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

Substance name: Dodecamethylcyclohexasiloxane (D6)
CAS number: 540-97-6
EC number: 208-762-8

The substance is proposed to be identified as meeting the following SVHC criteria set out in Article 57 of the REACH Regulation: PBT (Article 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	
4980
2018/04/13	GIFAS,
Industry or trade association,
France	Please refer to attached letter	Thank you for the information and comments. These are relevant for the Part II and hence will be considered in the follow-up steps after the identification process. 

You also have commented that regulatory risk management measures are not predictable after the SVHC identification step. This comment is not related to the hazard properties of the substance and therefore not responded here.	
		Attachment: 4980_20008_SVHC_Consultation_ECHA-othersubstances_13avr18.pdf

5016
2018/04/19	Framtiden i våre hender,
National NGO,
Norway	General comment: We, the Norwegian environmental NGO Framtiden i våre hender (Future in our hands) strongly support that D6 should be put on the SVHC list because of the potential risk the substance pose to the environment, and its extensive use in so many products. 	Thank you for your support. Thank you for the information and comment. Comments on socio economic aspects, use and exposure are not relevant for SVHC identification, but are thankfully recognized and will be considered in the context of prioritization for Annex XIV and restriction.	
5052
2018/04/20	The Personal Care Products Council,
Industry or trade association,
United States	Attachment: 5052_PCPC submission SVHC D4,D5,D6.pdf

	Thank you for the information and comment. Comments on socio economic aspects, use and exposure are not relevant for SVHC identification, but are thankfully recognized and will be considered in the context of prioritization for Annex XIV and restriction. With regard to your comments related to the selected risk management options we kindly point out that the SVHC-identification process is only covering questions related to the PBT/vPvB assessment as outlined in Articles 59 and 57 of REACH, section 4.0 and 4.1 of Annex I to REACH and Annex XIII to REACH. Generic questions related to the suitability of the regulatory risk management route are not to be addressed in the SVHC -proposal. In relation to your comments on the PBT/vPvB assessment we kindly refer you to the responses to comments number 5058 and 5123.	
5058
2018/04/21	Individual,
Canada	Attachment: 5058_Comments on Annex 15 Reports Gobas.pdf

	See attached document.
	
5086
2018/04/23	LightingEurope,
Industry or trade association,
Belgium	Attachment: 5086_LightingEurope Response to ECHA Consultation on D4 D5 D6 - 20180423 - FINAL.pdf
	Thank you for the information and comment. Comments on socio economic aspects, use and exposure are not relevant for SVHC identification, but are thankfully recognized and will be considered in the context of prioritization for Annex XIV and restriction.  	
5102
2018/04/23	Germany,
Member State	We support the identification of D6 as a substance of very high concern as proposed by ECHA.	Thank you for your support.	
5109
2018/04/23	Individual,
United Kingdom	Attachment: 5109_D4 D5 D6 Consultation regarding SVHC and candidate listing_2010423_PFA.docx

	In addition to the responses provided below, we kindly refer also to our responses to comments number 5058 and 5123.

 “The author does not consider that some of the PBT/vPvB criteria are sound scientifically, but it is of course necessary to accept the decision of the MSC that the criteria currently in the Regulation are met.”

We note that this comment acknowledges that the current criteria are met.

“The thrust of this document is to consider the properties of the substances in a general way, exposure of the environment to them, and then to suggest what is proportionate regulation. […] It is important to note that the effort required by all stakeholders if SVHC status was assigned would be disproportionate to any gain in the quality of the European or global environment.” 

The assessment of the different regulatory options is not part of the SVHC identification process. We note that the conclusion from the informal risk management option analysis (RMOA) for these substances is available on ECHA’s website (see “PACT”).

“Although it is understood that PBT and vPvB criteria relate to precaution, the Regulation is considered primarily with uncertain long term and remote effects. On the question of persistence, only sediment is a concern. […] Most of the substance partitions to air […]”

Even if only a small percentage of the substance partitions to sediment, modelling studies show that these concentrations in sediment will persist and act as a long-term reservoir. While pollution of remote areas is indeed of concern, the potential for long-range transport is not included in the PBT/vPvB criteria and hence, we do not see a focus on remote effects in the current SVHC proposal. Furthermore, the atmospheric half-life is significantly higher than 2 days and therefore, airborne D4 may be transported over large distances and reach remote areas. As mentioned in the comment, re-deposition is predicted to be low by current modelling tools. However, the potential to reach remote areas is at least worth noting in this context. 

“Bioconcentration is high but biomagnification data do not suggest that a food-chain route applies.”

We would like to note that, even though biomagnification was not observed in the majority of food webs, there are single studies with TMFs > 1 and predator-prey relationships with BMFs > 1. In addition, a dietary BMF > 1 (kinetic value, growth-corrected and lipid-normalised) was reported in Rainbow trout for D4 and D5. We also think that high bioaccumulation in a part of the food chain (e.g. via bioconcentration) is of concern as well.

“Toxicity effects are not severe ” 

D4 fulfills the REACH criterion for toxicity based on both aquatic and mammalian classification endpoints. Toxicity which would be due to D5 and D6 (excluding effects due to D4 as impurity) is not covered in the SVHC proposals. Hence no conclusion is attempted for D5 and D6 based on their intrinsic potential toxicity.

“following the restriction of D4 and D5, the absolute amounts in the environment are very low. Conventional risk characterisation ratio (RCR-based) risk-assessment is able to control these substances effectively. […] limitation of releases to air would provide no practical reduction risk of significant exposures of the environment.” 

Based on section 4.0.1 of Annex I to REACH conventional risk characterization does not address the risks of a PBT/vPvB substance in a sufficiently high certainty.	
5115
2018/04/23	Individual,
Canada	Attachment: 5115_cVMS-update-report-2018-04-22.pdf
	In addition to the responses provided below, we kindly refer also to our responses to comments number 5058 and 5123. Please, note that the comment has been submitted to all three substances D4, D5 and D6. The cited comment may refer to the German CA as Dossier Submitter, which is not the case for D6. For reasons of coherence and transparency, we have inserted the same extracts of the comment here as has been done in the responses to comments of the SVHC-proposals on D4 and D5 by Germany.

“The term weight of evidence is used ever increasingly to imply an objective examination of all the available information and its weighting for quality, weighting of individual types of evidence and the relevance of the findings. However, as in the reports by the MSC and the German CA the term is often used with no identification of the methodological details nor how these have been applied to reach the conclusions.” 

Please, see our responses to comments 5058 and 5123.
 
“the recent studies mentioned here were critically assessed for the above attributes and whether they were in support or provided contrary findings to our published assessment conclusions.” 

Our report contains a description and assessment of the new information and it is discussed whether this information is supportive or in contradiction to the weight of evidence that was applied in 2015 by the Member State Committee.

“In the German CA reports (ECHA 2018a, b, c) and in the previous MSC reports, there is no reference to either the methodology used to weigh the evidence and how it embraces the above ECHA criteria (apart from a single reference to ECHA REACH Annex XIII which provides no useful information on the methodology). In addition, there is no description of the way it was used by the MSC and the German CA to assess the quality and relevance of the extensive data on each of the three cVMSs.” 

