COMMON POSITION (EC) No 54/98 adopted by the Council on 24 September 1998 with a view to the adoption of Directive 98/.../EC of the European Parliament and of the Council 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: 1998-09-24
Institutions: Council of the European Union
Subjects: approximation of laws, dangerous substance, environmental protection, labelling, packaging, public health

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Official  Journal  of  the  European  Communities

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I

(Information)

COUNCIL

COMMON  POSITION  (EC)  No  54/98

adopted  by  the  Council  on  24  September  1998

with  a  view  to  the  adoption  of  Directive  98/. . ./EC  of  the  European  Parliament  and  of  the
Council concerning the approximation of the laws, regulations and administrative provisions of
the  Member  States  relating  to  the  classification,  packaging  and  labelling  of  dangerous
preparations

(98/C 360/01)

THE  EUROPEAN  PARLIAMENT  AND  THE  COUNCIL  OF
THE  EUROPEAN  UNION,

Having  regard  to  the  Treaty  establishing  the  European
Community,  and  in  particular  Article  100a  thereof,

Having  regard  to  the  proposal  of  the  Commission (1),

Having regard to the opinion of the Economic and Social
Committee (2),

Acting  in  accordance  with  the  procedure  laid  down  in
Article  189b  of  the  Treaty (3),

(1) Whereas  Council  Directive  88/379/EEC  of  7  June
1988 on the approximation of the laws, regulations
and  administrative  provisions  of  the  Member
States  relating  to  the  classification,  packaging  and
labelling  of  dangerous  preparations (4)  has  been
amended  on  several  occasions;  whereas  on  the
occasion  of  further  amendments,  the  said  Directive
should,  for  reasons  of  clarity,  be  recast;

(1) OJ  C  283,  26.9.1996,  p.  1  and  OJ  C  337,  7.11.1997,

p.  45.

(2) OJ  C  158,  26.5.1997,  p.  76.
(3) Opinion  of  the  European  Parliament  of  26  June  1997  (OJ
C  222,  21.7.1997,  p.  26),  Council  Common  Position  of
24 September 1998 and Decision of the European Parliament
of  . . .  (not  yet  published  in  the  Official  Journal).

(4) OJ  L  187,  16.7.1988,  p.  14.  Directive  as  last  amended  by
Commission  Directive  96/65/EC  (OJ  L  265,  18.10.1996,
p.  15).

(2) Whereas,  in  spite  of  Community  provisions,  the
rules  applying  to  certain  dangerous  preparations  in
the  Member  States  exhibit  considerable  differences
as  regards  classification,  packaging  and  labelling;
whereas  these  differences  constitute  a  barrier  to
trade,  create  unequal  competition  conditions  and
directly  affect  the  functioning  of  the 
internal
market; whereas it is therefore necessary to remove
this  barrier  to  trade  by  approximating  the  relevant
legislation  existing  in  the  Member  States;

(3) Whereas  measures  for  the  approximation  of  the
provisions  of  the  Member  States  affecting  the
internal
establishment  and  functioning  of  the 
market  must,  in  so  far  as  they  concern  health,
safety  and  protection  of  man  and  the  environment,
adopt a high level of protection as a basis; whereas
this  Directive  must,  at  the  same  time,  ensure
protection for the general public, and, in particular,
persons  who  come  into  contact  with  dangerous
preparations  in  the  course  of  their  work  or  in  the
pursuit  of  a  hobby,  protection  for  consumers  and
for  the  environment;

(4) Whereas  containers  containing  certain  categories
of  dangerous  preparations  offered  or  sold  to  the
general  public  must  be  fitted  with  child-resistant
fastenings and/or carry a tactile warning of danger;
whereas  certain  preparations  not  falling  within
these  categories  of  danger  may  nevertheless,  owing
to their composition, present a danger for children;
whereas 
the  packaging  of  such  preparations
should  therefore  be  equipped  with  child-resistant
fastenings;

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(5) Whereas  it  is  necessary  to  provide  concentration
limits  expressed  as  a  volume/volume  percentage  in
the  case  of  preparations  marketed 
in  gaseous
form;

(6) Whereas  this  Directive  contains  special  labelling
provisions  applicable 
to  certain  preparations;
whereas,  to  ensure  an  adequate  level  of  protection
for  man  and  the  environment,  special  labelling
provisions  must  also  be  introduced  for  certain
preparations which, although not dangerous within
the  meaning  of  this  Directive,  may  nevertheless
present  a  danger  to  the  user;

to 

(7) Whereas  on  30  April  1992  the  Council  adopted
Directive 92/32/EEC amending for the seventh time
Directive  67/548/EEC  on  the  approximation  of  the
laws,  regulations  and  administrative  provisions
relating 
the  classification,  packaging  and
labelling  of  dangerous  substances (1);  whereas  on
27  April  1993  the  Commission  adopted  Directive
93/21/EEC (2)  adapting  to  technical  progress  for
the  18th  time  Council  Directive  67/548/EEC (3);
whereas  new  criteria  developed  for  classifying  and
labelling  substances  dangerous  for  the  environment
were  introduced  by  those  Directives,  together  with
the appropriate symbols, indications of danger, risk
phrases  and  safety  advice  required  to  appear  on
labelling;  whereas  provisions  should  be  adopted  at
Community  level  on  the  classification  and  labelling
of  preparations  to  take  account  of  their  effects  on
is  therefore
the  environment  and  whereas 
necessary  to  introduce  a  method  for  assessing  the
hazards of a given preparation for the environment
either  by  a  calculation  method,  or  by  determining
the  ecotoxicological  properties  by  test  methods
under  certain  conditions;

it 

(8) Whereas 

laws, 

the  number  of  animals  used 

for
experiments  should  be  reduced  to  a  minimum,
in  accordance  with  the  provisions  of  Council
Directive  86/609/EEC  of  24  November  1986  on
the  approximation  of 
regulations  and
administrative  provisions  of  the  Member  States
regarding  the  protection  of  animals  used  for
experimental  and  other  scientific  purposes (4);
whereas Article 7(2) of that Directive stipulates that
an  experiment  shall  not  be  performed  if  another
scientifically  satisfactory  method  of  obtaining  the
results sought, not entailing the use of an animal, is
reasonably  and  practically  available;  whereas,
therefore,  this  Directive  makes  use  of  the  results  of
assessments  of  toxicological  and  ecotoxicological
properties  only  when  these  are  already  known
and  entails  no  obligation  to  conduct  further
experiments  on  animals;

(1) OJ  L  154,  5.6.1992,  p.  1.
(2) OJ  L  110,  4.5.1993,  p.  20.
(3) OJ  196,  16.8.1967,  p.  1.
(4) OJ  L  358,  18.12.1986,  p.  1.

(9) Whereas  it  is  necessary  to  define  what  human
experience  might  be  considered  for  the  evaluation
of  the  health  hazards  of  a  preparation;  whereas,  if
clinical studies may be accepted, it is taken as given
that  such  studies  comply  with 
the  Helsinki
Declaration  and  OECD  guidelines  for  good  clinical
practice;

(10) Whereas the characteristics of alloys are such that it
may  not  be  possible  accurately  to  determine  their
properties  using  currently  available  conventional
methods;  whereas 
therefore  necessary
to  develop  a  specific  method  of  classification
their  particular
which 
chemical  properties;  whereas  the  Commission,  in
consultation with Member States, will examine this
need  and  submit  a  proposal,  if  appropriate,  before
the  implementation  date  of  this  Directive;

account 

takes 

into 

is 

it 

to 

(11) Whereas  classification,  packaging  and  labelling  of
plant  protection  products  covered  by  Council
Directive  78/631/EEC  of  26  June  1978  on  the
approximation  of  the  laws  of  the  Member  States
relating 
the  classification,  packaging  and
labelling  of  dangerous  preparations  (pesticides) (5)
need to be revised taking into account technical and
scientific  developments  as  well  as  regulatory
developments  following  implementation  of  Council
Directive  91/414/EEC  of  15  July  1991  concerning
the  placing  of  plant  protection  products  on  the
market (6);

(12) Whereas  Directive  91/414/EEC  and  Directive
98/8/EC  of  the  European  Parliament  and  of  the
Council  of  16  February  1998  concerning  the
placing  of  biocidal  products  on  the  market (7),  in
contrast  to  the  provisions  applicable  to  chemical
preparations  covered  by  this  Directive,  provide  for
an authorisation procedure for each product on the
basis of a dossier presented by the applicant and an
assessment  carried  out  by  the  competent  authority
in  each  Member  State;  whereas  furthermore  that
authorisation  procedure  includes  a  control  relating
specifically  to  the  classification,  packaging  and
labelling  of  each  product  before  it  is  placed  on  the
market; whereas it is appropriate, as part of a clear
and transparent information process, to classify and
label  plant  protection  products  according  to  the
provisions  of  this  Directive,  and  also  to  provide
instructions  for  use  in  accordance  with  the  results
of  the  evaluation  carried  out  in  the  framework  of
Directive  91/414/EEC  and  to  ensure  that  the
labelling satisfies the high level of protection sought

(5) OJ  L  206,  29.7.1978,  p.  13.  Directive  as  last  amended  by

Council  Directive  92/32/EEC.

(6) OJ  L  230,  19.8.1991,  p.  1.  Directive  as  last  amended  by
Commission  Directive  96/68/EC  (OJ  L  277,  30.10.1996,
p.  25).

(7) OJ  L  123,  24.4.1998,  p  1.

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by  both  this  Directive  and  Directive  91/414/EEC;
whereas,  in  addition,  a  safety  data  sheet  has  to  be
established 
in
accordance  with  this  Directive;

for  plant  protection  products 

particular  on  its  understanding  and  application  by
users,  experience  with  publicity  campaigns  and
educational  and  training  programmes;  whereas,  on
the  basis  of  this  report,  the  Commission  will,  if
appropriate,  submit  the  necessary  proposals;

(13) Whereas  it  is  appropriate  to  provide,  in  relation  to
environmental labelling, that specific exemptions or
specific  provisions  may  be  decided  upon  in  specific
cases where it can be demonstrated that the overall
environmental  impact  of  the  product  types  in
question 
lower  than  that  of  corresponding
product  types;

is 

(14) Whereas,  although  munitions  are  not  covered  by
this  Directive,  explosives  marketed  to  produce  an
explosive  or  pyrotechnic  effect  may,  through  their
chemical  composition,  present  dangers  to  health;
whereas  it  is  therefore  necessary  as  part  of  a
transparent  information  process  to  classify  them
and  assign  to  them  a  safety  data  sheet 
in
accordance  with  the  provisions  of  this  Directive
and  also  to  label  them  in  accordance  with  the
international  rules  used  for  the  transport  of
dangerous  goods;

(15) Whereas,  in  order  to  take  account  of  certain
they  are  not
preparations  which,  although 
considered  dangerous  under  this  Directive,  may
nevertheless  present  a  danger  for  users, 
is
necessary  to  extend  certain  provisions  of  this
Directive  to  cover  such  preparations;

it 

(16) Whereas  the  label  constitutes  a  basic  tool  for  users
of  the  dangerous  preparations  in  so  far  as  it
provides  them  with  the  initial  essential  concise
information;  whereas  it  nevertheless  needs  to  be
supplemented  by  a  two-fold  system  of  more
detailed  information,  consisting  firstly  of  the  safety
data  sheet, 
intended  for  professional  users  as
defined  by  Commission  Directive  91/155/EEC  of
5  March  1991  defining  and  laying  down  the
detailed  arrangements  for  the  system  of  specific
information  relating  to  dangerous  preparations
implementation  of  Article  10  of  Directive
in 
88/379/EEC (1)  and 
the  bodies
appointed  by 
the  Member  States  which  are
responsible  for  the  provision  of  information  solely
for  medical  purposes,  both  preventive  and
curative;

secondly  of 

(17) Whereas, on the basis of information to be supplied
by  the  Member  States  and  the  various  parties
concerned,  the  Commission  will  submit  a  report  to
the  European  Parliament  and  the  Council  within
two  years  of  the  entry  into  force  of  this  Directive
on  experience  with  the  present  overall  approach  to
in
labelling  of  dangerous  preparations  and 

(1) OJ  L  76,  22.3.1991,  p.  35.  Directive  as  last  amended  by
Commission  Directive  93/112/EEC  (OJ  L  314,  16.12.1993,
p.  38).

information  on 

(18) Whereas it is necessary to require safety data sheets
providing  proportionate 
the
dangers  to  man  and  the  environment  arising  from
preparations  not  classified  as  dangerous  within  the
meaning of this Directive but containing substances
classified  as  dangerous  or  having  a  Community
exposure  limit;  whereas  the  Commission,  on  the
basis  of  information  submitted  by  Member  States,
will  review  Directive  91/155/EEC  and  submit
proposals,  if  appropriate,  before  the  expiry  of  the
date  for  implementation  of  this  Directive;

(19) Whereas,  in  the  case  of  preparations  classified  as
dangerous within the meaning of this Directive, it is
appropriate  to  permit  Member  States  to  allow
certain  derogations  with  respect  to  labelling  where
the  packaging  is  too  small,  or  otherwise  unsuitable
for  labelling,  or  where  such  small  packaging  or
such  small  quantities  are  involved  that  there  is
no  reason  to  fear  any  danger  to  man  or  the
environment;  whereas  in  such  cases  appropriate
the
consideration 
approximation  of 
relevant  provisions  at
Community  level;  whereas  the  Commission  will
therefore examine the needs for harmonisation and,
if  appropriate,  submit  proposals;

should  also  be  given 

the 

to 

(20) Whereas  the  confidentiality  of  certain  substances
contained in the preparations should be guaranteed
and  whereas  it  is  therefore  necessary  to  institute  a
system  which  allows  the  person  responsible  for
placing  the  preparation  on  the  market  to  request
confidentiality  for  such  substances;

(21) Whereas  the  provisions  of  this  Directive  will  have
regard  to  the  commitment  entered  into  by  the
Community  and  its  Member  States,  in  accordance
with  the  goals  for  sustainable  development  set
under  Agenda  21,  Chapter  19,  at  the  UNCED
conference  held  in  June  1992  in  Rio  de  Janeiro,  to
strive  for  the  future  harmonisation  of  systems  for
the  classification  of  dangerous  substances  and
preparations;

(22) Whereas  the  Commission  should  be  given  the
powers  necessary  to  adapt  all  the  Annexes  to  this
Directive  to  technical  progress;

the  obligations  of 

(23) Whereas  the  adoption  of  this  Directive  should  not
the  Member  States
affect 
concerning  the  deadlines  for  transposition  into
national  law  and  for  application  of  the  Directives
indicated  in  Annex  VIII;

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(24) Whereas  the  Directives  indicated  in  Annex  VIII
should  be  repealed,  subject  to  certain  conditions;
whereas  the  conditions  for  repealing  the  Directives
indicated  in  Annex  VIII  should  be  specified  for
Austria,  Finland  and  Sweden  in  order  to  take
account  of  the  present  level  of  their  legislation,  in
particular  as  regards  the  protection  of  health  and
the  protection  of  the  environment,

(a) medicinal  products  for  human  or  veterinary  use,  as

defined  in  Directive  65/65/EEC (1);

(b) cosmetic 

products 

as 

defined 

in  Directive

76/768/EEC (2);

(c) mixtures  of  substances  which,  in  the  form  of  waste,
are  covered  by  Directives  75/442/EEC (3)  and
78/319/EEC (4);

HAVE  ADOPTED  THIS  DIRECTIVE:

(d)

foodstuffs;

(e) animal  feedingstuffs;

Article  1

Objectives  and  scope

This  Directive  aims  at  the  approximation  of  the
1.
laws,  regulations  and  administrative  provisions  of  the
Member  States  relating  to:

— the 

classification,  packaging  and 

labelling  of

dangerous  preparations,  and  to

— the  approximation  of  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  of  the
Member  States.

2.

This  Directive  shall  apply  to  preparations  which:

— contain  at  least  one  dangerous  substance  within  the

meaning  of  Article  2,

and

(f) preparations  containing  radioactive  substances  as

defined  by  Directive  80/836/Euratom (5);

(g) medical  devices  which  are  invasive  or  used  in  direct
physical  contact  with  the  human  body  in  so  far  as
Community  measures  lay  down  provisions  for  the
classification  and  labelling  of  dangerous  substances
and  preparations  which  ensure  the  same  level  of
information  provision  and  protection  as 
this
Directive.

6.

This  Directive  shall  not  apply  to:

— the  carriage  of  dangerous  preparations  by  rail,  road,

inland  waterway,  sea  or  air,

— preparations  in  transit  which  are  under  customs
supervision,  provided  they  do  not  undergo  any
treatment  or  processing.

Article  2

Definitions

— are  considered  dangerous  within  the  meaning  of

Articles  5,  6  or  7.

1.

For  the  purposes  of  this  Directive:

3.

The  specific  provisions  set  out:

— in  Article  9  and  defined  in  Annex  IV,

— in  Article  10  and  defined  in  Annex  V,  and

— in  Article  14

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

4. Without  prejudice  to  Directive  91/414/EEC,  the
Articles  on  classification,  packaging,  labelling  and  safety
data  sheets  of  this  Directive  shall  apply  to  plant
protection  products.

5.
This  Directive  shall  not  apply  to  the  following
preparations  in  the  finished  state,  intended  for  the  final
user:

(a)

‘substances’:  means  chemical  elements  and  their
compounds  in  the  natural  state  or  obtained  by  any
production  process,  including  any  additive  necessary
to  preserve  the  stability  of  the  products  and  any
the  process  used,  but
impurity  deriving 
excluding  any  solvent  which  may  be  separated
without  affecting  the  stability  of  the  substance  or
changing  its  composition;

from 

(b)

‘preparations’:  means  mixtures 
composed  of  two  or  more  substances;

or 

solutions

(1) OJ  22,  9.2.1965,  p.  369.  Directive  as  last  amended  by

Directive  93/39/EEC  (OJ  L  214,  24.8.1993,  p.  22).

(2) OJ  L  262,  27.9.1976,  p.  169.  Directive  as  last  amended  by

Directive  97/18/EC  (OJ  L  114,  1.5.1997,  p.  43).

(3) OJ  L  194,  25.7.1975,  p.  39.  Directive  as  last  amended  by
Commission  Decision  96/350/EC  (OJ  L  135,  6.6.1996,
p.  32).

(4) OJ  L  84,  31.3.1978,  p.  43.
(5) OJ  L  246,  17.9.1980,  p.  1.  Directive  as  amended  by
Directive  84/467/Euratom  (OJ  L  265,  5.10.1984,  p.  4).

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(c)

‘polymer’: means a substance consisting of molecules
characterised  by  the  sequence  of  one  or  more  types
of  monomer  units  and  comprising  a  simple  weight
majority  of  molecules  containing  at 
least  three
monomer  units  which  are  covalently  bound  to  at
least  one  other  monomer  unit  or  other  reactant  and
consists  of  less  than  a  simple  weight  majority  of
molecules  of  the  same  molecular  weight.  Such
molecules  must  be  distributed  over  a  range  of
molecular  weights  wherein  differences 
the
to
molecular  weight  are  primarily  attributable 
differences  in  the  number  of  monomer  units.  In  the
context  of  this  definition  a  ‘monomer  unit’  means
the  reacted  form  of  a  monomer  in  a  polymer;

in 

(d)

‘(. . .)’;

(e)

(f)

(g)

(h)

‘placing  on  the  market’:  means  making  available  to
into  the  Community
third  parties.  Importation 
customs  territory  shall  be  deemed  to  be  placing  on
the  market  for  the  purposes  of  this  Directive;

‘scientific research and development’: means scientific
experimentation,  analysis  or  chemical 
research
carried  out  under  controlled  conditions;  it  includes
the 
properties,
of 
performance  and  efficacy  as  well  as  scientific
investigation  related  to  product  development;

determination 

intrinsic 

‘process-orientated 
and  development’:
research 
means  the  further  development  of  a  substance  in  the
course  of  which  pilot  plant  or  production  trials  are
used  to  test  the  fields  of  application  of  the
substance;

‘Einecs’  means  the  European  Inventory  of  Existing
Commercial  Chemical  Substances.  This  inventory
contains  the  definitive  list  of  all  chemical  substances
deemed  to  be  on  the  Community  market  on
18  September  1981.

