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

Substance name: Benz[a]anthracene (BaA)
CAS number: 56-55-3
EC number: 200-280-6

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	
4889
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 4889 for a more detailed evaluation of the content of the document.	
4919
2017/10/20	cefic "Coal Chemicals Sector Group (CCSG)",
Industry or trade association,
Belgium	Attachment: 
4919_CCSG PC BaA 171020 final.pdf
	Thank you for providing attached document for further evaluation. Please refer to response on specific comment number 4919 for a more detailed evaluation of the content of the document.	
4940
2017/10/27	Finland,
Member State	The Finnish CA agrees that Benz[a]anthracene (EC 200-280-6) 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 Benz[a]anthracene is 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)
Benz[a]anthracene 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)
Benz[a]anthracene 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 aquatic toxicity as well as the classification of the substance as Carcinogenic category 1 B.

Further comments on the Annex XV are specified below:
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 halflives of BaA 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 BaA 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 Chrysene 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 BaA 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 BaA that consists of four aromatic rings, standard tests for biodegradation in water demonstrated that BaA is biodegradable under aerobic conditions.”
Comment: It is unclear whether this refers to a specific test on BaA 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 BaA is released at equal rates to air, water, soil  and sediment) and default values of physico-chemical properties (done in February 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: The BCFs reported in Freitag et al. (1985) could be included (even if they are not specific to the parent substance due to the 14C method)
5.1.2.2 Long-term toxicity to aquatic invertebrates:
Comment: Please clarify whether the result is for Benz[a]anthracene or other substance.
5.1.3 Algae and aquatic plants:
Comment: Please clarify whether the results are for Benz[a]anthracene or other substance(s).
5.1.5 Other aquatic organisms:
“Acute toxicity studies with the marine bacterium Vibrio fischeri reported concentrations above the aqueous solubility (El-Alawi et al., 2002; Johnson & Long, 1998 cited in the Netherlands (2008)).”
Comment: Please specify what concentrations are referred to (toxicity values? concentration of test substance?) and what was the test substance (BaA or other substances)
Table 6:
Comment: It could be clarified in the Table caption whether all the data is specifically for BaA.
6.2.1.1 Persistence:
“Additionally, the study by Wild and Jones (1993) reports a half-life value of BaA 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 BaA 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.
6.2.1.3 Toxicity:
“The lowest aquatic chronic toxicity has been observed for the alga Pseudokirchneriella subcapitata with an EC10 of 1.2 μg/l for growth inhibition”.
Comment: Please correct, e.g., by adding the word “value”: “The lowest aquatic chronic toxicity value has been observed…”
6.2.2 Summary and overall conclusions on the PBT and vPvB properties:
Comment: The same comment as for 6.2.1.3.	Thank you for your support and specific comments. 

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. 

Response to comment 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 comment 5.1.2.2 and 5.1.3. Thank you. Paragraphs were revised for more clarity. 

Response to 5.1.5: Paragraph 5.1.5 revised for more clarity.

Response to Table 6: Thank you. BaA added to table description.

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	
4857
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.	German CA thanks you for your comment and your support.	
4887
2017/10/20	United Kingdom,
Member State	We thank the German CA for their dossier and whilst we can agree that Benz[a]anthracene 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.

3.4.1 bioaccumulation in aquatic organisms
P17. There are two sources of Daphnia magna bioaccumulation data which provide quite different results. Please include justification for why the steady state result is preferred to the kinetic result.

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
p 18 we do not agree that the earthworm BCF QSAR should be used in the weight of evidence. These data were 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.

3.4.4 summary & discussion of bioaccumulation
p18
Please consider re-phrasing
Bioaccumulation of BaA 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 BaA 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.	The German CA thanks you for your suggestions to improve the dossier.

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

However, we revised the bioaccumulation section 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.

