COMMISSION RECOMMENDATION of 3 March 1992 concerning the information to be provided by the person responsible for placing a dangerous preparation on the market when making use of the provisions relating to the confidentiality of the chemical name of a substance (92/214/EEC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Economic Community, and in particular the second indent of Article 155 thereof,

Whereas the second subparagraph of Article 7 (1) (c) of Council Directive 88/379/EEC of 7 June 1988 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations (1), as last amended by Commission Directive 90/492/EEC (2), specifies that the person responsible for placing a preparation on the market shall be permitted, in the case of certain harmful substances, to use either a name identifying the most important functional chemical groups or an alternative designation where he can demonstrate that disclosure of the chemical identity of these substances will put at risk the confidential nature of this property; whereas the third subparagraph of the same paragraph obliges the person responsible for placing a preparation on the market to inform the authorities of the Member State where the preparation is placed on the market, and requires those authorities to inform the Commission and the other Member States;

Whereas, on implementation of that Directive, the authorities of certain Member States have been confronted with this problem of confidentiality; whereas this experience has demonstrated a two-fold need: one, to define, clearly and uniformly, the information which the person responsible for placing on the market shall be required to supply to the authorities of Member States as provided for under the Directive; the other, to provide guidelines to this person in the choice of an alternative designation;

Whereas Commission Directive 91/155/EEC (3) defines and details, in accordance with Article 10 of Directive 88/379/EEC, the arrangements for a system of specific information in safety data-sheet form relating to dangerous preparations principally intended for use by industrial users; whereas the information contained in the safety data sheet must allow the user to take the necessary measures as regards the protection of health and safety at the place of work, it is important that the alternative designation chosen will allow them to take such measures;

Whereas there are within each Member State national associations representative of the majority of the undertakings in the chemical industry; whereas all of these national associations are members of either the ECCMF (European Council of Chemical Manufacturers' Federations) or other European associations;

Whereas this recommendation has been prepared in collaboration with the authorized representatives of the authorities of the Member States and the representatives of the ECCMF; whereas this recommendation should therefore be implemented as soon as possible in order to establish common rules in this area,

HEREBY FORMULATES THIS RECOMMENDATION:

Article 1

1. Where the person responsible for placing a dangerous preparation on the market makes use of the provisions of the second subparagraph of Article 7 (1) (c) of Directive 88/379/EEC relating to the confidentiality of the chemical identity of a substance present in that preparation, he shall inform the authorities of the Member State where this preparation is placed on the market for the first time.

This information shall include the elements set out in Annex I.

Any modification carried out by the person responsible for placing the preparation on the market and involving any of the elements of points 1 to 9 of Annex I shall be communicated to the national authority of the Member State where the initial declaration of confidentiality was made.

2. In the instances specified in Annex I, Note C, a single declaration of confidentiality may be made by the person responsible for placing several preparations on the market.

3. Anyone other than the person responsible for placing the preparation on the market as referred to in paragraph 1, who modifies only the designation or commercial name of a preparation the labelling of which contains one or more alternative designations (protecting the chemical identity of identities) shall inform the authorities of the Member States where this preparation, together with its new designation or commercial name, is placed on the market for the first time.

This information shall include:

- the old designation or commercial name,

- the new designation or commercial name,

- the alternative designation(s) employed.

The alternative designations shall not be modified.

Article 2

1. For the purposes of transmitting information to the national authorities concerning the alternative name designed to protect the chemical identity of the substance which may put at risk the confidential nature of his property, the person responsible for placing the preparation on the market should preferably use a generic name that identifies the most important functional chemical groups.

2. The glossary appearing in Annex II constitutes a guide to choosing the proposed alternative designation.

Article 3

1. Member States shall implement this recommendation through their competent authorities and in cooperation with the Commission as from 15 April 1992.

2. They shall inform the Commission of the steps taken to give effect to this recommendation.

3. Acting in conjunction with the Member States, the Commission shall organize periodic assessments of the implementation of this recommendation.

Article 4

The Commission shall, if necessary, and in collaboration with the Member States, initiate the revision of the present recommendation on the basis of the periodic assessments specified in Article 3 (3). Done at Brussels, 3 March 1992. For the Commission

Martin BANGEMANN

Vice-President

(1) OJ No L 187, 16. 7. 1988, p. 14. (2) OJ No L 275, 5. 10. 1990, p. 35. (3) OJ No L 76, 22. 3. 1991, p. 35.

