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

Substance name: Pyrene
CAS number: 129-00-0
EC number: 204-927-3

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	
5204
2018/10/17	Euroalliages,
Industry or trade association,
Belgium	See our position paper also submitted for Benzo[k]fluoranthene	Thank you for your comments. 
We take note of this comment although it is not directly relevant for SVHC identification that is based on the intrinsic properties of the substance. In particular, the rationale provided to question the legal basis of the SVHC identification refers exclusively to authorisation and is therefore not relevant for SVHC identification. A distinct Annex XV dossier has been submitted to present the basis of the proposed SVHC identification for each of the PAHs in discussion. There is therefore no source of legal uncertainty.
	
		Attachment: 5204_Position paper candidates listing of PAHs October 2018.pdf
		
5256
2018/10/19	Concawe,
Industry or trade association,
Belgium	-	Thank you for your comments.

Please see our response under comment 5256 in the next table (Specific comments).	
		Attachment: 5256_PYR.zip

Specific comments on the justification
Number / Date	Submitted by (name, submitter type, country)	Comment	Responses	
5191
2018/10/11	Germany,
Member State	The German MSCA supports the identification of pyrene as a PBT and vPvB substance according to Article 57 (d) and (e) of REACH.	Thank you for your support	
5196
2018/10/16	Belgium,
Member State	The Competent Authority of Belgium would like to thank the FR CA for submitting this Annex XV dossier. We recognize that the dossier submitter proposes to identify pyrene as persistent, bioaccumulative and toxic (PBT) according to Article 57 (d) and as very persistent and very bioaccumulative (vPvB) according to article 57 (e) of the REACH Regulation.
BE CA agrees with FR CA that an assessment of the PBT and vPvB properties of pyrene has already been carried out by the MSC in the context of the identification of CTPHT as SVHC, as documented in the MSC Support Document for identification of CTPHT as SVHC (ECHA, 2009), and that this information is still valid and allows a compact assessment of the substance properties with a focus on PBT and vPvB. Therefore, BE CA supports the identification of pyrene as both persistent, bioaccumulative and toxic (PBT) according to Article 57 (d) and very persistent and very bioaccumulative (vPvB) according to Article 57 (e) of the REACH Regulation.	Thank you for your support	
5199
2018/10/16	Finland,
Member State	The Finnish CA supports the identification of Pyrene 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, Pyrene 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:

3.1.2.4 Summary and discussion on biodegradation
“However, it was observed, that PAHs containing up to four aromatic rings are biodegradable under aerobic conditions.”
Comment: As no reference is given this can be misunderstood to refer to the preceding sentence (the Mackay et al. 1992 results). Please give more details (based on information on page 11) or remove the sentence if not necessary for the summary.

“These results confirm that the biodegradation of pyrene in soils is very low.”
Comment: Please change “confirm” to “indicate”. This is suggested because these are the only results available for the soil compartment.

6.2
“Furthermore, additional relevant data retrieved from a literature search until June 2018 were incorporated as support information to the conclusion already established in the support document for the identification of CTPHT as SVHC (ECHA, 2009).”.
Comment: Please modify as: “Furthermore, additional relevant data retrieved from a literature search until June 2018 were incorporated.”. This is suggested as it is not known in advance (before gathering and evaluating the data) whether the new data would support the conclusion already established (in the SVHC identification of CTPHT) or whether they would challenge it. In addition, the sentence could be misunderstood regarding on what basis the new data were searched and selected for the report. The role of the new information is already described e.g. in the Foreword section as well as under 6.2.1.2 and 6.2.1.3. For example, in the Foreword it is mentioned “…and supplemented with information from newer studies that are presented as further evidence as they do not trigger a need to modify the conclusions taken by authorities earlier on.”

“They all confirm the information leading to the identification of pyrene as SVHC.”
Comment: Please delete or modify the sentence because some of the new data (at least Bustamante et al., 2012) do not indicate that PBT criteria are fulfilled. The role of the new data is sufficiently described in the Foreword section as well as under 6.2.1.1, 6.2.1.2 and 6.2.1.3.

6.2.1.2
“Considering that the BCF values measured are above the B and vB criteria according to
REACH Annex XIII, it is concluded that pyrene is a bioaccumulative and very
bioaccumulative substance.”
Comment: Please modify the sentence (e.g. “Considering that all reliable BCF values measured are above the B and vB criteria…” because some of the new data (at least Bustamante et al., 2012) do not indicate fulfilment of criteria.	Thank you for your support, your remarks were considered in the support document.

Response to 3.1.2.4 Summary and discussion on biodegradation

The sentence has been removed.

The word “confirm” has been changed to “indicate”.

Response to 6.2 PBT and vPvB assessment.

The sentence has been modified to “Furthermore, additional relevant data retrieved from a literature search until June 2018 were incorporated”

The sentence “They all confirm the information leading to the identification of pyrene as SVHC“ has been removed.   

Response to 6.2.1.2      
The phase has been modified according your suggestion.	
5204
2018/10/17	Euroalliages,
Industry or trade association,
Belgium	See our position paper also submitted for Benzo[k]fluoranthene	No comment in this position paper relates to the justification of the proposed SVHC identification. Responses to general comments are provided in the corresponding table above.	
		See the corresponding embedded attachment in table 1 of Part I: 5204_Position paper candidates listing of PAHs October 2018.pdf		
5214
2018/10/19	Cefic "Coal Chemicals Europe",
Industry or trade association,
Belgium	General statement on PBT assessment
Industry notes that the conclusion on PBT/vPvB classification of PAHs in 2009 was part of the UVCB substance evaluation CTPHT. It was an agenda undisclosed to the public, thus not following the classification procedures. No Annex XV dossier was presented for pyrene in 2009. Therefore, the vPvB classification of pyrene claimed in 2009 is null and void. The 2009 conclusion needs a thorough reconsideration and is not solely a formal confirmation process now restarted with the Annex XV dossier prepared by the French Competent Authority.

Registration dossiers
p.7 confirms the existence of registration dossiers. On the contrary p.9 declares that pyrene is not intentionally produced. Same applies to p.27 and p.29.

Bioaccumulation
In the Foreword (p.5) and the Summary (p.6), the authors emphasise that the assessment of the PBT and vPvB properties in the present dossier and the conclusion that pyrene fulfils the criteria in Article 57 (d+e) were based mainly on the information in the MSC Support Document on CTPHT (ECHA, 2009) and supplemented with information from newer studies and that this information was considered together in a weight-of-evidence approach.

