COMMENTS ON AN ANNEX XV DOSSIER FOR IDENTIFCATION OF A SUBSTANCE AS SVHC AND RESPONSES TO THESE COMMENTS

Substance name:	Cadmium sulphide	
CAS number:	1306-23-6	
EC number:	215-147-8	

The substance is proposed to be identified as meeting the following SVHC criteria set out in Article 57 of the REACH Regulation: Article 57 (a) and (f)

Disclaimer: Comments provided during the public consultation are made available in this document as submitted by the commenting parties. It was the commenting parties own responsibility to ensure that their comments do not contain confidential information. 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. RCOM has not been agreed by the Member State Committee nor has the document been modified as result of the MSC discussions. The table does not contain any confidential information.

PART I: Comments and responses to comments on the SVHC proposal and its justification

General comments on the SVHC proposal
Number	Date	Submitted by (name, Organisation/
MSCA)	Comment	Response	
9	2013/10/17	Member State
Norway	The Norwegian REACH CA supports the proposal to identify cadmium sulfide as a SVHC in accordance with article 57 a) since cadmium sulfide is harmonised classified as carcinogenic (Carc. IB, H350: May cause cancer).

In addition the Norwegian REACH CA supports the proposal to identify cadmium sulfide as a SVHC in accordance with article 57 f) for equivalent level of concern owing to the adverse effects on kidney and bone tissue after prolonged exposure (harmonised classified STOT RE1, H372: Causes damage to organs through prolonged or repeated exposure). Since the toxic effects of cadmium sulfide is caused by the cadmium ion, the same justifications for equivalent level of concern given for cadmium applies to cadmium sulfide. Cadmium is on the Candidate List identified as an SVHC in accordance with Article 57a) and 57f).	Thank you for the support	
4	2013/10/08	Company
Nordenhamer Zinkhütte GmbH
Germany	.
	-	
2	2013/09/22	Company
ANDA Technology(Suzhou)Co.,Ltd
China	All materials supplied to STATS ChipPAC	No question	

Specific comments on the justification
Number	Date	Submitted by (name, Organisation/
MSCA)	Comment	Response	
11	2013/10/17	Industry or trade association
Belgium	Comment 1
p. 7 – “Since the toxic effect of all cadmium compounds are caused by the cadmium ion, the conclusions for ‘cadmium’ are relevant for cadmium sulphide”.   
This statement assumes that there will always be complete dissolution in the environment of the cadmium ion for the cadmium sulphide molecule which is not a correct assumption.  Data from dissolution tests (cfr table below) in water demonstrate that the release of Cd++ ions from CdS is in reality extremely limited.  
Table 1. Transformation/dissolution results on CdS (loading 1mg/l, pH 6), according to OECD N°29 (ECTX 2010)
CdS loading 1mg/l at pH6	X* µg Cd/l +/- SD (µg Cd/l)
After 7 days	2.71 ± 0.4
After 28 days	5.75 ± 0.68
*X: average of 3 vessels, 3 samples/vessel
Considering the loading of Cd specifically, 0.35% of Cd was released after 7 days and 0.74% after 28 days. Based on these test results, CdS was categorised as ‘insoluble’.

Comment 2
p.15 – “Cadmium sulphide has a very low solubility, compared to i.e. the oxide form. The potential for releasing cadmium ions is therefore very low, which decreases the bioavailability potential.”   
The dossier does not indicate what the contribution of cadmium sulphide is to the overall cadmium loading to the environment much less available for uptake by humans.   
Comment 3
p.22 – “. . . food is the main intake route and it is therefore important to reduce all input of cadmium to foodstuff.  The input of cadmium to soil is dominated by deposition from air, which therefore must be reduced . . .”   
The vast majority of deposition of cadmium to soil from air is the result of fossil fuel burning and to a certain extent the use of certain types of fertilizers.  Whether these forms of deposition involve cadmium sulphide is not indicated in the dossier.   The dossier provides no support for how foodstuff is impacted by cadmium sulphide.	The justification for art 57(a) is based on the harmonized classification (Carc. 1B). Also for 57(f) the harmonized classification (as STOT RE1) is of high relevance. 
It is recognized that CdS is less soluble than eg. CdO, but it should also be noted that despite the low solubility in some test systems, Cd compounds with” low solubility” still adds to the Cd pool in the environment. See eg. KemI PM 4/13 (http://www.kemi.se/Documents/Publikationer/Trycksaker/PM/PM%204_13.pdf).
Since cadmium from CdS in soil will ultimately be taken up by plants, CdS will enter the food chain and add to the exposure of Cd via food.  

The oxidation of CdS to Cd sulphate in air also adds to the solubility and bioavailability of CdS.	
			See also:
Comment 11 attachment: ECHA footnote – the attachment referred to has been transformed to a confidential attachment as it contained both personal and company identifiers. However there is no difference in the comments on the CdS SVHC proposal as provided in this RCOM. 		
10	2013/10/17	Industry or trade association
International Cadmium Association
Belgium	Summary of Comments:
A major problem related to this Annex XV document is that it covers not only CdS, but also other substances which are non hazardous and have their own separate REACH registration. An Annex XV document typically refers to a specific chemical. The current Annex XV document fails to distinguish between:
The current Annex XV document fails to distinguish between:
a)	Cadmium sulphide – (common chemical grade, EC 215-147-8, CAS 1306-23-6)  - classified as hazardous – used mainly for the manufacture of photovoltaic panels and as an intermediate in the manufacture of other cadmium compounds, including pigments.  It is also used in small quantities as intermediate in glass colouration and this involves full encapsulation.
b)	Cadmium pigments – EC numbers 261-218-1 / 235-758-3 / 232-466-8, CAS Registry numbers 58339-34-7 / 12656-57-4 / 8048-07-5 – which are not classed as hazardous.
The non-hazardous materials must not be confused with the intermediate and chemical grade CdS which have different properties, characteristics and applications as will be made clear in the commentary.  Any reference to non-hazardous Cd pigments, except to clarify their difference to CdS chemical grade, is not appropriate in this document. 
The Annex XV report on Cadmium sulphide highlights two areas of risks: 
1.	risk of increased bone and kidney effect on the general population due to exposure to Cd and its compounds from the environment and to releases of cadmium from cadmium sulphide containing articles,
2.	risk to a large number of EU workers occupationally exposed to cadmium compounds. 
These risks are taken forward as a basis to request that cadmium sulphide be submitted to the REACH authorization process.
However, no effort is made in this Annex XV to try to link “uses” of cadmium sulphide to the risks to the general population.
Moreover, the Annex XV fails to recognize that the vast majority (over 98%) of workers is exposed to cadmium and its compounds present as impurity in commodities.
In these comments, industry will show that:
1.	The contribution of the industry deliberately using cadmium sulphide to general population Cd-exposure is insignificant as compared to the contribution of the industry manipulating goods in which cadmium is an impurity.  In other words,  the manufacture and use of cadmium sulphide containing articles has no influence on general population cadmium exposure,
2.	The use of articles containing Cd and Cd compounds is already under many restrictions, prohibitions and limitations within the EU. Industry will show that exposure from the remaining articles specifically containing chemical CdS, including their end of life, is insignificant
3.	The sectors of industry that are deliberately using cadmium and its compounds (including the industry manufacturing and using CdS) only employ a small fraction of the estimated number of occupationally exposed workers (1.6%). These sectors deliberately using Cd and its compounds have a solid record of risk management and risk reduction; since 2008 they voluntarily implemented the Swedish Occupational Risk Agency management tools and implemented a DNEL based on the OEL set by SCOEL in 2010 (SUMDOC 136 2010).
In clarifying these points, it will become clear that authorization of CdS uses will not lead to any influence on general population and worker exposure, and as such will be insignificant to “ensure that the risks posed by the substance of very high concern will be properly controlled” (REACH art 55).  Indeed, it will be clear that any Risks are already properly controlled.
In the following, a number of comments on the Annex XV document on cadmium sulphide are given. More details on some of these comments are provided in the Master Comments Document(uploaded under IV Attachment) This master-file contains also the references. 

PART I Comments

Page 7, section “summary of how the substance meets the criteria set out in article 57(a) and 57(f) of REACH”, heading “equivalent level of concern”, 3rd  paragraph 
Comment 1
Annex XV states that “Since the toxic effect of all cadmium compounds are caused by the cadmium ion, the conclusions for ‘cadmium’ are relevant for “cadmium sulphide”.   This statement assumes wrongly that there will always be complete dissolution of the cadmium ion from the cadmium sulphide. Data from dissolution tests in water demonstrate that the release of Cd++ ions from CdS is in reality extremely limited.  
For data and references supporting the analysis above, see in uploaded attachment under IV Attachment, comment 1.

Page 7, section “summary of how the substance meets the criteria set out in article 57(a) and 57(f) of REACH”, heading “equivalent level of concern”, 4rd paragraph, 4rd line – 
Comment 2
Annex XV states that ”the input of cadmium to soil is dominated by deposition from air, which therefore must be reduced, and in order to achieve this, all uses of cadmium and cadmium compounds should, wherever possible, be substituted”. This statement ignores (a) the one major source of Cd-input to soil, i.e. use of P-fertilizer (see comment 42), and (b) makes the wrong assumption that (REACH) uses of cadmium contribute to human exposure, which is not the case (see comment 47).  
For data and references supporting the analysis above, see in uploaded attachment under IV Attachment, comment 2 and 47.