The  following  are  ‘dangerous’  within  the  meaning

2.
of  this  Directive:

(a)

‘explosive substances and preparations’: solid, liquid,
pasty  or  gelatinous  substances  and  preparations
which  may  also  react  exothermically  without
atmospheric  oxygen  thereby  quickly  evolving  gases,
and  which,  under  defined  test  conditions,  detonate,
quickly  deflagrate  or  upon  heating  explode  when
partially confined;

(b)

‘oxidising  substances  and  preparations’:  substances
and  preparations  which  give  rise  to  a  highly
exothermic reaction in contact with other substances,
particularly  flammable  substances;

and  gaseous  substances  and  preparations  which  are
flammable 
contact  with  air  at  ambient
temperature  and  pressure;

in 

(d)

‘highly  flammable  substances  and  preparations’:

— substances  and  preparations  which  may  become
hot  and  finally  catch  fire  in  contact  with  air  at
ambient  temperature  without  any  application  of
energy, or

— solid  substances  and  preparations  which  may
readily catch fire after brief contact with a source
of  ignition  and  which  continue  to  burn  or  to  be
consumed after removal of the source of ignition,
or

— liquid  substances  and  preparations  having  a  very

low  flash-point,  or

— substances  and  preparations  which,  in  contact
with  water  or  damp  air,  evolve  extremely
flammable  gases  in  dangerous  quantities;

(e)

(f)

(g)

(h)

(i)

(j)

(k)

(l)

‘flammable  substances  and  preparations’: 
substances 
flash-point;

and  preparations  having 

a 

liquid
low

‘very  toxic  substances  and  preparations’:  substances
and  preparations  which  in  very  low  quantities  cause
death  or  acute  or  chronic  damage  to  health  when
inhaled,  swallowed  or  absorbed  via  the  skin;

‘toxic  substances  and  preparations’:  substances  and
preparations  which  in  low  quantities  cause  death  or
acute  or  chronic  damage  to  health  when  inhaled,
swallowed  or  absorbed  via  the  skin;

‘harmful  substances  and  preparations’:  substances
and preparations which may cause death or acute or
chronic  damage  to  health  when  inhaled,  swallowed
or  absorbed  via  the  skin;

corrosive  substances  and  preparations’:  substances
and  preparations  which  may,  on  contact  with  living
tissues,  destroy  them;

and  preparations  which, 

‘irritant  substances  and  preparations’:  non-corrosive
substances 
through
immediate,  prolonged  or  repeated  contact  with
the 
skin  or  mucous  membrane,  may  cause
inflammation;

‘sensitising  substances  and  preparations’:  substances
and preparations which, if they are inhaled or if they
penetrate  the  skin,  are  capable  of  eliciting  a  reaction
of  hypersensitisation  such  that  on  further  exposure
to 
the  substance  of  preparation,  characteristic
adverse  effects  are  produced;

substances 

‘carcinogenic 
preparations’:
substances or preparations which, if they are inhaled
or  ingested  or  if  they  penetrate  the  skin,  may  induce
cancer  or  increase  its  incidence;

and 

(c)

‘extremely  flammable  substances  and  preparations’:
liquid  substances  and  preparations  having  an
extremely  low  flash-point  and  a  low  boiling-point

(m) ‘mutagenic  substances  and  preparations’:  substances
and  preparations  which,  if  they  are  inhaled  or
ingested  or  if  they  penetrate  the  skin,  may  induce
heritable  genetic  defects  or  increase  their  incidence;

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(n)

‘substances  and  preparations  which  are  toxic  for
reproduction’:  substances  and  preparations  which,  if
they  are  inhaled  or  ingested  or  if  they  penetrate  the
skin,  may  produce,  or  increase  the  incidence  of,
non-heritable  adverse  effects  in  the  progeny  and/or
impairment  of  male  or  female  reproductive
an 
functions  or  capacity;

(o)

‘substances  and  preparations  which  are  dangerous
for  the  environment’:  substances  and  preparations
which, were they enter to the environment, would or
could  present  an  immediate  or  delayed  danger  for
one  or  more  components  of  the  environment.

are  classified  as  dangerous  on  the  basis  of  their  health
and/or environmental effects, whether they are present as
impurities  or  additives,  shall  be  taken  into  consideration
when  their  concentrations  are  equal  to,  or  greater  than,
those  defined  in  the  following  table  unless  lower  values
are  given  in  Annex  I  to  Directive  67/548/EEC,  or  in
Part  B  of  Annex  II  to  this  Directive  or  in  Part  B  of
Annex  III  thereto,  unless  otherwise  specified  in  Annex  V
to  this  Directive.

Category  of  danger  of  the
substance

Concentration  to  take  into
consideration  for

Gaseous
preparations
% vol/vol

Other
preparations
%  w/w

Article  3

Determination  of  dangerous  properties  of  preparations

Very  toxic

Toxic

The evaluation of the hazards of a preparation shall

1.
be  based  on  the  determination  of:

Carcinogenic
Category  1  or  2

$ 0,02

$ 0,02

$ 0,02

$ 0,02

$ 0,02

$ 0,2

$ 0,02

$ 0,2

$ 0,2

$ 0,2

$ 0,2

$ 0,2

$ 0,1

$ 0,1

$ 0,1

$ 0,1

$ 0,1

$ 1

$ 1

$ 1

$ 1

$ 1

$ 1

$ 1

$ 0,1

$ 0,1

$ 0,1

$ 1

Mutagenic
Category  1  or  2

Toxic  for  reproduction
Category  1  or  2

Harmful

Corrosive

Irritant

Sensitising

Carcinogenic
Category  3

Mutagenic
Category  3

Toxic  for  reproduction
Category  3

Dangerous  for  the
environment  N

Dangerous  for  the
environment
ozone

Dangerous  for  the
environment

— physico-chemical properties,

— properties  affecting  health,

— environmental  properties.

These  different  properties  shall  be  determined 
in
accordance with the provisions laid down in Articles 5, 6
and  7.

Where  laboratory  tests  are  conducted,  they  shall  be
carried  out  on  the  preparation  as  placed  on  the  market.

2. Where  the  determination  of  dangerous  properties  is
carried  out  in  accordance  with  Articles  5,  6  and  7,  all
dangerous substances within the meaning of Article 2 and
in  particular  those  which:

— are  listed  in  Annex  I  to  Directive  67/548/EEC,

— are  listed  in  Elincs  in  accordance  with  Article  21  of

Directive  67/548/EEC,

— are  classified  and  labelled  provisionally  by  the  person
in

responsible 
accordance  with  Article  6  of  Directive  67/548/EEC,

the  placing  on 

the  market 

for 

— are classified and labelled in accordance with Article 7
of  Directive  67/548/EEC  and  are  not  yet  included  in
Elincs,

— are  covered  by  Article  8  of  Directive  67/548/EEC,

— are  classified  and 

labelled 

in  accordance  with

Article  13  of  Directive  67/548/EEC,

shall  be  taken  into  consideration  in  accordance  with  the
provisions  laid  down  in  the  method  used.

3.
For  the  preparations  covered  by  this  Directive,
dangerous substances as referred to in paragraph 2 which

Article  4

General  principles  of  classification  and  labelling

The 

classification  of  dangerous  preparations
1.
according to the degree and specific nature of the hazards
involved shall be based on the definitions of categories of
danger  laid  down  in  Article  2.

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The  general  principles  of  the  classificaiton  and
2.
labelling  of  preparations  shall  be  applied  in  accordance
with  the  criteria  laid  down  in  Annex  VI  to  Directive
67/548/EEC, save where alternative criteria referred to in
Article  5,  6,  7  or  10  and  the  relevant  Annexes  to  this
Directive  are  applied.

for  appropriate  classification  in  accordance  with  the
criteria  set  out  in  Annex  VI  to  Directive  67/548/EEC.
These  properties  shall  be  determined  by  means  of  the
methods  laid  down  in  Part  A  of  Annex  V  to  Directive
67/548/EEC  unless  other 
internationally  recognised
methods are acceptable in accordance with the provisions
of  Annexes  II  and  III  to  Directive  91/414/EEC. 

Article  5

Evaluation of the hazards deriving from physico-chemical
properties

Article  6

Evaluation  of  health  hazards

The  hazards  of  a  preparation  deriving  from  its
1.
physico-chemical  properties 
shall  be  assessed  by
determining, by means of the methods specified in Part A
of  Annex  V 
the
to  Directive 
physico-chemical  properties  of  the  preparation  necessary
for  appropriate  classification  and  labelling  in  accordance
with  the  criteria 
in  Annex  VI  to  that
Directive.

67/548/EEC, 

laid  down 

2.

By  way  of  derogation  from  paragraph  1:

the  determination  of  the  explosive,  oxidising,  extremely
flammable,  highly  flammable,  or  flammable  properties  is
not  necessary  provided  that:

— none of the constituents possesses such properties and
that,  on  the  basis  of  the  information  available  to  the
manufacturer,  the  preparation  is  unlikely  to  present
hazards  of  this  kind,

— in  the  event  of  a  change  in  the  composition  of  a
preparation of known composition, scientific evidence
indicates  that  a  reassessment  of  the  hazards  will  not
lead  to  a  change  in  classification,

— preparations  placed  on  the  market  in  the  form  of
aerosols  satisfy  the  provisions  of  Article  9a  of
Directive  75/324/EEC (1).

3.
For  certain  cases  for  which  the  methods  laid  down
in  Part  A  of  Annex  V  to  Directive  67/548/EEC  are  not
appropriate,  alternative  calculation  methods  are  laid
down  in  Part  B  of  Annex  I  to  this  Directive.

Certain  exemptions  from  the  application  of  the
4.
methods  laid  down  in  Part  A  of  Annex  V  to  Directive
67/548/EEC  are  referred  to  in  Part  A  of  Annex  I  to  this
Directive.

5.
The  hazards  deriving  from  the  physico-chemical
properties  of  a  preparation  covered  by  Directive
91/414/EEC  shall  be  assessed  by  determining 
the
physico-chemical  properties  of  the  preparation  necessary

The  health  hazards  of  a  preparation  shall  be

1.
assessed  by  one  or  more  of  the  following  procedures:

(a) by  a  conventional  method  described  in  Annex  II;

(b) by  determining  the  toxicological  properties  of  the
preparation  necessary  for  appropriate  classification
in  accordance  with  the  criteria  in  Annex  VI  to
Directive  67/548/EEC.  These  properties  shall  be
determined  by  means  of  the  methods  laid  down  in
Part  B  of  Annex  V  to  Directive  67/548/EEC,  unless,
in  the  case  of  plant  protection  products,  other
internationally  recognised  methods  are  acceptable  in
accordance with the provisions of Annexes II and III
to  Directive  91/414/EEC.

it  can  be 

2. Without  prejudice  to  the  requirements  of  Directive
scientifically
91/414/EEC,  only  where 
demonstrated  by  the  person  responsible  for  placing
the  preparation  on  the  market  that  the  toxicological
properties  of 
the  preparation  cannot  correctly  be
determined by the method outlined in paragraph 1(a), or
on  the  basis  of  existing  test  results  on  animals,  the
methods  outlined 
in  paragraph  1(b)  may  be  used,
provided  they  are  justified  or  specifically  authorised
under  Article  12  of  Directive  86/609/EEC.

When  a  toxicological  property  is  established  by  the
methods  outlined  in  paragraph  1(b)  to  obtain  new  data,
the  test  shall  be  conducted  in  compliance  with  the
principles  of  good  laboratory  practice  provided  for  in
Directive  87/18/EEC  of  18  December  1986  on  the
harmonisation  of  laws,  regulations  and  administrative
provisions  relating  to  the  application  of  the  principles  of
good  laboratory  practice  and  the  verification  of  their
applications  for  tests  on  chemical  substances (2)  and
the  provisions  of  Directive  86/609/EEC,  in  particular
Articles  7  and  12  thereof.

Subject  to  the  provisions  of  paragraph  3,  where  a
toxicological  property  has  been  established  on  the
basis  of  both  the  methods  outlined  in  paragraphs  1(a)
and  1(b),  the  results  from  the  methods  outlined  in
paragraph  1(b)  shall  be  used 
the
preparation, except in the case of carcinogenic, mutagenic

for  classifying 

(1) OJ  L  147,  9.6.1975,  p.  40.  Directive  as  last  amended  by

Directive  94/1/EC  (OJ  L  23,  28.1.1994,  p.  28).

(2) OJ  L  15,  17.1.1987,  p.  29.

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or  toxic  effects  for  reproduction  for  which  only  the
method  outlined  in  1(a)  shall  be  used.

the  definitions  set  out  in  Article  2,  are  introduced  by
the  manufacturer.

Any  of  the  toxicological  properties  of  the  preparation
which  are  not  assessed  by  the  method  outlined  in
paragraph  1(b)  shall  be  assessed  in  accordance  with  the
method  outlined  in  paragraph  1(a).

This  new  evaluation  will  apply  unless  there  is  valid
scientific justification for considering that a re-evaluation
in  a  change  of
of 
classification.

the  hazard  will  not  result 

3.

Furthermore,  where  it  can  be  demonstrated:

Article  7

the  assessment  of  data 

— by  epidemiological  studies,  by  scientifically  valid  case
studies  as  specified  by  Annex  VI  to  Directive
67/548/EEC  or  by  statistically-backed  experience,
such  as 
from  poison
information units or concerning occupational diseases,
that  toxicological  effects  on  man  differ  from  those
suggested  by  the  application  of  the  methods  outlined
in  paragraph  1,  then  the  preparation  shall  be
classified  according  to  its  effects  on  man,

— that,  owing  to  effects  such  as  potentiation,  a
conventional  assessment  would  underestimate  the
toxicological  hazard,  those  effects  shall  be  taken  into
account  in  classifying  the  preparation,

— that,  owing 

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

4.
For preparations of a known composition, with the
exception  of  those  covered  by  Directive  91/414/EEC,
classified  in  accordance  with  paragraph  1(b),  a  new
evaluation  of  health  hazard  by  the  methods  outlined  in
either  paragraph  1(a)  or 
(b)  shall  be  performed
whenever:

— changes of composition of the inital concentration, as
a  weight/weight  or  volume/volume  percentage,  of  one
or  more  of  the  dangerous  constituents  are  introduced
the
by 
following table:

in  accordance  with 

the  manufacturer, 

Initial  concentration  range  of
the  constituent

Permitted  variation  in  initial
concentration  of  the  constituent

# 2,5 %
. 2,5 # 10 %
. 10 # 25 %
. 25 # 100 %

– 30 %
– 20 %
– 10 %

5 %

— changes  of  composition  involving  the  substitution  or
addition  of  one  or  more  constituents,  which  may  or
may  not  be  dangerous  within  the  meaning  of

Evaluation  of  environmental  hazards

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

(a) by  a  conventional  method  described  in  Annex  III  to

this  Directive;

for 

the  environment  necessary 

(b) by  determining  the  hazardous  properties  of  the
for
preparation 
appropriate  classification  in  accordance  with  the
criteria set out in Annex VI to Directive 67/548/EEC.
These properties shall be determined by means of the
methods  laid  down  in  Part  C  of  Annex  V  to
Directive  67/548/EEC  unless,  in  the  case  of  plant
protection  products,  other  internationally  recognised
methods  are  acceptable  in  accordance  with  the
provisions  of  Annexes  II  and  III  to  Directive
testing
91/414/EEC.  Without  prejudice 
requirements  set  out  in  Directive  91/414/EEC,  the
conditions  for  application  of  the  test  methods  are
described  in  Part  C  of  Annex  III  to  this  Directive.

the 

to 

2. Where  an  ecotoxicological  property  is  established
by  one  of  the  methods  outlined  in  paragraph  1(b)  to
obtain  new  data,  the  test  shall  be  conducted 
in
compliance  with  the  principles  of  good 
laboratory
practice  provided  for  in  Directive  87/18/EEC  and  with
the  provisions  of  Directive  86/609/EEC.

Where  the  environmental  hazards  have  been  assessed  in
compliance  with  both  the  procedures  mentioned  above,
the  results  of  the  methods  referred  to  in  paragraph  1(b)
shall  be  used  for  classifying  the  preparation.

For preparations of a known composition, with the
3.
exception  of  those  covered  by  Directive  91/414/EEC,
classified  in  accordance  with  the  method  outlined  in
paragraph  1(b),  a  new  evaluation  of  environmental
hazard  either  by  the  method  outlined  in  paragraph  1(a)
or  that  outlined  in  paragraph  1(b)  shall  be  performed
whenever:

— changes of composition of the initial concentration, as
a  weight/weight  or  volume/volume  percentage,  of  one
or  more  of  the  dangerous  constituents  are  introduced
by 
the
following table:

in  accordance  with 

the  manufacturer, 

–
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Initial  concentration  range  of
the  constituent

Permitted  variation  in  initial
concentration  of  the  constituent

# 2,5 %
. 2,5 # 10 %
. 10 # 25 %
. 25 # 100 %

– 30 %
– 20 %
– 10 %

5 %

— changes  of  composition  involving  the  substitution  or
addition  of  one  or  more  constituents,  which  may  or
may  not  be  dangerous  within  the  meaning  of  the
definitions  set  out  in  Article  2,  are  introduced  by  the
manufacturer.

This  new  evaluation  will  apply  unless  there  is  valid
scientific justification for considering that a re-evaluation
in  a  change  of
of 
classification.

the  hazard  will  not  result 

Article  9

Packaging

1. Member  States  shall  take  all  necessary  measures  to
ensure  that:

1. preparations  within  the  meaning  of  Article  1(2)  and
preparations  covered  by  Annex  IV  pursuant  to
Article  1(3)  cannot  be  placed  on  the  market  unless
their  packaging  satisfies  the  following  requirements:

— it  shall  be  so  designed  and  constructed  that  its
contents  cannot  escape;  this  requirement  shall  not
apply  where  special  safety  devices  are  prescribed,

— the  materials  constituting  the  packaging  and
fastenings  must  not  be  susceptible  to  adverse
attack  by 
form
dangerous  compounds  with  the  contents,

the  contents,  or 

liable 

to 

Article  8

Obligations  and  duties  of  the  Member  States

— packaging and fastenings must be strong and solid
throughout to ensure that they will not loosen and
will  safely  meet  the  normal  stresses  and  strains  of
handling,

1. Member  States  shall  take  all  necessary  measures  to
ensure  that  the  preparations  covered  by  this  Directive
cannot  be  placed  on  the  market  unless  they  comply  with
it.

— containers fitted with replaceable fastening devices
shall  be  so  designed  that  the  packaging  can  be
refastened 
contents
escaping.

repeatedly  without 

the 

2.
In  order  to  ensure  compliance  with  this  Directive,
the  authorities  of  the  Member  States  may  request
information  on  the  composition  of  the  preparation  and
any  other  pertinent 
from  any  person
responsible  for  placing  the  preparation  on  the  market.

information 

2. containers  which  contain  preparations  within  the
meaning  of  Article  1(2)  and  preparations  covered  by
Annex IV puorsuant to Article 1(3) offered or sold to
the  general  public  do  not  have:

3. Member  States  shall  take  all  necessary  measures  to
ensure  that  those  responsible  for  placing  the  preparation
on  the  market  hold  at  the  disposal  of  the  authorities  of
the  Member  States:

— the data used for the classification and labelling of the

preparation,

information  relating  to  packaging
— any  pertinent 
in  accordance  with  Article  9(1)(3),
requirements 
including the test certificate issued in accordance with
Part  A  of  Annex  IX  to  Directive  67/548/EEC,

— either  a  shape  and/or  graphic  decoration  likely  to
attract or arouse the active curiosity of children or
to  mislead  consumers,  or

— a  presentation  and/or  a  designation  used  for
foodstuffs  or  animal  feedingstuffs  or  medicinal  or
cosmetic  products.

3. containers  which  contain  certain  preparations  offered
or sold to the general public covered by Annex IV to
this  Directive:

— are  fitted  with  child-resistant  fastenings,

— the data used for establishing the safety data sheet, in

accordance  with  Article  14.

and/or

4. Member  States  and  the  Commission  shall  exchange
information  concerning  the  name  and  full  address  of
the  national  authority 
for
communicating  and  exchanging  information  relating  to
the  practical  application  of  this  Directive.

(authorities)  responsible 

— carry  a  tactile  warning  of  danger.

