COMMENTS AND RESPONSE TO COMMENTS ON ANNEX XV SVHC: PROPOSAL AND JUSTIFICATION

Substance name:	Cobalt (II) carbonate	
CAS number:	513-79-1	
EC number:	208-169-4	

Reason of the submission of the Annex XV: CMR

Disclaimer: The European Chemicals Agency is not responsible for the content of this document. The Response to Comments table has been prepared by the competent authority of the Member State preparing the proposal for identification of a Substance of Very High Concern. The comments were received during the public consultation of the Annex XV dossier. 

General comments
No	Date	Submitted by (name, Organisation/
MSCA)	Comment	Response	
1	2010-10-14	Industry or trade association, Cobalt Development Institute (CDI), United Kingdom	The Cobalt Development Institute (CDI) is an international organisation of a wholly non-profit making character. The CDI is an association of producers, users and traders of cobalt. The CDI has the following objectives:
(1) Promoting the responsible and sustainable use of cobalt in all forms. 
(2) Consulting organisations, agencies and governments for research or investigations in all matters concerning cobalt. 
(3) Providing members with topical information on all cobalt matters including health & safety and environmental legislation plus regulatory affairs possibly affecting their interests. 
(4) Promoting co-operation between members and providing a forum for the exchange of information concerning the resources, production and uses of cobalt. 

Membership of the CDI includes 44 member companies from 18 countries including all the major cobalt producers. 

The Board of the CDI has also established three Cobalt REACH Consortia to implement REACH on behalf of the cobalt industry. A separate wholly-owned subsidiary of the CDI called CoRC (Cobalt REACH Consortium Ltd.) acts as the Secretariat to the Consortia.

The CDI Toxicologist has prepared technical comments on the information presented in the Annex XV Dossier. The CDI provides these technical comments to complement the joint response comments that have also been prepared by the Cobalt REACH Consortium (CoRC).  	Noted.	
2	2010-10-14	International NGO, Health and Environment Alliance, Belgium	We support the inclusion of Cobalt(II) carbonate on the candidate list, on the basis of the information in the Annex XV dossier  	Thank you for your support.
	
3	2010-10-14	Industry or trade association, Cobalt REACH Consortium Ltd. (CoRC), United Kingdom

(confidential attachment removed)	The following joint response comments are provided by the Secretariat of the Cobalt REACH Consortium (CoRC) on behalf of the Consortium member companies. The Cobalt REACH Consortium was founded in November 2007 by the Board of Directors of the Cobalt Development Institute (CDI) to implement REACH on behalf of the cobalt industry. There are currently 43 Regular members of the Consortium. The Consortium member companies and their affiliates constitute over 80 industry companies involved in the manufacturing and/or import of cobalt substances in Europe as well as other international jurisdictions. There are also some downstream users represented amongst the Consortium membership. The Cobalt Consortium has always contributed to the ECHA stakeholder consultations. 

BACKGROUND: 

CoRC was notified of the initial plans to place this cobalt substance (and also three other cobalt salts) onto the Registry of Intent. The Consortium reviewed the draft proposal(s) and, offered to provide more accurate information regarding the actual uses and volumes of cobalt carbonate in Europe. The Secretariat and Consortium member companies also met with representatives of the REACH Competent Authority (CA) for the Netherlands (proposing Member State) to discuss their preparation of the Annex XV dossier(s). At that time, the Consortium delegation respectfully requested that this process be deferred until after the current REACH deadline (30 November 2010) when cobalt carbonate would be registered, so that further dialogue could take place based on the Registration Dossier and CSR (Chemical Safety Report) and so more informed decisions would be possible. 

The Netherlands does not have any manufacturing facilities for the cobalt substance and there are only a few facilities where this substance is actually used. The main reason for nominating the cobalt substance(s) as potential SVHC is procedural, i.e. that the substance was selected from a list of one hundred plus ‘priority’ substances developed by a team of Member State Competent Authorities from over sixteen hundred PBT, vPvB and CMR substances. 

One reason offered for this selection was that there were non-intermediate uses of the substance where there were concerns for occupational safety, (although no specific examples were given). It was also indicated that there was a benefit from placing a substance on the Candidate list as this would trigger the generation of more information, (even though the full risk assessments are imminent through REACH). 

Over the past five years the cobalt industry has collated a vast amount of information for this and other cobalt substances through an extensive work programme with an estimated overall cost of participation of over 7 million Euros. Many technical experts have been employed by the Consortium to conduct a thorough Chemical Safety Assessment for this substance, and the outcome has been described in a comprehensive Chemical Safety Report (CSR). This data and detailed information, as well as a vast array of company-specific information on this substance, will soon be submitted to ECHA by all the companies that manufacture and import this substance in Europe. All of these companies will have shared in the costs of the major work programme conducted to obtain this information. 

As placing substances on the Candidate List will result in the stigmatization of these substances, this step should not be undertaken lightly. There are a number of multinational companies that are imposing arbitrary bans on any substance placed on the Candidate List. If a further cobalt substance(s) is placed on the Candidate list, this could potentially affect the economic viability of the cobalt industry. 

The Consortium also considers the timing of the current proposals was unfortunate as it was very difficult for industry stakeholders to participate in a public SVHC consultation on CMR substances at exactly the same time that the corresponding companies are also fully engaged and committed to meeting their obligations for the first REACH registration deadline.   

For these reasons the Consortium respectfully requests that ECHA and the Member States suspend and defer their decision regarding this proposal until after the first REACH Registration deadline (30 November 2010) to allow for consideration of the extensive information that will soon be provided in the full REACH Registration dossier for this substance. Afterwards the Consortium would be pleased to discuss any residual concerns with the proposing Member State, and to use our company membership and networking contacts to obtain further information, if this should be determined to be necessary. 

GENERAL COMMENTS:

Information collected by the Consortium shows the majority of the volume of this substance (over 99%) is manufactured/imported as an Intermediate. The majority of the uses and activity sectors described in the Annex XV Dossier are also as an Intermediate, according to the definition in the Regulation, and are therefore exempt from Authorisation. Other uses are also exempt as these are covered by other existing regulations (e.g. animal feed). These are extremely important facts which have been presented only in the very small footnotes to the tables and also concealed by the many general details presented in Part 2 of the Annex XV Dossier.  

The Annex XV Dossier presents data for cobalt production and other data which is taken from other jurisdictions. It is important to clarify that the volume information of this specific cobalt substance in Europe is estimated to be on the order of several thousand tonnes per year, with the majority (over 99%) as an Intermediate, and therefore only a relatively small volume as non-intermediate use (i.e. less than several 100 tonnes), which is also an exempted use (e.g. animal feed).

The EC and several Member States, including the Netherlands, have spent considerable investment in terms of years and research funds towards the development of specific applications where cobalt substances are replacements for other more hazardous substances. Such uses have been noted to present the potential to improve energy efficiency and also environmental performance. Therefore the current SVHC proposal appears to be counter-productive.  

The Annex XV Dossier correctly acknowledges there are no known alternatives for this cobalt substance (Section 2, page 22). Each cobalt substance has unique properties and characteristics that match the intended use for the cobalt substance. It is a misconception that one cobalt substance can be easily substituted by another cobalt salt. Alternatives have not been identified for cobalt substances as the unique properties imparted by the cobalt substances themselves are necessary and valued for the ability to provide for higher levels of performance, efficiency, safety and reliability, and environmental benefits. 

Cobalt is considered a minor metal, and the cobalt industry is essentially an “SME sector” when compared to similar sectors for the major or base metals. 

The cobalt market is small in tonnage terms compared to other metals but it is a highly important and valuable part of EU industry both for established to newly emerging technology. Cobalt substances are also strategically important for several reasons, such as their uses in highly vital and valuable industries and high value technology (such as gas turbines). Cobalt substances also figure prominently in several newly emerging technologies, in relation to energy storage and renewable energy production. Cobalt substances provide significant opportunities for improved energy efficiency as well as environmental benefits which will become increasingly important with regards to the future economy and Climate Change. 

Cobalt itself has also been identified by the EU through its Raw Materials Initiative as a metal with critical importance to Europe and the EU is therefore seeking to mitigate against any potential shortages of supply. 

For these reasons it may not be proportional to consider steps which could limit the manufacture, import and use of cobalt substances in Europe, particularly when the European Commission has clearly indicated that such uses are to be protected and encouraged.	Noted.

There maybe different reasons why a MS initiates a process leading to the preparation of an Annex XV dossier. The trigger of concern for cobalt carbonate is that it meets the criteria for carcinogenicity Article 57(a) and toxic for reproduction Article 57(c) under REACH.  Under Article 59(3) any member state may prepare a dossier in accordance with Annex XV for substances that in its opinion meet the criteria out in Article 57 and forward it to the agency.  The dossier, may be limited, if appropriate, to refer to an entry in Annex VI of the Directive 1202/2008.

Noted.

We agree that the data indicates that the main use of cobalt carbonate seems to be as an intermediate.  However, there is uncertainty with respect to the reported uses if they all can be regarded  as intermediate uses and the tonnage of non-intermediate uses may still be significant. This can mainly be attributed to different interpretations of the definition of intermediate Article 3(15).  We believe the differentiation between the use of cobalt carbonate in the manufacture of catalysts and the use of the substance as catalyst needs to be addressed.  In the ECHA clarification document of the definition of intermediates under REACH, substances used as a catalyst are not regarded as intermediates.  

4	2010-10-14	Company, Haldor Topsoe A/S, Denmark

	General comments to the Annex XV dossier

Cobalt carbonate has been nominated as a substance that fulfils the criteria of substances of very high concern due to the classification of the substance as CMR (Cat 2) in accordance with the first ATP to Regulation (EC) No 1272/2008. This classification cannot be discussed. However, the nomination of the substance as a substance for the candidate list can be discussed from the following perspectives:

• According to Article 58, 3 in the REACH Regulation, priority should normally be given to substances with PBT or vPvB properties. Cobalt carbonate does not fulfil these criteria.

• The predominant quantity of the substance is for intermediate use (estimated approximately 99%), where use in the production of catalyst is one of the main intermediate uses. During the production process the cobalt carbonate is decomposed to cobalt oxide. Cobalt carbonate is not contained in the catalyst that is placed on the market. 