Page 7, section “summary of how the substance meets the criteria set out in article 57(a) and 57(f) of REACH” (cont.), 5th paragraph - 
Comment 3
Reference is being made to the Council resolution on cadmium of 25 January 1988 -25 years ago- to justify further action on cadmium. The Annex XV fails to consider a) extensive EU legislation that was implemented since then on restrictions of the main cadmium uses, b) the extensive work that has been undertaken by the Commission since then on cadmium, with the EU risk assessment, as a result of which further measures were decided, c) the marked progress that was achieved on limiting documented Cd-emissions to air, water and soil. As such, the annex XV document ignores the significant reduction that has been observed since 1988 related to the cadmium exposure of the general population through the atmosphere (see comment 47 for data). 
In the bullet list describing the contents of the 1988 Council Resolution, the “extension of take back systems” is not mentioned. It is noted that this has now been made mandatory for batteries and a voluntary take back initiative has been set up by manufacturers of thin film photovoltaic panels using CdTe & CdS). We would like to emphasize that the above mentioned extension on ‘take back systems’ is very important to mention as example especially in this CdS dossier. 

Page 9, section “summary of how the substance meets the criteria set out in article 57(a) and 57(f) of REACH” (cont.), 2nd paragraph - 
Comment 4
The annex XV document mentions rightfully that there is a continuous publishing of new information on cadmium. It states that this demonstrates that “what can be considered as a safe exposure level is steadily decreasing”. This statement however ignores a number of recent publications that challenge the significance of Cd-U as a marker of cadmium exposure in situations of very low exposure (e.g. at or below Cd-U = 1 µg Cd/g creatinin), as it is the case with the general population (see comment 9).

Page 9, section “summary of how the substance meets the criteria set out in article 57(a) and 57(f) of REACH” (cont.). 5th paragraph - 
Comment 5
The estimation of annual costs of cadmium exposure in Sweden is based on the lowest estimation of the safe exposure level, measured by Cd-U. Cd-U is however recently challenged by academic research as a biomarker of  Cd-exposure in situations of very low exposure (see comment 9).  The estimation of annual costs therefore needs to be considered with great caution.
It is noted that a detailed study on the societal economic cost of fractures in Sweden and the possible relevancy of Cd for this is ongoing. 

Page 15, section 3.3 Bioavailibility, line 1-2 
Comment 6
Annex XV states that “Cadmium sulphide has a very low solubility, compared to i.e. the oxide form. The potential for releasing cadmium ions is therefore very low, which decreases the bioavailability potential.”   The dossier does not indicate what the contribution of cadmium sulphide is to the overall cadmium loading to the environment much less available for uptake by humans.

Page 16, section 3.3 Bioavailibility, first paragraph, line 6
Comment 7
The Annex XV document mentions (with reference to KEMI 2013b) that: CdS will be transformed into more water soluble forms. However, this assumption is based on processes in hypothetical environments. The transformation of CdS in water was proven to be very low (see comment 1). Therefore, the assumption of rapid transformation in soil is questionable. Such a theoretical model and single selective reference should certainly not be used in isolation.

Page 16, section 3.4: “food”
Comment 8
This paragraph makes reference to a recent EFSA report to conclude that “children and adults at the 95 percentile exposure can exceed health-based guidance values”. As is indicated in the EFSA report itself, this 95 percentile estimate is “speculative and potentially unrealistic” (section 3.2 page 17 of EFSA 2012) because it is based on the unlikely assumption that the same individuals retain the same high exposure throughout their whole life. This 95 percentile should thus be considered as clearly overestimated. The average Cd intake value calculated in this EFSA study is considered conservative as it is higher than recently published values in EU countries. However, it remains below the EFSA dietary intake standard, which is itself lower than the WHO dietary intake standard. Therefore, even following conservative assumptions, current observed dietary intakes in the EU can be considered safe in a life time perspective. See comment 60 for more detail.

Page 18, section 4.2 Kidney toxicity, para 2
Comment 9
Annex XV makes reference to KemI (2011), in which a number of studies were cited, “showing significant associations between cadmium in urine and/or blood and markers of impaired kidney function, mostly impaired tubular function”.  
It is concluded that adverse effects may occur at very low exposure levels as measured by Cd-U. 
However, recent evidence, which is not discussed in Annex XV, questions the causality of these associations between U-Cd and biomarkers of kidney effects (urinary proteins) in populations with low levels of exposure.  
Recent literature is showing that the association between Cd and protein excretion probably represents normal variability in renal physiology resulting in a temporarily increased or decreased Cd excretion, independent of kidney cadmium concentration (Kidney Cd) (Chaumont et al., 2012, Akerstrom et al., 2013a). 
These recent findings suggest that at low environmental exposures, U-Cd would be more a reflection of the functional integrity of the nephron than of the Cd exposure or of the Cd body burden (Chaumont 2012). 
These reverse causality mechanisms might have important implications in the risk assessment of Cd for the general population, which currently largely relies on the use of U-Cd as exposure indicator (Chaumont et al 2012).  
See also comment 55 for more details.
In conclusion, the scientific debate on the causal effect of low Cd exposures (measured as Cd-U) on kidney function is ongoing. Taking this debate into account, it is strongly recommended to consider the anticipated effects on kidney at low Cd exposure with caution. It is emphasized that at higher exposures, the causal relationship is not questioned (Chaumont et al 2011). The use of biological indicators in e.g. worker environment is thus justified. 
Referring to the recent study of (Åkerström et al, (2013b) showing a strong association between kidney Cd and urinary Cd (healthy kidney donors), we would like to emphazise this study should be interpreted very cautiously because the associations shown between concentrations of Cd in urine (or in blood) and the concentration of Cd in kidney are based on the whole population with no distinction between never and ever smokers. 
For more detailed data and references supporting the analysis above, see in uploaded attachment under IV Attachment, comment 9

Page 20, section 4.3 Bone toxicity, para 1, line 3
Comment 10
Annex XV suggests “that even a urinary concentration around 0.5 µg/g creatinin is associated with increased risk of osteoporosis and fractures”. 
It is emphasized (see also comments 9, 55) that the significance of Cd-U as an exposure marker in situations of very low exposure to Cd, has recently been questioned (Chaumont 2012, Akerstrom 2013a). Consequently, this association between urinary Cd and bone effects must be questioned too. 
Therefore the suggested threshold for bone effects of Cd at a level around 0.5 µg/g creat for the general population exposed by the oral route, should be treated with caution. 
There is evidence suggesting that low-level urinary Cd in the general population would be more a reflection of the recent intake and of the physiological variations in the urinary excretion of creatinine. This is relevant for all studies using urinary Cd as cumulative exposure indicator. 
A cautious interpretation of Cd-U data is needed because it is noted that the link between proteinuria and albuminuria at low Cd-U is physiological rather than causal (Cd-MT and LMW proteins share the same binding sites in the tubuli) (Akerstrom et al 2013a).  Moreover, since proteinuria and albuminuria are well known predictors of bone diseases (Barzilay et al., 2013), a causal relationship between CdU (at low levels) and bone effects is questionable.

Page 20, section 4.3 Bone toxicity, para 3,  line 6
Comment 11
The Annex XV document mentions: “it is concluded that the differences cannot be explained by differences in risk of slipping, low calcium intake, vitamin D deficiency or by inactivity”.  No references are given to explain this statement. We anticipate that “slipping risk” and “inactivity” are rather comparable between countries. However, the parameters low Ca and VitD are very important for the bone effect, so clear references should be provided for this statement. 

Page 22, section 6.2., 3rd paragraph, 4rd line. 
Comment 12
Section 6.2.  is largely similar to section “summary of how the substance meets the criteria set out in article 57(a) and 57(f) of REACH”. The comments 2 to 5 formulated above on this section, are also relevant here. Notably the sentence in paragraph 3, 3rd line “the input of cadmium to soil is dominated by deposition from air, which therefore must be reduced, and in order to achieve this all uses of cadmium and cadmium compounds should wherever possible be substituted” is misleading, since (a) it ignores the main single source of Cd to general population exposure, i.e. the use of P-fertilizer on agricultural land (see also comments 2 and 42), and (b) the fact that cadmium (REACH) uses do not contribute to the cadmium deposition from air on crops and soil (see comment 47).
We note that the percentages provided in comment 42 are averages for the EU, and that differences between countries in Cd-sources to soil can occur. Yet, the averages are quite consistent throughout EU member states (OJ 2008/C 149/03), see for more detail comment 42. 

Page 22, section 6.2,  3rd  paragraph 
Comment 13
Again, this section 6.2. is largely similar to section “summary of how the substance meets the criteria set out in article 57(a) and 57(f) of REACH”. Comment 2 formulated above on this section, is also relevant here. 

Page 22, section 6.2,  4th paragraph. 
Comment 14
Again, this section 6.2.  is largely similar to section “summary of how the substance meets the criteria set out in article 57(a) and 57(f) of REACH”. Comment 3 formulated above on this section, is also relevant here. 

Page 24, section 6.2. , heading “uncertainties on safe exposure” 1st paragraph. 
Comment 15
Again, this section 6.2. is largely similar to section “summary of how the substance meets the criteria set out in article 57(a) and 57(f) of REACH”. Comment 4 formulated above on this section, is also relevant here, see also comment 9 & 10 for more details. 

Page 25, section 6.2., heading “societal concern and impairment of quality of life”. 
Comment 16
See comment 5 made above	The SVHC proposal covers only CdS (EC 215-147-8, CAS 1306-23-6). This is also the case when referring to harmonized classification for CdS.

However, as the toxic species is cadmium ion, data for other cadmium compounds are also relevant, in particular when assessing effects after chronic exposure.

The justification for SVHC identification is based on intrinsic properties of the substance, not on exposure and risk.  The latter is only briefly mentioned in the section on “Societal concern” for 57(f).

Please see attached file for further responses. 

			See also:
Comment 10 attachment (CdS Annex XV_ICdA comments_master and summary.zip).zip		
8	2013/10/16	Member State
Ireland	The Irish CA notes that the current proposal to identify cadmium sulphide as a SVHC relates to both carcinogenicity (Article 57a) and equivalent level of concern (Article 57f). The following comments relate only to the Article 57(f) proposal.

In line with the previously agreed SVHC proposals for cadmium and cadmium oxide which were based on the intrinsic hazards of cadmium, the Irish CA supports the proposal to identify cadmium sulphide as a SVHC in accordance with Article 57(f) for equivalent level of concern, owing to adverse effects on kidney and bone tissue after prolonged exposure to cadmium sulphide, and thus cadmium.	

