30. 12. 87 Official Journal of the European Communities No C 353/1 
II 
(Preparatory Acts) 
COMMISSION 
Amendment to the 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(87) 633 final 
(Submitted by the Commission pursuant to Article 149 (3) of the EEC Treaty on 
25 November 1987) 
(87/C 353/01) 
THE COUNCIL OF THE EUROPEAN COMMUNITIES, 
Having regard to the Treaty establishing the European 
Economic Community, and in particular Article 100A 
thereof, 
Having regard to the proposal from the Commission (!), 
In cooperation with the European Parliament, 
Having regard to the opinion of the Economic and 
Social Committee (2), 
Whereas measures for the progressive establishment of 
the internal market over the period up to 31 December 
1992 have to be adopted; whereas the internal market 
comprises an area without internal frontiers in which 
the free movement of goods, persons, services and capi­
tal is guaranteed; 
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 
classification, packaging and labelling of dangerous 
substances (3), as last amended by Directive 79/831/ 
EEC(4); 
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 label­
ling of dangerous preparations (solvents) (5), as last 
amended by Directive 80/781/EEC(6), 
— 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 label­
ling of paints, varnishes, printing inks, adhesives 
and similar products (7), as last amended by Direc­
tive 83/265/EEC(8); 
Whereas despite the abovementioned Community 
measures the rules, if any, applying to dangerous prep­
arations 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 estab­
lishment 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 Com­
munity rules at present in force; 
Whereas this Directive must at the same time provide 
protection for the general public, in particular, for 
persons who come into contact with dangerous prep­
arations in the course of their work or in the pursuit 
of a hobby; and for consumers, especially children and 
the visually handicapped, and also for the environment; 
(J) OJ No C 211, 22. 8. 1985, p. 3. 
(2) OJ No C 189, 28. 7. 1986. 
(3) OJNoL 196, 16. 8. 1967, p. 1. 
(4) OJ No L 259, 15. 10. 1979, p. 10. s) OJNoL 189, 11.7. 1973, p. 7. 
6) OJ No L 229, 30. 8. 1980, p. 57. 
7) OJ No L 303, 28. 11. 1977, p. 23. 
8) OJNoL 147,6.6. 1983, p. 11. 
No C 353/2 Official Journal of the European Communities 30. 12. 87 
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 and risk and safety phrases have also to be 
brought into line with Directive 67/548/EEC; 
Whereas some preparations, although they contain con­
stituents which are dangerous to health, are not necess­
arily dangerous in the form in which they are placed 
on the market; whereas there are exceptions, however; 
whereas the latter must be the subject of special label­
ling, as appropriate, in accordance with the provisions 
of Directive 83/467/EEC or of Annex II to this Direc­
tive; 
Whereas the label constitutes a basic tool for users of 
the preparations by giving them the initial essential 
concise information that nevertheless needs to be sup­
plemented by a two-fold system of more detailed infor­
mation, one intended for professional users, and the 
second for the bodies appointed by the Member States 
and whose responsibility it is to give information 
reserved solely for medical purposes, both curative and 
preventive; 
Whereas dangerous preparations may, although confor­
ming to the provisions of this Directive, nevertheless 
constitute a danger to health or the environment; where­
as it is therefore advisable to provide a procedure to 
reduce this danger; 
Whereas the Commission will, on the basis of infor­
mation to be supplied by the Member States (within 18 
months of the Directive's implementation), submit a 
report, within two years of implementation of this 
Directive, concerning by inadequacies or loopholes in 
Directive 78/631/EEC as compared with the present 
Directive; whereas on the basis of this report, the Com­
mission will if appropriate submit the necessary pro­
posals, 
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 which 
are placed on the market in the Member States and: 
— contain at least one substance classified as danger­
ous, within the meaning of Article 2, or 
— are regarded as dangerous within the meaning of 
Article 3. This Directive shall also apply to the preparations listed 
in Annex II. 
3. This Directive shall not apply to provisions con­
cerning: 
(a) medicinal or veterinary products as defined by 
Directive 65/65/EEC; 
(b) cosmetic products as defined by Directive 76/768/ 
EEC; 
(c) mixtures of substances which, in the form of waste, 
are covered by Council Directives 75/442/EEC and 
78/319/EEC; 
(d) pesticides covered by Directive 78/631/EEC; 
(e) munitions and explosives placed on the market with 
a view to obtaining a practical effect by explosion 
or a pyrotechnic effect. 
In addition, this Directive shall not apply to: 
(f) foodstuffs in a finished stage intended for the final 
consumer; 
(g) animal feedingstuffs in a finished stage intended for 
the final consumer; 
(h) the carriage of dangerous substances by rail, road, 
inland waterway, sea or air; 
(i) preparations in transit which are under customs 
supervision provided they do not undergo any treat­
ment or processing. 
Article 2 
The definitions appearing in Article 2 of Directive 67/ 
548/EEC, with the exception of the definition in para­
graph 1 (d) thereof, shall apply to this Directive. 
Article 3 
1. The general principles of the classification and 
labelling of preparations shall be applied according to 
the criteria in Annex VI to Directive 67/548/EEC save 
where the alternative criteria referred to below are 
applied. 
2. The requisite physico-chemical properties for the 
classification of preparations shall be determined by 
the methods specified in Annex V (A) to Direc­
tive 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 of Directive 67/548 and the specific evaluation criteria 
detailed in those methods. 
30. 12. 87 Official Journal of the European Communities No C 353/3 
By way of derogation: 
(a) the determination of the explosive, oxidizing, 
extremely flammable, highly flammable or flam­
mable properties is not necessary provided, how­
ever, that none of the constituents possesses such 
properties and that on the basis of the information 
available to the manufacturer the preparation is 
unlikely to present dangers of this kind; 
(b) the preparations placed on the market in the form 
of aerosols are subject to the flammability criteria 
specified in paragraphs 1.8 and 2.2 (c) of the Annex 
to Directive 75/324/EEC. 
