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

Substance name: Terphenyl, hydrogenated
CAS number: 61788-32-7
EC number: 262-967-7

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

Disclaimer: Comments provided during public consultation are made available 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, submitter type, country)	Comment	Responses	
4981
2018/04/13	GIFAS,
Industry or trade association,
France	Please refer to attached letter	Thank you for your comments, which are on risk management issues.  We note that risk management issues are outside the scope of the present proposal, which is hazard based.	
		Attachment: 4981_20008_SVHC_Consultation_ECHA-othersubstances_13avr18.pdf

5005
2018/04/19	Chemservice S.A.,
Company,
Luxembourg	-	Thank you for your comments. 

You mention that for a final conclusion on vPvB, both vP and vB properties need to be demonstrated on the same constituent. In response to this comment we note that the SVHC proposal is in line with this as vP and vB are demonstrated for the same constituent. 

Regarding P assessment you mention that “vP seems to be a correct evaluation of the data set based on the recalculation done for the seawater simulation test by the Dossier Submitter.” We note that for the seawater study (ExxonMobil Biomedical Science Inc., 2009) the only recalculation made by the dossier submitter is the temperature conversion of the half-lives. In the case of o-terphenyl, the temperature conversion does not change the result with respect to vP criterion as the half-life (>182 days) exceeds the vP criterion even without the temperature conversion.

You question the approach used in the Annex XV report regarding studies with mixed C-sources (they are not used to support “not P or vP” in the present dossier). As discussed in the Annex XV report, increased degradation rates have been reported in the presence of other hydrocarbons, in studies cited in the SVHC report (page 43). Negative effects on biodegradation due to presence of other hydrocarbons are also possible. However, as it is not known to what extent these ‘mixture effects’ are occurring and what is their effect on the observed degradation rates, a conservative approach is used in the present SVHC dossier. These effects may depend in part on the combination of substances present in the mixture. Therefore, the composition of the test substance mixture should be taken into account. The test substance in the soil simulation test by Monsanto Company (1989) consists of constituents that are included in terphenyl, hydrogenated (or structurally similar to those) whereas the seawater study (ExxonMobil Biomedical Science Inc., 2009) is on a hydrocarbon mixture with a much higher structural variability. Therefore, the results from the Monsanto Company (1989) study are considered more relevant for the assessment of terphenyl, hydrogenated. 

You consider that “environmental exposure towards this substance (EC-292-967-7) will always be towards the mixture”.
Regarding this comment we note that the individual constituents will partition and distribute in the environment depending on the environmental conditions and the properties of each constituent. Therefore, each constituent will behave as an individual substance in the environment and the mixture of constituents available to the degrading microorganisms may change over time. This may have implications for relevance of mixture studies due to the abovementioned mixture effects.

You also consider that it might be worthwhile to test the degradation especially in soil with the UVCB substance as marketed in the EU for a final and conclusive assessment on vP for EC 262-967-7. We consider that the Monsanto Company (1989) soil simulation study on a mixture of terphenyl, quaterphenyl, and polyphenyl, together with other available data, is sufficient. As the half-life from the Monsanto Company (1989) study exceeds the vP criterion, this result can be accepted. Any ‘mixture effect’ which could be favourable for biodegradation does not affect the conclusion regarding P/vP in this case. In addition, 
the study is conducted on a test item with constituents relevant to terphenyl, hydrogenated.

Regarding your suggestion to conduct an OECD 301 test (manometric respirometry test) including a test item specific and substance screening analytical method, we do not see a need for a new screening test in this case from a PBT point of view as, in our view, there is already a sufficient basis for SVHC identification. As there is a reliable soil simulation test (belonging to assessment information according to REACH Annex XIII) indicating vP, we consider it unlikely that a new screening test (belonging to screening information according to REACH Annex XIII) would change the conclusion. 

Regarding your suggestion for a prolongation of an OECD 301 test to 60 days, ECHA guidance R.7b states that results from prolonged tests are not always adequate for P/vP assessment as ”a late acceleration of biodegradation is likely to reflect an adaptation of the microorganisms and in that case the prolongation of the test duration should not be regarded as adequate for the P/vP assessment.”

You consider that a weight of evidence over all the tests performed shows that hydrogenated terphenyls are inherently biodegradable (you do not specify which particular tests are considered for this conclusion). ECHA guidance R.11. indicates that “Due to the more favourable conditions of an inherent test, results need to meet specific criteria (specified in Table R.11—4 above and Section R.7.9.4.1 “Data on degradation/biodegradation” of Chapter R.7b of the Guidance on IR&CSA) in order for a substance to be considered as not P/vP.” The tests referred to in Table R.11-4 are the Zahn-Wellens test (OECD TG 302B) and the MITI II test (OECD TG 302C). These tests are not available for hydrogenated terphenyls. Therefore, we do not consider that there is a possibility to relieve any of the hydrogenated terphenyls from P/vP concern based on the available information. 

You also mention that “partially hydrolysed terphenyls (as far as tested) do not meet the criteria for vP.” We consider that currently the P/vP status for partially hydrogenated terphenyls is unclear. The conclusion for hydrogenated terphenyls (HT1, HT2, HT3) is “Potentially P or vP”.

You consider that “for none of the partially (fully) hydrolysed components a reliable and complete data set is at hand to conclude on vP/vB properties.”. You further note that “this is only confirmed in the Annex XV Dossier (see above) as most often the few available tests were done with mixtures of unknown composition.”. In response to this comment, we consider the data set sufficient for SVHC identification based on the weight of evidence assessment of available relevant information, which takes into account the reliability and relevance of the data. At least one constituent fulfills clearly the vPvB criteria. 

As already stated above, the data is considered sufficient for SVHC identification and it is unlikely that additional testing would change the conclusion. 

Regarding the B-assessment and specifically the study by Schlectriem (2016), we note that the study is rated as Klimish 1. Only minor deviations from the OECD 305 test guideline were observed. For further responses on the B-assessment see responses to Concawe comments. 

Regarding additional testing proposed by you, we consider the present data sufficient to conclude on vP/vB. 

Over all, we disagree with your statement that it is premature to conclude that the UVCB substance EC 262-967-7 (terphenyl, hydrogenated) is a proven vP/vB substance due to insufficient reliable data.