The  devices  must  conform  to  the  technical  specifications
given  in  Parts  A  and  B  of  Annex  IX  to  Directive
67/548/EEC.

–
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The  packaging  of  preparations  shall  be  deemed  to
2.
satisfy  the  requirements  of  paragraph  1(1),  first,  second
and  third  indents,  if  it  complies  with  the  requirements
for  carriage  of  dangerous  goods  by  rail,  road,  inland
waterway,  sea  or  air.

2.

substances  present 

for  preparations  classified  C  in  accordance  with
Article  6,  only  C 
in
concentration equal to, or greater than, the lowest
limit  (limit  Xi)  laid  down  in  Annex  I  to  Directive
67/548/EEC  or,  failing  that,  Part  B  of  Annex  II
into
to 
consideration;

this  Directive  have 

to  be 

taken 

Article  10

Labelling

1. Member  States  shall  take  all  necessary  measures  to
ensure  that:

1.

(a) preparations  within  the  meaning  of  Article  1(2)
cannot  be  placed  on  the  market  unless  the
labelling  on  their  packaging  satisfies  all  the
requirements  of  this  Article  and  the  specific
provisions  of  Parts  A  and  B  of  Annex  V;

(b) preparations  within  the  meaning  of  Article  1(3)
as  defined  in  Parts  B  and  C  of  Annex  V  cannot
be  placed  on  the  market  unless  the  labelling  on
their  packaging  satisfies  the  requirements  of
paragraph  2(1)  and 
specific
provisions  of  Parts  B  and  C  of  Annex  V.

(2)  and 

the 

2. With  respect  to  plant  protection  products  subject  to
Directive  91/414/EEC,  the  labelling  requirements  in
accordance  with  this  Directive  shall  be  accompanied
by  the  following  wording:

‘To  avoid  risks  to  man  and  the  environment,  comply
with  the  instructions  for  use.’

This  labelling  shall  be  without  prejudice  to  the
information  required  in  accordance  with  Article  16
of,  and  Annex  V  to,  Directive  91/414/EEC.

The  following  information  shall  be  clearly  and

2.
indelibly  marked  on  any  package:

1.

the  trade  name  or  designation  of  the  preparation;

2.

the  name,  full  address  and  telephone  number  of  the
person  established 
is
responsible for placing the preparation on the market,
whether  it  be  the  manufacturer,  the  importer  or  the
distributor;

the  Community  who 

in 

3.

the  name  of  the  substances  which  have  given  rise
to  the  classification  of  the  preparation  in  one  or
more  of  the  following  danger  categories:

— carcinogen  category  1,  2  or  3,

— mutagen  category  1,  2  or  3,

— toxic  for  reproduction  category  1,  2  or  3,

— very  toxic,  toxic  or  harmful  due  to  non-lethal

effects  after  a  single  exposure,

— toxic  or  harmful  due  to  severe  effects  after

repeated  or  prolonged  exposure,

— sensitising,

shall  be  mentioned  on  the  label.

listed 

The  chemical  name 
designations 
67/548/EEC  or  an 
chemical  nomenclature 
designation  is  yet  listed  in  that  Annex;

shall  be  one  of 
the
in  Annex  I  to  Directive
internationally  recognised
if  no  corresponding

4. As  a  consequence  of  the  above  provisions  the
name  of  any  substance  which 
the
classification  of  the  preparation  in  the  following
danger categories:

led 

to 

— explosive,

— oxidising,

— extremely flammable,

— highly flammable,

— flammable,

— irritant,

3.

the  chemical  name  of  the  substance  or  substances
present  in  the  preparation  in  accordance  with  the
following  detailed  rules:

1.

for preparations classified T+, T, Xn  in accordance
with  Article  6,  only  the  substances  T+,  T,  Xn
present  in  concentrations  equal  to,  or  greater
than,  the  lowest  limit  (limit  Xn)  for  each  of  them
laid down in Annex I to Directive 67/548/EEC or,
failing  that,  Part  B  of  Annex  II  to  this  Directive
have  to  be  taken  into  consideration;

— dangerous  for  the  environment,

need  not  be  mentioned  on  the  label  unless  the
substance  has  to  be  mentioned  pursuant  to
points  3.1,  3.2  or  3.3;

5. 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

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choice  of  the  corresponding  phrases  referring  to
the  risk  involved.  In  some  cases,  more  than  four
chemical  names  may  be  necessary;

4. The  danger  symbol(s)  and  indication(s)  of  danger:

The danger symbols, where specified in this Directive,
and  indications  of  the  dangers  involved  in  the  use  of
the  preparation,  shall  be  in  accordance  with  the
wording  of  Annexes 
to  Directive
67/548/EEC  and  shall  be  applied  in  accordance  with
the  evaluation  of 
in
accordance  with  Annexes  I,  II  and  III  to  this
Directive.

the  hazards  carried  out 

II  and  VI 

Where  more  than  one  danger  symbol  must  be
assigned  to  a  preparation  the  obligation  to  apply  the
symbol:

— T shall make the symbols C and X optional unless
in  Annex  I  to  Directive

otherwise  specified 
67/548/EEC,

— C  shall  make  the  symbol  X  optional,

— E  shall  make  the  symbols  F  and  O  optional,

— Xn  shall  make  the  symbol  Xi  optional.

The  symbol(s)  shall  be  printed  in  black  on  an
orange-yellow background;

6. The  safety  advice  (S  phrases):

The  indications  giving  safety  advice  (S  phrases)  shall
comply  with  the  wording  in  Annex  IV  and  with
Annex  VI  to  Directive  67/548/EEC  and  shall  be
assigned  in  accordance  with  the  results  of  the  hazard
evaluation  carried  out  in  accordance  with  Annexes  I,
II  and  III  to  this  Directive.

As  a  general  rule,  a  maximum  of  six  S  phrases  shall
suffice  to  formulate  the  most  appropriate  safety
advice;  for  this  purpose  the  combined  phrases  listed
in  Annex  IV  to  Directive  67/548/EEC  shall  be
regarded  as  single  phrases.  However,  in  some  cases
more  than  six  S  phrases  may  be  necessary.

Where it is physically impossible to include the advice
on  the  label  or  package  itself,  the  package  shall  be
accompanied  by  safety  advice  on  the  use  of  the
preparation;

7. The  nominal  quantity  (nominal  mass  or  nominal
volume)  of  the  contents  in  the  case  of  preparations
offered  or  sold  to  the  general  public.

3.
For  certain  preparations  classified  as  dangerous
within  the  meaning  of  Article  7,  by  way  of  derogation
from  paragraph  2(4),  (5)  and  (6)  of  this  Article,
exemptions  to  certain  provisions  on  environmental
labelling  or 
to
environmental labelling may be determined in accordance
with the procedure referred to in Article 20, where it can
be  demonstrated  that  there  would  be  a  reduction  in  the
environmental 
impact.  These  exemptions  or  specific
provisions  are  defined  and  laid  down  in  Part  A  or  B  of
Annex  V.

specific  provisions 

relation 

in 

5. The  risk  phrases  (R  phrases):

If  the  contents  of  the  package  do  not  exceed

4.
125  ml:

The  indications  concerning  special  risks  (R  phrases)
shall  comply  with  the  wording  in  Annexes  III  and  VI
to  Directive  67/548/EEC  and  shall  be  assigned  in
accordance  with  the  results  of  the  hazard  evaluation
carried  out  in  accordance  with  Annexes  I,  II,  and  III
to  this  Directive.

— in the case of preparations that are classified as highly
flammable,  oxidising,  irritant,  with  the  exception  of
those assigned R41, or dangerous for the environment
and assigned the N symbol it shall not be necessary to
indicate  the  R  phrases  or  the  S  phrases,

As  a  general  rule,  a  maximum  of  six  R  phrases  shall
suffice  to  describe  the  risks;  for  this  purpose,  the
combined  phrases  listed  in  Annex  III  to  Directive
67/548/EEC  shall  be  regarded  as  single  phrases.
However,  if  the  preparation  falls  within  more  than
one  danger  category,  those  standard  phrases  shall
cover  all  the  principal  hazards  associated  with  the
preparation.  In  some  cases  more  than  six  R  phrases
may  be  necessary.

‘extremely  flammable’  or
The  standard  phrases 
‘highly  flammable’  need  not  be  used  where  they
describe  an  indication  of  danger  used  in  accordance
with  point  4.

— in  the  case  of  preparations  that  are  classified  as
flammable  or  dangerous  for  the  environment  and  not
assigned the N symbol it shall be necessary to indicate
the R phrases but it shall not be necessary to indicate
the  S  phrases.

such 

indications 

5. Without  prejudice  to  Article  16(4)  of  Directive
91/414/EEC, 
‘non-toxic’,
‘non-harmful’,  ‘non-polluting’,  ‘ecological’  or  any  other
statement 
is  not
dangerous  or  likely  to  lead  to  underestimation  of  the
dangers  of  the  preparation  in  question  shall  not  appear
on  the  packaging  or  labelling  of  any  preparation  subject
to  this  Directive.

the  preparation 

indicating 

that 

as 

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Article  11

question  when  it  has  not  been  so  identified  on
the  label,

Implementation  of  the  labelling  requirements

or

1. Where the particulars required by Article 10 appear
on  a  label,  that  label  shall  be  firmly  affixed  to  one  or
more  surfaces  of  the  packaging  so  that  those  particulars
can  be  read  horizontally  when  the  package  is  set  down
normally.  The  dimensions  of  the  label  are  laid  down  in
Annex  VI  to  Directive  67/548/EEC  and  the  label  is
intended  solely  for  provision  of  the  information  required
by  this  Directive  and  if  necessary  of  any  supplementary
health  or  safety  information.

2.
A  label  shall  not  be  required  when  the  particulars
are  clearly  shown  on  the  package  itself,  as  specified  in
paragraph  1.

3.
The  colour  and  presentation  of  the  label  —  or,  in
the  case  of  paragraph  2,  of  the  package  —  shall  be  such
that  the  danger  symbol  and  its  background  stand  out
clearly  from  it.

The 

information  required  on  the 

label  under
4.
Article  10  shall  stand  out  clearly  from  its  background
and  shall  be  of  such  size  and  spacing  as  to  be  easily
read.

— where  appropriate, 

for  particular 

types  of
packaging  such  as  mobile  gas  cylinders,  if  the
specific  requirements  referred  to  in  Annex  VI  to
Directive  67/548/EEC  are  complied  with.

Where  dangerous  preparations  do  not  leave  the  territory
of  a  Member  State,  labelling  may  be  permitted  which
complies with national rules instead of with international
rules  on  the  transport  of  dangerous  goods.

Article  12

Exemptions  from  the  labelling  and  packaging
requirements

Articles  9,  10  and  11  shall  not  apply  to  explosives
1.
placed  on  the  market  with  a  view  to  obtaining  an
explosive  or  pyrotechnic  effect.

For  certain  dangerous  preparations  within  the
2.
meaning of Article 5, 6 or 7 defined in Annex VII which,
in  the  form  in  which  they  are  placed  on  the  market,  do
not  present  any  physico-chemical  risk,  or  risk  to  health
or  to  the  environment,  Articles  9,  10  and  11  shall  not
apply.

Specific provisions regarding the presentation and format
of  this  information  shall  be  laid  down  in  Annex  VI  to
Directive  67/548/EEC.

3. Member  States  may  also:

5. Member States may make the placing on the market
of  preparations  covered  by  this  Directive  within  their
territories  subject  to  use  of  their  official  language  or
languages  in  respect  of  the  labelling  thereof.

For 

6.
requirements  shall  be  deemed  to  be  satisfied:

the  purposes  of 

this  Directive, 

labelling

(a)

in  the  case  of  an  outer  package  containing  one  or
more inner packages, if the outer package is labelled
in  accordance  with 
international  rules  on  the
transport  of  dangerous  goods  and  the  inner  package
or  packages  are  labelled  in  accordance  with  this
Directive;

(b)

in  the  case  of  a  single  package:

— if  such  a  package  is  labelled  in  accordance  with
international  rules  on  the  transport  of  dangerous
goods  and  with  Article  10(2)(1),  (2),  (3),  (5)  and
(6);  for  preparations  classified  according  to
Article  7,  the  provisions  of  Article  10(2)(4)  shall
additionally apply with respect to the property in

(a) permit  the  labelling  required  by  Article  10  to  be
applied 
in  some  other  appropriate  manner  on
packages  which  are  either  too  small  or  otherwise
unsuitable 
in  accordance  with
Article  11(1)  and  (2);

labelling 

for 

(b) by way of derogation from Articles 10 and 11 permit
the  packaging  of  dangerous  preparations  which  are
classified  as  harmful,  extremely  flammable,  highly
flammable,  flammable,  irritant  or  oxidising  to  be
unlabelled  or  to  be  labelled  in  some  other  way,  if
they  contain  such  small  quantities  that  there  is  no
reason  to  fear  any  danger  to  persons  handling  such
preparations  or  to  other  persons;

(c) by  way  of  derogation  from  Articles  10  and  11,  for
preparations  classified  according  to  Article  7,  permit
the  packaging  of  dangerous  preparations  to  be
unlabelled  or  labelled  in  some  other  way  if  they
contain  such  small  quantities  that  there  is  no  reason
to  fear  any  dangers  to  the  environment;

(d) by way of derogation from Articles 10 and 11 permit
the  packaging  of  dangerous  preparations  which  are
not  mentioned  in  (b)  or  (c)  to  be  labelled  in  some
other  appropriate  way,  if  the  packages  are  too

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small for the labelling provided for in Articles 10 and
11  and  there  is  no  reason  to  fear  any  danger  to
persons  handling  such  preparations  or  to  other
persons.

Where  this  paragraph  is  applied,  the  use  of  symbols,
indications  of  danger,  risk  (R)  phrases  or  safety  (S)
phrases different to those laid down in this Directive shall
not  be  permitted.

4.
If  a  Member  State  makes  use  of  the  options
provided for in paragraph 3, it shall forthwith inform the
Commission  and  Member  States  thereof.  Where  it  is
appropriate,  measures  shall  be  decided  upon  in  the
framework  of  Annex  V  and  in  accordance  with  the
provisions  of  Article  20.

Article  13

Distance selling

Any  advertisement  for  a  preparation  within  the  meaning
of  this  Directive  which  enables  a  member  of  the  general
public  to  conclude  a  contract  for  purchase  without  first
having  sight  of  the  label  for  that  preparation  must  make
mention  of  the  type  or  types  of  hazard  indicated  on  the
label.  This  requirement  is  without  prejudice  to  Directive
97/7/EC  of  the  European  Parliament  and  of  the  Council
of  20  May  1997  on  the  protection  of  consumers  in
respect  of  distance  contracts (1).

Article  14

Safety  data  sheet

1.
The  safety  data  sheet  information  is  principally
intended  for  use  by  professional  users  and  must  enable
them  to  take  the  necessary  measures  as  regards  the
protection  of  health,  safety  and  the  environment  at  the
place  of  work.

2. 1. Member  States  shall 
measures  to  ensure  that:

take  all 

the  necessary

(a)

(b)

the  person  responsible  for  placing  on  the
market  a  preparation  within  the  meaning  of
Article  1(2)  provides  a  safety  data  sheet;

the  person  responsible  for  placing  on  the
market a preparation provides on request of a
professional user a safety data sheet providing
proportionate  information  for  preparations
not classified as dangerous within the meaning
of  Articles  5,  6  and  7  but  containing  in  an

(1) OJ  L  144,  4.6.1997,  p.  19.

individual  concentration  of  $  1 %  by  weight
for non-gaseous preparations and $  0,2 % by
volume  for  gaseous  preparations  at  least:

— one 

substance 
environmental  hazards,  or

posing 

health 

or

— one 

substance 

for  which 

there  are

Community  workplace  exposure  limits;

2. The  safety  data  sheet  and  its  supply  must  comply
with  the  provisions  of  Directive  91/155/EEC;

3. The  necessary  amendments  required  to  adapt  to
technical  progress  Directive  91/155/EEC  shall  be
adopted  in  accordance  with  the  procedure  laid
down  in  Article  20  of  this  Directive.

In  particular,  the  necessary  amendments  to  take
account  of  provisions  in  point  1(b)  shall  be
adopted  before  the  date  specified  in  Article  22(1);

4. The safety data sheet may be supplied on paper or
electronically,  provided  that  the  addressee  has  the
necessary  means  of  receiving  it.

Article  15

Confidentiality  of  chemical  names

Where the person responsible for placing the preparation
on the market can demonstrate that the disclosure on the
label  or  safety  data  sheet  of  the  chemical  identity  of  a
substance  which  is  exclusively  classified  as:

— irritant  with  the  exception  of  those  assigned  R41  or
irritant in combination with one or more of the other
properties  mentioned  in  point  3.4  of  Article  10(2),
or

— harmful or harmful in combination with one or more
in  point  3.4  of

of 
Article  10(2)  presenting  acute  lethal  effects  alone

the  properties  mentioned 

will  put  at  risk  the  confidential  nature  of  his  intellectual
property,  he  may,  in  accordance  with  the  provisions  of
Annex  VI,  be  permitted  to  refer  to  that  substance  either
by  means  of  a  name  that  identifies  the  most  important
functional chemical groups or by means of an alternative
name.  This  procedure  may  not  be  applied  where  the
substance  concerned  has  been  assigned  a  Community
exposure  limit.

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Where  the  person  responsible  for  placing  a  preparation
on the market wishes to take advantage of confidentiality
provisions,  he  shall  make  a  request  to  the  competent
authority  of  the  Member  State  in  which  the  preparation
is  to  be  first  placed  on  the  market.

information received. Such information may only be used
to  meet  any  medical  demand  by  formulating  preventive
and  curative  measures, 
in  case  of
emergency.

in  particular 

This  request  must  be  made  in  accordance  with  the
provisions of Annex VI and must provide the information
required  in  the  form  in  Part  A  of  that  Annex.  The
competent  authority  may  nevertheless  request  further
information  from  the  person  responsible  for  placing  the
preparation  on  the  market  if  such  information  appears
necessary 
in  order  to  evaluate  the  validity  of  the
request.

The authority of the Member State receiving a request for
confidentiality  shall  notify  the  applicant  of  its  decision.
The person responsible for placing the preparation on the
market  shall  forward  a  copy  of  this  decision  to  each  of
the  Member  States  where  he  wishes  to  market  the
product.

Confidential  information  brought  to  the  attention  of  the
authorities of a Member State or of the Commission shall
be  treated  in  accordance  with  Article  19(4)  of  Directive
67/548/EEC.

Member  States  shall  ensure  that  the  information  is  not
used  for  other  purposes.

Member  States  shall  ensure  that  the  appointed  bodies
have  at  their  disposal  all  the  information  required  from
the  manufacturers  or  persons  responsible  for  marketing
to  carry  out  the  tasks  for  which  they  are  responsible.

Article  18

Free  movement  clause

Without  prejudice  to  the  provisions  set  out  in  other
Community legislation, Member States may not prohibit,
restrict  or 
impede  the  placing  on  the  market  of
preparations  because  of  their  classification,  packaging,
labelling or safety data sheets if such preparations comply
with  the  provisions  laid  down  in  this  Directive.

Article  16

Rights  of  Member  States  regarding  safety  of  workers

Article  19

Safeguard clause

specify, 

the  Treaty, 

in  compliance  with 

This Directive shall not affect the right of Member States
the
to 
requirements they deem necessary to ensure that workers
are  protected  when  using  the  dangerous  preparations  in
question,  provided  that  this  does  not  mean  that  the
classification,  packaging,  and  labelling  of  dangerous
preparations  are  modified  in  a  way  not  provided  for  in
this  Directive.

Article  17

1. Where  a  Member  State  has  detailed  evidence  that
a  preparation,  although  satisfying  the  provisions  of
this  Directive,  constitutes  a  hazard  for  man  or  the
environment on grounds relating to the provisions of this
Directive, it may provisionally prohibit the placing on the
market  of  that  preparation  or  subject  it  to  special
conditions in its territory. It shall immediately inform the
Commission and the other Member States of such action
and  give  reasons  for  its  decision.

In  the  case  referred  to 

2.
in  paragraph  1,  the
Commission  shall  consult  the  Member  States  as  soon  as
possible.

Bodies  responsible  for  receiving  information  relating
to  health

The Commission shall take a decision in accordance

3.
with  the  procedure  laid  down  in  Article  20.

