Cosmetic regulations

Your Cosmetic Regulations Expert

We have been helping thousands of clients to sell cosmetic products quickly and safely in the EU, UK, the US (and in more than 60 countries) by delivering best-in-class regulatory, toxicology and certification services

  • 15+

    Years of Expertise
  • DEDICATED

    Relationship MANAGERS
  • 50,000+

    Compliant Products
  • 50+

    in-house Regulatory & Scientific Experts
  • IT PLATFORM

    Confidentiality & Protection of Your Data

EU & UK
Cosmetic regulations

Biorius provides a fast and reliable solution that go from A to Z for brands, manufacturers and importers to comply with the European Cosmetic Regulations (EC No 1223/2009) and the British Cosmetics Products Enforcement Regulations 2013 (UK CR).

OUR EU/UK COMPLIANCE SERVICES

  • Formula Review
  • CPSR Part A&B

    (Safety Assessment)

  • Label And Claims Review
  • PIF Preparation

    (Product InformationFile)

  • CPNP & SCPN Notifications
Legal Representation

EU & UK
Legal Representation

The Responsible Person (RP) is in charge of ensuring that cosmetic products marketed in the EU/UK comply with applicable regulations on an ongoing basis and acts as point of contact with local authorities during inspections, and with consumers in case of issues.

Many of the world’s leading brands have chosen to rely on Biorius for this role, both within the EU and UK.

  • Represents & defends your brand to the local authorities
  • Assists your cosmetic brand with any legal question
  • Manages customer complaints if and when they arise
  • Regulatory monitoring of ongoing compliance your products
  • Manages any undesirable effects from your products
  • Ensures your Product Information File is up to date
USA (MoCRA) & California Cosmetic Regulations

USA (MoCRA) & California
Cosmetic Regulations

To sell in the US, you must consider the Federal cosmetics legislation that applies equally to all States, as well as the State provisions that are usually specific. It is a common mistake to forget this second responsibility.

Specifically regarding the MoCRA: we can cover all your needs from the formula review to the legal representation (US Agent), and we can guarantee that you will comply with the legal deadline of December 29th, 2023.

OUR US COMPLIANCE SERVICES

  • Formula Review
    US Federal Legislation
    (MoCRA & existing regulations)

  • Label and claims review
    US Federal Legislation
    (MoCRA & existing regulations)

  • Report for Adequate Safety Substantiation
    US Federal Legislation (MoCRA)

  • Cosmetic Products Listing
    US Federal Legislation (MoCRA)

  • States Provisions
    Formula Review + Label and Claims Review in all States

  • Legal Representation of your products in the USA
    (US Agent)

US Agent

With 15 years of experience as a cosmetics regulatory expert, Biorius can assist your brand in selling products in the US while reducing business risks. We offer a comprehensive service package related to MoCRA, including acting as the US Agent through our legal entity, Biorius Inc.

Worldwide Cosmetic Regulations

With Biorius, your global business success is supported by international legislation experts. We offer registration solutions for access to more than 60 highly promising markets.

  • USA

  • CANADA

  • AUSTRALIA

  • JAPAN

  • SOUTH KOREA

  • CHINA

Our Cosmetic Certifications

Our certifications are well recognized in the cosmetics industry, valid worldwide and do not have to be renewed.  They have been developed by our team of scientists, toxicologists and regulatory experts.

Our logos can be added to your website and packaging labels to boost your marketing and inform consumers with honesty and transparency.

Natural and Organic
Certifications
Vegan
Certification
Clean
Certification
Gluten-Free & Soy-Free
Certifications
Gmo-Free
Certification

Natural and Organic
Certifications

Since the late 2000s, following a series of reports on the alleged dangers of cosmetics, consumers have shown renewed interest in products of natural and organic origin. Biorius developed Natural and Organic Certifications therefore.

In 2016 alone, the global market for organic and natural cosmetics accounted for more than 11 billion euros; roughly 5.5% of the cosmetics market, with this figure expected to double by 2024.

Vegan
Certification

Vegan certification highlights the importance your cosmetic brand places on animal well-being and allows you to share a wider message with your consumers regarding your brand’s ethics and values.

Among other elements, a vegan-certified cosmetic product is defined as containing no animal ingredients or by-products, using no animal ingredients or by-products in the manufacturing process and no testing on animals by any company or independent contractor.

As a reminder, European Cosmetics Regulation EC No 1223/2009 banned animal testing on cosmetic products in 2004 and on cosmetic ingredients in 2009 and 2013 (Article 18).

Clean
Certification

The BIORIUS ‘Clean’ certification is based on a modern, benevolent and positive worldview aimed at protecting the planet and its people. BIORIUS’ DNA ensures a certification that is scientifically robust and fully compliant with all relevant regulatory requirements.

Gluten-Free & Soy-Free
Certifications

‘Gluten-Free’ or ‘Soy-Free’ marketing communications include labels on cosmetics, as they highlight necessary information for specific groups of consumers. This certification helps people who are gluten/soy intolerant or have coeliac disease make well-informed decisions when selecting a cosmetic product.