Thank you for this support	
7	2013/10/15	Member State
Belgium	Belgium supports the proposal to identify cadmium sulphide as SVHC based on article 57(a) of the REACH Regulation due to the classification as carcinogen cat. 1B.
This substance is also classified as STOT RE 1. The following items are present in the Annex XV dossier and substantiate that the substance fulfills the article 57(f) criteria, based on Cd data  :
o	Serious organ dysfunction (for kidney : from minor tubular and glomerular dysfunction to an increase risk of end stage renal disease; and for bone : from disturbances homeostasis to actual bone fractures)
o	The health effects  can be irreversible
o	The delay of the effects can be very long
o	There is uncertainty about identifying safe exposure levels
o	For the kidney effects : huge costs for the society 
o	Cadmium has been proven to bioaccumulate in the human body.
o	The exposure to the Cd substance is of societal concern at EU level  (the EFSA report of 2012 on “Cadmium dietary exposure in the European population”, concluded on the need to reduce exposure to cadmium at the population level because of the limited safety margin). 
These arguments together demonstrate the scientific evidence of probable serious effects to human health, which give rise to an equivalent level of concern to CMR or PBT/vPvB substances. Therefore, Belgium supports also the identification as SVHC based on article 57(f) of the REACH Regulation.
Moreover, Cadmium and Cadmium oxide were included in the candidate list in June 2013 based on art. 57(a) and 57(f).	Thank you for this support.	
6	2013/10/15	International NGO
ChemSec
Sweden	ChemSec supports the Swedish proposal to list Cadmium sulphide to the REACH candidate list of Substances of Very High Concern (SVHC) on the basis of 
- its carcinogenic properties (Art. 57 a) and;
- its “equivalent concern” (Art. 57 f) properties. 

The substance is classified in Annex VI, part 3, Table 3.1 of the CLP Regulation (EC) No 1272 as Carc. 1B.
The listing of cadmium sulphide on the SVHC candidate list is therefore justified according to Art. 59 (2) of REACH.

The Member State Committee agreed on the June 2013 meeting that the toxic effects of all cadmium compounds are caused by the cadmium ions. They agreed that elemental cadmium and cadmium oxide is an equivalent concern SVHC (Art. 57 (f)) because it has properties causing adverse effects on kidney and bone tissues which are serious effects to human health that give rise to an equivalent level of concern to those of CMRs and PBTs/vPvBs. The same listing basis is therefore justified for cadmium sulphide. Further the substance is also classified as STOT RE Cat. 1. 
We consider that the Annex XV dossier provides for robust information justifying the additional Art. 57 (f) entry for the inclusion to the SVHC candidate list.

We thank the Swedish government for their engagement in environmental and human health protection.	Thank you for this support	
5	2013/10/15	Member State
Germany	We support the identification of cadmium sulphide as SVHC.	Thank you for this support.	
3	2013/09/25	Trade union
European Trade Union Confederation
Belgium	ETUC supports the identification of Cadmium sulphide as a SVHC. The substance is included in the Trade Union Pririty List for REACH authorisation: http://www.etuc.org/a/6023	Thank you for this support.	
2	2013/09/22	Company
ANDA Technology(Suzhou)Co.,Ltd
China	All materials supplied to STATS ChipPAC	-	

PART II: Comments and responses to comments on uses, exposures, alternatives and risks

Specific comments on use, exposure, alternatives and risks
Number	Date	Submitted by (name, Organisation/
MSCA)	Comment	Response	
11	2013/10/17	Industry or trade association
Belgium	Comment 4
p. 27, first bullet: With the inclusion of PV in the recast WEEE Directive and the development of associated recycling standards for material recovery from end-of-life PV modules, there is already a regulatory mechanism for waste management of solar cells.  This text should be removed or the above regulatory mechanism should be cited. It should also be noted, that even if chalcogenide thin film PV technologies employing CdS as a buffer layer in the P/N junction are significantly increasing market share going forward, the overall use of CdS (in comparison to the other identified uses) remains very small – as the following calculation demonstrates.
To date, chalcogenide thin film technologies employ CdS buffer layers in ultra-thin layers on the scale of 10-8 m thickness. The thickness of the buffer layer is going to stay constant, whereas overall module efficiencies are going to increase. This will lead to higher utilization rates in terms of generation capacity per employed volume of CdS. Taking the conservative assumption, that today’s thin film module efficiencies will stay constant over the next decades, one can depict the following utilization rates:
Chalcogenide Thin-film PV (CdTe/CdS; CI(G)S/CdS etc.): 
•	Typical weight of the module: 12 to 15 kg
•	Mass concentration of CdS: 0.001%
•	Power output: 100 - 130 W / module
•	Utilization rate = 12 … 15 kg x 0.001% / 100 … 130 Wp ≈ 0.001 g/W [gram CdS / Watt peak]
At current market share, global annual deployment of chalcogenide Thin-film PV is in the range of 2 to 3 GWp – equaling some 2 to 3 tonnes of CdS usage per annum – of which up to 95% can be managed in a closed recycling loop. Following the assumptions of the European Photovoltaic Industry Association (EPIA, 2012), PV deployment in Europe until 2030 will reach levels between 300 GWp (baseline) to 850 GWp (paradigm shift) cumulative installed capacities. To date the market is largely dominated by crystalline Silicon applications with a market share of over 80% (EPIA, “Global Market Outlook for Photovoltaics 2013 – 2017, 2013). If chalcogenide thin-film PV applications would significantly increase their market share to 50 % (a fivefold increase compared to today), this would lead to a total utilization rate of 300 (baseline scenario) to 900 (paradigm shift scenario) tonnes of CdS for the total cumulative installed capacity in 2030 – which on an annual installed basis would still be only a very minor fraction of the total use (below 50 tonnes per year).

Comment 5
p. 31, third paragraph: Beyond shifts in solar cell deployment, CdS use in the PV solar cell market depends on technological developments (including cell efficiency increases, reduced semiconductor layers, higher material utilization during deposition processes) that reduce the material intensity of solar cell production.  These additional factors should be stated. As stated above – even a fivefold increase in market share and a continued exponential growth of the overall PV market will not lead to a significant change in the consumption pattern in comparison to other uses.

Comment 6
p. 34, third paragraph: Nanoparticles of CdS are not used for production of buffer layers for thin film CdS/CdTe solar cells, with average raw material particle size above nanometer-scale for CdS powder.  The CdS buffer layer is deposited by convective vapor transport deposition in which the CdS powder is sublimated in a closed system to produce the ultrathin buffer layer.  Once deposited, the CdS layer is encapsulated in the monolithic structure of the PV module.  Currently, the concentration of cadmium in CdS/CdTe solar cells is less than 8 g/m2 with approximately 2% of this content from CdS.  The total concentration of CdS in a CdS/CdTe PV module is about 0.001%.  (Source: First Solar)

Comment 7
p. 39, third paragraph: The share of CdS/CdTe based solar cells within the new thin-layer technology was approximately 50% in 2011 (GTM, 2012). Overall market share of the thin-layer technology was between 5 to 10 %.

Comment 8
p. 39, Section 8.6.2, first paragraph: As discussed in this section, PV is included in the recast WEEE Directive and there is a decades-long interval between installing and decommissioning PV systems.  Therefore, recycling opportunities will be available at the time current facilities are decommissioned. In the case of thin film CdS/CdTe solar cells, recycling technology has been in commercial operation since 2005 and has recycled over 48,000 metric tons through 2012 with yields of approximately 95% for semiconductor recovery. (Source: First Solar)

Comment 9
p. 40, Section 9, first paragraph: In the case of CdS/CdTe solar cells, potential human exposure to CdS during the product life cycle is carefully managed and minimized. CdS/CdTe solar cell manufacturing has extremely low emissions of Cd content to air (5.34×10-9 kg/m2) and water (4.43×10-7 kg/m2) (Jungbluth et al. 2012) due to use of closed systems, HEPA filtration, and on-site wastewater treatment.  Medical monitoring data of CdS/CdTe solar cell manufacturing workers demonstrate no increase in worker blood and urine Cd as a function of years worked (Akbar, 2009).  During operation, the CdS/CdTe semiconductor layer is encapsulated within two layers of glass with an industrial laminate material and insulated with solar edge tape, thereby preventing the exposure of CdS/CdTe to the environment.  At end of product life, CdS/CdTe solar cell waste will be managed under the recast WEEE Directive, with commercially-scale recycling technology available since 2005.

Comment 10
p.41, Section 9.1, last paragraph: In the case of CdS/CdTe solar cells, solar cell manufacturing has extremely low emissions of Cd content to air (5.34×10-9 kg/m2) and water (4.43×10-7 kg/m2) (Jungbluth et al. 2012) due to use of closed systems, HEPA filtration, and on-site wastewater treatment.  At the waste management stage, there is already a regulatory mechanism for waste management of solar cells with the inclusion of PV in the recast WEEE Directive and the development of associated recycling standards for material recovery from end-of-life PV modules.

Comment 11
p.44, Section 9.2.1.1, third paragraph: With regards to waste management, potential landfill leaching risks associated with disposal of utility-scale volumes of CdS/CdTe PV modules were evaluated by fate and transport modeling using U.S. EPA Delisting Risk Assessment Software (DRAS).  Potential impacts to surface and groundwater media were below human health and ecological screening limits (Kaczmar, 2012). In the case of recycling operations, CdS/CdTe PV module recycling has extremely low emissions of Cd content to air (5.89×10-9 kg/m2) and water (8.92×10-8 kg/m2) due to use of closed systems, HEPA filtration, and on-site wastewater treatment (Sinha et al., 2012).