Member  States  shall  appoint  the  body  or  bodies
responsible  for  receiving  information,  including  chemical
composition,  relating  to  preparations  placed  on  the
market  and  considered  dangerous  on  the  basis  of  their
health  effects  or  on  the  basis  of  their  physico-chemical
effects.

Article  20

Adaptation  to  technical  progress

Member  States  shall  take  the  necessary  steps  to  ensure
that  the  appointed  bodies  provide  all  the  requisite
guarantees  for  maintaining  the  confidentiality  of  the

Amendments  required  to  adapt  the  Annexes  to  this
Directive  to  technical  progress  shall  be  adopted  in
accordance  with 
in
the  procedure 
Article  29(4)(b)  of  Directive  67/548/EEC.

laid  down 

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Article  21

Repeal  of  Directives

1.
The  Directives  listed  in  Part  A  of  Annex  VIII  are
hereby  repealed,  without  prejudice  to  the  obligation  of
the  Member  States  concerning 
for
transposition into national law and for application of the
Directives  indicated  in  Part  B  of  Annex  VIII.

the  deadlines 

The  Directives  listed  in  Part  A  of  Annex  VIII  shall
2.
apply  to  Austria,  Finland  and  Sweden  subject  to
provisions  laid  down  in  Part  C  of  that  Annex  and
pursuant  to  the  Treaty.

3.
References to the repealed Directives shall constitute
references  to  this  Directive  and  should  be  read  in
accordance  with 
in
the  correlation 
Annex  IX.

table  set  out 

Article  22

Transposition

1. Member States shall adopt and publish before . . . (1)
the 
laws,  regulations  and  administrative  provisions
necessary  to  comply  with  this  Directive.  They  shall
forthwith  inform  the  Commission  thereof.

(b)

to  preparations  within 
91/414/EEC  or  Directive  98/8/EC  as  from  . . . (3).

the  scope  of  Directive

3. When  Member  States  adopt  such  measures,  they
shall  contain  a  reference  to  this  Directive  or  shall  be
accompanied  by  such  reference  at  the  time  of  their
official  publication.  The  methods  of  making  such
reference  shall  be  laid  down  by  Member  States.

Article  23

Entry  into  force

This  Directive  shall  enter  into  force  on  the  day  of  its
publication  in  the  Official  Journal  of  the  European
Communities.

Article  21(2)  shall  apply  from  1  January  1999.

Article  24

Adressees

This  Directive  is  addressed  to  the  Member  States.

2. Member States shall apply the laws, regulations and
administrative  provisions  referred  to  in  paragraph  1:

Done  at  Brussels,  . . .

(a)

to  preparations  not  within  the  scope  of  Directive
91/414/EEC  or  Directive  98/8/EC  as  from  . . . (2);
and

For  the  European  Parliament

For  the  Council

The  President

The  President

(1) 36  months  after  the  entry  into  force  of  this  Directive.
(2) 36  months  after  the  entry  into  force  of  this  Directive.

(3) 60  months  after  the  entry  into  force  of  this  Directive.

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ANNEX  I

METHODS  FOR  THE  EVALUATION  OF  PHYSICO-CHEMICAL  PROPERTIES  OF  PREPARATIONS
IN  ACCORDANCE  WITH  ARTICLE  5

Exemptions  to  test  methods  of  Annex  V  —  Part  A  to  Directive  67/548/EEC

PART  A

See  point  2.2.5  of  Annex  VI  to  Directive  67/548/EEC.

PART  B

Alternative  calculation  methods

B.1. Non-gaseous  preparations

Method  for  the  determination  of  oxidising  properties  of  preparations  containing  organic  peroxides.

See  point  2.2.2.1  of  Annex  VI  to  Directive  67/548/EEC.

B.2. Gaseous  preparations

1. Method  for  the  determination  of  oxidising  properties:

See  point  9.1.1.2  of  Annex  VI  to  Directive  67/548/EEC.

2. Method  for  the  determination  of  flammability  properties:

See  point  9.1.1.1  of  Annex  VI  to  Directive  67/548/EEC.

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ANNEX  II

METHODS  FOR  THE  EVALUATION  OF  HEALTH  HAZARDS  OF  PREPARATIONS  IN
ACCORDANCE  WITH  ARTICLE  6

Introduction

An  assessment  must  be  made  for  all  the  health  effects  corresponding  to  the  health  effects  of  substances
contained  in  a  preparation.  This  conventional  method  described  in  Parts  A  and  B  of  this  Annex  is  a
calculation method which is applicable to all preparations and which takes into consideration all the health
hazards of substances contained in the preparation. For that purpose the dangerous health effects have been
subdivided  into:

1. acute  lethal  effects;

2. non-lethal  irreversible  effects  after  a  single  exposure;

3.

severe  effects  after  repeated  or  prolonged  exposure;

4. corrosive  effects,  irritant  effects;

5.

sensitising  effects;

6. carcinogenic  effects,  mutagenic  effects,  toxic  effects  for  reproduction.

The health effects of a preparation are to be assessed in accordance with Article 6(1)(a) by the conventional
method  described  in  Parts  A  and  B  of  this  Annex  using  individual  concentration  limits:

(a) where  the  dangerous  substances  listed  in  Annex  I  to  Directive  67/548/EEC  are  assigned  concentration
limits necessary for the application of the method of assessment described in Part A of this Annex, these
concentration  limits  must  be  used;

(b) where  the  dangerous  substances  do  not  appear  in  Annex  I  to  Directive  67/548/EEC  or  appear  there
without the concentration limits necessary for the application of the method of evaluation described in
Part A of this Annex, the concentration limits must be assigned in accordance with the specifications in
Part  B  of  this  Annex.

The  procedure  for  classification  is  set  out  in  Part  A  of  this  Annex.

The  classification  of  the  substance(s)  and  the  resulting  classification  of  the  preparation  are  expressed:

— either  by  a  symbol  and  one  or  more  risk  phrases,  or

— by  categories  (category  1,  category  2  or  category  3)  also  assigned  risk  phrases  when  substances  and
preparations  are  shown  to  be  carcinogenic,  mutagenic  or  toxic  for  reproduction.  Therefore  it  is
important  to  consider,  in  addition  to  the  symbol,  all  the  phrases  denoting  specific  risks  which  are
assigned  to  each  substance  under  consideration.

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

Where  they  are  not  given  in  Annex  I  to  Directive  67/548/EEC,  the  concentration  limits  to  be  taken  into
account  for  the  application  of  this  conventional  method  are  those  set  out  in  Part  B  of  this  Annex.

PART  A

Procedure  for  evaluation  of  health  hazards

The  evaluation  proceeds  stepwise  as  follows.

1.

The  following  preparations  are  to  be  classified  as  very  toxic:

1.1. Owing to their acute lethal effects and assigned the symbol ‘T+’, the indication of danger ‘very toxic’

and  the  risk  phrases  R26,  R27  or  R28:

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1.1.1. Preparations containing one or more substances classified as very toxic that produce such effects, in

individual  concentrations  equal  to  or  greater  than:

(a) either  the  concentration  specified  in  Annex  I  to  Directive  67/548/EEC  for  the  substance  or

substances  under  consideration;  or

(b)

the  concentration  specified  at  point  1  in  Part  B  of  this  Annex  (Tables  I  and  IA)  where  the
substance  or  substances  do  not  appear  in  Annex  I  to  Directive  67/548/EEC  or  appear  in  it
without  concentration  limits;

1.1.2. Preparations  containing  more  than  one  substance  classified  as  very  toxic  in  lower  individual

concentrations  than  the  limits  specified  under  1.1.1(a)  or  (b)  if:

LT+) $ 1
(PT+

where:

PT+ = the  percentage  by  weight  or  by  volume  of  each  very  toxic  substance  in  the  preparation

LT+ = the  very  toxic  limit  specified  for  each  very  toxic  substance,  expressed  as  a  percentage  by

weight  or  by  volume.

1.2. Owing  to  their  non-lethal  irreversible  effects  after  a  single  exposure  and  assigned  the  symbol  ‘T+’,

the  indication  of  danger  ‘very  toxic’  and  the  risk  phrase  R39/route  of  exposure.

Preparations  containing  at  least  one  dangerous  substance  that  produces  such  effects  in  individual
concentrations  equal  to  or  greater  than:

(a) either  the  concentration  specified  in  Annex  I  to  Directive  67/548/EEC  for  the  substance  or

substances  under  consideration;  or

(b)

the  concentration  specified  at  point  2  in  Part  B  of  this  Annex  (Tables  II  and  IIA)  where  the
substance  or  substances  do  not  appear  in  Annex  I  to  Directive  67/548/EEC  or  appear  in  it
without  limits.

2.

The  following  preparations  shall  be  classified  as  toxic:

2.1. Owing to their acute lethal effects and assigned the symbol ‘T’, the indication of danger ‘toxic’ and

the  risk  phrases  R23,  R24  or  R25.

2.1.1. Preparations  containing  one  or  more  substances  classified  as  very  toxic  or  toxic  that  produce  such

effects  in  individual  concentrations  equal  to  or  greater  than:

(a) either  the  concentration  specified  in  Annex  I  to  Directive  67/548/EEC  for  the  substance  or

substances  under  consideration;  or

(b)

the  concentration  specified  at  point  1  in  Part  B  of  this  Annex  (Tables  I  and  IA)  where  the
substance  or  substances  do  not  appear  in  Annex  I  to  Directive  67/548/EEC  or  appear  in  it
without  concentration  limits;

2.1.2. Preparations containing more than one substance classified as very toxic or toxic in lower individual

concentrations  than  the  limits  specified  under  point  2.1.1(a)  or  (b)  if:

(PT+

LT

+

PT

LT) $ 1

where:

PT+ = the  percentage  by  weight  or  by  volume  of  each  very  toxic  substance  in  the  preparation

PT = the  percentage  by  weight  or  by  volume  of  each  toxic  substance  in  the  preparation

LT = the  respective  toxic  limit  specified  for  each  very  toxic  or  toxic  substance,  expressed  as  a

percentage  by  weight  or  by  volume;

2.2. Owing to their non-lethal irreversible effects after a single exposure and assigned the symbol T, the

indication  of  danger  ‘toxic’  and  the  risk  phrase  R39/route  of  exposure.

Preparations  containing  at  least  one  dangerous  substance  classified  as  very  toxic  or  toxic  that
produce  such  effects  in  individual  concentrations  equal  to  or  greater  than:

(a) either  the  concentration  specified  in  Annex  I  to  Directive  67/548/EEC  for  the  substance  or

substances  under  consideration;  or

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(b)

the  concentration  specified  at  point  2  in  Part  B  of  this  Annex  (Tables  II  and  IIA)  where  the
substance  or  substances  do  not  appear  in  Annex  I  to  Directive  67/548/EEC  or  appear  in  it
without  concentration  limits;

2.3. Owing to their long-term effects and assigned the symbol T, the indication of danger ‘toxic’ and the

risk  phrase  R48/route  of  exposure.

Preparations  containing  at  least  one  dangerous  substance  that  produces  such  effects  in  individual
concentrations  equal  to  or  greater  than:

(a) either  the  concentration  specified  in  Annex  I  to  Directive  67/548/EEC  for  the  substance  or

substances  under  consideration,  or

(b)

the  concentration  specified  at  point  3  in  Part  B  of  this  Annex  (Tables  III  and  IIIA)  where  the
substance  or  substances  do  not  appear  in  Annex  I  to  Directive  67/548/EEC  or  appear  in  it
without  concentration  limits;

3.

The  following  preparations  shall  be  classified  as  harmful:

3.1. Owing  to  their  acute  lethal  effects  and  assigned  the  symbol  Xn  and  the  indication  of  danger

‘harmful’  and  the  risk  phrases  R20,  R21  or  R22.

3.1.1. Preparations  containing  one  or  more  substances  classified  as  very  toxic,  toxic  or  harmful  and  that

produce  such  effects  in  individual  concentrations  equal  to  or  greater  than:

(a) either  the  concentration  specified  in  Annex  I  to  Directive  67/548/EEC  for  the  substance  or

substances  under  consideration;  or

(b)

the  concentration  specified  at  point  1  in  Part  B  of  this  Annex  (Tables  I  and  IA)  where  the
substance  or  substances  do  not  appear  in  Annex  I  to  Directive  67/548/EEC  or  appear  in  it
without  concentration  limits;

3.1.2. Preparations  containing  more  than  one  substance  classified  as  very  toxic,  toxic  or  harmful  in  lower

individual  concentrations  than  the  limits  specified  under  point  3.3.1(a)  or  (b)  if:

(PT+

LXn

+

PT
LXn

+

PXn

LXn) $ 1

where:

PT+ = the  percentage  by  weight  or  by  volume  of  each  very  toxic  substance  in  the  preparation

PT = the  percentage  by  weight  or  by  volume  of  each  toxic  substance  in  the  preparation

PXn = the  percentage  by  weight  or  by  volume  of  each  harmful  substance  in  the  preparation

LXn = the  respective  harmful  limit  specified  for  each  very  toxic,  toxic  or  harmful  substance,

expressed  as  percentage  by  weight  or  by  volume;

3.2. Owing to their acute effects to the lungs if swallowed and assigned the symbol Xn  and the indication

of  danger  ‘harmful’  and  the  risk  phrase  R65.

Preparations  classified  as  harmful  according  to  the  criteria  specified  in  point  3.2.3  of  Annex  VI  to
Directive 67/548/EEC. In applying the conventional method according to point 3.1 no account shall
be  taken  of  the  classification  of  a  substance  as  R65.

3.3. Owing to their non-lethal irreversible effects after a single exposure and assigned the symbol Xn, the

indication  of  danger  ‘harmful’  and  the  risk  phrase  R40/route  of  exposure.

Preparations  containing  at  least  one  dangerous  substance  classified  as  very  toxic,  toxic  or  harmful
that  produces  such  effects  in  individual  concentrations  equal  to  or  greater  than:

(a) either  the  concentration  specified  in  Annex  I  to  Directive  67/548/EEC  for  the  substance  or

substances  under  consideration,  or

(b)

the  concentration  specified  at  point  2  in  Part  B  of  this  Annex  (Tables  II  and  IIA)  where  the
substance  or  substances  do  not  appear  in  Annex  I  to  Directive  67/548/EEC  or  appear  in  it
without  concentration  limits.

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3.4. Owing to their long-term effects and assigned the symbol Xn, the indication of danger ‘harmful’ and

the  risk  phrase  R48/route  of  exposure.

Preparations containing at least one dangerous substance classified as toxic or harmful that produces
such  effects  in  individual  concentrations  equal  to  or  greater  than:

(a) either  the  concentration  specified  in  Annex  I  to  Directive  67/548/EEC  for  the  substance  or

substances  under  consideration;  or

(b)

the  concentration  specified  at  point  3  in  Part  B  of  this  Annex  (Tables  III  and  IIIA)  where  the
substance  or  substances  do  not  appear  in  Annex  I  to  Directive  67/548/EEC  or  appear  in  it
without  concentration  limits.

4.

The  following  preparations  are  to  be  classified  as  corrosive:

4.1.

and  assigned  the  symbol  C,  the  indication  of  danger  ‘corrosive’  and  the  risk  phrase  R35.

4.1.1. Preparations  containing  one  or  more  substances  classified  as  corrosive  to  which  is  assigned  the

phrase  R35  in  individual  concentrations  equal  to  or  greater  than:

(a) either  the  concentration  specified  in  Annex  I  to  Directive  67/548/EEC  for  the  substance  or

substances  under  consideration;  or

(b)

the  concentration  specified  at  point  4  in  Part  B  of  this  Annex  (Tables  IV  and  IVA)  where  the
substance  or  substances  do  not  appear  in  Annex  I  to  Directive  67/548/EEC  or  appear  in  it
without  concentration  limits.

4.1.2. Preparations containing more than one substance classified as corrosive to which is assigned phrase

R35  in  lower  individual  concentrations  than  the  limits  specified  under  point  4.1.1(a)  or  (b)  if:

LC,  R35) $ 1
(PC,  R35

where:

PC,  R35 = the  percentage  by  weight  or  by  volume  of  each  corrosive  substance  which  is  assigned

phrase  R35  in  the  preparation

LC,  R35 = the  corrosive  limit  R35  specified  for  each  corrosive  substance  to  which  is  assigned  phrase

R35,  expressed  as  a  percentage  by  weight  or  by  volume;

4.2.

and  assigned  the  symbol  C,  the  indication  of  danger  ‘corrosive’  and  the  risk  phrase  R34;

4.2.1. Preparations  containing  one  or  more  substances  classified  as  corrosive  to  which  is  assigned  the

phrase  R35  or  R34  in  individual  concentrations  equal  to  or  greater  than:

(a) either  the  concentration  specified  in  Annex  I  to  Directive  67/548/EEC  for  the  substance  or

substances  under  consideration;  or

(b)

the  concentration  specified  at  point  4  in  Part  B  of  this  Annex  (Tables  IV  and  IVA)  where  the
substance  or  substances  do  not  appear  in  Annex  I  to  Directive  67/548/EEC  or  appear  in  it
without  concentration  limits.

4.2.2. Preparations containing more than one of the substances classified as corrosive to which is assigned
the  phrase  R35  or  R34  in  lower  individual  concentrations  than  the  limits  specified  under  point
4.2.1(a)  or  (b)  if:

(PC,  R35

LC,  R34

+

PC,  R34

LC,  R34) $ 1

where:

PC,  R35 = the  percentage  by  weight  or  by  volume  of  each  corrosive  substance  to  which  is  assigned

phrase  R35  in  the  preparation

PC,  R34 = the  percentage  by  weight  or  by  volume  of  each  corrosive  substance  to  which  is  assigned

phrase  R34  in  the  preparation

LC,  R34 = the  respective  corrosive  limit  R34  specified  for  each  corrosive  substance  to  which  is
assigned  phrase  R35  or  R34,  expressed  as  a  percentage  by  weight  or  by  volume.

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5.

The  following  preparations  are  to  be  classified  as  irritants:

5.1.

liable to cause serious eye damage and assigned the symbol Xi, the indication of danger ‘irritant’ and
the  risk  phrase  R41.

5.1.1. Preparations containing one or more substances classified as irritant to which is assigned phrase R41

in  individual  concentrations  equal  to  or  greater  than:

(a) either  the  concentration  specified  in  Annex  I  to  Directive  67/548/EEC  for  the  substance  or

substances  under  consideration;  or

(b)

the  concentration  specified  at  point  4  in  Part  B  of  this  Annex  (Tables  IV  and  IVA)  where  the
substance  or  substances  do  not  appear  in  Annex  I  to  Directive  67/548/EEC  or  appear  in  it
without  concentration  limits;

5.1.2. Preparations  containing  more  than  one  of  the  substances  classified  as  irritant  and  to  which  is
assigned phrase R41, or classified as corrosive and to which is assigned phrase R35 or R34, in lower
individual  concentrations  than  the  limits  specified  under  point  5.1.1(a)  or  (b)  if:

( PC,  R35

LXi,  R41

+

PC,  R34
LXi,  R41

+

PXi,  R41

LXi,  R41) $ 1

where:

PC,  R35 = the  percentage  by  weight  or  by  volume  of  each  corrosive  substance  to  which  is  assigned

phrase  R35  in  the  preparation

PC,  R34 = the  percentage  by  weight  or  by  volume  of  each  corrosive  substance  to  which  is  assigned

phrase  R34  in  the  preparation

PXi,  R41 = the  percentage  by  weight  or  by  volume  of  each  irritant  substance  to  which  is  assigned

phrase  R41  in  the  preparation

LXi,  R41 = the respective irritant limit R41 specified for each corrosive substance to which is assigned
phrase  R35  or  R34  or  irritant  substance  to  which  is  assigned  phrase  R41,  expressed  as
percentage  by  weight  or  by  volume;

5.2.

Irritant  to  eyes  and  assigned  the  symbol  Xi,  the  indication  of  danger  ‘irritant’  and  the  risk  phrase
R36.

