22. 8. 85~ Official Journal of the European Communities No C 211/3 
II 
(Preparatory Acts) 
COMMISSION 
Proposal for a Council Directive on the approximation of the laws, regulations and 
administrative provisions of the Member States relating to the classification, packaging and 
labelling of dangerous preparations 
COM(85) 364 final 
(Submitted to the Council by the Commission on 29 July 1985) 
(85/C 211/03) 
THE COUNCIL OF THE EUROPEAN COMMUNITIES, 
Having regard to the Treaty establishing the European 
Economic Community, and in particular Article 100 
thereof, 
Having regard to the proposal from the Commission, 
Having regard to the opinion of the European Par­
liament, 
Having regard to the opinion of the Economic and 
Social Committee, 
Whereas rules on dangerous substances have already 
been laid down in Council Directive 67/548/EEC of 
27 June 1967 on the approximation of the laws, regu­
lations and administrative provisions relating to the classi­
fication, packaging and labelling of dangerous sub­
stances ('), as last amended by Directive 79/831/ 
EEC (2); 
Whereas rules on certain dangerous preparations having 
very specific uses have already been laid down: 
— in Council Directive 73/173/EEC of 4 June 1973 on 
the approximation of the laws, regulations and 
administrative provisions of the Member States 
relating to the classification, packaging and labelling 
of dangerous preparations (solvents) (3), as last 
amended by Directive 80/781/EEC (4), 
— in Council Directive 77/728/EEC of 7 November 
1977 on the approximation of the laws, regulations 
and administrative provisions of the Member States 
relating to the classification, packaging and labelling 
of paints, varnishes, printing inks, adhesives and 
similar products (5), as last amended by Directive 
83/265/EEC (6), 
O OJNo 196, 16. 8. 1967, p. 1. 
O OJ No L 259, 15. 10. 1979, p. 10. 
(3) OJNoL 189, 11.7. 1973, p. 7. 
(4) OJ No L 229, 30. 8. 1980, p. 57. 
(5) OJ No L 303, 28. 11. 1977, p. 23. 
(') OJ No L 147, 6. 6. 1983, p. 11. — in Council Directive 78/631/EEC of 26 June 1978 
on the approximation of the laws of the Member 
States relating to the classification, packaging and 
labelling of dangerous preparations (pesticides) (7), as 
last amended by Directive 81/187/EEC (8); 
Whereas despite the abovementioned Community 
measures the rules, if any, applying to dangerous 
preparations in the Member States exhibit considerable 
differences as regards classification according to the 
degree of risk; whereas these differences constitute a 
significant barrier to trade and directly affect the 
establishment and functioning of the common market; 
Whereas it is therefore necessary to remove this barrier 
by approximating the relevant legislation existing in the 
Member States and incorporating in it the Community 
rules at present in force; 
Whereas this Directive must also aim to improve 
protection for the general public and, in particular, of 
persons who frequently come into contact with 
dangerous preparations in the course of their work or in 
the pursuit of a hobby, whereas it can also help to 
improve protection for consumers, especially children 
and the visually handicapped, through the provisions laid 
down; 
Whereas provisions on the classification, packaging and 
labelling of the preparations must be laid down at 
Community level; whereas the provisions concerning the 
information appearing on the label, the dimensions of 
the label and the assignment of the various danger 
symbols have also to be brought into line with Directive 
67/548/EEC; 
Whereas dangerous preparations may, although 
conforming to the provisions of this Directive, 
(7) OJ No L 206, 29. 7. 1978, p. 13. 
(") OJ No L 88, 2. 4. 1981, p. 29. 
No C 211/4 Official Journal of the European Communities 22. 8. 85 
nevertheless constitute a danger to health or safety; 
whereas it is therefore advisable to provide a procedure 
to reduce this danger, 
HAS ADOPTED THIS DIRECTIVE: 
Article 1 
1. The purpose of this Directive is to approximate the 
laws, regulations and administrative provisions of the 
Member States on the: 
— classification, 
— packaging, and 
— labelling 
of preparations dangerous to man and the environment 
when they are placed on the market in the Member 
States. 
2. This Directive shall apply to preparations placed on 
the market in the Member States which contain one or 
more dangerous substances as defined in Article 2. 
3. This Directive shall not apply to: 
(a) medicinal or veterinary products as defined by 
Council Directive 65/65/EEC ('); 
(b) preparations containing at least one radioactive 
substance; 
(c) foodstuffs; 
(d) animal feedingstuffs, their additives as defined in 
Council Directive 70/254/EEC (2), certain products 
used in animal nutrition as specified in Council 
Directive 82/471 /EEC (3) and medicinal 
feedingstuffs for animals; 
(e) the carriage of dangerous substances by rail, road, 
inland waterway, sea or air; 
(f) cosmetic products as defined by Council Directive 
76/768/EECO; 
(g) mixtures of substances in the form of waste, which 
are covered by Council Directives 75/442/EEC (5) 
and78/319/EEC(6); 
(h) substances in transit which are under customs 
supervision provided they do not undergo any 
treatment or processing; 
(') OJ No 22, 9. 2. 1965, p. 369. 
