BIORIUS, YOUR
COSMETICS
REGULATORY
EXPERT

EU Cosmetics Compliance

One of our main areas of expertise for which we are known all over the world is European conformity. BIORIUS offers a unique solution encompassing all steps from A to Z, from data collection to legal representation of cosmetic products in the EU and the UK.

Product assessment in the EU goes far beyond the requirements listed in the European Cosmetics Regulation (EC No 1223/2009). Ensuring the compliance of a cosmetic product in the EU means mastering the entire legal framework, which is anything but easy.

About Us

You Create Dreams,
We Protect Them

For over 13 years, BIORIUS has been supporting cosmetic brands and helping them deal with their regulatory challenges. Together, we bring products to market that are safe, respectful of the consumer and compliant with applicable regulations.

We are skilled regulatory experts, talented scientists and solution-oriented project managers focused on finding the best way for cosmetic brands to market their products and achieve global success.

Regulatory Toxicology

Sometimes it happens that the fusion of regulatory and safety issues generates very complex situations. Our toxicologists are experts in the cosmetic industry and can ensure the safety of final products and ingredients, as well as compliance with California’s Proposition 65.

BIORIUS stands at the intersection of science and regulation and is prepared to address all the difficulties posed to those in the cosmetics industry.

Cosmetic ingredients

Marketing a new cosmetic ingredient, raw material or complex natural extract without first verifying its safety is a risk not worth taking.

BIORIUS has real scientific expertise in evaluating the safety and performance of cosmetic ingredients, including the safety of more complex natural extracts.

References

Trusted by

800+

Cosmetics brands

Testimonials

What Do Our Customers Think About Us ?

Too Faced has enjoyed a long and helpful partnership with BIORIUS.
They have always made us feel confident in knowing that we are offering our customers the safest of products on the market and that we are always compliant in the many regulations that need to be adhered to in the EU.
The BIORIUS team are very supportive and work very hard to meet our needs.

JULI JONES

REGULATORY & INTERNATIONAL COMPLIANCY DIRECTOR/DANGEROUS LIAISON OF TOO FACED

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.

TED EBEL

CHIEF BUSINESS OFFICER
OF COLORESCIENCE

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!

ROXANA GHAVAMIAN

DIRECTOR, REGULATORY AFFAIRS & QUALITY ASSURANCE OF HOURGLASS

13+

YEARS OF EXPERTISE

1000+

INTERNATIONAL CLIENTS

50.000+

COMPLIANT PRODUCTS

60+

COUNTRIES COVERED

BIORIUS’ Team

50+

REGULATORY & SCIENTIFIC SPECIALISTS

200+

YEARS OF COMBINED EXPERIENCE IN THE INDUSTRY

CULTURES REPRESENTED

10+

Recent Blog

Latest Publications

Decrease of the threshold for the warning “releases formaldehyde”

Following a SCCS (the Scientific Committee on Consumer Safety) conclusion, the Commission Regulation (EU 2022/1181) decreases the Formaldehyde threshold for the labelling of a warning and changes the warning from ‘contains formaldehyde’ to ‘releases formaldehyde’. Indeed, the SCCS considers that the present threshold (0.05%) does not sufficiently protect consumers sensitised to formaldehyde from exposure to […]

Our Networking Reception Event at Cosmoprof Asia 2022!

To our delight, on November 17th, our long-awaited cocktail reception was held at Sinfonia Ristorante in Singapore and during the 2022 edition of “Cosmoprof Asia“. It was the occasion for Biorius to thank its dear partners for their trust and to gather many experienced cosmetic companies during a dinner and networking reception. And what a […]

Environmental Label Information

Our home is burning and after a record-breaking summer, climate change is at the heart of global concerns. To cope with climate change, European and national policies are evolving, becoming more stringent, and introducing new requirements, for example about the environmental label information & recycling obligations. The EU Legal framerwork is wide and includes: the […]

Selling detergents in Europe and/or UK

Do you wish to start selling detergents in Europe? Well, Biorius, your Regulatory Expert, can also completely help you with this matter. For your information, in order to be sold in Europe, detergents have to comply with: Detergents Regulation 648/2004 CLP Regulation 1272/2008 REACh Regulation 1907/2006 Biocidal regulation 528/2012 (depending on the property of the […]

Team Biorius at K-beauty Expo 2022!

