Study of REACH Regulation in EU about Electrolytic Capacitor

ELECTROLYTIC CONDENSER INVESTIGATION SOCIETY March 2008 ANNEX Study of REACH Regulation in EU about Electrolytic Capacitor ELECTROLYTIC CONDENSER INVESTIGATION SOCIETY Vol.59 No.1 Toshio Kagami 1. Background The chemical substance regulations covering products such as EU RoHS Directive of July 2006, Chinese RoHS of March 2007 and the European REACH Regulation enforcement of June 2007 becomes more severe. In this state, the reinforcement of the product component chemical regime is strongly requested from customers. Moreover, the reinforcement of chemical substance regimes becomes essential of observing the laws and ordinances as a company. On this occasion, the consideration of European REACH Regulation focusing on our main product, Electrolytic Capacitor is reported. 2. What is European REACH Regulation? It is an abbreviation of the Registration, Evaluation, Authorization and Restriction of Chemicals and is a European Regulation which refers to when producing and importing Chemicals, its producer and importer are obliged to register, evaluate for SVHC, seek Authorization and for more hazardous substances implement Restrictions inside the EU. (1)Chemical substance targeted for REACH Regulation Products produced in EU or imported to EU 1) Substance: annual amount produced, imported more than 1t/year per producer/importer 2) Preparation: all chemicals produced, imported more than1t/year per producer/importer 3) Article: the substance is intended to be released under normal or reasonably foreseeable conditions of use Annually over 1t/year per producer/importer, and in the case of intentional release from the Article Interpretation of Article Article means an object which during production is given a special shape, surface or design which determines its function to a greater degree than its chemical composition. from Article3 (3) (2)Key points of REACH 1) Aim: Protection of human health and environment, improvement of competitiveness in the European chemical industry 2) In the past, the public administration was in charge of Evaluation and Registration of Non-phase-in chemicals (new chemical substances). The following points are added by the enforcement of REACH Regulation. 1Phase in substances need to be evaluated and registered just like New chemical substance. 2Safety evaluation and risk evaluation which were done by public administration. 3 Understanding of information on existence (concentration) or nonexistence of chemicals in the Article and its use. 1

3) Following points are needed in order for companies to take action in 2). 1 Adequate transaction of information on safety and management of chemical substance through the supply chain. (distribution channel) (Article33) 2 Obligation to register and notify according to the conditions of the substances in the Article. 3 Obligation to authorize certain hazardous substances. (3)Flow until the enforcement of REACH 1) Process 12001/2 : White Paper Strategy of policy in chemicals hereafter published, draft being declared afterwards 2 2003/10 : proposal of REACH Regulation Draft by EU commission (6400 opinions from affiliates of WTO) 3 2005/11 :adoption of draft Regulation by EU Council First Reading, Political agreement at EU board meeting 4 2006/12 : Final adoption 5 2007/6 : Enforcement of REACH preparation period of ECHA (1year: 2007/6/1-2008/5/31) ECHA being established at present ECHA=European Chemicals Agency 2) Future Schedule 12008/6-12 : Pre-registration Implementation term 2 2008Autumn -2009/1: Declaration of SVHC list SVHC=Substance of Very High Concern When it is fulfilled the criteria of Article 57 and specified in case of Article 59(1), (Article7 (2)) 32011/12 : Registration Deadline (more than 1000t/y, others) 4 2011/6 :Application on notification of substances in Article 52013/6 : Registration Deadline (100-1000t/y) 6 2018/6 : Registration Deadline (1-100t/y) (4)Key points of REACH 1) Pre-registration 1Potential registrant of Phase-in substance which exceeds 1 ton annually, to provide the following information in order to get award (Article23: Registration Deadline) from transition system. (Article 28) 2If there is no pre-registration, cannot join the SIEF SIEF (Substance Information Exchange Forum) Aim: General registration among producers and importers, constitution of consortium in order to facilitate the exchange of specified information Participants: all the potential registrants, downstream users, third parties who submit the information to ECHA according to Article 28 (Pre-registration), will be the member of SIEF (Article 29) 2) Registration (Notification) and Evaluation 1Among the chemical substances which constitute the products being produced or imported into the EU, all the substances which exceed over 1 tonne are required to be registered. In cases over 10 tonnes need to register use information per substance. 1) Chemical Substance, Preparation 2) Substance included in Article and intended release under normal or foreseeable condition 2Registered by operator inside EU (chemical maker, manufacturer, import company, representative) 2

