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

Disclaimer: Comments provided during the consultation are made available as submitted by the commenting parties. It was in the commenting parties own responsibility to ensure that their comments do not contain confidential information. The Response to Comments table has been prepared by the competent authority of the Member State preparing the proposal for identification of a substance of very high concern. 

Substance name: Bis(4-chlorophenyl) sulphone
CAS number: 80-07-9
EC number: 201-247-9

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

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	
5748
2023/04/01	Vertellus Specialties Belgium NV, as OR for Vertellus Specialty Materials (India),
Company,
Belgium	Please see attached comment documents.	Thank you for your comments. 

Responses to the non-confidential comments (including the Appendix by Arnot, 2022) have been included directly into the non-confidential comments document.

		Attachment: 5748_DCDPS - nonConfidential Comments.zip

Confidential attachment removed.		
5754
2023/04/03	ANSES,
National Authority,
France	Minor comments
Page 21,  please change the word unter to under
Page 36, please add BCFSS in order to indicate that the BCF value was calculated considering a steady state.
Page 36, it is not really clear if the lipid content was measured. It seems that it was calculated by the Member State, could you please add some clarifications on this.  Finally, it is not clear if you are confident with the BCF value, do you consider that the value is underestimated? If yes, you may add a phrase on that sense.
Page 76, please add the link to the paper
Page 85 , the following phrase: The obtained concentrations are much lower than compared to breast muscle concentrations from Swedish guillemot (1600 – 1900 ng/g l.w.;Norström et al., 2004) may not be necessary. In our view, the comparison takes away from the main message. Besides, the comparison is conducted with different units lipids and fat and different species.

Page 86, in the paragraph which begins with “To conclude”, it is indicated that very limited BCF value indicate a low to moderate bioaccumulation potential for aquatic species. As the QSAR information and the only experimental data are on fish, the conclusion can be addressed only for fish. Please considers to change aquatic species by fish. In the same paragraph please add “rats” after toxicokinetic data.

	Thank you for your comments, we changed the text in the Support Document accordingly and added further clarifications. Please note that the page numbers used here refer to the original text in the Annex XV report and do not correspond to page numbering in the Support Document.

Page 21: amended
Page 36: BCFss added and included in text and list of abbreviations.

Page 36: The fish used in the study had a lipid content of 2.02% at the start and 2.05% at the end of the exposure. Following sentences have been extended and added: Therefore, the authors judged that a steady-state had been reached and the BCF at steady-state (BCFss) was calculated to be in the range of 75 – 83. A lipid normalisation was performed and a BCFss of 205 was calculated. 
No, we do not consider the value as underestimated. 

Page 76: Thank you. A link to the NTP study cited on page 76 has been provided in the reference section.

Page 85: deleted, as suggested. 

Page 86: “Aquatic species” has been deleted and changed to fish. Rat has been added to toxicokinetic. These changes were done for the whole Support Document. 	

Specific comments on the justification
Number / Date	Submitted by (name, submitter type, country)	Comment	Responses	
5742
2023/03/20	ChemSec,
International NGO,
Sweden	ChemSec supports the identification of this substance as an SVHC based on it being a vPvB substance. The evidence in the dossier are well presented and also show that substances can be bioaccumlative in reality, in humans and in the environment, even when not fullfilling log Kow criteria. And also that they can be widespread in the environment even when only used in industrial production.	Thank you for your support.	
				
5743
2023/03/24	Norway,
Member State	The Norwegian CA supports that bis(4-chlorophenyl) sulphone should be identified as a substance of very high concern and should be included in the Candidate List. Based on the evidence provided, we agree that the substance fulfills the vPvB criteria as described in Annex XIII of REACH.	Thank you for your support. 	
				
5745
2023/03/27	Sweden,
Member State	The Swedish CA thanks Austria for this proposal and agrees with the weight-of-evidence determination that BCPS meets the criteria according to Article 57(e) in REACH and is thus eligible for identification as a substance of very high concern.	Thank you for your support.	
				
