The New EU Borderline Manual 5.4 – Key Updates and Their Impact on the Cosmetics Industry
In June 2024, the European Commission published an updated version of the EU Borderline Manual, a crucial regulatory document that helps manufacturers, importers, and distributors determine whether their products fall under EU Cosmetics Regulation (EC) No 1223/2009 or if they should be classified as medicinal products, medical devices, or other regulated categories.
This latest edition, version 5.4, brings significant updates that clarify the classification of certain cosmetic products, particularly adhesives, magnetic eyeliners, and products presented in ampoules or vials. These changes reflect the growing complexity of the cosmetics industry, where innovation is constantly pushing the boundaries between cosmetics and other regulated product categories.
Adhesives and Glues – When Are They Considered Cosmetics?
One of the most notable updates in the EU Borderline Manual 5.4 addresses adhesives and glues used for artificial nails, false eyelashes, and even decorative tooth jewelry. This clarification has been long awaited by industry professionals, as the use of adhesives in beauty products has become increasingly sophisticated.
The new guidance makes an important distinction: if an adhesive itself alters the visual appearance of the area it is applied to, it may be classified as a cosmetic product. This is particularly relevant for nail adhesives that create an artificial nail layer, as they contribute directly to enhancing a person’s appearance.
However, if an adhesive’s only purpose is to attach another object to the body, such as securing false eyelashes or jewelry to teeth, then it does not qualify as a cosmetic product. Instead, it falls under the General Product Safety Directive (GPSD), which governs non-cosmetic consumer goods.
For cosmetic brands, this distinction is essential. Companies producing eyelash adhesives or nail bonding agents will need to carefully review how they market and classify their products, ensuring they comply with the appropriate regulations.
Magnetic Eyeliners – A New Cosmetic Innovation Recognized
In recent years, magnetic eyeliners have emerged as a popular alternative to traditional false eyelash glue. These products function like a regular eyeliner but contain magnetic particles that allow false eyelashes to be attached effortlessly, without the mess of adhesive.
The new version of the Borderline Manual confirms that magnetic eyeliners remain classified as cosmetics, as their primary function is to enhance the appearance of the eyes, just like traditional eyeliners. The fact that they provide an additional function—holding magnetic eyelashes in place—does not alter their classification.
This clarification is good news for cosmetic manufacturers, as it means they can continue marketing magnetic eyeliners under the EU Cosmetics Regulation without needing to comply with the stricter requirements of medical or consumer product safety regulations. However, companies must still ensure that their ingredients, labeling, and safety assessments meet all relevant EU cosmetic standards.
Ampoules and Vials – A More Defined Regulatory Framework
Perhaps one of the most impactful updates in EU Borderline Manual 5.4 is the new guidance on cosmetic products in ampoules or vials. With the rise of high-end skincare products packaged in single-use ampoules, there has been growing uncertainty over whether these products should be classified as cosmetics, medical devices, or even pharmaceutical products.
The new guidance states that ampoule-based products can be considered cosmetics as long as they meet specific conditions. Firstly, they must not be intended for injection. This is a crucial distinction, as many consumers might associate ampoule packaging with injectable treatments, which would fall under medical device regulations. If a product’s presentation or instructions suggest that it should be injected, it cannot be marketed as a cosmetic.
Additionally, for an ampoule or vial product to qualify as a cosmetic, it must have a clear cosmetic purpose, such as hydrating the skin, reducing wrinkles, or improving complexion. The packaging and instructions must explicitly state that the product is for external use only, ensuring that consumers do not mistakenly assume it should be applied below the epidermis.
Furthermore, the product must not be marketed with any device that enables injection or subcutaneous delivery. This means that cosmetic brands need to be careful when designing their packaging, ensuring that their ampoules and vials do not resemble injectable treatments.
This update is particularly relevant for the luxury skincare market, where ampoule-based treatments have become increasingly popular. Skincare brands offering serums, concentrates, or anti-aging treatments in ampoule form will need to ensure that their marketing materials and instructions clearly communicate their intended external application.
How These Changes Impact the Cosmetics Industry
The updated EU Borderline Manual 5.4 brings much-needed clarity to several cosmetic product categories, which will help businesses navigate regulatory requirements more effectively.
For manufacturers, the key takeaway is that classification decisions must be made with great precision. While some innovations, like magnetic eyeliners, clearly fall within the scope of cosmetic regulations, others—such as adhesives and ampoule-based products—require more careful consideration.
Regulatory compliance is becoming increasingly complex in the cosmetics sector, and companies need to ensure that their products are classified correctly from the start. Misclassification can result in regulatory penalties, product recalls, or even legal disputes.
Moreover, these new guidelines highlight the European Commission’s commitment to consumer protection. By clarifying classification rules, the EU ensures that cosmetic products are marketed transparently, preventing misleading claims and reducing the risk of consumer confusion.
For cosmetic brands, these updates may require adjustments in marketing, product labeling, and packaging design. Companies should review their product portfolios carefully and, if necessary, consult with regulatory experts to ensure compliance with the latest requirements.
Conclusion – What Comes Next?
The release of EU Borderline Manual 5.4 is a significant moment for the cosmetics industry, as it introduces clearer classification rules for products that previously existed in a regulatory gray area.
For manufacturers and distributors, the key challenge will be adapting their compliance strategies to align with these new definitions. This means reassessing product claims, ensuring clear labeling, and avoiding any misleading packaging that could suggest medicinal use.
The EU regulatory landscape continues to evolve, and staying informed about changes like those in the Borderline Manual is essential for any company operating in the European cosmetics market. Those who proactively adapt to these new guidelines will be better positioned to ensure compliance, maintain consumer trust, and avoid regulatory complications.
📌 For more details and access to the full document, visit the official website of the European Commission.