Regarding your comments related to risk management issues, we acknowledge the importance of a “functional grouping” approach. We note, however, that such risk management issues are outside the scope of the present proposal, which is hazard based. 	
		Attachment: 5005_Comments on Annex XV SVHC report_Terphenyl Hydrogenated.pdf
		
5007
2018/04/19	Eastman Chemical,
Company,
Netherlands	-	Thank you for your comments, which are on risk management issues.  We note that risk management issues are outside the scope of the present proposal, which is hazard based.	
		Attachment: 5007_Eastman Chemical_Public Consultation_Terphenyl_19-4-2018.pdf
		
5103
2018/04/23	Germany,
Member State	We support the identification of Terphenyl, hydrogenated as a substance of very high concern.	Thank you for your support. 	
5141
2018/04/23	ANSES,
National Authority,
France	Minor comments:
Some table numbers seem to be wrong, for example:
- page 17 section 3.1.2.1.1, 1st paragraph refers to table 2 instead of 3, table 6 instead of 8 and to tables 7 and 8 instead of 9.	Thank you for your comment. The table numbering has been checked and corrected. 	
5159
2018/04/23	Aerospace Industries Association,
Industry or trade association,
United States	-	Thank you for your comments (on the uses in aerospace industries and the difficulty to identify alternatives). We note that risk management issues are outside the scope of the present proposal, which is hazard based.	
		Attachment:5159_ECHA Terphenyl hydrogenated April 23 2018.pdf
		
5166
2018/04/23	Concawe,
Industry or trade association,
Belgium	-	Please see responses in specific comments section.  	
		Attachment: 5166_terphenyl hydrogenated SVHC comments - Concawe tables.docx

Specific comments on the justification
Number / Date	Submitted by (name, submitter type, country)	Comment	Responses	
4973
2018/04/12	ChemSec,
International NGO,
Sweden	ChemSec supports the identification of Terphenyl hydrogenated as vPvB and its inclusion on the Candidate List.	Thank you for your support.	
4981
2018/04/13	GIFAS,
Industry or trade association,
France	Please refer to attached letter	Thank you for your comments, which are focused on risk management issues.  	
		See the corresponding embedded attachment in table 1 of Part I: 
4981_20008_SVHC_Consultation_ECHA-othersubstances_13avr18.pdf		
5005
2018/04/19	Chemservice S.A.,
Company,
Luxembourg	Given the serious consequences of vPvB status (a hazard parameter) in terms of risk Management under REACH, we would respectfully argue that adequate consideration should be given to the scientific uncertainties presented in the attached document and to the specificities of Heat Transfer Fluids (HTFs) as a functional group of substances, before proceeding with a decision to identify terphenyl hydrogenated as an SVHC.	Please see responses in the general section.  	
		See the corresponding embedded attachment in table 1 of Part I: 
5005_Comments on Annex XV SVHC report_Terphenyl Hydrogenated.pdf		
5007
2018/04/19	Eastman Chemical,
Company,
Netherlands	-	Please see responses in the general section.  	
		See the corresponding embedded attachment in table 1 of Part I: 
5007_Eastman Chemical_Public Consultation_Terphenyl_19-4-2018.pdf		
5010
2018/04/19	Sweden,
Member State	The Swedish CA agrees that terphenyl, hydrogenated, meets the criteria according to Article 57(e) in REACH and is thus eligible for identification as a substance of very high concern. This is mainly based on the following reason:
- The terphenyl, hydrogenated constituent o-terphenyl fulfils both the vP and the vB criteria and occurs in concentrations > 0.1 % w/w.	Thank you for your support.	
5028
2018/04/20	Norway,
Member State	Norway supports that terphenyl hydrogenated should be identified as a substance of very high concern and should be included in the Candidate list. Terphenyl hydrogenated is an UVCB that is very persistent in soil and water. The UVCB has also been shown to have a BCF above 12 000, - proof that it is a highly bioaccumulative compound. Terphenyl hydrogenated meets the criteria for inclusion on the Candidate list as vPvB 57 e) REACH.	Thank you for your support.	
5068
2018/04/23	CHEM Trust,
National NGO,
United Kingdom	CHEM Trust  supports the inclusion of terphenyl, hydrogenated into the REACH candidate list on the basis of article 57 e) due to its vPvB properties meeting the criteria of REACH Annex XIII as  presented in the weight of evidence approach.	Thank you for your support.	
5140
2018/04/23	European Environmental Bureau (EEB),
International NGO,
Belgium	EEB supports the proposal to identify Terphenyl hydrogenated as SVHC according to REACH Article 57. We thank Finland for the in-depth evaluation of all information available for this UVCB as well as for the relevant constituents of the UVCB. It can be concluded that at least o-terphenyl meets the criteria for vPvB substances set out in Article 57(e). As o-terphenyl is a significant constituent (> 0.1% w/w) of the UVCB terphenyl hydrogenated, the latter can be concluded to be a vPvB substance.

Terphenyl hydrogenated is a vPvB substance, with high volume and wide dispersive use, therefore the substance should be included in the Candidate List and considered for inclusion in Annex XIV.	Thank you for your support.	
5141
2018/04/23	ANSES,
National Authority,
France	The substance terphenyl, hydrogenated (UVCB substance) is proposed for the identification as substance of very high concern due to the vPvB properties of at least o-terphenyl (o-T), a representative component which occurs in significant concentration (>0.1%) in the UVCB substance.

The MSC submitter has produced a well detailed analysis of the persistency properties of the representative structures of this UVCB substance. Some of them can be considered as P and vP (especially o-T) or potentially P or vP. Based on a weight of evidence assessment Terphenyl, hydrogenated fulfils the P and vP criteria.

Also based on a weight-of-evidence, Terphenyl, hydrogenated fulfils the B and vB criteria. A BCF value of 12993 of o-terphenyl (o-T) is measured in an experimental study. This result is also supported by BMF values and predicted BCF values for this component.

Therefore, a clear conclusion can be drawn for the component o-terphenyl (o-T) as fulfilling the vPvB criteria.
A definitive conclusion on the T criteria cannot be proposed based on the available ecotoxicity data.

Taking into account all the information regarding the persistence and bioaccumulation, ANSES supports the identification of terphenyl, hydrogenated as an SVHC according to Article 57(e) due to the vPvB properties of o-terphenyl, a representative component of this UVCB substance.	Thank you for your support.	
		-		
5159
2018/04/23	Aerospace Industries Association,
Industry or trade association,
United States	The Aerospace Industries Association (AIA) appreciates the opportunity to make comment on the proposal regarding the addition of Terphenyl hydrogenated (CAS: 61788-32-7, EC: 262-967-7) to ECHA’s Substances of Very High Concern (SVHC) list. AIA represents over 340 major U.S. aerospace and defense manufacturers and suppliers of civil, military, and business aircraft, helicopters, unmanned aerial systems, missiles, space systems, aircraft engines, material, and related components, equipment services, and information technology. The aerospace industry is inherently global, and many of our major suppliers are located in the European Union.
The industry is aware of several critical and diverse applications of this substance within aerospace and defense. There are no direct replacements in many critical applications listed below, and replacement would likely involve significant redesign and/or attendant requalification and recertification activities.	Please see responses in the general section.  	
		See the corresponding embedded attachment in table 1 of Part I: 
5159_ECHA Terphenyl hydrogenated April 23 2018.pdf		
5166
2018/04/23	Concawe,
Industry or trade association,
Belgium	SUBSTANCE IDENTITY

Very little appears to be known about the composition of hydrogenated terphenyl (CAS: 61788-32-7). The list of constituents (and their concentration ranges) (Table 2) is poorly characterized and is broken up into only a single easily identifiable group (terphenyls), which only accounts for up to 5% of the total mass in the substance. According to the “Health-based Reassessment of Administrative Occupational Exposure Limits” published by the Health Council of the Netherlands in 2002 (https://www.gezondheidsraad.nl/sites/default/files/0015040osh.pdf), the most common isomers in commercial-grade terphenyl are the m- and p-terphenyl (CAS: 26140-60-3), with m- and p-terphenyl comprising 45-49% and 25-35% of the isomeric mixture, respectively. The remaining composition is higher polyphenyls (2-18%) and o-terphenyl 2-10%). Given that the isomeric terphenyl mixture is listed as <5% of the concentration in the hydrogenated substance, this would suggest that o-terphenyl will comprise ~ 0.1 – 0.5% of the total substance.

