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

Substance name: Fluoranthene
CAS number: 206-44-0
EC number: 205-912-4

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

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

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

General comments on the SVHC proposal
Number / Date	Submitted by (name, submitter type, country)	Comment	Responses	
5202
2018/10/17	Euroalliages,
Industry or trade association,
Belgium	See our position paper also submitted for Benzo[k]fluoranthene	Thank you for your comment. We take note of your argumentation questioning the legal basis of the SVHC identification of the PAHs.
SVHC identification is however based on the intrinsic properties of a substance, more particularly in this case for fluoranthene on its PBT/vPvB properties. Therefore, the Belgian CA sees a special need to clearly identify the PBT and vPVB properties of fluoranthene.

The intention of this current proposal is to cover the substance as such (EC:205-912-4; CAS: 206-44-0) and therefore it does not propose to identify as SVHCs other substances that contain fluoranthene as an impurity or constituent. 

Therefore BECA is of the opinion that there is no source of legal uncertainty.	
		Attachment: 5202_Position paper candidates listing of PAHs October 2018.pdf
		
5254
2018/10/19	Concawe,
Industry or trade association,
Belgium	-	Thanks for the supplementary information. This information has been added to the Support document. 

Please refer to our answers provided under comment 5254 in the next table (Specific Comments).	
		Attachment: 5254_FA.zip

Specific comments on the justification
Number / Date	Submitted by (name, submitter type, country)	Comment	Responses	
5202
2018/10/17	Euroalliages,
Industry or trade association,
Belgium	See our position paper also submitted for Benzo[k]fluoranthene	Thank you for your comment. Please refer to comment 5202, PART 1 General comments for our answer.
	
		See the corresponding embedded attachment in table 1 of Part I: 5202_Position paper candidates listing of PAHs October 2018.pdf		
5213
2018/10/19	Norway,
Member State	The Norwegian CA supports that fluoranthene should be identified as a substance of very high concern and should be included in the Candidate List.
Fluoranthene is a polyaromatic hydrocarbon (PAH), a group of chemicals where several similar structures are already identified as PBT or vPvB, as described in the MSC opinion on the SVHC properites on coal tar pitch, high temperature (CTPHT) in 2009. Fluoranthene meets the criteria for inclusion on the Candidate list as PBT and vPvB in 57d) and 57 e) REACH.	Thank you for your support.	
5220
2018/10/19	EEB,
International NGO,
Belgium	EEB supports the proposal to identify Fluoranthene as SVHC based on its PBT and vPvB properties. MSC agreed already before on the PBT and vPvB properties of Fluoranthene in the context of the discussion on Coal Tar Pitch High Temperature containing Fluoranthene.	Thank you for your support.	
5227
2018/10/19	Netherlands,
Member State	1. General Comments
NL supports the identification of fluoranthene as PBT and vPvB. However, NL would like to propose that the section on bioaccumulation is updated based on the evaluation done by Bleeker and Verbruggen (2009), in which the reliability score of some studies mentioned in the European Union Risk Assessment Report on CTPHT (European Commission, 2008) has been revised. The report of Bleeker & Verbruggen (2009) also includes BCF values for several aquatic species that are not included in the Annex XV dossier. The highest reliable BCF values for Fluoranthene proposed by Bleeker & Verbruggen are:  2772  (5% lipid norm) for Pimephales promelas , 12250 (5% lipid norm) for Perna viridis (Mollusc), and 58884 (ww) for Diporeia spec. (Crustacean).  (https://www.rivm.nl/bibliotheek/rapporten/601779002.html).
Furthermore, in the updated assessment from RIVM for PAHs (Verbruggen, 2012) more toxicity data for fluoranthene were reported, and a further quality assessment of these data has been made, including reliability scoring. NL-CA would like these data to be included in the dossier (https://www.rivm.nl/bibliotheek/rapporten/607711007.html).	Thank you for your support.
The Support document has been amended accordingly.	
5235
2018/10/19	Finland,
Member State	The Finnish CA supports the identification of Fluoranthene as a substance of very high concern, on the basis that it fulfils the criteria for persistent, bioaccumulative and toxic substances (PBT) according to Article 57 (d) and the criteria for very persistent and very bioaccumulative (vPvB) according to Article 57 (e) of Regulation (EC) No 1907/2006 (REACH).

As stated in the Annex XV report, Fluoranthene is identified as a PBT and vPvB substance according to REACH Art. 57(d) and (e) of REACH by comparing all relevant and available information according to Annex XIII of REACH with the criteria set out in the same Annex, in a weight-of-evidence determination.

We have the following specific comments on the Annex XV report:

page 6:

“Fluoranthene consists of 4 aromatic rings, so standard tests for biodegradation in water may reveal that fluoranthene is biodegradable under aerobic conditions (European Commission, 2008).”

Comment:
Please clarify the sentence as it is unclear from the current sentence whether there are standard test results available or whether this is a speculation. In the cited report (European Commission 2008, i.e., the European Union Risk Assessment Report, Coal Tar Pitch High Temperature) there is a sentence “The results from standard test for biodegradation in water show that PAH with up to four aromatic rings are biodegradable under aerobic conditions but that the biodegradation rate of PAH with more aromatic rings is very low (EHC. 1998).”. However, the reference EHC 1998 is not in the reference list of European Commission (2008). Please include the reference (or if not known, please delete this sentence). The same applies to 3.1.2.4. and 6.2.2.	Thank you for your support. The corresponding text has been amended in the Support document  to reflect on this comment.	
		-		
5242
2018/10/19	CHEM Trust,
National NGO,
United Kingdom	CHEM Trust supports inclusion of fluoranthene under Article 57 d) and e)  in the REACH candidate list based on the presented data in the Annex XV dossier.	Thank you for your support.	
5250
2018/10/19	ChemSec,
International NGO,
Sweden	ChemSec supports the identification of Fluoranthene as an SVHC based on it being a PBT, vPvB, CMRand of equivalent level of concern, this in turn based on it being a constituent of the earlier identified SVHC CTPHT.	Thank you for your support.	
5254
2018/10/19	Concawe,
Industry or trade association,
Belgium	Introduction
Concawe welcomes the opportunity to comment on the draft SVHC assessment report on Fluoranthene, as submitted by the Belgian Competent Authority in September 2018.
As Fluoranthene 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.
A review by Concawe indicates that much of the reliable data has not been incorporated in the assessment. This is not consistent with a weight of evidence determination. According to REACH Annex XIII, for identification of PBT substances a weight-of-evidence determination should be applied considering all relevant and available information. Appropriate weighting of reliability and relevance should be applied to all the available information, and a conclusion drawn based on the total weight of evidence. If individual data have not been used in the assessment due to concerns of reliability or relevance then this should be made clear in the Annex XV report and the reasons documented. We would consider it unusual for a piece of evidence to be rejected outright unless it was determined to have serious methodological flaws affecting the reliability or relevance of the study such that it is of absolutely no value to the assessment.
The additional information presented in these comments should therefore be taken into account in a new determination that is based on weight-of-evidence. Once the document has been revised, Concawe requests that there is another opportunity for stakeholder review to ensure an objective weight of evidence evaluation of all available information is being presented to the Member State Committee.

PART I
1. IDENTITY OF THE SUBSTANCE AND PHYSICAL AND CHEMICAL PROPERTIES
1.2 Composition of the substance
In paragraph 1.2 FLA is described as “FLA 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 FLA is not produced intentionally is correct. However, it would be better to use the phrase “FLA is not produced, as such. However, it may occur as a UVCB 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 FLA, which is not correct, especially for lighter petroleum substances.

3. ENVIRONMENTAL FATE PROPERTIES
3.1 Degradation
There are several studies in the peer-reviewed literature that provide data relevant to degradation of fluoranthene, which have not been included in the Annex XV report. This is not consistent with a weight of evidence determination.

