Comments on ECHA’s Draft 11th Recommendation for ethylenediamine (EC number: 203-468-6) and references to responses

The present document compiles the comments received during the consultation on the draft 11th recommendation for inclusion of substances in Annex XIV of REACH for ethylenediamine (EC number: 203-468-6). The consultation took place between 2 February 2022 and 2 May 2022.

For each of the comments there is also a reference to specific section(s) of a document containing the responses to comments (“Response document”, available at the substance specific entry of the list of Recommendations for inclusion in the Authorisation List (https://echa.europa.eu/recommendations-for-inclusion-in-the-authorisation-list). The responses in the Response document are arranged by thematic block and level of information (see more detailed explanations at the beginning of that document).

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	Reference to responses	
3817
2022/04/27	Zeller+Gmelin GmbH & Co. KG,
Company,
Germany	Zeller+Gmelin in manufacturer of water miscible coolants for drawing steel cord for tires.
For decades, Ethylenediamine (EDA) is used in water miscible coolants for processing steel cord for all kind of tires. EDA has the functionalities to improve the lubrication performance during the drawing process and adhesion between steel cord and rubber in the manufactured tire. Over the long period of use, within the aging process (many years) of the tire, the later functionality is not lost. For a large amount of tires only less EDA is required. Therefore, the concentration of EDA in the applied emulsion (coolant) to draw the steel cord is below 0.5%. The need of EDA for our company is between 100 – 150 mt/y.
During the manufacturing process as industrial use the DNEL of EDA (long term systemic: 25 mg/m³) will certainly not be exceeded. As the coolant is used in closed, continuous processes with occasional controlled exposure, the exposure for workers is very low and easy to control.
As EDA is classified as respiratory sensitizer category 1, it would be the substance with the lowest risk mentioned on the authorization list. With the low hazard category and low exposure, this process poses a very low risk to human health.
Products without EDA are already developed for processing steel cord. However, this drawn steel cord have no approval from tire manufacturers yet to be used for the reinforcement of tires. The reason is that the approval process lasts many years. It is necessary to conduct several field tests with the tires under different conditions for a long time in different climate zones to ensure that there are no safety risks from this lubricant change.
It is obvious that a change within the tire production must be well checked since it is highly safety relevant, as can be seen with the Firestone example. A mistake can cost lives.
If, despite all the concerns, EDA will be included on the authorisation list, an exemption for the manufacture of steel cord for tires would be recommended.	A.1.1.3. Prioritisation approach applied
A.1.5.2. Authorisation is disproportionate and/or means a ban
A.1.5.3. Use specific considerations
A.1.5.4. Control of risks
A.1.5.5. Availability of suitable alternatives
A.2.01. Questioning the priority of EDA, as it has the lowest intrinsic property score	
				
3831
2022/04/27	STMicroelectronics,
Company,
Switzerland	Ethylenediamine is used in limited quantities as an essential ingredient in a specialty chemical for Nickel electroless deposition and in specific photolithography chemicals within the semiconductor manufacturing process
Due to strictly controlled conditions applied in semiconductor manufacturing environment, including double contained distribution system and local exhaust, there is no potential for workers exposure. Moreover, all waste streams are collected and treated. Emissions to air are treated in air scrubbers, spent chemical liquid waste are collected and sent for incineration and liquid rinsing waste are treated locally in the wastewater treatment plant.
There is evidence that industrial use of Ethylenediamine in the semiconductor manufacturing process does not induce exposure to workers, therefore the high score in the prioritization exercise as wide dispersive use may be considered excessive for this sector.
	A.1.3. Prioritisation: Wide-dispersiveness of uses
A.1.5.3. Use specific considerations
A.1.5.4. Control of risks
A.1.5.5. Availability of suitable alternatives
A.2.05. WDU score overestimated	
		3831_ST ETHYLENDIAMINE ECHA Consultation April 2022 FINAL.pdf
		
4068
2022/04/29	BASF SE,
Company,
Germany	For BASF SE's comments please see the attached document.	A.1.2.1. Volume in the scope of authorisation
A.1.3. Prioritisation: Wide-dispersiveness of uses
A.2.02. Volume in the scope of authorisation is overestimated
A.2.03. BASF Volume in the scope of authorisation
A.2.05. WDU score overestimated
A.2.06. Question the information on the structure and complexity of supply chain reported in the background document	
		4068_107-15-3 EDA Comments of BASF SE to annex XIV prioritisation 20220428f.pdf
		