With respect to the assessment method applied and the assignment of relevance to the different types of information, we would like to refer to the respective ECHA guidance documents. While we did not cite the ECHA Guidance in every section of the SVHC-proposal, we note that ECHA Guidance is describing the approach for authorities and registrants which we recommend to follow. The relevant MSC documents contain an extensive discussion of reliability, relevance and adequacy for PBT assessment. The MSC Opinion comprehensively discusses the different pieces of information and explains their relevance. The same accounts for the D6 -report. For the reports on D4 and D5, and data on D4 and D5 summarised in the D6 –report, reference is made to the MSC documents as these contain the essential information and we think that the MSC conclusion is still valid. However, new information is described and assessed for reliability and relevance. From our point of view, the basis of our conclusions is made transparent. We do not see a necessity for using a quantitative score in this case. The ECHA Guidance does not require that neither from authorities nor from registrants. For the purpose of weigh-of-evidence determination, derivation of such quantitative weight scores as requested by the comment would not necessarily provide increase of coherence of the data handling, because individual studies or the collated information on individual data types may contain such valuable information for the qualitative weight-of-evidence determination which cannot be expressed as numeric weight for the particular data point of line of evidence. Quite contrary, a qualitative assembly of weigh-of-evidence for each line of evidence and finally for the conclusion on each endpoint P, B, T respectively seems to enable more precise expression of the detailed justifications hence ensuring that the data are used in the assessment to the highest possible and appropriate extent. However, this view for this particular case does not exclude the interest of ours to further develop also quantitative weight-of-evidence methodology for appropriate elements of the PBT/vPvB assessment.

We also would like to note that ECHA has not applied quantitative weight-of-evidence approach in any of the previous SVHC-identifications of PBT/vPvB substances.

“there is no attempt to consider probability and risk” 

Risk and probability are considered in the context of quantitative risk assessment, but based on section 4.0.1 of Annex I to REACH are not appropriate for the PBT/vPvB assessment under REACH.

“For example, different conclusions are reached on the interpretation of the field studies for D5 and D6 although the studies that are apparently referred to are the same in each case.” It would have been helpful to cite the respective studies. 

We cannot find such differing conclusions in the documents. 

“For D5, negative findings from many field studies on biomagnification are discounted using the argument that there are some positive findings in some field studies indicating that bioaccumulation can occur in some food chains and therefore it is concluded that it meets the legal requirement to assign D5 as bioaccumulative. There is no apparent attempt to examine these studies in detail to check there is not a primary source of emissions of D5 in the vicinity. In contrast, for D6, the rationale used for discounting many of the same field studies appears to be that there is no standardized methodology to enable proper interpretation!” 

The dossiers of D5 and D6 were written by different authors and hence, they differ slightly in wording. Furthermore, the reports for D4 and D5 are mainly based on the existing MSC Opinion from 2015 and an assessment of new studies, while the D6 report includes a full review of data.

We do not discount or disregard the field studies with a TMF < 1. In contrast, our report explicitly acknowledges that the majority of field studies shows a TMF < 1. However, we note that these do not refute the concern arising from the high BCF values. We further stated that biomagnification was observed in certain field studies and predator-prey relationships, and that this finding supports the bioaccumulation concern – however, this is not equivalent to a specific conclusion based on all field data if looked at in isolation (without other data types). The dossier transparently explains that the high BCF values are essential for the conclusion, while the available field studies may be regarded as part of the weight-of-evidence. While we did not use the same wording as the authors of the D4 and D5 reports, all reports include a remark that the findings of field studies should be regarded with caution. A full discussion of the uncertainties inherent to field studies has already been extensively carried out in the MSC Opinion referred to in the SVHC –reports on D4, D5 and reference to the Opinion has now been added to Section 3.4.3. At the time of the MSC Opinion the uncertainties of field studies were already recognised the same way as they are today expressed in the ECHA Guidance which the SVHC -report also refers to. 

“The authors of the German CA report were clearly aware of our QWoE, but they did not refer to it other than to mention that we may not have cited a paper they favour. We assume therefore that they have no scientific criticism of the framework or methodology we used.”

While we acknowledge that the paper of Bridges and Solomon transparently describes their own approach for weight-of-evidence assessment, we note that this approach is not following the criteria of REACH Annex XIII and the principles derived from Annex I sections 4.0 and 4.1 of REACH as reflected in relevant ECHA Guidance. For a more detailed explanation, we would like to refer to the respective sections of the SVHC reports.

“the QWoE assessment (Bridges and Solomon 2016) concluded” 

The 2016 paper is now addressed in the SVHC-proposal. 

“Conclusions with respect to persistence in water were limited by great variance in results; however, a recent paper on the fate of cVMSs (Xu et al. 2017) provides insights as to pathways of degradation in water that have not been considered before.” 

The abovementioned study describes the fate of siloxanes in a landfill. Conditions at this site were not standardized and it is questionable whether they are suitable for concluding on degradation in the environment in general. However, the reported results do not seem to be in contradiction to our earlier findings. It is already known that there is significant volatilisation from water. A brief summary of the study has been added to the SVHC-proposal, but the results are not considered further due to the irrelevance of the conditions to the PBT/vPvB assessment. Furthermore, the results do not contradict the overall picture of the substances’ behaviour in air and water. We would also like to note that the vP conclusion of D4, D5 and D6 is based on persistence in sediment.

“These new data need to be considered in risk assessment and especially in modelling of discharges into shallow waters where photo-transformation by solar radiation will occur.” 
These data are not relevant for PBT/vPvB assessment (see ECHA Guidance). However, we agree that they may be useful for exposure assessment. For the sake of completeness, we have included this study in the updated report.

“A new paper on the environmental fate of cVMSs using multimedia fugacity models (Panagopoulos and MacLeod 2018) suggests that, for D5 and D6, but not D4, the persistence criteria for sediment will exceed the REACH-criterion for P.” 

The paper cited here is a multimedia modelling study. We understand that the comment above does not cover all aspects of the study. The paper of Panagopoulos and MacLeod concludes that “The modeled residence times in the water compartment of all chemicals are below the REACH criterion for freshwater. However, the modeled residence times of all chemicals in the sediment compartment exceed the REACH criterion for freshwater sediment, regardless of which KOC values are used.” In a specific regional modelling for Aventfjorden, Svalbard, different residence times in sediment were obtained when applying different modelling parameters. The authors reported that “in the case where we used the ΔHOW measurements of Xu and Kropscott, the residence times were very close to the criterion values for persistence in marine sediments. On the other hand, scenarios using the ΔHOC measurements of Panagopoulos et al. had residence times of VMS that exceeded the REACH criterion for marine sediments in all cases except for D4, where residence times were almost equal to the residence time of the REACH criterion.” While the results of this study are not decisive for our conclusion on persistence, we think that they are in line with the previous findings on persistence in sediment. It also should be noted that the MSC Opinions on D4 and D5 referred to in our SVHC-proposals discuss the question on why overall persistence as metric is not directly applicable for the P/vP assessment under REACH. In brief, this is because the P/vP criteria are compartment specific under REACH and the substance should already be concluded as P/vP if the criteria are exceeded for one compartment. It is the socio-economic assessment carried out as follow-up of SVHC –identification either for under restriction or authorization purpose which can address case specific factors such as overall persistence. It is worth noting the high overall residence times resulting from emission to water in the study of Panagopoulos and MacLeod. The reference has been added to the SVHC -proposal.

“A new paper on modeling the persistence of cVMSs further backs up this suggestion (Kim et al. 2018).” 

This study has been described and discussed in our assessment. This study found high residence times in sediment and therefore, we think that it actually backs our conclusion that the substances are very persistent. For more details, we would like to refer to the respective sections of our report. 

“These results further indicate that D4, D5, and D6 do not behave like the legacy POPs in local or global environments and that they should not be classified as persistent, especially when POV is considered.” 

We note that the criteria of Annex XIII to REACH are not equal to criteria of Annex D of the Stockholm Convention. However, we also note that the cited paper of Panagopoulos and MacLeod found high overall residence times in case these substances are emitted to water. Furthermore, as responded above, the role of overall persistence (Pov) in the persistence assessment according to Annex XIII to REACH is not decisive but persistence in individual compartments. 

