SVHC is short for “Substances of Very High Concern”. Typically, a SVHC substance is likely to be one that meets one or more of the following criteria:
• It is classified as a category 1A or 1B carcinogen under regulation 1272/2008.
• It is considered to be Persistent, Bioaccumulative and Toxic (PBT) or very Persistent and very Bioaccumulative (vPvB)
• It has other intrinsic properties that give rise to concerns of serious effects to human health or the environment posing a similar level of concern to those substances meeting the first two criteria. The example given in the regulation is substances with endocrine disrupting properties.
If a substance is identified as SVHC, it is very likely to end up on the process that will lead to authorization, although the speed with which this will happen will depend on the priority ECHA decides is appropriate for the given substance, dependent on its properties and uses.
REACH Candidate List
The first step on the road to authorization is for the substance to be proposed and then included on the Candidate List. The process by which this happens is that a member state will prepare an Annex XV dossier proposing and justifying addition of the substance to the Candidate list which is then published on the ECHA website. Proposals are published twice per year, in April and October. Any company producing or importing a substance that meets the criteria above for an SVHC would be wise to regularly check this part of the ECHA website. There is then an opportunity for comment: 60 days. Once a proposal is published, the process runs to a strict timetable for all parties involved (ECHA, member states and the Commission.); from the date of publication of the proposal, the whole process completes in 325 days. Experience suggests that if the substance meets the criteria, it will be forwarded for inclusion on the candidate list, whatever comments are submitted, since only comment on intrinsic properties are taken into account in the decision making process. However, it is a useful opportunity to submit to ECHA any new information on tonnages and uses. The up to date candidate list is available from the ECHA website. It is expected to be updated twice per year. Fortunately, it is possible to find out if a member state is preparing an Annex XV dossier by checking the registry of intentions.
There are certain obligations that arise once a substance appears on the candidate list:
• Suppliers should update their safety data sheets to advise their downstream users that the substance has been included on the candidate list.
• Suppliers of articles containing the substance at levels >0.1% must advise downstream users that the article contains the specific substance and, if necessary, provide information on safe use. If the article contains the substance at lower levels, they must provide the same information to downstream users on request.
• Producers or importers of articles containing the substance at levels >0.1% in quantities totaling >1tpa must notify ECHA of the fact. (The exception to this is if there is no release of the substance at any point in the life cycle, including the waste stage. The manufacturer or importer does not need to submit a justification to ECHA but should document this and retain it on file in case of audit.)
Once a substance is on the candidate list, it will be prioritized by ECHA for further attention. ECHA uses a scoring system to identify priority substances to take forward to the authorization process. This takes into account the intrinsic hazard, the uses and the tonnage produced and imported. There is no time limit between a substance appearing on the candidate list and proceeding to the next stage of authorization. Further information on prioritized substances is listed on the ECHA website.
This second part of the process leading to authorization starts with a further proposal being published for consultation on the ECHA website. This starts another fixed timetable, the first part of which is the public consultation which runs for 90 days. This is another opportunity for submissions by industry and other interested parties. This proposal will include, amongst other items, the proposed phase out period (‘sunset dates’) for non-authorized uses and the date by which authorization applications must be received (along with a substantial application fee!). The publication will include review dates for uses and uses exempt from authorization, if any. Proposals currently seem to appear in batches, typically around the middle and end of the year.
After the public consultation process closes, there are various further fixed periods for the member states and Commission to consider the results of the consultation and to agree the final Annex XV entry, which should occur 330 days after the close of the public consultation. Annex XV lists the substances subject to authorization. Once an entry appears in Annex XV for a substance, those manufacturers and importers who wish to continue producing or importing it must prepare and submit their applications for authorization. Authorization dossiers will be substantial works, containing justifications for use which will cover an assessment of the alternatives and, in the case of PBT and vPvB substance, a socioeconomic justification for continued use. Expect to see a time limit for submission of authorization requests of around 2-2.5 years (minimum 1.5 years) after the decision is officially published and 3.5-4 (minimum 3) years for sunset dates (based on current experience.) The length of time for the preparation of an authorization request should be taken as an indication of the likely work involved! It can also take up to 17 months from an authorization request being submitted to being granted (it can of course also be refused!). There is an opportunity during this period for the applicant to comment on the findings of the various ECHA committees (Risk Assessment and Socio-Economic) involved in the authorization process on the authorization request.
Authorizations are substance, use and supply chain specific but a single authorization request can be prepared by a consortium of interested parties (including downstream users) and can cover multiple uses in one application. Once a substance is authorized, the authorization number should be included on the safety data sheet. Granted authorizations are likely to run for a fixed period of time. It is unclear at present what will be required to renew an existing authorization.