• Due to the classification of cobalt carbonate as carcinogen in category 2, industrial use of the substance has to take place in compliance with the EU directives as well as national legislation regarding protection of workers from the risk related to exposure to carcinogens at work. Therefore, the level of protection is high at an industrial production using cobalt carbonate.
• Furthermore, compliance with the IPPC directive (96/61/EC) and the directive on major accident hazards involving dangerous substances (96/82/EC) is required.

Based on this, it is our conclusion that inclusion of the substance on the candidate list will not result in improvement of the protection level, as the standard of production is already very high, and as the substance is not placed on the market as such.	

Noted.

We disagree with this statement. Article 57 (a-f) of REACH lays down the criteria for identifying substance that may be included in the candidate list as SVHC: CMRs (cat 1 or 2), PBTs, vPvBs or substances of equivalent concern.  Under Article 58 (a-c) of the REACH regulation PBT or vPvB properties, wide dispersive use or high volumes are criteria that are taken into account to prioritize substances on the candidate list for inclusion in Annex XIV. 

See comment and response to comment No. 3.

This information will be taken into account in the process of priority setting for Annex XIV.

	
5	2010-10-14	Industry or trade association, EUROPEAN CATALYST MANUFACTURERS ASSOCIATION (ECMA), Belgium	Cobalt carbonate is used in the catalyst industry as an intermediate for the production of other cobalt compounds contained in catalysts and is consumed in the course of the manufacturing process. As such this use should be exempted from authorisation (Regulation EC No. 1907/2006 Title 1 Article 8).
Furthermore, considering the fact that to our knowledge over 99% of the volume of Cobalt carbonate has an intermediate use, a listing of this compound as a substance of very high concern seems disproportionate.	See comment and response to comment No. 3.
	
	2010-10-14	Company, Vale Europe Limited, United Kingdom	Vale is a major producer of cobalt metal and over the next few years expects to be producing significant quantities of cobalt carbonate from its mining operation in Goro, New Caledonia. A substantial proportion of this production will be imported into the EU. As a major producer and importer of cobalt metal and cobalt carbonate, Vale is a member of the Cobalt Development Institute (CDI) and Cobalt REACH Consortium (CoRC). Vale Europe Ltd is also Lead Registrant (LR) for cobalt carbonate.

One aspect that concerns Vale is the timing of the submission of the Annex XV dossier for cobalt carbonate. Vale as LR and CoRC are fully engaged in producing a high quality registration dossier for evaluation by the authorities. However, submission of the Annex XV dossier at this time is an unwelcome distraction, which results in diversion of resources away from this primary objective. We believe a pragmatic approach would be first to evaluate the dossier that will be submitted in the next few weeks before considering the substance for the SVHC Candidate List.

We are unclear why the Netherlands Competent Authority (RIVM) has chosen to submit the Annex XV dossier for cobalt carbonate. From our knowledge there are no cobalt carbonate manufacturing sites and very few facilities using the substance in the Netherlands. This suggests that there is a wider politically coordinated initiative by the member state competent authorities to place cobalt carbonate and other cobalt salts on the candidate list. It seems an unreasonable and disproportionate approach to target the cobalt industry in this way.

The majority of uses for cobalt carbonate by sector and volume are as an intermediate, as indicated in the Annex XV dossier. If this substance is placed on the candidate list, then according to the REACH Regulation very few uses will become subject to Authorisation. The Netherlands CA has put considerable effort into preparing the Annex XV dossier, but this can only result in a few minor uses of cobalt carbonate being potentially subject to Authorisation. In the wider context this will have little overall benefit to human health and the environment. It is also not clear from the Annex XV dossiers which of the few non-intermediate uses are of particular concern to the authorities and for what reasons.

Our understanding is that the Authorisation Process would be used to address the PBT and VPvB substances first, because they are of higher concern than the CMR’s. However, this does not seem to be how the process is working, as the current selection is clearly targeted towards substances with CMR classification; that is eight out of the eleven current proposals are CMR substances. CMR substances are generally well characterised and documented, whereas there is generally less information available for PBT and vPvB’s. If there has been a change in strategy to ‘prioritise’ CMR’s because there is more information available, then this should be communicated clearly to all stakeholders.

It is also unclear why CMR’s are being ‘prioritised’ as SVHC, when there are already very stringent controls on their use in the workplace. If it is perceived that the existing legislation is not working adequately then CMR Directive 2004/37/EC should be reviewed accordingly, rather than use the REACH Regulation to resolve the issue.

It has been indicated by a number of stakeholders that placing substances on the Candidate List is an effective means of generating additional information; that is it drives interested parties to gather new data. We believe this is an unreasonable approach as all CMR substances require a REACH Registration dossier to be submitted by the November 2010 deadline. There will then be a wealth of new information available to member state authorities which can be considered before making a decision on whether to submit an Annex XV dossier. It should be appreciated that placing substances on the Candidate List, immediately stigmatises them and potentially affects their commercial viability. There are a number of large multinational organisations that have already placed arbitrary bans on any substance appearing on the list. We also request that a procedure be put in place as soon as possible so that substances can be withdrawn from the Candidate List if new relevant scientific information becomes available.

Vale respectfully requests that ECHA and the Member States please defer their decision regarding this proposal until after the first REACH Registration deadline (30 November 2010) to allow for consideration of the extensive information that will soon be provided in the full REACH Registration dossier for this substance.	Noted.

There maybe different reasons why a MS initiates a process leading to the preparation of an Annex XV dossier. The trigger of concern for cobalt carbonate is that it meets the criteria for carcinogenicity Article 57(a) and toxic for reproduction Article 57(c) under REACH.  Under Article 59(3) any member state may prepare a dossier in accordance with Annex XV for substances that in its opinion meet the criteria out in Article 57 and forward it to the agency.  The dossier, may be limited, if appropriate, to refer to an entry in Annex VI of the Directive 1202/2008.

See comment and response to comment No. 3.

Article 57 (a-f) of REACH lays down the criteria for identifying substance that may be included in the candidate list as SVHC: CMRs (cat 1 or 2), PBTs, vPvBs or substances of equivalent concern.  Under Article 58 (a-c) of the REACH regulation PBT or vPvB properties, wide dispersive use or high volumes are criteria that are taken into account to prioritize substances on the candidate list for inclusion in Annex XIV. 

This information will be taken into account in the process of priority setting for Annex XIV.

Noted.

	
6	2010-10-14	Member State, Germany	Comment for the German CA

►We agree with the identification of soluble cobalt (II) salts as SVHC substances. 

►Exposure measurements from 1994 in several occupational scenarios revealed  concentrations of 68 – 89 µg/m3 (range 1 – 7700 µg/m3); Lison 1994 see part II, 1.2.1.2). More recent data on exposure measurement are not described in the annex XV reports. Long-term exposure of rats and mice (0, 60, 200, 600 µg/m3) detected a significant increase of tumour rates. In addition some genotoxicity was detected. Based on these data and further information in the open literature the occupational risk of carcinogenicity is supposed to be so high that an authorisation is justified.

►Editorial notes:
- References are not fully available (e.g. on page 28 Scansetti et al, 1994).

- Fine tuning of near-similar wording between Dossiers should be improved (e.g. In Acetate Dossier „Co“ is mentioned as foam additive for beer. This usage is not mentioned for the corresponding sulphate which literature reports as having been used as well).	

Thank you for your support.

This will be taken into account for the priority setting for Annex XIV, as information becomes available.

Information on the hazards properties (Annex I) were provided to the reader for informational purposes only as the classification on the substance has already been concluded.  The summaries used in Annex I were mainly copied from three major sources and these are referenced in the report.   The following text is added to the text where necessary to indicate to the reader where they can locate specific references under each section, “Information on the references cited in this section (in parenthesis) can be found in the cited summary document.”

Thank you for pointing this out. According to industry this use has been phased out and therefore may no longer be relevant. This use will be reviewed as information becomes available.	
7	2010-10-14	Company, Finland	We are interested to know why an Annex XV Dossier has been prepared at this time when it is known that the substance will be registered in 2010 and a registration dossier will be available within some months? The EU manufacturers/importers of this substance are just finalizing all work to fulfill the registration dossiers and it seems that all effort that the industry is making is not taken into account at all.
According to the REACH regulation Member States can suggest substances, which are fulfilling the outlined criteria’s, to be included on the Candidate List for Substances of Very High Concern (SVHC). It is in our interest to know why the Dutch authorities have suggested this substance for the Candidate List? To our knowledge there are no manufacturers of this substance in Netherlands and only a few facilities using the substance. We do not find this as a reason for suggesting the substance to be of very high concern (SVHC).
In addition to this it is our understanding that the substance is only used as an intermediate in Netherlands thus not fulfilling the criteria’s to be appointed on the Candidate List. There is only one industrial sector which to our understanding is using the substance as a non-intermediate - the Animal Feed sector. This sector is however exempted from REACH and is covered by the EU regulation on additives for use in animal nutrition (1831/2003). To be able to provide the Animal Feed sector with this substance in the future the industry must prepare and deliver an Authorization dossier at the latest on 7th November 2010. 
It is also our understanding that other industrial sectors like production of pigments, manufacture of catalysts and manufacturing of other chemicals are using the substance as an Intermediate. In addition to this, it is our understanding that the use in these sectors are of non-dispersive nature. We would like to know which non-Intermediate uses are of possible concern because this was not clear from the Annex XV Dossier?	

There maybe different reasons why a MS initiates a process leading to the preparation of an Annex XV dossier. The trigger of concern for cobalt carbonate is that it meets the criteria for carcinogenicity Article 57(a) and toxic for reproduction Article 57(c) under REACH.  Under Article 59(3) any member state may prepare a dossier in accordance with Annex XV for substances that in its opinion meet the criteria out in Article 57 and forward it to the agency.  The dossier, may be limited, if appropriate, to refer to an entry in Annex VI of the Directive 1202/2008.  

Regarding the use of the substance as an intermediate, see comment and response to comment No. 3.
	
8	2010-10-14	Company, Albemarle Catalyst Company B.V., Netherlands

(confidential attachment removed)	The annex XV dossier is based on the current classification of this cobalt compound. However, the classification for carcinogenicity refers to a general read across based on carcinogenicity studies with cobalt sulphate in rats and mice by the inhalation route. Even if a precautionary classification of cobalt compounds as carcinogens based on this study can be applied, we believe  that any further regulatory actions should take into consideration data (e.g. on bioavailability and genotoxicity) that have been  developed in the REACH process and also consider a possible threshold mode of action. 
- Similarly the fertility classification is based on studies with other soluble cobalt compounds and even if a grouping for classification is understandable, further regulatory actions should consider data that will become available soon with the REACH registration prior to November 30, 2010. Furthermore as effects on reproduction are classical threshold effects, DNELs can be derived and risks will be adequately controlled by implementing those thresholds. Further regulatory actions are not warranted to control for possible effects on fertility.

