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

Substance name:	Cobalt(II) dinitrate	
CAS number:	10141-05-6	
EC number:	233-402-1	

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) dinitrate 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 dinitrate 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 dinitrate 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 (approximately 80%) 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. 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 up to one thousand tonnes per year, with the majority (approximately 80%) as an Intermediate, and therefore only a relatively small volume as non-intermediate use (i.e. less than several 100 tonnes). 

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 dinitrate 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 dinitrate 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).  According to industry approximately 20% of cobalt dinitrate is used in surface treatment.  In the ECHA clarification document of the definition of intermediates under REACH, substances used as a surface treating agent are not regarded as intermediates.  We also believe the differentiation between the use of cobalt dinitrate in the manufacture of catalysts and the use of the substance as catalyst need to be addressed. The use of a substance as a catalyst is not regarded as an intermediate.

	
4	2010-10-14	Industry or trade association, EUROPEAN CATALYST MANUFACTURERS ASSOCIATION (ECMA), Belgium	Cobalt dinitrate 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 dinitrate has an intermediate use, a listing of this compound as a substance of very high concern seems disproportionate.	Noted. However, at present the actual percentage use volume reported for cobalt dinitrate as an intermediate remains uncertain (99% vs. 80%, ECMA and CDI, respectively). In addition, also the interpretation of the definition of intermediate seems to deviate from that of ECHA. See comment and response with respect to No. 3 under general comments. 	
5	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).

- p.27, please include a main-heading „Annexes“ as in the other dossiers	

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 (pers. comm.) this use has been phased out and therefore may no longer be relevant. This use will be reviewed as information becomes available. 	
6	2010-10-14	Company, Albemarle Catalyst Company B.V., Netherlands	- General comments on the Annex XV dossier 
- 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 dinitrate is used 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)).	Information on the hazardous properties of cobalt dinitrate 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.
	
7	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 is explained in the corresponding RMO-analysis.	
8	2010-10-14	International NGO, WWF European Policy Office, Belgium	WWF and CHEM Trust support the inclusion of Cobalt(II) dinitrate in the candidate list due to its carcinogenic and reprotoxic properties.	Thank you for your support.

9	2010-10-14	Industry or trade association, RECHARGE aisbl, EUROBAT & EPBA, Belgium

	Comments to Tables 5 & 6 of the Annex XV Report (§ 1.1.2. pages 16 & 17).

1. Cobalt-based substances used in batteries.
RECHARGE, EPBA and EUROBAT confirm that cobalt (II) dinitrate is not present as active substance in batteries placed on the market (Nickel-Metal Hydride (Ni-MH), Nickel-Cadmium (Ni-Cd), Nickel-Zinc (Ni-Zn), Lithium-Ion (Li-Ion)…). 

2. General Conclusions.
Cobalt (II) dinitrate is used as a precursor in the production of active substances placed in batteries and is considered as an “intermediate” under the definition of REACH.
This substance is not present in the finished product (article) placed on the market. Therefore, there is no possibility of exposure of industrial and consumer battery users to Cobalt (II) dinitrate.
The placing of this cobalt compound on the candidate list for authorisation is not justified for the battery industry for the following reasons:

• As precursors to the production of active material in batteries, it meets the definition of intermediate under REACH,
• It is not placed on the end user market,
• Strict control of exposure is already in place at the various steps of cobalt (II) dinitrate use during the manufacture of active material for batteries both for the protection of the environment and human health.

Therefore, we are inviting Competent Authorities and ECHA not to place Cobalt (II) dinitrate on the candidate list for substances subject to Authorization.

As mentioned in Tables 5 & 6 of the proposals of The Netherlands the substance, cobalt (II) dinitrate  is used as intermediate in preparation steps of active substances used in batteries. Cobalt (II) dinitrate is not present in batteries commercially available to industrial or individual users such as consumers.	Noted. This information will be taken into account in the process of priority setting for Annex XIV. 
	
10	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.

	
11	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.
	
12	2010-10-13	International NGO, International chemical secretariat, Sweden	Full support regarding its identification as a SVHC.	Thank you for your support.

13	2010-10-06	toxicology consultancy, R.I.S.K. Consultancy, Belgium

	p.1:  Please see my attached comment, including a collections of recent abstracts on Co toxicity.	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.	
14	2010-10-06	National Authority,
Austria,
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.	
15	2010-10-06	Member State,
Sweden	Sweden supports the proposal to identify Cobalt(II)dinitrate as a substance of very high concern.	Thank you for your support.	
16	2010-09-29	Industry or trade association,
ZVO - Central Agency of surface treatment,
Germany	1. Cobalt-(II) dinitrate 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) dinitrate 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 uptake 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. 	Noted. This information will be taken into account in the process of priority setting for Annex XIV.
	
