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
Date: 1992-05-01
Institutions: European Commission
Subjects: approximation of laws, carcinogenic substance, consumer protection, health risk, labelling, marketing standard

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 -

E X P L A N A T O RY  M E M O R A N D UM 

I . 

I N T R O D U C T I ON 

their 

e x a m i n ed 

Intention 

S t a t es  of 

the  matter 

to  r e s t r i ct 

In  June  1990  the  G e r m an  a u t h o r i t i es  n o t i f i ed  the  C o m m i s s i on 
and  Member 
the 
m a r k e t i ng  and  use  of  c r e o s o te  and  of  wood  t r e a t ed  t h e r e w i th 
so  as  to  protect  the  health  of  c o n s u m e r s.  The  C o m m i s s i o n, 
the 
having 
Member 
d e t a i l ed  o p i n i o ns  and  o b s e r v a t i o ns  of  the  o t h er 
S t a t e s,  gave  n o t i ce 
Its 
to  the  G e r m an 
Intention  of  p r o p o s i ng  to  the  Council  an  a m e n d m e nt  to  Annex 
I  of 
h a r m o n i z ed 
l i m i t a t i o ns  on  the  m a r k e t i ng  and  use  of  c r e o s o te  and  wood  so 
t r e a t e d. 
In  this  way  G e r m a ny  w as  r e q u i r e d,  In  a c c o r d a n ce 
with  A r t.  9 ( 2)  of  D l r.  8 3 / 1 8 9 / E E C,  to  p o s t p o ne  the  a d o p t i on 
of  its  draft  m e a s u re  for  a  period  of  1  year  from  the  date  of 
not i f i cat I o n. 

a u t h o r i t i es 

c o n s i d e r ed 

7 6 / 7 6 9 / E EC 

D i r e c t i ve 

p r o v i de 

h a v i ng 

and 

for 

of 

to 

to  the  general 

In  p r e p a r i ng  its  proposal  the  C o m m i s s i on  d e c i d ed  to  include 
In  a d d i t i on  to  c r e o s o te  two  further  c a t e g o r i es  of  s u b s t a n c es 
and  p r e p a r a t i o ns  w h i ch  pose  a  danger 
to  the  h e a l th  of 
c o n s u m e r s.  T h us  It  d e c i d ed  to  p r o p o se  l i m i t a t i o ns  on  the 
m a r k e t i ng 
c h l o r i n a t ed 
s o l v e n t s,  several  of  w h i ch  had  been  the  s u b j e ct  of  another 
a l so 
n o t i f i c a t i on 
d e c i d ed 
C a n c e r" 
l i m i t a t i o ns  on  use  by  the  general 
p r o g r a m me  to  p r o p o se 
c a r c i n o g e n i c, 
p u b l ic 
m u t a g e n ic  and  t e r a t o g e n ic 
1  and  2)  and  of 
p r e p a r a t i o ns  c o n t a i n i ng  t h e s e. 

In  the  context  of  the  " E u r o pe  a g a i n st 

c l a s s i f i ed 
( c a t e g o r i es 

p u b l ic  of  c e r t a in 

in  S e p t e m b er 

s u b s t a n c es 

G e r m a ny 

1 9 9 0. 

from 

all 

It 

as 

of 

The  C o m m i s s i on  c o n s i d e rs  that  this  proposal  is  c o n s i s t e nt 
with  the  high  level  of  p r o t e c t i on  r e q u i r ed  under  the  T r e a t y. 
The  r a t i o n a le  u n d e r l y i ng  the  C o m m i s s i o n 's  p r o p o s al  Is  g i v en 
be Iow. 

I I .  C R E O S O TE 

22.cJig.r_o.Lmd 

C r e o s o te  Is  a  b y p r o d u ct  of  the  m a n u f a c t u re  of  coke  from  coal 
and  may  also  arise  from  c e r t a in  p r o c e s s i ng  of  w o o d. 
It  has 
been  a v a i l a b le  In  q u a n t i ty  since  the  Industrial  R e v o l u t i on 
and  In  a  c o m p o s i t i on  d e p e n d i ng  on  several  f a c t o r s,  n o t a b ly 
the  type  of  c a r b o n i s a t i on  p r o c e ss  by  w h i ch  it  Is  p r o d u c ed 
and  the  c o m p os Ition  and  p r o p e r t i es  of  the  raw  m a t e r i a ls  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  y o u r s e lf  (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 
creosotes 
cause  harm  when  swallowed.  Furthermore,  all 
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) 
b) 
c) 

Creosote  (CAS  Nr  8001-58-9) 
Creosote  oil  (CAS  Nr  61789-28-4) 
Distillates  (coal  t a r ), naptttalene  oils  (CAS  Nr  84650-
04-4) 
Creosote  oil,  acenaphthene  fraction  (CAS  Nr  90640-84-9) 
Distillates  (coal  t a r ), upper  (CAS  Nr  65996-91-0) 

d) 
e) 

-  4 -

f) 
g) 
h) 
j) 

A n t h r a c e ne  oil  (CAS  Nr  9 0 6 4 0 - 8 0 - 5) 
Tar  A c i d s,  C o a l,  C r u de  (CAS  Nr  6 5 9 9 6 - 8 5 - 2) 
C r e o s o t e,  wood  (CAS  Nr  8 0 2 1 - 3 9 - 4) 
Low  t e m p e r a t u re  tar  o i l,  a l k a l i ne  e x t r a c t ed  (CAS  Nr 
1 2 2 3 8 4 7 8 5) 

This  d e f i n i t i on  thus  c o v e rs  any  liquid  b y - p r o d u ct  of  the 
c a r b o n i s a t i on  of  either  coal  or  w o o d. 

