Reply from Applicant Microporous GmbH to Comments - Consultation number

Transcription

1 Reply from Applicant Microporous GmbH to Comments - Consultation number (Reply of Microporous GmbH in blue colour - Comment submitted by third party in black color) Carcinogenic properties of Trichloroethylene (TRI) are known since a long time. In 1996 the Deutsche Forschungsgemeinschaft classified TRI as a proven carcinogen to humans. This classification has been confirmed and supported with additional data in In 2001, EU legislation (28. ATP to Directive 67/548/EEC) classified TRI as Carc.Cat. 2 (now Carc 1B according to CLP). In 2007 REACH Regulation came into force, and in 2010 TRI was included into the Candidate List with the clear expectance of incorporating TRI into REACH Annex XIV. In 2010, the German AGS (committee on hazardous substances) published the risk-based occupational exposure limit (3.3 mg/m³) associated with a low cancer risk level, deemed as acceptable (work lifetime risk of 4 EE-05). A standard acceptable work lifetime risk of 4:100,000 is consented, amongst others, in Germany, the Netherlands and France. In the UK, there is an analogous basic declaration from 2001 ( Reducing Risks, Protecting People. HSE s decision-making process ). Therefore, for all downstream users of TRI it was obvious since 17 years, that there is a need to substitute this carcinogenic substance. Since at least 7 years (since inclusion into Candidate List) it was clear, that there is an urgent need for substitution or at least for lowering occupational exposure below the risk based limit value of 3.3 mg/m³ (TWA). TRI has already been substituted in many DU applications in the past, which is obvious when looking at the volumes sold to solvent use, which decreased significantly during the last years. Despite classification of TRI as carcinogen and the related regulatory pressure to substitute TRI, there are still some DU for which TRI is mandatory. The reason is that in some cases substitution of TRI is very difficult or not yet possible. The REACH regulation foresees the option to ask for authorisation especially for these remaining cases where substitution is not possible or at least not possible within a short period of time until the sunset date. The fact that there are still DU uses of TRI is not in general a result of a lack of motivation at these DU to substitute, as implicitly assumed by the commenter but is due to technical limitations or other difficulties. The third party that commented claims that since at least 7 years (since inclusion into Candidate List) it was clear, that there is an urgent need for substitution or at least for lowering occupational exposure below the risk based limit value of 3.3 mg/m³

2 (TWA). It should be mentioned that TRI has been included in the candidate list on 18 th June 2010, which means 4.5 years ago, and identification of a substance as SVHC does not automatically result in uptake of the substance in Annex XIV. The prioritization phase for TRI to be included into ANNEX XIV only took place from June until September 2011, followed by the entry into ANNEX XIV on 21st of April Only during 2012 it became clear that a requested exemption date (the applicant asked for an exemption of his use as it was clear that he has no alternative), will not be granted. At this time it was clear for DUs that there is a need for authorisation in case they have no alternatives until the sunset date. However, again, the fact that despite the regulatory pressure to substitute TRI, companies still use TRI today and plan to use TRI in future, shows that substitution is not easily possible in any case. In general, authorisation according to REACH and compliance with national workplace exposure limit values should not be mixed up. There is no rationale to consider compliance with a specific (Austrian) national occupational exposure limit value as a requirement for authorisation on the European level or to conclude that all exposure levels in ES submitted as part of an AfA need to be below a national occupational exposure limit. It should also be taken into account that a harmonised European workplace exposure limit value does not exist for TRI and there is a controversial ongoing discussion in this respect, resulting in different occupational exposure limit values for TRI in Europe. In 2009, SCOEL proposed a threshold of 10 ppm considering TRI to be a threshold carcinogen and the implementation of this recommendation into the Carcinogens and Mutagens Directive (CMD) is still in the process. The tripartite committee of the Working Party Chemicals (WPC) has been discussing a number of SCOEL Recommendations and on the 5 th of December 2012 the plenary of the Advisory Committee adopted an Opinion on the possible amendment of the CMD. This includes a number of substances for which there are SCOEL recommendations exist such as TRI. Although RAC published dose-response relationships following the AGS approach shortly before the latest application date, which has been used as basis for the elaboration of the AfA documents, there is still no consensus regarding the question whether there is a threshold for TRI or not. Besides the fact that there is always a general call for lowering occupational exposure, we do not see a general correlation between identification of TRI as SVHC and a general requirement for European DU to lower occupational exposure below the risk based limit value of 3.3 mg/m³ which has been implemented in Austria. In this context, it is not understandable that the company is planning a new (third) production line using the same carcinogenic substance and process while other factories successfully use alternative technology without carcinogenic substances. The aim of authorisation is to ensure the good functioning of the internal market while assuring that the risks from substances of very high concern are properly controlled and that these substances are progressively replaced by suitable alternative substances or technologies where these are economically and technically viable.

