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

Substance name:	Cadmium oxide	
CAS number:	1306-19-0	
EC number:	215-146-2	

The substance is proposed to be identified as meeting the following SVHC criteria set out in Article 57 of the REACH Regulation: Carc. 1B (Art. 57 (a)) and Equivalent Level of Concern (STOT RE 1) (Art. 57 (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	
31	2013/05/03	Member State Finland	The Finnish CA agrees that cadmium oxide meets the criteria as SVHC according to article 57 a and f. The substance has a harmonized classification as Carc 1B (H350: may cause cancer). The dossier submitter also proposes to identify the substance according to Article 57 (f) because cadmium oxide has serious adverse effects on kidney and bone after continuous exposure. Cadmium oxide is classified as STOT RE 1 based on effects on kidneys, bone and probably also lungs. In general identification of a substance according to article 57 (f) shall be done on a case-by-case basis. The Finnish CA considers that the justification provided on severity of possible health effects, irreversibility of health effects, delay of health effects, and uncertainties on  derivation of a ‘safe concentration’ illustrates that there is scientific evidence of probable serious effects to human health which give rise to equivalent level of concern to CMRs.

The Finnish CA considers that after inclusion of substances identified based on article 57 (f) in the candidate list it still needs to be further considered which risk management measures would be the most appropriate. The coverage of existing measures shall be taken into account (e.g., Annex XVII restriction no 23).	Thank you for this support.	
29	2013/04/18	Industry or trade association
Aerospace Industries Association
United States	Section 8
As correctly noted in the dossiers, cadmium plating is applied to iron, steel, brass and aluminum alloys, and provides high resistance to corrosion in harsh marine and alkaline environments.  Cadmium plating also provides lubricity, and a “self-healing” or smearing characteristic.  As a result, cadmium plated components can reduce the risk of operating mechanism failure due to corrosion debris in a wide range of engineering applications throughout industry.  Cadmium plating is particularly useful in the electrical, electronic, aerospace, mining, offshore, automotive, and defense industries when applied to bolts and other fasteners, electrical connectors and other components. 

Cadmium and cadmium oxide are currently used in the manufacture of many products used in the aerospace industry, including the following applications:
o	cadmium plated electrical connectors and connector inserts
o	cadmium plated fasteners and bearing components, 
o	as an alloying element in copper, tin, and zinc alloys, 
o	electrical conductors (wires),
o	electrical contact materials used in line starters, solenoid relays, and other devices subjected to high surge current,
o	fusible alloys used in emergency fire sprinklers,
o	nickel-cadmium rechargeable batteries, 
o	pigment in plastic used in high temperature applications, 
o	inks used in microelectronic applications, 
o	dispersant in plastic and
o	silver-cadmium oxide composites used in aircraft circuit breakers and relays

To ensure that aerospace and defense products meet a multitude of performance requirements, the industry and its customers often specify that production adheres to the dictates of multiple standards.  Many of these specifications and standards require the use of cadmium and cadmium oxide.  A  sample list of standards that are used in the production of aerospace and defense products and require cadmium usage are provided in the Appendix A to this letter.  This list is not inclusive.
Appendix A

Example Standards Used in the Production of Aerospace and Defense Products that Require Cadmium

Please see attached letter for additional details.	Thank you for your comment 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 29 CONFIDENTIAL attachment is removed.		
27	2013/04/18	Individual
France	no comment	Thank you for your comment 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 27 CONFIDENTIAL attachment is removed.		
26	2013/04/18	International NGO
ChemSec, the International Chemical Secretariat
Sweden	ChemSec would have appreciated a deepened discussion about the endocrine disruptive effects of cadmium in the dossier. These effects are described in a number of publications including the recent WHO/UNEP report “State of the science of EDCs”.	The ED properties are briefly mentioned in the Annex, however it was considered more appropriate to base the SVHC identification according to Art. 57(f) on the well-studied and well recognised effects on bone and kidney.	
25	2013/04/18	International NGO
Health and Environment Alliance
Belgium	HEAL supports this substance being adopted as an SVHC	Thank you for this support.	
23	2013/04/18	Member State
United Kingdom	Please refer to our comments on Cadmium	Thank you for your comment and support.	
20	2013/04/18	Company
ŠKODA TRANSPORTATION a. s.
Czech Republic	1	Thank you for your comment 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 20 attachment (Response to the online consultation of ECHA Škoda Tr.pdf).pdf		
18	2013/04/18	Industry or trade association
BDLI e.V. German Aerospace Industries Association
Germany	Please find our expression of strong concern in the attached PDF document.	Thank you for your comment 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 18 attachment (BDLI-PREC_AnnXV-Comment.pdf).pdf		
17	2013/04/18	Company
Správa železniční dopravní cesty , státní organizace
Czech Republic	1	-	
15	2013/04/18	Company
Železničná spoločnosť Slovensko, a. s.
Slovakia	1	Thank you for your comment 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 15 CONFIDENTIAL attachment is removed.		
13	2013/04/17	Industry or trade association
ADS
United Kingdom	None	-	
12	2013/04/17	National NGO
United Kingdom	Please also see our comments on the Cadmium dossier.	The ED properties are briefly mentioned in the Annex, however it was considered more appropriate to base the SVHC identification according to Art. 57(f) on the well-studied and well recognised effects on bone and kidney.	
3	2013/04/11	Company
France	Placing cadmium in REACh authorization process, and adding nickel salts, some years later, in the same process would be devastating to our industry.
	Thank you for your comment.

Comments regarding use, exposure, alternatives and risks may, where relevant, be considered at later stages of the risk management process.	

