Introduction
Every cosmetic product sold in Great Britain or the European Union must have a designated Responsible Person a legal or natural person, established within that specific market, who is legally accountable for the product's ongoing compliance and safety. For brands manufacturing outside the UK or EU, appointing a Responsible Person in each relevant market is a precondition of market entry, not an optional add-on a product without a valid, correctly registered Responsible Person cannot lawfully be sold, notified, or, in practice, listed on most major online marketplaces.
Spectra acts as Responsible Person for cosmetic brands entering the UK, the EU, or both, taking on the full scope of duties this role carries under Regulation (EC) No 1223/2009 and, in the UK, its retained equivalent.
Who Can Be a Responsible Person?
Under the Regulation, the Responsible Person is either:
- A person established in the relevant market (UK or EU) designated by written mandate from a manufacturer based outside that market
- A distributor who places a cosmetic product on the market under their own name or trademark, or who modifies an already-marketed product in a way that could affect its compliance (for example, repackaging or relabelling)
- The importer, where there is no manufacturer or authorised representative established in the relevant market
For most overseas brands, this means appointing a UK-established RP for GB sales and a separate, EU-established RP for EU sales the two roles cannot be combined into a single non-UK, non-EU entity.
Responsible Person Duties We Carry Out
- Ensuring a safety assessment has been carried out and that a Cosmetic Product Safety Report has been produced for every product under our representation, in accordance with Annex I
- Maintaining the Product Information File (PIF) a comprehensive dossier including a description of the product, the CPSR, manufacturing method and good manufacturing practice (GMP) compliance evidence, proof of any claimed effects, and animal testing data (or confirmation none was conducted). The PIF is kept in English, at the address associated with the notification, and retained for 10 years after the last batch of the product is placed on the market
- Confirming the CPSR is complete, current and matches the finished formulation before market placement, and ensuring it's kept up to date as new information arises
- Completing product notification on the UK SCPN portal and/or EU CPNP portal ahead of market entry, and keeping that notification data accurate and current
- Post-market surveillance managing consumer complaints, monitoring for serious undesirable effects, reporting these to the relevant authority (the Secretary of State in the UK), and coordinating with enforcement bodies during inspections or incident reviews
- Acting as the named point of contact on your product labelling, providing the RP's name and address as required under the Regulation
Why Appointing an RP Is Mandatory
Regulation (EC) No 1223/2009 states that a cosmetic product may only be placed on the market where a Responsible Person is designated. In the UK, the equivalent obligation is enforced by OPSS under the retained legislation and the Cosmetic Products Enforcement Regulations 2013. Without a valid, correctly named RP, a product cannot legally be notified, cannot legally be sold, and because platforms such as Amazon independently verify RP details before accepting cosmetics listings is likely to have any marketplace storefront suspended until compliance is demonstrated.
What You Receive
- Confirmation of appointment as your UK and/or EU Responsible Person
- Secure retention of your PIF for the statutory 10-year period, held in English and accessible on request
- Ongoing post-market surveillance support, including handling of any adverse-event reporting
- Ongoing monitoring of regulatory changes ingredient restrictions, labelling rules and annex amendments relevant to your product category
Who Needs This Service
- Overseas manufacturers with no UK or EU establishment, for whom RP appointment is a precondition of market entry
- Brands expanding from one market into the other (UK-only brands entering the EU, or vice versa) who need a separate, correctly established RP for the new market
- Distributors or importers who fall into the RP role by default because there is no manufacturer-designated RP already established
- Brands whose existing RP arrangement has lapsed or needs replacing ahead of a product renewal
Process
- Formulation and documentation review we assess your product's finished formulation, CPSR (if one already exists) and label artwork.
- CPSR preparation, if needed where you don't yet have a compliant CPSR, we prepare one as part of the engagement.
- PIF compilation your complete Product Information File is built and structured to Annex I requirements.
- Ongoing representation ongoing PIF maintenance, post-market surveillance and regulatory monitoring continue for the duration of the engagement.
