Comments on ECHA’s Draft 12th Recommendation for Diphenyl(2,4,6-trimethylbenzoyl)phosphine oxide (EC number: 278-355-8) and references to responses

The present document compiles the comments received during the public consultation on the draft 12th recommendation for inclusion of substances in Annex XIV of REACH for Diphenyl(2,4,6-trimethylbenzoyl)phosphine oxide (EC number: 278-355-8). The public consultation took place between 7 February 2024 and 7 May 2024. Response to the comments received will be provided by ECHA when finalising the recommendation (indicative timeline: April 2025).

Public version

Content
	
I - General comments on the recommendation to include the substance in Annex XIV
II - Transitional arrangements. Comments on the proposed dates
III - Comments on uses that should be exempted from authorisation, including reasons for that

I - General comments on the recommendation to include the substance in Annex XIV
Number / Date	Submitted by (name, submitter type, country)	Comment	
5098
2024/04/23	FIDE-The Federation of the European Dental Industry,
Industry or trade association,
Germany	In the Draft 12th Recommendation of Priority Substances to be included in Annex XIV of the REACH Regulation (List of Substances Subject to Authorisation) of February 7, 2024 Diphenyl(2,4,6-trimethylbenzoyl)phosphine oxide (CAS Number 75980-60-8, EC number 278-355-8) was proposed for inclusion in REACH, Annex XIV based on its toxicity for reproduction (Article 57 c).

Based on REACH Art. 60(2), 62(6) substances that are subject to authorization only because of hazards to human health and are exempted from the authorization requirements for their use in medical devices (see as well, ECHA, Generic exemptions from the authorization requirement, 2. Exemptions specific to certain intrinsic properties, of February 7, 2024).

Because the inclusion of Diphenyl(2,4,6-trimethylbenzoyl)phosphine oxide is based only on the hazard of reproductive toxicity (a typical hazard for human health) we propose for the case of inclusion in Annex XIV:

Either:

to add in the Annex XIV-Table in the column “Exempted (categories of) uses” (see Table below) the text: “medical devices within the scope of Regulation (EU) No 2017/745”

Or:
to confirm the exemption from authorization for medical devices within the scope of Regulation (EU) No 2017/745 in the text of the final document.
	
		5098_FIDE_Comment for TPO Consultation_correction ET.pdf
	
5101
2024/04/30	Germany,
Member State	The current draft background document states that the release of the substance during the use of articles by consumers is not expected as the substance is assumed to have reacted. Furthermore, it is stated in ANNEX I that “Limited information is available on residual concentration on unreacted substance in articles.”

The DE CA would like to point out that consumer exposure during the use of articles cannot be excluded based on the current information. It remains unclear if residues of the substance are still present in articles or if they can migrate during use. A literature research was able to identify exemplary products (screen print inks) which are available to consumers (https://multimedia.3m.com/mws/mediawebserver?mwsId=SSSSSuUn_zu8lzU9Mx_ZnYtBlv7zg17zHvu9lxUb7SSSSSS--). The use of screen print indicates consumer exposure taking place and has a high potential of dermal exposure. This is supported by the fact that currently there is no information confirming that the whole substance reacts during the use of the screen-printing ink.

Therefore, adaptation of the WDU scoring in the draft background document to account for consumer uses should be considered.

5114
2024/05/03	Europacable aisbl,
Industry or trade association,
Belgium	We have noted that diphenyl(2,4,6-trimethylbenzoyl)phosphine oxide (DPPO) has been listed, together with 4 other substances, in the “Draft 12th Recommendation of Priority Substances to be included in Annex XIV of the REACH Regulation (List of Substances Subject to Authorisation)”. We would like to express our surprise regarding this priority treatment. Indeed, when consulting your document “Prioritisation assessment results of the Candidate List substances assessed - Substances included in the Candidate List by July 2023 and not yet recommended for inclusion in Annex XIV”, dated 7 February 2024, we noticed that DPPO has a lower score than 7 other substances that have not been included in your draft recommendation.
Whilst we understand that there might be other reasons to this, we strongly request, on the basis of its inferior score, that DPPO is de-prioritised from inclusion in Annex XIV.
Instead, we suggest that DPPO be submitted to a restriction process according to specific uses. This would allow to take into account its paramount importance for the production of optical fibre, together with its absence of suitable alternatives. Indeed, optical fibre is the key building block of an optical fibre cable. Critically, optical fibre cables are and will be the backbone of Europe’s telecom networks which will empower Europe’s digitalisation as expressed in the Digital Agenda for EU.	
			
