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.
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.
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.
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.
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.
CHIEF BUSINESS OFFICER
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!
DIRECTOR, REGULATORY AFFAIRS & QUALITY ASSURANCE OF HOURGLASS
YEARS OF EXPERTISE
REGULATORY & SCIENTIFIC SPECIALISTS
YEARS OF COMBINED EXPERIENCE IN THE INDUSTRY
Recent Regulatory articles
On December 29th, 2022, the biggest amendment of the U.S. Cosmetic Regulation since 1938 has been enacted. The publication of the Modernization of Cosmetic Regulation Act (MoCRA) in the USA is expected to have a large impact on the cosmetic industry, while it implies the reinforcement of FDA’s power. In this article, you will learn […]
How can clean cosmetic brands substantiate environmental claims What we call “clean beauty” has been a major trend for these past few years, and the beauty industry is slowly trying to decrease its environmental impact by developing natural or vegan cosmetics, manufacturing recyclable or biodegradable packaging and limiting its carbon footprint for instance. While cosmetic […]
Biorius will participate in the 54th edition of Cosmoprof Worldwide Bologna: hall 19 booth E/31 from March 16th to 19th.
With this article, we will take a detailed look together at what the European Cosmetics Regulation (EC) No. 1223/2009 consists of, what its main purpose is, and what the most important points are.
Consequences on the cosmetics industry’s compliance status in the European-Union Part 2 Claims, including a focus on “sensitive skin” and “hypoallergenic” The DGCCRF will also strengthen controls on packaging and in particular on claims. Before getting to the heart of the matter, let’s see what the European regulation tells us. 1) General context – common […]
Cosmetics trade fairs in Japan BIORIUS has Belgian roots but truly is an international company at heart. Participation to COSME WEEK TOKYO/OSAKA, American management school, offices in Belgium, France and London, global team of more than 10 nationalities and clients scattered around the globe, our ability to adapt to different cultures and to help cosmetics […]
Consequences on the cosmetics industry’s compliance status in the European-Union “In 2023, controls will continue, both on the “nanomaterials” aspect and on other regulated substances, particularly in other suncare products, including those containing chemical filters. The effectiveness of the measures requested in 2021 and 2022 will be monitored.” Announced in December 2022 through a press […]
The European Commission has notified the draft regulation “OMNIBUS VI” to the World Trade Association (WTO) on November 17th, 2022. This OMNIBUS VI regulation incorporate substances classified CMR by the regulation EEC 2022/692 aka ATP 18th of the CLP Regulation into the European Cosmetic Regulation 1223/2009. The aim of this amendment is to implement the […]
The Government of the United Kingdom has extended the initial transition period for cosmetic labeling and UKCA marking.
The cosmetic labeling requirements are quite complicated and even more in Europe! It’s a great idea to start selling your cosmetics products in EU and UK because these cosmetics and personal care markets are, along-side the USA, the largest markets for cosmetic products in the world (Valued at €80 billion at retail sales price in […]
Titanium Dioxide (TiO2) in the form of some powders is no longer considered as a carcinogenic compound via inhalation in the European Union The Court of Justice of the European Union (CJEU) has recently announced the cancellation of the CLP regulation (2020/217 regulation) known as ATP14, with regard to the harmonised classification and labelling of […]
BIORIUS had the honor to participate to the Belgian economic mission to Japan from December the 5th to the 9th of 2022 in Tokyo and Osaka. This large-scale event was organized by Belgian official organizations such as the AWEX and various state economic actors. Focused on the international reach of Belgian companies and Belgium-Japan bilateral […]
In the era of “Conscious beauty”, the shelf life and expiration date of cosmetics is an important issue for many brands. Here is a comprehensive compliance guide on this topic. EU context: PAO VS Expiration date According to the EU Cosmetic Regulation, art. 19 (c), it is stated that “Indication of the date of minimum durability shall not be mandatory for cosmetic products with […]
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 […]
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 […]
COSMOPROF & COSMOTALK ASIA 2022: Biorius thanks you all! It was a pleasure to be back after three long years! Contact us to get our lecture.
Octocrylene (CAS no 6197-30-4) and Benzophenone-3 (CAS no 131-57-7) restrictions and Commission Regulation (EU) 2022/1176.
Cosmetics regulatory updates in the European Union The European Union is constantly changing or adding new legal requirements ruling over cosmetics. A thorough legal watch is a must in Europe, and it is one of the first duties of the EU Responsible Person. Expert in regulatory affairs, BIORIUS is keeping track of every update as […]
Beauty in the world: most influential beauty trends in Australia, New Zealand, Italy, Japan and Korea.
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 […]
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 […]
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. […]
The Australian cosmetics and personal care market is a very important and promising one. Let’s take a look together at cosmetic trends and regulations in this country.
