COMMISSION OF THE EUROPEAN COMMUNITIES 
COM(92) 195 final - SYN 414 
Brussels, 1 June 1992 
Proposal for a 
COUNCIL DIRECTIVE 
amending for the thirteenth time Directive 76/769/EEC on the approximation 
of the laws, regulations, and administrative provisions of the Member States 
relating to restrictions on the marketing and use of certain 
dangerous substances and preparations 
(presented by the Commission) 
- 2 -
EXPLANATORY MEMORANDUM 
I . INTRODUCTION 
In June 1990 the German authorities notified the Commission 
and Member States of their Intention to restrict the 
marketing and use of creosote and of wood treated therewith 
so as to protect the health of consumers. The Commission, 
having examined the matter and having considered the 
detailed opinions and observations of the other Member 
States, gave notice to the German authorities of Its 
Intention of proposing to the Council an amendment to Annex 
I of Directive 76/769/EEC to provide for harmonized 
limitations on the marketing and use of creosote and wood so 
treated. In this way Germany was required, In accordance 
with Art. 9(2) of Dlr. 83/189/EEC, to postpone the adoption 
of its draft measure for a period of 1 year from the date of 
not i f i cat I on. 
In preparing its proposal the Commission decided to include 
In addition to creosote two further categories of substances 
and preparations which pose a danger to the health of 
consumers. Thus It decided to propose limitations on the 
marketing to the general public of certain chlorinated 
solvents, several of which had been the subject of another 
notification from Germany in September 1990. It also 
decided In the context of the "Europe against Cancer" 
programme to propose limitations on use by the general 
public of all substances classified as carcinogenic, 
mutagenic and teratogenic (categories 1 and 2) and of 
preparations containing these. 
The Commission considers that this proposal is consistent 
with the high level of protection required under the Treaty. 
The rationale underlying the Commission's proposal Is given 
be Iow. 
I I . CREOSOTE 
22.cJig.r_o.Lmd 
Creosote Is a byproduct of the manufacture of coke from coal 
and may also arise from certain processing of wood. It has 
been available In quantity since the Industrial Revolution 
and In a composition depending on several factors, notably 
the type of carbonisation process by which it Is produced 
and the compos Ition and properties of the raw materials from 
which it Is derIved . 
- 3 -
Creosote has been used traditionally In the treatment of 
wood for exterior use, especially for railway sleepers, 
telegraph poles and waterway construction but also for 
fencing and general "Do it yourself (DIY) applications. It 
Is also used Industrially, for example, in the manufacture 
of carbon black. 
As might be expected creosotes placed on the market can have 
widely different compositions and thus exhibit different 
properties. Potentially they may cause skin irritation and 
cause harm when swallowed. Furthermore, all creosotes 
contain aromatic type substances, some of which are known 
carcinogens. Ail contain phenols which may pose a threat to 
the water compartment of the environment. 
The public may come Into contact with creosote and wood 
treated therewith In a number of ways. Consumers can buy 
creosote and apply It by brush tn DIY applications. They 
can also buy wood freshly treated with creosote and old 
treated wood e.g. old railway sleepers for the same sort of 
appI i cat Ions. 
The environment may also come Into contact with creosote and 
especially with treated wood. The latter is used almost 
exclusively outdoors where It Is exposed to weathering over 
the period of its life. 
Given the hazards of creosote and of treated wood and the 
likelehood that man and the environment are likely to be 
exposed to these hazards In everyday situations It is 
desirable that the use of creosote for wood treatment and 
the use of treated wood should be limited so as to minimize 
the overall risk to man and the environment. 
_ailnlilfiii_fii_c._ftfi_fii_ 
The family of substances and preparations termed "creosote" 
had not previously been defined though certain Individual 
creosote substances had been identified and In some cases 
classified according to Directive 67/548/EEC. 
Creosote for the purposes of this directive is defined as 
any of the following substances either alone or In a 
mixture: 
a) Creosote (CAS Nr 8001-58-9) 
b) Creosote oil (CAS Nr 61789-28-4) 
c) Distillates (coal tar), naptttalene oils (CAS Nr 84650-
04-4) 
d) Creosote oil, acenaphthene fraction (CAS Nr 90640-84-9) 
e) Distillates (coal tar), upper (CAS Nr 65996-91-0) 
- 4 -
f) Anthracene oil (CAS Nr 90640-80-5) 
g) Tar Acids, Coal, Crude (CAS Nr 65996-85-2) 
h) Creosote, wood (CAS Nr 8021-39-4) 
j) Low temperature tar oil, alkaline extracted (CAS Nr 
122384785) 
This definition thus covers any liquid by-product of the 
carbonisation of either coal or wood. 
ELfi-_-li---fil--L_fi_fil-
Creosote may cause skin Irritation. Cases have been 
reported especially among workers applying creosote or 
handling wood treated therewith. There have also been 
reports of various cancers e.g. cancer of the scrotum among 
these same groups though no definite cause/effect 
relationship has been established. 
