Comments on ECHA’s Draft 7th Recommendation for 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 7th recommendation for inclusion of substances in Annex XIV of REACH for HHPA (EC number: 201-604-9, 236-086-3, 238-009-9 ). The public consultation took place between 18 November 2015 and 18 February 2016.

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/10162/13640/7th_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	
3061
2016/02/02	Norway,
Member State	The Norwegian CA supports the prioritisation of  Cyclohexane-1,2-dicarboxylic anhydride, cis-cyclohexane-1,2-dicarboxylic anhydride, trans-cyclohexane-1,2-dicarboxylic anhydride (HHPA)  for inclusion in Annex XIV.

In general, the Norwegian CA supports grouping of substances of very high concern to avoid substitution with substances with similar properties within the same use categories.
Respiratory sensitizers may pose a significant health problem for workers and we therefore agree that these substances fulfil the prioritisation criteria for inclusion in Annex XIV.
	Thank you for your opinion.	
				
3064
2016/01/14	Other contributor,
Germany	Request for a meeting due to new information.
Please see attachment.	A.1.2.1. Volume in the scope of authorisation
A.2.1. Intermediate status of the use of HHPA/MHHPA in resins
A.2.7. Request for a meeting to discuss intermediate status	
		
Confidential attachment removed		
3065
2016/02/05	Robert Bosch GmbH,
Company,
Germany		A.1.5. Aspects not considered in ECHA's prioritisation
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
A.1.5.7. Burden for industry and potential competitive disadvantage
A.2.1. Intermediate status of the use of HHPA/MHHPA in resins
B.1.2. Aspects not considered by ECHA when proposing latest application dates/sunset dates
B.1.2.2. Lack of alternatives, socio-economic aspects	
		
Confidential attachment removed		
3071
2016/02/11	ChemSec,
International NGO,
Sweden	ChemSec supports the inclusion of this substance on Annex 14	Thank you for your opinion.	
				
3087
2016/02/16	ASD,
Industry or trade association,
Belgium	See attachment below	A.1.5. Aspects not considered in ECHA's prioritisation
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
A.1.5.7. Burden for industry and potential competitive disadvantage
B.1.2. Aspects not considered by ECHA when proposing latest application dates/sunset dates
B.1.2.2. Lack of alternatives, socio-economic aspects	
		3087_ASD response - cyclic acid anhydrides - February 2016.pdf

			
3116
2016/02/17	Company,
Italy	We use MHHPA and HHPA in low quantity as part of our mix to produce epoxy parts. Risk mesures are in place to secure safe use of MHHPA and HHPA. No respiratory problems occured to our workers and no professional diseases also never occured in our company founded in 1971.	A.1.5. Aspects not considered in ECHA's prioritisation
A.1.5.4. Control of risks	
				
3124
2016/02/17	Polynt SpA on behalf of Cyclic Anhydride Cooperation Group,
Company,
Italy	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 supports the safe use of the HHPA throughout the whole life cycle and considers that appropriate risk management measures have already been adopted to reduce workers exposure.
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 timing, monomer use and risk management measures already in place. In any case, HHPA should not be recommended for inclusion in Annex XIV since the appropriate priority score should not result in prioritisation.

Inappropriate timing / premature proposal

1. The identification of HHPA as a Substance of Very High Concern (SVHC) on the basis of an equivalent level of concern, in accordance with Article 57(f) of REACH, and its inclusion in the Candidate List for authorisation is currently still being challenged through an appeal procedure before the Court of Justice of the European Union (Case C-323/15 P). Therefore, although the appeal does not have suspensive effects, it is still premature for ECHA to propose the inclusion of HHPA in Annex XIV since there is no final decision yet on the level of concern of HHPA and its inclusion on the Candidate List, which is the required first step for further possible inclusion in Annex XIV.