CCE notes that for BIOACCUMULATION…
1. on the contrary, new information was not adequately taken into account (information which in reality was not brand-new). This in particular concerns the outcome of the re-assessment by Bleeker and Verbruggen (RIVM 2009). Although the Annex XV dossier refers to this comprehensive analysis, it is obvious that this re-assessment was ignored, since it would have led to a different conclusion. => oui en effect, mais ça ne change pas la conclusion general que la substance es VB en se basant sur les invertebres. 
2. the dossier claims to follow a “Weight-of-Evidence” approach; however, the impression prevails that information deviating from the envisaged outcome is simply ignored. The rules laid down in the Guidance Chapter R.11, version 3.0 of June 2017 clearly state the primary role of fish data in BCF determination for PBT assessment (page 69 – 80), while results from invertebrates are taken as secondary sources and clearly play a subordinate role.
In this dossier results from invertebrates were given preference over valid fish data.
3. the well-founded classification proposal of Bleeker and Verbruggen (2009) says that pyrene does not fulfil the B- and vB criteria.

CCE does not see any scientific justification for the B- and vB- classification in view of valid BCF data in fish.

In the summary part on p.6, Bioaccumulation, the conclusion vB has been based only on invertebrate studies, although two valid (RL 1 and 2) and several further studies (RL3 and 4) in higher trophic fish are available (see below).

The relevant two fish tests are referred to in the Annex-XV dossier: Carlson et al. 1979 (newly introduced here, but not included in the MSC Support document of CTPht of 2009), and Jonsson et al. 2004. These had been re-evaluated in a comprehensive re-assessment by Bleeker and Verbruggen (2009): The BCF range of these studies was far below 2000 (range 97 – 1297), after lipid normalisation the upper limit was 1474), hence indicating “non-B”.

CCE notes that this demonstrates that the Annex XV dossier does not reflect recognised principles for B assessment within the scope of PBT assessment.

3.3.1, 3rd § (p.15):
For the study by Jonsson et al. (2004), the level of reliability should be provided in the text: Reliability 1 was assigned by ECHA (2009) and Bleeker and Verbruggen (2009).

3.3.1, §§4-6 (p.15):
The studies of de Voogt et al. (1991) had been downgraded by Bleeker and Verbruggen (2009) to Reliability 3 and 4, respectively. Therefore §6 referring to the second key study, Carlson et al. 1979, should be shifted upwards and be placed behind §3 (Jonsson et al. 2004). Thus, the relevance of data is reflected in the hierarchy of their presentation.

Additionally, Bleeker and Verbruggen (2009) refer to a field study published by Takeuchi et al. (2009) as supporting evidence: the results indicated that pyrene was not highly accumulating (BAF: 1010) in Acanthogobius flavimanus (yellowfin goby, endemic Asian fish in river and sea), supporting the non-bioaccumulative behaviour of pyrene in fish (mentioned in Section 3.3.3 Field data), rated with Reliability 2 (ditto, p. 14/15). This report should also be presented in this section 3.3.1 as part of WoE, rather than only mentioning it under 3.3.3 (Field                    studies). 
Remarkable to note that in the Support Document on CTPht (ECHA 2009) the fish study of de Voogt et al. (1991) had been adopted as relevant key study for classifying pyrene as vB. But after re-assessment by Bleeker and Verbruggen (2009), de Voogt´s results are no longer available for this purpose. Now, in this Annex XV dossier, the eMS´s “Weight of Evidence” approach made a flexible turn-around by simply exploiting the invertebrate data for retaining pyrene in the category vB.

3.3.1, p.15-17, invertebrate part:
With the intent to unfold ample evidence for vB, alone two pages of the invertebrate part have been filled with non-selective information often without a clear rating of validity.
In light of the fact that there are valid fish studies, this flood of invertebrate studies is not helpful and undermines a proper WoE process.

For the same reason of completeness, the full set of fish reports could have been included: as a matter of fact, Bleeker and Verbruggen (2009) analysed in total 16 reports covering some 12 fish species exposed to pyrene. Only two were classified Reliability(RL) 1 and 2 (with BCF <2000), a total of 12 citations obtained RL 3 and two RL4. The great majority of all studies produced BCFs distinctly below 2000, six were higher.

3.3.1 , p. 17, 3rd §
Reference “Carrasco-Navarro et al., 2015”: Please, check given exposure concentration mg/L-range is too high, should probably be µg/L.
3.3.1, p. 15-17, invertebrate part:
The high number of BCF values for invertebrates collected in these sections, the majority of which with BCF values greater than 5000, cannot be taken as convincing argument for disqualifying valid fish bioconcentration studies. First, it is well-known that invertebrate species lack capabilities to metabolise PAHs to a great extent, and thus “bioconcentration” can easily be proven by using this killing argument, while a scientific discussion would become futile on this simplistic basis, and secondly, the fish on the higher trophic level is acknowledged to be the representative species for estimating bioaccumulating/bioconcentrating potential in the aquatic environment and has to be given preference over invertebrate data in PBT assessment (again ECHA guidance Chapter R.11).
This clear principle is turned to the opposite in the conclusion giving a high preference to invertebrates  (see 6.2.1.2 Assessment of PBT).

CCE fully supports the conclusion of Bleeker and Verbruggen (2009) that - based on weight of evidence - the BCF values derived from fish support the qualification “non-bioaccumulative” rather than “very bioaccumulative(vB)” for the purpose of PBT-classification.

3.3.3, 1st phrase, p.18

The study of Takeuchi et al. (2009) is missing in the reference list. Please, add:

Reference:
Takeuchi I, Miyoshi N, Mizukawa K, Takada H, Ikemoto T, Omori K and Tsuchiya K, 2009. Biomagnification profiles of polycyclic aromatic hydrocarbons, alkylphenols and polychlorinated biphenyls in Tokyo Bay elucidated by δ13C and δ15N isotope ratios as guides to trophic web structure.
Mar. Pollut. Bull. 58: 663-671.	Thank you for providing your comments.

Specific comments are addressed below.

Response to “General statement on PBT assessment”

The agreement of the MSC on the identification of CTPHT as SVHC (ECHA, 2009) adopted on 2 December 2009 concludes on page 4 : “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 reflected this fact and added more recent data.

Response to “Registration dossiers”

There is a single registration of pyrene as intermediate. However, pyrene is generally not produced intentionally.  The support document has been amended accordingly.

Response to “Bioaccumulation”

Cefic disagrees with the approach followed to conclude on the B and vB properties of pyrene 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. 
Furthermore, the Guidance Chapter R11 version 3.0 of June 2017 states the following
(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 pyrene.