4230
2022/04/29	European Semiconductor Industry Association (ESIA),
Industry or trade association,
Belgium	The semiconductor industry does not have this information on other sectors. The European semiconductor industry is a provider of key enabling technologies and creates innovative solutions for industrial development, by contributing to economic growth and responding to major societal challenges. Being ranked as one of the most R&D-intensive sectors by the European Commission, the European semiconductor ecosystem supports approximately 200,000 jobs directly and up to 1,000,000 induced in systems, applications, and services in Europe. Overall, micro- and nano-electronics enable the generation of at least 10% of GDP in Europe and the world.
Semiconductor device fabrication is among the most complex and sophisticated manufacturing processes in the world, taking place in a strictly controlled and safe production environment (the cleanroom). All manufacturing processes are performed in dedicated and closed process equipment tools. Here, the presence of uncontrolled particles, as well as impurities in the form of chemical vapours and gases constitutes an unacceptable risk from a safety and health as well as from a production quality viewpoint.

Generally, semiconductors are essential for electronic systems in many industry sectors (including e.g., lighting, intelligent transport systems, automotive, aviation, aerospace, smart grids, renewable energy technologies, industrial tools, agriculture, computing, healthcare and medical devices, consumer electronics, encryption security and smart cards).
Should ethylenediamine be included in the authorisation list, the production of semiconductors would only be possible with an appropriate authorisation duration. Given that there is no replacement for ethylenediamine in the semiconductor industry, an authorisation does not constitute a viable long-term option, since it has a limited timeframe. It would be the responsibility of the semiconductor industry to apply for an authorisation. This would constitute an excessive administrative burden. In light of this, ESIA believes that ethylenediamine should not be included in Annex XIV of the REACH Regulation.
ESIA would suggest that ethylenediamine is better regulated and managed through a targeted REACH restriction in combination with creating binding occupational and biological exposure limits for ethylenediamine.
	A.1.5.1. Potential other regulatory actions
A.1.5.2. Authorisation is disproportionate and/or means a ban
A.1.5.3. Use specific considerations
A.1.5.4. Control of risks
A.1.5.5. Availability of suitable alternatives
A.1.5.6. Socio-economic benefits of continued use	
				
4268
2022/04/29	Ethylene Amines EU REACH Consortium for the lead registrant, Nouryon Functional Chemicals AB,
Other contributor,
Belgium	The Ethylene Amines REACH consortium consisting of the main EU producers of this substance has revised the Joint Submission dossier and removed several uses that are no longer supported/applicable (i.e. industrial uses as processing aid, scavenging agent or process additive).
Main uses of ethylenediamine are the use as intermediate and use as monomer for polymerization at industrial sites. These uses fall outside the scope of authorization and are greater than 92% of the market volume based on a survey conducted by the consortium.
The volumes per use type are indicated in the individual REACH registration dossiers of the registrants.
Based on feedback from customers and our assessment being the major EU EDA marketers (all being part of the Ethylene Amines REACH consortium) we strongly believe that the volume for uses in scope for authorization are maximum 1,000 t/y. Therefore, the score for Volume (V) should be lowered according to the prioritisation approach.
	A.1.2. Prioritisation: Volume
A.1.3. Prioritisation: Wide-dispersiveness of uses
A.2.02. Volume in the scope of authorisation is overestimated
A.2.05. WDU score overestimated	
		4268_EA REACH consortium -SVHC consultation April 2022_Final.docx
		
4767
2022/05/02	Dow Europe GmbH,
Company,
Switzerland	Please refer to the comments in the attached document.	A.1.2. Prioritisation: Volume
A.1.3. Prioritisation: Wide-dispersiveness of uses
A.2.02. Volume in the scope of authorisation is overestimated
A.2.05. WDU score overestimated	
		4767_EDA_EA REACH consortium_Comments on the draft recommendation_May2022.pdf
		
4896
2022/05/02	Freiberger Compound Materials GmbH,
Company,
Germany	Freiberger Compound Materials GmbH is the main producer of gallium arsenide wafers (GaAs) - one of only two existing companies - in the entire European Union. Ethylenediamine  is used as formulation additive in aqueous media only at a certain stage in the entire processing line of gallium arsenide wafers. The risk is minimized by following measures:
- The number of workers who are dealing with ethylenediamine is limited – only those of the facility department who are responsible for connecting the drums with the pumping system.
- A pipeline provides automatically ethylenediamine to a tank where it is diluted with water. This tank supplies the aqueous solution (ca. 1% concentrated) directly into the polishing machine.
- All workers are skilled and regularly trained according to the actual legislation. Related risk management measures are in place.
No incidents have been occurred during 20 years routinely usage of this substance.