5.2.1. Preparations  containing  one  or  more  substances  classified  as  corrosive  to  which  is  assigned  phrase
R35 or R34 or as irritant and to which is assigned phrase R41 or R36 in individual concentrations
equal  to  or  greater  than:

(a) either  the  concentration  specified  in  Annex  I  to  Directive  67/548/EEC  for  the  substance  or

substances  under  consideration;  or

(b)

the  concentration  specified  at  point  4  in  Part  B  of  this  Annex  (Tables  IV  and  IVA)  where  the
substance  or  substances  do  not  appear  in  Annex  I  to  Directive  67/548/EEC  or  appear  in  it
without  concentration  limits.

5.2.2. Preparations  containing  more  than  one  substance  classified  as  irritant  to  which  is  assigned  phrase
R41  or  R36,  or  as  corrosive  and  to  which  is  assigned  phrase  R35  or  R34,  in  lower  individual
concentrations  than  the  limits  specified  under  point  5.2.1(a)  or  (b)  if:

( PC,  R35

LXi,  R36

+

PC,  R34
LXi,  R36

+

PXi,  R41
LXi,  R36

+

PXi,  R36

LXi,  R36) $ 1

where:

PC,  R35 = the  percentage  by  weight  or  by  volume  of  each  corrosive  substance  to  which  is  assigned

phrase  R35  in  the  preparation

PC,  R34 = the  percentage  by  weight  or  by  volume  of  each  corrosive  substance  to  which  is  assigned

phrase  R34  in  the  preparation

PXi,  R41 = the  percentage  by  weight  or  by  volume  of  each  irritant  substance  to  which  is  assigned

phrase  R41  in  the  preparation

PXi,  R36 = the  percentage  by  weight  or  by  volume  of  each  irritant  substance  to  which  is  assigned

phrase  R36  in  the  preparation

LXi,  R36 = the respective irritant limit R36 specified for each corrosive substance to which is assigned
phrase  R35  or  R34  or  irritant  substance  to  which  is  assigned  phrase  R41,  or  R36
expressed  as  percentage  by  weight  or  by  volume;

5.3.

Irritant  to  skin  and  assigned  the  symbol  Xi,  the  indication  of  danger  ‘irritant’  and  the  risk  phrase
R38.

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5.3.1. Preparations containing one or more substances classified as irritant and to which is assigned phrase
R38 or as corrosive and to which is assigned phrase R35 or R34 in individual concentrations equal
to  or  greater  than:

(a) either  the  concentration  specified  in  Annex  I  to  Directive  67/548/EEC  for  the  substance  or

substances  under  consideration;  or

(b)

the  concentration  specified  at  point  4  in  Part  B  of  this  Annex  (Tables  IV  and  IVA)  where  the
substance  or  substances  do  not  appear  in  Annex  I  to  Directive  67/548/EEC  or  appear  in  it
without  concentration  limits.

5.3.2. Preparations  containing  more  than  one  of  the  substances  classified  as  irritant  and  to  which  is
assigned  phrase  R38,  or  as  corrosive  and  to  which  is  assigned  phrase  R35  or  R34  in  lower
individual  concentrations  than  the  limits  specified  under  point  5.3.1(a)  or  (b)  if:

( PC,  R35

LXi,  R38

+

PC,  R34
LXi,  R38

+

PXi,  R38

LXi,  R38) $ 1

where:

PC,  R35 = the  percentage  by  weight  or  by  volume  of  each  corrosive  substance  to  which  is  assigned

phrase  R35  in  the  preparation

PC,  R34 = the  percentage  by  weight  or  by  volume  of  each  corrosive  substance  to  which  is  assigned

phrase  R34  in  the  preparation

PXi,  R38 = the  percentage  by  weight  or  by  volume  of  each  irritant  substance  to  which  is  assigned

phrase  R38  in  the  preparation

LXi,  R38 = the respective irritant limit R38 specified for each corrosive substance to which is assigned
phrase  R35  or  R34  or  irritant  substance  to  which  is  assigned  phrase  R38,  expressed  as
percentage  by  weight  or  by  volume;

5.4.

Irritant to respiratory system and assigned the symbol Xi, the indication of danger ‘irritant’ and the
risk  phrase  R37.

5.4.1. Preparations containing one or more substances classified as irritant and to which is assigned phrase

R37  in  individual  concentrations  equal  to  or  greater  than:

(a) either  the  concentration  specified  in  Annex  I  to  Directive  67/548/EEC  for  the  substance  or

substances  under  consideration;  or

(b)

the  concentration  specified  at  point  4  in  Part  B  of  this  Annex  (Tables  IV  and  IVA)  where  the
substance  or  substances  do  not  appear  in  Annex  I  to  Directive  67/548/EEC  or  appear  in  it
without  concentration  limits.

5.4.2. Preparations  containing  more  than  one  substance  classified  as  irritant  and  to  which  is  assigned
phrase  R37  in  lower  individual  concentrations  than  the  limits  specified  under  point  5.4.1(a)  or  (b)
if:

LXi,  R37) $ 1
(PXi,  R37

where:

PXi,  R37 = the  percentage  by  weight  or  by  volume  of  each  irritant  substance  to  which  is  assigned

phrase  R37  in  the  preparation

LXi,  R37 = the irritant limit R37 specified for each irritant substance to which is assigned phrase R37,

expressed  as  percentage  by  weight  or  by  volume.

5.4.3. Gaseous  preparations  containing  more  than  one  of  the  substances  classified  as  irritant  to  which  is
assigned phrase R37 or as corrosive and to which is assigned phrase R35 or R34 in lower individual
concentrations  than  the  limits  specified  under  point  5.4.1(a)  or  (b)  if:

( PC,  R35

LXi,  R37

+

PC,  R34
LXi,  R37

+

PXi,  R37

LXi,  R37) $ 1

where:

PC,  R35 = the  percentage  by  volume  of  each  corrosive  substance  to  which  is  assigned  phrase  R35  in

the  preparation

PC,  R34 = the  percentage  by  volume  of  each  corrosive  substance  to  which  is  assigned  phrase  R34  in

the  preparation

PXi,  R37 = the percentage by volume of each irritant substance to which is assigned phrase R37 in the

preparation

LXi,  R37 = the respective irritant limit R37 specified for each gaseous corrosive substance to which is
assigned phrase R35 or R34 or gaseous irritant substance to which is assigned phrase R37,
expressed  as  percentage  by  weight  or  by  volume.

(cid:229)
(cid:229)
(cid:229)
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6.

The  following  preparations  are  to  be  classified  as  sensitising:

6.1.

by  skin  contact  and  assigned  the  symbol  Xi,  the  indication  of  danger  ‘irritant’  and  the  risk  phrase
R43.

Preparations  containing  at  least  one  substance  classified  as  sensitising  and  to  which  is  assigned
phrase  R43  that  produces  such  effects  in  individual  concentrations  equal  to  or  greater  than:

(a) either  the  concentration  specified  in  Annex  I  to  Directive  67/548/EEC  for  the  substance  or

substances  under  consideration;  or

(b)

the  concentration  specified  at  point  5  in  Part  B  of  this  Annex  (Table  V  and  VA)  where  the
substance  or  substances  donot  appear  in  Annex  I  to  Directive  67/548/EEC  or  appear  in  it
without  concentration  limits;

6.2.

by  inhalation  and  assigned  the  symbol  Xn,  the  indication  of  danger  ‘harmful’  and  the  risk  phrase
R42.

Preparations  containing  at  least  one  substance  classified  as  sensitising  to  which  is  assigned  phrase
R42  that  produces  such  effects  in  individual  concentrations  equal  to  or  greater  than:

(a) either  the  concentration  specified  in  Annex  I  to  Directive  67/548/EEC  for  the  substance  or

substances  under  consideration;  or

(b)

the  concentration  specified  at  point  5  in  Part  B  of  this  Annex  (Table  V  and  VA)  where  the
substance  or  substances  do  not  appear  in  Annex  I  to  Directive  67/548/EEC  or  appear  in  it
without  concentration  limits.

7.

The  following  preparations  are  to  be  classified  as  carcinogenic:

7.1.

those  of  category  1  or  2  which  are  assigned  the  symbol  T  and  the  phrase  R45  or  R49.

Preparations containing at least one substance producing such effects, classified as carcinogenic and
to  which  is  assigned  phrase  R45  or  R49  which  denotes  carcinogenic  substances  in  categories  1  and
2,  in  individual  concentrations  equal  to  or  greater  than:

(a) either  the  concentration  specified  in  Annex  I  to  Directive  67/548/EEC  for  the  substance  or

substances  under  consideration;  or

(b)

the  concentration  specified  at  point  6  in  Part  B  of  this  Annex  (Tables  VI  and  VIA)  where  the
substance  or  substances  do  not  appear  in  Annex  I  to  Directive  67/548/EEC  or  appear  in  it
without  concentration  limits;

7.2.

those  of  category  3  which  are  assigned  the  symbol  Xn  and  the  phrase  R40.

Preparations  containing  at  least  one  substance  producing  such  effects  classified  as  carcinogenic  and
to  which  is  assigned  phrase  R40  which  denotes  carcinogenic  substances  in  category  3,  in  individual
concentrations  equal  to  or  greater  than:

(a) either  the  concentration  specified  in  Annex  I  to  Directive  67/548/EEC  for  the  substance  or

substances  under  consideration;  or

(b)

the  concentration  specified  at  point  6  in  Part  B  of  this  Annex  (Tables  VI  and  VIA)  where  the
substance  or  substances  do  not  appear  in  Annex  I  to  Directive  67/548/EEC  or  appear  in  it
without  concentration  limits.

8.

The  following  preparations  are  to  be  classified  as  mutagenic:

8.1.

those  of  category  1  or  2  which  are  assigned  the  symbol  T  and  the  phrase  R46.

Preparations containing at least one substance producing such effects, classified as mutagenic and to
which  is  assigned  phrase  R46  which  denotes  mutagenic  substances  in  categories  1  and  2,  in
individual  concentrations  equal  to  or  greater  than:

(a) either  the  concentration  specified  in  Annex  I  to  Directive  67/548/EEC  for  the  substance  or

substances  under  consideration;  or

(b)

the  concentration  specified  at  point  6  in  Part  B  of  this  Annex  (Tables  VI  and  VIA)  where  the
substance  or  substances  do  not  appear  in  Annex  I  to  Directive  67/548/EEC  or  appear  in  it
without  concentration  limits;

C 360/24

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8.2.

those  of  category  3  which  are  assigned  the  symbol  Xn  and  the  phrase  R40.

Preparations containing at least one substance, producing such effects, classified as mutagenic and to
which  is  assigned  phrase  R40  which  denotes  mutagenic  substances  in  category  3,  in  individual
concentrations  equal  to  or  greater  than:

(a) either  the  concentration  specified  in  Annex  I  to  Directive  67/548/EEC  for  the  substance  or

substances  under  consideration;  or

(b)

the  concentration  specified  at  point  6  in  Part  B  of  this  Annex  (Tables  VI  and  VIA)  where  the
substance  or  substances  do  not  appear  in  Annex  I  to  Directive  67/548/EEC  or  appear  in  it
without  concentration  limits.

9.

The  following  preparations  are  to  be  classified  as  toxic  for  reproduction:

9.1.

those  of  category  1  or  2  which  are  assigned  the  symbol  T  and  the  phrase  R60  (fertility).

Preparations  containing  at  least  one  substance  producing  such  effects,  classified  as  toxic  for
reproduction and to which is assigned phrase R60 which denotes substances toxic for reproduction
of  categories  1  and  2,  in  individual  concentrations  equal  to  or  greater  than:

(a) either  the  concentration  specified  in  Annex  I  to  Directive  67/548/EEC  for  the  substance  or

substances  under  consideration;  or

(b)

the  concentration  specified  at  point  6  in  Part  B  of  this  Annex  (Tables  VI  and  VIA)  where  the
substance  or  substances  do  not  appear  in  Annex  I  to  Directive  67/548/EEC  or  appear  in  it
without  concentration  limits;

9.2.

those  of  category  3  which  are  assigned  the  symbol  Xn  and  the  phrase  R62  (fertility).

Preparations  containing  at  least  one  substance  producing  such  effects,  classified  as  toxic  for
reproduction and to which is assigned phrase R62 which denotes substances toxic for reproduction
of  category  3,  in  individual  concentrations  equal  to  or  greater  than:

(a) either  the  concentration  specified  in  Annex  I  to  Directive  67/548/EEC  for  the  substance  or

substances  under  consideration;  or

(b)

the  concentration  specified  at  point  6  in  Part  B  of  this  Annex  (Tables  VI  and  VIA)  where  the
substance  or  substances  do  not  appear  in  Annex  I  to  Directive  67/548/EEC  or  appear  in  it
without  concentration  limits;

9.3.

those  of  category  1  or  2  which  are  assigned  the  symbol  T  and  the  phrase  R61  (development).

Preparations  containing  at  least  one  substance  producing  such  effects,  classified  as  toxic  for
reproduction and to which is assigned phrase R61 which denotes substances toxic for reproduction
of  categories  1  and  2,  in  individual  concentrations  equal  to  or  greater  than:

(a) either  the  concentration  specified  in  Annex  I  to  Directive  67/548/EEC  for  the  substance  or

substances  under  consideration;  or

(b)

the  concentration  specified  at  point  6  in  Part  B  of  this  Annex  (Tables  VI  and  VIA)  where  the
substance  or  substances  do  not  appear  in  Annex  I  to  Directive  67/548/EEC  or  appear  in  it
without  concentration  limits;

9.4.

those  of  category  3  which  are  assigned  the  symbol  Xn  and  the  phrase  R63  (development).

Preparations  containing  at  least  one  substance  producing  such  effects,  classified  as  toxic  for
reproduction and to which  is assigned phrase R63 which denotes substances toxic for reproduction
of  category  3,  in  individual  concentrations  equal  to  or  greater  than:

(a) either  the  concentration  specified  in  Annex  I  to  Directive  67/548/EEC  for  the  substance  or

substances  under  consideration;  or

(b)

the  concentration  specified  at  point  6  in  Part  B  of  this  Annex  (Tables  VI  and  VIA)  where  the
substance  or  substances  do  not  appear  in  Annex  I  to  Directive  67/548/EEC  or  appear  in  it
without  concentration  limits.

23.11.98

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C 360/25

PART  B

Concentration  limits  to  be  used  in  evaluation  of  health  hazards

For  each  health  effect,  the  first  table  (Tables  I  to  VI)  sets  out  the  concentration  limits  (expressed  as  a
weight/weight percentage) to be used for non-gaseous preparations and the second table (Tables IA to VIA)
sets  out  the  concentration  limits  (expressed  as  a  volume/volume  percentage)  to  be  used  for  gaseous
preparations.  These  concentration  limits  are  used  in  the  absence  of  specific  concentration  limits  for  the
substance  under  considerateion  in  Annex  I  to  Directive  67/548/EEC.

1.

Acute  lethal  effects:

1.1. N o n - g a s e o u s   p r e p a r a t i o n s :

The  concentration  limits  fixed  in  Table  I,  expressed  as  a  weight/weight  percentage,  determine  the
classification of the preparation in relation to the individual concentration of the substance(s) present
whose  classification  is  also  shown.

Table  I

Classification  of  the
substance

Classification  of  the  preparation

T+

T

Xn

T+  with  R26,  R27,
R28

Concentration  $ 7 %

1 %  #  concentration
, 7 %

0,1 %  #
concentration  , 1 %

T  with  R23,  R24,
R25

Xn  with  R20,  R21,
R22

Concentration  $ 25 % 3 %  #  concentration

, 25 %

Concentration  $ 25 %

The  R  phrases  denoting  risk  are  to  be  assigned  to  the  preparation  in  accordance  with  the  following
criteria:

— the label shall include one or more of the abovementioned R phrases according to the classification

used,

— in  general,  the  R  phrases  selected  should  be  those  applicable  to  the  substance(s)  present  in  the

concentration  which  gives  rise  to  the  most  severe  classification.

1.2. G a s e o u s   p r e p a r a t i o n s :

The  concentration  limits  expressed  as  a  volume/volume  percentage  in  Table  IA  determine  the
classification  of  the  gaseous  preparations  in  relation  to  the  individual  concentration  of  the  gas(es)
present  whose  classification  is  also  shown

Table  IA

Classification  of  the  gaseous  preparation

T+

T

Xn

Concentration  $ 1 %

0,2 %  #
concentration  , 1 %

0,02 %  #
concentration  , 0,2 %

Concentration  $ 5 %

0,5 %  #
concentration  , 5 %

Concentration  $ 5 %

Classification  of  the
substance
(gas)

T+  with  R26,  R27,
R28

T  with  R23,  R24,
R25

Xn  with  R20,  R21,
R22

C 360/26

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The  R  phrases  denoting  risk  shall  be  assigned  to  the  preparation  in  accordance  with  the  following
criteria:

— the label shall include one or more of the abovementioned R phrases according to the classification

used,

— in  general,  the  R  phrases  selected  should  be  those  applicable  to  the  substance(s)  present  in  the

concentration  which  gives  rise  to  the  most  severe  classification.

2. Non-lethal  irreversible  effects  after  a  single  exposure:

2.1. N o n - g a s e o u s   p r e p a r a t i o n s :

For  substances  that  produce  non-lethal  irreversible  effects  after  a  single  exposure  (R39/route  of
exposure,  R40/route  of  exposure),  the  individual  concentration  limits  specified  in  Table  II,  expressed
as  a  weight/weight  percentage,  determine,  when  appropriate,  the  classification  of  the  preparation

Table  II

Classification  of  the
substance

Classification  of  the  preparation

T+

T

Xn

T+  with  R39/route  of
exposure

Concentration  $ 10 %
R39 (*)  obligatory

1 %  #  concentration
, 10 %
R39 (*)  obligatory

0,1 %  #
concentration  , 1 %
R40 (*)  obligatory

T  with  R39/route  of
exposure

Xn  with  R40/route  of
exposure

Concentration  $ 10 %
R39 (*)  obligatory

1 %  #  Concentration
, 10 %
R40 (*)  obligatory

Concentration  $ 10 %
R40 (*)  obligatory

(*) In  order  to  indicate  the  route  of  administration/exposure  (route  of  exposure)  the  combined  R  phrases  listed
under  points  3.2.1,  3.2.2  and  3.2.3  of  the  labelling  guide  (Annex  VI  to  Directive  67/548/EEC)  are  to  be  used.

2.2. G a s e o u s   p r e p a r a t i o n s :

For  gases  that  produce  non-lethal  irreversible  effects  after  a  single  exposure  (R39/route  of  exposure,
R40/route  of  exposure),  the  individual  concentration  limits  specified  in  Table  IIA,  expressed  as  a
volume/volume  percentage,  determine,  when  appropriate,  the  classification  of  the  preparation.

Table  IIA

Classification  of  the
substance  (gas)

Classification  of  the  gaseous  preparation

T+

T

Xn

T+  with  R39/route  of
exposure

Concentration  $ 1 %
R39 (*)  obligatory

0,2 %  #
concentration  , 1 %
R39 (*)  obligatory

0,02 %  #
concentration  , 0,2 %
R40 (*)  obligatory

T  with  R39/route  of
exposure

Xn  with  R40/route  of
exposure

Concentration  $ 5 %
R39 (*)  obligatory

0,5 %  #
concentration  , 5 %
R40 (*)  obligatory

Concentration  $ 5 %
R40 (*)  obligatory

(*) In  order  to  indicate  the  route  of  administration/exposure  (route  of  exposure)  the  combined  R  phrases  listed
under  points  3.2.1,  3.2.2  and  3.2.3  of  the  labelling  guide  (Annex  VI  to  Directive  67/548/EEC)  are  to  be  used.

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3.

Severe  effects  after  repeated  or  prolonged  exposure:

3.1. N o n - g a s e o u s   p r e p a r a t i o n s :

For  substances  that  produce  severe  effects  after  repeated  or  prolonged  exposure  (R48/route  of
exposure),  the  individual  concentration  limits  specified  in  Table  III,  expressed  as  a  weight/weight
percentage,  determine,  when  appropriate,  the  classification  of  the  preparation.

Table  III

Classification  of  the  substance

Classification  of  the  preparation

T

Xn

T  with  R48/route  of  exposure

Concentration  $ 10 %
R48 (*)  obligatory

1 %  #  concentration  , 10 %
R48 (*)  obligatory

Xn  with  R48/route  of  exposure

Concentration  $ 10 %
R48 (*)  obligatory

(*) In  order  to  indicate  the  route  of  administration/exposure  (route  of  exposure)  the  combined  R  phrases  listed
under  points  3.2.1,  3.2.2  and  3.2.3  of  the  labelling  guide  (Annex  VI  to  Directive  67/548/EEC)  are  to  be  used.