Bleeker et al. 2009 concluded on the page 27 of their report that pyrene do not accumulate in fish, due to biotransformation but is very boaaccumulative at lower trophic levels (molluscs and crustaceans)…  
“pyrene, benz[a]anthracene and benzo[a]pyrene do not accumulate in fish (due to biotransformation), but are very bioaccumulative at lower trophic levels (molluscs and crustaceans)”. The study has therefore been adequately considered in the SVHC dossier and its conclusion is therefore consistent with the conclusion that pyrene fulfils vB criteria based on invertebrate data.

Response to 3.3.1, 3rd § (p.15): The reliability score has been added in the supported document

Response to 3.3.1, §§4-6 (p.15): The study of Carlson et al., 1979 has been moved after the study of Jonsson et al., 2004 in the support document.

The studies of Takeuchi et al. (2009) and Voogt et al. (1991) have been appropriately included in the SVHC dossier. It is correct that the evaluation of bioaccumulation in fish has evolved since the CTPHT case and this is reflected in the current pyrene support document. However, as explained above and in conformity with guidance, fish is not considered as the most relevant species to conclude on vB properties of pyrene as other species lack biotransformation capacities. Based on invertebrate data and in agreement with previous CTPHT SVHC dossier on these species, pyrene fulfils vB criteria.

Response to 3.3.1, p.15-17, invertebrate part: 
All the studies showed in the SVHC proposal were selected regarding to their reliability score already determinate by ECHA (2009) and Bleeker and Verbruggen (2009) (1 and 2). The reliability scores were added in the Support document for studies with missing scores.
The document highlighted the most reliable information, it is for these reason that fish studies of reliability of 3 and 4 where not considered in the document. 

Response to 3.3.1, p. 17, 3rd §
The exposure concentration has been corrected.

Response to 3.3.1, p. 15-17, invertebrate part:
Please see previous response at the beginning of the bioaccumulation section on the same argument.

Response to 3.3.3, 1st phrase, p.18
The reference has been added to the list.	
		-		
5216
2018/10/19	Norway,
Member State	The Norwegian CA supports that pyrene should be identified as a substance of very high concern and should be included in the Candidate List.
Pyrene 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. Pyrene meets the criteria for inclusion on the Candidate list as PBT and vPvB in 57d) and 57 e) REACH.	
Thank you for your support	
5222
2018/10/19	EEB,
International NGO,
Belgium	EEB supports the proposal to identify Pyrene as SVHC based on its PBT and vPvB properties. MSC agreed already before on the PBT and vPvB properties of Pyrene in the context of the discussion on Coal Tar Pitch High Temperature containing Pyrene. Results from newer studies confirm the PBT and vPvB properties.	
Thank you for your support	
5229
2018/10/19	Netherlands,
Member State	1. General Comments
NL supports the identification of pyrene as PBT and vPvB, which is based on the results presented in the European Union Risk Assessment Report on CTPHT (European Commission, 2008) performed by NL. The dossier also considered the evaluation of the bioaccumulation of polycyclic aromatic hydrocarbons in aquatic organisms by Bleeker & Verbruggen (2009). However, in the updated assessment from RIVM for PAHs (Verbruggen, 2012) more toxicity data for pyrene 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 and the information provided. The information has been added in the support document.	
5237
2018/10/19	EEB,
International NGO,
Belgium	EEB supports the proposal to identify Pyrene as SVHC based on its PBT and vPvB properties. MSC agreed already before on the PBT and vPvB properties of Pyrene in the context of the discussion on Coal Tar Pitch High Temperature containing Pyrene. Results from newer studies confirm the PBT and vPvB properties.	Thank you for your support	
5244
2018/10/19	CHEM Trust,
National NGO,
United Kingdom	CHEM Trust supports inclusion of Pyrene 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	
5252
2018/10/19	ChemSec,
International NGO,
Sweden	ChemSec welcomes the identification of pyrene as an SVHC, based on it being a constituent of the earlier identified SVHC CTPHT.	Thank you for your support	
5256
2018/10/19	Concawe,
Industry or trade association,
Belgium	Introduction
Concawe welcomes the opportunity to comment on the draft SVHC assessment report on Pyrene, as submitted by the French Competent Authority in September 2018.
As Pyrene 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 PYR is described as “PYR 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 PYR is not produced intentionally is correct. However, it would be better to use the phrase “PYR 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 PYR, which is not correct, especially for lighter petroleum substances.

