Explanatory Memorandum to COM(1976)433 - - Main contents
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| source | COM(1976)433  |
| date | 08-09-1976 |
COLLECTION RELIEE DES DOCUMENTS 'COM'
COM (76)433
Vol. 1976/0134
Disclaimer
Conformement au reglement (CEE, Euratom) n° 354/83 du Conseil du ler fevrier 1983 concernant I’ouverture au public des archives historiques de la Communaute economique europeenne et de la Communaute europeenne de I’energie atomique (JO L 43 du 15.2.1983, p.
1), tel que modifie par le reglement (CE, Euratom) n° 1700/2003 du 22 septembre 2003 (JO L 243 du 27.9.2003, p.
1), ce dossier est ouvert au public. Le cas echeant, les documents classifies presents dans ce dossier ont ete declassifies conformement a I’article 5 dudit reglement.
In accordance with Council Regulation (EEC, Euratom) No 354/83 of 1 February 1983 concerning the opening to the public of the historical archives of the European Economic Community and the European Atomic Energy Community (OJ L 43, 15.2.1983, p.
1), as amended by Regulation (EC, Euratom) No 1700/2003 of 22 September 2003 (OJ L 243, 27.9.2003, p.
1), this file is open to the public. Where necessary, classified documents in this file have been declassified in conformity with Article 5 of the aforementioned regulation.
In Obereinstimmung mit der Verordnung (EWG, Euratom) Nr. 354/83 des Rates vom 1. Februar 1983 uber die Freigabe der historischen Archive der Europaischen Wirtschaftsgemeinschaft und der Europaischen Atomgemeinschaft (ABI. L 43 vom 15.2.1983, S.
1), geandert durch die Verordnung (EG, Euratom) Nr. 1700/2003 vom 22. September 2003 (ABI. L 243 vom 27.9.2003, S.
1), ist diese Datei der Offentlichkeit zuganglich. Soweit erforderlich, wurden die Verschlusssachen in dieser Datei in Obereinstimmung mit Artikel 5 der genannten Verordnung freigegeben.
COMMISSION OF THE EUROPEAN COMMUNITIES
C0MC76) 433 final Brussels., 8 September 1976
El°22.§al_for_a £0U NC INDIRECT IVE - '
■ ' ‘ I , '
the sixth modification of the Council Directive of
27 June 1967 on the approximation of the laws of , ■ \ : ’ Member States relating to the classification,
packaging and labelling of dangerous substances
(sybmitted by the Commission to the Council)
C0MC76) 433 final
EXPLANATORY MnOUEDUM
Contents
- 1. IFTRODUC TI ON
- This limitation or prohibition would tales place when the competent authority judged it to be necessary and indispensible for the protection of man and the environment. •
- VTfifc
- COMENTARIES ON THE MIN MODIFICATIONS ENVISAGED
- Article''
- Article 14
- Article 21
- III, CONSULTATION OF DTCEHBgPED PARTIES
- Having regard to the proposal of the Commission
- HAS ADOPTED THIS DIRECTIVE
- c) munitions and objects containing explosive matter in the form
- chemical elements and their compounds as they occur in the natural state or as produced by industry; ’
- laboratories. - ' •
- e) notification
- a) explosive
- c) easily flammable
- d) flammable
- e) toxic
- f) harmful
- i) dangerous for the environment
- 3. The determination of the categories toxic, harmful, corrosive and
- Article 4
- into Annex I. From the time the substance is listed in Annex I it must be : •
- 1. Tho notifier is required to carry out a study prior to marketing a now
- 2. The notifier may at the same time send a copy of the dossier to the
- 3. The notifier is further required to inform the competent authority
- ' Article 7
- 1. Ilember States shall appoint a competent authority (or authorities)
- Article 3 ‘
- Article 9
- Article 11
- 2. Tho Member States may bo called upon to give the Commission any information necessary to up-date this catalogue notably in respect of quant ties placed on the market. •
- Article 13
- k2. Every package must show clearly and indelibly the following s
- a) the name of the substance must bo one of the terms listed in Annex
- 4. When more than one danger symbol
- is assigned to a preparation : symbol T makes, in general, the
- Article 15
- Each symbol must oover at least one-tenth of the surface of the label
- a) permit the labelling required by Artiole 14 to bo applied in some
- Article 18
- Article 19
- 3. a) The Commission shall adapt the measures envisaged when they are in
- Article 20
- Article 21 •
- 1. Where a Member State has detailed grounds for establishing that a
- It shall immediately inform the Commission and the other Member States thereof and give reasons for its decision. •
- 2. The Commission shall, within six weeks, consult with the Member States
- ' Article 22
- Article 21
- Parameters for evaluating the environmental risk of
- A. Quantities
- A.1 Tonnages forecast by the manufacturer, expressed in tonnes/year
- B. 1 Acute toxicity to man determined by experiments on mammals depending
- B.2 Chronic and miscellaneous toxicity
- C. 1 Anticipated uses
- C.3 Stability in -the presenoe of natural agents
- C.4 Accumulation within receiving media and the creatures living therein
- ANNEX VII
- '' ' \
- to) h)
- 442. Delayed toxicity
- 4.2.2. Chronio toxicity (substance and its metabolites)
- 413.2 Carcinogenic effects
- 4.3.3 Effects on reproduction, including teratogenicity
- 5.1. Effects on typical species
- mg/l; duration of test: h
- For example: birds, bacteria
- Specify the data on which this evaluation is based (stability to heat photoohemical stability, biodegradability etc). •
- 8.2. Biotic accumulation
- 8.3. Abiotio accumulation
- CORROSIVE AND IRRITANT
- 4. If there are indications of the existence of toxic effects, apart from
- A full descrpition of the methods used or the appropriate bibliographical references!
