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Are You MDR Compliant?
Learn what are the new obligations for Medical Devices and how Biorius can help you comply with the new EU regulations.
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You Create Dreams,
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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.
Cosmetic Ingredients
Marketing a new cosmetic ingredient, a new raw material or a complex natural extract without first checking its safety is a risk that’s not worth taking.
BIORIUS has true scientific expertise in the safety and performance evaluation of cosmetic ingredients, including the safety of your complex natural extracts.
Regulatory Toxicology
Sometimes safety and regulatory issues mix and mingle with a high level of complexity. Our toxicologists are experts in the cosmetics industry and can ensure the safety of end products and ingredients as well as compliance with California Proposition 65.
BIORIUS is at the crossroads of science and regulation, ready to tackle all challenges faced by the cosmetics industry.
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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
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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 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 compliant […]
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 […]
Comme vous le savez probablement déjà (ou comme vous l’avez très certainement déjà remarqué), les exigences en matière de sécurité, de qualité, d’efficacité et d’étiquetage dans les cosmétiques sont réglementées différemment dans diverses régions du monde et, dans certains pays, une notification aux autorités nationales compétentes est requise. Par exemple, une notification (ou un enregistrement) […]
The keys to success in the Japanese cosmetic market Japan is the third largest cosmetics market in the world, making it a key target for cosmetic brands. Have you ever wondered how you could successfully implement in this country? This article aims at giving you the marketing keys to a well-planned development project and […]
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 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 […]
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 […]
As you probably already know (or as you surely already noticed), the safety, quality, efficacy and labeling requirements are regulated differently in various regions of the world and in some countries, a notification to the National Competent Authorities is required. As an example, a notification (or registration) is mandatory in the following countries: Europe UK […]
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 […]
The Vegan Certification allows your customers to make informed choices when it comes to buying vegan cosmetics and beauty products certified by an independent, honest, and competent third party, like Biorius.
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: Class I provided in sterilized condition […]
4 Requirements to Sell in Europe and the UK Before getting to the heart of the matter, it’s always a good practice to remember what is needed in order to sell any cosmetic product in Europe and the UK. As we already mentioned in our article “How to gain EU compliance in three steps”, you […]
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 International Implementation 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 (UK) regulation 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 Cosmetic Regulation and the UK Cosmetic Regulation are more or less the same but there are indeed some minor changes […]
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 […]
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 […]
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 […]
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