PRESERVATIVES & ANTI-MICROBIALS
Possible new preservative entry The SCCS recently published its final opinion on the preservative, HEBP. Anina van der Walt of Lumen Regulatory Solutions discusses the ins and outs of this development, particularly in the area of eye irritancy.
DID YOU KNOW?
HEPB is also used as skin conditioning agent. According to the Cosmetics Regulation 1223/2009, a substance authorised as preservative at specific conditions of use (e.g. maximum concentration) can only be used for other purposes at the same conditions of use set up for the preservative function.
a preservative in rinse-off, oral care and leave-on cosmetics products at a maximum concentration of 0.7 perent is indeed 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 to Regulation (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.
T
he cosmetics preservative
The authorisation process is not
At that stage, the SCCS also
4-(3-ethoxy-4-hydroxyphenyl)
concluded more evidence is needed to
butan-2-one (CAS Number
exclude the safety concern of possible
569646-79-3), also known as
eye irritation caused by this preservative.
Hydroxyethoxyphenyl Butanone (HEPB),
Eye irritation dismissed
not listed in the Regulation (EC) No
Following the concerns raised by several
1223/2009. Yet this is about to change.
EU Member States on HEPB having the potential to be a possible eye irritant, a
Consumer Safety (SCCS) concluded
follow-up assessment was conducted
in its opinion of 7 April 2017 that, under
using additional scientific data submitted
an aggregate exposure scenario, HEPB
by an applicant.
can be considered safe when used
are received on the suggested amendment, the proposed period of adoption will be during the fourth quarter 2019 (World Trade Organization
as per the INCI nomenclature, is currently
The Scientific Committee on
yet completed. If no comments
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. •
After this assessment, the SCCS
as a preservative in rinse-off, oral care
concluded in a subsequent opinion on
and leave-on cosmetics products at a
5 March 2019 that, under an aggregate
maximum concentration of 0.7 percent.
exposure scenario, the use of HEPB as
Lumen Regulatory Solutions – anina@lumen.co.za
Lumen Regulatory Solutions Consultant Business Lumen is a proudly South African business specialising in Cosmetic Product Safety Assessment & Regulatory Compliance Requirements Contact details: Anina van der Walt B.Pharm M.Sc Pharmaceutics +27 (0) 84 990 9080 anina@lumen.co.za
28
| JULY 2019 | P C Review
