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(α,α-dimethylbenzyl) peroxide
CAS number: 80-43-3
EC number: 201-279-3

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

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	
5842
2024/04/12	ASD-EUROSPACE,
Industry or trade association,
France	No comments	Thank you for your information regarding use of the substance. Comments regarding use, 
exposure, alternatives and risks may, where relevant, be considered at later stages of the risk management process, since identification of an 
SVHC is based on the intrinsic properties of the substance.
	
		Attachment: 5842_ASD_EUROSPACE_Comment on CAS 80-43-3_FINAL_11042024.pdf

5847
2024/04/12	Company,
Germany	In summary:
- Currently DCP is classified as reproductive toxicant category 1B (H360D) based on a rat OECD 414 study. While the additional mandatory testing is ongoing (OECD 443 study due by Q3 2024), the Signees consider that the available data (the rat OECD 414 study and a rabbit OECD 414 study, the latter being clearly negative for developmental toxicity) support a reproductive toxicant category 2 (H361d) classification.
- Based on the current uses by the Signees (whose dossiers will be updated accordingly at the latest by 15 April 2024), no exposure of consumers or professional users (no exposure outside industrial setting) is expected.
- All end uses of DCP by the Signees meet the REACH definition of “intermediate” (reactive initiator for polymer manufacturing), as a result of which these uses are not in the scope of authorisation pursuant to Article 2(8)(b) of REACH.
- The use as a synergist in flame retardant systems has been eliminated by the Signees.
- No registrant of DCP continues to support article service life uses in its dossier.
- The Signees note that the conclusions reached by ECHA in its ARN on organic hydroperoxides and aliphatic/cumyl peroxides (6 July 2023) points to a potential consideration on exposure-focused REACH restriction for non-industrial uses of DCP – which would be a more substantiated discussion. An occupational exposure limit could address concerns for uses of DCP in industrial settings.
	Thank you for your comments. The substance has already a harmonised classification and labelling as Repro 1B under the CLP Regulation. Therefore, the substance clearly meets the criteria for identification as Repro 1 B under Article 57(c) of the REACH Regulation. According to Article 59(3) of REACH the Annex XV dossier may in such circumstances be limited to a reference to an entry in Part 3 of Annex VI to Regulation (EC) No 1272/2008.
 
If you wish to have the harmonised classification reviewed, please follow the process set out in Article 37(6) of CLP which provides as follows:  “Manufacturers, importers and downstream users who have new information which may lead to a change of the harmonised classification and labelling elements of a substance in Part 3 of Annex VI shall submit a proposal in accordance with the second subparagraph of paragraph 2 to the competent authority in one of the Member States in which the substance is placed on the market.”
 
The SVHC process is therefore inappropriate to reassess the harmonised classification of the substance.

Comments regarding use, 
exposure, alternatives and risks may, where relevant, be considered at later stages of the risk management process, since identification of an 
SVHC is based on the intrinsic properties of the substance.	
		
Confidential attachment removed		
5848
2024/04/12	Company,
Netherlands	Summary of comment, confidential part see attachment:
- Currently DCP is classified as reproductive toxicant category 1B (H360D) based on a rat OECD 414 study. While the additional mandatory testing is ongoing (OECD 443 study due by Q3 2024), the Signees consider that the available data (the rat OECD 414 study and a rabbit OECD 414 study, the latter being clearly negative for developmental toxicity) support a reproductive toxicant category 2 (H361d) classification.
- Based on the current uses by the Signees (whose dossiers will be updated accordingly at the latest by 15 April 2024), no exposure of consumers or professional users (no exposure outside industrial setting) is expected.
- All end uses of DCP by the Signees meet the REACH definition of “intermediate”  (reactive initiator for polymer manufacturing), as a result of which these uses are not in the scope of authorisation pursuant to Article 2(8)(b) of REACH.
- The use as a synergist in flame retardant systems has been eliminated by the Signees.
- No registrant of DCP continues to support article service life uses in its dossier.
- The Signees note that the conclusions reached by ECHA in its ARN  on organic hydroperoxides and aliphatic/cumyl peroxides (6 July 2023) points to a potential consideration on exposure-focused REACH restriction for non-industrial uses of DCP – which would be a more substantiated discussion. An occupational exposure limit could address concerns for uses of DCP in industrial settings.
	Thank you for your comments. The substance has already a harmonised classification and labelling as Repro 1B under the CLP Regulation. Therefore, the substance clearly meets the criteria for identification as Repro 1 B under Article 57(c) of the REACH Regulation. According to Article 59(3) of REACH the Annex XV dossier may in such circumstances be limited to a reference to an entry in Part 3 of Annex VI to Regulation (EC) No 1272/2008.
 