- 2.4a Emergenoy measures in case of accidental spillage
- 3.12. Stability related pH
- 3.13. Other properties (e.g. chelating tendancy)
During the past few years, the large scale changes in the chemical industry have led to a rapid increase in both the number and quantity of synthetic chemical compounds which has in turn given rise to more and more serious problems with respect to their control.
Chemical compounds now have a place in most human activities and each year the list lengthens. There is a risk that among these compounds there may be substances which could have harmful effects directly or indirectly for man and the environment.
At the moment on a Community basis this is regulated by the Council Directive of 27 June 1967 (67/548/CEE) on dangerous substances which lays down conditions for their classification and the way in which they are offered for sale as well as by Council Directives on solvents (73/l73/CEE, detergents (73/404/CEH) and methods of measurement of the biodegradibility of anionic surfactants (73/405/CEE). .
Other directives on certain preparations are in course of adoption.
Today scientific circles, public opinion and the aiithorities of Member States are confronted increasingly by problems caused by toxic, harmful or polluting substances. Polychlorbiphenyls (PCB), polychlorterphenyls (PCT), vinyl chloride monomer (VCM), mercpry compounds, and certain organohalogen compounds are the most current examples. „
A directive on the limitation of the placing on the market and us .• of the first three substances was approved by the Council on 30 June 1967* This directive is not limited to these three pollutants it includes the possibility of extension of its field of application to any chemical substance which may prove to be dangerous,
In vie;/ of the growing ooncern of public authorities there is now increased interest in the different ways of evaluating the effects of chemical products before these offer a real danger so that this danger can be avoided as much as possible.
It seems more and mol's necessary at the moment not to continue placing on the market chemical compounds potentially dangerous for man and the environment without having available a minimum of knowledge about the ricks ’which . ,r are produced. By the nature and importance of the solutions and their impact on trade and the free circulation of goods this problem could only be solved on a Community basis notably because of the fundamental objectives of the European EoDnomic Community and in particular because of the measures arising from the existence of the directive of 27 June 1967.
In effect by the European Community Action Programme for the Environment of 22 November' 1973 the Council has charged the Commission to examine the possibilities of harmonizing and reinforcing the control which the public authorities should exercise on certain new synthetic substances and products before they are placed on the market. ‘ ‘
This examination has shown not only the necessity of setting up a system of control but equally of establishing this with a view to preventing pollution, in accordance with the first principle of the Environmental Polioy Programme previously mentioned, and to undertake this in a systematic 'way, that is to say by a generalised control.
In June 1975 the French Government in accordance with the information agreement on environment of 5 March 1973, notified to the Commission a draft lav; on the control of chemical products dispersed in the environment. The Commission invited the French authorities to postpone the application of the measures envisaged in order that it could prepare proposals for Community measures to be presented to the Council. The preparatory work was carried out with the help of the group of national experts "Elimination of technical harriers to trade: dangerous substances". Three plenary meetings and one restricted meeting were held to examine the draft modification of the directive of 27 June 1967.
In parallel with this work of modification of the directive of 19&7 include the criteria 'dangerous for the environment' the Committee for Ado.ptc.tion to Technical Progress unanimously voted a modification of Annexe3 I, III and IV of this directive respectively to the list of dangerous substances indications of risk and safety advice.
The present proposal of modification of the directive of 27 June 1967 envisages the reinforcement of measures relating to the classification, packaging and labelling of substances which had as its objective the i> protection of users and workers.
In order to supervisee the effects on man and the environment, it is proposed that any placing on the market of a new substance would imply the carrying out of a prior study by the manufacturer and notification to the competent authorities when the substance was first placed on the market in a Member State. To follow closely the evolution of substances . placed on the market and their use, a system shCuld bSoset Up which;provides for, the!’, listing! of .rail Anew sabstakceh which.' areA placbHc oar.thet mhrlcBi.
... <; _ bo 'at v.p.
In this way, the competent authority of a Member State will be in a position to evaluate the consequences which would result from the marketing of the substance and could if necessary intervene immediately in modifying the classification proposal either by limiting or forbidding the marketing of the substance.
