SkinConsult supports you in complying with all laws and regulations concerning cosmetic products. Our expertise is at the cutting-edge of dermatology, chemistry and legislation. This enables us to conduct well-substantiated safety assessments, compile files, notify your product, perform skin tests and make recommendations.
Product Information File
A Product Information File is required for each cosmetic product on the European market. The file contains all information on the product, from manufacturing to labeling.
SkinConsult knows exactly how a Product Information File should be compiled. We will gladly do this for you! We can also augment, check or conform files.
SkinConsult Product Information Files are:
- Are guaranteed to comply with all legal requirements
- Are compiled by a professional team
- Contain a scientifically substantiated Safety Assessment
Cosmetic Safety Assessments
A Cosmetic Safety Assessment (Safety Assessment) is required for each cosmetic product on the European market. SkinConsult has many years of experience in conducting Safety Assessments for cosmetic products. We work with all types of products.
SkinConsult Cosmetic Safety Assessments are:
- Scientifically based
- Delivered promptly
- Conducted by a certified assessor
- In accordance with European legislation
Due to the extensive knowledge and experience gained in the area of dermatology and Allergology, SkinConsult has in-depth knowledge about the interaction between the skin and a product’s ingredients. A safety certificate is issued only if it has been proven that the product can be used without side effects.
Medical Device Assessment
Medical devices to be used on the skin are chemically related to cosmetics. SkinConsult has know-how and experience regarding dermatology, chemistry, toxicology and cosmetics. This provides us with an excellent base from which to assess medical devices for the skin in terms of their safety. We conduct Medical Device Assessments for Class I and II medical devices. Our Medical Device Assessments are entirely scientifically grounded. We are familiar with European legislation regarding medical devices and with the advertising code of KOAG/KAG. [ Inspection Board for the Public Promotion of Medicines/Inspection Board for the Promotion of Health Products].
SkinConsult Medical Device Assessments:
- Contain an extensive toxicological Safety Assessment.
- Take the specific target group of the product into account.
- Evaluate beneficial effects with scientific substantiation.
- Explore complications based on literature.
For complete CE registration/Technical File, we work with Archy Consulting. Archy Consulting offers guidance and advice in the development of medical devices. Contact us to discuss the options that are available.
Every cosmetic product on the European market has to be registered at an online portal, the Cosmetic Products Notification Portal (CPNP). This registration is referred to as notification. SkinConsult can assist you with this notification.
The CPNP is a database that is accessible to the relevant authorities, the Food and Consumer Product Safety Authority, and hospitals. CPNP’s objective is to facilitate discovering the chemical substances contained by a cosmetic product in a hazardous situation, such as poisoning.
While submitting the notification, you should provide information about your product, such as the form of presentation, the packaging, the name, the ingredients and more. SkinConsult offers advice on the exact information that is required and how to go through the CPNP.
SkinConsult will gladly provide you with customized advice on everything related to cosmetics, the skin, and European legislation.
The following are matters with which we can assist you:
- Screening your files for compliance with EU Regulation 1223/2009;
- Ensuring that your products comply with the legislation
- Checking and evaluating your cosmetic labeling
- Registering, evaluating and authorizing chemical substances (REACh)
- Hypoallergenic product development
- Formulating products, including using preservatives
- Tracking adverse side effects (post-marketing surveillance)
Are you faced with a problem not stipulated here? Please contact us and we will see what we can do for you.
Of course, we treat your documentation and data in confidence. We work with NDAs as standard.