European cosmetics regulations: everything you need to know to ensure compliance

So, what are the significant changes and implementation dates you need to know about? Which ingredients will soon be banned? And how can you better anticipate and ensure compliance as a brand in the cosmetics industry? This article informs you about cosmetics regulations in Europe, how the framework will evolve in 2025, and gives you advice on how to secure the development of your products. 

European cosmetics regulations are based on Regulation (EC) No.° 1223/2009, which governs the marketing of products. Aimed at all players in the cosmetics industry, it imposes strict requirements in terms of formulation, risk assessment, and labeling.  

It comprises several significant obligations, including :  

• Designation of a Responsible Person: to ensure consumer product safety, companies must designate an entity responsible for guaranteeing product conformity. This may be the manufacturer, importer, or distributor, for example.

• CPNP notification: each product must be registered on the cosmetics notification portal before marketing. This declaration includes the product category, the identity and contact details of the person responsible, the member state of marketing, and the possible presence of nanomaterials or substances classified as CMR. 

• Compliance with good manufacturing practice (ISO 22716): all companies must comply with manufacturing standards to ensure product quality and safety for consumer health.   

• Product safety assessment: each product undergoes a safety assessment before it is placed on the market. A qualified expert carries out this analysis.
  Once a cosmetic product is on the market, it is subject to continuous monitoring (cosmetovigilance) to identify and report any undesirable effects. 

• The Product Information File: this is a document containing all the information required to demonstrate product conformity. It includes the product description, the safety assessment report, a description of the manufacturing method, evidence of the claimed effect, and animal testing data, if applicable.

European regulations are not set in stone. On the contrary, it is regularly updated with new texts to make it more effective and achieve its objectives.  

In addition to Regulation 1223/2009, other laws and directives influence cosmetic products and must be considered. These include France’s AGEC law, which imposes practices on packaging, and the directive on environmental claims, which combats greenwashing.  

In 2025, several significant changes will come into effect. Here’s a closer look at the changes you need to consider.  

The EU is continuing its drive to improve the safety of cosmetic products by introducing new bans and restrictions on certain substances used in formulations.  

Notable changes include bans on the UV filter 4-MBC, with non-compliant products no longer allowed on the market from May 1. Dimethyltolylamine and Trimethylbenzoyl Diphenylphosphine Oxide will be banned from September 1, 2025 

Specific nanomaterials have been added to the list of bans. Since February 1, products containing nano substances that do not comply with or are banned by the Nano Omnibus may no longer be marketed. They will be withdrawn from the market and unavailable to consumers from November 1. 

Other substances are subject to restrictions. This is the case for homosalate, a UV filter whose use is now limited to 7.34% and only authorized in facial products (except sprays and aerosols) as of January 1, 2025. Products not complying with the new rules must be withdrawn by July.  

The maximum concentrations of the Triclocarban and Triclosan preservatives will also be adjusted from January 2025, with non-compliant products to be withdrawn from November 2025.  

Another substance affected by the new regulations is vitamin A, whose concentrations will be limited to 0.05% in body lotions and 0.3% in other products from November 2025.  

In addition, certain substances used in skin care products, such as genistein, daidzein, kojic acid, arbutin, and alpha-arbutin, will be subject to new concentration limits from February 2025, with the withdrawal of non-compliant products imposed from early November 2025.  

• For more information and key deadlines, please visit calendar 2025 Cosmed. 

Consumers expect more and more transparency from brands. Legislators are aligning themselves with these expectations and imposing new rules in line with them.  

Since January in France, the dematerialized display of Environmental Qualities and Characteristics (EQC) has been compulsory for companies with sales of over 10 million euros and selling more than 10,000 units of products. This display informs consumers about the environmental impact of products 

The regulations also aim to improve packaging safety, notably with the ban on certain mineral oils (MOAH and MOSH) above a certain concentration level, in accordance with the requirements of the AGEC law, from January 1, again in France.  

The fight against deforestation and forest degradation is also being considered: the EUDR (European Union Deforestation Regulation) has seen its application postponed until December 31, 2025, but companies must already anticipate and prepare for this by ensuring that their plant-based raw materials do not come from deforested land after December 2020. 

To adapt, cosmetics brands must actively monitor and adjust their formulation processes in line with best practices.  

Faced with the many changes in European cosmetics regulations, cosmetics laboratories must adapt quickly to avoid any risk of non-compliance (and potential sanctions!). This implies constant regulatory monitoring, meticulous management at every stage of the formulation process, and perfect traceability of ingredients and information.  

Coptis is the ideal partner for professionals in this sector. Our PLM (Product Lifecycle Management) solution, dedicated to the cosmetics industry, enables companies to secure their new product developments. Coptis PLM centralizes all information and encourages best practices to be integrated immediately.  

Coptis integrates automatic alerts when ingredients are selected in the event of regulatory non-compliance or non-compliance with environmental claims defined in the marketing brief and relation to the target market. 

Moreover, Coptis automates the generation of regulatory files (PIF, labeling, etc.) to save time, concentrate on high-value-added tasks, and avoid manual errors.   

The Coptis Reg module continuously updates legal requirements to support formulators and check their formulas (country restrictions, alerts, etc.). In real-time, they can be assured of compliance with current international standards, thanks to data verified by experts covering some hundred countries.    

Would you like to find out more and receive further information? Don’t hesitate to contact our teams.