|
Tähelepanu! Tegemist on väljastpoolt asutust saabunud kirjaga. Tundmatu
saatja korral palume linke ja faile mitte avada.
|
Dear EU health authorities,
I need your guidance to determine whether the following products can be sold as cosmetic products in the EU. As a possible Responsible Person for these products, I am finding it difficult to make a decision on this matter since it is a completely new product,
and neither Regulation 1223/2009, the Borderline Manual or the Technical document on cosmetic claims mention anything about products that can soften and help remove tartar.
-
Type of product: Oral care formulations. Two lines:
-
Consumer market: toothpaste, dental gel and mouthwash.
-
Professional product market: Pre-treatment gel for dental professionals (dentists and hygienists).
-
Mechanism of Action: All products contain a novel cosmetic ingredient (INCI name application in process).
-
Consumer market: The novel ingredient in the three cosmetic formulations (toothpaste, dental gel and mouthwash) supports oral hygiene by softening tartar to aid in its removal through brushing.
-
Professional product market: The dental gel facilitates mechanical scaling by softening tartar, making it easier to remove. The product chemically modifies tartar before removal.
-
-
Instructions for use and precautions:
-
Consumer market: Use as directed for regular oral care (e.g., brushing with toothpaste or applying gel as per product instructions). No special precautions beyond standard oral care product usage.
-
Professional product market: Apply using a dental tray before mechanical scaling, following standard professional protocols. Ensure appropriate exposure time and avoid prolonged contact with soft tissues.
-
Claims intended to be placed in the packaging:
-
Consumer market: The packaging would not claim to treat or prevent disease. The claims would be: "Supports removal of tartar through brushing.", "Softens tartar for improved oral hygiene." and/or "Removes tartar with regular
use."
-
Professional Product: It does not claim to completely dissolve calculus.
-
The primary claims (performance and clinical benefits) would be: "Pre-treatment gel designed to soften dental calculus for easier removal during professional scaling.", "Reduces the effort and time required for mechanical scaling by
weakening mineralized deposits.", "Enhances patient comfort by minimizing the force needed for calculus removal.", "Optimizes the efficiency of professional dental cleanings by preparing calculus for easier removal.", "Improves access to hardened tartar, supporting
thorough plaque and calculus management.", "Facilitates a smoother and more effective scaling experience for both patients and clinicians."
-
The secondary claims (safety & handling) would be: "Non-invasive, biocompatible gel formulated for professional dental use.", "Designed for application with a dental tray to maximize exposure to calculus deposits.", "Safe for use in
dental treatments with a controlled application time of three minutes.", "pH-balanced formulation designed for optimal compatibility with oral tissues."
Could you please help me confirm if these products could be considered cosmetics, or at least the ones intended for the consumer market? Also, could you help me flag the claims above that are not allowed in cosmetics?
I would appreciate all your help with this.
Regards,
|
|
|
María José Coronado
Senior Safety Assessor, Taobé Consulting
|
|
|
|
|
|
|
|
|
IMPORTANT: The contents of this email and any attachments are confidential. They are intended for the named recipient(s) only. If you have received
this email by mistake, please notify the sender immediately and do not disclose the contents to anyone or make copies thereof.
|
|
|
|
|
|
|
|