3 It has been explained in the AoA why hexane, which is the only different solvent in use at older factories (we are not aware of an alternative technology), is not a feasible alternative for Microporous. As can be seen from the fact that also other manufacturers of PE separator foils (ENTEK) apply for the same use of TRI, it is not easily possible to substitute TRI in this application. Due to various reasons, production of PE separator foils using hexane has not been considered as a recommendable technology for new manufacturing sites. Modern manufacturing sites in Europe (see also ENTEK) and new manufacturing sites built in non-eu countries during the last years use TRI as solvent. This already shows that use of hexane is correlated with several disadvantages and is seen as outdated technology by industry worldwide. It is not the aim of REACH to punish companies which have no suitable alternatives and there is no reason why companies which have no alternative should in general not be able to extend their business. In case European companies using Annex XIV substances would in general not be allowed to increase their production in future, this would result in a discrimination compared to non-eu manufacturers and result in loss of competitiveness for EU companies. Implementation of the third production line will furthermore be correlated with adaptation of the whole manufacturing process like - Segregation of all permanent workplaces in a separate room connected to the main production process equipped with effective fresh air ventilation system - Encapsulation of dryer circulation fans (biggest source of fugitive TCE emissions) including ventilation connected to the solvent recovery system - Increase of ventilation capacities in the production area higher air volumes and reduced building volume due to segregation from converting facility and ware house A study on expected work place exposure levels will be conducted by an independent external service provider to demonstrate to local authorities that workplace exposure levels will be reduced with implementation of the 3 rd production line. All this will not result in higher exposure rates, but will allow the applicant to significantly reduce the existing workplace exposure levels. As soon as the permit for the 3 rd production line and authorization for continued use will be granted, the applicant will implement the described measures. The required investments have been agreed and financial resources are already available. Furthermore, it is neither understandable nor acceptable that in all these years no R&D program was conducted (as stated in the AoA document) to identify and to test alternative solvents and/or technologies. (Only a last-minute internet research has been done to compile the AoA document.) The obvious longstanding ignorance of the need to substitute the carcinogen cannot be accepted as a reason or a justification for a prolonged review period.

4 The applicant has not been ignorant but has already considered alternatives (namely hexane) when the site was planned. Before the site in Feistritz was built, the option to use hexane as solvent was discussed internally and together with local authorities. Taking into account that, as claimed by the third party, TRI is known to be a carcinogen since decades and there is a substitution requirement according to the CMD, the fact that it was decided to use TRI as solvent for the new production plant and the permit for the manufacturing site was granted by Austrian authorities, shows that feasible alternatives are not available and TRI has been considered to be the best technology. Nevertheless, to fulfil his legal obligations, the applicant has evaluated several potential alternative solvents for feasibility in the past, already before inclusion of TRI in Annex XIV and the AoA is not a result of a last-minute internet research as claimed by the third party but a result of intensive discussions with experienced technical staff and management people, which have been involved in production of PE separator foils since decades. It is however also clear, that a company like Microporous, which started production in 2008 cannot have long-lasting own experience in R&D 5 years later. A company cannot setup a R&D program before it is established and laboratory scale testing of alternatives does only make sense in case the potential alternatives fulfil the necessary general requirements for implementation, which is not given for the potential alternatives evaluated so far. As can be seen from other applications received for the same use, companies which are using TRI by far longer than Microporous also have not yet identified feasible alternatives. Against this background, it is not reasonable to blame Microporous to not have conducted an R&D program since all these years (5 years) and to be longstanding ignorant. In contrast thereto and due to the fact that there exists no feasible alternative for Microporous, since 2008 Microporous has invested considerable efforts in minimization of workplace exposure and releases to the environment. The result of these activities has been a reduction of the amount of TRI used per m 2 separator foil although the production volume has significantly increased in parallel (see section of the SEA). Against this background, we think that there is no basis for punishing Microporous with a short review period as recommended by the commenter. Oftentimes the AoA and SEA documents presumes that the local authorities would be accountable for the use of TRI in the plant. In contrast to this attempt to shift the burden to local authorities, it is the job of the company to manage substitution or, respectively, to guarantee worker s exposure below 3,3 mg TRI/m³. It is not correct that the applicant presumes that local authorities are accountable for the use of TRI and the applicant does not want to shift the burden to local authorities. We only want to highlight that at the time the manufacturing plant was planned in coordination with Austrian authorities, the best technology was