Specific comments on the justification
Number	Date	Submitted by (name, Organisation/
MSCA)	Comment	Response	
31	2013/05/03	Member State Finland	It seems that the proposal does not consider effects on lungs, which may give rise to equivalent level of concern to CMRs. In the literature the impairment of lung function has been reported after chronic exposure to cadmium oxide (such as fibrotic changes, emphysema, and pneumonitis). It would be important to know whether covering also these effects would give added value from a risk management point of view.	Cadmium has the ability to cause many different toxic effects, many of which have been mentioned briefly in the Annex of the Annex XV report. If was however decided to focus the 57f proposal on the most well studied and well recognized effects on bone and kidney, which both occur at low exposures. Lung effects would probably be covered by RMMs aiming at reducing the risk for lung cancer.	
30	2013/04/18	Industry or trade association
International Cadmium Association
Belgium	The document herewith attached in ‘IV Attachment (additional non-confidential information)’ is not intended as a replacement to the detailed comments on the CdO annex XV provided by ICdA to ECHA (uploaded on 16/04/2013 with reference number f6d1aae2-2622-4327-bf84-e4a72bba35dc). Its purpose is to summarize the main comments in a concise, easy to read format and thus can be used as a quick reference document. Each point is further developed in the “comments” supplied to ECHA or the attached “master comment document” posted on the ECHA web site (f6d1aae2-2622-4327-bf84-e4a72bba35dc).	Thank you for your comment 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 30 attachment (2013-04-18 Summary of Comments Cd CdO for ECHA.pdf).pdf		
28	2013/04/18	Industry or trade association
ASD
Belgium	None	Thank you for your comment 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 28 attachment (ASD Letter.docx).docx		
27	2013/04/18	Individual
France	no comment	Thank you for your comment 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 27 CONFIDENTIAL attachment is removed		
26	2013/04/18	International NGO
ChemSec, the International Chemical Secretariat
Sweden	We fully support the identification of cadmium oxide as an SVHC based on the hazardous properties below. Each of them alone being sufficient for SVHC identification:
- Classified as a carcinogen 1B
- Fulfilling the equivalent level of concern criteria, for having adverse effects on kidney ad bone tissue after prolonged exposure, following the classification STOT RE1 and further the evidence laid out in the dossier.	Thank you for this support.	
24	2013/04/18	Member State
Netherlands	We think it is currently not feasible to conclude on the equivalent concern route based on STOT RE 1/ kidney and bone effects at this stage. We would like to see a more thorough analysis of the appropriateness and consequences of applying STOT RE 1 as article 57f criterion within REACH as performed during the Ad-hoc Meeting of Competent Authorities for REACH, session of 28 June 2012: Identification of substances as SVHCs due to equivalent level of concern to CMRs (Article 57(f)) – sensitisers as an example. 	Thank you for your comment.
Please note that the document you refer to use sensitisers as an example. In the Annex XV dossier for cadmium this document was used as guidance for the equivalent levels of concern justification.	
23	2013/04/18	Member State
United Kingdom	Please refer to our comments on Cadmium	Thank you for your comment and support.	
22	2013/04/18	Other contributor
Alliance for Cancer Prevention
United Kingdom	We support this substances addition to the SVHC candidate list because of its toxicity.	Thank you for this support.	
19	2013/04/18	Company
Železničná spoločnosť Cargo Slovakia, a. s.
Slovakia	1	Thank you for your comment 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 19 attachment (ŽS Cargo Slovakia.pdf).pdf		
18	2013/04/18	Industry or trade association
BDLI e.V. German Aerospace Industries Association
Germany	Please find our expression of strong concern in the attached PDF document.	Thank you for your comment 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 18 attachment (BDLI-PREC_AnnXV-Comment.pdf).pdf		
17	2013/04/18	Company
Správa železniční dopravní cesty , státní organizace
Czech Republic	1	-	
16	2013/04/18	Company
Železničná spoločnosť Slovensko, a.s.
Slovakia	1	Thank you for your comment 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 16 attachment (European Chemicals Agency ŽSS .pdf).pdf		
15	2013/04/18	Company
Železničná spoločnosť Slovensko, a. s.
Slovakia	1	Thank you for your comment 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 15 CONFIDENTIAL attachment is removed		
13	2013/04/17	Industry or trade association
ADS
United Kingdom	None	-	
12	2013/04/17	National NGO
United Kingdom	CHEM trust supports the inclusion of cadmium oxide in the REACH candidate list according to 57 a) and f). 
It is important to also address the other properties of concern (i.e. damage to kidneys and bones) and not only the carcinogenic properties. In particular the accumulation potential in the kidney is of high relevance. Taken together with its persistence and toxicity, cadmium can be regarded basically as “PBT-like”. Therefore we support the inclusion of cadmium oxide in the candidate list on the basis of 57(f) as well as 57(a).  
	Thank you for this support.	
9	2013/04/16	Member State
Belgium	Belgium supports the proposal to identify cadmium oxide 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 :
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	The exposure to the substance is of societal concern at EU level. Additional data are the results for Cd of the DEMOCOPHES biomonitoring exercise in 17 EU countries (2011-2012), which give an average of 0.22 µg Cd/L in urine of the mothers (P90=0.62 µg/L) and an average of 0.07 µg Cd/L in urine of the children (P90=0.22 µg/L) (http://www.health.belgium.be/internet2Prd/groups/public/@public/@nehap/documents/ie2divers/19083496.pdf)
o	Cadmium has been proven to bioaccumulate in the human body.
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.	Thank you for your support and the information provided.	
8	2013/04/16	Industry or trade association
International Cadmium Association
Belgium	Summary of Comments: 
The Annex XV report on Cadmium oxide highlights two areas of risks: 
1.	risk of increased bone and kidney effect on the general population due to Cd and its compounds exposure from the environment and to releases of cadmium oxide from cadmium 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 oxide be submitted to the REACH authorization process, which links the right for industry to “use” cadmium oxide to the granting of a permit (the “Authorization”).
However, no effort is made in this Annex XV to try to link “uses” of cadmium oxide to the risks presented to the general population.
Moreover, the Annex XV fails to recognize that if there are workers exposed to cadmium in industry that deliberately uses cadmium and its compounds, 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 industry deliberately using cadmium oxide to general population exposure is marginal as compared to the contribution of the industry manipulating goods in which cadmium oxide is an impurity , In other words,  the manufacture and use of cadmium oxide containing articles has no influence on general population cadmium oxide exposure,
2.	The use of articles containing cadmium oxide is already under many restrictions, prohibitions and limitations within the EU. Industry will show that exposure from the remaining articles, including their end of life, is insignificant
3.	The sectors of industry that are deliberately using cadmium and its compounds only employ a small fraction of the estimated number of occupationally exposed workers (1.6%), and has a solid record of risk reduction, having since 2008 voluntarily implemented the Swedish Occupational Risk Agency management tools and having implemented as its DNEL the OEL set by SCOEL in 2010 (SUMDOC 136 2010).
In clarifying these points, it will become obvious that authorization on uses will not lead to any influence on general population and worker exposure, and as such will not “ensure that the risks posed by the substance of very high concern will be properly controlled” (REACH art 55).
In the following, a number of comments on the Annex XV document on cadmium oxide are given. More details of these comments are provided in the master-file (uploaded under IV Attachment). This master-file contains also the references. 
 08:50:58 AMComments

Page 6, 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” (cont.), 2nd paragraph, 3rd line - 
Comment 1
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 35), and (b) makes the wrong assumption that (REACH) uses of cadmium contribute to human exposure, which is not the case (see comment 39).  

Page 6, section “summary of how the substance meets the criteria set out in article 57(a) and 57(f) of REACH” (cont.), 3rd  paragraph - 
Comment 2
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 in the EU (see comment 39 and 40 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).

Page 7, section “summary of how the substance meets the criteria set out in article 57(a) and 57(f) of REACH” (cont.), 7th paragraph - 
Comment 3
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 8, section “summary of how the substance meets the criteria set out in article 57(a) and 57(f) of REACH” (cont.). 3rd paragraph - 
Comment 4
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.

Page 11, section 1.3 Physico-chemical properties
Comment 5
Table 4: water solubility: As the source of data refers to the registration file, the calculated value for cadmium oxide of 5.4 mg/L should be replaced by 6.1 mg/L conform the REACH registration dossier Cadmium Oxide.  Conform the REACH registration dossier it should also be mentioned: the “experimentally determined”  average water solubility.

Page 14, section 3, heading: “food”
Comment 6
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 95percentile 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 53 for more information.

Page 15, 1st paragraph, last line: 
Comment 7
Sentence not complete.

Page 15, section 4.1 Toxicokinetics (absorption, metabolism, distribution and elimination),  para 3,  line1-2
Comment 8
Annex XV states: “Once absorbed, cadmium will bind to metallothionein, forming a cadmium–metallothionein complex that is transferred (via blood) primarily to the liver and the kidney.”
Although this is literally cited from IARC 2012, we are not agreeing since as written, it is as if Cd-metallothionein (MT) complex is formed at the absorption site and afterwards transferred to the liver. Since this is not the case, we recommend following text:
“After absorption, Cd is transported in the blood to the liver. At the liver, Cd induces MT and forms a complex with MT.  Cd-MT is released from the liver and transported in blood to the kidney, where the Cd-MT complex is readily filtered at the glomerus….” (Cadmium Consortium 2012).

Page 16, 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., 2013). 
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 48 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. 
For data and references supporting the analysis above, see in uploaded attachment under IV Attachment, comment 9

Page 17, section 4.3 Bone toxicity, para 2, line 7
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”. References are missing for the specific studies mentioned.
It is emphasized (see also comments 9, 48) that the significance of Cd-U as an exposure marker in situations of very low exposure to Cd, has recently been questioned (Chaumont et al, 2012, Akerstrom et al, 2013). 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. 

Page 17, section 4.3 Bone toxicity, para 4,  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. 

Page 19, section 6.2., 4rd paragraph, 3rd 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 1 to 4 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 1 and 35), and (b) the fact that cadmium (REACH) uses do not contribute to the cadmium deposition from air on crops and soil (see comment 39).

