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)

2006 ANNUAL SCIENTIFIC MEETING
ARE You READY FoR REACH!
Mindy S. Goldstein, Ph.D.
Estee Lauder Companies, 125 Pinelawn Road, Melville, NY 11747
REACH stands for Registration, Evaluation and Authorization of CHemicals. REACH is
going to touch everyone in the personal care industry that manufactures or sells raw materials or
finished goods that are imported into Europe. European Union members agreed to institute these new
regulations on December 13, 2005. According to the EU, the major objective of the REACH program
is to cut occupational diseases and environmental issues through better monitoring of chemical
products. This will require a new level of safety and ecological data.
93
REACH will create a single system for both "existing'' and "new" chemicals. It applies to all
substances used in all products, including cosmetics, both synthetic and natural. There will be no
grandfathering of substances. The anticipated date for REACH to become law is April, 2007. There
will be a six month window (from April, 2008 through October, 2008) for pre-registration of phase-in
substances. Phase-in substances are defined as substances listed in EINECS or have ELINCS numbers
as well as materials manufactured in the European Community at least once in the last 15 years but not
placed on the EU market. New substances, those that do not have EINECS/ELINCS numbers, and are
not exempt, and manufactured in amounts over one ton, require full registration. Full registration will
also begin in April, 2008. In November, 2008, a list of pre-registered substances will be published and
registration for phase-in substances will be open. Dates by which registration, including safety and
ecological data, for phase-in substances are due will depend on the volume of the substance being
manufactured or imported: April, 2010 for substances over 1,000 tons April, 2013 for substances from
100 to 1,000 tons April, 2018 for substances from 1 to 100 tons.
Toe basic elements of REACH are:
1 -Registration requires manufacturers and importers of chemicals, in quantities of one ton
or more, to submit a registration dossier to the authorities for each substance and to obtain relevant
information (human and environmental safety data) on their substances and to use that data to manage
them safely. A registration dossier is to be submitted by each company registering a substance, thus, if
there is more than one company manufacturing or importing a substance, there will be more than one
registration dossier. There are increased requirements on the dossiers based on the imported tonnage
for each chemical with thresholds of 1, 10, 100 and 1,000 tons. The requirements are also modified by
the expected classification and use pattern. The time by which registration submission is required to be
submitted also depends on the quantity and the classification of the substance. Registration under
REACH is of substances only, not preparations (mixtures of substances or finished formulas).
However, every chemical in a preparation that is being imported into the EU needs to be registered.
Substances manufactured or imported in volumes less than one ton do not need to be registered.
2 -To reduce testing on vertebrate animals, data sharing is required for studies on such
animals. A system is being established to help registrants find other registrants of the same substance
with whom they can share data (a consortia). Pre-registrants of the same phase-in substance are then
required to share animal test data and agree on the generation of new animal test data in a substance
information exchange forum (SIEF).
3 -To provide better information on hazards and risks and how to manage them will be
passed down and up the supply chain.
4 -To bring downstream users (any industrial user of chemicals) in to the system.
5 -The aim of Evaluation is to prevent unnecessary testing, by having authorities evaluate
the proposals for testing made by industry and to check compliance with the registration requirements,
and if not, ask industry for further information. Evaluation also enables authorities to investigate
chemicals with potential risks by asking industry for further information. This information may be
used later to prepare proposals under Restrictions or Authorization