This limitation or prohibition would tales place when the competent authority judged it to be necessary and indispensible for the protection of man and the environment. •
The present proposal of directive has as its objective the laying down of Community measures in the field of chemical products in view of their danger for man and the environment and is a natural sequel to directives elaborated in the field of dangerous substances and preparations.
In order to facilitate the reading of the directive a new numbering of the artioles is proposed.
It is proposed to replace Articles 1 to 11 of the Council Direotive of £7 June by a-new'toxtj,;,• ;• ....;;-rT)
-.‘’■.-‘■XiV-J-l—'—-—.....------... --------------------—......
Article 7
This artiole envisages the nomination of competent authorities in fixing the framework of their responsibilities with regard to the marketing of a new substance.
Article 3 .
This artiole lists the sectors excluded from the notification procedure. This exclusion is necessary either to oover the needs for research or for other Community measures. Articles 9' 1° and 11 set up the Community notification procedure.
The principal modification of this article is at sub-paragraph 2c which unices the use of safety advice obligatory. It should also be noted that the new paragraph 5 envisages that the indications enumerated at paragraph 2 must, where necessary, be accompanied by appropriate inscriptions decided by application of Article 7 in the framework of the requirements relating to conditions of use.
Article 15 .
To paragraph 1 a new more complete format is proposed according to the capacity of the package.
Annex VI ,
Characteristics for assessment of danger for the environment which is offered V substances.
Annex VII .
Characteristics forming part of the technical dossier envisaged in Article 6.
Determination of the applicability of the categories toxic, harmful, corrosive and irritant.
the sixth modification of the Council Directive of 27'6.t967 on the approximation of the laws of Membor States relating to the classification, packing and labelling of dangerous substances
TIE COUNCIL OF THE EUROPEAN COMMUNITIES , ■
Laving regard to the Treaty establishing the European Eoonomic Community, and in particular Article 100 thereof .
Having regard to the Opinion of the European Parliament .
Having regard to the Opinion of the Economic and Social Committee,
Whereas to protect man and the environment against potential risks which • could arise from the placing on the market of new substances, it is necessary to lay down appropriate measures and in particular to reinforce the controls envisaged in Council Directive 67/54&/CEE of 27 Juno I967 on the approximation of the legislative^ regulatory and administrative measures relating to the classification, packing and labelling of dangerous substances (1) modified most recently by Directive 75/409/CEE (2),
Whereas it is necessary for these reasons to modify the Directive 67/54-8/CEE xvhich at the moment by a classification, packing and labelling of dangerous substances protects the population and principally the workers using them;
Whereas in order to control the effeots on can and the environment it is advisable that any new substance placed on the market is subjected to a • prior study by the manufacturer and a notification to the competent authorities conveying mandatorily certain information; and whereas it is, moreover, important to follow closely the evolution and use of new substances placed on the market, and that in order to do this it is necessary to instituto a system which allows all new substances to be listed;
Uhereas it is necessary to envisage measures allowinggthe Commission to introduce the prooedure of notification to all the Member States; and whereas it is, moreover, necessary to envisage that the measures relating to the classification, packing and labelling and the conditions of use of new substances may be laid down at the Community level by Directives of the Commission or Counoil as appropriate; ■
(1) 0J No 196, 16.3.1967, p.1 ^2) aj No LI33, 14.7.1975, p.22
Whereas the competent authority of a Member- State must be in a position to appraise the consequences resulting from the placing on the market of a new substance and may, inhere necessary, intervene in limiting or in prohibiting the placing on the market of the aforementioned substance when it judges this to be necessary for the protection of man and the environment;
Whereas it is necessary to make it obligatory that safety advice accompanies the packing of dangerous substances;
Whereas Article 2 of the above directive classes substances and preparations as toxic, harmful or corrosive by the use of general definitions; whereas in the absence, at the moment, of specifications allowing their allocation to these classes, it seems appropriate to envisage precise criteria for classification; whereas in addition Article 3 of the directive envisages an evaluation of danger for the environment and that arising from this it is necessary to enumerate oertain characteristics and parameters of assessment;
Whereas for the better understanding of the directive a new presentation and a different numbering of the articles have been necessary, ..
E.V3 .sacra'iD TT.T2 i>r:ra?rr:
Article 1 .
1' Articles 1 to tl of the Counoil Directive of 27 June 1967 relating to the approximation of legislative, regulatory and administrative measures oonceming the classification, packaging and labelling of. dangerous substances (67/MS/EEC) modified in the last instance by Directive 75/409/3EC are replaced by the following artioles :
./
"Article 1 ’
1. The purpose of this Directive is to approximate the laws, regulations and. administrative provisions of the Member States on :
— notification of new substances
- classification '
• • packaging, and ‘
• . ‘ l:'.rg •
of substances dangerous for man and the environment which aref placed on the market in the Ifember States of the Community.