17	2010-09-07	Trade union,
European Trade Union Confederation,
Belgium	ETUC suports the inclusion of Cobalt (II) dinitrate in the Candidate List.	Thank you for your support.	

Specific comments on the justification
No	Date	Submitted by (name, Organisation/MSCA)	Comment	Response	
18	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).  	Noted.

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).

	
19	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 (approximately 80%) 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 dinitrate are being supplied to the non-intermediate uses. 

(4) Due to its specific classification, cobalt dinitrate 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 will be taken into account in the process of priority setting for Annex XIV.	
20	2010-10-14	Industry or trade association, EUROPEAN CATALYST MANUFACTURERS ASSOCIATION (ECMA), Belgium	p8 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.
p 11 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 response to comment No. 18.	
21	2010-10-14	Member State, Germany	Comment for the German CA

►p.8/9 “2 HARMONISED CLASSIFICATION AND LABELLING”:
Based on expert judgement by BAM Federal Institute for Materials Research and Testing, Division II.2, and the known experience in handling and testing with similar inorganic substances we propose to classify Cobalt(II)-nitrate as “oxidising” and label with O, R8 (Ox. Sol. 2, H272).	Noted. 
	
22	2010-10-14	Company, Albemarle Catalyst Company B.V., Netherlands	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. 8 Classification and labelling 

This substance will be officially classified under EC Annex I entry 027-009-00-2 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 Toxicokinetics: 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 dinitrate. 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. 39-41 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.	Noted. 

See response to comment No. 18.	
23	2010-10-14	Industry or trade association, RECHARGE aisbl, EUROBAT & EPBA, Belgium

	No comment	Information supplied in support document is noted.	
24	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.

	
25	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.

26	2010-10-12	National Authority, Health & Safety Authority, Ireland	Cobalt dinitrate is classified as Carc. 1B and Repr. 1B (EC No. 790/2009), and therefore the Irish CA agrees 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.	
27	2010-10-06	toxicology consultancy, 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.	
28	2010-10-06	National Authority,
Austria,
Austria	P14, 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.	
29	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) dinitrate	
CAS number:	10141-05-6	
EC number:	233-402-1	

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	
30	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.	
31	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 14 of Section1 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. 

Section1 (page 14) 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 dinitrate 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 15) 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 15) are not uses of cobalt dinitrate (i.e. see Table 5 on page 16), 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 15 and 16, are not relevant in this case. The Cobalt Consortium provided the information about the volumes of cobalt dinitrate in the EU. However this important information is difficult to find in the Annex XV Dossier as it is presently written. 

Also on page 15, please note the facilities of the Consortium members that manufacture and/or import cobalt dinitrate are located in Belgium, France, Germany 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 15 it is also noted that the total EU tonnage of cobalt dinitrate manufactured and/or imported into Europe (i.e. relevant for REACH registration) is estimated to be in the order of up to one thousand tonnes per year. According to the industry the majority (approximately 80%) is used as intermediate. This leaves only a very small volume as non-intermediate use (i.e. less than several 100 tonnes). 

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 16) or included in footnotes (to table 6, page 17). We have attached the technical annex again for further reference. 

Table 5 (page 16) is very similar to the table that was provided from the Consortium, however there is a key word missing from the Table which is “Intermediate” for all four of the uses/activity sectors shown (i.e. Manufacture of Catalysts, Production of Other Chemicals, etc.).

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 dinitrate, the Manufacture of Catalysts and the Production of Other Chemicals (Intermediate) 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 19) states that no specific information was found and no additional data was provided by industry (i.e. CDI). Table 7 (page 19) shows this information was not available (NA) at that time. This information can be obtained, however it does take time to collect. Again, the data shown in Table 8 (page 20) is for many different cobalt substances, and does not correspond to cobalt dinitrate, and the study also dates back to 1994. The most recent and relevant information on the occupational exposure assessments for cobalt dinitrate 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 dinitrate. 
(1)The overall volume of cobalt dinitrate manufactured/imported in Europe has been estimated to be on the order of up to one thousand tonnes per year; 
(2) The majority of the cobalt dinitrate manufactured/imported in Europe is reported to be as an Intermediate (approximately 80%);  
(3) The majority of the uses of cobalt dinitrate have been identified as being an Intermediate use, and are therefore exempt from Authorisation under REACH;
(4) There are already very stringent controls on the use of cobalt dinitrate in the workplace. 