- Cobalt carbonate is used by Albemarle Catalyst Company B.V. as an intermediate for the production of other cobalt compounds contained in refinery catalysts and is totally transformed in the course of the manufacturing process. As such this use should be exempted from authorisation (Dir. 1907/2006, Title 1, Art. 2.(8)).
- Based on to our knowledge, over 99% of the volume of Cobalt carbonate is used as an intermediate. Therefore  a listing of this compound as a substance of very high concern seems disproportionate	Information on the hazardous properties of cobalt carbonate was provided for transparency reasons only as the classification as already has been concluded by the Technical Committee on Classification and Labelling (TC-C&L) and included in Annex VI.  According to Article 37(6) of the CLP regulation (Directive 2008/1272/EC): manufactures, importers and downstream users who have new information which may lead to a change of the harmonized classification and labelling elements of a substance in Part 3 of Annex VI shall submit a proposal in accordance with the second subparagraph of paragraph 2 to the authority in one of the member states in which the substance is placed on the market.

Noted. See also comment and response to comment No.3.

9	2010-10-14	Member State, United Kingdom	As it stands this Annex XV dossier does not demonstrate that the current uses of this cobalt compound presents an unacceptable risk. Further assessment is required to determine whether any regulatory action is required. Depending on the accessibility of information in registration dossiers to MS, we would suggest interrogation registration dossiers for information on exposure and current operating conditions and risk management measures. If MS cannot get sufficient information from registration dossiers then these substances should be considered for substance evaluation.	Thank you for your comments they are noted.  We are aware that the information presented in the Annex XV dossier is limited. The information that will become available following placing on the candidate list will be used to assess risk especially with respect to the use of this substance in consumer products and worker exposure and to assess if any further regulatory action is required as explained in the corresponding RMO-analysis.	
10	2010-10-14	International NGO, WWF European Policy Office, Belgium	WWF and CHEM Trust support the inclusion of Cobalt (II) carbonate in the candidate list due to its carcinogenic and reprotoxic properties.	Thank you for your support.	
11	2010-10-13	Company, Norway	We were disappointed by the overall quality of the annex XV dossier, with particular reference to the uses and exposure section, and the overall justification for proposing these substances. 

The information concerning the hazard classification of these substances is a matter of record, much of it derived by read across from other cobalt substances.  However, being a CMR is only one of the criteria for listing.  PBT, vPvB, widely dispersive use, high volume, and risk of exposure, are all part of the definition of a Substance of Very High Concern (SVHC).  If the Candidate List was intended to be simple list of CMRs, the process of selection would be obvious and require no public consultation.  Adding substances that do not meet any of the other requirements of an SVHC definition dilutes the effectiveness of the list, risks wasted effort, and ultimately threatens to discredit the entire process of prioritisation and authorisation within REACH.  

The annex XV dossier has little information on the substance that is the subject of the dossier.  The section is generic and addresses “cobalt” in general.  Most of the applications described and the associated tonnages are for cobalt metal, which is not the subject of the annex or listing.  There is little information on exposures, wide dispersive use, or whether the substances are on the market, or are used on site as intermediates.  What information of relevance that is contained in the final dossier was provided by the Cobalt Consortium following an informal approach by the Dutch authorities in advance of making the formal proposal.  We understand that the information provided by the Cobalt Consortium was used selectively in the final dossier, and, when mixed with the data from the original draft, was not representative of the data provided.  The fact that the Cobalt Consortium was attributed as the source of some of the data implies that the consortium agreed with how its data was used in the final dossier.   However, we understand that this was not the case in practice.   

While making a well intended attempt to provide comprehensive  information on the cobalt substance, the final dossier is actually misleading to anyone unfamiliar with the Cobalt Industry.  By using generic statistics for the entire Cobalt Industry, it implies that these are  large volume substances.  Similarly, it implies that it is widely dispersed in use, and that many people are exposed to the substances.  This is not the case for the substances in question.  The length of this section as written implies a wealth of information and a series of well founded concerns.  In practice, it does not contain the information required to justify that it is a SVHC, and so worthy of listing.     	Noted.

We disagree with this statement. Article 57 (a-f) of REACH lays down the criteria for identifying substance that may be included in the candidate list as SVHC: CMRs (cat 1 or 2), PBTs, vPvBs or substances of equivalent concern.  Under Article 58 (a-c) of the REACH regulation PBT or vPvB properties, wide dispersive use or high volumes are criteria that are taken into account to prioritize substances on the candidate list for inclusion in Annex XIV. 

See comment and response to comment No. 3.
	
12	2010-10-13	National Authority, Climate and Pollution Agency, Norway	The Norwegian CA supports that cobalt (II) sulphate (CAS number 10124-43-3), cobalt (II) dinitrate (CAS number 10141-05-6), cobalt (II) carbonate (CAS number 513-79-1) and cobalt (II) diacetate (CAS number 71-48-7) should be identified as  substances of very high concern and should be included in the Candidate List.	Thank you for your support.
	
13	2010-10-13	International NGO, International chemical secretariat, Sweden	Full support regarding its identification as a SVHC.	Thank you for your support.
	
14	2010-10-12	R.I.S.K. Consultancy, Belgium

	p.1: Please see my attached comments	Thank you for your support and for the additional information. .The focus of the Annex XV dossier, however, is on carcinogenicity and toxicity to reproduction, since these two effects make it an SVHC.	
15	2010-10-12	Company, ERAMET, France	ERAMET is a French mining and metallurgical Group active in the production and conversion of non ferrous metals and in alloys. Amongst its activities, ERAMET produces and uses cobalt carbonate as an intermediate in the production of CoCl2 at one site in France (site of Sandouville).  
ERAMET is a founding and active member of the Cobalt REACH Consortium dealing with cobalt carbonate and other cobalt compounds, which was officially created on 1st November 2007, and has thus participated in the work undertaken to prepare for pre-registration and registration. In the specific framework of this public consultation, the ERAMET Group also contributed with the other members of the Consortium to the preparation of joint comments that have been submitted by the Cobalt Development Institute (CDI) acting as the Secretariat of the Consortium. The main conclusions of these joint comments are the followings: (1) the overall volume of cobalt carbonate manufactured/imported in Europe has been estimated to be on the order of several thousand tonnes per year; (2) the majority of the cobalt carbonate manufactured/imported in Europe is reported to be as an Intermediate ;(3) the majority of the uses of cobalt carbonate have been identified as being an Intermediate use, and are therefore exempt from Authorisation under REACH;(4) relatively low volumes of cobalt carbonate are being supplied to the non-intermediate use that has been identified (e.g. animal food supplement);(5) the use of cobalt carbonate as an animal food supplement is covered by different EU legislation and is therefore also exempt from REACH;6) there are already very stringent controls on the use of cobalt carbonate in the workplace; and (7) all of these points strongly support the case not to consider cobalt carbonate as a potential SVHC that could become subject to Authorisation under REACH.  
In addition ERAMET would like to provide further information on production and uses of cobalt carbonate and on some elements referred to from page 15 to page 23 with a view to clarifying the information provided in these sections. More comprehensive and detailed information will soon be provided in the Registration dossier that will be submitted by ERAMET SA by the end of November 2010. We therefore join the other Consortium members in respectfully requesting that ECHA and the Member States suspend and defer their decision regarding this proposal until after the first REACH registration deadline to allow for consideration of the information that will soon become available.	Noted.

See comment and response to comment No. 3.

Points 5 and 6 will be taken into account in the process of priority setting for Annex XIV.

Noted.

	
16	2010-10-11	Company, Twickenham Plating Group Ltd, United Kingdom	Ref Page 17 (1.1.2)  “Uses for Cobalt Carbonate”

My company provides specialist technical plating services for electronics, telecommunication, security, military, aerospace and automotive applications. One of these plating processes is a proprietry hard acid gold-cobalt process, whereby the cobalt is deposited using cobalt carbonate.  Our consumption of cobalt carbonate is very low (<20 grams per annum).  This gold-cobalt alloy process is customer specific.  Operationally, my company abides by all the health and safety requirements stipulated in our supllier’s safety data sheets, in conjunction with our own risk assessment for this process. Emissions of this substance are controlled well below regulatory occupational exposure limits and environmental limits.  

If cobalt carbonate is designated as a SVHC – substance of very high concern - and eventually placed on the candidate list for authorisation, this will have an onerous impact on the provision of this process to meet the needs of these specialist industries.  	This information will be taken into account in the process of priority setting for Annex XIV.

17	2010-10-06	National Authority,
Allgemeine Unfallversicherungsanstalt,
Austria	Cobalt-salts in general and Co(II)sulfate specially are used in offset-printing. There is a variety of different alternatives for these uses already available. This use as a fountain solution (german: Feuchtwasser) can be seen as a wide dispersive use. We use this opportunity again to support the idea of grouping within the process of authorisation. Read across, QSAR, and other REACH-accepted methods have to be seen equal to grouping of identical cations, like Co(II), Cr(VI), etc. . Grouping will lead to a faster, less bureaucratic authorisation process.	Thank your for you support.  This information will be taken into account in the process of priority setting for Annex XIV.	
18	2010-10-06	Member State,
Sweden	Sweden supports the proposal to identify Cobalt(II)carbonate as a substance of very high concern.	Thank you for your support.	
19	2010-09-29	Industry or trade association,
ZVO Central Agency of surface treatment,
Germany	1. Cobalt(II) carbonate is used in plating technology for electroplating High-Tech products, e.g. magnetic layers, Gold-Alloys.  2. If used in electroplating, the substance is predominantly solved in water. The consumer contacts only the metallic product that is of no concern. 3. Cobalt(II) carbonate is used in Conversion layers for corrosion protection. 4. The use in the production process is clearly save and unambiguously controllable. 5. The available Risk Assessments identify the main risk in the exposure to the aqueous environment and uptaking by drinking water. The use in plating is forced by the wastewater legislation to expose less than 1.0 mg/L (proposed). This is guaranteed by the plating industry.	This information will be taken into account in the process of priority setting for Annex XIV.
	