 
Priority score

Inherent properties
2. HHPA is classified in Annex VI, part 3, Table 3.1 (the list of harmonised classification and labelling of hazardous substances) of Regulation (EC) No 1272/2008 as respiratory sensitiser (amongst other endpoints). Based on this intrinsic property, HHPA has been considered as a substance for which, in accordance with Article 57(f) of REACH, there is scientific evidence of possible serious effects to human health which give rise to an equivalent level of concern to those of other substances listed in points (a) to (e) of Article 57 (i.e. CMRs). However, as indicated above, the identification of HHPA as an SVHC, with an equivalent level of concern to CMRs having probable serious effects to human health, is still being challenged before the Court of Justice of the European Union and no final judgment has been adopted yet.
3. Furthermore, an assessment has been carried out for HHPA by the American Conference of Governmental Industrial Hygienists (ACGIH) and a TLV–CEILING of 0.005 mg/m3 (inhalable fraction and vapour) was adopted in 2015 (see the ACGIH report submitted under the specific field for annexes). This was based on the following: >50 μg/m3 yields antibody increase vs. control population; 10 μg/m3 with peak concentrations >50 μg/m3 resulted in increased antibodies; 10 μg/m3 without peak concentrations does not yield an antibody increase vs. control population. Minimizing antibody increases reduces respiratory symptoms. The adoption of, and adherence to, such a limit can be regarded as providing adequate protection to the workers.
4. According to the ACGIH report on HHPA, the findings do suggest that low exposure without any peak exposure incidents does not give rise to sensitization (induction) as determined by blood IgE levels and is used to recommend maintaining workplace concentration <10 µg/m3. In case a threshold is derived and accepted by the authorities, instead of authorisation, a restriction process comparable to that of the Diisocyanates would be an appropriate measure to manage the risk of respiratory sensitisation.
5. There are biomonitoring parameters for sensitization available (e.g. IgE and IgG) which can be used for an early identification of the first, symptom free induction phase of the sensitization process . Thus, subsequent development of clinical symptoms can effectively be avoided by removing the worker from the work place.

Volume (monomer use)
6. In the registration dossier there are identified uses reported as intermediate/monomer uses (ERC 6a and 6c respectively) and as a process regulator for polymerisation processes (ERC 6d). However, the independent expert statement attached confirms that the use of both MHHPA and HHPA in respect of the ERC 6d use clearly represents from a point of view of the reaction chemistry a monomer use (see statement from Fraunhofer IPA submitted under the specific field for annexes). However, the legal status of the substance (fulfilling the criteria of a monomer) has not been clarified with ECHA yet, which is key for the entire follow up process of the substance. Additionally, we refer to the confidential document submitted under the specific field for the confidential annexes (“Curing Epoxies and Anhydrides” – ref. LE022016 mpe  of 16th February 2016) which describes in detail the reaction mechanism and explains why HHPA and MHHPA behave as monomer when reacting with epoxy resins.
7. In case the expert statement is accepted by the authority, the registration dossiers will be updated accordingly and both MHHPA and HHPA would no longer be in the focus for authorisation since there would be no significant volume in the scope of authorisation and consequently no priority score for the volume criteria. In other words, the proposal for authorisation is premature as for intermediate/monomer uses the authorisation process does not apply according to Art. 2(8)(b) of REACH.

Wide dispersiveness of uses (WDU)
8. In the background document, it is stated that registered uses of HHPA in the scope of authorisation include uses at industrial sites and for this reason a score of 7 is given to the substance.
9. For HHPA, the initial score of 5 for WDU has been refined to 7 because the substance is used by professional workers in volumes <10 MT/Year. The Cyclic Anhydride Cooperation Group as well as the HHPA Cooperation Group do not agree with this approach. The lead registrant and the consortium members only support industrial use of the anhydrides due to the inherent properties of the substances and the related worker hygiene conditions.
10. It is our understanding that the information about the quantity of HHPA (< 10 Tons/year) for professional use comes from the responses/comments to the public consultation for the identification of the substance as SVHC, issued by ECHA on 23/11/2012. In this document a company indicated that they are using HHPA as  “hardener for epoxy resins in a process of production of coating in quantities < 10t/y. …Downstream user of this paint is a professional user”. However, to our knowledge, no professional use of HHPA has been registered in the registration dossiers. Therefore, this (non-registered) professional use should not be considered for purposes of prioritisation under REACH. This can even be strengthened by “using advice against this use” in the respective dossier. Additionally, it is possible that the company ceased such use (the information referred to 2012, while prioritisation took place in 2015). Consequently, the additional 2 priority point for professional use of HHPA should not be included.

