Are you excited about launching your cosmetic brand in Europe?
You’re not alone!
Europe’s cosmetics market is thriving, and it’s an excellent opportunity for businesses like yours to tap into this lucrative industry.
But before you dive in, there’s something you need to know: navigating the legal landscape can be tricky. That’s where this ultimate guide comes in handy.
Your one-stop resource for EU cosmetics regulations
In this comprehensive guide, we’ll walk you through the ins and outs of selling cosmetics in the European Union (EU).
We’ll cover the essential laws and regulations you need to be aware of, from the EU Cosmetics Regulation to labeling requirements and more.
We’ve designed this guide to be your one-stop resource for understanding the legalities of entering the European cosmetics market.
Making the complex simple
We know that starting a cosmetics business can be overwhelming, especially when you’re dealing with unfamiliar regulations.
But don’t worry – we’re here to help!
We’ll break down complex legal concepts into easy-to-understand language and provide practical tips to make your journey into the European market as smooth as possible.
Ready to conquer the European cosmetics scene?
So, are you ready to conquer the European cosmetics scene? Let’s get started!
The European Union Cosmetics Regulation (EC) No. 1223/2009
By understanding and complying with the European Union Cosmetics Regulation (EC) No. 1223/2009, you’ll be well on your way to successfully launching your cosmetics brand in the European market.


Ensuring cosmetic product safety
The backbone of cosmetics regulations in the EU is the European Union Cosmetics Regulation (EC) No. 1223/2009.
This regulation is designed to ensure the safety, quality, and efficacy of cosmetic products sold within the EU.
It’s crucial for you, as a cosmetics business owner, to familiarize yourself with this regulation, as it sets the foundation for selling cosmetics in Europe.
Navigating ingredient restrictions and prohibited substances
The EU Cosmetics Regulation includes a list of banned substances and restrictions on certain ingredients.
This means you’ll need to carefully review the ingredients in your products and ensure they comply with these regulations.
Keep in mind that the list is regularly updated, so staying informed about any changes is essential.
Mastering labeling requirements
Proper labeling is a critical aspect of compliance with EU Cosmetics Regulation.
The regulation lays out specific requirements for labeling cosmetic products, including:
- General labeling rules for all cosmetics including all mandatory information (see graphic below)
- Specific labeling requirements for different types of cosmetics (e.g., skincare, makeup, hair care, etc.)
- Language requirements (language of the target market)
- Special danger warnings for the use of certain active ingredients (text and/or symbols)
By adhering to these labeling requirements, you’ll ensure your products are transparent and informative to consumers, and you’ll avoid any potential regulatory issues.
To learn more about packaging, read our Ultimate Guide to Cosmetics and Makeup Packaging.


The importance of the Product Information File (PIF)
The Product Information File (PIF) is a crucial document that contains all relevant information about your cosmetic product.
This includes a description of the product, the safety assessment, data on ingredients, and proof of claims, among other things.
The PIF must be kept up-to-date and available for inspection by competent authorities.
Notifying your cosmetic products
Before you can sell your cosmetics in the EU, you’ll need to notify the European Commission through the Cosmetic Products Notification Portal (CPNP).
This process involves submitting information about your products, such as their name, ingredients, and Responsible Person. The CPNP serves as a central database for EU authorities to monitor the cosmetics market and ensure compliance.
For more guidance on starting a cosmetics business, visit our 12 Tips for Starting a Cosmetic Business blog post.


The Role of the Responsible Person (RP)
Definition and responsibilities
When launching your cosmetics brand in Europe, it’s essential to understand the crucial role of the Responsible Person (RP).
The RP is an individual or entity based in the EU who is legally responsible for ensuring that your cosmetic products comply with all the relevant EU regulations.
This includes overseeing the safety assessment, product notification, and maintenance of the Product Information File (PIF).
In short, the RP serves as your point of contact with regulatory authorities and plays a vital role in helping you navigate the complex world of cosmetics compliance.
Selecting and appointing an RP
Choosing the right RP is a critical decision for your cosmetics business, as they can significantly impact your brand’s success in the European market.
Here are a few tips to help you select and appoint an RP:
Look for expertise: Find an RP with experience in the cosmetics industry and a thorough understanding of EU regulations. They should be well-versed in the compliance process and able to guide you through it.
Check their credentials: Ensure that the RP you’re considering has the necessary qualifications and certifications to perform their duties effectively. This may include degrees in fields like chemistry or toxicology, as well as relevant industry experience.
Communication is key: A good RP should be easy to communicate with and responsive to your needs. Look for someone who can provide clear guidance and is willing to collaborate with you throughout the compliance process.
Get recommendations: Ask for references from other cosmetics businesses that have worked with the RP you’re considering. This can give you valuable insights into their performance and reliability.