5746
2023/03/30	Finland,
Member State	We thank Austria for this proposal. We have the following comments on the Annex XV report:

Page 9: “Based on reliable half-life data obtained from a water/sediment simulation test according to OECD TG 308 (reliable without restrictions), the vP criterion is fulfilled for the sediment. 

Under aerobic conditions at 20°C, the DT50, deg values were 1287.2 and 394.3 days in the Tilft and Goose water/sediment systems, respectively. Temperature corrected DT50, deg values at 12°C are between 842 – 2748 days. “

Comment: We propose to change as follows: “Based on a water/sediment simulation test according to OECD TG 308 (reliable without restrictions), the vP criterion is fulfilled for the sediment. 

Under aerobic conditions at 20°C, the DT50 values were greater than the study duration (100 days) (1287.2 and 394.3 days in the two studied water-sediment systems). 

No degradation products ≥5% of applied radioactivity (AR) at two consecutive sampling intervals were observed and 14CO2 formation was ≤ 0.5 % of AR. 

The results suggest that it is unlikely that ≥50% mineralisation or primary degradation would occur over a subsequent 80-day period at 20°C. Therefore, based on this study, it can be reasonably assumed that BCPS is very persistent in sediment (degradation half-lives higher than 180 days).”

Reasoning: The study duration is shorter than the vP criterion. Therefore, the fulfilment of the vP criterion is based on extrapolation of the data beyond the test duration. The wording that we propose is in general accordance with the MSC support document for the SVHC identification of Medium-chain chlorinated paraffins (MCCP).

Page 9 (and elsewhere in the document):
Comment: Please change the term “DT50, deg” to “DT50” throughout the document, or, provide an explanation on whether/how in the derivation of “DT50, deg” degradation has been differentiated from other dissipation processes (and why the “DT50, deg” is considered to represent only degradation). 

We also propose to indicate whether sterile controls were included in the study.

Reasoning: Sterile controls were apparently not included in the study as they are not mentioned. Therefore, it seems that abiotic dissipation is unknown.

Page 10: “An experimentally derived BCF value of 82 (NITE, 2001) is considered to be not assignable as several limitations are observed (e.g., the full study report is not available, no concentration of BCPS in fish is reported, no depuration has been conducted).”

Comment: We propose to change as follows: “An experimentally derived BCF value of 82 was reported (NITE, 2001). The reliability of the study is considered not assignable as several limitations are observed (e.g. no concentration of BCPS in fish is reported, no depuration has been conducted).“

Reasoning: Editorial changes.  To clarify that “not assignable” refers to reliability code. Reference to full study report to be removed as a lack of full study report does not automatically lead to reliability code “not assignable”. Here the problem seems to be that the information available from the available documentation is not sufficient.

Page 11: “Further line of evidence comes from field BMF values in three food-webs (fish – guillemot, fish – cormorants, fish – seals), which show BMF values significantly higher than 1 and BCPS concentrations, which are in the range of known POPs. “
Comment: Please specify the BCPS concentrations which are in the range of known POPs (were these measured in the environment, or in organisms?)

Page 20: “Under aerobic conditions potentially degradable substances are faster degraded than under anaerobic conditions. “

Comment: We propose to add “generally” before “faster” because there are compounds which degrade better at anaerobic conditions, as indicated e.g. in ECHA guidance R.11.

Page 22: “At 20°C, no degradation in the whole system was observed the DT50,deg values were 1287.2 and 394.3 days in the Tilft and Goose River water/sediment systems, respectively.”

Comment: We propose to reconsider the text because CO2 production indicates that a small amount of test substance underwent (primary and ultimate) degradation. Also based on other data degradation may have occurred. Based on the data in Tables 10 and 11, the SFO rate constants significantly differed from zero. Thus, there is a slow decrease in concentration, which is at least partly due to degradation (based on CO2 production). It is stated that “No degradation products ≥5% at two consecutive sampling intervals were observed.“ which does not exclude that transformation products may have been formed. In addition, NER was formed but not characterised. As some degradation has occurred and as NER may contain transformation products it is not correct to state that no degradation occurred. However, it cannot be excluded that the decrease in concentration may be partly due to other dissipation processes than degradation.