The likelihood of adverse health effects has been correlated 
with the presence of certain multi-ring aromatic compounds 
In creosote; of these Benzo-a-pyrene (BAP), a known 
carcinogen. Is Invariably found. In the absence of 
something better, it has been provisionally decided to 
choose the concentration of BAP as Indicator of the 
potential adverse health effects of creosote. 
According to available Information creosotes containing less 
than 50 ppm BAP pose negllble danger to health and those 
with more than 500 ppm present an unacceptable danger when 
used In wood treatment. 
Creosotes may also present a danger to the environment due 
to their content of water soluble phenols. The latter may 
be washed out of creosote treated railway sleepers, poles, 
fences etc to pollute the water compartment of the 
environment. The Commission therefore proposes that this 
danger should also be controlled by establishing a limit to 
the amount of water extractable phenols allowed In creosote 
which Is used Industrially for wood treatment. 
£&i&lftnc.ft-fil-&Ub_&limift£ 
Wood treatment chemicals by their very nature are 
potentially dangerous to health and the environment. Thus 
the use of several of the potential substitutes e.g. 
PentachlorophenoI and CCA, has already been limited. It Is 
very problematic to find substitutes for creosote In the 
outdoor applications where it is mainly used. 
Given the difficulty of finding safer substitutes and that 
creosote inevitably will continue to be produced as a 
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byproduct of the coke Industry the best policy Is to 
continue to allow creosote to be used for wood treatment but 
only under strictly controlled conditions. 
£finc.lu&lfin 
It is concluded that creosote and wood treated therewith can 
under certain circumstances pose dangers to human health and 
to the environment. The strategy proposed therefore Is the 
foI IowIng: 
Creosote with less than 50 ppm BAP and wood treated 
therewith should not be controlled. 
Creosote with from 50 to 500 ppm should be available 
only for industrial use while use of the wood so 
treated should be confined to professional applications 
where there is little chance of contact with the 
public. Only old wood treated many years before may be 
made available to consumers and then only for certain 
uses. 
The use for wood treatment of creosote with more than 
500 ppm BAP and the use of wood so treated should be 
totaI Iy banned. 
No creosote which Is covered by the proposal and which 
contains more than 3% water soluble phenols should be 
used for wood treatment nor should wood so treated be 
used . 
III. CHLORINATED SOLVENTS 
&a.c.fc.gxfiimd 
Chlorinated solvents are widely used In industry mainly to 
clean articles of all shapes, sizes and materials; this is 
because they are effective, cheap and non-flammable. 
Similar uses by consumers but on a much smaller scale have 
been developed for some such solvents. 
Many chlorinated solvents are dangerous when Inhaled or when 
swallowed; some cause concern for man owing to possible 
carcinogenic effects but In respect of which the available 
information is not adequate for making a satisfactory 
assessment . 
Given these hazards and the potential for misuse of 
chemicals In the home It Is proposed that the use of 
chlorinated solvents by consumers should be limited. 
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_Lfl._ft_QL__Q-i_ft_fl.l_aiiO._ 
Four criteria have been used In selecting candidates for 
controls. First Is their classification, if any, within the 
framework of Directive 67/548/EEC; the most dangerous 
solvents should clearly be avoided. Secondly, there Is the 
question of whether particular solvents are presently used 
by consumers; dangerous chemicals not presently used by 
consumers should not be used In the future. A third 
criterion is the availability of substitutes; dangerous 
chemicals which are presently used but for which substitutes 
exist should also be avoided. Finally a fourth criterion Is 
whether particular solvents are subject to control by 
existing Community legislation. 
____lan_fta_ft_a_l_ft_ 
Eleven chlorinated solvents were examined In terms of these 
four criteria to establish priorities for limiting use by 
the public. Three groups were identified which form a 
hierarchy for control purposes. 
_L__D._1 
The following substances: 
Chloroform (CAS Nr 67-66-3) 
Carbon Tetrachloride (CAS Nr 56-23-5) 
1,1,2 TrIchloroethane (CAS Nr 79-00-5) 
1,1,2,2 Tetrachloroethane (CAS Nr 79-34-5) 
1,1,1,2 Tetrachloroethane (CAS Nr 630-20-6) 
Pentachloroethane (CAS Nr 76-01-7) 
1,1 D I chloroethylene (CAS Nr 75-35-4) 
are dangerous, being classed "harmful" or worse, have no 
consumer uses or have both of these characteristics. These 
are regarded as high priority for control purposes. 
_£_____ 
The following substance: 
1,1,1 Tr Ichloroethane (CAS N* 71-55-6) 
is harmful and is used to some extent by consumers. It Is 
due to be banned entirely by 2005 within the framework of 
protecting the Ozone layer. Control of this substance has 
somewhat less priority. 
