Post-Brexit Cosmetic Labelling Errors Continue to Create Enforcement Risks

Introduction

The United Kingdom’s withdrawal from the European Union on 31 January 2020, followed by the end of the transition period on 31 December 2020, created a bifurcated regulatory landscape for cosmetic products that persisted throughout 2021 and beyond [1]. Despite substantial alignment between the UK Cosmetics Regulation (implemented via Schedule 34 of the Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019) and EU Regulation (EC) No 1223/2009, critical differences in labelling requirements, responsible person designation, and notification procedures generated widespread non-compliance [2]. By September 2021, enforcement authorities in both jurisdictions reported persistent labelling errors, particularly regarding responsible person identification, address requirements, and product information file (PIF) accessibility [3].

These compliance failures created significant enforcement risks under Article 25 of Regulation (EC) No 1223/2009 (for EU-marketed products) and corresponding UK provisions, which empower market surveillance authorities to prohibit or restrict the making available on the market of non-compliant products [4]. The Office for Product Safety and Standards (OPSS) in the UK and national competent authorities across EU Member States intensified surveillance activities, with particular focus on online sales channels where labelling errors were most prevalent [5]. For businesses operating in both markets, the administrative burden of maintaining dual compliance systems, coupled with supply chain complexity and artwork management challenges, necessitated systematic review of labelling processes and quality control procedures [6].

Regulatory Framework and Legal Analysis

Article 19 of Regulation (EC) No 1223/2009 establishes comprehensive labelling requirements for cosmetic products, mandating that containers and packaging display specific information in indelible, easily legible, and visible lettering [7]. Key requirements include: (a) the name and address of the Responsible Person; (b) the nominal content at the time of packaging; (c) the date of minimum durability or period after opening (PAO); (d) precautions for use; (e) the batch number or reference for product identification; (f) the function of the product; and (g) a list of ingredients in descending order of weight [8]. Article 19(1)(a) specifically requires that the Responsible Person’s name and address be indicated on the container and packaging, enabling consumers and authorities to identify the entity accountable for product compliance [9].

The UK Cosmetics Regulation retained these core requirements but introduced critical modifications reflecting the UK’s status as a third country relative to the EU [10]. Most significantly, products placed on the UK market must identify a UK Responsible Person—an entity established in the United Kingdom—rather than an EU-established Responsible Person [11]. Conversely, products placed on the EU market after 1 January 2021 must identify an EU-established Responsible Person, as UK entities no longer satisfy the establishment requirement under Article 4 of Regulation (EC) No 1223/2009 [12]. This divergence created immediate compliance challenges for businesses that had historically used a single Responsible Person for both markets [13].

Article 4 of Regulation (EC) No 1223/2009 defines the Responsible Person as a natural or legal person who ensures compliance with the regulation’s obligations, and Article 4(1) specifies that this person must be established within the European Union [14]. The Responsible Person’s obligations under Article 4(2) include ensuring product safety, compiling the PIF, conducting post-market surveillance, and reporting serious undesirable effects under Article 23 [15]. The requirement for EU establishment ensures that enforcement authorities can exercise jurisdiction and compel production of documentation under Article 21 (access to information) and Article 22 (sampling and analysis) [16].

In the UK, the OPSS published guidance clarifying that the UK Responsible Person must be established in the United Kingdom (England, Scotland, Wales, or Northern Ireland) and must maintain the PIF at a UK address accessible to enforcement authorities [17]. The UK also implemented the Submit Cosmetic Product Notifications (SCPN) portal, replacing the EU’s Cosmetic Products Notification Portal (CPNP) for products placed on the UK market [18]. Article 13 notification requirements apply in both jurisdictions, but separate notifications must be submitted to CPNP (for EU) and SCPN (for UK), with distinct Responsible Person details for each market [19].

Labelling errors observed during 2021 fell into several categories. First, many products continued to display only an EU Responsible Person address when placed on the UK market, violating UK labelling requirements [20]. Second, some businesses attempted to use dual labelling (listing both UK and EU Responsible Persons), which, while not explicitly prohibited, created confusion regarding accountability and PIF accessibility [21]. Third, online sales platforms frequently displayed product images showing outdated labelling, even when physical products had been updated, creating discrepancies between advertised and delivered products [22]. Fourth, Northern Ireland presented unique complexity due to the Northern Ireland Protocol, which maintained alignment with EU cosmetic regulations for goods placed on the Northern Ireland market, requiring EU Responsible Person designation for those products [23].

Toxicological and Safety Science Considerations

From a toxicological perspective, post-Brexit labelling errors do not directly implicate ingredient safety or alter the hazard profile of cosmetic products [24]. The safety assessment requirements under Article 10 of Regulation (EC) No 1223/2009 and corresponding UK provisions remain substantively identical, requiring evaluation of toxicological endpoints including acute toxicity, irritation, corrosivity, skin sensitization, dermal absorption, repeated-dose toxicity, mutagenicity, carcinogenicity, reproductive toxicity, and photo-induced toxicity [25]. The SCCS Notes of Guidance (10th Revision, SCCS/1602/18) provide the methodological framework for safety assessment in both jurisdictions, and the UK continues to reference SCCS opinions as authoritative scientific guidance [26].