Page 19, section 6.2,  5th 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 21, section 6.2. , heading “uncertainties on safe exposure” 1st 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, see also comment 9 & 10 for more details. 

Page 22, section 6.2., heading “societal concern and impairment of quality of life”. 
Comment 15
See comment 4 made above
	Thank you for your comment and the information provided.

Inclusion into the candidate list is based on the inherent hazardous properties of the substance. Risks are considered at a later stage of the risk management process.

See also attachment:

	
			See also:
Comment 8 attachment (2013-04-16 Master Comments Document on CADMIUM OXIDE Annex XV final submitted.docx).docx		
5	2013/04/16	Member State
Germany	The German CA supports the proposal to identify the substance as SVHC.	Thank you for your support and the information provided.	
			See also:
Comment 5 attachment (2011_004.pdf).pdf		
4	2013/04/11	Member State
Norway	The Norwegian REACH CA supports the proposal to identify cadmium oxide as a SVHC in accordance with article 57 a) since cadmium oxide is harmonised classified as carcinogenic (Carc. IB, H350: May cause cancer).

In addition the Norwegian REACH CA supports the proposal to identify cadmium oxide 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 oxide is caused by cadmium ion, the same justifications for equivalent level of concern given for cadmium applies to cadmium oxide.	Thank you for your support.	
3	2013/04/11	Company
France	1.	Cadmium plating :
Cadmium and cadmium oxide are mainly used in surface treatment so-called cadmium plating  within the aeronautic  applications for corrosion inhibiting, low coefficient of friction and conductivity properties in the following parts :
	Mechanical and dynamic parts (landing gears,  high strength parts, housings...)
	Electrical connectors,
	Fasteners, screws, rivets…,
in the frame of  current and legacy  programs for civil applications. 	Thank you for your comment and the information provided. 

Comments regarding use, exposure, alternatives and risks may, where relevant, be considered at later stages of the risk management process.	
1	2013/04/02	Member State
Ireland	The Irish CA notes that the current proposal to identify cadmium oxide 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.

The Irish CA supports the proposal to identify cadmium oxide 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. 

The identification of specific substances meeting Article 57(f) criteria should be done “on a case-by-case basis”. The Irish CA considers that the following specific properties of cadmium, and thus cadmium oxide, support a justification for equivalent level of concern to CMRs:
•	Human evidence of increasing severity of effects on kidney and bone observed in with increasing exposures
•	Irreversibility of effects, in particular effects on bone.
•	The long biological half-life of cadmium which results in continued internal exposure even after external exposure has been reduced.
•	Bioaccumulation of cadmium over a life-time which results in a delay in manifestation of health effects. In particular, bone effects are silent until first fracture and therefore difficult to manage the risk.
•	Uncertainty in deriving a safe exposure level for kidney and bone effects.

In addition, the effects on kidney and bone may be more sensitive critical endpoint for risk assessment than carcinogenicity, in particular for occupational exposure. 	Thank you for this support.	

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	
30	2013/04/18	Industry or trade association
International Cadmium Association
Belgium	The document herewith attached in ‘IV Attachment (additional non-confidential information)’ is not intended as a replacement to the detailed comments on the CdO annex XV provided by ICdA to ECHA (uploaded on 16/04/2013 with reference number f6d1aae2-2622-4327-bf84-e4a72bba35dc). Its purpose is to summarize the main comments in a concise, easy to read format and thus can be used as a quick reference document. Each point is further developed in the “comments” supplied to ECHA or the attached “master comment document” posted on the ECHA web site (f6d1aae2-2622-4327-bf84-e4a72bba35dc).	Thank you for your comment 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 30 attachment (2013-04-18 Summary of Comments Cd CdO for ECHA.pdf).pdf		
29	2013/04/18	Industry or trade association
Aerospace Industries Association
United States	Section 10.
A transition to the implementation of alternatives substances is an extremely complex process for the aerospace and defense industry.  The complexity is due to multiple factors that are not in place for products manufactured by other industries.  These factors include long product life cycles, multiple product performance requirements, and the necessity of meeting multiple specifications and standards.  Assuring that alternatives can meet these many and varied requirements leads to relatively longer transition periods.

Alternative materials must be evaluated for potential risks to a product if a critical attribute is not evaluated within the development and qualification phases.  This may cause multiple iterations, including disruption in production or service.  In addition, material changes introduced during product development cycles could affect overall product performance and require out-of-sequence re-design.  Once alternatives are developed and tested, both suppliers and manufacturers must certify new components with the EASA and FAA before they can be used in production.

The process for evaluating alternative materials for products manufactured for the United States Department of Defense military programs requires each DoD program office to approve any changes to any existing substance use and applications.  Each DoD program office will require qualification of the cadmium alternative to various military or industry standard specifications.  For legacy military aircraft originally designed and furnished with cadmium plated parts, upgrades must incorporate cadmium plated parts unless compatibility between legacy parts and upgraded parts with alternative finishes has been demonstrated and qualified.   

The long production cycles presents further difficulty in implementing alternatives.  The aerospace industry incurs long production cycles for its products – manufacturing of certain components may start as early as 18 months before the delivery of a product.  Significant lead time is needed for AIA members to ensure the viability and availability of new parts and to manage potential risks to their production processes.  In identifying potential alternatives, members must assess the risk that replacements developed today become obsolete due to future regulatory restrictions.  

Aerospace industry products are designed to be in service longer than those of most any other industry.  A typical, active service life span of aerospace industry products often is 20-30 years, and for some products, the active service life is longer.  The aerospace industry must therefore continue to service and provide spare parts for legacy products – planes and models that are no longer produced but are still in use throughout the world.  These products must be maintained, repaired and overhauled using parts that were designed for each product’s original production.  In cases where drop-in alternatives have not been certified, qualified, or available, changing a design and re-certifying individual parts is not feasible.  The original parts must remain available to ensure that the legacy product remains in service.

Finally, as noted above and shown in Appendix A, aerospace and defense industry equipment is governed by the requirements of many thousands of part standards that are issued by the United States government, military, and globally recognized industry standard development organizations committees including those of Aerospace Material Specification (AMS) and the National Aerospace Standards (NAS) committees that mandate use of cadmium plating without alternatives.  These part standards are currently in use by many industries. For these thousands of standards, it would require an absolute commitment by worldwide organizations and enormous generation of data to certify each part and use for equivalency before any transition plan could begin.  Since there are no absolute drop-in equivalent materials known to industry, this future transition state is not supportable at this time.  
Due to the critical applications of cadmium and cadmium oxide, the aerospace and defense industry must be assured that alternatives can and will be available in sufficient volumes to prevent any disruption to its production and product service cycles.  Inclusive to a transition to alternatives, the industry must have available supplies of alternatives to support not only the manufacture, but also the maintenance and overhaul of aerospace and defense industry products.  

With this background, AIA disagrees with the following statements within the dossiers regarding the adoption of alternatives:

•	“Except where the surface characteristics of a coating are critical (e.g. fasteners for aircraft), coatings of zinc or vapor-deposited aluminum can be substituted for cadmium in many plating applications.”

AIA Response: Fasteners for aircraft are not the only application for which surface characteristics of a coating that employ cadmium or cadmium oxide are critical.  The corrosion resistance of zinc plating in high humidity and marine environments is very low. Electroplated zinc alloys do not provide the lubricity or “self healing/smearing” characteristics of electroplated cadmium.  Ion vapor deposited (IVD) aluminum cannot be substituted for these many other plating applications because of poor galling resistance; masking is necessary to maintain electrical insulation where required; the coating does not deposit in deep recesses; and the coating must be densified to reduce porosity via a secondary glass bead peening process.  

