Comments on ECHA’s Draft 9th Recommendation for Cyclohexane-1,2-dicarboxylic anhydride and isomers (HHPA) (EC number: 201-604-9, 236-086-3, 238-009-9) and references to responses

The present document compiles the comments received during the public consultation on the draft 9th recommendation for inclusion of substances in Annex XIV of REACH for Cyclohexane-1,2-dicarboxylic anhydride and isomers (HHPA) (EC number: 201-604-9, 236-086-3, 238-009-9). The public consultation took place between 5 September 2018 and 5 December 2018.

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 https://echa.europa.eu/documents/10162/13640/9th_recom_respdoc_hhpa_mhhpa_en.pdf). 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	
3338
2018/12/05	ADS Group Limited,
Industry or trade association,
United Kingdom	Primary uses - These materials are used as hardeners in epoxy resin systems which provide unique chemical, mechanical, thermal and electrical properties.
Their uses are specifically
• as  hardeners in epoxy resins for filament winding wire
• as  hardeners in epoxy resins for some structural composite materials
• as  hardeners in resin systems used in high voltage electrical applications
• in resin systems used in Low Density Void Filler or composite part repair.

Alternatives - Eventual replacement may be possible within the cyclic acid anhydrides, for instance Methyl Tetrahydro Phthalic Anhydride or MTHPA (CAS No.: 26590-20-5) may be possible to replace HHPA or MHHPA, however, there are no commercially available alternatives to these chemical products at this time. Work is underway on the adaption of amine chemistry to create potential alternatives but that work is commencing with no indication of a successful completion date.
Exposure - Once the resin is cured the cyclic acid anhydride is no longer present having cross polymerised with the epoxy. As a result, there is no exposure risk present to Aerospace and Defence employees or Aviation passengers.
Why Aerospace Industry uses Cyclic Acid Anhydride containing products - The aerospace industry uses these hardening chemicals because the resulting resin systems meet Airworthiness requirements.
In this respect, Aerospace materials must be able to withstand extreme conditions including temperatures and pressures found at altitude, plus wide variations in humidity, friction, and rapid, repeated cycling during normal use. In addition, they must resist attack by aggressive fluids such as hydraulic fluids and de-icing agents.
	A.1.1.5. New information and next steps towards the final recommendation
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	
				
3346
2018/12/05	ChemSec,
International NGO,
Sweden	ChemSec supports the prioritisation of cyclohexane-1,2-dicarboxylic anhydride [1], cis-cyclohexane-1,2-dicarboxylic anhydride [2], trans-cyclohexane-1,2-dicarboxylic anhydride [3]1 (HHPA)for inclusion in Annex XIV.	Thank you for your opinion.	
				
3370
2018/12/05	CHEM Trust,
National NGO,
United Kingdom	CHEM Trust strongly supports the prioritisation of cyclohexane-1,2-dicarboxylic anhydride [1], cis-cyclohexane-1,2-dicarboxylic anhydride [2], trans-cyclohexane-1,2-dicarboxylic anhydride [3]1 (HHPA)for inclusion in Annex XIV.	Thank you for your opinion.	
				
3389
2018/12/05	Infineon Technologies AG,
Company,
Germany	The chemical substance cyclohexane-1,2-dicarboxylic anhydride is an ingredient in liquid mold compound material, which is currently used for FOWLP (Fan Out Wafer Level Packaging) products. In general, for these kind of packaging platform, the mold compound is a key material as it is influencing product performance, reliability characteristics and also manufacturing behavior. Therefore, up to the knowledge of Infineon, no phthalic anhydride free mold compound is available on the market fulfilling the extensive technical requirements.
The application for these kind of products mainly is driven from the automotive market: main focus is the market for safety applications like ADAS (Advanced Driver Assistance Systems) as e.g. use for emergency brake systems, which is a fast growing and very important feature in the automotive industry. A ban of these substance would strongly impact the manufacturing of these products within Europe.
In performed analysis tests after processing of the liquid mold material, cyclohexane-1,2-dicarboxylic anhydride couldn’t be detected in the final product. In addition, the final FOWLP devices will be capsulated again in a module before mounting into the car (please refer to attachment). Therefore direct contact with humans can be excluded during the life time within the application. As last point we would like to mention, that also during processing of the initial mold compound material any direct contact to employees can be excluded, as the material is delivered in form of sealed syringes and will be processed in encapsulated full automated equipment.
Therefore recommendation of Infineon is to exclude cyclohexane-1,2-dicarboxylic anhydride from the authorization list.
	A.1.1.5. New information and next steps towards the final recommendation
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	
		Attachment: 3389_Attachment_Final_Radar_module.pdf
		