If you wish to have the harmonised classification reviewed, please follow the process set out in Article 37(6) of CLP which provides as follows:  “Manufacturers, importers and downstream users who have new information which may lead to a change of the harmonised classification and labelling elements of a substance in Part 3 of Annex VI shall submit a proposal in accordance with the second subparagraph of paragraph 2 to the competent authority in one of the Member States in which the substance is placed on the market.”
 
The SVHC process is therefore inappropriate to reassess the harmonised classification of the substance.

Comments regarding use, 
exposure, alternatives and risks may, where relevant, be considered at later stages of the risk management process, since identification of an 
SVHC is based on the intrinsic properties of the substance.	
		
Confidential attachment removed		
5852
2024/04/15	GIFAS,
Industry or trade association,
France		Thank you for your comments. 

Comments regarding use, 
exposure, alternatives and risks may, where relevant, be considered at later stages of the risk management process, since identification of an 
SVHC is based on the intrinsic properties of the substance.
	
		Attachment: 5852_20001-GIFAS_ECHA Consultation_SVHC_2024 04 15.pdf

		

Specific comments on the justification
Number / Date	Submitted by (name, submitter type, country)	Comment	Responses	
5837
2024/04/10	Germany,
Member State	The German CA supports the identification of bis(α,α-dimethylbenzyl) peroxide as SVHC.
	Thank you for your support.	
				
5842
2024/04/12	ASD-EUROSPACE,
Industry or trade association,
France	No comments	Thank you for the comments. Please see our
response to your comment above.	
		See the corresponding embedded attachment in table 1 of Part I: 5842_ASD_EUROSPACE_Comment on CAS 80-43-3_FINAL_11042024.pdf		
5847
2024/04/12	Company,
Germany	See attachment.	Thank you for the comments. Please see our
response to your comment above.	
		
Confidential attachment removed		
5848
2024/04/12	Company,
Netherlands	See confidential Attachment	Thank you for the comments. Please see our
response to your comment above.	
		
Confidential attachment removed		
5849
2024/04/12	Company,
Netherlands	The substance CAS EC 201-79-3 CAS 80-43-3 is used in the die attach glues for semiconductor components
It is expected that the substance reacts during curing of the die attach glue and therefore not present in the final products greater than 1000 ppm
There is no test result to have the confirmation yet
During the manufacturing process of the semiconductor component there is no emission to the environment and in the working environment thanks to the strictly controlled conditions in clean room
A huge number of final electronic application rely on the use of the substance and there is limited evidence of alternatives available
The die attach glue serves inside the final semiconductor package therefore it is englobed in the semiconductor package by a molded resin, hence there is no expected release during the component lifetime
Once the electronic application reaches its end of life it is assumed that the semiconductor package is treated according to the WEEE Directive requirement.	Comments regarding use, 
exposure, alternatives and risks may, where relevant, be considered at later stages of the risk management process, since identification of an 
SVHC is based on the intrinsic properties of the substance.