20	2010-09-29	Industry or trade association,
ZVO Central Agency of surface treatment,
Germany	1. Cobalt-(II) carbonate is used in plating technology for electroplating High-Tech products, e.g. magnetic layers, Gold-Alloys.  2. If used in electroplating, the substance is predominantly solved in water. The consumer contacts only the metallic product that is of no concern. 3. Cobalt-(II) carbonate is used in Conversion layers for corrosion protection. 4. The use in the production process is clearly save and unambiguously controllable. 5. The available Risk Assessments identify the main risk in the exposure to the aqueous environment and uptaking by drinking water. The use in plating is forced by the wastewater legislation to expose less than 1.0 mg/L (proposed). This is guaranteed by the plating industry. 	This information will be taken into account in the process of priority setting for Annex XIV.
	
21	2010-09-07	Trade union,
European Trade Union Confederation,
Belgium	ETUC suports the inclusion of Cobalt(II) carbonate in the Candidate list.	Thank you for your support.	

Specific comments on the justification
No	Date	Submitted by (name, Organisation/
MSCA)	Comment	Response	
22	2010-10-14	Industry or trade association, Cobalt Development Institute (CDI), United Kingdom	The current classification for carcinogenicity by inhalation refers to a general read-across based on the results of a lifetime inhalation assay of cobalt sulphate conducted in two rodent species by the US National Toxicology Program (US NTP). 

We can understand exercising the precautionary principle regarding these cobalt compounds relative to inhalation hazard, however we believe that any further regulatory actions should take into consideration data that are currently being collected by the REACH process on cobalt bioavailability, lung effects, and mechanisms of action (e.g. threshold vs. non-threshold effects). Occupational  exposure of cobalt to humans (in the absence of mixed-metal exposure)  has not been associated with lung cancer.

It is also important to point out that human exposure to the currently-classified substances has never been associated with carcinogenicity by oral or dermal routes of exposure in either humans or experimental animals.  Similarly the fertility classification is based almost exclusively on non-guideline compliant studies of cobalt chloride and cobalt sulphate in experimental animals only. 

While we can understand a grouping for classification, further regulatory actions should consider data that will become available soon with REACH registration.  The effects on reproduction have never been reported for humans. For experimental animals, the effects reported have a threshold and DNELs can be derived where risks will be adequately controlled by implementing those thresholds. Therefore, we believe further regulatory actions are not warranted to control for possible effects on fertility. 

Identity of the substance and physical chemical properties: 
More data will become available in the REACH registration file. We suggest to wait for the Registration before pursuing this any further. 

Human Health Hazard Assessment:
Further work with regard to bioavailability of cobalt from cobalt compounds from various routes of exposure as been conducted and will be submitted in the REACH dossiers for Registration. However, specifically, it is also important to point out that cobalt sulphate, cobalt carbonate, cobalt chloride, and cobalt nitrate are inorganic cobalt salts, not organic compounds as reported in this paragraph (Annex 1).  Cobalt acetate is a carboxylic acid cobalt salt.  Contrary to the statement in Annex 1, dermal absorption of cobalt +2 ion does not appear to be a significant route of exposure for humans (see Annex 1). 

Carcinogenicity:
The tumours reported for rats were local in the respiratory tract in both species. There was a marginal increase of pheochromocytomas in rats, however this effect has been often reported in inhalation assays of this type and is believed to be due to respiratory stress affecting the adrenal glands rather than a systemic effect of the test substance. There is some indication that the reported tumours may be secondary to local inflammatory reactions in the respiratory tract because inflammation is reported at all doses in the 16-day, 90-day and the lifetime assays. In our opinion the changes observed in the animal carcinogenicity studies do not read across easily from one substance to another. The results of further work with regard to bioavailability and genotoxicity will be submitted in the REACH registration dossier. 

A threshold mechanism for carcinogenicity may be applicable to the currently classified cobalt compounds and if supported by the experimental data, adequate control can be ensured without any further additional regulatory actions. 

Human Data (Hardmetal Industry): 
Human data from the hard metal industry are not relevant for the assessment of cobalt compounds like cobalt salts. The epidemiology studies typically reflect mixed exposures and there is evidence that cobalt in the presence of tungsten carbide may promote synergistic effects. Cobalt metal powder is currently being evaluated by the US NTP for carcinogenic potential by inhalation. The only epidemiological studies evaluating lung carcinogenicity in cobalt occupational exposure by inhalation in the absence of mixed-metal exposures were equivocal. As pointed out in the Annex XV Dossier(s), interpretation of these studies is hindered due to the low number of exposed workers. 

Mutagenicity:
For the mutagenicity section many studies are referenced that are of questionable reliability due to the lack of guideline compliance. The genotoxicity data base of cobalt compounds has been thoroughly reviewed for the REACH registration. Further guideline-compliant in vitro and in vivo studies have been performed or obtained from Consortia participants and will be provided in the Registration dossiers. The results should be considered for the Annex XV Dossier(s) as well. 

Toxicity to Reproduction: 
While data from soluble cobalt compounds are used, most of the studies lack guideline compliance. A broader data base is being prepared based on guideline compliant studies made available by Consortia participants for the REACH registration and should be considered in the Annex XV Dossier(s).	

Information on the hazardous properties (for relevant endpoints) was provided for transparency reasons only as the classification already has been concluded by the Technical Committee on Classification and Labelling (TC-C&L) and included in Annex VI.  According to Article 37(6) of the CLP regulation manufactures, importers and downstream users who have new information which may lead to a change of the harmonized classification and labelling elements of a substance in Part 3 of Annex VI shall submit a proposal in accordance with the second subparagraph of paragraph 2 to the authority in one of the member states in which the substance is placed on the market.

Thank you for pointing this out. This has been corrected as suggested.
The text has not been changed since this statement is cited from summary reference on the toxicokinetics of cobalt and cobalt compounds from the RoC Background document for cobalt sulphate (US NTP 2002).

	
23	2010-10-14	Industry or trade association, Cobalt REACH Consortium Ltd. (CoRC), United Kingdom

[confidential attachment removed]	While this cobalt substance is currently classified in the EU as CMR (Cat 2) and can, as for any CMR substance, be identified as a potential Substance of Very High Concern (SVHC), the Consortium requests that it not be included in the Candidate list for several reasons. 
(1) Firstly because the priority for such nominations should be placed on substances identified as PBT or vPvB, since the CMR classified substances are already stringently controlled through existing regulations and Directives. There are very stringent controls on the use of the cobalt substance in the workplace. 

(2) Secondly because the majority of this cobalt substance (over 99%) is used as an Intermediate according to the definition of intermediate provided in the Regulation (Article 3.15), and is therefore exempt from Authorisation. 
(3) Thirdly, relatively low volumes of cobalt carbonate are being supplied to the non-intermediate use that has been identified (e.g. animal food supplement) which is covered under different EU legislation and is therefore also exempt from Authorisation under REACH.

(4) Due to its specific classification, cobalt carbonate falls under the requirements of Directive 2004/37/EC on the protection of workers from the risks related to exposure to carcinogens or mutagens at work (Sixth individual Directive within the meaning of Article 16(1) of Council Directive 89/391/EEC), which sets out conditions for the strict control of occupational exposure. 

Industry must also comply with the requirements of Directive 96/61/EC concerning integrated pollution prevention and control and Directive 96/82/EC on the control of major accident hazards involving dangerous substances, which set out conditions for the strict control of environmental risk. 

It should be noted that since 2007 the Cobalt Development Institute and the Cobalt REACH Consortium have been engaged in developing new data as required for REACH Registration and also to support the classifications of cobalt substances. As an urgent priority our Scientists have been fully engaged in development of new Chemical Risk Assessment (CSA) and a comprehensive Chemical Safety Report (CSR) for this cobalt substance, and the other cobalt substances which will be registered this year. This recent and more detailed information will be submitted to ECHA in the coming weeks as part of the Registration Dossier and will adequately complement and update the data provided in Part 1 of the Annex XV Dossier, Section 4 and the corresponding annexes.	Noted.

We disagree with this statement. Article 57 (a-f) of REACH lays down the criteria for identifying substance that may be included in the candidate list as SVHC: CMRs (cat 1 or 2), PBTs, vPvBs or substances of equivalent concern.  Under Article 58 (a-c) of the REACH regulation PBT or vPvB properties, wide dispersive use or high volumes are criteria that are taken into account to prioritize substances on the candidate list for inclusion in Annex XIV.

There is uncertainty regarding the uses described as intermediates and therefore information on actual volumes that fall under the scope of REACH still need to be identified. This is mainly attributed to different interpretations of the definition of intermediate Article 3(15) (see also comment and response to comment no. 3).  

This information has to be taken into account in the process of priority setting for Annex XIV.

	
24	2010-10-14	Industry or trade association, EUROPEAN CATALYST MANUFACTURERS ASSOCIATION (ECMA), Belgium	p9 Classification and Labelling: The annex XV dossier is based on the current classification of this cobalt compound. However, the classification for carcinogenicity refers to a general read across based on carcinogenicity studies with cobalt sulphate in rats and mice by the inhalation route. In the context of the REACH registration of Cobalt compounds further specific data have been developed that may allow a more differentiated view of the CMR properties of the substance.  We would therefore propose to take this information into consideration before taking a decision on a listing on the candidate list.
p12 Human Health Hazard Assessment: More relevant data for the different endpoints have been developed in the course of the REACH registration dossier preparation. These should be considered before a final decision on inclusion on the candidate list is taken.	Noted. See comment and response to comment No. 22.	
25	2010-10-14	Company, Vale Europe Limited, United Kingdom	Vale has no specific comments on Part 1 of the Annex XV Dossier as there is nothing new that isn’t already publically available. We have the following general comments:

Although cobalt carbonate is classified as CMR (Cat2) and can be nominated as a potential SVHC, there is nothing unique about it compared to hundreds of other CMR substances. In fact there are a number of reasons why there is no justification for nomination:

- Majority of uses are as intermediate and according to the REACH Regulation (Article 3.15) those uses are exempt from authorisation.
- The volumes of the few non-intermediate uses are small and of low concern in terms of prioritisation. 
- Cobalt carbonate is not a PBT or vPvB. Priority for nominations should be placed on these types of substances.
- The use of the substance is already strictly controlled according to Directive 2004/37/C on the protection of workers from the risks related to exposure of carcinogens or mutagens at work.
- New data will be shortly available as part of the REACH Registration dossier, which will enable the authorities to make a thorough and informed evaluation of the substance.	Noted. 