3393
2018/12/05	Cyclic Anhydride Cooperation Group (representing Chemservice GmbH, Envigo Consulting Limited and Polynt SpA),
Company,
Germany	The Cyclic Anhydride Cooperation Group, representing European producers and importers, would like to take the opportunity to comment on this proposal within the public consultation phase.
The Cyclic Anhydride Cooperation Group acts to ensure the safe use of HHPA throughout the whole life cycle. Improved risk management measures and guidance documents to ease the implementation at all facilities and to ensure the safe use of the substance, and a recommended exposure limit value for workers are communicated by the Cyclic Anhydride Cooperation Group to the downstream users.
In summary, the Cyclic Anhydride Cooperation Group considers that the authorisation process for HHPA is inappropriate, for the reasons explained below, notably in terms of monomer use and risk management measures already in place. As such, HHPA should not be recommended for inclusion in Annex XIV since the appropriate priority score does not result in triggering prioritisation.

The Cyclic Anhydride Cooperation Group has made every effort to ensure worker safety at all levels within the supply chain. As part of this process the exposure scenarios have been examined and, where necessary, modified to represent the actual uses within the supply chain more accurately. A limit value was included in the chemical safety report and eSDS, to ensure the highest level of worker protection even in the absence of an EU-wide Occupational Exposure Limit (OEL) Value.
Existing values from different countries for HHPA, MHHPA or combined exposure to organic anhydrides were considered to recommend a reliable and scientifically justified value that protects workers against induction and elicitation of respiratory sensitisation. The limit value of 0.005 mg HHPA/m3 air represents the OEL that is in place in several European countries either for HHPA, MHHPA or both (Finland 8 hour limit of 0.01 mg/m3 for MHHPA and HHPA; Swedish Work Environment Authority short term guide value of 0.005 mg/m3 air for combined exposure to organic anhydrides; Spain, Ireland, Belgium and Canada short term limit value of 0.005 mg/m3 air for HHPA, US TLV–CEILING of 0.005 mg/m3 air for HHPA).

Furthermore, more stringent risk management measures were developed in cooperation with downstream users through the Anhydrides Joint Industry Taskforce (AJIT). Those measures were included in the chemical safety report (CSR) earlier this year. They are communicated throughout the supply chain by eSDS. In addition, documentation developed in cooperation with AJIT is available to downstream users which has supported downstream users to implement more stringent risk management measures to further minimises exposure at the workplace. The documents, Best practice guide and Harmonised worker training programs, provide guidance and detailed descriptions of risk management measures for each process step, to ensure easy applicability of the information provided in eSDS and CSR.

No cases of respiratory sensitization have been reported for HHPA or the combination of cyclic anhydrides in recent years. A medical surveillance program including a medical diagnostic guideline is in place to ensure continued worker health and to be able to detect any adverse effects early. The program was developed in collaboration with Prof. P. Cullinan of the National Heart & Lung Institute at Imperial College in London, an expert for Occupational and Environmental Respiratory Diseases. It is communicated within the supply chain to downstream users to ensure a standardised procedure and best possible worker health protection throughout the supply chain.

In accordance to Art. 2(8)(b) of REACH the authorisation process does not apply for  intermediates. As monomers are considered as intermediates, they are also exempt from authorisation. This is also considered in the ECHA draft background document for HHPA (5 September 2018) since it is stated that “some uses appear to be not in the scope of authorisation, such as use as intermediate including use as a monomer in the manufacture of thermoplastics”. During the in-depth communication within the supply chain it became apparent that HHPA is acting as a monomer in more uses then previously apparent to the Cyclic Anhydride Cooperation Group. To reflect this situation and to represent the uses in easy-to-identify exposure scenarios to the different industrial sectors specific exposure scenarios, including the required risk management measures, were introduced into the CSR and eSDS. The exposure scenario “Use of intermediate” represents an intermediate use (ERC 6a) and the exposure scenarios “Use of monomers in polymerization processes”, “Use in the production of High Voltage Rotating Machines” and “Use in the production of Switch Gear” reflect monomer uses (ERC 6c). Furthermore an independent expert statement has previously confirmed that HHPA functions as monomer to form polymer chains. Therefore, the exposure scenario “Use of reactive process regulators in polymerization processes” (ERC 6d) represents a monomer use, too (see statement from Fraunhofer IPA submitted under the specific field for annexes). Additionally, we refer to the confidential document submitted in the confidential annexes (Curing epoxies and Anhydrides) which describes in detail the reaction mechanism and explains why MHHPA and HHPA behave as monomers when reacting with epoxy resins. Based on the above, the volume of HHPA within the scope of authorisation has to be reconsidered.
In the draft background document the volume of HHPA in the scope of authorisation was estimated to be in the range of 1000 to 10000 t/y. Taking into account the revised share of intermediate/monomer uses on the total volume and recent material flow analysis conducted by AJIT, the volume within the scope of authorisation drops significantly to 100-1000 t/y. Consequently 999 t/y represent the maximum tonnage which could be within the scope of authorisation (worst case). This amount reflects 11 % of the total tonnage of HHPA handled in the EU.
As a result of these considerations, the 74 % and 3-8 % estimated by the dossier submitter for the monomer and intermediate uses as included in the “Responses to comments” document (2012) and by ECHA in the current draft background document for HHPA are outdated. The share of the total tonnage of HHPA outside the scope for authorisation is at least 89 % based on intermediate/monomer use and export.
Consequently the priority score for the volume criteria is 9.
The resulting priority score based on the above consideration is at maximum 15 (IP: 1; V: 9 (100-1000 t/y); WDP: 5) instead of 18.