Comment 12
p.52, Section 10.3: Dye-sensitized solar cells are considered third generation PV technology that must overcome low cell efficiency and short lifetimes before they can be commercialized.  Because of the use of nanomaterials (nano-scale titanium oxide crystals), dye-sensitized solar cells have unique environmental, health and safety requirements outside of use of CdS.  More generally, alternative solar cells can be evaluated under the sustainability framework of eco-efficiency which promotes technologies that create economic value with low environmental impact on a life cycle basis.  For example, with low cost and life cycle environmental impact, CdS/CdTe solar cells are the most eco-efficient PV technology in the market (Seitz et al., 2013).
References:
F. Akbar, Letter to C. Chapman, Corporate Manager of Industrial Hygiene, First Solar Inc., regarding Medical Surveillance Program Review (June 30, 2009).
GTM Research. Thin film 2012-2016: technologies, markets and strategies for survival, 2012, Greentech Media.
N. Jungbluth, M. Stucki, K. Flury, R. Frischknecht, S. Büsser, Life Cycle Inventories of Photovoltaics, ESU Services (2012) 75-81.
S. Kaczmar, Evaluation of Potential Health and Environmental Impacts from End-of-Life Disposal of CdTe Photovoltaics, SETAC North America 33nd Annual Meeting, Long Beach, CA, November 2012.
M. Seitz, M. Kroban, T. Pitschke, S. Kriebe, 2013, Ökoeffizienzanalyse von Photovoltaikmodulen, Bayerisches Staatsministerium für Umwelt und Gesundheit.
P. Sinha, M. Cossette, and J.-F. Ménard. 2012. End-of-life CdTe PV Recycling with Semiconductor Refining. Proceedings : 27th EU PVSEC, Frankfurt, Germany, pp. 4653 – 4656.	Thank you for your comments and the information provided. 

Comments regarding use, exposure, alternatives and risks may, where relevant, be considered at later stages of the risk management process.	
			See also:
Comment 11 attachment ECHA footnote – the attachment referred to has been transformed to a confidential attachment as it contained both personal and company identifiers. However there is no difference in the comments on the CdS SVHC proposal as provided in this RCOM.		
10	2013/10/17	Industry or trade association
International Cadmium Association
Belgium	PART II Comments
More details on some of these comments are provided in the Master Comments Document(uploaded under IV Attachment)

Page 26, Part II, Conclusions, first bullet point
Comment 17
Cadmium sulphide occurs in many different technical/mixtures on the market (according to the substances identifications rules under REACH)
According to the CAREX data base, another 203,850 EU workers (= 207,350 – 3,500) are occupationally exposed to cadmium as an impurity and would see no benefit in Authorization. 
Cadmium sulphide (common chemical grade, EC 215-147-8,CAS 1306-23-6), when produced by wet process, and available for further use, has an amorphous or weakly cubic crystal structure; the fundamental crystallite size is typically very small, aggregated into sub-micron clusters with a high surface area. 
This common chemical can be used, as “Intermediate” to produce, by elevated temperature treatment, the cadmium pigments (CdxZn(1-x)S or CdSx Se(1-x)); those are other substances with other EC and CAS numbers, with very well defined hexagonal structure, a much larger fundamental crystallite size, large particle size, a typical 10-fold lower surface area, often with surface engineering and passing acid solubility test AP89(1) as well of course having specific pigmentation properties:
Cadmium zinc sulphide = CI Pigment Yellow 35, EC 232-466-8 /CAS 8048-07-5
Cadmium sulphoselenide orange = CI Pigment Orange 20, CAS 12656-57-4
Cadmium sulphoselenide red = CI Pigment Red 108, EC  215-149-9 /CAS 58339-34-7
None of the above are classified as hazardous and have separate REACH registration dossiers.

Page 26, Part II, Conclusions, second bullet point
Comment 18
Cadmium sulphide (common chemical grade, EC 215-147-8,CAS 1306-23-6), is no longer used today as a high-quality pigment and should not be confused with highly engineered non hazardous pigments.  The only direct application in the EU for pigmentary reasons is in the coloration of glass (<1T CdS/yr) where it is fully incorporated, as intermediate, and encapsulated during the high temperature melting and forming process.  As such it is not possible to be separated from the glass matrix. 

Page 26, Part II, Conclusions, third  bullet point
Comment 19
Current restrictions on cadmium and cadmium compounds in Europe (Entry 23 Annex XVII)  affect the use of Cd in 16 well identified resins since 2000. Restrictions exist, that the Cd industry supports, on cadmium content of specific consumers articles, imported or not, under the toys regulation, RoHS regulation and others.

Page 26, Part II, Conclusions, fourth  bullet point
Comment 20
Occupational exposure to cadmium sulphide is rather limited - less than 100 people on 5-6 industrial sites and adequately controlled as demonstrated by regular air monitoring on the workplaces and by biomonitoring (Cd-B and Cd-U and/or biomarkers of effect such as beta-2-microglobulin or RBP).

Page 26, Part II, Conclusions, fifth  bullet point
Comment 21
The main application (no Intermediate use) of cadmium sulphide (common chemical grade, EC 215-147-8, CAS 1306-23-6) is the photovoltaïc application where recycling is part of the service offered.

Page 26, Part II, Conclusions,sixth  bullet point
Comment 22
The main application (no Intermediate use) of cadmium sulphide (common chemical grade, EC 215-147-8, CAS 1306-23-6) is the photovoltaïc application where recycling is part of the service offered.

Page 26, part II, Conclusions, seventh bullet point
Comment 23
Main source of general population exposure is through dietary uptake (arising from cadmium in soil) which only marginally originates from deliberate uses of cadmium and even much more marginal if we refer, in this dossier, to the uses of cadmium sulphide. An analysis of the origin of cadmium in soil shows cadmium impurities present in commodities and natural releases vastly exceeds deliberate uses (REACH uses) of cadmium. Please refer to comment 42.
 Based on information provided in this comment, authorization would have no effect on the presence of cadmium in soil, and in turn would have no effect on cadmium levels in diet.  Therefore authorization would have no effect in reducing general population exposure to cadmium.

Page 27, part II, Conclusions (cont), first bullet point
Comment 24
With the inclusion of PV in the recast WEEE Directive and the development of associated recycling standards for material recovery from end-of-life PV modules, there is already a regulatory mechanism for waste management of solar cells.  This text should be removed or the above regulatory mechanism should be cited. It should also be noted, that even if chalcogenide thin film PV technologies employing CdS as a buffer layer in the P/N junction are significantly increasing market share, the overall use of CdS (in comparison to the other identified uses) remains very small – as the following calculation demonstrates.
To date, chalcogenide thin film technologies employ CdS buffer layers in ultra-thin layers on the scale of 10-8 m thickness. The thickness of the buffer layer is going to stay constant, whereas overall module efficiencies are going to increase. This will lead to higher utilization rates in terms of generation capacity per employed volume of CdS. Taking the conservative assumption, that today’s thin film module efficiencies will stay constant over the next decades, one can depict the following utilization rates:
Chalcogenide Thin-film PV (CdTe/CdS; CI(G)S/CdS etc.): 
•	Typical weight of the module: 12 to 15 kg
•	Mass concentration of CdS: 0.001%
•	Power output: 100 - 130 W / module
•	Utilization rate = 12 … 15 kg x 0.001% / 100 … 130 Wp ≈ 0.001 g/W [gram CdS / Watt peak]
At current market share, global annual deployment of chalcogenide thin-film PV is in the range of 2 to 3 GWp – equaling some 2 to 3 tonnes of CdS usage per annum – of which up to 95% is managed in a closed recycling loop. Following the assumptions of the European Photovoltaic Industry Association (EPIA, 2012), PV deployment in Europe until 2030 will reach levels between 300 GWp (baseline) to 850 GWp (paradigm shift) cumulative installed capacities. To date the market is largely dominated by crystalline Silicon applications with a market share of over 80% (EPIA, “Global Market Outlook for Photovoltaics 2013 – 2017, 2013). If chalcogenide thin-film PV applications would significantly increase their market share to 50 % (a fivefold increase compared to today), this would lead to a total utilization rate of 300 (baseline scenario) to 900 (paradigm shift scenario) tonnes of CdS for the total cumulative installed capacity in 2030 – which on an annual installed basis would still be only a very minor fraction of the total use (below 50 tonnes per year).

Page 28, Part II, 7,2,1 general Cd: Table 5 ,comments and pie-distribution in fig.1
Comment 25
Germany is also a primary producer of cadmium metal ( up to 450 t/y capacity)
Cadmium recycling plants (from batteries and PV-modules) are known in France, Germany, Poland and Sweden

Page 30, Part II, 7,2,2 Cadmium sulphide – worldwide
Comment 26
The referenced Manufacture of cadmium pigments in the EU  involves cadmium sulphide, but only  as intermediate  in the manufacturing process.
Small scale producers of cadmium sulphide (high purity) of PV applications are known in Germany

Page 30, Part II, 7.3  Functions of the substance
Comment 27
Although it is true that cadmium pigments are characterized by their particular brilliant shades, high hiding power, good intensities of color, good temperature stability (up to 1400 °C) and absolute migration resistance, cadmium sulphide (common chemical grade, EC 215-147-8, CAS 1306-23-6) does not show those properties and, although used historically, it is therefore no longer used as a high performance pigment.  It is still used sometimes as a coloring agent for glasses, as intermediate, (implicitly high temperature treatment) in very small quantities (<1 t/y in EU).

Page 31, Part II, 8.1 , 2nd paragraph
Comment 28
CdS, cadmium sulphide (common chemical grade, EC 215-147-8, CAS 1306-23-6) is not put on the market in EU as a pigment except for incorporation, as intermediate, into glass where it is fully encapsulated.  It is not used as stabilizer.  The only main use is in the photovoltaic application. CdS belongs to the very last category in volume (less than 10t/y in Europe).