3.1.1.3 Phototransformation/photolysis
Photodegradation is an important fate process for PAHs. Photolysis rates measured in laboratory tests equate to half-lives in the order of minutes to hours for phenanthrene, anthracene, fluoranthene, pyrene and benzo[a]pyrene (see attached data summary). Including photodegradation in risk assessment models (including the limited photic zone) shows decreases of up to 98% in the simulated water concentrations (Parkerton and Redman, 2015). It is therefore inappropriate to exclude this important fate process from consideration in the persistence assessment.
Furthermore, if photodegradation is excluded as a relevant fate process, then it should follow that photo-enhanced toxicity also be excluded from the hazard assessment, as this process would also be considered to not have a significant impact on the overall toxicity of PAHs in the environment.

3.1.2.1 Biodegradation in water and sediments
In total 13 measurements of fluoranthene degradation in environmental surface waters are available. Measured half-lives cover a range 0.2 – 17.7 days, with a geometric mean of 5.0 days. These results are clearly below the P cut-offs for freshwater and marine water of 40 and 60 days, respectively.
Degradation of fluoranthene in seawater and a rural lake water at low, environmentally relevant, concentrations has been tested (Birch et al, 2018). In these experiments, inconsistent degradation was observed, and no half-lives were reported. These results contrast with other data, and may have been due to the absence of specific degraders in the test inoculum as a result of the low concentrations and limited test volume used (Martin et al., 2017). In a similar test using activated sludge filtrate as the inoculum a half-life of 0.77 days was reported (Birch et al., 2018). A further study of the degradation of fluoranthene in passive dosed composed mixtures in seawater resulted in a half-life of 9.2 days (Concawe, 2012).
In previous SVHC public consultations, a concern has been raised as to the reliability of substance degradation data derived from testing of composed mixtures due to possible co-substrate effects. However, it should be noted that fluoranthene exists and is released to the environment in the presence of other hydrocarbons. These data should therefore be considered environmentally relevant and suitable for use in the persistence assessment. 

Furthermore, a more recent study investigating the influence of degradation rates of substances tested in isolation and in 3-, 8- and 16-part mixtures did not find a significant influence of number of components on measured degradation rates (Hammershoj et al, 2018 - see attached poster).

Degradation of fluoranthene has been measured in seawater dispersions in rotating carousel systems (Brakstad et al., 2015, 2018a, 2018b, Loftus et al., 2018, Ribicic et al, 2018). Crude oil dispersions were prepared using droplet generators, with and without dispersants, and in one case fluoranthene was dosed as part of a produced water (PW) from an offshore oil platform (Loftus et al., 2018). In one case seawater was pre-adapted to the test substance (Brakstad et al., 2015) but in other cases the inoculum was non-adapted and produced comparable results. A study comparing results derived with and without dispersant demonstrated no significant influence on the measured degradation rates (Brakstad et al., 2018a). Measured half-lives from these studies varied between 0.2 and 17.7 days.
Specific bacterial strains have also been demonstrated to rapidly utilise and mineralise PAHs. In one instance, dynamic passive dosing has been used to demonstrate that mineralisation rates of freely-dissolved phenanthrene and fluoranthene by S. paucimobilis were both comparable to one another and very fast (Smith et al., 2012).

The BioHCWin v1.01 QSAR, which is an EPA EPISuite model developed specifically for the biodedegradation half-life prediction of petroleum hydrocarbons, predicts a degradation half-life of 191.4 days for fluoranthene (Howard et al, 2005). This exceeds the aquatic vP cut-offs, but is not in line with the experimental data presented above. Recent comparisons of BioHCWin predictions to experimental degradation half-lives in aquatic tests have generally found predictions to be conservative (Prosser et al., 2016, Birch et al., 2018).

3.1.2.2 Biodegradation in soil
Degradation half-lives as low as 16 days have been reported for fluoranthene in spiked soils (Wild and Jones, 1993). This contrasts with the data presented in the Annex XV report, where PAHs have been introduced to the soil through application of sludge from a sewage treatment plant (STP). This is important, as the PAHs would have been introduced as part of a complex matrix and may have been bound to particulate matter affecting their bioavailability. Biodegradation experiments with activated sludge have indicated that bioavailable fluoranthene is subject to rapid degradation, hence any material remaining in STP sludge is expected to be of very limited bioavailability.
The source of PAHs can also have an influence on their bioavailability, with PAHs from pyrogenic origin (i.e. incomplete combustion) tending to be associated with soot carbon and of very limited bioavailability, whereas petrogenic PAHs are considered more susceptible to microbial degradation (Burgess et al., 2003).
The influence of bioavailability on degradation rate was further highlighted in a landfarming study investigating the degradation of PAHs from dredged sediments over a period of several years (Harmsen and Rietra, 2018). Here it was possible to identify fast, slowly and very slowly desorbing fractions of PAHs and to measure their individual degradation rates, which varied significantly.
Clearly, the bioavailability of a substance is critical to the rate at which it will biodegrade in any system, and is of similar importance to other environmental factors influencing biodegradation (e.g. availability of nutrients, oxygen and competent degraders). However, bioavailability is not explicitly addressed in the framework of a persistence assessment. It is important, as far as possible, to separate extrinsic environmental factors from substance properties in persistence assessment in order to arrive at conclusions which reflect the intrinsic biodegradability of the substance and allow for consistent comparison and prioritisation between substances. Simulation test data generated according to the standard information requirements, according to which persistence assessment criteria have been developed, allow for a consistent comparison between substances. Data from these tests and those with comparable methods should therefore be given a high priority in assessments based on weight-of-evidence.
It should also be noted here that substances which are not bioavailable are also expected to not pose a risk to either human health or the environment, and that the available evidence indicates that, should fluoranthene become bioavailable, it would be degraded by indigenous microbial populations. The greatly reduced bioavailability of PAHs in soils and sediments, particularly in the presence of black carbon, has previously been recognized by RIVM (Verbruggen, 2012). Here it was advocated to use bioavailability-based methods (e.g. SPME) for monitoring PAH levels and comparing to established environmental risk limits in order to account for this reduced bioavailability in risk assessments.
In addition to the concerns raised around the bioavailability of PAHs in the Wild et al (1991) field study, we would like to note some additional concerns:
• In a later publication the authors themselves highlight the inconsistency of this dataset with other field datasets and cite possible artefacts due to use of archived soils (Northcott and Jones, 2001).
• The PAH concentrations in control soils actually increase over the duration of the experiment indicating a continuous influx of PAHs not from the initial application, most likely as a result of aerial deposition.
• Data from only one of two soils is reported. The other soil appeared to show faster degradation.
• Initial concentrations in the experiments used to derive half-lives are estimates rather than measured values.
• Treatment groups appear to not have been replicated and measured concentrations appear based on single analyses.
• The results for different treatment groups and calculation methods produce very wide variation in half-lives for the same soil.
• PAHs dosed via STP sludge would be present as a complex mixture with other substances, including high levels of metals, which may have influenced the indigenous microbial populations and degradation of the PAHs.
• The experiments are lacking true controls for the measurement of PAH degradation, as the controls were not amended with STP sludge and are therefore different in other respects than simply the amounts of PAHs present.
• The SVHC Support Document for coal tar pitch, high temperature (EC number: 266-028-2) states that the Wild et al (1991) field data are given priority as they represent realistic conditions. However, according to the ECHA R.11 Guidance, field studies do not represent high-tier studies and should not override other results as they are dependent on local conditions and not directly comparable to laboratory tests or P/vP criteria.

