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Water-soluble zinc salts used in oral hygiene products: preliminary opinion open for comments

2023-08-09 Reference source : EU Commission

Cosmetic Products EU REACH


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



We acknowledge that the above information has been compiled from EU Commission .

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