In addition, please indicate the significance level used to determine whether a parameter is significantly different from zero. FOCUS (2014) states that due to the inherent uncertainties of fitting water sediment data, a significance level of 10 percent (p lower than 0.1) for the t-test (single-sided) is considered appropriate to decide if the degradation rate parameter is significantly different from zero”. Reference: FOCUS (2014). Generic guidance for Estimating Persistence and Degradation Kinetics from Environmental Fate Studies on Pesticides in EU Registration. Report of the FOCUS Work Group on Degradation Kinetics. 18 December 2014. Version 1.1, 440 pp).

Page 22: “The composition of non-extractable residues (NER) in sediment is unknown and was not taken into account, when calculating the DT50, deg as it would not change the vP conclusion.”
Comment: We propose to change as follows: “The composition of non-extractable residues (NER) in sediment is unknown. When calculating the DT50, deg, NER was not added to the parent substance concentration (i.e., it was assumed that NER represented irreversibly bound residues), as it would not change the vP conclusion.”

Reasoning: Editorial change as the composition of NER cannot be taken into account in the calculations as it is unknown.

Table 12 footnote: “** DT50, diss in water; DT50, deg in sediment”

Comment: Please change “sediment” to “water-sediment system”. In addition, we propose to change “water/sediment” to “water-sediment” throughout the document (for consistency within this report as well as e.g. with OECD TG 308 and ECHA guidance).

Page 23: Text and table regarding temperature correction.

Comment: It is not necessary to temperature-correct the results when the DT50 at 20°C is above the vP criterion. Therefore, this part is not necessary for the conclusion and could be deleted for shortening the text (if deleted, it could be briefly mentioned that if converted to reference temperature, the DT50 would be higher).

Page 25: 3.1.4 Summary and discussion of degradation
Comment: Please revise according to the comments above when relevant.

Page 39: The section presenting results from Valters et al., 1999
Comment: In the first sentence, it is stated that “In 1997, BCPS was analysed in the lateral muscle of perch (n= 23) at six different sampling sites in Latvia, the concentration ranged from 28 – 190 ng/g l.w. (ref. to Annex I).” However, further down in the same paragraph it is stated that “Concentrations of BCPS found from 6 sampling sites were in the range of 32-160 ng/g l.w.” Please clarify the section if these results are obtained from different samplings.

Page 42:  Figure 4
Comment: it seems that information from last two bars is missing from the legend

Overall comment for the B section: the word ‘average’ is missing from some places (e.g., page 39, 43) where average concentrations are discussed. Consider revising the section and add the words if they are missing.
	Thank you for your comments. 

We agree: In the Support Document, the text was amended accordingly. 

We agree. Following text is included on page 23 of the Support Document: “Under aerobic conditions at 20°C, the DT50,deg values were greater than the study duration of 100 days (1287 and 394 days in the two studied water-sediment systems).” 

We agree, following text is included on pages 8, 25 and 88 of the Support Document: "In the OECD TG study no degradation products of BCPS ≥5% of applied radioactivity (AR) at two consecutive sampling intervals were observed and 14CO2 formation was ≤ 0.5 % of AR.” as an additional important point.

We agree, following text is included on page 23 of the Support Document: “The results suggest that it is unlikely that ≥50% mineralisation or primary degradation would occur over a subsequent 80-day period at 20°C.” 

We included these explanations in the text where the water-sediment study was described (p. 22, Support Document) and not in the conclusion, as the conclusion is the summary and should reflect the results only briefly. 

We agree and added the definition for DT50, deg and DT50, diss on page 20 of the Support Document (ref. to SVHC dossier on UV-328) and we added following sentence on page 21 of the Support Document: “In this case, the DT50 for the total system is used as an estimate for the DT50 in sediment, which is in line with ECHA Guidance R.11, as for adsorptive substances, the half-life in the sediment can reasonably be estimated from the half-life for the total water-sediment system.” 