All of these points strongly support the case not to consider cobalt dinitrate 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 dinitrate are given.”

Table 3 (p15): presents production of cobalt (in all aggregated forms) in and outside the EU.
Table 4 (p15): 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 15 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 dinitrate are located in Belgium, France, Germany and the UK. The total EU tonnage of cobalt dinitrate manufactured and/or imported into Europe (i.e. relevant for REACH registration) is estimated to be in the order of up to one thousand tonnes per year. According to the industry the majority (approximately 80%) is used as intermediate.”

There is uncertainty with respect to the reported uses if they all can be regarded as intermediate use.  This can mainly be attributed to different interpretations of the definition of intermediate Article 3(15).  According to industry approximately 20% of cobalt dinitrate is used in surface treatment.  In the ECHA clarification document of the definition of intermediates under REACH, substances used as a surface treating agent are not regarded as intermediates.  We also believe the differentiation between the use of cobalt dinitrate in the manufacture of catalysts and the use of the substance as catalyst need to be addressed. The use of a substance as a catalyst is not regarded as an intermediate. 

Noted.

	
32	2010-10-14	Industry or trade association, EUROPEAN CATALYST MANUFACTURERS ASSOCIATION (ECMA), Belgium	p16 Exposure information: Use: Cobalt dinitrate 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.
p22 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.
p22 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 dinitrate 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.
	
33	2010-10-14	Member State, Germany	Comment for the German CA

►Page 20:
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.

►p. 21, 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 porcelain 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).

Information on risks related to alternatives:
►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.	

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

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

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.	
34	2010-10-14	Company, Albemarle Catalyst Company B.V., Netherlands	Information on use and exposure.
p. 16-18 Use: Cobalt dinitrate can be 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.
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. 22 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 enabling 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 response to comments No 33.

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

	
35	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.
	
36	2010-10-14	Industry or trade association, RECHARGE aisbl, EUROBAT & EPBA, Belgium

	Comments to Part II, § 1.2. Exposure

1. Workplace exposure.

Cobalt (II) dinitrate is classified under Directive 67/548/EEC as Carcinogenic Cat. 2, Mutagenic Cat. 3 and Reprotoxic Cat. 2. Therefore, Industry must 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). This Directive sets out conditions for the strict control of risks related to occupational exposure to such substances. 

2. Environment Exposure.

Cobalt (II) dinitrate is also classified as R50-53. 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. 

As a result of the implementation of these regulatory frameworks for many years in European plants, the exposure at the workplace (both human health and environment) is under strict control.

3. Portable Batteries: Consumer Exposure during use phase.

Under REACH, batteries meet the definition of article, with no intended release of substances during normal foreseeable conditions of use. In particular the manufacture of portable batteries of the types mentioned in § 1 above, for which the referenced chemical is used as an intermediate, is governed by strict quality criteria.

The manufacture of these types of batteries is governed by an International IEC Standard (IEC 62133) entitled: Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications. This International Standard specifies requirements and tests for the safe operation of portable sealed secondary cells and batteries containing alkaline or other non-acid electrolyte, under intended use and reasonably foreseeable misuse. Cells and batteries should be designed and constructed so that they are safe under conditions of both intended use and reasonably foreseeable misuse. In this Standard IEC 62133, the term “reasonably foreseeable misuse” is defined as the use of a product, process or service in a way which is not intended by the supplier, but which may result from readily predictable human behaviour. 
During their service life, portable batteries (rechargeable or not) do not require any maintenance. The only exchange with the surroundings is an exchange of electrons with the external circuit during the charge/discharge process. No abrasive technology is used during the service life of the battery that could alter the integrity of the battery.
The chance of misuse of the portable and rechargeable battery is limited: 
a. Design Misuse. Usually the battery assembly (or battery pack) is designed for a specific application. The geometry, design or shape of the battery does not allow e.g. the use of the mobile phone battery into a laptop or a cordless tool.
b. Electrical Current abuse. The abuse due to the use of high current that could damage electrodes materials and lead to unexpected reactions is prevented by a combination of the design, protective devices against abuses and the charging mode supplied by the battery charger. The plug design for the battery charging mode is manufactured to avoid such “electrical abuse”.
c. Other Aspects of the Safety Standard. The Safety Standard IEC 62133 also includes prevention of incident against the following risk sources: a) fire, b) burst/explosion, c) leakage of cell electrolyte, d) venting, e) burns from excessively high external temperatures, f) rupture of battery case with exposure of internal components.