See comments response to comments No. 22 and 23.	
26	2010-10-14	Member State, Germany	Comment for the German CA

No comments		
27	2010-10-14	Company, Finland	The information provided in Part I of the Annex XV dossier is not in any way new. The company would like to highlight that priority for nomination should be for substances with (a) PBT or vPvB properties or (b) wide dispersive use or (c) high volumes. We do not see that this substance fulfill any of those criteria’s.
The substance may meet the CMR –criteria as stated in Annex XV Part I conclusion 6.2, but it is our understanding that this dose not mean that the substance would be of very high concern. In addition to this it is our understanding that the substance is only used as an intermediate in Netherlands thus not fulfilling the criteria’s to be appointed on the Candidate List. Because the substance is used as an Intermediate it should have been exempt form Authorization under REACH. There is only one industrial sector which to our understanding is using the substance as a non-intermediate - the Animal Food sector. This sector is however exempted from Authorization under REACH and is covered by the EU regulation on additives for use in animal nutrition (1831/2003).

In addition there are already stringent controls on the use of this substance in workplaces. Because the substance is classified as CMR category 2, the industry must comply with the requirements on the protection of workers from the risks related to exposure to carcinogens or mutagens at work, which sets out conditions for the strict control of occupational exposure.
The substance is also classified as R50-53, and therefore industry must comply with the requirements concerning integrated pollution prevention and control and on the control of major accident hazards involving dangerous substances, which set out conditions for the strict control of environmental risk.
We would further like to stress that a full REACH registration dossier with new information on the Chemical Risk Assessment for this substance will be available soon. Now it seems that there is a need for authorities to get as many substances on the Candidate list as soon as possible and that they are hereby ignoring all the work the industry have done by not waiting on the information which is available within some months.	See comments and response to comments No. 22 and No. 23.	
28	2010-10-14	Company, Albemarle Catalyst Company B.V., Netherlands

[confidential attachment removed]	p. 7: Identity of the substance and physical chemical properties
More data will become available in the REACH registration file. We suggest to wait the registration before pursuing this any further.

P. 9 Classification and labelling 

This substance is officially classified under EC Annex I entry 027-010-00-8 as
T- Toxic
N_ Dangerous for the environment

R 49 – May cause cancer by inhalation
R 60-  May impair fertility
R42/43 – May cause sensitization by inhalation and skin contact.
R68 –Possible risks of irreversible effects
R 50/53 – Very toxic to aquatic organisms, may cause long-term adverse effects to the environment.

This classification already implies some severe restrictions/monitoring under other EU legislation like worker protection from the risks related to carcinogens or mutagens(e.g. EU Directive 2004/37/EC), on controls of major accidents hazards (EU directive 96/82/EC).
In addition, some OELs have been set in various EU countries to ensure worker protection and therefore, in industrial settings, monitoring and controls are already compulsory due to the classification..
- Human health hazard assessment
- p. 28 3rd par.: Further work with regard to bioavailability has been performed with cobalt compounds and will be submitted in the REACH registration dossier.
- p. 35-36 Carcinogenicity The tumours observed were mostly local in the respiratory tract in both species and there was a marginal increase of phaeocromocytoma in rats which is not clearly substance related. There is some indication that the tumours may have been secondary to local inflammatory reactions in the respiratory tract. In our opinion the changes observed in the animal carcinogenicity studies can not be transposed easily from one substance to another. Further work with regard to bioavailability and genotoxicity has been performed with cobalt compounds and will be submitted in the REACH registration dossier. A threshold mechanism for carcinogenicity may be applicable to cobalt compounds and thus adequate control can be ensured without any further additional regulatory actions.
- P37-38 Human data from the hard metal industry are not relevant for the assessment of cobalt compounds like cobalt carbonate. The epidemiology studies typically reflect mixed exposures and causal relations to one agent cannot be drawn. The exposure situation is also quite different. While this fact is acknowledged in the summary, we question the relevance of quoting these data in this dossier.
- P. 30-34 Mutagenicity. For the mutagenicity section many studies are referenced that are of questionable reliability. The genotoxicity data base of cobalt compounds has been thoroughly reviewed for the REACH registration and further guideline conform studies have been performed. The results indicate that the substance is most likely not genotoxic in vivo. These new guidelien studies  should be considered in an Annex XV dossier. 
- P. 40-42 Toxicity to reproduction: The data from soluble cobalt compounds are used. A broader data base is developed for the REACH registration and should be considered.	See comments and response to comments No. 22 and No. 23.

	
29	2010-10-13	Company, Norway	As explained in the other sections, while confirming what is already known in terms of classification, the annex XV dossier provides little or no information as to the other criteria required by the definition of an SVHC.  The definition of an SVHC implies a heightened concern beyond the simple CMR designation.  We do not believe the original legislation intended that this process be used to capture all substances meeting any one of the criteria, as this would have required only a desk study of the existing lists of classified substances, and not the involved, consultative process that is in place.  We are concerned that this may not be a legitimate use of the Candidate List.  At the very least, it risks damaging the credibility of this important component of the REACH legislation. 

We have also become concerned about the underlying process of selection of substances for the Candidate List.  It has gradually emerged that a small group of member states has collaborated to develop a “source List” from which substances are selected for the Candidate List.    With time, more has been revealed as to the details of this process, such as which member states are in this active group, and the fact that targets have been set by this group for listing substances by a certain date.  However, much secrecy still surrounds this process, including the identity of a reported 500 substances that are on the Source List, and the criteria for putting them onto this “Source List”.  Disturbingly, it seems the details of this list may have been revealed to some NGOs, but not to Industry, or the general public, for example, the European Trade Union Confederation cites the Source List in its own Substitute It Now (SIN) list of substances. 

In fact, publishing this Source List would potentially be as commercially damaging to the industries affected as addition to the formal Candidate List.  There is a stigmatisation associated with these lists which is very real.  From our own experience, once a substance is added to the Candidate List, we immediately receive questionnaires from end users, such as the electronics industry, asking us to confirm that none of these substances are in our own products or packaging.  It is reasonable to expect that publication of the Source List would trigger the same response, since the Candidate List, like the Source List, only indicates that a process towards possible Authorisation has begun.  These lists are widely used by NGOs and Industry alike.  We have already mentioned the use in SIN lists copied from these other lists.  Some large manufacturing companies also use these lists to create their own ‘black lists’ of substances to be designed out of their future generation of products.  Where there are genuine concerns about the substance, as in a ‘true’ SVHC, this would less of a problem as it stimulates the substitution that forms part of the later Authorisation process.  However, if the listing is inappropriate, the upstream manufacturing industries are damaged, with unforeseen consequences on other downstream industries and applications.  Mineral supplements to animal feels, low sulphur fuels, and rechargeable batteries for mobile phones, lap tops, and hybrid and electric cars are just some of the applications for which cobalt compounds are used in the manufacturing process.   

The German Federal Institute for Risk Management (BfR) has published their criteria for proposing substances to the Candidate List, but this is essentially an extension of the criteria in the legislation, with no indication of how substances are prioritized within these criteria.  It is not clear why these substances have been proposed this time, when France earlier cancelled their intention to list one of them, cobalt sulphate.  To our knowledge, there is no production of these substances in the Netherlands, and very little downstream use.  It raises questions for us as to what the real “high concern” is for these substances which has prompted the effort of preparing an annex XV for these substances. 

Our final concern is on the timing of this proposal.  The Cobalt Consortium is working hard to finalize the technical dossiers for the cobalt substances to be registered in 2010.  There is intense pressure on the staff, as there is on our own staff engaged in the REACH registration process.  In spite of this, the consortium, and the lead registrants for these substances, took time to meet with the Dutch authorities and to provide end use data on the substances in the short time allowed prior to the formal proposal.  If there is concern about the exposure scenarios for these substances, it would seem to have been appropriate to defer this proposal until the technical dossiers were complete and the REACH registrations made within the next few weeks, as suggested by the Cobalt Consortium.  Since 2007, the Cobalt Industry, through its REACH consortia, has spent an estimated €7 million developing new information on these and other cobalt substances. Within a few weeks, this information will be available.  Given that the Candidate List is a part of the REACH process, we do not understand why the REACH data would not be a core part of the selection process.                 

 The Cobalt Industry is small, but plays a very important role in many aspects of the European economy, particularly those associated with new emerging technologies and the green economy.  Cobalt was identified as a “critical raw material” for Europe in a recent DG Enterprise report on raw materials.  In many cases, the Cobalt Consortium has identified the main application of these cobalt compounds to be the feed for the manufacture of catalysts.  These catalysts are subsequently used for a variety of applications including desulphurization of fuel, synthetic fibres’ production, and for new ‘gas to liquid’ technology for producing alternative, clean fuels.  Not identifying the specific applications of the substance in question in the annex XV is likely to lead to negative, unintended consequences for downstream users of the substance the associated industry, with negative impacts on other European policies such as clean fuels, clean air, etc.  These are the same conditions that Mr. Barroso’s “Better Regulation” initiative across the European Commission was intended to address.  To our view, the listing of these cobalt compounds, based on the available data, does not appear to be “proportional”, risks unintended consequences for the European economy and environment, and dilutes the effort of the Commission and Member States.  	Noted.	
30	2010-10-13	International NGO, International chemical secretariat, Sweden	The classification is clearly justified due to its CMR properties and its wide dispersive use.	Noted.	
31	2010-10-12	National Authority, Health & Safety Authority, Ireland	Cobalt carbonate is classified is as Carc. 1B and Repr. 1B (EC No. 790/2009),  and therefore the Irish CA agrees that the substance meets the criteria for identification as an SVHC in accordance with Article 57 (a) and (c) of REACH.	Thank you for your support.	
32	2010-10-12	R.I.S.K. Consultancy, Belgium

	I support the proposal to list this Co compound as a REACh SVHC.	Thank you for your support and for the additional information.  
The focus of the Annex XV dossier, however, is on carcinogenicity and toxicity to reproduction, since these two effects make it an SVHC.	
33	2010-10-12	Company, ERAMET, France	Identity of the substance and physical and chemical properties
Classification and Labelling
Environmental fate properties
Human health hazard assessment
Human health hazard assessment of physiochemical properties
Environmental hazard assessment
PBT/vPvB and equivalent level of concern assessment		
34	2010-09-07	Trade union,
European Trade Union Confederation,
Belgium	That substance is also included in the Trade Union Priority List for REACH authorisation (version 2.0, June 2010) see http://www.etuc.org/a/7479 	Noted. This information will be taken into account in the process of priority setting for Annex XIV.	