2. This Directive does notably* rtot he provisions relating to :
a) medicinal products, narcotics and radioactive substances;
b) the carriage of dangerous substances by rail, road, inland . waterway, sea or air;
of igniters or motor fu&ls; •
d) addi-yives fobfbGdsfcaffsrs osdjft •feninaluf^'3afflgErtiiffs*cs to IK nf..
3. The classification, packaging and labelling provisions of this directive do not apply to dangerous substances exported to third countries.
4- Articles 13 to 15 of this Directive do not apply to containers for gases wnioh are compressed, liquefied or dissolved under pressure.
2
1. For the purpose of this Directive :
a) * substances' moans
chemical elements and their compounds as they occur in the natural state or as produced by industry; ’
b) ‘preparations' means
mixtures or solutions composed of two or more substances;
c) new substances
substances which have not previously been placed on the market . either as a substance or mixture before 2bt January-.r.
_■ Arbi.with the exception of those made available to research
d) environment .
Water, air, earth, biological forms; the relation between them and with man.
An informative declaration to the competent authority by the manufacturer or any other person placing a new substance on Nthe market, hereafter called the notifier.
' ' ; \ ' . . .
2. The following substances and preparations are ‘dangerous* within the moaning of this Directive :
substances and preparations which may explode under the effect of flame or which are more sensitive to shocks or friction than dini-trobenaene;
b) oxidising .
substances and preparations which give rise to highly exothermic reaction when in contact with other substances, particularly flammable substances;
- substances and preparations which may become hot and finally cathh fire in contact with air at ambient temperature without any application of energy, or
- solid substances and preparations which may readily catch fire after brief contact with a source of ignition and which continue to burn or to be consumed after removal of the source of ignition, or
- liquid substances and preparations having a flash point below 21°C,
■ or
- gaseous substances and preparations which are flammable in air at normal pressure, or
- substances and preparations which in contact with water or damp air, evolve highly flammable gases in dangerous quantities;
liquid substances and preparations having a flash point between 21°C and 55°C;
substances and preparations which, if they are inhaled or taken internally or if they penetrate the skin, may involve serious, acute.or chronic health risks and even death;
substances and preparations which, if they are inhaled or taken internally or if they penetrate the skin, may involve limited health risks; -
g) corrosive
substances and preparations which may, on contact with living tissues, destroy them; -
h) irritant .
non-corrosive substances and preparations which, through immediate, prolonged or repeated contact with the skin or mucous membrane, can cause inflammation.
substances, the use of which presents or could present immediate or prolonged risks for the environment. . ..
Article 3 . .
1. The flash point of the flammable liquid substances and preparations mentioned in Article 2 paragraph 2 (c) and (d) shall be determined according to the methods aid. with the apparatus laid down in Annex V.
2. The environmental or potential environmental hazard shall be determined in accordance with the characteristics set out in Annex VTI taking into account the parameters of;appreciation contained in Annex VT.
• irritant mentioned in Article 2, paragraph 2, e), f), g) and h) as is carried out according to the oriteria in Annex VIII.
The classification of dangerous substances according to the degree of hazard and specific nature of risks shall be based on the categories laid down in Article 2 (2). For categories (a) to (h) the substanoes shall bo olassifiod acoording to the greatest degree of hazard*
1• Member States shall take all the necessary measures to ensure that tho now substances referred to in Article 2 are not placed on the market unless they have been :
- notified to the competent authority in accordance with this directive;
- paokaged in accordance with the principles of Art. 13;
- labelled in accordance with the principles of Art. 14;
2. These JtestsuTOSaa' Ci are valid until the substance is listed
- packaged according to Art. 13;
- labelled aocording to Art. 14;
~ and used under.the conditions which, when necessary, have been laid down in respect of it in Annex I.
Artiole 6 •
substance to enable.its effects on man and tho environment to bo fnibrnit ‘
assessed and to \.T. to the competent authority envisaged in Art. 7'
at the latest on the date of marketing, a notification i/itlr.aii: acknowledgement of receipt including: .
- a technical dossier containing all the information necessary to evaluate forseeahle direct or indirect risks which the new substance might entail for man and the environment in respect of the various ■ uses envisaged and which contains at least comments relating to the characteristics listed in Annex VII which hear an asterisk.
- a declaration concerning the unfavourable effects of the substance;
- the classification and labelling of the substance in accordance •
. with this directive;
- proposals for any measures relating to the conditions of use which are intended to limit the unfavourable effects.
Commission.
of any significant change in or addition to the information previously
notified in particular in relation to :
- new uses for which he markets the substance (see Annex VII, para 2.1)
- annual increases in the quantities which he markets (see Annex VII, para 2.2)
- toxic or ecotoxic characteristics not previously notified.
who shall be responsible for : ‘
- receiving the notification and examining its conformity with tho
. prescriptions of the directive; j
- examining the forseoable risks that these new substances might give rise to;
- examining the classification and labelling proposal;
- examining the proposals of measures relating to the conditions of
use;
./
Moreover, if the authorities see fit they may :
- ask for further information and/or verification tests;
- carry out such sampling as is necessary for control purposes;
- take appropriate measures relating to conditions of use while awaiting Community dispositions*
“ c c bdirtg.' t "o >:t her pioccdurec Jhid- 'Artfoienl■$£Afaarqpr opbbala sfor
- classification .