•	"An alternative for the cadmium plating in the aircraft industry has been developed. It is based on a tin-zinc alloy (SIFCO 2012)"

o	AIA Response: The selection of alternatives will differ by company and application. Alternatives are not universal replacements for all substrates.  Individual equipment requirements and conditions including bonding, grounding, electromagnetic effects (EME), and specific threaded fastener characteristics (torque tension, insertion forces) must also be evaluated when assessing alternatives. As noted in the Mason et al paper referenced below, electroplated alkaline tin-zinc with a hexavalent chromium conversion coating, failed corrosion testing regardless of the presence of hexavalent chromium conversion coating, and failed testing to evaluate environmentally influenced cracking (EIC).

•	"Alternatives for cadmium in military electrical connectors have been assessed (Mason 2012).  ... the most promising candidate coating processes ... are technologies that are already being used on electrical connectors ... or demonstrate both considerable promise for the application and sufficient maturity.  These include: - Electroplated aluminum (AlumiPlate®), - Electroplated alkaline zinc-nickel (5–15% nickel in the deposit), - Electroplated tin-zinc (at least 20% zinc in the deposit)

AIA Response: If by “Mason 2012” is the cadmium dossier referencing the March 2010 Metal Finishing (page 12-20) article ‘Update on Cadmium Coatings on Military Electrical Connectors? 

AIA notes that the proposed alternatives have a number of drawbacks and do not match the performance of hexavalent chromium conversion coated cadmium plating.  The drawbacks noted in the Mason et al article include the following:

o	Electroplated alkaline zinc-nickel without hexavalent chromium conversion coating failed paint adhesion testing, failed unscribed cyclic corrosion testing, failed scribed cyclic corrosion testing, and failed wet notch environmentally influenced cracking (EIC) testing.
o	Electroplated alkaline zinc-nickel with hexavalent chromium conversion coating had borderline results for paint adhesion and corrosion testing, and failed EIC testing.
o	Electroplated tin-zinc failed corrosion testing regardless of the presence of hexavalent chromium conversion coating, and failed EIC testing.
o	While the AlumiPlate process was noted as passing corrosion testing, the dossier did not note that it is a sole source option that includes a hazardous (pyrophoric) processing environment, which could hinder its acceptance as a viable alternative.

The only coatings that passed the testing described within the Mason el al reference were the baseline hexavalent chromium conversion coated cadmium, and a titanium-cadmium coating that benefitted from a hexavalent chromium conversion coating. 

Further, the article specifically noted that the referenced coatings were under investigation and subject to further research.  That is the coatings did not exhibit “sufficient maturity” to be immediate replacements for cadmium.

Additionally, zinc-nickel alloy plating does not have the same lubricity as cadmium which may impact assembly processes.  Other requirements such as bonding & grounding, electromagnetic effects (EME), and specific threaded fastener characteristics (torque tension, insertion forces, etc) are still being evaluated for application of these technologies for aerospace and defense applications.
 
AlumiPlate is a sole source, single facility, proprietary process.  The business conditions associated with this process present potential risk for supply disruption due to limited production capability and increased costs.  These factors were described within the Mason et al article which further notes that the process contains additional hazards that are not included in the dossier.

Please see attached letter for further information	Thank you for your comment 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 29 CONFIDENTIAL attachment is removed.		
28	2013/04/18	Industry or trade association
ASD
Belgium	Section 8. Uses
Cadmium plating is widely used on steel parts as a corrosion prevention coating in high corrosive areas and as a preventative measure for galvanic corrosion (between Steel and Aluminium or Steel and Titanium parts) .E.g. Wing link bolts, Pylon bolts, undercarriage bolts and fittings. Cadmium also provides a significant degree of lubricity preventing galling (a condition whereby excessive friction between high spots results in localized welding with subsequent splitting and a further roughening of rubbing surfaces of one or both of two mating parts) between many hard metal fastener interfaces.
Cadmium plating is used to ensure the maintenance of electrical contacts where it primarily functions as a sacrificial anti-corrosion coating system.  It is widely used in this role in many aerospace systems and is especially effective in this role in salt laden (marine) atmospheres.

Section 19, Alternatives
Alternative materials and coating systems are available, but proven alternatives are less apparent, hence the slow speed of change.
Zinc spraying (as a galvanic prevention coating) has been seen but this is only viable if the zinc spray coating meets fit, form and function requirements for the specific part reducing the usefulness of  this alternative.  It is of limited value.
Zinc-Tin has been offered as a replacement and is under review by many of our members but it is too early to know whether such an alternative is viable.
Zinc-Nickel has been widely investigated as an alternative in recent years but the local environment can prove critical so that approval in one application cannot be taken as approval for many applications. This means that qualification periods can be very long because each individual application has to be separately assessed. Furthermore Zinc-Nickel has the disadvantage due to the potential risk for unknown regulatory control (e.g. nickel salts on the CoRAP list with a potential replacement system based around cobalt salts already subject to Annex 17 Restriction).

Section 8 uses
1.2- Batteries as Ni-Cd
Cadmium also plays a mission critical part in aerospace when incorporated into Cadmium-Nickel batteries. The majority of aerospace electronic systems rely on these batteries for power back-up hence they provide a degree of safety ensuring aircraft may still operate should a malfunction occur in the normal electrical systems. Such batteries require excellent reliability and must be able to operate at extremes of temperature and under significant mechanical stress. These are proven facts that lead aircraft manufacturers to select this technology time and time again.

Electrochemical batteries are a key component of the aircraft power back-up system. The “main battery” role is to provide power for starting onboard Auxiliary Power Units (APUs), used when the main electrical power source of an aircraft ceases to operate within set parameters. The “emergency battery” role is to provide back-up power to avionics and some other systems during critical flight phases (essentially landing). The “emergency battery” power supply ability is called only in the very rare occurrences when the aircraft no longer has electrical power available at all.
This mission-critical safety equipment ensures aircraft can continue to be flown in the eventuality of a severe electrical system malfunction, safeguarding both passengers and crew.
The batteries entrusted with this function need to have an excellent reliability, the ability to sustain extreme temperatures and difficult environmental conditions such as mechanical stress and vibrations, and have to show superior calendar life whilst requiring minimal maintenance, all of which under severe weight constraints. For these reasons, in almost all passenger and military aircrafts, the Ni-Cd battery technology has been selected as both the “main battery” and the “emergency battery”. 
Industrial Ni-Cd batteries offer a good overall environmental performance record. They have a very long life, are collected and recycled, and no chemical substances present in the battery are released. Therefore, no employee is exposed to cadmium during their use or maintenance.
Ni-Cd battery technology is the standard used in all Airbus types and is used by ATR, Dassault Aviation, Eurocopter. This is a proven and mastered technology that has demonstrated its efficiency for aviation. To guarantee the safety, airworthiness and reliability of our aircraft, any technology has to be well proven and mastered before it is selected in aircraft design. 

Section 8 Other uses
This substance is widely used throughout the European Aerospace, Defence and Security sectors. There is some limited application as a visible light transparent thin film in LCDs, photodiodes, photovoltaic cells and anti-reflection coatings.  The substance has an indirect impact on naval ships and in high power aviation applications arising from its role as an essential precursor material for manufacture of silver cadmium oxide (AgCdO ). This is a sinter product made from cadmium oxide and silver and has special preferred orientation crystallography suited to its use.
It exhibits excellent anti-arc welding, low erosion, superior conductivity and mechanical working properties.  This means it is routinely selected for contacts in many demanding control and switchgear products.  
It is also extensively used in cadmium [metal] electro-plating baths and this would affect cadmium plating as discussed above.

Section 10 Alternatives
Alternate materials have generally proved inadequate under demanding switch applications for which AgCdO is ideally suited. There are numerous AgCdO contacts in aviation power electrical systems and on naval ships. 
The potential adoption of solid state systems may mean, in the future there will be a lower reliance of Cadmium oxide but these systems are in their early stages of development and viable replacement is still many years hence.
 
