EU New Requirements for Peanut Oil and Hydrolysed Wheat Proteins

On 4 Dec., 2017, European Commission issued a new Regulation (EU) 2017/2228, regarding the safety use of peanut oil, its extracts, its derivatives and hydrolysed wheat proteins in cosmetics, to amend the Annex III of (EC) No 1223/2009. This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

Background

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

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).

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 sensitisation might have appeared through the use of cosmetic products containing peanut oil in the first six months of life.

SCCS Conclusion:

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 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 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.

  • Hydrolysed wheat protein  (INCI name: Hydrolysed 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 hydrolysed wheat proteins (revised on 22 October 2014).

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

SCCS Conclusion:

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.

New Requirements of (EU) 2017/2228

The use of peanut oil and hydrolysed 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.

Reference number

Substance identification

Restrictions

Wording of conditions of use and warnings

Chemical name/INN

Name of Common Ingredients Glossary

CAS number

EC number

 Product type, body parts

Maximum conc. in ready for use preparation

Other

a

b

c

d

e

f

g

h

i

X

Peanut oil, extracts and de­ rivatives

Arachis Hypogaea Oil

8002-03-7


232-296-4




Maximum conc. of peanut proteins: 0,5 ppm (*)


Arachis Hypogaea Seedcoat Extract

8002-03-7

232-296-4



Arachis Hypogaea Flour

8002-03-7

232-296-4

Arachis Hypogaea Fruit Ex­ tract

8002-03-7

232-296-4

Arachis Hypogaea Sprout



Extract



Hydrogenated Peanut Oil

68425-36-5

270-350-9

Peanut Acid

91051-35-3

293-087-1

Peanut Glycerides

91744-77-3

294-643-6

Peanut Oil PEG-6 Esters

68440-49-3


Peanutamide MEA

93572-05-5

297-433-2

Peanutamide MIPA



Potassium Peanutate

61789-56-8

263-069-8

Sodium Peanutamphoacetate



Sodium Peanutate

61789-57-9

263-070-3

Sulfated Peanut Oil

73138-79-1

277-298-6

 Reference number

Substance identification

Restrictions

Wording of conditions of use and warnings

Chemical name/ INN

Name of Common Ingredients Glossary

CAS number

EC number

 Product type, body parts

Maximum conc. in ready for use preparation

Other

a

b

c

d

e

f

g

h

i

Y

Hydrolyzed wheat protein

Hydrolyzed Wheat Protein

94350-06-8 /

222400-28-4 /

70084-87-6 /

100209-50-5

305-225-0

309-358-5



Maximum molecular weight average of the peptides in hydrolysates: 3,5 kDa (**)’


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 Comments:

  • China exporters should make adjustment of formulas containing peanut oil, its extracts, its derivatives and hydrolysed 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.