~ labelling '
- dispositions relating to conditions of use.
Member States and the Commission shall ensure that any information concerning marketing or manufacturing shall be kept secret.
Substances in as much as they are placed on the market in the fallowing ways shall be excluded from the notification procedure :
a) for research, development or analysis;
b) a3 substance or in mixtures for :
- special pharmaceutical products
— components’'of:madsMoils or objects intended to oome into * • contact'-.' wit h fobttsluff•sdiu - • riu/';' j
_____ . s. t
— components of' pestioides~'su&jected""t6 type approval""
. * : ’ui*- ■a''rr.--.cuw'ic:,l p.\ ;v.hi. are '"o-vt t
- cosmetic products.
i
A Member State which has received the notification dossier or additional information envisaged in Article 6 shall \ i.iho ■ .ont c-f the '.‘.or send a copy of it immediately to the Commission together with any relevant comments. .
Article 10 .
On receipt of the copy of the notification dossier or some other complementary information from a Member State, the Commission shall transmit :
- the elements of the notification to the other Member States;
— any relevant information which it has gathered to all Member States.
This transmission shall be deemed to constitute a notification to the competent authorities of other Member States within the meaning of ■. Artiole 6. . ■
1. The Commission shall keep at the disposal of the Member States a catalogue of all substances notified under this Directive.
2. Tho Member States may bo called upon to give the Commission any information necessary to up-date this catalogue notably in respect of quant ties placed on the market. •
Article 12
Annex I of this Directive contains tho list of substances classified under the provisions of Article 4 and where appropriate dispositions relating to conditions of use.
•/.
Member States shall take all necessary measures to ensure that dangerous substances cannot be placed on the market unless the strength and impermeability of their packaging satisfies the following requirements, any packaging meeting these requirements being regarded as adequate :
1. The packagings must be so arranged and fastened as to preclude any loss of the contents; this requirement does not apply where special safety devices are prescribed;
-2. The materials constituting the packaging and fastenings must not be liable to attack by the contents, or liable to form harmful or dangerous compounds with the oonbents; ■
2>l, The packaging? and fastenings must be strong and solid throughout to ensure that they will not loosen and will safely meet the normal stresses and strains of normal handling.
’ Article 14
1„ Member States shall take all necessary measures to ensure that dangerous substances cannot bo placed on the market unless the labelling on their packaging satisfies the following requirements. .
- the name of the substance, 1
- the origin of the substance, .
“ the danger symbol, when laid down, and indication of danger involved in the use of the substance, ,
- a reference to the speoial risks arising from such dangers;
I to this Directive; .
b) the indication of origin must include the name and address of the manufacturer, the- distributor or the importer;
c) thh following symbols and indications of danger are to be used :
•* explosive
- oxidising
- vary flammable.
- toxic
- harmful
' corrosive
- irritant
: an exploding bomb (E)•
: a flame over a circle (o)
: a flame (F) .
: a death’s head and crossbones : a St. Andrew’s Cross (Xn)
: the symbol showing the damaging effect of any aoid (C) s a St. Andrew’s Cross (Xi)
The symbols must conform to those in Annex II to this Directive; they shall be printed in black on an orange-yellow background.
d) The nature of the special risks involved in using the substances . mat be indicated by one or more of the standard phrases which, in conformity with the references contained in the list in Annex I, are sot out in Annex III to this Directive.
<•£) The packaging shall be accompanied by safety advice relating to the use of the substances where it is materially impossible for these to be given on the label or package itself. The wording of such precautions shall, in conformity with the references contained in the list in Annex I, be based on Annex IV to this Directive. '
3. For packages of harmful, irritant, highly flammable, flammable and oxidising substances, indication need not be given of special risks and Eafety advice where the paokage 'contains no more than 125 ml.
- the obligation to indicate the symbols X and 0 optional;
~ the obligation to indicate the
- the obligation to indioato the optional.
symbol C makes the symbol X optional; symbol E makes the symbols F and 0
5. Tho indications mentioned in paragraph 2 must, where necessary, he accompanied hy appropriate indications required in application of .Article 7 with respect to measures relating to conditions of use.
1, When the particulars required hy Artiolo 14 appear on a label, the latter must he placed on one or more faces of the package so that it can he read horizontally when the package is put down normally. The dimensions of the label must ho as follows :
Dimension
52 x 74 nm
B.§ckage_coQtent
if possible,
~ less than or equal to 0,5 litres
| groator than 0.5 litres, and not | at | least |
| exceeding 1 litre greater than 1 litre, and not | : at | least |
| exceeding 10 litres greater than 10 litres, and not | : at | least |
| exceeding 50 litres | : at | least |
| greater than 50 litres | : at | least |
74 ~ 105
105 x 148 mm
I4O x 210 mm 210 x 296 mm
2
and he at least 1 cm . The entire area of the label must adhere to the package immediately containing the substance<
2. A label is not required where tho particulars are clearly shown on tho immediate package, as specified in paragraph 1,
3. The oolour and presentation of tho label — or in the case of paragraph
2, of the package - must be such that the danger symbol stands out clearly from the background. ■
4. Member States may make the plading on tho market of dangerous substances in their territories subject to the use of the national language or languages in respect of the labelling thereof.