ELfi-_-li---fil--L_fi_fil-

skin 

may 
cause 
e s p e c i a l ly 
wood 

been 
C r e o s o te 
or 
reported 
handling 
been 
r e p o r ts  of  v a r i o us  c a n c e rs  e.g.  cancer  of  the  s c r o t um  among 
these 
c a u s e / e f f e ct 
no 
g r o u ps 
r e l a t i o n s h ip  has  been  e s t a b l i s h e d. 

have 
c r e o s o te 
a l so 

I r r i t a t i o n.  C a s es 

t h e r e w i t h.  T h e re 

among  w o r k e rs 

d e f i n i te 

a p p l y i ng 

treated 

though 

have 

same 

c r e o s o t e;  of 

The  likelihood  of  a d v e r se  health  e f f e c ts  has  been  c o r r e l a t ed 
with  the  p r e s e n ce  of  c e r t a in  m u l t i - r i ng  a r o m a t ic  c o m p o u n ds 
known 
In 
of 
c a r c i n o g e n. 
s o m e t h i ng  b e t t e r, 
to 
the 
choose 
potential  a d v e r se  health  e f f e c ts  of  c r e o s o t e. 

a 
a b s e n ce 
it  has  been  p r o v i s i o n a l ly  d e c i d ed 
as 

B e n z o - a - p y r e ne 
In 
found. 

( B A P ), 
the 

c o n c e n t r a t i on 

Invariably 

Indicator 

these 

the 

BAP 

Is 

of 

of 

A c c o r d i ng  to  a v a i l a b le  I n f o r m a t i on  c r e o s o t es  c o n t a i n i ng  less 
than  50  ppm  BAP  pose  n e g l l b le  danger  to  h e a l th  and  those 
with  m o re  than  500  ppm  present  an  u n a c c e p t a b le  danger  when 
used  In  wood  t r e a t m e n t. 

C r e o s o t es  may  also  present  a  danger  to  the  e n v i r o n m e nt  due 
to  their  content  of  water  s o l u b le  p h e n o l s.  The  latter  may 
be  washed  out  of  c r e o s o te  treated  r a i l w ay  s l e e p e r s,  p o l e s, 
to 
fences 
the 
e n v i r o n m e n t. 
The  C o m m i s s i on  t h e r e f o re  p r o p o s es  that  this 
danger  should  also  be  c o n t r o l l ed  by  e s t a b l i s h i ng  a  limit  to 
the  amount  of  water  e x t r a c t a b le  p h e n o ls  a l l o w ed  In  c r e o s o te 
which  Is  used  Industrially  for  wood  t r e a t m e n t. 

c o m p a r t m e nt 

p o l l u te 

water 

etc 

the 

of 

£&i&lftnc.ft-fil-&Ub_&limift£ 

treatment 

c h e m i c a ls 

are 
Wood 
n a t u re 
T h us 
p o t e n t i a l ly  d a n g e r o us  to  health  and  the  e n v i r o n m e n t. 
e.g. 
the  use  of  several 
s u b s t i t u t es 
It  Is 
P e n t a c h l o r o p h e n oI  and  CCA,  has  already  been  limited. 
very  p r o b l e m a t ic  to  find  s u b s t i t u t es  for  c r e o s o te  In  the 
outdoor  a p p l i c a t i o ns  w h e re  it  is  m a i n ly  u s e d. 

the  potential 

their 

very 

by 

of 

Given  the  d i f f i c u l ty  of  finding  safer  s u b s t i t u t es  and  that 
as  a 
c r e o s o te 

inevitably  will  c o n t i n ue 

to  be  p r o d u c ed 

-  5 -

b y p r o d u ct 
Is  to 
Industry 
c o n t i n ue  to  a l l ow  c r e o s o te  to  be  u s ed  for  w o od  t r e a t m e nt  but 
only  under  s t r i c t ly  c o n t r o l l ed  c o n d i t i o n s. 

of  the  coke 

the  best 

p o l i cy 

£finc.lu&lfin 

It  is  c o n c l u d ed  that  c r e o s o te  and  w o od  t r e a t ed  t h e r e w i th  can 
under  c e r t a in  c i r c u m s t a n c es  p o se  d a n g e rs  to  h u m an  h e a l th  and 
to  the  e n v i r o n m e n t. 
The  s t r a t e gy  p r o p o s ed  t h e r e f o re  Is  the 
foI IowIng: 

C r e o s o te  w i th  less  than  50  ppm  BAP  and  w o od  t r e a t ed 
t h e r e w i th  s h o u ld  not  be  c o n t r o l l e d. 

C r e o s o te  w i th  from  50  to  5 00  ppm  s h o u ld  be  a v a i l a b le 
o n ly  for 
industrial  use  w h i le  u se  of  the  w o od  so 
t r e a t ed  s h o u ld  be  c o n f i n ed  to  p r o f e s s i o n al  a p p l i c a t i o ns 
w h e re  t h e re 
the 
p u b l i c.  Only  old  w o od  t r e a t ed  m a ny  y e a rs  b e f o re  may  be 
m a de  a v a i l a b le  to  c o n s u m e rs  and  then  o n ly  for  c e r t a in 
u s e s. 

is  little  c h a n ce  of  c o n t a ct 

w i th 

The  use  for  w o od  t r e a t m e nt  of  c r e o s o te  w i th  m o re  than 
5 00  ppm  BAP  and  the  use  of  w o od  so  t r e a t ed  s h o u ld  be 
totaI Iy  b a n n e d. 

No  c r e o s o te  w h i ch  Is  c o v e r ed  by  the  p r o p o s al  and  w h i ch 
c o n t a i ns  m o re  than  3%  water  s o l u b le  p h e n o ls  s h o u ld  be 
used  for  wood  t r e a t m e nt  nor  s h o u ld  w o od  so  t r e a t ed  be 
used . 