5117
2024/05/06	JSR Corporation,
Company,
Japan		
		
Confidential attachment removed	
5140
2024/05/06	Aerospace Industries Association of America,
Industry or trade association,
United States of America	We understand that REACH registrations are the main source of information for ECHA's assessment.  However, uses in the aerospace and defense (A&D) sector are typically small (but may be critical to the sector’s products) and may not be fully reflected in registration dossiers.  This can be especially true of imports of specialty formulations where the tonnage may fall well below registration thresholds, but that provide critical functionality needed by our industry and its products.

AIA member companies rely on Diphenyl(2,4,6-trimethylbenzoyl)phosphine oxide in products and formulations for the manufacture, maintenance and repair of aerospace and defense  products.  Identified aerospace uses include the following uses
• UV cure maskant
• Adhesives
• Ink
• Primers
• Polymers

5145
2024/05/07	Chemical Inspection & Regulation Service Limited,
Company,
Ireland	Substance cas 75980-60-8 is identified as a component of ink used in UV printing process. The inks are specifically used to print on polymer surfaces (PVC or ABS) , cured in UV curing oven and covered by a special transparent varnish and/or a specific plastic layer (PVC). Main use is for smart cards printing (Sim card, bank card, ID card) Current use is evaluated in 10 kg/y for a final weight on the card of 0,2 ppm for 50M cards/year This use will cover almost the 75% of the total manufacturing of a smart card manufacturing location Printing process is highly automated, exposure to workers is controlled, all liquid waste are sent for external waste treatment, air emissions from the printing process are treated and regularly monitored The substance is present in all major inks, at present no supplier is able to propose alternative free of the substance
﻿
1. Application characteristics of photoinitiator：TPO as type I, in ink/paint or other formulations, cracking into free radicals and other ingredients in the formulation quickly cross-linked into macromolecules via UV light, it does not exist, so toxicity does not exist, it is recommended to assess the setting of the use of the threshold to guide users to avoid excessive use during the use of residues. And it makes more sense for workers to have the right kind of protective education to control the risk, rather than all the authorization or restriction of control;
2.TPO is mostly used in the optical fiber coating industry, which requires a very fast curing speed, and there is no alternative product at present, and in the curing process occurs in a closed environment of inert gas, all exposures are very well controlled, and it is recommended to exempt the application that can be well controlled;
3. For industries that cannot be exempted from authorization or without threshold knowledge, the entire supply chain is too complex and involves many links, so it is suggested to give a longer transition period to find or develop alternative products, such as 36 months or longer.	
			
5152
2024/05/07	European Aerospace, Security and Defence Industries Association (ASD),
Industry or trade association,
Belgium	ASD members have indicated the use of Diphenyl in a number of mixtures and formulations mainly inks, adhesives, decorative foils, resins in additional manufacturing technologies.	
			
5163
2024/05/07	European Semiconductor Industry Association (ESIA),
Industry or trade association,
Belgium	Please see attachment	
		5163_ESIA input to the consultation on draft recommendation for inclusion in the Authorisation List of Melamine and DTBPO.pdf

II - Transitional arrangements. Comments on the proposed dates
Number / Date	Submitted by (name, submitter type, country)	Comment	
5098
2024/04/23	FIDE-The Federation of the European Dental Industry,
Industry or trade association,
Germany	N/A	
		See the corresponding embedded attachment in Part I:
5098_FIDE_Comment for TPO Consultation_correction ET.pdf	
5117
2024/05/06	JSR Corporation,
Company,
Japan	Diphenyl(2,4,6-trimethylbenzoyl)phosphine oxide (EC Number: 278-355-8, Cas Number: 75980-60-8) is used in optical filters in electronic devices. Since no alternative technology has been found at this time, a regulatory option with a grace period of 7 years is appropriate.	
		
Confidential attachment removed	
5140
2024/05/06	Aerospace Industries Association of America,
Industry or trade association,
United States of America	At this stage of assessment AIA member companies (comprising mainly OEMs) consider that Authorisation may be required for some uses of Diphenyl(2,4,6-trimethylbenzoyl)phosphine oxide until alternatives can be developed, qualified and substituted.  AIA envisages that our member companies would actively support development and submission of applications for Authorisation for their uses where they do not have alternatives.  Members would not necessarily seek Authorisation themselves but rather as part of joint upstream applications.  Upstream applications supported by OEMs are essential for business continuity in the A&D sector.  A&D supply chains are complex and typically global with many actors at different levels.  OEMs control the end user requirements for the products they produce.  Upstream actors in the chemical supply chain (e.g formulators, importers of formulations), however, are better placed to hold Authorisations and distribute chemicals to the various users (e.g. processors, component manufactures, OEMs, etc.) of the substances.