However, labelling errors can indirectly compromise consumer safety by obscuring traceability and impeding post-market surveillance. Article 23 of Regulation (EC) No 1223/2009 requires Responsible Persons to report serious undesirable effects (SUEs) to the competent authority of the Member State where the effect occurred [27]. A serious undesirable effect is defined as an adverse reaction resulting in temporary or permanent functional incapacity, disability, hospitalization, congenital anomalies, or immediate vital risk, or which results in death [28]. Accurate Responsible Person identification on labelling enables healthcare professionals and consumers to report SUEs to the correct entity, facilitating investigation and, where necessary, implementation of corrective actions under Article 25 [29].

The SCCS Notes of Guidance emphasize that post-market surveillance data, including SUE reports and consumer complaints, constitute an essential component of ongoing safety assessment [30]. Part B of the CPSR must include a conclusion on product safety that considers “the foreseeable exposure to individual ingredients in the final formulation” and “the foreseeable exposure of the product” [31]. When labelling errors prevent accurate identification of the Responsible Person, the feedback loop between market experience and safety assessment is disrupted, potentially delaying detection of emerging safety signals [32].

Additionally, incorrect Responsible Person information may impede enforcement authorities’ ability to request documentation under Article 21, which grants competent authorities the right to require the Responsible Person to make available relevant documentation and information demonstrating compliance [33]. Article 22 empowers authorities to conduct sampling and analysis, and Article 22(2) requires that the Responsible Person or distributor provide information necessary to identify the product and its origin [34]. Labelling errors that misidentify the Responsible Person or provide inaccessible addresses frustrate these enforcement mechanisms, potentially allowing non-compliant or unsafe products to remain on the market [35].

Practical Compliance Guidance

For businesses operating in both UK and EU markets, systematic labelling compliance requires a multi-layered approach addressing artwork management, supply chain coordination, and quality assurance. First, companies must designate separate Responsible Persons for each market: a UK-established entity for products placed on the UK market (excluding Northern Ireland for goods moving from Northern Ireland to the EU) and an EU-established entity for products placed on the EU market (including Northern Ireland under the Protocol) [36]. These Responsible Persons must maintain separate PIFs at accessible addresses in their respective jurisdictions, as Article 11 requires that the PIF be readily accessible at the address indicated on the labelling [37].

Second, artwork management systems must accommodate market-specific labelling variants. Article 19 requires that labelling information appear on both the container and outer packaging, and businesses must ensure that each market receives appropriately labelled stock [38]. For products manufactured in a single facility and distributed to multiple markets, this may require late-stage customization such as market-specific stickers or sleeves, though Article 19(1) permits certain information to appear on packaging alone if container size precludes inclusion [39]. Quality control procedures should include verification that labelling matches the intended market destination and that online product listings display current, market-appropriate images [40].

Third, CPNP and SCPN notifications must be submitted with correct Responsible Person details for each market. Article 13(1) requires notification before a product is placed on the market, and Article 13(2) specifies that the notification must include the Responsible Person’s name and address [41]. Businesses should implement notification management systems that track submission status in both portals and flag products requiring updated notifications following Responsible Person changes or reformulations [42]. The OPSS has emphasized that failure to notify via SCPN constitutes a violation of UK cosmetic regulations, potentially resulting in enforcement action even if the product is compliant in all other respects [43].

Fourth, distributors must fulfill their obligations under Article 5, which requires verification that products bear the required labelling and that the Responsible Person has fulfilled applicable obligations [44]. Distributors who identify non-compliant labelling must inform the Responsible Person and, if the non-compliance persists, inform the competent authority [45]. For online marketplaces, this creates particular challenges, as Article 5(3) deems a distributor to be a Responsible Person if they place a product on the market under their own name or trademark, or modify a product in a way that may affect compliance [46]. Marketplace operators should implement seller verification procedures and listing review protocols to identify and remove non-compliant products [47].

Fifth, businesses should conduct periodic compliance audits covering both physical products and online listings. Article 25 empowers authorities to require withdrawal or recall of non-compliant products, and Article 25(2) permits authorities to prohibit or restrict making available on the market products that present a serious risk [48]. Proactive identification and correction of labelling errors reduces enforcement risk and demonstrates good faith compliance efforts that may mitigate penalties [49]. The UK OPSS and EU AdCo group increasingly share information regarding non-compliant products, and enforcement action in one jurisdiction may trigger scrutiny in the other [50].