INFORMATION ON USE, EXPOSURE, ALTERNATIVE AND RISKS ON ANNEX XV SVHC
Substance name:	Cobalt (II) carbonate	
CAS number:	513-79-1	
EC number:	208-169-4	

Reason of the submission of the Annex XV: CMR
Disclaimer: The European Chemicals Agency is not responsible for the content of this document. The Response to Comments table has been prepared by the competent authority of the Member State preparing the proposal for identification of a Substance of Very High Concern. The comments were received during the public consultation of the Annex XV dossier. 

Specific comments on use, exposure, alternatives and risks
No	Date	Submitted by (name, Organisation/
MSCA)	Comment	Response	
35	2010-10-14	Industry or trade association, Cobalt Development Institute (CDI), United Kingdom	Information on risks related to the substance: 
The ATSDR minimal risk levels are quoted in the Annex XV Dossier. These are based on other considerations than the EU REACH Regulation. We do not consider some of the studies used as the basis for these values as sufficiently robust. For example the medium and chronic inhalation risk level are based on a study that included exposure to dusts of several other metals and diamond dust in addition to cobalt. The number of workers evaluated was small (n=196) and their exposure history could not be documented.  The Human data base has been reviewed thoroughly for the REACH registration dossier and proposals for DNELs will be provided in the REACH registration dossiers. These should be considered in an Annex XV Dossier as well.	Noted. Information on the human health assessment (for relevant endpoints) was provided for informational purposes based on peer reviewed summaries.  New evaluations or assessments were not performed during the preparation of the Annex XV dossier. 
For the present time, we will not derive DMELs as these are not required for the Annex XV dossier.	
36	2010-10-14	Industry or trade association, Cobalt REACH Consortium Ltd. (CoRC), United Kingdom

[confidential attachment removed]	Part 2 of the Annex XV Dossier presents much general information on uses. On page 15 of Section 1 it is stated that information is given on inorganic cobalt salts as a group; but such an approach is inappropriate for an Annex XV Dossier which is for a single substance. 

Section 1 (page 15) also infers that little data on production and exposure could be found. It is also stated that “on the contrary, for the production process and use applications exclusively data for cobalt carbonate are given”. The Cobalt Consortium made a special effort to assemble and provide more information to make sure the Annex XV Dossier would be accurate. In summary, there is no data or information lacking, and a lot of data has been generated for the REACH registration of the substance and will become available soon.

LIST OF DISCREPANCIES: 

The information presented in Table 3 (page 16) concerns the production of cobalt in all aggregated forms and outside the EU, rather than for the target substance in the EU. The uses shown in Table 4 (page 16) are not uses of cobalt carbonate (i.e. see Table 5 on page 17), and steels and alloys cannot be produced using cobalt salts. 

Even though this cobalt data comes from the CDI, Tables 3 and Table 4 and the associated paragraphs on pages 16 and 17, are not relevant in this case. The Cobalt Consortium provided the information about the volumes of cobalt carbonate in the EU. However this important information is difficult to find in the Annex XV Dossier as it is presently written. 

Also on page 16, please note the facilities of the Consortium members that manufacture and/or import cobalt carbonate are located in Belgium, Finland, France, Germany, Norway, and the UK. It is also important to note that, based on information available to the Secretariat, there are no manufacturing sites for this cobalt substance in the Netherlands, although there are some facilities for downstream use.
 
On page 16 it is also noted that the total EU tonnage of cobalt carbonate manufactured and/or imported into Europe (i.e. relevant for REACH registration) is estimated to be in the order of several thousand tonnes per year. According to the industry the vast majority (over 99%) is used as intermediate. Furthermore, the Consortium notes that a large proportion of this Intermediate tonnage for cobalt carbonate is reported to be as an Intermediate under strictly controlled conditions. This leaves only a very small volume as non-intermediate use (i.e. less than several 100 tonnes), which the Consortium members have identified as a use in animal food supplement. This use is covered under different EU legislation and is therefore also exempt from Authorisation under REACH. 

The Consortium member companies that manufacture and use this cobalt substance have provided additional technical details and descriptions of the specific uses of this cobalt substance (please refer to technical annex). Their interpretations regarding the Intermediate nature of the use are based on the definition of Intermediate provided in the Regulation (Article 3.15). We regret to note that these interpretations have been either deleted (from table 5, page 17) or included in footnotes (to table 6, page 19). We have attached the technical annex again for further reference. 

Table 5 (page 17) is very similar to the table that was provided from the Consortium, however there are a few key words missing from the Table. These missing words are “Intermediate” for three of the uses/activity sectors (Manufacture of Catalysts, Production of Other Chemicals, etc.) and “Exempt from Authorisation” for the fourth activity sector of Animal food supplement. 

Regarding Table 5 it should have been noted that the volume estimates are based on EU tonnages that are reported for purposes of REACH. These estimates are presented in relative percentages, and are indicative of the use-volume information that had been communicated to the Consortium Secretariat in the time allowed, and that the relative percentages may change as further information is assembled. For cobalt carbonate the manufacture of catalysts (Intermediate use) accounts for the majority; and the minor uses (also Intermediate) would correspond to the REACH tonnage bands of <100 tonnes per year. 

For transparency, a copy of the original information, as provided from the Consortium to RIVM in July 2010, has been submitted along with these comments. 

Section 1.2 on Occupational Exposure (page 20) states that no specific information was found but some data was provided by industry (i.e. CDI). Table 7 (page 20) shows this information can be obtained, however it does take time to collect. Again, the data shown in Table 8 (page 21) is for many different cobalt substances, and does not correspond to cobalt carbonate, and the study also dates back to 1994. The most recent and relevant information on the occupational exposure assessments for cobalt carbonate will be presented in the REACH registration dossier.  

The Member State Competent Authorities are aware that the Consortium cannot provide company-specific information for reasons of commercial confidentiality and anti-trust. However the available exposure data provided to the Consortium Consultants has been considered in the detailed Exposure Scenarios that have been prepared for the Registration Dossier for this substance. Member State Competent Authorities can request and review the exposure data for manufacturing facilities located within their jurisdiction. However as noted previously, there are no manufacturing facilities for this cobalt substance located in the Netherlands. 

CONCLUSION:

In summary because the important points are not clear in the Annex XV Dossier, the Consortium has briefly summarised the main points that should be considered regarding cobalt carbonate. 
(1) The overall volume of cobalt carbonate manufactured/imported in Europe has been estimated to be on the order of several thousand tonnes per year.
(2) The majority of the cobalt carbonate manufactured/imported in Europe is reported to be as an Intermediate (over 99%). 
(3) The majority of the uses of cobalt carbonate have been identified as being an Intermediate use, and are therefore exempt from Authorisation under REACH.
(4) Relatively low volumes of cobalt carbonate are being supplied to the non-intermediate use that has been identified (e.g. animal food supplement). 
(5) The use of cobalt carbonate as an animal food supplement is covered by different EU legislation and is therefore also exempt from REACH. 
(6) There are already very stringent controls on the use of cobalt carbonate in the workplace. 

All of these points strongly support the case not to consider cobalt carbonate as a potential SVHC that could become subject to Authorisation under REACH.	Noted.

The text will be adjusted to read, “on the contrary, use applications data for cobalt dicarbonate are given.”

Table 3 (p16): presents production of cobalt (in all aggregated forms) in and outside the EU.
Table 4 (p16): as indicated in the text the data provided here is used for indicative and comparative purposes.

Regarding information about the volumes provided by the cobalt consortium, this appears in page 16 under section 1.1.1 as: “In addition, after consultation the CDI reported that manufacture and/or import facilities of the Cobalt REACH Consortia members for cobalt(II) carbonate are located in Belgium, Finland, Germany, Norway and the UK. The total EU tonnage of cobalt(II) carbonate manufactured and/or imported into Europe (i.e. relevant for REACH registration) is estimated to be in the order of up to several thousand tonnes per year. According to the industry the vast majority (>99%) is used as intermediate.”

There is uncertainty with respect to the reported uses if they all can be regarded  as intermediate uses.  This can mainly be attributed to different interpretations of the definition of intermediate Article 3(15).  We believe the differentiation between the use of cobalt carbonate in the manufacture of catalysts and the use of the substance as catalyst needs to be addressed.  In the ECHA clarification document of the definition of intermediates under REACH, substances used as a catalyst are not regarded as intermediates.  

See above comment regarding intermediate use.

This information will be taken into account in the process of priority setting for Annex XIV.

	
37	2010-10-14	Company, Haldor Topsoe A/S, Denmark

	Page 19 in the middle  please see enclosed attachment	Noted. This information will be taken into account in the process of priority setting for Annex XIV.
	
38	2010-10-14	Industry or trade association, EUROPEAN CATALYST MANUFACTURERS ASSOCIATION (ECMA), Belgium	p17 Exposure Information: Use: Cobalt carbonate is used as an intermediate in the sector of catalyst manufacture. It is consumed in the course of the manufacturing process. The obtained products are catalysts that are only handled in industrial settings. No exposure to consumers will occur.
p23 Information on risks relating to the substance : In the REACH registration dossiers risk assessments are included using the methodology outlined in the REACH guidance. It would be more appropriate to use this methodology than to refer to ATSDR minimal risk levels quoted in the document.
p23 Information on alternative substances and techniques: Cobalt containing hydro-processing catalysts play a critical role in the production of clean transportation fuels. The Cobalt co-promoter plays a crucial role to greatly enhance the hydrodesulphurisation activity of the catalyst, so that modern refineries can efficiently produce clean fuels of a very low sulphur content.

The use of cobalt compounds derived from cobalt carbonate intermediate in supported hydro-treating catalysts for petroleum refineries is the result of extensive research in order to optimize reduction of the emissions of sulphur dioxide and nitrogen oxide  
Without access to high activity Cobalt containing catalysts, the European refining industry would be disadvantaged as compared to refineries operating outside the European Union; 

Affordable clean fuels produced locally within the EU contribute to better air quality and better quality of life in many urban areas; 

Cobalt containing hydroprocessing catalysts are the Best Available Technology (BAT) to produce clean fuels efficiently (with minimal refinery footprint, and with minimal CO2 emissions).	Noted. This information will be taken into account in the process of priority setting for Annex XIV.

