Editorial Information
X1Substituted by Corrigendum to 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 (Official Journal of the European Union L 396 of 30 December 2006).
The name is the same as that used for the substance in Annex I to Directive 67/548/EEC. Whenever possible dangerous substances are designated by their EINECS (European Inventory of Existing Commercial Chemical Substances) or ELINCS (European List of Notified Chemical Substances) names. These are referred to as EC numbers in the table. Other entries not listed in EINECS or ELINCS are designated using an internationally recognised chemical name (e.g. ISO, IUPAC). An additional common name is included in some cases.
The index number is the identification code given to the substance in Annex I of Directive 67/548/EEC. Substances are listed in the Appendix according to this index number.
For each substance listed in the EINECS there is an identification code. The code starts at 200-001 8.
For each new substance notified under the Directive 67/548/EEC an identification code has been defined and published in the ELINCS. The code starts at 400-010-9.
Chemical Abstracts Service (CAS) numbers have been defined for substances to help in their identification.
The full text of the notes can be found in the Foreword of Annex I to Directive 67/548/EEC.
The notes to be taken into account for the purposes of this Regulation are the following:
The name of the substance must appear on the label in the form of one of the designations given in Annex I to Directive 67/548/EEC (see Article 23(2)(a) of that Directive).
In Annex I to Directive 67/548/EEC, use is sometimes made of a general description such as ‘ … compounds ’ or ‘ … salts ’ . In this case, the manufacturer or any other person who places such a substance on the market is required to state on the label the correct name, due account being taken of the Chapter entitled ‘ Nomenclature ’ of the Foreword to that Annex.
Directive 67/548/EEC also requires that the symbols, indications of danger, R- and S-phrases to be used for each substance shall be those shown in Annex I to that Directive (Article 23(2)(c), (d) and (e) of that Directive).
For substances belonging to one particular group of substances included in Annex I to Directive 67/548/EEC, the symbols, indications of danger, R- and S-phrases to be used for each substance shall be those shown in the appropriate entry in that Annex.
For substances belonging to more than one group of substances included in Annex I to Directive 67/548/EEC, the symbols, indications of danger, R- and S-phrases to be used for each substance shall be those shown in both the appropriate entries given in that Annex. In cases where two different classifications are given in the two entries for the same hazard, the classification reflecting the more severe hazard classification shall be used.
Some organic substances may be marketed either in a specific isomeric form or as a mixture of several isomers.
Certain substances which are susceptible to spontaneous polymerisation or decomposition are generally placed on the market in a stabilised form. It is in this form that they are listed in Annex I to Directive 67/548/EEC.
However, such substances are sometimes placed on the market in a non-stabilised form. In this case, the manufacturer or any person who places such a substance on the market must state on the label the name of the substance followed by the words ‘ non-stabilised ’ .
Substances with specific effects on human health (see chapter 4 of Annex VI of Directive 67/548/EEC) that are classified as carcinogenic, mutagenic and/or toxic for reproduction in categories 1 or 2 are ascribed Note E if they are also classified as very toxic (T+), toxic (T) or harmful (Xn). For these substances, the risk phrases R20, R21, R22, R23, R24, R25, R26, R27, R28, R39, R68 (harmful), R48 and R65 and all combinations of these risk phrases shall be preceded by the word ‘ Also ’ .
The classification and label shown for this substance applies to the dangerous property(ies) indicated by the risk phrase(s) in combination with the category(ies) of danger shown. The requirements of Article 6 of Directive 67/548/EEC on manufacturers, distributors, and importers of this substance apply to all other aspects of classification and labelling. The final label shall follow the requirements of section 7 of Annex VI to Directive 67/548/EEC.
This note applies to certain coal- and oil-derived substances and to certain entries for groups of substances in Annex I to Directive 67/548/EEC.
The classification as a carcinogen need not apply if it can be shown that the substance contains less than 0,1 % w/w benzene (EINECS No 200-753-7).
The classification as a carcinogen or mutagen need not apply if it can be shown that the substance contains less than 0,1 % w/w 1,3-butadiene (EINECS No 203-450-8). If the substance is not classified as a carcinogen or mutagen, at least the S-phrases (2-)9-16 should apply. This note applies to certain complex oil-derived substances in Annex I to Directive 67/548/EC
The classification as a carcinogen need not apply if it can be shown that the substance contains less than 3 % DMSO extract as measured by IP 346.
The classification as a carcinogen need not apply if it can be shown that the substance contains less than 0,005 % w/w benzo[a]-pyrene (EINECS No 200-028-5).
The classification as a carcinogen need not apply if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen.
The classification as a carcinogen need not apply if it can be shown that the substance contains less than 0,1 % w/w benzene (EINECS No 200-753-7).
The classification as a carcinogen need not apply to fibres with a length weighted geometric mean diameter, less two standard errors, greater than 6μm.
This substance may not require a label according to Article 23 of Directive 67/548/EEC (see section 8 of Annex VI of that Directive).]