3. ENVIRONMENTAL FATE PROPERTIES
There are several studies in the peer-reviewed literature that provide data relevant to the persistence assessment of pyrene, 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 15 measurements of pyrene degradation in environmental surface waters are available. Measured half-lives cover a range 0.2 – 151 days. Most measured values are below the P cut-offs for freshwater and marine water of 40 and 60 days, respectively.
Degradation of pyrene in seawater and a rural lake water at low, environmentally relevant, concentrations has been tested (Birch et al, 2018). In these experiments, limited degradation was observed, and DT50 values of >42 and >64 days were reported for the lake water and seawater, respectively. A further study of the degradation of phenanthrene in passive dosed composed mixtures in seawater resulted in a half-life of 151 days (Concawe, 2012). 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) Reference not found. In a similar test using activated sludge filtrate as the inoculum a half-life of 1 day was measured (Birch et al., 2018).
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 pyrene 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).=> Le poster n’apporte pas à la degradation de pyrene: not comments
Degradation of pyrene has been measured in seawater dispersions in rotating carousel systems (Brakstad et al., 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 pyrene was dosed as part of a produced water (PW) from an offshore oil platform (Loftus et al., 2018). Seawater was not pre-adapted to the test substance. 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 15.2 days, with a geometric mean of 4.2 days.
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 283.4 days for pyrene (Howard et al, 2005). This exceeds the aquatic vP cut-offs, but is not in line with the experimental data presented. Recent comparisons of BioHCWin predictions to experimental degradation hal               f-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 of around 50 days have been reported for pyrene in spiked soils (Wild and Jones, 1993; Sigmund et al, 2018). These results contrast 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 I         s 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 pyrene 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 pyrene become available, it is susceptible to degradation 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 WW for determining bioaccumulative (B) and very bioaccumulative (vB) substances, respectively.  These are useful screening criteria and were formalized in the 2001 Stockholm Convention on persistent organic pollutants.  The basis of these metrics was 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 B and 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 complement 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 Workshop 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 – 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 based 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, Chapter R.11: “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 and is insensitive to metabolism, which is a less 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 translated to greater uncertainty in BCF endpoints (Lo et al., 2016). Therefore, BMF becomes a critical objective line of evidence in evaluating bioaccumulation 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, CONCAWE PBT report from 2009, other reviews (Bleeker, 2010), as well as other data identified from a recent literature search in Google/Scholar October 2018 were compiled and critically assessed for reliability.  Tables of the available data are presented below with comments on how to consider these data.
Specific results for Pyrene
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’’). 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 11 fish species showing a range of BCF from 6.5 to 2000 L/kg.  Several of these are new data that were not included in the SVHC proposal and should be included in the evaluation. This suggests that PYR is a possible 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 that BCFs for fish are preferred for this assessment.  The status of PYR as B/vB is not supported by weight of evidence.
Given that PYR is a borderline B substance based on fish BCF data, additional lines of evidence are needed to conclude on bioaccumulation potential.
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 also include fish and higher order organisms that will reflect additional exposures introduced through secondary poisoning.  Due to variability noted above, multiple studies should be critically evaluated as part of weight of evidence for bioaccumulation assessments.  For Pyrene there are five studies reporting TMFs: Bohai Bay 0.17 (Wan et al., 2007), Baltic Sea 0.74 (Nfon, 2008), Tokyo Bay 0.62 (Takeuchi et al., 2009), Passaic River estuary 0.24 (Khairy, 2014), and Taihu Lake 1.12 (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 0.59 – 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 et al., 2012 as cited in the reference list below.
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 TMF < 1 (Table S4).
All 6 of these studies show that PYR does not biomagnify in the food chain (TMF values < 1 [ECETOC 2012]).  Therefore, Concawe is of the opinion that PYR 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, PYR included. The median and 90th percentile for PYR, are less than 0.06, and 0.41, respectively. While no threshold values are available for using BSAF values, these data provide further evidence that PYR does not biomagnify in the field, and is therefore not bioaccumulative.
BMF
As discussed above BMF have the largest weight of evidence for bioaccumulation assessments.  There are 5 studies that report BMF data for PYR for lab and field studies (Table 1).  The BMF magnitudes range from 0.005 to 0.1, which indicate a lack of transfer from diet items to fish.  This confirms the observations for TMF and confirms low B potential for PYR.  Therefore, Concawe is of the opinion that PYR is not bio-accumulative.
5. ENVIRONMENTAL HAZARD ASSESSMENT
The draft SVHC assessment report on pyrene, as submitted by the French 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 PAHs, including pyrene. Photo-enhanced toxicity data are subsequently used to demonstrate the toxicity of pyrene, 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 pyrene, as discussed in section 3.1.1 on abiotic degradation.
To perform a complete assessment of pyrene toxicity, exposure considerations should be included. For example, a recent assessment of pyrene showed that its 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 pyrene.

6. CONCLUSIONS ON THE SVHC PROPERTIES
6.2.1 Assessment of PBT/vPvB properties
In conclusion, there is evidence to support that pyrene, when in a bioavailable form, 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, pyrene can resist biodegradation processes. However, it should be noted that in this form pyrene is also expected to not to pose a risk to biological receptors, due to the same lack of bioavailability.
In Concawe’s opinion, there is new data available on the bioaccumulation potential for PYR under field and laboratory conditions that do not support the vB classification of PYR. A refined assessment according to the state-of-the-art of the bioaccumulation potential of PYR 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 PYR 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 PYR 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.

