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: 6,6'-di-tert-butyl-2,2'-methylenedi-p-cresol (DBMC)
CAS number: 119-47-1
EC number: 204-327-1

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 57 c)

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	
5584
2021/10/18	ASD-Eurospace,
Industry or trade association,
France	PAGE 15 OF THE ANNEX XV REPORT - 11.4 PREVIOUS ASSESSMENTS BY OTHER AUTHORITIES/ONGOING REGULATORY ACTIVITIES

We understand that the new harmonised classification of the Substance as Toxic for Reproduction Category 1B is the main rationale for the proposed identification as SVHC on the Candidate List. Follow-up measures under REACH post Candidate Listing, such as Annex XIV (authorisation) and/or Annex XVII (restrictions) have not been evaluated in detail in the Regulatory Management Option Analysis (RMOA) by Denmark.  Instead, the RMOA only points out that it may be appropriate to update the specific migration limit value for a group of substances, which includes DBMC in the EU legislation, Commission Regulation (EU) No 10/2011 of 14 January 2011 on plastic materials and articles intended to come into contact with food. Nevertheless, the “RMOA concludes that it would be appropriate as a next regulatory risk management (RRM) step to identify DBMC as a Substance of Very High Concern (SVHC) according to REACH Article 57c, and subsequently to include DBMC in Annex XIV of REACH.” The RMOA also reiterates that DBMC has many uses in different types of products, including several types of consumer products. The availability of alternatives has not been assessed.

Given the (very) limited assessments conducted by Denmark so far, focusing on follow-up measures under specific EU food contact materials regulation, we believe it is premature to consider any general regulatory follow-up measures under REACH at this point.

We would like to stress that Candidate listing and possible future Annex XIV (authorisation) or Annex XVII (restrictions) listing would further exacerbate the commercial obsolescence risk for the Substance in space applications without viable alternatives. The commercial obsolescence risk for the space industry as a niche sector is increasing, as the REACH authorisation process advances. Substitution efforts would have to be accelerated to mitigate the risk. This, in turn, is negatively affecting the industry’s competitiveness in a more competitive global space market. The impact would affect the entire complex EU space systems’ supply chain. For SME and laboratories, the financial and human investment would be even more important and critical. An even higher impact is expected in case the Substance would enter REACH Annex XIV, jeopardising Europe’s independent access to space as a key point of the EU’s Space Policy.

According to the Danish RMOA “EU-wide risk has not been proven”. Therefore, there is no sufficient information today to initiate a restriction under REACH Article 69(1). If a restriction should be justified beyond existing legislation and pursued for the Substance in the future, it should be tailored with a suitable derogation for essential space applications.	Thank you for your comments.

A Regulatory Management Option Analysis (RMOAs) is an informal assessment of regulatory needs. An evaluation of follow-up measures and availability of alternatives are not requirements for this process. 

Your position is noted. However, we believe that further risk management measures are warranted.

Thank you for your comments on uses of the substance. As noted in the comments, SVHC-identification is based on the intrinsic properties of the substance. Comments on uses and exposure may be relevant in a possible future Annex XIV recommendation. 

Essential uses will be assessed before a possible future restriction will enter into force. 	
		Attachment: 5584_ASD_EUROSPACE_Comment on DBMC_Final_18102021.pdf

5585
2021/10/18	LANXESS Deutschland GmbH,
Industry or trade association,
Germany	Please refer to the comments in the attachment for further information	Thank you for your comments and the provided information. The proposal is based on the intrinsic hazardous properties of the substance and considerations on risk and migration as well as information on uses and availability of alternatives will be taken into account in a possible future Annex XIV recommendation.	
		Attachment: 5585_CommentsDBMC_SVHC_18102021.pdf

5590
2021/10/18	European Semiconductor Industry Association,
Industry or trade association,
Belgium		Thank you for your comments and for the information on uses and exposure. Considerations on use and exposure will be taken into account in a possible future Annex XIV recommendation. 	
		Attachment: 5590_ESIA  ECHA SVHC Consultation DBMC Oct 2021.pdf

5598
2021/10/18	ETRMA, European Tyre and Rubber Manufacturers´ Association ,
Industry or trade association,
Belgium		Thank you very much for your comments. 
Information on uses of the substance will be taken into account in a possible future Annex XIV recommendation. 

