Cobalt Development Institute

As you will be aware, the EU’s new Regulation on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) entered into force on 1^st June 2007. It is designed, using the principle of ‘no data, no market’, to shift onto industry the responsibility for assessing any risks relating to the substances it places on the EU market.

All manufacturers and importers of chemical substances in the EU, including metals and metal compounds, in quantities exceeding one tonne per year will be required to submit a registration dossier to the new European Chemicals Agency. The registration dossier will contain detailed information on the substance, including a full chemical safety assessment and proposals for classification and labelling. The registration requirement comes into effect as of 1 June 2008.

REACH provides for a regime of phase-in registration which enables companies to continue placing cobalt substances on the EU market after 1 June 2008 without submitting a full registration dossier until at least 2010. Under this phase-in regime, for all substances manufactured or imported in quantities of 1,000 tonnes or more per year per registrant, a registration dossier must be submitted before 1 December 2010. The same deadline applies to substances, such as cobalt sulphate and cobalt dichloride, which are classified as carcinogenic, mutagenic or toxic to reproduction (CMR) category 1 or 2, and substances, such as cobalt monoxide and cobalt sulphide, classified as dangerous for the environment and manufactured or imported in quantities of at least 100 tonnes per year. Non-classified substances manufactured or imported in quantities of at least 100 tonnes per year per registrant will require registration before 1 June 2013, and non-classified substances manufactured or imported in quantities of 1 tonne or more per year per registrant will require registration before 1 June 2018.

In order to benefit from the phase-in regime described above, all potential registrants could pre-register their substances between 1 June and 1 December 2008. The pre-registration step involved the provision of some very basic information such as the identity of the company and the relevant substance(s), but did not commit companies to submit a registration dossier. All companies with an interest in cobalt or cobalt compounds were advised to pre-register their substance(s) to ensure access to the market after 1 December 2008. The rpe-registration period has now closed.

Downstream users of cobalt and cobalt compounds do not have to register, however there are requirements relating to the provision of information on their uses. As part of the registration dossier, manufacturers and importers that submit chemical safety assessment(s) are also required to generate ‘Exposure Scenarios’ covering the uses of their substances. Information on exposure that is required to develop the Exposure Scenarios will need to be provided to the manufacturers by the downstream users. Downstream users involved in less common applications should ensure that their uses are included in the registration dossiers.

REACH is based on the principle of one substance, one registration and all companies that pre-register the same substance will become members of a Substance Information Exchange Forum (SIEF) for that substance. It is envisaged that the members of a SIEF will share existing data (data sharing) and they must agree a classification for their substance.

Substances that come under the authorisation regime will require positive authorisation for continued use. Substances classified as CMR category 1 or 2, such as cobalt sulphate and cobalt dichloride, will almost certainly be added to a ‘candidate list’ of substances that are liable to authorisation. During 2009 the European Commission will publish proposals for a first list of substances that become subject to authorisation.

Both manufacturers/importers and downstream users may apply for authorisations for their uses, and authorisations will be granted to specific companies for specific uses depending on the demonstration of adequate control of risks to human health and the environment, and on the availability of suitable alternatives.

The CDI has now established at least three Consortia with the purpose of preparing the registration dossiers for cobalt and cobalt compounds. The Consortia were established to facilitate companies involved in manufacturing and/or importing of cobalt substances to comply with REACH obligations on data sharing and joint submission and to reduce industry-wide costs of compliance. Therefore, the CDI strongly encourages wide participation.

The agreements governing each of the Consortia are now available for signature and became effective from the 1^st November 2007. Example copies of the Consortia Agreement can be downloaded here.

Each Consortium is managed through a Steering Group comprising all manufacturers and/or importers who joined to register their substances (Regular Members). A CDI subsidiary called the Cobalt REACH Consortium Ltd (CoRC) acts as the Secretariat to all Consortia. Technical Working Groups for each Consortium have also been set up to undertake the scientific and technical work necessary for the preparation of the registration dossiers.

