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

Substance name: Chrysene
CAS number: 218-01-9
EC number: 205-923-4	

The substance is proposed to be identified as meeting the following SVHC criteria set out in Article 57 of the REACH Regulation: Carcinogenic (Article 57a), PBT (Article 57d), vPvB (Article 57e)
	
Disclaimer: Comments provided during public consultation are made available as submitted by the commenting parties. It was in 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.

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	
4890
2017/10/20	Concawe,
Industry or trade association,
Belgium	Confidential attachment removed

	Thank you for providing attached document for further evaluation. Please refer to response on specific comment number 4890 for a more detailed evaluation of the content of the document.	
4920
2017/10/20	cefic "Coal Chemicals Sector Group (CCSG)",
Industry or trade association,
Belgium	Attachment: 4920_CCSG PC CHR 171020 final.pdf
	Thank you for providing attached document for further evaluation. Please refer to response on specific comment number 4920 for a more detailed evaluation of the content of the document.	
4944
2017/10/27	Finland,
Member State	The Finnish CA agrees that Chrysene (EC 205-923-4) meets the criteria for identification as a substance of very high concern (SVHC).
According to the Annex XV report, the proposal for SVHC identification of Chrysene is mainly based on the information provided in the support document for the UVCB substance Coal Tar Pitch, High Temperature (CTPHT, EC 266-028-2) (ECHA, 2009).
Identification according to Article 57(a)
Chrysene meets the criteria of Article 57(a) of REACH Regulation based on the harmonised classification Carc. 1B; H350 (“May cause cancer”).

Identification according to Article 57(d) and (e)
Chrysene meets the criteria for a PBT and vPvB substance according to Article 57 (d) and (e) of REACH regulation based on a weight-of-evidence determination. The T criterion is fulfilled based on the classification of the substance as Carcinogenic category 1 B.

Further comments on the Annex XV are specified below:
Table 2: Overview of physicochemical properties:
Vapour pressure: ”reported vapour pressure values are within the range between of the two indicated values (3rd column)”
Comment: Please clarify how many reported values are available (are there others in addition to the values mentioned in the table?)
Comment: Water solubility: the same comments as above for vapour pressure.
3.1.1.3 Oxidation:
“CHR has 4 aromatic rings and a reported vapour pressure below 10-4 Pa.”
Comment: The highest value in Table 2 is not below 10-4 Pa. Please correct this discrepancy.
3.1.2.1.1 Estimated data:
Page 13: “As assessed in the Support Document for identification of CTPHT as SVHC (ECHA, 2009) Mackay et al. (1992) estimated half-lives in the different environmental compartments based on model calculations and literature research. The calculated half-lives of CHR in water and sediments are in the range of 42 to 125 days and longer than 1250 days respectively.”
Comment: Please specify the environmental compartment where the half-lives have been longer than 1250 days. In addition, we were not able to find the referred Mackay et al. (1992) half-lives for CHR in the Support Document of CTPHT. The part referring to the Mackay study in the CTPHT Support Document is “Mackay et al. (1992) estimated half-lives in the different environmental compartments based on model calculations and literature search. On the basis of the results of this study, dibenzo(a,h)anthracene and indeno(1,2,3-cd)pyrene are expected to be as well persistent in soil and sediment: the estimated half-lives for the two PAHs were in soil in the range of 420 to 1250 days, and in sediments longer than 1250 days.” Therefore, please check whether the reference to the Mackay et al. data is correct. A direct citation to the Mackay et al. reference would be preferred compared to the use of a secondary reference. Please also consider including more information of the estimation method used.
3.1.2.2 Biodegradation in soil:
Comment: Please include the incubation temperature used in the laboratory studies by Wild and Jones (1993) and Wild et al. (1991), and also the geographic location (and temperature range, if available) of the field studies. In addition, please consider including an explanation why the half-lives cited are exactly the same as those cited for BaA in its Annex XV report (were the half-lives determined for a group of substances or separately for individual compounds?)
3.1.2.4 Summary and discussion on biodegradation:
Comment: The subtitle number should apparently be 3.1.2.3.
“The half-life predicted by Mackay et al. (1992) indicate that CHR persists in sediment with half-lives higher than 1250 days. For water degradation, Mackay et al. (1992) predicted long elimination half-lives between 42 and 125 days.”
Comment: The half-lives of 42-125 days are not found in CTPHT Support Document) (see also the comments on 3.1.2.1.1).
“However, considering the chemical structure of CHR that consists of four aromatic rings, standard tests for biodegradation in water demonstrated that CHR is biodegradable under aerobic conditions.”
Comment: It is unclear whether this refers to a specific test on CHR or to a test on another compound with four aromatic rings. Please clarify which standard tests are meant and include more information on the biodegradation results in those. No standard water biodegradation tests are mentioned elsewhere in the document.
3.2.3 Distribution modelling:
“Mackay Level III fugacity modelling was performed  using EPI Suite (version 4.11) with default values of environmental emission rates (it is assumed that CHR is released at equal rates to air, water, soil and sediment) and default values of physico-chemical properties (done in April 2017).”
Comment: In Epi Suite the default emission setting for Level III fugacity modelling is equal emission rates to air, water, and soil (but no emission to sediment). Please check the correctness of the reported default emissions to sediment.
3.4.1. Bioaccumulation in aquatic organisms:
Comment: Regarding the Newstedt and Giesy (1987) study more information could be included (as is included in the Annex XV document for BaA). For example, information in Table 5 and footnotes in the BaA  document appears relevant.
“It might be likely, that the same mechanism leads to a bioaccumulation of CHR inorganisms of lower tropic levels.”
Comment: It is unclear what mechanism is referred to. Does it refer to limitation of biotransformation?
6.2.1.1 Persistence:
“Additionally, the study by Wild and Jones (1993) reports a half-life value of CHR in soil between 106 to 313 days and is therefore above the P and vP criteria set in REACH Annex XIII.”
Comment: A half-life of 106 days is below the P criterion for soil. The sentence could be modified to take into account this.
“Furthermore, model calculations done by Mackay et al. (1992) do confirm that CHR is very persistent in the compartment soil and predicted that P and vP criteria are fulfilled for the compartments water and sediment.”
Comment: Please consider using “support” instead of “confirm” as there is a limited amount of information available on these model calculations in the support document and as experimental data should generally have the highest priority.	Thank you for your support and specific comments. 