ANNEX I

INFORMATION TO BE GIVEN BY THE PERSON RESPONSIBLE FOR THE PLACING ON THE MARKET OF A PREPARATION WHEN THE PROVISION UNDER ARTICLE 7 (DIRECTIVE 88/379/EEC) REGARDING CONDIFENTIALITY IS USED

Notes

A. The second subparagraph of Article 7 (1) (c) specifies the conditions under which the person responsible for placing the preparation on the market may avail himself of the confidentiality clause, namely:

- the substance whose chemical identity he wishes to protect must be classified harmful and must not be assigned one of the type phrases R 39, R 40, R 42, R 43, R 42/43, R 45, R 46, R 47, and/or R 48,

- the person responsible for placing the preparation on the market must provide evidence that the divulging of the chemical identity of the preparation on the label will place at risk the confidential nature of his property.

B. The alternative designation used on the label must be the same as that given under heading 2 'Composition/information on ingredients' contained in the safety data sheet established for the preparation (Directive 91/155/EEC).

This implies that the alternative designation used will contain enough information about the substance to ensure risk-free handling.

C. In order to avoid multiple notifications, if a certain number of preparations:

- contain the same dangerous constituents in the same concentration range,

- have the same classification and labelling,

- have the same intended uses,

only one declaration of confidentiality is necessary.

The declaration of confidentiality must include all the elements provided for in this Annex, not forgetting the designation or commercial name of each preparation. A single consistent alternative designation must be used to protect the chemical identity of the same substance under consideration in the case of all the preparations referred to.

Declaration of confidentiality

1. 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 of distributor).

2. Precise identification of the substance(s) for which confidentiality is proposed and the alternative designation.

Case No No Einecs Chemical name according to international nomenclature and classification (Annex I to Council Directive 67/548/EEC or provisional classification) Alternative designation (a) (b) (c) 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.

3. Justification for the confidentiality (probability - plausability)

4. Designation(s) or commercial name(s) of the preparation(s)

5. Is this 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

Belgium:

Denmark:

Germany:

Greece:

France:

Spain:

Ireland:

Italy:

Luxembourg:

Netherlands:

Portugal:

United Kingdom:

6. Composition of the preparation(s) (defined in point 2 of the Annex to Directive 91/155/EEC)

7. Classification of the preparation(s) according to Article 3 of Directive 88/379/EEC.

8. Labelling of the preparation(s) according to Article 7 of Directive 88/379/EEC.

9. Intended uses for the preparation(s).

10. Safety data sheet(s) conforming to Directive 91/155/EEC to be attached.

Date and signature

ANNEX II

LEXICON-GUIDE FOR ESTABLISHING THE ALTERNATIVE DESIGNATIONS (GENERIC NAMES) PURSUANT TO THE PROVISIONS OF ARTICLE 7 OF DIRECTIVE 88/379/EEC

1. Introductory note

This 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.

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 013),

- organic substances whose properties are identified by having a common functional group as their chief characteristic.

The family name is derived from the functional group name.

These families are identified by the conventional number found in Annex 1 (601 to 650).

Sub-families bringing together substances with a common specific character have been added in certain cases.

2. Establishing the generic name

(a) General principles:

For the purposes of establishing the generic name, the following general approach, involving two successive stages, is adopted:

(i) identification of the functional groups and chemical elements present in the molecule;

(ii) 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 of this Annex in the form of a (non-restrictive) list.

(b) Practical application:

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:

(i) If the name of a family or sub-family is sufficient to characterize the chemical elements or important functional groups, this name will be chosen as the generic name.

Examples:

- 1,4 dihydroxybenzen

family 604: phenols and derivatives

generic name: phenol derivative

- butanol

family 603: alcohols and derivatives

sub-family: aliphatic alcohols

generic name: aliphatic alcohol

- 2-Isopropoxyethanol

family 603: alcohols and derivatives

sub-family: glycolethers

generic name: glycolether

- methacrylate

family 607: organic acids and derivatives

sub-family: acrylates

generic name: acrylate

(ii) If the name of a family or sub-family is not sufficient to characterize the chemical elements of important functional groups, the generic name will be a combination of the corresponding different family or sub-family names:

Examples:

- lead hexafluorosilicate

family 009: fluorine compounds

sub-family: inorganic fluorides

family 082: lead compounds

generic name: inorganic lead fluoride

- chlorobenzene

family 602: halogenated hydrocarbons

sub-family: halogenated aromatic hydrocarbons

family 017: chlorine compounds

generic name: chlorinated aromatic hydrocarbon

- 2,3,6-trichlorophenylacetic acid

family 607: organic acids

sub-family: halogenated aromatic acids

family 017: chlorine compounds

generic name: chlorinated aromatic acid

- 1-chloro-1-nitropropane

family 610: chloronitrated derivatives

family 601: hydrocarbons

sub-family: aliphatic hydrocarbons

generic name: chlorinated aliphatic hydrocarbon

- tetrapropyl dithiopyrophosphate

family 015: phosphorus compounds

sub-family: phosphoric esters

family 016: sulphur compounds

generic name: thiophosphoric ester

NB: 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

family 080: mercury compounds

generic name: inorganic mercury compound

- barium acetate

family 056: barium compounds

generic name: organic barium compound

- ethyl nitrite

family 007: nitrogen compounds

sub-family: nitrites

generic name: organic nitrite

- sodium hydrosulphite

family 016: sulphur compounds

generic name: inorganic sulphur compound

(The examples cited are substances taken from Annex I to Directive 67/548/EEC (12th adaptation) in respect of which requests for confidentiality may be submitted.)

