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

Substance name:	Hydrazine	
CAS number:	302-01-2, 7803-57-8	
EC number:	206-114-9	

Reason of the submission of Annex XV: CMR

Note: The Response to Comments table (RCOM) has been prepared by the European Chemicals Agency in consultation with the European Commission. 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 a result of 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	
33	2011/04/07	Industry or trade association
Association of Electricity Producers
United Kingdom	About AEP
The Association of Electricity Producers (AEP) represents large, medium and small companies accounting for more than 95 per cent of the UK generating capacity, together with a number of businesses that provide equipment and services to the generating industry.  Between them, the members embrace all of the generating technologies used commercially in the UK, from coal, gas and nuclear power, to a wide range of renewable sources of energy.

The Association welcomes the opportunity to comment on the Consultation on the Proposal for Identification of Anhydrous Hydrazine, EC number 206-114-9 and CAS number 302-01-2 as a Category 1A OR 1B CMR, PBT, vPvB or a substance of an equivalent level of concern.

General Comments

AEP welcomes the opportunity to respond to the consultation on the Proposal for Identification of Anhydrous Hydrazine, EC number 206-114-9 and CAS number 302-01-2 as a Category 1A OR 1B Carcinogenic, Mutagenic or toxic to Reproduction (CMR), Persistent, Bioaccumulative and Toxic (PBT) or very Persistent and very Bioaccumulative (vPvB) or a substance of an equivalent level of concern.  

Hydrazine is a critical component in the operation of power stations as there are no substitutes available that are as effective at scavenging oxygen from water for use within the boiler feed.  Removal of oxygen from boiler feed water prevents the corrosive effects of oxygenated water which ultimately maintains the integrity and efficiency of the plant.  

Hydrazine is used in power stations to abate and control corrosion so as to maintain the plant's performance level and optimise the life time of the power plant.  Oxygen corrosion is one of the most serious problems that can occur in steam generating power plant throughout the entire feed and boiler system.  Hydrazine is essential in maintaining the safe operation of power plants, particularly in the case of nuclear generation.  

The results of the detailed studies undertaken by industry were that no suitable alternative to hydrazine is available.  

Corrosion within the closed system will reduce the effective working life of the power plant.  It has been shown for nuclear power plant that the integrity of the system may become compromised by the use of hydrazine alternatives and could hamper the safe operation of these plants.  In the case of fossil fuel power stations the use of hydrazine alternatives will cause the plant to lose efficiency.  The resultant loss in efficiency per terawatt hour of electricity generated will deliver a higher volume of CO2 to the atmosphere than the same terawatt hour generated using hydrazine.  The loss of efficiency will undermine the European Commission’s targets of reducing anthropogenic carbon dioxide emissions by 2020 in response to climate change.  In all cases early closure of power plant would be required, which has the potential to cause an issue for the security of power supply. 

Hydrazine thermally decomposes at temperatures above 200°C with the rate increasing as the temperature increases.  Boiler temperatures for nuclear and fossil fuel powered stations operate at temperatures above 200°C.  Therefore any excess which does not react with oxygen will disproportionate at high temperatures to yield inert, organism tolerable, substances such as water and nitrogen.

It is understood that as a result of hydrazine being listed as a Substance of Very High Concern (SVHC) that there are a number of possible outcomes for Hydrazine.  We understand that it is likely to be heavily restricted or could even be phased out of common use.  However, REACH regulations specify that special dispensation for use in certain circumstances may be granted if it is shown that there is no sufficient alternative.     

Since 2006, with the introduction of the new COMAH requirements, the majority of hydrazine in the UK is now supplied as 5% solution.

In many thermal power plants zero volume couplings are used and the hydrazine is, in effect, kept in a closed system with the added protection that workers also use respiratory protection when changing containers.

AEP consider that ECHA must give careful consideration of the effects of their decision on the Energy Industry, security of supply and the climate change agenda when making its decision on whether to ban the use of Hydrazine.   

In response to the consultation on Hydrazine AEP would like to stress the importance for the continued use of hydrazine in the different power stations within our sector.   

It is important to distinguish between different types of power stations when considering the possibility of alternatives and the potential for environment emissions and potential health and safety concerns. This is because of the different chemistry, pressures, temperatures and materials in different types of power station boiler. Thus, the type of power plant for which the remark applies should be clearly stated throughout the dossier to avoid remarks appropriate for one type or types being applied incorrectly and misleadingly to other types or to the sector in general. 

Optimised use of hydrazine is and will remain a vital option available to power plant owners and operators to maintain plant performance, availability and life. Operators of such plant are aware of the health and safety considerations which responsible use of hydrazine involves and take appropriate steps to address them.

In our view, hydrazine qualifies for a special dispensation for use in power stations because there are no suitable alternatives resulting in serious consequences if a phase out was applied.  
	Thank you for this information. Provided the substance is identified as SVHC this will be considered in the next step of the authorisation process when deciding which substance to prioritise and recommend for inclusion in Annex XIV	
			See also:
Comment 33 attachment (EnvC53-11 AEP response to ECHA Hydrazine Consultation.doc).doc		
32	2011/04/07	International NGO
Health and Environment Alliance
Belgium	We support the inclusion of hydrazine on the candidate list, on the basis of information in the Annex XV dossier.	Thank you for providing your opinion	
31	2011/04/07	Company
United Kingdom	It is important to distinguish between different types of power stations when considering the possibility of alternatives and the potential for environment emissions and potential health and safety concerns. This is because of the different chemistry, pressures, temperatures and materials in different types of power station boiler. Thus, the type of power plant for which the remark applies should be clearly stated throughout the dossier to avoid remarks appropriate for one type or types being applied incorrectly and misleadingly to other types or to the sector in general. 

Optimised use of Hydrazine is and should remain a vital option available to power plant owners and operators to maintain plant performance, availability and life. Operators of such plant are aware of the health and safety considerations which responsible use of Hydrazine involves and take appropriate steps to address them.
	Thank you for this information. Provided the substance is identified as SVHC this will be considered in the next step of the authorisation process when deciding which substance to prioritise and recommend for inclusion in Annex XIV	
			See also:
Comment 31 attachment (ECHA - Hydrazine - Response 070411.pdf).pdf
Comment 31 CONFIDENTIAL attachment 		
30	2011/04/07	International organisation
Council of Europe, Directorate for the Quality of Medicines and HealthCare
France	We consider that the article 56(3) of the Regulation (EC) No 1907/2006 corr applies to analytical use. Irrespectively, hydrazine should remain on the market as a reagent for the convention on the elaboration of the European Pharmacopoeia (European Treaty Series 50) and the protocol to the elaboration of the European Pharmacopoeia, which are necessary for the implementation of the Directive 2001/82/EC on the community code relating to veterinary medicinal products and Directive 2001/83/EC on the community code relating to medicinal products for human use. 	Thank you for this information. Provided the substance is identified as SVHC this will be considered in the next step of the authorisation process when deciding which substance to prioritise and recommend for inclusion in Annex XIV.

Please note also that use(s) in medicinal products for human or veterinary use within the scope of Regulation (EC)
No 726/2004, Directive 2001/82/EC and Directive 2001/83/EC (REACH Art. 2(5a)) as well as use in scientific research and development (REACH Art. 56(3) (including use as analytical reagent) are exempted from the authorisation requirements.	
27	2011/04/07	Company
SSE
United Kingdom	SSE welcomes the opportunity to respond to the consultation on the Proposal for Identification of Anhydrous Hydrazine, EC number 206-114-9 and CAS number 302-01-2 as a Category 1A OR 1B Carcinogenic, Mutagenic or toxic to Reproduction (CMR), Persistent, Bioaccumulative and Toxic (PBT) or very Persistent and very Bioaccumulative (vPvB) or a substance of an equivalent level of concern.  

Hydrazine is a critical component in the operation of power stations as there are no substitutes available that are as effective at scavenging oxygen from water for use within the boiler feed.  Removal of oxygen from boiler feed water prevents the corrosive effects of oxygenated water which ultimately maintains the integrity and efficiency of the plant.  

Hydrazine is used in power stations to abate and control corrosion so as to maintain the plant's performance level and optimise the life time of the power plant.  Oxygen corrosion is one of the most serious problems that can occur in steam generating power plant throughout the entire feed and boiler system.  Hydrazine is essential in maintaining the safe operation of power plants, particularly in the case of nuclear generation.  

The results of the detailed studies undertaken by industry were that no suitable alternative to hydrazine is available.  

Corrosion within the closed system will reduce the effective working life of the power plant.  It has been shown for nuclear power plant that the integrity of the system may become compromised by the use of hydrazine alternatives and could hamper the safe operation of these plants.  In the case of fossil fuel power stations the use of hydrazine alternatives will cause the plant to lose efficiency.  The resultant loss in efficiency per terawatt hour of electricity generated will deliver a higher volume of CO2 to the atmosphere than the same terawatt hour generated using hydrazine.  The loss of efficiency will undermine the European Commission’s targets of reducing anthropogenic carbon dioxide emissions by 2020 in response to climate change.  In all cases early closure of power plant would be required, which has the potential to cause an issue for the security of power supply. 

Hydrazine thermally decomposes at temperatures above 200°C with the rate increasing as the temperature increases.  Boiler temperatures for nuclear and fossil fuel powered stations operate at temperatures above 200°C.  Therefore any excess which does not react with oxygen will disproportionate at high temperatures to yield inert, organism tolerable, substances such as ammonia, water and nitrogen.

It is understood that as a result of hydrazine being listed as a Substance of Very High Concern (SVHC) that there are a number of possible outcomes for Hydrazine.  We understand that it is likely to be heavily restricted or could even be fazed out of common use.  However, REACH regulations specify that special dispensation for use in certain circumstances may be granted if it is shown that there is no sufficient alternative.     

In our view, hydrazine qualifies for a special dispensation for use in power stations because there are no suitable alternatives resulting in serious consequences if a phase out was applied.  

SSE consider that ECHA must give careful consideration of the effects of their decision on the Energy Industry, security of supply and the climate change agenda when making its decision on whether to ban the use of Hydrazine.   

In response to the consultation on Hydrazine SSE would like to stress the importance for the continued use of hydrazine in the different power stations within our sector.   

It is important to distinguish between different types of power stations when considering the possibility of alternatives and the potential for environment emissions and potential health and safety concerns. This is because of the different chemistry, pressures, temperatures and materials in different types of power station boiler. Thus, the type of power plant for which the remark applies should be clearly stated throughout the dossier to avoid remarks appropriate for one type or types being applied incorrectly and misleadingly to other types or to the sector in general. 

