(Under forberedelse) Kommisjonsforordning om endring av vedlegg V til europaparlaments- og rådsforordning (EF) nr. 1223/2009 om kosmetiske produkter når det gjelder peanutolje og hydrolyserte hveteproteiner
(In preparation) Commission Regulation amending Annex V to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products as regards Peanut oil and Hydrolysed wheat proteins
Åpen konsultasjon igangsatt av Kommisjonen 1.4.2016
BAKGRUNN (fra Kommisjonens høringsnotat)
Peanut oil with the INCI name Arachis Hypogaea Oil (CAS number 8002-03-7), as well as its other extracts and derivatives, is currently not regulated in Regulation (EC) No 1223/2009 on cosmetic products.
On 27 March 2014, the Scientific Committee on Consumer Safety (SCCS) adopted an opinion on the sensitisation potential of peanut oil (revised on 23 September 2014).
The SCCS opinion reported that [p]eanut proteins are known to cause severe potentially life-threatening type-I allergic reactions. However, refined peanut oils contain very low levels of the peanut proteins which are the moiety that has the allergenic potential. Moreover, [d]ata to derive a safe level of exposure to food in sensitised individuals exist, however to derive a safe level of exposure of the skin (especially regarding induction) is problematic. There is mounting evidence of access of proteins to the immune system via the (even intact) skin.
The SCCS then concluded as follows:
There is no known safe threshold currently defined at which the skin of peanut allergic subjects can safely be exposed to peanut proteins, although such thresholds are available for oral intake.
The SCCS has followed the scientific debate about the importance of skin exposure as a route for induction of sensitisation to type I allergens such as peanut. The SCCS acknowledges that this is of concern, but that there are insufficient data to define a safe level of skin exposure in the non-sensitised population.
However, in view of the documented safe levels of oral intake of peanut protein in sensitised individuals and in view of the industry’s capability to refine peanut oil below a protein level of 0.5 ppm, the SCCS can accept this value as maximum allowable concentration in (refined) peanut oil for cosmetic use.
Hydrolysed wheat proteins
The use of hydrolysed wheat proteins (HWP) in cosmetic products is currently not regulated in Regulation (EC) No 1223/2009 on cosmetic products.
On 18 June 2014, the SCCS adopted an opinion on HWP (revised on 22 October 2014)2. The SCCS concluded as follows:
The SCCS is of the opinion that,
In view of the numbers of reported cases of immediate-type contact urticarial and systemic allergic reactions, the overall risk of sensitization to Hydrolysed Wheat Proteins (HWP) appears to be low, with the exception of an ‘epidemic’ in Japan associated with one particular HWP product used in some brands of soap.
Scientific concerns with regard to the use of HWP in cosmetic products include that
• there is evidence that sensitisation to HWP is via exposure to cosmetics, not via food.
• there are indications that the risk of sensitisation is higher when HWP’s of higher molecular weight are used on the skin, in particular as an ingredient of products that have strong surfactant properties such as soaps and liquid soaps.
The SCCS considers the use of hydrolysed wheat proteins safe for consumers in cosmetic products, provided that the maximum molecular weight average of the peptides in hydrolysates is 3,5 kDa.
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