PERSISTENCE

Summary
Our conclusion based on the data available is that a conclusion of P and vP for isomers of terphenyl (o-, m- and p-) is not supported.
We note that the Monsanto (1989) soil simulation test is given the most weight in the assessment of persistence for terphenyl and quaterphenyl, leading to the conclusions of P and vP for these substance groups. However, we have noted several concerns with this study, as discussed below. A general concern is with the use of the Arrhenius equation to extrapolate from test temperature to 12°C, which in this case is a difference of 13 degrees, and results in a change of conclusions from “not P” to “vP”. In such an extreme case it would be pertinent to generate further biodegradation data at the temperature of interest in order to reach robust conclusions on the persistence classification.
We would like to draw the assessor’s attention to recently published surface water biodegradation data for p-terphenyl, a substance relevant to this assessment (Birch et al., 2018). The study was conducted at the Danish Technical University (DTU) and employed a partitioning-based experimental platform to generate primary degradation kinetics for a number of hydrocarbon test compounds at 20 °C and concentrations well below their water solubility (ca. 1/1000). These were measured in three different inocula: seawater, a rural lake water, and activated sludge filtrate. Changes in concentration of individual hydrocarbons were measured at intervals relative to abiotic controls to determine biodegradation kinetics.
Depending on the fit of the data either a first order half-life (T1/2) or a degradation half-time (lag phase + half-life, DT50) was derived. The T1/2 for p-terphenyl was 5.1 and 20 days in the activated sludge and rural lake water, respectively. For seawater a DT50 of 20 days was determined. Therefore, in three separate inocula the half-life of p-terphenyl was below the cut-off P and vP. These data demonstrate the primary degradation of p-terphenyl in surface waters at environmentally relevant concentrations and are considered reliable.
It is reasonable to also consider these data along with the results from EMBSI (2009) in the assessment of m- and o-terphenyl. In doing so, before extrapolation with Arrhenius, only one data point (the result of >182 days for o-terphenyl) exceeds the cut-off for P/vP. As discussed later, this was likely due to the exclusion of specific degraders, which can be a problem for tests that utilise a low sample volume and concentration of inoculum, such as OECD 306 (Biodegradability in seawater) and water simulation tests (Martin et al., 2017). The remaining data support the conclusion that isomers of terphenyl do not meet the P or vP criteria.
Much of the other data presented are from screening studies, in which the test material will have been dosed in excess of its water solubility (e.g. MIC, 1983). This would result in limited bioavailability leading to difficulty in determining accurate estimations of half-lives, and may have resulted in microbial inhibition due to narcosis (toxicity).
It is our opinion that the available data do not support a conclusion of P or vP for isomers of terphenyl (T). Current conclusions are dependent on results from key studies being extrapolated over a very large temperature range using the Arrhenius equation, and without this extrapolation the results lead to a conclusion of “not P”. Given this extreme case it is recommended that further data be generated at the desired temperature of 12 °C in order to provide conclusive evidence of degradation kinetics at this temperature.

Specific comments
p.44 We disagree with the reliability assessment (Klimisch 4) of the EMBSI (2009) study. This study has been specifically designed for measuring primary degradation half-lives of multiple compounds with very low water solubilities, for which standard test guidelines are not appropriate. In the absence of appropriate test guidelines the data should be assessed on its own merit. The passive dosing methodology employed has enabled concentrations of test substances to be maintained at or below their limit of solubility, thereby removing bioavailability issues caused by the presence of undissolved test material, which are difficult to avoid using standard approaches. The methodology is therefore more fit-for-purpose for determining primary degradation half-lives for these substances. The reviewer acknowledges that the study is well documented and scientifically acceptable, therefore these data should be considered reliable.
We disagree with the remark that several compounds being tested simultaneously is a reason to compromise use of the data for persistence assessment under REACH. The influence of so-called “mixture effects”, such as co-metabolism and bioavailability, remains the subject of ongoing scientific research and discussion, and negative interactions have also been documented. Furthermore, it should be noted that terphenyl, hydrogenated is itself a UVCB, and is therefore likely to be influenced by such mixture effects (if applicable). This should be borne in mind also in considering the reliability of the data from Monsanto (1989), where the substance tested was also a mixture.
Regarding the data presented in Table 16, we note that of all relevant data points (9), only two exceed the P/vP cut-off for half-life in seawater. One of these, o-terphenyl, observed no degradation throughout the course of the test (>182 days). This was true of several test compounds in this particular study, and the likely explanation for this is that the low inoculum concentration and sample volume resulted in the exclusion of specific degraders from the test. This has been observed elsewhere in the literature, and has resulted in recommendations for improvements to standard biodegradation tests (Martin et al., 2017). We would therefore advise treating this result with caution, particularly in the presence of other data which indicate more rapid biodegradability.

p.54 Regarding the Monsanto (1989) soil simulation test, it was concluded that terphenyls (T) and quaterphenyls (Q) are P and vP. It should be noted that this conclusion was drawn despite some issues that may raise concerns/doubts over the validity of the results. These issues may be summarised as follows:
• Test substance – It is not certain that hydrogenated T,Q or P were not present. There is insufficient information to ascertain if the analytical method would be capable of making distinctions between fully aromatic and hydrogenated material. No information is available on the proportion of o, m and p isomers present. Both the degree of hydrogenation and isomer positioning is known to affect the rate of biodegradation, therefore the assumption that results from the persistence tests relates to all isomers of unhydrogenated material may not be correct.
• Sterile controls – A quality check on sterile controls, conducted at 8 weeks, resulted in faint colonies forming.  If losses found in the sterile control were due to biotic, as well as abiotic processes, this would result in an under- estimation of substance loss through biodegradation in active samples.
• The study consisted of two tests, with different test concentrations – 50 ppm and 0.5 ppm, in 2 different soils (A and B). 50 ppm is considered to be a very high concentration. The effect of test material on bacteria was measured prior to conducting soil tests; however, this consisted of running Microtox tests with a 5% ethanol control, a soil extract, test compound standards made up in methylene chloride (the solvent carrier to be used in soil dosing) and soil extract spiked with standard. EC50s were all less than 1%, including the soil extract, which should be non-toxic. This result casts doubt over the validity of the Microtox test and potential toxicity of test substance to soil micro-organisms cannot be ruled out. Conversely, the dose of 0.5ppm test material was rather too low to produce reliable analytical results.

p.55 We note that the results of the Monsanto (1989) have been extrapolated from 25ᵒC to 12ᵒC using the Arrhenius equation. Generally, we do not agree with this practice. However, we would like to highlight two reasons why this is seen as particularly questionable in this case:
1. Based on the original results measured at 25ᵒC, terphenyls are neither P or vP when compared to the criteria (see table below). Only when results are extrapolated to 12ᵒC using Arrhenius do they meet the vP criteria. It is our opinion that it is extremely questionable to use the Arrhenius equation to change the conclusion from not P to vP, and that in such a case, more data should be provided or generated to support this conclusion based on observed biodegradation at the temperature of interest.
2. The extrapolation from 25ᵒC to 12ᵒC is regarded as extreme. Typically the extrapolation is from 20ᵒC to 12ᵒC, and whilst we would generally not support this, an extrapolation from 25ᵒC would be expected to be subject to even greater error.

