UK Responsible Person (RP) for Cosmetics
This immediate requirement for an RP appointment, on 1 January, 2021, reveals that no grace period is foreseen for cosmetic products that are already in circulation on the UK market at the moment in which Brexit comes into full effect.
In the same vein as the EC Regulation 1223/2009 on cosmetics, so will the UK Draft Cosmetic Regulation provide an “RP by default” mechanism too, to ensure that, in theory, no cosmetic product on the UK market is left without an RP. This mechanism works on the basis of making the importer the entity responsible for the products that they introduce into a new market. In this case, the commercial entities that were distributors pre-Brexit will take on the role of importer post-Brexit, owing to the fact that GB will no longer be part of the European Single Market. Therefore, a commercial entity that was distributing products will shift one place up the supply chain overnight, become an importer and, consequently, the UK RP for the products they are distributing.
In practice, however, this mechanism involves a high degree of risk for non-UK manufacturers, who might find the representation representation of their products to be left to non-professional RPs with:
- Little to no knowledge of the new regulatory requirements in the UK;
- No knowhow of representation before the competent authorities;
- No awareness of their newfound role.
To avoid these risks, it is of paramount importance that all non-UK manufacturers of cosmetic products appoint a professional UK-based RP who can advise them on the regulatory compliance of their products, notify their products and handle all aspects of representation to the authorities. In order for Obelis UK to take on this role, manufacturers must:
- Sign an UK RP Agreement with Obelis UK;
- Ensure that they provide Obelis UK with a list of their UK distributors, so that Obelis UK can contact the distributors and make arrangements for the delegation of the RP by default role of the distributors to the professional RP (Obelis UK).
Following the appointment of a UK RP, those products that are already notified on EU CPNP portal and are circulating on the UK market will have to be notified to the new UK Cosmetic notification database, which can be seen as the CPNP’s counterpart for the UK market. Naturally, all new products to-be-placed on the UK market will also have to be notified to the new UK database.
By contrast to the immediate requirement for appointing a UK-based RP, the UK Draft Cosmetic Regulation foresees a grace period of 90 days for UK Notifications, starting from 1 January, 2021.
The new UK database and the EU’s CPNP will feature a download/reupload mechanism whereby information and documents can be swiftly transposed from the latter to the former. All UK RPs have a deadline on 31 December, 2020 to have downloaded, from the EU CPNP, everything that they intend to reupload to the new UK Cosmetic notification database.
By being both a UK and an EU RP, however, Obelis will maintain access to the CPNPafter this deadline and can assist you with the transposition of your products’ Notifications and accompanying documentation after 31 December, 2020. This is one of the added benefits of appointing Obelis UK as your UK-based professional RP, as we are in the unique position to represent your products in both markets as your one-stop-shop RP and regulatory consultant.
The new UK Cosmetic notification database will require the following information:
- Product’s name and category;
- Product’s formulation;
- The UK-based RP’s name and address (where the PIF will have to be made available) + name and contact details of a natural person representing the RP.
Ensuring that your products’ labelling is compliant with the relevant regulatory requirements is one of the most important steps that must be taken to ensure the products’ overall compliance. As the most obvious, and easily assessed, aspect of your products, non-compliant labelling can attract negative attention from consumers and authorities and give rise to further problems for your products, with far reaching consequences of both a legal and financial nature.
Timeline to comply with the UK Cosmetics Regulation
According to an update of September 2022, the original two-year grace period for the transition of labelling requirements has been extended to five years.
The UK Cosmetic Regulation foresees a five-year transition period for the labelling compliance of products that are placed on the UK market after January 1, 2021. This means that for five years after Brexit (until December 31, 2025), products can continue being placed on the UK market with labels that are compliant in the EU. Products which will have been placed on the UK market prior to January 1, 2021, and which will feature compliant labels under the EU regulation, can continue being sold on the UK market indefinitely.