The lack of migration observed in the presented migration studies does not prevent the substance from being identified as a SVHC. 

The SVHC-identification is based on the intrinsic hazardous properties of the substance. 	
		Attachment: 5598_20211018_BKF CAS 119-47-1_ETRMA answer_ Annex XV_SVHC_FINAL.pdf

Specific comments on the justification
Number / Date	Submitted by (name, submitter type, country)	Comment	Responses	
5557
2021/10/05	Health and Environment Alliance (HEAL),
International NGO,
Belgium	The Health and Environment Alliance (HEAL) thanks Denmark for its proposal to identify 6,6'-di-tert-butyl-2,2'-methylenedi-p-cresol (DBMC) as SVHC under article 57(c) and we fully support this proposal.

Considering the existing classification of the substance as toxic to reproduction category 1B (H360F May damage fertility) under the CLP regulation (regulation 1272/2008), we consider the proposed SVHC identification unequivocal.
	Thank you for your support.	
				
5564
2021/10/14	Norway,
Member State	The Norwegian CA supports that DBMC should be identified as a substance of very high concern and should be included in the Candidate List.	Thank you for your support.	
				
5571
2021/10/15	Germany,
Member State	The German CA supports the identification of EC 204-327-1 as substance of very high concern according to Article 57(c) of REACH.	Thank you for your support.	
				
5576
2021/10/16	CHEM Trust Europe,
International NGO,
Germany	CHEM Trust supports the inclusion of 6,6'-di-tert-butyl-2,2'-methylenedi-p-cresol in the REACH candidate list based on its classification as toxic for reproduction category 1B in accordance with Article 57 (c) of REACH.	Thank you for your support.	
				
5581
2021/10/18	Netherlands,
Member State	NL supports the proposal to include DBMC in the candidate list of SVHC in accordance with Article 57(c) of Regulation (EC) 1907/2006 (REACH) given the reprotoxic properties.	Thank you for your support.	
				
5584
2021/10/18	ASD-Eurospace,
Industry or trade association,
France	No input	Please see response to the comments above.	
		See the corresponding embedded attachment in table 1 of Part I: 5584_ASD_EUROSPACE_Comment on DBMC_Final_18102021.pdf		
5585
2021/10/18	LANXESS Deutschland GmbH,
Industry or trade association,
Germany	Please refer to the comments in the attachment for further information	Please see response to the comments above.	
		See the corresponding embedded attachment in table 1 of Part I: 5585_CommentsDBMC_SVHC_18102021.pdf		
5586
2021/10/18	ChemSec,
International NGO,
Sweden	ChemSec supports the identification as SVHC based on the agreed classification of this substances as being Toxic to Reproduction.	Thank you for your support.	
				
5590
2021/10/18	European Semiconductor Industry Association,
Industry or trade association,
Belgium		Please see response to the comments above. 	
		See the corresponding embedded attachment in table 1 of Part I: 5590_ESIA  ECHA SVHC Consultation DBMC Oct 2021.pdf		
5594
2021/10/18	European Environmental Bureau (EEB),
International NGO,
Belgium	The EEB supports the proposal submitted by Denmark to identify  6,6'-di-tert-butyl-2,2'-methylenedi-p-cresol (DBMC) as Substance of Very High Concern due to its reproductive toxicity. The substance is classified in the hazard class toxic for reproduction 1B and may damage fertility. The substance is registered under REACH at 1000 - 10.000 tpa and has a wide dispersive use in the EU, including widespread use by professional workers and consumers. The substance should be added to the Candidate List and prioritised for further regulatory risk management measures.
	Thank you for your support.	
				