REFERENCES
Birch, H., Hammershøj, R., Mayer, P., 2018. Determining Biodegradation Kinetics of Hydrocarbons at Low Concentrations: Covering 5 and 9 Orders of Magnitude of Kow and Kaw. Environmental Science & Technology 52, 2143-2151.
Bleeker, E. and E. Verbruggen, Bioaccumulation of polycyclic aromatic hydrocarbons in aquatic organisms. 2010.
Brakstad et al., 2018b. Dispersibility and biotransformation of oils with different properties in seawater. Chemosphere 191, 44–53.
Brakstad, O.G., Ribicic, D., Winkler, A., Netzera, R., 2018a. Biodegradation of dispersed oil in seawater is not inhibited by a commercial oil spill dispersant. Marine Pollution Bulletin 129, 555-561.
Burgess, R.M., Ahrens, M.J., Hickey, C.W., 2003. Chapter 3 Geochemistry of PAHs in Aquatic Environments: Source, Persistence and Distribution. PAHs: An Ecotoxicological Perspective, Ecological & Environmental Toxicology Series. John Wiley & Sons.
Burkhard, L.P., et al., Comparing laboratory and field measured bioaccumulation endpoints. Integrated Environmental Assessment and Management, 2011. 8(1): p. 17-31.
Burkhard, L.P., et al., Improving the Quality and Scientific Understanding of Trophic Magnification Factors (TMFs). Environmental Science & Technology, 2013. 47(3): p. 1186-1187.
Butler, J.D., Crossley, P., 1981. Reactivity of polycyclic aromatic hydrocarbons adsorbed on soot particles. Atmospheric Environ. 1967 15, 91–94. https://doi.org/10.1016/0004-6981(81)90129-3
Cailleaud, K., et al., Uptake and elimination of hydrophobic organic contaminants in estuarine copepods: an experimental study. Environmental toxicology and chemistry, 2009. 28(2): p. 239-246.
Carlson, R.M., Implications to the aquatic environment of polynuclear aromatic hydrocarbons liberated from Northern Great Plains coal. 1979: Environmental Research Laboratory, Office of Research and Development, US Environmental Protection Agency.
Cheikyula, J.O., J. Koyama, and S. Uno, Comparative study of bioconcentration and EROD activity induction in the Japanese flounder, red sea bream, and Java medaka exposed to polycyclic aromatic hydrocarbons. Environmental Toxicology: An International Journal, 2008. 23(3): p. 354-362.
Concawe Report 12/18, 2013 survey of effluent quality and water use at European refineries (p56)
Concawe, 2012. Primary biodegradation of petroleum hydrocarbons in seawater. Report no. 10/12.
EMBSI, 2001. Fish, dietary bioaccumulation test, study no. 100047AB. Report 01MRL61, ExxonMobilBiomedical Sciences Inc. (EMBSI), Annandale, NJ, USA.
Gobas, F.A., et al., Revisiting bioaccumulation criteria for POPs and PBT assessments. Integrated environmental assessment and management, 2009. 5(4): p. 624-637.
Hammershøj, R., Birch, H., Mayer, P., 2017. Mixture effects on biodegradation kinetics of petroleum hydrocarbons in surface water. Poster Presentation. SETAC Europe 27th Annual Meeting, Brussels. Society of Environmental Toxicology and Chemistry.
Harmsen & Rietra, 2018. 25 years monitoring of PAHs and petroleum hydrocarbons biodegradation in soil. Chemosphere 207, 229–238.
Howard, P.H., Meylan, W.M., Aronson, D., Stiteler, W.M., Tunkel, J., Comber, M., Parkerton, T.F., 2005.  A New Biodegradation Prediction Model Specific to Petroleum Hydrocarbons. Environmental Toxicology and Chemistry 24, 1847-1860.
Jaarrapport Lucht Emissies 2000-2016 en luchtkwaliteit in 2017 in Vlaanderen, VMM, 2018 (https://www.vmm.be/publicaties/jaarrapport-lucht-emissies-2000-2016-en-luchtkwaliteit-in-2017-in-vlaanderen) Report on the Flemish air quality monitoring.
Jonsson, G., et al., Bioconcentration, biotransformation, and elimination of polycyclic aromatic hydrocarbons in sheepshead minnows (Cyprinodon variegatus) exposed to contaminated seawater. Environmental Toxicology and Chemistry, 2004. 23(6): p. 1538-1548.
Ke, R., et al., Using semipermeable membrane devices, bioassays, and chemical analysis for evaluation of bioavailable polycyclic aromatic hydrocarbons in water. Archives of environmental contamination and toxicology, 2007. 53(3): p. 313-320.
Khairy, M.A., M.P. Weinstein, and R. Lohmann, Trophodynamic behavior of hydrophobic organic contaminants in the aquatic food web of a tidal river. Environmental science & technology, 2014. 48(21): p. 12533-12542.
Kim, J., et al., Evaluating the roles of biotransformation, spatial concentration differences, organism home range, and field sampling design on trophic magnification factors. Science of The Total Environment, 2016. 551-552: p. 438-451.
Klečka, G.M., et al., Introduction to special series: Science‐based guidance and framework for the evaluation and identification of PBTs and POPs. Integrated environmental assessment and management, 2009. 5(4): p. 535-538.
Kobayashi, J., et al., Respiratory uptake kinetics of neutral hydrophobic organic chemicals in a marine benthic fish, Pseudopleuronectes yokohamae. Chemosphere, 2013. 93(8): p. 1479-1486.
Korfmacher, W.A., Wehry, E.L., Mamantov, G., Natusch, D.F.S., 1980. Resistance to photochemical decomposition of polycyclic aromatic hydrocarbons vapor-adsorbed on coal fly ash. Environ. Sci. Technol. 14, 1094–1099. https://doi.org/10.1021/es60169a019
Lampi M and Parkerton T, 2009. Bioaccumulation Assessment of PAHs - Draft. ExxonMobil Biomedical Sciences, Inc. (EMBSI).
Li, Y., et al., Dissolved organic matter affects both bioconcentration kinetics and steady-state concentrations of polycyclic aromatic hydrocarbons in zebrafish (Danio rerio). Science of The Total Environment, 2018. 639: p. 648-656.
Lo, J.C., et al., In Vivo Biotransformation Rates of Organic Chemicals in Fish: Relationship with Bioconcentration and Biomagnification Factors. Environmental Science & Technology, 2016. 50(24): p. 13299-13308.
Lofthus et al., 2018. Biodegradation in seawater of PAH and alkylphenols from produced water of a North Sea platform. Chemosphere 206, 465–473.
Matthies, M., et al., The origin and evolution of assessment criteria for persistent, bioaccumulative and toxic (PBT) chemicals and persistent organic pollutants (POPs). Environmental Science: Processes & Impacts, 2016. 18(9): p. 1114-1128.
McLachlan, M.S., Can the Stockholm convention address the spectrum of chemicals currently under regulatory scrutiny? Advocating a more prominent role for modeling in POP screening assessment. Environmental Science: Processes & Impacts, 2018. 20(1): p. 32-37.
McLeese, D.W. and L.E. Burridge, Comparative accumulation of PAHs in four marine invertebrates. 1987.
Moermond, C.T.A., et al., Modeling Decreased Food Chain Accumulation of PAHs Due to Strong Sorption to Carbonaceous Materials and Metabolic Transformation. Environmental Science & Technology, 2007. 41(17): p. 6185-6191.
Newsted, J.L. and J.P. Giesy, Predictive models for photoinduced acute toxicity of polycyclic aromatic hydrocarbons to Daphnia magna, Strauss (Cladocera, Crustacea). Environmental Toxicology and Chemistry: An International Journal, 1987. 6(6): p. 445-461.
Nfon, E., I.T. Cousins, and D. Broman, Biomagnification of organic pollutants in benthic and pelagic marine food chains from the Baltic Sea. Science of the Total Environment, 2008. 397(1-3): p. 190-204.
Northcott, G.L. and Jones, K.C., 2001. Partitioning, Extractability, and Formation of Nonextractable PAH Residues in Soil. 1. Compound Differences in Aging and Sequestration. Environmental Science and Technology 35, 1103-1110.
Parkerton, T. and Redman, A., 2015. Assessment of Photochemical Processes in Environmental Risk Assessment of PAHs. Report to Concawe.
Parkerton, T.F., et al., Guidance for evaluating in vivo fish bioaccumulation data. Integrated environmental assessment and management, 2008. 4(2): p. 139-155.
Prosser, C.M., Redman, A.D., Prince, R.C., Paumen, M.L., Letinski, D.J., Butler, J.D., 2016. Evaluating persistence of petroleum hydrocarbons in aerobic aqueous media. Chemosphere 155, 542−549.
Ribicic et al., 2018. Oil type and temperature dependent biodegradation dynamics - Combining chemical and microbial community data through multivariate analysis. BMC Microbiology 18:83.
Richardson, B.J., et al., Uptake and depuration of PAHs and chlorinated pesticides by semi-permeable membrane devices (SPMDs) and green-lipped mussels (Perna viridis). Marine Pollution Bulletin, 2005. 51(8): p. 975-993.
Sigmund et al., 2018. Influence of compost and biochar on microbial communities and the sorption/degradation of PAHs and NSO-substituted PAHs in contaminated soils. Journal of Hazardous Materials 345, 107–113.
Soehl, A., Wu, C. Y., 2012. Assessment of Benzo[a]pyrene Emissions in the Great Lakes Region, 2012 International Emission Inventory Conference, August 16, 2012.  (http://www.epa.gov/ttnchie1/conference/ei20/session10/asoehl_pres.pdf).
Southworth, G., J. Beauchamp, and P. Schmieder, Bioaccumulation potential of polycyclic aromatic hydrocarbons in Daphnia pulex. Water Research, 1978. 12(11): p. 973-977.
Takeuchi, I., et al., Biomagnification profiles of polycyclic aromatic hydrocarbons, alkylphenols and polychlorinated biphenyls in Tokyo Bay elucidated by δ13C and δ15N isotope ratios as guides to trophic web structure. Marine Pollution Bulletin, 2009. 58(5): p. 663-671.
Verbruggen, E., 2012. Environmental risk limits for polycyclic aromatic hydrocarbons (PAHs) - For direct aquatic, benthic, and terrestrial toxicity. National Institute for Public Health and the Environment (RIVM). Report number: 607711007/2012.
Wan, Y., et al., Trophic dilution of polycyclic aromatic hydrocarbons (PAHs) in a marine food web from Bohai Bay, North China. Environmental science & technology, 2007. 41(9): p. 3109-3114.
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.
Wild et al., 1991. The persistence of polynuclear aromatic hydrocarbons (PAHs) in sewage sludge amended agricultural soils. Environmental pollution 72, 141–157.
Wild, S.R. & Jones, K.C., 1993. Biological and abiotic losses of polynuclear aromatic hydrocarbons (PAHs) from soils freshly amended with sewage sludge. Environmental Toxicology and Chemistry 12, 5–12.
Xia, X., et al., How does predation affect the bioaccumulation of hydrophobic organic compounds in aquatic organisms? Environmental science & technology, 2015. 49(8): p. 4911-4920.
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	Thank you for you detailed comment on SVHC assessment report on pyrene.