DT50 values measured from test data, produced at 25ᵒC plus adjusted values to 12ᵒC are presented in Table 1 (attached).

BIOACCUMULATION

Summary
The conclusion of “B and vB” for o-terphenyl reached by the rapporteur, which drives the vPvB conclusion for terphenyl, hydrogenated (CAS: 61788-32-7), is based solely on the single BCF value determined by Schlechtriem et al. 2016 and fails to take into account the weight of evidence presented by additional high-quality experimental data (NITE, Inoue, & ExxonMobil). Given that there is significant variability of over a factor of 10 in the experimental and QSAR-predicted BCFs for o-terphenyl, it is strongly suggested that a weight of evidence approach (as presented below) be considered in determining “B” classification when multiple high quality experimental and QSAR results are available for a substance. Consequently, it would be more appropriate that o-terphenyl be given a classification of “B” rather than “B and vB” as suggested by the rapporteur.
Given that o-terphenyl is most likely a minor constituent of terphenyl, hydrogenated (< 0.1 – 0.5% w/w), and that limited data are available for several other isomers, it is also recommended that additional whole substance bioaccumulation testing be conducted to determine the bioconcentration of the representative substance, with proper and complete quantification of individual constituents.

Specific comments

o-Terphenyl Studies
For ortho-terphenyl there is considerable variability in the computed BCF values between studies. The most recent Schlechtriem (2016) study estimates the growth and lipid-corrected BCF for o-terphenyl as 12,993 L/kg-ww, over an order of magnitude higher than the Nite (2012) study, which reported lipid-corrected BCF values of 1100 (±200) and 1900 (±300) at 0.1 µg/L and 1 µg/L, respectively. Further, lipid and growth-corrected BCFs computed from dietary studies (Inoue et al. 2012) were comparable to the NITE results, with computed BCFs of 1778 and 2108 L/kg-ww using two independent BMF to BCF models (Table 61) and was considered valid with restrictions (Klimish 2). Finally, a dietary BMF study by ExxonMobil (2010a) determined a range (n=6) of growth-corrected lipid-normalized BCFs (based on the selected BMF to BCF model employed) of 3513 – 7694 L/kg-ww. It should be noted that when the organism weight is included in the BCF/BMF model formulation (Barber 2003 and Sjim 1995, both in Brooke 2011) the predicted BCFs are considerably lower, and in closer agreement (3513-4132 vs. 3513-7694).
Of the 11 computed BCF values for o-terphenyl from the 4 studies included by the rapporteur, 3 computed BCFs were above the vB criteria, 6 were above the B criteria but below the vB criteria, and 3 were below both the B and vB criteria (see Table 2, attached).
If a geometric average of the computed BCF values and associated 95% confidence interval is computed for the 11 unique BCF values computed from the 4 studies included in the report, we obtain an average BCF value for o-terphenyl of 3522 L/kg-ww with a 95% confidence interval of 2300 – 5391 L/kg-ww). Consequently, if the whole of the BCF data for o-terphenyl is examined, a classification of vB based on a single study and BCF value which ignores all 3 other studies and 10 other computed BCF values is not appropriate. It would be more appropriate to consider o-terphenyl as “B” and not “B and vB”. Further, it should be noted that the QSAR predictions for o-terphenyl (BCFWIN and Arnot-Gobas Upper BCF) support this conclusion (BCF = 2041, and 1146 L/kg-ww, respectively).

m-Terphenyl, p-Terphenyl & iso-Terphenyl Studies
For m-terphenyl, the dietary BMF results and corresponding BCFs (ExxonMobil 2010b) were significantly lower, with a mean growth- and lipid-corrected BCF value of 636 ± 199, with values ranging from 469 – 984, based on the BCF/BMF model used (discussed previously). Similar to o-terphenyl, the BCF/BMF models which do not account for organism weight comprise the high end of the estimated range (830 and 984, as compared to 469-546) compared to those which explicitly consider organism weight. Further, it should be noted that the CAESAR BCF model (VEGA) predicts a BCF value of 1245 L/kg-ww with a reliability score of 3/3 (high) for m-terphenyl. This is consistent with both the experimental BCFs as well as the Arnot-Gobas BCF prediction. Given the reliability score of the experimental study and the corresponding predicted QSAR values both from CAESAR/VEGA as well as from the Arnot-Gobas upper trophic model (BCF(A-G, 5%) = 1035 L/kg-ww), it is appropriate to conclude that m-terphenyl is “probably not B or vB” as opposed to the conclusions of the rapporteur of “not possible to conclude”.
While no explicit studies were done on p-terphenyl, the bioaccumulation potential of this isomer can be inferred based on quantitative results from the ortho and meta isomers as well as mixture studies. The NITE (1978) BCF study using terphenyl (CAS: 26140-60-3) determined BCF values for the isomeric mixture of 15-129 L/kg-ww. While it is not clear if these results are growth or lipid-normalized, one can see that the results are qualitatively substantially lower than both the ortho (mean BCF = 3522 L/kg-ww (GeoMean, above)) and the meta (mean BCF = 636 L/kg-ww (Mean, above)) isomers, individually. Consequently, to observe a lower BCF than either of the two other isomers by themselves, this suggests the BCF of p-terphenyl to be low.