5598
2021/10/18	ETRMA, European Tyre and Rubber Manufacturers´ Association ,
Industry or trade association,
Belgium		Please see response to the comments above.	
		See the corresponding embedded attachment in table 1 of Part I: 5598_20211018_BKF CAS 119-47-1_ETRMA answer_ Annex XV_SVHC_FINAL.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	
5573
2021/10/15	Eurenco,
Industry or trade association,
France	This substance, 6,6'-di-tert-butyl-2,2'-methylenedi-p-cresol (DBMC), is used in the majority of Cast Cured Plastic Bonded Explosives compositions for energetic material by Eurenco.
The product presents a risk to human health but all risk management measures for operators are already implemented to avoid any contact with the product. Operators are equipped with protective suits over their work clothes only for handling hazardous products. They also wear an autonomous ventilation equipment. And, when possible, collective aspiration systems are put in place.
In addition, the amounts used are very low: less than 0.5% in the majority of the compositions and never more than 2.5%. Product handling is therefore very limited, less than 1 ton engaged per year. After being mixed in a closed system (mixer), the composition is integrated into another closed system (casing). In all the applications concerned by the use of this substance, the final compositions are completely exploded and burnt without leaving any residue of DBMC.

Today, there is no substance that can replace DBMC in a short term. So, at a first step, Eurenco will need time to define precisely the characteristics required to seek and find a possible new alternative substance. In a second step, Eurenco will have to seek and find a supplier to obtain some samples and test them in more than thirty different compositions. At the end, the qualification stages are quite long, several years, and cost consuming.

Moreover, these compositions are also used in major and strategic programs for the French Defence, especially missiles. A significant number of programs are impacted. For such programs, in case of substance replacement, it will be necessary to validate the behaviour of the new product, for safety and performance aspect, via a full qualification program.

These are the reasons why it would be very restrictive and impacting for Eurenco for 6,6'-di-tert-butyl-2,2'-methylenedi-p-cresol (DBMC) to be soon classified as an SVHC substance thus integrating the Candidate List.	Thank you very much for this information. It will be taken into account in a possible future Annex XIV recommendation. 	
				
5579
2021/10/18	Company,
Germany	We would like to highlight that the substance is used as anti-oxidant in propellants (such as for rocket motors) and in a very wide application of explosives as used in military context (explosives for bombs, torpedoes, explosive ammunition). The use of the substance in the military sector is in very low quanities. Exchanging this substance in explosives will likely be very time-consuming and difficult given that it is dangerous to test new variations and mixture contents. Given the danger of unwanted behaviour (up to unexpected explosion) in this application, industry is very reluctant to use or even test other substances not well-known and where we do not have adequate information on the substance's behaviour from the past decades.
The substance is also widely used in some sealants and glues, which are also used in military products. Exchangeing such glues can be difficult due to the necessary re-qualification of the equipment.	Thank you very much for this information. It will be taken into account in a possible future Annex XIV recommendation.	
				
5584
2021/10/18	ASD-Eurospace,
Industry or trade association,
France	PAGE 10 ET SEQQ. OF THE ANNEX XV REPORT – SECTION 9. INFORMATION ON USES OF THE SUBSTANCE

The Substance is registered under REACH at 1,000 to 10,000 t/y by three companies, while only two are producers. Their respective products are called VULKANOX BKF and LOWINOX 22M46.

For space applications, those products are used as an important anti-oxidizer in solid propellants (although in low mixture ratio), e.g. for the solid booster of the Ariane 5 and Ariane 6 launchers. There is an impact also for VEGA and VEGA C (first flight in 2022) propellants, interfaces (liners) and thermal protections. The use in energetic powder for pyro equipment (e.g. for orbital propulsion) is being investigated.

Specifically for military applications, DBMC is used e.g. in propellants, interfaces and thermal protection of military motors, in adhesives and sealants.

DBMC is one of only two anti-oxidizers on the world market today for space use. The other one is DBPC (2,6-di-tert-butyl-p-cresol; CAS no: 128-37-0; EC no: 204-881-4) which is under CoRAP assessment by France as a potential endocrine disruptor.

