Percorrer por data de Publicação, começado por "2025-05-02"
A mostrar 1 - 3 de 3
Resultados por página
Opções de ordenação
- SCCS Opinion on Butylparaben (CAS No. 94-26-8, EC No. 202-318-7) - Children's exposurePublication . European Commission. Scientific Committee on Consumer Safety (SCCS)The SCCS concludes the following: 1. In light of the data provided and taking under consideration the conclusions of the SCCS/1651/23 Opinion on children exposure, does the SCCS consider Butylparaben safe for children, when used as a preservative up to a maximum concentration of 0.14 %? Based on the safety assessment carried out in consideration of all available information, including the potential endocrine effects, the SCCS is of the opinion that the use of Butylparaben as preservative at a maximum concentration of 0.14 % (as acid) in all cosmetic products included in this exposure assessment is not safe for children between 0.5-1 years, 1-3 years, 3-6 years and 6-10 years when used in combination. With the exception of body lotion, it is safe in single dermal and oral product categories, when used only in the respective product category. 2.Alternatively, what is, according to the SCCS, the maximum concentration of Butylparaben that is considered safe for the age groups of children considered in this opinion”? In the SCCS’s opinion, Butylparaben could be considered safe for children of all age groups that were evaluated, provided that the maximum concentration of Butylparaben is reduced in some product types so that the aggregate exposure does not exceed 245 μg/kg bw/day. During the public consultation, the SCCS received a proposal from the Applicant to maintain the concentration of Butylparaben at 0.14 % (as acid) in rinse-off products and reduce it to 0.002 % (as acid) in leave-on products and 0.092 % (as acid) in oral care products. Based on these reduced concentrations, Butylparaben is considered safe for children of all age groups and product types included in the assessment, whether used individually or in combination. 3. Does the SCCS have any further scientific concerns regarding the use of Butylparaben in cosmetic products and children’s exposure? This Opinion is not applicable to any sprayable product (including mouth spray) that may lead to exposure of end-user’s lungs by inhalation. The SCCS mandates do not address environmental aspects. Therefore, this assessment did not cover the safety of Butylparaben for the environment.
- Scientific advice – children’s exposure to Methyl salicylate (methyl 2-hydroxybenzoate) - Revision of SCCS/1654/23Publication . European Commission. Scientific Committee on Consumer SafetyThe SCCS concludes the following: 1. Taking under consideration the conclusions of SCCS/1658/23 and the aggregate exposure, the SCCS is requested to re-assess the maximum concentration of Methyl Salicylate that is considered safe when used in products intended for children of age 0-3. The SCCS is of the view that, to be considered safe, the concentration of Methyl Salicylate should not exceed 0.4% in toothpaste and 0.02% in other products when used in products intended for children of age 0-3 years. 2. Does the SCCS have any further scientific concerns with regard to the use of Methyl Salicylate in cosmetic products and children’s exposure? The SCCS mandates do not address environmental aspects. Therefore, this assessment did not cover the safety of Methyl Salicylate for the environment.
- Opinion on Salicylic Acid (CAS No. 69-72-7, EC No. 200-712-3) - Children’s exposurePublication . Scientific Committee on Consumer SafetyThe SCCS concludes the following: 1 In light of the data provided, and taking under consideration the conclusions of the SCCS/1646/22 Opinion on children’s exposure, does the SCCS consider Salicylic Acid safe for children between 3-10 years of age: a) when used as a preservative in cosmetic products up to a maximum concentration of 0.5 %? Based on the safety assessment carried out in consideration of all available information, including the potential endocrine effects: • the SCCS is of the opinion that Salicylic Acid (CAS 69-72-7) is not safe when used as preservative at a concentration of 0.5% in all cosmetic products listed under conclusion (b), considering its current restrictions in place. With the exception of body lotion, it is safe in single dermal and oral product categories, when used only in the respective product category. • this Opinion is not applicable to any sprayable product (including mouth spray) that may lead to exposure of end-user’s lungs by inhalation. • The provided information shows that Salicylic Acid is an eye irritant with the potential to cause serious damage to the eye. b) when used for purposes other than inhibiting the development of micro-organisms at a concentration up to: i. 3.0 % for cosmetic rinse-off products ii. 2.0 % for cosmetic leave-on products except body lotion and oral products, and iii. 0.5 % for body lotion and oral products The SCCS assessment has shown that: The use of Salicylic Acid as a restricted ingredient for purposes other than inhibiting the development of micro-organisms is not safe at the following concentrations when aggregate exposure is considered: - up to 3.0% for the cosmetic rinse-off hair products used by children (shampoo, conditioner), - up to 2.0% for selected other dermally applied products used by children (face moisturizer, hand cream, liquid soap, shower gel), and - up to 0.5% for body lotion. With the exception of body lotion, it is safe in single dermal and oral product categories, when used only in the respective product category. 2 Alternatively, what is according to the SCCS the maximum concentration of Salicylic Acid that is considered safe for children 3-10 years of age? Reducing the concentration, for example to 0.1% in dermal products, would make the use safe for dermal products and toothpaste. During public consultation the SCCS has received a proposal of the Applicant to keep rinse-off products at 0.5%, reduce Salicylic Acid in leave-on products to 0.15% and oral Care products to 0.1%. Applying these concentrations Salicylic Acid is safe for children 3-10 years old. 3 Does the SCCS have any further scientific concerns with regard to the use of Salicylic Acid in cosmetic products and children’s exposure? Since the Cosmetic Regulation does not allow the use of Salicylic Acid in products for children under 3 years of age, this age category has not been considered in this Opinion. The conclusions of this Opinion refer only to Salicylic Acid as a cosmetic ingredient and not to other salicylates or salicylic acid salts. The SCCS is currently assessing the cumulative exposure to salicylates and the implications for risk assessment. The SCCS mandates do not address environmental aspects. Therefore, this assessment did not cover the safety of Salicylic Acid for the environment.