In the following we would like to respond to same specific comments. 

Response to comment Table 2: Please find the respective data for both the vapour pressure & water solubility in the embedded word document. 

Considering the water solubility we evaluated the highest value (17 µg L-1) as a statistical outlier. Different methods of measurement were used at different temperatures to obtain stated values in the handbook. Furthermore, no errors of the measured values are given so that the mathematical minimum and maximum values could not be determined. The stated maximum value of 3.3 µg L-1 in the SVHC dossier comprises most measured values without using the maximum value, disregarding the statistical outlier.  
Concerning the vapour pressure different methods lead to different values stated in the handbook data. We decided to state the overall range for this physicochemical endpoint as the individual reliabilities of the measurements could not be assessed.

Response to comment 3.1.1.3:
Discrepancy is corrected in the Support document.

Response to comment 3.1.2.1.1:
Thank you for your remark on 3.1.2.1.1. We revised the paragraph to address a correct citation. 

3.1.2.2: 
Please refer to the amended paragraph 3.1.2.2

Response to comment 3.1.2.4:
Subtitle/paragraph number updated. 
Further we revised paragraph 3.1.2.3 (and 3.1.2.1) in order to be more precise and strengthen the argumentation. 

Response to comment 3.2.3: 
Thank you. We corrected the paragraph 3.2.3.

Response to comment 3.4.1:
Please refer also to response to comments 4887, 4889 and 4907. Chapter 3.4 was revised including further data in B. 

Response to paragraph 6.2.1.1: 
Thank you. Paragraph was revised for more clarity.

Response to paragraphs 6.2.1.3 and 6.2.2: 
Thank you. Revised accordingly.	

Specific comments on the justification
Number / Date	Submitted by (name, submitter type, country)	Comment	Responses	
4856
2017/10/19	ChemSec,
International NGO,
Sweden	ChemSec supports the Candidate List nomination based on the CMR classification and the PBT/vPvB properties supported by the argumentation in the dossier.	Thank you for your support.
	
4885
2017/10/20	ANSES,
National Authority,
France	ANSES welcome the proposal to identify the different properties of Chrysene meeting SVHC criteria as it will ensure that the full scope of its properties are adequately considered in the possible next steps of the process.

Identification according to Article 57(a) – carcinogenicity

The identification of Chrysene as an SVHC under Art 57a is supported in relation to its classification Carc 1B- H350 in the Annex VI of CLP (index 601-048-00-0).

Identification according to Article 57(d) and (e) – PBT and vPvB

The identification of Chrysene as an SVHC under Art 57 d and e is supported based on a weight evidence determination fulfilling REACh regulation annex XIII criteria.	Thank you for your support.	
4888
2017/10/20	United Kingdom,
Member State	We thank the German CA for their dossier and whilst we can agree that chrysene meets the Article 57 (a), (d) and (e) SVHC criteria we would like to propose the following amendments to the way the evidence used to support these properties is presented in the dossier.

We note the approach for using non-fish aquatic bioaccumulation data is consistent with the previously agreed Coal tar pitch high temperature (CTPHT) SVHC dossier and ESR assessment.

3.4.2 Bioaccumulation in terrestrial organisms (soil dwelling
organisms, vertebrates)
p17. Please provide more detail for the earthworm QSAR, including a QMRF and QPRF.

3.4.4 summary & discussion of bioaccumulation
p18: we do not agree that the earthworm BCF QSAR should be used in the weight of evidence. This was not cited in the CTPHT dossier. While the data may be worst case for the purpose of a risk assessment (for example to investigate the need or not for measured earthworm bioaccumulation data), this is not sufficient as part of an argument to conclude vB. At present, there are not defined criteria for earthworm BCF data for B or vB.

In same section (3.4.4) – editorial: the earthworm data are predicted and this should be made clear.

3.4.4 summary & discussion of bioaccumulation
p18
Please consider re-phrasing
Bioaccumulation of CHR in those organism of low trophic level could contribute to a constant exposure of predators and therefore hamper the integrity of aquatic ecosystems.

The discussion in the CTPHT SVHC highlighted a concern from mollusc eating birds. However as noted in the chrysene dossier there are no mollusc bioaccumulation data. We are therefore less comfortable with the text above as we would expect the predators of zooplankton to be predominantly fish, which are known to biotransform the substance and consequently accumulation of the substance higher up the food chain will be limited.	Thank you for your proposed amendments. 

It is correct, that we base our assessment on the data issued at the CTPHT SVHC proposal which was agreed by MSC. 

We revised the bioaccumulation section of the Support document to strengthen the argumentation. Some additional data on bioaccumulation have been added to the Support document, including high BAF values for molluscs which support the concern also for this taxonomic group. The Support document has been revised to put less emphasis on the earthworm QSAR. The summary & discussion section has been revised to make the concern more clear.	
		-		
4890
2017/10/20	Concawe,
Industry or trade association,
Belgium	CONCAWE COMMENTS ON THE DRAFT ANNEX XV REPORT ON CHRYSENE (EINECS # 205-923-4)
Submitted by Germany in August 2017