Also taking into consideration the priority scores of other substances on the 9th draft list for recommendation of Priority Substances for inclusion in Annex XIV of REACH, HHPA should not be regarded as requiring priority. More than 10 substances being toxic to reproduction, carcinogenic, vPvB or acting as endocrine disruptors and with higher or similar priority score, compared to the score assigned by ECHA, should be considered before HHPA.
	A.1.1.5. New information and next steps towards the final recommendation
A.1.5.2. Authorisation is disproportionate and/or means a ban
A.1.5.4. Control of risks
A.2.01. claiming uses in production of high voltage rotating machines and switch gears as intermediate uses of (M)HHPA
A.2.02. Request to revise the priority score for (M)HHPA
A.2.03. Priority of (M)HHPA compared to other substances in the draft recommendation	
		Attachment: 3393_Expert statement_Opinion Cyclic Anhydrides.pdf

Confidential attachment removed
		
3396
2018/12/05	Aerospace Industries Association (AIA),
Industry or trade association,
United States	This substance proposed for annex XIV is not consistently identified on non-EU SDSs due to differences in GHS implementations by country.  Non-EU OEMs routinely place work in the EU and specify the use of certain formulations in the product design.  In the US, for example, substances that do not present an exposure hazard may be excluded from disclosure on SDSs.	A.2.04. (M)HHPA not always included in non-EU SDS	
				
3408
2018/12/05	AeroSpace and Defence Industries Association of Europe (ASD),
Industry or trade association,
Belgium		A.1.1.5. New information and next steps towards the final recommendation
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
A.1.5.7. Potential competitive disadvantage
B.1.2.2. Lack of alternatives, socio-economic aspects	
		Attachment: 3408_ASD input_on_anhydrides.pdf
		
3411
2018/12/05	EuPC/AJIT,
Industry or trade association,
Belgium	Please refer to the appended documents, which also contain table and graphs which cannot be inserted in this webform. : 2018_12_05_ AJIT_HHPA and MHHPA echa public consultation; 2018-12-05_AJIT_HHPA&MHHPA_Public Consultation Report 2018.
The Anhydrides Joint Industry Taskforce (AJIT) is a joint initiative of Producers/Importers, Formulators, and Downstream Users of the Anhydrides used as epoxy hardeners
The purpose of the AJIT is:
¡ To gather information on current exposure levels and risks associated with Anhydrides and propose protective measures;
¡ To evaluate socio-economic impacts of an authorisation;
¡ To inform authorities of possible risk management options for the use of Anhydrides.

General
We would like to highlight the progress made in the improvement of the risk management measures through the Anhydride Joint Industry Task Force (AJIT) Voluntary Commitment and the updated retrospective medical survey. Those elements may be found in the report in appendix.
As clearly indicated in the judgement by the European Court of justice in cases C323/15/P and C324/15/P, elements related to exposure are relevant for ascertaining an equivalent level of concern and the subsequent inclusion of a substance in the candidate list. Therefore, in the view of AJIT, it follows that elements related to exposure should be relevant also for the prioritization of the substance and, as a consequence it should be evaluated whether an Equivalent Concern is still relevant for this application.
Moreover, the recent European Court of Justice case C-650/15 P, also clarifies in which circumstances a use should be considered as intermediate use. Applied to this case, it will have as consequence at the minimum of reducing the scope of HHPA and MHHPA uses within the scope of authorization and therefore the priority scoring of HHPA and MHHPA.
The industry has recently updated its supply chain description by performing a new material flow analysis.

Classification
Remains.