3.3 Bioaccumulation
General approach to bioaccumulation assessments
Bioaccumulation assessments are a logical step in characterizing the potential significance of indirect exposure pathways of substances in the environment.  REACH PBT assessments utilize a laboratory Bioconcentration Factor (BCF) of 2000 L/kg WW and 5000 L/kg WWt for determining bioaccumulative (B) and very bioaccumulative (vB) substances.  These are useful screening criteria and were formalized in the 2001 Stockholm Convention on persistent organic pollutants.  The basis of these metrics were deduced from legacy persistent organic chemicals that exhibited no or limited degradation in the environment and were observed to biomagnify (i.e. tissue concentrations progressively increase with trophic level) through aquatic foodchains and terrestrial foodchains (Matthies, 2016; McLachlan, 2018).  Thus, the intent of the vB designation is to identify substances that potentially undergo biomagnification and pose higher exposures and subsequent risks than might be anticipated from direct air or water exposure routes.  However, use of BCF metrics alone reflects science that is more than two decades old.  Thus, recent advances in bioaccumulation science must be considered in order to compliment BCF data and provide a credible, objective, weight of evidence (WoE) evaluation to logically inform B decision-making.

SETAC Pellston workshops bring together experts from several stakeholder groups, including scientists from regulatory, industry and academic backgrounds and work to establish the state of the science on a particular topic.  In 2008, SETAC organized a Pellston worskhop to evaluate the state of PBT assessment science (Klečka et al., 2009). This resulted in several key publications that outlined consensus guidance to improve B assessments.  First, Gobas et al (2009), which was co-authored by RIVM, advocated for a tiered approach to B assessments, (as outlined in Figure 1 of this paper – see attachment ‘’graphs’’).  The highest tier includes evaluation of substance bioaccumulation in a field food web as expressed in terms of trophic magnification factors (TMF).  Biomagnification factors (BMF) obtained using laboratory based dietary exposures with fish were identified as the next best tier to reliably characterize substance biomagnification potential.  This recommendation was a key motivation for the subsequent development of an OECD guideline for conducting dietary bioaccumulation tests (OECD 2015).  The rationale for considering TMF and BMF as higher tier endpoints than the BCF test is that the underlying mechanistic basis for biomagnification is driven by the dietary route of exposure that is explicitly addressed using these B metrics. Use of bioconcentration factors (BCF) are used as lower tier assessments.  The BCFs can vary widely by species due to their metabolic capabilities.  The lowest tier is to screen on logKOW. Biota-sediment accumulation factors (BSAF) can also be considered in weight of evidence acknowledging the sediment as a source to certain foodchains (Burkhard et al., 2011).
It is recognised that logKOW screening is very simple so most evaluations rely upon BCF data, which are relatively common.  However, the choice of test organisms are important due to the role of metabolism.  The ultimate goal of B assessments is to identify additional risks through successive trophic levels.  Therefore, BCF data derived from fish that typically reside at an intermediate position in the foodweb are considered most relevant for B assessment.  This is outlined in the ECHA 2017 Guidance on endpoints R11 “For the start, it should be noted that, in normal cases where experimental information on bioaccumulation is needed, a flow-through bioaccumulation test with fish according to OECD TG 305-I or OECD TG 305-II is preferred due to the best possibilities of reliably comparing the results from such test with the B/vB criteria.”  This approach provides a degree of conservatism since higher trophic organisms (birds, mammals) can exhibit enhanced enzymatic capacity to metabolize substances.

Evaluation of BCFs on invertebrates with low metabolic capability, such as mussels, essentially equate to evaluating substances based on log KOW.  This is true because logKOW simply reflects the extent of equilibrium partitioning to lipids but is insensitive to metabolism, which is a less not an important process in mussels.  Screening on logKOW carries the lowest weight in a B assessment, and by extension invertebrate BCF data should be given low weight in a B assessment especially if reliable fish BCF data are available.

While TMF data are valuable in characterizing substance transfer through ecosystems, experience has proven that such field studies are prone to artefacts due to seasonality, or specific foodweb dynamics such as specific predator-prey relationships, which can complicate the interpretation of TMF data (Kim et al., 2016; Burkhard et al., 2013).  Therefore, BMF data are viewed as particularly influential in current B evaluations.   BMF tests are performed with spiked diets that usually deliver better defined exposures than BCF tests since aqueous concentrations of insoluble chemicals are more variable and translate to greater uncertainty in BCF endpoints (Lo et al., 2016). Therefore, BMF becomes a critical objective line of evidence in evaluating B and vB potential of organic chemicals.

Measurements of BCF have a number of important considerations including careful maintenance and measurements of the exposure concentrations (aqueous or diet), as well as characterizing the uptake and depuration kinetics.  At times experimental evaluations rely on radiolabelled compounds to track the bioaccumulation and metabolism kinetics in a test organisms.  While this is potentially useful data, the use of total radioactivity includes the accumulation of metabolic break down products that can be routed into the catabolic processes of the organism normal metabolism.  Potential incorporation of the radiolabelled material into subsequent biomass has the potential to overestimate the BCF for a given chemical.  For these reasons, consensus guidance concludes radiolabelled BCF data are generally considered not fit for purpose in B assessments (Parkerton et al., 2008). Additional consideration for judging the reliability of BCF studies for B decision-making include: (1) exposure concentrations that are below the solubility limit of the substances and (2) use of test concentrations at levels that are below acute and chronic effect levels to avoid confounding effects due to potentially altered physiology.

The outlined approach above represents the state of science related to bioaccumulation assessments.  To support this review, B data referenced in the draft PBT dossiers, the Concawe PBT report from 2009, other reviews (Bleeker, 2010), as well as other data identified from a recent literature search in Google/Scholar during October 2018 were compiled and critically assessed for reliability.  Tables of the available data are attached with comments on how to consider these data.

Specific results for Phenanthrene
As discussed above, radiolabelled BCF data are not considered fit for purpose of B assessments.  Also, mussel and invertebrate BCF data are not sufficient to characterize additional risks due to biomagnification.  Therefore, fish BCF data are considered the most reliable.  Fish BCF data are given in Table 1 (see attachment ‘’graphs’’), and invertebrate BCF data are given in Table 2 (see attachment ‘’graphs’’) for reference, but are not used to evaluate B potential.  There are data on 6 fish species showing a range of BCF from 266 to 1946 L/kg.  Several of these are new data that were not considered in the SVHC proposal and should be evaluated.  These results suggest that FLA is not a B substance and additional lines of evidence would confirm this status.

Comments on specific studies
Several studies cited in the SVHC dossier are not suitable for bioaccumulation assessments.  For example, several are derived from radiolabelled studies, which are not appropriate for BCF determinations since they capture total bioaccumulation including metabolites and parent chemicals.  They are therefore not comparable to standard BCF data and should be disregarded.  Data for mussels, crustaceans, and invertebrates are not useful for evaluating additional risks through the foodchain, as discussed above.  Also, the ECHA guidance, as cited above, states BCFs for fish are preferred for this assessment.  The status of FLA as B/vB is not supported by weight of evidence.
Several studies in the SVHC dossier proposal use data that were based on dry weight and are not comparable to the typical wet weight units.  These are corrected and noted in Table 1 (see attachment ‘’graphs’’).
TMF data
TMF data can be useful since they characterize the trophic transfer of contaminants in field datasets.  Derivation of TMF can include organisms at the base of the foodchain, like mussels that have poor metabolic capacity, but should also include fish and higher order organisms that will reflect additional exposures introduced through secondary poisoning.  Due to the variability noted above, multiple studies should be critically evaluated as part of weight of evidence for bioaccumulation assessments.  For Fluoranthene there are five studies reporting TMFs: Bohai Bay 0.11 (Wan et al., 2007), Baltic Sea 0.72 (Nfon, 2008), Tokyo Bay 0.60 (Takeuchi et al., 2009), Passaic River estuary 0.26 (Khairy, 2014), and Taihu Lake 1.20 (Wang et al., 2012).
The study by Wang et al (2012) is the sole study to cite a TMF > 1, which is inconsistent with available BMF data and other existing TMF data.  Further review of the data underlying this study (Table 1, Table S2) indicates that data for a single species (catfish) are driving this observed TMF greater than 1.  This data point is >30-fold higher than the other data points in table S2 and do not support a trend analysis. The other data collected are all of similar magnitude suggesting a general lack of biomagnification.  Further regression analysis of this data set using Excel indicates confidence intervals of 0.64 – 2.2, which is not significantly different than the benchmark of 1.0 and reflects the high uncertainty of this dataset.  Therefore, this TMF is not considered reliable and the weight of evidence from the other studies confirms the lack of trophic magnification behaviour.
Note, ‘Wang et al 2012’ is mis-cited in the SVHC dossiers, it should be (Wang, D.-Q., et al., Polycyclic aromatic hydrocarbons and organochlorine pesticides in fish from Taihu Lake: Their levels, sources, and biomagnification. Ecotoxicology and Environmental Safety, 2012. 82: p. 63-70.).
Lastly, another study (Moermond et al., 2007) measured PAH concentrations for different categories of organisms at different trophic levels, but did not include measurements of trophic position.  However comparing fish concentrations to concentrations in zooplankton suggests (Table S4) TMF < 1.
All 6 of these studies show that FLA does not biomagnify in the food chain (TMF values < 1 [ECETOC 2012]).  Therefore, Concawe is of the opinion that FLA is not bio-accumulative.

