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

Substance name:	Cobalt(II) diacetate	
CAS number:	71-48-7	
EC number:	200-755-8	

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	
17	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 en  vironmental 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.

	
16	2010/10/14	International NGO,
Health and Environment Alliance,
Belgium 	We support the inclusion of Cobalt(II) diacetate on the candidate list on the basis of the information in the Annex XV dossier	Thank you for your support.
	
15
	2010/10/14

(confidential attachment removed)

	Industry or trade association,
Cobalt REACH Consortium Ltd (CoRC),
United Kingdom  	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 diacetate 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 diacetate 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 94%) 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 94%) as an Intermediate, and therefore only a relatively small volume as non-intermediate use (i.e. less than several 100 tonnes), which also includes 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 diacetate 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 diacetate 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 <10% of cobalt diacetate 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. 

	
14	2010-10-14	MSCA, 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).

- Minor typing errors exist throughout the document, e.g. p.27 heading “HUMAN HEALTH HAZARD ASSESSMENT”, please retype “health”; p.28, change “parental” to “parenteral”	

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 were 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.

This has been changed as suggested.
p.28: The text has not been changed since “parental” is cited directly from summary reference on the toxicokinetics of cobalt and cobalt compounds from the RoC Background document for cobalt sulphate (US NTP 2002).	
13	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 Food 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 surface treatments 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?	Noted.

See comment and response to comment No. 15.

See comment and response to comment No. 15 under general comments.
	
12	2010-10-14	MSCA, 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.	
11	2010-10-14	International NGO, WWF European Policy Office, Belgium	WWF and CHEM Trust support the inclusion of Cobalt(II) diacetate in the candidate list due to its carcinogenic and reprotoxic properties.
	Thank you for your support.
	
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. 15.

	
9	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.
	
8	2010-10-13	International NGO, International chemical secretariat, Sweden	Full support regarding its identification as a SVHC.
	Thank you for your support.
	
7	2010-10-13	Industry or trade association, Committee Of PET Manufacturers in Europe, Belgium 	The following comments are submitted by the Committee of PET Manufacturers for Europe. (CPME)   This is an association representing all European manufacturers of the polymer PET (poly ethyleneterephthalate) and the manufacturers of some of their key raw materials (terephthalic acid (PTA), isophthalic acid (PIA) and dimethylterephthalate (DMT) ). The membership of CPME is comprised primarily of Companies who were formerly members of the PET Product group of PlasticsEurope.   CPME member companies manufacture all of the 2.7 million tonnes of PET manufactured in the EU and virtually all of the tonnage of PTA and PIA and a large percentage of the Dimethylterephthalte (DMT) tonnage (another key monomer of polyesters) manufactured in the EU.
Whilst we note that input was made to RIVM by the Cobalt Development Institute (Cobalt REACH Consortium) during the development of the draft dossier, the specifics of use in the sectors covered by CPME members were not covered by their input.  Our inputs below are informed by a recent survey of our members. 	Thank you for your comments they are noted. This information will be taken into account in the process of priority setting for Annex XIV. 
	
6
	2010-10-12	Toxicology consultancy, 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.	
5	2010-10-06	National Authority,
Allgemeine Unfallversicherungsanstalt,
Austria	Cobalt-salts in general and Co(II)diacetate 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.	
4	2010-10-06	Member State,
Sweden	Sweden supports the proposal to identify Cobalt(II)diacetate as a substance of very high concern.	Thank you for your support.
	
3	2010-09-29	Industry or trade association,
ZVO Central Agency of surface treatment,
Germany	1. Cobalt-(II) diacetate 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) diacetate 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. 	Noted. This information will be taken into account in the process of priority setting for Annex XIV. 	
1	2010-09-07	Trade union,
European Trade Union Confederation,
Belgium	ETUC supports the inclusion of Cobalt(II) diacetate in the Candidate List.	Thank you for your support.

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

	
9	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).

	
8
	2010/10/14	Industry or trade association,
Cobalt REACH Consortium Ltd (CoRC),
United Kingdom  	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. 

Secondly because the majority of this cobalt substance (over 94%) 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 diacetate are being supplied to the non-intermediate uses, also use as animal food supplement is covered under different EU legislation and is therefore exempt from Authorisation under REACH. 

(4) Due to its specific classification, cobalt diacetate 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. 15).  

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

	
7	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 like to further 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.	Noted. See comment and response to comment no. 8

	
	
6	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.

	
5	2010-10-13	International NGO, International chemical secretariat, Sweden	The classification is clearly justified due to its CMR properties and its wide dispersive use.	Thank you for your support.