Further considerations
11. In the draft HHPA background document, it is stated by ECHA that priority for HHPA was assessed by using the General Approach for prioritisation of SVHCs for inclusion in the Authorisation List, which is score based. However, the main argument for proposal for authorisation, i. e. grouping with MHHPA, is considered not to be part of the “General Approach” according to Art. 58(3) of the REACH Regulation.
12. Additionally, MHHPA is also separately recommended for inclusion in Annex XIV. Therefore, ECHA cannot at the same time apply the grouping approach in order to strengthen the prioritisation criteria and propose the inclusion of both substances separately, on the basis of the same grouping argument.
13. Furthermore, based on the priority score of 20, any proposal for authorisation for HHPA would not be expected at this early stage in particular as there are more than 10 substances with priority scores well above 20 especially due to reproductive toxicity which should be considered first.
14. Finally, based on the above considerations, a priority score of maximum 9 (IP: 1; V: 3 (<10 t/a); WDP: 5) instead of score 20 is appropriate. The value derived by ECHA does not properly reflect the current use of the substance (industrial use only) and its chemical behaviour (pure monomer use). Therefore, any authorisation proposal/procedure is inappropriate.
15. It should also be noted that, although the diisocyanates are also classified for respiratory sensitisation, H334, cat. 1 and occupational respiratory diseases are well known in all Member States of the EU, they were not identified to be substances of an equivalent level of concern and were not included on the Candidate List. Currently, the German competent authority proposes the diisocyanates for restriction. Restriction proposals comparable to those of the diisocyanates would also be the correct approach to tackle work place safety requirements related to HHPA and MHHPA. This would also be in line with the "Roadmap to SVHC", which is based on the Risk Management Options (RMO) approach and the principle of better regulation (i.e. identifying the best regulatory option to manage the risk), whereby the Commission and ECHA emphasize the importance of restrictions of Community legislation outside REACH as viable regulatory alternatives to authorisation.	A.1.1. General, recommendation process
A.1.1.1. ECHA's obligation to recommend/prioritise substances on the Candidate List
A.1.1.2. Legal basis for prioritisation
A.1.1.3. Prioritisation approach applied
A.1.1.4. Information taken into account for the draft recommendation
A.1.1.5. New information and next steps toward the final recommendation
A.1.2. Prioritisation: Volume
A.1.2.1. Volume in the scope of authorisation
A.1.3. Prioritisation: Wide-dispersiveness of uses
A.1.3.3. Refinement of WDU score based on article service-life
A.1.5. Aspects not considered in ECHA's prioritisation
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.2.1. Intermediate status of the use of HHPA/MHHPA in resins
A.2.2. Challenging the grouping approach
A.2.3. Challenging ELoC of the substance(s)
A.2.4. Challenging the prioritisation of HHPA and MHHPA with respect to both the volume score and the wide dispersiveness of the uses
A.2.5. ECHA should not proceed with the recommendation of HHPA and MHHPA as there is a court case ongoing	
		3124_15-07-21_Opinion Cyclic Anhydrides-supplmt_signed.pdf

Confidential attachment removed		
3136
2016/02/18	Company,
Belgium		A.1.1.5. New information and next steps toward the final recommendation
A.1.5.4. Control of risks	
		
Confidential attachment removed		
3142
2016/02/18	Company,
Germany	Siemens supports the comments from the AJIT submitted by Polymer Comply Europe (PCE) (AJIT - ECHA Comments)	Please see response to comments #3150 (AJIT)	
				
3150
2016/02/18	Anhydrides Joint Industry Taskforce,
Industry or trade association,
Belgium	The use of the industrial chemical HHPA for professional use and consumer use is has never been nor will ever be supported by AJIT. The AJIT could not identify any companies using this substance in a professional or consumer setting. The AJIT member companies would like to see this issue dealt with in the form of a restriction or adjustments to the registration dossier to advice against such use.