The main function of an anti-oxidizer is to avoid the destruction of the Hydroxyl-Terminated PolyButadiene (HTPB) “polymeric network”. The anti-oxidizer is thus crucial for the stability of HTPB composition.

EMWG participants were also surveyed on the volumes per use in preparation to this contribution. The available data cannot be fully aggregated on the sector level at this point. However, it can be said that Ariane and VEGA programmes are the main contributors to the total volume for the European Space Sector. Some (rough) estimates can also be provided: For Ariane 6, around 8 tonnes of DBMC per year are needed for solid rocket motors during its product life. For VEGA, the global volume is about 500 kg per year. Further information on the underlying assumptions is available upon request.

PAGE 14 OF THE ANNEX XV REPORT – SECTION 11.2 ALTERNATIVES

The drawback for substitution is, that it takes very long to substitute an anti-oxidizer because the product acts on the shelf life of the propellant. It would be necessary to realize ageing works which can last several years. Especially for military programmes the propellants should maintain their mechanical properties for a long time.

The Substance has been used for decades for high reliability applications in the European space industry. Risks are well known, managed and therefore considered as negligible. As indicated above, the volume of use is relatively low, but the value is very high. New technologies in the space industry require maturity (Technology Readiness Level; TRL) and Heritage before they can be implemented in space vehicles. Given the absence of viable alternatives the Substance is still widely used in the industry today.
	Thank you very much for this information. It will be taken into account in a possible future Annex XIV recommendation.	
		See the corresponding embedded attachment in table 1 of Part I: 5584_ASD_EUROSPACE_Comment on DBMC_Final_18102021.pdf		
5585
2021/10/18	LANXESS Deutschland GmbH,
Industry or trade association,
Germany	Please refer to the comments in the attachment for further information	Thank you very much for this information. It will be taken into account in a possible future Annex XIV recommendation.	
		See the corresponding embedded attachment in table 1 of Part I: 5585_CommentsDBMC_SVHC_18102021.pdf		
5590
2021/10/18	European Semiconductor Industry Association,
Industry or trade association,
Belgium	page9/12 uses at industrial sites:
The semiconductor industry uses specialty chemicals in the semiconductor manufacturing process step (photolithography). The substance DBMC can be used as a component part of a mixture in these specialty photolithography mixtures. To note DMBC is used dissolved in a liquid mixture (the manufacturing process chemical) (not in powder form). The use occurs in highly controlled workplace environment in semiconductor manufacturing factories where rigorous waste management and air emission procedures are in place to ensure emissions control. The potential risk to the environment and human health is managed in semiconductor manufacturing through stringent risk management measures and safety practices to prevent release of chemicals during the manufacturing process. There is typically no exposure to the workplace employee during normal production due to the use of closed systems. This potential risk is well controlled through the application of closed system manufacturing equipment which are installed in a cleanroom environment. Automated chemical delivery systems are installed to create a barrier between workers and the process and protect against chemical and physical hazards in the work environment.

It does not appear that the substance is being registered for the semiconductor uses. Semiconductor use is not referenced in section 9 of the annex XV proposal for a SVHC identification dossier.

In the attachment, there is a table of the relevant semiconductor manufacturing,  Reach exposure qualifiers for the Chemical Safety Assessment.

