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Study on IT Tools to Assist the Development of Chemical Safety Reports

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Study on IT Tools to Assist the Development of Chemical Safety Reports Ref. Ares(2014)74858 - 15/01/2014 European Commission DG Enterprise and Industry Study on IT tools to assist the development of Chemical Safety Reports Glossary Final version, 9/10/2007 Study on IT tools to assist the development of Chemical Safety Reports Glossary TABLE OF CONTENTS 1. INTRODUCTION 6 1.1 Purpose 6 1.2 References 6 1.3 Overview 8 2. ABBREVIATIONS AND ACRONYMS 9 2.1 Domain abbreviations and acronyms 9 2.2 Commission specific abbreviations and acronyms 15 2.3 Technical abbreviations and acronyms 16 3. BUSINESS DEFINITIONS 22 3.1 Actors in the supply chain 22 3.2 Agency 22 3.3 Animal testing 22 3.4 Annex XV 22 3.4.1 Annex XV dossier 22 3.4.2 Annex XV format 22 3.5 Applicant 23 3.6 Article 23 3.7 Authorisation 23 3.8 Category 23 3.9 Chemical category 23 3.10 Chemical 23 3.11 Chemical Safety Report (CSR) 23 3.12 Company 24 3.13 Legal Entity 24 3.14 Legal entity site 24 3.15 Competent Authority 24 3.16 Computer modelling 24 3.17 Confidentiality 24 3.17.1 Confidential Business Information 24 3.17.2 Intellectual Property 25 3.17.3 Confidential data 25 3.17.4 Non-confidential data 25 3.18 Consortium 25 3.19 Data holder 25 3.20 Dossier 25 3.20.1 Contextual data 25 Final version - 09/10/2007 2/50 Study on IT tools to assist the development of Chemical Safety Reports Glossary 3.21 Downstream user 26 3.22 End point 26 3.23 Evaluation 26 3.24 Exposure 26 3.25 Exposure scenario 27 3.26 Glossary 29 3.27 Group of substances 29 3.27.1 Category 29 3.27.2 Category Matrix 29 3.27.3 Group 29 3.27.4 Set 29 3.28 Importer 30 3.29 Information requirement 30 3.30 Intermediates 30 3.31 In vitro testing 30 3.32 Inventory 30 3.32.1 EC inventory 30 3.33 IUCLID 4 31 3.33.1 Data set 31 3.33.2 Export file 32 3.33.3 Harmonised data set 32 3.33.4 Subchapter 32 3.34 IUCLID 5 32 3.34.1 Endpoint 32 3.34.2 Endpoint study 32 3.34.3 Endpoint study description 32 3.34.4 Endpoint study type 32 3.34.5 Endpoint study record 32 3.35 Joint submission 33 3.35.1 Joint submission leader 33 3.36 Letter of access 33 3.37 Manufacturer 33 3.38 Member State Competent Authority 33 3.39 M/I/R 33 3.40 M/I/R/DU 33 3.41 Nomenclature 34 3.42 Only representative 34 3.43 Preparation 34 3.44 Mixture 34 3.45 Quantitative Structure Activity Relationship (QSAR) 35 3.46 REACH Implementation Project (RIP) 35 3.47 Registrant 35 3.47.1 Potential registrant 35 3.47.2 Previous registrant 35 Final version - 09/10/2007 3/50 Study on IT tools to assist the development of Chemical Safety Reports Glossary 3.48 Registration 35 3.48.1 Registration dossier 35 3.49 Restriction 36 3.50 Risk 36 3.51 Robust Study Summary (RSS) 36 3.52 Safety data sheet (SDS) 36 3.53 Studies 36 3.53.1 Robust Study Summary 36 3.53.2 Study Summary 37 3.53.3 Study Report 37 3.53.4 Key study 37 3.54 Submission 37 3.55 Substance 38 3.55.1 Alloy 38 3.55.2 Biocide (Biocidal product) 38 3.55.3 CMR (Carcinogenic, Mutagenic or toxic to Reproduction) 38 3.55.4 Composition profile 38 3.55.5 Endocrine disrupters 38 3.55.6 Existing substance 38 3.55.7 Intermediate 39 3.55.8 Intrinsic property (of a substance) 39 3.55.9 New substance 39 3.55.10 Not chemically modified substance 40 3.55.11 Notified substance 40 3.55.12 PBT (Persistent, Bio-accumulative and Toxic) 40 3.55.13 Pesticide 40 3.55.14 Phase-in substance 40 3.55.15 Polymer 40 3.55.16 POP (Persistent Organic Pollutant) 41 3.55.17 PPORD (Product and process orientated research and development) 41 3.55.18 Spectra 41 3.55.19 Substances in articles 41 3.55.20 Substance which occur in nature 42 3.55.21 Sunset date 42 3.55.22 SVHC (Substance of Very High Concern) 42 3.55.23 VPVB (Very Persistent Very Bio-accumulative) 42 3.56 Substance definition 42 3.57 Reference Substance 42 3.58 Substitution 42 3.59 Technical dossier 43 3.60 Technical Expert Working Groups 43 3.61 Tonnage threshold 43 3.62 Toxicity 43 3.63 Use 43 3.63.1 Registrant’s own use 43 3.63.2 Identified use 43 4. TECHNICAL AND IT-RELATED DEFINITIONS 44 Final version - 09/10/2007 4/50 Study on IT