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DEHP AOA USE 3 Update BIU Final

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DEHP AOA USE 3 Update BIU Final ANALYSIS OF ALTERNATIVES non-confidential report Legal name of applicant(s): DEZA, a.s. Submitted by: DEZA a.s. Substance: Bis(2-ethylhexyl) phthalate Use title: Use in ceramic sheets and printing pastes for production of capacitors and lambda sensor elements Use number: Use 3 ANALYSIS OF ALTERNATIVES CONTENTS 1. SUMMARY ............................................................................................................................................. 1 1.1. Background to this Application for Authorisation ......................................................................................... 1 1.1.1. Applicant and Uses .......................................................................................................................................... 1 1.1.2. The role of plasticizers ..................................................................................................................................... 2 1.2. Summary of Issues Considered When Determining the Approach to the AoA ............................................... 2 2. ANALYSIS OF SUBSTANCE FUNCTION.......................................................................................... 3 2.1. Background of the use of DEHP in the manufacture of ceramic sheets and printing pastes .......................... 3 2.2. Descriptions of the use of DEHP .................................................................................................................... 4 2.3. Conditions of DEHP use ................................................................................................................................. 9 2.3.1. Technical requirements for DEHP and alternative substances ...................................................................... 11 3. IDENTIFICATION OF POSSIBLE ALTERNATIVES ................................................................... 11 3.1. Description of efforts made to identify possible alternatives .......................................................................11 3.1.1. Research and development ........................................................................................................................... 11 3.1.2. Data searches ................................................................................................................................................ 11 3.1.3. Consulting ...................................................................................................................................................... 13 3.2. List of potential alternatives ........................................................................................................................13 4. SUITABILITY AND AVAILABILITY OF POSSIBLE ALTERNATIVES ................................... 16 4.1. ALTERNATIVE 1 ............................................................................................................................................16 4.2. ALTERNATIVE 2 ............................................................................................................................................16 4.3. ALTERNATIVE 3 ............................................................................................................................................16 4.4. ALTERNATIVE 4 ............................................................................................................................................16 4.5. ALTERNATIVE 5 ............................................................................................................................................16 4.6. ALTERNATIVE 6 ............................................................................................................................................17 5. OVERALL CONCLUSIONS ON SUITABILITY AND AVAILABILITY OF POSSIBLE ALTERNATIVES FOR USE 3 .................................................................................................................... 18 5.1. Conclusion on the technical feasibility of commercially proven alternatives ...............................................18 5.2. Conclusion on the economic feasibility of commercially proven alternatives ..............................................18 5.3. Conclusion on risk reduction potential of commercially proven alternatives ...............................................18 5.4. Overall conclusion........................................................................................................................................19 ii ANALYSIS OF ALTERNATIVES FIGURES Figure 1: Description of production ceramic chip capacitors-part 1 (Johanson Dielectrics) .............. 4 Figure 2 Description of production ceramic chip capacitors-part 2 (Johanson Dielectrics) ................ 4 Figure 3: Description of production ceramic chip capacitors (Lee, 2008) ......................................... 5 Figure 4: The principle of ceramic slurry preparing ........................................................................... 6 Figure 5: Manufacture dielectric paste and sheet formation (TDK, 2008) ......................................... 6 Figure 6: Electrode printing and sheet layering (TDK, 2008) ............................................................ 7 Figure 7: Cutting and sintering ............................................................................................................ 7 Figure 8: Application of terminal electrode, inspection and packaging (TDK, 2008) ........................ 8 Figure 9: The structure of ceramic capacitor (With, 1993; He, 2004) ................................................. 8 TABLE Table 1. Parameters for DEHP use in the manufacture of ceramic types .......................................... 10 Table 2. Key information sources used in the identification of potential alternatives ....................... 12 Table 3. Key information sources used in the collection of information on the properties of potential alternatives ......................................................................................................................................... 12 Table 4. Identities and REACH registration status of alternative substances .................................... 14 Table 5. Comparison of selected potential alternative substances against key technical comparison criteria ................................................................................................................................................ 15 iii ANALYSIS OF ALTERNATIVES 1. SUMMARY 1.1. Background to this Application for Authorisation 1.1.1. Applicant and Uses This Analysis of Alternatives constitutes part of the Application for Authorisation (AoA) submitted by DEZA, a.s. The substance of concern is bis(2-ethylhexyl) phthalate (hereafter referred to as DEHP), EC Number 204-211-0, CAS Number 117-81-7. The manufacture of DEHP takes place at DEZA, a.s., Valašské Mezi říčí, The Czech Republic. DEHP is used as a plasticiser in slurry for ceramic sheets and printing pastes manufacture and the uses for which Authorisation is sought is: 1. Use in ceramic sheets and printing pastes for production of capacitors and lambda sensor elements. The hazard profile of DEHP, together with the potential risks that this substance may pose, has been the subject of extensive expert assessment including a European risk assessment report (EU RAR 2008, Danish EPA 2011). This assessment reached a number of conclusions which indicated that concern was warranted with regard to human exposures (including workers, consumers and from exposure via the environment) and some environmental compartments. DEHP was included in the candidate list for Authorisation following ECHA’s decision ED/67/2008 on 28 October 2008, based upon its classification as Toxic to Reproduction, Category 2 (i.e. Category 1B, under CLP); this was based largely on information from the EU RAR, supplemented by limited additional information (ECHA 2008). DEHP was further reviewed in a background document prepared in support of its inclusion in Annex XIV (ECHA 2009), again drawing on the EU RAR together with data submitted by COWI, IOM and Entec and RCOM. Since DEHP met the criteria in Article 57(c) and, according to available information, it was possible to determine a toxicological threshold, it was noted that if the risks to human health from the use of the substance arising from its toxicity to reproduction were to be demonstrated to be adequately controlled in accordance with Section 6.4 of Annex I and that this was documented in the applicant’s chemical safety report (CSR), an authorisation would be granted in accordance with Article 60(2) (‘adequate control route’); if not, an authorisation would be granted in accordance with Article 60(4) (‘socio-economic route’). Alongside the Authorisation process, the Danish authorities submitted in 2011 a proposal for a restriction (together with the justification and background information documented in an Annex XV dossier) on the placing on the market and use of certain articles containing four classified phthalates (DEHP, benzyl butyl phthalate (BBP), dibutyl phthalate (DBP) and diisobutyl phthalate (DIBP)) in articles that are intended for indoor use, or in articles that come into contact with skin or mucous membranes, on the grounds of the aforementioned Toxic to Reproduction, Category 1B CLP classification. The Annex XV report conforming to the requirements of the REACH Regulation was made publicly available by ECHA on 16/09/2011. The final opinions of the ECHA Committees (i.e. the Committee for Risk Assessment
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