15+Years of Expertise
50+in-house Regulatory & Scientific Experts
IT PLATFORMConfidentiality & Protection of Your Data
CPSR Part A&B
Label And Claims Review
CPNP & SCPN Notifications
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
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.
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)
Formula Review + Label and Claims Review in all States
Legal Representation of your products in the USA
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.
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.
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 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).
Reef-Friendly Certification is great way for a brand and its consumers to show their commitment to helping reduce the alarming rate of coral reef damage.
In recent years there has been a sharp rise in consumers caring more and more about their environmental impact and climate change.
Biorius developed a Reef Friendly Certification therefore.
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’ 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.
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.
BIORIUS assists thousands of cosmetics brands with the evaluation of ingredients and ensures regulatory compliance of their end products.
For over 15 years, BIORIUS has been supporting and helping cosmetics companies navigate the various regulatory challenges that can arise when placing a product on the market. Thanks to our team’s regulatory and toxicological expertise.
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!
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.
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!
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.
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!
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.
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
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.
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!
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.
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.
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.
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.
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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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