Partially-hydrogenated Terphenyl Substances
The NITE (2004) study which addresses the bioaccumulation of the partially hydrogenated constituents (i-HT1 and i-HT2) of the hydrogenated terphenyl demonstrated a significant range of estimated BCFs (1551 – 12436 L/kg-ww) with the highest BCFs occurring for the higher aqueous exposure of the HT1 constituents. It should be noted that when dose levels are significantly below substance solubility, the resulting BCFs should be comparable. It is observed for the NITE study that consistently, the BCFs for the individual peaks (A-G) are considerably higher for the higher aqueous dose (level 1). For peaks A-G, the level 1 BCFs at 60 days are > 2x higher. This suggests that the higher aqueous dose may be sufficiently high that it saturates the metabolic clearing mechanism for the organism, and results in a concentration-dependent BCF. If the lower aqueous dose is considered, of the 7 identified peaks, 2 are < 2000 L/kg-ww (not B), 4 are between 2000 and 5000 (B), and only one isomer (peak D, i-HT1) would be classified as vB.
Additionally, the Monsanto (1983) study determined BCFs for several “groups” of hydrogenated terphenyl constituents. Group II in this study consisted of HT1 and HT2 isomers, similar to the NITE (2004) study.  The steady-state and kinetic BCFs were 2400 and 3548 L/kg-ww. This is in reasonable agreement with the NITE study, which attempted to quantify individual constituents. It should be noted that the Monsanto study indicates that group I contains o-terphenyl as well as some HT1 consitituents, which shows a greater bioaccumulation potential than groups II and III (BCF = 5200 – 8148 L/kg-ww). However, these results were considered by the author to be less reliable, since a constant quantifiable exposure was not maintained. Further, given o-terphenyl is present in this group, without exact quantification it is impossible to determine the contribution from the HT1 constituents, and the results from group I should not be used to inform a “B” decision for these constituents.
Considering the overall bioaccumulation potential of the substance, as well as the results from both the NITE and Monsanto studies it would be appropriate to consider the partially hydrogenated constituents (iHT1 and i-HT2) “B” as opposed to “B and vB” as indicated by the rapporteur. Finally, it should be noted that given the extreme variability between individual component peaks in the NITE study, accurate quantification and identification of individual constituents via testing and analytical validation of the whole substance would greatly reduce the uncertainty in the bioaccumulation potential of the partially hydrogenated constituents of the substance.

Partially-hydrogenated Quaterphenyls (HQ1 & HQ2) [ HQ3 Kow >10 therefore not Bioavailable]
Based on the log(Kow) values for the HQ1 (8.34) and HQ2 (9.26) quaterphenyls, bioaccumulation potential is expected to be low, due to low bioavailability and sorption to organic matter within the test system (and aquatic environment). Since no experimental data was available, several BCF models were used to predict the BCFs of the two partially hydrogenated quaterphenyls, the results of which are summarized in Table 3 (attached).
For both HQ1 and HQ2, the geometric means of the 5 model results demonstrate low predicted bioconcentration factors of 745 and 330 L/kg-ww, respectively. This suggests that a conclusion of “probably not B or vB” would be more appropriate for these constituents, given the general agreement between the models.

References

Martin, T.J., Snape, J.R., Bartram, A., Robson, A., Acharya, K., Davenport, R.J., 2017. Environmentally Relevant Inoculum Concentrations Improve the Reliability of Persistent Assessments in Biodegradation Screening Tests. Environmental Science & Technology 51, 3065-3073.
Birch, H., Hammershøj, R., Mayer, P, 2018. Determining Biodegradation Kinetics of Hydrocarbons at Low Concentrations: Covering 5 and 9 Orders of Magnitude of Kow and Kaw. Environmental Science & Technology 52, 2143-2151. Open access link: https://pubs.acs.org/doi/10.1021/acs.est.7b05624	SUBSTANCE IDENTITY

More detailed information on the composition of the substance is available in the registration dossier. The amount of o-terphenyl is considered relevant for vPvB identification. However, this information is considered potentially confidential and has therefore not been included in the Annex XV dossier. Only information publicly available on the ECHA website and in Safety Data Sheets could be shared in the public consultation. 

PERSISTENCE

We note that in your view, the conclusion P and vP for o-, m-, and p-terphenyl is not supported. Regarding m-terphenyl, your view is partly in accordance with the Annex XV report as the conclusion for m-terphenyl is “Potentially P or vP”. For o-, and p-terphenyls your conclusion differs from the Annex XV report, where o- and p-terphenyls are concluded “P or vP”.

Arrhenius equation: Regarding your comment on the test temperature (25°C) and the use of the Arrhenius equation for the results of the Monsanto Company (1989) study we note that ECHA guidance R.7b states: “If information on degradation half-life is already available from existing simulation degradation tests performed at a higher temperature, they should be normalised to a half-life corresponding to 12°C by using the Arrhenius equation (see paragraph below named “Temperature correction”). In every case, kinetic results such as the degradation rates and degradation half-lives should correspond to an environmentally relevant temperature, i.e. by default 12°C.”

The guidance document discusses the uncertainties related to the temperature correction, including that the specific activation energy (Ea) for a substance is rarely known, which is the case also with the constituents tested in the Monsanto Company (1989) study. According to the guidance, in the absence of valid substance specific data, the Arrhenius equation with the generic Ea value should be used if temperature correction is needed. We acknowledge that test temperature is above the range recommended in OECD 307 (20 ±2°C) (”A temperature of 20 ±2 °C is recommended for all test substances which may reach the soil in temperate climates”), which may increase the uncertainty in temperature correction. However, the deviation of the test temperature from the OECD recommendation is considered relatively small. In addition, the guidance does not explicitly set any maximum difference in temperature (between the test temperature and reference temperature) at which the temperature correction should not be used.  Therefore, we consider that no changes to the use of temperature correction are warranted. 

Birch et al (2018) study: Thank you for providing the reference to this article. It has been published in January 2018, just before the submission of the Annex XV report. We consider that the results for p-terphenyl in this study are not relevant for a direct comparison with P/vP criteria in the assessment of terphenyl, hydrogenated. The main reason is that the half-lives for p-terphenyl were determined in a test system in which other hydrocarbons were present and, as explained in the Annex XV report (3.1.2.1.3., Chapter concerning ExxonMobil Biomedical Science Inc., 2009.), results from such studies are not used to support “not P or vP” in this case. 

In addition, regarding the results for activated sludge filtrate, these results are of limited relevance for PBT/vPvB assessment due to the fact that wastewater treatment plant is not a relevant compartment for PBT/vPvB assessment. There are no P/vP criteria for degradation in a wastewater treatment plant. Regarding the results for seawater, it is noted that degradation in the seawater samples in this study may be of limited relevance for PBT/vPvB assessment due the possible preadaptation of the seawater microorganisms at sampling site. The article mentions that “seawater samples were taken in the vicinity of a trafficked shipping port, which likely implied pre-exposure of the natural bacterial consortia to petroleum hydrocarbons”. 

In addition, we note that if a definitive conclusion on P/vP in one compartment is drawn, the constituent/substance is concluded to be P/vP, despite the results for the other compartments. In the present case, in our view, o- terphenyl and p-terphenyl are concluded to be vP in soil (your comments on validity of this conclusion have been discussed above). Therefore, in our view, any new data on the water compartment would not change the overall conclusion. 

