Comments on ECHA’s Draft 7th Recommendation for MHHPA (EC number: 247-094-1, 243-072-0, 256-356-4, 260-566-1) 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 MHHPA (EC number: 247-094-1, 243-072-0, 256-356-4, 260-566-1). 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	
3060
2016/02/02	Norway,
Member State	The Norwegian CA supports the prioritisation of  Hexahydromethylphthalic anhydride, Hexahydro-4-methylphthalic anhydride, Hexahydro-1-methylphthalic anhydride, Hexahydro-3-methylphthalic (MHHPA) 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.	
				
3063
2016/01/14	Other contributor,
Germany	Request for a meeting due to new information.
Please see attachement.	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		
3066
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		
3067
2016/02/05	Robert-Bosch GmbH,
Company,
Germany		Please see responses referred to in comment #3066	
		
Confidential attachment removed		
3073
2016/02/11	ChemSec,
International NGO,
Sweden	ChemSec supports the inclusion of this substance on Annex 14	Thank you for your opinion.	
				
3085
2016/02/16	Company,
Austria	MHHPA is only used in industrial application; therefore the number of people exposed to MHHPA is limited. Further in an industrial environment it´s feasible to protect the people exposed to MHHPA in terms of respiratory-, eye-, skin- protection. Such measures are already taken in manufacturing plants and the hazard for the workers is already minimized.	A.1.5. Aspects not considered in ECHA's prioritisation
A.1.5.4. Control of risks	
				
3088
2016/02/16	ASD,
Industry or trade association,
Belgium	See comments attached 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	
		3088_ASD response - cyclic acid anhydrides - February 2016.pdf

3090
2016/02/16	Cefic SRM (Solvent Resin Manufacturers),
Industry or trade association,
Belgium	Members of the Solvent Resin Manufacturers (SRM) use the raw material HHPA (hexahydrophthalic anhydride - CAS# 85-42-7) solely as a transported isolated intermediate for industrial use. HHPA is used as a monomer and is consumed in the synthesis of resin polymers in a closed system. HHPA is used to a very large extent in the liquid (molten) form in closed systems and therefore exposure is neglectable.  HHPA is not intentionally added as an additive in the resin polymer mixture, but only used as a starting monomer for the preparation of the resin polymer. The concentration of free HHPA in the finished goods (resin polymers or resin polymer mixtures) is < 0.1 %. Our downstream users are paint companies who formulate their paint products for different coating applications.	A.2.1. Intermediate status of the use of HHPA/MHHPA in resins	
				
3091
2016/02/16	Austrian Economic Chamber / Wirtschaftskammer Österreich,
Industry or trade association,
Austria	Please see our comments attached.	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.1.5.7. Burden for industry and potential competitive disadvantage
A.2.1. Intermediate status of the use of HHPA/MHHPA in resins	
		3091_bd_15_Stellungnahme_Anhydride.pdf

3094
2016/02/16	Lindau Chemicals, Inc.,
Company,
United States	In the Annex XV – SVHC Dossier MHHPA – CAS No. 19438-60-9, the substance MHHPA is proposed to be identified as a substance of equivalent concern according to Article 57(f) of the REACH regulation EC No. 1907 / 2006.  Specifically, it has been documented that because MHHPA is a respiratory sensitizer, it meets the criteria of a substance of equivalent concern to CMR’s (cat 1A or !B).  The justification for this association is based on the following:
• Annex XV dossier provides evidence that MHHPA is a cyclic anhydride which causes a high degree of respiratory sensitization.
• Data is presented that suggests that a concentration-based risk assessment would be difficult to perform.  Therefore, safe use of the substance is not guaranteed.
• The Annex XV report indicates that there is evidence of sensitization related to an IgE antibody specific to workplace exposure which has not been detected in the general public.
• The Annex XV report provides evidence of the cross-reactivity of MHHPA and HHPA.
Most of the evidence for respiratory sensitization is based on information gained from limited applications.  In fact, cyclic acid anhydrides including MHHPA and HHPA are widely used in the chemical industry for uses including manufacture of polyester and alkyd resins, adhesives and coatings.  In addition, these anhydrides are also used as epoxy resin curing agents in the production of structural composites used in aerospace, electrical, energy and industrial applications.  MHHPA and HHPA are often selected because of their unique combination of processing conditions and cured-resin properties including mechanical, thermal and electrical resistance properties.  Of particular importance, is the fact that both MHHPA and HHPA contain a saturated ring structure which when used as a curing agent with a non-aromatic epoxy resin affords a cured resin with excellent chemical and electrical resistance as well as superior outdoor weathering characteristics.  While this resin system was developed many years ago, it is still the state of the art resin system in the electrical encapsulation field.  At the current time, there are no replacements that can match the performance of this resin system.
Generally, the evidence used in the preparation of this SVHC dossier dates back to the 1990’s and to limited applications where workers were directly exposed to anhydride vapors which as has been documented in the literature can lead to respiratory sensitization.  However, since the 1990’s, pro-active product stewardship programs resulting in state of the art engineering measures as well as standard operating procedures and classical risk management, based largely on scientific reports of incidence of sensitization by cyclic acid anhydrides,  has resulted in dramatic improvements in reducing worker exposure to MHHPA.  Specifically, preparation areas with zero exposure and curing ovens with total vapor removal have been developed.  This has resulted in a considerable reduction in the number of cases of sensitization to the point where no cases are found in the current literature (Annex XV SVHC dossier for MHHPA p. 19).

