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
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
