Nanomaterials future ban: the draft EU Regulation related to the ban of some nanomaterial ingredients in cosmetics described in IL-093 has been updated. The following changes have been included: We remind you that below ingredients are still into the draft EU regulation and remain into the list of ingredients to be banned: The adoption of […]

The final publication of the IFRA 51st amendment is now out. You can find all the detailed documentation related to this new amendment on the IFRA website. It consists in numerous changes like: This amendment will enter into force progressively:    Date for Standards entering into force for new creations Date for Standards entering into […]

The Omnibus VI Regulation has been published. It consists in a ban in Europe of 30 CMR classified ingredients from cosmetics. Omnibus VI Regulation: The cosmetic industry will mostly be impacted by the prohibition of Margoza Extract, Theophylline, Pentasodium Pentetate, Pentetic Acid, Trimethylolpropane Triacrylate and Benzophenone and Cumene (both mainly used as or present in […]

New EU allergens labeling regulation:  The European Commission published on the 27th of July 2023 Regulation (EU) 2023/1545 introducing news rules for allergens labeling and 56 new ingredients to label. This Regulation introduces several changes to Annex III of Cosmetic Regulation (EC) No 1223/2009: How to label allergens? The allergens listed in annex I must be disclosed if their […]

Responsible Person & US Agent under MoCRA US Agent: On December 29th, 2022, the most significant amendment to cosmetic requirements (21 U.S.C., Sec. 321-392) since 1938 was enacted. Under MoCRA, it becomes mandatory to have a Responsible Person designated for each cosmetic product placed on the US market. The Responsible Person can be the manufacturer, packager, or […]

BIORIUS Information Letter 118: The so awaited D4, D5 and D6 restrictions in wash-off and leave-on cosmetic products are notified The Draft Regulation on Cyclotetrasiloxane (D4), Cyclopentasiloxane (D5) and Cyclohexasiloxane (D6) has been notified to the World Trade Organization (WTO) on the 22nd of June (HERE and HERE). This Regulation will amend the Annex XVII […]

BIORIUS International Information Letter 006: Clarification regarding the definition of a Responsible Person in USA Responsible Person in USA: in our previous article regarding the Modernization of the Cosmetic Regulation Act, we informed you that a responsible person must be designated for each cosmetic product made available on the market. The Responsible Person must: On […]

BIORIUS Information Letter 117: New draft regulation on Vitamin A, Alpha-Arbutin, Arbutin and certain substances with potential endocrine disrupting properties A new Draft Regulation has been notified to the World Trade Organisation (WTO) on the 8th of June. This Regulation aims to modify the annexes of Regulation 1223/2009 to align with recent Scientific Committee on […]

The Modernization of the Cosmetics Regulation Act 2022 (MoCRA) On December 29th, 2022, the most significant to cosmetic requirements (21 U.S.C., Sec. 321-392) since 1938 was enacted. This new piece of legislation introduces new obligations for the cosmetics industry, and we anticipate a substantial impact for cosmetic brands distributing in the USA.  Beyond new regulatory provisions, MoCRA […]

The European Commission notified to the World Trade Organization (WTO) the cosmetic regulation project so-called “Omnibus VI” on November 17th, 2022. The draft is open for comments until the 16th of January 2023. We don’t expect any modification of the regulatory text at this stage.This OMNIBUS VI regulation incorporate substances classified CMR by the regulation […]

The initial transition period established by the Government of the United Kingdom about UKCA marking and labeling has been extended. Extension of transition period: on the 14th of November 2022, the Government placed legislation before Parliament extending the transition period for UKCA marking until 31 December 2024 and the provisions for UKCA labeling, importer information, […]

Navigating cosmetics European and International Markets To create a cosmetic label suitable for multiple countries can be a challenging task due to varying regulations and languages. BIORIUS, an expert in cosmetic regulations, has assisted numerous brands in selling their products worldwide. Compliance with packaging requirements, especially in the European Union (EU), United Kingdom (UK), and […]

Post-market surveillance refers to a surveillance system registering undesirable effects, serious or not, linked to the use of a cosmetic product. The issue generally occurs within the scope of a normal or reasonably foreseeable utilisation of a cosmetic, or in the case of a potential misuse. In Europe and the USA, this process is mandatory […]

” Since February 2023, France and Italy have started to implement their control strategies, verifying REACh restriction compliance at customs checkpoints for products entering the EU. As a result, many cosmetic brands have been blocked at customs for failing to demonstrate compliance with REACh. “ Executive Summary In 2019, the REACH Enforcement Forum of ECHA […]

With this article, we will detail the regulations in Europe and Australia: necessary requirements to have compliant products.