3. Division of substances into families and sub-families

Family No Annex I to Directive 67/548/EEC Families

Sub-families 001 Hydrogen compounds

Hydrides 002 Helium compounds 003 Lithium compounds 004 Beryllium compounds 005 Boron compounds

Boranes

Borates 006 Carbon compounds

Carbamates

Inorganic carbon compounds

Salts of hydrogen cyanide

Urea and derivatives 007 Nitrogen compounds

Quaternary ammonium compounds

Acid nitrogen compounds

Nitrates

Nitrites 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

Silicanes

Silicates 015 Phosphorus compounds

Acid phosphorus compounds

Phosphonium compounds

Phosphoric esters

Phosphates

Phosphites

Phosphoramides and derivates 016 Sulphur compounds

Acid sulphur compounds

Mercaptans

Sulphates

Sulphites 017 Chlorine compounds

Chlorates

Perchlorates 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 derivates 051 Antimony compounds 052 Tellurium compounds 053 Iodine compounds 054 Xenon compounds 055 Caesium compounds 056 Barium compounds 057 Lanthanum 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 Tantanium compounds 074 Tungsten compounds 075 Rhenium compounds 076 Osmium compounds 077 Iridium compounds 078 Platinum compounts 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 Americum 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

Aliphatic hydrocarbons

Aromatic hydrocarbons

Alicyclic hydrocarbons

Polycyclic aromatic hydrocarbons (PAH) 602 Halogenated hydrocarbons (*)

Halogenated aliphatic hydrocarbons (*)

Halogenated aromatic hydrocarbons (*)

Halogenated alicyclic hydrocarbons (*) (*) Specify according to the family corresponding to halogen 603 Alcohols and derivates

Aliphatic alcohols

Aromatic alcohols

Alicyclic alcohols

Alcanolamines

Epoxy derivatives

Ethers

Glycolehters

Glycols and polyols 604 Phenols and derivatives

Halogenated phenol derivatives (*) (*) Specify according to the family corresponding to halogen 605 Aldehydes and derivatives

Aliphatic aldehydes

Aromatic aldehydes

Alicyclic aldehydes

Aliphatic acetals

Aromatic acetals

Alicyclic acetals 606 Ketones and derivatives

Aliphatic Ketones

Aromatic Ketones (*)

Alicyclic Ketones (*) Quinones included 607 Organic acids and derivatives

Aliphatic acids

Halogenated aliphatic acids (*)

Aromatic acids

Halogenated aromatic acids (*)

Alicyclic acids

Halogenated alicyclic acids (*)

Aliphatic acid anhydrides

Halogenated aliphatic acid anhydrides (*)

Aromatic acid anhydrides

Halogenated aromatic acid anhydrides (*)

Alicyclic acid anhydrides

Halogenated alicyclic acid anhydrides (*)

Salts of aliphatic acid

Salts of halogenated aliphatic acid (*)

Salts of aromatic acid

Salts of halogenated aromatic acid (*)

Salts of alicyclic acid

Salts of halogenated alicyclic acid (*)

Esters of aliphatic acid

Esters of halogenated alicyclic acid (*)

Esters of aromatic acid

Esters of halogenated aromatic acid (*)

Esters of alicyclic acid

Esters of halogenated alicyclic acid (*)

Esters of glycol ether

Acrylates

Méthacrylates

Lactones

Acyl halogenides (*) specify according to the family corresponding to halogen 608 Nitriles and derivatives 609 Nitrated derivatives 610 Chloronitrated derivatives 611 Azoxy and azoic derivatives 612 Aminated derivatives

Aliphatic amines and derivatives

Alicyclic amines and derivatives

Aromatic amines and derivatives

Aniline and derivatives

Benzidine and derivatives 613 Heterocyclic bases and derivatives

Benzimidazote and derivatives

Imidazol and derivatives

Pyrethrinoids

Quinoline and derivatives

Triazine and derivatives

Triazole and derivatives 614 Glucosides and alcaloids

Alcaloid and derivatives

Glucosids and derivatives 615 Cyanates and isocyanates

Cyanates

Isocyanates 616 Amides and derivatives

Acetamide and derivatives

Anilides 617 Organic Peroxides 650 Various substances Do not use this family. Instead, use the families or sub-families mentioned above