3. The health hazards of a preparation shall be deter­
mined by one or more of the following methods: 
(a) by the conventional method described below using 
concentration limits; 
(b) by determining the toxicological properties of the 
preparation necessary for an appropriate classifi­
cation and label in accordance with the criteria in 
Annex VI to Directive 67/548/EEC. The toxicologi­
cal properties shall be determined by the methods 
specified in point B of Annex V to that Directive. 
Any one or more of the toxicological properties of 
the preparation which are not assessed by the 
method set out in Article 3 (3) (b) shall be assessed 
in accordance with the conventional method. 
Where a toxicological property has been established by 
both the methods above, the result of method (b) shall 
be used for classifying the preparation except in the 
case of carcinogenic, mutagenic and teratogenic effects. 
Furthermore, where it can be demonstrated that: health hazard assessment either by method 3 (a) or 
3 (b) shall be performed whenever: 
changes of composition of the initial concentration, 
expressed as a weight/weight percentage, of one or 
more of the dangerous constituents are introduced 
by the manufacturer, in accordance with the follow­
ing table: 
Initial 
concentration range 
of the constituent 
< 2,5 % 
> 2,5 < 10 % 
> 10 < 25 % 
> 20 < 50 % 
> 50 < 100 % Permitted 
variation 
in initial 
concentration 
of the constituent 
± 15 % 
± 10 % 
± 6 % 
± 5 % 
± 2,5% 
— changes of composition involving the substitution 
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 manufac­
turer. 
5. In accordance with Article 3 (3) (a), the health 
hazards shall be assessed by the conventional method 
described below, using individual concentration limits. 
Where the dangerous substances listed in Annex I to 
Directive 67/548/EEC are assigned concentration limits 
necessary for the application of the method of evalu­
ation described below, those concentration limits shall 
be used. 
Where the dangerous substances do not appear in 
Annex I to Directive 67/548/EEC or appear there with­
out the concentration limits necessary for the appli­
cation of the method of evaluation described below, 
the concentration limits shall be assigned in accordance 
with the specifications in Annex I to this Directive. 
toxicological effects on man differ from those 
suggested by a toxicological determination or a 
conventional assessment, then the preparation shall 
be classified according to its effects on man, 
owing to effects such as synergism or potentiation 
a conventional assessment would underestimate the 
toxicological hazard, these effects shall be taken 
into account in classifying the preparation, 
owing to effects such as synergism or antagonism 
a conventional assessment would overestimate the 
toxicological hazard, these effects shall be taken 
into account in classifying the preparation. 
4. For preparations of a known composition classi­
fied in accordance with method 3 (b) above a new In that case: 
(a) the following preparations shall be regarded as very 
toxic: 
(i) owing to their acute lethal effects, preparations 
containing one or more substances classified 
or regarded as very toxic in individual concen­
trations exceeding: 
— either the concentration specified in 
Annex I to Directive 67/548/EEC for the 
substance or substances under consider­
ation, 
— or the concentration specified at point 1 of 
Annex I (Table 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 concentration limits; 
No C 353/4 Official Journal of the European Communities 30. 12. 87 
(ii) owing to their acute lethal effects, preparations 
containing more than one substance classified 
or regarded as very toxic in individual concen­
trations not exceeding the limits specified either 
in Annex I to Directive 67/548/EEC or at 
point 1 of Annex I (Table I) to this Directive 
if the sum of the quotients obtained by dividing 
the percentage by weight of each very toxic 
substance in the preparation by the limit speci­
fied for that substance is 1 or more, i.e.: 
where: 
PT+ is the percentage by weight of each 
very toxic substance in the prep­
aration, and 
LT + is the limit specified for each very toxic 
substance expressed as a percentage; 
(iii) owing to their non-lethal irreversible effects 
after one exposure, preparations containing 
one or more dangerous substances that produce 
such effects in individual concentrations 
exceeding: 
— either the concentration specified in 
Annex I to Directive 67/548/EEC for the 
substance or substances under consider­
ation, 
— or the concentration specified at point 2 of 
Annex I (Table II) to this Directive where 
the substance or substances under consider­
ation do not appear in Annex I to 
Directive 67/548/EEC or appear in it with­
out concentration limits; 
(b) the following preparations shall be regarded as 
toxic: 
(i) owing to their acute lethal effects, preparations 
containing one or more substances classified 
or regarded as very toxic, toxic or in individual 
concentrations exceeding: 
— either the concentrations specified in 
Annex I to Directive 67/548/EEC for the 
substance or substances under consideration, 
— or the concentration specified at point 1 (a) 
of Annex I (Table 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 concentration limits; 
(ii) owing to their acute lethal effects, preparations 
containing more than one substance classified 
or regarded as very toxic or toxic in individual 
concentrations not exceeding the limits speci­
fied either in Annex I to Directive 67/548/EEC or at point 1 of Annex I (Table I) to this 
Directive if the sum of the quotients obtained 
by dividing the percentage by weight of each 
substance in the preparation by the toxic limit 
specified for that substance is 1 or more, i.e.: 
\ L-p Lj / 
where: 
PT+ is the percentage by weight of each 
very toxic substance in the prep­
aration, 
PT is the percentage by weight of each 
toxic substance in the preparation, 
and 
LT is the limit specified for each very toxic 
or toxic substance expressed as a per­
centage; 
(iii) owing to their non-lethal irreversible effects 
after one exposure, preparations containing 
one or more dangerous substances that produce 
such effects in individual concentrations 
exceeding: 
— either the concentration specified in 
Annex I to Directive 67/548/EEC for the 
substance or substances under consider­
ation, 
— or the concentration specified at point 2 of 
Annex I (Table II) to this Directive where 
the substance or substances under consider­
ation do not appear in Annex I to 
