The Responsible Person: Role and Statutory Obligations

Every cosmetic product placed on the United Kingdom or European Union market must have a Responsible Person established within that territory. The role is defined by Article 4 of Regulation (EC) No 1223/2009 and carries the legal accountability for the product’s compliance. It is the point of contact for the enforcement authorities and the name that appears on the label.

Who must be the Responsible Person (Article 4)

The role falls on a defined party according to the supply chain. For a product manufactured within the territory, the manufacturer, or a person it designates by written mandate, is the Responsible Person. For an imported product, the importer is the Responsible Person for the product it places on the market, though it too may designate another established person by written mandate. A distributor becomes the Responsible Person where it places a product on the market under its own name or trademark, or modifies a product already on the market in a way that may affect compliance. Since Brexit, the UK and EU each require a Responsible Person established in their own territory, so a product sold in both needs one in Great Britain and one in the Union; Northern Ireland follows the EU regime.

The central obligation (Article 5)

Article 5(1) requires the Responsible Person to ensure compliance with the obligations set out in Articles 3, 8, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19(1), (2) and (5), 20, 21, 23 and 24. Each is a distinct duty:

• Safety (Article 3). The product must be safe for human health under normal and reasonably foreseeable conditions of use.
• Good Manufacturing Practice (Article 8). Manufacture must conform to GMP; compliance with the harmonised standard ISO 22716 confers a presumption of conformity.
• Safety assessment (Article 10). A Cosmetic Product Safety Report must be drawn up by a qualified assessor, per Annex I, before the product is placed on the market.
• Product Information File (Article 11). A PIF must be held, kept current and retained for ten years after the last batch.
• Sampling and analysis (Article 12). Where conducted, by reliable and reproducible methods.
• Notification (Article 13). The product must be notified before being placed on the market (the CPNP in the EU, the SCPN in Great Britain), stating the category and name, the Responsible Person, the presence of nanomaterials or substances classified as CMR, the frame formulation or other information enabling a poison-centre response, and the original labelling where reasonably legible.
• Restricted substances (Article 14). The product must comply with the Annexes: Annex II (prohibited substances), Annex III (restricted substances and their conditions), and the positive lists of Annex IV (colorants), Annex V (preservatives) and Annex VI (UV filters).
• CMR substances (Article 15). Substances classified as carcinogenic, mutagenic or toxic to reproduction (categories 1A, 1B and 2) are prohibited save for the narrow derogations the Article permits.
• Nanomaterials (Article 16). Nanomaterials must be notified to the Commission six months before being placed on the market, and labelled with “[nano]”.
• Traces of prohibited substances (Article 17). Permitted only where technically unavoidable under good manufacturing practice and where the product remains safe.
• Animal testing (Article 18). The testing and marketing bans apply; the safety of the product or its ingredients may not be established through animal testing conducted to meet the Regulation.
• Labelling (Article 19(1), (2) and (5)). The mandatory particulars, the provisions where the container cannot carry them, and the language requirements must be met.
• Claims (Article 20). Only claims meeting the common criteria of Commission Regulation (EU) No 655/2013 may be made.
• Public access to information (Article 21). The qualitative composition, the quantitative composition for substances of concern, and existing data on undesirable and serious undesirable effects must be made accessible to the public.
• Information on substances (Article 24). On a reasoned request from an authority, the Responsible Person must provide the list of substances and their quantities where there is serious doubt about a substance’s safety.

Cosmetovigilance (Article 23)

The Responsible Person must, without delay, notify the competent authority of serious undesirable effects: the effects, the information allowing the product to be identified, and the corrective measures taken. This is a continuing obligation that does not end at launch.

Duties when a product is not compliant (Articles 5(2) to (4) and 25)

Where the Responsible Person considers, or has reason to believe, that a product does not conform, it must immediately take the corrective measures necessary to bring it into conformity, withdraw it or recall it. Where the product presents a risk to human health, the Responsible Person must immediately inform the competent authorities of its own territory and of every other Member State where the product was made available. Article 25 lists the non-compliances an authority may require the Responsible Person to remedy within a stated period, spanning GMP, the safety assessment, the PIF, sampling, notification, the substance restrictions, labelling, claims, public access and cosmetovigilance; failure to remedy obliges withdrawal or recall.

Traceability (Article 7)

For three years from the date a batch was made available, the Responsible Person must be able to identify the distributors it supplied, and provide that information to authorities on request.

The UK position

Great Britain operates the assimilated UK Cosmetics Regulation, enforced by the Office for Product Safety and Standards, with notification through the SCPN. A UK Responsible Person must be established in Great Britain, and a single entity cannot serve both the UK and the EU; the two roles are separate. We act as Responsible Person in both jurisdictions under one quality management system. See our Responsible Person service and product notifications.