With regard to the bioaccumulation data for D. magna it is asked, why the study by Newstedt and Giesy (1987) is preferred over the study by McCarthy et al. (1985). The studies were evaluated for the identification of CTPHT as SVHC (ECHA, 2009) and were not evaluated again. In the current dossier we follow this assessment. However, we note that for the study Newstedt and Giesy (1987) the wrong test type (reported as static) was reported. The study was performed as static-renewal acute toxicity test. The Support document was updated respectively.	
		-		
4889
2017/10/20	Concawe,
Industry or trade association,
Belgium	CONCAWE COMMENTS ON THE DRAFT ANNEX XV REPORT ON BENZO(A)ANTHRACENE (EINECS # 220-028-5)
Submitted by Germany in August 2017

1. Introduction
Concawe welcomes the opportunity to comment on the draft SVHC assessment report on benzo(a)anthracene, as submitted by the German Competent Authority in August 2017.
As benzo(a)anthracene 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 above.
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 # 200-280-6 (CAS 56-55-3) that has the IUPAC preferred name Benzo(a)anthracene (BaA).
In the first paragraph of the foreword, the way the paragraph is written suggests that BaA to be mutagenic, as well as, reprotoxic, which is not supported by its harmonised classification (601-033-00-9), according to the CLP Regulation (EC 1272/2008) that only indicates BaA to be a Class 1B carcinogen where it concerns the human health hazards.
Therefore, it is suggested to rephrase the opening sentence to for example: “Benzo(a)anthracene (BaA) is a Polycyclic Aromatic Hydrocarbon (PAH) that has a harmonised classification (601-033-00-9) as carcinogenic, 1B, according to the CLP Regulation (EC 1272/2008)”. This is factually correct, whereas the original sentence is not. The fact that BaA is a classified CMR is not disputed by Concawe and, therefore, BaA fulfils the criteria to be classified as an SVHC as defined in articles 57(a) of the REACH Regulation.
In Concawe’s opinion, there is new data available on the persistency of BaA under natural and stimulated conditions that no longer support the vP classification of BaA. Furthermore, a refined assessment according to the state-of-the-art of the bioaccumulation potential of BaA 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 BaA 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 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 BaA is described as “BaA 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 BaA is not produced intentionally is correct. However, it would be better to use the phrase “BaA is not produced, as such. However it may occur as a constituent in UVCB-substances that are derived from coal or some petroleum streams.”
The original sentence hints that all coal and petroleum stream derived UVCBs contain BaA, 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 BaA does have representative lifetimes between 15 min 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. It should also be noted that in the statement, “it was demonstrated by Behymer & Hites (1988) (cited in The Netherlands (2008)), that particle surface-adsorbed BaA does have representative lifetimes between 15 min and 7.8 days under natural conditions” both the wrong data and reference are presented. According to The Netherlands (2008), the correct data to be used in this proposal is “between 15 minutes and 3.3 days”. Additionally, according to The Netherlands (2008), the data is not taken from Behymer & Hites (1988), but from EC (2001). Attention should be paid such that the correct data is included and referenced accordingly.

