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

Substance name:	arsenic acid	
CAS number:	7778-39-4	
EC number:	231-901-9	

The substance is proposed to be identified as meeting the following SVHC criteria set out in Article 57 of the REACH Regulation: CMR

Disclaimer: The European Chemicals Agency is not responsible for the content of this document. The Response to Comments table has been prepared by the competent authority of the Member State preparing the proposal for identification of a Substance of Very High Concern. The comments were received during the public consultation of the Annex XV dossier. RCOM has not been agreed by the Member State Committee nor has the document been modified as result of the MSC discussions. 

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	
14	2011/10/13	National Authority
RIVM
Netherlands	NL supports the proposal to include arsenic acid in the candidate list of substances of very high concern.	Thank you for your support.	
12	2011/10/13	Industry or trade association
Switzerland	On the basis on EU applicable legislation that regulates semiconductor manufacturing operations, ST Microelectronics believes that any potential future nomination or inclusion in the candidate list of Arsenic Acid for semiconductor usage should identify an exemption for the semiconductor sector from an authorization for usage as being the most effective and appropriate measure. 

Use in semiconductor industry was not listed in the dossier.	Thank you for this useful information. 
Potential uses that should be exempted must be identified at a later stage. This is not relevant  in connection with the identification for the Candidate list, but could be considered in the next step of the authorisation process when deciding which substance to prioritise and recommend 
for inclusion into Annex XIV.
	
11	2011/10/13	Member State
Sweden	The Swedish CA agrees that arsenic acid, being classified as Carc. 1A, meets the criteria according to Article 57(a) in REACH and is thus eligible for identification as a substance of very high concern.	Thank you for your support	
10	2011/10/12	Member State
Belgium	Belgium supports the identification of arsenic acid as SVHC according to article 57 (a)	Thank you for your support	
9	2011/10/12	International NGO
Health and Environment Alliance
Belgium	HEAL supports the nomination of arsenic acid to the Candidate List based on the information in the Annex XV dossier.	Thank you for your support	
8	2011/10/12	National Authority
Allgemeine Unfallversicherungsanstalt
Austria	p11, 1.1 Manufacturing sites
“As of June 2011 arsenic acid is not manufactured by any companies in the EU
according to information obtained from the Arsenic Acid Consortium 3 (2011).”
P14, Import of the substance in mixtures and articles
“No import into the EU of arsenic acid in mixtures and articles has been identified.”
Obviously there is no longer need of this chemical!
	The statement on P 14 relates to import in mixtures and articles. Arsenic acid is still imported in 2011, see more details in confidential Annex).	
7	2011/10/12	Member State
Germany	The German CA supports the identification of the substance as a possible SVCH.

The group approach for arsenic compounds should be put into the focus of the dossier to improve the plausibility.  

	Thank you for your support. 

We agree that a group approach is preferable, but cannot see how it would improve the plausibility. For the identification of SVHCs each substance of a group entry must be identified according to feedback from ECHA.  	
6	2011/10/12	Company
Germany	The following laboratory uses should be exempted from the authorisation because they are within the scope of scientific R&D. There is very low exposure to consumers and the environment. The analytical standards are manufactured by industrial personnel, which are well trained. Therefore, the handling steps at professional users are reduced. The disposal of the substance is also controlled.	Potential uses that should be exempted from authorisation must be considered in connection with the authorisation process when deciding which substance to prioritise and recommend for inclusion into Annex XIV. Some general exemptions for Authorisation apply cf. REACH Articles 2, 56, 60.
	
5	2011/10/10	Trade union
European Trade Union Confederation
Belgium	ETUC supports the identification of arsenic acid as SVHC.	Thank you for your support.
	
4	2011/10/07	International NGO
ChemSec
Sweden	We fully support the inclusion of this substance into the candidate list.	Thank you for your support.
	
3	2011/10/07	International NGO
ChemSec
Sweden	We fully support the inclusion of this substance into the candidate list.	Thank you for your support. 
	
2	2011/10/07	International NGO
WWF European Policy Office
Belgium	WWF supports the inclusion of this substance in the candidate list owing to its classification as carcinogen 1A.	Thank you for your support.	
1	2011/10/06	Company
Hach Lange GmbH
Germany	Arsenic acid is a component for reagents for analytical reagents. The concentration is < 0.04%. 	Thank you for the information.	