	
39	2010-10-14	Company, Vale Europe Limited, United Kingdom	In Section 1 it is noted that little data is available concerning production volumes and exposure of cobalt carbonate. Rather than include generic information on cobalt metal and cobalt salts, it would have been preferable to wait a few months until the REACH registration dossier was submitted when most of this data would be available.

Although uses information specific to cobalt carbonate has been provided in Section 1.1.2, the presentation is not entirely clear. Table 5 was provided by the Cobalt REACH Consortium (CoRC) as means of explaining the intermediate uses etc but has been rearranged in way that could be confusing. In the original CoRC table it states clearly in the third column that manufacture of catalysts, production of other chemicals and production of pigments/adhesion are intermediate uses. These statements have been omitted in the table contained in the Annex XV dossier, so that any stakeholder unfamiliar with the industry might think these uses are non-intermediate and potentially dispersive. For the animal feed supplement sector, there is a footnote in the dossier explaining that the use (although non-intermediate) is covered by different EU legislation. However, this note is not prominent and therefore unhelpful.  

We would like to emphasise that the majority (over 99%) of the total tonnage of cobalt carbonate manufactured and/or imported into Europe is as an intermediate. Furthermore, a large proportion of this is reported to be as an intermediate under strictly controlled conditions. According to Article 2, paragraph of the REACH Regulation “on-site isolated intermediates and transported isolated intermediates” shall be exempted from the Authorisation Process. 

Table 6 provides more detail on uses but also lacks some clarity. In the section, Production of Pigments/Adhesion the footnote indicates that cobalt carbonate is not likely to be used in the manufacture of ceramic pigments. If this is correct, the use should be removed from the table. Likewise if the other uses ‘additives to soils/fertilizers’ and ‘temperature indicator’ are not applicable to cobalt carbonate (as indicated in the footnote) they should also be removed.

The section of text following Table 6, which provides further detail of how the homogenous oxidation, hydrotreating and hydrodesulphurization catalysts work, is not directly relevant to the manufacture of the catalysts but highlights the importance of these compounds for industry and society as a whole. In Section 2 no information is provided on possible alternatives or substitutes for cobalt carbonate, which is a good indicator that there are few known or available. 

The exposure information provided in Section 1.2 is generic, with no specific information provided for cobalt carbonate. Again it would have been preferable if the Netherlands CA had waited for submission of the Cobalt Carbonate REACH registration dossier, before considering this substance for the candidate list. 

Vale would like to provide the following summary to assist in clarifying the information presented in Part 2 of the Annex XV dossier:

- The overall volume of cobalt carbonate manufactured/imported into the EU has been estimated to be in the order of several thousand tonnes per year.
- The majority of cobalt carbonate manufactured/imported into the EU is reported as an intermediate (99%) and therefore exempt from Authorisation under REACH.
- Relatively low volumes of cobalt carbonate are being supplied for non–intermediate use as an animal supplement, but this use is 
covered by different EU legislation and exempt from REACH
- There are very stringent controls on the use of cobalt carbonate in the workplace through the existing CMR Directive 2004/37/EC.
- All of these points strongly support the point not to consider cobalt carbonate as a potential SVHC.	

See comment and response to comment No. 36.

Noted.

	
40	2010-10-14	Member State, Germany	Comment for the German CA

►p. 22, 1.2.2 Consumer Exposure
Cobalt has been detected with a concentration of 560 mg/kg in one out of 12 glass and ceramic colours for hobby use (Danish Environmental Agency, 2005: Survey and assessments of chemical substances in glass and procelain colours. Survey of chemical substances in consumer products No. 59). Cobalt has also been detected in cosmetic kohl products (concentrations between 0.11 and 51 mg/kg) and in cosmetic henna products (concentrations between 0.59 and 1.1 mg/kg) (Danish Environmental Agency, 2005: Survey of chemical substances in consumer products No. 65).

►p. 22, Please bring header in line with the Annex-XV-Dossiers of the other three cobalt salts (“1.2.3 Man exposed via the…”, instead of “1.3 Man exposed”)

►Page 22:
A German TRK value is mentioned in the dossiers. These former values are no longer valid and should be deleted. In addition, the translation of TRK to “technical correct values” is incorrect.

Information on risks related to alternatives:
►Page 23, 24:
The reference to MRL is from the German point of view misleading. Within the report these values are characterized as “based on non-cancer health effects only”. In consequence the have no relevance for a carcinogenic substance. Germany would prefer the calculation of a DMEL which should be compared to exposure levels to get a measure for the risk in our case for workers.	

This information will be taken into account in the process of priority setting for Annex XIV.

This has been corrected as suggested.

Thank you for pointing this out. TRK value is deleted as suggested.

Information on the human health assessment (for relevant endpoints) was provided for informational purposes based on peer reviewed summaries.  New evaluations or assessments were not performed during the preparation of the Annex XV dossier. 
For the present time, we will not derive DMELs as these are not required for the Annex XV dossier.	
41	2010-10-14	Company, Finland	The company would like to emphasize that the majority of uses for this substance in Europe are as an Intermediate and should therefore be exempt from Authorization under REACH.
Part 2 of the Annex XV Dossier presents general information on uses. In Part II and Section 1 it is stated that information is given on inorganic cobalt salts as a group. We find this approach inappropriate for an Annex XV Dossier which should be for a single substance. 
The information provided in Table 4: Reported U.S.A. consumption of cobalt by end use (expressed in tonnes of cobalt) may be misleading because a) it do not refer to EU uses b) it do not refer to uses of the substance in question c) it do not in anyway indicate if the substance is used as an intermediate or not. The same arguments (a, b and c) apply to the sentence after Table 4 - United States imported 182 tonnes of cobalt salts (cobalt acetates, cobalt carbonates, cobalt chlorides, and cobalt sulphates) from Finland (Kirk-Othmer 2010).
Table 5 do not contain any information on that the substance is used as an Intermediate in the mentioned use/activity sectors, except in the Animal Food sector where the substance is used as a substance. We find it misleading presenting information without mentioning use as an Intermediate, especially as use as Intermediate make the substance exempt from Authorization under REACH.
On the information on use in Table 6, the company would like to make the following comments:
The table may be mislaying as it is not clearly indicated that the uses are as Intermediates,
Manufacturing of catalysts - The substance is an Intermediate (Article 3 (15)) in this chemical process and is transformed into another substance and as such not subject to Authorization. 
Animal food supplement – This sector is exempt from REACH and is covered by the EU regulation on additives for use in animal nutrition (1831/2003). 
Production of other Chemicals - The substance is an Intermediate (Article 3 (15)) in this chemical process and is transformed into another substance and as such not subject to Authorization.
Other - Veterinary medication etc. – This use is subjected to Animal Feed and therefore exempt from REACH.	See comment and response to comment No. 36.	
42	2010-10-14	Company, Albemarle Catalyst Company B.V., Netherlands

[confidential attachment removed]	Information on use and exposure.
p. 17-18 Use: Cobalt carbonate is used as an intermediate in the sector of catalyst manufacture. It is consumed in the course of the manufacturing process. The obtained products are catalysts that are only handled in industrial settings. No exposure to consumers will occur.
Further details on handlign durign catalyst manufacture are given in the attached confidential document.
The applications of these catalysts contributes to a large scale positive effect in the reduction of sulphur in fuels and hence the reduction  sulphur dioxide and nitrogen oxide emissions upon burning of fossil fuels. 
For comparison 1 kg Cobalt contributes to a SOX emission reduction of 25,000 tons and a NOX emission reduction of 750 tons per year.
Compliance with several EU Directives on Ambient Air Quality and reduction Sulphur dioxide and Nitrogen Oxide emissions from fuel burning (e.g. Dir. 2008/50/EC, Dir. 1999/30 EC, dir. 80/779/EC and amendments, Dir. 93/12/EEC and amendments, Dir. 2005/33/EC) is dependent on the production of low sulphur and nitrogen containing fuels that is only achievable with cobalt containing catalysts.

Information on risks related to the substance

P. 23 ATSDR minimal risk levels are quoted in the document. These are based on other considerations than the EU REACH regulation. We do not consider the studies used as the basis for these values as sufficiently robust. The Human data base has been reviewed thoroughly for the REACH dossier and proposals for DNELs will be provided in the REACH dossiers. These should be considered in an Annex XV dossier as well.

Information on alternative substances and techniques
Cobalt oxide is used as a promoter in hydrodesulfurization (HDS) catalysts as used in virtually every refinery across the world. The promoting effect of cobalt has been subject of academic and industrial studies for many than half a century (M. Egorova , R. Prins, J. of Catalysis, 225 (2004) 417; Scheffer, E.M. van Oers, P. Arnoldy, V.H.J. de Boer and J.A. Moulijn, Applied Catalysis, 25 (1986) 303; E.G. Derouane, E. Pedersen, B.S. Clausen, Z. Gabelica, R. Candia and H. Topsoe, J. of Catalysis, 99 (1986) 253.;M. Boudart, J.S. Arrieta and R. Dalla Betta, J.  American Chem. Soc., 105 (1983) 6501)
State of the art catalysts are the result of thorough optimization in which alternatives have been extensively screened. The promoting effect of cobalt depends on the specific conditions and is roughly a factor 2-5. Hence,  HDS catalysts without Cobalt could not deliver the specified Sulphur specification (e.g. 10 ppm Sulphur in Diesel under Euro-V specifications), unless the refiners cut back the capacity by the same factor or accept a roughly prorata shorter catalyst cycle lengths against much higher costs ( IPIECA, 2006 Fuel Sulphur Strategies and options for enableing clean fuels and vehicles, Fuels and Vehicles working group report series Volume III www.ipieca.org)

For the production of low sulphur transportation fuels (either from fossil or biomass related sources) refiners can only use heterogeneous catalysts, because there are no viable alternative technologies. Alternatives for cobalt as a promoter are primarily nickel oxide (and its precursors in catalyst manufacturing), but the application window of nickel oxide promoted catalysts is not the same as cobalt oxide. Especially for low pressure HDS units, the nickel oxide promoted catalyst give a strong disadvantage. Other promoter metals like iron oxide are known to be far less effective than cobalt oxide and nickel oxide and face the same disadvantages as described for a cobalt-free catalyst.	Noted. This information will be taken into account in the process of priority setting for Annex XIV.

See comment and response to comment No.35.

Noted. This information will be taken into account in the process of priority setting for Annex XIV.