(2) OJ No L 270, 14. 12. 1970, p. 1. 
O OJ No L 213, 21. 7. 1982, p. 8. 
(4) OJ No L 262, 27. 9. 1976, p. 169. 
(») OJ No L 194, 15. 7. 1975, p. 39. 
(•) OJ No L 84, 31. 3. 1978, p. 43. (i) containers which contain a preparation in the form 
of gases compressed, liquified or dissolved under 
pressure, excluding aerosols which comply with the 
requirements of Council Directive 75/324/EEC (7); 
(j) munitions and explosives placed on the market with 
a view to obtaining a practical effect by explosion or 
a pyrotechnic effect. 
Article 2 
The definitions appearing in Article 2 of Directive 
67/548/EEC, with the exception of the definition in 
paragraph 1 (d) thereof, shall apply to this Directive. 
Article 3 
1. The requisite physico-chemical properties for the 
classification of preparations shall be determined by the 
methods specified in Annex V (A) of Directive 67/548/ 
EEC. 
Preparations shall be regarded as explosive, oxidizing, 
extremely flammable, highly flammable or flammable 
when the results of the tests carried out by the methods 
mentioned above comply with the definitions in Article 2 
and the specific evaluation criteria detailed in those 
methods. 
The determination of the explosive and oxidizing 
properties is not necessary, however, if none of the 
constituents possesses such properties and if, on the basis 
of the information available to the manufacturer, the 
preparation is unlikely to present dangers of this kind. 
2. The health hazards shall be assessed by the 
conventional method described below, using either 
hazard indices in accordance with Article 4 (2) of 
Directive 67/548/EEC, or individual concentration 
limits, or a combination of the two (hereinafter referred 
to as parameters). 
Where the dangerous substances listed in Annex I to 
Directive 67/548/EEC are assigned parameters necessary 
for the application of the method of evaluation described 
below, those parameters shall be used. 
Where the dangerous substances do not appear in Annex I 
to Directive 67/548/EEC or appear there without the 
parameters necessary for the application of the method 
of evaluation described below, the parameters shall be 
assigned in accordance with the specifications in Annex I 
to this Directive. 
O OJ No L 147, 9. 6. 1975, p. 40. 
22.8.85 Official Journal of the European Communities NoC211/5 
In that case: (b) The following preparations shall be regarded as toxic: 
(a) The following preparations shall be regarded as very 
toxic: 
(i) Owing to their acute lethal toxic effects, 
preparations containing one or more dangerous 
substances if: 
— for oral administration the sum of the 
products obtained by multiplying the 
percentage by weight of the dangerous sub­
stances in the preparation by their specific 
indices is greater than 8 000, i.e. 
2(PxIorl) > 8 000 
— for percutaneous administration the sum of 
the products obtained by multiplying the 
percentage by weight of the dangerous sub­
stances in the preparation by their specific 
indices is greater than 4 000, i.e. (i) Owing to their acute lethal toxic effects, 
preparations containing one or more dangerous 
substances if: 
— for oral absorption the sum of the products 
obtained by multiplying the percentage by 
weight of the dangerous substances in the 
preparation by their specific indices is 
between 1 000 and 8 000, i.e. 
8 000 > ^ (P x Iori) > 1 000 
— for percutaneous absorption the sum of the 
products obtained by multiplying the 
percentage by weight of the dangerous sub­
stances in the preparation by their specific 
indices is between 500 and 4 000, i.e. 
4 000> £(PxIskn) > 500 
I(PxIskn) > 4 000 
for administration by inhalation the sum of 
the products obtained by multiplying the 
percentage by weight of the various 
dangerous substances in the preparation by 
their specific indices is greater than 4 000, i.e. 
wh( 
!orl £(PxIihl) > 4 000, 
is the percentage by weight of each 
dangerous substance in the preparation, 
is the highest hazard index for oral 
administration specific to each dangerous 
substance present, 
is the highest hazard index for percu­
taneous administration specific to each 
dangerous substance present, 
Ijhl is the highest hazard index for inhalation 
specific to each dangerous substance 
present. 
(ii) Owing to their non-lethal irreversible effects 
after one exposure, preparations containing one 
or more dangerous substances that produce such 
effects in individual concentrations greater than: 
— either the concentration specified in Annex I 
to Directive 67/548/EEC for the substance 
or substances under consideration, 
— or the concentration specified at point 2.2 of 
Annex I to this Directive where the substance 
or substances under consideration do not 
appear in Annex I to Directive 67/548/EEC 
or appear in it without parameters. — for administration by inhalation the sum of 
the products obtained by multiplying the 
percentage by weight of the dangerous sub­
stances present in the preparation by their 
specific indices is between 1 000 and 4 000, 
i.e. 
4 000> I(PxIihl) > 1000. 
(ii) Owing to their non-lethal irreversible effects 
after one exposure, preparations containing one 
or more dangerous substances that produce such 
effects in individual concentrations greater than: 
— either the concentration specified in Annex I 
to Directive 67/548/EEC for the substance 
or substances under consideration, 
— or the concentration specified at point 2.2 of 
Annex I to this Directive where the 
substance or substances under consideration 
do not appear in Annex I to Directive 
67/548/EEC or appear in it without 
parameters. 