Biorius will participate at NYSCC Suppliers’ Day, New York from 2nd-3rd May 2023 at the Jacob K. Javits Convention Center, booth #2013.

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 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 […]

Cosmetic expiration date: 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 Cosmetic 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 […]

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 […]

This article considers the importance of the marketing communication of a cosmetic product by referring to REGULATION (EU) No 655/2013 and REGULATION (EC) No 1223/2009.

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: This would allow to put products in the US market that could not enter the EU market. However, dyes are much more limited and regulated in the US than […]

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 […]

How to ensure your cosmetics label compliance in the EU and the UK                Cosmetics sold in Europe and the UK, including their label, must comply with the local regulations. The requirements are: As BIORIUS has already introduced most of these topics, I invite you to check our dedicated publications. This article aims at clarifying […]

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 […]

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 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 BHT, […]

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.

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” […]

4 Requirements to Sell in Europe and the UK CPSR: 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”, […]

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 ? 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. Author Diego Benitez View all posts

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 […]

Hydroxyethylmethacrylate (HEMA) and Di-HEMA Trimethylhexyl Dicarbamate (Di-HEMA TMHDC) are two colorless viscous liquids that readily polymerize when exposed to UV-light. Because of their physical properties, these monomers are typically used in nail enhancement products. The skin sensitization potential of these cosmetic ingredients raised concerns since 2016. The restriction of HEMA and Di-HEMA TMHDC to professional […]

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 […]

Several regulatory developments related to endocrine disruptors are ongoing in the EU. Among them, the ECHA committees (European Chemicals Agency) have the duty to review ingredients suspected to be endocrine disruptors and that may have serious effects on human health or the environment. The first significant cosmetic ingredient to be reviewed in this regard was […]

Endocrine Disruptors in Europe: the WHO defines an endocrine disruptor as ‘an exogenous substance or mixture that alters function(s) of the endocrine system and consequently causes adverse health effects in an intact organism, or its progeny, or (sub)populations’. This definition has been retained by the European Union, which started a number of developments to better […]

Introduction: Responsible Person versus Importer By law (European Cosmetics Regulation EC No 1223/2009 Art. 4-5), every cosmetic product placed on the European Union market must be legally represented by a Responsible Person which can be a legal or a natural person and has to be based in the European Union. The Responsible Person ensures compliance with all legal […]

Since 2008, we have been helping small and large cosmetic brands enter the European market. The services we offer for this purpose: reviewing their formulas, issuing Cosmetic Product Safety Report (CPSR), notifying products on the Cosmetic Products Notification Portal (CPNP), and acting as Responsible Person in the EU. Today we are able to provide a […]

What are they and their regulatory status For now and for the sake of argument, lets ignore the controversy surrounding the term “cosmeceuticals” (more on this later) as proteins and peptides as used in cosmetics conveniently fall under such an umbrella term. The term “cosmeceuticals” was coined more than 25 years ago by Professor Albert […]

Author Frédéric Lebreux Dr. Frédéric Lebreux is Biorius’s Chief Executive Officer and has worked in the cosmetic industry for more than 13 years. He is regularly invited as a speaker or Professor to cosmetic events. View all posts

Since our first inception, preserving the environment was and still remains important to us. This is reflected in the choice of the green color and the waterlily for our logo. We have some internal initiatives in place already, such as digital sorting, eco-friendly search engine, special attention to our energy usage, and aiming to increase […]

Update: Future Restriction of HEMA and Di-HEMA Trimethylhexyl Dicarbamate April 9th, 2020 Hydroxyethylmethacrylate (HEMA) and Di-HEMA Trimethylhexyl Dicarbamate (Di-HEMA TMHDC) are two colorless viscous liquids that readily polymerize when exposed to UV-light. Because of their physical properties, these monomers are typically used in nail enhancement products. In 2016, Sweden activated the Safeguard Clause (Article 27 […]

Update March 4th, 2020 As reported below, the SCCS released a new interpretation regarding the classification of silica as ‘Nanomaterial’. This one has a considerable impact on all cosmetic brands using Silica in their products and it mainly affects the make-up product category. Indeed, the SCCS strongly contradicts the position of the industry and concludes […]