5 discussed and it was decided to use TRI as a solvent. The reason is of course not that the applicant and the Austrian authorities responsible for the permission have been ignorant, but that TRI was considered to be advantageous compared to hexane. This was not the exclusive opinion of Microporous but also the view of Austrian authorities and it should be taken into account by the committees that not Microporous alone decided to use TRI as a solvent. We again want to highlight that compliance with national workplace exposure limit values is not in the scope of the authorisation process. The 3.3 mg/m 3 limit is a value implemented exclusively in Austria (for more details see below) and therefore cannot be used as basis for evaluation of AfA submitted on European level. Compliance with this level is not a requirement for authorisation according to REACH. As shown in the AoA, there are some reasonable alternatives using NONcarcinogenic substances. Among others, n-hexane is a feasible alternative. n-hexane is neither a proven carcinogen nor a suspected carcinogen. Risks arising from the flammability of n-hexane can be mastered by technical means. For n-hexane a health-based OEL exists, i.e. a workplace air concentration below of which no adverse health effects occur. Due to current scientific knowledge this OEL is 180 mg n-hexane/m³ as 8-hour-TWA with a short time (15 min.) value 1440 mg/m³ (MAK Deutsche Forschungsgemeinschaft). Even though the binding OEL in Austria is lower (72 mg/m³; short time value 288 mg/m³), these limit values are more than 20 times higher than those for TRI. n-hexane shows a vapour pressure not much higher than that of TRI. Therefore the use of n-hexane provides a large margin of flexibility in operating the plant in different conditions compared with an air concentration restricted to 3.3 mg/m³. It is right that hexane can be considered to be a technical feasible alternative for part of the production of Microporous (assuming that a permit would be granted by local authorities). However, it has also been explained why hexane is not economically feasible. Again, the aim of authorisation is to ensure the good functioning of the internal market while assuring that the risks from substances of very high concern are properly controlled and that these substances are progressively replaced by suitable alternative substances or technologies where these are economically and technically viable. The risks related to flammability of hexane should not be underestimated and it has been shown in the past, that it is not such easy to control the related risks by technical means. Accidents in PE separator foil manufacturing sites using hexane has been one reason why TRI has been considered to be the better technology by industry in the past. For Microporous massive investments would be required to implement hexane as this would mean to guarantee that all parts of the production are made explosion proof. It has been explained that requalification of the produced separator foils would be necessary, and the related stop of supply would result in customers starting business with non-eu competitors. It has

6 to be taken into account that PE separator foils are high-tech products which have a fundamental influence on the functioning and life-time of batteries and that these foils are not just simple plastic foils. From a technical point of view risks arising from the flammability of n-hexane can be mastered by technical means but it has been shown in the AoA that for Microporous it is economically not feasible to implement hexane. Against this background, hexane is not a feasible alternative for Microporous as defined by REACH. Microporous is in negotiations with its TRI supplier SAFECHEM, which has long-term experience in substitution of TRI in degreasing applications, regarding implementation of a chemical leasing program which includes support for Microporous with identification and testing of potential alternatives. The implementation of the programme has been postponed against the background that DOW is seeking to sell its chlorinated solvents business which makes implementation of long-term agreements difficult. The statement that automobile sector (and the demand for battery foils) is steadily growing seems to be over-optimistic in the own interest of the SEA document. The fact that the automotive sector is growing is not an over-optimistic assumption in the own interest of the SEA document as can been seen from production figures of the automotive sector and business outlook of relevant companies (source e.g. The demand for battery foils can be expected to increase last but not least due to the fact that the market for electro mobility (cars bicycles) and the demand for storage capacities for electrical energy gained from renewable resources, like solar energy, can be expected to further increase in future (source e.g. The expectation for increasing demand is best demonstrated by the fact that the applicant plans to increase his production. The expected growth of sales for Microporous is also driven by an increasing demand in non-eu countries and increasing market shares of Microporous in non-eu countries. Worker contributing scenario 3: Mechanical processing of the separator sheet (chapter 9.1.4): Air concentration levels up to 44 mg/m³ had been measured. No measurement showed a concentration below the permissible exposure limit (3.3 mg/m³). All air concentrations, in the early shift as well as in the late shift, were at least 6.3- times higher than the permissible exposure limit (3.3 mg/m³). A limit value of 3.3 mg/m³ is legally binding in Austria. It corresponds with an acceptable work lifetime risk of 4:100,000. It is estimated that 10% of exposure levels even lie ABOVE 36.9 mg TRI/m³! This level is 11 times higher than the permissible exposure limit.