BSAF
Data from a US EPA BSAF database (US Environmental Protection Agency, 2008) provides information on field-derived fish BSAF factors for 17 PAHs, FLA included. The median and 90th percentile for FLA, are less than 0.06, and 0.65, respectively. While no threshold values are available for used BSAF values, these data provide further evidence that FLA does not biomagnify in the field, and is therefore not bioaccumulative.

BMF
As discussed above, BMFs have the largest weight of evidence for bioaccumulation assessments.  There are 6 studies that report BMF data for FLA for lab and field studies (Table 1 - see attachment ‘’graphs’’).  The BMF magnitude range from 0.006 to 0.066, which indicate a lack of transfer from diet items to fish.  This confirms the observations for TMF and confirms low B potential for FLA.  Therefore, Concawe is of the opinion that FLA is not bio-accumulative.

5. ENVIRONMENTAL HAZARD ASSESSMENT
The draft SVHC assessment report on fluoranthene, as submitted by the Belgian competent authorities, includes discussions on the T criterion of Article 57 (d) of REACH. The section on hazard discusses photo-enhanced toxicity as a relevant mode of action for fluoranthene and is subsequently used to demonstrate that fluoranthene meets the T criterion, as this property is environmentally relevant in the assessor’s opinion (extracted from the CTPHT risk assessment). The issue with this approach is that photo-degradation is not considered in the fate assessment of fluoranthene, as discussed in section 3.1.1 on abiotic degradation.
To perform a complete assessment of fluoranthene toxicity, exposure considerations should be included. For example, a recent assessment of similar PAHs showed that photo-enhanced hazard was mitigated by the more prominent effect of photo-degradation, which significantly reduced associated risk characterization ratios of the chemical (Parkerton and Redman, 2015). If the assessor believes photo-enhanced toxicity in the aquatic environment is relevant to the assessment of hazard, photo-enhanced degradation in the same aquatic environment should also be considered in the assessment of fluoranthene.

6. CONCLUSIONS ON THE SVHC PROPERTIES
6.2.1 Assessment of PBT/vPvB properties
In conclusion, the majority of the available evidence supports that fluoranthene is susceptible to microbial degradation with half-lives below the respective P and vP criteria. When bioavailability is reduced, either due to strong sorption or association with soot particles, fluoranthene can resist biodegradation processes. However, it should be noted that in this form fluoranthene is also expected to be unlikely to pose a risk to biological receptors.
Considering the total available weight of evidence, particularly the large number of studies available for the aquatic compartment, and soil studies where fluoranthene is dosed via spiking (i.e. most resembling standard simulation tests), fluoranthene does not meet the criteria of a P or vP substance.
In Concawe’s opinion, there is new data available on the bioaccumulation potential for FLA under field and laboratory conditions that do not support a vB classification of FLA. A refined assessment according to the state-of-the-art of the bioaccumulation potential of FLA 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 or vB substance.
In view of this recent scientific data, and in line with the correct interpretation of these data, Concawe is of the opinion that FLA should not be classified to be a PBT or vPvB substance.
The Coal Tar Pitch, High Temperature (CTPHT) decision comes to the PBT/vPvB conclusion for FLA by the application of a hazard assessment that does not take into account higher tier observations in the environment (e.g. TMF values), which should be included in this current PBT assessment using a Weight of Evidence approach.
This is in line with Concawe’s view that any assessment should be made upon the state-of-the-art of the science, especially, when these latest insights give rise to the revision of decisions taken in the past. In Concawe’s view this is a key point, because otherwise the main driver for performing dedicated research to address lacunas in knowledge becomes superfluous. When any new result that overrules hypotheses or decisions from the past are not used to correct the results of historic research, which no longer can be regarded to be state-of-the-art, this will prevent any future research into the fate and effects of chemical substances, which is one of the main objectives of the REACH regulation.

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Yokley, R.A., Garrison, A.A., Wehry, E.L., Mamantov, G., 1986. Photochemical transformation of pyrene and benzo[a]pyrene vapor-deposited on eight coal stack ashes. Environ. Sci. Technol. 20, 86–90. https://doi.org/10.1021/es00143a011	General response:
Thank you for your comments. 

In  your comments you remark critically that not much of the reliable data has been incorporated in the assessment and that the additional information presented in your comments should be taken into account in a weight-of-evidence approach. 
Indeed, in this dossier mainly information provided in the RAR for CTPHT has been used. However, BE CA would like to underline that based on this still valid information which also was provided in the SVHC dossier for CTPTH (2009), the Member State Committee has already concluded on the PBT and vPvB properties of fluoranthene. 
The information provided by you has been  evaluated and the Support document has been amended where considered relevant. Overall, the BE CA comes to the conclusion that the new information provided by you does not overrule the conclusions drawn by the MSC regarding identification of CTPTH, and hence fluoranthene, as SVHC. 

Response to 1. Identity of the substance and physical and chemical properties:
Thank you for this remark. The Support document has been amended accordingly. 

Response to 3.1 Degradation: 
Thank you for your comments. However, as indicated above, according to the BE CA this new information does not overrule this older but still valid information as introduced in the Support document. 

Response to 3.1.1.3 Phototransformation/photolysis
Being a highly conjugated system it is not unusual (if not to say expected) that FLA breaks down under the influence of UV radiation under controlled laboratory conditions and under high radiation. This specific laboratory settings do not simulate/represent the normal environmental conditions. This is further explained in the ECHA R.11 Guidance:
According to Castro-Jiménez and de Meent (2011), light absorption in natural water is significantly slower than measured in laboratory water with photo degradation occurring around 30 times more slowly for typical fresh water, 400 times more slowly for typical coastal sea water, and 500 times more slowly for ocean water. These authors also conclude that the “contribution of photodegradation in water to overall degradation is significant only for substances that reside in water to a considerable extent”. They highlight that many substances reside in sediment and soil, rather than in water.
Moreover, ECHA R.11 Guidance states that, “Appropriate data need to be available to conclude the P/vP-assessment with a conclusion “not P/vP” on all three compartments (or five, with marine compartments): water (marine water), sediment (marine sediment) and soil. […]if a conclusion “P” or “vP” is reached for one compartment, no further testing or assessment of persistence of other environmental compartments is normally necessary.” 
As concluded in the Annex XV dossier, fluoranthene is considered very persistent in soil and sediment and therefore fulfilling criteria for identification as P and vP. 