3.2. G a s e o u s   p r e p a r a t i o n s :

For  gases  that  produce  severe  effects  after  repeated  or  prolonged  exposure  (R48/route  of  exposure),
the  individual  concentration  limits  specified  in  Table  IIIA,  expressed  as  a  volume/volume  percentage,
determine,  when  appropriate,  the  classification  of  the  preparation.

Classification  of  the  substance
(gas)

T  with  R48/route  of  exposure

Xn  with  R48/route  of  exposure

Table  IIIA

Classification  of  the  gaseous  preparation

T

Xn

Concentration  $ 5 %
R48 (*)  obligatory

0,5 %  #  concentration  , 5 %
R48 (*)  obligatory

Concentration  $ 5 %
R48 (*)  obligatory

(*) In  order  to  indicate  the  route  of  administration/exposure  (route  of  exposure)  the  combined  R  phrases  listed
under  points  3.2.1,  3.2.2  and  3.2.3  of  the  labelling  guide  (Annex  VI  to  Directive  67/548/EEC)  are  to  be  used.

4.

Corrosive  and  irritant  effects  including  serious  damage  to  the  eye:

4.1. N o n - g a s e o u s   p r e p a r a t i o n s :

For substances that produce corrosive effects (R34, R35) or irritant effects (R36, R37, R38, R41), the
individual  concentration  limits  specified  in  Table  IV,  expressed  as  a  weight/weight  percentage,
determine,  when  appropriate,  the  classification  of  the  preparation.

Table  IV

Classification  of  the  preparation

Classification  of  the
substance

C  with  R35

C  with  R35

C  with  R34

Xi  with  R41

Concentration
$ 10 %
R35  obligatory

5 %  #
concentration
, 10 %
R34  obligatory

5 % (*)

Xi  with  R36,  R37,
R38

1 %  #
concentration
, 5 %
R36/38
obligatory

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23.11.98

Classification  of  the  preparation

C  with  R35

C  with  R34

Xi  with  R41

Concentration
$ 10 %
R34  obligatory

10 % (*)

Concentration
$ 10 %
R41  obligatory

Classification
of  the  substance

C  with  R34

Xi  with  R41

Xi  with  R36,
R37,  R38

Xi  with  R36,  R37,
R38

5 %  #
concentration
, 10 %
R36/38
obligatory

5 %  #
concentration
, 10 %
R36  obligatory

Concentration
$ 20 %
R36,  R37,  R38
are  obligatory  in
the  light  of  the
concentration
present  if  they
apply  to  the
substances  under
consideration

(*) According to the labelling guide (Annex VI to Directive 67/548/EEC), corrosive substances assigned risk phrases
R35  or  R34  must  also  be  considered  as  being  assigned  phrase  R41.  Consequently,  if  the  preparation  contains
corrosive  substances  with  R35  or  R34  below  the  concentration  limits  for  a  classification  of  the  preparation  as
corrosive,  such  substances  can  contribute  to  a  classification  of  the  preparation  as  irritant  with  R41  or  irritant
with  R36.

4.2. G a s e o u s   p r e p a r a t i o n s :

For  gases  that  produce  such  effects  (R34,  R35  or  R36,  R37,  R38,  R41),  the  individual  concentration
limits specified in Table IVA, expressed as a volume/volume percentage determine, when appropriate,
the  classification  of  the  preparation.

Classification  of  the
substance
(gas)

C  with  R35

C  with  R34

Xi  with  R41

Xi  with  R36,
R37,  R38

Table  IVA

Classification  of  the  gaseous  preparation

C  with  R35

C  with  R34

Xi  with  R41

Xi  with  R36,  R37,
R38

Concentration
$ 1 %
R35  obligatory

0,2 %  #
concentration
, 1 %
R34  obligatory

Concentration
$ 5 %
R34  obligatory

0,2 % (*)

5 % (*)

Concentration
$ 5 %
R41  obligatory

0,02 %  #
concentration
, 0,2 %
R36/37/38
obligatory

0,5 %  #
concentration
, 5 %
R36/37/38
obligatory

0,5 %  #
concentration
, 5 %
R36  obligatory

Concentration
$ 5 %
R36,  R37,  R38
obligatory as
appropriate

(*) According to the labelling guide (Annex VI to Directive 67/548/EEC), corrosive substances assigned risk phrases
R35  or  R34  must  also  be  considered  as  being  assigned  phrase  R41.  Consequently,  if  the  preparation  contains
corrosive  substances  with  R35  or  R34  below  the  concentration  limits  for  a  classification  of  the  preparation  as
corrosive,  such  substances  can  contribute  to  a  classification  of  the  preparation  as  irritant  with  R41  or  irritant
with  R36.

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5.

Sensitising  effects:

5.1. N o n - g a s e o u s   p r e p a r a t i o n s :

Preparations  that  produce  such  effects  are  classified  as  sensitising  and  assigned:

— the  symbol  Xn  and  phrase  R42  if  this  effect  can  be  produced  by  inhalation,

— the  symbol  Xi  and  phrase  R43  if  this  effect  can  be  produced  through  contact  with  the  skin.

The  individual  concentration  limits  specified  in  Table  V,  expressed  as  a  weight/weight  percentage,
determine,  when  appropriate,  the  classification  of  the  preparation.

Table  V

Classification  of  the  substance

Classification  of  the  preparation

sensitising  with  R42

sensitising  with  R43

sensitising  with  R42

sensitising  with  R43

Concentration  $ 1 %
R42  obligatory

Concentration  $ 1 %
R43  obligatory

5.2. G a s e o u s   p r e p a r a t i o n s :

Gaseous  preparations  that  produce  such  effects  are  classified  as  sensitising  and  assigned:

— the  symbol  Xn  and  phrase  R42  if  this  effect  can  be  produced  by  inhalation,

— the  symbol  Xi  and  phrase  R43  if  this  effect  can  be  produced  through  contact  with  the  skin.

The  individual  concentration  limits  specified  in  Table  VA,  expressed  as  a  volume/volume  percentage,
determine,  when  appropriate,  the  classification  of  the  preparation.

Table  VA

Classification  of  the  substance
(gas)

Classification  of  the  gaseous  preparation

sensitising  with  R42

sensitising  with  R43

sensitising  with  R42

sensitising  with  R43

Concentration  $ 0,2 %
R42  obligatory

Concentration  $ 0,2 %
R43  obligatory

6.

Carcinogenic/mutagenic/toxic  effects  for  reproduction:

6.1. N o n - g a s e o u s   p r e p a r a t i o n s :

For  substances  which  produce  such  effects,  the  concentration  limits  laid  down  in  Table  VI,  expressed
as  a  weight/weight  percentage,  shall  determine,  where  appropriate,  the  classification  of  the
preparation.  The  following  symbol  and  risk  phrases  are  assigned:

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Carcinogenic  categories  1  and  2:

Carcinogenic  category  3:

Mutagenic  categories  1  and  2:

Mutagenic  category  3:

Toxic  for  reproduction  fertility  categories  1  and  2:

Toxic  for  reproduction  development  categories  1  and  2:

Toxic  for  reproduction  fertility  category  3:

Toxic  for  reproduction  development  category  3:

T;  R45  or  R49

Xn;  R40

T;  R46

Xn;  R40

T;  R60

T;  R61

Xn;  R62

Xn;  R63

Table  VI

Classification  of  the  preparation

Categories  1  and  2

Category  3

Classification  of  the  substance

Carcinogenic  substances  of
category  1  or  2  with  R45  or
R49

Carcinogenic  substances  of
category  3  with  R40

Mutagenic  substances  of
category  1  or  2  with  R46

Mutagenic  substances  of
category  3  with  R40

Concentration  $ 0,1 %
carcinogenic
R45,  R49  obligatory  as
appropriate

Concentration  $ 0,1 %
Mutagenic
R46  obligatory

Substances  ‘toxic  for
reproduction’  of  category  1  or
2  with  R60  (fertility)

Concentration  $ 0,5 %
Toxic  for  reproduction
(fertility)
R60  obligatory

Substances  ‘toxic  for
reproduction’  of  category  3
with  R62  (fertility)

Substances  ‘toxic  for
reproduction’  of  category  1  or
2  with  R61  (development)

Concentration  $ 0,5 %
Toxic  for  reproduction
(development)
R61  obligatory

Substances  ‘toxic  for
reproduction’  of  category  3
with  R63  (development)

6.2. G a s e o u s   p r e p a r a t i o n s :

Concentration  $ 1 %
Carcinogenic
R40  obligatory

Concentration  $ 1 %
Mutagenic
R40  obligatory

Concentration  $ 5 %
Toxic  for  reproduction
(fertility)
R62  obligatory

Concentration  $ 5 %
Toxic  for  reproduction
(development)
R63  obligatory

For gases which produce such effects, the concentration limits laid down in Table VIA, expressed as a
volume/volume  percentage,  shall  determine,  where  appropriate,  the  classification  of  the  preparation.
The  following  symbol  and  risk  phrases  are  assigned:

Carcinogenic  categories  1  and  2:

Carcinogenic  category  3:

T;  R45  or  R49

Xn;  R40

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Mutagenic  categories  1  and  2:

Mutagenic  category  3:

Toxic  for  reproduction  fertility  categories  1  and  2:

Toxic  for  reproduction  development  categories  1  and  2:

Toxic  for  reproduction  fertility  category  3:

Toxic  for  reproduction  development  category  3:

T;  R46

Xn;  R40

T;  R60

T;  R61

Xn;  R62

Xn;  R63

Table  VIA

Classification  of  the  gaseous  preparation

Categories  1  and  2

Category  3

Classification  of  the  substance
(gas)

Carcinogenic  substances  of
category  1  or  2  with  R45  or
R49

Carcinogenic  substances  of
category  3  with  R40

Mutagenic  substances  of
category  1  or  2  with  R46

Mutagenic  substances  of
category  3  with  R40

Concentration  $ 0,1 %
Carcinogenic
R45,  R49  obligatory  as
appropriate

Concentration  $ 0,1 %
Mutagenic
R46  obligatory

Substances  ‘toxic  for
reproduction’  of  category  1  or
2  with  R60  (fertility)

Concentration  $ 0,2 %
toxic  for  reproduction
(fertility)
R60  obligatory

Substances  ‘toxic  for
reproduction’  of  category  3
with  R62  (fertility)

Substances  ‘toxic  for
reproduction’  of  category  1  or
2  with  R61  (development)

Concentration  $ 0,2 %
toxic  for  reproduction
(development)
R61  obligatory

Substances  ‘toxic  for
reproduction’  of  category  3
with  R63  (development)

Concentration  $ 1 %
Carcinogenic
R40  obligatory

Concentration  $ 1 %
Mutagenic
R40  obligatory

Concentration  $ 1 %
toxic  for  reproduction
(fertility)
R62  obligatory

Concentration  $ 1 %
toxic  for  reproduction
(development)
R63  obligatory

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ANNEX  III

METHODS  FOR  THE  EVALUATION  OF  THE  ENVIRONMENTAL  HAZARDS  OF  PREPARATIONS
IN  ACCORDANCE  WITH  ARTICLE  7

Introduction

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

Part A gives the calculation procedure according to Article 7(1)(a) and gives the R phrases to be assigned to
the  classification  of  the  preparation.

Part  B  gives  the  concentration  limits  to  be  used  when  applying  the  conventional  method  and  relevant
symbols  and  R  phrases  for  classification.

In  accordance  with  Article  7(1)(a)  the  environmental  hazards  of  a  preparation  shall  be  assessed  by  the
conventional  method  described  in  Parts  A  and  B  of  this  Annex,  using  individual  concentration  limits:

(a) where  the  dangerous  substances  listed  in  Annex  I  to  Directive  67/548/EEC  are  assigned  concentration
limits necessary for the application of the method of assessment described in Part A of this Annex, these
concentration  limits  must  be  used;

(b) where  the  dangerous  substances  do  not  appear  in  Annex  I  to  Directive  67/548/EEC  or  appear  there
without the concentration limits necessary for the application of the method of evaluation described in
Part A of this Annex, the concentration limits shall be assigned in accordance with the specification in
Part  B  of  this  Annex.

Part  C  gives  the  test  methods  for  the  evaluation  of  the  hazards  for  the  aquatic  environment.

PART  A

Procedure  for  the  evaluation  of  environmental  hazards

(a) Aquatic  environment

I. C o n v e n t i o n a l   m e t h o d  

f o r  

t h e  

e v a l u a t i o n   o f   h a z a r d s  

t o  

t h e   a q u a t i c

e n v i r o n m e n t :

The  conventional  method  for  the  evaluation  of  hazards  to  the  aquatic  environment  takes  into
account  all  the  hazards  that  a  substance  may  entail  for  this  medium  according  to  the  following
specifications.

The  following  preparations  are  to  be  classified  as  dangerous  for  the  environment:

1.

and  assigned  the symbol N, the indication of danger ‘dangerous for the environment’ and the
risk  phrases  R50  and  R53  (R50—53):

1.1. preparations containing one or more substances classified as dangerous to the environment and

to  which  is  assigned  phrases  R50—53  in  individual  concentrations  equal  to  or  greater  than:

(a) either the concentration specified in Annex I to Directive 67/548/EEC for the substance or

substances  under  consideration;  or

(b)

the  concentration  specified  in  Part  B  of  this  Annex  (Table  1)  where  the  substance  or
substances  do  not  appear  in  Annex  I  to  Directive  67/548/EEC  or  appear  in  it  without
concentration  limits;

1.2. preparations  containing  more  than  one  substance  classified  as  dangerous  for  the  environment
and  to  which  is  assigned  phrases  R50—53  in  lower  individual  concentrations  than  the  limits
specified  under  point  1.1(a)  or  (b)  if:

LN,  R50—53) $ 1
(PN,  R50—53

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where:

PN,  R50—53 = the  percentage  by  weight  of  each  substance  dangerous  for  the  environment  to

which  is  assigned  phrases  R50—53  in  the  preparation

LN,  R50—53 = the limit R50—53 for each substance dangerous for the environment to which is
assigned  the  phrases  R50—53,  expressed  as  percentage  by  weight;

2.

and assigned the symbol N, the indication of danger ‘dangerous for the environment’ and the
risk  phrases  R51  and  R53  (R51—53)  unless  the  preparation  is  already  classified  according  to
point  1;

2.1. preparations  containing  one  or  more  than  one  substance  classified  as  dangerous  to  the
individual

is  assigned  phrases  R50—53  or  R51—53 

in 

environment  and  to  which 
concentrations  equal  to  or  greater  than:

(a) either the concentration specified in Annex I to Directive 67/548/EEC for the substance or

substances  under  consideration;  or

(b)

the  concentration  specified  in  Part  B  of  this  Annex  (Table  1)  where  the  substance  or
substances  do  not  appear  in  Annex  I  to  Directive  67/548/EEC  or  appear  in  it  without
concentration  limits;

2.2. preparations  containing  more  than  one  of  the  substances  classified  as  dangerous  for  the
environment  and  to  which  is  assigned  phrases  R50—53  or  R51—53  in  lower  individual
concentrations  than  the  limits  specified  under  point  2.1(a)  or  (b)  if:

(PN,  R50—53

LN,  R51—53

+

PN,  R51—53

LN,  R51—53) $ 1

where:

PN,  R50—53 = the  percentage  by  weight  of  each  substance  dangerous  to  the  environment  to

which  is  assigned  phrases  R50—53  in  the  preparation

PN,  R51—53 = the  percentage  by  weight  of  each  substance  dangerous  for  the  environment  to

which  is  assigned  phrases  R51—53  in  the  preparation

LN,  R51—53 = the respective limit R51—53 for each substance dangerous for the environment to
which  is  assigned  phrases  R50—53  or  R51—53,  expressed  as  percentage  by
weight;

3.

and  assigned  the  risk  phrases  R52  and  R53  (R52—53)  unless  the  preparation  is  already
classified  according  to  point  1  or  2.

3.1. preparations containing one or more than one of the substances classified as dangerous for the
environment and to which is assigned phrases R50—53 or R51—53 or R52—53 in individual
concentrations  equal  to  or  greater  than:

(a) either the concentration specified in Annex I to Directive 67/548/EEC for the substance or

substances  under  consideration;  or

(b)

the  concentration  specified  in  Part  B  of  this  Annex  (Table  1)  where  the  substance  or
substances  do  not  appear  in  Annex  I  to  Directive  67/548/EEC  or  appear  in  it  without
concentration  limits;

3.2. preparations  containing  more  than  one  substance  classified  as  dangerous  for  the  environment
and  to  which  is  assigned  phrases  R51—53  or  R50—53  or  R52—53  in  lower  individual
concentrations  than  the  limits  specified  under  point  3.1(a)  or  (b)  if:

(PN,  R50—53

LR52—53

+

PN,  R51—53
LR52—53

+

PR52—53

LR52—53) $ 1

where:

PN,  R50—53 = the  percentage  by  weight  of  each  substance  dangerous  for  the  environment  to

which  is  assigned  phrases  R50—53  in  the  preparation

PN,  R51—53 = the  percentage  by  weight  of  each  substance  dangerous  for  the  environment  to

which  is  assigned  phrases  R51—53  in  the  preparation

PR52—53

= the  percentage  by  weight  of  each  substance  dangerous  for  the  environment  to

which  is  assigned  phrases  R52—53  in  the  preparation

LR52—53

= the respective limit R52—53 for each substance dangerous for the environment to
which  is  assigned  phrases  R50—53  or  R51—53  or  R52—53,  expressed  as
percentage  by  weight;

4.

and assigned the symbol N, the indication of danger ‘dangerous for the environment’ and the
risk  phrase  R50  unless  the  preparation  is  already  classified  according  to  point  1.

