In order to sell a cosmetic product in the USA, it is essential to ensure the compliance of the product with the current regulatory requirements.
Two types of analysis are possible:

A “federal + states” review (by default) which is a complete analysis including the states specificities.
A “federal” review which is a general one.

These regulatory requirements vary depending on if the product is considered as a cosmetic or an Over-The-Counter Drug (OTC).
BIORIUS helps you to respect each requirement, no matter the category of your product.

Cosmetics labelling requirements

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: A PIF A compliant formula A compliant label A notification on the EU CPNP or SCPN portal A EU or UK Responsible […]

25 April 202225 April 2022

MADE IN ITALY VS IMPORTED IN ITALY – 2020/2021

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?

21 April 202219 May 2022

The importance of the UK market and why brands should invest time in gaining compliance with the UK legislation

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 […]

15 April 202215 April 2022

How to sell cosmetics in Japan and comply with local regulations

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 […]

7 April 20227 April 2022

COSMOPROF WORLDWIDE BOLOGNA 2022

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.

31 March 20221 April 2022

Labeling Threshold Formaldehyde Donors

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

16 March 202217 March 2022

SCCS opinion on Butylated hydroxytoluene (BHT)

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

14 March 202214 March 2022

Omnibus V Regulation and Omnibus IV Reminder

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

3 March 20227 March 2022

The CPNP notification

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 […]

25 February 202225 February 2022

La notification CPNP

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) […]

15 April 202215 April 2022

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 […]

22 February 202225 February 2022

HOW TO GET VEGAN CERTIFICATION FOR YOUR COSMETICS

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.

21 February 202221 February 2022

Nanomaterials Future Ban

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

21 February 202221 February 2022

GMO-free Certification

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.

15 February 202215 February 2022

DID MY COSMETIC PRODUCT BECOME A MEDICAL DEVICE?

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

3 February 202225 February 2022

New Requirements for Class I Medical Devices under the MDR

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 […]

31 January 202225 February 2022

CPSR – COSMETIC PRODUCT SAFETY REPORT

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 […]

28 January 202214 February 2022

Cosmetic Business Trends 2022 (Part 2 )

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

28 January 20227 February 2022

Packaging Adaptation in International Marketing

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 […]

14 January 20227 February 2022

BEAUTY TRENDS 2022

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

31 December 202131 December 2021

The First Steps for Compliant Cosmetic Products in Europe or UK

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 […]

30 December 202131 December 2021

The Impact of the COVID-19 Crisis on the EU/UK Cosmetic Markets:

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 […]

10 December 202122 December 2021

Why Choose BIORIUS for your Cosmetic Certifications?

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

9 December 202114 December 2021

What is a Product Information File (PIF)

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

4 November 20218 February 2022

Biorius presentation for the KCA event of October 28th

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.

26 October 20214 November 2021

Changes in the US FDA Colorants List

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

21 October 202121 October 2021

Labeling of additional fragrance allergens

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

27 July 20217 February 2022

Italian Environmental Labelling postponed to 2022 and further clarifications.

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

2 July 20217 February 2022

Future Restriction of Microplastics in Cosmetic Products

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

3 May 202117 August 2021

“Omnibus IV” Regulation

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

8 April 202117 August 2021

Application of the Italian Environmental Labelling to cosmetic products

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 […]

24 March 202130 March 2022

Impact of the AGEC Law on Cosmetic Products Sold in France

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 […]

18 March 20217 February 2022

European Cosmetics Regulation Change due to “Omnibus III”

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

18 March 202117 August 2021

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 […]

4 March 20215 July 2021

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

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

26 February 202126 February 2021

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

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

17 February 202118 February 2021

Did You Know that Cosmetic products have REACH obligations? Part 2

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 […]

17 February 202126 February 2021

New Approved UV Filter in the EU

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

10 February 202117 August 2021

Hair dyes update

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

8 February 202117 August 2021

The Impact of Directive EU No 2019/904 and Regulation EU No 2020/2151 on Cosmetic Products

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 […]

2 February 20215 July 2021

Did you know that Cosmetic products have REACH obligations?

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

6 January 20215 July 2021

China Cosmetic Supervision and Administration Regulation

Chinese New Year’s Resolution – IIL 01

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

18 December 202023 December 2020

Brexit impact on cosmetic compliance – IL 077

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

17 December 20205 July 2021

GMP (Good Manufacturing Practices)

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

27 April 202227 April 2022

Within the framework of the registration of your products on the Canadian market, our experts evaluate the formula and the labels according to the Canadian requirements and regulation. BIORIUS can also notify your products to Health Canada in order to provide you with the registration number.
The equivalent of OTC in Canada is called Natural health products (NHPs). Our experts can also help you with this type of products.

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