1. Introduction
Concawe welcomes the opportunity to comment on the draft SVHC assessment report on Chrysene, as submitted by the German Competent Authority in August 2017.
As Chrysene has not been registered under REACH, the obligation of gathering and assessing the missing science lies with the Rapporteur, who should, as a minimum, apply the standards that any Competent Authority demands Industry to employ when delivering their assessment reports on any substance. Before this has been done, it is difficult for any report reviewer to come to a balanced conclusion.
Notwithstanding the above, Concawe has reviewed the report and provides below their initial observations, trusting that a second opportunity for commenting will arise, when the report is completed with the information mentioned below.
These comments will follow the report structure and after some generic observations, will address the physical chemical data, the fate chapter focussing on persistence and bioaccumulation, followed by a short remark on consideration of fate of test substances in ecotoxicity assessments.
Thereafter the content of part 2 will be addressed.
2. Generic remarks
The report addresses the substance with EINECS # 205-923-4 (CAS 218-01-9) that has the IUPAC preferred name Chrysene (CHR).
In the first paragraph of the foreword, the way the paragraph is written suggests that CHR to be, reprotoxic, which is not supported by its harmonised classification, according to the CLP Regulation (EC 1272/2008) that only indicates CHR to be a Class 1B carcinogen and a Class 2 mutagen.
Therefore, the opening sentence should be revised to for example: “Chrysene (CHR) belongs to the eight Polycyclic Aromatic Hydrocarbons (PAHs) that have a harmonised classification, according to the CLP Regulation (EC 1272/2008) as a Class 1B carcinogen and a Class 2 mutagen”. This is factually correct, whereas the original sentence is not. The fact that CHR is a CMR is not disputed by Concawe and, therefore, CHR fulfils the criteria to be classified as an SVHC as defined in article 57(a) of the REACH Regulation. However, it should be noted that it does not fulfil the criteria of Article 57(b), nor the T criterion of REACH Annex XIII, 3.2.3(d) for mutagenicity, as its harmonised classification does assign the Hazard Phrase H340. It is therefore not regarded as a mutagen for the purpose of this assessment.
In Concawe’s opinion, there is new data available on the persistency of CHR under natural and stimulated conditions that no longer support the vP classification of CHR. Furthermore, a refined assessment according to the state-of-the-art of the bioaccumulation potential of CHR also indicates that this substance does not biomagnify in the food chain, which in Concawe’s view is the main protective goal of a B-assessment. Therefore, it should be considered neither a B nor vB substance
In view of recent scientific data and the correct interpretation of these data, Concawe is of the opinion that CHR should not be classified to be a PBT or vPvB substance. The CTPHT report comes to this conclusion by the application of a hazard assessment that does not take into account higher tier observations in the environment, which should be included in a PBT assessment using a Weight of Evidence approach. Moreover, there is new scientific data available that has been generated after the CTPHT report was issued that has to be considered for this assessment.
This is in line with Concawe’s view that any assessment should be based upon the available, state-of-the-art of the science, especially, when new data and insights give rise to the revision of past decisions. For Concawe this is a very important point of view, because the main driver for performing dedicated research to address lacunas in knowledge becomes superfluous if new data, which contradict hypotheses or decisions from the past, are not then taken into account in current or future decision-making.
3. Comments to Chapter 1
In paragraph 1.2 CHR is described as “CHR is not produced intentionally but does occur as constituent in UVCB2 – often together with other PAHs - mainly derived from the coal and petroleum stream”.
The fact that CHR is not produced intentionally is correct. However, it would be better to use the phrase “CHR is not produced, as such. However, it may occur as a constituent in UVCB-substances that are derived from coal or in several petroleum streams.”
The original sentence hints that all coal and petroleum stream derived UVCBs contain CHR, which is not correct, especially for lighter petroleum substances.
4. Comments to Chapter 3
4.1. Comments on Persistence section
In section 3.1.1.3.1, the following is stated “While half-lives for direct photolysis of PAHs are in the range of hours (Vu Duc & Huynh, 1991, cited in The Netherlands, 2008), it was demonstrated by Behymer & Hites (1988) (cited in The Netherlands (2008)), that particle surface-adsorbed Chrysene does have representative lifetimes between 10 hr and 7.8 days under natural conditions.” This statement suggests that the half-lives from direct photolysis from Vu Duc & Huynh (1991) are under estimating the lifetimes of PAHs under natural conditions (Behymer & Hites (1988)), however, the lifetimes are in agreement with the half-lives, and this should be made clearer in the text.
In section 3.1.1.4, the following statement is made “It is concluded that in the atmosphere, free PAHs degrades within a range of minutes to days by direct photolysis. The substance is however mostly particle-associated and when adsorbed onto fine particles, CHR may be more stable in the atmosphere.” This statement is incorrect. In the original source (EC (2001)), the lifetimes quoted were “Representative lifetimes of some surface-absorbed PAHs with respect to photolysis”, and hence represent particle bound lifetimes. Therefore, the data presented do not support that lifetimes for CHR in the atmosphere will be longer than 10hr to 7.8 days due to the substance being particle bound.
With regard to biodegradation in water and sediments, the proposal states that biodegradation in water has already been assessed in the Support Document for identification of CTPTH as SVHC and will not be assessed again, which implies that new studies on CHR generated, since 2009 have been excluded in this review. This is not acceptable, as any assessment has to be based upon the latest science available.
Additionally, while in the proposal it is stated that “Tests for biodegradation in water have demonstrated that PAHs with up to four aromatic rings are biodegradable under aerobic conditions”, the report states that calculated half-lives of CHR in water [and sediments] range from 42 to 125 days [and longer than 1250 days respectively]. As should be standard procedure, the reliability and validity of such tests for persistence testing should be carried out, before such data are included in a definitive persistence assessment.
In addition, recent data on biodegradation of chrysene in surface water (seawater and freshwater) and activated sludge filtrate clearly shows that chrysene has the potential to be microbially degraded in the environment. Available half-lives are 3.3 days for activated sludge filtrate, 54 days for a relatively pristine lake, 20.9 and 54.9 days in cold (5 °C) seawater and >182 days for temperate seawater (Mayer and Birch, 2017, Brakstad et al., 2015, Concawe, 2012). In the latter case no biodegradation was observed in the test, however this is most likely due to the absence of specific degraders in the test inoculum, based on a limited environmental sampling volume in the test (Martin et al., 2017).
The result for cold seawater is particularly important because it demonstrates the potential for microorganisms to degrade chrysene at low temperatures with rates comparable to tests conducted at higher temperatures. Of these results, the longer half-life was for test preparations with larger droplet sizes so this difference in half-life is likely to be, in part, a result of reduced bioavailability.
Of the remaining values where biodegradation was observed, the result for rural lake water is the only value above the P cut-off. However, it should be noted that this environmental sample produced characteristically slow half-lives when compared with other environmental samples in a separate study (Mayer and Birch, 2017). This inoculum sample is therefore considered to be highly conservative. Furthermore, in Mayer and Birch (2017), a test in seawater was also conducted, which appeared to show biodegradation and a half-life below 60 days. However a half-life has not been calculated by the authors due to the final data point being inconsistent with the series (Mayer and Birch, 2017). Nevertheless, Concawe is of the opinion that these data are evidence of biodegradation below the P and vP half-life cut-offs.