We changed the footnote in Table 12. at page 22 of the Support Document, and we included: “The study showed that BCPS dissipated from water into the sediment with a nearly similar DT50,diss value of 7.1 and 6.2 days in the Tilft and Goose River system, respectively. Within the first 30-days negligible ultimate degradation occurred, as the 14CO2 level was very low (0.1%) and the amount of transformation products was low.  Therefore, the DT50 calculated is attributed mainly to dissipation processes other than degradation. 
At 20°C, negligible mineralisation (max. 0.5% 14CO2 at 100 days) in the whole system was observed and the DT50,deg values were 1287.2 and 394.3 days in the Tilft and Goose River water-sediment systems, respectively.” 
The sentence: “BCPS dissipated from water into the sediment with a DT50,diss value of 7.1 and 6.2 days in the Tilft and Goose River system, respectively.” was deleted. As in this case primary degradation is not a pathway, the word “primary” was deleted from the text. The text “DT50 values from the slow phase are preferred” was deleted. 

As suggested, we included that “No sterile controls were included in the study.” (on page 18 of the Support Document). 

However, there was negligible mineralisation (max. 0.5% CO2 in 100 days) in the water phase and in the sediment phase. Dissipation from water to the sediment occurred. No metabolites and negligible amount of CO2 occurred. On page 20 of the Support Document the word “preferential” was deleted “.

Page 9 and 86 of the Support Document: 
The text for the BCF study was changed throughout the document. “An experimentally derived BCFss value of 82 (NITE, 2001) is considered to be reliable with restriction. There is no evidence for a significant bioaccumulation in fish.”

Reasoning: there are uncertainties, but not enough to claim as Klimisch 3 or 4 “not assignable”, full study has been obtained, partially with translations, with enough information to come to this conclusion. 

Page 11: Table 39 gives an overview of detected BCPS concentration in biota in comparison to known POPs. We amended the sentence by adding the reference (see Table 39) and by explicitly referring to concentrations in biota.

Page 19:
 We agree, “generally” included. 

Page 22: “no” was changed to “negligible” 

We agree, and following text was added on page 21 of the Support Document: “The FOCUS guidance (2014) recommends that a t-test (or examination of the confidence intervals) is used in order to assess the reliability of the individual rate parameter estimates of each model. If a parameter is not significantly different from zero, then the parameter is either very uncertain due to variability in the data or the model is not adequate with respect to the data. The parameter is considered significantly different from zero if the probability is smaller than 0.1 (i.e. considering a 10% significance level for water-sediment studies; FOCUS, 2014). Similarly, if zero is not included in the confidence interval, the parameter is significantly different from zero. Both, the t-test and the confidence interval give the same answer”. 

For further clarification, a new column was added with the heading “parameter values” to give all the information coming from CAKE. The values for “g” and “tb” values for DFOP and HS were included in table 10 and 11, respectively. 

We agree, changed accordingly. 

We agree, changed accordingly.

Page 23, response: We will leave the text as it is for consistency reasons, as 12°C is the reference temperature. 

Summary and discussion of degradation: Changed accordingly.

Page 39: The concentration of 28 of the Support Document is a minimum individual level and 190 is the maximum level found. The first sentence now includes “min.” 28 “to max”. 190 ng/l.w.

The range from 32 – 160 ng/g l.w. are geometric mean values, therefore in the text “based on geometric mean values” was included on page 28 of the Support Document.

Page 42: 
We agree, was not visible to the reader, but present – figure was reformatted and the legend is visible now. 

We agree, changed accordingly e.g. on page 45 (last paragraph). 

5747
2023/03/31	Netherlands,
Member State	NL supports the proposal to include Bis(4-chlorophenyl) sulphone (BCPS)  in the candidate list of SVHC in accordance with Article 57 (e) of Regulation (EC) No 1907/2006 (REACH).

We do however have the following the comments:

- In the summary and in the conclusion, it is still mentioned that the BCF study is unassignable, not available and limited. 

