Possible new preservative entry

The cosmetics preservative 4-(3-ethoxy-4-hydroxyphenyl) butan-2-one (CAS Number 569646-79-3), also known as Hydroxyethoxyphenyl Butanone (HEPB), as per the INCI nomenclature, is currently not listed in the Regulation (EC) No 1223/2009. Yet this is about to change.

The Scientific Committee on Consumer Safety (SCCS) concluded in its opinion of 7 April 2017 that, under an aggregate exposure scenario, HEPB can be considered safe when used as a preservative in rinse-off, oral care and leave-on cosmetics products at a maximum concentration of 0.7 percent.

At that stage, the SCCS also concluded more evidence is needed to exclude the safety concern of possible eye irritation caused by this preservative.

Eye irritation dismissed

Following the concerns raised by several EU Member States on HEPB having the potential to be a possible eye irritant, a follow-up assessment was conducted using additional scientific data submitted by an applicant.

After this assessment, the SCCS concluded in a subsequent opinion on 5 March 2019 that, under an aggregate exposure scenario, the use of HEPB as a preservative in rinse-off, oral careand leave-on cosmetics products at amaximum concentration of 0.7 perent isindeed safe in terms of eye irritation.

Amendment to the annex

In the light of the data presented, and with the SCCS conclusion, the EU published the Draft Commission Regulation, amending Annex V toRegulation (EC) No 1223/2009. The draft Regulation proposes the authorisation of a new preservative ingredient, HEPB, in rinse-off, oral care and leave-on products at a maximum concentration of 0.7 percent applicable for cosmetics.

The authorisation process is not yet completed. If no comments are received on the suggested amendment, the proposed period of adoption will be during the fourth quarter 2019 (World Trade Organization Technical Barrier to Trade notification: G/TBT/N/EU/650).

For brand owners and manufacturers in the South African cosmetics industry, this possible new preservative entry is yet to be decided. •