The geometric mean of half-lives from more recent data where degradation has been observed is 21.3 days, which is clearly below the P/vP criteria for the water compartment.
For the sediment, one study referenced is by Durant et al. (1993), which investigated the in situ biodegradation of phenanthrene and naphthalene, under aerobic and anaerobic conditions, using sites with PAH-acclimated and nonacclimated microorganisms in sediment from a groundwater site. 10 first order half-lives were derived for naphthalene, ranging from 11 days to 169 days, with a geomean of 54 days. 5 first order half-lives were derived for phenanthrene, ranging from 36 days to 330 days, with a geomean of 89 days. In section 3.1.2.1, this study by Durant et al. (1993) is references as “it has been shown that half-lives of PAHs in estuarine sediment are proportionally related to the octanol-water partition coefficient (Kow)”, however the study by Durant et al. (1993) also clearly shows that PAHs degrade in both aerobic and anaerobic sediments.
Regarding biodegradation in soil, the two key studies presented in this document are the microcosm study by Wild and Jones (1993) and the field study by Wild et al. (1991). In these studies, no distinction was made between benz[a]anthracene and CHR – and only a single value was given for both. The two soil studies presented in this dossier, namely the microcosm study by Wild and Jones (1993) and the field study by Wild et al. (1991) should also be assessed for the validity of their results for such a P assessment. In the study by Wild and Jones (1993), half-lives in days for soils were derived, for two agricultural soil, one rural coniferous forest soil and one roadside soil. It should be noted that two out of these four soils (the latter two), half-lives were modelled by linear regression models, and not by first-order models. The two soils for which first-order kinetics could be modelled resulted in half-lives for BaA/CHR of 106-199 days. Additionally, given that the study by Wild et al. (1991) is a field study, it is rather unclear how valid the half-lives are for a P assessment, with regards to the experimental set up, the representativeness of the samples and the calculations made. Particularly, since “PAH concentrations in the control plot steadily increase in time”, indicating a continuous source, and from the data shown in table 2, a steady decrease in the BaA/CHR concentration over time is observed for none of the soils. It should be noted, that according to the guidance document, field studies do not represent higher-tier studies, and their results should not override other results.
The data on sediment and soil for which the P criteria is assessed for chrysene is not deemed sufficient, and additional data would be required in order to conclude whether chrysene fulfils the P/vP criteria. However, Concawe is of the opinion that the latest data for the water compartment are representative of the degradation potential of chrysene, and that based on these data the substance can be concluded to be not P.
4.2. Comments on Bioaccumulation section
Our observations regarding the B-assessment are provided below:
Only one experimental study was included in the assessment of bioaccumulation in aquatic organisms (pelagic & sediment organisms). However, additional reliable and relevant data are available, and should be included in a robust bioaccumulation assessment.
The key study used in this B-assessment is the study by Newsted and Giesy (1987), in which the BCF for the D. magna is measured. Concawe strongly disagrees that the BCF for D. magna, an organism with limited ability to biotransform, is a plausible result for the conclusion on the B criteria. This is particularly the case when fish aqueous BCF data for CHR are available. In both the REACH regulation, and in the Guidance document, it is clearly stated that bioaccumulation data from fish is the preferred metric. Fish represent a higher trophic level than crustaceans, and hence through both aqueous BCF data and dietary BMF for fish, a better judgement can be made on whether a substance biomagnifies through the food chain. If experimental BCF data for lower organisms are given preference for B evaluation, then any neutral organic substance with a log Kow greater than ca. 5 will likely fulfil the vB criterion, as equilibrium partitioning will drive bioconcentration.
It is Concawe’s understanding that this approach is inconsistent with the approach originally intended for the B assessment. The focus was to protect the ecosystem as a whole, by reducing any uncertainty in the long term resulting from chemical accumulation in the food web. Data for CHR in fish show clearly that bioconcentration and bioaccumulation of CHR is effectively mitigated by metabolism. Therefore, no unpredictable high levels may be reached in the ecosystem in the long term. The study by Newsted and Giesy (1987) is based on a single 24 hour exposure, resulting in equilibrium partitioning of CHR between the organism and water. While this could be argued as a plausible result, as organisms with limited ability to metabolise PAHs may be the most sensitive species, 21-day chronic toxicity studies with D. magna (and other lower trophic levels) are available (presented in 4.3 below), and hence any long term effect is indeed predictable.
Two studies are available that provide BCF data for rainbow trout: 450 (Gobas & Lo 2016) and 153 (EMBSI, 2009 – present in CONCAWE report (2016)). In EMBSI (2009), the method used is based on the OECD TG 305, with improvements in maintaining dissolved test exposure based on passive dosing. According to the REACH guidance document, the OECD TG 305 test is the preferred test due to the best possibilities of reliably comparing the result with the B/vB criteria.
Additionally, on page 17, it is stated that the study included in the assessment (Newsted and Giesy (1987)) was evaluated in the Support document for the Identification of CTPHT as SVHC, however, only experimental data for fish and molluscs were evaluated for reliability, and all data presented for crustaceans were not evaluated for reliability. Therefore, the reliability of this study should be critically evaluated.
Additional data to build a weight of evidence assessment, as stated in REACH Annex XIII, is also available, and in order to draw a conclusion on bioaccumulation, the following data should also be considered.
• Dietary bioaccumulation study results: Results from dietary bioaccumulation experiments are of relevance for substance with high log Kow values such as for CHR, which will partition to organic matter or lipid. Three studies are available for CHR showing laboratory BMF values far below 1: BMF 0.016 (EMBSI, 2006), BMF 0.04 (EMBSI 2008) and BMF 0.004 (Lo et al, 2015). While there are no direct criteria to compare the outcome of the dietary exposure test with the B criterion, these BMF values clearly document a low potential for CHR bioaccumulation in fish.
• BSAF values for fish: data from a US EPA BSAF database (US Environmental Protection Agency, 2008) provides information on field-derived fish BSAF factors for 17 PAHs, CHR included. The median and 90th percentile for CHR, are less than 0.01. While no threshold values are available for used BSAF values, these data provide further evidence that CHR does not biomagnify in the field, and is therefore not bioaccumulative.
• TMF values: Four different studies from different global locations provide information on the TMF for PAHs – including CHR:
o TMF from Bohai Bay of 0.26 (Wan et al. 2007),
o TMF from the Baltic Sea of 0.66 (Nfon et al. 2008),
o TMF from Tokyo Bay of 0.65 (Takeuchi et al. 2009),
o TMF from the Passaic River estuary of 0.17 (Khairy et al. 2014)
All four of these studies show that CHR does not biomagnify in the food chain but rather undergoes trophic dilution (TMF values < 1 [ECETOC 2012]).Therefore, relevant bioaccumulation data that have not been considered are available to support the conclusion that CHR is not bio-accumulative.