In this study (Birch et al. 2018), degradation of p-terphenyl was studied using a mixture of 19 hydrocarbons. The total initial concentration of the hydrocarbons was 241 µg/l (sum of concentrations of the 19 hydrocarbons). The concentration of naphthalene (initial test conc. 170 µg/l) in this mixture was much higher compared to the other hydrocarbons (pyrene 40 µg/l; 1,2-dimethylnaphthalene 10µg/l; other hydrocarbons 0.09-5 µg/l per each hydrocarbon). The concentration of p-terphenyl (0.05 µg/l) was among the four lowest concentrations of the studied hydrocarbons and represented 0.02% of the test mixture. Therefore, degradation of p-terphenyl in this study may be significantly influenced by the presence of other hydrocarbons, which are not constituents of terphenyl, hydrogenated. The effect of test mixture on degradation rates is not discussed in the article; however, the authors mention that “further research is needed for determining possible co-substrate effects on the biodegradation kinetics at low concentrations”. We note that the reasons for not using mixture studies to support “not P or vP” in this case are already discussed in the Annex XV dossier (please see also the responses to the comments by Chemservices S.A.). We note that for some hydrocarbons tested in the same mixture, degradation was similar or faster compared to p-terphenyl (in the case of seawater these were at least 1,4,6,7-tetramethylnaphthalene, 2-ethylanthracene, and 2-methylcyclopenta(I)phenanthrene; in the case of lake water, these were at least:2-ethylanthracene, and 2,6-diisopropylnaphthtalene). Therefore, it is possible that the presence of other hydrocarbons increased the degradation of p-terphenyl. In addition, it is noted that this study addressed only primary degradation whereas no information is available on transformation products

Therefore, for the reasons discussed above, we consider that the results for p-terphenyl in this study are not relevant for a direct comparison with P/vP criteria in the present case. 

Use of mixture studies: We note your disagreement with the Annex XV report regarding the use of mixture studies for persistence assessment under REACH. In our view, for accepting mixture studies for P/vP assessment of, e.g., p-terphenyl, more information would be needed regarding the possible effects of the other constituents and their concentrations on the degradability of p-terphenyl. Studies comparing degradability of a hydrocarbon as a single substrate vs. as a part of a mixture in environmentally relevant conditions would provide more information on this. As discussed in our responses to the comments by Chemservices S.A., it is also important to take into account the composition of the test mixture.

Mic 1983 study: You do not specify whether you refer to Mic 1983a or Mic 1983b. We note that in Mic 1983a the test substance concentration was relatively low (≤50 µg/l).

Further testing: As explained above, we consider that it is appropriate to use the Arrhenius equation in this case. We do not consider that further testing in context of P/vP are necessary as sufficient data for SVHC identification is available. 

Exxonmobil Biomedical Sciences, Inc. (2009) study (EMBSI 2009) reliability score: The reliability score of 4 (not assignable) is used mainly because the raw data has not been available for this assessment, in contrast with the soil simulation tests. With raw data, a different reliability score could be possible. However, for the present dossier, a more in-depth assessment of this seawater test is not considered necessary, as vP is concluded for the soil compartment already. 

Simultaneous testing of several compounds: 
Please see responses to the comments by Chemservices S.A. above. 

Low inoculum concentration in Exxonmobil Biomedical Sciences, Inc. (2009) study (EMBSI 2009):
Thank you for providing this information. This result is already treated with caution in the Annex XV dossier as a reliability score of 4 is assigned. As noted above, for the present dossier, a more in-depth assessment of this seawater test is not considered necessary, as vP is concluded for the soil compartment already. 

Test substance in Monsanto (1989) study: As there is no indication of any hydrogenation applied in the test report, we consider that it is reasonable to assume that the substance includes unhydrogenated terphenyl and quaterphenyl to such an extent that the study can be used for the persistence assessment of unhydrogenated terphenyl and quaterphenyl constituents. In addition, information from other studies (on specific isomers) is used for the conclusions. 

Sterile controls in Monsanto (1989) study: We agree with your observations that a possible biological activity in the sterile control would cause underestimation of biodegradation if biodegradation is estimated from the difference between active tests and sterile controls. However, in this case the half-lives from the active tests exceed the vP criterion even without the subtraction of the sterile control so the potential biological activity in sterile controls does not change the conclusion here. This is already discussed in the Annex XV report.

Microtox test in Monsanto (1989) study:  Based on your comment we have assessed the Microtox test in more detail. It is noted that there are several weaknesses related to this toxicity test. The test report does not give results on only the solvent methylene chloride. In addition, from the original report it is unclear how the test solutions were prepared and what were the actual concentrations. Ethanol at the tested concentrations and the unspiked soil extract are not expected to be toxic. The colour of the test samples was not reported and no colour correction was used for soil extracts. Soil extracts in general may hamper the detection of luminescence in Microtox test either due to colour or due to extracted soil components especially if the extract is something else than water. 

The results of the Microtox test do not indicate any significant differences between spiked and unspiked soil extract samples, and ethanol used for extraction, in their toxicities towards luminescent bacteria. This suggests that in the soil degradation test inhibition by test substance is not expected. In addition, we note that the possible effect of a relatively high test substance concentration has been already considered in the Annex XV document (page 55), e.g.: “The comparison of the results at 0.5 and 50 ppm tests in Soil A suggest that the relatively high concentration used at the 50 ppm test did not negatively affect the degradation.” and “The results for the lower test concentration (0.5 ppm) are less accurate; however, they indicate that degradation rate at 0.5 ppm is likely to be similar or slower than at 50 ppm.”. Therefore, we consider that inhibition by test substance was not an issue in the study. 

Arrhenius equation: Please see response above.

Regarding the Table 1 (the DT50 values) attached to your comments, we note that for quaterphenyl, the estimated half-lives are above the vP criterion in soil even without a temperature correction (no acceptable kinetic fits were obtained for the quaterphenyl tests). We also note that the decrease in concentration in this study may be only partially due to degradation as it may be contributed e.g. by formation of non-extractable residues. Therefore, the DT50 values based on decrease in concentration represent ‘best-case’ values and the real half-lives for degradation may be higher. In addition, the biodegradation half-lives (calculated using the results from the active test and sterile control) for terphenyl were 101 and 182 days for the two soils, thus exceeding the vP criterion in one of the two soils tested, even without a temperature correction. 

BIOACCUMULATION

The conclusion of “B and vB” for o-terphenyl is based on all available data in a weight-of-evidence assessment. Good quality measured data is given most weight. For o-terphenyl there are 5 bioaccumulation studies available, the validity of which is rated Klimish 1 or 2. Two studies are on Carp and three on Rainbow trout. The BCF values for Rainbow trout and Carp deviate significantly and the data should not be combined. Also according to ECHA guidance (Guidance on Information requirements and risk assessment R.7c, chapter R.7.10.4.6): “When more reliable BCF values are available for the same species and life stage etc., the geometric mean (of the lipid normalised values, where appropriate) may be used as the representative BCF value for that species for bioaccumulation”, suggesting that combining results from different species is not recommended. For Rainbow trout all BCF values are either above 5000 (Schlectriem 2016, OECD 2012) or very close to it (4887 ± 1611 in ExxonMobile 2010a). Therefore, the conclusion “B and vB” is considered justified. 

We note further that in your weight-of-evidence analyses (Table 2, see general comments nro 5166) you have left out the OECD validation report results (OECD 2012). These should be included in the analyses.