Response to 3.1.2.1 Biodegradation in water and sediments

Thank you for this information. As already concluded in the annex XV dossier, fluoranthene may biodegrade under aerobic conditions in water and hence the identification as P and vP is based on very slow degradation in soil and sediment, which is in line with ECHA R.11 Guidance.  Furthermore, soil and sediment are the most affected compartments according to distribution modelling (Fugacity Level III EpiSuite) whatever the direct release route may be. As fluoranthene is highly adsorptive to soil/sediment, risks for organisms residing in these compartments cannot be excluded.

Regarding Birch et al., 2018, activated sludge filtrate used in this study could be considered as pre-adapted to hydrocarbons (some hydrocarbons were present at or above 10% of the test concentration). Results are always dependent on the character of the inoculum. So the variation observed is highly related to the test conditions. Therefore the BE CA considers this study as of limited suitability for assessing persistence.

Furthermore, in the poster of Hammershøj et al (2017) early results show that increasing number of concentrations of mixture constituents and increasing constituent concentration did not change markedly the biodegradation kinetics for hydrocarbons.  However, the tested hydrocarbons are not PAHs and, thus, read-across is not considered acceptable. 

In the article by Brakstad et al. (2015), biodegradation of dispersed oil droplets at low temperature was examined using pre-adapted seawater. The method used is however not suitable to evaluate P in a PBT/vPvB assessment for pristine environments (ECHA R.11 Guidance).
It is also not clear which inoculate of sea water has been used by Brackstad et al. (2018a and b), Loftus et al. (2018), Ribicic et al. (2018). As the origin of the samples is close to a harbor area they can be considered as pre-adapted. Half-lives are expressed relative to internal markers. These internal markers are not selected based on their similarity in physical and chemical properties (and thus cannot be expected to behave similarly: evaporation, solubility, etc.). The use of a dispersant is not an environmental relevant condition. 
Specific bacterial strain cited cannot be used in regulatory assessment. They are part of bioaugmentation process, and are considered as adapted bacteria.
 
Regarding the use of BioHCWin v1.01 , BE CA would like to stress that relevant and reliable studies have prevalence on QSAR estimations. 

Smith et al. (2012) studied biodegradation kinetics of phenanthrene and fluoranthene by the bacterium Sphingomonas paucimobilis EPA505 using a dynamic passive dosing technique. Similar mineralization fluxes were observed for both substances, which increased by two orders of magnitude with increasing dissolved concentrations.

At present fluoranthene has not been tested in a sediment simulation study (OECD 308). However, during the public consultation of phenanthrene, a summary of such a study was submitted, in which the degradation of phenanthrene was studied (Meisterjahn et al. 2018). When converted to 12°C, the half-lives observed were higher than the vP criterion. Considering that the biodegradation rates decrease with increasing number of aromatic rings and the half-lives of PAHs in estuarine sediment are proportionally related to the octanol-water partition coefficient (Kow) (Durant et al. (1995) cited in the Annex XV transitional dossier for CTPHT (The Netherlands, 2008)), it can be assumed that fluoranthene will also meet the P and vP criterion in sediment.  

Response to 3.1.2.2 Biodegradation in soil

Thank you for your comments. 
BE CA agrees completely with the observation that bioavailability of the substance to microorganisms constitutes a crucial factor in biodegradation. On the other hand one must keep in mind that the main criterion to decide on the persistence character of a substance in soil/sediment is the half-life in relevant conditions (field conditions if possible). Lack of bioavailability may be the reason why the substance meets the (v)P criterion but this does not deny  that the substance is (v)P. 

The Harmsen and Rietra (2018) reference, provided during the public consultation, performed a long-term study on soil and sediment focusing on biodegradation of PAHs and total petroleum hydrocarbons (TPH), which has been monitored on seven experimental fields during periods up to 25 years. The study took place on experimental fields at Kreekraksluizen, situated in the Netherlands. Landfarms were initiated on a semi-field scale in 1990. About 50 cm of dredged sediment was applied and the layer thickness of the dewatered sediments was about 30 cm. The sediments were intensively treated to stimulate biodegradation during the first years. Treatments used were cultivation, no cultivation, adding wood chips and adding sludge from a sewage system adapted to PAHs. In 1993, the sediment from the different experimental fields were combined into two new experimental fields containing sediments that originated from two harbors in a thicker layer. These sediments were further treated in a passive way (passive landfarming), only allowing vegetation to grow to create aerobic conditions and were followed for 20 years. The bioavailable fraction was measured using Tenax extraction. The study detailed the remaining concentration of every PAH measured and also of fluoranthene after 7.2 years and 22 years. The initial concentration of fluoranthene was 132 mg/kg, after 7.2 years, the remaining amount was estimated being 3.3 mg/kg and after 22 years, estimated of being 1.5 mg/kg. In other sediment from a harbour in Wemeldinge an initial concentration of fluoranthene of 15 mg/kg was estimated, after 7.2 years it remained 6.5 mg/kg and after 22 years 2.4 mg/kg. It is observed that degradation of fluoranthene may depend on the initial concentration. These data also reflected that fluoranthene can remain for a long period of time in the environment. It is observed that the degradation rate of fluoranthene may depend on the initial concentration and that a certain fraction can remain for a long period of time in the environment (Harmsen and Rietra, 2018).   

Additionally, the difference between pyrogenic and petrogenic origin is highlighted in your comments, however BE CA believes that this is not related to intrinsic properties of PAHs but rather to the ad hoc circumstances of specific tests/studies.
You underlined that bioavailability is not explicitly addressed in the framework of persistency assessment, which BE CA agrees upon. However, we consider this as not directly relevant. Intrinsic properties cannot be separated from „extrinsic conditions“.
Regarding the weight-of-evidence approach, the BE CA is of the opinion that all reliable information has to be taken into consideration. Thus, although field studies depend on local conditions, they can have high merits because of high relevance. 
It should also be underlined that there is a clear distinction between risk assessment and PBT assessment. 
Regarding the information provided in the studies by Wild and Jones (1993) and Wild et al. (1991), BE CA would like to point out that the MSC has already considered their use in the PBT assessment of CTPHT as SVHC (2009), and hence also for fluoranthene. In conclusion, the data used in the Annex XV dossier for identification of fluoranthene as SVHC, demonstrate that fluoranthene is P and vP also in soil. 

Response to 3.3 Bioaccumulation
Thank you for your comments.  The Support document has been amended with relevant and reliable data. 
BE CA would like to point out that the MSC has already identified fluoranthene as PBT and vPvB substance amongst seven of the 12 PAH-constituents present in CTPHT in concentrations equal to or above 0.1% (ECHA, 2009).
In principle all trophic levels in the food web should be considered. If there is a concern for a specific trophic level, then that is enough reason to identify the substance as meeting the B criterion. Moreover, according to the ECHA R.11 Guidance, a substance can be considered as B or vB if results from a bioconcentration or bioaccumulation study in aquatic species allow to conclude on the B/vB property. 
BE CA also points out that the BCF-value is not a screening criterion but a definitive criterion, and that the log Kow is a screening criterion for B/vB.

You however disagree with the approach taken to conclude on the B and vB properties of fluoranthene. 

BE CA proposed to identify fluoranthene as B and vB substance based on the BCF value of 9054 L/kg for fish (Weinstein and Oris (1999)), however according to the report by Bleeker and Verbruggen (2009) the reliability of this study is downgraded to 4 (not assignable). Nevertheless, other study in fish with reliability 2 (as assessed by Bleeker and Verbruggen (2009)) delivered a lipid normalized BCF of 2772 in P. promelas (De Maagd, 1996), what fulfils the B criterion. 
Moreover, following the ECHA R.11 Guidance version 3.0 of June 2017 (page 69): Also use of other taxonomic groups than fish (e.g. mussel bioconcentration test, ASTM, 2003) is possible for measuring bioconcentration in the aquatic environment and the valid BCFs determined in other taxonomic groups can be used in assessing whether or not the B/vB criteria are met. Therefore it is completely valid to use the most reliable data with invertebrate to conclude in the B/vB properties of fluoranthene. Hence, this substance fulfil B/vB criterion due to BCF of 5920 L/kg in M. edulis (reliability 1).
 
