Vastuskiri
| Dokumendiregister | Terviseamet |
| Viit | 10.2-6/25/204-2 |
| Registreeritud | 21.03.2025 |
| Sünkroonitud | 24.03.2025 |
| Liik | Väljaminev dokument |
| Funktsioon | 10.2 Toodete terviseohutusega seotud toimingud |
| Sari | 10.2-6 Teabenõuded, selgitustaotlused, märgukirjad toodete ohutuse valdkonnas |
| Toimik | 10.2-6/2025 |
| Juurdepääsupiirang | Avalik |
| Juurdepääsupiirang | |
| Adressaat | Taobe Consulting |
| Saabumis/saatmisviis | Taobe Consulting |
| Vastutaja | Natali Promet (TA, Peadirektori asetäitja (1) vastutusvaldkond, Kemikaaliohutuse osakond) |
| Originaal | Ava uues aknas |
Failid
From: Natali Promet
Sent: Fri, 21 Mar 2025 07:36:53 +0000
To: 'María José Coronado Rodríguez' <mcoronado@taobe.consulting>
Subject: Vs: Question about a product's classification as cosmetic
Hello
From my opinion toothpaste and mouthwash definitely are the cosmetic products.
Concerning dental gel it is borderline case and could be medical device or cosmetic product.
To define it as a cosmetic product it seems to me that it should be stronger cosmetic claim reffered to cosmetics f.e. „helps cleaning teath from tartar and plaque“ (what is after application – it has to be spit out or rinsed-off after application?) which have a stronger link to the definition of cosmetic product: ‘cosmetic product’ means any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours;
Kind regards
Natali Promet
Chief specialist
Chemicals Safety Department
+372 794 3533
| Health Board +372 794 3500 info@terviseamet.ee Paldiski mnt 81, 10614 Tallinn |
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Saatja: María José Coronado Rodríguez <mcoronado@taobe.consulting>
Saatmisaeg: esmaspäev, 10. märts 2025 21:32
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Teema: Question about a product's classification as cosmetic
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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:
- a. Consumer market: toothpaste, dental gel and mouthwash.
- b. 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).
- a. 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.
- b. 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:
- a. 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.
- b. 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:
- a. 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."
- b. Professional Product: It does not claim to completely dissolve calculus.
- i. 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."
- ii. 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,
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