4	2010-10-13	Industry or trade association, Committee Of PET Manufacturers in Europe, Belgium 	We note that cobalt (II) diacetate has already been classified as a carcinogen and as a reprotoxic agent, having been assigned a harmonised classification under the CLP Regulation (Regulation EC 1272/2008).  On this basis we have no specific comments on this section.	Noted.	
3	2010-10-12	MSCA, Ireland	Cobalt diacetate is classified 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.	
2
	2010-10-12	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.	
1	2010-09-17	Individual,
Germany	  COMMENTS ON ECHA DOCUMENT:  Prioritisation of Substances of Very High Concern (SVHC) for Inclusion in the List of Substances Subject to Authorisation.  Here: Cobalt Diacetate.  Reactana GmbH of 64584 Biebesheim in Germany has been manufacturing Cobalt Diacetate aqueous solution since 1981 in their premises near Frankfurt am Main. Our comments are as follows:  1. )  Cobalt Diacetate from REACTANA GmbH is exclusively being produced in form of an aqueous solution, containing on an average 25 % of Cobalt Diacetate.   Cobalt metal is the only source of cobalt contained in this  solution. No cobalt salts or oxides are ever being used.  Production is taking place in closed systems.  2. ) Our Cobalt Diacetate is being produced by us and used by  our customers under very strictly controlled conditions and  workers are  being provided with all relevant information.  3. ) Cobalt Acetate solution is exclusively used in industrial  applications, only.  4. ) The Product is being used as a catalyst in the Production of various types of Therephtalic Acid.  5. ) A substitution of Cobalt Diacetate is impossible, since other metals do not possess the required catalytical properties. 6. ) Since Cobalt Diacetate is only produced and used in form of an aqueous solution, the formation of respirable dust or aerosols  is impossible an consequently no risks of exposure occur. 7. ) An exposition of workers does not take place and is being controlled with care. 8. ) Cobalt Acetate solution is being produced and delivered exclusively to a very limited number of industrial users since 1981. The industrial users operate with highly experienced and continuously trained staff. All deliveries are accompanied by continuously updated Safety Data Sheets. 9. ) The records kept over decades do not  give any evidence of any accidents or work - related diseases. Biebesheim am Rhein,  15th September 2010  	Thank you for your comments. 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) diacetate	
CAS number:	71-48-7	
EC number:	200-755-8	

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	
18	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).	
12	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.

11
	2010/10/14	Industry or trade association,
Cobalt REACH Consortium Ltd (CoRC),
United Kingdom  	Part 2 of the Annex XV Dossier presents much general information on uses. On page 16 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. 

Section 1 (page 16) 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 diacetate 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 diacetate (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 diacetate 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 diacetate are located in Belgium, Finland, France, and 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 diacetate 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 94%) is used as intermediate. This leaves only a very small volume as non-intermediate use (i.e. less than several 100 tonnes). The Consortia members have identified few non-intermediate uses of cobalt acetate (e.g. animal feed, adhesion promoter, etc.). However use as an adhesion promoter is a very minor use, and can also be considered an intermediate use in certain cases. The use as an animal feed supplement 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 four of the uses/activity sectors (Manufacture of Catalysts, Production of Other Chemicals, etc.) and “Exempt from Authorisation” for the fifth 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 diacetate, 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 19) states that no specific information was found but some data was provided by industry (i.e. CDI). Table 7 (page 19) shows 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 diacetate, and the study also dates back to 1994. The most recent and relevant information on the occupational exposure assessments for cobalt diacetate 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 diacetate. 
(1)The overall volume of cobalt diacetate manufactured/imported in Europe has been estimated to be on the order of several thousand tonnes per year; 
(2) The majority of the cobalt diacetate manufactured/imported in Europe is reported to be as an Intermediate (over 94%);  
(3) The majority of the uses of cobalt diacetate have been identified as being an Intermediate use, and are therefore exempt from Authorisation under REACH;
(4) Relatively low volumes of cobalt diacetate are being supplied to the non-intermediate uses that have been identified (e.g. animal food supplement, adhesion promoter, etc.);  
(5) The use of cobalt diacetate 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 diacetate in the workplace. 

All of these points strongly support the case not to consider cobalt diacetate 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 (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 dinitrate are located in Belgium, Finland, France and the UK. The total EU tonnage of cobalt di(acetate) 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 (over 94%) 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).  According to industry approximately <10% of cobalt diacetate 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. 

	
10	2010-10-14	MSCA, Germany	Comment for the German CA

► 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 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).

►Page21:
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 22,23:
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 they 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.

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.	
9	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).
On the information on use in Table 6, the company would like to make the following comments:
The table may be misleading 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. 
Other - Sympathetic (invisible) inks – The Company is not aware of this application and it is unlikely that cobalt diacetate is used commercially for this purpose.
Other - Dryer in paint and varnish. – Cobalt diacetate is not anymore used in dryer applications.
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). 	Noted. See comment and response to comment No. 11.