Clearly there is no alternate for cadmium oxide in its role in cadmium (metal) plating baths.	Thank you for your comment 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 28 attachment (ASD Letter.docx).docx		
27	2013/04/18	Individual
France	Diagnostica Stago wishes to comment on the public consultation relating to Cadmium / Cadmium oxide. See attached confidential documents.	Thank you for your comment 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 27 CONFIDENTIAL attachment is removed.		
26	2013/04/18	International NGO
ChemSec, the International Chemical Secretariat
Sweden	The following additional alternative to cadmium is available, as presented in the SUBSPORT database:
 
Alternative for PVC stabilisation
Hydrotalcite, synthetic
CAS No. 11097-59-9 EC No. 234-319-3
Information from the following report:
http://www.subsport.eu/case-stories/294-en?lang=	Thank you for this information.	
23	2013/04/18	Member State
United Kingdom	Please refer to our comments on Cadmium	Thank you for your comment.	
21	2013/04/18	National Authority
Greece	Concerning Chapter 10, "Alternatives", p. 41-43, of the Annex XV dossier for cadmium oxide, it is noted that any alternative to this substance may be used during maintenance works, only if it is specified by the manufacturer of the equipment/ hardware, so that its functionality is preserved in case of substitution.	Thank you for your comment 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 21 CONFIDENTIAL attachment is removed.		
20	2013/04/18	Company
ŠKODA TRANSPORTATION a. s.
Czech Republic	1	Thank you for your comment 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 20 attachment (Response to the online consultation of ECHA Škoda Tr.pdf).pdf		
19	2013/04/18	Company
Železničná spoločnosť Cargo Slovakia, a. s.
Slovakia	1	Thank you for your comment 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 19 attachment (ŽS Cargo Slovakia.pdf).pdf		
18	2013/04/18	Industry or trade association
BDLI e.V. German Aerospace Industries Association
Germany	Please find our expression of strong concern in the attached PDF document.	Thank you for your comment 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 18 attachment (BDLI-PREC_AnnXV-Comment.pdf).pdf		
17	2013/04/18	Company
Správa železniční dopravní cesty , státní organizace
Czech Republic	1	-	
16	2013/04/18	Company
Železničná spoločnosť Slovensko, a.s.
Slovakia	1	Thank you for your comment 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 16 attachment (European Chemicals Agency ŽSS .pdf).pdf		
15	2013/04/18	Company
Železničná spoločnosť Slovensko, a. s.
Slovakia	1	Thank you for your comment 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 15 CONFIDENTIAL attachment is removed.		
14	2013/04/17	Company
Poland	I wish to provide comments to my uses in an attachment.	Thank you for your comment 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 14 attachment (doc01672420130412123740.pdf).pdf		
13	2013/04/17	Industry or trade association
ADS
United Kingdom	These comments are provided by the Hazardous Materials Group of ADS. ADS is the trade organisation advancing the UK AeroSpace, Defence, Space and Security industries with Farnborough International Limited as a wholly-owned subsidiary, and also encompasses the British Aviation Group (BAG). ADS comprises around 900 member companies within the industries it represents. Together with its regional partners, it represents over 2,600 companies across the UK supply chain.
The lifespan of aerospace and defence products is significantly longer than that of most other products, ranging from 30 to 90 years. In order to maintain and repair the products, the industry needs to have qualified materials and processes that have a high degree of compatibility with previously used materials and meet regulatory or customer approvals. Aerospace and defence materials are highly engineered, low-volume products (when compared to other industries).

Section 8.2 End Uses of Cadmium Metal
P28 Section 8.2.1 Use in Ni-Cd Batteries
ADS members employ Ni-Cd batteries in the manner described in the Annex XV report. 
P29 Section 8.2.2 Coatings
ADS can add further information to the uses described in this section Cadmium plating is used on steel parts as a corrosion prevention coating in high corrosive areas, to prevent galvanic corrosion between Steel and Aluminium or Steel and Titanium parts. Examples from the aerospace sector include wing link bolts, engine pylon bolts, undercarriage bolts and fittings. It also acts as a very effective solid lubricant to reduce assembly torque requirements and eliminate the risk of thread galling during maintenance and overhaul procedures. These unique low friction properties are also exploited in wear contacts such as aircraft fuel pump thrust faces. Cadmium plating is used to ensure the maintenance of electrical contacts functioning primarily as a sacrificial anti-corrosion coating system. It is especially effective in this role in the marine, salt-laden environment in electrical systems and in aerospace environments. Use in this manner in such transport or defence electronic equipment is allowed under the RoHS Directive 2011/65/EU, use in consumer goods and non-critical equipment being restricted by the directive.
P29 Section 8.2.3 Cadmium in alloys
Silver electric contacts (Silver-Cadmium Oxide) incorporating 10 to 15% cadmium are useful in many heavy duty electrical applications such as relays, switches, circuit breakers and thermostats in the aerospace and defence sector. The presence of cadmium improves resistance to material transfer and electric erosion.
P32 Section 8.4 Volumes
The use of cadmium as a pigment is noted here. Cadmium compounds are used in the aerospace, defence & security sector to provide durable colouring to cables and safety equipment. The colouring is important to these items as it is ensures systems can be distinguished from one another during build, maintenance and repair or readily identified in emergency situations. The key performance benefit that Cadmium provides is the permanence of the pigment over the expected lifecycle of the equipment’s exposure to ultra-violet radiation or high temperatures.
Section 10 Alternatives
Page 41 Section 10.1 Battery
The unique set of performance characteristics make industrial Nickel-Cadmium batteries meet the performance and reliability requirements of the aerospace and defence sector. The alternatives (as listed in the Annex XV report) do not possess the characteristics of long service life, wide operating temperature range, ability to with stand the rigors of use in the aerospace and defence sector. 
P42 Section 10.2 Metal Coating
ADS support the statement in the Annex XV document that aerospace and defence fasters have critical performance requirements that cannot, currently, be satisfied by alternatives in all applications. ADS would like to high light that there are examples of critical applications that are not confined to the aerospace sector e.g. in the marine environment. None of the current alternatives to Cadmium plate possess the unique property combination of galvanic corrosion protection combined with low friction solid lubrication. There are applications outside of aerospace where alternatives are also less effective, such as in the maritime domain.
P 42 10.2.2 Military Electrical Connectors
The electrical connectors referred to are also used in commercial aviation, as allowed within the RoHS directive for modes of transport. This derogation is established based on the needs for high integrity within the transportation sector. Military electrical connectors fall within the derogation for military equipment.
Of the alternatives listed there are concerns over the long term viability of those that are listed;
•	AlumiplateTM - is a single source proprietary treatment businesses would then be exposed to the vulnerability of this supplier remaining in business or amending its pricing models. Also, we understand that this process is an electroplated aluminium deposit produced from an organic solvent electrolyte. The solvent used is toluene. Toluene is on the CoRAP list of substances due to its Human health/CMR and systemic toxicity. Toluene is also flammable. Suppliers in Europe who have carried out this process have ceased operations due fire safety concerns.
•	Electroplated alkaline zinc-nickel – It is known that there are bodies that wish to have Nickel salts identified as SVHCs and eventually placed on Annex XIV. Substitution to a nickel based alternative would be short term solution. It’s utility in applications such as connectors that need to be un-made and re-made during maintenance is limited due to its low ductility and resistance to galling.
•	Electroplated tin-zinc – Has not been demonstrated to satisfy the corrosion requirements.
ADS recognises that there are potential alternatives, however, there are no widely accepted and approved alternatives with backward compatibility to existing equipment. Cadmium components will be required to sustain the maintenance of current equipment fleets or for the manufacture of designs that are mature. Any alternatives that are selected must be capable of meeting the performance requirements and demonstrating a benefit over the product lifecycle.	Thank you for your comment and the information provided. 