It is Lindau Chemicals, Inc. conclusion that MHHPA should not be banned from use, but at the minimum should be given specific usage through the Authorization process for the following reasons:
• Currently, methods have been developed to reduce worker exposure; thus the exposure picture as presented in the Annex XV dossier is no longer consistent with the current-day situation.
• The general population is not affected.
• MHHPA is used in applications of considerable importance for which there is no currently available resin system with similar performance.
• MHHPA has been labeled as a SVHC on the basis that it a substance with an equivalent concern to CMR’s having serious effects to human health (Article 57f).  This characterization is based on the fact that MHHPA is a respiratory sensitizer.  In fact, there are numerous respiratory sensitizers which have not been designated as CMR’s.  Therefore, with current control measures available, MHHPA is no different than other substances with similar hazardous qualities which have not been placed on the Candidate List as a SVHC.
	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.1.5. Aspects not considered in ECHA's prioritisation
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	
				
3100
2016/02/17	FEEI - Association of the Austrian Electrical and Electronics Industries,
Industry or trade association,
Austria	please find our answers to your questionaire within the attachment	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.1.5.7. Burden for industry and potential competitive disadvantage
A.2.8. Questionnaire on socio-economic consequences	
		3100_recom_com_call_for_info_questionnaire_en_FEEI.docx

3101
2016/02/17	Company,
France	General context
The semiconductor industry uses highly sophisticated technologies and relies on a complex global supply chain in the world. Material handling takes place in a highly controlled environment, ensuring minimization of product contamination risks and employees’ exposure control. In the present application, the aimed substance is used in extremely low quantity in a Quality Assurance laboratory as a component of a molding compound.

Hexahydromethylphthalic Anydride Resin Description
The substance Hexahydromethylphthalic Anydride is used as a constituent of a resin. The presence of the substance in the resin formulation ensures the final cured resin reaches the required hardness and heat resistance. The resin is not used in production, but for Quality Assurance testing only, following a requirement of the medical market.

Conditions of use
In the Quality Assurance laboratory, the resin containing the Hexahydromethylphthalic Anydride is used in a controlled environment with adequate LEV (Local Exhaust Ventilation) to manufacture specific complex electrical components in order to validate the reliability of the entire device lot.  Once the parts are molded in the resin, they are tested and stored for the time required by the traceability requirements, and then sent to waste incineration with heat recovery. Therefore, there is no substance in any delivered product and no consumer exposure.
In the laboratory, the resin is dispensed under LEV and cured in polymerization oven with exhaust. A lot is made of 32 parts. Approximatively ten lots are made each year.
The whole process takes place in a controlled environment applying strict risk management measures, ensuring controlled release to the environment and minimizing employees’ exposure.
The resin is used for a total quantity below 20 g/year in one site, located in France, containing about 2 g/year of Hexahydromethylphthalic Anydride CAS 25550-51-0 equivalent to the 0.2 part by Billion of the total quantity of Hexahydromethylphthalic Anydride in the authorization scope (Draft background).
This quantity is required for the execution of reliability tests for the approval of electronics components for a medical market representing more than 1 M$ billing /year.
The resin is imported into Europe and, due to low quantity used, is not registered for this specific use in the semiconductor industry.