The main challenge in preparing an upstream application is obtaining detailed information about site operations for lower tier suppliers of OEMs.  A typical A&D sector supply chain may have four or five or more tiers or levels of companies that supply each other.  Each tier of the supply chain is responsible for establishing contracts with lower tiers to obtain products that meet their requirements, but they rarely share sensitive business information (such as supplier identity) with higher-tier suppliers or the OEM that can inhibit their competitiveness.  This structure allows for the deliberate flow of requirements, but not of sensitive business information (such as employee exposure data, socioeconomic business date, etc.) essential for Authorisation applications.  The A&D sector relies instead on surveys and encourages affected downstream users (DUs) to collaborate in Authorisation consortia (by joining or contributing) and voluntarily provide relevant data to third party consultants that aggregate the available data.  This approach is both time consuming and dependent on supplier cooperation.  In the short 18 to 24 month timeframe after substance listing on Annex XIV and the Last Application Date there is not always sufficient time to encourage enough supply chain actors to gather the pertinent data and develop a solid application.

Because of the many supply chain actors that need to be coordinated we strongly suggest that a longer transition period be adopted (i.e., at least 24 months).

5163
2024/05/07	European Semiconductor Industry Association (ESIA),
Industry or trade association,
Belgium	Please see attachment	
		See the corresponding embedded attachment in Part I:
5163_ESIA input to the consultation on draft recommendation for inclusion in the Authorisation List of Melamine and DTBPO.pdf	

III - Comments on uses that should be exempted from authorisation, including reasons for that
Number / Date	Submitted by (name, submitter type, country)	Comment	
5098
2024/04/23	FIDE-The Federation of the European Dental Industry,
Industry or trade association,
Germany	N/A	
		See the corresponding embedded attachment in Part I:
5098_FIDE_Comment for TPO Consultation_correction ET.pdf	
5117
2024/05/06	JSR Corporation,
Company,
Japan		
		
Confidential attachment removed	
5145
2024/05/07	Chemical Inspection & Regulation Service Limited,
Company,
Ireland	Substance cas 75980-60-8 is identified as a component of ink used in UV printing process. The inks are specifically used to print on polymer surfaces (PVC or ABS) , cured in UV curing oven and covered by a special transparent varnish and/or a specific plastic layer (PVC). Main use is for smart cards printing (Sim card, bank card, ID card) Current use is evaluated in 10 kg/y for a final weight on the card of 0,2 ppm for 50M cards/year This use will cover almost the 75% of the total manufacturing of a smart card manufacturing location Printing process is highly automated, exposure to workers is controlled, all liquid waste are sent for external waste treatment, air emissions from the printing process are treated and regularly monitored The substance is present in all major inks, at present no supplier is able to propose alternative free of the substance
﻿
1. Application characteristics of photoinitiator：TPO as type I, in ink/paint or other formulations, cracking into free radicals and other ingredients in the formulation quickly cross-linked into macromolecules via UV light, it does not exist, so toxicity does not exist, it is recommended to assess the setting of the use of the threshold to guide users to avoid excessive use during the use of residues. And it makes more sense for workers to have the right kind of protective education to control the risk, rather than all the authorization or restriction of control;
2.TPO is mostly used in the optical fiber coating industry, which requires a very fast curing speed, and there is no alternative product at present, and in the curing process occurs in a closed environment of inert gas, all exposures are very well controlled, and it is recommended to exempt the application that can be well controlled;
3. For industries that cannot be exempted from authorization or without threshold knowledge, the entire supply chain is too complex and involves many links, so it is suggested to give a longer transition period to find or develop alternative products, such as 36 months or longer.	
			
5152
2024/05/07	European Aerospace, Security and Defence Industries Association (ASD),
Industry or trade association,
Belgium	Exemptions are unlikely to be needed for this substance due to the limited impact and the fact that alternative processes/technologies may be available.	
			
5163
2024/05/07	European Semiconductor Industry Association (ESIA),
Industry or trade association,
Belgium	Please see attachment	
		See the corresponding embedded attachment in Part I:
5163_ESIA input to the consultation on draft recommendation for inclusion in the Authorisation List of Melamine and DTBPO.pdf