In the main text this has been been amended as the Japanese BCF study is available and is assigned as RI2. 

Further, it is stated in the main text that “In the BCF study, the duration of exposure was 35 days and has been prolonged as no steady-state could be reached after 28 days.” Indeed, the study duration was 35 days, but this was not because no steady-state was reached after 28 days, as steady state was already observed from the first time point (7 days). This is important to note, because the relatively high depuration rate and fast kinetics are in accordance with the low BCF observed. The text in the whole document reads as if the low BCF is still doubted, but it must be concluded that the result of the BCF (BCF5%~200) fits perfectly in the screening information such as QSARs and log Kow. The study is not fully in line with the current OECD 305, but reliable enough to be assigned RI2 and this should be reflected in all sections of the document, which refer to this study.

- On page 58 the study by Franklin (2015) is not correctly cited. This should be amended. 

Franklin notes that BMF values for liver are not a good measure for whole body BMF, because the liver contains only a small part of the substance. If it is not a good representative of whole body concentrations, this can be either way: or a higher or a lower BMF, not necessarily systematically lower as stated on page 58, which is actually demonstrated by the data for seals: 
the BMF based on the liver concentration is higher (not lower) than the BMF based on blubber concentration. Blubber is of course more close to whole body due to the high blubber content of seals. Besides that it must be noted that the publication by Franklin deals with PFAS, and although some protein binding is predicted for BCPS, it is reasonable to assume that BCPS will behave more like hydrophobic substances than like PFAS.

- In the Summary and discussion of bioaccumulation section an increasing BCPS trend in fish and birds is put forward as additional evidence of bioaccumulation. However, this is not relevant for bioaccumulation and should be removed from this section (page 66). 

It could be a reflection of high persistence though, especially if emission can be assumed to be more or less constant.

- The legends to figures 4 and 5 on page 42 and 43 might need to be checked as they are incomplete or not in accordance with the text.

- On Page 45 there seems to be an error in the description of the study by Helander concerning the sentence: 

“The authors conclude that the non-ideal clean-up procedure may explain the large variations in BCPS levels (n.d. to 0.17 ng/g l.w.).” First of all, this should be n.d. (lower than 1) to 170 ng/g l.w. as the concentrations are expressed as µg/g l.w. and second, the value of 170 is a mean value. 

It is also stated that “In the time period 1971 – 1991 BCPS was detected from a non-detectable level up to highest values of 610 ng/g l.w. in the eggs (n=21).” The two sentences seem to present the same information, but the value of 610 is a maximum individual value. This is difficult to interpret without further clarification. 

Further, in the next paragraph it is stated that “A positive trend of BCPS was detected.” Probably a time trend is meant, if so please add ‘time’. Please check this also for other occurrences of “trend” (e.g. bottom of Page 49).

- On Page 46 it is stated “Further, in Norström et al., 2004, the concentration obtained was higher than compared to the concentration in eggs the years before and after (ref. to Table 33 and Figure 7).” It is not clear what is meant by this.

- On Page 46, concerning the study of Jörundsdóttir et al (2008), please make clear that the 1.6% is an annual decrease (and not over the total period of 30 years).

- In table 33 on page 47 the range in the summary line does not match with the rest of the data in the table and with the geometric mean for this summary line.

- In table 40 on page 71 it is stated “After 3 and 5 weeks the total excretion was 99% and 106 %, respectively, of the dose administered during that period (data not shown in the publication).” This should be explained in more detail. What is meant by that period? Now it reads if more is eliminated than is administered in total. Probably it should be that in the period between 3 and 5 weeks, the eliminated part is roughly equal to the administered part (99 and 106%), indicating that steady-state has been reached.
	Thank you for your support and your comments.

We agree, the main text was amended accordingly.

The text including “not assignable” was deleted throughout the document, when referring to the BCF study. As the study is available, we deleted that “the full study report is not available” (page 9 and page 86 of the Support Document).