Directive 67/548/EEC or appear in it with­
out concentration limits; 
(iv) owing to their long-term effects, preparations 
containing one or more dangerous substances 
that produce such effects in individual concen­
trations exceeding: 
— either the concentration specified in 
Annex I to Directive 67/548/EEC for the 
substance or substances under consider­
ation, 
— or the concentration specified at point 3 of 
Annex I (Table III) to this Directive where 
the substance or substances under consider­
ation do not appear in Annex I to Directive 
67/548/EEC or appear in it without concen­
tration limits; 
(c) the following preparations shall be regarded as 
harmful: 
(i) owing to their acute lethal effects, preparations 
containing one or more substances classified 
or regarded as very toxic, toxic or harmful in 
individual concentrations exceeding: 
— either the concentration specified in 
Annex I to Directive 67/548/EEC for the 
substance or substances under consider­
ation, 
30. 12. 87 Official Journal of the European Communities No C 353/5 
— or the concentration specified at point 1 of 
Annex I (Table 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 concentration limits; 
(ii) owing to their acute lethal effects, preparations 
containing more than one of the substances 
classified or regarded as very toxic or toxic 
or harmful in individual concentrations not 
exceeding the limits specified either in Annex I 
to Directive 67/548/EEC or at point 1 of An­
nex I (Table I) to this Directive if the sum of 
the quotients obtained by dividing the percent­
age by weight of each substance in the prep­
aration by the harmful limit specified for that 
substance is 1 or more, i.e.: 
JXn JXn Xn 
JXn >1 — or the concentration specified at point 3 of 
Annex I (Table III) to this Directive where 
the substance or substances under consider­
ation do not appear in Annex I to 
Directive 67/548/EEC or appear in it with­
out concentration limits; 
(v) owing to their sensitizing effects by inhalation, 
preparations containing at least one dangerous 
substance to which is assigned phrase R42 that 
produces such effects in individual concen­
trations exceeding: 
— either the concentration specified in 
Annex I to Directive 67/548/EEC for the 
substance or substances under consider­
ation, 
— or the concentration specified at point 5 of 
Annex I (Table V) to this Directive where 
the substance or substances under consider­
ation do not appear in Annex I to 
Directive 67/548/EEC or appear in it with­
out concentration limits; 
whe: 
PT+ 
PT 
PXn 
LXn is the percentage by weight of each 
very toxic substance in the prep­
aration, 
is the percentage by weight of each 
toxic substance in the preparation, 
is the percentage by weight of each 
harmful substance in the preparation, 
and 
is the limit specified for each very 
toxic, toxic or harmful substance 
expressed as a percentage; 
(iii) owing to their non-lethal irreversible effects 
after one exposure, preparations containing 
one or more dangerous substances that produce 
such effects in individual concentrations 
exceeding: 
— either the concentration specified in 
Annex I to Directive 67/548/EEC for the 
substance or substances under consider­
ation, 
— or the concentration specified at point 2 of 
Annex I (Table II) to this Directive where 
the substance or substances under consider­
ation do not appear in Annex I to 
Directive 67/548/EEC or appear in it with­
out concentration limits; 
(iv) owing to their long-term effects, preparations 
containing one or more dangerous substances 
that produce such effects in individual concen­
trations exceeding: 
— either the concentration specified in 
Annex I to Directive 67/548/EEC for the 
substance or substances under consider­
ation, (d) the following preparations shall be regarded as very 
corrosive for the skin: 
(i) preparations containing one or more substances 
classified or regarded as corrosive to which is 
assigned phrase R35 in individual concen­
trations 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 4 of 
Annex I (Table IV) to this Directive where 
the substance or substances do not appear 
in Annex I to Directive 67/548/EEC or 
appear in it without concentration limits; 
(ii) preparations containing more than one substan­
ce classified or regarded as corrosive to which 
is assigned phrase R35 in individual concen­
trations not exceeding the limits specified either 
in Annex I to Directive 67/548/EEC or at point 
4 of Annex I (Table IV) to this Directive if the 
sum of the quotients obtained by dividing the 
percentage by weight of each corrosive sub­
stance in the preparation by the corrosive limit 
specified for that substance is 1 or more, i.e.: 
C, R35 
X, R35 >1 
where: 
p 
1 C, R35 
X, R35 is the percentage by weight of each 
corrosive substance in the prep­
aration, and 
is the corrosive limit specified for each 
corrosive substance to which is assig­
ned phrase R35 expressed as a per­
centage by weight; 
No C 353/6 Official Journal of the European Communities 30. 12. 87 
(e) the following preparations shall also be regarded as 
corrosive for the skin: 
(i) preparations containing one or more substances 
classified or regarded as corrosive to which is 
assigned phrase R34 in individual concen­
trations exceeding: 
— either the concentration specified in An­
nex I to Directive 67/548/EEC for the sub­
stance or substances under consideration, 
— or the concentration specified at point 4 of 
Annex I (Table IV) to this Directive where 
the substance or substances do not appear 
in Annex I to Directive 67/548/EEC or 
appear in it without concentration limits; 
(ii) preparations containing more than one substan­
ce classified or regarded as corrosive to which 
is assigned phrase R34 in individual concen­
trations not exceeding the limits specified either 
in Annex I to Directive 67/548/EEC or at point 
4 of Annex I (Table IV) to this Directive if the 
sum of the quotients obtained by dividing the 
percentage by weight of each corrosive substan­
ce in the preparation by the corrosive limit speci­
fied for that substance is 1 or more, i.e.: 
V / ^c' R35 , Pc, R34 . > 1 
JC, R34 -C, R34 in Annex I to Directive 67/548/EEC or 
appear in it without concentration limits; 
(ii) preparations containing more than one of the 
substances classified or regarded as corrosive 
or irritant to which is assigned phrase R41 in 
individual concentrations not exceeding the 
limits specified either in Annex I to Directive 
67/548/EEC or at point 4 of Annex I (Table IV) 
to this Directive if the sum of the quotients 
obtained by dividing the percentage by weight 