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4.1. preparations  containing  one  or  more  than  one  substance  classified  as  dangerous  to  the
environment  and  to  which  is  assigned  phrase  R50  in  individual  concentrations  equal  to  or
greater  than:

(a) either the concentration specified in Annex I to Directive 67/548/EEC for the substance or

substances  under  consideration;  or

(b)

the  concentration  specified  in  Part  B  of  this  Annex  (Table  2)  where  the  substance  or
substances  do  not  appear  in  Annex  I  to  Directive  67/548/EEC  or  appear  in  it  without
concentration  limits;

4.2. preparations  containing  more  than  one  substance  classified  as  dangerous  for  the  environment
and  to  which  is  assigned  phrase  R50  in  lower  individual  concentrations  than  the  limits
specified  under  point  4.1(a)  or  (b)  if:

LN,  R50) $ 1
(PN,  R50

where:

PN, R50 = the percentage by weight of each substance dangerous for the environment to which

is  assigned  phrases  R50  in  the  preparation

LN,  R50 = the limit R50 for each substance dangerous for the environment to which is assigned

phrases  R50,  expressed  as  percentage  by  weight;

4.3. preparations containing one or more than one of the substances classified as dangerous for the
environment  and  to  which  is  assigned  phrase  R50  not  meeting  the  criteria  under  point  4.1  or
4.2  and  containing  one  or  more  than  one  substance  classified  as  dangerous  for  the
environment  and  to  which  is  assigned  phrases  R50—53  if:

(PN,  R50

LN,  R50

+

PN,  R50—53

LN,  R50 ) $ 1

where:

PN,  R50

= the  percentage  by  weight  of  each  substance  dangerous  for  the  environment  to

which  is  assigned  phrases  R50  in  the  preparation

PN,  R50—53 = the  percentage  by  weight  of  each  substance  dangerous  for  the  environment  to

which  is  assigned  phrases  R50—53  in  the  preparation

LN,  R50

= the  respective  limit  R50  for  each  substance  dangerous  for  the  environment  to
which  is  assigned  phrases  R50  or  R50—53,  expressed  as  percentage  by  weight

5.

and  assigned  the  risk  phrase  R52  unless  the  preparation  is  already  classified  according  to
point  1,  2,  3  or  4:

5.1. preparations  containing  one  or  more  than  one  substance  classified  as  dangerous  to  the
environment  and  to  which  is  assigned  phrase  R52  in  individual  concentrations  equal  to  or
greater  than:

(a) either the concentration specified in Annex I to Directive 67/548/EEC for the substance or

substances  under  consideration;  or

(b)

the  concentration  specified  in  Part  B  of  this  Annex  (Table  3)  where  the  substance  or
substances  do  not  appear  in  Annex  I  to  Directive  67/548/EEC  or  appear  in  it  without
concentration  limits;

5.2. preparations  containing  more  than  one  substance  classified  as  dangerous  for  the  environment
and  to  which  is  assigned  phrase  R52  in  lower  individual  concentrations  than  the  limits
specified  under  point  5.1(a)  or  (b)  if:

LR52) $ 1
(PR52

where:

PR52 = the percentage by weight of each substance dangerous for the environment to which is

assigned  phrase  R52  in  the  preparation

LR52 = the  limit  R52  for  each  substance  dangerous  for  the  environment  to  which  is  assigned

phrase  R52,  expressed  as  percentage  by  weight

6.

and  assigned  the  risk  phrase  R53  unless  the  preparation  is  already  classified  according  to
point  1,  2  or  3:

6.1. preparations  containing  one  or  more  than  one  substance  classified  as  dangerous  to  the
environment  and  to  which  is  assigned  phrase  R53  in  individual  concentrations  equal  to  or
greater  than:

(a) either the concentration specified in Annex I to Directive 67/548/EEC for the substance or

substances  under  consideration;  or

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(b)

the  concentration  specified  in  Part  B  of  this  Annex  (Table  4)  where  the  substance  or
substances  do  not  appear  in  Annex  I  to  Directive  67/548/EEC  or  appear  in  it  without
concentration  limits;

6.2. preparations  containing  more  than  one  substance  classified  as  dangerous  for  the  environment
and  to  which  is  assigned  phrase  R53  in  lower  individual  concentrations  than  the  limits
specified  under  point  6.1(a)  or  (b)  if:

LR53) $ 1
(PR53

where:

PR53 = the percentage by weight of each substance dangerous for the environment to which is

assigned  phrase  R53  in  the  preparation 

LR53 = the  limit  R53  for  each  substance  dangerous  for  the  environment  to  which  is  assigned

phrase  R53,  expressed  as  percentage  by  weight;

6.3. preparations containing one or more than one of the substances classified as dangerous for the
environment and to which is assigned phrase R53 not meeting the criteria under point 6.2 and
containing one or more than one substance classified as dangerous for the environment and to
which  is  assigned  phrases  R50—53  or  R51—53  or  R52—53  if:

(PR53

LR53

+

PN,  R50—53
LR53

+

PN,  R51—53
LR53

+

PR52—53

LR53 ) $ 1

where:

PR53

= the  percentage  by  weight  of  each  substance  dangerous  for  the  environment  to

which  is  assigned  phrase  R53  in  the  preparation

PN,  R50—53 = the  percentage  by  weight  of  each  substance  dangerous  for  the  environment  to

which  is  assigned  phrase  R50—53  in  the  preparation

PN,  R51—53 = the  percentage  by  weight  of  each  substance  dangerous  for  the  environment  to

which  is  assigned  phrase  R51—53  in  the  preparation

PR52—53

= the  percentage  by  weight  of  each  substance  dangerous  for  the  environment  to

which  is  assigned  phrase  R52—53  in  the  preparation

LR53

= the  respective  limit  R53  for  each  substance  dangerous  for  the  environment  to
which is assigned phrase R53 or R50—53 or R51—53 or R52—53, expressed as
percentage  by  weight;

(b) Non-aquatic  environment

1. OZONE  LAYER

I. C o n v e n t i o n a l   m e t h o d   f o r   t h e   e v a l u a t i o n   o f   p r e p a r a t i o n s   d a n g e r o u s   f o r   t h e

o z o n e   l a y e r :

The  following  preparations  are  to  be  classified  as  dangerous  for  the  environment:

1.

and  assigned  the  symbol  N,  the  indication  of  danger  ‘dangerous  for  the  environment’  and
the  risk  phrase  R59:

1.1. preparations containing one or more substances classified as dangerous to the environment
and  to  which  is  assigned  the  symbol  N  and  the  risk  phrase  R59  in  individual
concentrations  equal  to  or  greater  than:

(a) either  the  concentration  specified  in  Annex  I  to  Directive  67/548/EEC  for  the

substance  or  substances  under  consideration;  or

(b)

the  concentration  specified  in  Part  B  of  this  Annex  (Table  5)  where  the  substance  or
substances do not appear in Annex I to Directive 67/548/EEC or appear in it without
concentration  limits

2.

and  assigned  the  risk  phrase  R59:

2.1. preparations containing one or more substances classified as dangerous to the environment
and  to  which  is  assigned  R59  in  individual  concentrations  equal  to  or  greater  than:

(a) either  the  concentration  specified  in  Annex  I  to  Directive  67/548/EEC  for  the

substance  or  substances  under  consideration;  or

(b)

the  concentration  specified  in  Part  B  of  this  Annex  (Table  5)  where  the  substance  or
substances do not appear in Annex I to Directive 67/548/EEC or appear in it without
concentration  limits

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2. TERRESTRIAL  ENVIRONMENT

I. E v a l u a t i o n   o f   p r e p a r a t i o n s   d a n g e r o u s   f o r   t h e   t e r r e s t r i a l   e n v i r o n m e n t

Classification  of  preparations  using  the  risk  phrases  below  will  follow  after  the  detailed  criteria
for  use  of  the  phrases  have  been  incorporated  in  Annex  VI  to  Directive  67/548/EEC.

R54 Toxic  to  flora

R55 Toxic  to  fauna

R56 Toxic  to  soil  organisms

R57 Toxic  to  bees

R58 May  cause  long-term  adverse  effects  in  the  environment.

PART  B

Concentration  limits  to  be  used  for  the  evaluation  of  environmental  hazards

I. For  the  aquatic  environment

The  concentration  limits  fixed  in  the  following  tables,  expressed  as  a  weight/weight  percentage,
determine  the  classification  of  the  preparation  in  relation  to  the  individual  concentration  of  the
substance(s)  present  whose  classification  is  also  shown.

Table  1

Acute  aquatic  toxicity  and  long-term  adverse  effects

Classification  of  the
substance

Classification  of  the  preparation

N,  R50—53

N,  R51—53

R52—53

N,  R50—53

Concentration  $ 25 %

N,  R51—53

R52—53

2,5 %  #
Concentration  , 25 %

0,25 %  #
Concentration
, 2,5 %

Concentration  $ 25 %

2,5 %  #
Concentration  , 25 %

Concentration  $ 25 %

Table  2

Acute  aquatic  toxicity

Classification  of  the  substance

N,  R50

N,  R50—53

Classification  of  the  preparation
N,  R50

Concentration  $ 25 %

Concentration  $ 25 %

Table  3

Aquatic  toxicity

Classification  of  the  substance

R52

Classification  of  the  preparation
R52

Concentration  $ 25 %

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Table  4

Long-term  adverse  effects

Classification  of  the  substance

Classification  of  the  preparation
R53

R53

N,  R50—53

N,  R51—53

R52—53

Concentration  $ 25 %

Concentration  $ 25 %

Concentration  $ 25 %

Concentration  $ 25 %

II. For  the  non-aquatic  environment

The  concentration  limits  fixed  in  the  following  tables,  expressed  as  weight/weight  percentage  or,  for
gaseous  preparations  as  a  volume/volume  percentage,  determine  the  classification  of  the  preparation  in
relation  to  the  individual  concentration  of  the  substance(s)  present  whose  classification  is  also  shown:

Table  5

Dangerous  for  the  ozone  layer

Classification  of  the  substance

N  with  R59

Classification  of  the  substance

R59

Classification  of  the  preparation
N,  R59

Concentration  $ 0,1 %

Classification  of  the  preparation
R59

Concentration  $ 0,1 %

PART  C

Test  methods  for  the  evaluation  of  the  hazards  for  the  aquatic  environment

Normally, the classification of a preparation is made on the basis of the conventional method. However, for
the  determination  of  the  acute  aquatic  toxicity,  there  may  be  cases  for  which  it  is  appropriate  to  carry  out
tests  on  the  preparation.

The  results  of  these  tests  on  the  preparation  may  only  modify  the  classification  concerning  acute  aquatic
toxicity  which  would  have  been  obtained  by  the  application  of  the  conventional  method.

If such tests are chosen by the person responsible for the placing on the market, it must be ensured that the
quality  criteria  of  the  test  methods  in  Part  C  of  Annex  V  to  Directive  67/548/EEC  have  been  complied
with.

Furthermore, the tests are to be carried out on the three species in conformity with the criteria of Annex VI
to Directive 67/548/EEC (algae, daphnia and fish), unless the highest hazard classification relating to acute
aquatic  toxicity  has  been  assigned  to  the  preparation  after  testing  on  one  of  the  species.

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ANNEX  IV

SPECIAL  PROVISIONS  FOR  CONTAINERS  CONTAINING  PREPARATIONS  OFFERED  OR  SOLD
TO  THE  GENERAL  PUBLIC

PART  A

Containers  to  be  fitted  with  child-resistant  fastenings

1. Containers  of  whatever  capacity,  containing  preparations  offered  or  sold  to  the  general  public  and
labelled  as  very  toxic,  toxic  or  corrosive  in  accordance  with  Article  10  and  under  the  conditions  laid
down  in  Article  6  of  this  Directive,  are  to  be  fitted  with  child-resistant  fastenings.

2. Containers of whatever capacity containing preparations presenting an aspiration hazard (Xn, R65) and
classified and labelled according to point 3.2.3 of Annex VI to Directive 67/548/EEC with the exception
of preparations placed on the market in the form of aerosols or in a container fitted with a sealed spray
attachment.

3. Containers  of  whatever  capacity,  having  at  least  one  of  the  substances  mentioned  below  present  in  a

concentration  equal  to  or  greater  than  the  maximum  individual  concentration  specified:

Number

Concentration  limit

CAS  Reg  Number

Name

Einecs  Number

Identification  of  the  substance

1

2

67-56-1

75-09-2

Methanol

2006596

Dichloromethane

2008389

$  3 %

$  1 %

which  are  offered  or  sold  to  the  general  public  are  to  be  fitted  with  child-resistant  fastenings.

PART  B

Containers  to  be  fitted  with  a  tactile  warning  of  danger

Containers of whatever capacity, containing preparations offered or sold to the general public and labelled
as  very  toxic,  toxic,  corrosive,  harmful,  extremely  flammable  or  highly  flammable  in  accordance  with
Article  10  and  under  the  conditions  laid  down  in  Articles  5  and  6  of  this  Directive,  are  to  carry  a  tactile
warning  of  danger.

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

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ANNEX  V

SPECIAL  PROVISIONS  CONCERNING  THE  LABELLING  OF  CERTAIN  PREPARATIONS

A. For  preparations  classified  as  dangerous  within  the  meaning  of  Articles  5,  6  and  7

1.

Preparations  sold  to  the  general  public:

1.1. The labels on packages containing such preparations, in addition to the specific safety advice, must
bear  the  relevant  safety  advice  S1,  S2,  S45  or  S46  in  accordance  with  the  criteria  laid  down  in
Annex  VI  to  Directive  67/548/EEC.

1.2. When such preparations are classified as very toxic (T+), toxic (T) or corrosive (C) and where it is
physically  impossible  to  give  such  information  on  the  package  itself,  packages  containing  such
preparations  must  be  accompanied  by  precise  and  easily  understandable  instructions  for  use
including,  where  appropriate,  instructions  for  the  destruction  of  the  empty  package.

2.

Preparations  intended  for  use  by  spraying:

The  package  label  containing  such  preparations  must  compulsorily  bear  the  safety  advice  S23
accompanied by safety advice S38 or S51 assigned to it in accordance with the criteria laid down
in  Annex  VI  to  Directive  67/548/EEC.

3.

Preparations  containing  a  substance  assigned  phrase  R33:  Danger  of  cumulative  effects

When  a  preparation  contains  at  least  one  substance  assigned  the  phrase  R33,  the  label  of  the
preparation  must  carry  the  wording  of  this  phrase  as  set  out  in  Annex  III  to  Directive
67/548/EEC,  when  the  concentration  of  this  substance  present  in  the  preparation  is  equal  to  or
higher  than  1 %,  unless  different  values  are  set  in  Annex  I  to  Directive  67/548/EEC.

4.

Preparations  containing  a  substance  assigned  phrase  R64:  May  cause  harm  to  breastfed  babies

When  a  preparation  contains  at  least  one  substance  assigned  phrase  R64,  the  label  of  the
preparation  must  carry  the  wording  of  this  phrase  as  set  out  in  Annex  III  to  Directive
67/548/EEC,  when  the  concentration  of  this  substance  present  in  the  preparation  is  equal  to  or
higher  than  1 %,  unless  different  values  are  set  in  Annex  I  to  Directive  67/548/EEC.

B. For  preparations  irrespective  of  their  classification  within  the  meaning  of  Articles  5,  6  and  7

1.

Preparations  containing  lead

1.1. P a i n t   a n d   v a r n i s h e s

Labels  of  packages  of  paints  and  varnishes  containing  lead  in  quantities  exceeding  0,15 %
(expressed as weight of metal) of the total weight of the preparation, as determined in accordance
with  ISO  standard  6503/1984,  must  show  the  following  particulars:

‘Contains  lead.  Should  not  be  used  on  surfaces  liable  to  be  chewed  or  sucked  by  children’.

In the case of packages the contents of which are less than 125 millilitres, the particulars may be
as  follows:

‘Warning!  Contains  lead’.

2.

Preparations containing cyanoacrylates

2.1. A d h e s i v e s

The  immediate  packaging  of  adhesives  based  on  cyanoacrylate  must  bear  the  following
inscriptions:

‘Cyanoacrylate

Danger

Bonds  skin  and  eyes  in  seconds

Keep  out  of  the  reach  of  children’.

Appropriate  advice  on  safety  must  accompany  the  package.

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3.

Preparations  containing  isocyanates

The package labels of preparations containing isocyanates (as monomers, oligomers, prepolymers,
etc.,  or  as  mixtures  thereof)  must  bear  the  following  inscriptions:

‘Contains isocyanates

See  information  supplied  by  the  manufacturer’

4.

Preparations  containing  epoxy  constituents  with  an  average  molecular  weight  < 700

The  package  labels  of  preparations  containing  epoxy  constituents  with  an  average  molecular
weight  < 700  must  bear  the  following  inscriptions:

‘Contains  epoxy  constituents

See  information  supplied  by  the  manufacturer’

5.

Preparations  sold  to  the  general  public  which  contain  active  chlorine

The  packaging  of  preparations  containing  more  than  1 %  of  active  chlorine  must  bear  the
following  particular  inscriptions:

‘Warning!  Do  not  use  together  with  other  products.  May  release  dangerous  gases  (chlorine)’

6.

Preparations  containing  cadmium  (alloys)  and  intended  to  be  used  for  brazing  or  soldering

The packaging of the abovementioned preparations must bear the following inscription printed in
clearly  legible  and  indelible  characters:

‘Warning!  Contains  cadmium

Dangerous  fumes  are  formed  during  use

See  information  supplied  by  the  manufacturer

Comply  with  the  safety  instructions’

7.

Preparations  available  as  aerosols

Without  prejudice  to  the  provisions  of  this  Directive,  preparations  available  as  aerosols  are  also
subject to the labelling provisions in accordance with points 2.2 and 2.3 of the Annex to Directive
75/324/EEC.

8.

Preparations  containing  substances  not  yet  tested  completely

Where  a  preparation  contains  at  least  one  substance  which,  in  accordance  with  Article  13(3)  of
Directive 67/548/EEC, bears the inscription ‘Warning — substance not yet tested completely’, the
label  of  the  preparation  must  bear  the  inscription  ‘Warning  —  this  preparation  contains  a
substance  not  yet  tested  completely’  if  this  substance  is  present  in  a  concentration  > 1 %.

9.

Preparations  not  classified  as  sensitising  but  containing  at  least  one  sensitising  substance

The packaging of preparations containing at least one substance classified as sensitising and being
present in a concentration equal to or greater than 0,1 % or in a concentration equal to or greater
than  that  specified  under  a  specific  note  for  the  substance  in  Annex  I  to  Directive  67/548/EEC
must  bear  the  inscription:

‘Contains  “name  of  sensitising  substance”

May  produce  an  allergic  reaction  in  persons  already  sensitised’

10. Liquid  preparations  containing  halogenated  hydrocarbons

For liquid preparations which show no flash point or a flash point higher than 55 oC and contain
a  halogenated  hydrocarbon  and  more  than  5 %  flammable  or  highly  flammable  substances,  the
packaging  must  bear  the  following  inscription  as  appropriate:

‘Can  become  highly  flammable  in  use’

or  ‘Can  become  flammable  in  use’

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C. For  preparations  not  classified  within  the  meaning  of  Articles  5,  6  and  7  but  containing  at  least  one

dangerous  substance

Preparations  not  intended  for  the  general  public

The label on the packaging of the preparations referred to in Article 14(2)(1)(b) must bear the following
inscription:

‘Safety  data  sheet  available  for  professional  user  on  request’

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ANNEX  VI

CONFIDENTIALITY  FOR  THE  CHEMICAL  IDENTITY  OF  A  SUBSTANCE

PART  A

Information  to  be  communicated  in  the  request  for  confidentiality

Introductory  notes:

A. Article  15  indicates  the  conditions  in  which  the  person  responsible  for  placing  a  preparation  on  the

market  may  avail  himself  of  the  confidentiality.

B. To  avoid  multiple  requests  for  confidentiality  relating  to  the  same  substance  used  in  different
preparations,  a  single  request  for  confidentiality  may  suffice  if  a  certain  number  of  preparations  have:

— the  same  dangerous  constituents  present  in  the  same  concentration  range,

— the  same  classification  and  labelling,

— the  same  expected  uses.

A single alternative denomination must be used to mask the chemical identity of the same substance in
the  preparations  concerned.  Furthermore,  the  request  for  confidentiality  must  contain  all  information
indicated  in  the  following  request,  without  forgetting  the  name  or  the  trade  name  of  each
preparation.

C. The  alternative  designation  used  on  the  label  must  be  the  same  as  that  given  unter  heading  2
‘Composition/information  on  ingredients’  of  the  Annex  to  Directive  91/155/EEC  as  last  amended  by
Directive  93/112/EEC (1).

This  implies  that  the  alternative  designation  used  will  contain  enough  information  about  the  substance
to  ensure  risk-free  handling.

D.

In making the request to use an alternative designation the person responsible for placing on the market
must  take  into  account  the  need  to  provide  enough  information  for  necessary  health  and  safety
precautions to be taken in the workplace and to ensure that risks from handling the preparation can be
minimised.

Request  for  confidentiality

In  accordance  with  Article  15  the  request  for  confidentiality  must  obligatorily  contain  the  following
information:

1. Name and full address (including telephone number) of the person established in the Community who
is  responsible  for  placing  the  preparation  on  the  market  (manufacturer,  importer  or  distributor).

2. Precise  identification  of  the  substance(s)  for  which  confidentiality  is  proposed  and  the  alternative

designation.

CAS  No

Einecs  No

Chemical  name  according  to  international
nomenclature  and  classification
(Annex  I  to  Council  Directive  67/548/EEC
or  provisional  classification)

Alternative
designation

(a)

(b)

(c)

NB:
Where  substances  are  classified  provisionally,  accompanying  information  (bibliographical  references)
should be provided as evidence that the provisional classification takes account of all existing pertinent
information  available  on  the  properties  of  the  substance.

(1) OJ  L  314,  16.12.1993,  p.  38.

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3.

Justification  for  confidentiality  (probability  —  plausibility).

4. Designation(s)  or  commercial  name(s)  of  the  preparation(s).

5.

Is  the  designation  or  commercial  name  the  same  for  all  the  Community?

YES

NO

If  no,  specify  the  designation(s)  or  commercial  name(s)  used  in  the  different  Member  States:

Austria:

Belgium:

Denmark:

Germany:

Greece:

Finland:

France:

Spain:

Sweden:

Ireland:

Italy:

Luxembourg:

Netherlands:

Portugal:

United  Kingdom:

6. Composition  of  the  preparation(s)  defined  in  point  2  of  the  Annex  to  Directive  91/155/EEC.

7. Classification  of  the  preparation(s)  according  to  Article  6  of  this  Directive.

8. Labelling  of  the  preparation(s)  according  to  Article  10  of  this  Directive.

9.