III.  C H L O R I N A T ED  S O L V E N TS 

&a.c.fc.gxfiimd 

C h l o r i n a t ed  s o l v e n ts  are  w i d e ly  used  In  i n d u s t ry  m a i n ly  to 
clean  a r t i c l es  of  all  s h a p e s,  s i z es  and  m a t e r i a l s; 
this  is 
n o n - f l a m m a b l e. 
e f f e c t i v e, 
b e c a u se 
Similar  u s es  by  c o n s u m e rs  but  on  a  much  s m a l l er  s c a le  have 
been  d e v e l o p ed  for  some  such  s o l v e n t s. 

c h e ap 

they 

are 

and 

Many  c h l o r i n a t ed  s o l v e n ts  are  d a n g e r o us  w h en  Inhaled  or  w h en 
s w a l l o w e d;  some  c a u se  c o n c e rn  for  m an  o w i ng  to  p o s s i b le 
c a r c i n o g e n ic  e f f e c ts  but  In  respect  of  w h i ch  the  a v a i l a b le 
i n f o r m a t i on 
s a t i s f a c t o ry 
a s s e s s m e nt . 

for  m a k i ng 

a d e q u a te 

is  not 

a 

these 

G i v en 
c h e m i c a ls 
c h l o r i n a t ed  s o l v e n ts  by  c o n s u m e rs  s h o u ld  be  l i m i t e d. 

h a z a r ds 
In  the  home 

It  Is  p r o p o s ed 

p o t e n t i al 

that 

and 

the 

for 

m i s u se 

of 
the  use  of 

-  6 -

_Lfl._ft_QL__Q-i_ft_fl.l_aiiO._ 

of 

D i r e c t i ve 

6 7 / 5 4 8 / E E C; 

Four  c r i t e r ia  have  been  used  In  s e l e c t i ng  c a n d i d a t es  for 
c o n t r o l s.  First  Is  their  c l a s s i f i c a t i o n,  if  a n y,  w i t h in  the 
f r a m e w o rk 
d a n g e r o us 
s o l v e n ts  should  c l e a r ly  be  a v o i d e d. 
S e c o n d l y,  t h e re  Is  the 
q u e s t i on  of  w h e t h er  p a r t i c u l ar  s o l v e n ts  are  p r e s e n t ly  used 
by  c o n s u m e r s;  d a n g e r o us  c h e m i c a ls  not  p r e s e n t ly  used  by 
third 
s h o u ld 
c o n s u m e rs 
c r i t e r i on 
d a n g e r o us 
is  the  a v a i l a b i l i ty  of  s u b s t i t u t e s; 
c h e m i c a ls  w h i ch  are  p r e s e n t ly  used  but  for  w h i ch  s u b s t i t u t es 
F i n a l ly  a  f o u r th  c r i t e r i on  Is 
exist  s h o u ld  a l so  be  a v o i d e d. 
w h e t h er 
by 
are  s u b j e ct 
s o l v e n ts 
p a r t i c u l ar 
e x i s t i ng  C o m m u n i ty  l e g i s l a t i o n. 

to  c o n t r ol 

f u t u r e.  A 

be  used 

In  the 

most 

the 

not 

____lan_fta_ft_a_l_ft_ 

Eleven  c h l o r i n a t ed  s o l v e n ts  w e re  e x a m i n ed  In  t e r ms  of  t h e se 
four  c r i t e r ia  to  e s t a b l i sh  p r i o r i t i es  for  limiting  use  by 
form  a 
the  p u b l i c.  T h r ee  g r o u ps  w e re 
h i e r a r c hy  for  control  p u r p o s e s. 

i d e n t i f i ed  w h i ch 

_L__D._1 

The  f o l l o w i ng  s u b s t a n c e s: 

C h l o r o f o rm  (CAS  Nr  6 7 - 6 6 - 3) 
C a r b on  T e t r a c h l o r i de  (CAS  Nr  5 6 - 2 3 - 5) 
1,1,2  T r I c h l o r o e t h a ne  (CAS  Nr  7 9 - 0 0 - 5) 
1,1,2,2  T e t r a c h l o r o e t h a ne  (CAS  Nr  7 9 - 3 4 - 5) 
1,1,1,2  T e t r a c h l o r o e t h a ne  (CAS  Nr  6 3 0 - 2 0 - 6) 
P e n t a c h l o r o e t h a ne  (CAS  Nr  7 6 - 0 1 - 7) 
1,1  D I c h l o r o e t h y l e ne  (CAS  Nr  7 5 - 3 5 - 4) 

are  d a n g e r o u s,  being  c l a s s ed  " h a r m f u l"  or  w o r s e,  have  no 
consumer  u s es  or  have  both  of  these  c h a r a c t e r i s t i c s. 
T h e se 
are  r e g a r d ed  as  high  p r i o r i ty  for  control  p u r p o s e s. 

_ £ _ _ _ __ 

The  f o l l o w i ng  s u b s t a n c e: 

1,1,1  Tr I c h l o r o e t h a ne  (CAS  N*  7 1 - 5 5 - 6) 

is  harmful  and  is  used  to  some  extent  by  c o n s u m e r s. 
It  Is 
due  to  be  banned  e n t i r e ly  by  2005  w i t h in  the  f r a m e w o rk  of 
p r o t e c t i ng  the  O z o ne  layer.  Control  of  this  s u b s t a n ce  has 
somewhat  less  p r i o r i t y. 

-  7 -

The  f o l l o w i ng  s u b s t a n c e s: 

M e t h y l e ne  C h l o r i de  (CAS  N*  7 5 - 0 9 - 2 ), 
Tr I c h l o r o e t h y l e ne  (CAS  N*  7 9 - 0 1 - 6 ), 
P e r c h l o r o e t h y l e ne  (CAS  N*  1 2 7 - 1 8 - 4) 

are  a l so  harmful  and  are  u s ed  to  a  c o n s i d e r a b le  e x t e nt  by 
c o n s u m e r s.  H o w e v e r,  s u b s t i t u t i on 
C o n t r ol 
of  these  s u b s t a n c es  d o es  not  seem  w a r r a n t ed  at  p r e s e n t. 