- 7 -
The following substances: 
Methylene Chloride (CAS N* 75-09-2), 
Tr Ichloroethylene (CAS N* 79-01-6), 
Perchloroethylene (CAS N* 127-18-4) 
are also harmful and are used to a considerable extent by 
consumers. However, substitution Is problematic. Control 
of these substances does not seem warranted at present. 
____l_alQ_ 
It Is proposed that that the use by the public of the 
substances In Group 1 and of preparations containing them 
should be banned on entry into force of this directive. 
It is further proposed that the single substance in Group 2 
viz 1,1,1 TrIchIoroethane and preparations containing It be 
banned five years from entry Into force. 
In the case of Group 3 substances the Commission Intends to 
carry out a review on their continued use three years from 
ent ry Into force . 
IV. CMT SUBSTANCES AND PREPARATIONS 
The programme "Europe against Cancer" has focused the 
attention of the Community on substances and preparations 
termed carcinogenic (may cause cancer), mutagenic (may cause 
heritable genetic damage) and teratogenic (may cause birth 
defects). 
A first Initiative was to develop a methodology for the 
classification of carcinogenic, mutagenic and teratogenic 
substances. As a similar system has been adopted for each 
of the three cases, only the classification of carcinogens 
will be outlined here. 
Directive 91/325/EEC defines the three categories of 
carcinogens viz categories 1, 2 and 3 as follows: 
Category 1 
Substances known to be carcinogenic to man. There Is 
sufficient evidence to establish a causal association 
between human exposure to a substance and the development of 
cancer. 
Category 2 
Substances which should be regarded as if they are 
8 -
carcinogenic to man. There Is sufficient evidence to 
provide a strong presumption that human exposure to a 
substance may result In the development of cancer, generally 
on the bas Is of: 
appropriate long-term animal studies, 
other relevant information. 
Category 3 
Substances which cause concern for man owing to possible 
carcinogenic effects but In respect of which the available 
Information Is not adequate for making a satisfactory 
assessment. There is some evidence from appropriate animal 
studies, but this Is insufficient to place the substance in 
category 2. 
Annex I to this same directive establishes CMT 
classifications for a first batch of substances. 
The present proposal would establish a further procedure 
according to which the placing on the market for use by the 
general public of substances classified In Annex I of 
Directive 67/548/EEC as carcinogens of categories 1 and 2, 
mutagens of categories 1 and 2 and teratogens of categories 
1 and 2 Is prohibited; furthermore an automatic ban for 
consumer use will apply to substances that may be classified 
as such in the future. In addition the placing on the 
market for use by the general public of preparations 
containing the same substances will also be banned if the 
concentration of such a substance is above a certain value; 
the latter may be specified in the classification of the CMT 
substance; failing this It Is the general value provided by 
Directive 88/379/EEC which applies. 
V. CONFORMITY WITH THE TREATY 
As Is clear from sections II, III and IV above, this 
proposal Is Intended to afford a high level of protection 
for both persons and the environment and Is therefore In 
conformity with Article 100A(3) of the Treaty. 
The proposal does not call for any special provisions of the 
kind referred to In Article 8c of the Treaty. 
VI. CONSULTATION OF THE EUROPEAN PARLIAMENT AND THE 
ECONOMIC AND SOCIAL COMMITTEE 
In compliance with Article 100A of the Treaty, the 
cooperation procedure with the European Parliament Is 
applicable. The Economic and Social Committee has to be 
consuIted. 
-*-
ProposaI for a 
_0___C_iL__lRE_IiYE 
amending for the thirteenth time Directive 76/769/EEC on the 
approximation of the laws, regulations and administrative 
provisions of the Member States relating to restrictions on 
the marketing and use of certain dangerous substances and 
prepar at Ions 
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,1 
In cooperation with the European Parliament,2 
Having regard to the opinion of the Economic and Social 
CommI 11ee , 3 
Whereas measures should be adopted for the progressive 
establishment of the Internal market by 31 December 1992; 
whereas the internal market is an area without Internal 
frontiers In which the free circulation of goods, persons, 
services and capital is guaranteed; 
1 OJ No 
2 OJ No 
3 OJ No 
- 10 -
Whereas work on the internal market should gradually improve 
the quality of life, health protection and consumer safety; 
whereas the measures proposed by this Directive are in line 
with the Council Resolution of 9 November 1989 on future 
priorities for relaunching consumer protection policy;4 
Whereas the Council and the representatives of the 
Governments of the Member States, meeting within the 
Council, adopted Decision 90/238 / Euratom, ECSC, EEC concerning a 
1990-94 action plan in the context of the "Europe against 
cancer" programme; 
Whereas the substances which appear in Annex I to Council Directive 
67/548/EEC, as last amended by Commission Directive 91/632/EEC, 
and are classified as carcinogens category 1 or category 2 may cause 
cancer; whereas to improve health protection such substances 
and preparations containing them should not be placed on the 
market for use by the general public; 
Whereas the substances which appear in Annex I to Directive 67/548/EEC 
and are classified as mutagens category 1 or category 2 may cause 
heritable genetic damage; whereas to improve health 
protection such substances and preparations containing them 
should not be placed on the market for use by the general 
pub I Ic; 
Whereas the substances which appear in Annex I to Directive 67/548/EEC 
and are classified as teratogens category 1 or category 2 may cause 
birth defects; whereas to improve health protection such 
substances or preparations containing them should not be 
placed on the market for use by the general public; 
4 0J No C 294, 23.11.1989, p. 1. 