(iii) Owing to their long-term effects, preparations 
containing one or more dangerous substances 
that produce such effects in individual 
concentrations greater than: 
— either the concentration specified in Annex I 
to Directive 67/548/EEC for the substance 
or substances under consideration, 
— or the concentration specified at point 2.3 of 
Annex I to this Directive where the 
substance or substances under consideration 
do not appear in Annex I to Directive 
67/548/EEC or appear in it without 
parameters. 
No C 211/6 Official Journal of the European Communities 22. 8. 85 
(c) The following preparations shall he regarded as 
harmful: 
(i) Owing to their acute lethal toxic effects, 
preparations containing one or more dangerous 
substances if: 
— for oral administration the sum of the 
products obtained by multiplying the 
percentage by weight of the dangerous sub­
stances in the preparation by their specific 
indices is between 100 and 1 000, i.e. 
1000> £(PxIorI) > 100 
— for percutaneous absorption the sum of the 
products obtained by multiplying the 
percentage by weight of the dangerous sub­
stances in the preparation by their specific 
indices is between 100 and 500, i.e. 
500 > £(PxIskn) > 100 
— for administration by inhalation the sum of 
the products obtained by multiplying the 
percentage by weight of the dangerous sub­
stances present in the preparation by their 
specific indices is between 100 and 1 000, i.e. 
1000 > £(PxIihl) > 100. 
(ii) Owing to their non-lethal irreversible effects 
after one exposure, preparations containing one 
or more dangerous substances that produce such 
effects in individual concentrations greater than: 
— either the concentration specified in Annex I 
to Directive 67/548/EEC for the substance 
or substances under consideration, 
— or the concentration specified at point 2.2 of 
Annex I to this Directive where the 
substance or substances under consideration 
do not appear in Annex I to Directive 
67/548/EEC or appear in it without 
parameters. 
(iii) Owing to their long-term effects, preparations 
containing one or more dangerous substances 
that produce such effects in individual 
concentrations greater than: 
— either the concentration specified in Annex I 
to Directive 67/548/EEC for the substance 
or substances under consideration, 
— or the concentration specified at point 2.3 of 
Annex I to this Directive where the 
substance or substances under consideration 
do not appear in Annex I to Directive 
67/548/EEC or appear in it without 
parameters. (d) The following preparations shall be regarded as 
corrosive: 
(i) Preparations containing one or more substances 
classified or regarded as corrosive in individual 
concentrations exceeding: 
— either the concentration specified in Annex I 
to Directive 67/548/EEC for the substance 
or substances under consideration, 
— or the concentration specified at point 3.1 of 
Annex I to this Directive where the substance 
or substances do not appear in Annex I to 
Directive 67/548/EEC or appear in it 
without parameters. 
(ii) Preparations containing more than one 
substance classified or regarded as corrosive in 
individual concentrations not exceeding the 
limits specified either in Annex I to Directive 
67/548/EEC or at point 3.1 of Annex I to this 
Directive if the sum of the quotients obtained by 
dividing the weight percentage of each corrosive 
substance in the preparation by the corrosive 
limit specified for that substance exceeds 1, i.e. 
p 
v——> ]> 
where: 
Pcor is the weight percentage of each corrosive 
substance in the preparation, 
Lcor is the corrosive limit specified for each 
corrosive substance expressed as a 
percentage. 
(e) The following preparations shall be regarded as 
irritant: 
(i) Preparations containing one or more substances 
classified or regarded as irritant in individual 
concentrations exceeding: 
— either the concentration specified in Annex I 
to Directive 67/548/EEC for the substance 
or substances under consideration, 
— or the concentration specified at point 3.1 of 
Annex I to this Directive where the substance 
or substances do not appear in Annex I to 
Directive 67/548/EEC or appear in it 
without parameters. 
22. 8. 85 Official Journal of the European Communities No C 211II 
(ii) Preparations containing more than one of the 
substances classified or regarded as corrosive or 
irritant in individual concentrations not 
exceeding the limits specified either in Annex I 
to Directivie 67/548/EEC or at point 3.1 of 
Annex I to this Directive if the sum of the 
quotients obtained by dividing the weight 
percentage of each substance in the preparation 
by the irritant limit specified for that substance 
exceeds 1, i.e. 
P P 
x cor x irr 
where: 
Pcor is the weight percentage of each corrosive 
substance in the preparation, 
P;rr is the weight percentage of each irritant 
substance in the preparation, 
Ljrr is the irritant limit specified for each 
corrosive or irritant substance expressed as 
a percentage. 
(f) Preparations shall be regarded as carcinogenic if they 
contain a substance listed in Annex I to Directive 
67/548/EEC to which is assigned the standard 
phrase R 45 denoting that particular hazard in a 
concentration exceeding the limit specified in that 
Annex. 