Page 31, third paragraph
Comment 29
Beyond shifts in solar cell deployment, CdS use in the PV solar cell market depends on technological developments (including cell efficiency increases, reduced semiconductor layers, higher material utilization during deposition processes) that reduce the material intensity of solar cell production.  These additional factors should be stated. As stated above – even a fivefold increase in market share and a continued exponential growth of the overall PV market will not lead to a significant change in the consumption pattern in comparison to other uses.

Page 33, Part II, 8.2 
Comment 30
CdS, cadmium sulphide (common chemical grade, EC 215-147-8, CAS 1306-23-6) is not significantly used as pigments, is not used as stabilizer. CdS belongs to the very last category in volume (less than 10-15 t/y in Europe)

Page 34, third paragraph, line 10
Comment 31
Nanoparticles of CdS are not used for production of buffer layers for thin film CdS/CdTe solar cells, with average raw material particle size above nanometer-scale for CdS powder.  The CdS buffer layer is deposited by convective vapour transport deposition in which the CdS powder is sublimated in a closed system to produce the ultrathin buffer layer.  Once deposited, the CdS layer is encapsulated in the monolithic structure of the PV module.  Currently, the concentration of cadmium in CdS/CdTe solar cells is less than 8 g/m2 with approximately 2% of this content from CdS.  The total concentration of CdS in a CdS/CdTe PV module is about 0.001%.  

Page 35, Part II, 8.3.2 , 1st paragraph
Comment 32
Cadmium sulphide (commun chemical grade, EC 215-147-8, CAS 1306-23-6) occurs indeed in two crystalline forms (hexagonal and cubic) and even in an additional amorphous form. It is only when it is treated carefully at elevated temperature that it is completely transformed to the hexagonal lattice with coarse grains. It is than transformed to other substances, cadmium pigments, with different shades from yellow to maroon, depending on the lattice additions

Page 36, Part II, 8.3.2.1 , 1st paragraph
Comment 33
Cadmium sulphide (commun chemical grade, EC 215-147-8, CAS 1306-23-6) is not used as pigment in significant quantities (<1t/y). 

Page 37, Part II, 8.3.3.1 , 1st paragraph
Comment 34
To the best of the Cd industry’s knowledge, CdS has never been used as a plastic stabilizer and is not currently used for this application.

Page 38, Part II, 8.5 , 1st paragraph
Comment 35
Cadmium sulphide (common chemical grade, EC 215-147-8, CAS 1306-23-6) is produced in minor quantities (10-15 t/y); as the chemical grade CdS is classified CMR, registration was compulsory in November 2010.  Lead Registrant is a supplier of CdS for photovoltaic applications; 6 co-registrants registered effectively in 2010

Page 39, Part II, 1st paragraph
Comment 36
Cadmium sulphide (common chemical grade, EC 215-147-8 ,CAS 1306-23-6 is not put on the market in EU as a pigment except for incorporation into glass, as intermediate,  where it is fully encapsulated.  It is not used as stabilizer.  Since 2000 cadmium sulphide and Cd compounds are restricted in use in preparations and articles made of (<100ppm), in PVC-polymers and 15 other resins

Page 39, third paragraph
Comment 37
The share of CdS/CdTe based solar cells within the new thin-layer technology was approximately 50% in 2011 (GTM, 2012). Overall market share of the thin-layer technology was between 5 to 10 %.

Page 39, Section 8.6.2, first paragraph
Comment 38
As discussed in this section, PV is included in the recast WEEE Directive and there is a decades-long interval between installing and decommissioning PV systems.  Therefore, recycling opportunities will be available at the time current facilities are decommissioned. In the case of thin film CdS/CdTe solar cells, recycling technology has been in commercial operation since 2005 and has recycled over 48,000 metric tons through 2012 with yields of approximately 95% for semiconductor recovery. 

Page 40, section 9, exposure, paragraph 1, line 2
Comment 39
Industrial and professional workers exposed to deliberate uses of cadmium represent a minor fraction of exposed workers.
An estimated 3,500 Industrial and professional workers (including 1,000 exposed workers in Zn smelters which do not deliberately refine Cd), are exposed to cadmium used deliberately. This group represents a small number as compared to the number of workers exposed in scenarios where cadmium is an impurity, which are being estimated at 203,850 workers (207,350 from CAREX database - 3,500 in industries in which cadmium is deliberately used).
In the case of CdS/CdTe solar cells, potential human exposure to CdS during the product life cycle is carefully managed and minimized. CdS/CdTe solar cell manufacturing has extremely low emissions of Cd content to air (5.34×10-9 kg/m2) and water (4.43×10-7 kg/m2) (Jungbluth et al. 2012) due to use of closed systems, HEPA filtration, and on-site wastewater treatment.  Medical monitoring data of CdS/CdTe solar cell manufacturing workers demonstrate no increase in worker blood and urine Cd as a function of years worked (Akbar, 2009).  During operation, the CdS/CdTe semiconductor layer is encapsulated within two layers of glass with an industrial laminate material and insulated with solar edge tape, thereby preventing the exposure of CdS/CdTe to the environment.  At end of product life, CdS/CdTe solar cell waste will be managed under the recast WEEE Directive, with commercially-scale recycling technology available since 2005.

Page 40, section 9, exposure, paragraph 2, line 1
Comment 40
It is incorrect to state that “exposure of man via the environment occurs as a result of emissions from industrial and professional processes.”
See comment 42.

Page 40, section 9, exposure, paragraph 2, line 1
Comment 41
It is incorrect to state that “exposure of man via the environment occurs as a result of (…) diffuse releases from private uses of goods.” According to industry, there is no such exposure. If there are data proving the contrary, industry would be interested to see the information regarding the goods which give rise to cadmium releases during their private use, the amount of cadmium released, and the size of the general population exposed to such releases.

Page 40, section 9, 3rd paragraph, lines 2-4
Comment 42
It is correctly stated in the Annex XV document that for non-smokers, food is the primary exposure source of the general population, and that the Cd in food is coming from uptake from agricultural soils. However, contamination via atmosphere and “end use of Cd containing products” are mentioned as the two sources of Cd addition to agricultural soil. This is not correct and incomplete: 
-	the major single source of Cd input to agricultural soils, i.e. the use of P-fertilizer, is ignored in the assessment. P-fertilizer which may have significant Cd-content of natural origin (3-90ppm, see Annex XV document table 9), is directly applied on the soil and as such is the main direct source of Cd into the food chain. The contribution of P-fertilizer to human exposure is estimated to be significant, as is explained below (see figure 42.1 ) This was also recognized by Sweden where, at one time, taxes on fertilizers with high cadmium contents were imposed. (These taxes were dropped later for unknown reason.) 
-	Industrial emissions to atmosphere are also important. These are mainly related to the cadmium that is present as an impurity in mineral commodities that are processed/combusted by industry (see comment 43 and 47).
-	Last but not least, it is emphasized that manufacturing and use of Cd-containing products (including end of life) does not lead to exposure to the general population, as is demonstrated in the next comment 43 and 47. 
For data and references supporting the analysis above, see in uploaded attachment under IV Attachment, comment 42. 

Page 41, section 9, exposure, paragraph 1
Comment 43
In order to assess the effectiveness of the regulatory measure envisioned, it is important that for each exposure situation described further in section 9, the contribution of each origin of cadmium is properly assessed. 
In this context, it must be kept in mind that Authorization (or a denial thereof) only has an impact on REACH uses (essentially “deliberate anthropogenic uses”) but not on anthropogenic origins in which cadmium is an impurity, and not on natural releases of cadmium.
In this comment, we will redefine the categories of origin, while in comment 47 we will present quantitative data that allow the identification of the relevant sources to human exposure.
Industry disagrees with the description and number of these categories mentioned in this section. Dietary intake essentially stems from cadmium present in soil, and direct atmospheric deposition on edible crop parts (comment 42). Cadmium present in soil originates from atmospheric deposition and physical additions, which can be broken down in four categories (see below). The most important single source, i.e. P-fertilizer addition (see comment 42) is ignored in Annex XV.
1)	Anthropogenic atmospheric deposition from deliberate use: industrial processes in which cadmium is deliberately used. These are cadmium refining, specialty cadmium compounds including pigments (the latter being non-hazardous) manufacturing, manufacturing of cadmium containing articles (batteries, thin film PV panels…), recycling.
2)	Anthropogenic atmospheric deposition as impurity: industrial processes in which cadmium is an impurity. These are ferrous and non-ferrous metals refining (including Zn refining), fossil fuel incineration (such as coal and fuel power plants), cement and glass manufacturing. 
3)	Natural atmospheric deposition: naturally occurring atmospheric releases and deposition.
4)	Soil amendments: addition of phosphate fertilizers, manure, and sewage sludge onto agricultural soil.

Page 43, Section 9.1, last paragraph: point 11  
Comment 44
In the case of CdS/CdTe solar cells, solar cell manufacturing has extremely low emissions of Cd content to air (5.34×10-9 kg/m2) and water (4.43×10-7 kg/m2) (Jungbluth et al. 2012) due to use of closed systems, HEPA filtration, and on-site wastewater treatment.  At the waste management stage, there is already a regulatory mechanism for waste management of solar cells with the inclusion of PV in the recast WEEE Directive and the development of associated recycling standards for material recovery from end-of-life PV modules.

Page 44, Section 9.2.1.1., third paragraph: point 11  
Comment 45
With regards to waste management, potential landfill leaching risks associated with disposal of utility-scale volumes of CdS/CdTe PV modules were evaluated by fate and transport modelling using U.S. EPA Delisting Risk Assessment Software (DRAS).  Potential impacts to surface and groundwater media were below human health and ecological screening limits (Kaczmar, 2012). In the case of recycling operations, CdS/CdTe PV module recycling has extremely low emissions of Cd content to air (5.89×10-9 kg/m2) and water (8.92×10-8 kg/m2) due to use of closed systems, HEPA filtration, and on-site wastewater treatment (Sinha et al., 2012).