Is  p r o b l e m a t i c. 

_ _ _ _ l _ a l Q_ 

It  Is  p r o p o s ed  that  that  the  use  by  the  p u b l ic  of  the 
s u b s t a n c es  In  G r o up  1  and  of  p r e p a r a t i o ns  c o n t a i n i ng  them 
s h o u ld  be  b a n n ed  on  e n t ry  into  f o r ce  of  t h is  d i r e c t i v e. 

It  is  f u r t h er  p r o p o s ed  that  the  s i n g le  s u b s t a n ce  in  G r o up  2 
viz  1,1,1  T r I c h I o r o e t h a ne  and  p r e p a r a t i o ns  c o n t a i n i ng  It  be 
banned  five  y e a rs  from  e n t ry  Into  f o r c e. 

In  the  case  of  G r o up  3  s u b s t a n c es  the  C o m m i s s i on  Intends  to 
carry  out  a  r e v i ew  on  their  c o n t i n u ed  use  t h r ee  y e a rs  from 
ent ry  Into  force . 

IV.  CMT  S U B S T A N C ES  AND  P R E P A R A T I O NS 

" E u r o pe 

The  p r o g r a m me 
the 
a t t e n t i on  of  the  C o m m u n i ty  on  s u b s t a n c es  and  p r e p a r a t i o ns 
termed  c a r c i n o g e n ic  (may  c a u se  c a n c e r ),  m u t a g e n ic  (may  c a u se 
h e r i t a b le  g e n e t ic  d a m a g e)  and  t e r a t o g e n ic  (may  c a u se  birth 
d e f e c t s ). 

C a n c e r" 

f o c u s ed 

a g a i n st 

has 

A  first  I n i t i a t i ve  w as  to  d e v e l op  a  m e t h o d o l o gy  for  the 
c l a s s i f i c a t i on  of  c a r c i n o g e n i c,  m u t a g e n ic  and 
t e r a t o g e n ic 
s u b s t a n c e s.  As  a  s i m i l ar  s y s t em  has  b e en  a d o p t ed  for  each 
of  the  three  c a s e s,  only  the  c l a s s i f i c a t i on  of  c a r c i n o g e ns 
will  be  o u t l i n ed  h e r e. 

D i r e c t i ve 
c a r c i n o g e ns  viz  c a t e g o r i es  1,  2  and  3  as  f o l l o w s: 

9 1 / 3 2 5 / E EC 

d e f i n es 

three 

the 

c a t e g o r i es 

of 

C a t e g o ry  1 

Is 
S u b s t a n c es 
s u f f i c i e nt 
a s s o c i a t i on 
b e t w e en  h u m an  e x p o s u re  to  a  s u b s t a n ce  and  the  d e v e l o p m e nt  of 
c a n c e r. 

to  be  c a r c i n o g e n ic 

k n o wn 
e v i d e n ce 

to  m a n.  T h e re 

a  causal 

e s t a b l i sh 

to 

C a t e g o ry  2 

S u b s t a n c es  w h i ch  s h o u ld  be  r e g a r d ed  as  if  they  are 

8 -

to 
c a r c i n o g e n ic 
p r o v i de  a  s t r o ng  p r e s u m p t i on 
to  a 
s u b s t a n ce  may  result  In  the  d e v e l o p m e nt  of  c a n c e r,  g e n e r a l ly 
on  the  bas Is  o f: 

that  h u m an  e x p o s u re 

to  m a n.  T h e re 

Is  s u f f i c i e nt 

e v i d e n ce 

a p p r o p r i a te  long-term  animal  s t u d i e s, 
other  relevant  i n f o r m a t i o n. 

C a t e g o ry  3 

S u b s t a n c es  w h i ch  c a u se  c o n c e rn  for  man  o w i ng  to  p o s s i b le 
c a r c i n o g e n ic  e f f e c ts  but  In  respect  of  w h i ch  the  a v a i l a b le 
s a t i s f a c t o ry 
I n f o r m a t i on 
a s s e s s m e n t.  T h e re  is  some  e v i d e n ce  from  a p p r o p r i a te  animal 
s t u d i e s,  but  this  Is  i n s u f f i c i e nt  to  p l a ce  the  s u b s t a n ce  in 
c a t e g o ry  2. 

for  m a k i ng 

a d e q u a te 

Is  not 

a 

Annex 
c l a s s i f i c a t i o ns  for  a  first  batch  of  s u b s t a n c e s. 

d i r e c t i ve 

same 

this 

to 

I 

e s t a b l i s h es 

CMT 

p u b l ic  of  s u b s t a n c es  c l a s s i f i ed 

The  p r e s e nt  proposal  w o u ld  e s t a b l i sh  a  f u r t h er  p r o c e d u re 
a c c o r d i ng  to  w h i ch  the  p l a c i ng  on  the  m a r k et  for  use  by  the 
general 
I  of 
D i r e c t i ve  6 7 / 5 4 8 / E EC  as  c a r c i n o g e ns  of  c a t e g o r i es  1  and  2, 
m u t a g e ns  of  c a t e g o r i es  1  and  2  and  t e r a t o g e ns  of  c a t e g o r i es 
1  and  2  Is  p r o h i b i t e d;  f u r t h e r m o re  an  a u t o m a t ic  ban  for 
consumer  use  will  apply  to  s u b s t a n c es  that  may  be  c l a s s i f i ed 
In  a d d i t i on  the  p l a c i ng  on  the 
as  such  in  the  f u t u r e. 
market 
p r e p a r a t i o ns 
c o n t a i n i ng  the  same  s u b s t a n c es  will  a l so  be  b a n n ed  if  the 
c o n c e n t r a t i on  of  such  a  s u b s t a n ce  is  a b o ve  a  c e r t a in  v a l u e; 
the  latter  may  be  s p e c i f i ed  in  the  c l a s s i f i c a t i on  of  the  CMT 
s u b s t a n c e;  f a i l i ng  this  It  Is  the  general  v a l ue  p r o v i d ed  by 
D i r e c t i ve  8 8 / 3 7 9 / E EC  w h i ch  a p p l i e s. 

for  use  by 

the  general 

In  A n n ex 

p u b l ic 

of 

V. 