General Response:

The information provided in the RAR for CTPHT has been used as a basis for this dossier. This valid information was provided in the SVHC dossier for CTPHT (2009) to the Member State Committee that has already concluded on the PBT and vPvB properties of pyrene. More recent data have also been added when relevant and reliable.

Many of the studies identified as missing by CEFIC in this comment were therefore not initially included because of poor reliability or lack of relevance for the discussion as detailed in the specific responses below. 

For transparency and when relevant,  the additional information that you mentioned in your comment has been added to the support document. However, ANSES considers that there is no new relevant and reliable information presented.
Therefore, it is concluded that the information provided does not change the original conclusions on the identification of pyrene as SVHC for its PBT and vPvB properties.

Specific comments are addressed below.

Response Part 1, section 1. IDENTITY OF THE SUBSTANCE AND PHYSICAL AND CHEMICAL PROPERTIES

The section has been modified accordingly in the support document.

Reponses to section 3. ENVIRONMENTAL FATE PROPERTIES

3.1.1.3 Phototransformation/photolysis

The R11 ECHA guidelines clearly states in page 43, that data derived from abiotic studies such as photodegradation cannot be used on their own for the assessment of  persistence. 

3.1.2.1 Biodegradation in water and sediments

Based on information from the CTPHT assessment regarding biodegradation in water it is indicated as follows: “Experimental information for biodegradation in water has demonstrated that PAH substances with up to four aromatic rings are biodegradable under aerobic conditions, but that  biodegradation rates of PAHs with more than four aromatic rings,  are very low (The Netherlands, 2008)“. Thus, the information that you provided in your comments does not change the previous statement and the evaluation presented in the SVHC dossier for pyrene. 

In the study of Birch et al., 2018, the authors used as inoculum activated sludge filtrate, seawater and lake water. Activated sludge filtrate could be considered as pre-adapted to hydrocarbons (some of the hydrocarbons were present at or above 10% of the test concentration) and seawater could be considered also as pre-adapted to hydrocarbons (obtained in the vicinity of a trafficked shipping port). In addition, the tests were conducted in relative small systems (15mL), which implies a rather limited population of microoganisms.
It was noted that, the DT 50 calculated is higher than 42 days in the results with lake water. Considering the experimental points in the supplementary data (S25), it is not possible to exclude a DT50 even higher than 120 days. In addition, considering the remarks above FR considers that the study is of limited suitability for the assessment of persistence.

Regarding the study of Concawe, 2012, indeed it is noted that for pyrene a half-life of 151 days was calculated, however the reliability of the study is questionable, due to the addition of mineral media and the relatively small test systems (15 mL) used in the experiments, which implies a rather limited population of microorganisms.

The reference Martin et al., 2017, refers to the comparison of results from a ready biodegradation test (OCDE 301B) with an equivalent test using more inocula concentrations (100 times more concentrated at 300 mg/L). The authors used 5 differents 14C-labelled compounds (aniline, 4-fluorophenol, 4-nitrophenol, 4-chloroaniline and pentachlorophenol), pyrene was not tested in the study. Thus, FR considers the information from the publication as not relevant in P assessment of pyrene. 

In the study of Brakstad et al., 2018 a,b, the authors studied the biodegradation of oil with and without dispersion in natural seawater at 5°C. The experiments conducted with dispersant are not considered as an environmentally relevant condition. Furthermore, no abiotic control was used and it is not possible to determinate the loss of the substance by abiotic process. In addition, no information about the dissolved pyrene is available in the study.  The authors calculated the half-life from rate coefficient using the equation t1/2=0.693/k1 Therefore, FR considers that the study is of limited suitability for the P assessment.

The study of Loftus et al., 2018 is also questionable for P-assessment, due to the use of “produce water” from offshore oil production installation containing dispersed oil compounds. As the sample contained dispersants, this condition is not considered as an environmentally relevant condition. In addition, for the determination of half-lifes, the authors expressed the values relative to internal marker (30 ab Hopane) and no justification is provided in the paper about the use of this marker, especially about the similarity with pyrene.

In the study of Ribicic et al, 2018. The authors investigate a comparative multivariable approach for studying the biodegradation of dispersed oil in seawater. The use of dispersant in the experiments is not considered as an environmentally relevant condition. In the figure S1 the authors show biotransformation of PAHs relative to an internal marker 30ab Hopane. No justification is provided in the paper about the use of this marker, specially about the similarity with pyrene.  No information is available regarding the determination of DT50 for every PAHs. Overall, considering all these remarks, FR concluded that the study is of limited suitability for the P assessment. 

In addition, the results of one poster (Hammershoj et al., 2018) related to the degradation of mixtures was transmitted. As pyrene was not tested, the information have not been further considered in the current assessment.
At present, pyrene has not been tested in a sediment simulation study (OECD 308). However, during the public consultation 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 Netherlands, 2008), it can be assumed that pyrene will also meet the P and vP criterion in sediment.  