In section 3.1.1.4, the following statement is made “It is concluded that in the atmosphere, free BaA degrades within periods of 15 min to 7.8 days by direct photolysis. The substance is however mostly particle-associated and when adsorbed onto fine particles, BaA may be more stable in the atmosphere.” This statement is in 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 BaA in the atmosphere will be longer than 15 min to 3.3 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 BaA 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 BaA 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. Furthermore, Concawe is concerned about the correctness of the half-live values presented, as these are identical to values provided in the SVHC assessment report for Chrysene. Given the properties of Chrysene and BaA, these should not be identical.
In addition, recent data on biodegradation of BaA in surface water (arctic and temperate sea water, freshwater) and activated sludge filtrate clearly shows that BaA has the potential to be microbially degraded in the environment. Available half-lives are 2.8 days for activated sludge filtrate, 40 days for a relatively pristine lake, 26.6 days for arctic seawater (test temperature:  1°C) and >182 days for temperate seawater (McFarlin et al., 2014, Mayer and Birch, 2017, 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 remaining values do not meet the P or vP criteria for either the freshwater or marine water compartment. The result for arctic seawater is particularly important because it demonstrates the potential for microorganisms to degrade BaA at very low temperatures with rates comparable to tests conducted at higher temperatures. The geometric mean of half-lives from more recent data where degradation has been observed is 14.4 days, which is clearly below the P/vP criteria for the water compartment.
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). However, Concawe is of the opinion that these data are further evidence of biodegradation below the P and vP half-life cut-offs.
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 BaA and Chrysene – 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 BaA is not deemed sufficient, and additional data would be required in order to conclude whether BaA 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 BaA, 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:
The assessment on data available for BaA used in the Support Document for the Identification of CTPHT as SVHC is presented again here. It is clearly shown in Table 5 that the fish data has been previously evaluated for reliability, and data for P. promelas (from a study with a Klimisch score of 2) shows that BaA does not fulfil the B/vB criteria.
Text from the European Union Risk Assessment Report is also copied into this proposal, including “In view of the high BCF values of molluscs“, however, no data for molluscs is presented that support this conclusion. Particularly as this paragraph concludes with “However, for BaA no study analysing the BCF in mussels is available yet”. It is unclear why the text from the EU Risk assessment report is included in this proposal, as it only serves to distract from the data available. Inconsistencies between the EU Risk assessment report and the Support Document for the Identification of CTPHT as SVHC should have been identified and corrected before including in this report – namely “Because they [molluscs] do not metabolise PAHs, their BCF values may be higher than BCF values for fish.”, as opposed to “Whereas fish, and to some extent also molluscs, have the ability to metabolise PAHs, no evidence of metabolism of PAHs has been observed in algae, or oligochaeta.”
From Table 5, it is apparent that the studies for which crustacean data is available have not been evaluated for validity, as no Klimisch score is given. This process should be done, before it can be assigned a key study. Note also that the reference indicated for McCarthy et al. 1985 is incorrect, and should instead read: “McCarthy JF, Jimenez BD, and Barbee T (1985): Effect of dissolved humic material on accumulation of polycyclic aromatic hydrocarbons: Structure-activity relationships. Aquat Toxicol, 7, 15-24.”
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 BaA 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 BaA in fish show clearly that bioconcentration and bioaccumulation of BaA 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 BaA 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 for several PAHs, and hence any long term effect is indeed predictable.
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 BaA, which will partition to organic matter or lipid. Two studies are available for BaA showing laboratory BMF values far below 1: BMF 0.005 (EMBSI, 2005), and BMF 0.001 (Niimi and Palazzo, 1986). 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 BaA 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, BaA included. The median and 90th percentile for BaA, are less than 0.01. While no threshold values are available for used BSAF values, these data provide further evidence that BaA 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 BaA:
o TMF from Bohai Bay of 0.2 (Wan et al. 2007),
o TMF from the Baltic Sea of 0.75 (Nfon et al. 2008),
o TMF from Tokyo Bay of 0.83 (Takeuchi et al. 2009),
o TMF from the Passaic River estuary of 0.15 (Khairy et al. 2014)
All four of these studies show that BaA does not biomagnify in the marine food chain (TMF values < 1 [ECETOC 2012]). Therefore, relevant bioaccumulation data that have not been considered are available to support the conclusion that BaA is not bio-accumulative.
Ultimately, QSAR data for estimating BCF value for BaA in Eisenia Andrei was provided in the bioaccumulation assessment in terrestrial organisms. A value of 9800 is given in this report. However, as no threshold values are available for BSAF in soil, this is not sufficient to conclude that BaA could be B or vB. Furthermore, this is an estimated value and not experimental data point, as suggested in part 3.4.4.
4.3. Comments on environmental hazard assessment section (Chapter 5)
The section on ecotoxicity discusses photo-enhanced toxicity, as a relevant mode of action for PAHs, including BaA. Photo-enhanced toxicity data are subsequently used to conclude on the ecotoxicity of BaA, 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 BaA. In order to perform a complete assessment of BaA 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 BaA 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.
In addition, as neither BaA 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”.
4.4. Comments on the Assessment of PBT/vPvB properties (6.2)
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, BaA is not classifiable as a persistent substance. Therefore it neither be P nor vP.
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 BaA is not classifiable as a bio-accumulative substance. Therefore it neither be B nor vB.
Synthesis and conclusion
The Rapporteur claims BaA 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, as included in the references provided, we have come to the conclusion that BaA is neither P nor B. In view of this, BaA is incorrectly assigned to be PBT or vPvB.
Therefore, in Concawe’s opinion, BaA does not fulfil the criteria of REACH Article 57 d and e.
Concawe acknowledges the fact that BaA is classified to be a Class 1B carcinogen the CLP Regulation (EC 1272/2008). Therefore, it does fulfil the criterion of Article 57(a), which qualifies BaA to be an SVHC.

