Last reviewed 7 April 2015
As the sunset date draws near for the next batch of substances to be replaced under REACH, Gill Pagliuca of Denehurst Chemicals reviews the key processes and obligations for substances deemed to be of high concern.
Regulation (EC) No. 1907/2006 on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) aims to ensure a high level of protection of human health and the environment by encouraging the replacement of substances of high concern to health or to the environment with less dangerous substances, where suitable economically and technically viable alternatives are available. In certain instances, this substitution may be enforced by way of a binding obligation.
The REACH process begins with manufacturers and importers compiling a dossier of information identifying any hazardous properties for the substance, together with information on use patterns and levels of exposure. This is the Registration (the “R”) part of REACH. Where substances are identified as having properties of concern, they may be evaluated (the “E” in REACH) as part of the Community Rolling Action Plan (CoRAP).
If, as a result of this evaluation, it is considered that there is a need for further action to control risks, particularly where the use of these substances is considered to be widespread and not well controlled, the substance may be added to the Candidate List of Substances of Very High Concern (SHVCs), triggering a number of duties for those supplying these substances either on their own, or in mixtures and articles above a certain threshold.
The Candidate List is periodically reviewed and substances are prioritised and recommended for inclusion in Annex XIV of REACH, the Authorisation List (the “A”) part of REACH. Once added to the Authorisation List a “sunset date” is agreed after which all uses of the substance must stop unless either an exemption for certain uses in included in the entry in Annex XIV or an Authorisation for specific use(s) has been obtained. An alternative to the Authorisation process where it is deemed necessary only to control particular uses, rather than all uses, of a substance, is to include a Restriction in Annex XVII of REACH, specifying particular controls on the substance for those uses identified.
Consultations and the ECHA
At each stage of this process, lists of substances under consideration are published and consultations are carried out to give all parties the opportunity to comment and present evidence for or against the inclusion of a substance in this process. The process aims to be transparent, and progress can be viewed on the European Chemicals Agency (ECHA) website.
ECHA have recently improved the search function of the website and a search for a substance by name, CAS number or EC number from either the Home Page of the ECHA website or the Information on Chemicals page will bring up a list of results for each list that the substance appears in. An alternative way to find substances under consideration is to check the lists directly, starting with the CoRAP list and the Registry of Intentions which aims to make interested parties aware that a dossier for an SVHC or Restriction proposal is being prepared for submission.
Information on Consultations following submission of a dossier can be found via the Addressing Chemicals of Concern page. Following a consultation period, the dossier will be considered by the appropriate ECHA committee, either the Member State Committee for SVHCs, or the Risk Assessment Committee and Committee for Socio-economic Analysis for restrictions and authorisations. The decisions of these committees and also the Candidate List and Authorisation List can be found via links from the Authorisation page at http://echa.europa.eu.
A substance may be identified as a SVHC and enter these processes if it meets the criteria set out in Article 57 of REACH. These criteria include:
mutagens and reproductive toxins classified as Category 1A or Category 1B under the CLP Regulationt
substances meeting the criteria for persistent, bioaccumulative and toxic (PBT) and very persistent, very bioaccumulative (vPvB) set out in Annex XIII of REACH
and any other substance presenting an equivalent level of concern.
Currently this last category has been used to identify several endocrine disrupting chemicals for inclusion in the Candidate List.
Inclusion on the Candidate List
Suppliers of articles to industrial and professional users
Once a SVHC is included in the Candidate List there is an immediate obligation on suppliers of the substance, and on suppliers of any mixture containing 0.1% or more of the substance, to communicate this information to their customers by providing a Safety Data Sheet for the substance or mixture.
Suppliers of articles to industrial and professional users containing 0.1% or more of a SVHC must also pass on suitable information to their customers to enable them to use the article safely, including, as a minimum, the name of the SVHC. Suppliers of articles for consumer use must also make such information available to their customers within 45 days when requested.
Producers and importers
Producers and importers of articles may also need to submit a notification to ECHA if the substance:
is included on the Candidate List
is present in the articles above a concentration of above 0.1% by weight
exceeds one tonne per producer or importer per year (NB total amount of substance in the articles)
has not been registered for that specific use.
Sunset dates, exemptions and applications for continued use
If the SVHC is then included in Annex IV of REACH, all use of the substance must cease by the sunset date given in the list, unless either a specific exemption has been included as part of the entry in Annex XIV, or unless an authorisation for continued use has been granted. The process for obtaining an authorisation is complex and costly; deliberately so, to encourage companies to seek safer alternatives. Applicants for an authorisation will need to demonstrate that there are no viable alternatives immediately available, and that risks to health or the environment can be adequately controlled. If the application is made on socio-economic grounds, applicants will need to demonstrate that the socio-economic benefits outweigh the risks.
Where an authorisation is granted it will be time-limited, and companies are expected to show that they are conducting research to find safer alternatives. Applications for authorisation will need to be made at least 18 months before the sunset date. Provided the application is made in time, companies can continue to use the substance until a decision on the application is made. If the application is not submitted in time, use must cease by the sunset date until such time as an authorisation is granted.