2006 ANNUAL SCIENTIFIC MEETING
Chart 2 -Effect of alkalisers on HPSDC peak temperature
1 · ....,....,.......,...............,Treatment·.· · _· __· ............· ----·· HPSDC Peak temperature T d
0
c .............,J
[Virgin Hair 149.0 !
�----·--·-- +Ammonium Hydroxide pH)O ·--·---- .______-·-- ..........143.0 .._.......................
.+Ammonium Hydroxide Dialysed 150.7 .l .+Ethanolamine pH 10
�--w .
147.5 1
'+Ethanolamine Dialysed 150.l 1
91
We then looked at the effect on the HPDSC peak temperature of multiple cycles of a bleaching product. 5
repeat cycles of treatment were performed with 10 shampoo cycles between each treatment. Samples were taken
at 1, 3 and 5 cycles and dialysed in deionised water.
Chart 3 demonstrates that the HPDSC temperature is composed of a component that is reversible (likely due
to incorporation of formulation components such as salts, alkalisers, surfactants etc) and a component that is
irreversible (likely due to oxidative breakdown of the keratin covalent bonds).
Chart 3 -Effect of multiple treatment with a bleaching product on HPDSC peak temperature
Treatment
Virgin Hair ,..,,,....,=,
-=m•=·=--� 1 cycle bleaching product
1 cycle +dialysis
3 cycle bleaching product
3 cycle +dialysis
_5 cycle bleachin�product
5 cycle +dialysis
HPSDC Peak temperature
==I
149.0
143.5
=h -�----«--,�------�--,- 149.1
·.r.-.-.-.....-. --m-= ....,..,.,,,_....,�....,."t/Y�-,- ...� ,-,,.v.,-�-�--"'---��•,r,,-.·���--137.9
145.5
134.5
135.1

92 JOURNAL OF COSMETIC SCIENCE
INTRODUCTION TO REACH
Barbara Wolf, Ph.D.
Estee Lauder Companies, 155 Pinelawn Road, Suite 1505, Melville, NY 11747
A new European Union chemicals regulation will be passed by the European Parliament in early 2007. Although
this is a chemicals regulation, the cosmetics industry has not been exempted and will be impacted. REACH stands
for Registration, Evaluation and Authorization of ,Chemicals. All cosmetics ingredients manufactured and sold
within the European Union or those imported in after REACH takes effect will require a registration number.
Finished goods that are imported into the European Union will require documentation that all individual ingredients
are similarly registered.
What is REACH and why was it drafted? According to the drafters of this new chemicals regulation, the previous
collection of regulations was flawed because only 200 of the approximately 100,000 "existing" chemicals have been
identified for risk assessment. Only 27 risk assessments have been completed. These shortcomings are thought to
have potentially put human health and the environment at risk. The REACH regulation shifts the burden for data
generation and risk assessment from the regulators to the manufacturers and importers. No existing chemicals are
grandfathered. A key principle is NO DATA, NO MARKET. Very few categories of chemicals are exempted,
namely, natural substances and polymers. However, the definition of these two classes of ingredients is very
narrow-much narrower than cosmetic or even non-regulatory chemical definitions. The REACH data
requirements are extensive and there is no indication that the requirements will be flexible since REACH is based on
the precautionary principle. In other words, a menu of tests will need to be submitted regardless of risk.
Further, the requirements of REACH differ depending upon whether a company is a downstream user, a
manufacturer or an importer. Of course, these categories of receivers of ingredients have specific REACH
definitions as well. A cosmetic manufacturer may be all three categories of receivers depending upon the
circumstances relevant to an ingredient. If a cosmetic company uses an ingredient or mixture of ingredients
(referred to as a preparation in the REACH regulations) from an European Union supplier, then the cosmetic
company is a DOWNSTREAM USER and need only register the ingredients and make sure the European Union
supplier includes cosmetic use in their safety assessment and registration. However, if a cosmetic company imports
finished goods or receives ingredients from a non-European Union supplier, even though the cosmetics finished
product is made in the European Union, then the cosmetics company is an IMPORTER. If the cosmetic company
alters the ingredients, it is a MANUFACTURER. The importers and manufacturers are required to register the
ingredients even though they are used for cosmetics. Certain chemicals, such as, CMR's, those that are persistent in
the environment (vPvB) and any substance having scientific evidence of probable serious effects to humans or to the
environment, will require evaluation and authorization.
This introduction to the REACH regulations will give key definitions of REACH terms and several points to
stimulate discussion. The REACH regulation is anticipated to pass in April, 2007 and registration of new chemicals
and pre-registration of phase-in chemicals (that have EINECS numbers) will likely begin in April, 2008 and close
October, 2008. Consortia of suppliers will begin fonning in November, 2008 as the REACH principle of "one
substance, one registration" will mandate sharing of data and testing costs among suppliers (manufacturers and
importers) and perhaps downstream users. Some of the data submission deadlines are in conflict with the Seventh
Amendment to the Cosmetics Directives marketing ban on animal testing of cosmetic ingredients. All of the safety
and environmental infonnation will be available to the public through the Internet.
The legislation is still under debate in the European Parliament and may change but this presentation will provide an
update on the status at this point in time. This presentation will lay the foundation for other presenters to discuss in
more detail what the requirements are by category and how their companies are preparing for the new legislation.
Come to the session and share what your company is doing or the outstanding questions you have on this impact
legislation.
Helpful websites: http://ecb.jcr.it/REACH/
http://ecb.jrc.it/REACH-IT-INFORMATICS (for RIP reports)