EUROPEAN LIST OF NOTIFIED CHEMICAL …

1 EUR 23923 EN - 2009 EUROPEAN LIST OF NOTIFIED CHEMICAL SUBSTANCES ELINCS In support of Directive 92/32/EEC, the 7th amendment to Directive 67/548/EEC Baraibar Fentanes Joaquin / Olsson Heidi / Sokull-Kl ttgen Birgit The mission of the JRC-IHCP is to protect the interests and health of the consumer in the framework of EU legislation on chemicals, food, and consumer products by providing scientific and technical support including risk-benefit assessment and analysis of traceability. EUROPEAN Commission Joint Research Centre Institute for Health and Consumer Protection Contact information IHCP Communication Address: Via E. Fermi 2749 21027 Ispra (Varese) - Italy E-mail: Tel.: +39 0332 789111 Fax: +39 0332 789059 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 this publication. Europe Direct is a service to help you find answers to your questions about the EUROPEAN Union Freephone number (*): 00 800 6 7 8 9 10 11 (*) Certain mobile telephone operators do not allow access to 00 800 numbers or these calls may be billed.

2 A great deal of additional information on the EUROPEAN Union is available on the Internet. It can be accessed through the Europa server JRC C52455 EUR 23923 EN ISSN 1018-5593 Luxembourg: Office for Official Publications of the EUROPEAN Communities EUROPEAN Communities, 2009 Reproduction is authorised provided the source is acknowledged Printed in Italy 3 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.

3 A 6th edition, comprehensive of substances NOTIFIED until 30th June 1998, and published as a Commission document, is available on-line via Europa EUR-Lex address: , located under COM documents - Direct access to PDF documents by searching for COM(2003) 642, dated Due to resource limitations on translating CHEMICAL names into all official EU languages, thereafter ELINCS was maintained in the English language only, and published only as an internet document by the EUROPEAN Chemicals Bureau (ECB)4: , where the latest update replaces previous versions. The current version is indicated with compilation date, rather than edition number. ELINCS supplements the EUROPEAN INventory of Existing Commercial Substances (EINECS)5, which lists reported substances on the EU market before 18th September 1981. While EINECS is a definitive inventory of substances exempt from notification, ELINCS does not create analogous exemptions.

4 An original notification is generally designated as file leader for the substance. Additional suppliers of NOTIFIED substances to the EU market were liable to repeat notification, in accordance with the Directive. This final edition of ELINCS is comprehensive of all NOTIFIED substances, concluded by expiry of the Directive on 31st May 2008. On 1st June 2008 the notification scheme was revoked and replaced by Regulation (EC) No 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)6. Transitional arrangements regarding new NOTIFIED substances are laid down in Articles 24 and 135 of the REACH Regulation. These articles stipulate that a notification in accordance with Directive 67/548/EEC and which have been found conforming to the Directive shall be regarded as a registration under REACH. New manufacturers/importers of NOTIFIED substances to the EU market are required to submit a registration in accordance with the REACH Regulation.

5 In order to facilitate data sharing, avoid unnecessary testing and enable the preparation of a joint registration these new manufacturers/importers have the duty to inquire prior to registration (REACH Article 26). 1 OJ L 30, , p. 33 2 OJ 196, , p. 1 [Directive 7th amendment: OJ L 154, , p. 1] 3 OJ C 72, , p. 1 4 ECB coordination of the notification scheme formally terminated on with implementation of REACH and transfer of responsibility to the EUROPEAN Chemicals Agency 5 OJ C 146 A, , p. 1 6 OJ L 396, , p. 1 [Corrigenda: OJ L 136, ] 4 Explanatory Detail 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.

6 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) 11. Spain (ES) 21. Lithuania (LT) 02. Belgium (BE) 12. Portugal (PT) 22. Hungary (HU) 03. Netherlands (NL) 13. Finland (FI) 23. Malta (MT) 04. Germany (DE) 14. Austria (AT) 24. Poland (PL) 05. Italy (IT) 15. Sweden (SE) 25. Slovenia (SI) 06. United Kingdom (UK) 16. Norway (NO) 26. Slovakia (SK) 07. Ireland (IE) 17. Czech Republic (CZ) 27. Bulgaria (BG) 08. Denmark (DK) 18. Estonia (EE) 28. Romania (RO) 09. Luxembourg (LU) 19. Cyprus (CY) 10. Greece (GR) 20.

7 Latvia (LV) 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 ( , substance composition not completely defined), a name is assigned according to EINECS reporting rules (Manual of Decisions section 27). The 7th Amendment of the Directive defines substances "as CHEMICAL elements and their compounds in the natural state or obtained by any production process, including any additive necessary to preserve the stability of the products and any impurity deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition".

8 The substance definition in REACH is equal. In both cases the definition goes beyond a pure CHEMICAL compound defined by a single molecule. By contrast, preparation refers to a mixture or solution composed of two or more substances. ELINCS lists substances only. 7 The 'Manual of Decisions for implementation of the sixth and seventh amendments to Directives 67/548/EEC on dangerous substances (Directives 79/831/EEC and 92/32/EEC) non-confidential version ( ), EUR 22311' can be downloaded free of charge from the following web-site: 5 By convention for ELINCS, substance components8 are defined as molecules present at 10%. Impurities are defined as molecules present at < 10%. An individual molecule present at 80% defines a single component substance9, listed in ELINCS as that one molecule name only. Individual molecules present in the range 10% to < 80% define components of a reaction mixture substance10, listed with all component molecule names.

9 In previous versions of ELINCS such a substance was named as "mixture of ..". In order to harmonise the naming with the 'Guidance for identification and naming of substances under REACH'11 in this version such a substance is named as "reaction mass of ..". Impurities are not listed in ELINCS as part of the substance name unless significant contribution is made to the substance hazard classification. Level of confidentiality In practice, options are available to notifiers (subject to Competent Authority 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.

10 IUPAC name and trade name. E. trade name only, pending inclusion of substance in Annex I of Directive. Options C and E, respective of non-classified and classified substances, would frequently be favourable choices for notifiers. 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, pending formal vote for entry into Annex I, are identified with an asterisk. 8 The 'Guidance for identification and naming of substances under REACH' uses the wording "constituent". 9 The 'Guidance for identification and naming of substances under REACH' uses the wording "mono-constituent substance". 10 The 'Guidance for identification and naming of substances under REACH' uses the wording "multi-constituent substance".