BE CA points out that the ECHA R.11 guidance also indicates that trophic magnification factors (TMFs) can provide supplementary information indicating that the substance does or does not have bioaccumulation potential. On the other hand TMF > 1 from Wang et al. (2012) supports the decision on B criterion. 
 TMF and BMF-values provide an indication whether concentrations increase or decrease within the various members of a foodweb but they are only a relative indicator. The decisive elements that cause adverse effects and the hazard are the absolute concentrations in the various organisms and that is mainly determined by the bioconcentration potential of the substance. It has to be taken into account that if the organisms at the lower trophic level(s) experience substantial bioconcentration (what is certainly the case for mussels) the exposure via food for the higher organisms is also inevitably high. So, it is reasonable to foresee that rather high concentrations will build up that can easily cause adverse effects not only in the lower organisms but also in the higher ones. Unless substantial bioelution is observed, then the risk induced by the substance can propagate through the whole food web.
In your comments you refer to 5 studies that examine TMF-values from various locations. The presented TMF-values range from 0.11 to 1.2 gfood/gbw with an average value of 0.58 gfood/gbw. This average value is lower than 1 but it also indicates that the higher organisms metabolize the substance hardly better than the lower ones. Taking into account that the vB-criterion (BCF > 5000 L/kgbw) is clearly met for mussels and that the concern is hardly mitigated for higher organisms, BE CA is still of the opinion that fluoranthene should be identified as very bioaccumualtive.
Further, there is the principal observation that the fact that the (v)B-criterion is met for an organism in one trophic level forms already a sufficient basis for the identification as (very) bioaccumulative because all organisms should be protected irrespective of their position in the food web.

Regarding results from radiolabeled studies, the BE CA underlines that already Bleeker and Verbruggen (2009) in their report considered this issue and consequently indicated studies with downgraded reliability. This is because of the use of total radioactivity in the studies, which deems it impossible to distinguish between the concentration of the parent compound and that of its transformation products. Thus the BE CA does no longer consider these studies relevant for identification as B/vB. 

Response to 5. Environmental hazard assessment:

Thank you for your comment. 
As indicated in the annex XV dossier, the lowest chronic no effect concentration for fluoranthene was determined for Mysidopsis bahia with an NOEC reproduction value of 0.6 µg/L (Spehar et al, 1999), which was also revised by Verbruggen (2012). Therefore, fluoranthene fulfils the T criterion according to Annex XIII 1.1.3 a) of REACH.

Response to B. Conclusions on the SVHC properties:

In your comments you disagree with the fulfilment of either P/vP or B/vB criteria. However, BE CA would like to underline that based on still valid information which also was provided in the SVHC dossier for CTPTH (2009), the Member State Committee has already concluded on the PBT and vPvB properties of fluoranthene.

		See the corresponding embedded attachment in table 1 of Part I: 5254_FA.zip		
5264
2018/10/30	Finland,
Member State	As an addition to the FI CA comments submitted before, please find below summaries of benzo[k]fluoranthene, fluoranthene, phenanthrene, and pyrene concentrations in biota as determined in field studies.

Benzo[k]fluoranthene:
Benzo[k]fluoranthene has been determined in 22 pike samples (white muscle) from Finnish lakes and rivers, and coastal areas of Baltic sea, in 2003-2004 (Finnish Environment Institute 2018). Benzo[k]fluoranthene concentration was above limit of determination in 13 samples (0.01-0.03 µg/kg). For the other 11 samples, Benzo[k]fluoranthene concentration was below limit of determination of 10 µg/kg.
Benzo[k]fluoranthene has been determined in 50 mussel samples (blue mussel, duck mussel, painter’s mussel, and unspecified freshwater mussels (Anodonta)) from Finnish lakes and rivers and coastal areas of Baltic sea, in 2016-2017 (Finnish Environment Institute 2018). Benzo[k]fluoranthene concentration was above the limit of determination in four blue mussel samples (1.1-4.4 µg/kg). For the other 46 samples (blue mussel, duck mussel, painter’s mussel, and unspecified freshwater mussels (Anodonta)), Benzo[k]fluoranthene concentration was below the limit of determination (limits of determination were 1 or 2µg/kg for different sets of samples).
Benzo [b + k + j] fluoranthenes have been detected in caged blue mussels (Mytilus trossolus) 2.9-10.3 ng/g dw outside Finnish (Porvoo and Hanko) and Swedish (Gävle and Sundsvall) towns in the Baltic Sea (Turja et al 2014; Turja et al 2013). In addition, a concentration of 14.3 ng/g dw for  benzo [b + k + j] fluoranthenes was observed in native mussels used for the experiment before caging (Turja et al. 2014). Hanko was the reference site of these studies whereas the other sites were affected by anthropogenic pollution.

There is no data on concentrations of benzo[k]fluoranthene in the water for these studies.
Bioaccumulation factors were not quantified in these studies. However, the results indicate the occurrence of benzo[k]fluoranthene in pike and in mussels. It is noted that high BCFs in mussels have been reported for other PAHs, such as fluoranthene (BCF 4120-5920), pyrene (4430-77000) and benzo[a]pyrene (41000-142000) (ECHA, 2009). Therefore, mussels may be relevant target species for bioaccumulation of Benzo[k]fluoranthene.
References:
ECHA (2009): Support Document for identification of Coal Tar Pitch, High Temperature as
a SVHC because of its PBT and CMR properties.
http://echa.europa.eu/documents/10162/73d246d4-8c2a-4150-b656-
c15948bf0e77
Finnish Environment Institute 2018. Open information. Ympäristötiedon hallintajärjestelmä Hertta. Kertymärekisteri (KERTY). Available at https://wwwp2.ymparisto.fi/scripts/kirjaudu.asp (registration required) (in Finnish)

Turja, R., Soirinsuo, A., Budzinski, H., Devier, M. H., Lehtonen, K. K. 2013. Biomarker responses and accumulation of hazardous substances in mussels (Mytilus trossulus) transplanted along a pollution gradient close to an oil terminal in the Gulf of Finland (Baltic Sea). Comparative Biochemistry and Physiology, Part C 157 (2013) 80–92. http://dx.doi.org/10.1016/j.cbpc.2012.09.006
Turja, R., Höher, N., Snoeijs, P., Baršienė, J., Butrimavičienė, L., Kuznetsova, T., Kholodkevich, S. V., Devier, M.-H., Budzinski, H., Lehtonen, K.K. 2014. A multibiomarker approach to the assessment of pollution impacts in two Baltic Sea coastal areas in Sweden using caged mussels (Mytilus trossulus). Science of the Total Environment 473-474, 398-409. https://doi.org/10.1016/j.scitotenv.2013.12.038

Fluoranthene:
Fluoranthene has been determined in 51 mussel samples (blue mussel, duck mussel, painter’s mussel, and unspecified freshwater mussels (Anodonta)) from Finnish lakes and rivers and coastal areas of Baltic sea, in 2016-2017 (Finnish Environment Institute 2018). Fluoranthene concentration was above the limit of determination in 30 mussel samples (1.1-10 µg/kg) (blue mussel, duck mussel, painter’s mussel, and unspecified freshwater mussels (Anodonta)). For the other 21 samples (blue mussel, duck mussel, freshwater mussels (Anodonta)), fluoranthene concentration was below the limit of determination of 1 µg/kg.
Fluoranthene has also been detected in caged blue mussels (Mytilus trossolus) 3.6-23.8 ng/g dw outside Finnish (Porvoo and Hanko) and Swedish (Gävle and Sundsvall) towns in the Baltic Sea (Turja et al 2014; Turja et al 2013). In addition, a fluoranthene concentration of 67.6 ng/g dw was observed in native mussels used for the experiment before caging (Turja et al. 2014). Hanko was the reference site of these studies whereas the other sites were affected by anthropogenic pollution.