3 In case of SVHC, included with concentration of 0.1wt% in Article, and moreover, if annually produced or imported more than 1 t/y per producer/importer needs to be notified. (Article7 (2)) 4 Amount of chemical substances used and estimated cost(japan Chemical Industry Association) Amount of chemical substance Estimated cost Less than 1t not applicable for registration 1t-less than 10t 6.5miilion yen/substance 10t-less than 100t 30-40million yen/substance 100t-less than 1000t 45million- yen/substance More than 1000t 80million- yen/substance 3) Authorization and Restriction (In case of SVHC) 1 Authorization: in case carcinogenicity, mutagenicity, reproductive toxicity, endocrine disrupting chemicals are used, disclosure scenario has be clarified along with registration. Notification and Authorization is needed (Article 62) 2 Restriction: Annex of substances with even more risk (76/769/EEC) and persistent organic pollutants will be evaluated and severely restricted. (Article 67) 3. Issues and concerns with the interpretation of REACH Regulation regarding Electrolytic Capacitors In this presentation, with RIP3.8 which is published in October 2007 by EU Commission and RIP3.8Final Draft published in November 2007, we examine the following: RIP3.8 Final Draft is by the SEG-meeting in EU, November14-15 2007 and is not yet officially published. (1)Is electrolyte of Electrolytic Capacitor, a Preparation or an Article? 1) According to Article 3 (3) of REACH Regulation, Article is defined as follows: Article: means an object which during production is given a special shape, surface or design which determines its function to a greater degree than does its chemical composition; 2) As a reference case, an explanation about battery is written on Annex 2. The main function of batteries is to provide energy. The voltage is produced through a chemical reaction of two unlike materials, such as the positive and negative plates, which are immersed in an electrolyte. Without the chemical reaction, no voltage would be produced. Hence the chemical composition is very important for the function. The shape and design of the battery ensure that the reaction takes place in a controlled way and that the energy is provided continuously, at the time needed and in a useable form. Thus, also the shape and design of the battery are important for the function. 3

1) The electrolyte as such cannot provide any energy outside the battery. Filled into other containers without the specific design of a battery, they would also fail to provide energy. The container part of the battery, emptied of the electrolyte, is also not able to fulfill its function. However, there are different types of electrolytes which could be used in one battery casing. 2) The electrolyte is not released from the battery, thus the container does not have a function of delivering it and does not control its release 3) The electrolyte and the battery casing are normally discarded together. As a consequence, the battery should be regarded as an Article containing a preparation as an integral part. There are different types of batteries and some of them may not fulfill all criteria in the same way. For example in car batteries the electrolyte may in certain cases be exchanged and both elements are discarded separately. Also the shape and design can vary to a very large extent. However, the principle of functioning is the same and thus, all batteries should be treated in the same way. In the same manner as batteries, Electrolytic Capacitor is firmly sealed; there is no intended release of electrolyte from inside the capacitor. Moreover, capacity and design, distance of electrode, shape of electrode, and function of surface are affected. Furthermore, from Table 1 (borderline case: Preparation/ Article) of RIP3.8 Annex, REACH Regulation Article7 (1) (Registration) is not applicable to batteries. As described above, an Electrolytic Capacitor would be considered as an Article and the electrolyte would be regarded as substance contained in the Article and considered as a part of the Article. The main function of an Electrolytic Capacitor is to store electricity. In an Electrolytic Capacitor current is conducted between positive plates and negative plates through electrolyte. Therefore the release of electrolyte caused by vent is not the primary function. Moreover, the meaning of intentional release is a considered from the following example 1) There is an explanation of Intended release of a substance from an Article in the original draft of RIP3.8. Registration of substances in Articles is required when all conditions listed under Article 7(1) are fulfilled: The substance is intended to be released17 under normal or reasonably foreseeable conditions of use The total amount of the substance present in all Articles with intended release produced or im726 ported by one actor exceeds 1 tonne per year The substance has not been registered for that use (see Chapter 7) As a general rule, the term intended to be released implies that a certain function or quality of an Article is connected to the release of a substance or preparation. Thus, all substance releases which occur because of aging of Articles, because of wear and tear or as a result of accidents, are no in tended releases. 4