Optimised use of hydrazine is and will remain a vital option available to power plant owners and operators to maintain plant performance, availability and life. Operators of such plant are aware of the health and safety considerations which responsible use of hydrazine involves and take appropriate steps to address them.
	Thank you for this information. Provided the substance is identified as SVHC this will be considered in the next step of the authorisation process when deciding which substance to prioritise and recommend for inclusion in Annex XIV.	
26	2011/04/07	International NGO
WWF European Policy Office
Belgium	WWF supports the inclusion of this substance in the candidate list owing to its classification as carcinogen category 1B.	Thank you for providing your opinion	
25	2011/04/06	Industry or trade association
Eurospace
France	Concerns expressed in the name of the European Space manufacturing industry.	See answer in part II ‘Comments and responses to comments on uses, exposures, alternatives and risks’	
24	2011/04/06	Member State
Norway	The Norwegian CA supports that Hydrazine should be identified as a substance of very high concern and should be included in the Candidate list.	Thank you for providing your opinion	
23	2011/04/06	Member State
Netherlands	The NL-CA supports the proposal to include hydrazine in the candidate list of substances of very high concern. 	Thank you for providing your opinion	
22	2011/04/06	Company
Lansdowne ChemicalsPLC
United Kingdom	Please see the confidental attachment	Thank you for this information. Provided the substance is identified as SVHC this will be considered in the next step of the authorisation process when deciding which substance to prioritise and recommend for inclusion in Annex XIV	
			See also:
Comment 22 CONFIDENTIAL attachment 		
19	2011/04/06	National Authority Allgemeine Unfallversicherungsanstalt
Austria	We support Hydrazine being identified as a substance of very high concern. We also agree with a grouping concept that allows also regulating Dihydrazine sulphate (CAS-No: 13464-80-7) and Hydrazine hydrochloride (CAS-No: 2644-70-4) within the same authorisation process.

R&D is up to 1 t/a exempted from the authorisation part of REACH regulation. Therefore this cannot be a hindering reason for a stricter regulation of this substance.
	Thank you for providing your opinion.
Regarding the grouping we are not sure what you mean by this comment as this is not addressed in the report.
Provided that the substance is identified as SVHC, you will have the opportunity to clarify this further in the follow-up stages of the risk management process.	
18	2011/04/06	Industry or trade association
EURELECTRIC
Belgium	It is of utmost importance for power plants to prevent corrosion. To prevent corrosion, hydrazine is widely used as a reducing chemical agent. Hydrazine is used in strictly regulated manners in closed processes where very little potential of exposure exists. There is no alternative covering all aspects of hydrazine.

It is important to distinguish between different types of power stations when considering the possibility of alternatives and the potential for environment emissions and potential health and safety concerns. This is because of the different chemistry, pressures, temperatures and materials in different types of power station boiler. Thus, the type of power plant for which the remark applies should be clearly stated throughout the dossier to avoid remarks appropriate for one type or types being applied incorrectly and misleadingly to other types or to the sector in general. 

Optimised use of hydrazine is and will remain a vital option available to power plant owners and operators to maintain plant performance, availability and life. Operators of such plant are aware of the health and safety considerations which responsible use of hydrazine involves and take appropriate steps to address them. 
	Thank you for this information. Provided the substance is identified as SVHC this will be considered in the next step of the authorisation process when deciding which substance to prioritise and recommend for inclusion in Annex XIV	
			See also:
Comment 18 attachment (Eurelectric Additional comments hydrazine.pdf).pdf		
14	2011/04/05	Member State
Belgium	Belgium supports the identification of Hydrazine as SVHC according to article 57(a).	Thank you for providing your opinion	
13	2011/04/05	Industry or trade association
Federchimica
Italy	p.1 We are Federchimica (the Italian Federation of the chemical industry). Federchimica is a member of Confindustria (General Confederation of the Italian Industry) and CEFIC (European Chemical Industry Council) too. At the present time 1300 companies, with a total of 90.000 employees, are part of Federchimica. They are grouped into 16 Associations. One of this is Aschimfarma the Italian Association of producers of pharmaceutical fine chemicals. The Aschimfarma’s Members produce organic chemical substances obtained through high technological industrial processes, both in the development and production phases. Italy holds a primary position in the world market in this sector and exports more than 85% of its production to more than 90 countries. About  65 companies associated to ASCHIMFARMA are characterised by their strict application of good manufacturing practices (GMP) which allows them to reach the highest levels of quality and reliability. 
After a deep evaluation of the document reporting reasons why the Annex XV dossier was submitted (PBT/vPvB, CMR, equivalent concern), we noted that in Paragraph 4.1 “Overview of Hydrazine Uses”, Table 4.1 (Pag. 28), in the section dedicated to hydrazine hydrate, application area of chemical synthesis, no uses are reported for the use of hydrazine as reducing agent in the selective reduction of carbonyl to alkane group (Wolff-Kishner reduction).
This reaction is widely described in literature since 1939 and, still today, many chemical-pharmaceutical companies are using Hydrazine in their processes, e.g in the manufacture of steroid derivatives, whose particular spatial configuration doesn’t allow any other hydrazine derivative substance to be used with comparable results (ref. table 4.2).
In the chemical-pharmaceutical field, Wolff Kishner reduction, i.e. using hydrazine as intermediate to form the corresponding hydrazone, successively decomposed to form gaseous nitrogen, is a useful and quite common chemical reaction.
Hydrazine in the chemical pharmaceutical field, specifically in Wolff Kishner reaction, should be considered as an intermediate and, in accordance with Article 3(15) of the REACH Regulation and its  definition of intermediate (“a substance that is manufactured for and consumed in or used for chemical processing in order to be transformed into another substance (hereinafter referred to as synthesis. The status of a substance as an intermediate is in fact not specific to its chemical nature but to how it is used following manufacturing”), it should not be subject to authorisation (i.e. Title VII – Authorisation - does not apply) (Article 2 (8)(b)).
Based on your report, as shown in section 4.1.3.1” Information from Literature – Historical Information on Global Consumption”, it appears a very limited use in the pharmaceutical field (2003, Japan) corresponding to the 0.6%. We believe that this data grossly underestimates real consumption of this substance in chemical-pharmaceutical field, as we know that hydrazine hydrate is widely applied in processes carried out in Europe, but data on this are lacking in the report. Since pharmaceutical synthesis is subjected to REACH, an eventual shortage, at first, and a future impossibility to find hydrazine in the European market could push chemical pharmaceutical companies production sites, still in Europe, to stop their production of active pharmaceutical ingredients here, and move their production outside the EU boundaries. That could be for the effect of the simply inclusion of the substance in Candidate List as the experience is showing for substances just inserted in Candidate List.
It should be noted that, being pharmaceuticals outside REACH scope, and since their administration as drugs is essential for the treatment of some diseases, the same pharmaceutical products will reach the European market as finished products but no control on the safety of pharmaceutical production will be ever achieved, i.e. the only effect of the inclusion in Candidate List or in any case the  authorisation  procedure for hydrazine, at least for the pharmaceutical sector, will be the socioeconomic impact caused by the displacement of EU based pharmaceutical industry outside EU.

	Thank you for this information. Provided the substance is identified as SVHC this will be considered in the next step of the authorisation process when deciding which substance to prioritise and recommend for inclusion in Annex XIV	
			See also:
Comment 13 attachment (Idrazina FDC.doc).doc		
11	2011/04/05	Member State
Sweden	The Swedish CA agrees that hydrazine, being classified as Carc. 1B, 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 providing your opinion	
8	2011/04/01	Company
Belgium	p. 36 and p. 89
As a power generation company, we use hydrazine hydrate for reduction of oxygen in our steam systems. This reduction of oxygen is necessary for corrosion control. At present there is no good alternative available for hydrazine.	Thank you for this information. Provided the substance is identified as SVHC this will be considered in the next step of the authorisation process when deciding which substance to prioritise and recommend for inclusion in Annex XIV	
7	2011/04/01	Individual
United States	The report should be submitted to a committee of experts for peer review.	The substance is classified as a carcinogen, Carc. 1B according to Regulation (EC) No 1272/2008 in Annex VI, part 3, Table 3.1. As a consequence the substance fulfils Article 57(a) of Regulation (EC) 1907/2006 (REACH) and can be identified as a substance of very high concern following article 59 of the same regulation.	
			See also:
Comment 7 attachment (ECHA-EWS-critique of ECHA-SVHC-Hydrazine-2011.pdf).pdf		
5	2011/03/30	Company
Lanxess Deutschland GmbH as lead company/registrant of the REACH hydrazine consortium. Members: Arkema France, Otsuka-MGC, Lanxess
Germany	General comment on the Annex XV dossier on hydrazine from the REACH hydrazine consortium

Hydrazine and hydrazine hydrate are mainly used in closed systems and under strictly controlled conditions (80 % intermediate and monomer use according to the annex XV dossier). These uses are not concerned by the authorization process.

Other uses mentioned in the Annex XV dossier as

- corrosion inhibitor in water treatment (including nuclear and thermal power generation plants    
   as well as water steam circulation for district heating and cooling)
- reducing agent in the deposition of metals on plastics and glass 
- reducing agent in precious metal and basic metal recovery 
- reducing agent in purification of chemical reagents 
- stabilizing agent in aromatic amines (for subsequent paint/ink manufacture) 
- laboratory chemical reagent 

would be subjected to the authorization process if hydrazine and hydrazine hydrate are included in Annex XIV. However, these intended uses are performed according to standard industrial procedures and occur in closed systems as well or/and are related to very low end use concentrations (<0.1 %). 

Furthermore, based on their hazard profiles, hydrazine and its hydrate have no broad use pattern. This leads firstly to a relative small volume for hydrazine applications and secondly to the restriction of these applications to a limited group of workers. They exclusively work under strict occupational safety regulations resulting in a low, and regularly monitored, extent of exposure only. Because the classification of hydrazine and its hydrate as carcinogens (Cat 1B) is valid for many years, end users are consequently informed by conclusive MSDS, additional information and rules provided by the suppliers as well as standards given by authorities of member states (for example relevant German regulations are TRGS 608, BGI 567 (ZH1/127), BGV C14). Available techniques allow the industrial users to comply with the threshold limit values as proposed in the REACH dossier.