As can be reviewed in the attached report approximately 2300 – 2760 ton of the use of this substance is in the scope of authorisation. According to the collected data 100% of this is used in an industrial setting. 57.2% of the use occurs in a closed process.	A.1.1. General, recommendation process
A.1.1.3. Prioritisation approach applied
A.1.1.4. Information taken into account for the draft recommendation
A.1.1.5. New information and next steps toward the final recommendation
A.1.2. Prioritisation: Volume
A.1.2.1. Volume in the scope of authorisation
A.1.3. Prioritisation: Wide-dispersiveness of uses
A.1.3.1. Scope of the assessment of wide-dispersiveness of uses
A.1.3.2. Assignment of WDU score based on use types and their associated volumes
A.1.5. Aspects not considered in ECHA's prioritisation
A.1.5.1. Potential other regulatory actions
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. Burden for industry and potential competitive disadvantage	
		3150_AJIT - Public Consultation Report [Final; 16-02-2016].pdf

3152
2016/02/18	Huntsman Advanced Materials (Europe) bvba,
Company,
Belgium	Although HHPA and MHHPA have been included in the candidate list, we come to the view that prioritising the substances for inclusion in the authorisation list would be a disproportionate option. Taking into account all available data and information, as well as our value chain experience, HHPA and MHHPA do not score the highest on the prioritisation scale. The absence of wide dispersive use and a more realistic rather than very high level of concern tell us that other scenarios would best guarantee workers’ safety without compromising technologies and industrial activities, which support key strategic sectors in Europe.
1. The criteria of “wide dispersive use”
Neither HHPA nor MHHPA are used in consumer or professional applications. As acknowledged by ECHA in its draft recommendation on MHHPA, applications are limited to industrial uses. As far as HHPA is concerned – and based on Huntsman’s knowledge, as well as Huntsman supply chains’ – applications are also strictly limited to industrial uses.
2. The criteria of “inherent properties”
In our view, authorisation is not the best option to tackle the actual, realistic level of concern the substances present.
First of all, neither HHPA nor MHHPA are PBT or vPvB substances and therefore do not score the highest in the prioritisation scale as far as inherent properties are concerned. Likewise, they are not CMRs.
The question is therefore to know whether the respiratory sensitisation properties of the substances raise a level of concern that justifies their prioritisation.
Our intention is not to challenge the inclusion of the substances in the candidate list: HHPA and MHHPA have been identified as substances of equivalent concern according to article 57(f) of REACH. Our point, however, is to draw ECHA’s attention to the fact that the actual level of concern the substances present, do not justify their inclusion in Annex XIV for the reasons developed below. The data set (WHO CICAD documents) based on which both substances have been identified as substances of equivalent concern indeed show a number of limitations that should be considered as prioritisation may move forward.
• Data do not reflect today’s reality
The WHO CICAD documents rely on 5 studies reporting on field investigations made in industrial plants in the 80’s and 90’s (the most recent paper is from 2001). The exact number and representativity of visited plants is in fact unclear. Since then, tremendous work hygiene improvements have been achieved. For instance, the culture of wearing personal protective equipment (PPE) and their efficiency have greatly improved over the last 3 decades.
• Data lack details and statistical significance
The first and main purpose of these studies was not the derivation of a threshold level, the(existence of which was neither suggested nor excluded at that time). Therefore, low exposure levels were not accurately investigated. Instead, these investigations were meant to find out whether there was a statistical correlation between occupational exposure level (duration, air concentration) and the occurrence of sensitisation. In the end, these papers show a rough correlation and lack nuances and precision. Statistical deficiencies are even acknowledged by the authors themselves due to the following elements:
- The size of the samples was very limited
- The selection of workers lacked background information on sensitisation and long term exposure as well as variable predisposition to be sensitised
- Personal protection equipment (PPE) was mentioned marginally, therefore leading to statistical distortion. PPEs was only referred to as a factor creating statistical distortion but were not evaluated on purpose, although it would have been a very relevant element to assess the actual risk and the potential of risk management measures.