Page 45, section 9.3.2 Potential for release from degrading pigments
Comment 46
Reference is made to KemI 2013b, in which it is concluded that Cadmium sulphide (CdS) and cadmium selenide (CdSe) will be unstable in the surface horizon of agricultural soils, based on the redox conditions prevailing in Swedish soils.  The main problem with this conclusion, making it of only limited relevancy for the Cd-pigments, is that it is based on a modelling of the pure chemicals CdS and CdSe in hypothetical environments. Cadmium sulphide (common chemical grade, EC 215-147-8,CAS 1306-23-6), is no longer used today as a high-quality pigment and should not be confused with highly engineered non hazardous pigments.  The only direct application in the EU for pigmentary reasons is again in the coloration of glass (<1T/yr), as intermediate, where it is fully incorporated and encapsulated during the high temperature melting and forming process.  As such it is not possible to be separated from the glass matrix. 
Given the significant physic-chemical differences between the pure substances mentioned by the KEMI paper, and the engineered Cd-pigments, notably related to their stability under environmental conditions, great caution should be applied in interpreting the predictions from the KEMI study for Cd-pigments. In addition, several other factors such as dissolved organic content (DOC) which chelates any ions should be taken into consideration in any analysis.  Real data should be used rather than modelling.  This is elaborated further below.
a)	It should be noted that industrially prepared Cd-pigments are prepared from Cd +Zn sulphide, followed by repeated washing and, importantly, calcination. The dissolution tests in water with the pure CdS mentioned in the KEMI study did use freshly precipitated minerals that were poorly crystalline CdS  (Barrett and McBride, 2007) or have compared that with CdS that was oven dried at 60°C (de Livera et al., 2011). Both these minerals dissolve very rapidly in oxygenated water, i.e. nearly complete in weeks.  In contrast to that, the transformation dissolution tests using commercial Cd-pigments did not show detectable release of Cd. This is explained by the different Cd phase formed by calcinations.
b)	It should be noted as well that weathering in soil is different from that in water which makes the relevancy of the predictions based on dissolution rate in water doubtful. Some ‘validation’ is based on the predicted transformation of sphalerite,( shown in Fig.3, solid line), that is similar to that experimentally observed  in a 2-4 year soil transformation study (Voegelin et al., 2007). The ZnS (sphalerite) used in that experimental study was however very fine grained and XRD suggested that particles were 25-40 nm (nanoparticles), potentially leading to a more pronounced dissolution.  In addition, weathering of metal sulphides in sludge amended soils may be slower than in soils mixed with pure sulphides, because weakly degradable organic matter derived from sludge has a long persistence and may locally protect sulphides from being oxidised. Moreover, the sphalerite transformation data were obtained at pH 2-4, not at the pH 6 at which they are applied. Lower pH increases the weathering rate.  Considering all these elements,  the rate of release of Cd from the ‘pigments’ (actually ‘chemicals’, not pigments) as predicted in the KEMI report is questioned since these predictions are based on sphalerite dissolving in acid water (overestimated  the rate), and are not based on the pigments themselves. The lack of actual pigment dissolution in water suggests that pigment dissolution needs to be tested in soil rather than being predicted from a different chemical species. 
Modern day pigments are carefully engineered products manufactured in regulated chemical plants with full Health and Safety and Environmental permits under responsible care management.  Current pigments have a carefully defined and engineered particle size, crystal structure, surface area and surface treatment to ensure they are not only correct for colour but also meet extremely low solubility limits of AP(89)1.  These pigments may have surface and other treatments which the modelling paper fails to take account of.  
For data and references supporting the analysis above, see in uploaded attachment under IV Attachment, comment 46

Page 46, section 9.5, releases from natural sources
Comment 47
As follows from the analysis under comment 42 on sources of cadmium to general population exposure, the Cd inputs to atmosphere are an important contributing factor, because they are a direct source of crop/food cadmium content. The annex XV fails to make a quantitative analysis of the relative importance of the different origins of cadmium going into the atmosphere and being deposited on/taken up by the crops. As such, Annex XV fails to assess the importance of the different atmospheric Cd-sources in the perspective of human exposure. 
The inventory of current atmospheric emissions from the different sources in the EU shows that the main sources are: a) public power generation, b) industrial combustion, c) small combustion; d) industrial processes (EMEP inventory (2012)).
It follows from these data that the major part of cadmium emissions to atmosphere is from anthropogenic use where Cd is an impurity (category 2 in comment 43). The emissions from deliberate Cd production and use (category 1) are further discussed below. 
Overall, Cd emissions to the atmosphere decreased by >60% over the period 1990-2010 (EMEP 2012). It should be noted that the EMEP inventory does not report natural emissions. These have been estimated at ca. 15T/yr (Cd/CdO RAR ECB 2008).
The emissions from the companies manufacturing Cd-products (Cd-production, Cd-recycling, production of Cd compounds, manufacture of NiCd batteries, pigments, and thin-film photovoltaic panels) are minimal (0.18% of EU total emissions). Consequently the contribution of this industrial activity to the total anthropogenic Cd-exposure of the general population is only of the order 0.08% (= 0.18 x 0.42). 
During service life, emissions from Cd-containing products are negligible; there is no emission of consumer exposure at all (see also comment 53). 
At end of life, most of the Cd in products is recycled (e.g. industrial NiCd batteries, photovoltaic panels). The small amount that ends up in the municipal waste stream and can be incinerated, results in <0.8% of total Cd-emissions to the atmosphere (EMEP 2012, Arche 2012). 
All EU Cd-emissions taken together i.e. from production, processing, use and end-of-life incineration of Cd products account for <1% (= 0.18% + <0.8%) of the anthropogenic Cd-emissions to the atmosphere and, accordingly, for <0.42% of the Cd-exposure of the general population (sum of Cd-industry emissions + emissions from incineration <1% x 0.42) 
In other words, the emissions from deliberate Cd production and use are minimal compared to the total emissions, and therefore their impact on general population exposure is negligible. Therefore the effect of measures taken against the use of Cd-products on general population would be insignificant and disproportionate.
For data and references supporting the analysis above, see in uploaded attachment under IV Attachment, comment 47.

Page 49, heading cadmium exposure over time, 3rd paragraph, line 2
Comment 48
This section concludes that “Cd exposure based on biomarkers of exposure and measured dietary intake in Sweden shows no decrease over the last 2-3 decades”. A generalisation of this conclusion of “no change” is challenged, for the following reasons:
For Sweden, there are 3 studies available on kidney-Cd content of general population. Most relevant for comparing the general exposure are the data on the “ever non-smokers”, since the smokers/ever smokers data are dominated by smoking behaviour. The “never smoker” data show that between the 1970s and 1990s, there was a rather significant decrease in Cd-content of forensic autopsy kidney samples (compare Elinder et al 1976) with Friis et al 1998). Kidney Cd values were subsequently evaluated by Barregard et al 2010), related to the period 2003-2006. These samples had Cd content that was not different from the Friis data, and, while still lower, the differences with Elinder et al (1976) were smaller in the comparable age groups. When considering these kidney Cd data, it needs to be taken into account that the number of samples was small (order of magnitude ~=10) in all studies. Moreover, the time lapse between the period considered by Friis et al 1998 (period 1995-1996) and Barregard et al 2010 (period 2003-2006) was probably too small to allow indication of any further trend. 
	The interpretation of the Swedish Cd-U data presented in figure 4 of Annex XV is odd: of the 12 populations, where a comparison was made in Cd-exposure (measured via Cd-U) between 2002-2004 and 2008-2009 (in the areas of Vastra Gotaland, Stockholm, Vaster och Naarbotten), a decrease was observed in 10 out of 12 cases; while in 2 cases there was an increase. The decreases are sometimes quite large (reductions can amount to -40%), but are put in doubt because of “analytical differences that are still under investigation”. We consider this a weak argument to refuse the data. Moreover, we consider that nowadays differences in analytical performance between labs leading to such differences would be unacceptable. 
	In the section Cadmium exposure over time, second paragraph p48: the lack of trend in Cd-B levels in Sweden is mentioned. However, this statement probably (no reference given) refers to table 2 in Bilaga 3 ‘Health effects of cadmium in Sweden’, in Kemi 2011, where Cd-B data are summarized as a function of time. It is noted that the data in this table are not comparable, since a) smokers and non-smokers, b) rural and urban populations and C) different age groups are all mixed. 
In conclusion, and in contrast to what is concluded in this section of Annex XV, the data show that the exposure of the general population in Sweden to Cd has decreased over the last 2-3 decades.  
Dietary Cd-intake data are also an indication of the exposure of the general population. 
In general, when interpreting Swedish data in a European context, it should be noted that the historical Cd-exposure in Sweden is generally lower than in other EU-countries. For this reason, trends are expected to be less clear in Sweden than elsewhere as is indicated e.g. by the Cd-intake data for Sweden (Nat food agency 2012), which are at the low end of the range described by IPCS (1992)(10-25 µg/day) for the general population.  Correspondingly, levels of Cd in Swedish foodstuff are generally lower than in other regions. Therefore, the observation related to the Cd content in Swedish flour of wheat and rye are related to this low exposure. The German data on Cd content in rye and wheat however indicate a clear and continuing decrease of Cd in their major foodstuff. These German data are considered to reflect a middle European trend. 
The decrease in Cd exposure of the general population can be explained by the parallel decrease of Cd-emissions to atmosphere, observed over the same period. Due to the direct relationship between atmospheric Cd emissions/deposition and crop Cd-content. Cd emissions to atmosphere have decreased significantly, not only in Sweden (Rühling and Tyler 2001) but also in the EU over the last decades as follows clearly from the yearly data between 1990 and 2010 from EMEP (2012).
The general decrease of atmospheric Cd-emissions in the EU (>60% reduction) over the last 2 decades (EMEP 2012) is anticipated to have resulted in a decrease of Cd-deposition on exposed edible plant parts, and, as a result, in a general decrease of Cd-content of food in the EU, and consequently, a decrease in Cd-intake through food in the EU. 
Such decrease in cadmium content of crop is confirmed by the continuing decrease of the Cd content measured in 2 base cereals (wheat and rye) with about -40% over the period 1975-2004 in Germany (BfR 2009). Cereals are a general basis for food products, and a main source (33% of total) of dietary Cd intake by the general population (BfR 2009). Given the central geographical position of Germany in the EU, these data put the time trend of Cd-exposure to the general population in a broader EU-perspective. 
In conclusion, the statement in annex XV that “there is no evidence for a decrease in Cd exposure over time during the last 2-3 decades in Sweden” is is in conflict with the weight of evidence suggesting a decrease of Cd-exposure to the general population in the EU and also in Sweden. The main factor for this is most probably the general decrease of  atmospheric Cd-emissions observed all over the EU, having resulted most probably in a decrease of Cd content of food and thus of intale through the diet. The main cause for this decrease in atmospheric emissions is the decrease of industrial Cd-emissions to the EU atmosphere. In other words, a decrease of environmental exposure to Cd through the diet (the objective of the current Annex XV exercise) is ongoing in the EU.
For data and references supporting the analysis above, see in uploaded attachment under IV Attachment, comment 48