Conclusion

Post-Brexit cosmetic labelling errors during 2021 highlighted the operational complexity of navigating bifurcated regulatory systems that remain substantively aligned yet diverge on critical administrative requirements. While labelling errors do not directly alter product safety profiles, they compromise traceability, impede post-market surveillance, and frustrate enforcement mechanisms essential to the regulatory framework established by Regulation (EC) No 1223/2009 and its UK equivalent. Responsible Persons and distributors must implement robust artwork management, notification tracking, and quality assurance systems to ensure market-specific compliance. As regulatory divergence between the UK and EU continues to evolve, businesses should anticipate further differentiation in requirements and maintain flexible compliance infrastructure capable of accommodating jurisdiction-specific obligations while preserving operational efficiency across both markets.

[1] UK Government. (2019). The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019. SI 2019/696.

[2] UK Government. (2019). The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019. SI 2019/696.

[3] Office for Product Safety and Standards. (2021). Guidance on cosmetic product safety and compliance. UK Government.

[4] Regulation (EC) No 1223/2009, Article 25.

[5] Office for Product Safety and Standards. (2021). Guidance on cosmetic product safety and compliance. UK Government.

[6] Office for Product Safety and Standards. (2021). Guidance on cosmetic product safety and compliance. UK Government.

[7] Regulation (EC) No 1223/2009, Article 19.

[8] Regulation (EC) No 1223/2009, Article 19(1).

[9] Regulation (EC) No 1223/2009, Article 19(1)(a).

[10] UK Government. (2019). The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019. SI 2019/696.

[11] UK Government. (2019). The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019. SI 2019/696.

[12] Regulation (EC) No 1223/2009, Article 4(1).

[13] Office for Product Safety and Standards. (2021). Guidance on cosmetic product safety and compliance. UK Government.

[14] Regulation (EC) No 1223/2009, Article 4.

[15] Regulation (EC) No 1223/2009, Article 4(2).

[16] Regulation (EC) No 1223/2009, Articles 21 and 22.

[17] Office for Product Safety and Standards. (2021). Guidance on cosmetic product safety and compliance. UK Government.

[18] Office for Product Safety and Standards. (2021). Submit Cosmetic Product Notifications (SCPN) portal guidance. UK Government.

[19] Regulation (EC) No 1223/2009, Article 13.

[20] Office for Product Safety and Standards. (2021). Guidance on cosmetic product safety and compliance. UK Government.

[21] Office for Product Safety and Standards. (2021). Guidance on cosmetic product safety and compliance. UK Government.

[22] Office for Product Safety and Standards. (2021). Guidance on cosmetic product safety and compliance. UK Government.

[23] UK Government. (2020). Protocol on Ireland/Northern Ireland. UK-EU Withdrawal Agreement.

[24] Scientific Committee on Consumer Safety. (2018). SCCS Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation, 10th revision. SCCS/1602/18.

[25] Scientific Committee on Consumer Safety. (2018). SCCS Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation, 10th revision. SCCS/1602/18.

[26] Scientific Committee on Consumer Safety. (2018). SCCS Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation, 10th revision. SCCS/1602/18.

[27] Regulation (EC) No 1223/2009, Article 23.

[28] Regulation (EC) No 1223/2009, Article 2(1)(p).

[29] Regulation (EC) No 1223/2009, Article 25.

[30] Scientific Committee on Consumer Safety. (2018). SCCS Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation, 10th revision. SCCS/1602/18.

[31] Scientific Committee on Consumer Safety. (2018). SCCS Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation, 10th revision. SCCS/1602/18.

[32] Regulation (EC) No 1223/2009, Article 23.

[33] Regulation (EC) No 1223/2009, Article 21.

[34] Regulation (EC) No 1223/2009, Article 22.

[35] Regulation (EC) No 1223/2009, Article 25.

[36] Office for Product Safety and Standards. (2021). Guidance on cosmetic product safety and compliance. UK Government.

[37] Regulation (EC) No 1223/2009, Article 11.

[38] Regulation (EC) No 1223/2009, Article 19.

[39] Regulation (EC) No 1223/2009, Article 19(1).

[40] Office for Product Safety and Standards. (2021). Guidance on cosmetic product safety and compliance. UK Government.

[41] Regulation (EC) No 1223/2009, Article 13.

[42] Office for Product Safety and Standards. (2021). Submit Cosmetic Product Notifications (SCPN) portal guidance. UK Government.

[43] Office for Product Safety and Standards. (2021). Guidance on cosmetic product safety and compliance. UK Government.

[44] Regulation (EC) No 1223/2009, Article 5.

[45] Regulation (EC) No 1223/2009, Article 5(2).

[46] Regulation (EC) No 1223/2009, Article 5(3).

[47] Office for Product Safety and Standards. (2021). Guidance on cosmetic product safety and compliance. UK Government.

[48] Regulation (EC) No 1223/2009, Article 25.

[49] Office for Product Safety and Standards. (2021). Guidance on cosmetic product safety and compliance. UK Government.

[50] Office for Product Safety and Standards. (2021). Guidance on cosmetic product safety and compliance. UK Government.