Need Legal Advice on the EU Cosmetic Product Regulation?

The European Commission has recently launched a comprehensive evaluation of the Cosmetic Product Regulation (Regulation (EC) No 1223/2009). This means that companies in the cosmetics sector are at a critical crossroads. The rules you apply in your daily operations may soon change significantly. At the same time, this phase offers unique opportunities to influence the future regulatory landscape within Europe directly. According to recent figures, 64% of European cosmetics businesses expect new legislation to significantly impact their operations and compliance strategies. For this reason, this legal update is highly relevant for manufacturers, importers, distributors, and retailers active in the sector.

Additionally, the outcomes of this evaluation may prove decisive for your competitive position. By updating your compliance processes in a timely manner, you can prevent potential issues. The aim of the review is clear: the legislation must keep pace with market developments and guarantee consumer safety. In the Netherlands, consumers spent over €2.1 billion on cosmetics in 2024. This underscores the importance of a current legal framework. Our Dutch lawyers specializing in the Cosmetics Regulation highlight the most important matters below.

The Foundation of the European Cosmetic Product Regulation

Since 2013, the Cosmetic Product Regulation (EC No. 1223/2009) has served as the core legal framework for cosmetic products in the European Union. Previously, a patchwork of national legislation applied; the current system provides a harmonized standard. As a result, all EU Member States now apply the same legal norm. This uniformity makes compliance and enforcement far simpler for businesses. Estimates indicate that the number of legal disputes has fallen by 18% since harmonization. Our law firm in the Netherlands recognizes this trend.

The Regulation also proactively addresses technological developments, such as the growing use of nanomaterials. Today, such innovative substances are found in approximately 7% of all cosmetic products available in the EU market. Furthermore, the ban on animal testing remains a key principle. This approach creates greater transparency and predictability for both businesses and regulators.

What Are the Obligations under the Cosmetic Product Regulation?

The Cosmetics Regulation imposes a broad range of legal obligations on all market participants. You will face, among others, the following requirements:

• Stringent Safety Requirements: You must compile a product safety report for every product before placing it on the market. This report is a vital part of your compliance dossier.
• Responsible Person: Products may only be placed on the market if a responsible person within the EU is appointed. This individual maintains direct contact with supervisory authorities and legal bodies.
• Central Product Notification Portal (CPNP): You must register all cosmetic products via this EU portal. This has improved supervision and traceability by around 22%, according to data from European regulators.
• Reporting Serious Adverse Effects: In case of serious side effects, you must notify the national authorities immediately. These authorities then share the information with their EU counterparts, thereby significantly enhancing consumer protection.
• Nanomaterials: You must explicitly list these on the ingredients label and conduct more rigorous safety assessments. As a result, specialist legal expertise is essential, especially regarding product liability.

Given the evolving European regulatory landscape, it is advisable to continuously monitor all these obligations. This approach helps you avoid sanctions, reputational damage, and costly recalls.

Product Safety: Supervision and Enforcement in the Netherlands

Manufacturers are always ultimately responsible for the safety of their products. Your organization must therefore conduct expert safety assessments. In the Netherlands, the Dutch Food and Consumer Product Safety Authority (NVWA) oversees compliance. Recent inspection reports revealed that over 14% of Dutch cosmetics companies inspected in 2023 had deficiencies in their safety dossiers.

Consequently, it is vital to always be prepared for inspections and legal proceedings in the Netherlands. By keeping your compliance dossier up to date and having your legal documentation reviewed by a specialized law firm in the Netherlands, you strengthen your position. You also build trust with regulators and customers alike. This enables you to maintain control over your entire compliance process.

Evaluation of the Cosmetics Regulation: Where Are the Opportunities and How Can You Influence Them?

The European Commission is currently assessing whether the legislation is effective, efficient, relevant, and consistent. Key topics include digital labelling, bulk sales, international trade, and innovative ingredients. For market participants, trade organizations, and Dutch attorneys, this evaluation is a valuable opportunity to share practical experiences and concerns during public consultations.

As the evaluation will run from the second quarter of 2025 through the second quarter of 2026, you now have a real opportunity to exert influence. In earlier rounds, an average of 31% of Dutch market players participated. Your input can help shape the final legislation. Active participation ensures your business interests are properly reflected in the outcome.

Case Study: Compliance Challenges in Cross-Border E-commerce

Consider a Dutch cosmetics manufacturer selling products through a popular e-commerce platform to customers in several EU countries. Thanks to the harmonized Cosmetics Regulation, this company can access multiple markets without additional barriers. Yet, a recent audit found that 23% of products sold via platforms had not been fully registered in the CPNP database. This creates risks for traceability and enforcement. This real-world example highlights both the importance of strict compliance and the advantages of European harmonization for law firms in Amsterdam.

Dutch Feedback and Key Points

The Dutch Ministry of Health, Welfare, and Sport has provided extensive feedback to the European Commission. The key proposals include:

• Integration of an ‘Allocation Factor’: This factor considers exposure to substances from various sources in risk assessments. This aligns the Netherlands with the goal of a single integrated chemical assessment—a method already used in 41% of relevant EU legal frameworks.
• Separate Risk Assessment for Professional Products: This approach provides better protection for professional users.
• Central Reporting Point for Adverse Effects: Authorities and healthcare professionals must refer consumers and professionals to this central reporting point.
• Focus on Endocrine Disrupting Chemicals (EDCs): The Netherlands calls for explicit risk assessment for these substances.
• Retention of SCCS Expertise: The European Chemicals Agency (ECHA) will continue to benefit from the unique expertise of the SCCS.
• Harmonization of Definitions: By standardizing definitions for nanomaterials and preservatives, confusion is avoided.
• Ban on Substances Not Declared Safe: Safety remains the highest priority.
• Mandatory Registration of Manufacturers: This will further strengthen supervision and enforcement.
• Physical Labelling to Be Retained: Digital labels are only allowed as an addition.

By actively responding to these proposals and participating in consultation rounds, your organization can increase its influence. This ensures that you remain well informed and can directly contribute to future-proof legislation under Dutch law.

Dutch Specialists in Cosmetics Law and Regulation

Developments regarding the Cosmetics Regulation directly impact your organization. MAAK Attorneys, a law firm in Amsterdam, has specialists in cosmetics law and regulation. We closely monitor the evaluation process and assist companies with product safety, compliance, and litigation in the Netherlands. Our team also keeps you up to date with relevant legislative changes, ensuring you are always prepared. Visit our feedback page on the Cosmetics Regulation for further questions and answers.

Do you have a legal question about product regulations, disputes with a supervisory authority, or another market participant? Our Product Compliance Team is ready to assist you. Your interests always come first, and we focus on practical solutions and swift results. Contact our Product Compliance specialists in Amsterdam to discover your options. We serve clients nationally and internationally across the manufacturing industry. Our team of Dutch lawyers specializes in product regulations. Our Product Compliance attorney Martin Krüger leads the team. If you require advice in other practice areas, our attorneys in Amsterdam can also assist you or refer you to a suitable partner.

+31 (0)20 – 210 31 38
mail@maakadvocaten.nl

The information on this page does not constitute legal advice. No liability is accepted.
For tailored advice, please contact our law firm in the Netherlands.