(g) Preparations shall be regarded as mutagenic if they 
contain a substance listed in Annex I to Directive 
67/548/EEC to which is assigned the standard 
phrase R 46 denoting that particular hazard in a 
concentration exceeding the limit specified in that 
Annex. 
(h) Preparations shall be regarded as teratogenic if they 
contain a substance listed in Annex I to Directive 
67/548/EEC to which is assigned the standard 
phrase R 47 denoting that particular hazard in a 
concentration exceeding the limit specified in that 
Annex. 
(i) Preparations shall be regarded as having specific effects 
on health (carcinogenic, mutagenic or teratogenic) 
without further definition if they contain a substance 
which, although it does not yet appear in Annex I to 
Directive 67/548/EEC, has been provisionally 
assigned the phrase R 40 xx because its 
concentration exceeds the limit specified in Annex I 
to this Directive. 3. For preparations covered by this Directive: 
(a) No account shall be taken of substances whether or 
not listed in Annex I to Directive 67/548/EEC, 
whether existing as impurities or as additives, if their 
concentration by weight is less than: 
— 0,1% for substances classified as very toxic or 
toxic, 
— 1,0% for substances classified as harmful, 
corrosive or irritant, 
unless lower values have been specified in Annex I to 
Directive 67/548/EEC. 
(b) Dangerous substances not listed in Annex I to 
Directive 67/548/EEC but used as constituents of a 
preparation in a concentration by weight higher than 
that given at point (a) above shall be given 
parameters characterizing the health hazards. 
Some substances may have more than one property 
harmful to health, e.g. harmfulness/irritation, 
corrosiveness/harmfulness/sensitization, etc., each of 
these properties being characterized by its specific 
parameter: hazard index and/or concentration limit. 
These parameters shall be determined in accordance 
with Annex I to this Directive by-the manufacturer 
or any other person who places such a preparation 
on the market on the basis either of toxicological 
data from the available literature or of information 
based on experience. 
(c) In the case of the substances referred to at (b) the 
manufacturer or his representative shall send as soon 
as possible to the authorities of the Member State in 
which the preparation is manufactured or placed on 
the market for the first time all the data used to 
establish the parameters specific to each substance 
and/or the concentration limits. 
4. (a) By way of derogation from paragraph 2 the 
health hazards of a preparation can be assessed by 
determining the toxicological properties necessary 
for the definition of an appropriate classification 
and labelling in accordance with the criteria in 
Annex VI to Directive 67/548/EEC. 
The toxicological properties shall be determined 
by the methods specified at point B of Annex V to 
that Directive. 
(b) For preparations of well-defined composition 
classified in accordance with this derogation, a 
No C 211 /8 Official Journal of the European Communities 22. 8. 85 
new toxicological assessment shall be performed 
in accordance with the criteria set out at (a) 
whenever: 
— changes of composition exceeding ±5% of 
the initial content of one or more of the 
constituents are introduced by the manu­
facturer, 
— changes of composition involving the subs­
titution of one or more constituents, which 
may or may not be dangerous within the 
meaning of the definitions of this Directive, 
are introduced by the manufacturer. 
Article 4 
1. The Member States shall appoint the authority or 
authorities responsible for receiving and examining the 
information specified in Article 3 (3) (b) and in particular 
all the data used to determine the parameters specific to 
each of the health-endangering properties of every 
constituent in the preparation and the proposed 
concentration limits. 
2. To enable Annex I to Directive 67/548/EEC to be 
brought up to date by the procedure laid down in Article 
21 thereof, the Member States shall forward to the 
Commission upon request the information notified to 
them pursuant to Article 3 (3) (b). 
Article 5 
The classification of dangerous substances according to 
the degree of hazard and the specific nature of the risks 
involved shall be based on the definitions laid down in 
Article 2. The substances shall be classified according to 
the greatest degree of hazard in accordance with Article 
8(9). 
Article 6 
Member States shall take all necessary measures to 
ensure that the dangerous preparations referred to in 
Article 2 are not placed on the market unless they 
comply with the provisions of this Directive. 
Article 7 
1. The Member States shall take all necessary 
measures to ensure that: 
— dangerous preparations are not placed on the market 
unless their packaging meets the requirements of 
Article 15 (1) of Directive 67/548/EEC with respect 
to strength, tightness and fastening system, 
— containers which contain dangerous preparations 
offered or sold to the general public do not have a shape and/or graphic decoration likely to attract or 
arouse the active curiosity of children, nor an 
appearance resembling that of packagings generally 
used for foodstuffs. 
2. Member States shall take all necessary measures to 
ensure that containers containing certain categories of 
dangerous preparations retailed to the general public and 
defined in accordance with the procedure referred to in 
paragraph 3: 
(a) are initially closed with a seal in such a way that, 
when the package is opened for the first time, the 
seal is irreparably damaged; 
(b) are fitted with childproof fastenings; 
(c) carry a tactile warning of danger. 
3. Dangerous preparations the packagings of which 
have to be fitted with the devices referred to in 
paragraph 2 (b) and (c) shall be defined by the procedure 
referred to in Article 21 of Directive 67/548/EEC. 
