SVHCs Support Services
The road to REACH authorisation starts when a Member State or ECHA, at the request of the European Commission, proposes a substance to be identified as SVHC
In terms of REACH Substances of Very High Concern ( SVHCs) are substances meeting one or more of the following criteria:
- CMR ( Carcinogenic, Mutagenic or Toxic for reproduction) category 1A or 1B in accordance with CLP regulation
- PBT ( Persistent, Bioaccumulative and Toxic substances) or vPvB ( Very persistent and very accumulative) according to Annex XIII of the REACH regulation.
- ELoC (Substances presenting an Equivalent Level of Concern) and identified on a case-by-case basis (e.g. those having endocrine disrupting properties).
The Public Activities Coordination Tool (PACT) lists the substances for which a risk management option analysis (RMOA) by ECHA or a Member State is either under development or has been completed since the implementation of the SVHC Roadmap commenced in February 2013.
The RMOA aims to identify whether or not further regulatory risk management activities are needed for a substance and if so, to identify the most appropriate instrument to address the concern.
If the RMOA conclusions on the PACT list indicate that a critical substance for your business is considered as a relevant SVHC for the authorisation process, you need to start thinking how to act in the best interest of your business. If the RMOA is still ongoing, it may be prudent to provide relevant input to the authority.
The subsequent SVHC identification process includes a 45-day public consultation on the SVHC proposal of a Member State or ECHA. The related intention is published in the ECHA Registry of Intentions list before the proposal is submitted, to inform industry and other third parties.
During the 45-day consultation anyone can comment on the SVHC proposal, e.g. by providing information that demonstrates that the substance doesn’t meet the SVHC criteria, or information related to future stages of the authorisation process (on uses, alternatives, socio-economic impacts, other Risk Management Options, etc.). This is the time when industry has the chance to influence whether their substances are considered or not as SVHCs and to alert the authorities to the possible impacts of inclusion in the authorisation process.
Once the substance is included in the candidate list, companies may have legal obligations such as the ones listed in the Article 33 of REACH for EU article suppliers. At present (August 2018) there are 191 substances included in the candidate list. Companies should be aware that this number may increase steadily within the coming years as the Commission’s “SVHC Roadmap” states an EU-wide commitment of having all relevant and currently known SVHCs on the candidate list by 2020.
Furthermore, companies should be prepared that substances listed in the candidate list are likely to be included in the Authorisation list (Annex XIV) sooner or later, depending on their priority for risk management.
However, before this happens companies can still influence the outcome for their business by taking a proactive approach such as:
- Reviewing their substances portfolio,
- Analysing their substances and
- Preparing for the next public consultation on the ECHA draft recommendation for the Authorisation list, which now also includes a parallel call for information on behalf of the European Commission on the possible socio-economic consequences of Annex XIV inclusion.
Therefore, a strategic-level analysis and action plan as well as early technical assessments (Analysis of Alternatives, Socio-Economic Analysis, etc.) are recommended to be prepared and advocate suitable risk management options that authorities may apply. REACHLaw can help you with this.
At REACHLaw we support your company to create a suitable authorisation strategy. We also help you determine the impacts of using vs. not using the SVHCs not only in your company but also in your business sector and society at large.
Furthermore, REACHLaw supports you with the public consultations and RMOA phases by providing you with the right set of arguments and analyses, at the right time, to the right recipients and with the right strategy. In fact we have been a strategic advisor for a number of SVHC related projects prior to REACH Annex XIV inclusion.
Our service includes
The public consultation is the only official route to provide the decision makers with information that is not available in the registration dossier. The information concerning the use conditions, volumes, alternatives, as well as the socio-economic effects can help authorities to make the most proportionate regulatory decisions.
In addition to individual companies’ activities, the trade associations often play an important role in lobbying for a more appropriate regulatory option. For example, a use already regulated by specific EU laws that aim to protect human health or the environment may give grounds to claim an exemption from the authorisation list (Annex XIV), based on REACH Article 58(2).
At REACHLaw we have extensive experience in the preparation of dossiers, comments and other technical input needed prior to REACH Annex XIV inclusion. REACHLaw has extensive know-how from various industry sectors, such as the pharmaceutical and IVD industry, the metals industry, oil and petrochemical, aerospace & defence which are some of the most complex areas in REACH. At REACHLaw we would be happy to help you preparing your comments for the public consultations phase.
As part of the European Commission’s SVHC Roadmap to 2020, the risk management option analysis (RMOA) was introduced as a step in the decision-making process for authorities.
Associated with it, we have the public activities coordination tool (PACT), published by Echa. This lists the substances for which a RMOA or an informal hazard assessment for persistent, bioaccumulative and toxic/very persistent and very bioaccumulative (PBT/vPvB) or endocrine disruptor properties is under development or has been completed since February 2013, when the the SVHC Roadmap was launched.
RMOA is a voluntary step, it is not part of the processes as defined by the legislation. For authorities, documenting the RMOA allows early discussion and sharing of information which leads to a common understanding. An RMOA is a case-by-case analysis, conducted by the authorities (member states or Echa if requested by the European Commission), to:
- conclude if a substance should be identified as a concern; and
- if additional regulatory instrument(s) should be proposed, to manage the risks from its use to human health or the environment, as well as which instruments to use.
We would be glad to support you with the RMOA phases by providing you with the right set of arguments and analyses, at the right time, to the right recipients and with the right strategy.
In addition to the intervention activities, companies should develop a regulatory roadmap as part of their strategic planning. This may address key issues such as:
- processes to be designed or optimised on the substance and use information collection;
- mitigation of regulatory risks along the supply chain;
- timely obsolescence management;
- cost-effective replacement plan;
- portfolio optimisation; and
- effective public communication
REACHLaw has been a strategic advisor for a number of SVHC related projects prior to REACH Annex XIV inclusion and we would be happy to help your company to create a suitable authorisation strategy.