The derivation of BCF values from BMF values has been done based on models reported in Crookes and Brooke (2011). Two of the models are based on log Kow values, and three on fish weight. No specific preference/weight has been given to one kind of model over another kind. BCF values have been derived with all models (provided that necessary input values were available) and the mean value and standard deviation were reported. BCF estimations based on fish weight (1015 and 1027) are added in the Support Document for the Inoue 2012 results as they were missing from the Annex XV report. However, they do not change the overall conclusion “B and vB” for o-terphenyl. 

m-terphenyl fulfils the screening criterion for B/vB (logKow > 4.5). There is one experimental BMF value available for m-terphenyl (ExxonMobile 2010b), which results in rather low estimated BCF values (636 ± 199). The study is rated Klimish 2, as there is some uncertainty regarding the exposure of fish. (In the study difficulties of keeping the corn oil / test substance suspension homogeneous during preparation and sampling of feed are reported. Only mean values of measured concentrations in feed matrix are reported, thus not enabling an assessment of the variability of test substance concentrations in the feed.) The BCF estimated by Episuite (regression) is 2041 exceeding the B criterion. Therefore, considering these uncertainties and that the data are contradictory in respect to the B criterion, it is not possible to conclude “probably not B or vB”. 

The relevance of the NITE 1978 study is considered low and it has therefore not been used is the assessment. (Crucial tables are missing from the test report and some figures are illegible, it is not clear whether steady-state was achieved in the test. The study is rated Klimish 4.) It is not possible to clearly conclude on what isomers the reported BCF values 15 – 129 relate to, as apparently the used LC-method could not deviate between o-, m- and p-terphenyls. Therefore, we disagree that the study suggests that the BCF of p-terphenyl is low.

We agree that metabolic saturation can in some situations explain higher BCF values determined at higher exposure concentrations. Whether this is the case in the NITE (2004) study, is not known. There can be other reasons too for concentration-dependent BCFs, such as if the fish were stressed and therefore increased their respiration rate at the higher concentration. Additional text to reflect these considerations is included in the Support Document. We consider, however, that the BCF values determined in the NITE 2004 study at the higher exposure level (1.99 µg/L) are relevant and should be taken into consideration in the weight-of-evidence. An exposure level of 1.99 µg/L is commonly used in BCF studies and is relatively low. 

We note that the Monsanto (1983) study has not been used for HT1 (see e.g. Table 64 of Annex XV), because within group I it is not possible to deviate between o-terphenyl and HT1 constituents. 

There are only screening level data (QSAR estimations) available for HQ1, HQ2 and HQ3. All three constituents fulfil the screening criterion logKow > 4.5, and therefore potentially fulfil the B/vB criteria. However, in accordance with ECHA guidance on PBT assessment (R.11), the aquatic BCF of a substance is probably lower than 2000 if the calculated log Kow is higher than 10. The logKow of HQ3 is > 10 and therefore, it can be concluded that it probably is not B/vB. 

For HQ1 the logKow values is 8.34 and QSAR estimations for BCFs are 296 – 2941. 

For HQ2 the logKow value is 9.26 and QSAR estimation (Episuite BCF BAF regression) is 1038. We note that for the Arnot-Gobas estimations it is stated that, “model predictions may be highly uncertain for chemicals that have estimated log KOW values > 9.” Therefore, the Arnot-Gobas estimates are not used in the weight-of-evidence for HQ2 and HQ3.
As HQ1 and HQ2 fulfil the screening criterion for B/vB and as the QSAR estimates show relatively high BCFs, it is concluded that the substances are potentially B/vB. 	
		See the corresponding embedded attachment in table 1 of Part I: 
5166_terphenyl hydrogenated SVHC comments - Concawe tables.docx		

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, submitter type, country)	Comment	Responses	
4948
2018/03/09	WeylChem Wiesbaden GmbH,
Company,
Germany	The substance in question has unique properties as heat transfer fluid, because it can be used up to 340°C without technical modification of the plan. The material is further used in a closed circuit, thus any kind of exposure is not expected.	Thank you for your comments. 
	
4981
2018/04/13	GIFAS,
Industry or trade association,
France	Please refer to attached letter	Thank you for your comments. 
	
		See the corresponding embedded attachment in table 1 of Part I: 
4981_20008_SVHC_Consultation_ECHA-othersubstances_13avr18.pdf		
5004
2018/04/19	PHOENIX INTERNATIONAL A/S,
Company,
Denmark	We would like to thank ECHA for this opportunity to comment on the proposed identification of terphenyl hydrogenated as a Substance of Very High Concern (SVHC) under REACH.
Phoenix International A/S uses terphenyl hydrogenated for the following purposes:
Is an important ingrediens in formulation of a bitumenbased polyurethane where the two main products are used for: Expansion joints in concrete constructions. Filling compound for underground high voltage joints up to 550 kV.
Should Authorisation be applied to terphenyl hydrogenated, we would estimate the following socioeconomic consequences for our business:
• no substitues tested so far and likely to be less efficient
• high costs involved in system replacements
• business may close due to loss of performance of product and price increase due to change of formulation	Thank you for your comments. 
	
5005
2018/04/19	Chemservice S.A.,
Company,
Luxembourg	-	Thank you for your comments. 
	
		See the corresponding embedded attachment in table 1 of Part I: 
5005_Comments on Annex XV SVHC report_Terphenyl Hydrogenated.pdf		
5007
2018/04/19	Eastman Chemical,
Company,
Netherlands	Eastman would like to thank ECHA for this opportunity to comment on the proposal by Finland to identify terphenyl hydrogenated as a Substance of Very High Concern (SVHC) under the EU Regulation on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH).

Terphenyl hydrogenated is a significant commercial product in the EU, manufactured by Eastman in Newport, Wales under the name Therminol 66. The predominant use of terphenyl hydrogenated is as a high temperature non-pressurised heat transfer fluid (HTF) in closed manufacturing systems, including for polymers, waste heat recovery, oil and gas, petrochemicals, and renewable energy. It is also used as a plasticiser in high-voltage underground cables, in aircraft sealants and other plasticiser applications.

Given that terphenyl hydrogenated’s predominant used as an HTF is within a closed-system and so with negligible potential for exposure, we would respectfully argue that a Restriction under REACH would be a more proportionate and equally effective risk management option compared to SVHC listing and Authorisation.  Indeed, a Restriction could target those applications where there is actual potential for exposure while preserving core uses as an HTF. This would fulfil the requirements for a high level of environmental protection and prevent disproportionate regulation with significant economic and societal cost.

In addition, known HTF alternatives to terphenyl hydrogenated are likely to carry similar hazard properties based on their functionality.  However, these alternatives have not been subject to the same amount of scrutiny applied to terphenyl hydrogenated.  We would therefore argue that a functional grouping approach should be used to assess jointly the potential risk management options for this group of substances. As recommended by ECHA itself in its latest annual report on the implementation of the SVHC Roadmap (April 2018), there should be increasing focus on “grouping of substances to ensure authorities address all substances that matter”.  This would prevent uninformed or regrettable substitution taking place in the HTF user sectors.