Article 19 (1)(a) transitional arrangements states that, until December 31, 2025, name, address, and country of origin labelling requirements are met when they comply with the EU Cosmetics Regulation.
The majority of the labelling requirements and mandatory elements under the new UK Cosmetic law will be the same as those under the EU law. However:
· One of the new requirements under the UK Regulation will be that the country of origin must be stated on the label for all products manufactured outside of the UK, for ex. Made in EU is not compliant;
· Another element which is not new, as such, but will indirectly call for updated labels, is the requirement to include on the label (inner and outer) the UK-based RP’s details. Manufacturers will therefore have five years to start printing and putting into circulation product labels with the name and address of their newly appointed UK RP.
In order to update the label during the transition period and prepare towards December 31, 2020, companies that are selling on both markets may choose to label both the UK and the EU-27 RP addresses, highlighting the current RP address. The requirement to add and underline your UK RP to the label is applicable as of January 1, 2021, however, with a transition period of 5 years for an EU-compliant label that already has an EU RP affixed.
The EU Regulation on Cosmetics, and its Annexes, are constantly updated with regards to substances that are formally declared in the banned or restricted category. Moreover, substances are constantly assessed by scientific committees of the EU, which issue opinions that guide best practices and can be eventually formalised in the form of an above-mentioned ban or restriction. All such changes that occur in the EU, with regards to substances and their regulatory status, until 31 December, 2020 will be automatically implemented into the UK Regulation, too.
As of 1 January, 2021, however, the UK might restrict and ban substances on its own accord, and as it sees fit. At this stage, the only substances for which a uniformed approach shall be maintained between the EU and UK are CMRs.
Obelis, with branches in both the UK and EU can advise you on the formulation of your product in either market. As your professional RP, we will keep you informed on developments regarding ingredients that may affect the compliance of your products.
The compilation and review of a complete and up-to-standard PIF is the corner stone for the successful notification of a compliant product. The RP that is entrusted with this review must, therefore, have expertise on the regulatory requirements for cosmetic products in a given jurisdiction and be able to handle the authorities’ enquiries on the PIF, post-notification.
Under the draft UK Cosmetic Regulation, the requirements on the contents of a PIF remain the same as in the EU. The only difference is that the PIF must now be made available in the registered address of the UK RP of non-UK manufacturers. Moreover, there is the requirement that the PIF must be provided in English, but this does not disrupt Obelis and our clients in any way, as our working language for all services, including cosmetics, has always been English.
The Safety Assessor that will run the toxicological assessment of the product, on the basis of the PIF documentation, must have UK-recognised qualifications The UK will continue to accept EU qualification which are currently recognised as equivalent.
Lastly, the Safety Assessment Report (CPSR) that is to be issued must refer to the UK RP. This means that all products for which there currently is a valid CPSR for the EU, must also have another CPSR issued with the UK RP’s details to make it valid in the UK.
Based on the Ireland/Northern Ireland (NI) Protocol that will apply as of 1 January, 2021, EU Regulation on Cosmetics (1223/2009) will continue to apply in NI. Based on this, we can determine the following for the regulation of cosmetics in NI post-Brexit:
- Cosmetic products that will be placed on the NI market after 1 January, 2021 will have to comply with EC Regulation 1223/2009 on cosmetics;
- Cosmetic products that are manufactured in NI and shipped to the EU, or vice versa,are not considered as imported products;
- Cosmetic products which are manufactured in GB and shipped to NI, or vice versa,are to be considered as imported products;
- Cosmetic products placed on the NI market must have an EU RP;
- Cosmetic products placed on the NI market must be notified on the EU CPNP by the EU RP.
As a consequence of this arrangement, products can circulate freely on the island of Ireland, with the border being placed in the sea. Based on this, customs checks and tariffs will take place during the shipment of products from GB to the island of Ireland.
Regulatory Affairs Department
If you are intending to place your products on the UK market, or if you want to enter the EU market from the UK, contact us now and our expert consultants will guide you!