General comments
Ref.	Date/Type/Org.	Comments	
32	Date: 2022/06/15 11:29
Org. type: Industry or trade association
Org. name: Japan Auto Parts Industries Association
Org. country: Japan
Country: Japan
Attachment:
	General Comments:
The Japan Auto Parts Industries Association (JAPIA) was established in August 1969 as a “public interest incorporated association” aimed at working to promote the auto parts industry of Japan. 
Since its reorganization in December 2011 as a “general incorporated association”, JAPIA has been engaging in various activities for the further development of the industry.
For automobile safety and comfortable driving, the high quality of each automobile part is a great contribution. The environmental situation in the auto parts industries ran into unprecedented difficulties such as structural change, promotion of international corporations, etc. However, JAPIA actively makes an effort towards these problems together with JAPIA member companies. 
The number of Japanese Automotive Suppliers are 6,700 companies with 686,000 people directly employed. The yearly sales are 290.2 billion euros. Automobile industries accounts for 17.5% of the total manufacturing shipment value in Japan. Automobile parts account for more than 50% of total automobile industry shipment value and half of them are from JAPIA member companies.
JAPIA agree with this draft restriction to adequately reduce BPA, but there are suggestions and concerns as follows.
	
		Submitter response:
Thank you for your agreement to “this draft restriction”.
You propose to perform an assessment of BPAF because BPA and BPAF are used in completely different ways and the toxicity may be different. We agree and therefore provided with this report an assessment of the ED properties of BPAF.	
Ref.	Date/Type/Org.	Comments	
33	Date: 2022/06/16 12:25
Country: Finland
	General Comments:
FI CA considers that for BPAF (EC 216-036-7)  and eight BAF salts the criteria for endocrine disruption as defined by the WHO/IPCS (2002) are met for the environment.	
		Submitter response:
Thank you for your supporting comment.	
35	Date: 2022/06/17 10:08
Org. type: Company
Org. name: EDITED
Org. country: Japan
Country: Japan
Attachment:
EDITED

Privacy statement: Yes	General Comments:
	
		Submitter response:
As the attachment is marked as confidential, the response to the comments therein are included in the non-public version of the “response to comments” document.	
36	Date: 2022/06/17 17:34
Org. type: Other contributor
Org. name: Environment Agency Austria
Org. country: Austria
Country: Austria
	General Comments:
The provided evidence is considered sufficient for an identification as endocrine disruptor for the environment: The adverse effects are relevant for populations, the endocrine activity is sufficiently demonstrated and the link is plausible. 
In order to improve the report, we recommend the following: 
•	The mammalian data should be included into the report
	