“Moreover, studies to measure metabolism of 14-C-labelled D4 and D5 in orally gavaged rainbow trout showed low rates of uptake in the gut (Domoradzki et al. 2017), metabolism in the liver, and rapid clearance from the blood. Elimination half-lives from blood were 38 and 70 h for D4 and D5, respectively (Domoradzki et al. 2017).”

These results had been submitted to the authorities before publication and they were discussed in the MSC Opinion on D4 and D5. 

“In a study conducted using modeled and measured values for organisms in a subarctic freshwater food web, D4, D5, and D6 did not display trophic magnification (Krogseth et al. 2017).” 

This study has been added to our assessment and we also note that this study did not find trophic magnification.

“A study of D4, D5, and D6 in the pelagic food web in Tokyo Bay did not show trophic magnification but rather biodilution (Powell et al. 2017).” 

These results had been submitted to the authorities before publication and they are already discussed in the assessment.

“The results of a similar study on D4, D5, and D6 in pelagic and demersal (bottom dwelling) food chains in the inner and outer regions of Oslofjord were consistent with the observations in Tokyo Bay (Powell et al. 2018).” 

These results had been submitted to the authorities before publication and they were already included in the assessment (under Powell et al, 2010b).

“One paper reported on concentrations of D4, D5, and D6 in the plasma of turtles, cormorants, and seals sampled in various locations in Canada (Wang et al. 2017). […] although these data demonstrate uptake from food, they are not useful for characterization of biomagnification or transfer in the food web.” 

This study has been added to the report. We agree that these findings are related to bioaccumulation, but do not allow for a direct characterisation of bioaccumulation. This is consistent with the way this study and similar studies in our assessment are considered in the overall conclusions.

“A second similar study also reported presence of D4, D5, and D6 in the eggs of European starlings, herring gull, glaucous-winged gull, and California gull collected across Canada (Lu et al. 2017). […] it is not possible to characterise the potential for biomagnification.” 

We have included now the study in our assessment. However, we agree that these findings are related to bioaccumulation, but do not allow for a direct characterisation of bioaccumulation. There are a manifold studies detecting cyclic volatile methyl siloxanes in biota. However, as long as exposure is not quantified in connection with the measurements of concentrations in biota, characterisation of bioaccumulation is not sufficiently accurate. Therefore, this study does not affect our conclusion and in this aspect, we are in agreement with the authors of this comment.

“The assignment of toxicity for all three siloxanes is not related at all to D5 or D6 per se but to the information ECHA has on the possible levels of contamination with D4 which they state is toxic and could be present at the ECHA regulatory threshold of ≥ to 0.1%.” 

We note that the reports for D5 and D6 explicitly state that the intrinsic toxicity of these substances was not assessed. The reports do not conclude on the toxicity of D5 and D6. However, constituents and impurities of a substance are relevant for PBT/vPvB assessment generally if their concentration is ≥ 0.1% (w/w). Therefore, D5 and D6 are considered as PBT in case the respective D4 impurities are above this threshold. This is not equivalent to a conclusion on the toxicity of D5 and D6. D5 and D6 containing less than 0.1% D4 are not considered as PBT. We have added a note to the proposal to clarify this further. Please, see our more detailed response to this issue under comment 5058 (response to “Errors and misinterpretation…”). 

“We note that, although read-across is used for P and B, it is not used for T; indeed, no consideration of read-across from D5 and D6 was used in their assignment of toxicity of D4.” 

Possibility for read across and its justification is dependent on the endpoint. With regard to the conclusion on toxicity of D4 based on classification endpoints, harmonised classification is generally applied. This is coherent with previous SVHC-identifications of PBT substances.

“however, a recent paper has reported on risks from acute and chronic exposures of benthic invertebrates to D4, D5, and D6 (Woodburn et al. 2018).”

This paper is described and discussed in the SVHC –reports on D4 and D5. In those reports it is concluded that the results do not invalidate the T-conclusion for D4, which is based on RAC opinion on harmonised classification of aquatic toxicity and a harmonised classification as reprotoxic cat. 2.  We also refer to our response to your comment “The assignment of toxicity”). 

“The claims that there is no threshold for the D4 toxicity, citing a source which does not provide an adequate basis for this crucial conclusion.”

Such claim that there is no threshold for D4 toxicity has not been made in the SVHC-proposal of DE. They cited the ECHA Guidance when mentioning that “that the properties of a PBT/vPvB substance like D4 lead to an increased uncertainty in the estimation of risk to human health and the environment when applying quantitative risk assessment methodologies (ECHA, 2017a).” They also stated that “For PBT/vPvB substances, it is considered that a safe threshold does not exist.” These statements are based on section 4.0.1 of Annex I to REACH, which highlights that no quantitative risk assessment can be carried out with sufficient reliability for PBT/vPvB substances. They also are based on section 6.5, para 2 of Annex I to REACH, which requires minimisation of emissions and exposures. 

“The Reports ignore the fact that, in the real world, even with worst case scenarios, the levels of D4 do not reach saturation levels in either water or sediment. Since the levels that produce toxicity are substantially greater than these, D4 is not toxic in the real world.” 

Please, see the previous response. Assessment of risks or toxicity of a PBT/vPvB substance in a conventional risk assessment approach encompasses unacceptable uncertainties.

“Weight of evidence analysis has two main components; quality and relevance. To ignore relevance is not a valid use of weight of evidence analysis.” 

In the context of weight of evidence, the term “relevance” refers to relevance for the respective endpoint and /or the respective assessment. Environmental exposure is relevant for concluding on risk assessment, but not for PBT/vPvB assessment. Relevance of the available toxicity data was considered adequately. Hence, we do not share the position that relevance was ignored. 

“It is noted in the report of D4, but not further considered, that, in fact, it is an intermediate and not a commercially used siloxane.” 

Use and exposure are not considered in the context of PBT/vPvB assessment. However, this information will be considered at a later stage (i.e. when substances are prioritised for inclusion in Annex XIV and/or for restriction).

“The focus therefore, as identified above, is the possibility that the presence of D4 as a contaminant […] in D5 and D6 requires that both these siloxanes should be classified as toxic. 

As mentioned above, there is no conclusion on the intrinsic toxicity of D5 and D6, but it is concluded that D5 and D6 may contain a PBT substance and in such case when the specified concentration limit of 0.1 % w/w is exceeded, should be considered as SVHC based on PBT properties. Please, see our more detailed response to this issue under comment 5058 (response to “Errors and misinterpretation…”) and our response below. The proposal for identifying D6 as PBT based on its impurity D4 and its concentration is not equivalent situation to concluding D5 and D6 as fulfilling T criterion and hence being themselves intrinsically PBT. It may be possible to produce D5 or D6 with a D4 content below 0.1%, in which case the respective substance D5 or D6 would be according to the proposals considered vPvB but not PBT.

“It should be noted that […] once released into the environment D4 will not remain co-associated with either D5 or D6.” 

The concern with substances containing PBT constituents/impurities is not that they might be co-associated with their PBT impurities, but that the PBT impurities will be in short or in long-term released from the substance composition matrix and then behave in the environment based on their own intrinsic properties. The concentration limit of 0.1 % (w/w) is in line with other EU-legislation and with previous SVHC-identifications (see also ECHA Guidance).

“It is difficult to understand the benefits of such labelling to consumers and other users.” 

This aspect is not in the scope of PBT/vPvB assessment in the SVHC-identification. Please, see for related discussion in the risk management options analysis of the substances (see “PACT”). 

