European Commission calls for opinions on three new ingredients

The task was assigned to the Scientific Committee on Consumer Safety as published on its' website on December 16th.

The deadline for comments is January 30th. 

Ethyl lauroyl arginate HCl - SCCS/1519/13​

The SCCS will consider whether Ethyl lauroyl arginate HCl is safe for use as a preservative, when used up to a maximum concentration of 0.15% in mouthwashes, though not in oral cosmetic products as a whole.

The Committee will look at the following:

1) In the light of the data provided, does the SCCS consider that Ethyl Lauroyl Arginate HCl is still safe for consumers at current use in all cosmetic product including oral products, considering the exposure from other sources?

2) In particular does the SCCS consider that Ethyl Lauroyl Arginate HCl is safe considering the specific age groups who might be particularly susceptible to the effects of total exposure to Ethyl Lauroyl Arginate HCl, used in both cosmetic and food products?

For example, when considering 9 year old children (body weight 25 kg) the oral exposure from cosmetics would be 0.14 mg/kg bw/day and the sum would be 0.58 mg/kg bw/day. Both of these values (0.58 and 0.73 mg/kg bw/day) are not covered by the ADI. Thus, the Committee must consider the use of Ethyl Lauroyl Arginate in mouthwashes for children at the concentration of 0.15% for longer time periods as not safe.

3) Does the SCCS have any further scientific concerns? As no human data concerning local toxicity of Ethyl lauroyl arginate HCl in toothpaste are available, the safety of Ethyl lauroyl arginate HCl in toothpaste cannot be assessed.

Basic Blue 124 (3-Amino-7-(dimethylamino)-2-methoxyphenoxazin-5-ium chloride)​

1. In light of the data provided, does the SCCS consider Basic Blue 124 safe when used as a direct hair dye in semi-permanent as well as in permanent (oxidative) hair dye formulations at on-head concentration up to a maximum of 0.5% (w/v)?

The safety of Basic Blue 124 cannot be assessed since no final conclusion on mutagenicity can be drawn without further studies to exclude gene mutation potential.

2. Does the SCCS have any further scientific concerns with regard to the use of Basic Blue 124 in cosmetic products?
The SCCS considers Basic Blue 124 a strong skin sensitiser. Basic Blue 124 is a tertiary amine. It should not be used together with nitrosating agents. Total nitrosamine content should be < 50 ppb.

Poly(hexamethylene) biguanide hydrochloride (PHMB) or polyaminopropyl biguanide (INCI)​

1. Taking into account the scientific data provided, SCCS is requested to give its opinion on the safety of Polyaminopropyl Biguanide (PHMB) when used as a preservative in cosmetics products up to a maximum concentration of 0.3%.

The Committee cannot assess the safety of Polyaminopropyl Biguanide (PHMB) as no firm conclusion on the genotoxic potential can be drawn based on the available data. Before any further consideration, adequate data (i.e. a properly performed gene mutation study) is required to rule out the genotoxic potential of PHMB.

In the absence of a valid dermal absorption study, a 10% dermal absorption might be taken as default according to SCCS Notes of Guidance. Deviation from the default assumption of 10 % dermal absorption would be possible if a valid dermal absorption study according to SCCS Notes of Guidance is submitted.

2. SCCS is requested to address any further scientific concerns on the ingredient Polyaminopropyl Biguanide (PHMB) in particular regarding its use in spray formulation.  As the vapour pressure is low, no respiratory irritation or toxic effects are expected from the evaporation of PHMB when present in 0.3% in cosmetic formulation.