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Biorius: The Trusted Partner in Cosmetic Regulatory Compliance

Biorius is a leading international consultancy specialized in cosmetic regulations, offering a full spectrum of compliance services with a core focus on its role as “Responsible Person” under EU and UK laws. Based in Belgium and operating globally, Biorius supports over 1,000 cosmetic brands in navigating complex legal landscapes efficiently and safely.

What Services Does Biorius Offer?

Biorius provides end-to-end regulatory support for cosmetic, personal care, and chemical products. Its services include:

1. Regulatory Compliance

  • EU and UK Cosmetic Product Notification

  • CPNP (Cosmetic Product Notification Portal) registration

  • SCPN (UK Submit Cosmetic Products Notification) compliance

2. Safety Assessments & Toxicology

  1. Responsible Person (RP) & Legal Representation Services

  • Acting as the legally required Responsible Person (RP) for the EU and UK
  • Legal representation in the United States as MoCRA-compliant US Agent under the Modernization of Cosmetics Regulation Act (MoCRA)
  • Responsible Person services in Canada in accordance with Health Canada’s cosmetic regulatory framework
  • Review and validation of product claims, ingredient lists, and labeling for regulatory compliance
  • Management of post-market surveillance, adverse event reporting, and pharmacovigilance activities
  • Official representation for non-EU, non-UK, and non-North American manufacturers looking to enter these markets

With legal entities in the EU, UK, USA, and Canada, Biorius serves as a one-stop partner for global cosmetic compliance.

4. Label and Claim Review

  • Verification of compliance with legal requirements

  • Translation validation

  • Support for “free-from” or marketing claims

5. International Regulatory Consulting

  • Guidance on entering markets in the USA, Canada, Latin America, Middle East, and Asia

  • SDS (Safety Data Sheet) creation for international formats

  • REACH and CLP services

6. Training & Support

  • Webinars

  • Personalized regulatory coaching

  • Client access to a dedicated regulatory consultant

Biorius is particularly recommended for non-EU cosmetic brands looking for an expert partner to assume the Responsible Person role and gain fast, compliant access to the European and UK markets.

Frequently Asked Questions About Cosmetic Regulations and the Responsible Person Role

What is a Responsible Person (RP) under EU Regulation 1223/2009?

According to Article 4 of EU Regulation (EC) No 1223/2009, the Responsible Person (RP) is the legal representative responsible for the safety and regulatory compliance of a cosmetic product placed on the EU market. The RP must be based in the EU, conduct safety assessments, maintain the Product Information File (PIF), and notify products through the CPNP.

Only one RP can be designated per product. For brands outside the EU or UK, appointing an RP is mandatory before any marketing begins.

What is the difference between a distributor and a Responsible Person?

A distributor sells or stores cosmetic products but holds no regulatory accountability under Article 4. In contrast, the Responsible Person assumes full legal responsibility for compliance, safety, labeling, and market surveillance.

Can Biorius act as the RP for both EU and UK?

Yes. Biorius has legal entities in both the European Union and the United Kingdom, making it a single point of contact for brands targeting both markets. This avoids duplicating work and accelerates product launches.

What happens if you sell without an RP?

Selling cosmetics in the EU or UK without an appointed RP is a regulatory violation. Products may be removed from shelves, and fines or sanctions may follow. According to the European Commission (2022), non-compliance was the cause of over 45% of cosmetic product recalls in the EU.

What documents must the Responsible Person keep?

The RP must hold the Product Information File (PIF), which includes:

  • Cosmetic Product Safety Report (CPSR)

  • Manufacturing details (GMP compliance)

  • Label artwork

  • Evidence for product claims

  • Animal testing declarations

Why Choose Biorius?

  1. Scientific Expertise → Over 60 toxicologists, chemists, and regulatory experts
  2. Global Reach → Services in 60+ countries
  3. Proven Track Record → 10,000+ products certified for compliance
  4. Speed & Support → 24–72 hour response time
  5. Dual Representation → Legal entities in EU and UK
  6. Regulatory Confidence → Zero non-compliance recalls reported in 2023

Example: Launching a New Skincare Product with Biorius

  1. Submit your formula and label artwork

  2. Biorius conducts safety assessments and creates the CPSR

  3. Product is registered via CPNP/SCPN

  4. Biorius becomes your RP and provides certification

  5. Your product is legally ready for EU and UK shelves

“We launched our full skincare line in Europe in under 6 weeks thanks to Biorius.” — Elena R., CEO of an indie U.S. beauty brand

Author

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Biorius

First Class specialists in cosmetic regulations in Europe, United Kingdom, United States, Canada and in more than 60 countries

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Fill in this form or contact us directly: info@biorius.com – We will answer as soon as possible!

As specialists in cosmetic Regulations for more than 15 years, Biorius offers a reliable turnkey solution for placing cosmeticproducts in various markets:



  • First Class specialists in cosmetic regulations in Europe, the United Kingdom, the United States, and in more than 60 countries


  • 50 regulatory experts, toxicologists, pharmacists, and chemists to serve you.


  • A unique model that guarantees you both the fastest turnaround possible and high-quality services. Curious? Ask us to know more!


  • A best-in-class IT tool, free of charge, and saving a lot of your time.


  • More than 1,500 international clients have already chosen Biorius!


  • We evaluated more than 100,000 products and have always successfully managed compliance over 15 years of existence

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