Earlier this month, CosmeticObs posted this article written by Dr Frédéric Lebreux, our COO, about the Nonfunctional Slack Fill. Here is the translated article. The Frog that wants to make itself as big as beef: phenomenon of the “Nonfunctional Slack Fill” in the cosmetic industry Let us remember our tender years during which opening our […]

The United Kingdom will formally leave the European Union on January 31st, 2020. As communicated previously via information letter, BIORIUS will assist you with the compliance of your products on both sides of the Channel. Please note that cosmetic companies will benefit from a transition period until December 31st, 2020 to comply with the new rules applied […]

The whole team wishes a Happy Lunar New Year to its Korean clients, partners and collaborators. Author andrea.tkint@biorius.com View all posts

BIORIUS’ team wishes you all the best for this new year! Author andrea.tkint@biorius.com View all posts

Best wishes from the whole BIORIUS team for this holiday season. May you enjoy a Merry Christmas with your loved ones and have a great start of 2020! Author andrea.tkint@biorius.com View all posts

Update December 16th, 2019 The International Fragrance Association (IFRA) published the Notification Letter related to the 49th Amendment to the IFRA Code of Practice. The numerous requirements of this Amendment will be enforced on January 10th, 2020. All fragrances will have to comply with the 49th IFRA Amendment within 25 months. Although IFRA Standards are self-regulation, the European Authorities […]

‘Omnibus Regulation 2019’ : Update December 13th, 2019 As estimated below, the Omnibus Regulation 2019 has been published and we invite you to consult the legal text EU No 2019/1966. The main (if not unique) impact of this new Regulation on the cosmetic industry concerns the use of Salicylic Acid and its salts. Furthermore, the transition period […]

Are you Brexit ready? Brexit will for sure impact the cosmetic industry and a quick reaction from cosmetic brands is required. What are the key points for you as a cosmetic company? Following a series of internal political issues, the United Kingdom has been forced to negotiate a new Brexit extension. Based on the new […]

The European Commission added a new preservative to Annex V of the European Cosmetics Regulation, namely Hydroxyethoxyphenyl Butanone (HEPB, CAS 569646-79-3). The maximum use level related to this new entry follows the recommendations of the SCCS, namely 0.7 % in all product categories. Regulation EU No 2019/1858 is available here. Author Frédéric Lebreux Dr. Frédéric […]

New Approved Coatings for Titanium Dioxide (nano) November 17th, 2019 The nano form of Titanium Dioxide is used in cosmetic products as a UV filter and this use is regulated via the European Cosmetics Regulation (Annex VI, Entry 27a). One of the use conditions is the coating of Titanium Dioxide with one of these materials: […]

Upcoming Ban of Lilial (Butylphenyl Methylpropional) October 17th, 2019 Lilial, also called Butylphenyl Methylpropional (CAS 80-54-6) is an important fragrance ingredient commonly found in cosmetic products. This is also an ingredient well-known from cosmetic brands since it is one of the 26 official fragrance allergens that have to be reported in cosmetics’ lists of ingredients. […]

According to KITA’s report, the strength of Korean beauty products lies in their cost-effectiveness and good quality, while containing natural substances instead of artificial chemicals. In addition, the cute and innovative packaging as well as the opportunity of customizing products are also seducing Europeans. GOOD VALUE FOR MONEY Korean consumers are very knowledgeable about cosmetic […]

The Internet and its numerous platforms such as Amazon are an easy way to make cosmetic products accessible to a great deal of potential consumers all over the world. However, it is important to remember that any kind of cosmetic products sale targeting EU consumers is subject to EU cosmetic regulations. That is to say, […]

It’s that time of the year again! The great K-Beauty Expo KOREA will be held in Seoul from 10th to 13th October in KINTEX, and BIORIUS will be there as usual. As a reminder, K-Beauty Expo KOREA, which celebrated its 10th anniversary last year, is the most famous and renowned beauty trade show in Korea. […]

Climbazole (CAS 38083-17-9) is a preservative regulated by the European Cosmetics Regulation (EC No 1223/2009) and reported at Entry 32 of Annex V. Until now, this substance could only be used as a preservative at a maximum concentration of 0.5%. Climbazole also exhibits interesting anti-dandruff properties and the industry submitted a safety dossier to the […]