5852
2024/04/15	GIFAS,
Industry or trade association,
France		Thank you for the comments. Please see our
response to your comment above.	
		See the corresponding embedded attachment in table 1 of Part I: 5852_20001-GIFAS_ECHA Consultation_SVHC_2024 04 15.pdf		
5854
2024/04/15	CHEM Trust Europe,
International NGO,
Germany	CHEM Trust supports the inclusion of Bis(α,α-dimethylbenzyl) peroxide in the REACH candidate list due to its reprotoxic  properties, based on article 57 (c).

	Thank you for your support.	
				
5860
2024/04/15	European Environmental Bureau (EEB),
International NGO,
Belgium	The EEB supports the proposal of Norway to identify Bis(α,α-dimethylbenzyl)
peroxide as a Substance of Very High Concern according to REACH Article 57 (c) due to its classification under the CLP regulation in the hazard class toxic for reproduction, category 1B (H360D: May damage the unborn child).

The total registered volume of the substance under REACH is 10 000 - 100 000 tpa. Further regulatory action is urgently needed on Bis(α,α-dimethylbenzyl) peroxide and other organic peroxides to minimise exposure of citizens and the environment.
	Thank you for your support.

Comments regarding use, 
exposure, alternatives and risks may, where relevant, be considered at later stages of the risk management process, since identification of an 
SVHC is based on the intrinsic properties of the substance.

5863
2024/04/15	ChemSec,
International NGO,
Sweden	ChemSec supports the identification of this substance as an SVHC based on it being classified for being toxic to reproduction. For the same reason, we added it to the SIN List in 2021.
	Thank you for your support and for the information.

				

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	
5841
2024/04/12	Company,
Japan	  (1) About use
Our company uses DCP as a rubber compound crosslinking agent, but there is no organic peroxide with the same decomposition rate and same oxidizability of the generated radicals, so when considering substitutes, it is necessary to examine each compound.
There are also a large number of products that use DCP, so substantial human, time, and financial resources are required to use substitutes.
　(2) Conveyance product family
The heat-resistant conveyor belts which represent these products have been used in the market for a long time, and are used around blast furnaces in the ironmaking field as well as in the cement manufacturing field. Track records in the market are also required for substitution.
Therefore, substitution is difficult in a short period of time.
　(3) Scraping product family
DCP is used to handle ink in screen printing.
It is also used in the basic fields of industry, and it also requires a track record in the market to replace it. In the process of substitution, it is necessary to evaluate the durability and reliability of the product. It is not possible to substitute it quickly.
　(4) Transmission product family
It is used for important functional parts that are incorporated into the steering of automobiles, and when considering substitutes, a certain period of time is required for design to guarantee durability, etc., so a grace period is required (at least six years).
Given the characteristics of this product family to which the DCP is applied, we would like to set a grace period of six to ten years for the regulation of rubber products to proceed with the study of substitutes.
　(5) About exposure
When using the product as intended, we found that DCP decomposes at the time of crosslinking and uses the radicals which are generated.
Therefore, DCP has been designed not to remain in the product.　Since there is no manufacturing process in Europe that deals with DCP, the DCP itself will not be exposed.
　(6) About proposed substitutes
Due to the above-mentioned exposure concept, crosslinking agent applications of rubber products should be exempted from the application.
Even if applied, a transition period of six to ten years will be required for evaluation.
In addition to the difficulty of technical substitution, DCP as a chemical substance can be obtained at a low cost, so it is necessary to consider the period until such substitutes become as economical as DCP, even if there are currently candidate substitutes.	Thank you for your comments. 

Comments regarding use, 
exposure, alternatives and risks may, where relevant, be considered at later stages of the risk management process, since identification of an 
SVHC is based on the intrinsic properties of the substance.