		Submitter response:
Thank you for your supporting comment. With regard to the inclusion of mammalian data, we refer to the RAC opinion on the respective CLH dossier for reproductive toxicity.	
40	Date: 2022/06/20 16:20
Org. type: National NGO
Org. name: CHEM Trust Europe eV
Org. country: Germany
Country: Germany
	General comments:
CHEM Trust strongly supports the development of a restriction proposal to address the risks of BPA and structurally relevant bisphenols to the environment. In our report from 2018 ´ From BPA to BPZ – a toxic soup?´  https://chemtrust.org/toxicsoup/ , we demonstrated the fact that companies are being allowed to replace the well-known hormone disrupting chemical BPA with chemicals having a similar hazardous profile to BPA. Our analysis also highlighted BPF and BPAF as relevant substitutes which need to be addressed as a priority in a group approach.
We have long argued that a group restriction for BPA and structurally related bisphenols is long overdue (https://chemtrust.org/bisphenol_group/). A comprehensive group restriction for the bisphenols would be a very important step forward to increase the protection level. It would also be responding to the EU Chemicals Strategy for Sustainability which commits to a ban of EDCs in consumer products as soon as they are identified and allowing their use only, where it is proven to be essential for society. Thus, any derogation should only be granted in exceptional cases based on well-documented reasons and with a time-limit.
In April this year ECHA published the results of an in-depth evaluation of the regulatory needs on the group of bisphenols (see: https://echa.europa.eu/nl/-/group-assessment-of-bisphenols-identifies-need-for-restriction). ECHA and the Member States have assessed a group of 148 bisphenols and recommended that more than 30 bisphenols need to be restricted due to their potential hormonal or reprotoxic effects.  BPF and BPAF are among those 34 bisphenols recommended for a group restriction
We support the chosen procedure of asking MSC for an opinion of the ED properties in order to make efficient use of previous ECHA committee assessments and to avoid further delays and duplication of work.
Specific Comments: 
On the evaluation of endocrine disrupting properties for the environment for 4,4'-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]diphenol (EC 216-036-7, CAS 1478-61-1, “Bisphenol AF”) and its salts (BPAF and salts) by Germany.
CHEM Trust supports the evaluation conducted by Germany that BPAF, and in addition eight BPAF salts, have endocrine disrupting properties for the environment. 
Overall, the presented data clearly show that BPAF has endocrine disrupting properties. BPAF has clearly shown estrogenic and anti-androgenic activity in fish studies as well as BPAF shows clear adverse and population-relevant effects on reproduction in fish, which are very plausibly linked to the estrogenic and anti-androgenic mode of action. Significant adverse effects on the fertilization rate of spawned eggs are shown in zebra fish and both estrogenic and anti-androgenic modes of action are well known to be involved in the regulation of sexual development and reproduction. The link to the estrogenic/anti-androgenic MoA is further supported by a concomitant decrease in testosterone levels, increases in plasma estradiol and vitellogenin levels as well as by gene expression in male fish. 
RAC adopted an opinion for classification as reprotoxicant 1B. During the assessment RAC concluded that BPAF clearly caused adverse effects on sexual function and fertility in mammals and based on the available data, an estrogenic or anti-androgenic mechanism area thought to play a dominant role in vivo. This is further supported by the analogy of BPAF to BPA and BPB, both of which have been identified as having endocrine disrupting properties for human health and the environment. The expected dissociation of the eight salts of BPAF under environmental conditions justify a read across from BPAF, so these BPAF salts should also be  identified as having endocrine disrupting properties.
In conclusion, there is clear evidence that BPAF fulfils the WHO/IPCS definition for an ED in line with the 2013 recommendations from the ECHA ED Expert Advisory Group and further, the substance has similar properties as BPA and BPB, both of which have been identified as endocrine disruptors. Therefore, the substance and the salts can be identified to have endocrine disrupting properties for the environment as proposed by Germany without the need for any duplication of resource-intensive assessment procedures. Further, in our opinion, BPAF  should also be identified as an ED for human health considering the conservation of the hormonal system across species, and the fact that adverse effects on sexual function and fertility, indicative of endocrine activity, have also be shown in rats as concluded by RAC.
	
