The EU REACH Regulation and the CDI
As you will be aware, the EU’s new Regulation on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) entered into force on 1st 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.
Manufacturers and Importers
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 will need to pre-register their substances between 1 June and 1 December 2008. The pre-registration step involves the provision of some very basic information such as the identity of the company and the relevant substance(s), but does not commit companies to submit a registration dossier. Therefore it is recommended that all companies with an interest in cobalt or cobalt compounds pre-register their substance(s) to ensure access to the market after 1 December 2008.
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.
Downstream Users
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.
Authorisation
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.
Timelines
NB: Substance lists are not exhaustive or finalised at this time
CDI Activities
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 become effective from the 1st November 2007.
Each Consortium will be managed through a Steering Group comprising all manufacturers and/or importers who joined to register their substances (Regular Members). A separate CDI Division will act as Secretariat to all Consortia. Technical Working Groups for each Consortium will also be 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 Groups. The Consortium will be managed to reduce industry-wide costs of compliance and avoid duplication of effort by individual companies.
Signing-on Fee
To become a member of one or more of the cobalt REACH Consortia you will be required to pay a signing on fee to cover general management and administrative costs for the initial set up and running of the Consortia. Please note that there will be additional and separate costs associated with the implementation of the REACH Regulations which will be shared in a fair, transparent and non-discriminatory way according to the Consortium Funding Principles outlined in Article 9.3 of the Agreement.
In order to fund the initial set up of the cobalt REACH Consortia there is a single signing on fee of Euro 10,000 (ten thousand euros). This amount represents the minimum contribution for the first year of operation of the Consortia and relates to administration and management costs. It is anticipated that this signing on fee will later be factored into an annual subscription fee. The actual cost of this annual subscription fee will ultimately depend upon the number of Consortia members, tonnage involved and the number of substances involved. The greater the number of members the lower the annual subscription for each member. Payment is due upon signature of the Consortium Agreement which becomes effective on the 1st November 2007.
Penalties for late joiners may be applied to compensate for access to the know-how already acquired by the Consortium Members at the date of accession of the new Consortium Member. The amount of these penalties will be determined by the Consortium Steering Group on the basis of fairness, transparency and non-discrimination. In any case, all applying members will have to pay the full signing-on fee when joining the CDI cobalt REACH Consortium.
Ongoing subscription costs will be determined by the Consortium Steering Group once membership and tonnages have been established, and there will be separate costs for REACH implementation which are to be divided as determined by the Consortium Steering Group.
Enquiries
The CDI has created three cobalt REACH Consortia covering cobalt metal (blue Consortium), inorganic cobalt compounds (green Consortium) and cobalt carboxylates (red Consortium). A list of substances identified by the CDI for potential inclusion in the Consortium may be downloaded from the following link: substance link.
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 and in which tonnage band you would like to register and return to:
Dr. Paul Marsh
The Cobalt Development Institute Ltd
167 High Street
Guildford
Surrey
GU1 3AJ
Tel: +44 (0)1483 510472/578877
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 Dr. Paul Marsh at the above address to consider its inclusion.
After you submit your request the CDI will then send you two copies each of the relevant cobalt REACH Consortium Agreement(s) for review. If you wish to become part of a cobalt REACH Consortium the agreement(s) should be signed and returned to the address above. The CDI will then issue an invoice by return for the signing-on fee.
Downstream users of cobalt and cobalt compounds will be welcome to join the cobalt consortia as associate members for the purposes of data sharing.
If you would like to know more about the requirements of REACH or the cobalt REACH Consortia, please contact Dr Paul Marsh at the CDI (email pmarsh@thecdi.com, tel +44 1483 510472).
|