• Huntsman’s experience and industry’s commitment
The reality described in these reports is far from Huntsman’s experience, as well as its downstream users’ . Indeed according to regular medical checks and investigations in Huntsman plants, no case of sensitisation in relation with (M)HHPA was ever recorded in the last 25 years.
We therefore came to the conclusion that HHPA and MHHPA do not raise the same level of concern as CMR or PBT/vPvB substances. In fact, when statistical studies on plant workers were conducted in the 80’s and 90’s, it was done without any sense of urgency in terms of worker safety, although the sensitising properties of these substances were already known. Otherwise such plant surveys would not have been envisaged. Instead, risk management measures would have been put in place upfront and evaluated . Moreover we are not aware of the reaction of the authorities, we are not either aware of any such risk management measures/plan, which would have been implemented following these studies, nor do we find any possible evaluation of such measures.
On the one hand the reference publications report on relatively high sensitisation rates at high exposure level. On the other hand the clinical observations show that sensitisation develops over weeks or months when no or poor personal protection is in place. Moreover the clinical pattern does not infer serious impairment of vital functions. In addition one of these papers shows that sensitisation signs, including the presence of specific antibodies are virtually gone after one year. Finally in a more recent paper (2006) the main contributors, i.e. H. Welinder and J. Nielsen, suggest a safe occupational exposure limit < 5 μg/m3)
For all these reasons we came to the conclusion that prioritisation of HHPA and MHHPA would be disproportionate until accurate and statistically relevant occupational measurements at realistic low level (microgram) and an assessment of the current work hygiene conditions in Europe (including PPE and their efficiency) are available.
And precisely, in order to address limitations of existing data and have a more detailed and accurate picture of reality, Huntsman and the industry at large under the umbrella of the Anhydrides Joint Industry Taskforce (AJIT) has developed a work programme in order to provide a comprehensive and accurate assessment of the current work hygiene conditions in connection with the various uses of these substances as well as to manage the risks, workers could be exposed to. According to this programme, industry will perform in 2016 a number of actions in order to generate and gather all relevant data on the exposure and the actual risks associated with the use of HHPA and MHHPA.
Concretely, the following steps are foreseen:
- Exposure inventory
By end of February 2016, members of the industry task force will agree upon and promote the best available method for measuring HHPA and MHHPA Companies are committed to performing these measurements within their plants in the 1st semester of this year in view of putting together an exposure report, including a detailed workplace assessment.
- Inventory of respiratory sensitization
In the first semester this year, the task force will hire an independent consultant to review currently available medical records at the member companies to ascertain the incidence of sensitization. This information will be compared with exposure levels obtained at the same plants in the exposure inventory and included in the exposure report.
- Recommendations
Finally, based on the exposure report, the task force will provide specific detailed instructions on the use of HHPA and MHHPA in order to eliminate/minimize the risk of respiratory sensitization. Such recommendations will be communicated without delay to the lead registrant and suppliers of HHPA and MHHPA for inclusion in the registration dossier.
	A.1.1. General, recommendation process
A.1.1.1. ECHA's obligation to recommend/prioritise substances on the Candidate List
A.1.1.2. Legal basis for prioritisation
A.1.1.3. Prioritisation approach applied
A.1.1.4. Information taken into account for the draft recommendation
A.1.1.5. New information and next steps toward the final recommendation
A.1.2. Prioritisation: Volume
A.1.2.1. Volume in the scope of authorisation
A.1.3. Prioritisation: Wide-dispersiveness of uses
A.1.3.1. Scope of the assessment of wide-dispersiveness of uses
A.1.3.2. Assignment of WDU score based on use types and their associated volumes
A.1.5. Aspects not considered in ECHA's prioritisation
A.1.5.1. Potential other regulatory actions
A.1.5.2. Authorisation is disproportionate and/or means a ban
A.1.5.4. Control of risks
A.1.5.7. Burden for industry and potential competitive disadvantage	
		3152_FINAL_Comments ECHA's draft recommendation.pdf
		
3158
2016/02/18	The Federation of Finnish Technology Industry,
Industry or trade association,
Finland	Using HHPA as a curing agent an effective and efficient function of the machine in the voltage range can be quaranteed. HHPA is not present in the finnished product.	A.1.5. Aspects not considered in ECHA's prioritisation
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
A.1.5.7. Burden for industry and potential competitive disadvantage
A.2.1. Intermediate status of the use of HHPA/MHHPA in resins
A.2.8. Questionnaire on socio-economic consequences	
		3158_Comments on the draft recommendation of HHPA for inclusion in Annex XIV.docx