	
8	2010-10-14	MSCA, 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.
	
7	2010-10-13	Company, Norway 		COBALT ACETATE 

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 ACETATE:     

(1) The overall volume of COBALT ACETATE manufactured/imported in Europe has been estimated to be on the order of several thousand tonnes per year; 
(2) The majority of the COBALT ACETATE manufactured/imported and used in Europe is reported to be as an intermediate (~95%) and is therefore exempt from Authorisation under REACH 
(3) Relatively low volumes of COBALT ACETATE are being supplied to the non-intermediate use, and only one application has been identified for certain, i.e. that of an animal food supplement.  The use of COBALT ACETATE  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. 95% of the uses of this cobalt compound that are used as intermediates, and so not subject to Authorisation: 
(a) 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 ACETATE 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 ACETATE 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. 
(b) Notwithstanding this, the member companies of the Cobalt Consortium will be submitting the complete substance dossier of COBALT ACETATE 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 ACETATE 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. 11.	
6	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.
	
5	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.

	
4	2010-10-13	Industry or trade association, Committee Of PET Manufacturers in Europe, Belgium 	In relation to Table 5 (page 17) we have the following comment.  Cobalt (II) diacetate is used directly as an oxidation catalyst in the manufacture of substances such as terephthalic acid and isophthalic acid.   This activity is distinct from the use of cobalt (II) diacetate in the “Manufacture of catalysts” and so deserves a separate line in this table.  The likely total tonnage used in this application would suggest it should be considered a major use  i.e. > 100 tonnes / year of cobalt (II) diacetate in the application across all users in the EU.  

In relation to Table 6 (page 18) we believe that the section of text in the further information column under “Manufacture of Catalysts” is confusing.  We suggest that in the “Use and/or Activity Sector” the heading “Manufacture of Catalysts” should be edited to read “Manufacture and Use of Catalysts”.

We understand that cobalt (II) diacetate is used as an intermediate in the manufacture of cobalt oxide and similar catalysts which are widely used in petroleum refining processes.  This use is not covered by the current text in the “Further information” column of table 6.  

Editing the text in relation to use as an oxidation catalyst  (including use in the manufacture of PTA) would help clarify this section.  We would suggest the following text:-

Homogenous oxidation catalyst: cobalt(II) carboxylates, oleate, acetate, and naphthenate, may be  used in the liquid-phase oxidations of 
p-xylene to terephthalic acid, 
cyclohexane to adipic acid,
acetaldehyde to acetic acid, and 
cumene to cumene hydroperoxide.
These reactions each involve a free-radical mechanism. Cobalt-catalyzed oxidations form the largest group of homogenous liquid phase oxidations in the chemical industry. 
 
In the EU cobalt (II) diacetate is the only substance used as a catalyst in the
oxidation of p-xylene to produce Purified Terephthalic Acid and Dimethylterephthalate (  raw materials for the manufacture of  polyesters including PET.) This cobalt containing liquid
catalyst is generally recycled.” 

Reference to the use of cobalt (II) diacetate in tinting PET polymer is made in table 6 under the “Manufacture of Catalysts” section.   This application would be more appropriately listed under the heading of “Dyes” or “other”.   However of the nine (9) CPME members manufacturing PET in the EU only 3 have indicated that they currently use cobalt (II) diacetate as a colour modifier in PET. All 3 companies are committed to cease the use of cobalt (II) diacetate in this application by the end of 2011.

 We have no knowledge of the use of cobalt (II) diacetate as a catalyst “in the manufacture of PET monomer” and therefore doubt if this specific activity happens in the EU.

In relation to Table 7 (Page 19) a line should be introduced to cover use as a catalyst in PTA/PIA manufacture.  There are currently 6 producers in the EU and each operates at a single site.

In relation to Section 1.2.1.2 (Workplace concentrations and exposure measurements) and Table 8 (Page 20).  All of the producers of PTA/PIA reported that they handle only liquid preparations of catalyst, thus avoiding handling dusty solids.   Reactors using the catalyst operate under closed conditions (PROC 1) and ancillary handling of catalyst is under PROC 2 with tight control of potential exposure at sampling.  Review of measured exposure data suggests that where these conditions apply exposure to cobalt acetate is much lower than that reported in Table 8. (Table 8 gives mean exposure to cobalt salts as being between 68 and 89 µg/ m3.)  Measurements in PTA/PIA plants have shown that, apart from some specific maintenance operations which are carried out using full PPE including air fed respirators, exposures are generally  < 1 µg/ m3. (analysed as cobalt -8h TWA).   Although the workforce in PTA/PIA production probably numbers approximately 300 workers across the EU, very few of these workers have any significant exposure to cobalt.  In cases where exposure happens, this is usually for short time periods (< 30 minutes) and to relatively low levels.   

