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Institute for Health and European List of Notified Consumer Protection Chemical Substances European In support of Chemicals Directive 92/32/EEC, Bureau th the 7 amendment to Directive 67/548/EEC 1 EUR 22543 EN The mission of the IHCP is to provide scientific support to the development and implementation of EU polices related to health and consumer protection. The IHCP carries out research to improve the understanding of potential health risks posed by chemical, physical and biological agents from various sources to which consumers are exposed. The Toxicology and Chemical Substances Unit (TCS), commonly known as the European Chemicals Bureau (ECB), provides scientific and technical input and know-how to the conception, development, implementation and monitoring of EU policies on dangerous chemicals including the coodination of EU Risk Assessments. The aim of the legislative activity of the ECB is to ensure a high level of protection for workers, consumers and the environment against dangerous chemicals and to ensure the efficient functioning of the internal market on chemicals under the current Community legislation. It plays a major role in the implementation of REACH through development of techncial guidance for industry and new chemcials agency and tools for chemcial dossier registration (IUCLID5). The TCS Unit ensures the development of methodologies and software tools to support a systematic and harmonised assessment of chemicals addressed in a number of European directives and regulation on chemcials. The research and support activities of the TCS are executed in close co-operation with the relevant authorities of the EU MS, Commission services (such as DG Environment and DG Enterprise), the chemical industry, the OECD and other international organisations. European Commission Directorate-General Joint Research Centre Institute of Health and Consumer Protection (IHCP) European Chemicals Bureau (ECB) Contact information: Institute of Health and Consumer Protection (IHCP) Address: Via E. Fermi 1 – 21020 Ispra (Varese) – Italy E-mail: [email protected] Tel.: +39 0332 785959 Fax: +39 0332 785730 http://ihcp.jrc.cec.eu.int/ European Chemicals Bureau (ECB) E-mail: [email protected] http://ecb.jrc.it/ Directorate-General Joint Research Centre http://www.jrc.cec.eu.int Legal Notice Neither the European Commission nor any person acting on behalf of the Commission is responsible for the use which might be made of the following information. A great deal of additional information on the European Union is available on the Internet. It can be accessed through the Europa Server (http://europa.eu.int). EUR 22543 EN ISSN 1018-5593 Luxembourg: Office for Official Publications of the European Communities, 2006 © European Communities, 2006 Reproduction is authorised provided the source is acknowledged. Printed in Italy 2 FOREWORD TO ELINCS Publication In accordance with Commission Decision 85/71/EEC1 [pursuant to Directive 92/32/EEC, the 7th amendment to Directive 67/548/EEC2 (hereinafter "the Directive") on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances] the European LIst of Notified Chemical Substances (ELINCS) has been established with publication in the Official Journal of the European Union (OJ). A 5th edition of ELINCS, compiling substances notified in accordance with the Directive until 30th June 1995, is the last available update published in the OJ3. A 6th edition, comprehensive of substances notified until 30th June 1998, and published in all EU languages as a Commission document, is available on-line via Europa EUR-Lex address: http://europa.eu.int/eur-lex/, located under ‘Documents of public interest’ with reference: COM(2003) 642, dated 29.10.2003. Due to resource limitations on translating chemical names into all official EU languages, ELINCS is currently maintained in English language only, and published only as an internet document via ECB address: http://ecb.jrc.it/new-chemicals/, where the latest update replaces previous versions. Pending any eventual resumption of official printing of further ELINCS updates, the current version is indicated with compilation date, rather than edition number. However, allocation of resources for translation of chemical names, requisite for publication in the OJ, is not currently projected. ELINCS supplements the European INventory of Existing Commercial Substances (EINECS)4, which lists reported substances on the EU market before 18 September 1981. While EINECS is a definitive inventory of substances exempt from notification, ELINCS does not create analogous exemptions. An original notification is generally designated as file leader for the substance. Additional suppliers of notified substances to the EU market are liable to repeat notification, in accordance with the Directive. However, when a substance has already been notified, it is recommended for animal welfare, that the repeat notifier (with approval of a Competent Authority) make reference to assays reported in previous notifications, assuming written agreement from the previous notifier. Explanatory Detail Numbers EC Number (analogous to a bar code) is unique to each substance, allocated by the Commission. Registration Number (chronological per member state) is unique to each notification, allocated by a Competent Authority. For multiple notifications of the same substance, the original dossier is designated file leader. 