No information on BIOWIN predictions have been included in the dossier because the available experimental information was considered enough and more relevant to conclude about the persistence and very persistence properties of pyrene in soils.

Response to 3.1.2.2 Biodegradation in soil

Degradation half-lifes from the study of Wild and Jones, 1993 were reported from 127 to 320 days respectively depending on of the type of soils tested. Concawe suggests that bioavailability of PAHs in the test may have been affected by the application of sludge from a sewage treatment plant. However, the relevance and pertinence of study of wild and Jones 1993 was already assessed in the framework of CTPHT and the MSC has considered their use in the PBT assessment of CTPHT as SVHC in 2009, and their results are still valid for the assessment of persistence. Furthermore, applying the correction for temperature (12°C, Arrhenius equation) the half-life would be even higher for pyrene (still above vP threshold). 
 
During the public consultation, another reference to a soil degradation study was transmitted (Sigmund et al, 2018) in which the half life of pyrene when spiked to soil was comparable to the value found by Wild and Jones (1993). This study has been assessed for its reliability and relevance according to OECD and ECHA guidelines (R11 and R7b). It is noted that the study Sigmund et al, 2018 is not comparable to the study of Wild and Jones, 1993 due to methodological differences. The experiment objective was to investigate the effects of compost amendment, both with and without biochar on PAHs and NSO-PAH degradation in soils. The soil samples were spiked with 25 mg of pyrene/kg of soil, and additionally spiked with 100 mg/kg of Zn and 10 mg/kg of Cd, heavy metals. This may cause changes in bacterial community and their capacity to biodegrade PAHs. The study was conducted for 120 days with non-radiolabelled pyrene, no information about the recovery of the substance (formation of NER) is available in the publication. Furthermore, the study did not performed an abiotic control. The data presented in the publication for the half-life is limited to a graphical representation making the determination of the real half-life value difficult. Due to methodological limitations, no reliable half-life can be determined from this study.

It is mentioned by Concawe that the source of PAHs can have an influence on their bioavailability. The differences between pyrogenic and petrogenic orignin is highlighted in the article by Burges et al (2003). However, FR believes that this is not related to the ad hoc circumstances of specific tests/studies. Furthermore, Concawe underlines that bioavailability is not explicitly addressed in the persistence assessment, which FR agrees upon because we consider this is not directly relevant for SVHC identification that shall be based on the intrinsic properties of pyrene.  

Regarding the study of Wild et al (1991), the half-life calculated under field conditions supports the very low degradation of pyrene in soils, observed in the study under laboratory conditions of Wild and Jones (1993). FR highlights that the MSC has agreed on the relevance of this study on the assessment of persistence properties of pyrene in the context of CTPHT assessment.

The data on persistence reviewed in the current dossier have been considered and conclusions agreed by the MSC within the CTPHT assessment (2009). The studies referenced in comments do not undermine the conclusion that pyrene is P and vP in soil and sediments and therefore do not change the conclusion.

Response to 3.3. Comments on Bioaccumulation

The agreement of the MSC on the identification of CTPHT as SVHC (ECHA, 2009), adopted on 2 December 2009 concludes on page 4 : “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. 
Phenanthrene fulfils the vPvB criteria, but not the PBT criteria.” The SVHC dossier submitter correctly reflected this fact and added more recent data.

Concawe disagrees with the approach followed to conclude on the B and vB properties of pyrene 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. 
Furthermore, the Guidance Chapter R11 version 3.0 of June 2017 states the following:
(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 pyrene.

We note that the PBT/vPvB assessment addresses the differences between the various BCF values as well as differences between the various reported B-metrics. This encompasses a discussion on the difference of the bioaccumulation potential in invertebrates compared to, e.g., fish. It should be noted, that the purpose of the PBT/vPvB assessment is not only to protect from biomagnification in the food chain, but also from high bioaccumulation at any individual food chain steps.   

Most of the information presented in the dossier was already assessed by Bleeker and Verbruggen, 2009. The authors assigned analysis Klimisch scores to each BCF value to indicate the reliability. In addition, the authors clearly indicate that a validity of 4 is allocated to BCF values being based on total radioactivity (which deems it impossible to distinguish between the concentration of the parent compound and that of its transformation products), studies with uncertainties about the exposure concentration (e.g. exposure concentration reported in graphs only, nominal concentration reported only, exposure via sediment or diet, exposure to oil) or uncertainties about (pre-)exposure duration (e.g. for field collected animals). Assessment of reliability scores by Bleeker and Verbruggen, 2009 has been used in the current SVHC proposal for pyrene and the studies scored with a reliability 3 and 4 are therefore not further considered for the conclusion.

Regarding the table that Concawe presented as supporting material for fish BCF data for pyrene, some of the studies were already included in the SVHC proposal (Johnson et al., 2004, Carlson, 1974). The study of Cheikyula, 2008 was not included because a reliability of 3 was assigned to the BCFs by Blecker and Verbruggen 2009. Concerning the other studies, a paragraph has been added in the support document for transparency. However, the low BCF values reported for these species of fish does not change the overall conclusion of the B/vB properties of pyrene based mainly on invertebrate data. 

According to the results from field studies and biomagnification, Concawe is of the opinion that PYR is not bio-accumulative. However, the R11 ECHA guidelines on page 77, indicates clearly that “as dietary and trophic biomagnification represent different process that bioconcentration in aquatic organisms, BMF and/or TMF values<1 cannot be directly used to disregard a valid assessment based on reliable BCF data indicating that a substance meets the numerical B/vB criteria in Annex XIII to the Reach regulation”. Thus, the fact that no trophic magnification is observed in the studies reported it does not invalid the previous conclusion that Pyrene fulfils the B/vB criteria, based on the data from molluscs and crustacea.

 The reference Wang et al, 2012 has been modified in the support document.

The data from the US EPA BSAF (biota sediment accumulation factor) database was not considered in the assessment, because any information about the methodology followed in the experiments, the method of calculation of BSAF and the source of the data are reported in the database. In addition, as it is stated in the page 75 of R11 guideline, no threshold values for using sediment BSAF values in PBT assessment are available. Thus, for all these reasons, FR does not considered the information from the database.

Response 5. ENVIRONMENTAL HAZARD ASSESSMENT

FR considers photo-enhanced toxicity for the aquatic environment as relevant. In the upper layers of surface water, photo inducted degradation of pyrene may occur yielding a substance that is toxic for aquatic organisms. Available reliable information from long term studies showed that the substance is more toxic in presence of UV radiations. The NOEC/EC10 are lower than the threshold value for T properties. In addition, reliable experimental studies conducted without exposition of UV radiation in long term studies (algae, ceriodaphnia dubia, Mytilus galloprovincialis) are also available. The results show also that the pyrene meets the T criteria.