5 0J No L 137, 30.5.1990, p. 31. 
6 0J No L 196, 16.8.1967, p. 1. 
7 0J No L 338, 10.12.1991, p.23, and 0J No L 338A, 10.12.1991, p. 2 
- r; -
Whereas Annex I to Directive 67/548/EEC lays down individual 
concentration limits for such substances and, in the absence 
of such limits. Table VI of Annex I to Council Directive 
8 9 
88/379/EEC, as last amended by Commission Directive 90/492/EEC, 
lays down general concentration limits which apply to such 
substances contained in preparations; 
Whereas creosote, as defined in the Annex to this Directive, 
may be damaging to health because of its content of known 
carcinogens; whereas for these reasons the use of creosote 
in wood treatment and the marketing and use of creosote 
treated wood should be limited; 
Whereas some of the components of creosote are poorly 
degradable and deleterious to organisms in the environment; 
whereas these components may enter the environment as a 
result of the use of treated wood; 
Whereas some chlorinated solvents present a danger to health 
and should not be marketed to the general pub I ic in 
substances and preparations; 
Whereas the restrictions on the use of creosote in wood 
treatment, on the marketing and use of creosote treated wood 
and on the marketing and use of chlorinated solvents laid 
down by this Directive take into account the current state 
of knowledge and techniques regarding safer alternatives; 
8 OJ No L 187, 16.7.1988 p.14. 
9 OJ No L 275, 5.10.1990, p. 35. 
- 12 -
Whereas limitations already adopted by certain Member States 
on the use or marketing of the substances mentioned above or 
the preparations" containing them directly affect the 
completion and functioning of the internal market; whereas 
it is therefore necessary to approximate the laws of the 
Member States in this field and consequently amend Annex I 
1 0 to Council Directive 76/769/EEC, as last amended by 
Directive 91/339/EEC; 11 
Whereas this Directive does not affect Community 
legislation laying down minimum requirements for the 
protection of workers, contained in Council Directive 
1 2 89/391/EEC and in individual Directives based thereon, 
1 3 in particular Council Directive 9U/394/EEC, 
HAS ADOPTED THIS DIRECTIVE: 
Article 1 
Annex I to Directive 76/769/EEC is hereby amended as set out 
in the Annex hereto. 
10 0J No L 262, 27.9.1976, p. 201 
11 0J No L 186, 12.7.1991, p. 64. 
12 0J No L 183, 29.6.1989, p. 1. 
13 0J No L 196, 26.7.1990, p. 1. 
)- 13 -
Article 2 
1. Member States shall adopt and publish the laws, 
regulations and administrative provisions necessary to 
comply with this Directive no later than 1 year after 
the date of its adoption and shall forthwith inform the 
Commission thereof. They shall apply these provisions 
from /_3 months after the date stated above?. 
2. Should Annex I to Directive 67/548/EEC be amended 
after notification of this Directive with 
respect to the substances and preparations referred to 
in points 29, 30 & 31 of the Annex to this Directive, 
Member States shaI If bring into force the laws, 
regulations and administrative provisions necessary to 
introduce the limitations provided for in this Directive 
arising from any amending Directives by the deadlines 
laid down for implementation of such amending Directives. 
Member States shall forthwith inform the Commission 
that the provisions referred to in this paragraph have 
been brought into force. 
3. When Member States adopt the provisions referred to in 
paragraphs 1 and 2, these shall contain a reference to 
this Directive or shall be accompanied by such reference 
at the time of their official puDlication. Tne procedure 
for such reference shall be adopted by Member States. 
Article 3 
This Directive is addressed to the Member States. 
Done at Brussels, For t he Counc i I 
The President 
- 14 -
ANNEX 
Annex I to Directive 76/769/EEC is hereby amended as 
foI Iows: 
Designation of the substance. Condition of Restrictions 
of the group of substances 
or of the preparation 
29. Substances which appear May not be used in an 
in Annex I to Directive individual concentration 
67/548/EEC classified as equal to or greater than: 
carcinogen category 1 or - either the concentration 
carcinogen category 2 and specified in Annex I to 
labelled at least as "Toxic Directive 67/548/EEC, or 
(T)H with risk phrase R45: - the concentration specified 
"May cause cancer" or risk in Point 6 Table VI of Annex I 
phrase R49: "May cause to Directive 88/379/EEC 
cancer by inhalation". where no concentration limit 
appears in Annex I to 
Directive 67/548/EEC 
in the substances and 
preparations placed on the 
market for sale to the general 
pub lie. 