Alternatives to the use of hydrazine and the hydrate have been explored for a long time, but no alternatives will be in place in the near future. As the actual uses are indispensable for the industry, the users have elaborated safe techniques for the application enabling a safe handling of hydrazine and hydrazine hydrate.

Therefore from the Consortium’s point of view, hydrazine and hydrazine hydrate in general are of low priority with respect to the Annex XIV inclusion process. Substance characteristics like
- a high tonnage band
- a broad use pattern 
- a significant extent of exposure and
- the availability of using alternative substances
would trigger the prioritization of such a substance for the inclusion into Annex XIV. These characteristics do not apply to hydrazine or hydrazine hydrate. 

The carcinogenicity of hydrazine and hydrazine hydrate - as observed in animal studies - is assumed to be a secondary effect after a primary cell damage (for a more detailed argumentation see below “Specific Comment on Part I Justification”). These cytotoxic effects are observed at significant lower exposure concentrations than the carcinogenic effect. Working out a sound limit value for the primary effects will be a prerequisite for the evaluation of the workers safety situation in different applications of hydrazine. This is in line with the recent conclusions of the SCOEL (Scientific Committee on Occupational Exposure Limits) who highlighted the lack of adequate data to derive a health based OEL for Hydrazine. (SCOEL/SUM 164, April 2009).

To strengthen the data base and to identify the cytotoxicity threshold, a new repeated dose inhalation study is proposed in the dossier. The Consortium would appreciate if this testing proposal is evaluated by ECHA with high priority as the outcome of the planned study could strongly influence the overall assessment of hydrazine. 

In summary, from the Consortium’s point of view – taking into account the low priority of hydrazine for annex XIV inclusion as referred above as well as the uncertainty concerning the primary mode of action - the decision on an inclusion of hydrazine in the candidate list should be postponed until the results of the proposed test will be available.    
	Thank you for this information. Provided the substance is identified as SVHC this will be considered in the next step of the authorisation process when deciding which substance to prioritise and recommend for inclusion in Annex XIV.

Regarding the hazard profile of the substance we will inform our evaluation colleagues about your testing proposal request. However the substance is classified as Carcinogen 1B and can therefore be identified as SVHC and included in the candidate list.	
6	2011/03/30	Member State
Germany	In general the dossier is very well written and the information is presented in a structured way. The German CA supports ECHA’s effort for the identification of hydrazine as an SVHC. The matter addressed in the TRGS 608 (BAuA (1991)) about alternative substances and techniques for hydrazine in water and steam systems, representing the situation in Germany, is well described in the Annex XV dossier.	Thank you for providing your opinion	
3	2011/03/28	Company
Italy	Dear Sirs, 

after a deep evaluation of the document reporting reasons why the Annex XV dossier was submitted (PBT/vPvB, CMR, equivalent concern), we noted that in Paragraph 4.1 “Overview of Hydrazine Uses”, Table 4.1, in the section dedicated to hydrazine hydrate, application area of chemical synthesis, no uses are reported for the use of hydrazine as reducing agent in the selective reduction of carbonyl to alkane group (Wolff-Kishner reduction).
This reaction is widely described in literature since 1939 and, still today, many chemical-pharmaceutical companies are using Hydrazine in their processes, e.g in the manufacture of steroid derivatives, whose particular spatial configuration doesn’t allow any other hydrazine derivative substance to be used with comparable results (ref. table 4.2).	Thank you for this information. Provided the substance is identified as SVHC this will be considered in the next step of the authorisation process when deciding which substance to prioritise and recommend for inclusion in Annex XIV	
			See also:
Comment 3 attachment (IV-Non confidential attachment.pdf).pdf
Comment 3 CONFIDENTIAL attachment 		
2	2011/03/25	Company
France	No general comments about this Annexe XV which is well documented	Thank you for this information. Provided the substance is identified as SVHC this will be considered in the next step of the authorisation process when deciding which substance to prioritise and recommend for inclusion in Annex XIV	
			See also:
Comment 2 attachment (LE 16-11SME   ECHA inquiry for Hydrazine.pdf).pdf		
1	2011/03/15	Trade union
European Trade Union Confederation
Belgium	ETUC supports the identification of hydrazine as SVHC.	Thank you for providing your opinion	

Specific comments on the justification
Number	Date	Submitted by (name, Organisation/
MSCA)	Comment	Response	
34	2011/04/07	Company
EDF
France	The term "diamine" could be added to the list of synonyms for hydrazine.
Given the large differences between use of anhydrous hydrazine and hydrazine hydrate, it is proposed to add a table of physico-chemical properties of hydrazine hydrate. The values given below are valid for hydrazine hydrate at about 100%.

Property	Value
Formula	N2H4·H2O (no CAS 7803-57-8)N2H4·xH2O (no CAS 10217-52-4)
Chemical structure	 Hydrazine hydrate
Molécular weight	50,6 g/mol (no CAS 7803-57-8)
Physical state at 20°C and 120,3 kPa 	colorless liquid
Melting point	- 51,7°C
Boiling point at 1013 hPA	120,1°C
Vapor pressure	20 hPa at 20°C
Water solubility	Miscible 
Log Kow(partition coefficient n-octanol-eau)	- 3,8 
dynamic viscosity	1,5 mPa. S at 20°C
Flashpoint	75°C coupelle ouverte
                 33°C coupelle fermée	Thank you for this information which will be added in the report. 	
			See also:
Comment 34 attachment (DP-6 April 2011 hydrazine EDF résponse VF_EN.pdf).pdf		
33	2011/04/07	Industry or trade association
Association of Electricity Producers
United Kingdom	No comment. 	Thank you for this information. Provided the substance is identified as SVHC this will be considered in the next step of the authorisation process when deciding which substance to prioritise and recommend for inclusion in Annex XIV	
			See also:
Comment 33 attachment (EnvC53-11 AEP response to ECHA Hydrazine Consultation.doc).doc		
31	2011/04/07	Company
United Kingdom	No comment.	Thank you for this information. Provided the substance is identified as SVHC this will be considered in the next step of the authorisation process when deciding which substance to prioritise and recommend for inclusion in Annex XIV	
			See also:
Comment 31 attachment (ECHA - Hydrazine - Response 070411.pdf).pdf
Comment 31 CONFIDENTIAL attachment		
28	2011/04/07	Member State
United Kingdom	We have comments on 2 issues:

1) Is this the most appropriate risk management option for this substance?

Hydrazine was proposed as an SVHC by the Commission and the Annex XV dossier prepared by ECHA. As no RMO paper was produced it is unclear what the intention is, what options were considered and whether authorisation is the intended outcome? 

Many of the uses are intermediate uses however; some are not marked as such in the dossier. For the uses "Reducing agent in precious metal recovery" & "Reducing agent in basic metal recovery" the intention is to produce the metal and the hydrazine is consumed in this as a reducing agent. This is an exact parallel to an example of using lithium aluminium hydride as a reducing agent in the ECHA guidance on intermediates. Similarly, the use" Reducing agent in purification of chemical reagents" could be viewed as intermediate use as the purification process is part of the synthesis. In addition there are a number of defence issues with certain uses. 
 
Thus, many of the uses are exempt from authorisation and in the remaining major use (water treatment for power stations) alternatives are difficult to bring in. Therefore, Candidate listing would appear to achieve little in reducing risk. Could restriction of certain uses be considered instead?

2) If candidate listing is the outcome, will the identity of the substance(s) covered be clear?

The identity of hydrazine itself and its CMR classification are not in any doubt, so it could proceed directly to the SVHC list without discussion. 

However, as indicated in the dossier, pure hydrazine is rarely supplied as such it is usually supplied as a solution in water. Formally, the hydrazine reacts with the water to form a different substance, hydrazinium hydroxide (formula N2H5+ OH-); but this cannot be isolated from water and is regarded as a simple solution of hydrazine in water (often called hydrazine hydrate).  Hydrazinium salts can be isolated and some are listed on EINECS.  

Whilst the dossier considers hydrazine and all hydrated forms it is essential that this is clear on the candidate list entry. The hydrate has its own CAS numbers (7803-57-8 & 10217-52-4) and it could be claimed that these are not covered if the SVHC listing simply says hydrazine. 

We have seen a similar issue with chromium trioxide and chromic acids where the acids are not subject to registration as they are only formed when the chromium trioxide is added to water (again they can't be isolated, but salts can). In this case separate dossiers were submitted, one for the chromium trioxide and another for the acids obtained from it. Both were added to the SVHC list. Perhaps there should be 2 entries in this case.

We also have the following editorial comment:
 
In Table 4.11 reference is made to the 'manufacture' of hydrazine hydrate. This is potentially misleading  as it implies that manufacture in the REACH sense is taking place.  It  can be argued that manufacture does take place when hydrazine is added to water, but it is often produced in solution. Perhaps the word 'manufacture' could be substituted for 'production' and this avoids any conflict with the REACH definition of manufacture. 	Thank you for your comment.

There was insufficient time to prepare an RMO analysis between the request by the COM to prepare the Annex XV dossier and the submission deadline. However, we intend to make an RMO paper available before the next step in the authorisation process provided the substance is included in the Candidate List.

Regarding your second point we acknowledge your concern and are looking further into the issue. At this stage further investigation is still needed but a proposal will be available at the next MSC meeting in May. 	
27	2011/04/07	Company
SSE
United Kingdom	No comment.	-	
25	2011/04/06	Industry or trade association
Eurospace
France	Hydrazine is a key component for Space industry, used for in-space motorisation of spacecraft.	Thank you for this information. Provided the substance is identified as SVHC this will be considered in the next step of the authorisation process when deciding which substance to prioritise and recommend for inclusion in Annex XIV	
18	2011/04/06	Industry or trade association
EURELECTRIC
Belgium	For fossil fired power plants, hydrazine is used in the water- steam cycle for start-up, shut-down, upset conditions and conservation (depending on customer demand but not necessarily recommended by manufacturers). Carbohydrazide is applied in the closed cooling water systems.

In Nuclear Power Plants hydrazine is used to control corrosion in the primary- and secondary circuit and in auxiliary systems, although in this case it is not consistent for all operators.  Hydrazine reacts with oxygen to form water and nitrogen, thus reducing the oxygen concentration in the mentioned circuits. An excess of hydrazine decomposes to ammonia, which elevates the pH-value of the water (alkalizing effect). Both effects reduce corrosion of systems and components. Hydrazine is consumed by both reactions. Effluents normally contain very low concentrations. Limiting values exist. Appropriate measures are taken to reduce the impact on the environment by minimizing the discharges (destroying hydrazine with oxidizing agents). 