Although much information on the exposure and effects of cobalt and cobalt compounds is already available, it is anticipated that a significant amount of further research will be required in order to carry out the chemical safety assessments required under REACH. The research programme will be coordinated by the Working Groups within the relevant consortia, and the costs shared according to principles of fairness, transparency and non-discrimination laid down in the Consortium Agreements and applied by the Consortium Steering Group(s). The Consortium will be managed to reduce industry-wide costs of compliance and avoid duplication of effort by individual companies.

The Consortium Steering Group meets twice a year in person at a full meeting and also holds regular teleconference call meetings (e.g. every two months). The Working Groups (Blue, Red, Green and Joint) hold full meetings every two months and also hold teleconference call meetings. Project teams and task groups are formed by volunteers as needed for work on specific topics and tasks.

There is currently no fee for Associate members to join the consortia. To become a Regular member of one or more of the cobalt REACH Consortia you will be required to pay a signing on fee. This represents an advance deposit onto the new member’s account, to cover their share of the general management and administrative costs for the initial set up and running of the Consortia. It should be understood that every new member joining the consortia has to pay the annual subscription fees for the first year, and that these back-payments are due from the date that the consortia were formed (1^st November 2007).

Starting in January 2009 the potential new members have two options for paying the joining fee:

A. Provide the CDI (as Trustee) with a letter outlining their EU cobalt tonnage and the Secretariat can then give an invoice (initial estimate for the annual subscription fee for the year 2007-2008); or

B. The company can pay an advance deposit onto their account as a signing-on fee based on a scale related to their tonnage bands (as outline below)

Note that the joining fees are also subject to an advantage compensation payment (as described in the Consortium Agreement). The advantage compensation payment is calculated as an interest charge (percentage) applied onto (A) the annual subscription fee for 2007-2008; or (B) the Signing-on fee, depending on which option is selected by the new member. The compensation payment is proportional to the elapsed time (number of months) since the establishment of the consortia (i.e. since 1st November 2007) and the month that the new member decides to join. The following calculation applies:

Note that an additional surcharge of 25% will also apply for companies that decide to join the consortia after 1 May 2009.

Starting in 2009, the Regular members will pay annual subscriptions that are based on their annual cobalt tonnage. The consortia members share in the costs for the management and administration of the consortia and the general studies and this share is based on the cobalt tonnage that is relevant for REACH. The consortia members also share in the costs for specific science/technical studies and test work based on the number of substances that they will register and the associated tonnage bands. The actual cost of the annual subscription fees will ultimately depend upon the number of Consortia members, tonnage involved and the number of substances involved. With a greater number of consortia members, then the annual subscription fees for each member will be lower.

The Consortia also encourages membership for data access, as well as participation in the work programme for development of the REACH Registration Dossiers for the cobalt substance covered by the Consortia. The additional and separate costs associated with the implementation of the REACH Regulations will be shared in a fair, transparent and non-discriminatory way according to the Consortium Funding Principles outlined in Article 9.3 of the Consortium Agreement. The Steering Group has adopted a cost-sharing structure that is described in the Funding Structure document along with illustrative examples:

The Consortia is currently looking at options such as a Letter of Access for non-members who intend to register the cobalt substances covered by the consortia. However, the details and the costs are not yet available for the other options. This will depend on the number of potential registrants that are identified in the SIEFs (Substance Information Exchange Forum) for the cobalt substances.

The CDI has created three cobalt REACH Consortia covering cobalt metal (BLUE Consortium), inorganic cobalt compounds (RED Consortium) and cobalt carboxylates (GREEN Consortium). A list of substances identified by the CDI for potential inclusion in the Consortium may be downloaded from the following link: Substance list

Should you have an interest in joining one or more of the cobalt REACH Consortia then please physically download the substance list mentioned above, indicate which substance(s) and in which tonnage band you would like to register and return the substance form to the Secretariat at:

The list of substances in the Red and Green Consortium is still open and in the event that your particular substance does not appear on the list please contact the Secretariat at the above address to consider its inclusion.

After you submit your request the Secretariat will send you copies of the relevant cobalt REACH Consortium Agreement(s) for signature. If you wish to become part of a cobalt REACH Consortium, two copies of each agreement(s) should be signed and returned to the address above. The Cobalt REACH Consortium Ltd will then issue an invoice by return for the signing-on fee.