Without prejudice to the 
implementation of other 
Community provisions relating 
to the classification, 
packaging and labelling of 
dangerous substances and 
preparations, the packaging of 
such substances and 
preparations must be marked 
legibly and indelibly as 
follows: "Restricted to 
professional users" 
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By way of derogation, this 
provision shall not apply to: 
a) medicinal or veterinary 
products as defined by 
Directive 65/65/EEC< 14>, as 
last amended by Directive 
89/381/EEC< 15); 
b) cosmetic products as 
defined by Directive 
76/768/EEC< 16), as last 
amended by Directive 
89/679/EEC< 17); 
c) motor fuels which are 
covered by Directive 
85/210/EEC<18 ) ; 
d) waste covered by Directives 
75/442/EECd° ) and 
78/319/EEC<20) ; 
e) substances and preparations 
listed In Annex I to Dir. 
76/769/EEC which are not the 
subject of points 29, 30 & 31 
of the annex to this Directive 
(14) 
(15) 
(16) 
(17) 
(18) 
(19) 
(20) 0J No 22, 9.2.1965, p. 369. 
0J No L 181, 28.6.1989, p. 44. 
0J No L 262, 27.9.1976, p. 169. 
0J No L 398, 30.12.1989, p. 25. 
0J No L 96, 3.4.1985, p. 25. 
0J No L 194, 25.7.1975, p. 39. 
0J No L 84, 31.3.1978, p. 43. 
- 16 -
30. Substances which appear 
in Annex I to Directive 
67/548/EEC classified as 
mutagen category 1 or 
mutagen category 2 and 
labelled with risk phrase 
R46: "May cause heritable 
genet i c damage" . May not be used in an 
individual concentration 
equal to or greater than: 
- either the concentration 
specified in Annex I to 
Directive 67/548/EEC, or 
- the concentration specified 
in Point 6 Table VI of Annex I 
to Directive 88/379/EEC 
where no concentration limit 
appears in Annex I to 
Directive 67/548/EEC 
in the substances and 
preparations placed on the 
market for sale to the general 
pub lie. 
Without prejudice to the 
implementation of other 
Community provisions relating 
to the classification, 
packaging and labelling of 
dangerous substances and 
preparations, the packaging of 
such substances and 
preparations must be marked 
legibly and indelibly as 
foI Iows: 
"Restricted to professional 
users " . 
By way of derogation, this 
provision shall not apply to: 
(a) medicinal or veterinary 
products as defined by 
Directive 65/65/EEC, . as 
last amended by Directive 
89/381/EEC; 
(b) cosmetic products as 
-17-i 
defined by Directive 
76/768/EEC , as last 
amended by Directive 
89/679/EEC; 
(c) motor fuels which are 
covered by Directive 
85/210/EEC; 
(d) waste covered by 
Directives 75/442/EEC and 
78/319/EEC; 
(e) substances and 
preparations listed in Annex I 
to Dir. 76/769/EEC which are 
not the subject of points 29, 
30 & 31 of the annex to of 
this Di rect i ve-
- 18 -
31. Substances which appear 
in Annex I to Directive 
67/548/EEC classified as 
teratogen category 1 or 
teratogen category 2 and 
labelled with risk phrase 
R47: "May cause birth 
defects". May not be used in an 
individual concentration 
equal to or greater than: 
- either the concentration 
specified in Annex I to 
Directive 67/548/EEC or 
- the concentration specified 
in Point 6 Table VI of Annex I 
to Directive 88/379/EEC 
where no concentration limit 
appears in Annex I to 
Directive 67/548/EEC 
in the substances and 
preparations placed on the 
market for sale to the general 
pub lie. 
Without prejudice to the 
implementation of other 
Community provisions relating 
to the classification, 
packaging and labelling of 
dangerous substances and 
preparations, the packaging of 
such substances and 
preparations must be marked 
legibly and indelibly as 
foI Iows: 
"Restricted to professional 
user s" . 
By way of derogation, this 
provision shall not apply to: 
(a) medicinal or veterinary 
products as defined by 
Directive 65/65/EEC, as 
last amended by Directive 
89/381/EEC; 
(b) cosmetic products as 
- \9 -
defined by Directive 
76/768/EEC > as last 
amended by Directive 
89/679/EEC; 
(c) motor fuels which are 
covered by Directive 
85/210/EEC ; 
(d) waste covered by 
Directives 75/442/EEC and 
78/319/EEC; 
(e) substances and 
preparations listed in Annex I 
to Dir. 76/769/EEC which are 
not the subject of points 29, 
30 & 31 of the annex to this 
Direct I v e . 
