Everything You Need to Know About Dermocosmetics: Regulations, Safety, and Best Practices
1. Introduction: What Are Dermocosmetics?
Simple definition:
Dermocosmetics are products positioned midway between traditional cosmetics and dermatology. Although there is no official legal definition of the term, it is widely used to describe skincare developed with a scientific approach and often recommended by healthcare professionals.
However, these products do not have any medicinal purpose: they are not intended to prevent or cure diseases.
Market growth:
Demand for these products is growing rapidly, as more and more consumers are looking for effective and safe solutions for their skin, especially in cases of specific dermatological conditions. Dermocosmetics aim to address specific skin issues (acne, rosacea, psoriasis, dryness, etc.) while improving the skin’s appearance.
2. Regulatory Requirements for Dermocosmetics
European Regulation (Regulation 1223/2009): This text defines the rules to be followed for all cosmetic products sold in Europe. Since dermocosmetics fall under this category, they must comply with it.
The European regulation, which is very strict, ensures a high level of protection for consumer health.
Safety, performance, and benefits:
Dermocosmetics cannot make medical claims; otherwise, they would be classified as medicines. Brands must prove, through clinical studies—very often under the supervision of experienced practitioners such as dermatologists, allergists, or ophthalmologists—that their products are safe and effective.
3. Risks of Non-Compliance
Possible sanctions:
Non-compliance with existing regulations can lead to product withdrawals or recalls, fines, or even a sales ban. It can also damage the brand’s reputation.
Problems with false claims:
If a brand makes unproven promises, it risks severe legal and/or criminal penalties for fraud or misleading consumers.
4. How to Ensure Compliance for Your Dermocosmetic Products
- Choose ingredients wisely: Use safe and authorized ingredients for dermocosmetic products. These products include clinically tested active ingredients for both effectiveness and safety.
- Document tests and results: Make sure all clinical tests are conducted rigorously and that you have the necessary evidence to support your claims.
- Regularly update your Product Information Files: Each product must be accompanied by a file ensuring its safety and effectiveness. This file should be updated regularly and include all required data about raw materials, finished products, and even packaging.
5. Best Practices for Optimal Dermocosmetic Management
- Collaborate with experts: Work with dermatologists and toxicologists to ensure the safety and effectiveness of your products.
- Continuous training: Make sure your teams are trained on the latest regulatory requirements and best practices for developing and manufacturing cosmetic products.
- Regulatory monitoring: Stay informed about changes in national and international regulations to ensure your products always comply with current standards.
6. Conclusion: Regulatory Compliance as a Key to Success for Dermocosmetics
In a sector where consumer trust is crucial, regulatory compliance stands out as a strategic pillar for dermocosmetic brands. More than just a legal obligation, it is a mark of quality, safety, and transparency—essential for standing out in a demanding and competitive market.
By complying with current regulations—whether clinical testing, ingredient traceability, or labeling—companies strengthen their scientific credibility and legitimacy with both consumers and healthcare professionals.
Thus, compliance should not be seen as a constraint but as a real lever for success, capable of transforming a brand into a leading reference in dermocosmetic care.
Why choose EcoMundo?
EcoMundo supports every player in the cosmetics industry—manufacturers, distributors, laboratories, and brands—at every stage: formulation, regulatory compliance, international monitoring, substance management, and go-to-market strategy. Thanks to our scientific expertise and innovative digital solutions, we secure your projects and accelerate their success on a global scale. 👉 Contact our experts today!
1. Introduction: What Are Dermocosmetics?
Simple definition:
Dermocosmetics are products positioned midway between traditional cosmetics and dermatology. Although there is no official legal definition of the term, it is widely used to describe skincare developed with a scientific approach and often recommended by healthcare professionals.
However, these products do not have any medicinal purpose: they are not intended to prevent or cure diseases.
Market growth:
Demand for these products is growing rapidly, as more and more consumers are looking for effective and safe solutions for their skin, especially in cases of specific dermatological conditions. Dermocosmetics aim to address specific skin issues (acne, rosacea, psoriasis, dryness, etc.) while improving the skin’s appearance.
2. Regulatory Requirements for Dermocosmetics
European Regulation (Regulation 1223/2009): This text defines the rules to be followed for all cosmetic products sold in Europe. Since dermocosmetics fall under this category, they must comply with it.
The European regulation, which is very strict, ensures a high level of protection for consumer health.
Safety, performance, and benefits:
Dermocosmetics cannot make medical claims; otherwise, they would be classified as medicines. Brands must prove, through clinical studies—very often under the supervision of experienced practitioners such as dermatologists, allergists, or ophthalmologists—that their products are safe and effective.
3. Risks of Non-Compliance
Possible sanctions:
Non-compliance with existing regulations can lead to product withdrawals or recalls, fines, or even a sales ban. It can also damage the brand’s reputation.
Problems with false claims:
If a brand makes unproven promises, it risks severe legal and/or criminal penalties for fraud or misleading consumers.
4. How to Ensure Compliance for Your Dermocosmetic Products
- Choose ingredients wisely: Use safe and authorized ingredients for dermocosmetic products. These products include clinically tested active ingredients for both effectiveness and safety.
- Document tests and results: Make sure all clinical tests are conducted rigorously and that you have the necessary evidence to support your claims.
- Regularly update your Product Information Files: Each product must be accompanied by a file ensuring its safety and effectiveness. This file should be updated regularly and include all required data about raw materials, finished products, and even packaging.
5. Best Practices for Optimal Dermocosmetic Management
- Collaborate with experts: Work with dermatologists and toxicologists to ensure the safety and effectiveness of your products.
- Continuous training: Make sure your teams are trained on the latest regulatory requirements and best practices for developing and manufacturing cosmetic products.
- Regulatory monitoring: Stay informed about changes in national and international regulations to ensure your products always comply with current standards.
6. Conclusion: Regulatory Compliance as a Key to Success for Dermocosmetics
In a sector where consumer trust is crucial, regulatory compliance stands out as a strategic pillar for dermocosmetic brands. More than just a legal obligation, it is a mark of quality, safety, and transparency—essential for standing out in a demanding and competitive market.
By complying with current regulations—whether clinical testing, ingredient traceability, or labeling—companies strengthen their scientific credibility and legitimacy with both consumers and healthcare professionals.
Thus, compliance should not be seen as a constraint but as a real lever for success, capable of transforming a brand into a leading reference in dermocosmetic care.
Why choose EcoMundo?
EcoMundo supports every player in the cosmetics industry—manufacturers, distributors, laboratories, and brands—at every stage: formulation, regulatory compliance, international monitoring, substance management, and go-to-market strategy. Thanks to our scientific expertise and innovative digital solutions, we secure your projects and accelerate their success on a global scale. 👉 Contact our experts today!