C O N F O R M I TY  W I TH  THE  T R E A TY 

As  Is  clear 
this 
proposal  Is  Intended  to  afford  a  high  level  of  p r o t e c t i on 
for  both  p e r s o ns  and  the  e n v i r o n m e nt  and  Is  t h e r e f o re  In 
c o n f o r m i ty  with  A r t i c le  1 0 0 A ( 3)  of  the  T r e a t y. 

from  s e c t i o ns 

II,  III  and 

IV  a b o v e, 

The  proposal  d o es  not  call  for  any  special  p r o v i s i o ns  of  the 
kind  r e f e r r ed  to  In  A r t i c le  8c  of  the  T r e a t y. 

V I.  C O N S U L T A T I ON 

OF 
E C O N O M IC  AND  S O C I AL  C O M M I T T EE 

THE 

E U R O P E AN 

P A R L I A M E NT 

AND 

THE 

c o m p l i a n ce 

the 
In 
c o o p e r a t i on 
Is 
a p p l i c a b l e.  The  E c o n o m ic  and  Social  C o m m i t t ee  has  to  be 
c o n s u I t e d. 

T r e a t y, 
P a r l i a m e nt 

of 
E u r o p e an 

A r t i c le 
with 

p r o c e d u re 

with 

100A 

the 

the 

- *-

P r o p o s aI  for  a 

_0___C_iL__lRE_IiYE 

a m e n d i ng  for  the  t h i r t e e n th  time  D i r e c t i ve  7 6 / 7 6 9 / E EC  on  the 

a p p r o x i m a t i on  of  the  laws,  r e g u l a t i o ns  and  a d m i n i s t r a t i ve 

p r o v i s i o ns  of  the  Member  S t a t es  r e l a t i ng  to  r e s t r i c t i o ns  on 

the  m a r k e t i ng  and  use  of  c e r t a in  d a n g e r o us  s u b s t a n c es  and 

prepar at Ions 

THE  C O U N C IL  OF  THE  E U R O P E AN  C O M M U N I T I E S, 

H a v i ng  regard  to  the  T r e a ty  e s t a b l i s h i ng  the  E u r o p e an 

E c o n o m ic  C o m m u n i t y,  and  in  p a r t i c u l ar  A r t i c le  100a  t h e r e o f, 

Having  regard  to  the  p r o p o s al  from  the  C o m m i s s i o n ,1 

In  c o o p e r a t i on  with  the  E u r o p e an  P a r l i a m e n t ,2 

Having  regard  to  the  o p i n i on  of  the  E c o n o m ic  and  Social 

CommI 11ee , 3 

W h e r e as  m e a s u r es  s h o u ld  be  a d o p t ed  for  the  p r o g r e s s i ve 

e s t a b l i s h m e nt  of  the  Internal  m a r k et  by  31  D e c e m b er  1 9 9 2; 

w h e r e as  the  internal  m a r k et  is  an  area  w i t h o ut  Internal 

f r o n t i e rs  In  w h i ch  the  free  c i r c u l a t i on  of  g o o d s,  p e r s o n s, 

s e r v i c es  and  capital  is  g u a r a n t e e d; 

1 

2 

3 

OJ  No 

OJ  No 

OJ  No 

-  10 -

W h e r e as  work  on  the  internal  m a r k et  s h o u ld  g r a d u a l ly  improve 

the  quality  of  life,  health  p r o t e c t i on  and  c o n s u m er  s a f e t y; 

w h e r e as  the  m e a s u r es  proposed  by  this  D i r e c t i ve  are  in  line 

with  the  Council  Resolution  of  9  N o v e m b er  1989  on  future 

p r i o r i t i es  for  relaunching  c o n s u m er  p r o t e c t i on  p o l i c y ;4 

W h e r e as  the  Council  and  the  r e p r e s e n t a t i v es  of  the 

G o v e r n m e n ts  of  the  Member  S t a t e s,  m e e t i ng  w i t h in  the 

Council,  adopted  Decision  90/238 / E u r a t o m,  E C S C,  EEC 

c o n c e r n i ng  a 

1 9 9 0 - 94  a c t i on  plan  in  the  context  of  the  " E u r o pe  against 

c a n c e r"  p r o g r a m m e; 

W h e r e as  the  s u b s t a n c es  which  appear  in  A n n ex  I  to Council  D i r e c t i ve 

6 7 / 5 4 8 / E E C,  as  last  amended  by  C o m m i s s i on  D i r e c t i ve  9 1 / 6 3 2 / E E C, 

and  are  c l a s s i f i ed  as  c a r c i n o g e ns  c a t e g o ry  1  or  category  2  may  cause 

c a n c e r;  w h e r e as  to  improve  h e a l th  p r o t e c t i on  such  s u b s t a n c es 

and  p r e p a r a t i o ns  c o n t a i n i ng  them  s h o u ld  not  be  placed  on  the 

market  for  use  by  the  general  p u b l i c; 

Whereas  the  s u b s t a n c es  which  a p p e ar  in  Annex  I to  D i r e c t i ve  6 7 / 5 4 8 / E EC 

and  are  c l a s s i f i ed  as  mutagens  c a t e g o ry  1  or  category  2  may  cause 

h e r i t a b le  g e n e t ic  d a m a g e;  w h e r e as  to  improve  h e a l th 

p r o t e c t i on  such  s u b s t a n c es  and  p r e p a r a t i o ns  c o n t a i n i ng  them 

s h o u ld  not  be  placed  on  the  m a r k et  for  use  by  the  general 

pub I Ic; 