5. For the purpose of this Directive, labelling requirements shall bo deemed to ho satisfied :
a) in the case of an outer package containing one or more inner packages, where the outer paokage is labelled in accordance with international rules on the transport of dangerous substances and the inner paokage or paolcages are labelled in accordanco with this Directive;
b) in the case of a single package, where such a package is labelled in accordance with international rules on the transport of dangerous substances and with Artiole 14 (2) (a), (b) and (d).
In the case of dangerous substances, which do not leave the sovereign territory of a Member State, labelling may bo permitted which complies with national rules instoad of with international rules on tho transport of dangerous substances.
Article 16
Member States may :
other appropriate manner on packages which are either too small or otherwise unsuitable to allow labelling in accordance with Article 15* .
b) by way of derogation from Articles 14 and 15, permit the packaging of dangerous substances which aro neither explosive nor toxic to be uniabclled, or to bo labelled in some other way if they oontain such small quantities that there is no danger to workers or others.
Articlo 17 .
-•The amendments neoessary to adapt tho Annexes to technical progress shall be adapted in accordance with the procedure laid down in Artiolo 19
1* A Committee shall "be established for the adaptation to technical progress of Directives for removing technical barriers to trade in the sector of dangerous substances and preparations, hereinafter called 'Committee*,; which shall consist of representatives of the Member States under the Chairmanship of a representative of the Commission.
2. The Committee shall establish its internal regulations.
1. In the event that reference is made to the procedure laid down in this Article, the matter shall bo referred to the Committee by the Chairman, either on his initiative, or at the request of the representative of a Member State,
2. The representative from the Commission shall submit a draft of the ■ measures to be taken to the Committee. The Committee shall e:cpress its
. Opinion on this draft within a period specified by the Chairman in the light of the urgency of the matter in question. A majority of 41 votes shall suffice for a Decision, the votes of the Member States being woighted as laid down in Article 143 subparagraph 2 of the Treaty.
‘' The Chairman shall not vote. •
■ • accordance with the Opinion of the Committee. " ' ■'
b) When the measures have not been agreed on by the Committee, or in the absence of an Opinion, tho Commission shall submit to the Council without delay a proposal on tho measures to be taken. The Council shall give judgement by the qualified majority.
o) If, after the matter has been before the Council for a period of three months, there has been no decision by the Council, tho proposed measures shall be adopted by tho Commission.
-A
Member States shall not prohibit, restrict or impede on the grounds of notification, classification,- packaging or labelling as defined in this Directive, the placing on the market of dangerous substances which satisfy the requirements of this Directive and the Annex thereto.
dangerous substance, although satisfying the requirements of this Dirootive, constitutes a hazard to health or safety, it may provisionally prohibit the sale of that substance or subject it to special conditions ruling in its territory. It may similarly take suoh meas’.ires where it is obvious that the information notified according to Article 6 is fdlsely false. ... . ■
It shall immediately inform the Commission and the other Member States thereof and give reasons for its decision. •
concerned, express its Opinion without delay and take the appropriate stops. .
3. Where the Commission is of the opinion that technical adaptations to this Directive are necessary, suoh adaptations shall be adopted by either the Commission or the Council tinder the procedure laid down in Artiole 19*
In this event, the Member State having adopted safeguard measures may maintain them until suoh adaptations enter into force.
Member States shall inform the Commission of all laws, regulations and administrative provisions whioh they adopt in the field covered by this Diroctive„"
Annexes VI, VII and VIII, which appear in the annex to this directive, are added to the directive mentioned in the first paragraph of this artiole.
Member States shall adopt the measures needed in order to comply with this Directive and shall apply them by 1st January 1979 at the latest. They will inform the Commission and the other Member States immediately of such measures.
Article 5-'.
This Directive is addressed to the Member States.
• • AMEX VI • .
certain substances
The environmental risk of a substance is evaluated, on the basis of the following primary ooncopts and their possible correlation.
B. Potential toxicity for various targets
C. Exposure of various targets
As regards these concepts the following parameters should particularly bo taken into account :
A. 2 Production broken down according to type of utilization and expressed
as a percentage of the total production.
i
on the intended use of the substance. They may be administered in these tests orally, percutaneously or by inhalation, !
The following parameters should be taken into consideration as appropriate :
- sub-chronic toxioity (repeated daily doses on rats for 90 <3ays)'
- chronic toxicity (studies on rats (1 year) and possibly on dogs
. (3 years)), :
- caroinogenesis .