There is no data on concentrations of fluoranthene in the water for these studies.
Bioaccumulation factors were not quantified in these studies. However, the results indicate the occurrence of phenanthrene in mussels.
References:
Finnish Environment Institute 2018. Open information. Ympäristötiedon hallintajärjestelmä Hertta. Kertymärekisteri (KERTY). Available at https://wwwp2.ymparisto.fi/scripts/kirjaudu.asp (registration required) (in Finnish)

Turja, R., Soirinsuo, A., Budzinski, H., Devier, M. H., Lehtonen, K. K. 2013. Biomarker responses and accumulation of hazardous substances in mussels (Mytilus trossulus) transplanted along a pollution gradient close to an oil terminal in the Gulf of Finland (Baltic Sea). Comparative Biochemistry and Physiology, Part C 157 (2013) 80–92. http://dx.doi.org/10.1016/j.cbpc.2012.09.006
Turja, R., Höher, N., Snoeijs, P., Baršienė, J., Butrimavičienė, L., Kuznetsova, T., Kholodkevich, S. V., Devier, M.-H., Budzinski, H., Lehtonen, K.K. 2014. A multibiomarker approach to the assessment of pollution impacts in two Baltic Sea coastal areas in Sweden using caged mussels (Mytilus trossulus). Science of the Total Environment 473-474, 398-409. https://doi.org/10.1016/j.scitotenv.2013.12.038

Phenanthrene:
Phenanthrene has been determined in 22 pike samples (white muscle) from Finnish lakes and rivers, and coastal areas of Baltic sea, in 2003-2004 (Finnish Environment Institute 2018). Benzo[k]fluoranthene concentration was above the limit of determination in 9 samples (0.18-0.82 µg/kg). For the other 13 samples, Benzo[k]fluoranthene concentration was below the limit of determination (limits of deteramination were 0.01 or 20 µg/kg for different sets of samples).
Phenanthrene has been determined in 51 mussel samples (blue mussel, duck mussel, painter’s mussel, and unspecified freshwater mussels (Anodonta)) from Finnish lakes and rivers and coastal areas of Baltic sea, in 2016-2017 (Finnish Environment Institute 2018). Phenanthrene concentration was above the limit of determination in 28 mussel samples (blue mussel, duck mussel, painter’s mussel, and unspecified freshwater mussels (Anodonta)) (1-3.7 µg/kg). For the other 23 samples (blue mussel, duck mussel, and unspecified freshwater mussels (Anodonta)), phenanthrene concentration was below the limit of determination of 0.01 µg/kg.
Phenanthrene has also been detected in caged blue mussels (Mytilus trossolus) 12.8-72.3 ng/g dw outside Finnish (Porvoo and Hanko) and Swedish (Gävle and Sundsvall) towns in the Baltic Sea (Turja et al 2014; Turja et al 2013). In addition, a phenanthrene concentration of 334.0 ng/g dw) was observed in native mussels used for the experiment before caging (Turja et al. 2014). Hanko was the reference site of these studies whereas the other sites were affected by anthropogenic pollution.

There is no data on concentrations of phenanthrene in the water for these studies.
Bioaccumulation factors were not quantified in these studies. However, the results indicate the occurrence of phenanthrene in pike and in mussels.

References:

Finnish Environment Institute 2018. Open information. Ympäristötiedon hallintajärjestelmä Hertta. Kertymärekisteri (KERTY). Available at https://wwwp2.ymparisto.fi/scripts/kirjaudu.asp (registration required) (in Finnish)

Turja, R., Soirinsuo, A., Budzinski, H., Devier, M. H., Lehtonen, K. K. 2013. Biomarker responses and accumulation of hazardous substances in mussels (Mytilus trossulus) transplanted along a pollution gradient close to an oil terminal in the Gulf of Finland (Baltic Sea). Comparative Biochemistry and Physiology, Part C 157 (2013) 80–92. http://dx.doi.org/10.1016/j.cbpc.2012.09.006
Turja, R., Höher, N., Snoeijs, P., Baršienė, J., Butrimavičienė, L., Kuznetsova, T., Kholodkevich, S. V., Devier, M.-H., Budzinski, H., Lehtonen, K.K. 2014. A multibiomarker approach to the assessment of pollution impacts in two Baltic Sea coastal areas in Sweden using caged mussels (Mytilus trossulus). Science of the Total Environment 473-474, 398-409. https://doi.org/10.1016/j.scitotenv.2013.12.038

Pyrene:
Phenanthrene has been determined in 51 mussel samples (blue mussel, duck mussel, painter’s mussel, and unspecified freshwater mussels (Anodonta)) from Finnish lakes and rivers and coastal areas of Baltic sea, in 2016-2017 (Finnish Environment Institute 2018). Phenanthrene concentration was above the limit of determination in 24 mussel samples (blue mussel, duck mussel, painter’s mussel) (1.1-11 µg/kg). For the other 27 samples (blue mussel, duck mussel, freshwater mussels (Anodonta), phenanthrene concentration was below the limit of determination of 0.01 µg/kg.
Pyrene has also been detected in caged blue mussels (Mytilus trossolus) 3.6-44.4 ng/g dw outside Finnish (Porvoo and Hanko) and Swedish (Gävle and Sundsvall) towns in the Baltic Sea (Turja et al 2014; Turja et al 2013). In addition, a pyrene concentration of 129.9 ng/g dw was observed in native mussels used for the experiment before caging (Turja et al. 2014). Hanko was the reference site of these studies whereas the other sites were affected by anthropogenic pollution.

There is no data on concentrations of pyrene in the water for these studies.
Bioaccumulation factors were not quantified in these studies. However, the results indicate the occurrence of pyrene in mussels.
References:
Finnish Environment Institute 2018. Open information. Ympäristötiedon hallintajärjestelmä Hertta. Kertymärekisteri (KERTY). Available at https://wwwp2.ymparisto.fi/scripts/kirjaudu.asp (registration required) (in Finnish)

Turja, R., Soirinsuo, A., Budzinski, H., Devier, M. H., Lehtonen, K. K. 2013. Biomarker responses and accumulation of hazardous substances in mussels (Mytilus trossulus) transplanted along a pollution gradient close to an oil terminal in the Gulf of Finland (Baltic Sea). Comparative Biochemistry and Physiology, Part C 157 (2013) 80–92. http://dx.doi.org/10.1016/j.cbpc.2012.09.006
Turja, R., Höher, N., Snoeijs, P., Baršienė, J., Butrimavičienė, L., Kuznetsova, T., Kholodkevich, S. V., Devier, M.-H., Budzinski, H., Lehtonen, K.K. 2014. A multibiomarker approach to the assessment of pollution impacts in two Baltic Sea coastal areas in Sweden using caged mussels (Mytilus trossulus). Science of the Total Environment 473-474, 398-409. https://doi.org/10.1016/j.scitotenv.2013.12.038	Thank you for providing us with this information. After careful consideration, it has been decided not to be included to the support document, as the existing weight-of-evidence argumentation on the conclusion of the substance as vB was deemed enough.	

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	
5202
2018/10/17	Euroalliages,
Industry or trade association,
Belgium	See our position paper also submitted for Benzo[k]fluoranthene	Please refer to our response to your comment under PART I (General comments)	
		See the corresponding embedded attachment in table 1 of Part I: 5202_Position paper candidates listing of PAHs October 2018.pdf		
5235
2018/10/19	Finland,
Member State	Page 29: “Fluoranthene is not produced as such, but it may occur together with other PAHs as constituent in UVCB substances that are derived from coal or in several petroleum streams. Among the PAHs benzo[a]pyrene (B[a]P, EC number: 200-028-5), anthracene (EC number: 204-371-1), chrysene (EC number: 205-923-4) and benz[a]anthracene (EC number 200-280-6) are already included into the Candidate List due to PBT and vPvB properties”.