The technical specifications relating to such devices are 
given in parts A and B of Annex IX to Directive 67/548/ 
EEC. 
;4mc/e 8 
1. Member States shall take all necessary measures to 
ensure that dangerous preparations are not placed on the 
market unless the labelling on the package complies with 
the requirements set out in paragraphs 2 to 10. 
2. The following information shall be clearly and 
indelibly marked on any package: 
(a) The trade name or designation of the preparation. 
(b) The chemical name of the very toxic, toxic, harmful, 
corrosive or irritant substance or substances in 
accordance with the following procedures: 
— substances having specific effects on health 
irrespective of their classification: 
the chemical name of the substance or substances 
together with the percentage concentration that 
requires the standard phrases R 45, R 46 or R 47 
to be shown on the label of the preparation in 
accordance with Article 3 (2) (f) (g) (h), 
22. 8. 85 Official Journal of the European Communities No C 211/9 
— very toxic or toxic substances: 
the chemical name of the substance or substances 
contained in a percentage exceeding 0,1% 
together with the percentage concentration or the 
percentage zone on the following scale: 
cone. < 1 % 
1 < cone. < 5 % 
5 < cone. < 20 % 
20 < cone. < 50 % 
cone. > 50 % 
Indication of the name of the substance or subs­
tances shall not, however, be necessary if the 
preparation is not classified as very toxic, toxic or 
harmful; the chemical name of the substance or substances 
shall be stated if the preparation is classified as 
irritant only; 
— substances liable to cause sensitization: 
the chemical name of the substance or substances 
or the words specified at point 3 of Annex II to 
this Directive. 
The chemical name of the substance or subs­
tances need not be stated if the preparation is 
classified as extremely flammable, highly 
flammable, flammable, oxidizing or explosive. 
The chemical name shall be one of the designations 
listed in Annex I to Directive 67/548/EEC or an 
internationally recognized designation if it is not yet 
listed therein. 
— harmful substances: 
the name of the substance or substances present 
if: 
— their individual concentration is higher than 
that specified either for their acute non-lethal 
effects after a single exposure or for their 
severe effects after repeated or prolonged 
exposure, 
— where they do not produce the effects 
described above, their individual 
concentration exceeds 10%; (c) The names and addresses of the person resident in 
the Community who is responsible for placing the 
preparation on the market, whether it be the manu­
facturer, the importer or the distributor. 
(d) Symbols where specified in this Directive and 
indications of danger involved in the use of the 
preparation in accordance with Article 16 (2) (c) of 
Directive 67/548/EEC read in conjunction with 
Annex II thereto, and, in the case of aerosol 
preparations, in accordance with points 1.8 and 2.2 
(c) of the Annex to Directive 75/324/EEC where 
flammability hazards are concerned. 
corrosive substances: 
the name of the substance or substances present 
if: 
— in the case of the substances that appear in 
Annex I to Directive 67/548/EEC, their 
individual concentration exceeds the limit 
specified in that Annex, 
— in the case of substances that do not appear in 
Annex I to Directive 67/548/EEC, their 
individual concentration exceeds 10%, 
the words 'acidic character' or 'alkaline 
character' depending on the circumstances, where 
the individual concentration of the corrosive 
substances present is lower than their specified 
corrosive limit, but where, taken together, they 
require a corrosive classification. This 
specification is applicable to all corrosive subs­
tances whether or not they appear in Annex I to 
Directive 67/548/EEC; (e) One or more standard phrases indicating the special 
risks involved in the use of the preparation (R 
phrases). 
(f) One or more standard phrases indicating the safety 
advice relating to the use of the preparation (S 
phrases). 
(g) The nominal quantity (nominal mass or nominal 
volume) of the contents in the case of preparations 
sold to the general public. 
3. The indications concerning special risks (R phrases) 
shall conform to the wording in Annex III to Directive 
67/548/EEC and shall be selected by the manufacturer 
or any other person placing the preparation on the 
market. 
irritant substances: 
the chemical name of the substance or substances 
if their individual concentration exceeds the 
irritant limit specified in Annex I to Directive 
67/548/EEC, A maximum of four R phrases are generally sufficient to 
describe the risks; in this connection the combined 
phrases listed in the aforementioned Annex II shall be 
regarded as single phrases. If the preparation falls within 
several danger categories, however, these standard 
NoC211/10 Official Journal of the European Communities 22.8.85 
phrases must cover all the principal hazards associated 
with the preparation. 
The standard phrases 'extremely flammable' or 'highly 
flammable' need not be shown if they repeat an 
indication of danger used pursuant to paragraph 2. 
4. The indications concerning safety advice (S 
phrases) shall conform to the wording in Annex IV to 
Directive 67/548/EEC and shall be selected by the 
manufacturer or any other person placing the 
preparation on the market. 
A maximum of four S phrases are generally sufficient to 
give the most appropriate safety advice; in this 
connection the combined phrases listed in the 
aforementioned Annex IV shall be regarded as single 
phrases. 
5. The package shall be accompanied by safety advice 
on the use of the preparation where it is physically 
impossible for this to be given on the label or package 
itself. 