BIORIUS’ ‘Gluten-Free’ certification is a trustworthy designation issued by independent third-party experts, ensuring that the product does not contain any wheat, rye, oats, barley or any other form of gluten, while BIORIUS’ “Soy-Free” certification ensures that no soy exists in the final product.

Gmo-Free
Certification

Plant-based cosmetic ingredients and food-based ingredients are common in the cosmetics industry. However, in a world where a great deal of importance is placed on health and nature, it can be beneficial for a brand to highlight its non-GMO certified products. GMO-Free certification will help you stand out from your competitors.

Why Biorius?

For over 15 years, BIORIUS has been an
essential partner for
numerous cosmetic
brands, aiding in ingredient evaluation
and guaranteeing regulatory
compliance
for their final products.

Our accomplished team, proficient in
regulatory and toxicological expertise,
guides cosmetics companies through
the diverse challenges encountered while
launching products into the market.

1500+

Cosmetic Brands Trust Biorius

What Do Our Customers Think About Us?

Crystal McElroy

VP International Affairs, Clinical Skin

Navigating the regulatory landscape for skincare products in the EU and UK markets can be incredibly complex and daunting. However, partnering with Biorius has been a game-changer for our brand, Clinical Skin. Thanks to Biorius, Clinical Skin successfully entered and expanded in the EU and UK markets, ensuring our customers have access to safe, effective, and high-quality skincare products. We highly recommend Biorius to any skincare brand looking to navigate the regulatory landscape with ease and confidence.

Helena Weir

Finance and Operations Lead, Antipodes

We would like to thank BIORIUS for all of the advice we have received over the last year. We would only ever go to Biorius for our regulatory queries. Biorius have always been able to provide great advice/ reviews in a timely manner, ranging from small queries to larger projects. We are looking forward to growing our relationship and partnership with Biorius in the future!

Emily Manatan

PRODUCT DEVELOPMENT MANAGER, ESALON

Biorius has been instrumental to our growth globally. Biorius worked with our unique business model to create a truly innovative solution for us. Not only are the people at Biorius responsive, forward-thinking, and informative, but they’re also wonderful to work with.

Andy Peitz

PRODUCT REGULATORY DIRECTOR, BRIOGEO

Biorius provides best-in-class service and regulatory expertise while bringing each product to market. The team’s attention to detail and easy-to-use online portal makes the process smooth and efficient. I look forward to partnering with Biorius for our next product launch!

Stephanie Muni

ASSOCIATE DIRECTOR OF REGULATORY AFFAIRS & INTERNATIONAL REGISTRATION, AMYRIS

Biorius started as our RP for 1 brand, through the incredible partnership they offered, we decided to move our entire portfolio over to them. They have gone above and beyond on multiple occasions to work with our team, have flexibility, and provide real, true, easy to understand expertise on everything Personal Care. They provide simple clear guidances for new regulations, real-time answers to our incredibly nuanced questions, and help us navigate those tricky grey areas that allow us to remain competitive in the market. They are true partners and having them as our RP has made my job easier, my understanding of EU regulations better, and continues to impress our Executive Leadership on their execution of a wide array of global insights.

Sibel Tüzün

R&D MANAGER, DALAN

BIORIUS represents Dalan Kimya as a Responsible Person, giving regulatory support to be sure of launching Dalan products seamlessly into the market. It is a trustworthy partner which always serves its expertise immediately and communicates with competent authority on time. BIORIUS is a dependable and up-to-date company which is the most important item as an RP for collaboration. As a result, its counseling is reliable. We are pleased to work with BIORIUS, thanks for our partnership

Jillian Procopio

DIRECTOR OF OPERATIONS, KOSAS

BIORIUS is prompt, thorough, and pleasant to work with. We are appreciative of attention to detail as well as transparency of the regulatory process. BIORIUS has been a reliable partner and we look forward to continuing our work together.

Roxana Ghavamian

DIRECTOR, REGULATORY AFFAIRS & QUALITY ASSURANCE, HOURGLASS

I’ve been working with BIORIUS for several years through different companies and at different stages of my career. Not only does BIORIUS offer excellent assistance with registrations, their representatives are also always readily available and happy to answer any questions. Additionally, they are quick to inform us of any changes and updates to the regulations. It’s truly a pleasure working with the BIORIUS team!

John Wochner

CHIEF SALES OFFICER, COVALENCE LABORATORIES

We were introduced to BIORIUS years ago when we first began exploring the best options for helping the brands we manufacture for gain access to the EU market. Years later Biorius is still our best choice for EU assessments and registrations. Their professional staff has been an essential source of information for us and they are always willing to educate us on the necessary requirements. The online portal system is easily the best way for manufacturers such as ourselves to manage the process for our clients, I definitely recommend taking advantage of this feature. We’ve enjoyed the working relationship with BIORIUS and will continue to make them our first choice for our clients.