Alternative products that have been tested or evaluated have several disadvantages. For example, to increase the pH-value some of them contain other alkalizing substances like morpholine. The decomposition products of these substances contaminate the water and raise its conductivity thus perturbing the monitoring system of the circuits. Some of them form together with ubiquitous corrosion products sludge that reduces the heat transfer capacity of heat transfer surfaces. In most cases they also contain hydrazine to remove oxygen (“hidden” hydrazine).

‘Material safety data sheets’ (MSDS) are handed out as an example for risks and handling.	Thank you for this information. Provided the substance is identified as SVHC this will be considered in the next step of the authorisation process when deciding which substance to prioritise and recommend for inclusion in Annex XIV	
			See also:
Comment 18 attachment (Eurelectric Additional comments hydrazine.pdf).pdf		
13	2011/04/05	Industry or trade association
Federchimica
Italy	p.2 As far as we know, there are at least some European (mainly located in Italy) and extra-European (Far-East) chemical pharmaceutical companies that apply in their production processes of steroidal structure intermediates the Wolff Kishner reduction using as reagent hydrazine hydrate. Such intermediates are important substances in many active pharmaceutical ingredients.
The chemistry of this reaction is widely reported in many literature articles since early thirties.  
The most probable mechanism, as reported, involves the elimination of an alkyl anion as the final step (for the step please see the attachment in section IV) 
The mechanism first involves the formation of the hydrazone in a way that is probably analogous to the formation of an imine. Successive deprotonation results always in gas nitrogen development, being such gas formation the thermodynamic driving force. 
The Huang-Minlon modification is a convenient modification of the Wolff–Kishner reduction and involves heating the carbonyl compound, potassium hydroxide, and hydrazine hydrate together in ethylene glycol in a one-pot reaction. 
The development of the industrial process applying such Wolff Kishner reduction is linked to its suitability to obtain the removal of keto group without giving origin to by-products that form in other kinds of reduction – see Clemmensen reaction with formation of carbinols and unsatured compounds-, if the conditions of reactions are strictly controlled. 
The different results obtained applying both the Clemmensen and Wolff Kishner reduction are described in Organic reactions , Wiley & Sons, vol. IV (David Todd, Amberst College), chapter 8, Table 1, pag.387.  
	Thank you for this information. Provided the substance is identified as SVHC this will be considered in the next step of the authorisation process when deciding which substance to prioritise and recommend for inclusion in Annex XIV	
			See also:
Comment 13 attachment (Idrazina FDC.doc).doc		
9	2011/04/04	Member State
Ireland	Hydrazine is classified as Carc. 1B according to Regulation EC No. 1272/2008, and 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 providing your opinion	
7	2011/04/01	Individual
United States	I do not see any justification to list hydrazine as an SVHC carcinogen.	The substance is classified as a carcinogen, Carc. 1B according to Regulation (EC) No 1272/2008 in Annex VI, part 3, Table 3.1. As a consequence the substance fulfils Article 57(a) of Regulation (EC) 1907/2006 (REACH) and can be identified as a substance of very high concern following Article 59 of the same regulation.	
			See also:
Comment 7 attachment (ECHA-EWS-critique of ECHA-SVHC-Hydrazine-2011.pdf).pdf		
5	2011/03/30	Company
Lanxess Deutschland GmbH as lead company/registrant of the REACH hydrazine consortium. Members: Arkema France, Otsuka-MGC, Lanxess  
Germany	Specific Comment on Part I of the Annex XV Dossier on Hydrazine from the REACH hydrazine consortium (members: LANXESS Deutschland GmbH, ARKEMA France, Otsuka-MGC Chemical Company) 

As mentioned in the Annex XV dossier the reason for the proposal to add hydrazine to the candidate list is the existing classification as carcinogen category 1B. Whereas we agree that by this the proposal is in line with Article 57(a) of REACH we would like point to the following aspects that in our view argue against a high priority for inclusion in case of hydrazine:

Hydrazine is classified as a carcinogen (Cat 2 carcinogen, R 45 (R67/548/EEC); Carcinogenicity Class 1B; Hazard Statement H350 (Regulation No. 1272/2008 (GHS). For the overall evaluation it is important that the carcinogenic effects of hydrazine have been shown only with maximally tolerated unambiguously toxic doses or locally irritating concentrations. Tumour responses are limited to the first site of contact in inhalation studies (nasal cavity) or the first organ of systemic availability after oral dosing (liver), respectively. Studies on the mode of action led to the conclusion that it is plausible that the liver tumours after long-term high dose exposure are secondary to liver toxicity. Regarding the local effects after inhalation exposure from the dose-response assessment (irritation threshold with a LOAEC of 0.066 mg/m³ much lower than the concentration of 1.3 mg/m³ leading to tumours) it can be derived that a direct cytotoxic mechanism is most probably dominant. Hydrazine showed evidence of a genotoxic activity mainly in in-vitro assays, but the potential seems to be weak based on the fact that positive responses were not very pronounced and mainly in cytotoxic concentrations and that the in-vivo studies do not give a clear positive response even at very high doses. Therefore, even if some role of genotoxicity at very high doses can not be excluded based on the available data the overall weight of evidence points to a non-genotoxic mechanism for the tumour responses in animal experiments. Furthermore, an epidemiological study from the hydrazine production currently available does not show any significant excess of cancer. Even with their limited scope (essentially because of the restricted size of the population sample examined), this survey does not allow us to conclude whether or not hydrazine is carcinogenic to man. Nevertheless, it is very unlikely that it would be a powerful carcinogen as, if this would be the case, visible increases in cancer cases would have been observed despite the small sample of population surveyed. Therefore, hydrazine should be regarded as a substance that showed a weak carcinogenic activity in animal studies most probably as a consequence of cytotoxicity. Genotoxicity is regarded not to be the main cause for the tumour response observed. Instead, local toxicity is regarded to be of main importance with tumour development as secondary response.
In such a situation avoiding of the primary effect (local toxicity) should be the main objective of work place safety. However, the database on repeated dose inhalation toxicity has some limitations especially regarding the irritation threshold (not a clear dose response relationship), whereas irritation is the assumed most relevant effect due to hydrazine after repeated inhalation. To strengthen the database and to assist the human health risk assessment and the DNEL derivation, a testing proposal is proposed within the REACH dossier that will examine the irritation threshold after repeated inhalation and will aim to define the most sensitive level of the respiratory tract (nose, larynx, trachea, bronchioles or deep lung) after repeated exposure, as well as the threshold for irritation after repeated exposure and on the respective dose-response relationship. At a later step an additional study on in vivo genotoxicity might be helpful to clarify the mode of action. 
We would appreciate to receive a response to the testing proposal as soon as possible, so that we can initiate the study. As this planned experimental work could strongly influence the overall assessment of hydrazine in our view the decision on an inclusion of hydrazine in the candidate list should be postponed.
	See reply to your comment in the previous section. 	
3	2011/03/28	Company
Italy	As far as we know, there are at least some European (mainly located in Italy) and extra-European (Far-East) chemical pharmaceutical companies that apply in their production processes of steroidal structure intermediates the Wolff Kishner reduction using as reagent hydrazine hydrate. Such intermediates are important substances in many active pharmaceutical ingredients.
The chemistry of this reaction is widely reported in many literature articles since early thirties.  
The most probable mechanism, as reported, involves the elimination of an alkyl anion as the final step. The mechanism first involves the formation of the hydrazone in a way that is probably analogous to the formation of an imine. Successive deprotonation results always in gas nitrogen development, being such gas formation the thermodynamic driving force. 
The Huang-Minlon modification is a convenient modification of the Wolff–Kishner reduction and involves heating the carbonyl compound, potassium hydroxide, and hydrazine hydrate together in ethylene glycol in a one-pot reaction. 
The development of the industrial process applying such Wolff Kishner reduction is linked to its suitability to obtain the removal of keto group without giving origin to by-products that form in other kinds of reduction – see Clemmensen reaction with formation of carbinols and unsatured compounds-, if the conditions of reactions are strictly controlled. 
The different results obtained applying both the Clemmensen and Wolff Kishner reduction are described in Organic reactions , Wiley & Sons, vol. IV (David Todd, Amberst College), chapter 8, Table 1, pag.387.  
	Thank you for this information. Provided the substance is identified as SVHC this will be considered in the next step of the authorisation process when deciding which substance to prioritise and recommend for inclusion in Annex XIV	
			See also:
Comment 3 attachment (IV-Non confidential attachment.pdf).pdf
Comment 3 CONFIDENTIAL attachment		
2	2011/03/25	Company
France	No specific comments about Part 1 "Justification"	Thank you for this information. Provided the substance is identified as SVHC this will be considered in the next step of the authorisation process when deciding which substance to prioritise and recommend for inclusion in Annex XIV	
			See also:
Comment 2 attachment (LE 16-11SME   ECHA inquiry for Hydrazine.pdf).pdf		
1	2011/03/15	Trade union
European Trade Union Confederation
Belgium	Hydrazine is included in the Trade Union Priority List for REACH authorisation (entry No 58)
see http://www.etuc.org/a/6023	Thank you for this information	

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	
33	2011/04/07	Industry or trade association
Association of Electricity Producers
United Kingdom	Section 1.3:  AEP supports the identification of thermal power station boiler and steam generator water treatment as an important use.

Section 1.4:  Alternatives in boiler water treatment – AEP consider it inappropriate to deal with the power sector in an undifferentiated way.  There is a distinct need to consider a variety of conditions occurring in different types of plant. The power sector in general feels that reducing concentration of hydrate solution used and total amounts stored on site coupled with appropriate equipment and working practices, is sufficient to manage operational site Health & Safety risks whilst ensuring plant performance.

Section 4.1.1: AEP supports the identification of use of hydrazine hydrate for water treatment in the power generation sector including AGR and PWR nuclear plant.

Section 5.1.1.1:  AEP is surprised by the reference to the data suggesting apparent emission of hydrazine in some water discharges of Canadian nuclear plant. AEP do not consider Canadian nuclear power plant representative of European power plant or operational practices known to us. We note and support the comments of Company 8, 32 and 52 which indicate that no environmental emission will occur as hydrazine will break down into inert, organism tolerable, substances such as water and nitrogen at temperatures above 200°C.  