of each substance in the preparation by the 
irritant limit specified for that substance is 1 or 
more, i.e.: 
Xi, R41 
JXi, R41 >1 
where: 
p 
1 Xi, R41 
L Xi, R41 is the percentage by weight of each 
irritant substance to which is assig­
ned phrase R41 in the preparation, 
and 
is the irritant limit specified for 
each irritant substance to which is 
assigned phrase R41 expressed as 
a percentage by weight; 
where: 
^C, R3.5 
C, R34 
JC, R34 is the percentage by weight of each 
corrosive substance to which is assig­
ned phrase R35 in the preparation, 
is the percentage by weight of each 
corrosive substance to which is assig­
ned phrase R34 in the preparation, 
and 
is the corrosive limit specified for each 
corrosive substance to which is assig­
ned phrase R34 expressed as a per­
centage by weight; (g) the following preparations shall be regarded as skin 
irritants: 
(i) preparations containing one or more sub­
stances classified or regarded as corrosive or 
irritant to which is assigned phrase R38 in 
individual concentrations exceeding: 
— either the concentration specified in 
Annex I to Directive 67/548/EEC for the 
substance or substances under consider­
ation, 
— or the concentration specified at point 4 of 
Annex I (Table IV) to this Directive where 
the substance or substances do not appear 
in Annex I to Directive 67/548/EEC or 
appear in it without concentration limits; 
(f) the following preparations shall be regarded as 
liable to cause serious eye damage: 
(i) preparations containing one or more substances 
classified or regarded as irritant and to which is 
assigned phrase R41 in individual concen­
trations 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 4 of 
Annex I (Table IV) to this Directive where 
the substance or substances do not appear (ii) preparations containing more than one of the 
substances classified or regarded as corrosive 
or irritant to which is assigned phrase R38 
in individual concentrations not exceeding the 
limits specified either in Annex I to Directive 
67/548/EEC or at point 4 of Annex I (Table IV) 
to this Directive if the sum of the quotients 
obtained by dividing the percentage by weight 
of each substance in the preparation by the 
irritant limit specified for that substance is 1 
or more, i.e.: 
PC, R35 PC, R34 PXi, R38 . > 
JXi, R38 -Xi, R38 JXi, R38 
30. 12. 87 Official Journal of the European Communities No C 353/7 
where: 
p 
1 C, R35 
C, R34 
Xi, R38 
JXi, R38 is the percentage by weight of each 
corrosive substance to which is 
assigned phrase R35 in the prep­
aration, 
is the percentage by weight of each 
corrosive substance to which is 
assigned phrase R34 in the prep­
aration, 
is the percentage by weight of each 
irritant substance to which is assig­
ned phrase R38 in the preparation, 
and 
is the irritant limit specified for 
each corrosive or irritant substance 
to which is assigned phrase R38 
expressed as a percentage by 
weight; 
(iii) owing to their sensitizing effects by skin con­
tact, preparations containing at least one 
dangerous substance to which is assigned 
phrase R43 that produces such effects in indi­
vidual concentrations exceeding: 
— either the concentration specified in 
Annex I to Directive 67/548/EEC for the 
substance under consideration, 
— or the concentration specified at point 5 of 
Annex I (Table V) to this Directive where 
the substance or substances do not appear 
in Annex I to Directive 67/548/EEC or 
appear in it without concentration limits; 
(h) the following preparations shall be regarded as eye 
irritants: 
(i) preparations containing one or more substances 
classified or regarded as irritant to which is 
assigned phrase R41 or R36 in individual con­
centrations 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 4 of 
Annex I (Tabel IV) to this Directive where 
the substance or substances do not appear 
in Annex I to Directive 67/548/EEC or 
appear in it without concentration limits; 
(ii) preparations containing more than one of the 
substances classified or regarded as irritant to 
which is assigned phrase R41 or phrase R36 
in individual concentrations not exceeding the 
limits specified in Annex I to Directive 67/548/ 
EEC or at point 4 of Annex I (Table IV) to this 
Directive if the sum of the quotients obtained 
by dividing the percentage by weight of each 
substance in the preparation by the irritant limit 
specified for that substance is 1 or more, i.e.: *Xi, R41_ ^Xi, R36 . > 1 
•mere: 
Xi, R41 
Xi, R36 
JXi, R36 *-Xi, R36 ^Xi, R36 
is the percentage by weight of each 
irritant substance which is assigned 
phrase R41 in the preparation, 
is the percentage by weight of each 
irritant substance to which is assigned 
phrase R36 in the preparation, and 
is the irritant limit specified for each 
irritant substance to which is assig­
ned, phrase R41 or R36 expressed as 
a percentage by weight; 
the following preparations shall be regarded as irri­
tants for the respiratory system: 
(i) preparations containing one or more substances 
classified or regarded as irritant to which is 
assigned phrase R37 in individual concen­
trations 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 4 of 
Annex I (Tabel IV) to this Directive where 
the substance or substances do not appear 
in Annex I to Directive 67/548/EEC or 
appear in it without concentration limits; 
preparations containing more than one of the 
substances classified or regarded as irritant to 
which is assigned phrase R37 in individual con­
centrations not exceeding the limits specified 
either in Annex I to Directive 67/548/EEC or at 
point 4 of Annex I (Tabel IV) to this Directive 
if the sum of the quotients obtained by dividing 
the percentage by weight of each substance in 
the preparation by the irritant limit specified for 
that substance is 1 or more, i.e.: 
Xi, R37 
JXi, R37 
where: 
p 
1 Xi, R37 
JXi, R37 is the percentage by weight of each 
irritant substance to which is assigned 
phrase R37 in the preparation, and 
is the irritant limit specified for each 
irritant substance to which is assigned 
phrase R37 expressed as a percentage 
by weight; 
No C 353/8 Official Journal of the European Communities 30. 12. 87 
(j) preparations shall be regarded as carcinogenic and 
classified at least as toxic if they contain a substance 
producing such effects, to which is assigned the 
standard phrase R45, which denotes carcinogenic 
substances in category 1 and category 2, in a concen­
tration equal to or exceeding: 
— either the concentration specified in Annex I to 
Directive 67/548/EEC for the substance under 
consideration, 
