CELEX: 31992H0214
Language: en
Date: 1992-03-03 00:00:00
Title: 92/214/EEC: 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

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31992H0214

92/214/EEC: 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  

Official Journal L 102 , 16/04/1992 P. 0047

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