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

Substance name:	Trixylyl phosphate	
CAS number:	25155-23-1	
EC number:	246-677-8	

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

Disclaimer: Comments provided during the public consultation are made available in this document as submitted by the commenting parties. It was the commenting parties own responsibility to ensure that their comments do not contain confidential information. The Response to Comments table has been prepared by the competent authority of the Member State preparing the proposal for identification of a Substance of Very High Concern. RCOM has not been agreed by the Member State Committee nor has the document been modified as result of the MSC discussions. The table does not contain any confidential information.

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

General comments on the SVHC proposal
Number	Date	Submitted by (name, Organisation/
MSCA)	Comment	Response	
10	2013/10/17	International organisation
Global Cabin Air Quality Executive
United Kingdom	page 17 - 7.3.2- Occupational exposure
Regular lower-level exposure to TXP as part of the TCP lubricant additive formulation can be expected for aircrew, ground maintenance & ramp workers.Lower-level oil leakage is a design and operational feature of using the bleed air system, with higher exposure possible under select operational conditions and maintenance failures.

page 18 - 7.3.3- Consumer exposure
Regular lower-level exposure to TXP as part of the TCP lubricant additive formulation can be expected for airline passengers who breathe the air bled off the engines as do the aircrew. Lower-level oil leakage is a design and operational feature of using the bleed air system, with higher exposure possible under select operational conditions and maintenance failures.

page 24 - Table 9- Phosphate esters
TXP is used as a triaryl phosphate in selected aviation engine oils

page 32 - 9.2- Risk characterization- Human health
A range of adverse health effects are being experienced by aircrew, maintenance and ramp personnel and passengers working and traveling in aircraft known to allow regular and expected lower-level leakage into the aircraft cabin air along with higher level exposure with maintenance failures that occur on a less frequent basis.Many of these adverse effects are consistent with the hazards attributed to TXP and the other oil substances in the levels used in the lubricants.

page 33 - 9.3- Risk characterization- Environment
TXP as part of the TCP formulation used in selected aviation engine oils can and will leak into the environment via the oil system breather as well as during spillages during engine servicing.

Page 37 Annex 1
Recent studies (Baker et al 2012) have shown inhibition of  numerous enzymes based upon exposure to triaryl phosphates.	Thank you for the information provided. 

In general information on uses, exposure, release and alternatives will be forwarded for discussion at later stages of the authorization process (prioritization, possible exemptions if applicable) in case the substance is identified as SVHC.

The information provided gives further evidence that TXP, known to be used in jet engine oils, may enter the cabin air in commercial aircraft, when “bleed air” is used for cabin air conditioning, although no measured data became available on TXP itself so far and most information relates to the substance tricresyl phosphate (TCP). 	
					
8	2013/10/17	Member State
Norway	The Norwegian CA supports that trixylyl phosphate should be identified as a substance of very high concern and should be included in the Candidate List.	Thank you for the support.	
6	2013/10/15	Company
United Kingdom	1	Use of Trixylyl phosphate based fluids within EDF Energy’s Existing Nuclear Stations 

EDF Energy operates eight nuclear power stations in the UK.  These comprise seven Advanced Gas-Cooled Reactors stations (AGR), each has two reactors.  Each reactor has its own turbine and conventional system.  We also have one Pressurised Water Reactor (PWR) which uniquely has a single reactor with a two turbine conventional system.     

1.1	Advanced Gas-Cooled Reactor (AGR)

All Stations with the exception of Dungeness B use Trixylyl phosphate based hydraulic fluids within their EHC systems

1.2	Pressurised Water Reactor (PWR)   

EDF pressurised water reactor, Sizewell B, has a Trixylyl phosphate based hydraulic fluid within its EHC systems
2	Use of EHC fluids within EDF Energy’s fossil fuel stations.  

2.1	General Information

EDF Energy operates two coal fired power stations, West Burton and Cottam, each with a generation capacity of 2000MW.  EDF also operates a Combined Cycle Gas Turbine (CCGT) power station at West Burton with a generation capacity of 1300MW. 