- 20 -
32. Substances and Prepa­
rations, containing 
one or more of the fol­
lowing substances 
a) Creosote 
EINECS Nr 232-287-5 
CAS Nr 8001-58-9 
b) Creosote o i I 
EINECS Nr 263-047-8 
CAS Nr 61789-28-4 
c) Distillates (coa I 
tar), napht ha Iene 
oils 
EINECS Nr 283-484-8 
CAS Nr 84650-04-4 
d) Creosote Oil, ace-
naphthene fraction 
EINECS Nr 292-605-3 
CAS Nr 90640-84-9 
e) Distillates (coa I 
tar) .upper 
EINECS Nr 266-026-1 
CAS Nr 65996-91-0 
f) Anthracene O i I 
EINECS Nr 292-602-7 
CAS Nr 90640-80-5 
g) Tar Ac i ds , CoaI , 
Crude 
EINECS Nr 266-019-3 
CAS Nr 65996-85-2 
h) Creosote, wood 
EINECS Nr 232-419-1 
CAS Nr 8021-39-4 32.1. May not be used for wood 
treatment if they contain 
a) Benzo-a-Pyrene at a 
concentration of greater 
than 0.005% by mass 
or b) water extractable 
phenols at a concen­
tration of greater 
than 3% by mass 
or both a) and b) 
Furthermore wood so 
treated may not be 
placed on the market 
However by way of deroga-
gat i on : 
(i) Rotating to the substan­
ces and preparations: 
these may be used for wood 
treatment in industrial 
installations if they 
conta i n: 
a) Benzo-a-Pyrene at 
a concentration of 
less than 0.05% by mass 
and 
b) Water extractable 
phenols at a concen­
tration of less than 
3% by mass. 
- 21 -
J) Low temperature 
tar oil, alkaline 
extracted 
EINECS Nr 310 t9f 5 
CAS Nr 122384785 Such substances and 
prepa r a t i ons 
- may be placed on the 
market only in packaging 
of a capacity equal to or 
greater than 200 litres 
- may not be sold to the 
gener a I pub I i c 
Without prejudice to the 
application of other 
Community provisions on 
the classification, 
packaging and labelling 
of dangerous substances 
and preparations, the 
packaging of such sub­
stances and preparations 
shall be legible and 
indelibly marked as 
fo I Iows: 
"For use in industrial 
installations only" 
(ii) Relating to wood treated 
according to (i) which is 
placed on the market for 
the first time: 
this is permitted for 
profess i onaI and 
industrial use only e.g. 
on railways, in electric 
power transmission and 
telecommunications, for 
fencing and in harbours 
and wa t erways. 
However, such wood may not 
- 22 -
be used: 
- inside buildings whether 
for decorative purposes or 
not whatever their purpose 
(residence, employment, 
Ie i sure) ; 
- for the manufacture of 
containers intended for 
growing purposes and any 
re-treatment and the 
manufacture of packaging 
which may come into 
contact with or other 
materials which may 
contaminate raw, 
intermediate and/or 
finished products intended 
for human and/or animal 
consumption and any re-
t reatment; 
- in playgrounds and in 
other outdoor places of 
public pleasure or in 
other situations where 
there is a risk that it 
may come into contact with 
skin. 
(iii) Relating to old treated 
wood: 
the prohibition shall not 
apply where this is placed 
on the second hand market. 
However such wood may not 
be used: 
- inside buildings whether 
for decorative purposes or 
-'23 -
not whatever their purpose 
(residence, employment, 
leisure); 
- for the manufacture of 
containers intended for 
growing purposes and any 
re-treatment and the 
manufacture of packaging 
which may come into 
contact with or other 
materials which may 
contaminate raw, 
intermediate and/or 
finished products intended 
for human and/or animal 
consumption and any re-
t reatment; 
- in playgrounds and in 
other outdoor places of 
pub lie pieasur e. 
33. Chioroform 
CAS Nr. 67-66-3 
34. Carbon Tetrachloride 
CAS Nr. 56-23-5 
35. 1,1,2 Trich I oroethane 
CAS Nr. 79-00-5 
36. 1,1,2,2 Tetrachloroethane 
CAS Nr. 79-34-5 
37. 1,1,1,2 TetrachIoroethane 
CAS Nr. 630-20-6 
38. PentachI oroethane 
CAS Nr. 76-01-7 
39. 1,1 DichIoroethyIene 
CAS Nr. 75-35-4 "\ 
y 
j May not be used in 
concentrations equal to 
or greater than 0,1% by 
weight in substances and 
preparations placed on 
the market for sale to 
the general public. 
Without prejudice to the 
application of other 
Community provisions on 
the classification, packa­
ging and labelling of 
- 24 -
dangerous substances and 
preparations, the packa­
ging of such substances 
and preparat i ons 
conta i n i ng them i n 
concentrations equal to or 
greater than 0.1% 
shall be legible and inde­
libly marked as follows: 
"Restricted to professio-
na I users" 
By way of derogation this 
provision shall not apply 
to: 
(a) med i c i na I or 
veterinary products as 
defined by Directive 
65/65/EEC, as last 
amended by Directive 
89/381/EEC; 
(b) cosmetic products as 
defined by Directive 
76/768/EEC, as last 
amended by Directive 
89/679/EEC; 
(c) waste covered by 
Directives 75/442/EEC 
and 78/319/EEC. 
