Since Brexit took effect on January 1, 2021, cosmetic companies have faced new regulatory and compliance challenges when marketing their products in the United Kingdom (UK). While UK and European Union (EU) regulations share many foundational principles, there are key differences that must be understood before entering the UK market. This blog will explore both the similarities and differences between these regulatory frameworks, offering insights into the essential considerations for marketing cosmetic products in the UK.
Common Principles of UK and EU Cosmetic Regulations
The United Kingdom consists of Great Britain (England, Wales, and Scotland) and Northern Ireland. Cosmetic products introduced in Great Britain must comply with GB regulations, while those marketed in Northern Ireland must follow EU Regulation 1223/2009 as outlined in the Windsor Framework. Despite these distinctions, both regulatory frameworks share several common principles:
- Definition of a cosmetic product.
- Requirement for a Responsible Person.
- Performance of a safety assessment before placing the cosmetic product on the market.
- Manufacturing of the product under Good Manufacturing Practices (GMPs). Compliance is assumed if the product is manufactured following the International Standard Organisation (ISO) Guidelines on Good Manufacturing Practices ISO 22716.
- Maintaining a Product Information File (PIF) containing the product description, the Cosmetic Product Safety Report (CPSR), manufacturing methods in compliance with GMP, proof of the claimed effect(s) and data on animal testing for each cosmetic product marketed. The PIF must be kept by the RP and be available for inspection by health authorities.
- Appropriate labelling of the cosmetic products per Article 19 of the regulation.
- Using ingredients in the cosmetic product that are not banned in the regulation and not classified as carcinogenic, mutagenic or reprotoxic (CMR), unless specifically allowed.
- Compliance of the claims with the Commission Regulation (EU) No 655/2013 Common Criteria for Justification of Claims. The six common criteria involve legal compliance, truthfulness, evidential support, honesty, fairness and informed decision‐making.
- Notification of the cosmetic product to the authorities prior to introducing it on the market. Cosmetic products containing nano materials that are not already regulated must be notified six months before being placed on the market.
- Reporting any Serious Undesirable Effects (SUEs) to the corresponding authorities without delay. SUEs occurring in Great Britain or Northern Ireland must be reported to the UK authorities.
- Market surveillance.
Additional Requirements for Great Britain
Schedule 34 of the Product Safety and Metrology Statutory Instrument (referred to as “the GB Regulation” in this post), along with the Cosmetic Products Enforcement Regulations 2013 and subsequent amendments, govern the marketing of cosmetic products in Great Britain. When launching a cosmetic product in the Great Britain market, it is essential to consider the following key factors:
- Cosmetic products introduced in the Great Britain market must comply with the GB regulation exclusively.
- The Responsible Person must be in Great Britain.
- The labelling transitional provisions for Responsible Person information and, where applicable, importer information have been extended until 31 December 2027.
- The cosmetic product must be notified to the Office for Product Safety and Standards (OPSS) through the Submit Cosmetic Products Notifications (SCPN) portal.
- Products manufactured in Northern Ireland or the EU and shipped to Great Britain are considered imported products. As the country of origin must be displayed on the label, cosmetic products manufactured in Northern Ireland should display “Made in UK”. “Made in the EU” is not in compliance with the legislation.
- GB currently follows its own fragrance allergen labelling requirements, which may differ from the EU framework.
- The ingredients that are banned and restricted under the UK law.
- The GB Classification, Labelling and Packaging Regulation (CLP) and the list of substances contained in Annex II of the UK Regulation provide the list of substances classified as CMR that should not be used in the cosmetic product, unless specifically allowed.
- Labelling requirements are evolving under the Extended Producer Responsibility (EPR) framework, so companies should continue monitoring future recyclability and labelling obligations.
- Additional Requirements for Northern Ireland
Although UK authorities oversee and regulate cosmetic products marketed in Northern Ireland, these products must adhere to EU law. When introducing a cosmetic product to the Northern Ireland market, the following considerations are essential:
- Cosmetic products intended for the Northern Ireland market must comply with the EU regulation exclusively.
- The Responsible Person must be situated in the European Economic Area (EEA) or Northern Ireland.
- The cosmetic product must be notified to the European Commission (EC) through the Cosmetic Product Notification Portal (CPNP).
- For NI, EU fragrance allergen labelling updates apply under Regulation 2023/1545.
- There are banned and restricted ingredients under the EU law.
- The Classification, Labelling and Packaging Regulation (CLP) provides the list of substances classified as CMR, in addition to the list of substances contained in Annex II of the EU Regulation, unless specifically allowed.
- Cosmetic products manufactured in Great Britain and shipped to Northern Ireland are considered imported products. The product should be labelled as “Made in UK”.
- The incoming Packaging and Packaging Waste Regulation (PPWR), which introduces changes in the packaging design.
- The Packaging and Packaging Waste Regulation (PPWR), has now been adopted and will apply from August 2026. It introduces new requirements affecting packaging design, recyclability, labelling and producer responsibility.
Conclusion
In summary, while GB and EU regulations share many similarities, understanding their differences is crucial for ensuring compliance when marketing cosmetic products in Great Britain and Northern Ireland. Cosmetic companies intending to sell their products across the UK must appoint responsible persons in both Great Britain and Northern Ireland (or the EEA) to adhere to the relevant laws. Additionally, companies should be aware of regional variations in regulatory frameworks, including differences in restricted and banned ingredients, and ensure their products are registered on both the SCPN portal and the CPNP.
With offices in the UK and EU, Inter Regulatory can assist in all areas of regulatory compliance for products placed on the market across the UK and Europe. For more information contact: info@inter-regulatory.com