Amended proposal for a European Parliament and Council Directive concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations
Date: 1997-09-23
Institutions: European Commission
Subjects: approximation of laws, dangerous substance, labelling, packaging, preparation for market

COMMISSION OF THE EUROPEAN COMMUNITIES 

£ 
it 

-il 
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Brussels, 23.09.1997 
COM(97) 462  final 

96/0200 (COD) 

Amended proposal  for a 

EUROPEAN  PARLIAMENT AND COUNCIL  DIRECTIVE 

concerning the approximation  of the laws, regulations and administrative provisions of 
ihe Member  States relating to the classification,  packaging and labelling of dangeiimc 
preparations 

(presented  by the Commission pursuant to Article  189 a (2) 
of the EC-Treaty) 

EXPLANATORY  MEMORANDUM 

1. 

Introduction 

Pursuant  to  Article  189(a)  paragraph  2  of  the  EC  Treaty,  the  Commission  submits  an 
amended  proposal  for  an  European  Parliament  and  Council  Directive  concerning  the 
approximation  of  the  laws,  regulations  and  administrative  provisions  of  the  Member 
States  relating  to  the  classification,  packaging  and  labelling  of  dangerous  preparations. 
The  amended  proposal  takes  account  a  number  of  amendments  from  the  European 
Parliament,  adopted  at  its Plenary  Session  on 26 June  1997  . 

The  Parliament  adopted  26  amendments  (originally  28, but  amendment  10 was  included 
in  amendment  11  and  amendment  23  in  amendment  22).  The  amendments  are  related  to 
the  following  topics: labelling,  classification,  packaging,  other  issues and  editorial  issues. 

Out  of  26  amendments  the  Commission  can  accept  13  as  such  and  3  amendments  are 
acceptable  in  principle. 

Amendments  relating  to  following  issues are not  acceptable: 

Article  3(3)  (amendment  4) 
Article  10 paragraph  2.3.1  (amendment  8) 
Article  10 paragraph  2.3.2  (amendment  9) 
Article  10 paragraph  2.3.3  (amendment  11) 
Article  10 paragraph  2.3.4  (amendment  12) 
Article  10 paragraph  2.3.4  a (new)  (amendment  13) 
Article  15, paragraph  1 (new)  (amendment  16) 
Article  16 paragraph  2, first  indent  (amendment  40) 
Annex  III, part  C, paragraph  4, (amendment  20) 
Annex  V,  Part  C (1) (first  part of amendment  22) 
Annex  V,  Part  Cb  (new)  (amendment  26). 

2. 

Labelling 

The  new  recital  13  (a)  (amendment  1)  emphasises  the  need  to  launch  a  study  on 
comprehensibility  of  contents  of  labels  and  to  review  the  existing  rules  on  labelling,  if 
necessary.  The  Commission  welcomes  this amendment  and  will  launch  this  study  as  soon 
as  possible. 

Amendments  to  Article  10 paragraph  2.3.1  (amendment  8), paragraph  2.3.2  (amendment 
9),  paragraph  2.3.3  (amendment  11),  paragraph  2.3.4  (amendment  12)  and  paragraph 
2.3.4  a  (new)  (amendment  13)  would  result  in  a  label  overloaded  with  chemical  names 
whilst  not  improving  the  level  of  protection.  The  Commission  is,  by  accepting  a  new 
recital  13 (a)  (amendment  1), committing  itself  to  launch,  as  soon  as  possible,  a  study  on 

Reference  - minutes of the session of 26 June  1997, Baldi report A4-0186/97 

2 

the comprehensibility  of labels to the users. This study  will  examine  all  labelling  issues, 
including  those  raised  by  amendments  8,  9,  11,  12 and  13. Based  on  the  results  of  this 
study the  Commission  will  review all  labelling requirements. Therefore  the  amendments 
proposed on naming of substances on the label are not accepted by the Commission. 

Amendment  to  Article  10  paragraph  4,  first  indent  (amendment  14)  introduces  an 
exemption  from  full  labelling requirements also to be applied to preparations classified  as 
dangerous  for  the  environment,  when  the  preparation  is  supplied  in  small  packages 
(volume  less  than  125 ml). This  amendment  is acceptable  and  justified  by  the  fact  that 
such  small  amounts  of  chemicals  would  not  cause  risk  to the environment.  Though  full 
labelling  is  not  required  the  packages  have  to  be  labelled  in  any  case  by  a  warning 
symbol indicating the danger to the environment. 