7 Even the mean exposure level (28 mg/m³) is more than 8 times above the exposure limit. Therefore, the workers underlying the Contributing Scenario 3 are subjected to a cancer risk up to 13 times higher than the acceptable cancer risk. This is definitely inacceptable. The worker contributing scenario 3 (mechanical processing of the separator sheet) only provides a basic general ventilation (2 air changes per hour) of the 45,000 m³ hall. No LEV is envisaged. Improvement of general ventilation and implementation of LEV could reduce the worker s exposure to TRI to a considerable extent. These improvements are indispensable, in particular to comply with EU legislation on Safety and Health at Work [see Articles 5 and 6 of CAD (98/24/EC) and Articles 4 and 5 of CMD (2004/37/EC)]. Suggested alternative: If an authorisation should be granted for the use regarding Worker contributing scenario 3: Mechanical processing of the separator sheet it is indispensable to include ENHANCED GENERAL VENTILATION and LOCAL EXHAUST VENTILATION of work zones in the conditions to be given in the authorisation according to REACH Article 60/8. Again, authorisation according to REACH and compliance with national workplace exposure limit values should not be mixed up. There is no rationale to consider compliance with a specific (Austrian) national occupational exposure limit value as a requirement for authorisation on the European level or to conclude that all exposure levels in ES submitted as part of an AfA need to be below a national occupational exposure limit. The aim of the AfA is to demonstrate that no feasible alternatives exist and that benefits of continued use outweigh risks correlated to minimized exposure. Minimisation of risks is not always automatically correlated with compliance with a specific national occupational limit value like the acceptance level of 3.3 mg/m 3 established in Austria. It is correct that the draft exposure-risk relationship for TRI developed by AGS has been published in However, the final TRGS 910, which provides and specifies rules to apply the AGS ERB concept in Germany, has been published, hence came into force only in April 2014 (GMBl 2014 S vom [Nr. 12]). Austria went ahead of implementing an acceptance level (based on the German ERB concept) of 3.3 mg/m³ already in In Germany this level is aimed to be implemented only in 2018 and also this deadline has been questioned recently. In Austria, the 3.3 mg/m 3 value is included as a TRK limit value (= technical guidance/reference concentration) in the annex of the GrenzwerteVO For the definition of TRK, 3 of the GrenzwerteVO 2011 refers to 45 Abs 2 ASchG. This regulation defines TRK values as concentration in air at workplaces which can be

8 achieved according to the state of the art and as reference point for RMMs to be implemented. This value can therefore be understood as reference point rather than binding limit value and provides authorities with a certain flexibility in the same way as in Germany. In the justification paper for the dose response relationship published by AGS it is stated that at a concentration of 6 ppm, renal damage which might provide the basis for the promotion/progression to a clinically manifest tumour is not expected. This means that reduction of the acceptance level to 3.3 mg/m 3 is rather due to a safety margin than driven by real tumour risk. Besides acceptance levels, the AGS concept foresees tolerance levels. A theoretical additional cancer risk of 4:1000 that is regarded as a tolerable risk. This risk relation roughly corresponds to the risk of an agricultural worker to be killed in an accident or the risk of a non-smoker who is not exposed to hazardous substances at work to develop lung cancer. The ministry of labour in Germany requires as a minimum compliance to the tolerance levels. Above the tolerance risk, which is 60 mg/m 3 for TRI, employees should not be exposed. According to the AGS concept, an exposure above the acceptance and below the tolerance level calls for further protective measures according to a graduated concept. The concept lists individual measures classified into five categories (administration, technology, organisation, occupational medicine and substitution). The extent to which these measures are obligatory depends on the respective risk area. This means that the AGS concept does not consider the acceptance level as a binding maximum workplace exposure level but as the risk at the workplace which does not call for any additional risk management measures due to the low remaining additional substance-associated cancer risk. In case a workplace exposure level exceeds the acceptance level but is below the tolerance level, this does not automatically mean that the company does not comply with existing law. The existing Austrian TRK should be handled similarly against the background that it has not been taken into account whether it is technically possible for Austrian companies to comply with the TRK. In cases where it can be demonstrated that it is technically impossible to keep the TRK exemptions are necessary. It also has to be taken into account that the Austrian TRK of 3.3 mg/m 3 is in place since and the national occupational exposure limit value (MAK) in 2008 when the plant started production was 270 mglm 3. This means that the occupational exposure limit has been lowered by a factor of nearly 100. In the German TRGS 910 it is stated that: In view of the fact that achieving a value at this level (acceptance level) makes very high demands on many activities and processes and many areas, a graduated approach is proposed: During an introductory phase, this limit will be temporarily set to a value of 4: Depending on the experience with the implementation of the concept of risk-based limit values for carcinogenic substances, the temporary values are to be replaced with final values concerning the acceptable risk no earlier than five and no later than ten years after the introduction of the concept.... This shows that German authorities recognized the potential difficulties for companies to implement the RMM required to achieve such a low occupational