Compliance with Good Manufacturing Practices (GMP)
Overview of GMP in the cosmetics industry
Good Manufacturing Practices (GMP) are a set of guidelines that ensure the consistent quality and safety of cosmetic products.
In the EU, complying with GMP is a must, as it helps to minimize risks associated with cosmetic production and guarantees that your products meet the high standards expected by consumers and regulators.
GMP covers various aspects of the manufacturing process, from raw materials and equipment to personnel and quality control procedures.
Key aspects of GMP compliance
To ensure your cosmetics business complies with GMP, you’ll need to focus on several key aspects:
Facilities and equipment: Your manufacturing facility should be clean, well-maintained, and designed to prevent contamination. Equipment used in production should be regularly inspected and maintained to guarantee optimal performance.
Personnel: Employees involved in the manufacturing process should be well-trained, qualified, and follow proper hygiene practices. This helps to prevent contamination and ensure the consistent quality of your products.
Quality control: Implement a robust quality control system that includes regular testing of raw materials, in-process samples, and finished products. This will help you identify and address any quality issues before your products reach the market.
Documentation: Maintain detailed records of your manufacturing processes, quality control procedures, and employee training. This documentation will be crucial in demonstrating your GMP compliance during inspections or audits.
Our Contract Manufacturer Cosmetics article offers more information on choosing a manufacturer that follows GMP guidelines.


Watch out for the ISO 22716 certification
ISO 22716 is an internationally recognized standard for GMP in the cosmetics industry.
Achieving ISO 22716 certification demonstrates your commitment to quality and safety, and it can give your brand a competitive edge in the market.
By working with an ISO 22716 certified manufacturer, you can ensure that your products meet the highest GMP standards, giving you and your customers peace of mind.
EU Cosmetic Claims Regulation
Definition and scope
When marketing your cosmetic products in Europe, it’s essential to be aware of the EU Cosmetic Claims Regulation.
This regulation sets the standards for claims made about cosmetic products, ensuring that they are truthful, clear, and backed by evidence.
The regulation applies to any statements made about a product’s features, performance, or efficacy, whether on the packaging, in advertising, or through other marketing channels.


Criteria for cosmetic claims
To comply with the EU Cosmetic Claims Regulation, your product claims must meet several key criteria:
Legal compliance: Claims should not contradict the legal requirements for cosmetic products, including safety, efficacy, and labeling regulations.
Truthfulness: All claims should be honest and backed by reliable evidence, such as scientific studies or consumer testing.
Evidential support: Claims must be supported by adequate, verifiable evidence that can be easily accessed and understood by consumers and regulators.
Honesty: Claims should fairly represent the product’s performance and not exaggerate its benefits or features.
Informed decision-making: Claims should provide clear, accurate information that allows consumers to make informed choices about the products they purchase.
Common claims and examples
When marketing your cosmetics in Europe, it’s essential to be cautious about the claims you make.
Here are some common claims and examples of how to ensure they comply with the EU Cosmetic Claims Regulation:
Navigating National Laws and Regulations
Understanding variations between EU member states
Although the European Union has a harmonized set of regulations for cosmetics, individual member states may have additional requirements or variations.
As a cosmetics seller, it’s vital to be aware of these differences to ensure compliance in each market you enter.
Familiarizing yourself with the specific rules and regulations in each country will help you adapt your business strategy accordingly and avoid any potential legal issues.
Examples of country-specific regulations
Let’s take a look at a few examples of country-specific regulations in the EU.
In France, for instance, you might need to comply with additional safety assessments and provide French translations of your product labels.
Germany has specific rules regarding the use of certain ingredients, like alcohol in cosmetic products, which might require a different formulation for the German market.
In Italy, you may need to adhere to stricter rules on the use of specific preservatives.
These are just a few examples; the requirements can vary significantly across the EU, so it’s crucial to research and understand the regulations in each market.
Steps to ensure compliance in each market
- Research the specific laws and regulations in each country where you plan to sell your cosmetics.
- Consult with local experts or legal professionals to help you understand and navigate the country-specific requirements.
- Customize your product labels, packaging, and formulations to meet the specific regulations in each market.
- Stay up-to-date with any changes in laws or regulations and adapt your business practices accordingly.


Selling Cosmetic Products online in Europe
eCommerce regulations and requirements
Navigating the world of eCommerce can be challenging, especially when selling cosmetics online in Europe.
To help you out, let’s discuss some essential aspects you need to consider.
First and foremost, create product descriptions that are not only accurate but also transparent.
This means listing all ingredients, explaining usage instructions, and highlighting any potential risks associated with your products.
Don’t forget to be upfront about pricing, including any taxes and shipping fees.
Your customers will appreciate the transparency!
Also, having a customer-friendly returns policy in line with EU consumer rights directives will ensure that your online store is compliant and trustworthy.
Cross-border sales considerations
Selling cosmetics across European countries comes with its own set of challenges.
Reliable shipping partners can make a world of difference, ensuring that your customers receive their products promptly and without any issues.
When it comes to taxes, make sure you’re on top of VAT registration in each country where you exceed the distance-selling threshold.
Charging the appropriate VAT rate based on the destination country is equally important.
And, of course, it’s essential to have product labels customized to meet the language requirements and safety standards of each country you’re selling in.


