Mineral oils in cosmetics
The Federal Institute for Risk Assessment (BfR) has investigated dermal absorption of MOSH and MOAH from cosmetic products. Cosmetic products use mineral oils and microcrystalline waxes which are highly refined and comply with the purity requirements for pharmaceuticals. Purification processes reduce the MOAH contents in these mineral oils. MOSH are absorbed through the skin only at low levels and therefore are not systemically available in relevant amounts after dermal application of mineral oil-containing cosmetic products.
Considering all available scientific evidence, health risks for consumers caused by the uptake of the mineral oils in cosmetics through the skin are unlikely from the BfR’s point of view. No effects on health attributable to the mineral oil components of cosmetic products have been reported up to now despite the fact that they have been in widespread use for many years.
The oral intake of mineral oil through lipcare accounts for less than 10% of the ADI. When the recommendations of Cosmetics Europe are adhered to, no health effects from oral intake are to be expected from BfR's point of view.
SCCS opinion on nano silver
Only a limited amount of data was provided by the Applicants that corresponded to the SCCS Guidance on Safety Assessment of Nanomaterials in Cosmetics (SCCS 1484/12). The provided data were also not in line with the SCCS Memorandum on Relevance, Adequacy and Quality of Data in Safety Dossiers on Nanomaterials (SCCS/1524/13). Although other information is available in open literature relating to the toxicity of nano silver, their relevance with respect to the materials in this submission has not been considered by the Applicants. Due to a number of major data gaps, the SCCS is not in the position to draw a conclusion on the safety of nanosilver when used in oral and dermal cosmetic products.
A variety of private and voluntary standards exists, all implementing different criteria.
ISO 16128 finally fulfils the request for a standardised and worldwide accepted guideline for natural and organic cosmetics. No license fees, or fees for association memberships incur for the manufacturer. The certifications, which are required for other labels, are no longer strictly required to advertise natural cosmetics. Especially for SME, this market-entry barrier now drops.
The Scientific Committee on Consumer Safety (SCCS), concluded that the use of Benzophenone-3 as a UV-filter at a concentration of up to 6% w/w in cosmetic sunscreen products and up to 0.5% w/w in all types of cosmetic products to protect the formulation does not pose a risk to human health, apart from its contact allergenic and photoallergenic potential.
Consequently, the maximum concentration of 10% w/w for Benzophenone-3 used as a UV-filter in cosmetic products is decreased to 6 % w/w (the amendment of the cosmetic regulation applies from 3 September 2017).