3.3 Product Legislation
33
required amount of safety data regarding a substance’s inherent hazardous properties
increases with the increasing amount (tonnage) of the substance annually placed on
the market.
Most substances produced in or imported into the EU at an amount of 1 t per
year or above must be registered, which requires the collection of a defined set
of safety data and submission of a registration dossier to the European Chemicals
Agency (ECHA). Member states of the EU, as well as ECHA, can then choose
to further evaluate specific substances. Companies wanting to use chemicals that
meet set criteria (see Sect. 3.3.1.3) can then be required to have all specific uses of
the chemicals authorized in advance by the agency. For dangerous substances, it is
possible that their manufacture or placement on the market is specifically regulated
or banned under a restriction.
The requirements under REACH do not apply to substances that are radioactive,
subject to customs supervision, non-isolated intermediates, wastes, or considered
to be included within the transport of dangerous substances. Some of the specific
REACH requirements also do not apply to substances that are already regulated
under other EU legislation. This includes, for example, pesticides, medicinal
products, food additives, and additives in animal feed. The following subsections
introduce each of the four main foundations that structure the REACH regulation:
registration, evaluation, authorization, and restriction.
3.3.1.1 Registration
Newly manufactured or imported substances need to have a completed registration
with ECHA before they are allowed to be produced or imported. Substances
that were already manufactured or imported before June 2007, when the REACH
legislation entered into force, are known as phase-in substances. Depending on their
production or import volume, these phase-in substances had different deadlines for
registration from 2010 to 2018.
To register a substance under REACH, a registration dossier needs to be
submitted to ECHA. This always consists of a technical dossier, and if the
substance is manufactured or imported in quantities exceeding 10 t per year, a
chemical safety report (CSR) is also required. The technical dossier needs to
include various physicochemical properties of the substance (such as the octanolwater partition coefficient, density, flash point, etc.), as well as toxicological and
ecotoxicological information (covering, for example, skin sensitization, short-term
toxicity in invertebrates, acute oral toxicity on vertebrates, or biodegradability).
When required, the chemical safety report must show the results of a chemical
safety assessment that demonstrates “that the risks from the exposure to a substance,
during its manufacture and use, are controlled when specific operational conditions
and risk management measures are applied” (ECHA, 2019c). To do this, critical
exposure scenarios are defined that describe relevant routes of exposure and releases
of the chemical into the environment. This helps to identify any appropriate actions
that should be taken to manage risks that might be present. These concepts of
exposure and risk management will be more thoroughly introduced and discussed
in Chap. 6.
33
required amount of safety data regarding a substance’s inherent hazardous properties
increases with the increasing amount (tonnage) of the substance annually placed on
the market.
Most substances produced in or imported into the EU at an amount of 1 t per
year or above must be registered, which requires the collection of a defined set
of safety data and submission of a registration dossier to the European Chemicals
Agency (ECHA). Member states of the EU, as well as ECHA, can then choose
to further evaluate specific substances. Companies wanting to use chemicals that
meet set criteria (see Sect. 3.3.1.3) can then be required to have all specific uses of
the chemicals authorized in advance by the agency. For dangerous substances, it is
possible that their manufacture or placement on the market is specifically regulated
or banned under a restriction.
The requirements under REACH do not apply to substances that are radioactive,
subject to customs supervision, non-isolated intermediates, wastes, or considered
to be included within the transport of dangerous substances. Some of the specific
REACH requirements also do not apply to substances that are already regulated
under other EU legislation. This includes, for example, pesticides, medicinal
products, food additives, and additives in animal feed. The following subsections
introduce each of the four main foundations that structure the REACH regulation:
registration, evaluation, authorization, and restriction.
3.3.1.1 Registration
Newly manufactured or imported substances need to have a completed registration
with ECHA before they are allowed to be produced or imported. Substances
that were already manufactured or imported before June 2007, when the REACH
legislation entered into force, are known as phase-in substances. Depending on their
production or import volume, these phase-in substances had different deadlines for
registration from 2010 to 2018.
To register a substance under REACH, a registration dossier needs to be
submitted to ECHA. This always consists of a technical dossier, and if the
substance is manufactured or imported in quantities exceeding 10 t per year, a
chemical safety report (CSR) is also required. The technical dossier needs to
include various physicochemical properties of the substance (such as the octanolwater partition coefficient, density, flash point, etc.), as well as toxicological and
ecotoxicological information (covering, for example, skin sensitization, short-term
toxicity in invertebrates, acute oral toxicity on vertebrates, or biodegradability).
When required, the chemical safety report must show the results of a chemical
safety assessment that demonstrates “that the risks from the exposure to a substance,
during its manufacture and use, are controlled when specific operational conditions
and risk management measures are applied” (ECHA, 2019c). To do this, critical
exposure scenarios are defined that describe relevant routes of exposure and releases
of the chemical into the environment. This helps to identify any appropriate actions
that should be taken to manage risks that might be present. These concepts of
exposure and risk management will be more thoroughly introduced and discussed
in Chap. 6.