Percorrer por autor "European Commission. Scientific Committee on Consumer Safety (SCCS)"
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- SCCS - Scientific Opinion on Hydroxyapatite (nano) - Submission IVPublication . European Commission. Scientific Committee on Consumer Safety (SCCS)The SCCS concludes the following: (1) In view of the above, and taking into account the scientific data provided, does the SCCS consider Hydroxyapatite (nano) safe when used in toothpaste up to a maximum concentration of 29.5% and in mouthwash up to a maximum concentration of 10% according to the specifications as reported in the submission, taking into account reasonably foreseeable exposure conditions? Based on the data provided, the SCCS considers hydroxyapatite (nano) safe when used at concentrations up to 29.5% in toothpaste, and up to 10% in mouthwash. This conclusion is based on the available evidence, which shows that hydroxyapatite (nano) does not pose a mutagenic hazard or cytotoxicity or inflammatory effects even when tested at high concentrations in a buccal mucosa cell model. Any uptake of hydroxyapatite (nano) by buccal mucosa is considered negligible, and the epithelial cells with internalised particles will be shed out over time as they are continually replaced. Also, any unintentionally ingested HAP nanoparticles during the use of oral-care products will undergo rapid dissolution in the gastric fluid and therefore do not raise any nano-specific concern over safety. This safety evaluation only applies to the hydroxyapatite (nano) that have the following characteristics: - composed of rod-shaped particles of which at least 87% (in particle number) have aspect ratios equal to or less than 3, and the remaining 13% have aspect ratios not exceeding 9. - the HAP particles are not coated or surface modified. - the Opinion is related to HAP particles with max length of the HAP nanoparticles in the present Opinion, i.e. 122 ± 43 nm. 1. Alternatively, what is according to the SCCS the maximum concentration considered safe for use of Hydroxyapatite (nano) in cosmetic products? / 2. Does the SCCS have any further scientific concerns with regard to the use of Hydroxyapatite (nano) in oral cosmetic products? This Opinion is not applicable to any hydroxyapatite (nano) material that is composed of or contains needle-shaped particles.
- 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.