Comments regarding use, exposure, alternatives and risks may, where relevant, be considered at later stages of the risk management process.	
11	2013/04/17	Company
Fokker Technologies B.V.
Netherlands	This substance is widely used throughout the European Aerospace, Defence and Security sectors. There is some limited application as a visible light transparent thin film in LCDs, photodiodes, photovoltaic cells and anti-reflection coatings.  The substance has an indirect impact on naval ships and in high power aviation applications arising from its role as an essential precursor material for manufacture of silver cadmium oxide (AgCdO ) which is a sinter product made from cadmium oxide and silver and has special preferred orientation crystallography suited to its use.
It exhibits excellent anti-arc welding, low erosion, superior conductivity and mechanical working properties.  This means it is routinely selected for contacts in many demanding control and switchgear products.  
It is also extensively used in cadmium [metal] electro-plating baths and this would affect cadmium plating as discussed above.

Alternate materials have generally proved inadequate under demanding switch applications for which AgCdO is ideally suited. There are numerous AgCdO contacts in aviation power electrical systems and on naval ships, especially in the LV electrical system. 
The potential adoption of solid state systems may mean, in the future there will be a lower reliance of Cadmium oxide but these systems are in their early stages of development and viable replacement is still many years hence.
 
Clearly there is no alternate for cadmium oxide in its role in cadmium (metal) plating baths!	Thank you for your comment and the information provided. 

Comments regarding use, exposure, alternatives and risks may, where relevant, be considered at later stages of the risk management process.	
10	2013/04/17	Company
France	Combustible : Le cadmium est utilisé lors de l'élaboration des grappes de combustible nucléaire. Le Cadmium présent dans l’Ag-In-Cd : ce matériau est utilisé depuis l’origine du PWR et aucun substitut n'a fait l'objet d'une validation par l'ensemble de la chaine aval à ce jour	Thank you for your comment and the information provided. 

Comments regarding use, exposure, alternatives and risks may, where relevant, be considered at later stages of the risk management process.	
8	2013/04/16	Industry or trade association
International Cadmium Association
Belgium	PART II Comments:
More details of these comments are provided in the master-file (uploaded under IV Attachment). 
This master-file contains also the references. 

Page 23, Part II, Conclusions, second bullet point
Comment 16
Metals coated with cadmium metal (including corrosion inhibition) are not widely used in society. 
Should the author of Annex XV have specific information regarding wide use of articles coated with cadmium, amount of releases, and size of exposed population, ICdA would welcome receiving details. See comment 26 for coating specific information.
Tonnage of cadmium oxide in this use: 5t/yr (expressed as Cd).

Page 23, Part II, Conclusions, third bullet point
Comment 17
Articles that contain cadmium oxide are even more infrequent than cadmium metal containing articles. 
Ni-Cd batteries once ready to be sold (whether charged or discharged), do not contain cadmium oxide. 
Some corrosion is likely to happen on the surface of the few remaining examples of cadmium coated articles, generating cadmium oxide.

Page 23, part II, Conclusions, fourth bullet point
Comment 18
Authorization would have no material effect in reducing worker exposure.
The workforce occupationally exposed to cadmium and its compounds in production processes, REACH uses and recycling (which can be regulated by Authorization) totals ca. 3,500 workers within the EU EU (this number includes ca. 1,000 workers in non Cd-refining Zn smelters, in which Cd is an impurity). For these employees, exposure is monitored and documented, and a high level of compliance with the legally binding DNEL of the REACH registration dossier is observed (see comment 46). 
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.

Page 23, part II, Conclusions, fifth bullet point
Comment 19
Main source of general population exposure is through dietary uptake (arising from cadmium in soil) which only marginally originates from deliberate uses of cadmium. 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 35.
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 23, part II, Conclusions
Comment 20
Alternative conclusion from this section should be:
- Over 200,000 workers are exposed to cadmium and cadmium compounds in the EU, but only 3,500 are under specific exposure reduction programs and specific medical supervision for cadmium. To address this situation, as stated in COM Communication 2008/C 149/3 on the risk reduction strategy following the Cd/CdO RAR, “it is recommended to set at community level occupational exposure limit values and a biological limit value for cadmium according to Directive 98/24/EC (2) or Directive 2004/37/EC as appropriate,”
- Cadmium oxide use in articles, (including plating and corrosion inhibition), is even more marginal than the use of cadmium metal. Based on notification requirements of article 7.2 of REACH, articles that contain cadmium and cadmium oxide  will have to be reported and there will be no need to make speculative assumptions on the wide use of non-existing articles,
- Restrictions are in place for cadmium in batteries (which contain no cadmium oxide), and are in the process of being further tightened up. End of life collection and recycling is already well regulated. Emissions due to recycling activities is marginal relative to total emissions,
- The main route of general population exposure to cadmium is dietary intake, which mainly finds its source in cadmium present in soil. The major part of cadmium compounds in soil is due to p-fertilizers and atmospheric deposition linked to the presence of cadmium as a naturally occurring impurity in widely traded/processed mineral goods,
- Deliberate uses of cadmium and cadmium compounds play only a marginal role in worker and general population exposure,
- For a better understanding of risks and already agreed effective actions addressing these risks, please refer to the COM risk reduction strategy (building on ECB Cd/CdO risk assessment) in Communication 2008/C 149/3.

Page 23, section 7.1, Manufacturers of cadmium oxide, para 1, line 1
Comment 21
Cadmium oxide is manufactured from pure cadmium metal. This process is ongoing at 2 facilities within the EU.  Another 2 facilities produce CdO from recycling streams.

Page 24, section 7.2, quantities manufactured, import and exports, line 1
Comment 22
EU production of cadmium oxide is
- used within the EU with non-intermediate status and is estimated at 800t/yr (expressed in Cd content), of which an overwhelming fraction is used to manufacture negative electrodes of industrial nickel-cadmium batteries
- used within the EU with intermediate status for approximately 400t/yr (expressed as Cd content), a great majority of which for the manufacture of non CMR mixed metal oxide pigments 
- A greater amount manufactured in the EU is shipped overseas to non EU manufacturers of nickel-cadmium batteries.

Page 26, section 8.1, general, para 2, line 4
Comment 23
Cadmium oxide is not used to manufacture Sintered (S) electrodes, it is used:
- As a full substance; to manufacture Plastic Bonded Electrodes (PBE) 
- With intermediate status; to manufacture Pocket Plate (PP) electrodes.
See comment 24 for more details.

Page 28, section 8.2.2 Use in nickel cadmium batteries, para 2, line 3 and para 3, line 2
Comment 24
In industrial batteries, there are four technologies of negative electrodes. The negative electrode is the one for which there is a use of cadmium compounds. 
These are the:
	- Pocket Plate electrode (PP)
	- Sintered electrode (S) 
	- Plastic Bonded electrode (PBE)
	- Fiber electrode (F).
Cadmium oxide is used as a substance to manufacture PBE electrodes only. In other technologies, it is either used as an intermediate or not used at all. 
It should be noted that once embedded inside the battery; the cadmium oxide is fully transformed and is no longer present in the finished battery.
Estimated tonnage of CdO (expressed as Cd) in this use: slightly below 800t/yr.

Page 28, section 8.2.1 Use in nickel cadmium batteries, para 5
Comment 25
Portable batteries are not manufactured within the EU. Such articles are manufactured in Asia and imported into the EU as such or within a limited number of appliances (essentially cordless power tools), which fall within the temporary exemptions from the portable Ni-Cd battery prohibition spelled out under 2006/66/EC.
Moreover, they do not contain cadmium oxide.