Page 49, section 9.7, worker exposure to cadmium, paragraph 2
Comment 49
Sectors of EU industry which deliberately use cadmium total 3,500 employees out of a grand total of 208,350 cadmium exposed employees as indicated by CAREX (CArcinogen EXposure 1990-1993).
The following sectors of EU industry which are deliberately using cadmium (Cd refiners, specialty cadmium compounds manufacturers, including pigment manufacturers, battery manufacturers, thin-film PV cells manufacturers and recyclers), beyond complying with the mandatory DNEL of the registration dossiers, have consolidated their knowledge and experience regarding employee exposure, ways to minimize it, and results.
The number of cadmium exposed employees in the EU in these sectors is approximately 3,500.
Most of the remaining 203,850 employees exposed to cadmium (as estimated by CAREX) work in industrial sectors in which cadmium is an impurity.

Page 50, section 9.8, consumer exposure, 3rd paragraph, line 2-3
Comment 50
The Annex XV document states that “…given the wide range of potential uses for Cd it cannot be completely ruled out that some consumer exposure from articles containing cadmium may still take place”. No evidence is however given in Annex XV to support this statement. 
Cd and Cd-substances are in general, physically and/or chemically contained in a stable matrix, or present in massive metallic form, and as such not available for exposure of the consumer. In the EU risk assessment (RA), an analysis for consumer exposure was made, integrating exposure from all Cd substances (RA Cd/CdO, ECB 2007). 
According to the EU RA, the consumer uses of cadmium oxide, metal (and compounds) fall into five categories corresponding to at least 5 scenarios of exposure. For these scenarios consumer exposure is considered to be “very low” Two scenarios were an exemption on this general observation:
-significant concentrations of cadmium (conceivably cadmium metal) were encountered in jewels ("silver" bracelets) imported from South and South East Asia. 
-Brazing material containing up to 20% w/w Cd can be purchased by the consumer through Do-It-Yourself shops. All consumer uses of Cd metal involving brazing sticks that could result in exposure of consumers were advised against in the REACH registration of Cd (cadmium consortium, 2010). 
Referring to the EU risk assessment, it is concluded that consumer exposure through the use of Cd-containing products is negligible. The statement made in the Annex XV file is thus not supported by any facts. 
For data and references supporting the analysis above, see in uploaded attachment under IV Attachment, comment 50

Page 52, Section 10.3.1. Dye-sensitised solar cell
Comment 51
Dye-sensitized solar cells are considered third generation PV technology that must overcome low cell efficiency and short lifetimes before they can be commercialized.  Because of the use of nanomaterials (nano-scale titanium oxide crystals), dye-sensitized solar cells have unique environmental, health and safety requirements outside of use of CdS.  More generally, alternative solar cells can be evaluated under the sustainability framework of eco-efficiency which promotes technologies that create economic value with low environmental impact on a life cycle basis.  For example, with low cost and life cycle environmental impact, CdS/CdTe solar cells are the most eco-efficient PV technology in the market (Seitz et al., 2013).

Page 57, section 11.1, risk for workers, para 1, line 4
Comment 52
Industry wishes to clarify that data indicated as respirable fraction in the CSR are indeed measured as respirable fraction. In absence of such measured respirable data, the respirable fraction was derived from inhalable measurements by applying a factor of 2.5, which is expressed in the CSR.

Page 57, section 11.1, risk for workers
Comment 53
In addition to the information provided in Annex XV, ICdA wishes to provide the following additional information.
Risk management measures have been developed by industry in two stages.
Stage ONE: adopting and disseminating the Swedish legislation throughout the EU
In 2006, the cadmium producing, using and recycling industry, represented by ICdA built an industry Guidance on the Protection of Occupationally Exposed Workers. This Industry Guidance was built on the basis of the Swedish legislation developed by ARBETSMILJÖVERKETS FÖRFATTNINGSSAMLING (the Swedish Work Environment Agency), amended and published in MEDICINSKA KONTROLLER I ARBETSLIVET (Medical Surveillance in Occupational Setting) publication AFR 2005:6.
Implementation of this legislation had been on-going (under version 2005, following previous versions) in a large industrial Ni-Cd battery manufacturing plant since its inception, and has proven excellent at keeping exposure of workers extremely low.
This Industry Guidance (available upon request) was published in 2006, dissemination followed, and implementation started in 2007.
Industry sectors who have committed to implementing this program are Zn producers, Cd refiners, specialty cadmium compound manufacturers, pigment manufacturers, Ni-Cd battery manufacturers, thin-film PV panel manufacturers, Ni-Cd battery recyclers.
This industry Guidance is built along three pillars; 
-keeping the workplace clean,
-implementing collective and individual hygiene policies,
-ensuring individual exposure is properly controlled by means a medical surveillance program which takes advantage of: 
o	exposure bio-markers: [Cd-U] for cumulated exposure and [Cd-B] for recent exposure,
o	as well as effect biomarkers: measurement of the urinary excretion of specific proteins.
CdB and CdU based action levels, taken over from this Swedish regulation, determine what added surveillance must be implemented should an employee exceed these action levels. Removal from exposure is decided should a certain threshold be exceeded. 
Stage TWO: selecting risk based OEL (set by SCOEL) as the DNEL for workers
As mandated after the conclusion of the Cd/CdO RAR (ECB 2007), a COM Risk Reduction Strategy was agreed, and the setting of an OEL (and possibly a BLV) was decided. SCOEL was therefore tasked with developing a health based proposal. 
SCOEL published its (health based) OEL recommendation of [Cd-air] = 4 µg/m3 (respirable fraction) in February 2010. Industry therefore decided to take this OEL forward as its worker DNEL in the cadmium registration dossier.
Since that date, this is the workplace air quality standard that industry is legally bound to comply with.
Results of Industry Guidance implementation; current exposure of workers in industry deliberately using cadmium
Two sets of Cd-U distributions (the biomarker which integrates all routes of exposure) are tracked.
First set of data: 
This data tracks the distribution of exposure of workers from 15 industrial sites (deliberately using cadmium) whose occupational doctors have started reporting anonymous data since the inception of the program in 2008. The size of this exposed workforce is 2,605 workers.
This data shows that in 2012, 79 workers (3.0%) have a [Cd-U] greater than the maximum value allowed under the Swedish regulation (5µgCd/g creatinine). This number was 142 in 2008.
As strongly recommended by the Swedish regulation, most of these workers are removed from exposure. Only in limited cases will the occupational doctor allow such employees to continue work in exposed positions.
This data also shows that 288 workers (11.0%) of workers have a [Cd-U] greater than the BLV proposed by SCOEL in February 2010 (2µgCd/g creatinine). This number was 373 in 2008.
Both numbers are being reduced at a rapid pace.
Second set of data:
This second set of data tracks the distribution of exposure of all workers from all industrial sites (deliberately using cadmium) whose occupational doctor have started reporting anonymous data, either in 2008 or at a later date. In 2012; 25 sites have reported data for 3,296 workers. It is estimated that the whole industry employs ca. 3,500 workers.
This data also shows a strong decrease of both categories of workers, those with a [Cd-U] greater than 5 and those with a [Cd-U] greater than 2. In 2012, the first category represented 2.6% of workers (down from 7.7% in 2008), and the second category represented 9.5% of workers (down from 20.3% in 2008).
Due to the progress observed, and the continued implementation of strict risk reduction measures, it can be expected that this will continue to rapidly decrease.

Page 58, section 11.2., 2nd paragraph, line 7-9.
Comment 54
It is stated that “a critical review of the database on biomarkers of Cd-exposure provides no evidence for a decrease in Cd exposure over time during the last 2-3 decades in Sweden”. 
This statement is challenged, not only for Sweden, but also for the EU, as there is clear indication for decreasing exposure, see comment 48.

Page 58, section 11.2, para 4
Comment 55
Annex XV states that “There is the debate concerning the causality and the health significance of the associations between urine-based biomarkers of cadmium exposure and kidney effects that occur at very low cadmium concentration. Thus, it is difficult to ascertain the exact lowest effects dose for a clear adverse effect. However, several recent mechanistic studies support effects at low exposure.”

It is emphasized that there is indeed recent debate on the significance of Cd-U as indicator of exposure at very-low Cd-exposure levels: (Chaumont 2012, Akerstrom 2013) concluded that “There is evidence of non-causal associations between low-level urinary Cd and urinary proteins. The co-variability observed between Cd-U and urine based biomarkers would have a strong physiological basis. This evidence is suggesting that low-level urinary Cd (e.g.for Cd-U at or below 1 µg Cd/g creatinine) in the general population would be more a reflection of the recent intake and of the physiological variations in the urinary excretion of creatinine and of the renal function (diuresis, renal handling of proteins and glomerular filtration rates). This is relevant for all studies using U-Cd as cumulative exposure indicator.
In conclusion, the threshold for kidney effects of Cd < 1 µg/g creatinine for the general population exposed by the oral route should be questioned because of the non-causal associations between low-level U-Cd and urinary proteins mentioned in recent reports. 
Consequently, the major hypothesis of the Annex XV document that there may be risk of impaired kidney function already at urinary Cd-levels below 1 µg/g creatinin has also to be questioned. 