2-Chloro-p-Phenylenediamine (CAS 615-66-7), including its sulfate (CAS 61702-44-1) and dihydrochloride (CAS 615-46-3) salts, is used in formulations for coloring eyebrows and eyelashes. The Scientific Committee on Consumer Safety (SCCS) evaluated the substance and did not consider its use safe for the consumer in hair dye products, including eyebrow dye products, and eyelash dye products. Its […]

Cannabis derivatives such as Hemp seed oil and Cannabidiol (CBD) are very fashionable those last days and many cosmetic brands pay attention to this new market trend. As usual, new developments, new technologies and new practices raise legal questions and the European Authorities start to raise questions (and sometimes concerns) about these Cannabis derivatives. Following […]

The French Authorities will shortly publish a new legal requirement related to Phenoxyethanol-containing leave-on products (ANSM Decision of March 13th, 2019). This is an administrative decision triggering Article 27 of the European Cosmetics Regulation, the safeguard clause. This requirement will remain in place until a formal decision is taken at the European level. The product […]

Follow-up February 17th, 2019 The new guidelines interpreting the ‘Common Criteria’ for the justification of marketing claims in the European Union will be implemented on July 2nd, 2019. From this date, National Authorities and Courts of Justice will start to use these guidelines as a reference. The new rules have serious consequences as some very […]

2018 was a successful year for BIORIUS full of developments and meetings. DEVELOPMENTS? Always seeking to innovate, BIORIUS created a new expert IT system that enables us to improve the project management. This new system speeds up the evaluation process and makes it more reliable.  Moreover, BIORIUS bought a French competitor called CERT. This acquisition […]

o-Phenylphenol (also called Biphenyl-2-oln CAS 90-43-7) and its derivatives (MEA o-Phenylphenate, Potassium o-Phenylphenate and Sodium o-Phenylphenate) are official preservativesreported under Entry 7 of Annex V to the European Cosmetics Regulation EC No 1223/2009. As of today, these preservatives can be used at up to 0.2% (as phenol) in all cosmetic products. In practice, it appears […]

Tagetes erecta (CAS 90131-43-4), Tagetes minuta (CAS 91770-75-1, 8016-84-0) and Tagetes patula (CAS 91722-29-1, 8016-84-0) extracts and oils are widely used fragrance ingredients of many fragrance compounds used in perfumery. Furthermore, it can be used “as such” in cosmetic products. The common name of these plants is Marigold, their extracts smell sweet-herbaceous with a powerful […]

Methylene Bis-Benzotriazolyl Tetramethylbutylphenol (MBBT, CAS 103597 45-1) is an official UV filter reported in Annex VI, Entry 23 of the European Cosmetics Regulation. As of today, this ingredient can be used at up to 10% in its normal form. Until now, the nano-form of this material could also be used but only by complying with […]

BIORIUS realized that many of its clients are confused by the language requirements in the EU. Although this aspect falls under the responsibility of your distributors (according to Article 6 of the EU Cosmetics Regulation), it is important to make a reminder of the rules currently in application as the design and edition of labels […]

Overlooked for decades, cosmetic packaging raises more and more questions and BIORIUS observed that the European Commission and the National Authorities are getting gradually interested in this topic. BIORIUS is keen to adapt itself to the state of art and defend at best the interests of its clients. For that reason, we summarized below the […]

The Regulation restricting the use of D4 and D5 in wash-off cosmetics has been published January 18th, 2018 BIORIUS informed you about the status of the project aiming to restrict the use of Cyclopentasiloxane (D5) and Cyclotetrasiloxane (D4) in the scope of the REACH Regulation (EC No 1907/2006). With this update, BIORIUS informs you that […]

Follow-up: New Legal Requirements for Peanut Oil and Hydrolyzed Wheat Protein December 5th, 2017 On December 4 th , 2017, the EU Commission published a new amendment to the EU Cosmetics Regulation (EU No 2017/2228) related to Peanut Oil (plus its extracts and derivatives) and Hydrolyzed Wheat Protein. The use of these two ingredients will […]

The EU Commission published a new piece of legislation (Regulation EU No 2017/1413) that restricts the use of Zinc Oxide when used as a colorant (CAS 1314-13-2, CI 77947). Zinc Oxide is an official colorant listed in Annex IV (Entry 144). Until now, it could be added (in its non-nano form) at any concentration in […]