Comment: Please note that in addition to the listed PAHs, also Benzo[ghi]perylene (B[ghi]P, EC Number: 205-883-8) has been included in the Candidate List due to PBT and vPvB properties.	Thank you for your comment. 
The corresponding text in the Support document has been changed accordingly.	
5254
2018/10/19	Concawe,
Industry or trade association,
Belgium	7. REGISTRATION AND C&L NOTIFICATION STATUS
As there is no registration dossier for fluoranthene, Concawe queries the relevance of this part of the dossier, because there is no REACH data source available (a registration dossier).  In that respect, it has to be clearly stated that fluoranthene 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 fluoranthene, Concawe considers part II obsolete.  Moreover, in the analytical database in Concawe comprising of 295 samples, 75 samples with Fluoranthene levels above 1 ppm and a total of 83 samples where fluoranthene was not detected or quantitated are present.
Notwithstanding this opinion, Concawe will comment on some of the content of this part.
As fluoranthene is not produced as such the Rapporteur has to alter the text in Chapter 8, as fluoranthene is only present is minor amounts in petroleum substances.  Furthermore, fluoranthene is not used in a broad range of uses, but the substances that might contain fluoranthene in minor amounts.  In addition, Concawe, after consulting its Membership, no longer supports the use of petroleum substances with high PAH contents for road construction.  During the latest dossier update, this professional use is no longer supported.  Therefore, this should be removed from this report.
Regarding the sources of fluoranthene, Concawe observes that the focus of the Rapporteur is reduced to a selective number of anthropogenic sources that may introduce fluoranthene into the environment or lead to human exposures, without highlighting that residential wood burning being the major source for fluoranthene observed in the atmosphere (Soehl & Wu, 2012; Jaarrapport, 2018).  Also smoking, barbequing and the overcooking of meat are considerable human exposure sources that are not mentioned.  Concawe would have expected that the Rapporteur should have referenced their own national findings on this, as well as, asked the other Member States on similar data and source reports.
As discussed in Part I, The source will heavily influence the environmental fate, behaviour and bioavailability of a PAH: PAHs are generally categorized as either of pyrogenic or petrogenic origin. Pyrogenic PAHs are formed rapidly during incomplete combustion of organic material: forest or grass fires, volcanic eruptions, combustion engine exhausts, residential wood burning, coal-fired power plant emissions, coke-oven emissions, and coal-tar from legacy manufactured gas plants and pavement sealants (Baldwin et al., 2017). Pyrogenic PAHs associated with soot carbon formed during the incomplete combustion process are far less available for bio- or photodegradation and are thus much more prevalent in the environment than petrogenic PAHs (Burgess et al., 2003, Butler and Crossley, 1981; Korfmacher et al., 1980; Yokley et al., 1986).
Petrogenic PAHs are formed naturally from biomass at low temperatures (100-150°C) over long geologic time scales and are released from natural oil seeps or unintentionally from unprocessed coal, crude oil or refined petroleum products (petroleum fuels, lubricants, asphalt). Petrogenic PAHs are released into the environment in complex mixtures of aliphatic and aromatic hydrocarbons and are associated with a local or point source, such as refineries and petroleum industries, offshore and onshore oil and gas drilling, and adjacent to roads and navigational routes. In contrast, pyrogenic PAHs occur on broader geographical scales (Burgess et al. 2003). In contrast to soot associated pyrogenic PAHs, released petrogenic PAHs are generally available for abiotic and biotic degradation and partitioning processes, as supported by the data presented in Part I. Atmospheric vapor phase PAHs are expected to be rapidly removed in the atmosphere by photochemical oxidation. Petrogenic PAHs reaching the aquatic environment (either by wet deposition or direct influx) will be exposed to photochemical oxidation, biodegradation, (re)volatization and sedimentation. In the sediment, dissolution and further biodegradation can occur in especially the oxic upper layers. In contrast, particle associated pyrogenic PAHs are far less available to degradation or partitioning process and tend to end up in the sediment, where their potential for dissolution or biodegradation is limited. This, along with the relative contributions from these sources, explains why pyrogenic PAHs tend to dominate in the aquatic environment and that petrogenic PAHs do not occur in the sedimentary record to the same extent (Burgess et al., 2003).
Therefore, Concawe questions if applying measures on substances that contain fluoranthene in minor quantities will be an effective way of mitigating the potential risks associated with this.
On page 28 the Rapporteur mentions that “fluoranthene is not produced, as such and is not registered within the scope of the REACH Regulation. However, it may occur as a constituent in UVCB-substances that are derived from coal or in several petroleum streams. There is a broad range of different uses, e.g. production of other chemicals and rubber, uses in road construction and as lubricants”.  Concawe is of the opinion that this statement is not entirely correct and should, as a minimum, be accompanied by a reference that allows the reader to verify and comment on the screening of the Rapporteur.
Moreover, the presence of fluoranthene in any petroleum stream is due to its presence in crude oil, the processes that deliver these UVCB substances and the physical-chemical properties of Fluoranthene Therefore, fluoranthene is only observed in a limited number of petroleum UVCBs.  The Concawe analytical database, comprising of 295 individual PS-samples, has no analytical result for any substance with a fluoranthene content above the classification threshold of 1000 ppm. Where REACH restrictions are concerned, Restriction #50 covers fluoranthene in extender oils.  However, from the aforementioned database, it is observed that in 220 samples fluoranthene was not detected or was quantified to be below 1 ppm.
With respect to the information on the use of substances that might contain fluoranthene, Concawe is surprised to read the statement that “numerous UVCB substances that contain Fluoranthene”.  As far as Concawe is aware, from the 198 registered petroleum substances, there are only 92 substances that have demonstrable levels of fluoranthene, as determined by analysis.  Of these, 42 contain less than 1 ppm fluoranthene and the highest analytical amount reported is 525 ppm which is below the C&L-threshold of 1000 ppm.

11. ADDITIONAL INFORMATION
11.2 Alternatives
Concawe has a severe objection to the statement in chapter 11.2 on page 29, namely: “articles derived from coal or mineral oil (see for example use of low aromatic oils in tyres, (KEMI, 2003)).”  Concawe is not aware of any article that are derived from petroleum, directly.  The example provide concerns the use of a petroleum substance during the manufacture of rubber tyres, as the tyres themselves are made from rubber that is either a natural product or synthesised from isoprene, butadiene or a combination of these.
This is incorrect for Petroleum Substances as the amount of FLA 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 PHE 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 section 11.2, the extender oil in tire manufacture, is a good example of this, as the PAH reduction is not 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.
Concawe remains of the opinion that the report would gain considerable value when the current conclusions are compared and placed into the correct context with the total fluoranthene emissions and the major sources of fluoranthene intake by humans like smoking, char-coal barbeques, eating of burned or barbequed meat, residential wood burning, ill-functioning stoves and open fire places, etc.
Finally, Concawe would like to point out that the refining sector is consistently monitoring and attempting to reduce its PAH emissions, including fluoranthene emission, to both air and water. For example, the Concawe 2010 effluent survey revealed that the total amount of fluoranthene measured in refinery effluents for all over 100 European refineries that process crude oils is less than 30 kg/annum on a total amount of PAH discharges of 180 kg/annum.  This is a gross overestimation, as for the purpose of this analysis, not detected concentrations are included as ½ LoQ (Limit of Quantitation).
The rationale for sampling refinery effluents for fluoranthene is found in the fact that it is a WFD priority substance.	Thank you for your comment and for the information provided. However, BE CA would like to point out that any comments regarding use, exposure, alternatives and risk may, when relevant, be considered at later stages of the risk management process.	
		See the corresponding embedded attachment in table 1 of Part I: 5254_FA.zip