In This Article
- Every cosmetic product sold in the EU requires a designated EU Responsible Person by law.
- This role ensures compliance under Regulation (EC) No 1223/2009, including safety and labelling.
- Appointment processes must be formalised, with access to technical documentation ensured.
- UK brands must appoint a separate EU Responsible Person post-Brexit.
- Third-party RP providers offer expertise, risk mitigation, and multilingual regulatory support.
- Avoid common compliance failures with checks, trained personnel, and proper documentation archiving.
What is an EU Responsible Person?
Understanding the Legal Role
The term EU Responsible Person refers to a legal or natural individual within the European Union who ensures a cosmetic product’s full compliance with EU regulations before it reaches the market. This role is mandated under Regulation (EC) No 1223/2009 — a cornerstone of EU cosmetics legislation. Every cosmetic product must have one Responsible Person, and that person must be located within an EU Member State.
The EU Responsible Person acts as the primary liaison between cosmetic brands and EU regulatory authorities, such as the competent authorities of the Member States and the European Commission. Their role is pivotal: they assume legal responsibility for single or multiple cosmetic products placed on the EU market. This includes verifying safety, maintaining documentation, ensuring labelling conforms with requirements, and coordinating with authorities in case of complaints or product recalls.
Why is an EU Responsible Person Required in 2024?
Key Compliance Drivers
Effective from the implementation of Regulation (EC) No 1223/2009, the existence of an EU Responsible Person ensures that only safe and compliant cosmetic products are made available on the European Union market. In 2024, this requirement remains crucial as EU authorities continue to intensify inspection protocols and scrutinise the global supply chain. Companies importing or selling beauty and personal care items in the EU must therefore maintain an appointed EU Responsible Person or risk severe legal consequences, including penalties and market withdrawal.
With advancements in ingredient innovation, an expanding marketplace, and consumer demand for transparency, the EU has stepped up enforcement. As a result, having an EU Responsible Person is not simply a box to tick — it forms the foundation of sustainable market access. For non-EU companies, particularly from the UK or US, this role enables lawful participation in the single market post-Brexit.
“Appointing an EU Responsible Person is more than a regulatory obligation — it’s a strategic move to build consumer trust and avoid enforcement setbacks.”
Regulation (EC) No 1223/2009 Overview
Regulation (EC) No 1223/2009 serves as the fundamental legal framework governing cosmetic products within the EU. Enforced since 2013, it seeks to harmonise safety, labelling, and market surveillance standards across all EU Member States.
The regulation outlines several key provisions that directly involve the EU Responsible Person, including:
- Product Safety Assessments: Compulsory evaluation of cosmetic safety by a qualified safety assessor.
- Notification via the CPNP: Submission of comprehensive product information to the Cosmetic Products Notification Portal (CPNP) before market entry.
- Good Manufacturing Practice (GMP): Manufacturing must align with ISO 22716 to ensure hygienic and consistent product quality.
- Cosmetic Product Safety Report (CPSR): A central, two-part document proving a product’s compliance and safety.
- Responsible Labelling: Include required details such as INCI ingredients, warnings, and Responsible Person’s name and address on packaging.
Without adherence to these requirements, no cosmetic product is legally marketable in the EU, underscoring the importance of appointing a qualified EU Responsible Person.
Duties and Responsibilities of the Responsible Person
The responsibilities of the EU Responsible Person are vast and legally binding. They include verifying the safety and regulatory compliance of every product before EU distribution. Key responsibilities include:
1. Maintain the Product Information File (PIF)
This comprehensive file must include a detailed cosmetic product safety report (CPSR), evidence of product function, manufacturing methods, and supporting lab tests. It must be retained for at least ten years after the last batch has been released for sale.
2. Ensure CPNP Notification
Before placing on the market, the product must be properly notified to the Cosmetics Product Notification Portal (CPNP), which centralises information for EU regulatory bodies.
3. Label Approval
The Responsible Person must confirm that the packaging and labelling conform to Article 19 of the regulation, including the Responsible Person’s contact details, country of origin, and relevant warnings or allergens.
4. Vigilance and Compliance
They must respond to any serious undesirable effects (SUEs), manage product recalls, and promptly cooperate with national authorities upon request.
How to Appoint a Responsible Person for Your Brand
Selecting your EU Responsible Person requires careful diligence. A cosmetic brand may appoint itself, a distributor, a consultant, or a third-party compliance provider. The entity must be physically located within an EU country and possess sufficient expertise in cosmetic regulatory affairs.
Key steps in appointing an EU Responsible Person include:
- Identify a qualified individual or entity with demonstrable knowledge in Regulation (EC) No 1223/2009.
- Formalise the relationship through an EU Responsible Person Agreement covering roles, responsibilities, and liabilities.
- Ensure your Responsible Person has full access to technical documentation, lab results, and formulas.