Ultimately, QSAR data for estimating BCF value for CHR in Eisenia Andrei was provided in the bioaccumulation assessment in terrestrial organisms. A value of 7800 is given in this report. However, as no threshold values are available for BSAF in soil, this is not sufficient to conclude that CHR could be B or vB.
4.3. Comments on Toxicity section
The section on toxicity discusses photo-enhanced toxicity, as a relevant mode of action for PAHs, including CHR. Photo-enhanced toxicity data are subsequently used to conclude on the toxicity of CHR, as in the assessor’s opinion (extracted from the CTPHT risk assessment) this property is environmentally relevant.
Concawe has an issue with this approach, as in section 3.1.1.3 on abiotic degradation, photo-degradation is considered irrelevant as an environmental property for the fate assessment of CHR. In order to perform a complete assessment of CHR toxicity, exposure considerations should be included, and if photo-enhanced toxicity in the aquatic environment is considered plausible, photo-enhanced degradation in the same aquatic environment should be considered plausible as well. If however, exposure of chrysene to light in environmental compartments is considered to be limited, such that photo-degradation is not relevant, then it should also be considered that photo-induced enhanced toxicity is not relevant to the T assessment. Moreover, the HOMO-LUMO gap for CHR of 7.71 eV is not indicative for photo-induce enhanced ecotoxicity (Mekenyan 1994; Veith, 1995). Hence the relevance of this process is unclear and warrant further study under a rigorous CLP regime, before concluding the importance of this UV-Light in enhancing toxicity.
In addition, as neither CHR nor the other PAHs emit radiation, Concawe has difficulty with the terminology “Phototoxicity”, as, if present, the enhanced toxicity is the result of external light sources. Therefore, to remain factually correct Concawe strongly advises that the term “Phototoxicity” is replaced by “Photo-enhanced toxicity”.
In the summary of the environmental hazard assessment it is mentioned that the only study showing a considerable effect for chrysene was Newsted & Giesy, 1987. This study was of very short duration, following a non-standard methodology and exposed organisms to UVA and UVB radiation in order to maximis photo-induced enhanced toxicity. Furthermore, no dose-response relationship and quantitative toxicity thresholds can be derived in this study. In view of this and the content of the preceding paragraphs, Concawe is of the opinion that this study is not sufficient evidence on which to base a conclusion on T, and that the rapporteur should have concluded that CHR, as such, appears not toxic at the limit of the water solubility.
This is confirmed by the recent publications of Bragin et al. 2016 and Butler, et al., 2016. In the first paper, both EC50 and EC10 of CHR for P. subcapitata and C. dubia exhibit no effects at the water solubility using a passive dosing test system. In the Butler paper, fish ELS test data are presented on zebrafish (D. rerio) again using a passive dosing system to deliver constant exposure concentrations. No effects were reported at the solubility limit based on 30d embryo-larval exposures based on either survival and larval growth endpoints.
4.4. Comments on the Assessment of PBT/vPvB properties (6.2)
Toxicity
As CHR is a classified CMR (C Class 1B), it fulfils the criterion for T, as defined in Article 57 of the REACH Regulation and the latest text of Annex XIII.
Concawe concurs with the T-assessment, as presented that excludes the environmental hazard assessment.
Persistence
In line with the arguments provided above, Concawe does not agree with the conclusions of the Rapporteur.
Based upon the data available today, as presented above, CHR is not classifiable as a persistent substance. Therefore it neither be P, nor vP.
As indicated, Concawe recognises that there is a need for additional data on the persistence of CHR that is generated according to experiments that are following the appropriate test protocols, as the data available today does not fulfil these.
Bioaccumulation
In line with the arguments provided above, Concawe does not agree with the conclusions of the Rapporteur.
Data are available to support the conclusion that CHR is not classifiable as a bio-accumulative substance. Therefore it neither be B nor vB.
Synthesis and conclusion
The Rapporteur claims CHR to be PBT, as well as, vPvB based upon the MSC decisions from 2009.
Concawe has intensively reviewed the literature and based upon the state-of-the-art of today’s science, we have come to the conclusion that CHR is neither P nor B. In view of this, CHR is incorrectly assigned to be PBT or vPvB.
Therefore, in Concawe’s opinion, CHR does not fulfil the criteria of REACH Article 57 d and e.
Concawe acknowledges the fact that CHR is a Class 1B carcinogen. Therefore, it does fulfil the criterion of Article 57(a), which qualifies CHR to be an SVHC.
References
Bragin, G., Parkerton, T., Redman, A., Butler, J., Léon Paumen, M., Sutherland, C.S., Knarr, T.M., Comber, M. & Den Haan, K.H. (2016) Chronic Toxicity of Selected Polycyclic Aromatic Hydrocarbons to Algae and Crustaceans Using Passive Dosing. Environmental Toxicology and Chemistry, 35(12), 2948–2957
Butler, JD, Parkerton, TF, Redman, AD, Letinski, DJ, Cooper, KR. (2016) Assessing Aromatic-Hydrocarbon Toxicity to Fish Early Life Stages Using Passive-Dosing Methods and Target-Lipid and Chemical-Activity Models. Environmental Science and Technology, 50 (15), pp 8305–8315
Brakstad, O.G., Nordtug, T., Throne-Holst, M., (2015). Biodegradation of dispersed Macondo oil in seawater at low temperature and different oil droplet sizes. Mar. Pollut. Bull. 93, 144e152.
CONCAWE (2012). Primary biodegradation of petroleum hydrocarbons in seawater.
CONCAWE (2016). An evaluation on the persistence, bioaccumulation and toxicity of petroleum hydrocarbons (revised).
ECETOC Technical Report No 112 (2012). Refined approaches for risk assessment of PBT/vPvB chemicals.
EMBSI (2006). Fish, dietary bioaccumulation test, study no. 0681647. ExxonMobil Biomedical Sciences Inc. Annandale, NJ
EMBSI (2008). Fish, dietary bioaccumulation study, study no. 0818447. ExxonMobil Biomedical Sciences Inc. Annandale, NJ.
EMBSI (2009). Fish, aqueous bioaccumulation study, study no. 0829644. ExxonMobil Biomedical Sciences Inc. Annandale, NJ.
Gobas FAPC & Lo JC (2016) Deriving bioconcentration factors and somatic biotransformation rates from dietary bioaccumulation and depuration tests, Environmental Toxicology and Chemistry, 35, 2968-76.
Khairy M A, Weinstein M P, Lohmann R. (2014). Trophodynamic Behavior of Hydrophobic Organic Contaminants in the Aquatic Food Web of a Tidal River. Environmental Science & Technology 48, 12533−12542.
Lo JC, Campbell DA, Kennedy CJ, Gobas FAPC (2015) Somatic and gastrointestinal in vivo biotransformation rates of hydrophobic chemicals in fish. Environmental Toxicology and Chemistry, Vol. 34, No. 10, pp. 2282–2294.
Martin TJ, Snape RJ, Bartram A, Robson A, Acharya K, Davenport RJ (2017). Environmentally Relevant Inoculum Concentrations Improve the Reliability of Persistent Assessments in Biodegradation Screening Tests. Environmental Science & Technology 51, 3065−3073. DOI: 10.1021/acs.est.6b05717.
Mayer P, Birch H (2017). Concerning primary biodegradation kinetics of chrysene and benz(a)anthracene. Letter to Concawe and ECHA. DTU Environment, 2017.
Mekenyan OG, Ankley GT, Veith GD, Call DJ. (1994). QSARs for photoinduced toxicity: I. Acute lethality of polycyclic aromatic hydrocarbons to Daphnia magna. Chemosphere 28:567–582.
Nfon E, Cousins IT, Broman D. (2008). Biomagnification of organic pollutants in benthic and pelagic marine food chains from the Baltic Sea. Science of the Total Environment. 397:190-204.
Takeuchi I, Miyoshi N, Mizukawa K, Takada H, Ikemoto T, Omori K, Tsuchiya K. (2009). Biomagnification profiles of polycyclic aromatic hydrocarbons, alkylphenols and polychlorinated biphenyls in Tokyo Bay elucidated by delta 3C and delta 15N isotope ratios as guides to trophic web structure. Marine Pollution Bulletin 58:663-671.
Veith GD, Mekenyan OG, Ankley GT, Call DJ. (1995). AQSAR analysis of substituent effects on the photoinduced acute toxicity of PAHs. Chemosphere 30:2129–2142
Wan Y, Jin X, Hu J, Jin F. (2007). Trophic dilution of polycyclic aromatic hydrocarbons (PAHs) in a marine food web from Bohai Bay, North China. Environmental Science and Technology 41:3109-3114.	Thank you for you detailed comment on SVHC assessment report on Chrysene. 
General Response:

CONCAWE remarks critically that only comparably old references have been used in the SVHC proposal. This is due to the fact that mainly information provided in the RAR for CTPHT has been used for the dossier. Based on this older but still valid information also provided in the SVHC dossier for CTPHT, the Member State Committee has already concluded on the PBT and vPvB properties of CHR.In the following we address some specific comments. 

Response to 2. Generic remarks
FOREWORD: 
We agree and rephrased opening sentence as suggested.

Response on Concawe’s opinion on B and P assessment are provided in the following respective sections of this response concluding that new scientific evidences will not allow a relief of CHR as PBT or vPvB substance. 
However, the German CA welcomes any efforts undertaken by Concawe to characterize the fate and behaviour of CHR. 

Response to 3. Comments to Chapter 1

Paragraph 1.2 re-phrased as suggested by Concawe for more clarity. 

Response to 4.1 Comments on P section

Section 3.1.1.3.1 and section 3.1.1.4: Thank you for your comments. Please refer to revised paragraphs.

The data on persistence reviewed in the current dossier have been considered and conclusions - confirmed upon among MSC within the CTPHT assessment. The studies, referenced in comment 4890 do not undermine the conclusion that CHR is P and vP and therefore do not change the conclusion. 
P in water: Mayer and Birch (2017) described the experimental procedure barely, making an evaluation of the study difficult, especially the origin of inocula (pre-adaptation of the environmental inocula possible). The authors however, calculated a DT50CHR = 71d in lakewater, qualifying CHR as vP according Annex XIII of REACH. No half-lives have been provided in saltwater. 
Brakstad et al. (2015) used a pre-adapted seawater to determine biodegradation of dispersed oil droplets at low temperature. The method used is not suitable to evaluate P in a PBT/vPvB assessment for pristine environments. 

The study by Durant et al (1995) analysized the low molecular weight PAH biodegradation with Bacteria collected from contaminated (gas plant) soil. Estimated degradation rates are therefore not suitable for PBT assessment of pristine environment. 

The MSC agreed on the evaluation of the studies by Wild and Jones (1993) and Wild et al. (1991) in the scope assessment of CTPHT as SVHC. In agreement with MSC conclusions made within the CTPHT assessment, the SVHC dossier submitter evaluated the study Wild et al. (1991) as a most reliable evidence of persistency of CHR, which is suitable for PBT assessment of pristine environment. Further evidence have been considered (please refer to paragraph 6.2.1.1).
The data discussed in the dossier and which have been evaluated during SVHV identification of CTPHT by MSC, demonstrate that CHR is P and vP in sediment and soil. Further studies cited in you comment support the conclusion by giving evidence of P and vP properties of CHR in water (DT50 = 71d for CHR in lakewater (Birch and Mayer, 2017), and saltwater (CONCAWE, 2012)).