Meet Biorius at K-beauty Expo We are excited to share news that Team Biorius will present “K-beauty Expo 2022 in South Korea”. From October 6th to 8th, Biorius will be presenting at stand D26. The stands are at KINTEX hall #4 and #5 and will be opened for the three days from 10:00 to 17:00. […]

Cosmetic, medicinal product, Medical Device or Biocide?

What makes your product a cosmetic in the European Union and the United Kingdom During the product’s development phase, brands or manufacturers are often confused about the categorisation. We were contacted more than once by companies with the same question: “Is our product considered a cosmetic or a medicinal product?”. In the most extreme cases, […]

Sunscreen products

Summer is in full swing, and sunscreen products are out. Y and Z Gens are increasingly concerned about the risks associated with sun exposure. Gone are the days of long tanning sessions without any protection, consumers now want to use products with an SPF often even beyond the summer. With important health issues at stake […]

2022 cosmetic trends and EU/UK compliance

Top-selling cosmetics’ specificities you need to know to sell in the EU/UK Probiotics, prebiotics, waterless beauty, DIY or face gems, the 2002 cosmetic trends are reflecting the cosmetic industry’s pledge to a cleaner way of consumption. While every cosmetic must comply with the Regulation EC No 1223/2009 and the UK Cosmetics Regulation to be sold in […]

Comparison between the US and EU cosmetics regulations

Firstly, it is important to note that the US and EU cosmetics regulations are completely different! The major difference is in the spirit of the law: The EU is a protective society: the key words are safety and certainty. The EU is very directive (or managerial) and leaves very little room to manufacturers by establishing […]

CBD in cosmetics: what you need to know to be compliant

CBD cosmetics regulations around the world Since 2019, CBD cosmetics have been meeting a huge success around the world. Despite growing sales and a promising future, cannabidiol use in beauty products is subject to strict regulations and is even still illegal in some countries. Have you ever wondered if your CBD infused beauty products were […]

GMP (Good Manufacturing Practices)

Do you wish to start selling your home-made cosmetics products? Well pay attention because, although everybody can make homemade cosmetic products for them, their family and their friends, it’s a completely different story when you wish to sell them. Your products indeed have to be compliant and regulatory… and this process firstly starts with the […]

Labeling Threshold Formaldehyde Donors

Following a request from the European Commission (EC), the Scientific Committee on Consumer Safety (SCCS) published on May 10th, 2021, scientific advice on the threshold for the warning ‘contains formaldehyde’ in Annex V of Regulation (EC) No 1223/2009, preamble point 2 for formaldehyde-releasing substances. SCC Conclusion and the Proposal of the European Comission The SCCS […]

SCCS opinion on Butylated hydroxytoluene (BHT)

SCCS opinion on BHD BHT (Butylated hydroxytoluene) (CAS No 128-37-0, EC No 204-881-4) is part of the priority list and the Scientific Council on Consumer Products (SCCS) published its opinion on BHT on December 2nd, 2021. On the basis of a safety assessment, and considering the concerns related to potential endocrine-disrupting properties of BHT, the […]

Omnibus V Regulation and Omnibus IV Reminder

Following the Omnibus IV article, we remind you that Commission Regulation (EU) 2021/1902, the so-called Omnibus IV Regulation, enters into force on the 1st of March 2022. Thus, from now on, only compliant products can be placed on the market and made available on the market. A market withdrawal of non-compliant products must be organized […]

Nanomaterials Future Ban

The Intention of the European Comission for Nano Ingredients The European Commission notified the World Trade Association (WTO) of its intention to ban the following nano ingredients from the composition of cosmetic products: STYRENE/ACRYLATES COPOLYMER (nano) (CAS: 9010-92-8) SODIUM STYRENE/ACRYLATES COPOLYMER (nano) (CAS: 9010-92-8) COPPER (nano) (CAS: 7440-50-8) COLLOIDAL COPPER (nano) (CAS: 7440-50-8) HYDROXYAPATITE (nano) […]

DID MY COSMETIC PRODUCT BECOME A MEDICAL DEVICE?