Brands should formally publish the Responsible Person’s address on the product’s primary packaging. For external support, consider agencies offering turnkey Responsible Person services — many provide ongoing regulatory monitoring and multilingual support. Learn more about EU Cosmetics Compliance and Responsible Person Regulation
Required Documentation for Cosmetics Compliance
Documentation is the linchpin of any successful EU compliance strategy. Your EU Responsible Person must maintain accurate, audit-ready records ensuring transparency and traceability. Essential documents include:
- Cosmetic Product Safety Report (Parts A and B): Scientific justification and expert assessment of the product’s safety.
- Product Information File (PIF): Includes description, manufacturing methods (ISO 22716), claims substantiation, and safety assessments.
- CPNP Notification Confirmation: Evidence of successful product registration.
- Adverse Effects Reporting Log: Collates consumer complaints, undesirable effects, and corresponding corrective actions.
- Ingredient Certificate and Lab Testing Reports: Validate the formula composition and microbiological integrity.
These records must be instantly retrievable at the request of Member State authorities. Non-compliance in document management could result in product bans, heavy fines, or both.
Checklist for 2024 EU Cosmetics Compliance
- ✅ Appoint a legally established EU Responsible Person
- ✅ Complete and archive a full Product Information File (PIF)
- ✅ Draft a compliant Cosmetic Product Safety Report (CPSR)
- ✅ Notify the product to the CPNP portal
- ✅ Apply correct product labelling under Article 19
- ✅ Adhere to ISO 22716 GMP guidelines during production
- ✅ Monitor and report serious undesirable effects (SUEs)
- ✅ Comply with national poison centre requirements (Annex VIII to CLP)
This robust checklist helps ensure that no compliance detail is overlooked throughout the product lifecycle.
Post-Brexit Considerations for UK Brands
Since the UK’s exit from the European Union, cosmetic companies based in the UK can no longer act as the EU Responsible Person for products entering the EU market. Consequently, UK brands must designate an EU-based entity to serve this function. Failure to appoint an EU Responsible Person will result in blocked imports or product delisting within the EU bloc.
In parallel, UK firms must also observe separate UK Cosmetics Regulation compliance, which introduces the concept of a UK Responsible Person. These two roles — for EU and UK markets — must now be filled independently, although some agencies offer dual representation. Read a related article
Common Compliance Mistakes and How to Avoid Them
Common pitfalls around EU cosmetics compliance can place your brand at serious risk. Mistakes we frequently observe among cosmetic enterprises include:
- ❌ Improper or missing PIF components
- ❌ Inaccurate or incomplete CPNP notifications
- ❌ Non-GMP-compliant production facilities
- ❌ Labelling in languages not appropriate for the marketing country
- ❌ Failure to log and report undesirable effects promptly
These errors can be mitigated through proper staff training, engaging with qualified compliance consultants, and conducting periodic internal audits.
Benefits of Using a Third-Party Responsible Person
Entrusting a knowledgeable third-party organisation as your EU Responsible Person can offer multiple advantages:
- ✔️ Expertise in dealing with ever-evolving EU regulations
- ✔️ Fast-track access to regulatory portals like CPNP
- ✔️ Objective third-party audit of safety documentation
- ✔️ Capability to manage communications with inspectors and health authorities
- ✔️ Multilingual legal support for multilingual labelling and packaging review
Furthermore, third-party EU Responsible Persons typically provide annual compliance reviews, helping your brand stay ahead of changes in labelling rules, forbidden ingredients, or packaging disclosures. Official EU cosmetic product regulations
EU Country-Specific Considerations and Fees
While the regulation is harmonised across the EU, individual Member States may impose local nuances. For example, specific requirements exist for Portugal, France, and Italy with regard to notification languages or additional packaging guidelines.
Fees charged by third-party EU Responsible Persons vary depending on product volume, service scope, and consultation hours. On average, annual fees range between €1,500 to €5,000 per product line. Additional costs may apply for document translation, SDS authoring, or ingredient testing. Conducting market-specific due diligence prevents delays and escalated compliance costs. Mastering seamless EU business compliance
Conclusion: Achieve Compliance with Confidence
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Great guide on eu-responsible-person-cosmetics-2024-requirements – Community Feedback
Who can act as an EU Responsible Person for cosmetics in 2024?
Any legal or natural person based in the EU who has accepted written responsibility can act as an EU Responsible Person, including companies, agents or third-party service providers.
What are the main responsibilities of the EU Responsible Person?
The Responsible Person ensures cosmetic products comply with Regulation (EC) No 1223/2009, including documentation, safety assessments, labelling, and acting as contact for authorities.
Are there penalties for failing to appoint a Responsible Person?
Yes. Products without an appointed Responsible Person cannot be legally sold in the EU, and authorities may impose fines, ban sales, or recall products if requirements are not met.