3161
2016/02/18	Company,
Italy		A.1.5. Aspects not considered in ECHA's prioritisation
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. Burden for industry and potential competitive disadvantage
A.2.8. Questionnaire on socio-economic consequences
B.1.2. Aspects not considered by ECHA when proposing latest application dates/sunset dates
B.1.2.2. Lack of alternatives, socio-economic aspects	
		3161_recom_com_call_for_info_questionnaire_en.docx

3169
2016/02/18	Company,
Germany	No accidents or allergizations known in production since using products with (M)HHPA. Safe use of substances can be provided through modern processes.	A.1.5. Aspects not considered in ECHA's prioritisation
A.1.5.1. Potential other regulatory actions
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
A.1.5.7. Burden for industry and potential competitive disadvantage
A.2.1. Intermediate status of the use of HHPA/MHHPA in resins
A.2.8. Questionnaire on socio-economic consequences	
		3169_20160218_Questionaire (M)HHPA.pdf

Confidential attachment removed		
3176
2016/02/18	Transmission & Distribution Europe,
Industry or trade association,
Belgium	T&D Europe is concerned about the application of the REACH Regulation to the anhydrides - MHHPA and HHPA - and proposing them for inclusion into the Authorization List. T&D Europe is the European Association of the Electricity Transmission & Distribution Industry being an important backbone of the European power grid. http://www.tdeurope.org
In the last 15 years, the industry members of T&D Europe have intensified their risk management measures in handling chemical substances and in taking care of workers so that there is no need to replace these substances and put the burden of high development costs on the European branch of the T&D Europe companies. A position paper of T&D Europe is found under:  http://www.tdeurope.eu/en/position-papers/
	A.1.5. Aspects not considered in ECHA's prioritisation
A.1.5.4. Control of risks
A.1.5.7. Burden for industry and potential competitive disadvantage	
				
3183
2016/02/19	Company,
Romania		A.1.5. Aspects not considered in ECHA's prioritisation
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. Burden for industry and potential competitive disadvantage	
		
Confidential attachment removed		

II - Transitional arrangements. Comments on the proposed dates
Number / Date	Submitted by (name, submitter type, country)	Comment	Reference to responses	
3116
2016/02/17	Company,
Italy	Timeframe suggested by Authority is too short to ensure supply to energy production and distribution utilities in Europe.Supply chain till utilities request long time qualification of epoxy part (in situ test)	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	
				
3124
2016/02/17	Polynt SpA on behalf of Cyclic Anhydride Cooperation Group,
Company,
Italy	16. In conclusion, the use of HHPA is considered as a monomer use, a threshold below which no immune response is expected can be derived and there is no case of respiratory sensitization in more than ten years. Therefore, based on these facts, any authorisation proposal/procedure is inappropriate.	Please see references to responses in section I	
		3124_15-07-21_Opinion Cyclic Anhydrides-supplmt_signed.pdf
Confidential attachment removed		
3142
2016/02/18	Company,
Germany	The comments from the AJIT are clearly describing the complex framework of product standards and requirements for product placement of equipment for infrastructure with long service life	Please see also response to comment #3150 (AJIT)	
				
3150
2016/02/18	Anhydrides Joint Industry Taskforce,
Industry or trade association,
Belgium	Due to the complexity of the processes performed by the AJIT member companies it is not feasible to substitute within the deadline for application for authorisation currently recommend even if a suitable alternative is found. Part of this complexity is resulting from the need for certification of the material. The certification for High Voltage Rotating Machines and Switchgear is described below.

For High Voltage Rotating Machines the relevant standard is IEC 60034-18 which takes 1.5 – 2 years of testing of new candidate insulation systems which occurs after an R&D period of around 3 – 5 years required to develop a system that could potentially pass such certification (no guarantee of success).