Response to 4.2 Comments on B section 
It is correct that mainly information provided in the RAR for CTPHT and the Support Document for the Identification of CTPHT as SVHC have been used for this dossier. Based on this older but still valid information also provided in the SVHC dossier for CTPHT, the Member State Committee has already concluded on the PBT and vPvB properties of CHR within the CTPHT identification process.

CONCAWE disagrees with the approach to conclude on the B and vB properties of CHR based on data for lower trophic levels. However, the most sensitive organisms towards PAHs are those lacking a cytochrome P450 enzyme system. It has been shown without a doubt that bioaccumulation occurs in those organisms because they cannot degrade PAHs. This has been clearly assessed in the SVHC proposal and is supported by further data which has been added to the Support document according to a comment provided by the Netherlands. Bioaccumulation of CHR in those organism of low trophic level could contribute to a constant exposure of predators with an unpredictable level of CHR, which would be of concern for such predator species that are unable to biotransform PAHs. Due to the absence of data, there is a concern for other species that feed on crab or molluscs and one high field BAF indicates that also for fish a risk cannot be excluded for at least some fish species. 
In addition bioaccumulation in low trophic level themselves is considered relevant as such. We have included the data on bioaccumulation and biomagnification in the food chain  into the Support document as they based on our assessment support the understanding on the bioaccumulation potential in higher trophic levels. However, they do not change the overall result of our assessment. We kindly refer to the Support document (chapter 3.4) for an amended, detailed discussion on bioaccumulation of CHR. Reliability values have been added to the Support document.

Response to 4.3 Comments on environment hazard assessment 
Thank you for your comment. We agree that the term “photo-enhanced toxicity” should be preferred over the term “phototoxicity”. However, due to consistency with previous dossiers on CTPHT, we prefer to keep the term.

Thank you for commenting the aquatic toxicity and referencing to recent publication by Bragin et al. (2016) and Butler et al. (2016). We did not added these studies to the dossier as the assessment of T (T due to harmonized classification due to carcinogen category 1B) in the PBT assessment would remain unchanged. 

Response to 4.4 Comments on Concawe’s assessment of PBT/vPvB properties
As detailed earlier, eMCSA does not agree with Concawe’s P and B assessment. In agreement with the assessment done for CHR during the identification of CTPHT as SVHC, CHR fulfils the criteria of REACH Art. 57 a), d) and e).
Overall we come to the conclusion that the new information provided by Concawe does not disqualify the studies already included in the SVHC dossier and evaluated during MSC decision on coal tar pitch high temperature and that can thus not change the conclusion.

		Confidential attachment removed		
4902
2017/10/20	Norway,
Member State	The Norwegian CA supports that chrysene should be identified as a substance of very high concern and should be included in the Candidate List.	Thank you for your support.	
4905
2017/10/20	Netherlands,
Member State	NL supports the proposal to include chrysene in the candidate list of SVHC in accordance with Article 57 (a) of Regulation (EC) 1907/2006 (REACH), as there is a harmonized classification for Carcinogenicity Category 1B, and in accordance with Article 57 (d) and (e) of REACH due to PBT and vPvB properties, respectively. A formal recognition will raise awareness of the SVHC-properties of benz[a]anthracene and is a preferred RMO to further support RMM on UVCBs and PetCo substances in particular.
The PBT and vPvB assessment of chrysene is based on the information provided and analysed in the Support Document for the Identification of CTPHT as SVHC that was agreed upon by the MSC. While these data are considered sufficient, the NL-CA feels that the bioaccumulation section could be strengthened by putting less emphasis on the estimated BCF for E. Andrei, and including more recent bioaccumulation data that underpin the B and vB properties of chrysene. Please consider the RIVM report Environmental risk limits for chrysene (Verbruggen and van Herwijnen, 2011) ((www.rivm.nl/bibliotheek/rapporten/601357008.pdf ../../Application Data/Microsoft Office/Outlook/SecureTempFolder/www.rivm.nl/bibliotheek/rapporten/601357009.html) that provides an overview of chrysene bioaccumulation data, and reports reliable lipid normalized BAF values for several taxa that are well above 5000, i.e. 10,300-17,700 L/kgww for several bivalve species, 30,800 L/kgww for a krab species and 21,700 L/kgww for a fish species (Takeuchi et al., 2009).	Thank you for your support and suggestions. We added selected bioaccumulation data in the Support document to strengthen the argumentation of bioaccumulation in molluscs and to provide evidence for bioaccumulation in fish. We acknowledge the valuable work done by Verbruggen and van Herwijnen (2011) and include this reference in the Support document as it strongly provides further evidence for B and vB properties of CHR.	
4918
2017/10/20	CHEM Trust,
National NGO,
United Kingdom	CHEM Trust supports the inclusion of chrysene in the REACH candidate list owing to its classification as carcinogen 1 B and its PBT as well as its vPvB properties. The addition should therefore be carried out based on REACH article 57 a, d) and e) as proposed by the dossier submitter.	Thank you for your support.	
4920
2017/10/20	cefic "Coal Chemicals Sector Group (CCSG)",
Industry or trade association,
Belgium	all comments are included in attached pdf-file	Thank you for providing you views and thoughts. Please accept our following response to your comments.

Response p.5 Foreword First and second sentence: 
We revised to two sentences. Please refer to comment 4889 as well.

Response to p.5 Foreword 3rd paragraph and P.6. Art. 57 (d) and (e): In the agreement of the MSC on the identification of CTPHT as SVHC (ECHA, 2009), adopted at 2. December 2009, page 4 has written: “Based on the data available, it is concluded that seven of the 12 PAH-constituents present in CTPHT in concentrations equal to or above 0.1% are to be considered as both vPvB and PBT substances. These are: fluoranthene, pyrene, benz(a)anthracene, chrysene, benzo(a)pyrene, benzo(k)fluoranthene and benzo(ghi)perylene.” The SVHC dossier submitter correctly reflexed this fact at respective paragraphs.at respective paragraphs. 