- mutagenesis over three generations,
- teratoganesis
B. 3 To:d.o effects on other living creatures • .
Depending on the anticipated uses of the substance and on the poton-tial receiving media, an analysis should he made of the toxicologioal effects on other forms of life such as baoteria, algae, fish and birds,
• 'i
— Initial ‘media : the specific purpose of the substance should bo considered with a view to identifying primary targets liable to exposure;
- type of distribution : this involves an assessment of dispersal risks. As a guide, the following distinctions might be borne in mind :
. substances whose use is confined to dosed systems;
. substances used only by approved users or specialists; substances whose use is confined to a limited number of industrial estaT>-lishments;
This involves Assessing the stability of a substance under abiotic and biotic conditions in various environments.
The physico-chemical properties of the substance should be takon into account, for example, stability as a function of pH, thermostability, redoc potential, and the possibilities of biodegradation in the receiving medium. Where studies have been carried out tfm ' models, consideration should be givon to the half-life figures; whore this is not possible, a rough assessment of this period should be made on the basis of the data available.
Tho aim here is to assess as far as possible whether the substance is likely to build up in a given target in the receiving ^aedium.
This may either take tho form of ge©accumulation or bioaccumulation.
Whore studios (o.g., accumulation in fish) have been carried out on modols, consideration should be given to relative preferential accumulation figures; when this cannot be done, the possible extent of any accumulation phenomena should be considered in the light of the relevant physico-ohenical properties, o.g., tho partition coefficients of H20/organio solvents. .
C.5 Possibilities of disposal ...
At issue here is whether the substance, onoe it has become waste material, can be disposed of by suitable treatment bearing in mind.the behaviour of the substanoe in a purification or incineration plant.
INFORMATION REQUIRED FOR THE TECHNICAL DOSSIER REFERRED TO IN ARTICLE 6 OF THIS DIRECTIVE
Thi' Annex is in-tended as a guide. Consequently, some of the information requested may at time he superfluous or alternatively require amplification,
• <' 1 • c <
The obligatory information which the manufacturer must provide is marked by an asterisk; if it is not possible to give an answer, the reasons must be stated. ' ' ‘ ' ' •
* I. IDENTITY OF THE SUBSTANCE . ’ ... .
* 1,1, Chemical name
* 1,1,1, Name in the IUPAC nomenclature ....
* 1.1.2. Other names . ..... ...
* 1.2. Empirical and structural formula • ,
* 1,3, Composition of the chemical product
* 1.3,1, Degree of purity ($) . ' ■ . •
* 1.312. Nature of impurities, including isomers .’and seoohdaryjproduct s
* I.3,3i Percentage of main impurities
* 2.1. Proposed uses
* 2.1.1. Type of use
Describe : — the function of the substance
' - the desired effects •••.•••••
* 2.1.2. TJype of distribution
Indicate destination of substance :
— Closed system
• ''!•(,.... . .
. — Processing industries .••••••••••••••••
— Farmers and skilled trades ...••••......
— The substance is retailed to the public
* 2.2. Estimated production and/or imports for each of the anticipated uses
or application
* 2.2.1. Overall production and/or imports:
— First 12 months •••••.......2.......t/year
— Thereafter ........1............ t/year . .
* 2.2.2. Breakdown of production and/or imports according to points 2.1.1.
and 2.1.2| expressed as a percentage
— First 12 months \ .
— Thereafter - .
* 2.3# Recommended methods and precautions concerning: .
* 2.3#la Handling .iaaai.aa.aiaii.aa
* 2.3a 2. Storage aaaa.a.aaaalaaaaim .
* 2.3a3a Transport .aa.aaa.aa.lllall
* 2.3.4. Fire •
3. PHYSIC0—CJHHJ-1ICALS PROPERTIES OF THE SUBSTANCE
(State whether this is the pure or the commercial substance and give the reference of the internationally recognized methods or a.. description of the methods used).
* 3.1. Melting point ' .
' I t I i I I I I
..........°C
* 3.2. Boiling point . . .
......... °C at .•••••.. Pa
| * 333. Relative density | |
| o420) | |
| *3.4. Vapour pressure | |
| Pa at ...... |
| * 3.5.' | Surfaoe tension | |
| * 3.6. | Water-solubility | |
*3'73 Pat-solubility
Solvent = j/fish oil - corn oil^
........mg/lOO gr, solvent (.3^..°C)
* 3.8. Partition coefficient ,
Water/non-miscible solvent (please specify):
Water/lipid (please specify);
4 TOXICOLOGICAL, STUDIES ■ • ,
(state whether the tests were carried out with the pure or the commercial
substances) ' ■
* 4'1. Acute toxicity .
* 4.1.1. Absorbed orally
LD50 (rat) (m
Symptoms observed in the organs affected (including allergic reactions) ........<
* 4.1.2. Absorbed through the skin ,
LD^Q (RAT) (MG/KG)
Symptoms observed in the organs affected (including allergic reactions) .........
