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

Substance name: Benzo[ghi]perylene
CAS number: 191-24-2
EC number: 205-883-8

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

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

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

General comments on the SVHC proposal

Number / Date	Submitted by (name, submitter type, country)	Comment	Responses	
4990
2018/04/18	Finland,
Member State	-	Thank you for sharing this information with us.	
		Attachment: 4990_Vähä_et_al_2017_PAHs_in_freshwater_mussels_in_Finland.pdf

Specific comments on the justification
Number / Date	Submitted by (name, submitter type, country)	Comment	Responses	
4965
2018/04/12	ChemSec,
International NGO,
Sweden	ChemSec supports the identification of benzo(ghi)perylene as a PBT/vPvB substance based on the evidence presented in the dossier.	Thank you for your support.	
4977
2018/04/13	Germany,
Member State	The German CA thanks the Danish CA for preparing an Annex XV dossier for the identification of benzo[ghi]perylene as SVHC. We fully support the Danish proposal, which in our view is sufficiently justified.
Editorial note:
Page 2 “Contents”; 2nd entry PART I 6: Please change to PART I [tab] 6
Page 9 and e.g. page 10: The citation ECHA 2009 and ECHA, 2009 is inconsistent within the document. It is recommended to unify this citation. The same applies for the citation The Netherlands 2008 and The Netherlands, 2008. Generally, the latter should be better suited.
In addition, please format other citations as, i.e. Jiminez et al., 1987.

Page 11, citation RIVM, 2009: Citation is missing in references for Part I section or needs to be updated to Bleeker and Vergruggen, 2009?

e.g. Page 16/18: inconsistency between Daphnia Magna and Daphnia magna
Reference Section: Reference ECHA (2009b) was not found in Part I of the dossier. It is recommended to move the reference to subsection “part II” within the reference section.

Comment on B:
Page 11, section 3.3.1 first paragraph: It is not clear for which substance (BgP) a BCF of 28288 was obtained. Please specify if possible. Furthermore, it would strengthen the argumentation for B, if a reliability assessment could be added for the study RIVM, 2009.
If applicable, a reference to the conclusion in the Support Document for identification of CTPHT as SVHC (ECHA, 2009) could be made in section 3.3.2 (summary).

Page 5, “Bioaccumulation” paragraph: In scope of consistency, please give the full name of the abbreviation BCF as it is mentioned here for the first time. Also in the same paragraph, reword to: “(measured BCF values in aquatic species >2000 and >5000, respectively)

Page 7, first paragraph: Please change to “occurs”

Page 9, third paragraph: Please change “derived in” to “derived from”

Page 11, section 3.3.1, first paragraph: If the study on Azellus aquaticus was rated as non-reliable. We are not sure, if the study was assessed for the purpose of this dossier or the assessment was taken from previous ones. Please indicate and add Klimisch score if available.

Page 12, Table 4: Since a study with a reliability score of 3 is given here, the study mentioned above (page 11, study on Azellus aquaticus) could also be presented since it relates to BgP.

Page 12, Section 3.3.2, second paragraph: Please change to “In fish, PAHs are…”. PAHs or PAH compounds. Please check the rest of the dossier for further inconsistencies.

Page 13, Section 5.1.1.1: Please rephrase the first sentence as it is confusing “…with no exposure…with the freshwater fish…showed <20% mortality was observed…”

Page 14, Section 5.1.2.2: Bisson et al., 2000, Bragin et al., 2016  Please be consistent throughout the dossier with the way references are reported. It should always be “et al.,” followed by year (the year not in parenthesis). In addition, decide if you want references to have “et al” with italics or not and change accordingly throughout the dossier. Alternatively, you could have Bisson et al. (2000) and Bragin et al. (2016) as another in-text reference style, but please take care that it is consistent for all references in the dossier [i.e. ECHA (2009)]

Page 17, Section 6.2.1, third paragraph: “In general, the…”. Also, either “the biod. rate of PAH cmpd. decreases” or “the biod. rates of PAH cmpd. decrease”. “PAHs with more than four aromatic rings, e.g. BgP, biodegrade…”

Page 17, Section 6.2.1, fourth paragraph: Rephrasing suggestion“…with an aquatic environment half-life of 1000-3000 hours in water phase, ..., and >30000hours in sediments,…”

Page 20, Section 9, first paragraph: “by the industry” and shouldn’t it rather be “in the context of substances”? Also, “shows reports of BgP”

Page 20, Section 9.1: Please reword “…to replace the use of CTPHT in these uses”. Also, the last sentence “research…has been reported” should be reworded.	Thank you for your support and comments. The suggested editorial notes have been taken into consideration. A consistency screening has been performed and the support document has been revised accordingly. 

The substance has been specified.

A reference to the support document for CTPHT has been made.

The assessment was taken from a previous study. Reference and Klimisch score have been added.

The study on Azellus aquaticus is not presented in the table, as the table only includes studies mentioned in the CTPHT support document.

The sentence has been rephrased.