“This is a purely qualitative statement with no context identified.” 

ECHA note: this comment and response are not related to the SVHC-proposal on D6 but are kept here for reasons of coherence as the comment document was addressed to all three proposals D4, D5 and D6.

The sentence in question refers to effects that have been observed in sediment species. Quantitative information is not given as this information is not used for concluding on toxicity. However, the cited source contains quantitative information. We do not agree that there is no context, as this sentence is part of the section about toxicity to sediment organisms.

“i.e. a qualitative statement has less uncertainty attached to it than assessment of the actual risk” 

Uncertainties and policy choices are inherent to any quantitative risk assessment, but in the case of PBT/vPvB substances, uncertainty of exposure assessment and toxicity assessment is too high. Therefore, section 4.0.1 of Annex I to REACH defines that for PBT/vPvB substances quantitative risk assessment cannot be carried out with sufficient reliability.

“In addition, presumably to strengthen their argument, the German CA report draws attention to concerns regarding effects of D4 on human fertility to support their conclusions.” 

ECHA note: this comment and response are not related to the SVHC-proposal on D6 but are kept here for reasons of coherence as the comment document was addressed to all three proposals D4, D5 and D6.

The harmonised classification as reprotoxic cat. 2 is relevant for concluding on toxicity and hence
“No mention is made of the fact that the EU expert scientific committee (SCCS 2016) examined in depth the health risks from D5 which might contain up to 5% D4.” We have not conducted a human health hazard assessment. This information is not decisive for the conclusion as long as D4 fulfils the criteria for classification as reprotoxic cat. 2.

“Potential for long range transport”

The potential for long range transport was not assessed in our report and it is not relevant for identification of a PBT/vPvB substance. 

“the full documentation of the methodology for conducting the weight of evidence and transparency of how the conclusions were reached is not mentioned in any of the three documents from ECHA. […]” 
As mentioned above in this document, the assessment of D4, D5 and D6 follows the relevant ECHA Guidance documents. These are publicly available. 

“It appears that, in the report, relevance to real world conditions is not important and that comparison of the behaviour in the environment of D4, D5, and D6 with traditional POPs, which provided the basis for the legislation, also is irrelevant.” 

See also our explanations above. The REACH PBT/vPvB criteria do not refer to environmental exposure. It is important to apply these criteria consistently to all substances in the scope of Annex XIII to REACH. Annex XIII and ECHA Guidance together outline the understanding which tests, and which conditions are considered most relevant, which less relevant. REACH We would further like to note that the REACH Annex XIII criteria are not equivalent to the POP criteria of Annex D of the Stockholm Convention. Furthermore, while it is of scientific interest to compare overall persistence and physico-chemical properties, the criteria specified in REACH are most relevant for this assessment. 

“if relevance is not included, it is not weight of evidence at all!” 

Please see our response with respect to “relevance” above.

“Harmonisation across borders of the regulation of chemicals that may be released into the environment is very important for many reasons (Finne and Wendell 2018).” 

While we agree that harmonisation is desirable, we also note that regulatory frameworks for chemicals are the result of science based policy decisions. The European Union has decided to follow a precautionary approach and to strive for a high level of protection for man and the environment. We are committed to this goal and it is of outstanding importance that we apply the legal text consistently. 

“Based on publications since our very detailed QWoE analysis in 2016, the evidence has been strengthened that D4, D5 and D6 do not warrant classification as P, B or T. if real world conditions (i.e., relevance) is properly considered.” 

We do not agree with this conclusion. While we have responded to the specific details above.	
5121
2018/04/23	Dow,
Company,
United Kingdom	Confidential attachment removed
	Confidential response removed
	
5123
2018/04/23	Cefic CES - Silicones Europe,
Industry or trade association,
Belgium	CES-Silicones Europe urges MSC members to:
• consider a separate in-depth scientific discussion on the applicability of the Annex XIII criteria to inorganic/organic siloxanes;
• question the “PBT” proposal for D6 based on D4 impurity level, as it is questionable that D4 meets the T and it does not reflect test results on those substances;
• consider the data on PBT/vPvB properties in context of relevant conditions applicable to the substance in the environment, as required by Annex XIII;	Please, see responses in the attached document.

		Attachment: 5123_D6 CES Submission.zip

5130
2018/04/23	Verband der Chemischen Industrie e.V.,
Industry or trade association,
Germany	Siloxanes have unique physico-chemical properties due to their ‘hybrid’ nature, namely an inorganic backbone chain of successive silicon and oxygen atoms (Si-O-Si units) and organic entities on the Si atoms of the chain. The inorganic backbone drives the unique properties of silicone polymers and makes this type of chemistry distinctly different from carbon-based chemistry (e.g. the Si-O bond is stronger than a C-O bond). The ‘hybrid’ nature of siloxanes raises questions about the applicability of the REACH Annex XIII criteria to this set of chemistry, as these criteria specifically apply to “organic substances, including organo-metals”, as stated in the introduction of REACH Annex XIII.

Although new studies contesting the PBT and/or vPvB properties attributed to D4, D5 and D6 have been published, to our knowledge Germany and ECHA seem not to have included some of this more recent information and have not documented in a systematic and robust manner how they had applied a weight-of-evidence determination comparing the new studies against the information listed in Annex XIII.

Against this background it is necessary to have a much more thorough and more transparent discussion on these substances. Industry experts should be closely involved. The future discussion should consider D4, D5 and D6 separately. New studies must be included in the assessment.  Especially all data on PBT/vPvB properties in context of relevant conditions applicable to the substance in the environment, as required by Annex XIII, need to be considered. A weight-of-evidence approach should be used in an overall assessment of all studies. It is important to discuss and advise on how to apply a predefined and transparent weight-of-evidence step-wise approach to this specific chemistry set, including how metabolism and field data can be weighed in the assessment.	While we acknowledge that siloxanes are a specific group of compounds, we consider them to be organic compounds. Generally, the term “organic chemistry” comprises all compounds of carbon with a few exceptions; these exceptions do not include methylsiloxanes. 
Therefore, methylsiloxanes are considered to be in the scope of Annex XIII. No specific reason is given why the Annex XIII criteria should not be applicable to methyl siloxanes.

The comment refers to new studies contesting the PBT and/or vPvB properties not included in the assessment of German CA. Regrettably, it remains unclear to which studies the comment refers to precisely. We had included all relevant new information that we were aware of. Some of the other comments cited single missing studies that we have included in our updated reports. The assessment of the PBT and vPvB properties of D4 is based – to our knowledge – on all relevant studies available for the assessment of these properties. 
While this comment does not give a clear explanation what it refers to with “relevant conditions” and “predefined and transparent weight-of-evidence”, we note that similar aspects were discussed in the comments 5123 and the response on the comment number 5115. Please see our response to these comments for a further discussion on these aspects.
We do not agree with the claim that the documentation is not systematic and robust and that a weight of evidence is lacking. No justification is given for that statement.
We describe and discuss the new information and their relevance with respect to the MSC Opinion.
It is transparently documented how both the existing MSC assessment and the new data were considered for reaching a conclusion in a weight of evidence. While the MSC Opinion contains a comprehensive weight of evidence determination for the data available at that time, we considered the new information and evaluated whether it leads to different conclusions in a new weight of evidence determination.

We consider that no further discussion beyond the SVHC-identification on the PBT/vPvB properties of these substances is necessary. In accordance with REACH and the relevant ECHA Guidance, the available information is sufficient to conclude.	
		-		
5145
2018/04/23	Cosmetics Europe,
Industry or trade association,
Belgium	Attachment: 5145_Cosmetics Europe comments on the proposal for a SVHC classification of D4 D5 and D6.pdf

	We kindly refer you to the responses to comments number 5058 and 5123.

