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3 The Role of Legislation
REACH operates under the principle that, conceptually, each substance only
needs to have a single registration, even if produced or imported by multiple companies (in reality, however, this is not followed; as of August 2020, there were close to
five times as many registration dossiers as substances (ECHA, 2020)). This principle
allows registrants to submit a registration dossier jointly and reduce the overall
costs by avoiding unnecessary, duplicate testing. To do this, information can be
shared between registrants either through a substance information exchange forum
(SIEF), using data from preregistered phase-in substances, or through an inquiry to
ECHA. ECHA then publishes the information submitted in the registration dossiers
that it deemed nonconfidential. All registration dossiers can be accessed on ECHA’s
website (ECHA, 2020).
Information requirements for registering intermediate substances are reduced,
and no chemical safety report is needed. These are defined as substances that exist
only temporarily since they are transformed into another substance under controlled
conditions and at the same manufacturing site. Substances used in product- and
process-oriented research and development (PPORD) can also be exempted from
the registration obligation for up to 5 years.
3.3.1.2 Evaluation
Once submitted, registration dossiers can then undergo an evaluation by ECHA for
completeness. If the dossier involves any proposals for safety testing that makes use
of vertebrate animals, these are examined to prevent unnecessary animal testing.
In addition, at least 5% of all submitted dossiers in each registration tonnage band
(i.e., 1–10 t, 10–100 t, 100–1000 t, and >1000 t) are checked by ECHA to see if
they contain all of the required information. Such checks can be either targeted or
done randomly, and ECHA has the right to determine if the registrants should submit
additional information or carry out additional testing. If ECHA determines this is the
case, relevant authorities from EU member states need to also support this decision.
Member states can also themselves request an evaluation of a dossier if there is
a concern about the substance’s impacts on human health or the environment. This
can then result in requesting additional information from the registrant. Should any
evaluation conclude that the risks posed by a substance are not being sufficiently
managed, then EU-wide risk management measures may be proposed, such as
restricting the substance’s manufacture, import, or use.
3.3.1.3 Authorization
The process of authorization within REACH aims to promote the identification
and replacement of highly hazardous substances. Such substances can be formally
identified as a substance of very high concern (SVHC) following a proposal
by an EU member state or ECHA. To do this, the substance has to meet set
criteria for either being CMR (carcinogenic, mutagenic, or toxic to reproduction),
PBT (persistent, bioaccumulative, and toxic), or vPvB (very persistent and very
bioaccumulative). Alternatively, it could also be considered to cause an equivalent
level of concern, which has been applied in the case of chemicals with endocrinedisrupting effects (ECHA, 2018).
3 The Role of Legislation
REACH operates under the principle that, conceptually, each substance only
needs to have a single registration, even if produced or imported by multiple companies (in reality, however, this is not followed; as of August 2020, there were close to
five times as many registration dossiers as substances (ECHA, 2020)). This principle
allows registrants to submit a registration dossier jointly and reduce the overall
costs by avoiding unnecessary, duplicate testing. To do this, information can be
shared between registrants either through a substance information exchange forum
(SIEF), using data from preregistered phase-in substances, or through an inquiry to
ECHA. ECHA then publishes the information submitted in the registration dossiers
that it deemed nonconfidential. All registration dossiers can be accessed on ECHA’s
website (ECHA, 2020).
Information requirements for registering intermediate substances are reduced,
and no chemical safety report is needed. These are defined as substances that exist
only temporarily since they are transformed into another substance under controlled
conditions and at the same manufacturing site. Substances used in product- and
process-oriented research and development (PPORD) can also be exempted from
the registration obligation for up to 5 years.
3.3.1.2 Evaluation
Once submitted, registration dossiers can then undergo an evaluation by ECHA for
completeness. If the dossier involves any proposals for safety testing that makes use
of vertebrate animals, these are examined to prevent unnecessary animal testing.
In addition, at least 5% of all submitted dossiers in each registration tonnage band
(i.e., 1–10 t, 10–100 t, 100–1000 t, and >1000 t) are checked by ECHA to see if
they contain all of the required information. Such checks can be either targeted or
done randomly, and ECHA has the right to determine if the registrants should submit
additional information or carry out additional testing. If ECHA determines this is the
case, relevant authorities from EU member states need to also support this decision.
Member states can also themselves request an evaluation of a dossier if there is
a concern about the substance’s impacts on human health or the environment. This
can then result in requesting additional information from the registrant. Should any
evaluation conclude that the risks posed by a substance are not being sufficiently
managed, then EU-wide risk management measures may be proposed, such as
restricting the substance’s manufacture, import, or use.
3.3.1.3 Authorization
The process of authorization within REACH aims to promote the identification
and replacement of highly hazardous substances. Such substances can be formally
identified as a substance of very high concern (SVHC) following a proposal
by an EU member state or ECHA. To do this, the substance has to meet set
criteria for either being CMR (carcinogenic, mutagenic, or toxic to reproduction),
PBT (persistent, bioaccumulative, and toxic), or vPvB (very persistent and very
bioaccumulative). Alternatively, it could also be considered to cause an equivalent
level of concern, which has been applied in the case of chemicals with endocrinedisrupting effects (ECHA, 2018).