Intended release means intended to be released under normal or reasonably foreseeable conditions during the service life of the Article. In addition, all substance releases which occur because of aging of Articles, because of wear and tear or as a result of accidents, are not intended releases. 2) Explanation of Intended release is interpreted in Annex 1 of RIP3.8 as follows. The requirements in Article 7(1) relate to substances as such or in preparations that are intended to be released under normal or reasonably foreseeable conditions during the service life of the Articles. As a general rule, the intention of the Article producer in relation to the release of the substance is relevant. So, the question Is it wanted that the substance is separated from the Article during its use? should be answered with yes. Thus, intended releases are deliberately planned and have a specific function for the Article, which is not the main function of the object1 but an additional quality. If a release is incidental, this is not an intended release. Substances with intended release are required to be separated from the Article during its use. If there is no intended release during its use and if the release is incidental, it would not be considered as intended release. Therefore, for the reasons stated as follows, the release of electrolyte caused by vent in an Electrolytic Capacitor is not considered as intended release. 3) An example of intended release is written on Annex 1 of RIP3.8 as follows: A release of substances from Articles is intended when: The release contributes to a quality or minor function of the Article, or, in other words the, release contributes to an added value of the Article, which is not directly connected to the end use function. Example: Intended release in this sense is: Release of perfume from a perfumed eraser (function = to erase, added value / function for convenience = quality to smell good), fade-out Jeans: it is intended that the dyes are released from the Jeans with every washing. The intended release must contribute to its characteristic or sub-function. When there is an intended release of electrolyte caused by vent is an Electrolytic Capacitor, it does not contribute to the characteristics of an Electrolytic Capacitor. 4) An example of Non-intended release is written on Annex 1 of RIP3.8 as follows. 1.A release occurs during removal of 'impurities' from a semi-finished or finished Article during its production process (before marketing as a finished Article). Example: A size is added to a fabric to improve its process ability. Sizes are released during further wet processing of the textile 5

2.A release occurs during use or maintenance of the Article and is meant to improve the product quality in a wide sense or the safety as a side effect but the released substances do not contribute to the function of the Article. Example: Washing of clothes by the consumer where remnants of different chemicals (dye, softener, starch etc.) from processing are removed over some washing cycles 3. A release of substances is an unavoidable side-effect of the functioning of the Article. Without the release, the Article would not work, however it is not intended that the release really happens. Examples: wear and tear of materials under conditions with high frictions, e.g. break linings, tire. 4. A release of substances formed during chemical reactions of any kind Examples: Release of substances from Articles catching fire, releases that are unavoidable for achieving the end use function, like ozone released from copy machine, release of substances chemicals reactions caused by accidents or product malfunction, such as combustion products from Articles catching fire 5. A release is incidental, could be forced by undue use or in an accident Examples: release of substances from a thermometer which it drops and breaks. This also includes any form of misuse and inappropriate use which is not in accordance with the use instructions or functionality, even if it could have been anticipated: A release caused by a long term, extremely intensive use of a tool by a consumer, who, when building his own house, uses it in disregard of the recommendations in respect of operating time provided in the instructions of use) Regarding Intended release of electrolyte caused by venting is applicable to Example2, Example3 and Example5. 1 When electrolyte is released as a result of venting in an Electrolytic Capacitor, it is safely done through the case vent. The substance released does not contribute to the function of Article. (Example2) 2 When the release of a substance is unavoidable, with minor effect on the function of the Article, it is not intentional. (Example 3) 3 The release of electrolyte caused by venting is incidental. (Example5) For all of these reasons, it can be interpreted that the release of electrolyte caused by venting is not considered as intended release. Therefore, Electrolytic Capacitor is taken as Article without any intended release. Example 3 and 5 are examples of products that apply to varistors. (3)Is a Conductive polymer which is used as the electrolyte for a Conductive polymer solid Capacitor exempted from registration? 6