- 25 -
40. 1,1,1 TrichIoroethane 
CAS Nr. 71-55-6 From five years of entry 
into force of 
this Directive, may not be 
used in concentrations 
equal to or greater than 
0,1% by we i ght in 
subs t ances and 
preparations placed on the 
market for sale to the 
gener a I pub lie. 
Without prejudice to the 
application of other 
Community provisions on 
the classification, 
packaging and labelling of 
dangerous substances and 
preparations, the 
packag i ng of this 
substance and of 
preparations containing it 
in concentrations equal to 
or greater than 0.1% shall 
be legible and indelibly 
marked as follows: 
"Rest r i cted to 
professional users" 
By way of derogation this 
provision shall not apply 
to: 
( a ) med i c i naI or 
veterinary products as 
defined by Directive 
65/65/EEC, as last 
amended by Directive 
89/381/EEC ; 
(b) cosmetic products as 
- 26 -
defined by Directive 
76/768/EEC, as last 
amended by Directive 
89/679/EEC; 
(c) waste covered by 
Directives 75/442/EEC 
and 78/319/EEC. 
- 27 
i 
} FINANCIAL STATEMENT 
SECTION 1: FINANCIAL IMPLICATIONS 
1. Title of operation 
Proposal for a thirteenth amendment to Directive 76/769/EEC 
2. Budget heading Involved 
Article B5-300: completing the Internal market 
3. Legal basis 
- Article 100a of the Treaty 
- Council Resolution of 7 May 1985 on a new approach to technical 
harmonization and standardization 
4. Description of operation 
4.1 Specific objective of operation 
The proposed operation involves: 
- restricting the marketing and use of creosote, chlorinated solvents 
and substances class I fed as carcinogenic, mutagenic or teratogenic-, 
restricting the marketing and use of preparations containing these 
three categories of substance. 
4.2 Duration 
This is a "one-off" operation 
4.3 Target population 
Industrialists and consumers 
5. Classification of expenditure 
- Differentiated appropriation 
Non-compuIsory 
m mi. ii- iiII•-..!.i m-mmmmmm*m*-v*~*'~~m-immw*mmmm'm "'—i^mm^immmmmmmmmmilHIB 
- 28 -
6. Type of expenditure 
The expenditure would consist of financial support granted by the 
Commission to standardization organizations. As In the case of other 
"New Approach" directives, the Commission Intends to entrust the CEN 
with the task of drafting a harmonized standard. This will apply only 
to creosote Intended for controlled use; no standards are needed In the 
other two cases, where the substances concerned are banned. The 
necessary mandate for this task comes under the framework contract 
signed on 10 October 1985, which provides for Just such financial 
support from the Commission. 
Financial Impact on appropriations for operations 
7.1. Method of calculating the cost 
The calculation method relating to Article B5-300 applies here. 
According to calculations performed by the European Committee for 
Standardization (CEN) on the basis of their experience of existing 
mandates, the average cost to the Commission of each new standard 
Is ECU 50 000. 
Since only one standard is to be Introduced, the Impact should be 
about ECU 50 000. 
7.2 Proportion of the mini-budget 
N/A 
7.3 Schedule of commitment (CE) and payment (CP) appropriations 
(Article 5B-300) 
CE CP 
1992 50 000 25 000 
1993 25 000 
TOTAL 50 000 50 000 
8. What anti-fraud measures are planned? 
Expenditure under the CEN contract is subject to the anti-fraud measures 
laid down in that contract and to any audits carried out by CEN. 
SECTION 2: ADMINISTRATIVE EXPENDITURE 
No new administrative expenditure Is foreseen. Any meetings to be held 
would take place pursuant to Directive 76/769/EEC and would be covered by 
the budget for that Directive. 
-;29 " 
SECTION 3: ELEMENTS OF COST-EFFECTIVENESS ANALYSIS 
1. Objective and coherence with financial programming 
1. The aim of the proposed operation Is to harmonize restrictions on the 
marketing and use of the three types of product concerned (creosote, 
chlorinated solvents, CMT) so as to avoid creating obstacles to trade 
and, at the same time, to provide a high level of protection for humans 
and the environment. 
The proposal lays down essential requirements In the case of creosote. 
These will provide a solid basis for standardization In Europe. The amount 
of work to be done on standards should thus be reduced and, consequently, 
the Impact on the Community budget lessened. 
2. The operation is Incorporated In DG Ill's financial programming and is 
Included In the appropriations allocated to technical standardization and 
harmonlzatIon. 
3. The general objective Is to complete the Internal market. 
II. Grounds for the operation 
Harmonization serves to prevent obstacles to trade and, at the same time, 
to provide a high level of protection for humans and the environment. 