We agree, changed the text accordingly on page 36 of the Support Document to: “Steady-state was reached during the exposure phase. The study authors stated that the variation in the bioconcentration factors (mean) after 21, 28 and 35 days were within 20% of the mean value for the BCF in these 3 analyses from the 3 timepoints (NITE, 2001). The BCF at steady-state (BCFss) was calculated to be in the range of 75 – 83. A lipid normalisation was performed  and a BCFss of 205 was calculated.”

We agree. Reference was corrected to Franklin J. (2016), How reliable are field-derived biomagnification factors and trophic magnification factors as indicators of bioaccumulation potential? Conclusions from a case study on per- and polyfluoroalkyl substances. Integr Environ Assess Manag, 12: 6-20.

We agree, the following text has been included/amended:

Franklin (2016) notes that BMF values for liver are not a good measure for the whole body BMF, as the BMF might be higher or lower. For PFAS the author noted that liver-based BMFs are systematically lower than values on muscle or whole-body concentrations, as liver often represents less than 50% of the total body burdens (Franklin, 2016). BCPS behaves differently to PFAS mentioned. For BCPS it is reasonable to assume a more hydrophobic mode for bioaccumulation. In this case, taking whole fish and cormorant breast muscle or liver BCPS concentrations, the calculated BMF value results are 3.3 and 10.9 (Table 38), respectively. Using seals liver and herring, the calculated BMF value is 6.7. 

Trends were deleted in the summary on page 9 and 91, also on page 69 and 88. 

We agree. Due to bad formatting the legends were not visible to the reader, this has been fixed. 

We agree, for clarification text was revised: 

“The authors explained that the clean-up method used was not primarily designed for analysis of BCPS. Samples were extracted by MTBE after surrogate addition (for recovery determination). The purified extract was analysed by GC-ECD. Mean recoveries range from 75% (13 samples, CB-77 (3,3',4,4'-tetrachlorobiphenyl)) to 99% (11 samples, CB-53 (2,2',5,6'-tetrachlorobiphenyl)). Other validation parameters (i.e., LOD, LOQ, calibration range) were not disclosed. From all investigated substances within this study only BCPS increased over time from the 70s to the 80s. 

In detail, in the years from 1971-76 BCPS ranged from n.d. to low concentrations of maximum of 16 ng/g. From 1987-1991 BCPS was detected in all eggs with geometric mean conc. of 170 (egg from eagles with no reproduction) and geometric mean concentration of 110 ng/g l.w. (eggs from eagles with good reproduction). The highest value was obtained for one egg with a BCPS concentration of up to 610 ng/g l.w. (time period: 1987 – 1991).”

-We agree, “time” added in paragraph and bottom of page 49. 

-Sentence was deleted.

We agree, “annually” added on page 46.

Explanation: the BCPS range in the table from 890-1100 is the range of geometric mean values, a footnote has now been included to better explain it; and in addition, the individual range is given with 760 – 2600, these numbers were added as well. To the value of 1118, following footnote was added: “Geometric mean calculated from all geometric BCPS egg concentrations (=45 eggs)”.

-Thank you for this remark. We have rephrased the sentence according to your suggestion, since it is more meaningful: “In the period between 3 and 5 weeks, the eliminated part is roughly equal to the administered part (99% and 106%) indicating that the steady-state has been reached”.

	
				
5748
2023/04/01	Vertellus Specialties Belgium NV, as OR for Vertellus Specialty Materials (India),
Company,
Belgium	Vertellus Specialties Belgium NV, as OR for Vertellus Specialty Materials (India) and Lead Registrant for this substance, submits the attached comments, annex and confidential annex on behalf of the Registrants as represented by the DCDPS Consortium.  Please see attached comment documents.	Thank you for your comments. 

Responses to the non-confidential comments (including the Appendix by Arnot, 2022) have been included directly into the non-confidential comments document.

See our responses to your comment in the document attached under section ‘General comments on the SVHC proposal’.

