Global Implications of Third-Party RPs
Using a Third-Party Responsible Person in the UK/EU — and What Happens When You Go Global
Expanding your cosmetic brand into new global markets is an exciting step, but it also introduces a range of regulatory challenges. One aspect that is often underestimated and frequently addressed too late, is how to manage the role of the Responsible Person (RP), particularly when your brand is using a third-party RP in the EU/UK.
In this article, we break down what brands need to know about third-party RPs when entering markets such as the US, Canada, and ASEAN.
Concept of EU/UK 3rd party RPs
Under the Cosmetics Regulation in both the UK (Schedule 34 of the Product Safety & Metrology etc (Amendment etc) (EU Exit) Regulations 2019) and the EU (Regulation EC No 1223/2009), each cosmetic product placed on the market must be associated to a RP within the UK/EU respectively. An RP is defined as a ‘legal or natural person’ (usually a business) and it is their responsibility to ensure product compliance with the Cosmetic Regulations.
A brand may choose to act as its own RP, or it may appoint a third-party RP to carry out this role. See our article for the pros and cons of choosing different RP strategies: https://www.bloomregulatory.com/articles/responsible-person-option-strategies.
Planning to Go Global? Key Questions If You Use a Third-Party RP
If your brand relies on a third-party RP in the EU or UK and you’re preparing to enter new markets, you should consider the following:
Do you need a local entity representation in the new market?
If a local entity is not required, are there specific RP-related obligations such as labelling or notification? Should you or your third-party RP fulfil these requirements?
Geographical scope of your RP agreement (i.e. UK and EU only)
Case Study: Entering the US market
(Canada follows a broadly similar structure)
The US is often the first non-EU/UK expansion point for cosmetic brands. Understanding the regulatory landscape is key.
Requirement under FD&C/ FPLA
The name and address of the manufacturer, packer, or distributor are required by the Food, Drug, and Cosmetic Act (FDC) and the Federal Fair Packaging and Labelling Act (FPLA). Therefore, they must appear on both the inner and outer containers of a cosmetic product.
If the name that appears on the label is not the name of the manufacturer, it should be qualified with a phrase such as “Distributed by,” “Manufactured for,” etc., which expresses the connection the named person has with the product.
Section 701.12(e) of the FDA regulations permits labelling of the principal place of business of the manufacturer, packer, or distributor, in lieu of the actual site of these activities. The regulation recognizes that many manufacturers, packers, and distributors may have a principal place of business other than the actual location where the manufacturing, packing, or distributing is performed.
Conclusion: A third party RP is not the manufacturer, packer or distributor and so inclusion of their address alone does not fulfil the obligations. The address of the manufacturer, distributor or packer must be included on the label.
Requirement under MoCRA
Cosmetics Direct Product Listing:
A responsible person must list each marketed cosmetic product with the FDA, including product ingredients, and provide any updates annually.
For MoCRA, Responsible person means the manufacturer, packer, or distributor of a cosmetic product whose name appears on the label of such cosmetic product in accordance with section 609(a) of the FD&C Act or section 4(a) of the Fair Packaging and Labeling Act.
Conclusion: The UK/EU third party RP is not eligible to be the US RP (they are not the manufacturer, distributor or packer) and so does not fulfil the labelling requirement of the FPLA. Therefore, the ‘manufacturer’ (i.e. brand owner) is obligated to list their products, or this may be performed by the US distributor or packer if these are relevant to the supply chain.
Additionally
Each cosmetic product shall bear a label that includes a domestic address, domestic phone number, or electronic contact information, which may include a website, through which the responsible person can receive adverse event reports with respect to such cosmetic product. The deadline for inclusion of this is 29 December 2024.
To summarise
To be compliant with both requirements (MoCRA + FPLA) you must either have
'Manufactured for/ Distributed by' US entity address within the supply chain (manufacturer, packer or distributor where the 'RP' can receive adverse event report)
'Manufactured for/ Distributed by' Non US entity (manufacturer, packer or distributor) PLUS a web address where the 'RP' can receive adverse event report
If you use a 3rd-party Responsible Person (RP) in the EU/UK and plan to sell your UK/EU packs in the US, you’ll need:
The name and address of your EU/UK RP for EU/UK compliance.
The name and address of the manufacturer, distributor, or packer on the packaging, preceded by “Manufactured for,” “Distributed by,” or “Packed by.”
Electronic contact information (e.g. website address) for reporting adverse events if all addresses are oversees.
Other international markets – ASEAN
ASEAN countries (e.g., Singapore, Malaysia, Vietnam) operate under the ASEAN Cosmetic Directive, which requires a local Responsible Person in each country.
This means:
Your UK/EU third-party RP cannot act as the RP in ASEAN markets.
You must appoint a local entity to take on the RP role.
Need further help?
It can be complex to streamline global compliance when using a third-party RP in the EU/UK. However, developing a thoughtful RP strategy from the outset you can save significant time and resources as you scale and ensure smoother market entry.
At Bloom, we specialise in helping brands navigate these regulatory challenges. If you have questions or would like support tailoring the right approach for your global expansion, our team is here to help.
Sayali Garud