The EU Commission published a new piece of legislation (Regulation EU No 2017/1410) that prohibits the use of Hydroxyisohexyl 3-Cyclohexene Carboxaldehyde (HICC, trade name: Lyral), 2,6-Dihydroxy-4-methyl benzaldehyde (Atranol) and 3-Chloro-2,6-Dihydroxy-4-methylbenzaldehyde (Chloroatranol). These three fragrance allergens caused the highest number of contact allergies cases in past years, which justifies a total ban according to the SCCS […]

Update: Methylisothiazolinone will be restricted at 15 ppm in Rinse-Off Products July 7th, 2017 Methylisothiazolinone in cosmetic products: on July 6 th, 2017, the EU Commission published a new piece of legislation (Regulation EU No 2017/1224), which aims to restrict the use of MIT in rinse-off cosmetic products at a maximum concentration of 15 ppm […]

Article 15 of the EU Cosmetics Regulation regulates the use of CMRs1 in cosmetic products. By default, the use of CMR substances is prohibited in the EU, although exemptions remain possible under specific conditions. Silent until recently, the regulatory procedure now implies the publication of an amendment to Annex II (prohibited substances) before a ban […]

On June 23rd, 2017, the Market Surveillance Authorities in France (DGCCRF) published a report on the in-market control campaign launched in 2016, which focused on almost 8,000 cosmetic products and 1,527 shops. We are proud to announce that all products evaluated by BIORIUS were considered safe and compliant by the French Authorities. Out of these […]

Like almost every cosmetics legislation in the world, the EU Cosmetics Regulation prohibits the use of heavy metals in cosmetic products. Arsenic (As), Cadmium (Cd), Mercury (Hg), Lead (Pb) and Antimony (Sb) have the greatest potential to cause harm and are responsible for serious diseases. Other metals such as Nickel (Ni) or Chromium (Cr) are […]

Retinol and Retinyl Esters – A New Approach to Manage these Ingredients May 16th, 2017 Retinol and its esters (Retinyl Acetate, Retinyl Propionate and Retinyl Palmitate) are active ingredients commonly found in anti-aging skincare products. As communicated below, Retinol and the three outlined above esters have been evaluated by the SCCS (Scientific Committee on Consumer […]

Update March 30th, 2017 You may know that Theresa May, Prime Minister of the UK, triggered Article 50 of the Treaty of Lisbon yesterday at 1:30pm. Sir Tim Barrow, the UK’s permanent representative in Brussels, personally handed over the official letter to the European Council president, Donald Tusk. Today, the clock begins ticking on two […]

A word of caution The reformulation of cosmetic products is something serious that requires time and money. For this reason, you need to be informed about possible regulatory developments as early as possible… Just keep in mind that the SCCS is usually very conservative in its assumptions and very stringent in its recommendations. Therefore, their […]

Numerous peer-reviewed articles highlighted the toxicity of hair dye substances and notably theirconcerning carcinogenic, genotoxic and skin sensitizing properties. Concerned by the potential risks for the consumers, the SCCS, the EU Commission, the Member States and the Industry developed an overallstrategy to evaluate a number of hair dye substances and, when necessary, regulate them via […]

Benzophenone-3 is a useful UV filter regulated by the EU Cosmetics Regulation through Entry 4 of Annex VI. As of today, this ingredient can be used in cosmetic products at up to 10%. Its presence should be highlighted on the product label via a specific warning ‘Contains Benzophenone-3’*. The Scientific Committee on Consumer Safety (SCCS) […]

As provided for in the EU Cosmetics Regulation (EC No 1223/2009, Article 20), the acceptability of cosmetic product claims is determined by their compliance with the common criteria. Established by the EU Commission and the EU Member States, these common criteria are reported in the Regulation EU No 655/2013 and further detailed in guidelines made […]

Zinc Pyrithione (CAS 13463-41-7) is a cosmetic ingredient used in hair products for its antimicrobial properties but also because this is an effective antidandruff and anti-seborrheic substance. As of today, the EU Cosmetics Regulation allows this ingredient as a preservative via Annex V, Entry 8 and as an antidandruff ingredient via Annex III, Entry 101. […]

Although the REACH Regulation (EC No 1907/2006) mainly pertains to the registration ofsubstances by their manufacturers or their EU representatives, the Cosmetic Industry (manufacturers of finished products, brand owners and their importers to the EU) also have to comply with some provisions of this piece of legislation. What is the REACH Regulation? As explained by […]