Section 5.1.1.3: AEP considers this conclusion incorrect and potentially misleading.  While it is impossible to assert that no release can ever occur, in our opinion, we do not anticipate discharge of hydrazine during operation.  Furthermore, with appropriate equipment and working practices the risk of release during storage and handling of the product is appropriately managed.

Section 5.2.2.1: AEP supports the HSE characterisation of ‘events’.  However, it is more appropriate to describe them as ‘potential exposure events’ when all the controls are taken into account.

Since 2006, with the introduction of the new COMAH requirements, the majority of hydrazine in the UK is now supplied as 5% solution.

In many thermal power plants zero volume couplings are used and the hydrazine is, in effect, kept in a closed system with the added protection that workers also use respiratory protection when changing containers.

Section 5.2.2.3:  AEP would be grateful for clarification with regard to whether the calculations acknowledge the use of zero volume couplings or not. AEP considers that this is important as it has the potential to influence the risk of potential exposure. 

Section 6.1.1.1 and 2:  Discussion of alternative chemicals – AEP is of the opinion that the literature provides different views on the effectiveness of oxygen removal. 

AEP would request that the full carbohydrazide reactions are included, as they show that the reaction goes via hydrazine.  In considering the feasibility of alternatives there should be increased recognition of the requirements of modern high pressure power sector units operating in a commercial and competitive market  particularly regarding the plant flexibility required (e.g. 2-shifting) and the physical requirements of the steam turbine manufacturers which are required to be complied with for warranty/guarantee issues.

Section 6.1.1.3:  Even with newly constructed power stations there can be significant issues with oxygen ingress which requires the use of oxygen scavenger.  This can be a particular problem with units incorporating air cooled condensers.  Modern designs of CCGT power plants incorporating once through air coolers have stringent limits on dissolved oxygen particularly when chloride is present due to the synergistic impact on corrosion. This necessitates the use of an oxygen scavenger with no impact on cation conductivity analysers used for the analysis of low level chlorides in water; the only oxygen scavenger which meets this requirement is hydrazine.

Section 6.1.2:  Experience of alternatives – AEP supports the position of Company 32 which has undertaken a review and concluded hydrazine is the best option and optimised management of it. 

Additional comments

For completeness, some of the information below includes material that was provided during the pre-consultation process in Nov 2010.

1.	Nuclear
1.1	Advanced Gas-Cooled Reactor (AGR)

Within any power station the control of corrosion is critical to maintain the plant's performance, availability and life while obtaining the most from capital investment in the plant.  This is especially important in the case of AGR boilers.  AGR boilers consist of once through tubes comprising of three different metals: 

•	Mild steel at the economizer;
•	9Cr steel in the evaporator; and 
•	316 stainless Steel in the superheater and reheater sections.

Oxygen corrosion is one of the most serious problems that can occur in steam generating plant.  Such corrosion can take place throughout the entire feed and boiler system.  Some oxygen (in the range 5-100 ppb) is required at the economizer inlet to promote the formation of protective haematite layer.  However, should oxygen reach the austenitic sections then significant levels of stress corrosion cracking and ultimately tube failure would quickly occur.  This would have significant operational issues as tube failures are not generally repairable and early Station closure could result.  To ensure that oxygen does not persist within the boiler, hydrazine is dosed into the boiler feed water (at a level ~1.8 x [O2]) to scavenge and hence remove the oxygen and so maintain the required reducing conditions in evaporator and superheater regions.

The oxygen scavenging capabilities of hydrazine is also utilised during off-load operation.  Here, the rate of oxygen removal is very different from full power conditions because of the lower temperature and pressure, and the constant values of these throughout the circuit.  Hydrazine is therefore preferentially utilised for its versatility when varying power in the reactor.

1.1.2	Pressurised Water Reactor (PWR)

Minimisation and prevention of corrosion is important in all boilers.  However, in the Pressurised Water Reactor primary circuit it is import to control the transport of corrosion products around the primary circuit as they can become activated and contribute to the radiation doses received by plant personnel.  During start up, oxygen concentration is required to be <100ppb and this can only be achieved by the injection of hydrazine.  We estimate that ~5-10 litres of 35% hydrazine is required on each occasion.

Similar to an AGR, hydrazine is injected in to the secondary circuit to remove oxygen and hence maintain reducing conditions.  Excessive corrosion of the thin walled steam generator tubes, would lead to the transport of radioactivity into the secondary circuit and an increase operator radiation doses, which would be unacceptable.  Hydrazine is dosed continuously at a concentration of 50 ppb to maintain an oxygen concentration of <1 ppb. 

Again, similar to the AGR’s, hydrazine is also used during the wet lay up of secondary circuit components during outages to protect the steam generators. 

1.2	Hydrazine as reagent of choice 

Hydrazine thermally decomposes at temperatures above 200°C with the rate increasing as the temperature increases. The typical steam outlet temperature from an AGR boiler is in the region of 540 °C and that for a PWR is ~280 °C, therefore there is little or no emissions of hydrazine to the environment.  Hydrazine is therefore the reagent of choice due to its oxygen scavenging capability and any excess which does not react with oxygen will disproportionate at high temperatures to yield inert, organism tolerable, substances such as water and nitrogen. 

Hydrazine Standards (50 ppb) are also used in a power station laboratory to formulate standards for hydrazine analysis, typically by UV/Vis spectroscopy.

1.3	Possible alternatives to hydrazine

Concern has been raised over the use of hydrazine for many years due to it’s classification as a carcinogen and known volatility at ambient temperatures.  In light of this, a number of studies were carried out to compare the performance of potential alternatives to hydrazine under AGR plant operating conditions.

A number of candidate chemical scavengers have been tested.  Some of the tested substances are listed below: 

i)	Carbohydrazide; (catalysed and uncatalysed)
ii)	Diethylhydroxylamine;
iii)	Isopropylhydroxylamine; and
iv)	Hydrogen.

In all instances, these alternatives have been found to be sufficiently slow and/or ultimately degrade to form hydrazine or undesirable by-products e.g. carbon dioxide.  

A number of these substances possess known technical limitations and require catalysts to facilitate their respective reactions.  Of the alternatives tested, none removed oxygen from the boiler as efficiently as hydrazine.  To date, there are no known suitable alternatives, essential in maintaining the operation of the plant and most importantly nuclear safety.

1.4	Optimising Hydrazine use and supply/handling considerations

The health and safety considerations for the responsible use of hydrazine are acutely known and industry takes appropriate steps to address them.

Adverse operational consequences of the alternative reagents promoted the use of hydrazine as the primary substance for oxygen scavenging. The focus for the industry has been on optimising its use to minimise any hazards.

The electricity generating sector regards environmental and personal safety of employees as one of its primary priorities and rigorously enforces Control of Substances Hazardous to Health (COSHH) to minimise personnel exposure to hydrazine during handling and storage.  

Volumes of the substance held on site are further regulated by Control of Major Accident Hazards (COMAH) Regulations and subsequently low volumes of hydrazine are stored at nuclear power station sites at any one time.

Hydrazine use by New Nuclear Stations  

1.5	General Information

Some of the planned new nuclear power stations in the UK will be constructed to the Evolutionary Pressurised Water Reactors (EPR) design.

1.5.1	Evolutionary Pressurised Water Reactors (EPR)

The EPR is an evolutionary plant design which has been developed utilising the experience and safety record of existing pressurised water reactors.  It is therefore similar in design to modern PWR, such as Sizewell B, currently the UK’s only PWR.  The first EPR under construction is Olkiluto 3 in Finland and the first EDF fleet EPR is under construction at Flammanville in France.

The EPR will require the use of hydrazine for three purposes.  Firstly, small quantities will be required for the maintenance of reducing conditions in the primary circuits during start-up and shut-down.  This contributes to the minimisation of corrosion and, importantly, the control of the transport of corrosion products around the primary circuit that can become activated and contribute to the radiation doses received by plant personnel.  Secondly, hydrazine will be employed during operation in the secondary circuit for the removal of oxygen and the maintenance of reducing conditions.  This contributes to the minimisation of corrosion, in particular of the thin walled steam generator tubes, which, if they leak due to corrosion, will lead to the transport of radioactivity into the secondary circuit and an increase in operator radiation doses.  Finally, hydrazine is used during the wet lay up of secondary circuit components during outages, in particular steam generators, again for oxygen removal and the maintenance of reducing conditions. This is for the minimisation of corrosion, the consequences of which are similar to the corrosion risk during operation. 

The dominant use of hydrazine is for secondary circuit treatment during operation, where a constant feed water concentration is yet to be defined for UK EPR, but, is likely to be in the range 50-100 µg/kg.

The proposal to employ hydrazine in these roles for UK EPR is currently progressing through the UK nuclear and environmental regulators as part of the “Generic Design Assessment” of the EPR for application in the UK. It is anticipated that hydrazine will be approved for use in the EPR design by the UK regulators on the basis of the reasons already provided within this response and in previous submissions to ECHA for the continued selection of hydrazine in these systems.

1.5.2	Hydrazine as reagent of choice 

Hydrazine is a unique chemical for the purposes of corrosion control in nuclear reactor cooling water systems. It reacts with oxygen at appropriate temperatures; it is sufficiently stable that it will remove oxygen before it is hydrolysed itself; it reacts to give benign degradation products that neither threaten the integrity of the plant nor prevent the plant from detecting other more damaging chemical species through on-line monitoring; and it is volatile allowing its use in a water-steam circuit. 

The industry is committed to improving safety and recognises the safety benefit that would be achieved if a suitable alternative could be found. Much work has been performed to investigate alternatives to hydrazine over many years, and submissions describing this work have already provided to ECHA. However, no practicable alternative has been identified that doesn’t compromise safety via lack of effectiveness under plant conditions or via the formation of unsuitable breakdown products. Furthermore, the best performing alternative, carbohydrazide, is an analogue of hydrazine via decomposition to hydrazine. Hence, whilst there is a benefit in reducing risk to the operator during delivery and handling, and this is only a small benefit given the limited exposure risk via the use of engineered systems for the handling of hydrazine, there is no benefit in reducing risk for plant inspection or discharge to the environment. 

It is a statement on the unique properties and suitability of hydrazine that it remains the oxygen scavenger of choice for PWR applications world-wide, and this remains the case for new plants such as those planned to be build in the UK.

1.5.3	Optimising Hydrazine use and supply/handling considerations

The systems used for the delivery, storage and handling of hydrazine in the EPR units will take advantage of the best industry experience in minimising risks to site personnel, the public and the environment.