In average Freiberger uses a quantity of about 2.2 t/y ethylenediamine. Compared with very hazardous substances used more than 1000 t/y in the chemical industry this is not much for an industrial use only.
Freiberger recommends to exempt the use of ethylendiamine in the production of semiconductor substrates. This specific industrial application leads to a semifinished product, which does not contain ethylendiamine. In consequence, finished consumer products like smartphones do not contain any ethylenediamine originated from Freiberger substrates. The usage is closed, regulated and the risk is properly controlled.
No suitable alternative with lower risk has been identified to ethylenediamine in order to achieve the required effects for gallium arsenide wafers used in semiconductor industry.	A.1.2. Prioritisation: Volume
A.1.3. Prioritisation: Wide-dispersiveness of uses
A.1.5.2. Authorisation is disproportionate and/or means a ban
A.1.5.3. Use specific considerations
A.1.5.4. Control of risks
A.1.5.5. Availability of suitable alternatives
A.2.04. Use of the substance in specific application in low tonnage	
		4896_2022_05_02 Freiberger - comments for EDA to the ECHA on inclusion in the Authorisation list.pdf

II - Transitional arrangements. Comments on the proposed dates
Number / Date	Submitted by (name, submitter type, country)	Comment	Reference to responses	
3831
2022/04/27	STMicroelectronics,
Company,
Switzerland	There is no alternative to current use of Ethylendiamine in in a specialty chemical for Nickel electroless deposition in the semiconductor manufacturing process. STMicroelectronics is in touch with the suppliers to identify some alternatives. There is no evidence an alternative will be found soon. Therefore, it is unlikely a substitution plan can be completed before the latest authorization date. Consequently, we believe that the latest application date of 24 months should be chosen.	A.1.5.5. Availability of suitable alternatives
B.1.1. General principles for setting latest application dates/sunset dates
B.1.2. Aspects not considered by ECHA when proposing latest application dates/sunset dates
B.2.01. Request LAD of 24 months’	
		See the corresponding embedded attachment in Section I: 
3831_ST ETHYLENDIAMINE ECHA Consultation April 2022 FINAL.pdf		
4068
2022/04/29	BASF SE,
Company,
Germany	For BASF SE's comments please see the attached document.		
		See the corresponding embedded attachment in Section I: 
4068_107-15-3 EDA Comments of BASF SE to annex XIV prioritisation 20220428f.pdf		
4230
2022/04/29	European Semiconductor Industry Association (ESIA),
Industry or trade association,
Belgium	If ethylenediamine was included in Annex XIV of the REACH Regulation, ESIA requests that, in light of the highly complex nature of the manufacturing process, the long R&D and investment cycles of the semiconductor industry, the 24-month timeframe would be selected for the Latest Application Date.	B.1.1. General principles for setting latest application dates/sunset dates
B.2.01. Request LAD of 24 months’	
				
4268
2022/04/29	Ethylene Amines EU REACH Consortium for the lead registrant, Nouryon Functional Chemicals AB,
Other contributor,
Belgium			
		See the corresponding embedded attachment in Section I: 
4268_EA REACH consortium -SVHC consultation April 2022_Final.docx		
4767
2022/05/02	Dow Europe GmbH,
Company,
Switzerland	No comments.		
		See the corresponding embedded attachment in Section I: 
4767_EDA_EA REACH consortium_Comments on the draft recommendation_May2022.pdf		
4896
2022/05/02	Freiberger Compound Materials GmbH,
Company,
Germany	Freiberger recommends to exempt the use of ethylendiamine in the production of semiconductor substrates (electronic sector). This specific industrial application leads to a semifinished product, which does not contain ethylendiamine. In consequence, finished consumer products like smartphones do not contain any ethylenediamine originated from Freiberger substrates. The usage is closed, regulated and the risk is properly controlled.
If an inclusion in Annex XIV is unavoidable we request the max. LAD of 24 months after the date of inclusion in Annex XIV since the work on an application for authorization in electronic sector and needed data for that purpose are very complex, gathering would be very time-consuming and expensive.	B.1.1. General principles for setting latest application dates/sunset dates
B.1.2.1. Extensive time needed in the supply chain to get organised for preparing application (e.g. due to high number of users)
B.2.01. Request LAD of 24 months’	
		See the corresponding embedded attachment in Section I: 
4896_2022_05_02 Freiberger - comments for EDA to the ECHA on inclusion in the Authorisation list.pdf		