Data protection and GDPR compliance
Protecting your customers’ data is of utmost importance when selling online in Europe.
To comply with GDPR, start by developing a clear privacy policy that outlines your data collection, processing, and storage practices.
Be proactive in seeking consent from customers before gathering their data and always use secure methods for data storage and transmission, like encryption and SSL certificates.
Also, have a plan in place to handle data subject access requests and be ready to modify or delete personal data as needed.
This shows your customers that you value their privacy and are committed to keeping their information safe.
Recap of what we have learned
Recap of key points
We’ve covered a lot of ground in this guide, so let’s take a moment to revisit the essential points.
To successfully sell cosmetics in Europe, it’s crucial to adhere to EU regulations, including labeling requirements, product safety, and ingredient restrictions.
You’ll need to appoint a Responsible Person to ensure compliance and keep up with Good Manufacturing Practices.
Moreover, be aware of country-specific regulations.
Don’t forget the importance of navigating the world of eCommerce, which involves adhering to regulations and requirements, managing cross-border sales, and ensuring data protection and GDPR compliance.
Emphasizing the importance of compliance
Compliance with European laws and regulations is not just a legal obligation but also a way to build trust and credibility with your customers.
By showing that you prioritize safety, transparency, and consumer rights, you’ll foster a loyal customer base and set yourself apart from competitors who might not be as diligent in their compliance efforts.


Encouragement for potential cosmetics sellers in the EU
Embarking on a journey to sell cosmetics in the European Union might seem daunting, but with the right knowledge, preparation, and commitment to compliance, you’ll be well on your way to success.
As you navigate the various regulations and requirements, remember that you’re not alone—there are countless resources and experts available to help you along the way.
By following the guidelines and best practices outlined in this guide, you’ll create a thriving cosmetics business in the European market, reaching more customers and making a positive impact on the industry.
So go ahead, take the plunge, and bring your unique cosmetic products to the vibrant and diverse European market!
Contact us now and we take care of everything
Navigating the complex world of cosmetics laws and regulations in Europe can be challenging, but you don’t have to do it alone.
At SBLC, we’re here to guide you through every step of the process. From product development and manufacturing to ensuring compliance with EU requirements, we’ve got your back.
Get in touch with our team of experts today, and let us help you bring your vision to life in the European cosmetics market.
Don’t wait – your successful cosmetics business starts here!
FAQ
What are the main cosmetics regulations in the European Union?
The main cosmetics regulations in the EU include the EU Cosmetics Regulation (EC) No. 1223/2009, Good Manufacturing Practices (GMP), and the EU Cosmetic Claims Regulation.
These regulations cover product safety, ingredient restrictions, labeling requirements, and marketing claims.
What is the role of a Responsible Person (RP) in the EU cosmetics market?
A Responsible Person (RP) ensures that a cosmetic product complies with EU regulations.
They oversee the product’s safety assessment, manage product information files, and handle any adverse reactions reported by consumers.
How can I ensure my cosmetic products comply with Good Manufacturing Practices (GMP)?
To comply with GMP, follow the guidelines in the ISO 22716 standard.
This includes maintaining a clean and hygienic production environment, implementing quality control procedures, and ensuring proper documentation of manufacturing processes.
If you have a private label cosmetics supplier like us, ask for their GMP certification.
How do I make cosmetic claims compliant with EU regulations?
To comply with GMP, follow the guidelines in the ISO 22716 standard.
This includes maintaining a clean and hygienic production environment, implementing quality control procedures, and ensuring proper documentation of manufacturing processes.
If you have a private label cosmetics supplier like us, ask for their GMP certification.
How do I make cosmetic claims compliant with EU regulations?
Ensure your claims are substantiated by scientific evidence, such as clinical studies, research data, or expert opinions. This means that the effects claimed must be proven and measurable.
Be very careful when making claims about the product’s performance.
Please consult a lawyer in any case, but especially if you intend to print promises of effectiveness on your product.
Because then you can not simply undo it, as you could for example in your online shop.
Are there variations in cosmetics regulations between EU member states?
While the main regulations apply across the EU, some member states may have additional requirements or specific regulations.
It’s essential to research and understand the unique requirements of each market where you plan to sell your products.
What should I consider when selling cosmetic products online in Europe?
When selling cosmetics online in Europe, you must follow eCommerce regulations, address cross-border sales considerations, and ensure compliance with data protection laws like the GDPR.
Additionally, it’s crucial to pay attention to the product claims you make regarding the product’s performance, as making misleading or false claims can result in penalties or legal actions.