References
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 (2005). Fish, dietary bioaccumulation test, study no. 100047P. ExxonMobil Biomedical Sciences Inc. Annandale, NJ
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.
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.
McFarlin, K.M., Prince, R.C., Perkins, R., Leigh, M.B. (2014). Biodegradation of dispersed oil in arctic seawater at -1°C. PLOS ONE. 9(1): e84297. doi:10.1371/journal.pone.0084297
Niimi Aj, Palazzo V. (1986) Biological half-lives of eight polycyclic aromatic hydrocarbons (PAHs) in rainbow trouts (Salmo gairdneri). Water Research 20:503-507.
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.
US Environmental Protection Agency. (2008). Biota-Sediment Accumulation Factor Data Set. http://www.epa.gov/med/Prods_Pubs/bsaf.zip. Accessed 2 October.
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 B(a)A. 
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 BaA.

However, we add additional studies to the B-section (chapter 3.4) to strengthen our argumentation. 

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 is provided at the following sections. 

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
Thank you for informing about the data value and reference discrepancy. We agree and revised paragraph 3.1.1.3.1 and 3.1.1.4.

The data on persistence reviewed at current dossier have been considered and conclusions - confirmed upon among MSC within the CTPHT assessment. Further, the studies, referenced in comment 4889 clearly support that BaA is P and vP 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 DT50BaA = 40d in lakewater. No half-lives have been provided saltwater. 
McFarlin et al. (2014) investigated degradation of Alaska North Slope crude oil with an inocula (artic seawater) collected at Chukchi Sea, 1 km from Barrow, AK. No information is given, whether a pre-adaptation of the inocula occurred. Nevertheless, the authors estimated approx. loss of BaA of 50% after 56 days. 

The methods used at the studies McFarlin et al. (2014) and Mayer and Birch (2017) are not suitable to evaluate P in a PBT/vPvB assessment for pristine environments. The study by Concawe (2012) reporting no degradation of BaA in saltwater might give a further indication, that degradation of BaA under pristine environmental conditions might be very limited.

The study by Durant et al (1995) analysed the low molecular weight PAH biodegradation with Bacteria collected from contaminated (gas plant) sediments and “relatively uncontaminated (still gas plant) segments of the subsurface” (Durant et al. 1995). Durant et al (1995) more precisely demonstrated that benzene, phenanthrene and naphthalene are degraded under aerobic conditions, while only naphthalene is mineralized under anaerobic conditions. Further, the authors detected acclimated populations from relative clean zones. Therefore, the study is not suitable to conclude on degradation rates for a P assessment of PAHs for PBT/vPvB 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 BaA, 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 SVHC identification of CTPHT by MSC, demonstrate that BaA 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 BaA in water (DT50 = 40d for BaA 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 BaA within the CTPHT identification process.

CONCAWE disagrees with the approach to conclude on the B and vB properties of BaA 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 likely because they cannot degrade PAHs. This has been clearly assessed in the SVHC proposal. Further evidence for bioaccumulation of BaA in molluscs is now included into the dossier supporting the conclusion that has already been drawn in the EU risk assessment report and the support document for CTPHT with regard to PAHs in general.
Bioaccumulation of BaA in those organism of low trophic level could contribute to a constant exposure of predators with an unpredictable level of BaA, 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 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 dossier (chapter 3.4) for an amended, detailed discussion on bioaccumulation of BaA. Reliability values have been added to the dossier and the citation for McCarthy et al. (1985) has been corrected.

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.

Response to 4.4 Comments on Concawe’s assessment of PBT/vPvB properties
As detailed earlier, SVHC dossier submitter does not agree with Concawe’s P and B assessment. In agreement with the assessment done for BaA during the identification of CTPHT as SVHC, BaA fulfils the criteria of REACH Art. 57 a), d) and e). The evidences (reviewed literature), which form the basis of Concawe’s assessment are evaluated insufficient to draw Concawe’s conclusion on PBT/vPvB properties of BaA. Please refer to respective sections above for details.

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.	
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4899
2017/10/20	ANSES,
National Authority,
France	ANSES welcome the proposal to identify the different properties of Benz[a]anthracene  (BaA) 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 Benz[a]anthracene as an SVHC under Art 57a is supported in relation to its classification Carc 1B- H350 in the Annex VI of CLP (index 601-033-00-9).

Identification according to Article 57(e) – vPvB

The assessment of PBT/vPvB properties of  Benz[a]anthracene has been already done  in the context of the identification of Coal-Tar Pitch, high temperature  (CTPHT) as SVHC (ECHA, 2009). Based in this assessment, it has been concluded by the MSC that Benz[a]anthracene fulfils the PBT and vPvB criteria of Annex XIII to the REACH Regulation.