2	General Information
2.1.1	Coal Fired Power Station

The coal-fired stations in the UK generally consist of generating units supplied by steam from recirculating boilers. Many have been in operation for the last 40 years under an all volatile treatment regime, i.e. hydrazine.

Since 2006, with the introduction of the new COMAH requirements, the majority of hydrazine in the UK is now supplied as 5% solution. At some older plant Hydrazine is supplied as hydrazine hydrate at 99% and diluted to 1.5% and 7.5% hydrazine hydrate on site for use as continuous on load dosing and start up / 2 shifting / boost dosing respectively.

Hydrazine is continuously dosed to the boiler feed water to maintain low levels of oxygen and elevated pH in order to protect the boiler from corrosion.

Hydrazine is also used during long term storage of boilers, where the boiler is dosed with hydrazine to higher than normal operational levels prior to being blown empty at pressure. Some items of plant will not fully drain and have to be stored flooded, again hydrazine is added and levels maintained in order to exclude oxygen and thus corrosion.

2.1.2	Combined Cycle Gas Turbine (CCGT) Station

The choice of oxygen scavenger for these new units has been based on the very tight specification from the turbine manufacturer.  Historically, the turbine manufacturers set tight specifications due to worries about blade corrosion arising from the possible suppression of pH in the first steam condensation.  They have stipulated that the maximum cation conductivity of the steam entering the turbine should be 0.15 uS/cm.  This cannot be achieved by many of the alternative, particularly carbohydrazide, hence hydrazine is the only oxygen scavenger of choice.

As an example, one of the newest CCGT in the UK,  which is under construction, is currently planned to use a 3% solution and look to see if its practicable to reduce that further, e.g. to 2.5% to eliminate the Chemicals Hazard Information and Packaging (CHIP) hazard of danger to the environment.  This will depend on the performance of the dearators and operating regime. 

2.3	Possible alternatives to hydrazine

Industry testing has confirmed that hydrazine is the reagent of choice.  No alternatives have been tested on site and any testing would require a prolonged test on one unit potentially for an outage cycle of four years.  If the alternative was less effective, then significant plant damage would occur.

2.4	Optimising Hydrazine use and supply/handling considerations

Electricity generators regard environmental and personal safety of employees as one of their primary priorities.  The Control of Substances Hazardous to Health (COSHH) is enforced across the industry in order to minimise personnel exposure to hydrazine via handling and storage.  

Volumes held on site are further regulated by Control of Major Accident Hazards (COMAH) Regulations and subsequently low volumes of hydrazine are stored at fossil fuel power stations at any one time.

As there is no suitable alternative to hydrazine, efforts have been focussed on improving the hydrazine handling infrastructure, personnel training and emergency response procedures on power station sites.

In order to ensure health and safety risks are properly managed, the primary requirement is that the manual handling of the reagent is limited to minimise the risk of exposure. Electricity generator personnel wear appropriate Personal Protective Equipment (PPE), including respirators is worn during these activities.
	Thank you for this information. Provided the substance is identified as SVHC this will be considered in the next step of the authorisation process when deciding which substance to prioritise and recommend for inclusion in Annex XIV	
			See also:
Comment 33 attachment (EnvC53-11 AEP response to ECHA Hydrazine Consultation.doc).doc		
31	2011/04/07	Company
United Kingdom	Section 1.3:  EDF energy supports the identification of thermal power station boiler and steam generator water treatment as an important use.

Section 1.4:  Alternatives in boiler water treatment – EDF Energy does not feel that it is appropriate to deal with the power sector in an undifferentiated way.  There is a distinct need to consider a variety of conditions occurring in different types of plant.  

Section 4.1.1: EDF Energy supports the identification of use of Hydrazine hydrate for water treatment in the power generation sector including AGR and PWR nuclear plant.

Section 5.1.1.1:  EDF Energy is surprised by the reference to the data suggesting the apparent emission of Hydrazine in some water discharges of Canadian nuclear plant. We do not consider Canadian nuclear power plant representative of EDF energy power stations.  We note and support the comments made previously of Company 8, 32 and 52 which indicate that no significant environmental emission will occur as Hydrazine will break down into inert, organism tolerable, substances such as ammonia, water and nitrogen at temperatures above 200°C i.e. during all periods of on-load operation.  However, our investigations do show that there is some discharge following long shutdown periods or post wet lay-up.  This is expected to be once every 3 years, one station estimates this could be up to 25-50kg (of 35% Hydrazine).  Discharge is carefully controlled to ensure compliance with Environment Agency and Scottish Environmental Protection Agency discharge consents.  

Section 5.1.1.3: EDF Energy believes that the conclusion is potentially misleading.  While it is impossible to assert that no release can ever occur, in our opinion, we do not anticipate discharge of Hydrazine during on load operation as it will break down into inert substances.  Further more, with appropriate equipment and working practices the risk of release during storage and handling of the product is appropriately managed.

Section 5.2.2:  As long as handled properly, the risks of use, storage and transportation are manageable.  Hydrazine is applied in very low concentrations and it is routinely injected into the circuits with closed systems whenever this is possible.  As long as it is handled properly, the risks of use, storage and transportation are adequately managed with: 
 
•	Operator training;
•	No-loss couplings from bulk storage;
•	Vacuum transfer to day tanks;
•	Scrubber units to remove all fumes; 
•	Strict rules for maintenance of pumping systems ( Permit for Work, COSHH & MSDS's);
•	Personal Protection Equipment where necessary; and 
•	Medical supervision.

Section 5.2.2.1: EDF Energy supports the HSE characterisation of ‘events’.  However, it is more appropriate to describe them as ‘potential exposure events’ when all the controls are taken into account.

With the introduction of the Seveso II Directive or COMAH Regulation the storage of Hydrazine is strictly controlled.  All our sites are classed as ‘Lower Tier’.

In many thermal power plants zero volume couplings are used and the Hydrazine is, in effect, kept in a closed system with the added protection that workers also use respiratory protection when changing containers.

Section 5.2.2.3:  EDF Energy would be grateful for clarification with regard to whether the calculations acknowledge the use of zero volume couplings or not. EDF Energy feels that this is important as it has the potential to influence the risk of potential exposure. 

Section 6.1.1.1 and 2:  Discussion of alternative chemicals – EDF Energy is of the opinion that the literature provides different views on the effectiveness of oxygen removal. 

EDF Energy request that the full carbohydrazide reactions are included which shows that the reaction goes via Hydrazine.  In considering the feasibility of alternatives there should be increased recognition of the requirements of modern high pressure power sector units operating in a commercial and competitive market  particularly regarding the plant flexibility required (e.g. 2-shifting) and the physical requirements of the steam turbine manufacturers which are required to be complied with for warranty/guarantee issues.

Section 6.1.1.3:  Even with newly constructed power stations there can be significant issues with oxygen ingress which requires the use of oxygen scavenger.  This can be a particular problem with units incorporating air cooled condensers.  Modern designs of CCGT power plants incorporating once through air coolers have stringent limits on dissolved oxygen particularly when chloride is present due to the synergistic impact on corrosion. This necessitates the use of an oxygen scavenger with no impact on cation conductivity; the only oxygen scavenger which meets this requirement is Hydrazine.

Section 6.1.2: 	Experience of alternatives – We support the position of Company 32 which has undertaken a review and concluded Hydrazine is the best option and optimised management of it. 
	Thank you for this information. Provided the substance is identified as SVHC this will be considered in the next step of the authorisation process when deciding which substance to prioritise and recommend for inclusion in Annex XIV.	
			See also:
Comment 31 attachment (ECHA - Hydrazine - Response 070411.pdf).pdf
Comment 31 CONFIDENTIAL attachment		
30	2011/04/07	International organisation
Council of Europe, Directorate for the Quality of Medicines and HealthCare
France	The quality of medicines including their containers and raw materials may be compromised, if hydrazine is withdrawn from the market. Hydrazine is used in the iodine test for monograph Diosmin (1611).	See reply to your comment in the previous sections.	
29	2011/04/07	Company
AJAY EUROPE
France	Response proposition concerning Reach Classification for Hydrazine.

1°) Presentation of the plant

Ajay Europe is a company, based in Evron in France; our Group (3 plants of similar sizes, in France, US (Georgia) and Chile) is the world leader in the production of iodine derivatives. 
Our group is worldwide and the French company is serving Europe, India and also for a small part in China.

Our main product lines are : 
-	Iodate (by oxidation of Iodine): calcium Iodate and Potassium Iodate
-	Iodides (by reduction of Iodine): Potassium Iodide, Sodium Iodide, Copper Iodide

We use hydrazine as a reducer to convert Iodine to Iodide. The Iodides we produce are used in several applications. The main markets we are serving are:
1.	Pharmaceutical synthesis (as an intermediate)
2.	Production of polyamides, where our product will deliver to the final polyamide some physical properties like heat stabilization
3.	Food additives
4.	Feed additives
5.	Others 

2°) Use of Hydrazine

Hydrazine Hydrate is used in our plant in a very clean process that does not generate hazardous waste and by-product. It is important to insist on the fact that hydrate hydrazine is a very clean product in our process and that  the by-products generated during the reaction are N2 (gaseous Nitrogen) and H20 (water).

Worker exposure to hydrazine hydrate is regularly checked and controlled. Risk management measures are in place.

3°) Consequences of the interdiction of Hydrazine

If we cannot use  hydrate hydrazine, this means that we have to use another reducer and finding a suitable substitution for hydrazine hydrate is difficult: 

•	It will affect strongly productivity: Hydrazine Hydrate is a very fast reducer, other reducers such as formic acid can be used in large excess at the beginning of the reduction but cannot be used to finish it without leaving un-reacted reducer in the final product.( We are currently using formic acid to start the reduction and lower the quantity of hydrazine hydrate used but it is not possible to complete the reduction within a reasonable time without leaving un-reacted formate into the product)
•	It will affect product quality as other reducers may leave by-products which could later interfere in the pharmaceutical synthesis. The approval of our iodides will have to be renewed for most of their usages and we may lose customers versus non-European competition

With these elements, it is clear that our competitiveness will fall down and economically, we will not be able to face our competitors in the rest of the world (Canada, South America, Asia), competitors who will still be able to use Hydrate hydrazine.

4°) Conclusion

In this world where the competition is everywhere, if we want to keep our industry and our plants competitiveness, we need to have the same means that our competitors. 