Ted Ebel

CHIEF BUSINESS OFFICER, COLORESCIENCE

I just want to thank you all so much for the very rigorous, but thoughtful and supportive process.  I’m very impressed by the rigor of your approach and equally reassured that we have the right Responsible Party in Europe.  Thank you very much!  This is important for us.

Russel de la Mare

REGULATORY & SCIENTIFIC AFFAIRS SUPERVISOR, SR. EU LEAD, ARBONNE

We’ve had the pleasure of working with BIORIUS since their inception and have never found reason to seek alternative services. Their service is attentive and timely, the online platform grows to better suit customers’ needs. They are also proactive and well networked with regards to industry alertness, which they communicate through focused Information Letters, alerts in coordination with ICMAD and even on the fly- if a topic comes up which affects an ongoing assessment, ensuring that the product is both as safe as can be and also market-ready for the foreseeable future. We’ve found them to be open to discuss delicate issues to reach solutions that work well for all, so much so that we’ve integrated these solutions into our internal processes.

Alison Mcclellan

REGULATORY AFFAIRS MANAGER, ULTRACEUTICALS

We have found BIORIUS to be a valuable and trusted partner in expanding our European markets. Of course, BIORIUS assess and notify cosmetic products through the cosmetic portal. In addition to this, BIORIUS is patient in providing clear answers to our many regulatory queries and have been helpful in directing us to further partners to assist us in bringing additional types of products to market in Europe.

Alara Zeren

Product and Go-To-Market Director at Hairstory, Hairstory

Biorius has been providing us with exceptional regulatory support for both the USA and EU/UK markets. Their team is consistently available to answer any questions we might have, demonstrating unparalleled responsiveness and expertise. Their support has been invaluable in navigating complex regulatory landscapes, and their helpfulness ensures we always feel confident and informed. We are grateful for their partnership and highly recommend their services.

Sittidej Somprakit

Marketing Manager, Bts Spaceship

We are incredibly grateful for the exceptional service provided by Biorius. Their expertise in EU & UK cosmetics regulations has been invaluable in helping us navigate the complex certification process. With their guidance, our Thai-manufactured product received certification swiftly, ensuring a smooth market entry. The prompt assistance and frequent consulting calls truly demonstrate their commitment to customer success. Biorius is a trusted partner in delivering regulatory excellence!

DS & Durga

Biorius has been a great partner in assisting us in bringing products into the EU and UK markets. The online portal is seamless to navigate, and the Biorius team is always prompt to respond and eager to assist. We would highly recommend Biorius to any business looking for a reliable RP to navigate the complex regulatory landscape alongside.

Lissy Alvaran

Product Development, ELLUS & KRUE

BIORIUS has been instrumental in helping us navigate the very complicated world of international cosmetic compliance. They have very clear processes and excellent communication along the way. Whenever we deal with BIORIUS we know we are getting the correct information and best advice. We look forward to growing our portfolio with BIORIUS. 

Pallavi Nagrale

Global Regulatory Affairs Manager, Manscaped

Biorius has been instrumental in providing excellent regulatory support navigating the complex cosmetic regulations in the EU/UK regions. Their team has excellent communication, quick turnaround time and are very responsive to all queries and requests. The team has very knowledgeable regulatory experts always providing us with the most current information on upcoming cosmetic regulations & changes across the globe as well as risk assessments affecting or product portfolio. Biorius has been our trusted partner-RP for over 5 years with excellent regulatory support. Highly recommend their service.

Julie Castel

Product Development Manager, Juice Beauty

I am very pleased to work with Biorius due to their clear communication, professional advice, and quick product registration. We recently collaborated on EU/UK cosmetic notifications as well as MoCRA compliance. For both projects, they successfully registered our numerous products in a very much appreciated short time. Thank you for supporting and securing our business. I would recommend your services without a doubt.

Proud member of key cosmetics industry associations:

               

           

Latest Regulatory Cosmetic News

Stay atop the latest regulatory and market trends with the Biorius expert team.

EU Cosmetics Regulation: State of play of the current regulatory developments

Omnibus Regulation 2019

Several important cosmetic ingredients are currently in the process of being regulated by the EU Commission and the biggest uncertainty now concerns the timeline for…

Read More

A new piece of legislation on fragrance allergens

Omnibus Regulation 2019

Important regulatory development focusing on fragrance allergens The European Commission and the trade associations (IFRA, Cosmetics Europe, UEAPME, etc.) worked for years on this future…

Read More

A New Allowed Use of Thioglycolic Acid and its Salts

Omnibus Regulation 2019

Thioglycolic acid and its salts (mainly sodium and potassium thioglycolate) are cosmetic ingredients regulated by Annex III (entry 2a) of the EU Cosmetics Regulation and…

Read More

Get in Touch

Need a piece of advice, a quotation or answers to your questions? Contact us…

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 cosmetic products 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!
  • No hidden costs: Biorius does not charge you for any question, call, or meeting.
  • 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 never had any compliance issues (fines, withdrawals from the market, etc.) in 15 years of existence.

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