The Borderline Between a Cosmetic Product and a Medical Device One important change in the Medical Device Regulation (EU) 2017/745 (the MDR) is the integration of 6 groups of products in its scope: the “Cosmetic Products” listed in Annex XVI which reads the following: While some products listed are easy to identify, such as “decorative” […]

Cosmetic Business Trends 2022 (Part 2 )

The Cosmetics Industry in 2022 As you surely already noticed, the cosmetic industry is continuously changing or evolving… and it’s changing a lot and regularly! The cosmetic industry is a bit like a butterfly before coming out of the chrysalis… it’s always transforming and evolving! Eco-Friendly Cosmetics More and more consumers now want to have […]

Cosmetics Packaging Adaptation in International Marketing

The success of your cosmetics’ exportation Local legislation is the first parameter to consider when commercializing a cosmetic on a new market. If adapting products compliance should be a priority to ensure a legal implementation, consumers will not only look forward to your beautiful INCI list or your expertly translated instructions of use. Indeed, catching […]

BEAUTY TRENDS 2022

Without a doubt, 2021 was a very difficult year. Who would have thought that the global Covid-19 pandemic would still be impacting people’s lives the way it has this year, even after the vaccine? Shops, schools, offices, theatres, and boarders reopened sporadically throughout the course of the year only to have to close their doors […]

Why Choose BIORIUS for your Cosmetic Certifications?

Impact of a Cosmetic Certification on the Purchasing Decision Seeking the perfect cosmetics and ingredients has become an important part of everyone’s routine. Is it really the perfect product for my skin type? And if it is, does the brand also respect and represent the battles I am fighting for, for example, buying products that […]

How to Gain EU Compliance in 3 steps

Introduction I’d like to take you on an imaginative journey for a moment, shall we? Let’s set off together to discover the old continent. Wow, France with its Eiffel Tower, without mentioning the magnificent Rialto Bridge in Venice and finally the flowering tulip fields in Holland. It certainly gives us some breathtaking views, I could […]

What is a Product Information File (PIF)

Cosmetic Product Information File (PIF) Definition How to Create a Product Information File (PIF)? Where Do I Find the Right Data? Which Documents and Information Must Be Part of the Cosmetic PIF ? Do you Need Help to Create Your Cosmetic Product Information File (PIF)? Biorius, Your Regulatory Expert can assist you in many ways […]

Changes in the US FDA Colorants List

Colorants in the United States The US FDA colorants list has been amended to ban Lead Acetate and add Silver Nitrate to the list of allowed colorants. Ban of the Lead Acetate The ban of the Lead Acetate has been officially published and will be effective from January 6th, 2022. A transition period of 12 […]

Labeling of additional fragrance allergens

Introduction In 2012, in its opinion SCCS/1459/11, the SCCS concluded that consumers should be made aware of more fragrance allergens potentially present in cosmetic products, in order to protect sensitized people against the risk of skin rashes. The current list of 26 fragrance allergens, already subject to individual labelling as part of the list of […]

Italian Environmental Labelling postponed to 2022 and further clarifications.