5174
2018/04/23	European Siliconized Paper Association ,
Industry or trade association,
Germany	No specific comments - see attached letter	Thank you for the information and comment. Comments on socio economic aspects, use and exposure are not relevant for SVHC identification, but are thankfully recognized and will be considered in the context of prioritization for Annex XIV and restriction. In relation to your comments on the PBT/vPvB assessment we kindly refer you to the responses to comments number 5058 and 5123.	
		Attachment: 5174_ESPA Response to the Call for Evidence on D4-D5 SVHC Listing - 01.pdf
		
5178
2018/04/24	CES-Silicones Europe,
Industry or trade association,
Belgium	Attachment: 5178_Details comments on Section 3 0  Environmental Fate D6 SVHC dossier (002).pdf
	Thank you for your comment. We have included the relevant new studies to the report. Please, refert to the responses to comments number 5058 and 5123 in relation to your concerns on the assessment approach.	

Specific comments on the justification

Number / Date	Submitted by (name, submitter type, country)	Comment	Responses	
4968
2018/04/12	ChemSec,
International NGO,
Sweden	ChemSec supports the identification of Dodecamethylcyclohexasiloxane (D6)
as a PBT/vPvB substance based on the evidence presented in the dossier, including read-across to the structurally similar D4 and D5.	Thank you for your support.	
4980
2018/04/13	GIFAS,
Industry or trade association,
France	Please refer to attached letter	Please see our response to your comment in table containing General comments.	
		See the corresponding embedded attachment in table 1 of Part I: 
4980_20008_SVHC_Consultation_ECHA-othersubstances_13avr18.pdf
		
4993
2018/04/18	Finland,
Member State	The Finnish CA supports the identification of dodecamethylcyclohexasiloxane, D6, 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 substances (vPvB) according to Article 57 (e) of Regulation (EC) No 1907/2006 (REACH).

As stated in the Annex XV report, “Dodecamethylcyclohexasiloxane (D6) meets the criteria for a vPvB substance according to Article 57 (e) of REACH based on its intrinsic properties. Additionally, D6 meets the criteria for a vPvB substance due to its impurity octamethylcyclotetrasiloxane (D4) and/or decamethylcyclopentasiloxane (D5) (concentration ≥ 0.1 % w/w). Furthermore, D6 meets the criteria for a PBT substance. This conclusion is drawn because D6 contains octamethylcyclotetrasiloxane (EC no: 209-136-7; D4) which is typically present as an impurity in relevant concentrations (typically above or equal to 0.1 % w/w). In conclusion, dodecamethylcyclohexasiloxane (D6) is identified as a PBT/vPvB substance according to Art. 57(d) and (e) of REACH by comparing all relevant and available information listed in Annex XIII of REACH with the criteria set out in the same Annex, in a weight-of-evidence determination.”

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

Page 11, Table 3:
Comment: In table 3 there is no information about typical concentrations of impurities of D6. It is mentioned in the Annex XV report (on page 8) that” D6 contains octamethylcyclotetrasiloxane (EC no: 209-136-7; D4) which is typically present as an impurity in relevant concentrations (typically above or equal to 0.1 % w/w).”. This information could be added also to Table 3, for consistency. If for the other impurities listed in Table 3 (D3, D5, D7) similar (non-confidential) information is available, this could also be added to Table 3.

Page 21: “Although these deviations from the OECD Test Guideline are not ideal, the results of the study suggest strongly that degradation of D5 in sediment is predominantly an abiotic process and so the prolonged storage of the sediment prior to test initiation may not be so important in this case.”
Comment: Please consider modifying this for example by: “Although these deviations from the OECD Test Guideline are not ideal, it is noted that the study was conducted at 24 oC and the half-lives are above the vP criterion for sediment even without applying a temperature correction to 12 oC, which is regarded as a reasonable alleged average temperature for the European Union”.
Reasons: The results from this OECD 308 based test (Xu 2010) do not seem to support the statement that degradation in sediment is predominantly an abiotic process. The half-life was 2.3-fold in the sterile aerobic test (2700 days) compared to the biotic aerobic test (1200 days), suggesting that biotic degradation was higher than abiotic degradation. In the sterile anaerobic test the half-life (800 days) was lower (0.26-fold) of that in the biotic anaerobic test (3100 days). This suggests that abiotic degradation would be lower in the biotic anaerobic test compared to the sterile anaerobic test, which is difficult to explain. Therefore, at least without further information on the test (e.g. derivation of the half-lives) it seems difficult to conclude from this study alone that degradation in sediment is predominantly an abiotic process. We note that the half-lives exceed the test duration which increases their uncertainty. In addition, it is stated earlier on the same page that, “The effect of the prolonged storage used in the current study on the biological viability of the sediment is unknown.”. If there is no information on whether/how the prolonged storage has affected the degradation half-lives, it does not seem possible to conclude on the relative importance of abiotic and biotic degradation in sediment. In addition, differentiating between abiotic and biotic processes seems to be of less relevance in this case as the half-lives for both biotic and sterile tests are clearly above the P/vP criteria.

The main question therefore is why the results, especially for the biotic test, are considered acceptable for persistence assessment despite the long storage time. We note that this study (Xu 2010) has been used by UK-CA and MSC in their conclusions that D4 and D5 are vP in sediment (MSC opinion and Annex 3 – PBT report for D5; https://echa.europa.eu/fi/about-us/who-we-are/member-state-committee/opinions-of-the-msc-adopted-under-specific-echa-s-executive-director-requests).

The Finnish CA do not contest the conclusion vP. However, we consider that some further information could be given on why the conducted OECD 308 based test (Xu 2010) can be accepted for persistence assessment, taking into account that the effect of the prolonged storage in the study on biological viability of the sediment is unknown.

Page 24, Table:
Comment: Please clarify whether the half-lives presented in the table are from the same study as referred on page 23 (“Under these conditions, the half-lives for D5 and D6 are 0.08 days (1.9 hours) and 1.38 days, respectively, compared with 58 minutes for D4 under the same conditions”. If they are from the same study it could be explained why the results differ substantially from those on page 23 (particularly for the temperate soil).

Page 24, Chapter 3.1.2.3: “D6 has been measured to degrade fast in dry tropical soil conditions whereas half-lives have been observed to increase with increasing humidity of the soil. Half-lives up to ca. 200 days have been obtained in the same study in temperate condition”
Comment: The expressions “tropical soil conditions” and “temperate conditions” are a bit misleading as they refer to laboratory studies. Please add the study temperature and consider modifying, e.g.: “In a non-standard laboratory study (conducted at temperature of x oC) D6 has been measured to degrade fast in dry tropical soil whereas half-lives have been observed to increase with increasing humidity of the soil. Half-lives up to ca. 200 days have been obtained in the same study in temperate soil.”

Page 42: “Uptake of the substance in fish drops off at the final measurement during uptake.
Comment: Please indicate the experimental day that “the final measurement during uptake” refers to. (day 47?)

Page 42: “There is a delay between the final uptake measurement (and exposure continues) and the start of depuration in clean water.”
Comment: Please indicate the experimental days “final uptake measurement” and “start of depuration in clean water” refer to. (days 47, 62, respectively?)

Page 45: Comment: Please remove the duplicated paragraph (starting with “In the tests using Fathead minnow…”).