Page 30, section 8.2.2, cadmium coatings
Comment 26
Use of cadmium oxide in coating is an ”Intermediate use”, as it is being transformed to cadmium metal; moreover such application is already very limited. 
Such use is restricted under entry 23 of Annex XVII of REACH regulation in a broad spectrum of industries. These cover cadmium plating for articles or components of articles used in equipment and machinery for food production, agriculture, cooling and freezing, printing and book-binding, equipment and machinery for the production of household goods, furniture, sanitary ware, central heating and air conditioning plants, cadmium plated articles or components of such articles when used in equipment and machinery for the production of paper and board, industrial handling equipment, road and agricultural vehicles, rolling stock, vessels (please refer to the exact wording for the detailed scope of restrictions in points 5 and 6 of entry 23 of annex XVII). 
Entry 23 of Annex XVII also prohibits the use of cadmium compounds in several plastics  paint, jewelry, and brazing fillers.
Additional restrictions on the use of cadmium (including plating) are in place for vehicles (ELV directive), electric and electronic equipment (RoHS 2 directive: 2011/65/EU), batteries (batteries directive: 2006/66/EC), and packaging (packaging directive: 94/62/EC).
Estimated tonnage of CdO (expressed as Cd) in this use: 5t/yr (with intermediate status).

Page 31, section 8.2.3, cadmium in alloys
Comment 27
Cadmium oxide is not used in alloys. This section is therefore not relevant to cadmium oxide.
Tonnage of cadmium oxide in this use: 0t/yr.

Page 31, section 8.2.4, other uses of cadmium oxide
Comment 28
Material production/inclusion into polymer matrices, plastics and related preparations: 
 Cadmium and compounds are restricted in 19 different plastic materials as listed in point 1 of entry 23 of Annex XII of REACH.
Transparent conductors:
A reported use that has been identified in optronics is within infrared detectors used in both military and civilian applications, as well as very narrow RoHS exemptions number 39 and 40.
Raw material for inclusion in ceramic glass:
Information available to industry is that current uses of cadmium in ceramic glass are the red and yellow mixed oxides pigments chemical forms.
Plastic coating:
Information available to industry is that cadmium metal may be used for coating, and oxide is essentially the natural result of natural atmospheric oxidation.
Other uses:
Industry has no information confirming the use as catalyst, pharmaceutical or laboratory reagent. 
Specific use as CdO layer, in the electrical switching industry, on top of metal alloys (primarily silver cadmium oxide, Ag.Cd/CdO) has been confirmed to manufacture high quality power switching contacts (NEMA 2008).

Page 33, section 8.4, volumes, para 5, line 1
Comment 29
Nickel-cadmium batteries may not be used in electric vehicles, hybrid electric vehicles or electric busses. These uses are prohibited under 2000/53/EC (the ELV directive).

Page 33, section 8.6.1, Ni-Cd batteries, line 1
Comment 30
Cadmium compounds are used only in nickel-cadmium batteries and not in any other battery chemistry. See comment 25

Page 34, section 8.6.3 and 8.6.4, alloys and joining and fusible alloys, para 2
Comment 31
Cadmium oxide is not used in cadmium containing alloys. This section is therefore not relevant to cadmium oxide.

Page 34, section 9, exposure, paragraph 1, line 2
Comment 32
Industrial and professional workers exposed to deliberate uses of cadmium represent a minor fraction of exposed workers.
Industrial and professional workers exposed to cadmium used deliberately, estimated to be 3,500 workers (including 1,000 exposed workers in Zn smelters which do not refine Cd), represent 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).

Page 34, section 9, exposure, paragraph 2, line 1
Comment 33
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 35.

Page 34, section 9, exposure, paragraph 2, line 1
Comment 34
It is incorrect to state that “exposure of man via the environment occurs as a result of (…) diffuse releases from private uses of goods.”
Information would be welcome 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 34, section 9, 3rd paragraph, lines 2-4
Comment 35
In the Annex XV document 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 12), 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 significant (37% of total human exposure) Industrial emissions to atmosphere are equally important (42% of total human exposure)  . These are mainly related to the cadmium that is present as an impurity in mineral commodities that are processed/combusted by industry (see also comment 36 and 39).
-	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  comments 36 and 39. 

For data and references supporting the analysis above, see in uploaded attachment under IV Attachment, comment 35. 

Page 34, section 9, exposure, paragraph 4
Comment 36
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 be 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 39 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 35). 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 35) 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 37, section 9.2, releases during the service life
Comment 37
This section needs to be qualified by volumes, and the examples given need to be re-examined in light of existing regulations.
As presented in comments 16 and 27, total use of cadmium metal in these uses (plating and alloying) is respectively 5t/yr and 0t/yr and decreasing, and is limited to a few highly engineered industrial articles. 
Disk brakes and steering columns are components of vehicles; they are therefore regulated by 2000/53/EC (ELV directive) and may not incorporate cadmium. Indeed, there is only one cadmium entry (entry number 16) in Annex II of the ELV directive (listing exemptions). It allows for the supply of spare part batteries for electric vehicles placed on the market on or before December 31st 2008.
More generally, there are the restrictions/prohibitions in place, which are not presented in the Annex XV:
By “nature” of the use: COATING
Such use is restricted under entry 23 of Annex XVII of REACH regulation in a broad spectrum of industries. These cover cadmium plating for articles or components of articles used in equipment and machinery for food production, agriculture, cooling and freezing, printing and book-binding, equipment and machinery for the production of household goods, furniture, sanitary ware, central heating and air conditioning plants, cadmium plated articles or components of such articles when used in equipment and machinery for the production of paper and board, industrial handling equipment, road and agricultural vehicles, rolling stock, vessels (please refer to the exact wording for the detailed scope of restrictions in points 5 and 6 of entry 23 of annex XVII). 
By “nature” of the use: ALLOYS
Cadmium alloys in jewelry and brazing sticks are fully restricted under entry 23 of Annex XVII of REACH.
By “type of article”: VEHICLES
Use of cadmium in vehicles is regulated by 2000/53/EC (ELV directive) and vehicles may not contain cadmium. There is only one cadmium exemption to this restriction (entry number 16 of Annex II of the ELV directive which lists exemptions) which allows for the supply of spare part batteries for electric vehicles placed on the market on or before December 31st 2008.
By “type of articles”: BATTERIES
Use of cadmium in batteries is regulated by 2006/66/EC which prohibits the use of cadmium in portable batteries (with three exemptions) and requires that producers take back spent batteries for recycling.
By “type of articles”: PACKAGING
Directive 94/62/EC imposes a maximum total concentration limit for all heavy metals present in the packaging.
By “type of articles”: PLASTICS
Entry 23 of Annex XVII also prohibits the use of cadmium in several plastics (in which cadmium metal is never used), paint.
By “type of articles”: ELECTRIC AND ELECTRONIC EQUIPMENT
Directive 2011/65/EC (ROHS 2) prohibits the use of cadmium in all electric and electronic equipment.

Page 37, section 9.3, releases during the waste life stage
Comment 38
General population exposure to cadmium arises, for a significant fraction (P-fertilizers is the other significant fraction) from cadmium emissions to air. Comment 39 shows that the contribution of waste incinerators to total cadmium emissions to air is smaller than 0.8%. Consequently, the contribution of end of life of cadmium containing products (including batteries) is insignificant.

Page 37, section 9.4, releases from natural sources
Comment 39
As follows from the analysis under comment 35 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, 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 36). The emissions from deliberate Cd production and use (category 1) are further discussed below. 
Overall, Cd emissions to the atmosphere decreased with >60% (from 124T to 48T) 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, 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 46). 
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 39.