In relation to Section 1.2.2 Consumer Exposure (Page 21)
There is no consumer exposure to cobalt (II) diacetate as a result of its use in PTA/PIA manufacture.   As industrial monomers PTA and PIA are not made available to consumers.   
When polyester (eg PET) is manufactured, cobalt entering the process as an impurity in PTA and PIA is bound to the polymer chain.”
.   Because of its use in food packaging applications, polymer used for this application is restricted to material which can meet the migration test criteria in 72/EC/2002 and its five amendments.

Section 2 CURRENT KNOWLEDGE ON ALTERNATIVES (Page 22)

cobalt acetate is the catalyst material of choice for the manufacture of PTA/PIA across the global industry. This is based on its high performance which contributes to the energy efficiency of the process.

No viable alternative materials are known for this application.

For the application as a colour modifier in PET this is not seen as essential and other technical solutions are available and are currently being implemented. 

Section 3 RISK RELATED INFORMATION (Page 22)

It is noted that Minimal Risk Levels have been cited from the ATDSR report carried out for the US Department of Health and Human Services.  It should be made clear that in themselves these Minimal Risk Levels have no direct regulatory relevance in the Context of EU Regulation.

ANNEX 1 HUMAN HEALTH HAZARD ASSESSMENT (Page 27 et seq)

It is noted that this section is provided for information only, given that EU Classification decisions have already been finalised.  The text consists of extracts from various review documents but does not have a reference list for the cited publications. Whilst citing data in relation to other soluble Co 2+ salts in support of a dossier on cobalt (II) diacetate is valid it does not seem relevant to cite data on insoluble cobalt substances and hard metal in this context.    

ANNEX II – ANIMAL CARCINOGENICITY AND RELATED EFFECTS DATA OF COBALT COMPOUNDS (Page 43 et seq)  

this Annex tabulates data in relation to all manner of studies carried out on cobalt associated test materials. It  is appropriate to limit the content of this Annex to data on other soluble Co 2+ salts which may provide valid read across to cobalt (II) diacetate.

The data relating to insoluble forms of cobalt especially that involving implantation or injection of metallic materials causing artefactual local sarcomas is not relevant to the substance that is subject of this Annex XV dossier and could be misleading.   It should be removed from the dossier. 	Thank you for your comments and information.  This information will be taken into account in the process of priority setting for Annex XIV. 

Suggestions and information will be taken into account.

Information on use and exposure will be taken into account in the process of priority setting for Annex XIV.

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.

Noted. 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 were 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.”

Noted.  We prefer to keep Annex II for informational purposes.  To make it clear to the reader that the information in Annex II refers to different forms of cobalt the following heading is added (p. 36) under section 1.8.3.1, “Other cobalt compounds.”

	
3	2010-10-12	Company,  Germany 	The use of Cobalt (II)-acetate (CAS-Nummer:71-48-7, water free) as a catalyst for production of Dimethylterephthalate (DMT), CAS-No. 120-61-6 is state of the art.
The catalyst allows an optimized production yield hence it is essential for  the economic efficiency of the so called “Witten DMT production process”.
The development of a new catalyst is very expensive and requires additional costs for research and development. So far no alternative catalysts have been used in the Witten DMT production process. It is unlikely to find an alternative catalyst that will allow an economically acceptable production of DMT in the near future. 
Although Cobalt(II)-acetate has dangerous intrinsic properties the risk for human health of workers during the production of DMT is absolutely minimized. During the DMT production Cobalt(II)-acetate is only used in liquid form as an aqueous solution therefore no relevant exposure via inhalable dust is possible.
During the DMT production process Cobalt(II)acetate is only lost within the esterification process resulting with metallic cobalt which is recycled. 
Recycling of the catalyst, done via an extraction which is part of the so called  “Witten DMT process” significantly reduces the need for fresh Cobalt(II)-acetate.
During the „Witten DMT production process“, a distillation step isolates and purifies DMT resulting in an end product which contains no Cobalt(II)-acetate at all.
All operations in which Cobalt(II)-acetate is used are regularly controlled and audited by a certified body.
Human health of workers who are in contact with Cobalt(II)-acetate is regularly controlled by work place controls and occupational physicians.  	Noted. This information will be taken into account in the process of priority setting for Annex XIV.	
2	2010-10-08	Company,
Germany	p.15 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. 	Noted. This information will be taken into account in the process of priority setting for Annex XIV.
	
1	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.