III - Comments on uses that should be exempted from authorisation, including reasons for that
Number / Date	Submitted by (name, submitter type, country)	Comment	Reference to responses	
3817
2022/04/27	Zeller+Gmelin GmbH & Co. KG,
Company,
Germany	As I desribed above, the manufacture of water miscible coolants for steel cord of tires should be exempted. It is used in proc. 2.	C.1.1. General principles for exemptions under Art. 58(2)
C.1.3. Aspects not justifying an exemption from authorisation	
				
3831
2022/04/27	STMicroelectronics,
Company,
Switzerland			
		See the corresponding embedded attachment in Section I: 
3831_ST ETHYLENDIAMINE ECHA Consultation April 2022 FINAL.pdf		
4068
2022/04/29	BASF SE,
Company,
Germany	For BASF SE's comments please see the attached document.		
		See the corresponding embedded attachment in Section I: 
4068_107-15-3 EDA Comments of BASF SE to annex XIV prioritisation 20220428f.pdf		
4268
2022/04/29	Ethylene Amines EU REACH Consortium for the lead registrant, Nouryon Functional Chemicals AB,
Other contributor,
Belgium	We do not recognise and are not aware of the use in consumer products as reported in the Nordic Product Registers (SPIN database). Consumer uses are not and never have been part of the registered uses in the registered REACH dossiers and were never supported by the Ethylene Amines REACH consortium. Moreover, we have now included all consumer uses as a "Use advised against" to make it more explicit that such use is not supported. The reporting in the SPIN database seems to be misreporting. SPIN itself also states "...the European Chemicals Bureau (ECB) does not use the same system, which makes analyses linking data from different sources more complicated and less useful"  . Therefore, the score for Wide dispersiveness of uses (WDU) should be lowered.	Please see references to responses in section I	
		See the corresponding embedded attachment in Section I: 
4268_EA REACH consortium -SVHC consultation April 2022_Final.docx		
4767
2022/05/02	Dow Europe GmbH,
Company,
Switzerland	Please refer to the comments in the attached document.		
		See the corresponding embedded attachment in Section I: 
4767_EDA_EA REACH consortium_Comments on the draft recommendation_May2022.pdf		
4769
2022/05/02	Redel Elektronika Kft,
Company,
Hungary	At Redel Elektronika Kft are plating nickel to our components. During our rework processes we are using Ethylenediamine as substance of solvent. Yearly consommation is 25-30 l. Waste solution is handled as hazardous waste and it doesn't imply any risk to workers, consumers or environment. Ethylenediamine isn't part of our final product therefore it doesn't imply any risk to our final costumers.	Please see references to responses in section I	
				
4896
2022/05/02	Freiberger Compound Materials GmbH,
Company,
Germany	Freiberger recommends to exempt the use of ethylendiamine in the production of semiconductor substrates (electronic sector). This specific industrial application leads to a semifinished product, which does not contain ethylendiamine. In consequence, finished consumer products like smartphones do not contain any ethylenediamine originated from Freiberger substrates. The usage is closed, regulated and the risk is properly controlled. There is no risk for the environment by using this small quantity of ethylendiamine as described above.
There are some socio-economic reasons to grant this exemption as described in the public consultation started by the European Commission.	C.1.1. General principles for exemptions under Art. 58(2)
C.1.3. Aspects not justifying an exemption from authorisation	
		See the corresponding embedded attachment in Section I: 
4896_2022_05_02 Freiberger - comments for EDA to the ECHA on inclusion in the Authorisation list.pdf