Page 39, heading cadmium exposure over time, last paragraph, line 2
Comment 40
This section of Annex XV concludes that “Cd exposure based on biomarkers of exposure and measured dietary intake in Sweden shows no decrease over the last 2-3 decades. This  conclusion  is in conflict with data that demonstrate that general population exposure is going down in Sweden and in the EU.
-No dietary intake data are presented in this section of the Annex XV at all, so it is impossible to check this part of the statement.
-The interpretation of the data presented in figure 4 of Annex XV is challenged: of the 12 populations, where a comparison was made in Cd-exposure (measured via Cd-U) between 2002-2004 and 2008-2009, 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 and the clear trend they indicate. Moreover, we consider that nowadays differences in analytical performance between labs leading to such differences would be unacceptable. 
-In addition, Annex XV mentions “two earlier Swedish studies that assessed kidney-cadmium in diseased people at autopsy”. No results are however presented on these studies, and no references are given. We are aware of 1 study in Sweden (Friis et al 1998) that compared kidney cortex Cd levels of victims of accidents during the period august 1995-June 1996, with similar data from 1976. Geometric mean Cd in kidney cortex in subjects 40 years of age and younger was in 1995-1996 only about 40% of the concentration found in 1976. This study clearly demonstrated a decrease in Cd-exposure of the Swedish population over the time period considered (Friis et al 1998).  We don’t understand why these results are ignored and invite the authors to check this relevant paper showing a clear decrease of Cd-exposure in Sweden. 
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.  
This 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 challenged based on evidence pointing clearly at decreasing exposure in Sweden.  Moreover, more general EU data on atmospheric Cd-emissions suggest that the decrease of environmental exposure to Cd through the diet can be generalised to the EU and is ongoing, due to the observed continuing 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 40

Page 40, section 9.6, worker exposure to cadmium, paragraph 2
Comment 41
Sectors of EU industry which deliberately use cadmium and cadmium compounds 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 40, section 9.6, worker exposure to cadmium, paragraph 4
Comment 42
Exposure data in the lead registrant’s exposure assessment are not mostly EU RAR data (ECB 2007), as incorrectly stated in Annex XV. These data are for the most part more recent. Updated 2012 data is now available (see comment 46).

Page 41, section 9.7, consumer exposure, second paragraph, line 3
Comment 43
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, 2012). 
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 43

Page 41, section 10.1, Pb/acid batteries, line 1
Comment 44
Pb/acid battery technology fulfills approximately 90-95% of the industrial storage market need in weight, but due to the price of Ni-Cd batteries relative to Pb/acid batteries (thrice the price), the industrial battery market share in value of Pb/acid batteries is in the range 70-80%.

Page 44, section 11.1, risk for workers, para 2, line 4
Comment 45
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 43, section 11.1, risk for workers
Comment 46
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 44, section 11.2., summary, 2nd paragraph, line 7-9.
Comment 47
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 40.

Page 44, section 11.2, summary, para 4
Comment 48
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 45, section 11.2, para 2, line 4-5
Comment 49
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)
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 4) has also to be questioned. 

Page 45, section 11.2, para 3,  line 4-6
Comment 50
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 55 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 45, section 11.2, last paragraph, line 3-4
Comment 51
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 45, section 11.2 last paragraph, line 4-6
Comment 52
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 46, section 11.3.  risk via food intake
Comment 53
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 53.

Page 51, section 13.1 Developmental toxicity, para 3
Comment 54
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 51-52, section 13.2 Endocrine effects
Comment 55
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 50), 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 55. 	Thank you for your comment 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 8 attachment (2013-04-16 Master Comments Document on CADMIUM OXIDE Annex XV final submitted.docx).docx		
7	2013/04/16	Industry or trade association
GIFAS
France	Please refer to attached document (20006_ECHA_SVHC_Cd_CdO_16apr13)	Thank you for your comment 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 7 attachment (20006_ECHA_SVHC_Cd_et_CdO_16apr13.pdf).pdf		
6	2013/04/16	Company
Germany	CdO is used as such for scientific R&D.
These applications are routine analytical uses in a laboratory within the scope of scientific R&D. The risk for the environment and consumers is very low. Usually the volumes and the concentration of the substance are low. The disposal of the substance is also controlled.	Thank you for your comment and the information provided. 

Comments regarding use, exposure, alternatives and risks may, where relevant, be considered at later stages of the risk management process.	
5	2013/04/16	Member State
Germany	The German CA would like to comment on Chapter 9.6 "Worker exposure to cadmium" as
follows:
Chapter 9.6 of the SVHC Dossier only gives estimates of the number of workers potentially exposed to cadmium and cadmium compounds but no quantitative estimates of the level of
exposure. In the German CA's view it would help to substantiate the concern related to Cadmium exposure at workplaces more impressively if a couple of quantitative exposure
estimates would be provided. In this context we would like to draw attention to a report [1] that provides quantitative estimates on work-related exposure to cadmium and its
compounds in Germany. The exposure estimates come from various sectors of industry, e.g. production of batteries, alloys, pigments and stabilisers. To ensure easy access the corresponding pdf has been attached.
[1] Arbeitsbedingte Exposition gegenüber krebserzeugenden, erbgutverändernden oder fortpflanzungsgefährdenden Substanzen in Deutschland Teil 1: Cadmium und seine Verbindungen (Work-related exposure to carcinogenic, mutagenic and reprotoixic
substances in Germany - Part 1: cadmium and its compounds), Steinhausse, M., Van Gelder, R., Gabriel, S., Gefahrstoffe - Reinhaltung der Luft 71 (2011) Nr. 1/2 "
Unfortunataly the report is only available in German.	Thank you for your comment 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 5 attachment (2011_004.pdf).pdf		
3	2013/04/11	Company
France	Substitution programmes are in progress and the replacement solutions rely on nickel-based coatings which can provide similar anti-corrosion protections and can be applied on certified aircraft with reasonable engineering adaptations.
Nickel-based coatings require the use of nickel salts in the bathes of treatment. The use of nickel salts is done under stringent safety conditions in our shops or our suppliers’, and, moreover, the salts are only used in the process and do not remain on the treated parts. The use of nickel coating is therefore a very significant improvement compared to cadmium coating where the cadmium itself is located on the parts.
Nickel salts are under investigation by ECHA in order to identify what are the Risk Management Options. Our industry fully supports this study and is committed to provide all assistance to ANSES which is in charge, in order to mitigate the corresponding risks via a Restriction process and not an  Authorization process.	Thank you for your comment and the information provided. 

Comments regarding use, exposure, alternatives and risks may, where relevant, be considered at later stages of the risk management process.	
2	2013/04/03	Company
Régie Autonome des Transports Parisiens
France	Nous vous remercions par avance de bien vouloir prendre connaissance des données concernant le saccumulateurs utilsés en transport ferroviaire urbain et, en conséquence de prendre en compte les besoins opérationnels particuliers, généralement peu connus, des entreprises et opérateurs de transport urbain, dans le cadre de vos processus d’évaluation.	Thank you for your comment 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 2 attachment (Courrier RATP Agence Chimique ECHA.pdf).pdf		

Attachments

Comment number	Public attachment	
2	
Comment 2 attachment (Courrier RATP Agence Chimique ECHA.pdf).pdf	
5	
Comment 5 attachment (2011_004.pdf).pdf	
7	
Comment 7 attachment (20006_ECHA_SVHC_Cd_et_CdO_16apr13.pdf).pdf	
8	
Comment 8 attachment (2013-04-16 Master Comments Document on CADMIUM OXIDE Annex XV final submitted.docx).docx	
14	
Comment 14 attachment (doc01672420130412123740.pdf).pdf	
16	
Comment 16 attachment (European Chemicals Agency ŽSS .pdf).pdf	
18	
Comment 18 attachment (BDLI-PREC_AnnXV-Comment.pdf).pdf	
19	
Comment 19 attachment (ŽS Cargo Slovakia.pdf).pdf	
20	
Comment 20 attachment (Response to the online consultation of ECHA Škoda Tr.pdf).pdf	
28	
Comment 28 attachment (ASD Letter.docx).docx	
30	
Comment 30 attachment (2013-04-18 Summary of Comments Cd CdO for ECHA.pdf).pdf