9 exposure level within short term and granted a transition period until In contrary thereto, Austrian authorities ignored this fact. Between 2008 and 2013 (implementation of TRK in Austria) Microporous fulfilled all national requirements regarding worker safety and complied with all permit requirements e.g. regarding environmental releases. Since 2008 and especially within the last years Microporous has implemented additional RMMs to reduce workplace exposure and has also reduced the time workers have to be present in relevant areas as far as possible. Microporous is in contact with local authorities to discuss further options for reduction of workplace exposure. As already explained above, Microporous will adapt the process and implement additional RMMs in the near future. The most important improvement will be the separation of workplaces of choppers or cutters and packagers from areas where TRI is used like the extraction and drying steps. As described in the AoA and the ES, Microporous has implemented and continuously improved RMM to minimise workplace exposure in the past and plans to take further actions in the near future. It should however been taken into account that a reduction of workplace exposure levels by a factor of 100 is challenging for companies, why in Germany a transition period until 2018 has been implemented. Human Biomonitoring not suitable: In Worker contributing scenarios 2, 3, 4 and 5 the following RMM is stated: Human biomonitoring of all workers takes place every 6 months. In case of increased concentrations of TRI are found, the interval for the next check is only 3 months. 1. This procedure is not in accordance with Austrian law any more. The determination of a metabolite of TRI (trichloroacetic acid) in urine has been withdrawn because the former metabolite guidance level was associated with the former, very high OEL (270 mg TRI/m³). 2. Instead of trichloroacetic acid determination now a general check of liver enzymes in blood has to be made. This parameter is quite unspecific. Determination of liver enzymes is NOT a measure of Biomonitoring, but a measure of effect monitoring which allows only much less conclusions than Biomonitoring data. 3. There is no biological parameter for low or high cancer risk due to workplace TRI exposure. Enhanced trichloroacetic acid levels in urine as well as enhanced levels of liver enzymes in blood are indications of possible ACUTE liver damage, in particular of already severe liver damage. They do not provide any information on liver cancer risk because hepatic tumours are long-term effects of TRI. The same is true for renal cancer and non-hodgkin lymphomas. In spite of the fact that the former OEL for TRI was associated with a very high cancer risk of the exposed workers, the medical examinations (as quoted in SEA document, chapter ) did not show increased trichloroacetic acid levels. The

