COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT - Sixth publication of Elincs (according to Article 21 of Directive 67/548/EEC)

COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT - Sixth publication of Elincs (according to Article 21 of Directive 67/548/EEC)

(Text with EEA relevance)

In accordance with Commission Decision 85/71/EEC of 21 December 1984 [1] the list of chemical substances notified pursuant to Directive 67/548/EEC [2] (hereinafter "the Directive") on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (Elincs) has been established and appears in this Official Journal of the European Union.

[1] OJ L 30, 2.2.1985, p. 33.

[2] OJ 196, 16.8.1967, p. 1. Directive last amended by Directive 2001/59/EC (OJ L 225, 21.8.2001, p. 1).

This list replaces the previous list [3] and consists of all the chemical substances notified up to 30 June 1998 in accordance with Article 7 of the Directive.

[3] OJ C 72, 11.3.2000, p. 1.

This list supplements the European Inventory of Existing Commercial Chemical Substances (Einecs) published on 15 June 1990 [4], which lists all substances placed on the market up to 18 September 1981. Apart from the exceptions provided for in Articles 1 and 13 of the Directive, all substances placed on the Community market or, in the case of a new substance, notified no later than 30 June 1998, including those which are components of preparations, appear in either Einecs or Elincs.

[4] OJ C 146 A, 15.6.1990, p. 1.

Apart from the above mentioned exceptions, substances placed on the market which do not appear in either Einecs or Elincs must have been notified or must be notified in accordance with the Directive, and will be included in an update of Elincs.

The presence of a substance in Elincs nevertheless does not dispense any new importer and/or new manufacturer placing it on the Community market from notifying it in accordance with the Directive. However, if the substance has already been notified, the competent authority may accept that the new notifier refer, as far as the technical dossier is concerned, to the results of studies carried out by a previous notifier or notifiers, with his or their written agreement, in particular to avoid as far as possible the repetition of tests using vertebrate animals.

In accordance with Decision 85/71/EEC, the classification of these substances is included in Elincs only if it has been officially adopted at Community level and therefore appears in Annex I to the Directive. The other dangerous substances on the list, provisionally classified by the notifier, are in the process of being officially classified, and the official classification will be included in an update of Elincs.

Commission communication pursuant to Article 2 of Commission Decision 85/71/EEC of 21 December 1984 concerning the list of chemical substances notified pursuant to Council Directive 67/548/EEC on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances

Elincs (European list of notified chemical substances)

EXPLANATORY NOTE

The European list of notified chemical substances (Elincs) is published pursuant to Commission Decision 85/71/EEC [5]. It consists of all chemical substances notified within the European Community up to 30 June 1998, pursuant to Article 7 of Directive 67/548/EEC [6] (hereinafter "the Directive"). It is planned to update the list annually.

[5] OJ L 30, 2.2.1985, p. 33.

[6] OJ 196, 16.8.1967, p. 1. Directive last amended by Directive 2001/59/EC (OJ L 225, 21.8.2001, p. 1).

Each entry in the list corresponds to one chemical substance. However, many dossiers have been submitted by one or more importers and/or manufacturers.

For each substance, the following information is provided, if relevant and if not confidential:

(a) Numbers

EC number: // number allocated by the Commission of the European Communities

Dossier numbers: // file leader dossier number first (number of first dossier received for the substance, in application of Article 7 of the Directive, by any Member State), followed by all other dossier numbers.

The dossier number has the following standard structure: xx - xx - xxxx.

The two first digits represent the year of notification, the next two indicate the Member State where the substance has been notified and the last four digits represent the number of the dossier in the chronological order in which it was received within the country concerned. Codes of the different Member States are as follows: 01: France; 02: Belgium; 03: The Netherlands; 04: Germany; 05: Italy; 06: United Kingdom; 07: Ireland; 08: Denmark; 09: Luxembourg; 10: Greece; 11: Spain; 12: Portugal; 13: Finland; 14: Austria; 15: Sweden; 16: Norway.

(b) Identification of the substance

According to the Annex to Decision 85/71/EEC, each substance is identified by its trade name(s) and its chemical name or by its trade name(s) only if confidentiality has been granted to the latter by one competent authority, upon request of one notifier, for reasons of commercial secrecy.

Taking into account the above paragraph, the following identification sections are given in the list, for each substance:

Trade name(s): all trade names under which the substance is marketed within the Community market.

Chemical name: generally this is the name of the substance according to the rules of the International Union of Pure and Applied Chemistry (IUPAC). If it is not possible to allocate a precise chemical name (e.g. if the substance is not completely defined), a name has been allocated according to the rules defined for the identification of such substances in the European Inventory of Existing Commercial Chemical Substances (Einecs) [7]. Some chemical names listed in the fifth publication of Elincs( [8] were amended according to the notification and the IUPAC nomenclature rules.

[7] OJ C 146 A, 15.6.1990, p. 1.

[8] OJ C 72, 11.3.2000, p. 1.

- An Elincs entry will be regarded as a (mono-)substance, when the main component is present at a level of 80% or more (SNIF( [9],Section 1.1.00: mixture "no"). The substance will be listed in Elincs with the name of the (mono-)substance, only.

[9] Summary Notification Interchange Format.

- An Elincs entry will be a regarded as a mixture, when the main component is present at a level of less than 80% (SNIF, Section 1.1.00: mixture "yes"). All components present at levels of at least 10% will be listed in Elincs.

If there is no indication of the contrary, minor components and impurities are not mentioned in Elincs. In any case they will also appear in the identification section, if they contribute significantly to the classification of the substance.

These rules have been applied to all notifications and notification updates since the forth publication of Elincs. The systematic examination of all Elincs entries is under way.

(c) Classification

Classification as published in Annex I to the Directive for the substance in question.

This section is only filled in if the substance has obtained a harmonised classification at Community level according to Article 4 of the Directive and its classification has been published in Annex I to this Directive.

Where the substance is classified as dangerous, but has not yet entered in Annex I, an asterisk is placed in this section.

Note:

For labelling of the substance, refer to the rules laid down in the Directive, in particular Articles 4 and 23 and Annex VI (General classification and labelling requirements for dangerous substances and preparations).

ANNEX

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