Tonnage band
Here below the updated figures of the AJIT Material Flow Analysis. Both HHPA and MHHPA fall into the tonnage band 1000 – 10.000T when considering the uses listed by Echa subject to authorization, although the fractions of both HHPA and MHHPA within the scope of authorisation when following the Echa recommendation would fall near the lower limit of this tonnage range.

According to the legal opinion formulated by Noerr LLP (full document reported in Annex V of the AJIT report), the uses in High Voltage Rotating Devices (HVRD), Switch Gear (SG) production and part of the other uses (see confidential submission) should be considered as intermediates. The executive summary from the legal report is shown below:
• The definition of the term “intermediate” according to Article 3(15) REACH is interpreted differently by ECHA and by the ECJ.
• Whereas ECHA is of the opinion that the use of a substance qualifies as an intermediate use only in case the main aim of the chemical processing is the manufacturing of another substance, the ECJ rejects this interpretation with reference to the clear wording of Article 3(15) REACH.
• According to the interpretation provided by the ECJ, HHPA and MHHPA used as curing agents for epoxy resins in High Voltage Switchgear production by Automatic Pressure Gelation and Vacuum Casting and in High Voltage Electric Rotating Machines production by Vacuum Pressure Impregnation are intermediates.
• Although ECHA explicitly rejected the intermediate status of HHPA and MHHPA for the named uses by referring the decision of the General Court in Case T-268/10 RENV of 24 September 2015, it can be presumed that ECHA will follow the interpretation provided for in the subsequent judgment of the ECJ in Case C-650/15 P dated 25 October 2017 and, thus, acknowledges the intermediate status of HHPA and MHHPA for the aforementioned uses.
• While the arguments provided by ECHA to reject the intermediate status need to be reconsidered against the background of the ECJ judgment in Case C-650/15 P dated 25 October 2017, it cannot be excluded that any other argument will be developed by the authorities to maintain the rejection of the intermediate status of HHPA and MHHPA. On basis of the REACH legal text and the interpretation provided by the ECJ in its judgment in Case C-650/15 P of 25 October 2017, however, it seems to be likely that the intermediate status can be defended either on level of ECHA and the EU Commission or, in case ECHA further denies to follow the ECJ interpretation, at level of the ECJ.
• Given that HHPA and MHHPA used as curing agents for epoxy resins in High Voltage Switchgear production by Automatic Pressure Gelation and Vacuum Casting and in High Voltage Electric Rotating Machines production by Vacuum Pressure Impregnation qualify as intermediates, they are exempted from authorization obligations according to Article 56 REACH as stipulated in Article 2(8) b) REACH.
• The principles of “strictly controlled conditions” are not relevant for the interpretation of the term “intermediate” as such, as well as for the exemption of Article 2(8) b) REACH. Therefore, HHPA and MHHPA used as curing agents for epoxy resins in High Voltage Switchgear production by Automatic Pressure Gelation and Vacuum Casting and in High Voltage Electric Rotating Machines production by Vacuum Pressure Impregnation qualify as intermediates exempted from authorization requirements irrespective whether strictly controlled conditions are met on site.
If the use in high voltage rotating device and switchgear is considered as intermediate use, the volume of anhydrides within the scope of authorisation changes. Therefore, the range of tonnage into which the anhydrides fall is 100 – 1000 tons/y and just the category other uses (or part of those uses) should be considered, as shown in Table 3. Indeed, according to this option, 2486.3 tons/y would be considered intermediate use and 1385.2 tons/y, or potentially even less, of anhydrides would be possibly within the scope of authorisation (see separate confidential submission).
*for confidentiality reasons, the exact tonnage of HHPA and MHHPA (given as separate values) cannot be disclosed. However, both substances fall into the range 100 – 1000 tons/y.

Type of use
HHPA and MHHPA are industrial uses. In the full EU market, according to extrapolations done after considering the data collected during the last Industry Consultation in 2018, the estimated amount of potentially exposed workers is about 1600 on a population of workers involved in the HHPA and MHHPA industry of about 20000. Those numbers will be reduced to less than 500 in case the uses in Switch Gear, High voltage rotating devices and other uses are considered as intermediate uses.