2.2	Coal Fired Power Station

The coal stations consist of 4x 500 MW generating units at each site supplied by steam from four re-circulating boilers that have been in operation for the last 40 years.    Neither of the coal fires stations uses fire resistant fluids in their control systems.

2.3	CCGT Station

EDF Energy operates a gas fired combined cycle station at West Burton and do not use fire resistant fluids.
3. 	Use of EHC fluids within EDF Energy’s New Build Stations

EDF Energy, New Nuclear Build GenCo, will be the nuclear site licence holder for the new nuclear plants that EDF Energy intends to construct and operate in the UK.  The power stations will be constructed to the Evolutionary Pressurised Water Reactors (EPR) design.

3.1	Evolutionary Pressurised Water Reactors (EPR)

EDF Energy, New Nuclear Build GenCo, will be the nuclear site licence holder for the new nuclear plants that EDF Energy intends to construct and operate in the UK.  The power stations will be constructed to the Evolutionary Pressurised Water Reactors (EPR) design.

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.

Similar to SZB, the new EPR design will also require the use of Trixylyl phosphate based hydraulic fluids within their EHC systems	Thank you for the information provided. 

In general information on uses, exposure, release and alternatives will be forwarded for discussion at later stages of the authorization process (prioritization, possible exemptions if applicable) in case the substance is identified as SVHC.

Possible alternatives and their suitability are foreseen to be examined in the authorisation process by the applicant. Based on the discussion there, authorisation will be permitted for a period of time for cases where appropriate alternatives are missing. This should enable industry to finally develop alternative techniques or to find alternative substances to substitute TXP.
It should be mentioned, that it is no prerequisite for the inclusion of a substance in the candidate list that well-established alternative substances and technologies are already in place. In fact, Title VII of REACH is particularly designed for cases where there is currently no alternative for certain uses available. 
Socio-Economic-Aspects are not to be considered at this stage of the process but at a later step during individual authorization applications by industry.	
			See also:
Comment 6 attachment (EDF Energy Response 2013 10 15.pdf).pdf		
2	2013/09/22	Company
ANDA Technology(Suzhou)Co.,Ltd
China	All materials supplied to STATS ChipPAC	Comment is not clear.	

Specific comments on the justification
Number	Date	Submitted by (name, Organisation/
MSCA)	Comment	Response	
9	2013/10/17	National Authority
Allgemeine Unfallversicherungsanstalt, Austria	It is difficult to comment on the substance identification if the composition is in the confidential part of the document (p 6). Especially when the substance is an uvcb.	We agree that more transparency is desirable, however the confidentiality rules given by the REACH-Regulation and ECHA have to be applied.	
7	2013/10/17	Member State
Germany	The German CA supports the proposal to identify trixylyl phosphate as SVHC.	Thank you for the support.	
6	2013/10/15	Company
United Kingdom	No comment. 	See response to comment 6 in Part I -general comments.	
			See also:
Comment 6 attachment (EDF Energy Response 2013 10 15.pdf).pdf		
5	2013/10/15	Member State
Belgium	Belgium supports the proposal to identify trixylyl phosphate as SVHC, based on article 57(c) of the REACH Regulation due to the classification as Repr. Cat. 1B.	Thank you for the support.	
4	2013/10/15	International NGO
ChemSec
Sweden	ChemSec supports the Austrian proposal to list Trixylyl phosphate to the REACH candidate list of Substances of Very High Concern (SVHC) on the basis of meeting the criteria for classification as toxic for reproduction (Art. 57 c).

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

We thank the Austrian government for their engagement in environmental and human health protection.	Thank you for the support.	
3	2013/09/25	Trade union
European Trade Union Confederation
Belgium	ETUC supports the identification of Trixylyl phosphate as SVHC.	Thank you for the support.	
2	2013/09/22	Company
ANDA Technology(Suzhou)Co.,Ltd, China	All materials supplied to STATS ChipPAC	Comment is not clear.	