The sentence has been rephrased.

Thank you for your comments on p. 20. These are relevant for the Part II and hence will be considered in the follow-up steps after the identification process. 
	
		-		
4990
2018/04/18	Finland,
Member State	The Finnish CA supports the identification of Benzo[ghi]perylene as a substance of very high concern, on the basis that it fulfills 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, Benzo[ghi]perylene 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 note that in the Annex XV dossier only one bioaccumulation study is available for Benzo[ghi]perylene. This is for a Crustacean species. BCF results for other PAH compounds are also presented (for Crustaceans and fish).

There is a recent study on concentrations of PAHs in freshwater mussels. In this study, 21 PAHs were analysed. Duck mussels (Anodonta anatina) were collected from 11 freshwater sites and 1 coastal site with anthropogenic impact and from a reference site. Painter’s mussels (Unio pictorum) or Swan mussels (Anodonta cygnea) were chosen if duck mussels were not found. Altogether 15 PAH compounds out of the 21 analyzed were found in the samples. Benzo[ghi]perylene was detected in mussels in three sites (1.5-6 µg/kg fw). The detection limit was 1-2 µg/kg. Concentrations of PAHs in the water were not analysed in this study. The results in graphical form are available in a poster (Vähä et al. 2018). Results in numerical form and information on the methods is available in a web database (Finnish Environment Institute 2018).

Benzo[ghi]perylene has also been detected in caged blue mussels (Mytilus trossolus) 0.8-7.5 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). Hanko was the reference site of these studies whereas the other sites were affected by anthropogenic pollution.

Blue mussels have also been caged in ten Finnish coastal sites in 2016 and 2017. Benzo[ghi]perylene was detected in two sites: 1.4 µg/kg fw in Airisto and 7.15 µg/kg fw in Kotka (unpublished data, available in database) (Finnish Environment Institute 2018).

Even if these studies did not determine BCF values, the results could be added to the report as an indication of occurrence of Benzo[ghi]perylene in mussels. As stated in the Annex XV report metabolism of PAHs is not observed in molluscs. High BCFs in mussels have been reported for a PAH compound with five aromatic rings benzo(def)chrysene (ECHA 2016). Therefore, mussels may be relevant target species for bioaccumulation of Benzo[ghi]perylene.

References:
ECHA 2016. Member State Committee support document for identification of benzo[def]chrysene (benzo[a]pyrene) as a substance of very high concern. Adopted on 27 May 2016.
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
Vähä, E., Siimes, K., Nuutinen, J., Syväranta, J. PAHs in freshwater mussels in Finland. Poster. Available at http://www.syke.fi/hankkeet/uupri.	Thank you for your support and comments. The presented studies in English have been taken into consideration and a new paragraph on BCF in mussels for BaP has been added in section 3.3.1. 

	
		See the corresponding embedded attachment in table 1 of Part I: 
4990_Vähä_et_al_2017_PAHs_in_freshwater_mussels_in_Finland.pdf		
5008
2018/04/19	Sweden,
Member State	The Swedish CA agrees that benzo[ghi]perylene meets the criteria according to Articles 57 (d) and (e) in REACH and is thus eligible for identification as a substance of very high concern. This was already concluded in the SVHC identification of Coal Tar Pitch, high temperature.	Thank you for your support.	
5021
2018/04/20	Norway,
Member State	Norway supports that benzo[ghi]perylene should be identified as a substance of very high concern and should be included in the Candidate list. Benzo[ghi]perylene is a polyaromatic hydrocarbon (PAH), a group of chemicals where several similar structures are already identified as PBT or vPvB. It is therefore of importance to identify compounds within this group that fulfils the PBT and vPvB criteria. Benzo[ghi]perylene meets the criteria for inclusion on the Candidate list as PBT and vPvB in 57d) and 57 e)  REACH.	Thank you for your support.	
5065
2018/04/23	CHEM Trust,
National NGO,
United Kingdom	CHEM Trust supports inclusion of Benzo[ghi]perylene 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. 	
5131
2018/04/23	ANSES,
National Authority,
France	ANSES agrees on the identification of benzo[ghi]perylene as an SVHC under Art 57 (d) and (e), which is supported by a weight evidence determination fulfilling annex XIII criteria of REACh regulation. We note that the bioaccumulation data in fish show limited bioaccumulation potential but high bioaccumulation factors are observed in invertebrate organisms and the B criteria is fulfilled. Overall, the identification of PBT/vPvB properties of benzo[ghi]perylene is consistent with the assessment of the previously agreed coal tar pitch high temperature (CTPHT) SVHC dossier.	Thank you for your support. A section on PAHs in mussels has been added and the BCF for BgP has been compared to the BCF for benzo[a]pyrene to strengthen the argumentation.  	

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	
4990
2018/04/18	Finland,
Member State	-	Thank you for sharing this information with us.	
		See the corresponding embedded attachment in table 1 of Part I: 
4990_Vähä_et_al_2017_PAHs_in_freshwater_mussels_in_Finland.pdf