- Latest available (Revised)
- Point in Time (13/02/2006)
- Original (As adopted by EU)
Directive 1999/45/EC of the European Parliament and of the Council of 31 May 1999 concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations (repealed)
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Version Superseded: 01/01/2007
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Article 15 indicates the conditions in which the person responsible for placing a preparation on the market may avail himself of the confidentiality.
To avoid multiple requests for confidentiality relating to the same substance used in different preparations, a single request for confidentiality may suffice if a certain number of preparations have:
the same dangerous constituents present in the same concentration range,
the same classification and labelling,
the same expected uses.
A single alternative denomination must be used to mask the chemical identity of the same substance in the preparations concerned. Furthermore, the request for confidentiality must contain all information indicated in the following request, without forgetting the name or the trade name of each preparation.
The alternative designation used on the label must be the same as that given under heading 2 ‘Composition/information on ingredients’ of the Annex to Directive 91/155/EEC as last amended by Directive 93/112/EEC.
This implies that the alternative designation used will contain enough information about the substance to ensure risk-free handling.
In making the request to use an alternative designation the person responsible for placing on the market must take into account the need to provide enough information for necessary health and safety precautions to be taken in the workplace and to ensure that risks from handling the preparation can be minimised.
In accordance with Article 15 the request for confidentiality must obligatorily contain the following information:
Name and full address (including telephone number) of the person established in the Community who is responsible for placing the preparation on the market (manufacturer, importer or distributor).
Precise identification of the substance(s) for which confidentiality is proposed and the alternative designation.
NB: Where substances are classified provisionally, accompanying information (bibliographical references) should be provided as evidence that the provisional classification takes account of all existing pertinent information available on the properties of the substance. | |||
CAS No | Einecs No | Chemical name according to international nomenclature and classification (Annex I to Council Directive 67/548/EEC or provisional classification) | Alternative designation |
---|---|---|---|
(a) | |||
(b) | |||
(c) |
Justification for confidentiality (probability — plausibility).
Designation(s) or commercial name(s) of the preparation(s).
Is the designation or commercial name the same for all the Community?
YES ☐ | NO ☐ |
If no, specify the designation(s) or commercial name(s) used in the different Member States:
[F1Belgium:
Czech Republic:
Denmark:
Germany:
Estonia:
Greece:
Spain:
France:
Ireland:
Italy:
Cyprus:
Latvia:
Lithuania:
Luxembourg:
Hungary:
Malta:
Netherlands:
Austria:
Poland:
Portugal:
Slovenia:
Slovakia:
Finland:
Sweden:
United Kingdom:]
Composition of the preparation(s) defined in point 2 of the Annex to Directive 91/155/EEC as last amended by Directive 93/112/EEC.
Classification of the preparation(s) according to Article 6 of this Directive.
Labelling of the preparation(s) according to Article 10 of this Directive.
Intended uses for the preparation(s).
Safety data sheet(s) conforming to Directive 91/155/EEC as last amended by Directive 93/112/EEC.
Textual Amendments
F1 Substituted by Council Directive 2004/66/EC of 26 April 2004 adapting Directives 1999/45/EC, 2002/83/EC, 2003/37/EC and 2003/59/EC of the European Parliament and of the Council and Council Directives 77/388/EEC, 91/414/EEC, 96/26/EC, 2003/48/EC and 2003/49/EC, in the fields of free movement of goods, freedom to provide services, agriculture, transport policy and taxation, by reason of the accession of the Czech Republic, Estonia, Cyprus, Latvia, Lithuania, Hungary, Malta, Poland, Slovenia and Slovakia.
The lexicon guide is based on the procedure for the classification of dangerous substances (division of substances into families) which appears in Annex I to Directive 67/548/EEC.
Alternative designations to those based on this guide may be used. However, in all cases the names chosen must provide enough information to ensure the preparation can be handled without risk and that necessary health and safety precautions can be taken in the workplace.
The families are defined in the following manner:
inorganic or organic substances whose properties are identified by having a common chemical element as their chief characteristic. The family name is derived from the name of the chemical element. These families are identified as in Annex I by the atomic number of the chemical element (001 to 103),
organic substances whose properties are identified by having a common functional group as their chief characteristics.
The family name is derived from the functional group name.
These families are identified by the conventional number found in Annex I (601—650).
Sub-families bringing together substances with a common specific character have been added in certain cases.
General principles
For the purposes of establishing the generic name, the following general approach, involving two successive stages, is adopted:
identification of the functional groups and chemical elements present in the molecule;
determination of the extent to which account should be taken of the most important functional groups and chemical elements.
The identified functional groups and elements taken into account are the names of the families and sub-families set out in point 3 in the form of a non-restrictive list.