There is no need to include exposure considerations since this it is not relevant for the identification of pyrene as SVHC that is based on its intrinsic properties.

Response 6. Conclusions in the SVHC properties

Concawe does not agree with the identification of pyrene as SVHC for its PBT/vPvB properties. Furthermore, Concawe addressed studies presented as new to take into consideration in the assessment especially in the persistence of the substance. FR assessed the data submitted and concluded that these information does not change the conclusion that pyrene is persistent and very persistent in soils and sediment.

Moreover, it is important also to remind that ECHA R.11 Guidance states the following: “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.” It therefore acknowledges that persistence demonstrated in two compartments is sufficient to conclude that a substance is P/vP.
As concluded in the Annex XV dossier, pyrene is considered very persistent in soils and sediment and therefore fulfils criteria for its identification as P and vP. 

Regarding bioaccumulation, the data presented by Concawe regarding fish and the observations about field studies, don’t change the fact that pyrene is bioaccumulable and very bioaccumulable, based principally on data from invertebrates.

Available reliable data from long term studies with aquatic invertebrates with and without UV radiation shows that Pyrene is toxic for aquatic invertebrates (NOEC/EC10 < 10 µg/L). Thus the substance fulfils the criteria for T properties.

With consideration of all relevant data and in accordance to the methodology recommended in the appropriate guidance, pyrene therefore fulfils criteria of article 57 (d) and (e) as a PBT and vPvB substance.	
		See the corresponding embedded attachment in table 1 of Part I: 5256_PYR.zip		
5266
2018/10/30	Finland,
Member State	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 the information provided. 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	
5199
2018/10/16	Finland,
Member State	Page 29: “Pyrene is not produced intentionally but occurs together with other PAHs as constituent of coal and petroleum stream UVCB substances. Among the PAHs benzo[a]pyrene (B[a]P, EC number: 200-028-5), chrysene (EC number 205-923-4), benz[a]anthracene (B[a]A, EC number 200-280-6) and anthracene (EC number: 204-371-1) are included in the Candidate List due to PBT and vPvB properties already”

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.	Noted.	
5204
2018/10/17	Euroalliages,
Industry or trade association,
Belgium	See our position paper also submitted for Benzo[k]fluoranthene	See response provided in the table for general comments.	
		See the corresponding embedded attachment in table 1 of Part I: 5204_Position paper candidates listing of PAHs October 2018.pdf		
5256
2018/10/19	Concawe,
Industry or trade association,
Belgium	7. REGISTRATION AND C&L NOTIFICATION STATUS
As there is no registration dossier for Pyrene, 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 Pyrene is never added to substances but is present due to its presence in starting materials, which often are of natural origin.
In view of this, Concawe queries if Pyrene is assessed as a SVHC, how Risk Management Options on the substance can be implemented.
Furthermore, as it will never lead to an authorisation process for the substance Pyrene, Concawe considers part II obsolete.  Moreover, in the analytical database at Concawe comprising of 295 samples, 125 samples with Pyrene levels above 1 ppm and a total of 49 samples where the Pyrene was not detected or quantitated, are present.  Of these analytical results only 7 samples have levels > 1000 ppm and these are only found in the HFO category that are fuels and exempted from Authorisation under REACH through article 56 sub 4 c & d.
Notwithstanding this opinion, Concawe will comment on some of the content of this part.
As Pyrene is not intentionally produced as such the Rapporteur has to alter the text in Section 8, as Pyrene is only present is minor amounts in petroleum substances of which there are only 198 registered.  Therefore, claiming that there are “numerous petroleum UVCBs” is exaggerated and the correct number should have been used.  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 use should be removed from this report.
Regarding the sources of Pyrene, Concawe observes that the focus of the Rapporteur does not mention any other anthropogenic sources that may introduce Pyrene into the environment or lead to human exposures other than the petroleum and coal based substances.  Concawe considers this to be a major omission, as without highlighting that residential wood burning being the major source for Pyrene observed in the atmosphere Soehl & Wu, 2012; Jaarrapport, 2018), this provides a totally incorrect impression on the potential Pyrene sources.  Also smoking, barbequing and the overcooking of food items are considerable human exposure sources that are not mentioned.  Industry is responsible for 1% of PAH air emissions, while households are responsible for 75% of PAH emissions (mainly due to woodburning) (Jaarrapport, 2018). 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 on 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 measures on substances that contain Pyrene in minor quantities will be an effective way of mitigating the potential risks associated with this substance.
On page 27 the Rapporteur mentions that Pyrene is not produced intentionally, as such. Although it has been registered as an intermediate within the scope of the REACH Regulation, which, therefore, is exempted from authorisation. However on page 28 the Rapporteur mentions that it may occur as a constituent in UVCB-substances that are derived from coal or in several petroleum streams and that 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 Pyrene 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 Pyrene.  Therefore, Pyrene is only observed in a limited number of petroleum UVCBs.  The Concawe analytical database, comprising of 295 individual PS-samples, only has analytical results for 7 tested samples with a Pyrene content above its classification threshold of 1000 ppm. With respect to the information on the use of substances that might contain Pyrene, Concawe is surprised to read the statement that “numerous UVCB substances that contain Pyrene”.  As far as Concawe is aware, from the 198 registered petroleum substances, there are only 84 substances that have demonstrable levels of Pyrene, as determined by analysis.  Of these, 21, contain less than 1 ppm Pyrene, whereas, 7 substances supersede the classification 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.
Concawe has a severe objection to the statement on page 29: i “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 as the amount of pyrene 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, 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.  However, as this restriction is not applicable to Pyrene this whole section should be removed.
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 Pyrene emissions and the major sources of Pyrene 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., etc.
Finally, Concawe would like to point out that the refining sector is consistently monitoring and attempting to reduce its PAH emissions.  However, as Pyrene is not subject to any regulatory obligation to be monitored, Concawe has no data on this substance.  However, as the trend in PAH-discharges still demonstrates a decrease in PAH concentrations and loads in effluents, it can be assumed that this also applies to Pyrene (Concawe Report, 2013).	Thank you for your comment and the information provided. 

Comments regarding use, exposure, alternatives and risks may, when relevant, be considered at later stages of the risk management process of the SVHC dossier.

		See the corresponding embedded attachment in table 1 of Part I: 5256_PYR.zip