Page 100: "There are differences between the results from the two statistical methods of kinetic fitting. Preference is given to the sequential results of 12 632 and 7071 l/kg as the fitting appears to be less affected by the delay in depuration commencing and drop in fish concentration towards the end of uptake."
Comment: The report mentions a range of 6600 - 12 600 l/kg for a kinetic BCF of in common carp (Cyprinus carpio) several times (on pages 7, 106, and 125). However, currently the value 6600 l/kg is not included in 3.4.4. or in Table 38. It is indicated in 3.4.4. that preference is given to the sequential results of 12 632 and 7071 l/kg. Therefore, please check whether the 6600 value on pages 7, 106, and 126 should be replaced by 7071 (or 7100) l/kg.

Page 105, Chapter 6.1.1.2: “Difference in bioaccumulation observed between Fathead Minnow and common carp can be explained by the fact that Fathead minnow is able to metabolise D6 while common carp does not seem to metabolise it.
Comment: Please clarify if the difference in bioaccumulation between fathead minnow and  common carp is known fact based on scientific knowledge or if that is an assumption based on the bioaccumulation studies in the Annex XV report.

Page 123, Table 43.
Comment: Please consider including in Table 43 the half-lives from the analysis of the soil degradation data from the Xu and Chandra (1999) study (on page 24 in Annex XV report) and adding these results as an additional argument in the weight of evidence for vP of D6. These half-lives for D6 were significantly higher than for D4 and D5 (results for D4 and D5 from Environment Agency [EA] (2009b) and Environment Agency [EA] (2009a)). In addition, a comparison of these soil half-lives between D4, D5 and D6 could be added to the summary on persistence on pages 7, 103 and 106 to strengthen the conclusion on the vP property of D6 especially when considering the long storage time of sediment samples in the Xu (2010) study and the fact that the Xu (2010) study is on a read-across substance and not on D6. Even if the soil half-lives (Xu and Chandra 1999) may not be applicable for a direct comparison to P/vP criteria (as the method deviates from standard tests), a comparison of the relative degradation rates of D4, D5, and D6 could be included.

References:
Environment Agency [EA] (2009a). Environmental Risk Assessment Report: Decamethylcyclopentasiloxane. Environment Agency Science Report, SCHO0309BPQX-E-P, April 2009., (page 79, Table 3.9)
Environment Agency [EA] (2009b). Environmental Risk Assessment Report: Octamethylcyclotetrasiloxane. Environment Agency Science Report, SCHO0309BPQZ-E-P, April 2009., (page 64, Table 3.8)	Thank you for supporting our proposal. With respect to the specific comment, please, see attached file.

		-		
5025
2018/04/20	Norway,
Member State	Norway supports that Dodecamethylcyclohexasiloxane (D6) should be identified as a substance of very high concern and should be included in the Candidate list. We agree that the substance fulfil the criteria of Annex XIII of REACH as a vPvB substance. This is sufficiently demonstrated by the laboratory-generated data and field data described in the report. Concerning P we support that read-across to D4 and D5 (sediment data) is appropriate (and the assumption that D6 can be expected to be even more persistent than D4 and D5). Concerning bioaccumulation, we agree that the field data described in the report demonstrate that D6 undergoes biomagnification and trophic magnification in certain food webs in the environment. As a further support to the data included in the report we would like to mention that monitoring of cyclic siloxanes in the food webs of Lake Mjøsa and Randsfjorden has been continued each year since the Borgå et al. studies referenced in the Annex XV report. In the latest report M-807 (see link below) all data from the period 2010–2016 was compiled. They confirm biomagnification of D5 in Mjøsa and Randsfjorden with a common trophic magnification factor (TMF) of 2.34 (95% confidence interval: 2.03-2.70) and biomagnification of D6 with a common TMF of 1.92 (1.62-2.30).
We agree that information indicating that biodilution occurs in some food chains or in parts of some food chains does not invalidate the other lines of evidence.
Furthermore, D6 also meets the criteria for a PBT substance according to Art. 57(d) of REACH when containing D4 as an impurity above or equal to 0.1 % w/w.

(http://www.miljodirektoratet.no/Documents/publikasjoner/M807/M807.pdf)	Thank you for your support. We have updated the report with the data provided.

5052
2018/04/20	The Personal Care Products Council,
Industry or trade association,
United States	D4, D5 and D6 do not meet the criteria for SVHC, and scientific assessments in the EU and other countries have demonstrated that prohibition of these substances in leave-on cosmetic products would be a disproportionate measure in light of the minimal environmental impact.Please see attached document for further detail.	Please, see our response to your comment in the General comments –table.	
		See the corresponding embedded attachment in table 1 of Part I: 
5052_PCPC submission SVHC D4,D5,D6.pdf		
5058
2018/04/21	Individual,
Canada	Re: Annex XV report: PROPOSAL FOR IDENTIFICATION OF A SUBSTANCE OF VERY HIGH CONCERN ON THE BASIS OF THE CRITERIA SET OUT IN REACH ARTICLE 57

Chemical Substance: D6
CAS-Number: 540-97-6
EC Number: 208-762-8

Pages : 7-8 and following pages.

I wish to report a number of mistakes, omissions and unclarities in the Annex 15 reports for D6, that I have summarized in an attachment submitted in section IV of the Comments on an Annex XV SVHC report published in the context of SVHC identification in accordance with REACH Article 59 as additional non-confidential information. The file attachment is named Comments on Annex 15 Reports Gobas.pdf.	Please, see our response to your comment in the General comments –table.	
		See the corresponding embedded attachment in table 1 of Part I: 
5058_Comments on Annex 15 Reports Gobas.pdf		
5078
2018/04/23	CHEM Trust,
National NGO,
United Kingdom	CHEM Trust supports the inclusion of dodecamethylcyclohexasiloxane (D6) in the REACH candidate list based on its identification as a PBT/vPvB substance according to Art. 57(d) and (e) as presented by the comprehensive data assessment in the Annex XV dossier in a weight-of-evidence determination.	Thank you for your support.	
5086
2018/04/23	LightingEurope,
Industry or trade association,
Belgium	No specific comments.	Please, see our response to your comment in the General comments –table.	
		See the corresponding embedded attachment in table 1 of Part I: 
5086_LightingEurope Response to ECHA Consultation on D4 D5 D6 - 20180423 - FINAL.pdf		
5092
2018/04/23	Individual,
Canada	A Discussion of Aspects of the Environmental Fate and Effects of D4, D5 and D6.
Donald Mackay, Trent University and University of Toronto, April 2018