Conductive polymer solid capacitors should be considered as an Article and the conductive polymer as electrolyte is regarded as a substance included in Article. Furthermore in (2), the release of electrolyte caused by venting is not considered as intended release and this applies to conductive polymer solid capacitor as well. Therefore a conductive polymer solid capacitor is regarded as an Article without intended release and as in Article 7 (1) of the REACH Regulation, it is not applicable to Registration of substance in an Article. Article 7 Registration and notification of substances in Articles 1. Any producer or importer of Articles shall submit a registration to the Agency for any substance contained in those Articles, if both the following conditions are met: (a) the substance is present in those Articles in quantities totaling over 1 tonne per producer or importer per year; (b) the substance is intended to be released under normal or reasonably foreseeable conditions of use. In addition, a reference is stated in Article2 (9) of the REACH Regulation as follows: Article 2 Application 9.The provisions of Titles II and VI shall not apply to polymers. 4. Conclusion (1) An Electrolytic Capacitor is firmly sealed and electrolyte is not dispersed from inside the capacitor during its use. Furthermore, the function of an Electrolytic Capacitor is affected by functions such as the design, distance between electrodes, the shape of electrodes and their surface. For all reasons above, Electrolytic Capacitors should be considered as an Article and the electrolyte is regarded as a Substance included in Article and also as the part of the Article. (2) The main function of an Electrolytic Capacitor is to store the electricity and the release of electrolyte is considered as not being intended release from each example. Therefore, an Electrolytic Capacitor is an Article without intended release and is exempted from registration. (3)The Conductive Polymer used as an electrolyte in a Conductive Polymer Solid Capacitor is not applicable to Registration under REACH Regulation in the same manner as an Electrolytic Capacitor. Furthermore, based on this, the concept applies to Electric Double Layer Capacitor that has same structure. 5. Future tasks In the days ahead, there is a need to check and take action towards the revised content of the texts and Annex of the REACH and RIP. There is a possibility that a different interpretation might be made inside the EU and therefore this consideration is not necessarily the final conclusion. When the RIP3.8 Guideline is officially published, we can finally start making conclusion. 7

This text is a consideration of REACH Regulations focusing on Electrolytic Capacitors. All the interpretations and views about European REACH Regulation are not to be confirmed nor authorized by any public institution in Japan, EU nor any other country. Therefore please bear in mind that we cannot guarantee in any form the adequacy nor legality. 6. Reference (1) Ministry of the Environment: Guideline for REACH (published on 2007/2/14,finally amended on 2007/7/2) (2) JETOC :European Parliament and Council of European Union Regulation about REACH (EC) No.1907/2006 Introduction, Content, Annex (3) Environment Ministry: Translation of Technical Guidance on RIP3.8 (Ver 1.0) (published on 2007/3/30) (4) Reach Implementation Projetct3.8:Draft Technical Guidance Document on requirements for substances in Articles (5) JEITA: Professional Guidance on requirements on substances in Articles (2007/10 draft) (6) Reach Implementation Project 3.8:Draft Final Technical Document on requirements for substances in Articles (7) Japan Chemical Industry Association: Amount of Chemical Substance used and estimated cost of evaluation (8) JAMP(Japan Article Management Promotion): About Definition of Article (9) Ministry of Economy, Trade and Industry: Guideline of REACH Regulation (2008.2.5) 8