tools to assist the development of Chemical Safety Reports Glossary 4.1 Communication network 44 4.1.1 Intranet 44 4.1.2 Extranet 44 4.2 Data exchange 44 4.2.1 Marshalling 44 4.2.2 Unmarshalling 44 4.3 Interface 44 4.4 Internationalisation 44 4.5 Locale 45 4.6 Localisation 45 4.7 Security 45 4.7.1 Authentication 45 4.7.2 Certification Authority 45 4.7.3 Confidentiality 45 4.7.4 Digital certificate 45 4.7.5 Digital signature 46 4.7.6 Integrity 46 4.7.7 Key pair 46 4.7.8 Message authentication 46 4.7.9 Non repudiation 46 4.7.10 Private key 46 4.7.11 Public key 46 4.8 Workflow 46 4.8.1 Notification 47 4.9 XML 47 4.9.1 Schematron 47 5. UML STEREOTYPES 48 5.1 RUP stereotypes 48 5.2 Additional stereotypes 49 Final version - 09/10/2007 5/50 Study on IT tools to assist the development of Chemical Safety Reports Glossary 1. INTRODUCTION 1.1 Purpose The present document is produced in the framework of the “Study on IT tools to assist the development of Chemical Safety Reports” governed by contract n° 30-CE-0123621/00-47 between the Commission (DG Enterprise) and the Trasys-TechniData Consortium (E- Techemia). The purpose of this Glossary is to provide a common and unified terminology to the project. 1.2 References References to external documents or information are enumerated in this section. When mentioning such a reference in the present document, the “Reference ID” value will be used, like in [REACH], which refers to the REACH Regulation or [REACH, 9 (1)], which refers to Article 9, Paragraph 1 of that document. (Article references in quotes from the Regulation are kept as in the original text, not using this notation). Table 1-1 External References Reference ID Description [REACH_Q&A] “Q and A on the new Chemicals policy REACH” Date: 29/11/2003. http://europa.eu.int/rapid/start/cgi/guesten.ksh?p_action.getfile=gf&doc= MEMO/03/213|0|RAPID&lg=EN&type=PDF [WP_CHEM] “WHITE PAPER Strategy for a future Chemicals Policy” http://europa.eu.int/eur-lex/en/com/wpr/2001/com2001_0088en01.pdf [OECD_HPV] “Manual for investigation of HPV chemicals” September 2004 http://www.oecd.org/document/7/0,2340,en_2649_201185_1947463_1_1 _1_1,00.html (last accessed 13-06-2007) [RAC, 1995] “Risk Assessment of chemicals: An Introduction” Edited by C.J. van Leeuwen and J. L. M. Hermans; Published by Cluver Academy Publishers, 1995 [JRC, 2003] “Report of JRC Expert Group on Chemical Intermediates” Brussels, 23 January 2003; BSS/DS (2003) 1187B Final version - 09/10/2007 6/50 Study on IT tools to assist the development of Chemical Safety Reports Glossary Reference ID Description [REACH] “REGULATION (EC) No 1907/2006 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC” http://eur-lex.europa.eu/JOHtml.do?uri=OJ:L:2006:396:SOM:EN:HTML and http://eur- lex.europa.eu/LexUriServ/site/en/oj/2006/l_396/l_39620061230en000108 49.pdf Table 1-2 Technical references Reference Description [CRYPT] “Cryptography decrypted” H.X.Mel and D. Baker; Addison-Wesley, 2001, ISBN 0-201-61747-5 [PKI_GLOSS] “A Glossary of Common PKI Terms” http://www.tbs-sct.gc.ca/pki-icp/beginners/glossary/glossary_e.asp (last accessed 13-06-2007) [WFMC_GLOSS] “Workflow Management Coalition – Terminology & Glossary” Doc. Number: WFMC-TC-1011; Doc. Status: Issue 3.0 http://www.wfmc.org/standards/docs/TC-1011_term_glossary_v3.pdf (last accessed 13-06-2007) [Dictionary.com] The “Dictionary.com” web site http://dictionary.reference.com [UML] “The Unified Modeling Language User Guide” Grady Booch, James Rumbaugh and Ivar Jacobson; Addison-Wesley; 1998 [RUP] IBM Rational Unified Process, version 2003.06.13 http://www.ibm.com/developerworks/rational/products/rup/ (last accessed 13-06-2007) Table 1-3 IUCLID 4 references Reference Description [IUCLID_GUID] “IUCLID Guidance Document”, Version 1.1, 14 December 2000 Prepared on behalf of the European Chemical Industry Council (CEFIC) by the Fraunhofer Institute of Toxicology and Aerosol Research. Final version - 09/10/2007 7/50 Study on IT tools to assist the development of Chemical Safety Reports Glossary Reference Description [IUCLID_GS] “IUCLID 4.0 Getting Started”, Version 1 Prepared on behalf of the European Commission JRC by TechniData.
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