— or the concentration specified at point 6 of 
Annex I (Table VI) to this Directive where the 
substance or substances do not appear in Annex 
I to Directive 67/548/EEC or appear in it with­
out concentration limits; 
(k) preparations shall be regarded as suspect for 
humans owing to their possible carcinogenic effects 
and classified at least as harmful if they contain a 
substance producing such effects to which is assig­
ned the standard phrase R40, which denotes carci­
nogenic substances in category 3, in a concentration 
equal to or exceeding: 
— either the concentration specified in Annex I to 
Directive 67/548/EEC for the substance under 
consideration, 
— or the concentration specified at point 6 in 
Annex I (Table VI) 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 concentration limits; 
(1) preparations shall be regarded as mutagenic and 
classified at least as toxic if they contain a substance 
producing such effects, to which is assigned the 
standard phrase R46 which denotes mutagenic sub­
stances in category 1, in a concentration equal to 
or exceeding: 
— either the concentration specified in Annex I to 
Directive 67/548/EEC for the substance under 
consideration, 
— or the concentration specified at point 6 of 
Annex I (Table VI) to this Directive where the 
substance or substances under consideration do 
not appear in Annex I to Directive 67/548/EEG 
or appear in it without concentration limits; 
(m) preparations shall be regarded as having to be 
treated as mutagenic and classified at least as harm­
ful if they contain a substance producing such effects 
to which is assigned the standard phrase R46, which 
denotes mutagenic substances in category 2, in a 
concentration equal to or exceeding: 
— either the concentration specified in Annex I to 
Directive 67/548/EEC for the substance under 
consideration, 
— or the concentration specified at point 6 of 
Annex I (Table VI) to this Directive where the 
substance or substances under consideration do not appear in Annex I to Directive 67/548/EEG 
or appear in it without concentration limits; 
(n) preparations shall be regarded as suspect for 
humans because of their possible mutagenic effects 
and classified at least as harmful if they contain a 
substance producing such effects to which is assig­
ned the standard phrase R40, which denotes muta­
genic substances in category 3, in a concentration 
equal to or exceeding: 
— either the concentration specified in Annex I to 
Directive 67/548/EEC for the substance under 
consideration, 
— or the concentration specified at point 6 of 
Annex I (Table VI) 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 concentration limits; 
(o) preparations shall be regarded as teratogenic and 
classified at least as toxic if they contain a substance 
producing such effects, which is assigned the stan­
dard phrase R47, which denotes teratogenic sub­
stances in category 1, in a concentration equal to 
or exceeding: 
— either the concentration specified in Annex I to 
Directive 67/548/EEC for the substance under 
consideration, 
— or the concentration specified at point 6 of 
Annex I (Table VI) 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 wihtout concentration limits; 
(p) preparations shall be regarded as having to be 
treated as teratogenic and classified at least as harm­
ful if they contain a substance producing such effects 
to which is assigned the standard phrase R47, which 
denotes teratogenic substances in category 2, in a 
concentration equal to or exceeding: 
— either the concentration specified in Annex 1 to 
Directive 67/548/EEC for the substance under 
consideration, 
— or the concentration specified at point 6 of 
Annex I (Table VI) 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 wihtout concentration limits; 
(q) preparations shall be regarded as having specific 
effects on health not further defined and classified 
at least as harmful if they contain a substance which 
does not yet appear in Annex I to Directive 67/548/ 
EEC but to which is provisionally assigned the 
standard phrase R40 denoting such substances in a 
concentration exceeding that specified at point 6 of 
Annex I (Table VI) to this Directive. 
30. 12. 87 Official Journal of the European Communities No C 353/9 
6. For preparations covered by this Directive: Article 6 
(a) no account shall be taken of substances whether 
or not listed in Annex 1 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, cor­
rosive 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 Direc­
tive 67/548/EEC but used as constituents of a prep­
aration in a concentration by weight higher than 
that given at point (a) above shall be given concen­
tration limits 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 
concentration limit. 1. Member States shall take all the necessary 
measures to ensure that: 
— dangerous preparations are not placed on the mar­
ket unless their packaging meets the requirements 
of Article 15 (1) of Directive 67/548/EEC with 
respect to their strength, leak-tightness and fasten­
ing systems, 
— containers which contain dangerous preparations 
offered or sold to the general public do not have 
(a) either a shape and/or graphic decoration likely 
to attract or arouse the active curiosity of chil­
dren or to mislead consumers, 
(b) or a presentation and/or a designation used for 
foodstuffs, medicinal or cosmetic products. 
2. Member States shall take all the necessary meas­
ures to ensure that containers containing certain catego­
ries of dangerous preparations offered or sold to the 
general public and defined in accordance with the pro­
cedure referred to in paragraph 3: 
— are fitted with child-resistant fastenings, 
— carry a tactile warning of danger. 
These concentration limits 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. 3. The categories of dangerous preparations the 
packaging of which have to be fitted with the devices 
referred to in paragraph 2 (b) shall be defined by the 
procedure referred to in Article 21 of Directive 67/548/ 
EEC. 
Article 4 
The classification of dangerous preparations 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 preparations shall be classified 
according to the greatest degree of hazard in accordance 
with Article 8 (2) (d). 
Article 5 
1. Member States shall take all necessary measures 
to ensure that the preparations cannot be placed on the 
market unless they comply with the provisions of this 
Directive. 
2. In this context, if there is any doubt, Member 
States may request information on the composition of 
the preparation and any other pertinent information. 