43	2010-10-14	Member State, United Kingdom	Exposure Information: 

The exposure assessment in these documents is very limited. The assessment seems to focus on one workplace exposure study and it is not possible to determine if the exposure data presented here are representative for the various uses that have been identified. The assessments of consumer exposure and exposure to man via the environment are also limited. 

Monetisation of the consequences of exposure would be useful if possible. 

Cobalt is naturally occurring in the environment. Exposure occurs mainly via food (mainly as inorganic cobalt but also as vitamin B12) and drinking water with a lesser amount inhaled. Some information on levels in the diet is presented based mainly on data from the US and Canada. 
EFSA have recently published an opinion on the use of cobalt compounds in animal nutrition (see: http://www.efsa.europa.eu/en/scdocs/scdoc/1383.htm). It would be useful to note EFSA’s conclusions that dietary cobalt supplementation is required for ruminants, horses and rabbits. EFSA also suggested that the risks to consumers from threshold based effects of cobalt are expected to be minimal where daily oral intakes are 0.6 mg or less. This would help to put information on human dietary exposure into context.

Alternatives:
We note that no information on alternatives was found. Does this mean that none exist? If there are no alternatives available what are the cost implications?
Is there any cost information available for this cobalt compound? For example, what is its market value or the value of end products?	Thank you for your comments they are noted.  We are aware that information on exposure for the mentioned populations is limited. 

This option can be considered at a later stage when more information becomes available on volumes, uses, and alternatives.

Your comments are noted and will be taken into account.

This information will be taken into account in the process of priority setting for Annex XIV.

This means that we were unable to find information on alternatives and we do not know if alternatives exist.
	
44	2010-10-13	Company, Norway	COBALT CARBONATE 

We have been advised that more complete data on the specific substances will be uploaded by the Cobalt Consortium as part of their submission.  This represents an updated version of the information originally supplied to the Dutch authorities as part of the informal consultation. 

However, in summary, we understand the following statements can be made specific to COBALT CARBONATE:     

(1) The overall volume of COBALT CARBONATE manufactured/imported in Europe has been estimated to be on the order of several thousand tonnes per year; 
(2) The majority of the COBALT CARBONATE manufactured/imported and used in Europe is reported to be as an intermediate (~99%) and is therefore exempt from Authorisation under REACH 
(3) Only low volumes of COBALT CARBONATE are being supplied to the non-intermediate use, and one application has been identified as that of an animal food supplement.  The use of COBALT CARBONATE  as an animal food supplement is covered by different EU legislation and is therefore also exempt from REACH

On the issue of exposures, this information will become available with the completion of the REACH dossiers, as will greater clarity on end uses and volumes.  However, two statements can be made with regard to the approx. 99% of the uses of this cobalt compound that are used as intermediates, and so NOT subject to Authorisation: 
(c) Intermediates, by definition in REACH, need to be handled under ‘strictly controlled conditions’.  This implies little or no exposure in the workplace, or else the existence of personal protection equipment and procedures to protect workers.  As COBALT CARBONATE is classified under Directive 67/548/EEC as CMR category 1B, industry must already comply with the requirements of Directive 2004/37/EC on the protection of workers from the risks related to exposure to carcinogens or mutagens at work (Sixth individual Directive within the meaning of Article 16(1) of Council Directive 89/391/EEC), which sets out conditions for the strict control of occupational exposure.  Similarly, COBALT CARBONATE is also classified as R50-53, and therefore industry must comply with the requirements of Directive 96/61/EC concerning integrated pollution prevention and control and Directive 96/82/EC on the control of major accident hazards involving dangerous substances, which set out conditions for the strict control of environmental risk.   The risks associated with this hazard are therefore already well regulated. 
(d) Notwithstanding this, the member companies of the Cobalt Consortium will be submitting the complete substance dossier of COBALT CARBONATE when it registers under REACH.  The Cobalt Industry has therefore gone beyond the minimum requirements of the legislation by this action.  

On the issue of alternatives, COBALT CARBONATE is expensive compared to other base metals compounds.  The applications used today utilize the unique characteristics of the compound in question.  The cost imperative ensures that, if cheaper, or more effective, alternatives were available, they would be used.  We must therefore assume that alternatives are not available without loss of performance or excessive increase cost.	Noted. See also response to comment No. 36.

	
45	2010-10-13	International NGO, International chemical secretariat, Sweden	This substances is most probably used in a very similar way as Cobalt Suplhate. Porcelain, glass, batteries, paints, inks, linoluem, varnishes, ceramics, enamels, glazes, mineral supplement for animals, beer, fertilizers. 

Sources: US NTP; Ravensdown NZ	Noted. This information will be taken into account in the process of priority setting for Annex XIV.

	
46	2010-10-13	Industry or trade association.CONCAWE, Belgium	Cobalt containing catalysts are currently used in the production of ultra low sulphur diesel in many petroleum refinery hydroprocessing units. As the composition of the catalyst is proprietary to the catalyst manufacturer, the specific form of cobalt used in catalysts is unknown to the refiner. In the absence of any identified alternatives, and an assessment of their benefits and disadvantages, restricting the use of Cobalt containing catalysts for use in European refineries will lead to a competitive disadvantage of the European refining industry and could result in a decrease of refining activity in Europe. 

There is no exposure to the general public from Cobalt containing catalysts used at petroleum refineries. The handling of these catalysts occurs in well secured industrial complexes and carried out by professionals specifically trained for this purpose. There are specific waste management practices in place to ensure that the metals present on the catalyst are recovered at the end of the catalyst life. 
  
There is also no exposure to the general public during the handling of spent catalyst which is also carried out by specifically trained professionals and takes place in well secured industrial complexes. Hence Cobalt compounds used in catalysts in refinery processing operations do not meet the criteria of 'wide dispersive use' with reference to criteria for inclusion of substances in Annex XIV (Article 58 of REACH regulation).	Noted. This information will be taken into account in the process of priority setting for Annex XIV.	
47	2010-10-12	Company, ERAMET, France	1.Information on manufacture and uses:
ERAMET participated in the exercise of reviewing the list of uses conducted by the CDI and the other companies of the REACH Consortium dealing with cobalt carbonate. We would like to underline the fact that the list of uses of cobalt carbonate needs to be clarified. 
We note that the uses of cobalt carbonate are not as numerous as underlined on page 15 (introductory paragraph) and described on page 16 in Table 4: steel and alloys can certainly not be produced using cobalt carbonate. 
The major uses of cobalt carbonate are those described in Table 5 Page 17 which was provided by the CDI.  
ERAMET’s use corresponds to the third use described in Table 5 page 17 as well as in Table 6 page 18 (“Production of Other Chemicals”). The Cobalt carbonate which is produced at the Sandouville site is totally consumed on site. It is used  as an intermediate in the synthesis of cobalt dichloride. 
To reflect this situation, paragraph 1 below Table 3 on page 16, should be modified to include France amongst the EU countries where manufacture and/or import facilities are located. 
In addition, the information presented in Table 3 on page 16 relates to the production of cobalt in all aggregated forms and outside the EU, rather than for the target substance in the EU. With a view to providing ECHA and the authorities with a more precise view on the volumes at stake you will find below ERAMET’s production mass (which concern the dry mass of Cobalt carbonate over the last 4 years):
2007 (t/year) 2008 (t/year) 2009 (t/year) 2010(t/year)
35          35              40          40

2.Exposure Information:
Cobalt carbonate at Sandouville site is used under strictly controlled conditions.  Firstly cobalt carbonate is produced from sodium carbonate by reaction with cobalt dichloride; then it is consumed as an intermediate in the synthesis of cobalt dichloride in continuous operations and therefore is not present in the final product. The cobalt carbonate is used in a fully automated process. A video surveillance system allows workers to oversee the process. Handling is limited to some checking interventions, sampling operations, and cleaning or maintenance interventions. The cobalt carbonate use at Sandouville site is therefore not dispersive. 
As previously mentioned for uses, we would like to underline the fact that exposure data provided in Table 8 on page 21 do not correspond to cobalt carbonate per se but refer to cobalt metal, oxides and several salts. In addition, those data dates back to 1994. The values shown in this table do not reflect our situation in the Sandouville plant. These exposure data will be available to our competent authorities upon request.

3.Information on risks related to the substance:
The Sandouville manufacturing site strictly complies with the regulatory requirements on the protection of workers with regard to CMR substances, Cobalt carbonate being classified as a carcinogen category 2 by inhalation and cobalt carbonate on Sandouville site is exclusively used as an intermediate under strictly controlled conditions.
The Sandouville sites also complies with the specific requirements relating to ICPE (Installations Classées pour la Protection de l’Environnement) and Seveso plants. 

4.Information on alternative substances and techniques 5.Information on risks related to alternatives
In order to meet our customer product specification, there are no other alternative substances.	Thank you for comments. This information will be taken into account in the process of priority setting for Annex XIV. 	
48	2010-10-11	Company, Twickenham Plating Group Ltd, United Kingdom	Ref Page 23 (2)
“Information On Alternatives - No information on possible alternatives for cobalt (II) carbonate was found.”

There is no alternative available for our cobalt carbonate process that would meet the specification demands of our security, telecommunications and automotive customers.  The low percentage of cobalt deposited with the gold, typically 0.15 – 0.25% cobalt and 99.25 – 99.5% gold, produces a plated finish that has a high wear-resistance, hard deposit, low porosity and is resistant to oxidation.  These properties fulfill the requirements of our aforementioned customer specifications.	Noted. This information will be taken into account in the process of priority setting for Annex XIV.	
49	2010-10-06	National Authority,
Allgemeine Unfallversicherungsanstalt,
Austria	P17, Table 5: Within this table uses as an intermediate and as a catalyst are distinguished. Sometimes parts of an intermediate end up in the final product. A complete removing of heavy metal-traces is still very difficult. Therefore we fear that intermediates might end up in substances that will occur in the workplace. 	Noted. This information will be taken into account in the process of priority setting for Annex XIV.	
50	2010-10-28	National Authority, Anses (French agency for food, environmental and occupational health safety), on behalf of the French Competent Authority, France

	The comment is provided as an attachment.	Thank you for your comments they are noted.  Information on exposure will be taken into account in the process of priority setting for Annex XIV. 
Regarding comment on substitution and grouping approach.  Cobalt dichloride (CAS 7646-79-9) is already included in the candidate list of substances of very high concern for authorisation based on its carcinogenic potential (date of inclusion: 28-10-2008).