4. Industrial Batteries: worker exposure during use phase.

Industrial batteries are closed in order to secure their functioning and to avoid any exposure of maintenance specialists to their content. 

When maintenance is required, maintenance teams are trained for servicing the battery which consists of water refill to correct for evaporation. There is no exposure to the substances contained in the battery.
Mechanical integrity (as well as other safety features) is governed by either IEC or industry specific standards. 

The main examples are supplied below:
• Railway rolling stock batteries: IEC 61373: Railway applications – Railway rolling stock and equipment - Shock and vibration tests,
• Stationary use: IEC 77,
• Aircraft batteries: DO 160 (issued jointly by RTCA & EUROCAE) - Environmental conditions and test procedures for airborne equipment.

NB. End users such as consumers are not exposed to industrial batteries operating environment.

5. End of life and exposure via the environment.

a. Portable Batteries.

The disposal of portable / rechargeable batteries containing cobalt substances is regulated by Directive 2006/66/EC which established rules for their end-of-service life collection, recycling, treatment and disposal, and mandates collection rates of at least 25% or 45% by 26 September 2012 and 26 September 2016 respectively. However, not all batteries will be collected for recycling and some of them will end-up in the Municipal Waste Stream (MWS). 
Therefore there are 3 potential options for consumer batteries concerning their waste disposal:
• Processing of the spent battery in a Municipal Solid Waste Incinerator
• The spent battery is placed in a Municipal Waste Landfill with household waste.
• The spent battery is recycled and the cobalt recovered. 

Emissions from Recycling plants, Municipal Waste Incinerators and Municipal Waste Landfills are strictly regulated under sector specific EU legislation (Directive 2008/1/EC on Integrated Pollution Prevention and Control that will be amended in the context of the new Industrial Emission Directive, Directive 2000/76/EC on the incineration of waste with amendments and Council Directive 99/31/EC on the landfill of waste with its amendments.

b. Industrial Batteries.

The Batteries Directive 2006/66/EC also regulates the end of life of industrial batteries. This Directive requires that all waste industrial batteries are collected at the end of their life by Producers or entities acting on their behalf. It also prohibits the land filling and incineration of these products when they have become and requires their recycling. Mandatory recycling efficiencies are also imposed by the Batteries Directive.	Noted. This information will be taken into account in the process of priority setting for Annex XIV.

	
37	2010-10-13	Company, Norway	COBALT DI-NITRATE 

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 DI-NITRATE:     

(4) The overall volume of COBALT DI-NITRATE manufactured/imported in Europe has been estimated to be on the order of up to one thousand tonnes per year; 
(5) The majority of the COBALT DI-NITRATE manufactured/imported and used in Europe is reported to be as an intermediate (~80%) and is therefore exempt from Authorisation under REACH 
(6) Relatively low volumes of COBALT DI-NITRATE are being supplied to the non-intermediate use.

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. 80% of the uses of this cobalt compound that are used as intermediates, and so not subject to Authorisation: 
(e) 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 DI-NITRATE 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 DI-NITRATE 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. 
(f) Notwithstanding this, the member companies of the Cobalt Consortium will be submitting the complete substance dossier of COBALT DI-NITRATE 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 DI-NITRATE 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.31. 	
38	2010-10-13	International NGO, International chemical secretariat, Sweden	This substance is most probably used in a very similar way as Cobalt Suplhate. Porcelain, glass, batteries, paints, inks, linoleum, 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.
	
39	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.	
40	2010-10-08	Company,
Germany	p. 14 General remarks: The following laboratory uses should be exempted from the authorisation because there is very low exposure to consumers and the environment. The analytical standards are manufactured by industrial personnel, which are well trained. Therefore, the handling steps at professional users are reduced. The disposal of the substance is controlled also.   Detailed information: The substance is used in a preparation or solution as an analytical standard for test and measuring instruments by industrial and professional users. The use of the substance might be e.g. for calibration purposes or as reactive compound in a test kit. These applications are laboratory uses and therefore, the risk for the environment and consumers is very low. It is a routine application in environmental laboratories. Usually the volumes and the concentration of the substance are low.  Additionally, the substance is described in standard references like e.g. Reag. Ph. Eur and ACS or referenced in NIST. Applications described in these references should also be exempted from authorisation. 	Noted. This information will be taken into account in the process of priority setting for Annex XIV.
	
30	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).