Amendment  to  Article  10  paragraph  5  (amendment  15)  prohibits  using  on  labels  of 
preparations covered by the Directive expressions such as "environmentally  friendly''  and 
"ecological"  or  an  expression  that  leads  to  an  underestimation  of  the  danger.  This 
amendment  completes  the  text  of  the  Commission's  original  proposal  by  adding 
examples of such expressions which are related to environmental properties. 

Amendment  to  Annex  V,  Part  C (1) (amendment  22) addresses  the  specific  warning  on 
sensitising effects  to all persons. The Parliament's amendment for a more general  version 
covers in any case the target population and is therefore acceptable to the Commission. 

Amendment  to  the  first  part  of  paragraph  1 of  Annex  V  Part  C  (corresponding  to  the 
original  amendment  23  and  combined  with  amendment  22)  is  not  acceptable  to  the 
Commission. It relates to labelling of sensitisers and would make the proposed  provision 
unworkable. The approach proposed by this amendment does not specify  any limit  for  the 
specific  warning on sensitising  effects.  In practice this would  mean that the general  limit 
of  1 % defined  in Article  3 of the proposal will apply  to all sensitisers. The  Commission 
thinks that this limit is too high to trigger this requirement. 

Amendment  to  Annex  V  Part  C  (2)  (amendment  24)  introduces  a  modification  of  the 
specific  phrase  for  packages  of  non-classified  preparations  for  which  the  Safety  Data 
Sheet  is available  on request.  The label  is to be placed  on preparations  used  exclusively 
by professional  users. Such preparations are not available to the public at large. The label 
is put  only  on preparations  which are not classified  as dangerous.  Since this  amendment 
supports  the  provision  on  a  Safety  Data  Sheet  for  non  classified  preparations  the 
Commission can accept it in a slightly modified  form. 

Amendment  to  Annex  V,  Part  Ca  (new)  (amendment  25)  proposes  a  specific  part  of 
Annex  V  to  be  introduced  for  labelling  of  Plant  Protection  Products.  The  Commission 
agrees that this part to Annex V is necessary. 

Amendment  to  Annex  V,  Part  Cb  (new)  (amendment  26)  proposes  a  specific  part  of 
Annex  V to be  introduced  for  labelling  of Biocides. The Commission  cannot  accept  this 
amendment  as it contradicts the position  taken  by the Parliament  and  the  Council  on  the 
proposal  for the Directive on Biocides which has already passed its second  reading. 

3. 

Classification 

Amendment  to  Article  3(3)  (amendment  4) would  introduce  changes  to  application  of  the 
conventional  method.  The  Commission  cannot  accept  this  amendment  as  it  would 
eventually  lead  to  unnecessary  animal  testing  because  the  conventional  method  would  be 
unworkable. 

Amendment  to  Article  6  paragraph  3  (amendment  6)  introduces  restrictions  on  animal 
testing  in  cases  where  alternative  methods  are  available  and  also  provides  for  provisions 
on  specification  of  data  on  effects  on  man.  The  Commission  welcomes  this  amendment 
but  introduces  it in a reworded  form. 

The  new  formulation  of  paragraphs  1 and  2 enables  references  to  harmonised  in  vivo  and 
in vitro  test  methods  of Annex  V to Directive  67/548/EEC. 

The  formulation  of  paragraph  3  clearly  states  as  amendment  6,  that  the  conventional 
method  or  the  in  vitro  test  methods  (alternative  methods)  are  given  the  preference  in 
classification  of preparations. The  in vivo  methods using  vertebrate  animals  could  only  be 
used  in  cases  where  the  person  responsible  for  placing  on  the  market  can  demonstrate 
that  the  alternative  methods  cannot  be  used.  The  results  of  existing  animal  tests  can  be 
used  for  classification. 

to  Annex  III,  Part  B,  Table  V  (amendment  18)  introduces  a  lower 
Amendment 
concentration  limit  (0,1  %  instead  of  0,5%)  for  classification  of  preparations  containing 
ozone  depleting  substances.  The  amendment  will  ensure  a  high  level  of  protection  by 
laying  down  the  practice  already  existing,  as the  marketing  of ozone  depleting  substances 
has already  been  prohibited  by  Regulation  3093/94  . 

