Subject: Question about a product's classification as cosmetic
From: María José Coronado Rodríguez <[email-masked]>
To: <[email-masked]>, <[email-masked]>, <[email-masked]>, <[email-masked]>, <[email-masked]>, <[email-masked]>, <[email-masked]>, <[email-masked]>, <[email-masked]>, <[email-masked]>, <[email-masked]>, <[email-masked]>, <[email-masked]>, <[email-masked]>, <[email-masked]>, <[email-masked]>, <[email-masked]>, <[email-masked]>, <[email-masked]>, <[email-masked]>, <[email-masked]>, <[email-masked]>, <[email-masked]>, <
Date: Mon, 10 Mar 2025 21:32:00 +0200

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.

1.

	Type of product: Oral care formulations. Two lines:

1.

	Consumer market: toothpaste, dental gel and mouthwash.
2.

	Professional product market: Pre-treatment gel for dental
professionals (dentists and hygienists).

2.

	Mechanism of Action: All products contain a novel cosmetic
ingredient (INCI name application in process).

1.

	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.
2.

	Professional product market: The dental gel facilitates mechanical
scaling by softening tartar, making it easier to remove. The product
chemically modifies tartar before removal.

3.

4.

	Instructions for use and precautions:

1.

	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.
2.

	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.

5.

	Claims intended to be placed in the packaging:

1.

	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."
2.

	Professional Product: It does not claim to completely dissolve
calculus.

1.

	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."
2.

	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

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