On 3 July 2023, the EU’s Scientific Committee on Consumer Safety (SCCS) adopted Opinion on Water-soluble Zinc Salts Used in Oral Hygiene Products (II). Water-soluble zinc compounds are used in oral cosmetics to minimize mouth malodor, tartar, and plaque development. Water-soluble zinc salts are now controlled under Annex III to Regulation (EC) 1223/2009 (Cosmetics Regulation). Comments are accepted until 8 September 2023.
The SCCS assessment is based on overall exposure, which takes zinc in the diet into account. For toothpaste, it suggests a safe dosage of 0.72% for infants and toddlers. For all ages, 0.1% Zn zinc in mouthwash is considered safe.
Since the use of mouthwash is not suggested for children aged 5 and under, no mouthwash exposure evaluation is undertaken for this age group.
Estimated amounts of zinc exposure for both the separate products and aggregated exposures for children (0.5-5 years and 6-17 years) and adults.
|
Age Group |
Product |
Zinc% |
Daily intake level (mg/day) |
|
Adults (>18 yrs) |
Toothpaste |
1.0 |
1.38 |
|
|
Mouthwash |
0.1 |
2.16 |
|
Aggregated exposure adults (>18 yrs) |
|
|
3.54 |
|
Children (6-17 yrs) |
Toothpaste |
1.0 |
1.38 |
|
|
Mouthwash |
0.1
|
2.16 |
|
Aggregated exposure children (6- 17 yrs) |
|
|
3.54 |
|
Children (0.5-5 yrs) |
Toothpaste |
1.0 |
1.00-2.00 |