Amendment  to  Annex  III,  Part  C, paragraph  4  (amendment  20)  provides  that  the  existing 
test  results  should  be  applicable  for  assessment  of  effects  dangerous  for  the  environment. 
According  to the  Commission's  view  this  is superfluous  as this  is already  the  case. 

4. 

Packaging 

Amendment  to  Article  9  paragraph  2  (new)  (amendment  7)  lays  down  the  practice 
already  existing  between  transport  and  supply  packages.  This  amendment  improves  the 
clarity  of  the  legislation. 

Amendment  to  Annex  IV,  Part  B,  paragraph  2  (new)  (amendment  21)  removes  the 
requirement  for  a tactile  danger  warning  (a special  warning  for  blind  persons)  on  aerosols 
classified  as  extremely  flammable  and  highly  flammable.  This  amendment  is  introduced 
at  the  request  of  the  European  Blind  Association.  According  to  the  Commission  this 
amendment  can  be  accepted  but  recognises  at  the  same  time  that  there  is  a  need  to 
the  comprehensibility  of  the  system  of  warnings  for  blind  and  visually 
examine 
if  necessary.  This 
the  present 
handicapped  persons,  and 
examination  can  be  linked  to the  study  introduced  by the  new  recital  13 (a). 

legislation, 

to  review 

OJNo.  L 333 ,22.12.1994, p.  1 

5. 

Other issues 

Amendment  to  Article  15  paragraph  1  (amendment  16)  goes  beyond  what  is  the 
Commission's  intention with this provision. The intention of the Commission's  proposal 
is not to introduce provisions for advertisement, but to deal with  a very  specific  situation 
of  offering  a  product  for  sale  on  the  market  through  the  so-called  "distance  selling". 
Amendment  16 is not accepted by the Commission. 

Amendment  to  Article  16 paragraph  2, first  indent, (amendment  40)  is related  to  Safety 
Data  Sheets  for  non-classified  preparations.  Although  the  Commission  understands  the 
rationale  for  this amendment  the Commission  would  like to  have  more time to  examine 
in  depth  what  kind  of  consequences  such  an  amendment  will  have  in  practice  and,  in 
particular,  in  relation  to  the  implementation  of  such  a  requirement  by  the  small  and 
medium  size  enterprises.  All  classification  and  labelling  rules  concerning  preparations 
deemed  dangerous  for  the  environment,  as  well  as  the  obligation  to  establish  a  Safety 
Data  Sheet  for  non-classified  preparations,  are completely  new  elements  in  the  field  of 
harmonised  rules  for  dangerous  preparations.  The  introduction  of  this  additional 
requirement  could  increase further  the burden on industry.  Commission  cannot  therefore 
accept this amendment. 

Article  21  of  the  Commission's  original  proposal  specifies  the  Committee  procedure 
which  will  be  used  in the  context  of  Directive  on  dangerous  preparations  leaving  open, 
however,  which  of  the  two  Committee  procedures  specified  in  Article  29  of  Directive 
67/548/EEC  will be applied. 

Article  20a  (new)  (amendment  17) adopted  by  the  Parliament  specifies  exclusively  the 
Committee  procedure  which  is  applied  to  adaptation  for  technical  progress  of  the 
Directive.  The  reworded  amendment  should  replace  the  text  of  Article  21.  This 
amendment  is acceptable  in principle to the Commission  as  it makes the  provision  more 
transparent. The text of the amendment should be reworded  to take into consideration  the 
fact that the Committee is the same as in the context of Directive 67/548/EEC. 

Amendment  to Annex  VIII, Part  A (amendment 27) proposes that reference  to  Directive 
96/65/EC  should  be  added  to  the  list  of  Directives  that  need  to  be  repealed.  This 
amendment is acceptable and necessary. 

6. 

Editorial issues 

Amendments  to  Article  1  paragraph  1,  (amendment  2),  to  Article  1  paragraph  3 
(amendment  3), to  Article  4  paragraph  2  (amendment  5), to  Article  10 paragraph  2.3.3 
(amendment  10 included  in amendment  11) and to Annex III, Introduction  to  paragraphs 
1 (a) to  1  (e) (amendment  19) are editorial and they improve the text. 

The Commission  has introduced  a clarification  on the heading of Article  15 to bring  it in 
line with its contents. 