For explosion proofed motors worldwide certification is required by amongst others:
IEC-Ex - worldwide (also EN 60079-7, and -15)
PESO (CCOE) – India
Inmetro – Brasil
CQST, NEPSI – China
EAC (Russia and others in region)
KOSHA – Korea
CSA – Canada

Other market areas, like International ship building industries, require their own approvals (Marine Certifications):
ABS – USA
Bureau Veritas
CCS (China)
DNV (Det Norske Veritas)
GK (German Lloyd)
KR (Korean)
Lloyds Register
Nippon Kaiji Kyokai (Japan)
Russian Maritime Register of Shipping

Additionally, major customers in the market require 5 years or even more “service experience” to accept a new technology.

You may find a quite good compilation of these procedures in:
Greg C. Stone, Ian Culbert, Edward A. Boulter, Hussein Dhirani
Electrical Insulation for Rotating Machines: Design, Evaluation, Aging, Testing, and Repair, 2nd Edition
August 2014, Wiley-IEEE Press
ISBN: 978-1-118-05706-3

Insulating parts made of solid epoxy are important components in electrical switchgear. If the composition in particular of polymeric materials like epoxy is changed, the impact on the performance of the switchgear has to be carefully evaluated and verified by tests. Epoxy components have first to provide the insulation of the high voltage against earth, second to give mechanical support for current carrying conductors, and third to sustain their properties over the whole life of the switchgear (more than 30 years), in particular when used outdoors. Therefore these components are tested for the following properties:
- dielectric properties (IEC 62271-1)
- short-time current carrying properties (IEC 62271-1)
- mechanical properties (IEC 62271-100 and others depending on the kind of switchgear)
- climatic properties (IEC 62271-304, IEC 60815-1)

It might not be necessary to re-test all variants and types of these components under all possible arrangements in electrical switchgear, but only those in most onerous applications. However, polymeric materials cannot be treated in the same way as metals, the properties of which can be clearly described with few parameters. Thus, there is a residual risk of failure when only the performance of selected components is verified so that eventually the complete variety of components and applications need to be tested. In addition, there are special customers who require tracing of materials, such as marine and nuclear industry or the navy. Electrical switchgear is a key element on ships and power plants.  In this case re-testing and re-certification according to the customers’ specification is a must.

Due to these certification and the complexity of the processes wherein HHPA is used the Anhydrides joint Industry Taskforce requests later application data as well as a later sunset data.
	B.1.1. General principles for setting latest application dates/sunset dates
B.1.1.2. ECHA's proposal for sunset dates
B.1.1.3. ECHA's proposal for latest application dates
B.1.2. Aspects not considered by ECHA when proposing latest application dates/sunset dates
B.1.2.1. Extensive time needed in the supply chain to getting organised for preparing application (e.g. due to high number of users)	
		3150_AJIT - Public Consultation Report [Final; 16-02-2016].pdf		
3152
2016/02/18	Huntsman Advanced Materials (Europe) bvba,
Company,
Belgium	First of all we would like to reiterate our views that prioritising HHPA and MHHPA would be a disproportionate option. The actual level of concern and absence of wide dispersive use lead us to the conclusion that other policy options and adjusted risk management measures would best guarantee workers’ safety. This is precisely why the industry has engaged in the 2016 work programme described above. This work programme will indeed address the limitations of existing data and allow policy makers as well as industry to take the most efficient next steps (RMOA).
Should, however, the substances be prioritised and included in Annex XIV, we are of the opinion that transitional arrangements foreseen by ECHA in their recommendations are much too short. Supply chains may be short but they are not simple. HHPA and MHHPA are used in a wide range of applications, many of them supporting key heavy and strategic industrial sectors for Europe (energy production and distribution, automotive, renewable, etc…). All detailed information can be found in our contribution to the European Commission’s call for socio-economic information.
For these reasons, longer transitional arrangements should be foreseen in order to allow industry to organise and prepare robust applications.	B.1.1. General principles for setting latest application dates/sunset dates
B.1.1.2. ECHA's proposal for sunset dates
B.1.2. Aspects not considered by ECHA when proposing latest application dates/sunset dates
B.1.2.1. Extensive time needed in the supply chain to getting organised for preparing application (e.g. due to high number of users)	
		3152_FINAL_Comments ECHA's draft recommendation.pdf		
3158
2016/02/18	The Federation of Finnish Technology Industry,
Industry or trade association,
Finland	HHPA should be released from the autherisation for the time period that is needed to develope economically and environmentally effective substitute.	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.1.2.2. Lack of alternatives, socio-economic aspects	
		3158_Comments on the draft recommendation of HHPA for inclusion in Annex XIV.docx		
3169
2016/02/18	Company,
Germany	Supply chain till utilities request long qualification of parts. Timeframe suggested by authorities is too short to ensure continuous supply of electrical components in Europe.	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	
		3169_20160218_Questionaire (M)HHPA.pdf
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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	
3065
2016/02/05	Robert Bosch GmbH,
Company,
Germany	production of isolation material for ignition coils in gasoline engines	C.1.1. General principles for exemptions under Art. 58(2)
C.1.2. Generic exemptions	
		