6. For highly flammable and flammable oxidizing 
preparations, the special risks and safety advice need not 
be stated if the package contains no more than 125 ml. 
This shall also apply in the case of irritant preparations 
except where they contain substances that might cause 
sensitization. In that case point 3 of Annex II shall apply. 
7. The special provisions applicable to certain 
preparations are set out in Annex II. 
8. Article 3 (3) (a) shall apply mutatis mutandis to 
labelling. 
9. Where more than one danger symbol is assigned to 
a preparation, the following shall apply: 
— the obligation to indicate the symbol T makes the 
symbols C and X optional, 
— the obligation to indicate the symbol C makes the 
symbol X optional, 
— the obligation to indicate the symbol E makes the 
symbols F and O optional. 
10. If a preparation is classified as both harmful and 
irritant, it shall be labelled 'harmful' and attention shall 
be drawn to its harmful and irritant characteristics by the 
appropriate R phrases in accordance with paragraph 3 
above. Article 9 
1. Where the particulars required by Article 8 appear 
on a label, that label shall be firmly affixed to one or 
more surfaces of the packaging so that the said parti­
culars can be read horizontally when the package is set 
down normally. The dimensions of the label shall be as 
follows: 
Capacity of the package. 
Dimensions (in millimetres) if possible, 
— not exceeding 3 litres: 
at least 52 x 74, 
— greater than 3 litres but not exceeding 50 litres: 
at least 74 x 105, 
— greater than 50 litres but not exceeding 500 litres: 
at least 105 x 148, 
— greater than 500 litres: 
at least 148 x 210. 
Each symbol shall cover at least one-tenth of the surface 
area of the label but shall not be less than 1 cm2. The 
entire surface of the label shall adhere to the package 
immediately containing the preparation. 
These dimensions are intended solely for provision of the 
information required by this Directive and if necessary of 
any supplementary health or safety information. 
2. A label is not required when the particulars are 
clearly shown on the package itself, as specified in 
paragraph 1. 
3. The colour and presentation of the label — or, in 
the case of paragraph 2, of the package — shall be such 
that the danger symbol and its background stand out 
clearly from it. 
4. Member States may make the placing of dangerous 
preparations on the market in their territory subject to 
the use of their official language or languages for the 
purposes of labelling. 
5. For the purpose of this Directive, labelling 
requirements shall be deemed to be satisfied: 
(a) in the case of an outer package containing one or 
more inner packages, if the outer package is labelled 
in accordance with international rules on the 
transport of dangerous substances and the inner 
package or packages are labelled in accordance with 
this Directive; 
22.8.85 Official Journal of the European Communities NoC211/ll 
(b) in the case of a single package, if such a package is 
labelled in accordance with international rules on the 
transport of dangerous substances and with Article 8 
(2) (a), (b), (c), (e) and (f). 
For dangerous preparations that are not leaving the 
territory of a Member State, the labelling may be in 
accordance with national regulations instead of with the 
international rules on the transport of dangerous subs­
tances. 
Article 10 
1. Member States may: 
(a) permit the labelling required by Article 8 to be 
applied in some other appropriate manner on 
packages which are either too small or otherwise 
unsuitable for labelling in accordance with Article 9 
(1) and (2); 
(b) by way of derogation from Articles 7 and 8, permit 
the packaging of dangerous preparations which are 
neither explosive nor toxic to be unlabelled or to be 
labelled in some other way if they contain such small 
quantities that there is no reason to fear any danger 
to persons handling such preparations or to other 
persons. 
2. If a Member State makes use of the options 
provided for in paragraph 1, it shall forthwith inform the 
Commission thereof. 
Article 11 
For dangerous preparations retailed to the general 
public, any Member State may, to facilitate prompt and 
effective medical treatment in the event of illness, require 
adequate information relevant to the substances 
contained in the preparations to be made available to a 
body appointed for that purpose, which will ensure that 
such information is used only for treatment purposes. 
Article 12 
Member States shall not prohibit, restrict or impede, on 
the grounds of classification, packaging or labelling as 
defined in this Directive, the placing on the market of 
dangerous preparations which satisfy the requirements of 
this Directive and Annex II thereto. 
Article 13 preparation, although satisfying the requirements of this 
Directive, constitutes a hazard for man or the 
environment by reason of its classification, packaging or 
labelling, it may provisionally prohibit the sale of that 
hazardous preparation or subject it to special conditions 
in its territory. It shall immediately inform the 
Commission and the other Member States of such action 
and give reasons for its decision. 
2. The Commission shall consult the Member States 
concerned as soon as possible, then deliver its opinion 
without delay and take the appropriate measures. 
3. If the Commission considers that technical adap­
tations to this Directive are necessary, such adaptations 
shall be adopted in accordance with the procedure laid 
down in Article 21 of Directive 67/548/EEC. In such a 
case, Member States which have adopted safeguard 
measures may maintain them until the adaptations enter 
into force. 
Article 14 
Amendments required to adapt the Annexes to technical 
progress shall be adopted in accordance with the 
procedure laid down in Article 21 of Directive 67/548/ 
EEC. 
