EU importer; for products where the manufacturer assigns responsibility, the RP is the mandated EU-based entity. In all cases, the RP can be designated by written mandate to a specific person or company established in the EU.
The Responsible Person's obligations include: ensuring the product complies with all requirements of the Cosmetics Regulation (safety, labeling, ingredient restrictions), maintaining the Product Information File (PIF) including the CPSR, submitting CPNP notifications before market placement, reporting serious undesirable effects to competent authorities, cooperating with national authorities during market surveillance, and taking corrective action (including recall) when a product does not conform.
Post-Brexit, the UK requires a separate UK Responsible Person for products placed on the Great Britain market. An EU RP is not valid for the UK and vice versa. Many third-party regulatory consulting firms offer Responsible Person services for brands that do not have their own EU or UK legal entity.
Related Terms
EU Cosmetics Regulation (EC 1223/2009)
The primary European Union law governing cosmetic products, establishing requirements for safety assessment, CPNP notification, responsible person designation, ingredient restrictions (Annexes II-VI), labeling, and post-market surveillance across all EU/EEA member states.
DocumentProduct Information File (PIF)
A mandatory dossier required under EC 1223/2009 (Article 11) that the Responsible Person must maintain for each cosmetic product on the EU market. It contains the CPSR, product description, manufacturing method, GMP evidence, and claims substantiation.
DocumentCosmetic Products Notification Portal (CPNP)
The European Commission's online portal where responsible persons must notify cosmetic products before placing them on the EU market, as required by Article 13 of EC 1223/2009. Notifications include product details, ingredient composition, and labeling information.
DocumentSubmit Cosmetic Product Notification (SCPN)
The UK government's online portal for notifying cosmetic products sold in Great Britain, managed by OPSS. It serves as the UK's post-Brexit equivalent of the EU's CPNP, requiring product and responsible person details before market placement.
DocumentCosmetic Product Safety Report (CPSR)
A two-part safety assessment document required within the PIF under EC 1223/2009 (Annex I). Part A compiles safety data for each ingredient; Part B is a qualified safety assessor's conclusion on whether the product is safe for human health.
RegulationUK Cosmetic Products Enforcement Regulations 2013
The UK domestic legislation (SI 2013/1478, as amended post-Brexit) governing cosmetic product safety, requiring SCPN notification, a UK Responsible Person, and compliance with product safety standards substantially mirroring the EU Cosmetics Regulation.
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