* 441.3.
Absorbed by inhalation LC^0 (rat) ............
Symptoms observed in the organs affected. _ _ _ ......
(including allergic reactions) ......
* 4.144.
Irritant/corrosive effects . . .
(Within the meaning of this Directive, Annex VIII Points 2 & 3).
* 4.2.1. Subacute toxicity (<?0 days)
Symptoms observed according to the concentrations used:
Symptoms observed during tests lasting more than 90 days:
4.3. Other_effeets
4.3.1. Mutagenic effects * 4.3.1.1 Screening test^.
,[V t ' ■ . ■
4' 3". 1 • 2 "Whole' study " '
4.4. Special studies specific to the substance
Tor example : "biochemical kinetic studies, neurophysiological toxicity studies
*; 5; ECOTOXICOLpGICAL_STL'DIES '
(State whether the tests were carried out with the pure or the commercial substance). • .
* 5.1.1. Effects on fish: at least two species including rainbow trout
LC
50
5.1.2. Specific effects of the substance on other typical species in relation with its dispersion in the environment.
* 6. BIOTIC AND ABIOTIC DEGRADABILITY AND EERSISTANCE
Evaluate the half-life of the substance:
| T 1 | 1 year | a | |
| 2 | . | ||
| 3 months | < T1 | -C, 1 year | D |
| 2 | |||
| 1 month | < T 1 | 3 months | in |
| 2 | |||
| 1' week | < T1 | ^ 1 month | n |
| 2 | |||
| T 1 | 1 week | D |
Specify the data on which this evaluation is based (stability to heat photoohemical stability, biodegradability etc). •
* 7. POSSIBILITIES OF RENDERING THE SOBSTANCE HARMLESS
* 7.1. For industry/craft trades
* 7.1.1. Recovery possibilities:
*7.1.2, Neutralization possibilities:
* 7'1.3. Destruction poosibilities:
— Controlled discharge '
- Incineration
— Water purification station
- Others
* 7.2. For the public at large
* 7.2.1. Recovery possibilities:
* 7*2.2. Destruction possibilities:
- Controlled discharge — Incineration
- Water purification station
- Others
8. SPECIAL STUDIES.....
- 8.1. Degradation products and metabolites
AMEX VIII
DETERMINATION OP CLASSIFICATION IN TEC CATEGORIES, TOXIC, EIRUFJL,
. (See Art. 3> para 3)
. Substances and preparations shall he classified by establishing the actual acute toxicity of the comaercial product, expressed in LD^q values, determined in animals. For this purpose the following LC^q values shall be taken as reference values:
Absorbed orally: (LD^^ oral in rat)
up to 25 mg/kg body weight: ■ 'highly toxic',
over 25 mg/kg but nab more than 200 mg/kg body weight: 'Toxic'
over 200 mg/kg but not more than 2,000 mg/kg body weight: 'harmful'.
Absorbed through the skin: (LD^^ cutaneous in rat or tabbit)
• ' up to 50 mg/kg body .weight: 'highly toxic',
over 50 mg/kg but not more than 400 mg/lcg body weight: 'toxic'
over 400 mg/kg but not more than 2,000 mg/kg body weight: 'harmful'.
Absorbed by inhalation (LC^q inhalation in rat)
For gaseous and volatile products or products whioh contain volatile components:
up to 0.5 mg/l air: 'highly toxic'
over 0.5 mg/l air but not more than 2 mg/l air: 'toxic', over 2 mg/l air but not more than 20 mg/l air: 'harmful'.
For mixtures of components with varying vapour pressures, for preparations as are not unequivocally gasedus and for fumigants and aerosols, it must be checked whether' the commercial preparation contains volatile components which could be released into the environment in aotively toxio quantities:
If the rat does not die within 14 days of being exposed for 1 hour to c; +nratecl a'r-vapour mixture (not acute respiratory toxicity), the classification shall be aligned on the LD^q values fovind. Should death occur, the LCvalue will have to be ascertained.
2. Substances and preparations shall be classified as:
"corrosive" if, in tests on rabbits, the commercial product destroys the tissue (necrosis) within 30 minutes of being in uninterrupted contact with the skin for a period 6£ 7 days in a quantity of 0.5 ail or 0.5 gf
3. Substances and preparations shall be classified as:
"irritant" if, in tests on rabbits, they cause inflammation within 30 minutes of being in uninterrupted contact with the skin for a period of 3 days in a quantity of 0.5 ml or 0.5 g.
acute effects (e.g. carcinogenic effects, etc.), substances and prepjira-tions may also be classified as highly toxic, toxic or harmful depending on the importance of these effects. •
1
1.41 Methods of detection and determination
2
3
339. Plash point
•= a open-air situation D enclosed situation
* 3.10. Explodability (within the meaning of Directive 67/548/EEC)
‘ 3.11. Redox potential
4
A.2.2.1 Substances retailed to the public as forseen on point 2.1.2 Ath dash A.2.2.2 Other substances •