Use descriptor
The below table reports the relevant descriptor as per Appendix R.12.1 to R.12.6 of the ECHA Guidance on Use Descriptor System (R12) and based on the ECHA-10-R-005-EN publication EXPOSURE SCENARIOS FOR THE SEMICONDUCTOR INDUSTRY EXAMPLES – August 2010

Sector of use (SU)
SU 3  Industrial manufacturing
SU 16  Manufacturing of computer, electronic and optical product, electrical equipment
Chemical product category (PC)
PC1  Adhesives, sealants
PC21  Laboratory Reagent
Process category (PROC)
PROC 5  Mixing or blending in batch processes for formulation of articles (multistage and/or significant con-tact)
PROC 15  Use as laboratory reagent
PROC 19  Hand-mixing with intimate contact and only PPE available
Article category (AC)
Not applicable
Environmental release category
ERC4 Industrial use of processing aids in processes and products, not becoming part of articles

Non applicability of the wide dispersive criteria
With reference to the Draft background document for Hexahydromethylphthalic Anydride - there is a further clarification need: the total quantity of resin is 20 g/year in one industrial site, outside any production process. The number of potentially exposed employees is limited to 3 employees on one site. Therefore the use of Hexahydromethylphthalic Anydride in this manufacturing site of the semiconductor industry cannot be considered to contribute to the wide dispersive use criteria for prioritization.
There is no release to the environment since the parts are made for electrical testing purpose only. Once the electrical test is performed, the parts are stored for traceability purpose for a defined period of time. When the required time is storage is over, the parts are sent to waste management. Consumer exposure cannot happen.
	A.1.2.1. Volume in the scope of authorisation
A.1.3.1. Scope of the assessment of wide-dispersiveness of uses
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
C.2.1. Used in Quality Assurance testing system	
		3101_phthalicnaydrude20160127answer_ST.pdf

3122
2016/02/17	Company,
Italy	In our company risk measure are in plase to sacure safe use of MHHPA and HHPA. No workers never had respiratory problems neither professional diseases never occurred in our company founded in 1971.	A.1.5. Aspects not considered in ECHA's prioritisation
A.1.5.4. Control of risks	
				
3126
2016/02/17	Cyclic Anhydride Cooperation,
Other contributor,
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 supports the safe use of the MHHPA 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 MHHPA is inappropriate, for the reasons explained below, notably in terms of timing, monomer use and risk management measures already in place. In any case, MHHPA 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 MHHPA 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-324/15 P). Therefore, although the appeal does not have suspensive effects, it is still premature for ECHA to propose the inclusion of MHHPA in Annex XIV since there is no final decision yet on the level of concern of MHHPA 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. MHHPA 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, MHHPA 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 MHHPA 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. Additionally, for MHHPA there is, so far, no current information on the prevalence of occupational asthma available. No specific cases of respiratory allergy for MHHPA alone have ever been reported. At present, available literature reports show only single cases of cross-reaction effects following exposure to MHHPA together with other substances (e.g. HHPA). These reported cases are often older than a decade and a recent comprehensive European downstream user survey has confirmed no cases of respiratory sensitization in more than ten years.
4. 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. In the absence of such an assessment on MHHPA a comparable limit to that adopted for HHPA can be proposed based on the inhalation sensitising properties of both anhydrides. The adoption of, and adherence to, such a limit can be regarded as providing adequate protection to the workers.
5. 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.
6. 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 (Grammer et al. (1995); Grammer et al. (1996). Thus, subsequent development of clinical symptoms can effectively be avoided by removing the worker from the work place.

Volume (monomer use)
7. 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 in 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.
8. 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.