Scores
18 for each substance folowing Echa analysis. In case SwitchGear and High Voltarge Rotating Device Uses are considered intermediate , the score falls to 15 for both substances.	A.1.1.3. Prioritisation approach applied
A.1.3.3. Refinement of WDU score based on article service-life
A.1.5.2. Authorisation is disproportionate and/or means a ban
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
A.1.5.7. Potential competitive disadvantage
A.1.5.8. Uncertainty as to whether authorisation will be granted
A.2.01. claiming uses in production of high voltage rotating machines and switch gears as intermediate uses of (M)HHPA
A.2.02. Request to revise the priority score for (M)HHPA	
		Attachment: 3411_2018-12-05_consultation Echa AJIT_HHPA and MHHPA.zip

Confidential attachment removed 

II - Transitional arrangements. Comments on the proposed dates
Number / Date	Submitted by (name, submitter type, country)	Comment	Reference to responses	
3338
2018/12/05	ADS Group Limited,
Industry or trade association,
United Kingdom	Work continues within the aerospace and defense supply chains to develop qualifiable alternate hardening systems. The ability of the industry to qualify alternates is rarely rapid and with no commercially available alternate systems yet presented to the market it is difficult to see how it could comply with the typical five year cycle that REACH legislation appears based upon.  Any alternate must meet the requirements of industry standards set by other regulators, as well as aerospace and defence company internal specifications. Extensive empirical data may be required to demonstrate both flight safety and airworthiness, which is a lengthy a process that could take over 10 years. Note that, in this respect, many of the applications of these resin systems are in areas that are subject to a type-approval from the European Aviation Safety Agency (EASA)
ADS cautions against blanket assumptions for validation of aerospace alternatives. Rigorous qualification testing is required based on engine application, hardware requirements, customer contracts and Airworthiness requirements set by the regulatory authorities.
If this proposed recommendation proceeds when there are no commercially alternatives available to even begin testing, it will ultimately jeopardise the competitiveness of the EU operators by restricting their ability to perform scheduled maintenance or on-wing repairs, where there would be no option but to take place outside of the EU.
	B.1.2.2. Lack of alternatives, socio-economic aspects	
				
3393
2018/12/05	Cyclic Anhydride Cooperation Group (representing Chemservice GmbH, Envigo Consulting Limited and Polynt SpA),
Company,
Germany	Considering the supply chains of several manufactures/importer each with several downstream users, the Cyclic Anhydride Cooperation Group considers that the work and time needed to prepare authorisation applications exceeds the time and work for a standard case. Therefore the LAD of 21 months after the Date of inclusion in Annex XIV is considered appropriate.	B.1.1.1. Legal background
B.1.1.2. ECHA's proposal for sunset dates
B.1.1.3. ECHA's proposal for latest application 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)	
		See the corresponding embedded attachments in table 1 of Part I:
3393_Expert statement_Opinion Cyclic Anhydrides.pdf

Confidential attachment removed		
3396
2018/12/05	Aerospace Industries Association (AIA),
Industry or trade association,
United States	The aerospace sector relies on surveys and encourages affected downstream users to collaborate in authorisation consortia (by joining or contributing) and voluntarily provide relevant data to third party consultants that aggregate the available data.  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 develop an accurate and comprehensive application.	B.1.1.3. ECHA's proposal for latest application 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)

3411
2018/12/05	EuPC/AJIT,
Industry or trade association,
Belgium	As shown in the attached AJIT public consultation report, from the description of uses and the material flow analysis it is possible to observe that the structure of the supply chain is not overly complex. The supply chain is composed by a limited number of manufacturers, formulators and downstream users, which can be either large companies or SMEs. Therefore, we would recommend a latest application date of 21 months after the inclusion in the annex XIV.	B.1.1.1. Legal background
B.1.1.2. ECHA's proposal for sunset dates
B.1.1.3. ECHA's proposal for latest application dates	
		See the corresponding embedded attachments in table 1 of Part I:
3411_2018-12-05_consultation Echa AJIT_HHPA and MHHPA.zip

Confidential attachment removed

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	
3389
2018/12/05	Infineon Technologies AG,
Company,
Germany	As mentioned before, no substitution substance is available. So, we ask to exempt the use in Semiconductor Industry from the authorisation requirement. During the processing of the initial mold compound material containing cyclohexane-1,2-dicarboxylic anhydride any direct contact to employees can be excluded, as the material is delivered in form of sealed syringes and will be processed in encapsulated full automated equipment.	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 table 1 of Part I:
3389_Attachment_Final_Radar_module.pdf		
3411
2018/12/05	EuPC/AJIT,
Industry or trade association,
Belgium	From the Industry Consultation carried out in 2018, one downstream user reported that a fraction of HHPA and MHHPA is used for the production of medical devices. In this case, exemption from authorisation may apply.	C.1.1. General principles for exemptions under Art. 58(2)

C.1.2. Generic exemptions	
		See the corresponding embedded attachments in table 1 of Part I:
3411_2018-12-05_consultation Echa AJIT_HHPA and MHHPA.zip

Confidential attachment removed