1 OJ L 30, 2.2.1985, p. 33 2 OJ 196, 16.8.1967, p. 1 [Directive 7th amendment: OJ L 154, 5.6.1992, p. 1] 3 OJ C 72, 11.3.2000, p. 1 4 OJ C 146 A, 15.6.1990, p. 1 3 ELINCS tabulates substances by EC number, corresponding to single substance entries, listing repeat notifications beginning with the file leader. The registration number has standard format: xx-xx-xxxx. The first two digits represent year of notification, the next two indicate country of notification, and the last four digits allow sequential numbering of individual dossiers respective of the country. The two digit country codes refer to member states (and Norway) as follows: 01. France (FR) 10. Greece (GR) 19. Cyprus (CY) 02. Belgium (BE) 11. Spain (ES) 20. Latvia (LV) 03. Netherlands (NL) 12. Portugal (PT) 21. Lithuania (LT) 04. Germany (DE) 13. Finland (FI) 22. Hungary (HU) 05. Italy (IT) 14. Austria (AT) 23. Malta (MT) 06. United Kingdom (UK) 15. Sweden (SE) 24. Poland (PL) 07. Ireland (IE) 16. Norway (NO) 25. Slovenia (SI) 08. Denmark (DK) 17. Czech Rebublic (CZ) 26. Slovakia (SK) 09. Luxembourg (LU) 18. Estonia (EE) Identification Each substance is identified, either by trade name(s) and chemical name, or by trade name(s) only. The latter is applicable when confidentiality has been granted by a Competent Authority, upon request of a notifier, to protect commercial sensitivity. ELINCS includes all trade names registered for a substance. Chemical names are cited according to the rules of the International Union of Pure and Applied Chemistry (IUPAC). Where allocation of a precise IUPAC name is not possible (e.g., substance composition not completely defined), a name is assigned according to EINECS reporting rules (Manual of Decisions section 2). In practice, options are available to notifiers (subject to CA approval) determining level of confidentiality to be respected in publishing substance identities in ELINCS, indicated in notification summaries as follows: Non-Classified substances A. IUPAC name and trade name. B1. Trade name only for period of 1year. B2. Trade name only for period of 2 years. B3. Trade name only for period of 3 years. C. Trade name only for an indefinite period, for reasons of commercial secrecy. Classified substances D. IUPAC name and trade name. E. Trade name only, pending inclusion of substance in Annex I of Directive. 4 Options C and E, respective of non-classified and classified substances, would frequently be favourable choices for notifiers. ELINCS conventions: components versus impurities In general, ‘substance’ refers to a product obtained from a chemical process, which may include distinct components (and/or impurities) present as a reaction mixture. By contrast, ‘preparation’ refers to a blend of substances, integrated in measured proportions. Typically, reaction mixtures would comprise isomers or generically related species as components, while preparations would include solvents or other substances combined as a formulation appropriate for storage, transport, marketing, use application, etc. ELINCS lists substances only. Formulated preparations are not listed. ELINCS defines substance components as molecules present at >10%. An individual molecule present at >80% defines a single component substance, listed as that one molecule name only. Individual molecules present in the range >10% to <80% define components of a reaction mixture substance, listed with all component molecule names. Impurities, defined as individual molecules present at <10%, are not listed in ELINCS unless significant contribution is made to the substance classification. Percentage compositions are obtained by reference to notification summaries prepared using Data Entry Screens (DES) software, so-called SNIF (Structured Notification Interchange Format) files. Classification ELINCS quotes substance classifications from official source only (Annex I to the Directive) with insertion of recent classifications in updated editions, as available from official update of the Annex I list of classified substances. Substances unofficially classified,
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