Nuevos requisitos de (UE) 2017/2228 El uso de aceite de maní y proteínas de trigo hidrolizado en productos Cosméticos

EU Issues Regulatory Requirements for Use of Peanut Oil and Hydrolyzed Wheat Proteins

Published on 2018-01-08. Author : SpecialChem 

European Commission has issued a new Regulation (EU) 2017/2228, regarding the safety use of peanut oil, its extracts, its derivatives and hydrolyzed wheat proteins in cosmetics, to amend the Annex III of (EC) No 1223/2009. 

Peanut Oil in Cosmetics

Peanut oil (INCI name: Arachis Hypogaea Oil; Cas: 8002-03-7; Function: Emollient, Solvent)

The Scientific Committee on Consumer Safety (SCCS) had adopted an opinion on the sensitization potential of peanut oil (revised on 23 September 2014). Concerns were raised over the fact that an unexpected risk of food allergy to peanuts was reported in particular at young children (0-3 years), where it was suspected that the induction of the sensitization might have appeared through the use of cosmetic products containing peanut oil in the first six months of life.

SCCS Conclusion

Peanut Oil

There is no known safe threshold currently defined at which the skin of peanut allergic subjects can be safely 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 sensitization to type I allergens such as peanut. The SCCS has acknowledged that this is of concern, but that there are insufficient data to define a safe level of skin exposure in the non-sensitized population.

However, in view of the documented safe levels of oral intake of peanut protein in sensitized 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.

Hydrolyzed Wheat Protein

Hydrolyzed wheat protein (INCI name: Hydrolyzed wheat protein; Cas: 94350-06-8/222400-28-4/70084-87-6/100209-50-5; Function: Antistatic, hair conditioning, skin conditioning)

On 18 June 2014, the Scientific Committee on Consumer Safety (SCCS) adopted an opinion on the hydrolyzed wheat proteins (revised on 22 October 2014).

Safety problems indicated as contact urticaria provoked by the cosmetic products containing hydrolyzed wheat protein, followed by anaphylactic shock after the ingestion of food containing wheat proteins, have been recently reported.

SCCS Conclusion

Hydrolyzed Wheat Protein

In view of the numbers of reported cases of immediate-type contact urticarial and systemic allergic reactions, the overall risk of sensitization to Hydrolyzed 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 sensitization to HWP is via exposure to cosmetics, not via food.
• There are indications that the risk of sensitization 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 hydrolyzed wheat proteins safe for consumers in cosmetic products, provided that the maximum molecular weight average of the peptides in hydrolysates is 3,5 kDa.

New Requirements of (EU) 2017/2228

The use of peanut oil and hydrolyzed wheat proteins in cosmetic products are currently not regulated in Regulation (EC) No 1223/2009. In order to ensure the safety of such cosmetic products for human health, SCCS opinions mentioned above are added to the Annex III of Regulation (EC) No 1223/2009. The details can be found below.

From 25 September 2018 cosmetic products containing one or more of the substances restricted by this Regulation and not complying with the restrictions laid down in this Regulation shall not be placed on the Union market.

From 25 December 2018 cosmetic products containing one or more of the substances restricted by this Regulation and not complying with the restrictions laid down in this Regulation shall not be made available on the Union market.

CIRS commented:

China exporters should make adjustment of formulas containing peanut oil, its extracts, its derivatives and hydrolyzed wheat proteins in cosmetics in time. The requirements of these two ingredients used in cosmetics especially for baby care products in China might be regarded as a concern.

Source: CIRS