Article 15 
1. Member States shall bring into force not later than 
31 December 1986 the laws, regulations and 
administrative provisions necessary to comply with this 
Directive and shall forthwith inform the Commission 
thereof. 
2. Member States shall communicate to the 
Commission the text of the main provisions of national 
law which they adopt in the field covered by this 
Directive not later than 30 June 1987. 
3. On the date this Directive enters into force, 
Directives 73/177/EEC (solvents), 77/728/EEC (paints, 
varnishes and similar products) and 78/631/EEC 
(pesticides) shall be repealed. Nevertheless, preparations 
which are in conformity with the specifications of the 
abovementioned Directives may continue to be placed on 
the market until . . . (one year after the date of entry into 
force). 
Article 16 
1. Where a Member State has detailed evidence that a This Directive is addressed to the Member States. 
No C 211/12 Official Journal of the European Communities 22. 8. 85 
ANNEX I 
Method of defining parameters characterizing the health hazards of a substance used as a constituent in a 
preparation 
Introduction 
Article 1 (2) states that the Directive is applicable to preparations containing one or more dangerous subs­
tances that may or may not appear in Annex I to Directive 67/548/EEC. 
For dangerous substances that already appear in the abovementioned Annex, the parameters to be taken 
into account in assessing health hazards pursuant to Article 3 are also included. 
For dangerous substances that do not yet appear in Annex I to Directive 67/548/EEC, the parameters 
characterizing such substances shall be defined by the method described below. 
1. General criteria 
Aside from any synergetic or antagonistic phenomena, the health hazards of a preparation are a 
function of the hazards peculiar to each of the constituents and their concentration in the preparation. 
Accordingly, a systematic assessment must be made of all the health hazards that the use of a substance 
might entail. For that purpose the dangerous health effects have been subdivided into: 
Systemic effects including: 
— acute lethal effects, 
— non-lethal irreversible effects after a single exposure, 
— severe effects after repeated or prolonged exposure. 
Local effects including: 
— corrosive effects, 
— irritant effects, 
— sensitizing effects. 
Specific health effects including: 
— carcinogenesis, 
— mutagenesis, 
— teratogenesis. 
The systematic assessment of all the dangerous health effects is expressed by means of a hazard index, a 
concentration limit or a combination of the two. 
2. Assessment of systemic effects. 
2.1. Assessment of acute lethal effects (DL50/LC5CI). 
These effects shall be characterized by a hazard index, which shall be determined in the light of the 
results of the acute toxicity tests for each type of exposure, as follows: 
For each dose/concentration range (LD50 expressed in mg/kg or LC50 in mg/1 4 h) there is an 
acute lethal toxicity index specific to each type of exposure. 
These indices are set out in Table I. 
22. 8. 85 Official Journal of the European Communities No C 211 /13 
TABLE I 
Dose/concentration ranges and corresponding indices for acute toxicity (LD50/LC50) 
Dose/concentration ranges for each type of exposure and corresponding indices 
Categories and 
Subdivisions 
Very toxic 1 
2 
3 
4 
Toxic 1 
2 
3 
4 
Harmful 1 
2 
3 
4 LD50 oral 
(mg/kg) 
< 1 
> 1, < 3 
> 3, < 9 
> 9, < 25 
> 25, < 40 
> 40, < 70 
> 70, < 120 
> 120, < 200 
> 200, < 350 
> 350, < 600 
> 600, < 1 100 
> 1 100, < 2 000 liorl 
3 500 
1 100 
400 
130 
60 
35 
20 
12 
7 
4 
2,5 
1,5 LD50 percutaneous 
(mg/kg) 
< 2 
> 2, < 6 
> 6, < 18 
> 18, < 50 
> 50, < 80 
> 80, < 140 
> 140, < 230 
> 230, < 400 
> 400, < 600 
> 600, < 900 
> 900, < 1 300 
> 1 300, < 2 000 liskn 
1700 
600 
200 
70 
30 
20 
10 
6 
4 
3 
2,5 
1,5 Inhalation LC50 
(mg/1 4 h) 
< 0,02 
> 0,02, < 0,06 
> 0,06, < 0,18 
> 0,18, < 0,5 
> 0,5, < 0,7 
> 0,7, < 1,0 
> 1, < 1,4 
> 1,4 < 2 
> 2, < 3,5 
> 3,5, < 6 
> 6, < 11 
> 11, < 20 Iiiw 
1 700 
600 
200 
70 
30 
20 
17 
12 
7 
4 
2,5 
1,5 
2.2. Assessment of the non-lethal irreversible effects after a single exposure. 
These effects shall be assessed on the basis of concentration limits. 
For substances that produce such effects the individual concentration limit determining the classi­
fication of the preparation shall be specified as follows: 
— substances classified as very toxic owing to such effects: 
> 0,2%, < 1%: at least harmful, 
> 1%, <10%: at least toxic, 
> 10 %: very toxic; 
— substances classified as toxic owing to such effects: 
> 1% <10%: at least harmful, 
> 10%: at least toxic; 
— substances classified as harmful owing to such effects: 
>10%: at least harmful. 