Italy has introduced the so-called “Environmental labelling” already discussed and analyzed in our previous article “Application of the Italian Environmental Labelling to cosmetic products”. The labelling is mandatory on all packaging in Italy, including cosmetics. Its scope is to prevent and reduce the impact of packaging and packaging waste on the environment, ensuring at the […]

Future Restriction of Microplastics in Cosmetic Products

Toward a (Quasi-)Ban of Microplastics in Cosmetic Products ECHA, the European Chemical Agency, released its conclusions to the European Commission on the future restriction of microplastics in the EU. The proposed restriction, yet to be approved by the Commission, is expected to impact the cosmetics industry. An adoption of this new piece of legislation may […]

“Omnibus IV” Regulation

The Main Dates Concerning “Omnibus IV” The European Commission has notified the draft regulation “OMNIBUS IV” to the World Trade Association (WTO) on the 22nd January 2021. This proposal was open to comments until the end of March and is supposed to enter into force on March 1st, 2022. The next step consists in the […]

European Cosmetics Regulation Change due to “Omnibus III”

Introduction On May 26th, 2021, the European Commission published a new amendment to the European Cosmetics Regulation (EU No 2021/850, so-called “OMNIBUS III”). The provisions of this regulation will be implemented on October 1st, 2021. This piece of legislation includes a number of modifications in Annexes II, III, IV, and VI of the European Cosmetic […]

Impact of Single-Use Plastic Directive on Cosmetic Products: Mandatory Marking Requirements for Wet Wipes – IL 081

According to the Directive (EU) 2019/904 on the reduction of the impact of certain plastic products on the environment and its related Regulation (EU) 2020/2151, some considerations must be made regarding their future impact on cosmetics products. The goal of this Directive – also known as Single-Use Plastic (SUP) Directive – is to reduce plastic […]

Peptides and Proteins in Cosmetics – Part 2 (Safety Aspects)

Introduction In the previous part, it was highlighted that peptides and proteins are interesting cosmetic ingredients, notably because of their anti-aging activities. There is already a plethora of peptide-based cosmetic raw materials on the market, with more being researched constantly. So far, regulation of these ingredients largely involves their origin (must be synthesized or extracted […]

Think Global! KOTRA x BIORIUS, Co-Hosting Online Business Event for Korean Cosmetic Brands

With global demand for Korean cosmetics growing, compliance with different countries’ cosmetic regulations is becoming increasingly important. In effect, regulatory compliance in multiple countries is no longer optional but mandatory for global cosmetic brands. Following this trend, KOTRA Brussels and BIORIUS are holding a joint webinar for Korean cosmetic brands on March 10th, 2021. Dr. […]

New Approved UV Filter in the EU

The European Commission approved the use of Methoxypropylamino Cyclohenylidene Ethoxyethylcyanoacetate (CAS number 1419401-88-9) as UV filter, following the conclusions of the Scientific Committee on Consumer Safety (SCCS/1605/19). To the best of our knowledge, this new ingredient is a promising UVA Filter with a λmax of 385 nm. The Commission Regulation EU No 2020/1684, adds Methoxypropylamino […]

Hair dyes update

Numerous peer-reviewed articles highlight the possible toxicity of hair dye substances and notably their concerning carcinogenic, genotoxic, and skin sensitizing properties. In order to properly protect consumers, the Scientific Committee on Consumer Safety (SCCS), the European Commission, the Member States, and the Industry developed an overall strategy to evaluate hair dye substances. As their work […]

Did you know that Cosmetic products have REACH obligations?

Part I I recently started working for Biorius with the responsibility of managing chemical regulations questions. I quickly noticed that there was a question for which there are many divergent opinions around, a lot of hearsay and very little substantiated answers. And this question was: How the REACH regulation applies to cosmetics? While you’ll find […]

Chinese New Year’s Resolution – IIL 01

China will implement a new legislation called Cosmetic Supervision and Administration Regulation (CSAR) on January 1, 2021. After the US, China is the world’s second-largest cosmetic market and those changes will have a huge impact for many companies around the globe. The actual text of reference is Regulation Concerning the Hygiene Supervision over Cosmetics, in […]

Brexit impact on cosmetic compliance – IL 077

The United Kingdom (UK) formally left the European Union (EU) on January 31, 2020. Northern Ireland and Great Britain will follow different routes to maintain a cosmetic regulation in their respective territory. Northern Ireland (NI) will continue to apply European Cosmetic regulation (EC) No 1223/2009, to cosmetic products manufactured or sold in NI, as mentioned […]

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