Response to p.5 Foreword 4th paragraph: Please kindly refer to response to comment 4890. 

Response to p.9 Composition of the substance: Please kindly refer to response to comment 4890 and the revised paragraph in the dossier. 
Response to p.17-18 Bioaccumulation: 
CCSG remarks critically that only comparably old references have been used in the SVHC proposal. This is due to the fact that mainly information provided in the RAR for CTPHT has been used for the dossier. Based on this older but still valid information also provided in the SVHC dossier for CTPHT, the Member State Committee has already concluded on the PBT and vPvB properties of CHR within the SVHC identification of CTPHT . Nevertheless, additional information has been added to the Support document to strengthen the argumentation.

CCSG does not support the conclusion that CHR fulfils the B and vB criteria as available data show no bioaccumulation in fish. 
However, the most sensitive organisms towards PAHs are those lacking a cytochrome P450 enzyme system. It has been shown without a doubt that bioaccumulation occurs in those organisms because they cannot degrade PAHs. This has been clearly assessed in the SVHC proposal and is supported by further data on crustaceans and molluscs which has been included now. Bioaccumulation of CHR in those organism of low trophic level could contribute to a constant exposure of predators with an unpredictable level of CHR, which would be of concern for such predator species that are unable to biotransform PAHs. Due to the absence of data, there is a concern for other species that feed on crab or molluscs and one high field BAF indicates that also for fish a risk cannot be excluded for at least some fish species.

Response to p.19 Environment hazard assessment: Please kindly refer to response to comment 4890.	
		Please see attachment embedded in table 1 of Part I                                                     4920_CCSG PC CHR 171020 final.pdf		
4929
2017/10/20	Belgium,
Member State	Belgium supports the proposal to identify Chrysene (CHR) as SVHC , based on article 57(a), art.57(d) and art.57(e) of the REACH Regulation due to its classification as Carc. Cat. 1B, its PBT and its vPvB properties.	Thank you for your support.	

PART II: Comments and responses to comments on uses, exposures, alternatives and risks

Specific comments on use, exposure, alternatives and risks
Number / Date	Submitted by (name, submitter type, country)	Comment	Responses	
4890
2017/10/20	Concawe,
Industry or trade association,
Belgium	As there is no registration dossier for CHR, Concawe queries the relevance of this part of the dossier, because there is no REACH data source. In that respect, it has be clearly stated that CHR is never added to substances but is present due to its presence in starting materials, which often are of natural origin.
Furthermore, as it will never lead to an authorisation process for the substance CHR, Concawe considers part II obsolete.
Notwithstanding this opinion, Concawe will comment on some of the content of this part.
Concawe does not understand why the sentences “CHR is not produced intentionally but occurs together with other PAHs as constituent of coal and petroleum stream UVCB substances. Among the PAHs benzo[a]pyrene (B[a]P, EC number: 200-028-5) and anthracene (EC number: 204-371-1) are included in the Candidate List due to PBT and vPvB properties already.” are included in this report that should be purely on CHR. The fact that B(a)P and Anthracene are on the candidate list is not relevant for a CHR evaluation. This evaluation should follow, purely, the science available on CHR.
Concawe queries whether the statements that are given in Chapter 9 (p-23) are in line with the recent information present in REACH IT, as earlier this year a total revision of the registration dossiers for Petroleum Substances (PS) has been rolled out that entails updated PS specific information with respect to mentioned uses (e.g. coatings, road construction, cleaning agents, etc.) for each registered PS. A thorough survey and review of the information provided by the manufacturers has revealed that in most of these cases, it concerns the use of PS as the intermediate for the manufacture of hydrocarbon solvents, which then become different substances that are duly registered by their manufacturers, when required. Therefore, these uses are covered in these registration dossiers and no longer supported in the Concawe registration dossiers.
Concawe has a severe objection to the statement on page 24 in the alternatives section (11.2) “It is possible to considerably decrease the PAH content of UVCB substances derived from coal or mineral oil (see for example use of low aromatic oils in tires, (KEMI, 2003)).”
This is incorrect for Petroleum Substances (PS), as the amount of CHR or any other PAH cannot be reduced without altering the substance’s properties and use potential. The technology available for that in the refining sector would be hydro-treatment that besides reacting with CHR will completely alter the composition of the substance completely, leading to a new substance that is no longer fit for the original purpose. Moreover, it would become another substance under REACH that, giving the fact that these upgrading processes already take place at many refineries, has been registered under another EINECS number.
The example quoted in in section 11.2, the extender oil in tire manufacture, is a good example of this, as the PAH reduction has not been achieved by treating the original extender oils but by shifting to other feedstocks of Petroleum Substances with similar physical-chemical properties that never contained PAHs, above the limits stipulated in the REACH Restriction #50. Hence, restriction #50 has led to a decrease of the mentioned PAHs, including CHR, below the thresholds mention by seeking for alternative feedstocks or petroleum streams that fulfilled the Restriction #50 criteria, suitable for their intended use in tyre manufacturing.	Thank you for providing your thoughts on Part II. 

IUCLID was accessed in November 2016. Further Concawe’s compilation on uses (received in August 2016 via PetCo) - to our knowledge the basis for the 2017th update of the registration dossier - was considered for section 9. 

Thank you for providing detailed information on depletion of PAHs. Considering your response, we suggest to update the paragraph 11.2 as following: “It is possible to considerably decrease the PAH content of articles derived from coal or mineral oil (see for example use of low aromatic oils in tires, (KEMI, 2003)). Alternative feedstocks of Petroleum Substances with similar physical-chemical properties that never contained PAHs can be used to substitute critical feedstocks.”	
		Confidential attachment removed		
4920
2017/10/20	cefic "Coal Chemicals Sector Group (CCSG)",
Industry or trade association,
Belgium	Please see attachment embedded in table 1 of Part I                                                     4920_CCSG PC CHR 171020 final.pdf	Please refer to response at specific comment section 4920.