3. To this end, the manufacturer, or those respon­
sible for placing the preparation on the market, shall 
hold the data used for the classification and labelling 
of the preparation at the disposal of the authorities of 
the Member States. The technical specifications relating to such devices are 
given in parts A and B of Annex IX to Directive 67/ 
548/EEC. 
Article 7 
1. The following information shall be clearly and 
indelibly marked on any package: 
(a) The trade name or designation of the preparation. 
(b) The names and full addresses including the tele­
phone number of the person established in the Com­
munity who is responsible for placing the prep­
aration on the market, whether it be the manufac­
turer, the importer or the distributor. 
(c) The chemical name of the substance or substances 
present in the preparation in accordance with the 
following detailed rules: 
(1) — in the case of preparations classified as T + , 
T or Xn in accordance with Article 3, only 
T +, T and Xn substances present in concen­
trations equal to or in excess of the lowest 
limit (Xn limit) for each of them laid down 
in Annex I to this Directive or to Directive 
67/548/EEC must be taken into consider­
ation, 
No C 353/10 Official Journal of the European Communities 30. 12. 87 
— in the case of preparations classified as C in 
accordance with Article 3, only C substances 
present in concentrations equal to or in 
excess of the lowest limit (Xi limit) laid 
down in Annex I to this Directive or to 
Directive 67/548/EEC must be taken into 
consideration, 
— in the case of preparations to which are 
assigned phrases R42 or R43, and/or R42/ 
43 in accordance with Article 3, only sub­
stances to which those phrases are assigned 
and which are present in concentrations 
equal to or in excess of the limit laid down 
in Annex 1 to this Directive or to Directive 
67/548/EEC need be taken into consider­
ation. 
If the preparation: 
— in accordance with Article 3 is assigned one 
of the standard phrases R39, R40, R42, R43, 
R42/43, R45, R46, R47 and/or R48, the 
name of the substance or substances must 
be mentioned; 
(2) As a general rule a maximum of 4 chemical 
names shall suffice to identify the substances 
primarily responsible for the major health haz­
ards which have given rise to the classification 
and the choice of the corresponding phrases 
referring to the risk involved. In some cases, 
more than 4 chemical names may be necessary. 
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. 
Where a manufacturer can demonstrate that the 
disclosure of the chemical identity of a harmful 
substance not assigned one or more of the R phrases 
mentioned above on the label of a preparation will 
put at risk his confidential property he shall be 
permitted to refer to that substance by means of a 
name that identifies the most important functional 
chemical groups. Where this is the case, the manu­
facturer must inform the authorities of the Member 
State where the product is first placed on the market. 
These authorities shall inform the Commission and 
the other Member States. 
Confidential information brought to the attention 
of the authorities of a Member State or of the 
commision shall be treated in accordance with 
Article 11 (4) of Directive 67/548/EEC. 
(d) The symbols, where specified in this Directive, for 
and indications of the dangers 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 as far 
as flammability hazards are concerned. Where more than one danger symbol has to be 
assigned to a preparation: 
— the obligation to apply the symbol T shall make 
the symbols C and X optional, 
— the obligation to apply the symbol C shall make 
the symbol X optional, 
— the obligation to apply the symbol E shall make 
the symbols F and O optional. 
(e) One or more standard phrases indicating the special 
risks involved in the use of the preparation 
(R phrases). 
The indications concerning special risks (R phrases) 
shall conform to the wording in Annex III to Direc­
tive 67/548/EEC and shall be provided by the manu­
facturer or any other person placing the preparation 
on the market, in accordance with Annex I to this 
Directive and Annex VI (II) (d) to Directive 67/548/ 
EEC. 
A maximum of four R phrases is generally sufficient 
to describe the risks; for this purpose the combined 
phrases listed in the aforementioned Annex III shall 
be regarded as single phrases. If the preparation 
falls within more than one danger category, how­
ever, these standard phrases must cover all the prin­
cipal hazards associated with the preparation. 
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 character­
istics by the appropriate R phrases. 
The standard phrases 'extremely flammable' or 
'highly flammable' need not appear if they repeat 
an indication of danger used pursuant to paragraph 
(d) above. 
(f) One or more standard phrases giving safety advice 
on the use of the preparation (S phrases). 
The indications giving safety advice (S phrases) shall 
conform to the wording in Annex IV to Directive 
67/548/EEC and shall be provided by the manufac­
turer or any other person placing the preparation 
on the market, in accordance with Annex II to this 
Directive and Annex VI (II) (d) to Directive 67/548/ 
EEC. 
A maximum of four S phrases is generally sufficient 
to formulate the most appropriate safety advice; for 
this purpose the combined phrases listed in the 
aforementioned Annex IV shall be regarded as single 
phrases. 
The package shall be accompanied by safety advice 
on the use of the preparation where it is physically 
impossible to include the advice on the label or 
package itself. 
30. 12. 87 Official Journal of the European Communities No C 353/11 
In the case of highly flammable and flammable 
oxidizing preparations, there is no need to give a 
reminder of the special risks or the safety advice if 
the contents of the package do not exceed 125 ml. 
The same shall apply in the case of irritant prep­
arations except where they contain substances that 
might cause sensitization. In that case point 3 of 
Annex II shall apply. 
(g) The nominal quantity (nominal mass or nominal 
volume) of the contents in the case of preparations 
sold to the general public. 
2. The special provisions applicable to certain prep­
arations are set out in Annex II. 
3. Article 3 (6) (a) shall apply mutatis mutandis to 
labelling. 
4. Informaton such as 'non toxic', 'not harmful' or 
any other statement indicating that the preparation is 
not dangerous may not appear on the packaging or 
labelling of the preparations referred to in this Direc­
tive. 
Article 8 
1. Where the particulars required by Article 7 appear 
on a label, that label shall be firmly affixed to one or 
more surfaces of the packaging so that the said particu­
lars 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 mm) if poss­
ible): 
— not exceeding three litres: at least 52 x 74, 
— greater than three 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 necess­
ary 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 danger­
ous 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 require­
ments 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 trans­
port of dangerous substances and the inner package 
or packages are labelled in accordance with this 
Directive. 