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3071
2016/02/11	ChemSec,
International NGO,
Sweden	Following the intentions of REACH, socio-economic information should not play a role in the inclusion of substances on the authorisation list. The availability of alternatives as well as socio-economic implications should only be taken into account when companies apply for authorisation and for specific uses.
Information about how well industries using SVHCs are doing today and how much they will loose if a SVHC is added to annex XIV is of no use if there is not anything to compare with, the economic consequences and benefits for producers and users of alternatives and economic consequences of innovative industries using totally different techniques which all clearly would benefit from an annex XIV listing.
ChemSec calls on the Commission to focus more on getting economic information from producers and users of alternatives in order to get a more balanced picture of the socio-economic effects of adding SVHCs to annex XIV.
ChemSec will release a new report on the 23:d of February on this specific issue. The report is called “The bigger picture, assessing economic aspects of substitution”. We hope this report will provide a larger understanding on what aspects needs to be look at to make a solid economic assessment of substitution and regulation.
Moreover, lack of alternatives is not an incentive for not putting a substance on annex XIV. But lack of alternatives could give a rough indication on how many applications for authorisation ECHA will get for a specific substance.
	A.2.6. Socio-economic information and availability of alternatives should not play a role in the inclusion of substances in Annex XIV / Call on COM when and which socio-economic aspects to consider	
				
3116
2016/02/17	Company,
Italy	Our workers are not in direct contact with MHHPA and HHPA we use automatic process (APG)	C.1.1. General principles for exemptions under Art. 58(2)
C.1.3. Aspects not justifying an exemption from authorisation	
				
3150
2016/02/18	Anhydrides Joint Industry Taskforce,
Industry or trade association,
Belgium	The use of this substance in scientific research and development according to article 56(3) of REACH should be exempted from registration.	C.1.2. Generic exemptions	
		3150_AJIT - Public Consultation Report [Final; 16-02-2016].pdf		
3152
2016/02/18	Huntsman Advanced Materials (Europe) bvba,
Company,
Belgium	Amongst the wide range of downstream users’ activities and technologies supported by HHPA and MHHPA, a few ones show a high level of automation, combined with low or no worker exposure, e.g. automatic pressure gelation process (APG) or vacuum casting. However planned measurements are expected to provide the basis for a full assessment.	C.1.1. General principles for exemptions under Art. 58(2)
C.1.3. Aspects not justifying an exemption from authorisation	
		3152_FINAL_Comments ECHA's draft recommendation.pdf		
3158
2016/02/18	The Federation of Finnish Technology Industry,
Industry or trade association,
Finland	HHPA for the use as curing agent for epoxy resins in complex electrical insulation systems.	C.1.1. General principles for exemptions under Art. 58(2)
C.1.3. Aspects not justifying an exemption from authorisation	
		3158_Comments on the draft recommendation of HHPA for inclusion in Annex XIV.docx		
3169
2016/02/18	Company,
Germany	Workers are not in direct contact with substance. Automatic processes and closed processes (Vacuum Casting) provide high safety level.	C.1.1. General principles for exemptions under Art. 58(2)
C.1.3. Aspects not justifying an exemption from authorisation	
		3169_20160218_Questionaire (M)HHPA.pdf
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