Standardization is necessary In the case of creosote; otherwise the various 
tests and conditions considered necessary before marketing the product 
might act as obstacles to trade. 
III. Monitoring and evaluation of the operation 
The Committee set up under Directive 76/769/EEC will be responsible for 
monitoring the application of this Directive. 
Evaluation will be carried out annually via the progress reports on the 
adoption of the standard drafted by the CEN. 
«»t*.««c*»n«-
- 30 -
COMPETITIVENESS AND EMPLOYMENT IMPACT ASSESSMENT 
1. The current proposal concerns restrictions on the marketing and use of 
three families of substances and preparations viz creosote, chlorinated 
solvents ami CMT. 
1 .1 Creosote 
Creosote Is produced as a byproduct of coke production. It is used by 
industry as an Intermediate for making certain industrial products. It 
is also used by Industry and by the consumer for wood treatment. 
Creosote for wood treatment and treated wood may endanger human health 
and the environment. 
It has been decided, therefore that the marketing and use for wood 
treatment of certain creosotes and the marketing and use of treated 
wood should be limited. 
1.2 Chlorinated solvents 
Certain chlorinated solvents are used to a small extent by the general 
public and certain others may potentially be used In the future. 
Such solvents present or potentially present varying degrees of hazard 
to the health of consumers. 
Depending on the potential hazard to health, the extent of use, the 
existance of substitues and the provisions of existing Community 
legislation, priorities for limiting use by consumers have been 
established. Seven solvents would be Immediately banned for consumer 
use, another would be banned from 5 years and a further three would be 
reviewed after three years. 
31 -
1,3 CMT 
Substances which are carcinogenic, teratogenic or mutagenic may at 
present be used by consumers either alone or In preparations. 
Consumers may thus be put at risk. 
it has been decided that substances and preparations classified as 
carcinogenic, mutagenic and teratogenic In categories 1 and 2 or that 
may In future be so classified can no longer be placed on the market 
for use by the general public. 
II, Features of the Business In Question 
Creosote is a byproduct of the coke Industry which Is of course 
concentrated In the big coal producing Member States viz Germany and 
UK. Industrial treatment of wood with creosote Is also largely 
concentrated in these same Member States. Treated wood Is marketed 
throughout the Community. 
Chlorinated solvents are widely used In Industry mainly for various 
cleaning purposes e.g. metal degreasing. A very small amount is used 
in consumer products e.g. stain removers, paint removers etc. 
CMT substances and preparations are also used to a very small extent by 
consumers except for the case of motor fuels which, being covered by an 
existing directive, are excluded from the proposal limitations. 
III. What direct obligations does the Measure Impose on Industry? 
In the case of creosote the producing Industry will have to modify Its 
process plant so that product meets the essential requirements set down 
in this directive. It must also ensure that creosote for Industrial 
use Is appropriately packaged and labelled. These costs, which will be 
borne mainly by large companies, are likely to be small. Neither the 
cost of the measures nor the timing are of particular concern to the 
Industry. 
The chlorinated solvents industry must begin now to examine alternative 
solvents and systems for consumer use. The proposed measures will 
however be phased in over a period of years thus giving the industry 
adequate time for the transition. The costs, which again are down 
mainly to large companies, will be small. Neither the cost of the 
measures nor the timing are of particular concern to the Industry. 
The measures on CMT substances and preparations are not expected to 
Impose significant obligations beyond labelling. The cost of the 
measures are not of particular concern to the Industry. The timing 
could pose a problem as limitations on CMT substances will follow 
automat leally on. class if I cat Ion. 
- 32 -
IV. What Indirect obligations are local authorItes likely to impose on 
business? 
None. 
V. Are there any special measures in respect of SME's? 
No. As indicated In Section III above, the proposal will Impact mainly 
on large companies. 
VI What is the likely effect on: 
(a) 
(b) 
(a) 
(b) competitiveness of Industry 
employment 
There may be a very marginal Increase in the cost of treated wood 
and of certain preparations for consumer use. The effects on 
competitiveness are however likely to be negligible. 
It Is unlikely that the measure will have significant Impact on 
employment. 
VII. Consul tat Ion 
The following Industry groups were consulted on preparation of the proposal 
and participated in meetings of the Member States experts : 
Section of Proposal Industry Association Consulted 
1. Creosote Western European Institute for 
Wood Preservation, Brussels 
2. Chlorinated solvents European Chlorinated Solvent 
Association, Brussels 
3. CMT CEFIC. Brussels 
AM are In broad agreement. CEFIC however expressed some concern about the 
automatlclty of CMT limitations. 
The European consumer representative group BEUC was also consulted. 
- 33 -
ISSN 0254-1475 
COM(92) 195 final 
DOCUMENTS 
EN 06 
Catalogue number: CB-CO-92-212-EN-C 
ISBN 92-77-44024-4 
Office for Official Publications of the European Communities 
L-2985 Luxembourg