		Submitter response:
Thank you for your supporting comment.	
42	Date: 2022/06/20 16:33
Country: Norway
Attachment:
	General Comments:
Norwegian comments on endocrine disrupting properties for the environment of bisphenol F, bisphenol AF and 8 salts of BPAF
We thank the German CA for preparing a proposal to restrict bisphenol A, other bisphenols and bisphenols derivatives based on their endocrine disrupting properties for the environment.  
Since the substances bisphenol F, bisphenol AF and eight BPAF salts have not been identified as substances of very high concern, we welcome the elaboration of an MSC opinion whether endocrine disrupting properties for the environment are fulfilled. 
Bisphenols are a group of concern for several hazardous properties and should be regulated as a group. This will also avoid that regulated substances of this group could be substituted with compound with similar hazardous properties. 
The Norwegian CA agrees that bisphenol F, bisphenol AF and eight BPAF salts meet the criteria for an endocrine disrupting substance for the environment as defined by the WHO /IPCS ( 2002).
Bisphenols are used in a wide range of products and with potential exposure of humans and the environment. Monitoring data from Norway demonstrate that bisphenol F, AF and several of their derivates have been detected in environmental compartments and biota. 
Please find a compilation of monitoring data from Norway attached.	
		Submitter response:
Thank you for your support and for the compilation of monitoring data from Norway. This information will be taken into account in the restriction dossier which will be submitted later this year since the Art. 77(3) report focuses on the hazard properties.	
44	Date: 2022/06/20 16:44
Org. type: Industry or trade association
Org. name: Verband der Chemischen Industrie e.V.
Org. country: Germany
Country: Germany
	General Comments:
Art. 77 c) request supporting information report, page 2:
Decisions and options foreseen to be taken during the restriction process should not be undermined by other arbitrary processes as this is actually intended related to two diphenoles via a mandate from the ECHA director for the MSC: “To avoid that RAC [the ECHA committee in charge of providing an option related to risks (= hazard and exposure) under the restriction procedure] has to prepare an opinion on this [ED properties] and introduce a potential risk of divergent of opinions between ECHA committees, the MSC will be tasked with providing an opinion …, which then can be used in the further deliberation of RAC.” 
Companies need processes that are transparent and predictable with a proper time window for their input. For this, the process for harmonised classification and, in absence of CLP hazard classes for ED, the SVHC identification process are accepted approaches including early alerts (registry of intentions) and consultation options for companies. Bypassing these “hazard identification” steps and prying out the hazard part of the risk identification step in the assessment of the annex XV restriction dossier undermines the role attributed to these processes by the REACH and the CLP regulations.
It sounds strange when there is already the expectation that there might be divergent opinions of MSC and RAC regarding the ED properties assessed by the dossier submitter. It is not foreseen in the REACH legislation that committees (RAC/SEAC) empowered to provide an opinion are excluded on purpose from opinion making on key elements of the restriction dossier (here the hazard assessment as part of the risk assessment). 
Thus, we ask to stick to the processes for hazard identification provided for under REACH and CLP and to avoid shortcuts not foreseen in applicable legislation.
	
		Submitter response:
The Art. 77(c) process allows MSC to provide an opinion on specific issues. This opinion is valuable here since ED ENV identification issues have been broadly discussed in the MSC. RAC will take note of the MSC Opinion when assessing the restriction proposal. Thus, this process will provide information on the hazard with regard to endocrine disrupting properties for the environment for BPF and BPAF and hence on the question whether or not both bisphenols will be covered as “bisphenols of similar concern” in the restriction proposal. If they will be included, issues with regard to risk and appropriate risk management options will be discussed in the restriction dossier. Since for both processes, the Art. 77 (c) as well as the restriction process public consultations are performed, you are able to provide your input on hazard and risk issues and the related legislations and consequences.	
53	Date: 2022/06/20 21:23
Org. type: International NGO
Org. name: European Environmental Bureau
Org. country: Belgium
Country: Netherlands
	General Comments:
The EEB welcomes the assessment prepared by the German Competent Authority (DE CA) on the endocrine disrupting properties of 4,4'-[2,2,2-trifluoro-1- (trifluoromethyl)ethylidene]diphenol (Bisphenol AF, BPAF) and its salts in the environment. We support the conclusion that  BPAF and its salts meet the criteria for endocrine disrupting substances for the environment as defined by the WHO/IPCS (2002).  
The dossier submitter convincingly demonstrated endocrine activity by BPAF both in vitro as well as in vivo studies related to estrogenic and/or anti-androgenic activity. The ED activity is biologically plausible linked to adverse and population relevant effects of Bisphenol AF (BPAF) on reproduction in zebrafish, including significant adverse effects on egg fertilisation, decrease in testosterone levels and increase in vitellogenin. In addition, RAC concluded on adverse effects of BPAF on sexual function and fertility in mammals. These effects on reproduction in mammals are indicative of an endocrine mode of action with relevance at the population level  as well.
The conclusion that BPAF meets the definition for an ED substance in the environment is also supported by the structural similarity with BPA and BPB that both have been identified as Substance of Very High Concern under REACH. Overall, the EEB agrees that Bisphenol AF and its salts act as endocrine disruptors in the environment according to the definition of the WHO/IPCS (2002). Bisphenol AF and its salts should be covered by the restriction proposal for Bisphenol A and other bisphenols exhibiting a similar concern for the environment. 
	
		Submitter response:
Thank you for your support.