Amended proposal for a 

EUROPEAN  PARLIAMENT AND COUNCIL  DIRECTIVE 

concerning the approximation of the laws, regulations and administrative provisions of 
the Member States relating to the classification,  packaging and labelling of dangerous 
preparations 

Pursuant  to  Article  189(a)  paragraph  2  of the  EC  Treaty,  the  Commission  has  decided  to 
amend  the  proposal3  for  an  European  Parliament  and  Council  Directive  concerning  the 
approximation  of  the  laws,  regulations  and  administrative  provisions  of  the  Member 
States  relating  to  the  classification,  packaging  and  labelling  of  dangerous  preparations  as 
follows: 

Original  proposal 

Modified  proposal 

Recital  13 a  (new) 

a 

report 

submit 

the 
Whereas  the  Commission  will,  on 
basis  of  information  to  be  supplied  by  the 
Member  States  and  the  various  parties 
concerned, 
the 
to 
the  Council 
European  Parliament  and 
within  two  years  of the  entry  into  force  of 
this  Directive  on  experience  with 
the 
present  overall  approach  to  labelling  of 
dangerous  preparations  and  in  particular 
on  its  understanding  and  application  by 
users. 
publicity 
campaigns  and  educational  and  training 
programmes:  whereas  on  the  basis  of  this 
will. 
report 
if 
the 
necessary 
appropriate. 
proposals: 

Commission 
the 
submit 

experience 

with 

Article  1(1) 

This  Directive 

1. 
the 
approximation  of  the  laws,  regulations 
and  administrative  provisions  of 
the 
Member  States  concerning: 

aims 

at 

This  Directive 

1. 
the 
approximation  of  the  laws,  regulations 
and  administrative  provisions  of 
the 
Member  States  concerning: 

aims 

at 

the  classification,  packaging  and 

labelling  of dangerous  preparations, 
specific  provisions 

for  certain 
preparations  which  may  present  hazards, 
whether  or  not  they  are  classified  as 
dangerous  within  the  meaning  of  this 
Directive,  when  such  preparations  are 
placed  on  the  market. 

OJ No C 283, 26.9.1996, p. 1 

the  classification,  packaging  and 

for 

labelling  of dangerous  preparations, 
specific  provisions 

certain 
preparations  which  may  present  hazards, 
whether  or  not  they  are  classified  as 
dangerous  within 
this 
Directive, 
when  such  preparations  are  placed  on  the 
market  of the  Member  States. 

the  meaning  of 

Article  1(3) 

3. 

The  specific  provisions  set  out: 
in Article  9 and  defined 

in Annex  IV, 

3. 

The  specific  provisions  set  out: 
in Article  9 and  defined 

in Annex  IV, 

in  Article  10  and  defined 

in 

in  Article  10  and  defined 

in 

Annex  V,  and 

in Article  16 

this  Directive  shall  also  apply 
of 
to 
preparations  which  are  not  considered 
dangerous  within  the  meaning  of  Articles 
5,  6  or  7  but  may  nevertheless  present  a 
hazard  to the  user. 

Annex  V, and 

in Article  16 

of 
to 
this  Directive  shall  also  apply 
preparations  which  are  not  considered 
dangerous  within  the  meaning  of  Articles 
5,  6  or  7  but  may  nevertheless  present  a 
specific  hazard  to the  user. 

Article  4(2) 

labelling 

The  general  principles  of 

the 
2. 
classification 
of 
and 
preparations  shall  be  applied  according  to 
the  criteria  in  Annex  VI  to  Directive 
67/548/EEC 
alternative 
save  where 
criteria  referred  to  in  Articles  5,  6  or  7  of 
this  Directive  are  applied. 

and 

labelling 

The  general  principles  of 

the 
2. 
classification 
of 
preparations  shall  be  applied  according  to 
the  criteria  in  Annex  VI  to  Directive 
67/548/EEC 
alternative 
save  where 
criteria referred  to in Articles  5, 6,  7 or  10 
and  the  corresponding  Annexes  of  this 
Directive  are  applied. 