Whereas  the  s u b s t a n c es  which  appear  in  Annex  I  to  Directive  6 7 / 5 4 8 / E EC 

and  are  classified  as  t e r a t o g e ns  c a t e g o ry  1  or  category  2  may  cause 

birth  d e f e c t s;  w h e r e as  to  improve  h e a l th  p r o t e c t i on  such 

s u b s t a n c es  or  p r e p a r a t i o ns  c o n t a i n i ng  them  s h o u ld  not  be 

p l a c ed  on  the  market  for  use  by  the  g e n e r al  p u b l i c; 

4 
5 
6 

7 

0J  No  C  2 9 4,  2 3 . 1 1 . 1 9 8 9,  p.  1. 

0J  No  L  137,  30.5.1990,  p.  31. 

0J  No  L  196,  16.8.1967,  p.  1. 

0J  No  L  3 3 8,  1 0 . 1 2 . 1 9 9 1,  p . 2 3,  and  0J  No  L  338A,  1 0 . 1 2 . 1 9 9 1,  p.  2 

- r; -

Whereas  Annex  I  to  D i r e c t i ve  6 7 / 5 4 8 / E EC  lays  down  i n d i v i d u al 

c o n c e n t r a t i on  limits  for  such  s u b s t a n c es  and,  in  the  a b s e n ce 

of  such  l i m i t s.  Table  VI  of  Annex  I  to  C o u n c il  D i r e c t i ve 

8 

9 

8 8 / 3 7 9 / E E C, 

as  last  amended  by  C o m m i s s i on  D i r e c t i ve  9 0 / 4 9 2 / E E C, 

lays  down  g e n e r al  c o n c e n t r a t i on  limits  which  a p p ly  to  such 

s u b s t a n c es  c o n t a i n ed  in  p r e p a r a t i o n s; 

W h e r e as  c r e o s o t e,  as  defined  in  the  Annex  to  t h is  D i r e c t i v e, 

may  be  d a m a g i ng  to  health  b e c a u se  of  its  c o n t e nt  of  k n o wn 

c a r c i n o g e n s;  w h e r e as  for  these  r e a s o ns  the  use  of  c r e o s o te 

in  wood  t r e a t m e nt  and  the  m a r k e t i ng  and  use  of  c r e o s o te 

treated  w o od  s h o u ld  be  limited; 

W h e r e as  s o me  of  the  c o m p o n e n ts  of  c r e o s o te  are  p o o r ly 

d e g r a d a b le  and  d e l e t e r i o us  to  o r g a n i s ms  in  the  e n v i r o n m e n t; 

w h e r e as  t h e se  c o m p o n e n ts  may  enter  the  e n v i r o n m e nt  as  a 

result  of  the  use  of  treated  w o o d; 

W h e r e as  s o me  c h l o r i n a t ed  s o l v e n ts  p r e s e nt  a  d a n g er  to  health 

and  s h o u ld  not  be  m a r k e t ed  to  the  g e n e r al  pub I ic  in 

s u b s t a n c es  and  p r e p a r a t i o n s; 

W h e r e as  the  r e s t r i c t i o ns  on  the  u se  of  c r e o s o te  in  w o od 

t r e a t m e n t,  on  the  m a r k e t i ng  and  u se  of  c r e o s o te  t r e a t ed  wood 

and  on  the  m a r k e t i ng  and  use  of  c h l o r i n a t ed  s o l v e n ts  laid 

down  by  this  D i r e c t i ve  take  into  a c c o u nt  the  c u r r e nt  s t a te 

of  k n o w l e d ge  and  t e c h n i q u es  r e g a r d i ng  safer  a l t e r n a t i v e s; 

8 
9 

OJ  No  L  1 8 7,  1 6 . 7 . 1 9 88  p . 1 4. 
OJ  No  L  2 7 5,  5 . 1 0 . 1 9 9 0,  p.  3 5. 

-  12 -

W h e r e as  l i m i t a t i o ns  a l r e a dy  a d o p t ed  by  c e r t a in  M e m b er  S t a t es 

on  t he  u se  or  m a r k e t i ng  of  t he  s u b s t a n c es  m e n t i o n ed  a b o ve  or 

the  p r e p a r a t i o n s"  c o n t a i n i ng  t h em  d i r e c t ly  a f f e ct  t he 

c o m p l e t i on  a nd  f u n c t i o n i ng  of  t he  i n t e r n al  m a r k e t;  w h e r e as 

it  is  t h e r e f o re  n e c e s s a ry  to  a p p r o x i m a te  t he  l a ws  of  t he 

M e m b er  S t a t es  in  t h is  f i e ld  a nd  c o n s e q u e n t ly  a m e nd  A n n ex  I 
to  C o u n c il  D i r e c t i ve  7 6 / 7 6 9 / E E C, 

as  last  a m e n d ed  by 

1 0 

D i r e c t i ve  9 1 / 3 3 9 / E E C; 

11 

W h e r e as 

t h is 

D i r e c t i ve  d o es  n ot  a f f e ct  C o m m u n i ty 

l e g i s l a t i on  l a y i ng  d o wn  m i n i m um  r e q u i r e m e n ts  for  t he 

p r o t e c t i on  of  w o r k e r s,  c o n t a i n ed  in  C o u n c il  D i r e c t i ve 

8 9 / 3 9 1 / E EC 

1 2 

and  in  i n d i v i d u al  D i r e c t i v es  b a s ed  t h e r e o n, 

in  p a r t i c u l ar  C o u n c il  D i r e c t i ve  9 U / 3 9 4 / E E C, 

1 3 

H AS  A D O P T ED  T H IS  D I R E C T I V E: 

A r t i c le  1 

A n n ex  I  to  D i r e c t i ve  7 6 / 7 6 9 / E EC  is  h e r e by  a m e n d ed  as  set  o ut 

in  t he  A n n ex  h e r e t o. 