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, […]
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 […]
Top-selling cosmetics’ specificities you need to know to sell in the EU/UK Probiotics, prebiotics, waterless beauty, DIY, face gems or solid cosmetics, the 2023 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 […]
REACh is a complex European regulation nd we will try to explain it as simply and understandable as possible.
Medical Devices embody a very complex field in Europe, making billions of profit. Varieties and categories are numerous, while their usage is always leading to high stakes involving human safety. All these factors are making the Medical Device framework confusing, especially since it is constantly evolving. The EU is currently deeply modifying its Medical Devices […]
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 […]
There are three main types of testing for cosmetic products in the EU/UK:
– Stability and Compatibility tests
– Challenge test (Preservative Efficacy Test, abbreviated PET)
– Microbiological Quality Analysis
BIORIUS provides assistance from A to Z.
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 […]
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 […]
It’s no secret that Italy is one of the most important homelands of cosmetics. But how important is the Italian cosmetics market, taking into account cosmetics products that are produced in Italy and exported abroad and those produced abroad and imported into Italy?
A few words and key figures about the UK cosmetic market The United Kingdom is among the leading three cosmetic markets in Western Europe after Germany and France followed by Italy and is the 8th biggest cosmetic industry in the world, behind the USA, China, Japan, India, Brazil, Germany and France. The global cosmetics market […]
Save the date! From 28 April to 2 May, the amazing team from Biorius will be thrilled to welcome you at hall 19, stand D/16.
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 BHT (Butylated hydroxytoluene) 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 […]
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 […]
A CPNP notification is the act of informing Europe that you are going to sell a cosmetic product on the European market.
POST-MARKET SURVEILLANCE & POST-MARKET CLINICAL FOLLOW UP UNDER THE EUROPEAN MEDICAL DEVICE REGULATION
This is a brief overview of the most important points regarding Post Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF). Post Market Survey (PMS) Definition PMS (Post Market Survey) refers to all activities carried out by manufacturers, in collaboration with other Economic Operators*, to establish and keep up to date a systematic proactive data collection […]
Obtaining Biorius Vegan certification is easy: contact us, meet the standards and you will receive our logo and certificate!
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) […]
As an internationally recognized certifier, Biorius offers a GMO-free certification following the EC 2011/18 regulation. Our certifications are valid worldwide and are provided by an honest and qualified compliance specialist.
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” […]
Medical Devices Categorization in Europe Medical Devices are categorized in the European Union in 4 classes: Class I, Class IIa, Class IIb and Class III. Class I being the lowest risk ones and Class III the highest risk ones. There are also 3 “subclasses” in the Class I category: All medical device classes require the […]
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 […]
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 […]
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 […]
Difficulties of the EU and UK Cosmetic Regulations and BIORIUS’ expertise A lot of people are not always aware of it, but the EU and UK Cosmetic Regulations are the most complicated in the world. The EU and UK Cosmetic Regulations are more or less the same but there are indeed some minor changes (due […]
Emergence of New Opportunities in the Cosmetic Sector We all know it. The COVID-19 crisis had, and still has today, a dramatic impact on the world’s economy. The cosmetic industry is making no exception. However, the market is already recovering. The beauty industry has always shown a strong ability to adapt to crisis thanks to […]
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 […]
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 […]
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 […]
The K-beauty market is growing in the EU despite the pandemic. At the same time, the European Commission is introducing more and more restrictions for foreign cosmetics to comply with. This does not make it easy for Korean cosmetic brands to enter the EU market.
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 […]
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 […]
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 […]
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 […]
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 […]
The Italian Legislative Decree of 3 September 2020, n°116 – in force since 26 September 2020 – has made “environmental labeling” mandatory on all packaging in Italy, including cosmetics. The aim is to prevent and reduce the impact of packaging and packaging waste on the environment, ensuring at the same time a high level of […]
Anti-Waste Law for a Circular Economy The French Anti-Waste Law for a Circular Economy n°2020-105 (known as the AGEC law) has been published in February 2020. The objective of this law is to improve reuse and recycling, and to reduce plastic consumption. It aims to gradually transform the current linear way of producing, consuming and […]
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 […]
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 […]
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. […]
Introduction In part 1 I explained why finished cosmetics products are not exempted from REACH regulation obligations, particularly from the registration. The main message was that every component of your finished cosmetic product is “registrable” individually. In part 2, I will explain in more detail what needs to be registered, who has to register, and […]
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 […]
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 […]
New Mandatory Marking Requirements for Wet Wipes at the Horizon The effects plastic pollution has on natural habitats are familiar to everyone, just think of the Pacific trash vortex – literally a plastic island – or the tiny pieces of plastic scattered all over the sand. In light of this global emergency, Europe is finally […]
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 […]
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 […]
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 […]