Article  6(1), (2) and  (3) 

The 

health 

a 
1. 
preparation  shall  be  assessed  by  one  or 
more  of the  following  procedures  : 

hazards 

of 

1.  The  health  hazards  of  a  preparation 
shall  be  assessed  by  one  or  more  of  the 
following  procedures: 

by 

the 

(a) 
conventional  method 
described  in  Annex  II  parts  A  and  B  to 
this  Directive  using  concentrationiimits; 

by 

the 

(a) 
conventional  method 
described  in  Annex  II  parts  A  and  B  to 
this  Directive  using  concentration  limits: 

Directive 

(b) 
by  determining,  by  means  of  the 
methods  specified  in point  B of  Annex  V 
67/548/EEC 
the 
to 
the 
of 
toxicological 
preparation  necessary 
for  appropriate 
classification  and  labelling  in  accordance 
with  the  criteria  in  Annex  VI  to  that 
Directive. 

properties 

in  part  B  of  Annex  V 

(b) 
by  determining,  by  means  of  the 
methods  using  vertebrate  animals  and 
specified 
to 
Directive  67/548/EEC,  the  toxicological 
properties  of  the  preparation  necessary 
for 
and 
labelling  in  accordance  with  criteria  in 
Annex  VI  to that  Directive; 

classification 

appropriate 

(c) 
by  determining  by  means  of  the 
methods  not  using  vertebrate  animals  and 

in  part  B  of  Annex  V 

specified 
to 
Directive  67/548/EEC  the  toxicological 
properties  of  the  preparation  necessary 
for 
and 
labelling  in  accordande  with  the  criteria 
in Annex  VI to that  Directive. 

classification 

appropriate 

2.  The  health  hazards  of  a  preparation 
covered  by  Directive  91/414/EEC  shall 
the 
be  assessed  by  one  or  more  of 
following  procedures: 

hazards 

health 
covered 

a 
2. 
The 
preparation 
by  Directive 
9I/414/EEC  shall  be  assessed  by  one  or 
more  of the  following  procedures  : 

of 

by 

the 

(a) 
conventional  method 
described  in  Annex  II  parts  A  and  B  to 
this Directive  using concentration  limits; 

by 

the 

(a) 
conventional  method 
described  in  Annex  II  parts  A  and  B  to 
this Directive  using  concentration  limits; 

appropriate 

classification 

by  determining  the  health  effect 
(b) 
properties  of  the  preparation  necessary 
for 
in 
accordance  with  criteria  of  Annex  VI  to 
Directive  67/548/EEC.  These  health 
effect  properties  will  be  determined  by 
means  of  the  methods  laid  down  in  part 
B  of  Annex  V  to  Directive  67/548/EEC 
unless  other  internationally  recognized 
methods  are  acceptable 
in  accordance 
with  the  provisions  of  Annexes  II  and  III 
to Directive  91/414/EEC. 

When  a  toxicological  property 

3. 
is 
established  by method  Kb)  or 2fb)  to  obtain 
new  data,  the  test  shall  be  conducted  in 
compliance  with 
the  principles  of  good 
laboratory  practice  provided  for  in  Directive 
87/18/EEC4  and  with  the  provisions  of 
Directive  86/609/EEC. 

OJNo.  L 15, 17.1.1987, p. 29 

unless 

in  part  B  of  Annex  V 
67/548/EEC. 

the 
(b)  by  determining,  by  means  of 
methods  using  vertebrate  animals  and 
to 
specified 
Directive 
other 
internationally  recognised  methods  are 
acceptable 
the 
provisions  of  Annexes 
II  and  III  of 
Directive  91/414/EEC,  the  toxicological 
properties  of  the  preparation  necessary 
for 
and 
labelling  in  accordance  with  the  criteria 
in Annex  VI  to  Directive  67/548/EEC: 

accordance  with 

classification 

appropriate 

in 

internationally 

(c) by determining, by means of the  methods 
not using vertebrate  animals  and  specified  in 
part B of Annex  V to  Directive  67/548/EEC. 
unless  other 
recognised 
methods  are  acceptable  in  accordance  with 
the  provisions  of  Annexes  II  and  HI  of 
Directive  91/414/EEC. 
toxicological 
properties  of  the  preparation  necessary  for 
appropriate  classification  and  labelling  in 
accordance  with  the  criteria  in  Annex  VI  to 
Directive 67/548/EEC: 

the 

placing 

responsible 
on 

for 
the  market 

3.  Where  it  can  be  demonstrated  by  the 
the 
person 
preparation 
a 
toxicological  property  of  a  preparation 
cannot  be  determined  by  method  1 (a)  or 1 
(c).  or  by  method  2(a)  or  2  (c).  or  on  the 
basis  of  existing  test  results  on  vertebrate 
animals, the  methods  1 (b)  or 2 

that 

Any  of  the  toxicological  properties  of  the 
preparation  which  are  not  assessed  by  the 
method  set  out  in  Kb)  or 2(b) above  shall 
be  assessed 
the 
conventional  method. 