10 

11 

12 

13 

0J  No  L  262,  27.9.1976,  p.  201 

0J  No  L  186,  12.7.1991,  p.  64. 

0J  No  L  183,  29.6.1989,  p.  1. 

0J  No  L  196,  26.7.1990,  p.  1. 

)-  13  -

A r t i c le  2 

1. 

M e m b er  S t a t es  s h a ll  a d o pt  a nd  p u b l i sh  t he  l a w s, 

r e g u l a t i o ns  a nd 

a d m i n i s t r a t i ve  p r o v i s i o ns  n e c e s s a ry  to 

c o m p ly  w i th  t h is  D i r e c t i ve  no  l a t er  t h an  1  y e ar  a f t er 

t he  d a te  of  its  a d o p t i on  a nd  s h a ll  f o r t h w i th  i n f o rm  t he 

C o m m i s s i on  t h e r e o f. 

T h ey  s h a ll  a p p ly  t h e se  p r o v i s i o ns 

f r om  /_3  m o n t hs  a f t er  t he  d a te  s t a t ed  a b o v e ?. 

2. 

S h o u ld  A n n ex  I  to  D i r e c t i ve  6 7 / 5 4 8 / E EC  be  a m e n d ed 

a f t er 

n o t i f i c a t i on 

of 

t h is 

D i r e c t i ve 

w i th 

r e s p e ct  to  t he  s u b s t a n c es  a nd  p r e p a r a t i o ns  r e f e r r ed  to 

in  p o i n ts  2 9,  30  &  31  of  t he  A n n ex  to  t h is  D i r e c t i v e, 

M e m b er  S t a t es  s h aI  If b r i ng  i n to  f o r ce  t he  l a w s, 

r e g u l a t i o ns  a nd  a d m i n i s t r a t i ve  p r o v i s i o ns  n e c e s s a ry  to 

i n t r o d u ce  t he  l i m i t a t i o ns  p r o v i d ed  f or  in  t h is  D i r e c t i ve 

a r i s i ng  f r om  a ny  a m e n d i ng  D i r e c t i v es  by  t he  d e a d l i n es 

l a id  d o wn  for  i m p l e m e n t a t i on  of  s u ch  a m e n d i ng  D i r e c t i v e s. 

M e m b er  S t a t es  s h a ll  f o r t h w i th  i n f o rm  t he  C o m m i s s i on 

t h at  t he  p r o v i s i o ns  r e f e r r ed  to  in  t h is  p a r a g r a ph  h a ve 

b e en  b r o u g ht  i n to  f o r c e. 

3. 

W h en  M e m b er  S t a t es  a d o pt  t he  p r o v i s i o ns  r e f e r r ed  to  in 

p a r a g r a p hs  1  and  2,  t h e se  s h a ll  c o n t a in  a  r e f e r e n ce  to 

t h is  D i r e c t i ve  or  s h a ll  be  a c c o m p a n i ed  by  s u ch  r e f e r e n ce 

at  t he  t i me  of  t h e ir  o f f i c i al  p u D l i c a t i o n. 

T ne  p r o c e d u re 

for  s u ch  r e f e r e n ce  s h a ll  be  a d o p t ed  by  M e m b er  S t a t e s. 

A r t i c le  3 

T h is  D i r e c t i ve  is  a d d r e s s ed  to  t he  M e m b er  S t a t e s. 

D o ne  at  B r u s s e l s, 

F or  t he  C o u nc i I 

T he  P r e s i d e nt 

- 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 
( T )H  with  risk  phrase  R45: 

Directive  67/548/EEC,  or 

-  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" 

- 15 -

By  way  of  derogation,  this 
provision  shall  not  apply  to: 
a) medicinal  or  veterinary 
products  as  defined  by 
Directive  65/65/EEC< 1 4>,  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) 

22, 9.2.1965,  p. 369. 
0J  No 
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 

May  not  be  used  in  an 

in Annex  I to  Directive 

individual  concentration 

67/548/EEC  classified  as 

equal  to  or  greater  than: 

mutagen  category  1 or 

-  either  the  concentration 

mutagen  category  2  and 

specified  in  Annex  I to 

labelled  with  risk  phrase 

Directive  67/548/EEC, 

or 

R46:  "May  cause  heritable 

-  the  concentration  specified 

genet i c  damage" . 

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 

May  not  be  used  in  an 

in  Annex  I to  Directive 

individual  concentration 

67/548/EEC  classified  as 

equal  to  or  greater  than: 

teratogen  category  1 or 

-  either  the  concentration 

teratogen  category  2  and 

specified  in  Annex  I to 

labelled  with  risk  phrase 

Directive  67/548/EEC 

or 

R47:  "May  cause  birth 

-  the  concentration  specified 

defects". 