5842
2024/04/12	ASD-EUROSPACE,
Industry or trade association,
France	PAGE 9 ET SEQQ. OF THE ANNEX XV REPORT – SECTION 9. INFORMATION ON USES OF THE SUBSTANCE

MPTB participants have identified several products containing the Substance in use for space applications without current alternatives:

DiCup® R / Luperox® DCP dicumyl peroxide is used as a high temperature crosslinker in rubber and plastics applications. DiCup® R / Luperox® DCP can be used also in the polymerization of expandable polystyrene as finisher and as synergist for fire retardant EPS (Expanded Polystyrene) applications. MPTB participants have confirmed that this product is used in most of their rubber formulations which are used for civilian (Ariane 6), space military and EU security-sensitive (such as IRIS2 and other complex missions such as Copernicus or Galileo, which are reliant on European launcher manufacturers) applications. So far, there are no alternatives existing. Therefore, the investigation on proper substitution and a subsequent qualification of a new substitute raw material will be very long (probably more than one decade). During this period, it remains essential to continue production by using this product. In 2024, they will evaluate other products to replace this product but these are also peroxides.

The product JEMA42B6, it is a purchased sealing ring and the producer uses the Substance to produce this product.

This contribution has been prepared by the participants of the Materials and Processes Technology Board of the European Space Components Coordination (ESCC MPTB). It is also supported by the Aerospace, Security and Defence Industries Association of Europe (ASD).
The contribution paper is attached in section IV. of this webform, providing also the list of MPTB participants in the Annex (page 3). For the avoidance of doubt, the attachment does not include additional technical information but reflects the input given in this section III.	Thank you for your comments. 

Comments regarding use, 
exposure, alternatives and risks may, where relevant, be considered at later stages of the risk management process, since identification of an 
SVHC is based on the intrinsic properties of the substance.
	
		See the corresponding embedded attachment in table 1 of Part I: 5842_ASD_EUROSPACE_Comment on CAS 80-43-3_FINAL_11042024.pdf		
5847
2024/04/12	Company,
Germany	See attachment.	Thank you for the comments. Please see our
response to your comment above.	
		
Confidential attachment removed		
5848
2024/04/12	Company,
Netherlands	See confidential attachment,
	Thank you for the comments. Please see our
response to your comment above.	
		
Confidential attachment removed		
5852
2024/04/15	GIFAS,
Industry or trade association,
France	On 1st March 2024, the European Chemicals Agency published a proposal to identify two substances as Substances of Very High Concern (SVHC).
In the frame of this consultation, the French Aerospace Industries Association (GIFAS)  would like to provide comments regarding its use of the following substances:
- Triphenyl phosphate (CAS n° 115-86-6) called TPhP, submitted by France;
- Bis(α,α-dimethylbenzyl) peroxide (CAS n°80-43-3) submitted by Norway.	Thank you for the comments. Please see our
response to your comment above.	
		See the corresponding embedded attachment in table 1 of Part I: 5852_20001-GIFAS_ECHA Consultation_SVHC_2024 04 15.pdf		
5854
2024/04/15	CHEM Trust Europe,
International NGO,
Germany	As ECHA`s  Assessment of Regulatory Needs (ECHA, 2023b) has shown Bis(α,α-dimethylbenzyl) peroxide is a member of the group "organic peroxides"  . This has to be considered in the subsequent risk management decisions to ensure regrettable substitution is avoided.	Thank you for the comment. In this proposal we only address the identification as SVHC, so possible subsequent steps are not commented on by us.	
				
5863
2024/04/15	ChemSec,
International NGO,
Sweden	We have on the Marketplace alternative cross-linkers that might potentially be safer alternative to this substance:
https://marketplace.chemsec.org/Alternative/NeoAdd-Low-toxicity-crosslinker-for-waterborn-industrial-coating-systems--584?notPublished=true
https://marketplace.chemsec.org/Alternative/NeoAdd-Low-toxicity-crosslinker-for-coating-packging-applications-583?notPublished=true	Thank you for your comments. 

Comments regarding use, 
exposure, alternatives and risks may, where relevant, be considered at later stages of the risk management process, since identification of an 
SVHC is based on the intrinsic properties of the substance.