		See the corresponding embedded attachment in table 1 of Part I: 5748_DCDPS - nonConfidential Comments.zip

5751
2023/04/03	European Environmental Bureau (EEB),
International NGO,
Belgium	The EEB supports the proposal by Austria to identify bis(4-chlorophenyl) sulphone (BCPS) as SVHC according to Article 57(e) of the REACH regulation. BCPS meets the criteria for very persistent and very bioaccumulative (vPvB) substances based on all weight of evidence.
The substance meets the criteria for persistent and very persistent substances based on a simulation degradation test in sediment. The substance has a biomagnification potential in air breathing organisms, including terrestrial and marine mammals and humans based on the high log Koa. The substance is widely detected in predatory organisms at the top of food chains. In particular, BCPS was detected in seals, mink, otters and (eggs of) fish-eating bird species like white-tail sea eagles, cormorants and guillemots. Field BMFs exceeding the value of 1 have been detected in various food chains (seals/fish, cormorants/fish, and guillemot/fish). Furthermore, BCPS was detected in human liver samples and kinetic data indicate long half-lifes in rats. Based on all weight of evidence the substance meets the criteria for vPvB substances under REACH. The substance is registered under REACH in the tonnage band 1000 - 10.000 tonnes per year and BCPS is widely detected in the environment and biota. Given the vPvB properties of BCPS, further risk management measures are urgently needed to prevent further, irreversible and long-lasting environmental pollution.
	Thank you for your support. 

5753
2023/04/03	Germany,
Member State	The German CA supports the identification of bis(4-chlorophenyl) sulphone (BCPS) as SVHC based on its vPvB properties.	Thank you for your support.

5754
2023/04/03	ANSES,
National Authority,
France	ANSES supports the proposal of identification of Bis(4-chlorophenyl) sulphone (BCPS) as SVHC according to article 57e.

BCPS is persistent/very persistent, the available data clearly shows limited degradation of the Substance in sediment. The half-lifes calculated in a sediment simulation study (half-lifes 842 and 2748 days) exceed substantially the vP criterion for the sediment (hal-life higher than 180 days). The conclusion is supported by screening information and monitoring data which shows the presence of the substance in all the environmental compartments, including air.

Furthermore, based on half-life in air (gas phase: 27.3 days - 54.7 days), models and monitoring data in remote areas, the Substance have a potential of long range transport.

Regarding bioaccumulation properties, the substance seems to exhibits a low bioaccumulation potential on fish. However, the concern increases considerably on air breathing organisms.  Terminal half-life of 12 days in adipose tissue (after single intra-venous application) has been determined in rats. Based in this information, it is expected a BMF value higher than 1 for air-breathing mammals. Monitoring data on wildlife species (fish, birds, eggs, seals) shows that the substance is effectively transfered in the food chain. Indeed, indication of biomagnification from prey to predator is observed in some food chains of the Baltic Region and in Austria resulting in BMF values significantly higher than 1. This is an indication of the very high bioaccumulation of the Substance.  Furthermore, the levels of BCPS found in some wildlife predator species are in the range of some known POP substances (Lindane, PCB-99, α-HCH) which are vB.
Therefore, based on the overall information, the Substance is bioaccumulative/very bioaccumulative.

On this basis, considering the overall lines of evidence, ANSES agrees that the substance meets the criteria for a vPvB substance in accordance with Annex XIII of the REACH Regulation and a SVHC identification under article 57e is justified.
	Thank you for your support.

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

Specific comments on use, exposure, alternatives and risks
Number / Date	Submitted by (name, submitter type, country)	Comment	Responses	
5748
2023/04/01	Vertellus Specialties Belgium NV, as OR for Vertellus Specialty Materials (India),
Company,
Belgium	Please see attached comment documents.	Thank you for your comments. 

Responses to the non-confidential comments (including the Appendix by Arnot, 2022) have been included directly into the non-confidential comments document.

See our responses to your comment in the document attached under section ‘General comments on the SVHC proposal’.	
		See the corresponding embedded attachment in table 1 of Part I: 5748_DCDPS - nonConfidential Comments.zip