in  accordance  with 

for  classifying 

Where  a  toxicological  property  has  been 
established  by  both  the  methods  above, 
the  result  of  method  Kb)  or  2(b)  shall  be 
used 
the  preparation 
except 
the  case  of  carcinogenic. 
mutagenic  effects  and  toxic  effects  for 
reproduction 
the 
for  which 
conventional  method  described  in  Annex 
II  applies. 

only 

in 

(b) may  be  used. 

the 

specified 

test  methods 

Where  a  health  hazard  has  been  assessed 
by 
in 
paragraphs  1(b)  or  1(c).  or  2(b)  or  2(c). 
these  methods 
for 
shall 
classifying  the  preparation  instead  of  the 
conventional  method,  except  in  the  case 
of  carcinogenic,  mutagenic  effects  and 
toxic  effects  for  reproduction  for  which 
only  the  conventional  method  described 
in  Annex  II applies. 

used 

be 

Where  results  of  both  methods  Kb)  and 
1(c).  or  2(b)  and  2(c)  are  available-
method  1(b)  or  2(b)  shall  normally  be 
used  for  classifying  the  preparation. 

Furthermore, 
demonstrated  that : 

where 

it 

can 

be 

Furthermore, 
demonstrated: 

where 

it 

can 

be 

suggested  by 

- toxicological  effects  on  man  differ  from 
toxicological 
those 
determination 
conventional 
assessment,  then  the  preparation  shall  be 
classified  according  to its effects  on  man, 

or 

a 

a 

or 

of 

by 

use 

studies, 

preparations 

epidemiological 

by 
scientifically  valid  case  studies  based  on 
the 
by 
statistically-backed  experience,  such  as 
from  poison 
the  assessment  of  data 
occupational 
or 
information 
diseases  that toxicological  effects  on  man 
differ 
In 
those 
application  of  methods  provided  for  in 
paragraphs  1  or  2.  then  the  preparation 
shall  be  classified  according  to  its  effects 
on  man. 

suggested 

units 

from 

-  owing  to  effects  such  as  potentiation  a 
conventional 
would 
underestimate  the  toxicological  hazard, 
these  effects  shall  be  taken  into  account 
in classifying  the  preparation, 

assessment 

-  owing  to  effects  such  as  antagonism,  a 
assessment 
conventional 
would 
overestimate 
toxicological  hazard, 
these  effects  shall  be  taken  into  account 
in classifying  the  preparation. 

the 

10 

to 

such 

effects 

that  owing 

- 
as 
potentiation  a  conventional  assessment 
would  underestimate 
toxicological 
hazard,  these  effects  shall  be  taken  into 
account  in classifying  the  preparation. 

the 

to 

such 

effects 

that  owing 

- 
as 
antagonism,  a  conventional  assessment 
would  overestimate 
toxicological 
hazard,  these  effects  shall  be  taken  into 
account  in classifying  the  preparation. 

the 

Article  9, 2nd  paragraph  (new) 

2.  Preparations  shall  be  deemed  to  satisfy 
the  requirements  of  point  1.  first  to  third 
indents,  if  their  packaging  complies  with 
the  requirements  for  carriage  by  rail 
road, inland  waterway, sea  or air. 

Article  10(2.3.3) (2.3.4(a)  (new) 

classified 

2.3.3.  for  preparations 
as 
sensitizing,  in  accordance  with  Article  6, 
only  the  sensitizing  substances  present  in 
concentrations  equal  to  or  greater  than 
their respective  limits  laid  down  in  Annex 
I to  Directive  67/548/EEC  or,  failing  that. 
Annex  II  B  of  this  Directive  have  to  be 
taken  into  consideration. 

classified 

for  preparations 

2.3.3. 
as 
sensitizing,  in  accordance  with  Article  6, 
only  the  sensitizing  substances  present  in 
concentrations  equal  to  or  greater  than 
their  respective  limits  laid  down  in  Annex 
I to  Directive  67/548/EEC  or,  failing  that, 
Annex  II  B  of  this  Directive  have  to  be 
taken  into  consideration. 