Specific comments on the justification
Number	Date	Submitted by (name, Organisation/MSCA)	Comment	Response	
13	2011/10/13	Member State
Ireland	Arsenic acid is covered by the group entry for “arsenic acid and its salts” (index number 033-005-00-1 of Regulation EC No. 1272/2008) and so is classified as Carc. 1A. Therefore, the Irish CA agrees that the substance meets the criteria for identification as an SVHC in accordance with Article 57 (a) of REACH. 	Thank you for your support.	
5	2011/10/10	Trade union
European Trade Union Confederation
Belgium	Arsenic acid is included in the Trade Union priority List for REACH authorisation.
see :http://www.etuc.org/a/6023
	Thank you for your 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	
12	2011/10/13	Industry or trade association
Switzerland	On the basis of the following extensive section of EU legislation that regulates semiconductor manufacturing operations, ST Microelectronics believes that any potential future nomination or inclusion in the candidate list of Arsenic Acid for semiconductor usage should identify an exemption for the semiconductor sector from an authorization for usage as being the most effective and appropriate measure. 

EU. Indicative Exposure Limit Values in Directives 91/322/EEC, 2000/39/EC, 2006/15/EC, 2009/161/EU, thru OJ (L 338) 87, 17 Dec 2009) 
EU. Directive 98/24/EC on the protection of workers from the risks related to chemical agents, Art. 2(b)(i), OJ (L 131) 11, 5 May 1998 (updated thru table 3.2 of Annex VI to CLP, 5 Sep 2009) 
EU. Directive 92/85/EEC on pregnant workers and workers who have recently given birth or are breastfeeding, O.J. (L 348) 1, 28 Nov 1992 (updated thru table 3.2 of Annex VI to CLP, 5 Sep 2009) 
EU. Directive 94/33/EC on young people at work, OJ (L 216) 12, 20 Aug 1994, as amended by Directive 2007/30/EC, OJ (L 165) 21, 27 Jun 2007 (updated thru table 3.2 of Annex VI to CLP, 5 Sep 2009) 

CE Marking Directives (Machinery 2006/42/EC, Electromagnetic (EMC) 2004/108/EC, Low Voltage (LVD) 2006/95/EC) 
Regulation 1272/2008 CLP of substances and mixtures 
Solvent Emissions Directive 1999/13/EC 
IPPC Directive 2008/1/EC 
Water Framework Directive 2000/60/EC 
Waste Directive 2006/12/EC 

The highly sophisticated and detailed risk management measures employed in manufacturing environment at our premises in Europe for this substance alongside 
•	the highly controlled workplace environment and 
•	the relevant industrial hygiene measurements used in the our manufacturing plants,  
•	the reduced annual consumption  
•	the minimal environmental emissions to air 
•	the rigorous waste management in place

ensure a rigorous and strictly managed usage of arsenic acid.
 
STMicroelectronics would like to comment on the par 
2.3 Other potential uses page 15
3. RELEASES FROM USES page 16
4 CONCLUSIONS ON MANUFACTURE, USES, RELEASES AND EXPOSURE page 18
5 CURRENT KNOWLEDGE ON ALTERNATIVES page 19

2.3 Other potential uses page 15

Within STMicroelectronics European sites the use as processing aid of arsenic acid in diluted preparations of nickel salts is considered in nickel plating process of semiconductors device.
The use of arsenic acid as processing aid does not imply any intentional presence of arsenic in the final semiconductor device (article).  Vapors are collected and treated within the existing acid scrubbing facilities and spent preparations are collected and treated outside plant as liquid hazardous waste. 

3 RELEASES FROM USES page 16

Process descriptors and environmental release categories for the use of arsenic acid in industrial semiconductor industry are based on Exposure Scenarios for the Semiconductor Industry Examples   Reference: ECHA-10-R-005-EN

“Exposure Scenario for surface treatment with inorganic acids in production of semiconductor devices”

Process category (PROC)	
PROC 1 	
Use in rigorously contained processes 
PROC 13	
Treatment of articles by dipping and pouring - Industrial or non industrial setting
PROC 8b  
Transfer of substance or  preparation (charging/discharging) from/to vessels/large containers at dedicated  facilities
Article category (AC)	
NOT APPLICABLE	 
Environmental Release Category (ERC)	
ERC 4 
Industrial use of processing aids in processes and products, not becoming part of articles 