Further considerations
9. In the draft MHHPA background document, it is stated by ECHA that priority for MHHPA 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 HHPA, is considered not to be part of the “General Approach” according to Art. 58(3) of the REACH Regulation.
10. Additionally, HHPA 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.
11. Furthermore, based on the priority score of 18, any proposal for authorisation for MHHPA would not be expected at this early stage in particular as there are more than 10 substances with priority scores well above 18 especially due to reproductive toxicity which should be considered first.
12. Finally, based on the above considerations, a priority score of maximum 9 (IP: 1; V: 3 (<10 t/a); WDP: 5) instead of score 18 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.
13. 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	
		3126_Expert statement_Cyclic Anhydrides.pdf

Confidential attachment removed		
3137
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		
3141
2016/02/18	Siemens AG,
Company,
Germany	Siemens supports the comments from the AJIT submitted by Polymer Comply Europe (PCE) (AJIT - ECHA Comments)	Please see response to comment #3151 (AJIT)	
				
3143
2016/02/18	Cummins Generator Technologies,
Company,
United Kingdom	No known historical issues from the use of the products containing the related substance. Risk control measures are in place and also Bio Metric Surveillance in place (as a standard) with no historical issues (10 - 15 Years + approx usage on site).Risk Assessments show no high levels requiring further controls in comparison to eg PBT's or CMR's. Only use is in industrial applications of MHHPA	A.1.5. Aspects not considered in ECHA's prioritisation
A.1.5.4. Control of risks	
				
3151
2016/02/18	Anhydrides Joint Industry Taskforce,
Industry or trade association,
Belgium	The use of the industrial chemical MHHPA 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.

As can be reviewed in the attached report approximately 4500 – 5400 ton of the use of this substance is in the scope of authorisation. 31.3% 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	
		3151_AJIT - Public Consultation Report [Final; 16-02-2016].pdf
		
3153
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	
		3153_FINAL_Comments ECHA's draft recommendation.pdf

3154
2016/02/18	ACSIEL,
Industry or trade association,
France	General context
The semiconductor industry uses highly sophisticated technologies and relies on a complex global supply chain in the world. Material handling takes place in a highly controlled environment, ensuring minimization of product contamination risks and employees’ exposure control. In the present application, the aimed substance is used in extremely low quantity in a Quality Assurance laboratory as a component of a molding compound.

Hexahydromethylphthalic Anydride Resin Description
The substance Hexahydromethylphthalic Anydride is used as a constituent of a resin. The presence of the substance in the resin formulation ensures the final cured resin reaches the required hardness and heat resistance. The resin is not used in production, but for Quality Assurance testing only, following a requirement of the medical market.

Conditions of use
In the Quality Assurance laboratory, the resin containing the Hexahydromethylphthalic Anydride is used in a controlled environment with adequate LEV (Local Exhaust Ventilation) to manufacture specific complex electrical components in order to validate the reliability of the entire device lot.  Once the parts are molded in the resin, they are tested and stored for the time required by the traceability requirements, and then sent to waste incineration with heat recovery. Therefore, there is no substance in any delivered product and no consumer exposure.
In the laboratory, the resin is dispensed under LEV and cured in polymerization oven with exhaust. A lot is made of 32 parts. Approximatively ten lots are made each year.
The whole process takes place in a controlled environment applying strict risk management measures, ensuring controlled release to the environment and minimizing employees’ exposure.
The resin is used for a total quantity below 20 g/year in one site, located in France, containing about 2 g/year of Hexahydromethylphthalic Anydride CAS 25550-51-0 equivalent to the 0.2 part by Billion of the total quantity of Hexahydromethylphthalic Anydride in the authorization scope (Draft background).
This quantity is required for the execution of reliability tests for the approval of electronics components for a medical market representing more than 1 M$ billing /year.
The resin is imported into Europe and, due to low quantity used, is not registered for this specific use in the semiconductor industry.