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 

32.1.  May  not  be  used  for  wood 

rations,  containing 

treatment  if  they  contain 

one  or  more  of  the  fol 

a)  Benzo-a-Pyrene  at  a 

lowing  substances 

a)  Creosote 

concentration  of  greater 

than  0.005%  by  mass 

EINECS  Nr  232-287-5 

or  b)  water  extractable 

CAS  Nr  8001-58-9 

b)  Creosote  o i I 

phenols  at  a  concen 

tration  of  greater 

EINECS  Nr  263-047-8 

than  3%  by  mass 

CAS  Nr  61789-28-4 

or  both  a)  and  b) 

c)  Distillates  (coa I 

t a r ),  napht ha Iene 

oils 

EINECS  Nr  283-484-8 

CAS  Nr  84650-04-4 

Furthermore  wood  so 

treated  may  not  be 

placed  on  the  market 

d)  Creosote  Oil,  ace-

However  by  way  of  deroga-

naphthene  fraction 

gat i on : 

EINECS  Nr  292-605-3 

(i)  Rotating  to  the  substan 

CAS  Nr  90640-84-9 

ces  and  preparations: 

e)  Distillates  (coa I 

these  may  be  used  for  wood 

tar) .upper 

treatment  in  industrial 

EINECS  Nr  266-026-1 

installations  if  they 

CAS  Nr  65996-91-0 

conta i n: 

f) Anthracene  O i I 

EINECS  Nr  292-602-7 

CAS  Nr  90640-80-5 

a)  Benzo-a-Pyrene  at 

a  concentration  of 

less  than  0.05%  by  mass 

g)  Tar  Ac i ds , CoaI , 

and 

Crude 

EINECS  Nr  266-019-3 

CAS  Nr  65996-85-2 

b)  Water  extractable 

phenols  at  a  concen 

tration  of  less  than 

h)  Creosote,  wood 

3%  by  mass. 

EINECS  Nr  232-419-1 

CAS  Nr  8021-39-4 

- 21 -

J) Low  temperature 

Such  substances  and 

tar  o i l,  alkaline 

prepa r a t i ons 

extracted 

-  may  be  placed  on  the 

EINECS  Nr  310  t9f  5 

market  only  in  packaging 

CAS  Nr  122384785 

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  w h a t e v er  their  p u r p o se 

( r e s i d e n c e,  e m p l o y m e n t, 

l e i s u r e ); 

-  for  the  m a n u f a c t u re  of 

c o n t a i n e rs  intended  for 

g r o w i ng  p u r p o s es  and  any 

r e - t r e a t m e nt  and  the 

m a n u f a c t u re  of  p a c k a g i ng 

w h i ch  may  come  into 

c o n t a ct  with  or  other 

m a t e r i a ls  w h i ch  may 

c o n t a m i n a te  raw, 

i n t e r m e d i a te  and/or 

f i n i s h ed  p r o d u c ts  intended 

for  h u m an  a n d / or  animal 

c o n s u m p t i on  and  any  r e-

t r e a t m e n t; 

-  in  p l a y g r o u n ds  and  in 

other  o u t d o or  p l a c es  of 

pub lie  p i e a s ur e. 

33. 

C h i o r o f o rm 

"\ 

May  not  be  used  in 

CAS  N r.  6 7 - 6 6 -3 

c o n c e n t r a t i o ns  equal  to 

3 4.  C a r b on  T e t r a c h l o r i de 

or  g r e a t er  than  0 , 1%  by 

CAS  N r.  5 6 - 2 3 -5 

w e i g ht  in  s u b s t a n c es  and 

3 5.  1,1,2  Trich I o r o e t h a ne 

p r e p a r a t i o ns  p l a c ed  on 

CAS  Nr.  7 9 - 0 0 -5 

36.  1,1,2,2  T e t r a c h l o r o e t h a ne 

CAS  Nr.  7 9 - 3 4 -5 

y 

3 7.  1,1,1,2  T e t r a c h I o r o e t h a ne 

CAS  Nr.  6 3 0 - 2 0 -6 

3 8.  P e n t a c hI o r o e t h a ne 

the  m a r k et  for  sale  to 

the  g e n e r al  p u b l i c. 

CAS  Nr.  7 6 - 0 1 -7 

W i t h o ut  p r e j u d i ce  to  the 

39. 

1,1  D i c h I o r o e t h y I e ne 

a p p l i c a t i on  of  other 

CAS  Nr.  7 5 - 3 5 -4 

C o m m u n i ty  p r o v i s i o ns  on 

j 

the  c l a s s i f i c a t i o n,  p a c k a 

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 -

4 0. 

1,1,1  T r i c h I o r o e t h a ne 

From  five  y e a rs  of  entry 

CAS  N r.  7 1 - 5 5 -6 

into  f o r ce  of 

this  D i r e c t i v e,  may  not  be 

used  in  c o n c e n t r a t i o ns 

equal  to  or  g r e a t er  than 

0 , 1%  by  we i ght  in 

subs t a n c es  and 

p r e p a r a t i o ns  p l a c ed  on  the 

m a r k et  for  sale  to  the 

gener a I  pub lie. 

W i t h o ut  p r e j u d i ce  to  the 

a p p l i c a t i on  of  other 

C o m m u n i ty  p r o v i s i o ns  on 

the  c l a s s i f i c a t i o n, 

p a c k a g i ng  and  labelling  of 

d a n g e r o us  s u b s t a n c es  and 

p r e p a r a t i o n s,  the 

p a c k ag i ng  of  this 

s u b s t a n ce  and  of 

p r e p a r a t i o ns  c o n t a i n i ng  it 

in  c o n c e n t r a t i o ns  equal  to 

or  g r e a t er  than  0 . 1%  shall 

be  l e g i b le  and  indelibly 

m a r k ed  as  f o l l o w s: 

"Rest r i cted  to 

p r o f e s s i o n al  u s e r s" 

By  way  of  d e r o g a t i on  this 

p r o v i s i on  shall  not  apply 

to: 

( a )  med i c i naI  or 

v e t e r i n a ry  p r o d u c ts  as 

d e f i n ed  by  D i r e c t i ve 

6 5 / 6 5 / E E C, 

as  last 

a m e n d ed  by  D i r e c t i ve 

8 9 / 3 8 1 / E EC ; 

(b)  c o s m e t ic  p r o d u c ts  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 
1993 

TOTAL  50 000 

25 000 
25 000 

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. 

I I I.  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) 

competitiveness of  Industry 
employment 

(a) 

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. 

(b) 

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 

2. Chlorinated  solvents 

Western  European  Institute for 
Wood Preservation, Brussels 

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 
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