As  a  general  rule  a  maximum  of  four 
chemical  names  shall  suffice  to  identify 
the  substances  primarily  responsible  for 
the  major  health  hazards  which  have 
given  rise  to  the  classification  and  the 
choice  of 
the  corresponding  phrases 
referring  to  the  risk  involved.  In  some 
cases,  more  than  four  chemical  names 
may  be  necessary. 

the 

substances 

2.3.4  (a)  As  a  general  rule  a  maximum  of 
four  chemical  names  shall  suffice 
to 
identify 
primarily 
responsible  for  the  major  health  hazards 
which  have  given  rise  to the  classification 
and 
the  corresponding 
phrases  referring  to  the  risk  involved.  In 
some  cases,  more  than  four  chemical 
names  may  be  necessary. 

the  choice  of 

Article  10(4), first  indent 

in 

the  case  of 

irritant,  highly 
flammable  and  oxidizing  preparations 
with  the  exception  of  those  assigned  the 
phrase  R41,  there  is  no  need  to  indicate 
the  special  risks  (R  phrases)  or  the  safety 
advice  (S  phrases); 

11 

in 

oxidizing 

the  case  of 

irritant,  highly 
flammable, 
and 
environmentally  dangerous  preparations 
with  the  exception  of  those  assigned  the 
phrase  R41,  there  is  no  need  to  indicate 
the  special  risks  (R  phrases)  or  the  safety 
advice  (S  phrases); 

Article  10(5) 

5. 
Information  such  as 
'non-toxic', 
'non-harmful'  or  any  other 
statement 
indicating 
is  not 
the 
dangerous  must  not  appear  on 
packaging  or  labelling  of  the  preparations 
subject  to this  Directive. 

the  preparation 

that 

Information  such  as 

'non-toxic'. 
5. 
'environmentally-friendly', 
'non-harmful', 
'eco'  or  any  other  statement 
indicating 
that  the  preparation  is  not  dangerous  or 
which  might  lead  to  an  underestimation 
of  the  hazards  of  such  preparations  must 
not  appear  on  the  packaging  or  labelling 
of 
this 
Directive. 

the  preparations 

subject 

to 

Article  15 

Advertisements 

Distance  selling 

exclusively 

the  meaning  of 

Any  advertisement 
for  a  preparation 
within 
this  Directive 
communicated 
by 
catalogue  which 
correspondence 
imposes  an  obligation  on  the  buyer  shall 
be  prohibited 
is  made 
therein  of  the  type  or  types  of  hazard 
indicated  on the  label. 

if  no  mention 

or 

Article 21 

exclusively 

the  meaning  of 

for  a  preparation 
Any  advertisement 
this  Directive 
within 
by 
communicated 
catalogue  which 
correspondence 
imposes  an  obligation  on  the  buyer  shall 
be  prohibited 
is  made 
therein  of  the  type  or  types  of  hazard 
indicated  on the  label. 

if  no  mention 

or 

to 

adapt 

Amendments 
to 
required 
technical  progress  the  Annexes  to  this 
Directive  shall  be  adopted  in  accordance 
with  the  procedure  laid  down  in  Article 
29 of  Directive  67/548/EEC. 

to 

adapt 

Amendments 
to 
required 
technical  progress  the  Annexes  to  this 
Directive  shall  be  adopted  in  accordance 
with  the  procedure  laid  down  in  Article 
of  Directive 
29 
67/548/EEC. 

paragraph 

(a) 

4 

ANNEX  III,  Introduction,  paragraphs  1A to  IE  (new) 

the 
Ihe  systematic  assessment  of  all 
dangerous  properties  for  the  environment 
is  expressed  by  means  of  concentration 
limits,  expressed  as  a  weight/weight 
gaseous 
percentage 
preparations  where  they  are  expressed  as 
a  volume/volume  percentage  and 
in 
conjunction  with  the  classification  of  a 
substance. 

except 

for 

12 

the 
The  systematic  assessment  of  all 
dangerous  properties  for  the  environment 
is  expressed  by  means  of  concentration 
limits,  expressed  as  a  weight/weight 
gaseous 
percentage 
preparations  where  they  are  expressed  as 
a  volume/volume  percentage  and 
in 
conjunction  with  the  classification  of  a 
substance. 