Use descriptor
The below table reports the relevant descriptor as per Appendix R.12.1 to R.12.6 of the ECHA Guidance on Use Descriptor System (R12) and based on the ECHA-10-R-005-EN publication EXPOSURE SCENARIOS FOR THE SEMICONDUCTOR INDUSTRY EXAMPLES – August 2010

Sector of use (SU)
SU 3  Industrial manufacturing
SU 16  Manufacturing of computer, electronic and optical product, electrical equipment
Chemical product category (PC)
PC1  Adhesives, sealants
PC21  Laboratory Reagent
Process category (PROC)
PROC 5  Mixing or blending in batch processes for formulation of articles (multistage and/or significant con-tact)
PROC 15  Use as laboratory reagent
PROC 19  Hand-mixing with intimate contact and only PPE available
Article category (AC)
Not applicable
Environmental release category
ERC4 Industrial use of processing aids in processes and products, not becoming part of articles

Non applicability of the wide dispersive criteria
With reference to the Draft background document for Hexahydromethylphthalic Anydride - there is a further clarification need: the total quantity of resin is 20 g/year in one industrial site, outside any production process. The number of potentially exposed employees is limited to 3 employees on one site. Therefore the use of Hexahydromethylphthalic Anydride in this manufacturing site of the semiconductor industry cannot be considered to contribute to the wide dispersive use criteria for prioritization.
There is no release to the environment since the parts are made for electrical testing purpose only. Once the electrical test is performed, the parts are stored for traceability purpose for a defined period of time. When the required time is storage is over, the parts are sent to waste management. Consumer exposure cannot happen.
	C.2.1. Used in Quality Assurance testing system	
				
3157
2016/02/18	The Federation of Finnish Technology Industry,
Industry or trade association,
Finland	Using MHHPA as a curing agent an efficient and effective function of the machine in the high voltage range can be quaranted. MHHPA 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	
		3157_Comments on the draft recommendation of MHHPA for inclusion in Annex XIV.docx

3162
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	
		3162_recom_com_call_for_info_questionnaire_en.docx

3168
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	
		3168_20160218_Questionaire (M)HHPA.pdf

Confidential attachment removed		
3181
2016/02/18	T&D Europe,
Industry or trade association,
Belgium	See attachment	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.2.3. Challenging ELoC of the substance(s)
A.2.5. ECHA should not proceed with the recommendation of HHPA and MHHPA as there is a court case ongoing	
		3181_TD Europe position paper Anhydrides 7th draft recommendation.docx

3182
2016/02/18	European Coil-Coating Association,
Industry or trade association,
Belgium		A.2.1. Intermediate status of the use of HHPA/MHHPA in resins	
		3182_position paper HHPA - ECCA.doc

3184
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	
3085
2016/02/16	Company,
Austria	Our customers (electric supply companies and authorities) demand long time tests for electrically active parts of the large rotating machines.  Any such fundamental change in material in such active parts of machine will require extensive research on the materials including long term tests in order to secure the properties and function of the materials over more than 40 years.  Such testing is necessary in order to minimize the risk of failures in operation causing fatal consequences in energy supply.
The named proposed periods to substitute MHHPA are far too short for this sector of industry in order to find an alternative material. Therefore  it is requested to have later dates for application for authorization and sunset date.
	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.1.2.2. Lack of alternatives, socio-economic aspects	
				
3091
2016/02/16	Austrian Economic Chamber / Wirtschaftskammer Österreich,
Industry or trade association,
Austria	Please see our comments attached.	B.1.1. General principles for setting latest application dates/sunset dates	
		3091_bd_15_Stellungnahme_Anhydride.pdf		
3101
2016/02/17	Company,
France	Time line for Hexahydromethylphthalic Anydride substitution
As of today, alternative materials are not able to meet all the required properties of the resin containing the Hexahydromethylphthalic Anydride, especially a low level of stress on the silicon die further to the molding.
3 resins have been evaluated so far: 1 with worse health risk effects, 2 giving unacceptable results in terms of performance with regards to the electrical testing.
Since no substance-free equivalent resin is currently available on the market, a development plan is required by the resin supplier, prior to access any test in the semiconductor industry.
Supplier development may take 2 years minimum and subsequent on site will take same length of time.
Therefore a replacement material will not be available and fully deployed within 7 years.
The sites using this substance will be forced to request an authorization for use with a long expiration time (more than 4 years).
	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	
		3101_phthalicnaydrude20160127answer_ST.pdf		
3122
2016/02/17	Company,
Italy	Timeframe proposed by Authory is too short to ensure supply to energy production and distribution Sector. Supply chain till utilities requests long time qualification of epoxy parts.	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	
				