10 argumentation given in the SEA document that therefore the exposure of TRI is safe, is without any reason and is unjustified. 4. The only way for risk control and risk surveillance referring to workplace TRI exposure is recurrent air monitoring at the workplaces. Instead of medical examination of the workers, monitoring (measurement) of workplace air concentration levels is necessary as RMM. 5. Former monitoring of trichloroacetic acid levels in urine and future determination of liver enzymes in blood does not allow any statement on the critical endpoint of TRI exposure which is tumorigenic action. They are no risk management measures. Microporous performed biomonitoring as requested by Austrian law in the past and decided to continue with biomonitoring of trichloroacetic acid in urine on a voluntarily basis, although no longer requested (since the commenter in detail explains in the comment the difficulties occurring with biomonitoring and that biomonitoring should not be considered as an RMM). The actual German TRGS 910, which is the basis for the acceptance level of 3.3 mg/m 3 implemented in Austria and which the third party refers to in nearly all the comments, still includes substance-specific equivalence values in biological material for acceptable and tolerable concentrations for TRI. Furthermore, in TRGS 910, it is mentioned that in the case of skinresorptive substances, dermal uptake may make a considerable contribution to the occupational exposure. In the case of possible skin contact with such substances, measuring exposure by inhalation exclusively is not sufficient when assessing the cancer risk at the workplace. Biomonitoring is therefore more suitable in order to determine the overall exposure by oral, dermal and inhalation route, insofar as an appropriate procedure is available. In order to assess the measurements from biomonitoring, the substance-specific equivalence values in biological material with regard to the acceptable or tolerable concentration must be used. The applicant sees future biomonitoring of trichloroacetic acid in urine as a voluntarily additional action and nothing more. Despite this, the applicant is of the view that biomonitoring provides information on the health status of the workers and in general valuable information on workplace exposure. The applicant is of the view that contrary to personal workplace exposure monitoring, which provides information on a short time period (measurement period) and uptake by inhalation only, monitoring of trichloroacetic acid concentration in urine provides valuable information on long-term exposure of workers including potential uptake by other routes. Furthermore, information on the functioning of the overall system of RMM and information on whether workers follow safety instructions like use of PPE is gained by biomonitoring data. Workers not regularly using the mandatory PPE can be identified by increased trichloroacetic acid levels and respective follow up actions like repeated safety instructions can be taken. Even in case the commenter is of the view that the equivalence levels provided in the German TRGS 910 are meaningless, we think that biomonitoring of trichloroacetic acid in urine is not useless. Monitoring of workplace

11 exposure levels has been performed by Microporous in the past and will be performed in future to demonstrate efficiency of new implemented RMMs. Suggested alternative: If an authorisation should be granted for the referring uses, it is indispensable to include REGULAR AIR MONITORING instead of biomonitoring in the conditions to be given in the authorisation according to REACH Article 60/8. Only a short review period seems to be justified in this authorisation. Stationary continuous monitoring of workplace concentrations is not useful in case of Microporous as workers do not work at fixed places in the production hall over a full shift but change locations several times. Results of stationary on-line monitoring of air concentration would therefore not be representative for exposure of workers. This means that personal exposure monitoring is the only suitable measure and Microporous is open to establish a regular personal exposure monitoring program in cooperation with external partners like the Austrian AUVA (Austrian Social Insurance for Occupational Risks) which performed the last personal exposure monitoring campaigns at Microporous in 2013 and We do not understand why only a short review period should be justified. We again want to highlight that the aim of the authorisation process is not to punish companies which have no suitable alternatives. If this would be the case, companies which cannot implement an alternative would have to relocate to non-eu countries. Uptake of a substance in Annex XIV does not automatically mean that all users of the substance will be able to substitute in due course. As explained in the AoA and the SEA, in case only a short review period will be granted, this simply means that the applicant will have to apply for authorisation again within short term. There is no possibility for Microporous to substitute TRI in the short term. Because the legal binding Austrian exposure limit for TRI is heavily exceeded in the plant, any authorisation should NOT be granted without imposing conditions as described above, including air monitoring, on the applicant. Regarding compliance with the Austrian exposure limit for TRI, we refer to the comments provided above. It is not in the scope of the authorization procedure to ensure that companies comply with national TRK as this would discriminate applicants from countries with lower exposure levels compared to applicants from countries with higher occupational exposure levels. Since the applicant is well aware that TRI exposure should be minimized to the lowest value possible, several technical implementation are planned within the build-up of the 3 rd production line. These implementations will lead to a significant reduction of the TRI exposure concentrations, see also comment above.