Page 58, section 11.2, para 6, line 4-5
Comment 56
The threshold for bone effects of cadmium concentration in urine around 0.5 µg/g creatinine for the general population exposed by the oral route should be questioned because of the non-causal associations between low-level U-Cd and low Cd-exposure mentioned in recent reports (see also comment 9-10)
Consequently, the major hypothesis of the Annex XV document suggesting that already a cadmium concentration in urine of around 0.5µg/g creatinine is associated with increased risk of osteoporosis and fractures and the estimated societal cost related to that (see comment 5) has also to be questioned. 

Page 59, section 11.2, para 2,  line 4-6
Comment 57
Annex XV suggests that results from experimental and epidemiological studies are raising concern that cadmium might have estrogen-like effect and possibly increase the risk of hormone-related cancers. It is emphasized that although there are indications that this is the case, this needs to be confirmed by other studies, for several reasons (see also comment 56 for more details): 
-most positive in vivo studies were conducted with acute Cadmium exposures. Kortenkamp (2011) emphasized in his review that a key issue that needs to be resolved in the context of human risk assessment is whether the estrogenic effects of Cd occur at dose levels that are lower than those known to be associated with kidney dysfunction or pulmonary carcinogenesis.
-most studies apply non-physiological routes of Cd-administration e.g. peritoneal injection. When relevant physiological routes of exposure (e.g. oral) were used, no positive effects were observed (Höfer et al 2009)
-CdCl2 is used for most studies; however no effects were observed after oral administration of dietary Cd

-Finally, it is noted that in the general environment, humans are simultaneously exposed to metals (cadmium and others), but also to organic compounds that might also be endocrine disruptors. There is a need to study the possible additive, synergistic, or antagonistic effects on the endocrine system following exposure to such substances. 

Page 59, section 11.2, para 4, line 3-4
Comment 58
Annex XV states: « Causal relationships are supported by mechanistic experimental studies”. 
No references are given. In comment 9, references are given which strongly suggest non-causal relationships. 

Page 59, section 11.2 para 4, line 4-6
Comment 59
Annex XV emphasises on bone effects of cadmium and their relationship with Cd-U as a marker for cadmium exposure. 
As indicated, the significance of Cd-U as a biomarker of exposure in situations of very low Cd exposure (like in general population) is currently under scientific debate. Therefore the relationship between bone effects and Cd-U levels in the general population is questioned. 

Page 61, section 11.3.  risk via food intake
Comment 60
The Annex XV document presents the abstract of the EFSA study on dietary Cd intake in the European population (EFSA 2012). Calculated lifetime cadmium dietary exposure was estimated at a middle bound overall weekly average intake of 2.04µg Cd/kg BW, and a potential 95 percentile value of 3.66µg Cd/kg BW. 
The following comments are made on the EFSA study:
-the dietary intake was calculated from food Cd-content data and dietary information. It has been observed that such approach may overestimate the Cd-intake, since considerable loss of Cd can occur during food preparation (Fouassin & Fondu 1981).  
-the authors of the EFSA-report themselves note that the 95 percentile estimate is “speculative and potentially unrealistic” because it is based on the unlikely assumption that the same individuals retained the same high exposure throughout their whole life”. The 95 percentile should thus be considered with caution, since it appears that it is clearly an overestimation.
-the EFSA-report notes also that “many of the reported results for meat and edible offal…might include a high proportion of samples targeting potential problem areas and thus might not reflect the average situation”.
Recent (post year 2000) values reported for weekly dietary intake in a number of EU member states show lower values than the average reported by EFSA. The points raised above may explain why. Even for a country like Belgium, which has a historical contamination of Cd, the 95 percentile value is only just at the level of the EFSA-average. These country data suggest that the EFSA average is slightly overestimating current dietary Cd-intake. 
The weekly intake data mentioned above are general figures, which are related to the average exposure of general populations. Such data make sense for a cumulative toxicant such as cadmium, where critical exposure levels relate to chronic Cd accumulation at the level of the kidney cortex and therefore relate well to chronic average exposures. For that reason also, worst-case estimates may not be realistic, since such situations are unlikely to proceed for longer time. Yet, situations of consistent enhanced exposure can occur in particular related to specific dietary habits involving systematic consumption of high-Cd food. 
In conclusion, recent (post-2000) weekly dietary Cd-intakes in the EU are of the order 1 -2 µg/kg BW. and as such below the WHO PTWI standard of 5.8 µg Cd/kg BW, and below the more stricter EFSA standard of 2.5 µg Cd/kgBW. Calculations of dietary intake based on life-time continued worst case are considered unrealistic. 
For data and references supporting the analysis above, see in uploaded attachment under IV Attachment, comment 60.

Page 67, section 13.1 Developmental toxicity, para 3
Comment 61
The studies of Ciesielski et al (2012) and Kippler et al (2012), showing associations between low-level environmental cadmium exposure in children (measured as Cd-U) and adverse neurodevelopmental outcomes should be interpreted with caution, in light of the recent literature data challenging the significance of U-Cd as biomarker of cumulative exposure in situations of low exposure (see comment 9). 

Page 67-68, section 13.2 Endocrine effects
Comment 62
The Annex XV document mentions experimental studies (although not all references are clearly cited), that suggest that cadmium may have estrogen-like effects. Swedish epidemiological studies have shown associations between estimated dietary exposure and increased risk of hormone-related cancers (endometrial cancer). However, as noted in Annex XV, this needs to be confirmed by other studies (see also comment 57), for the following reasons: 
To date, most cadmium in vivo studies have largely focused on acute cadmium exposures and there are only few studies studying the effects of chronic exposure to low levels of cadmium.
The observed effects are very much dependant not only of dose but also of route of administration.  It should be noted that only few studies used the main relevant human exposure route, i.e. ingestion, as the route of Cd administration. Most studies apply non-physiological routes of exposures, e.g. intraperitoneal injection. 

It is noted that the studies of Ali et al (2010; 2012), as cited on page 51, para 1 lines 20-29; para 2 in which the mechanism of the estrogen-like effects of cadmium were investigated, are also acute exposure cadmium studies, in which transgenic ERE-luciferase reporter mouse were exposed subcutaneously for 3 days. This study design might be questioned in examining whether chronic, low-level exposures to cadmium can directly result in the development and progression of hormone-related cancers.  
Moreover, in most in vivo studies to date, the estrogenic effects of Cd were estimated after exposure to inorganic Cd salts dissolved in a buffer or saline by injections or gavage (Höfer et al 2009, Ali et al 2010; 2012), while human populations are exposed to Cd mainly through diet. This difference was shown in the study of Ramachandran et al (2011) where estrogen-like effects were only observed after oral administration of CdCl2 and not after dietary exposure. 
In conclusion, the elements listed above show the need for more basic, physiologically relevant research is needed (a) on the mechanisms of interaction between Cd and estrogen signalling, (b) biologically active species of Cd, and (c) biomarkers of estrogen-like effects of Cd in vivo, before conclusions on possible  hormone disruptive effects of Cd can be drawn. 
For data and references supporting the analysis above, see in uploaded attachment under IV Attachment, comment 62	Thank you for your comments and the information provided. 

Comments regarding use, exposure, alternatives and risks may, where relevant, be considered at later stages of the risk management process.	
			See also:
Comment 10 attachment (CdS Annex XV_ICdA comments_master and summary.zip).zip		
4	2013/10/08	Company
Nordenhamer Zinkhütte GmbH
Germany	The justification in the dossier is weak:
Most data are not substance data but of Cadmium or Cadmiumoxide. The only link to these data is the remark, that Cadmiumsulfide might be oxidized in contact with oxygen. But this occurs with measurable reaction velocity only at very small particle size and elevated temperature.
It is well known, that exposure of men through the environment originates mainly from Cadmium compounds in phosphate fertilizers.
Cadmium is naturally occurring as accompanying element in Phosphates and in non-ferrous metals ores. The compound in these ores is not pure CdS, but mixed crystals with the main compounds. The Cd compounds are very stable and not leachable. Sweden is one of the EU-countries in which such ores are mined.
There are already a lot of restrictions for Cadmium compounds in place (annex XVII No 23 of the REACh regulation and directives 2000/53/EC and 2011/65/EC). These cover use in paints, brazing sticks, jewellery, electric and electronic equipment, cars, surface treatment and as stabilizer in plastics. This makes the effect of an annex XIV entry marginal. Most imports of articles would not be affected because of the low Cadmium content of the articles.
Not mentioned is the very low solubility product of CdS, which makes nearly complete removal of Cadmium compounds from contamined water by sulphide precipitation possible.	Thank you for your comment.

Please note that the justification for art 57(a) is based on the harmonized classification (Carc. 1B). Also for 57(f) the harmonized classification (as STOT RE1) is of high relevance. 

It is recognized that CdS is less soluble than many other cadmium compounds, but it should also be noted that despite the low solubility in some test systems, Cd compounds with” low solubility” still adds to the Cd pool in the environment. See eg. KemI PM 4/13 (http://www.kemi.se/Documents/Publikationer/Trycksaker/PM/PM%204_13.pdf).
Since cadmium from CdS in soil will ultimately be taken up by plants, CdS will enter the food chain and add to the exposure of Cd via food.  	
2	2013/09/22	Company
ANDA Technology(Suzhou)Co.,Ltd
China	All materials supplied to STATS ChipPAC	-	

Attachments

Comment number	Public attachment	
10	
Comment 10 attachment (CdS Annex XV_ICdA comments_master and summary.zip).zip