On July 11th, 2016, the EU Commission published a new piece of legislation (Regulation EU No 2016/1121), which aims to allow the use of Ethyl Lauroyl Arginate HCl in mouthwashes under certain conditions. This new amendment to the EU Cosmetics Regulation (EC No 1223/2009) will enter into force on August 1st, 2016 and foresees no […]

On July 11th, 2016, the EU Commission published a new piece of legislation (Regulation EU No 2016/1120), which aims to regulate further the use of Carbon Black (both in its normal and nanometer forms) in cosmetic products. This new amendment to the EU Cosmetics Regulation (EC No 1223/2009) will enter into force on August 1st, […]

On September 18th, 2015, the “Service Public Fédéral Santé Publique, Securité de la Chaîne Alimentaire et Environnement” from Belgium published a Royal Decree to set a framework defining the biodegradability and disintegrability requirements for products designed to be evacuated in the toilets. To be allowed on the Belgian market, the products designed to be evacuated […]

On December 14th, 2015, Health Canada amended the Cosmetic Ingredient Hotlist entry related to MI/MCI. The Hotlist is a list of ingredientsthat Health Canada believes may cause injury to the health of the user when used in cosmetics under certain conditions. Such use of an ingredient in cosmetics may be in violation of the Food […]

BIORIUS is pleased to inform you that the amendments to the EU Cosmetics Regulation on Zinc Oxide and Potassium Hydroxide finally got published. The publication of new amendments is not always the synonym of bad news and these two modifications of the EU Cosmetics Regulation annexes have been eagerly awaited for years. The first one […]

The EU Commission sent a request for a Scientific Opinion to the SCCS on Phenoxyethanol. The terms of this mandate were ‘Does SCCS consider Phenoxyethanol safe for use as a preservative with a maximum concentration of 1.0 %, taking into account the information provided?’. This SCCS Opinion was released by the EU Commission yesterday and, […]

The regulation (EU) No 2016/314 has just been published and will enter into force on March 25th, 2016. This new piece of legislation considers the recent toxicological investigations carried out on Ethoxydiglycol and implements use restrictions on this basis. Ethoxydiglycol, also known as DEGEE (CAS 111-90-0), is a cosmetic ingredient widely used as a solvent […]

Italy published a new decree setting detailed penalties in relation to the EU Cosmetics Regulation (Decreto Legislativo 4 dicembre 2015, n.204). Indeed, and as laid down in Article 37 of the EU Cosmetics Regulation, setting the penalties in case of non-compliance is an obligation of the EU Member States. This legislative text will fully apply […]

Biorius published an article on Polyaminopropyl Biguanide in its newsletter of January 2015. The article was relatively pessimistic about the future of this preservative and it was recommended at this time that problematic products be quickly reformulated. The main trade associations (Cosmetics Europe, COSMED, EFfCI, etc.) tried to influence the EU Commission on the basis […]

The latest Standing Committee on Cosmetic Products took place on October 22nd in Brussels. This meeting brings together the representatives of all EU Member States and aims to vote the regulatory proposals developed by the EU Commission. Several important decisions taken by this committee are worth sharing and will be published in the next few […]

Most of you are already aware of the microbeads issue and the gradual ban of this problematic ingredient in cosmetic products at global level. BIORIUS recommends that you progressively phase out these materials (in particular the non-biodegradable microbeads) of all existing cosmetic formulae. Microbeads are plastic microspheres that are widely used in cosmetics as exfoliating […]

The European Commission published a new amendment of the Cosmetics Regulation (EU No 2015/1298) to ban the use of 3-Benzylidene Camphor in cosmetic products. Until now 3-Benzylidene Camphor was considered as a safe UV filter, allowed at maximum 2% in Annex VI of the Cosmetics Regulation. However, and after being reevaluated by the SCCS in […]

Numerous peer-reviewed articles highlighted the toxicity of hair dye substances and notably their concerning carcinogenic, genotoxic and skin sensitizing properties. Concerned by the potential risks for the consumers, the SCCS, the EU Commission, the Member States and the Industry developed an overall strategy to evaluate a number of hair dye substances and, when necessary, regulate […]

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 used for their depilatory and hair waving / straightening properties. According to the Regulation, hair products do not include application on eyelashes because the level of risk is different when […]

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 piece of legislation and its adoption is expected to take place in February 2016 although there is no certainty about the exact date. Background The European Cosmetics Regulation provides that […]

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 enforcement and implementation of these new risk management measures. Biorius informed you about several ongoing issues and made assumptions on when these amendments of the EU Cosmetics Regulation would get […]