As an HTF, terphenyl hydrogenated has important uses in, among others, the manufacturing of polyethylene terephthalate (PET) and the conversion of biomass to energy. The high replacement costs stemming from a broad ban on terphenyl hydrogenated could significantly impact these industries, potentially causing production to move outside of Europe and resulting in lower growth and lost jobs within the EU. Disproportionate regulation of terphenyl hydrogenated could negatively affect both these industries, ultimately undermining progress towards the EU’s circular economy, bioeconomy and clean energy goals.

For a more detailed explanation of Eastman’s views and more extensive information on the upstream and downstream impacts of SVHC listing and Authorisation, please see the detailed attachment submitted together with these comments.	Thank you for your comments. 
	
		See the corresponding embedded attachment in table 1 of Part I: 
5007_Eastman Chemical_Public Consultation_Terphenyl_19-4-2018.pdf		
5047
2018/04/20	Eurofoil Paper Coating GmbH,
Company,
Germany	The safety equipment of our thermal oil plant (heat transfer oil plant) is set up according to the DIN Standard 4754 "heat transfer plants with organic heat carriers". The requirements of The VDI Guideline 3033, the Pressure Equipment Directive 97/23 EC, the Machinery Directive 2006/42 EC are fulfilled and the “AD 2000-Regelwerk” will be followed for operation and maintenance of our thermal oil plant. Therefore a safe and controlled use of the substance terphenyl hydrogenated  is warranted and secured through the existing legislations etc.  Since (2003) we are using terphenyl hydrogenated  we had no incident, leakage or accident, therefore no exposure to the environment above maintenance quantities with was accordingly to law absorbed and disposed . In addition due to the stability of terphenyl hydrogenated  we even had not the necessity to exchange it.  Any additional and more restricted regulation of the use of terphenyl hydrogenated  would not led to a higher environment safety and only cost additional money, depending if an alternative heat transfer fluid is available or a new installation  of a heat transfer oil plant is necessary (Estimation starting from 0,2 up to 1,5 Mio Euro).	Thank you for your comments. 
	
5063
2018/04/23	Rodun Benelux bv,
Company,
Netherlands	The substance,Therphenyl hydrogenated is of extreme importance for the industries we serve. All users of this substance are in general all chemical and petrochemical producers. The substance extreme chemical stability provides an very economical fluid for heat transfer due to its very high life time. Used in closed loop systems it does not give any environmental risk.
As there is no alternative for this substance it creates high investments to look for alternatives. Presently the substance is annually analyzed at each user of the substance to see if the performance and the quality of the substance is still allright minimizing the environmental risk for the uses as well as for the surroundings. The substance ability to keep the internal systems clean from any fouling maximize the safety of the installation in which the substance is being used. All other competitive products do not have this advantage and is the main reason why so much chemical and petrochemical plants are using this substance.	Thank you for your comments. 
	
5139
2018/04/23	Framatome,
Company,
France	We would like to thank ECHA for this opportunity to comment on the proposed identification of terphenyl hydrogenated as a Substance of Very High Concern (SVHC) under REACH.
Framatome has been using terphenyl hydrogenated as heat transfer fluid for more than 30 years in the process of producing zirconium metal which is key to efficient and safe nuclear fuel.
The substance is used in a closed system, and the overall fluid is changed every 5 years. Terpheny hydrogenated were chosen for their heat transfer capacity, their practicality of use, but also for its high flashpoint. This last point is of great importance as we are using the substance at temperatures exceeding this flashpoint. It is therefore crucial for preventing fire that the difference between the temperature of use and the flashpoint remains small.

Potential for environmental exposure from our uses is very small as the product is pumped into a container, which is built within a leak-proof containment, and then into the closed system.
Should Authorisation be applied to terphenyl hydrogenated, we have not yet identified suitable alternatives for our use. The considered alternatives so far did not offer the right balance between the key parameters: heat transfer capacity, viscosity/practicality of use and a high flashpoint. Switching to such an alternative would therefore mean an increased risk of a fire, decreased production efficiency but also a risk of having a final product of decreased quality, with possible consequences on the efficiency of the nuclear fuel.	Thank you for your comments. 
	
5142
2018/04/23	Pietro Carini Spa,
Company,
Italy	Therphenyl hydrogeneted is used in Italy by more than 400 users as an heat transfer fluid. My first comment is that the exposure is low due to the fact that the material is put in a closed system that operates at very high temperature (over 300°C) and therefore by definition the exposure has to be low. My second comment is that the objective of a HTF is to be stable at high temperature and this fact by defintion implies that its biodegradibilty is  low. Therefore every potential substituion would face the same problem.
My third comment is that a limitation of the use of this  molecule as an HTF would limit the investment in Europe of  new plants with need of temperature over 270°C. This would  mean to stop investment on many renewable energy (solar, biomass production) and to limt also many application in the chemical reaction indutry. My fourth comment regards  all customers that have made investments designing their  plant and investing based on a life expectancy of more than  20 years and that have already the fluid in their  closed system. What should they do in the future?	Thank you for your comments. 
	
5154
2018/04/23	Krahn Chemie GmbH,
Company,
Germany	We would like to thank ECHA for this opportunity to comment on the proposed identification of terphenyl hydrogenated as a Substance of Very High Concern (SVHC) under REACH.

Terphenyl hydrogenated products like Terminol 66 is to our knowledge the most performing thermal oil in the market (in terms of temperature resistance). It is been used for applications above 300°C. The very limited number of possible alternatives are less performing and with a much shorter lifetime, especially if it comes to high temperatures above 300°C. Furthermore, and up to our understanding, these alternatives are also as critical as Therminol 66 to the environment, even if the chemical nature of these alternatives is different.

The molecules of high temperature thermal oils are pretty stable and therefore by definition they are not bio-degradable, or highly degradable at all. The use of high temperature thermal oils in Germany is always in closed technical systems (also to reduce oxidation and thermal degradation) to enhance the lifetime of its usage to 10+ up to 20 years, dependent on the application. The use of Terphenyl hydrogenated products also helps the operator to run their systems smooth and in a safe mode over a long period. Less performing products tent to reduce the flash point over time to a critical limit for the entire operation.

Terphenyl hydrogenated products are in use in large-scale productions as well as is small applications. In large-scale processes the thermal oil is of high importance and could define the level of economic scale.

The application that uses Therminol 66 is for example ORC (Organic Rankine Cycle), a technical solution that is in use for biomass to transform to electrical energy, Waste Heat Recovery or Solar Thermic Systems. All these investments have been made based on the long-term use (10+ years) of Terphenyl hydrogenated products. All other applications are also based on the long-term use of its thermal oils. We believe that there are more than 400 systems installed in Germany and Austria.	Thank you for your comments. 
	
		-		
5159
2018/04/23	Aerospace Industries Association,
Industry or trade association,
United States	-	Thank you for your comments. 
	
		See the corresponding embedded attachment in table 1 of Part I: 
5159_ECHA Terphenyl hydrogenated April 23 2018.pdf		
5166
2018/04/23	Concawe,
Industry or trade association,
Belgium	-	Thank you for your comments. 
	
		See the corresponding embedded attachment in table 1 of Part I: 
5166_terphenyl hydrogenated SVHC comments - Concawe tables.docx