12 Microporous The Danish Working Environment Authority (DWEA) comments on Trichloroethylene ( ) - Ref.No: 603 The aim of authorisation and considerations for substitution is to ensure that the risks from substances of very high concern (SVHC) are properly controlled and that these substances are progressively replaced by suitable alternative substances or technologies where these are economically and technically viable. It is clearly stated in Carcinogens and Mutagens Directive (CMD) 2004/37 article 5 (1 and 2), that the carcinogen or mutagen substance should be replaced with less dangerous substance where it is technically possible. And if it is not technically possible, then the carcinogen or mutagen substance should be used in a closed system. It is mentioned in the analysis of alternatives, that trichloroethylene is used in closed systems. Trichloroethylene is already covered by (CMD) and trichloroethylene should already be used in closed systems according to CMD. The experience and practice in Denmark is that trichloroethylene can be substituted with sodium hydroxide solution as a degreasing agent for most of the surfaces only exempt from very complex surfaces. The Danish Working Environment Authority (DWEA) recommends sodium hydroxide solution as alternative instead of trichloroethylene as a degreasing agent for most of the surfaces. The authorisations should only be given to very complex surfaces with complex geometry for a limited period time and until trichloroethylene can be replaced by suitable alternative substance or technology for very complex surfaces. It is not convincing in the analysis of alternatives that the mentioned alternatives and other alternatives are not suitable for substitution of trichloroethylene. And it is not clear that all the mentioned surfaces are in fact some very complex surfaces. The substitution transition period takes time and costs money therefore the authorisations should only be given in a temporary time up to 2-3 years and then the new alternatives should be used. Reply from Applicant Microporous GmbH to Comments from the Danish Working Environment Authority - Consultation number This comment from third parties addresses trichloroethylene as a degreasing agent and the identical comment has been submitted for the AfA of Dow for industrial parts cleaning. As explained in detail in the AoA and the ES, the use of TCE at Microporous is completely different to the use of TCE in surface cleaning and the aim of the process is not to remove oil from the produced foil but to reduce the oil content in the foil to a specific concentration, which is mandatory for the functioning of the final product. To achieve the required open pores of the specific size (to allow ion transfer in the final battery), it is furthermore mandatory that the used solvent can enter the pores (µm size) and remove process oil from the pores.

13 Against this background, it is not clear for us whether this comment really addresses the use Microporous applies for. Nevertheless, we take the opportunity to provide our answers: 1. Referring to the comment regarding the CMD directive, we would like to highlight that as explained in the AoA, the ES and the SEA, TCE is of course used in a closed system at Microporous. 2. The commenter states that it is not convincing in the analysis of alternatives that the mentioned alternatives and other alternatives are not suitable for substitution of trichloroethylene. And it is not clear that all the mentioned surfaces are in fact some very complex surfaces. Nowhere in our documents do we refer to different surfaces or very complex surfaces. 3. It is stated that the experience and practice in Denmark is that trichloroethylene can be substituted with sodium hydroxide solution as a degreasing agent for most of the surfaces only exempt from very complex surfaces. The experiences made in Denmark with degreasing cannot be transferred to manufacturing of PE separator foils as the aim of the process is not degreasing of the produced foil. This should be clear from the process description presented in the AoA. 4. The third party recommends sodium hydroxide as an alternative and recommends a review period of 2-3 years. In section Discussion of aqueous solvents of the AoA it has been explained why aqueous solvents are not feasible for Microporous and have not been further discussed. The same is true for sodium hydroxide solution due to the following reasons: In aqueous based solvents oil is generally not dissolved but lifted-off the surface with help of mechanical shear forces and with help of micelles formed. Although it might be possible to adjust an aqueous solvent to a fixed concentration of process oil, as the process oil is not dissolved, it would not be possible to reduce the oil content in the product to a defined concentration. After removal of water, in the dryer, detergents would remain on the foil surface and the oil would be heterogeneously distributed on the surface not forming the required uniform layer. Any kind of residues on the foil are not accepted by the clients as performance of the final batteries is negatively influenced. Although detergents reduce the surface tension of aqueous solvents it would not be possible to remove oil from the fine pores in the foil with water based solvents. Furthermore, high amounts of waste water would result from the process and a reuse of process oil would not be possible. This is because the separation of process oil and aqueous based solvents would entail some difficulties. For instance, distillation of water demands higher energy amounts with the disadvantage that only water but most likely not the active ingredients in aqueous solvents, e.g. surfactants, would be regained. Regained water would need to be amended with new surfactants again. Oil would need to be separated again from active ingredients in order to reuse it.

14 Against this background, aqueous solvents cannot be considered as potential alternatives for TRI in the production of PE separator foils. Even if sodium hydroxide solution would be a technical feasible alternative, the existing equipment cannot be used for aqueous solvents. Massive investments and a complete change of the manufacturing process would be required. Due to the required efforts for change of the manufacturing equipment, required stop of production, qualification of new product with customers, higher operating costs due to waste water treatment and no reuse of process oil, sodium hydroxide is not an economically feasible alternative. As explained in detail in section 2.4 of the SEA and section 4.3 of the AoA, a review period of 2-3 years would not even be sufficient to implement a technically feasible alternative.