The liquid preparations containing arsenic acid in diluted solution of nickel salts and other chemicals are used within the manufacturing processed of semiconductor devices (‘microchips’) on silicon wafers in fabrication areas (Fab) called ‘clean rooms’ in which the temperature, humidity and airborne particle contamination are strictly controlled. The Fab environment is thousands of times cleaner than a hospital operating room. Uncontrolled chemical vapors and gases are equally controlled as their presence is unacceptable due to their potential for contaminating products, as well as for occupational health and safety concerns. 
In Fabs a number of Risk Management Measures RMM are used to prevent and control chemical release to the environment and exposure of workers. Equipments are enclosed and extraction removes fumes and vapors to air abatement systems done by acid scrubbers to treat the exhaust to prevent undesired emissions to the environment. 
Local exhaust ventilation (LEV) is always used; the LEV is checked routinely, the ducts have visual gauges to indicate flow; when the preparation is manually poured, personal protective equipment (PPE) are worn to reduce the exposure of the worker.  During maintenance operation or chemical sampling PPE are worn as well.

According to voluntary management system in place, at STMicroelectronics sites frequent monitoring of manufacturing process equipment (tools) where arsenic acid is used, are undertaken.  All measurements are undertaken twice a year in the working environment were exposure may occur, although there are not regulatory applicable limits. 
All measurements performed are resulting between 0.000236 mg/m3 and 0.119 mg/m3 arsenic acid in air.

Spent chemical solution containing arsenic acid are collected at site level and sent to waste contractor for waste management in adequate waste treatment plants, thus avoiding any direct liquid release form STMicroelectronics site into the environment.
 
4CONCLUSIONS ON MANUFACTURE, USES, RELEASES AND EXPOSURE page 18
Current quantity used at STMicroelectronics is < 5 ton/y of arsenic acid chemical preparation, equivalent to < 100 kg/y arsenic acid, due to solution dilution. 
Use is very limited to some specific processes key for the fabrication for specific semiconductor devices, used in the field of alternating current control, especially where high currents and voltages are involved.
Site has a permit to operate from their national and local authorities
No direct inclusion of arsenic in finished articles is deriving from this specific use of arsenic acid solution. 
Arsenic acid is added into the Nickel salt for plating solution in order to better control the electro less rate of Nickel plating, ensure reaction stabilization and avoid some peeling of the metal on the final product.
Exposure in the working environment is highly controlled within the manufacturing areas.
Release to the environment is prevented thanks to: 
o	acid scrubber of fume exhaust
o	separate collection of liquid waste
o	rigorous preventive measures in place to prevent nay accidental spillage/release

5 CURRENT KNOWLEDGE ON ALTERNATIVES page 19

The preparation utilized at STMicroelectronics being very peculiar we do not have evidences of available solution yet. The supplier very recently has forecasted a possibility. Although chemical substitution could be available for the time being, there is no evidence that substitution would be feasible, yet.	See response provided above.

The general EU legislation listed does not preclude an inclusion of a SVHC substance into the Candidate list or into Annex XIV. 

Thank you for this useful information.
 
If arsenic acid will be included into annex XIV at a later stage, the implemented risk management measures described would need to be documented in connection with applications for Authorisation.

Thank you for the information about this use.

This information has to be evaluated in the further process of inclusion into Annex XIV and granting of Authorisation.

Thank you for the information relating to tonnage.

Thank you for this information about potential alternatives.
	
7	2011/10/12	Member State
Germany	The German Authorities is actually discussing an exposure-Risk-Relationship (ERB (Abbreviation of the German name Expositions-Risiko-Beziehung)) for arsenic acid and its salt. As soon as it is finalised Germany will forward this document to ECHA.
	Thank you for the information that will be of relevance in the further process of granting authorisations.
	
6	2011/10/12	Company
Germany	Arsenic acid is used in a preparation or solution as an analytical standard for test and measuring instruments, e.g. as calibration standard for ICP and AAS by industrial and professional users.
These applications are laboratory uses 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 filling/packaging of analytical standards for scientific R&D purposes should be exempted from authorisation, too.
	Potential uses that should be exempted must be considered in connection with the proposal for inclusion into Annex XIV. Some general exemptions for Authorisation apply cf. REACH Articles 2, 56, 60.  	
1	2011/10/06	Company
Hach Lange GmbH
Germany	The use is only for professional users allowed. 	Thank you for the information.