So far, the usage of hydrazine hydrate has been proven to be possible with no hygiene problem for our people. Hydrazine Hydrate is a clean and efficient chemical which allows us to make clean and environmentally friendly chemistry. As at this moment , we have no competitive alternative, we ask to maintain the use of this product, under strict rules.

	Thank you for this information. Provided the substance is identified as SVHC this will be considered in the next step of the authorisation process when deciding which substance to prioritise and recommend for inclusion in Annex XIV.	
27	2011/04/07	Company
SSE
United Kingdom	Section 1.3:  SSE supports the identification of thermal power station boiler and steam generator water treatment as an important use.

Section 1.4:  Alternatives in boiler water treatment – SSE consider it inappropriate to deal with the power sector in an undifferentiated way.  There is a distinct need to consider a variety of conditions occurring in different types of plant. The power sector in general feels that reducing concentration of hydrate solution used and total amounts stored on site coupled with appropriate equipment and working practices, is sufficient to manage operational site Health & Safety risks whilst ensuring plant performance.

Section 4.1.1: SSE supports the identification of use of hydrazine hydrate for water treatment in the power generation sector including AGR and PWR nuclear plant.

Section 5.1.1.1:  SSE is surprised by the reference to the data suggesting apparent emission of hydrazine in some water discharges of Canadian nuclear plant. SSE do not consider Canadian nuclear power plant representative of European power plant or operational practices known to us. We note and support the comments of Company 8, 32 and 52 which indicate that no environmental emission will occur as hydrazine will break down into inert, organism tolerable, substances such as ammonia, water and nitrogen at temperatures above 200°C.  

Section 5.1.1.3: SSE considers this conclusion incorrect and potentially misleading.  While it is impossible to assert that no release can ever occur, in our opinion, we do not anticipate discharge of hydrazine during operation as it will break down into inert substances.  Furthermore, with appropriate equipment and working practices the risk of release during storage and handling of the product is appropriately managed.

Section 5.2.2.1: SSE supports the HSE characterisation of ‘events’.  However, it is more appropriate to describe them as ‘potential exposure events’ when all the controls are taken into account.

Since 2006, with the introduction of the new COMAH requirements, the majority of hydrazine in the UK is now supplied as 5% solution.

In many thermal power plants zero volume couplings are used and the hydrazine is, in effect, kept in a closed system with the added protection that workers also use respiratory protection when changing containers.

Section 5.2.2.3:  SSE would be grateful for clarification with regard to whether the calculations acknowledge the use of zero volume couplings or not. SSE considers that this is important as it has the potential to influence the risk of potential exposure. 

Section 6.1.1.1 and 2:  Discussion of alternative chemicals – SSE is of the opinion that the literature provides different views on the effectiveness of oxygen removal. 

SSE would request that the full carbohydrazide reactions are included, as they show that the reaction goes via hydrazine.  In considering the feasibility of alternatives there should be increased recognition of the requirements of modern high pressure power sector units operating in a commercial and competitive market  particularly regarding the plant flexibility required (e.g. 2-shifting) and the physical requirements of the steam turbine manufacturers which are required to be complied with for warranty/guarantee issues.

Section 6.1.1.3:  Even with newly constructed power stations there can be significant issues with oxygen ingress which requires the use of oxygen scavenger.  This can be a particular problem with units incorporating air cooled condensers.  Modern designs of CCGT power plants incorporating once through air coolers have stringent limits on dissolved oxygen particularly when chloride is present due to the synergistic impact on corrosion. This necessitates the use of an oxygen scavenger with no impact on cation conductivity analysers used for the analysis of low level chlorides in water; the only oxygen scavenger which meets this requirement is hydrazine.

Section 6.1.2: 	Experience of alternatives – SSE supports the position of Company 32 which has undertaken a review and concluded hydrazine is the best option and optimised management of it. 
	Thank you for this information. Provided the substance is identified as SVHC this will be considered in the next step of the authorisation process when deciding which substance to prioritise and recommend for inclusion in Annex XIV.	
25	2011/04/06	Industry or trade association
Eurospace
France	No equivalent is currently available, although research is going on for a substitute.	Thank you for this information. Provided the substance is identified as SVHC this will be considered in the next step of the authorisation process when deciding which substance to prioritise and recommend for inclusion in Annex XIV	
22	2011/04/06	Company
Lansdowne ChemicalsPLC
United Kingdom	Please see the confidential attachment, containing information on how hydrazine is used and exposure controlled within the UK and the impact of the CoMAH (Seveso) regulations.

	Thank you for this information. Provided the substance is identified as SVHC this will be considered in the next step of the authorisation process when deciding which substance to prioritise and recommend for inclusion in Annex XIV	
			See also:
Comment 22 CONFIDENTIAL attachment 		
20	2011/04/06	Company
Belgium	Information on Use of hydrazine anhydrous form:

The application of Hydrazine hydrate as intermediate substance (as defined in the REACH regulation) in the synthesis of pharmaceuticals is well described in the Annex XV report.

Application of Hydrazine anhydrous form as intermediate in the chemical synthesis of Active Pharmaceutical Ingredients and associated intermediates should be considered as well, since this Hydrazine anhydrous is being applied for this purpose in our process since many years.

Occupational exposure and release to the environment are considered to be very low, since manufacturing processes in the pharmaceutical sector are tightly controlled and a high level of containment is generally required. Dedicated storage & detection systems are in place. 

At this moment no alternatives are known for the very specific synthesis reaction in which the substance is used. 

In the context of pharmaceutical manufacturing, the proposal to include Hydrazine anhydrous form into annex XIV is purely based on the hazardous characteristics of the substance.
Exposure scenario’s, taking into account the specific handling of the substance by the pharmaceutical industry, should be generated for justifying the prioritization for inclusion into annex XIV.
	Thank you for this information. Provided the substance is identified as SVHC this will be considered in the next step of the authorisation process when deciding which substance to prioritise and recommend for inclusion in Annex XIV.	
19	2011/04/06	National Authority Allgemeine Unfallversicherungsanstalt
Austria	p26, Table
This table shows that within the production of hydrazine OELs are over-run. There is a significant exposition of workers.
Furthermore we fear that hydrazine will be treated as an isolated intermediate according to REACH without – in practice – meeting the criteria of strictly controlled conditions. We emphasise the importance of a stricter regulation of this HPV chemical.

The Annex XV dossier shows the wide use of hydrazine in different sectors of use: From lab scale to industrial scale. This shall be kept in mind when thinking about priorisation of this substance.
	Thank you for providing your opinion.	
18	2011/04/06	Industry or trade association
EURELECTRIC
Belgium	Sec 1.3 Support identification of thermal power station boiler and steam generator water treatment as an important use

Sec 1.4 alternatives in boiler water treatment – not appropriate to deal with the power sector in an undifferentiated way – need to consider variety of conditions occurring in different types of plant. Support the inclusion of the Eurelectric submission on alternatives (the power sector in general feels that reducing concentration of hydrate solution used and total amounts stored on site coupled with appropriate equipment and working practices, is sufficient to manage operational site Health & Safety risks whilst ensuring plant performance.)

Support 4.1.1 identification of use of hydrazine hydrate for water treatment in the power generation sector

Sec 4.3.1 statements beyond the Eurelectric position bottom page 36&37

Company 26 – use of hydrazine hydrate both in operation and shut down

Company 32 – use in AGR & PWR nuclear plant

Company 22 – low concentrations in boilers, higher in district heating circuits – we note that the potential occurrence of hydrazine in the circulating water in district heating systems, with associated potential health and safety and environmental issue from leaks or releases in distribution systems, may be an issue to consider for plant for which district heating plant, it should not influence the position on use of hydrazine in power plant not supplying district heating systems. 

Company 44 – steam generator cleaning in nuclear plants (rather than feed water treatment)

4.3.2.4 

The Ringhals site, Sweden’s largest nuclear power plant with 4 operating reactors, approximately uses 11 tonnes a year of 100% hydrazine.

5.1.1.1 It is important to distinguish between different types of power plants when considering the potential for environment emissions. Examples from nuclear power plants are not representative of thermal plant. 

5.1.1.3 – The summary conclusion is potentially misleading for thermal plant not connected to district heating. Whilst it is impossible to assert that no release can ever occur, as discussed in our submissions we do not anticipate discharge of hydrazine in operation (it will breakdown in and, with appropriate equipment and working practices, risk of release in storage and handling of the product is appropriately managed.

5.2.2 
As long as handled properly, the risks of use, storage and transportation are manageable 
Hydrazine is applied in very low concentrations. Routinely it is injected into the circuits with closed systems whenever this is possible. As long as handled properly, the risks of use, storage and transportation are manageable. This however requires in the power plants: 
•	Operator training 
•	No-loss couplings from bulk storage 
•	Vacuum transfer to day tanks 
•	Scrubber units to remove all fumes 
•	Strict rules for maintenance of pumping systems ( Permit for Work, COSHH & MSDS's) 
•	Personal Protection Equipment where necessary
•	Medical supervision

5.2.2.1 – We support the HSE characterisation of ‘events’ but it is more appropriate to describe them as ‘potential exposure events’ when all the controls are taken into account

Since 2006, with the introduction of the new COMAH requirements, the majority of hydrazine in the UK is now supplied as 5% solution.

In many thermal power plants zero volume couplings are used and the hydrazine is, in effect, kept in a closed system with the added protection that workers also use respiratory protection when changing containers.

5.2.2.3 - It is not clear whether or not these calculations acknowledge the use of zero volume couplings. This would be important in influencing the potential exposure risk. 

6.1.1.1/2 discussion of alternative chemicals. Reviewers state literature has different views on effectiveness of oxygen removal. 

We request that the full carbohydrazide reactions are included which shows that it goes via hydrazine. In considering the feasibility of alternatives there should be increased recognition of the requirements of modern high pressure power sector units operating in a commercial and competitive market  particularly regarding the plant flexibility required (eg 2-shifting) and the steam requirements of the steam turbine manufacturers which are required to be complied with for warranty/guarantee issues.

6.1.1.3 Even with newly constructed power stations there can be significant issues with oxygen ingress which require the use of oxygen scavenger this can be a particular problem with units incorporating air cooled condensers. Modern designs of CCGT power plants incorporating once through air coolers have stringent limits on dissolved oxygen particularly when chloride is present due to the synergistic impact on corrosion. This necessitates the use of an oxygen scavenger with no impact on after cation conductivity analysers used for the analysis of low level chlorides in water, the only oxygen scavenger which meets this requirement is hydrazine.