(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 7 (2) (a), (b), (c), (e) and (f) and Article 7 
(3). 
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 
substances. 
Article 9 
1. Member States may: 
(a) permit the labelling required by Article 7 to be 
applied in some other appropriate manner on pack­
ages which are either too small or otherwise unsuit­
able for labelling in accordance with Article 8 (1) 
and (2); 
(b) by way of derogation from Articles 6 and 7, permit 
the packaging of dangerous preparations which are 
neither explosive, very toxic nor toxic to be unlabel-
led 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 prep­
arations or to other persons. 
2. If a Member State makes use of the options pro­
vided for in paragraph 1, it shall forthwith inform the 
Commission thereof. 
Article 10 
The Member States shall take the measures necessary 
to implement a system of specific information (in safety 
data-sheet form) relating to dangerous preparations. 
The detailed arrangements for this system shall be laid 
down in accordance with the procedure provided for 
in Article 21 of Directive 67/548/EEC within a period 
No C 353/12 Official Journal of the European Communities 30. 12. 87 
of three years after the adoption of the Directive, taking 
into account the systems in force in the Member States. 
This information is principally intended for use by 
industrial users and must enable them to take the 
necessary measures for the protection of health and the 
safety at the place of work. 
Article 11 
The Member States shall appoint the body or bodies 
responsible for receiving information on dangerous 
preparations, including their chemical composition, 
placed on the marked. 
The Member States shall take the necessary steps to 
ensure that the appointed bodies are able to provide all 
the requisite guarantees for maintaining the con­
fidentiality of the information received. Such infor­
mation may only be used to meet any medical demand 
by formulating preventive and curative measures, in 
particular in emergencies. 
The Member States shall ensure that the information 
is not used for other purposes. 
For existing products, the Member States shall take 
measures to comply with this Directive within two 
years after the adoption of this Directive. 
The Member States shall determine the detailed 
arrangements for the aforementioned exchange of infor­
mation so as to ensure that the appointed bodies have 
all the information required for the tasks for which 
they are responsible. 
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 require­
ments of this Directive and Annex II thereto. 
Article 13 
1. Where a Member State has detailed evidence that 
a preparation, although satisfying the requirements of 
this Directive, constitutes a hazard by reason of its classification, packaging or labelling, it may provision­
ally 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 pro­
cedure laid down in Article 21 of Directive 67/548/EEC. 
Article 15 
1. Member States shall bring into force not later 
than 18 months after the adoption of this Directive the 
laws, regulations and administrative provisions necess­
ary to comply with this Directive and shall forthwith 
inform the Commission thereof. 
2. Member States shall communicate to the Com­
mission the text of the main provisions of national law 
which they adopt in the field covered by this Directive 
not more than six months later. 
3. On the date this Directive enters into force Direc­
tives 73/177/EEC (solvents) and 77/728/EEC (paints, 
varnishes and similar products) shall be repealed. 
Nevertheless, preparations wich are in conformity with 
the specifications of the abovementioned Directives may 
continue to be placed on the market until three years 
after the date of entry into force. 
Article 16 
This Directive is addressed to the Member States. 
30. 12. 87 Official Journal of the European Communities No C 353/13 
ANNEX 1 
CONCENTRATION LIMITS TO BE USED IN APPLYING THE CONVENTIONAL METHOD OF 
ASSESSING HEALTH HAZARDS IN ACCORDANCE WITH ARTICLE 3 (5) 
An 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 subdivised into: 
— acute lethal effects, 
— non-lethal irreversible effects after a single exposure, 
— severe effects after repeated or prolonged exposure, 
— corrosive effects, 
— irritant effects, 
— sensitizing effects, 
— carcinogenesis, 
— mutagenesis, 
— teratogenesis. 
The systematic assessment of all the dangerous health effects is expressed by means of concentration limits 
in conjunction with the classification of the substance, i.e. the symbol and phrases denoting the risk. 
Therefore, given the symbol priority rule, it is important to consider, in addition to the symbol, all the 
phrases denoting specific risks which are assigned to each substance under consideration. 
1. Acute lethal effects 
The concentration limits fixed in Table I determine the classification of the preparation in relation to the 
individual concentration of the substance(s) present whose classification is also shown. 
TABLE I 
Classification of the substance 
T+ with R26, R27, R28 
T with R23, R24, R25 
Xn with R20, R21, R22 Classification of the preparation 
T + 
cone. > 7 % T 
1% <conc. < 7% 
cone. > 25 % Xn 
0,1 % < cone. < 1 % 
3 % < cone. < 25 % 
cone. > 25 % 
The R phrases shall be assigned to the preparation in accordance with the following criteria: 
— The label shall include one or more of the abovementioned R phrases according to the classification used. 
— In general, the R phrases selected should be those applicable to the substance(s) present in the concentration 
which gives rise to the most severe classification. 
2. Non-lethal irreversible effects after a single exposure 
For substances that produce non-lethal irreversible effects after a single exposure (R39/R40) the individual 
concentration limits specified in Table II determine, when appropriate, the classification of the preparation 
and shall determine which particular standard R phrase is to be assigned. 
TABLE II 
Classification of the substance 
T+ with R39 
T with R39 
Xn with R40 Classification of the preparation 
T + 
cone. >: 10 % 
R39(*) obligatory T 
1% <conc. < 10% 
R39(*) obligatory 
cone. > 10% 
R39(*) obligatory xn 
0,1 %< cone. < 1% 
R40(*) obligatory 
l%<conc. < 10% 
R40(*) obligatory 
cone. > 10 % 
R40(*) obligatory 
No C 353/14 Official Journal of the European Communities 30. 12. 87 
3. Severe effects after repeated or prolonged exposure 
For substances that produce severe effects after repeated or prolonged exposure (R48) the individual 
concentration limits specified in Table III determine, when appropriate, the classification of the preparation 
and shall determine which particular standard R phrase is to be assigned. 