except 

for 

Part  A  gives  the  calculation  procedure 
according  to  Article  7(l)(a)  and  7(2)(a) 
and  gives  the  R  phrases  to  be  assigned  to 
the classification  of the  preparation. 
Part  B gives the concentration  limits to  be 
the  conventional 
used  when  applying 
method  and  the  relevant  symbols  and  R 
phrases  for  classification. 
Part  C  gives  the  test  methods  for  the 
evaluation  of  the  hazards  for  the  aquatic 
environment-
Part  D  gives  the  R  phrases  to  use  on  the 
label 
Part  E  gives  the  indications  concerning 
safety  advice to put on the  label. 

ANNEX  III, Part  B, Table  V, second  column,  first  line 

concentration  > 0.5% 

concentration  >QJ_% 

ANNEX  IV, Part  B, 2nd  paragraph  (new) 

This  provision  shall  not  apply  to  aerosols 
classified  and  labelled  only  as  extremely 
flammable  or highly  flammable. 

ANNEX  V, Part  C(l) 

substance 

Preparations  containing  at 
but 
dangerous 

least 
1. 
one 
not 
classified  within  the  meaning  of  Articles 
5, 6 and  7. 
of 
The 
label 
preparations  containing  at 
least  one 
substance  classified  as  sensitizing  and 
accompanied  by  a  specific  note  under 
Annex  I  to  Directive  67/548/EEC  must 
bear  the  inscription: 

packaging 

the 

on 

substance 

Preparations  containing  at 
but 
dangerous 

least 
1. 
one 
not 
classified  within  the  meaning  of  Articles 
5, 6 and  7. 
of 
The 
label 
preparations  containing 
least  one 
substance  classified  as  sensitizing  and 
accompanied  by  a  specific  note  under 
Annex  I  to  Directive  67/548/EEC  must 
bear the  inscription: 

packaging 
at 

the 

on 

"Contains  'name  of sensitizing  substance'. 
May  produce  an  allergic 
in 
persons  already  sensitized" 

reaction 

"Contains  'name  of  sensitizing  substance'. 
May  produce  an allergic  reaction/" 

13 

ANNEX  V, Part  C(2) 

Preparations  not  intended  for  the 

2. 
general  public. 
The 
the 
label  on 
preparations  referred  to  in  Article  16.2 
must  bear the  following  inscription: 
'Safety  data  sheet  available  on  request' 

the  packaging  of 

the  packaging  of 

Preparations  not  intended, for  the 

2. 
general  public. 
The 
the 
label  on 
preparations  referred  to  in  Article  16.2 
must  bear  the  following  inscription: 
'Contains  dangerous  substances  in  such 
amounts 
is  not 
justified.  Safety  data  sheet  available  on 
request.' 

that  warning 

label 

ANNEX  V, Part  D  (new) 

Special 

provisions 

for 
D. 
preparations  placed  on  the  market  solely 
as  authorized  plant  protection  products 
pursuant  to Directive  91/414/EEC. 

ANNEX  VIII, Part  A, 2nd  indent,  3rd  subindent  a  (new) 

on 

Directive 
the 
88/379/EEC 
approximation  of  the  laws  of the  Member 
classification, 
to 
relating 
States 
packaging  and 
labelling  of  dangerous 
preparations  and 
its  following  adaptations 
progress: 

technical 

the 

to 

on 

Directive 
the 
88/379/EEC 
approximation  of  the  laws  of  the  Member 
classification, 
relating 
States 
to 
packaging  and 
labelling  of  dangerous 
preparations  and 
its  following  adaptations 
progress: 

technical 

the 

to 

-Directive  89/178/EEC 
-  Directive  90/492/EEC 
-Directive  93/18/EEC 

-Directive  89/178/EEC 
-  Directive  90/492/EEC 
-Directive  93/18/EEC 
-  Directive  96/65/EC 

14 

ISSN 0254-1475 

COM(97) 462  final 

DOCUMENTS 

EN 

02  07  14  17 

Catalogue  number  :  CB-C0-97-477-EN-C 

ISBN  92-78-24908-4 

Office  for Official  Publications of the European  Communities 

L-2985 Luxembourg 

4C