3126
2016/02/17	Cyclic Anhydride Cooperation,
Other contributor,
Germany	14. In conclusion, the use of MHHPA 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	
		3126_Expert statement_Cyclic Anhydrides.pdf
Confidential attachment removed		
3141
2016/02/18	Siemens AG,
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 response to comment #3151 (AJIT)	
				
3143
2016/02/18	Cummins Generator Technologies,
Company,
United Kingdom	Timeframe suggested does have implications due to it's short period. This could heavily impact on sourcing the appropriate (alternative) electrical grade requirements for product within the supply chain.	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	
				
3151
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 MHHPA 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)	
		3151_AJIT - Public Consultation Report [Final; 16-02-2016].pdf		
3153
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)	
		3153_FINAL_Comments ECHA's draft recommendation.pdf		
3154
2016/02/18	ACSIEL,
Industry or trade association,
France	Time line for Hexahydromethylphthalic Anydride substitution
As of today, alternative materials are not able to meet all the required properties of the resin containing the Hexahydromethylphthalic Anydride, especially a low level of stress on the silicon die further to the molding.
3 resins have been evaluated so far: 1 with worse health risk effects, 2 giving unacceptable results in terms of performance with regards to the electrical testing.
Since no substance-free equivalent resin is currently available on the market, a development plan is required by the resin supplier, prior to access any test in the semiconductor industry.

A typical time frame for a substitution process in its specific use in our semiconductor industry would be as described in Fig. 1.
	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	
				
3157
2016/02/18	The Federation of Finnish Technology Industry,
Industry or trade association,
Finland	MHHPA should be released from the autherisation for the time period that is needed to develope an 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	
		3157_Comments on the draft recommendation of MHHPA for inclusion in Annex XIV.docx		
3168
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	
		3168_20160218_Questionaire (M)HHPA.pdf
Confidential attachment removed		
3181
2016/02/18	T&D Europe,
Industry or trade association,
Belgium	See attachment	Please see references to responses in section I	
		3181_TD Europe position paper Anhydrides 7th draft recommendation.docx		

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	
3066
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	
		
Confidential attachment removed		
3067
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	
		
Confidential attachment removed		
3073
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	
				
3085
2016/02/16	Company,
Austria	MHHPA shall be available and allowed to be used in scientific research as well as in industrial  development and therefore be exempted from registration.	C.1.2. Generic exemptions	
				
3090
2016/02/16	Cefic SRM (Solvent Resin Manufacturers),
Industry or trade association,
Belgium	Monomer use (already exempted from Authorization)	C.1.2. Generic exemptions	
				
3091
2016/02/16	Austrian Economic Chamber / Wirtschaftskammer Österreich,
Industry or trade association,
Austria	Please see our comments attached.	C.1.2. Generic exemptions	
		3091_bd_15_Stellungnahme_Anhydride.pdf		
3122
2016/02/17	Company,
Italy	our workers are not in direct contacts with MPHHA and HHPA we use automatic process APG. Our workers never had respiratory problems either professional diseases never occurred to our company.	C.1.1. General principles for exemptions under Art. 58(2)
C.1.3. Aspects not justifying an exemption from authorisation	
				
3143
2016/02/18	Cummins Generator Technologies,
Company,
United Kingdom	Customer process use. Workforce are not in direct contact with either the substance or released vapours due to enclosed system feeds and engineering controls in place when being applied. The process is enclosed (Mechanically sealed and under negative pressure with automatic feed of substance to the product requiring coated.	C.1.1. General principles for exemptions under Art. 58(2)
C.1.3. Aspects not justifying an exemption from authorisation	
				
3151
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	
		3151_AJIT - Public Consultation Report [Final; 16-02-2016].pdf		
3153
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	
		3153_FINAL_Comments ECHA's draft recommendation.pdf		
3157
2016/02/18	The Federation of Finnish Technology Industry,
Industry or trade association,
Finland	MHHPA for the use as curing agent for epoxy resins used 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	
		3157_Comments on the draft recommendation of MHHPA for inclusion in Annex XIV.docx		
3168
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	
		3168_20160218_Questionaire (M)HHPA.pdf
Confidential attachment removed		
3181
2016/02/18	T&D Europe,
Industry or trade association,
Belgium	See attachment	Please see references to responses in section I	
		3181_TD Europe position paper Anhydrides 7th draft recommendation.docx