6.1.2 experience of alternatives –We support the position of Company 32 (PWR & AGR) which has done a review and concluded hydrazine remains the best option and optimised management of it. 

Support box 6.1 Eurelectric position	Thank you for this information. Provided the substance is identified as SVHC this will be considered in the next step of the authorisation process when deciding which substance to prioritise and recommend for inclusion in Annex XIV.	
			See also:
Comment 18 attachment (Eurelectric Additional comments hydrazine.pdf).pdf		
16	2011/04/05	Company
Germany	General description of the reaction
Hydrazine hydrate is used as intermediate in the chemical production of a fine chemical. According to the specification of the final product hydrazine hydrate is not allowed in this highly purified product. Customers of the product are located in the electronic industry. Neither professionals nor consumers are exposed to hydrazine hydrate due to this chemical synthesis. 

Exposure of workers
Well-trained industrial workers are using hydrazine hydrate in enclosed batch processes. The exposure of the industrial workers is estimated to be negligible. The personal protection equipment is adapted to the risk requirements. In rare cases of open handling as disconnecting of pipes after filling of tanks or technical failure a chemical protection suit, gas masks, gloves and rubber boots are worn.

Exposure of environment
The exposure of the environment with hydrazine hydrate due to this use is negligible. All waste is incinerated.
	Thank you for this information. Provided the substance is identified as SVHC this will be considered in the next step of the authorisation process when deciding which substance to prioritise and recommend for inclusion in Annex XIV.	
15	2011/04/05	Company
Germany	p. 16 'uses' and p. 57 "other uses' - Additional use of hydrazine in its hydrated form.	Thank you for this information. Provided the substance is identified as SVHC this will be considered in the next step of the authorisation process when deciding which substance to prioritise and recommend for inclusion in Annex XIV.	
			See also:
Comment 15 CONFIDENTIAL attachment 		
13	2011/04/05	Industry or trade association
Federchimica
Italy	p.3 Use
Active pharmaceutical ingredient manufacturers are obliged to work in strictly controlled conditions in order to guarantee  the application of both European and national laws and regulations on worker safety conditions, environmental protection, Seveso directive and cGMP (current Good Manufacturing Practices), too. 

Exposure 
Exposure linked to the substance use is very limited being in force the above mentioned restrictions.

Alternatives 
In literature other reduction reactions to transform from keto to alkane group are reported, e.g. Clemmensen reaction. The substrate, unlike the Wolff Kishner reaction, must be stable to strong acid.    The reduction takes place at the surface of the zinc catalyst as shown in Figure 1(for figures 1 please see the attachment in section IV).    
In “Organic reactions” , Wiley & Sons, vol. IV (David Todd, Amberst College), chapter 8, Table 1, pag.387, results coming from application of both Wolff Kishner and Clemmensen reductions on steroid substrates show that the Clemmensen reaction cannot work like the Wolff Kishner one.

Risks

Human health
Systems like closed loading equipment, emergency blowdown devices, individual protection devices for operators reduces risks linked to its use in manufacturing processes by operators. Medical controls are performed by chemical pharmaceutical companies according to European and national provisions. 

Environmental risk
Risks of accidental release in air, water, land, sewer and waste are taken under control for the above mentioned reasons. Safety devices on equipments have been implemented in order to reduce any potential risks. Moreover hydrazine is almost completely consumed and/or recycled in the process and no substantial release in the environment is ever foreseeable.
	Thank you for this information. Provided the substance is identified as SVHC this will be considered in the next step of the authorisation process when deciding which substance to prioritise and recommend for inclusion in Annex XIV.	
			See also:
Comment 13 attachment (Idrazina FDC.doc).doc		
12	2011/04/05	Company
Denmark	Hydrazine hydrate as a raw material in the first step of a GMP (Good Manufacturing Practices) synthesis of an active pharmaceutical ingredient (API)

General description of the process

(Liquid) hydrazine hydrate is used as a raw material in the first step of a GMP process. There are further steps in the synthesis of the active pharmaceutical ingredient before it is processed by pharmaceutical companies.

The reaction takes place in closed equipment and the remaining hydrazine hydrate, if any at trace level, is recovered in the waste which is burned by an authorized company. The whole process takes place in a plant with general and local ventilation.

We do not have an alternative to replace the product.

Exposure of workers
Since the process is performed in closed equipment, the workers are not exposed to the product. When needed, PPI (personal protective equipment) is worn, e.g. in case of connecting/disconnecting pipes.

Analysis of the exposure of the workers to hydrazine is performed on a regular basis.

Exposure of customers

Due to the fact that further steps take place in the synthesis of the API and due to the fact that the product is cleaned during the different steps, customers (direct and indirect) have no chance to be in contact with hydrazine.

Exposure of the environment: 

The product is used as a raw material. The exceeding hydrazine goes into the waste which is burned in an authorized process plant.	Thank you for this information. Provided the substance is identified as SVHC this will be considered in the next step of the authorisation process when deciding which substance to prioritise and recommend for inclusion in Annex XIV.	
10	2011/04/05	Company
IVBO
Belgium	p.16: We use hydrated hydrazine as a corrosion inhibitor in a thermal power generation plant.
p.19: In the past we did two experiments with alternative corrosion inhibitors. The experiments both went wrong within a couple of weeks. The first time there was heavy corrosion in the high pressure circuit (280°C, 24bar), leading to multiple steam leaks. The second time there was heavy corrosion in the air cooled condensors, also leading to multiple leaks. On both occasions large parts of the affected systems needed to be replaced leading to great costs. In the case of corrosion in the high pressure circuit, there was also potential danger for the employees due to the steam leaks. 	Thank you for this information. Provided the substance is identified as SVHC this will be considered in the next step of the authorisation process when deciding which substance to prioritise and recommend for inclusion in Annex XIV.	
4	2011/03/29	Other contributor
contributor
centre national d' études spatiales
France	Despite the efforts dedicated to the next generation of propellants, no mid-term solution can be suggested. It appears that a ban of hydrazine would lead to major technical difficulties for space applications and to a loss of competitiveness for the European space industries.(conclusion of the letter enclosed herewith)	Thank you for this information. Provided the substance is identified as SVHC this will be considered in the next step of the authorisation process when deciding which substance to prioritise and recommend for inclusion in Annex XIV.	
			See also:
Comment 4 attachment (consultation ECHA Hydrazine 29_mars_2011.pdf).pdf		
3	2011/03/28	Company
Italy	Use
Active pharmaceutical ingredient manufacturers are obliged to work in strictly controlled conditions in order to guarantee  the application of both European and national laws and regulations on worker safety conditions, environmental protection, Seveso directive and cGMP (current Good Manufacturing Practices), too. 

Exposure 
Exposure linked to the substance use is very limited being in force the above mentioned restrictions.

Alternatives 
In literature other reduction reactions to transform from keto to alkane group are reported, e.g. Clemmensen reaction. The substrate, unlike the Wolff Kishner reaction,  must be stable to strong acid.    The reduction takes place at the surface of the zinc catalyst.
In “Organic reactions” , Wiley & Sons, vol. IV (David Todd, Amberst College), chapter 8, Table 1, pag.387, results coming from application of both Wolff Kishner and Clemmensen reductions on steroid substrates show that the Clemmensen reaction cannot work like the Wolff Kishner one.

Risks

Human health
Systems like closed loading equipment, emergency blowdown devices, individual protection devices for operators reduces risks linked to its use in manufacturing processes by operators. Medical controls are performed by chemical pharmaceutical companies according to European and national provisions. 

Environmental risk
Risks of accidental release in air, water, land, sewer and waste are taken under control for the above mentioned reasons. Safety devices on equipments have been implemented in order to reduce any potential risks. Moreover hydrazine is almost completely consumed and/or recycled in the process and no substantial release in the environment is ever foreseable.
	Thank you for this information. Provided the substance is identified as SVHC this will be considered in the next step of the authorisation process when deciding which substance to prioritise and recommend for inclusion in Annex XIV.	
			See also:
Comment 3 attachment (IV-Non confidential attachment.pdf).pdf
Comment 3 CONFIDENTIAL attachment 		
2	2011/03/25	Company
France	No alternative of Hight Purity Hydrazine for space activities is available before 10 years;
Comments on pages 51 & 104 are introduce in the attachment in section IV	Thank you for this information. Provided the substance is identified as SVHC this will be considered in the next step of the authorisation process when deciding which substance to prioritise and recommend for inclusion in Annex XIV	
			See also:
Comment 2 attachment (LE 16-11SME   ECHA inquiry for Hydrazine.pdf).pdf		
1	2011/03/15	Trade union
European Trade Union Confederation
Belgium	Hydrazines are causal agents of occupational diseases.
See the EU Commission publication: Information Noticeson Occupational Diseases: a guide to diagnosis
http://www.beroepsziekten.nl/sites/default/files/documents/Information-Notices-2009.pdf
	Thank you for this information. Provided the substance is identified as SVHC this will be considered in the next step of the authorisation process when deciding which substance to prioritise and recommend for inclusion in Annex XIV	

Attachments

Comment number	Public attachment	Confidential attachment	
2	
Comment 2 attachment (LE 16-11SME   ECHA inquiry for Hydrazine.pdf).pdf		
3	
Comment 3 attachment (IV-Non confidential attachment.pdf).pdf	
Comment 3 CONFIDENTIAL attachment 	
4	
Comment 4 attachment (consultation ECHA Hydrazine 29_mars_2011.pdf).pdf		
7	
Comment 7 attachment (ECHA-EWS-critique of ECHA-SVHC-Hydrazine-2011.pdf).pdf		
13	
Comment 13 attachment (Idrazina FDC.doc).doc		
15		
Comment 15 CONFIDENTIAL attachment 	
17	
Comment 17 attachment (GIFAS_Hydrazine.zip).zip		
18	
Comment 18 attachment (Eurelectric Additional comments hydrazine.pdf).pdf		
21	
Comment 21 attachment (Let ASD - Hydrazine.zip).zip		
22		
Comment 22 CONFIDENTIAL attachment 	
31	
Comment 31 attachment (ECHA - Hydrazine - Response 070411.pdf).pdf	
Comment 31 CONFIDENTIAL attachment 	
33	
Comment 33 attachment (EnvC53-11 AEP response to ECHA Hydrazine Consultation.doc).doc		
34	
Comment 34 attachment (DP-6 April 2011 hydrazine EDF résponse VF_EN.pdf).pdf