	Thank you very much for this information. It will be taken into account in a possible future Annex XIV recommendation.	
		See the corresponding embedded attachment in table 1 of Part I: 5590_ESIA  ECHA SVHC Consultation DBMC Oct 2021.pdf		
5598
2021/10/18	ETRMA, European Tyre and Rubber Manufacturers´ Association ,
Industry or trade association,
Belgium	1. Use and function of DBMC CAS 119-47-1 in rubber goods
DBMC CAS 119-47-1 is used as antioxidant and stabilizer for synthetic rubber. DBMC protects rubber articles against the effects of oxygen and heat without influencing the processing of uncured rubber mixtures and the vulcanization process itself.
DBMC also avoids blooming and discoloration common of antioxidants.  Rubber matrices, some more than others, will degrade with exposure to environmental factors such as oxygen, heat, UV and ozone. These environmental factors cause free radicals that attach to the polymer chains and cleavage bonds in the rubber. This reaction can cause unsaturated polymer chain modification leading either to softening or to hardening of the final articles, depending on the type of polymers used.  Antioxidants are added to rubber formulations to prevent the above-mentioned degradation reactions. Antioxidants might ultimately come to the surface, causing bloom.
Rubber Bloom refers to the formation of a dust or film on the surface of rubber compounds. Blooming is observed with recrystallised rubber compounds not enough compatible with the rubber when the material cools down to room temperature after vulcanisation and also during the service life of the article.
DBMC is also used in light coloured rubbers, as it retards the crazing - fissures that occur in an oxidized surface layer when excessive tensile stress is applied. Rubber goods with light colour, when exposed to light in the absence of DBMC, would evolve to a pink tint; This colour evolution is slow downed and reduced thanks to DBMC.
DBMC can be used in general rubber goods that are used outdoors, such as O-rings, hoses or sealing. It is also used in bicycle tyres. Tyre formulations, automotive, could also contain DBMC in tread or carcass compounds. DBMC present in uncured rubber mixtures reaches up to 1.5 % w/w.  The content in of DBMC in the final rubber article will depend of the different compounds used and the content, the shape and the size. For some rubber articles, the content of DBMC would exceed 0.1% w/w.
DBMC holds an harmonised classification as Repro 1b  - index number 604-095-00-5 EC 021/849, Annex IV. DBMC does not have chronic nor acute aquatic effects, according to the REACH dossier public information  as the endpoint summary for aquatic toxicity  unequivocally concludes that the toxicity test showed not need to issue an environmental classification. Additionally, no PNEC has been derivate.
 
2. Absence of migration in sweat fluids from uncured rubber mixtures containing DBMC
The Harmonised classification prompts the need to prepare safety data sheets with the hazards and the risk that the substance poses to the human health. The information on the hazards and the risk the substance poses is duly transmitted across the value chain with safety data sheets. Rubber manufacturers, as downstream users of DBMC, ensure that every measure is taken at industry sites to address the potential risk associated with the use. It shall be highlighted that the boiling point of DBMC, 445ºC, is higher than the process temperatures of uncured rubber mixtures during extrusion, calendering and other machinery process.
ETRMA conducted migration studies on sweat simulant at 37ºC in order to mimic potential dermal intake of DBMC from rubber matrices for two typical uncured rubber mixtures containing DBMC:
• Natural rubber (44.9%); carbon black (33.9%) with DBMC content of 1.3 % w/w  and
• Chloroprene (1,3-butadiene, 2-chloro-, homopolymer) (52.4%) with DBMC content of 1.5 % w/w
The migration study - described at the Annex of this answer – was conducted by expert consultant FoBIG and laboratory test Eurofins  in June 2021. DBMC was not detected in any of the migration eluates, concluding that there are not significant releases of DBMC from rubber matrices through dermal contact.

3. The regulatory framework of DBMC secures information across the value chain and safe use for general rubber goods
DBMC is included Annex VI of the CLP and holds an harmonised classification as Repro 1b . It secures that the information of the Reprotoxic proprieties is communicated across the value chain and measures are set in place to protect worker´s safety.
Further, for those rubber articles where the presence of DBMC reaches more than 0.1% w/w, entries in the SCIP database will have to be conducted by rubber manufacturers of articles. Informing recyclers and end users on the presence of the substance in the articles.
Additionally, migration studies on uncured rubber mixtures containing BKF show absence of migration - Annex I of this answer-   confirming the strong matrix effect of rubber matrices and the safe use of handling rubber articles by consumers or professional workers.
In conclusion, the conditions of use of DBMC in the rubber industry are well controlled and rubber articles containing DBMC are safe for consumers and professional users.

	Thank you very much for this information. It will be taken into account in a possible future Annex XIV recommendation.	
		See the corresponding embedded attachment in table 1 of Part I: 5598_20211018_BKF CAS 119-47-1_ETRMA answer_ Annex XV_SVHC_FINAL.pdf