a Specify according to the family corresponding to halogen. | |
b Quinones included. | |
Family NoAnnex I to Directive 67/548/EEC | FamiliesSub-families |
---|---|
001 | Hydrogen compounds Hydrides |
002 | Helium compounds |
003 | Lithium compounds |
004 | Beryllium compounds |
005 | Boron compounds
|
006 | Carbon compounds
|
007 | Nitrogen compounds
|
008 | Oxygen compounds |
009 | Fluorine compounds Inorganic fluorides |
010 | Neon compounds |
011 | Sodium compounds |
012 | Magnesium compounds Organometallic magnesium derivatives |
013 | Aluminium compounds Organometallic aluminium derivatives |
014 | Silicon compounds
|
015 | Phosphorus compounds
|
016 | Sulphur compounds
|
017 | Chlorine compounds
|
018 | Argon compounds |
019 | Potassium compounds |
020 | Calcium compounds |
021 | Scandium compounds |
022 | Titanium compounds |
023 | Vanadium compounds |
024 | Chromium compounds Chromium VI compounds |
025 | Manganese compounds |
026 | Iron compounds |
027 | Cobalt compounds |
028 | Nickel compounds |
029 | Copper compounds |
030 | Zinc compounds Organometallic zinc derivatives |
031 | Gallium compounds |
032 | Germanium compounds |
033 | Arsenic compounds |
034 | Selenium compounds |
035 | Bromine compounds |
036 | Krypton compounds |
037 | Rubidium compounds |
038 | Strontium compounds |
039 | Yttrium compounds |
040 | Zirconium compounds |
041 | Niobium compounds |
042 | Molybdenum compounds |
043 | Technetium compounds |
044 | Ruthenium compounds |
045 | Rhodium compounds |
046 | Palladium compounds |
047 | Silver compounds |
048 | Cadmium compounds |
049 | Indium compounds |
050 | Tin compounds Organometallic tin derivatives |
051 | Antimony compounds |
052 | Tellurium compounds |
053 | Iodine compounds |
054 | Xenon compounds |
055 | Caesium compounds |
056 | Barium compounds |
057 | Lanthanum compounds |
058 | Cerium compounds |
059 | Praseodymium compounds |
060 | Neodymium compounds |
061 | Promethium compounds |
062 | Samarium compounds |
063 | Europium compounds |
064 | Gandolinium compounds |
065 | Terbium compounds |
066 | Dysprosium compounds |
067 | Holmium compounds |
068 | Erbium compounds |
069 | Thulium compounds |
070 | Ytterbium compounds |
071 | Lutetium compounds |
072 | Hafnium compounds |
073 | Tantalum compounds |
074 | Tungsten compounds |
075 | Rhenium compounds |
076 | Osmium compounds |
077 | Iridium compounds |
078 | Platinum compounds |
079 | Gold compounds |
080 | Mercury compounds Organometallic mercury derivatives |
081 | Thallium compounds |
082 | Lead compounds Organometallic lead derivatives |
083 | Bismuth compounds |
084 | Polonium compounds |
085 | Astate compounds |
086 | Radon compounds |
087 | Francium compounds |
088 | Radium compounds |
089 | Actinium compounds |
090 | Thorium compounds |
091 | Protactinium compounds |
092 | Uranium compounds |
093 | Neptunium compounds |
094 | Plutonium compounds |
095 | Americium compounds |
096 | Curium compounds |
097 | Berkelium compounds |
098 | Californium compounds |
099 | Einsteinium compounds |
100 | Fermium compounds |
101 | Mendelevium compounds |
102 | Nobelium compounds |
103 | Lawrencium compounds |
601 | Hydrocarbons
|
602 | Halogenated hydrocarbonsa |
603 | Alcohols and derivatives
|
604 | Phenols and derivatives Halogenated phenol derivativesa |
605 | Aldehydes and derivatives
|
606 | Ketones and derivatives
|
607 | Organic acids and derivatives
|
608 | Nitriles and derivatives |
609 | Nitro compounds |
610 | Chlornitrated compounds |
611 | Azoxy and azo compounds |
612 | Amine compounds
|
613 | Heterocyclic bases and derivatives
|
614 | Glycosides and alkaloids
|
615 | Cyanates and isocyanates
|
616 | Amides and derivatives
|
617 | Organic peroxides |
647 | Enzymes |
648 | Complex coal derivatives
|
649 | Complex oil derivatives
|
650 | Various substances Do not use this family. Instead, use the families or sub-families mentioned above. |
After having conducted a search to see if the substance belongs to one or more families or sub-families on the list, the generic name can be established in the following way:
Examples:
1,4 dihydroxybenzen
:
phenols and derivatives
:
phenol derivatives
butanol
:
alcohols and derivatives
:
aliphatic alcohols
:
aliphatic alcohol
2-Isopropoxyethanol
:
alcohols and derivatives
:
glycolethers
:
glycolether
methacrylate
:
organic acids and derivatives
:
acrylates
:
acrylate
Examples:
chlorobenzene
:
halogenated hydrocarbons
:
halogenated aromatic hydrocarbons
:
chlorine compounds
:
chlorinated aromatic hydrocarbon
2,3,6-trichlorophenylacetic acid
:
organic acids
:
halogenated aromatic acids
:
chlorine compounds
:
chlorinated aromatic acid
1-chloro-1-nitropropane
:
chloronitrated derivatives
:
hydrocarbons
:
aliphatic hydrocarbons
:
chlorinated aliphatic hydrocarbon
tetrapropyl dithiopyrophosphate
:
phosphorus compounds
:
phosphoric esters
:
sulphur compounds
:
thiophosphoric ester
In the case of certain elements, notably metals, the name of the family or sub-family may be indicated by the words‘organic’ or ‘inorganic’.
Examples:
dimercury chloride
:
mercury compounds
:
inorganic mercury compound
barium acetate
:
barium compounds
:
organic barium compound
ethyl nitrite
:
nitrogen compounds
:
nitrites
:
organic nitrite
sodium hydrosulphite
:
sulphur compounds
:
inorganic sulphur compound
(The examples cited are substances taken from Annex I to Directive 67/548/EEC (19th adaptation) in respect of which requests for confidentiality may be submitted).
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