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	
10	2013/10/17	International organisation
Global Cabin Air Quality Executive
United Kingdom	See attached document for comments on section: 
page 17 - 7.3.1-Routes of exposure:
TXP is available for human dermal and inhalation exposure by way of its use in some aviation engine oil additive TCP formulations. Engine oil  is known to leak into the aircraft air supply that is bled off the (high temperature) compressor of the engine as a function and design of using the bleed air system.	See response to comment 10 in Part I above.	
					
9	2013/10/17	National Authority
Allgemeine Unfallversicherungsanstalt
Austria	We support the inclusion of TXP in the authorisation process.
p 16 We work for the Austrian workers‘ compensation. From our point of view RCRs should not be confidentiol in the Annex XV document. We cannot see the high confidentiality of this information that can be took from an eSDS easily. Unfortunately we could not find the suitable eSDS because the ones available were not up to date. Nevertheless in the document one can read: „especially with high exposure“. This may indicate that exposure to TXP is not always to easy control and therefor a priorisation will be useful.	Thank you for the support.

We agree that more transparency is desirable, however the confidentiality rules given by the REACH-Regulation and ECHA have to be applied.	
7	2013/10/17	Member State
Germany	Page 18 Section 7.3.3. The phenomenon of „aerotoxic syndrome“ is currently widely discussed, but still poorly understood. Without further proof, any relationship between TXP and this syndrome remains purely speculative. However, if it would be proven relevant for consumers (airline passengers) it would also be relevant for professional workers in this sector (flight personal). We would suggest to limit discussion of this syndrome to the absolute minimum, but also mention this in the section on worker exposure.

Information on risks related to the substance:
On page 32 a list of PROCs with highest possible exposure as predicted by ECETOC TRA is provided including a.o. PROC 3. This seems a bit odd as PROC 3 is specifically referring to closed systems.	We agree that professional workers (flight personal) might be affected as well. We have mentioned this briefly in section 7.3.3. and agree that it should be mentioned under occupational exposure as well (7.3.2).

We agree. This information was taken from the registration.	
6	2013/10/15	Company
United Kingdom	Section7.3.2.     EDF energy has a Health and Safety policy which includes compliance with the Control Of Substances Hazardous to Health regulations (COSHH) which is intended to minimise employee dermal and respiratory exposure to chemicals.

Section 8.1.1.  Electro Hydraulic Controls (EHC) used for governing steam supply to turbine generators are also applications in which high pressures and temperatures dictate the use of fire-resistant fluids to mitigate the potential for dangerous and asset damaging fires.   Phosphate esters are the most common fluid used in EHC in power turbine control systems.   EDF Energy supports the identification that Trixylyl phosphate based fluids provide the best available alternative for the purpose in the power generation sector including AGR and PWR nuclear plant.

Section 8.1.3.   EDF Energy concur with the statement that it is critical to select materials which are compatible with reactor components and minimises the production of radioactive waste.

Section 9.2.1:  EDF Energy is committed to the good maintenance of its assets avoiding leakage and loss from systems and EDF’s Trixylyl phosphate EHC systems operated in closed loop systems and any topping up is done via pumps minimising employee exposure to fume or mists.     

Section9.3:    EDF’s  EHC systems are designed not to have any direct discharge routes of fluid to waterways.    EDF Energy proactively manages and maintains its plant to minimise releases of process fluids to the environment in compliance with authorisation granted by Environmental protection Agency (EPA) and the Scottish Environmental Protection Agency (SEPA).  	See response to comment 6 in Part I.	
			See also:
Comment 6 attachment (EDF Energy Response 2013 10 15.pdf).pdf		
2	2013/09/22	Company
ANDA Technology(Suzhou)Co.,Ltd, China	All materials supplied to STATS ChipPAC	Comment is not clear.	

Attachments

Comment number	Public attachment	
6	
Comment 6 attachment (EDF Energy Response 2013 10 15.pdf).pdf