TABLE III 
Classification of the substance 
T with R48 
Xn with R48 Classification of the preparation 
T 
(*) cone. 2:10% 
R48 obligatory Xn 
(*) l%<conc. < 10% 
R48(*) obligatory 
(*) cone. > 10% 
R48(*) obligatory 
(*) In accordance with the labelling guide and depending on the classification, the standard R phrases R26, R27, R28, 
R23, R24, R2.5, R20, R21, R22 are also to be assigned to indicate route of administration/exposure. 
4. Corrosive and irritant effects 
For substances that produce corrosive effects (R34/R35) or irritant effects (R36, R37, R38, R41) the individual 
concentration limits specified in Table IV determine, when appropriate, the classification of the preparation. 
TABLE IV 
Classification 
of the substance 
and/or relevant 
standard risk 
phrase 
At least C with R35 
At least C with R34 
At least Xi with R41 
At least Xi with R36, 
37,38 Classification of the preparation and standard risk phrase 
At least C 
with R35 
cone. > 10% 
R35 obligatory At least C 
with R34 
5% <conc. < 10% 
R34 obligatory 
cone. > 10% 
R34 obligatory At least Xi 
with R41 
cone. > 10% 
R41 obligatory At least Xi 
with R36, 37, 38 
1 % < cone. < 5 % 
R36/38 obligatory 
5% <cone. < 10% 
R36/38 obligatory 
5% <cone. < 10% 
R36 obligatory 
cone. > 20% 
R36, R37 and R38 
are obligatory in the 
light of the concen­
tration present if 
they apply to the 
substances under 
consideration 
5. Sensitizing effects 
Substances that produce such effects are classified: 
— at least as harmful (Xn) and assigned R42 if this effect can be produced by inhalation, 
— at least as irritant (Xi) and assigned R43 if this effect can be produced through contact with the skin, 
30. 12. 87 Official Journal of the European Communities No C 353/15 
— at least as harmful (Xn) and assigned R42/43 if this effect can be produced in both these ways. 
The individual concentration limits specified in Table V determine, when appropriate, the classification of 
the preparation, and shall determine which particular R phrase is to be assigned. 
TABLE V 
Classification of the substance 
At least Xn and R42 
At least Xi and R43 
At least Xn and R42/43 Classification of the preparation and standard risk phrase 
At least Xn and R42 
cone. > 1 % 
R42 obligatory 
cone. > 1 % 
R42/43 obligatory At least Xi and R43 
cone. > 1 % 
R43 obligatory 
6. Carcinogenic/mutagenic/teratogenic effects 
For substances which produce such effects and for which specific concentration limits do not yet appear in 
Annex I to Directive 67/548/EEC and for those which, in accordance with paragraph 3 (1) (1) of Directive 
83/467/EEC, are provisionally assigned the phrase R40, the concentration limits laid down in Table VI shall 
determine, when appropriate, the classification of the preparation and the compulsory R phrase to be assigned 
to it. 
TABLE VI 
Classification of the substance 
At least T with R45 for carcinogenic 
substances of category 1 or 2 
At least Xn with R40 for carcinogenic 
substances of category 3 
At least T with R46 for mutagenic 
substances of category 1 
At least Xn with R46 for mutagenic 
substances of category 2 
At least Xn with R40 for mutagenic 
substances of category 3 
At least T with R47 for teratogenic 
substances of category 1 
At least Xn with R47 for teratogenic 
substances of category 2 
At least Xn and R40 provisionally in 
accordance with 3.1.1 of Directive 83/ 
467/EEC Classification of the preparation and standard risk phrase 
At least T 
>0,1% 
R45 obligatory 
>0,1% 
R46 obligatory 
> 0,5 % 
R47 obligatory At least Xn 
>1% 
R40 obligatory 
> 0,1 % 
R46 obligatory 
>1% 
R40 obligatory 
>5% 
R47 obligatory 
>1% 
R40 obligatory 
No C 353/16 Official Journal of the European Communities 30. 12. 87 
ANNEX II 
SPECIAL PROVISIONS ON THE LABELLING OF CERTAIN PREPARATIONS 
1. PREPARATIONS CLASSIFIED AS VERY TOXIC, TOXIC OR CORROSIVE SOLD TO THE GEN­
ERAL PUBLIC 
1.1. The labels on packages containing such preparations shall bear the inscriptions S1/S2 and S49 in addition 
to the specific safety advice. 
1.2. 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. 
2. PREPARATIONS CONTAINING LEAD 
2.1. Paints and varnishes 
Labels of packages of paints and varnishes containing lead in quantities exceeding 0,25 % expressed as 
weight of metal, of the total weight of the preparation, as determined in accordance with ISO standard 
6503/1984 shall show the following particulars: 
'Contains lead. Should not be used on surfaces liable to be chewed or sucked by children.' 
In the case of packages the contents of which are less than 125 ml, the particulars may be as follows: 
'Warning. Contains lead.' 
3. PREPARATIONS CONTAINING CYANOACRYLATES 
3.1. 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. 
4. PREPARATIONS CONTAINING ISOCYANATES 
The package labels of preparations containing isocyanates (as monomers, oligomers, prepolymers, etc., 
or as mixtures thereof) shall bear the following inscriptions: 
'Contains isocyanates. 
See information supplied by the manufacturer.' 
5. Preparations containing epoxy constituents with an average molecular weight 700 shall bear the following 
inscriptions: 
'Contains epoxy constituents. 
See information supplied by the manufacturer.' 
6. PREPARATIONS INTENDED FOR USE BY SPRAYING 
The package label on preparations intended for use by spraying shall bear the safety advice S23 and S38 
or S23 and S51 depending on the application criteria specified in Directive 83/467/EEC.