3.3 Product Legislation
35
Proposals to identify an SVHC need to include both information to justify its
identification and information on volumes of the substance placed on the EU market,
its uses, and possible alternatives. A 45-day public consultation period follows the
submission of a proposal, and any stakeholder is invited to provide comments and
further information. If the identification is challenged during this process, the case
is referred to a ruling board known as the Member State Committee, which then
decides unanimously on a verdict or refers the case to the European Commission
for a decision. If a substance is successfully identified as an SVHC, it is placed on
the so-called Candidate List for Authorization (ECHA, 2019b). This immediately
obliges suppliers of the substance to (i) provide customers with a Safety Data Sheet,
(ii) communicate on the substance’s safe use, (iii) respond to consumer requests for
information within 45 days, and (iv) to inform ECHA if any article they produce
contains the SVHC in quantities above 0.1% by weight or if they produce or import
more than 1 metric ton of the SVHC per year.
Newly identified SVHCs are added to the Candidate List, and ECHA then prioritizes which substances on the Candidate List should be recommended for placement
on the Authorization List (ECHA, 2019a). Substances on the Authorization List
are prohibited from being used or placed on the market without authorization from
ECHA.
To move an SVHC to the Authorization List, ECHA makes a recommendation
considering criteria such as inherent hazardous properties of the substance and the
scope and scale of use. After a 90-day public consultation period on the recommendation and input from the Member State Committee, the European Commission
uses the recommendation to make a final decision. In general, chemicals placed
on the Authorization List can be approved for specific applications if an applicant
can show that the risks from using the substance are controlled to the point that
exposure is below levels not expected to cause adverse effects or if no suitable
alternative substances exist to replace it and its socioeconomic benefits outweigh
its risks. ECHA’s Risk Assessment Committee (RAC) and Socioeconomic Analysis
Committee (SEAC) then prepare draft opinions, which provide the basis for the final
decision by the European Commission.
3.3.1.4 Restriction
If a substance is found to pose an unacceptable risk(s), a member state or ECHA
can suggest applying a restriction(s) to the substance, which can include banning it;
limiting production, use, or import; as well as requiring specific labeling or technical
control measures. Restrictions can also apply to substances where no registration
would be necessary, for example, when the production or import volume is below
1 t per year. However, on-site intermediates, substances used in scientific research,
and substances that only provide a risk to human health from their use in cosmetics
are exempt from any restrictions.
After a dossier proposing a restriction has been submitted to ECHA, a public
consultation period begins allowing stakeholders to comment on the proposal.
Additionally, and similar to the authorization process, ECHA’s RAC and SEAC also
give their opinions on whether the proposed restrictions provide adequate measures
35
Proposals to identify an SVHC need to include both information to justify its
identification and information on volumes of the substance placed on the EU market,
its uses, and possible alternatives. A 45-day public consultation period follows the
submission of a proposal, and any stakeholder is invited to provide comments and
further information. If the identification is challenged during this process, the case
is referred to a ruling board known as the Member State Committee, which then
decides unanimously on a verdict or refers the case to the European Commission
for a decision. If a substance is successfully identified as an SVHC, it is placed on
the so-called Candidate List for Authorization (ECHA, 2019b). This immediately
obliges suppliers of the substance to (i) provide customers with a Safety Data Sheet,
(ii) communicate on the substance’s safe use, (iii) respond to consumer requests for
information within 45 days, and (iv) to inform ECHA if any article they produce
contains the SVHC in quantities above 0.1% by weight or if they produce or import
more than 1 metric ton of the SVHC per year.
Newly identified SVHCs are added to the Candidate List, and ECHA then prioritizes which substances on the Candidate List should be recommended for placement
on the Authorization List (ECHA, 2019a). Substances on the Authorization List
are prohibited from being used or placed on the market without authorization from
ECHA.
To move an SVHC to the Authorization List, ECHA makes a recommendation
considering criteria such as inherent hazardous properties of the substance and the
scope and scale of use. After a 90-day public consultation period on the recommendation and input from the Member State Committee, the European Commission
uses the recommendation to make a final decision. In general, chemicals placed
on the Authorization List can be approved for specific applications if an applicant
can show that the risks from using the substance are controlled to the point that
exposure is below levels not expected to cause adverse effects or if no suitable
alternative substances exist to replace it and its socioeconomic benefits outweigh
its risks. ECHA’s Risk Assessment Committee (RAC) and Socioeconomic Analysis
Committee (SEAC) then prepare draft opinions, which provide the basis for the final
decision by the European Commission.
3.3.1.4 Restriction
If a substance is found to pose an unacceptable risk(s), a member state or ECHA
can suggest applying a restriction(s) to the substance, which can include banning it;
limiting production, use, or import; as well as requiring specific labeling or technical
control measures. Restrictions can also apply to substances where no registration
would be necessary, for example, when the production or import volume is below
1 t per year. However, on-site intermediates, substances used in scientific research,
and substances that only provide a risk to human health from their use in cosmetics
are exempt from any restrictions.
After a dossier proposing a restriction has been submitted to ECHA, a public
consultation period begins allowing stakeholders to comment on the proposal.
Additionally, and similar to the authorization process, ECHA’s RAC and SEAC also
give their opinions on whether the proposed restrictions provide adequate measures