The  actual proposal of identification of  Benz[a]anthracene as SVHC presented by Germany is based on the information provided and analyzed in the support document for the identification of CTPHT as SVHC (ECHA, 2009) and ANSES supports the identification of  Benz[a]anthracene as an SVHC due to its vPvB properties.	Thank you for your support.	
4901
2017/10/20	Norway,
Member State	The Norwegian CA supports that benz[a]anthracene should be identified as a substance of very high concern and should be included in the Candidate List.	Thank you for your support.	
4907
2017/10/20	Netherlands,
Member State	NL supports the proposal to include benz[a]anthracene 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 benz[a]anthracene 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 benz[a]anthracene. Please consider the RIVM report Environmental risk limits for benz[a]anthracene  (Verbruggen and van Herwijnen, 2011) (www.rivm.nl/bibliotheek/rapporten/601357009.pdf../../Application Data/Microsoft Office/Outlook/SecureTempFolder/www.rivm.nl/bibliotheek/rapporten/601357009.html) that provides an overview of benz[a]anthracene bioaccumulation data, and reports reliable lipid normalized BAF values for several taxa that are well above 5000, i.e. 19,000-48,000 L/kgww for several bivalve species, 13,000 L/kgww for a krab species and 12,000 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 bioacculation 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 BaA. 	
		-		
4919
2017/10/20	cefic "Coal Chemicals Sector Group (CCSG)",
Industry or trade association,
Belgium	The comments for all parts are compiled in attached pdf-file	Thank you for providing you views and thoughts. 
In the following we address some specific 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. 

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 BaA within the SVHC identification of CTPHT. Nevertheless, additional information has been added to the Support document to further strengthen the argumentation.

CCSG does not support the conclusion that BaA 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 BaA in those organism of low trophic level could contribute to a constant exposure of predators with an unpredictable level of BaA, 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.20 Environment hazard assessment: The chapter is essential to assess the hazard caused by BaA for the environment.	
		4919_CCSG PC BaA 171020 final.pdf		
4924
2017/10/20	Belgium,
Member State	Belgium supports the proposal to identify Benz[a]anthracene (BaA) 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.	
4933
2017/10/20	CHEM Trust,
National NGO,
United Kingdom	CHEM Trust supports the inclusion of benz[a]anthracene in the REACH candidate list owing to its classification as carcinogen category 1 B and its PBT as well as its vPvB properties. The addition should therefore be based on REACH article 57 a, d) and e) as proposed by the dossier submitter.	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	
4889
2017/10/20	Concawe,
Industry or trade association,
Belgium	5. Comments on part II
As there is no registration dossier for BaA, Concawe queries the relevance of this part of the dossier, because there is no REACH data source. In that respect, it has to be clearly stated that BaA 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 BaA, Concawe considers part II obsolete.
Notwithstanding this opinion, Concawe will comment on some of the content of this part.
Concawe queries whether the statements that are given in Chapter 9 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.
In addition, Concawe has has derived PAH concentrations in some PS, in response to a recent request for information on substance identity and compositional information from the German BAuA. Concawe anticipates that this additional field data will be taken into consideration, when BaA or substances containing this in sufficient amount become subject to follow-up activities.
Concawe has a severe objection to the statement on page 27 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 BaA 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 BaA will completely alter the composition of the substance, leading to a new substance, which then would be registered under the appropriate EINECS entry and that is no longer fit for the original purpose. Hence, these would become other PSs under REACH that, given the fact that these upgrading processes already take place at many refineries, already have been registered under the appropriate EINECS numbers.
The same rationale is also applicable to PS that have been subject to extraction or other physical treatment processes.
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 appropriate physical-chemical properties that never contained PAHs, above the limits stipulated in the REACH Restriction #50. Hence, it is correct that restriction #50 has led to a decrease of the mentioned PAHs, including BaA, 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.	IUCLID was accessed in November 2016. Further Concawe’s compilation on uses (received in August 2016 via PetCo) - to our knowledge the basis the 2017th dossier update - 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.	
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4919
2017/10/20	cefic "Coal Chemicals Sector Group (CCSG)",
Industry or trade association,
Belgium	Please see attachment embedded in table 1 of Part I                                                     4919_CCSG PC BaA 171020 final.pdf	Please refer to the response to comment 4919 at specific comment section.