Summary
This is a brief personal perspective of aspects of the scientific basis for the environmental management of the chemicals D4, D5 and D6 (collectively termed the cyclic volatile methylsiloxanes or cVMS). It is based on my observations of recent monitoring and modeling advancements on their fate and possible effects. The aim is to contribute to the science underlying a decision on possible nomination as ‘Substances of Very High Concern’ based on their PBT properties (European Chemicals Agency (ECHA), 2018; German CA, 2018a; German CA, 2018b). These reflections are presented in six subject areas.  A high-level summary is also provided.
1. Chemical Space Perspective: cVMS occupy a space far removed from the conventional POPs. The cVMS compounds have much larger values of KAW (by factors of typically 105) although KOW values are similar. They are also generally more reactive than persistent substances such as HCB and PCBs, especially when exposed to strong oxidants such as OH radicals and to certain enzymes.
2. Extreme Hydrophobicity:  cVMS have extreme hydrophobicity.  Traditional POPs (such as HCB and many PCBs) are often less hydrophobic which results in a substantial fraction of these substances being present in the aqueous environment. In addition, the extreme hydrophobicity of cVMS results in values of KAW of 500 to 1400 compared to values less than 0.1 for PCBs. As a result, any free cVMS in an aqueous environment is subject to rapid volatilization. Therefore, cVMS will be short-lived in the aqueous environment as freely dissolved substances once released.
3. Reactivity and Persistence: The cVMS compounds will predominately be present environmentally in water as cVMS-OM (organic matter) complexes leading to some persistence in water and sediment.  It is known that cVMS are also metabolized In biota with half-lives ranging from days/weeks to months. This contrasts with the longer half-lives of years for HCB and PCBs. This increased rate of cVMS biotransformation has profound implications for bioaccumulation and toxicity.
4. Bioconcentration, Bioaccumulation and Biomagnification: Partitioning from water (i.e., bioconcentration factor (BCF)) is no longer relevant for cVMS because the low aqueous concentrations caused by the low inherent solubility in water and sorption to OM cause respiratory uptake and loss rates to be negligible.
5. BMFs, TMFs and lipid normalization: For cVMS it is important to assess both wet- and lipid-weight normalizations to understand the most relevant mechanism of bioaccumulation, namely dietary uptake.
6. Aquatic Toxicity: Standard aquatic toxicity tests are inappropriate for cVMS. It is important to take into consideration the relevant conditions that these substances will be found in the environment when considering toxicity potential.
Weighing these issues leads to a conclusion that when considering whether or not to designate cVMS as substances of high concern, the use of conventional PBT-POP criteria can be highly misleading. In my opinion there is a need to revise the chemical assessment protocols to address risk under the real environmental conditions that result in human and ecosystem exposure. As discussed recently by McLachlan (2018), cVMS are but one example of this need.	Please, see our responses in the following document and to comments 5123 and 5058:

	
		-		
5109
2018/04/23	Individual,
United Kingdom	Page 106. The Part I of the document (section 6.1.2) concludes that PBT/vPvB criteria are met, and it is therefore implied that should be sufficient for identification as SVHC. That is accurate in a strict sense as long as BCF is taken as the key measure of B (without a real assessment of weight of evidence). Further, the conclusion takes no account of the fact that the possible impacts on the environment are limited in respect of environmental compartment (sediment), and that only a small fraction of the produced substances arrives in sediment. The attachment expands on these points.	Please, see our response to your comment in the General comments –table.	
		See the corresponding embedded attachment in table 1 of Part I: 
5109_D4 D5 D6 Consultation regarding SVHC and candidate listing_2010423_PFA.docx		
5115
2018/04/23	Individual,
Canada	All
In 2016, we published a quantitative weight of evidence (QWoE) assessment of the persistence, bioaccumulation, toxicity and potential for long range transport of the cyclic volatile methyl siloxanes.  Several recent studies have been published in the scientific literature that do not appear to have been considered by ECHA. The attached Summary Report is an analysis of the regulatory reviews and the recently published studies in the context of the fully documented QWoE analysis of the cyclic volatile methyl siloxanes.

Prof. James Bridges, Toxicology and Environmental Health, University of Surrey, Guildford, Surrey, United Kingdom < j.bridges@surrey.ac.uk >

Prof. Keith R Solomon, Centre for Toxicology, School of Environmental Sciences, University of Guelph, Guelph, Ontario, Canada < ksolomon@uoguelph.ca >	Please, see our response to your comment in the General comments –table.	
		See the corresponding embedded attachment in table 1 of Part I: 
5115_cVMS-update-report-2018-04-22.pdf		
5121
2018/04/23	Dow,
Company,
United Kingdom	Confidential D6 composition information attached.	Please, see our response to your comment in the General comments –table.	
		Confidential attachment removed
		
5123
2018/04/23	Cefic CES - Silicones Europe,
Industry or trade association,
Belgium	See P 3 to 13 of the document: Comments SVHC dossier D6 long version.
Taking into consideration the requirement under Annex XIII that, “The information used for the purposes of assessment of the PBT/vPvB properties shall be based on data obtained under relevant conditions”, although D6 may meet some of the numerical criteria under Annex XIII, it is critical to consider the data in context of relevant conditions applicable to D6 in the environment.

Although the DS has ignored the recently published weight-of-evidence by Bridges and Solomon, 2016, the authors actually do exactly what Annex XIII specifies to do regarding taking into consideration “data obtained under relevant conditions” in their weight of evidence assessment to conclude that D6 should not be considered vPvB.

We urge the MSC members to consider an in-depth scientific discussion on the applicability of the Annex XIII criteria and application of weight-of-evidence to this specific chemistry set and regret that such considerations have not been made before proposing an SVHC identification review.	Please, see our response to your comment in the General comments –table.	
		See the corresponding embedded attachment in table 1 of Part I: 
5123_D6 CES Submission.zip		
5133
2018/04/23	ANSES,
National Authority,
France	The proposal for the identification of Dodecamethylcyclohexasiloxane (D6) as substance of very high concern is based on a weight of evidence approach of relevant available information. The proposal document includes the assessment of experimental data with D6, QSAR and modelling information, read across with similar substances as D4 and D5 and a benchmarking approach.

Contrary to D4 and D5, D6 has not been discussed previously in the RAC or the MSC.

Persistence (P): According to the results of an OECD TG 310 study, D6 is not ready biodegradable, thus the substance meets the screening criteria for P/vP properties. Furthermore, considering that the analogues D4 and D5 fulfil criteria for vP in the sediment compartment, the same conclusion is expected for D6, with even more persistence than both analogues due to physical chemical properties.

Bioaccumulation (B): Several studies show the bioaccumulation of D6 in aquatic organisms. From the key study of CERI, 2010, the kinetics BCFs calculated in common carp (Cyprinus carpio) after growth correction are up to 12632. Furthermore, some field studies regarding biomagnification suggest that the substance can biomagnify in some food chains (TMF or BMF>1). Thus, considering all the available information presented in the dossier, D6 fulfils the vB criterion of Annex XIII of REACH.

Regarding to Toxicity (T) properties, human health toxicity and ecotoxicity information were not assessed in the proposed document.

Additionally to its intrinsic properties, D6 meets the criteria for PBT as well as  for  vPvB substance due to the presence of  octamethylcyclotetrasiloxane (D4)  and  decamethylcyclopentasiloxane (D5) as impurities at more than 0.1% in the composition.

Taking into account all the information presented in the proposal, ANSES supports the identification of Dodecamethylcyclohexasiloxane (D6) as an SVHC according to Article 57(d,e) due to its PBT/vPvB properties.	Thank you for your support.	
		-		
5136
2018/04/23	European Environmental Bureau (EEB),
International NGO,
Belgium	EEB supports the conclusion of the Annex XV proposal to identify dodecamethylcyclohexasiloxane (D6) as an SVHC on the basis of the criteria set out in Annex XIII of the REACH regulation. D6 meets the criteria to be identified as vPvB according to Article 57(e). D6 also fulfills the criteria for identification as PBT according to Article 57(d) if containing > 0.1% w/w octamethylcyclotetrasiloxane (D4) as an impurity.

The substance is vP based on all weight of evidence, including read-across from D4 and D5.
Various reliable experimental studies report BCFfish  > 5000 for D6, indicating that D6 should be considered vB. This is further supported by field data suggesting trophic magnification in certain environmental food webs.

D6 is a high volume substance with wide dispersive use pattern, including consumer use. D6 may be considered as a substitute for D5 and D4. Therefore D6 should be listed on the Candidate List without delay and further risk management measures should cover D4, D5 and D6 together.	Thank you for your support.	
5145
2018/04/23	Cosmetics Europe,
Industry or trade association,
Belgium	Considering the most recent data summarized by CES, CE does not consider D4, D5, or D6 as being chemicals with a PBT profile.
In particular, Cosmetics Europe would like to highlight the following points:
-Although new studies contesting the PBT and / or vPvB properties attributed to D4, D5 and D6 have been published, Germany and ECHA have not taken them into consideration properly as WoE.

