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Water-soluble zinc salts used in oral hygiene products - Submission I

Final Opinion

Informação detalhada

Data de publicação
22 junho 2018
Autor/Autora
Scientific Committee on Consumer Safety (SCCS)

Descrição

WG on Cosmetic Ingredients
SCCS members: U. Bernauer, L. Bodin, L. Celleno, Q. Chaudhry, P. Coenraads (Chairperson), M. Dusinska, J. Ezendam, C.L. Galli, B. Granum (Rapporteur), E. Panteri, V. Rogiers, C. Rousselle, M. Stępnik, T. Vanhaecke, S. Wijnhoven
Former SCCS member: J. Duus-Johansen
Contact:SANTE-C2-SCCS@ec.europa.eu
On request from: European Commission
SCCS Number: SCCS/1586/17
Adopted on: 21-22 June 2018

Conclusion of the opinion:

1. According to the data available, does the SCCS consider water soluble Zinc salts safe for all age groups at the current allowed concentration of up to 1% as Zinc when used in toothpastes and at the use level of up to 0.1% as Zinc when used in mouthwashes?

The SCCS has estimated that exposure to water-soluble zinc salts via toothpaste and mouthwash at the concentrations of 1 and 0.1%, respectively, may lead to a daily intake level of 3.54 mg for adults and children aged 6-17 years. This exposure constitutes between 14 and 35% of the Upper Limit (UL) for these age groups. Therefore, the SCCS considers that the use of zinc in toothpaste and mouthwash per se is safe for adults and children aged 6-17 years.

The SCCS has estimated that exposure to water-soluble zinc salts via toothpaste at the concentrations of 1% may lead to a daily intake level of 1.0-2.00 mg for children aged 0.5-5 years. This exposure constitutes between 10 and 29% of the UL for this age group. Therefore, the SCCS considers that the use of zinc in toothpaste per se is safe for children aged 0.5-5 years.

2. Does the SCCS have any concerns related to the use of water-soluble Zinc salts in oral products for the particular age group 1 to 17-year old?

Exposure to zinc may also occur from sources other than oral hygiene products. An important source of zinc in the population is the diet. This assessment has not taken into account the daily dietary intake of zinc.

The dietary zinc intake (estimated by EFSA in 2014) ranges from 6.8 to 14.5 mg/day in adolescents aged 10 to < 18 years, from 5.5 to 9.3 mg/day in children aged 3 to < 10 years and from 4.6 to 6.2 mg/day in children aged 1 to <3 years. Therefore, exposure to zinc via the diet may already exceed or be close to exceeding the upper limits of 18, 13, 10 and 7 mg/day for the age groups 11-14, 7-10, 3-7 and 1-3 years, respectively. Any additional source of exposure, including cosmetics, may lead to exceeding the upper limits for children.

The SCCS cannot advise which portion of the upper limit should be allocated to exposure from cosmetic products. When assessing exposure to chemicals, allocation factors that reflect a reasonable level of exposure while still being protective may be applied. For exposure via toys or drinking water, for example, allocation factors of 10% or 20% of the reference value may be considered as safe. In the case of zinc, the use of 1% in toothpaste and 0.1% in mouthwash constitutes between 10 and 35% of the upper limit depending on the age group. The SCCS is aware that upper limits may be exceeded in some cases because the default values used in this Opinion are based on conservative estimates.

Keywords:

SCCS, scientific opinion, water-soluble zinc salts, oral hygiene products, zinc acetate CAS: 557-34-6 EC: 209-170-2, zinc chloride CAS: 7646-85-7 EC: 231-592-0, zinc gluconate CAS: 4468-02-4 EC:/, zinc citrate CAS: 546-46-3 EC:/, zinc sulphate/zinc sulphate monohydrate/zinc sulphate heptahydrate CAS: 7733-02-0/7446-19-7/7446-20-0 EC:/, SCCS/1586/17, Regulation 1223/2009

Opinion to be cited as:

Opinion to be cited as: SCCS (Scientific Committee on Consumer Safety), Opinion on watersoluble zinc salts used in oral hygiene products - Submission I, preliminary version adopted on 7 March 2017, final version adopted on 21-22 June 2018, SCCS/1586/17.

Ficheiros

sccs_o_207.pdf
English
(543.63 KB - PDF)
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