2.3. Assessment of severe effects after repeated or prolonged exposure. 
These effects shall be assessed on the basis of concentration limits. 
For substances that produce such effects the individual concentration limit determining the class­
ification of the preparation shall be specified as follows: 
— substances classified as toxic owing to such effects: 
> 1 % < 10 %: at least harmful, 
> 10%: at least toxic; 
— substances classified as harmful owing to such effects: 
> 10 %: at least harmful. 
3. Assessment of local effects 
For substances that produce such effects but do not yet appear in Annex I to Directive 67/548/EEC, the 
concentration limits specified below shall be taken into consideration when classifying the preparation. 
3.1. Corrosive effects: 
For substances that produce such effects the individual concentration limit determining the classi­
fication of the preparation shall be specified as follows: 
> 10%: Corrosive, 
5 — 10%: Irritant. 
No C 211 /14 Official Journal of the European Communities 22.8.85 
3.2. Irritant effects: 
For substances that produce such effects the individual concentration limit determining the classi­
fication of the preparation shall be specified as follows: 
> 5 %: Irritant to the skin, 
> 2 %: Irritant to the eyes. 
3.3. Sensitizing effects: 
For substances that produce such effects, the individual concentration limit determining the classi­
fication of the preparation shall be specified as follows: 
— substances that produce a sensitizing effect by inhalation: 
> 1 %: at least harmful 
— substances that produce a sensitizing effect through contact with the skin: 
> 2 %: at least irritant. 
Note 
Some substances may produce sensitizing effects in both these ways — through contact with the skin 
and by inhalation. In this case the concentration limit assigned to such substances corresponds to the 
concentration at which the first sensitizing effect occurs. A preparation containing such a substance in a 
concentration exceeding 1 % shall be classified as harmful unless there are other effects that call for a 
stricter classification. 
4. Assessment of specific health effects 
In accordance with Directive 83/467/EEC, substances that produce such effects but do not yet appear 
in Annex I to Directive 67/548/EEC shall be provisionally classified as at least harmful. 
For substances that produce these effects, not more closely defined, the individual concentration limit 
determining the classification of the preparation shall be specified as follows: 
. . . %: at least harmful. 
ANNEX II 
Special provisions on the labelling of certain preparations 
1. The labelling or packaging of the preparations shall not carry information such as 'non toxic', 'not 
harmful' or any other statement indicating that the preparation is not dangerous. 
2. Preparations classified as very toxic, toxic or corrosive sold to the general public. 
2.1. The labels on packages containing such preparations shall bear the inscriptions S 1/S 2 and S 49 in 
addition to the specific safety advice. 
2.2. Where it is physically impossible to give such information on the package itself, packages 
containing such preparations shall be accompanied by precise and easily understandable instructions 
for use including, where necessary, instructions for the destruction of the empty package. 
3. Preparations containing one or more substances liable to cause sensitization. 
The package label of preparations containing one or more substances liable to cause sensitization shall 
show: 
(a) the name of the substance or substances and the standard phrases (R 42, R 43, R 42/43) indicating 
these particular risks if: 
— in the case of substances that appear in Annex I to Directive 67/548/EEC, their individual 
concentration exceeds the limits laid down in that Annex, 
22.8.85 Official Journal of the European Communities NoC211/15 
— in the case of substances that do not yet appear in Annex I to Directive 67/548/EEC, their 
individual concentration exceeds 1 %. 
(b) the inscription 'Contains (a) sensitizing substance(s)' if their individual concentration is lower than 
the limits given above. 
4. Preparations containing lead. 
4.1. Paints and varnishes: 
Labels on packages of paints and varnishes containing a quantity of lead exceeding / 0,5 % / 
(expressed as weight of metal) in the total weight of the preparation shall bear the following 
inscription: 
'Contains lead. Must not be used on objects liable to be chewed or sucked by children.' 
In the case of packages the contents of which are not more than 125 millilitres, the inscription may 
be as follows: 
'Warning. Contains lead.' 
5. Preparations containing cyanoacrylates. 
5.1. Glues: 
The immediate packaging of glues based on cyanoacrylate shall bear the following inscriptions: 
'Cyanoacrylate 
Danger 
Bonds skin and eyes in seconds. 
Keep out of the reach of children.' 
Appropriate advice on safety shall accompany the package. 
6. Preparations containing isocyanates. 
The package labels of preparations containing isocyanates (as monomers, obligomers, prepolymers, etc., 
or as mixtures thereof) shall bear the following inscriptions: 
'Contains isocyanates. 
See information supplied by the manufacturer.' 
7. Preparations containing epoxy constituents with an average molecular weight, < 700 shall bear the 
following inscriptions: 
'Contains epoxy constituents. 
See information supplied by the manufacturer.' 
8. Preparations intended for use by spraying. 
The package label on preparations intended for use by spraying shall bear the safety advice S 23 and 
S 38 or S 23 and S 51 depending on the application criteria specified in Directive 83/467/EEC.