-Cosmetics Europe does not understand the basis for the conclusion that D5 and D6 should be considered as PBT on the basis of their impurity profile because D5 and D6 have been individually tested on their own merit and  the results indicated that there was no basis for the decision to propose D5 as PBT.

For more details on the points mentioned above, Cosmetics Europe refers to the input to the present public consultation on the SVHC dossiers for D4, D5 and D6 submitted by CES.	Please, see our response to your comment in the General comments –table.	
		See the corresponding embedded attachment in table 1 of Part I: 
5145_Cosmetics Europe comments on the proposal for a SVHC classification of D4 D5 and D6.pdf		
5174
2018/04/23	European Siliconized Paper Association ,
Industry or trade association,
Germany	No specific comments - see attached letter	Please, see our response to your comment in the General comments –table.	
		See the corresponding embedded attachment in table 1 of Part I: 
5174_ESPA Response to the Call for Evidence on D4-D5 SVHC Listing - 01.pdf		
5178
2018/04/24	CES-Silicones Europe,
Industry or trade association,
Belgium	The attached document summarises CES-Silicones Europe’s comments on D6 SVHC Dossiers specific to Section 3 which summarized the Environmental fate data.	Please, see our response to your comment in the General comments –table.	
		See the corresponding embedded attachment in table 1 of Part I: 
5178_Details comments on Section 3 0  Environmental Fate D6 SVHC dossier (002).pdf		

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	
4980
2018/04/13	GIFAS,
Industry or trade association,
France	Please refer to attached letter	Please, see our response to your comment in the General comments –table.	
		See the corresponding embedded attachment in table 1 of Part I: 
4980_20008_SVHC_Consultation_ECHA-othersubstances_13avr18.pdf		
5019
2018/04/19	G. Pohl-Boskamp GmbH & Co. KG,
Company,
Germany	Modern head lice treatment products are based on dimeticon and silicon oil. Dimeticons contain one or more cyclosiloxanes as contaminants: octamethylcyclotetrasiloxane (D4), decamethylcyclopentasiloxane (D5) and/or dodecamethylcyclohexasiloxane (D6).
Even today, infestations with head lice are still the second most common childhood ailment after the common cold. According to estimates, one third of all children have had head lice at least once by the age of 18.
The treatment with a conventional head louse agent based on a classic insecticide with a neurotoxic mode of action can increase the problem of resistance of head lice to conventional neurotoxic insecticides. Modern pediculicides based on dimeticone have a physical mode of action. Dimeticone penetrates deep into the breathing system of the lice and larvae and into the breathing openings of the nits and blocks them irreversibly, thus suffocating both mature lice and their intermediate stages.
G. Pohl-Boskamp GmbH & Co. KG is a manufacturer of pediculicides, and of a product for physical removal of scales and encrustations of the skin. These products contain D4 or D5, only as contaminants in concentrations of not more than 1%, depending of the dimeticone used for production. The above mentioned products containing D4/D5 are substance-based medical devices regulated by the Medical Device Directive (MDD) 93/42/EEC and thus affected by possible restrictions through REACH regulation.
The cyclosiloxanes D4/D5/D6 are contaminants of the containing silicone oils, which are the functional components of the products responsible for the physical mode of action.
Possible alternatives to D4/D5/D6 are not available, since there are no contaminant-free silicone oils present on the market. G. Pohl-Boskamp GmbH & Co. KG got the following statement of a manufacturer of silicone oils: “Given the current manufacturing process, these substances are impurities technically unavoidable under good manufacturing processes.”
With regard to socio-economic impacts of a potential restriction (e.g. possible costs for our company or our supply chain or the public) we cannot present precise data for Europe. But in Germany, the market share of pediculicides based on dimeticone among all head lice preparations is 55.9% (source: Pharmatrend national, IQVIA). An estimate of the costs is difficult but as the medical devices in question made up more than 15% of the annual turnover of G. Pohl-Boskamp GmbH & Co. KG in 2017, the socio-economic impacts would be noticeable for us.
Without any doubt, a restriction which would force the silicone oil manufacturers to reduce the contaminants D4/D5/D6 in their product to a minimum would lead to higher prices for these raw materials, which in turn would lead to higher production costs of the medical devices and to higher prices on the health market either for the patient or the health insurances.
If a future restriction of cyclosiloxanes would forbid the use of dimeticones in substance-based medical devices regulated by the Medical Device Directive (MDD) 93/42/EEC a treatment of head lice with acceptable risk-benefit-ratio would be complicated.	Thank you for the information and comment. Comments on socio economic aspects, use and exposure are not relevant for SVHC identification, but are thankfully recognized and will be considered in the context of prioritization for Annex XIV and restriction.	
		-		
5052
2018/04/20	The Personal Care Products Council,
Industry or trade association,
United States	See the corresponding embedded attachment in table 1 of Part I: 
5052_PCPC submission SVHC D4,D5,D6.pdf	Please, see our response to your comment in the General comments –table.	
5058
2018/04/21	Individual,
Canada	See the corresponding embedded attachment in table 1 of Part I: 
5058_Comments on Annex 15 Reports Gobas.pdf	Please, see our response to your comment in the General comments –table.	
5086
2018/04/23	LightingEurope,
Industry or trade association,
Belgium	See the corresponding embedded attachment in table 1 of Part I: 
5086_LightingEurope Response to ECHA Consultation on D4 D5 D6 - 20180423 - FINAL.pdf	Please, see our response to your comment in the General comments –table.	
5109
2018/04/23	Individual,
United Kingdom	See the corresponding embedded attachment in table 1 of Part I: 
5109_D4 D5 D6 Consultation regarding SVHC and candidate listing_2010423_PFA.docx	Please, see our response to your comment in the General comments –table.	
5115
2018/04/23	Individual,
Canada	See the corresponding embedded attachment in table 1 of Part I: 
5115_cVMS-update-report-2018-04-22.pdf	Please, see our response to your comment in the General comments –table.	
5121
2018/04/23	Dow,
Company,
United Kingdom	Confidential attachment removed
	Confidential response removed
	
5123
2018/04/23	Cefic CES - Silicones Europe,
Industry or trade association,
Belgium	See pages 14 to 16 of the document: Comments SVHC dossier D6 long version.
	Please, see our response to your comment in the General comments –table.	
		See the corresponding embedded attachment in table 1 of Part I: 
5123_D6 CES Submission.zip		
5145
2018/04/23	Cosmetics Europe,
Industry or trade association,
Belgium	Please see attached document to the present submission. Additional information can also be found in the Cosmetics Europe submission for the public consultation on the proposed identification of D5 as SVHC.	Please, see our response to your comment in the General comments –table.	
		See the corresponding embedded attachment in table 1 of Part I: 
5145_Cosmetics Europe comments on the proposal for a SVHC classification of D4 D5 and D6.pdf		
5174
2018/04/23	European Siliconized Paper Association ,
Industry or trade association,
Germany	No specific comments - see attached letter	Please, see our response to your comment in the General comments –table.	
		See the corresponding embedded attachment in table 1 of Part I: 
5174_ESPA Response to the Call for Evidence on D4-D5 SVHC Listing - 01.pdf		
5178
2018/04/24	CES-Silicones Europe,
Industry or trade association,
Belgium	See the corresponding embedded attachment in table 1 of Part I: 
5178_Details comments on Section 3 0  Environmental Fate D6 SVHC dossier (002).pdf	Please, see our response to your comment in the General comments –table.