Intended  uses  for  the  preparation(s).

10. Safety  data  sheet(s)  conforming  to  Directive  91/155/EEC.

PART  B

Lexicon  guide  for  establishing  the  alternative  designations  (generic  names)

1.

Introductory  note:

The lexicon-guide is based on the procedure for the classification of dangerous substances (division of
substances  into  families)  which  appears  in  Annex  I  to  Directive  67/548/EEC.

Alternative  designations  to  those  based  on  this  guide  may  be  used.  However,  in  all  cases  the  names
chosen  must  provide  enough  information  to  ensure  the  preparation  can  be  handled  without  risk  and
that  necessary  health  and  safety  precautions  can  be  taken  in  the  workplace.

The  families  are  defined  in  the  following  manner:

— inorganic  or  organic  substances  whose  properties  are  identified  by  having  a  common  chemical
element  as  their  chief  characteristic.  The  family  name  is  derived  from  the  name  of  the  chemical
element. These families are identified as in Annex I by the atomic number of the chemical element
(001  to  103),

— organic  substances  whose  properties  are  identified  by  having  a  common  functional  group  as  their

chief characteristics.

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The  family  name  is  derived  from  the  functional  group  name.

These  families  are  identified  by  the  conventional  number  found  in  Annex  I  (601—650).

Sub-families bringing together substances with a common specific character have been added in certain
cases.

2.

Establishing  the  generic  name:

General principles

For  the  purposes  of  establishing  the  generic  name,  the  following  general  approach,  involving  two
successive  stages,  is  adopted:

(i)

identification  of  the  functional  groups  and  chemical  elements  present  in  the  molecule;

(ii) determination  of  the  extent  to  which  account  should  be  taken  of  the  most  important  functional

groups  and  chemical  elements.

The  identified  functional  groups  and  elements  taken  into  account  are  the  names  of  the  families  and
sub-families  set  out  in  point  3  in  the  form  of  a  non-restrictive  list.

3.

Division  of  substances  into  families  and  sub-families:

Family Number
Annex  I  to  Directive
67/548/EEC

Families

Sub-families

001

Hydrogen  compounds

Hydrides

002

003

004

005

Helium  compounds

Lithium  compounds

Beryllium  compounds

Boron  compounds

Boranes

Borates

006

Carbon  compounds

Carbamates

Inorganic  carbon  compounds

Salts  of  hydrogen  cyanide

Urea  and  derivatives

007

Nitrogen  compounds

Quaternary  ammonium  compounds

Acid  nitrogen  compounds

Nitrates

Nitrites

008

009

Oxygen  compounds

Fluorine  compounds

Inorganic  fluorides

010

Neon  compounds

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Family Number
Annex  I  to  Directive
67/548/EEC

Families

Sub-families

011

012

Sodium  compounds

Magnesium  compounds

Organometallic magnesium derivatives

013

Aluminium  compounds

Organometallic aluminium derivatives

014

Silicon  compounds

Silicones

Silicates

015

Phosphorus  compounds

Acid  phosphorus  compounds

Phosphonium  compounds

Phosphoric  esters

Phosphates

Phosphites

Phosphoramides  and  derivatives

016

Sulphur  compounds

Acid  sulphur  compounds

Mercaptans

Sulphates

Sulphites

017

Chlorine  compounds

Chlorates

Perchlorates

Argon  compounds

Potassium  compounds

Calcium  compounds

Scandium  compounds

Titanium  compounds

Vanadium  compounds

Chromium  compounds

Chromium  VI  compounds

Manganese  compounds

Iron  compounds

Cobalt  compounds

018

019

020

021

022

023

024

025

026

027

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Family Number
Annex  I  to  Directive
67/548/EEC

Families

Sub-families

028

029

030

031

032

033

034

035

036

037

038

039

040

041

042

043

044

045

046

047

048

049

050

051

052

Nickel  compounds

Copper  compounds

Zinc  compounds

Organometallic zinc derivatives

Gallium  compounds

Germanium  compounds

Arsenic  compounds

Selenium  compounds

Bromine  compounds

Krypton  compounds

Rubidium  compounds

Strontium  compounds

Yttrium  compounds

Zirconium  compounds

Niobium  compounds

Molybdenum  compounds

Technetium  compounds

Ruthenium  compounds

Rhodium  compounds

Palladium  compounds

Silver  compounds

Cadmium  compounds

Indium  compounds

Tin  compounds

Organometallic tin derivatives

Antimony  compounds

Tellurium  compounds

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Family Number
Annex  I  to  Directive
67/548/EEC

Families

Sub-families

053

054

055

056

057

058

059

060

061

062

063

064

065

066

067

068

069

070

071

072

073

074

075

076

077

078

Iodine  compounds

Xenon  compounds

Caesium  compounds

Barium  compounds

Lanthanum  compounds

Cerium  compounds

Praseodymium  compounds

Neodymium  compounds

Promethium  compounds

Samarium  compounds

Europium  compounds

Gandolinium  compounds

Terbium  compounds

Dysprosium  compounds

Holmium  compounds

Erbium  compounds

Thulium  compounds

Ytterbium  compounds

Lutetium  compounds

Hafnium  compounds

Tantalum  compounds

Tungsten  compounds

Rhenium  compounds

Osmium  compounds

Iridium  compounds

Platinum  compounds

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Family Number
Annex  I  to  Directive
67/548/EEC

Families

Sub-families

079

080

081

082

083

084

085

086

087

088

089

090

091

092

093

094

095

096

097

098

099

100

101

102

103

Gold  compounds

Mercury  compounds

Organometallic mercury derivatives

Thallium  compounds

Lead  compounds

Organometallic lead derivatives

Bismuth  compounds

Polonium  compounds

Astate  compounds

Radon  compounds

Francium  compounds

Radium  compounds

Actinium  compounds

Thorium  compounds

Protactinium  compounds

Uranium  compounds

Neptunium  compounds

Plutonium  compounds

Americium  compounds

Curium  compounds

Berkelium  compounds

Californium  compounds

Einsteinium  compounds

Fermium  compounds

Mendelevium  compounds

Nobelium  compounds

Lawrencium  compounds

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Family Number
Annex  I  to  Directive
67/548/EEC

Families

601

Hydrocarbons

Sub-families

Aliphatic hydrocarbons

Aromatic  hydrocarbons

Alicyclic hydrocarbons

Polycyclic  aromatic  hydrocarbons  (PAH)

602

Halogenated  hydrocarbons (1)

Halogenated  aliphatic  hydrocarbons (1)
Halogenated  aromatic  hydrocarbons (1)
Halogenated alicyclic hydrocarbons (1)

603

Alcohols  and  derivatives

Aliphatic alcohols

Aromatic alcohols

Alicyclic alcohols

Alcanolamines

Epoxy derivatives

Ethers

Glycolethers

Glycols  and  polyols

604

Phenols  and  derivatives

Halogenated  phenol  derivatives (1)

605

Aldehydes and derivatives

Aliphatic aldehydes

Aromatic aldehydes

Alicyclic aldehydes

Aliphatic acetals

Aromatic acetals

Alicyclic acetals

606

Ketones  and  derivatives

Aliphatic  Ketones
Aromatic  Ketones (2)
Alicyclic Ketones

607

Organic  acids  and  derivatives

Aliphatic acids
Halogenated aliphatic acids (1)
Aromatic acids
Halogenated  aromatic  acids (1)
Alicyclic acids
Halogenated alicyclic acids (1)
Aliphatic  acid  anhydrides

Halogenated  aliphatic  acid  anhydrides

Aromatic  acid  anhydrides
Halogenated  aromatic  acid  anhydrides (1)
Alicyclic acid anhydrides
Halogenated alicyclic acid anhydrides (1)
Salts  of  aliphatic  acid
Salts  of  halogenated  aliphatic  acid (1)
Salts  of  aromatic  acid

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Family Number
Annex  I  to  Directive
67/548/EEC

Families

Sub-families

607
(cont’d)

608

609

610

611

612

Salts  of  halogenated  aromatic  acid (1)
Salts  of  alicyclic  acid
Salts  of  halogenated  alicyclic  acid (1)
Esters  of  aliphatic  acid
Esters  of  halogenated  alicyclic  acid (1)
Esters  of  aromatic  acid
Esters  of  halogenated  aromatic  acid (1)
Esters  of  alicyclic  acid
Esters  of  halogenated  alicyclic  acid (1)
Esters  of  glycol  ether

Acrylates

Methacrylates

Lactones

Acyl halogenides

Nitriles  and  derivatives

Nitro  compounds

Chlornitrated  compounds

Azoxy  and  azo  compounds

Amine  compounds

Aliphatic  amines  and  derivatives

Alicyclic amines and derivatives

Aromatic  amines  and  derivatives

Aniline  and  derivatives

Benzidine  and  derivatives

613

Heterocyclic  bases  and  derivatives

Benzimidazole and derivatives

Imidazol  and  derivatives

Pyrethrinoids

Quinoline  and  derivatives

Triazine and derivatives

Triazole and derivatives

614

Glycosides  and  alkaloids

Alkaloid and derivatives

Glycosides  and  derivatives

615

Cyanates  and  isocyanates

Cyanates

Isocyanates

616

Amides  and  derivatives

Acetamide and derivatives

Anilides

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Family Number
Annex  I  to  Directive
67/548/EEC

Families

Sub-families

617

Organic  peroxides

647

Enzymes

648

Complex  coal  derivatives

Acid  extract

Alkaline extract

Anthracene  oil

Anthracene  oil  extract  residue

Anthracene  oil  fraction

Carbolic oil

Carbolic  oil  extract  residue

Coal  liquids,  liquid  solvent  extraction

Coal  liquids,  liquid  solvent  extraction  solvents

Coal  oil

Coal  tar

Coal  tar  extract

Coal  tar  solids  residue

Coke  (coal  tar)  low  temperature,  high  temperature  pitch

Coke  (coal  tar),  high  temperature  pitch

Coke  (coal  tar),  mixed  coal  high  temperature  pitch

Crude  benzole

Crude  phenols

Crude  tar  bases

Distillate bases

Distillate  phenols

Distillates

Distillates  (coal),  liquid  solvent  extraction,  primary

Distillates  (coal),  solvent  extraction,  hydrocracked

Distillates  (coal),  solvent  extraction,  hydrocracked  hydrogenated  middle

Distillates  (coal),  solvent  extraction,  hydrocracked  middle

Extract  residues  (coal),  low  temperature  coal  tar  alkaline

Fresh  oil

Fuels,  diesel,  coal  solvent  extraction,  hydrocracked,  hydrogenated

Fuels,  jet  aircraft,  coal  solvent  extraction,  hydrocracked,  hydrogenated

Gasoline,  coal  solvent  extraction,  hydrocracked  naphtha

Heat  treatment  products

Heavy  anthracene oil

Heavy  anthracene  oil  redistillate

Light  oil

Light  oil  extract  residues,  high  boiling

Light  oil  extract  residues,  intermediate  boiling

Light  oil  extract  residues,  low  boiling

Light  oil  redistillate,  high  boiling

Light  oil  redistillate,  intermediate  boiling

Light  oil  redistillate,  low  boiling

Methylnaphthalene  oil

Methylnaphthalene  oil  extract  residue

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Family Number
Annex  I  to  Directive
67/548/EEC

Families

Sub-families

648
(cont’d)

Naphtha  (coal),  solvent  extraction,  hydrocracked

Naphthalene  oil

Naphthalene  oil  extract  residue

Naphthalene  oil  redistillate

Pitch

Pitch  redistillate

Pitch  residue

Pitch  residue,  heat  treated

Pitch  residue,  oxidised

Pyrolysis  products

Redistillates

Residues  (coal),  liquid  solvent  extractions

Tar  brown  coal

Tar  brown  coal,  low  temperature

Tar  oil,  high  boiling

Tar  oil,  intermediate  boiling

Wash  oil

Wash  oil  extract  residue

Wash  oil  redistillate

649

Complex  oil  derivatives

Crude  oil

Petroleum  gas

Low  boiling  point  naphtha

Low  boiling  point  modified  naphtha

Low  boiling  point  cat-cracked  naphtha

Low  boiling  point  cat-reformed  naphtha

Low  boiling  point  thermally  cracked  naphtha

Low  boiling  point  hydrogen-treated  naphtha

Low  boiling  point  naphtha  —  unspecified

Straight-run  kerosine

Kerosine  —  unspecified

Cracked  gas  oil

Gas  oil  —  unspecified

Heavy  fuel  oil

Grease

Unrefined  or  mildly  refined  base  oil

Base  oil  —  unspecified

Distillate  aromatic  extract

Distillate  aromatic  extract  (treated)

Foots  oil

Slack wax

Petrolatum

650

Various  substances (3)

(1) Specify  according  to  the  family  corresponding  to  halogen.
(2) Quinones  included.
(3) Do  not  use  this  family.  Instead,  use  the  families  or  sub-families  mentioned  above.

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4.

Practical application:

After having conducted a search to see if the substance belongs to one or more families or sub-families
on  the  list,  the  generic  name  can  be  established  in  the  following  way:

4.1.

If  the  name  of  a  family  or  sub-family  is  sufficient  to  characterise  the  chemical  elements  or  important
functional  groups,  this  name  will  be  chosen  as  the  generic  name.

Examples:

— 1,4  dihydroxybenzen

family  604:  phenols  and  derivatives
generic  name:  phenol  derivatives

— Butanol

family  603:  alcohols  and  derivatives
sub-family: aliphatic alcohols
generic  name:  aliphatic  alcohol

— 2-Isopropoxyethanol

family  603:  alcohols  and  derivatives
sub-family: glycolethers
generic  name:  glycolether

— methacrylate

family  607:  organic  acids  and  derivatives
sub-family: acrylates
generic name: acrylate

4.2.

If  the  name  of  a  family  or  sub-family  is  not  sufficient  to  characterise  the  chemical  elements  of
important  functional  groups,  the  generic  name  will  be  a  combination  of  the  corresponding  different
family  or  sub-family  names.

Examples:

— chlorobenzene

family  602:  halogenated  hydrocarbons
sub-family:  halogenated  aromatic  hydrocarbons
family  017:  chlorine  compounds
generic  name:  chlorinated  aromatic  hydrocarbon

— 2,3,6-trichlorophenylacetic acid

family  607:  organic  acids
sub-family:  halogenated  aromatic  acids
family  017:  chlorine  compounds
generic  name:  chlorinated  aromatic  acid

— 1-chloro-1-nitropropane

family  610:  chloronitrated  derivatives
family  601:  hydrocarbons
sub-family:  aliphatic  hydrocarbons
generic  name:  chlorinated  aliphatic  hydrocarbon

— tetrapropyl  dithiopyrophosphate

family  015:  phosphorus  compounds
sub-family:  phosphoric  esters
family  016:  sulphur  compounds
generic  name:  thiophosphoric  ester

NB:

In the case of certain elements, notably metals, the name of the family or sub-family may be indicated
by  the  words  ‘organic’  or  ‘inorganic’.

Examples:

— dimercury chloride

family  080:  mercury  compounds
generic  name:  inorganic  mercury  compound

— barium acetate:

family  056:  barium  compounds
generic  name:  organic  barium  compound

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— ethyl  nitrite

family  007:  nitrogen  compounds
sub-family: nitrites
generic  name:  organic  nitrite

— sodium  hydrosulphite

family  016:  sulphur  compounds
generic  name:  inorganic  sulphur  compound

(The examples cited are substances taken from Annex I to Directive 67/548/EEC (19th adaptation) in
respect  of  which  requests  for  confidentiality  may  be  submitted).

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ANNEX  VII

PREPARATIONS  COVERED  BY  ARTICLE  12(2)

Preparations  as  specified  by  point  9.3  of  Annex  VI  to  Directive  67/548/EEC.

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ANNEX  VIII

PART  A

Directives  repealed  in  accordance  with  Article  21

— Directive  78/631/EEC  on  the  approximation  of  the  laws  of  the  Member  States  relating  to  the

classification,  packaging  and  labelling  of  dangerous  preparations  (pesticides)

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

— Directive  89/178/EEC (1)

— Directive  90/492/EEC (2)

— Directive  93/18/EEC (3)

— Directive  96/65/EC

— Directive  90/35/EEC (4)  defining  in  accordance  with  Article  6  of  Directive  88/379/EEC  the  category  of
preparations  the  packaging  of  which  must  be  fitted  with  child-resistant  fastenings  and/or  carry  a  tactile
warning  of  danger

— Directive  91/442/EEC (5)  on  dangerous  preparations  the  packaging  of  which  must  be  fitted  with

child-resistant  fastenings

Deadlines  for  transposition  and  for  application  in  accordance  with  Article  22

PART  B

Directive

Deadline  for  transposition

Deadline  for  application

1  January  1981

1  January  1981

7  June  1991

1  December  1990

1  June  1991

1  July  1994

7  June  1991

1  June  1991

8  June  1991

1  July  1994

1  August  1992

1  November  1992

1  August  1992

1  November  1992

31  May  1998

31  May  1998

PART  C

78/631/EEC

88/379/EEC

89/178/EEC

90/492/EEC

93/18/EEC

90/35/EEC

91/442/EEC

96/65/EC

Special provisions for Austria, Finland and Sweden concerning the application of the following Directives in
accordance  with  Article  21

1. Austria, Finland and Sweden do not transpose or apply Council Directive 78/631/EEC of 26 June 1978
on  the  approximation  of  the  laws  of  the  Member  States  relating  to  the  classification,  packaging  and
labelling  of  dangerous  preparations  (pesticides),  as  last  amended  by  Directive  92/32/EEC.

(1) OJ  L  64,  8.3.1989,  p.  18.
(2) OJ  L  275,  5.10.1990,  p.  55.
(3) OJ  L  104,  29.4.1993,  p.  46.
(4) OJ  L  19,  24.1.1990,  p.  14.
(5) OJ  L  238,  27.8.1991,  p.  25.

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2. Austria  is  to  apply  Council  Directive  88/379/EEC  of  7  June  1988  on  the  approximation  of  laws,
regulations  and  administrative  provisions  relating  to  the  classification,  packaging  and  labelling  of
dangerous  preparations,  as  last  amended  by  Directive  96/65/EC  under  the  following  conditions:

The  following  provisions  of  Directive  88/379/EEC  will  not  apply  to  Austria

(a) Article  13  in  conjunction  with  Articles  3  and  7  with  respect  to  preparations  containing  substances

listed  in  Appendix  1;

(b) Article 13 in conjunction with Article 7 with respect to labelling respecting the Austrian provisions

on

— safety  advice  for  waste  disposal,

— pictogram  for  waste  disposal  until  two  years  after  the  entry  into  force  of  this  Directive,

— safety  advice  for  counter-measures  in  case  of  accidents;

(c) Article  13  in  conjunction  with  Article  7(1)(c)  concerning  the  chemical  names  of  dangerous
substances  present  in  dangerous  preparations,  until  two  years  after  the  entry  into  force  of  this
Directive.

3. Sweden  is  to  apply  Council  Directive  88/379/EEC  of  7  June  1988  on  the  approximation  of  laws,
regulations  and  administrative  provisions  relating  to  the  classification,  packaging  and  labelling  of
dangerous  preparations,  as  last  amended  by  Directive  96/65/EC  under  the  following  conditions:

The  following  provisions  of  Directive  88/379/EEC  will  not  apply  to  Sweden:

(a) Article  13  in  conjunction  with  Articles  3  and  7  with  respect  to  preparations

— containing  substances  listed  in  Appendix  2,

— containing substances presenting neurotoxic effects and defatting effects on the skin not covered
by  criteria  for  classification  of  Annex  VI  to  Directive  67/548/EEC,  and  by  risk  phrases  of
Annex  III  to  Directive  67/548/EEC,

— containing substances presenting acutely toxic effects not covered by criteria for classification of
Annex  VI  to  Directive  67/548/EEC,  and  by  risk  phrases  of  Annex  III  to  Directive  67/548/EEC,
until  two  years  after  the  entry  into  force  of  this  Directive,

— which are not classified as dangerous according to the ‘måttligt skadliga’ (Swedish: ‘moderately

harmful’)  criteria  of  Directive  88/379/EEC;

(b) Article  13  in  conjunction  with  Articles  3  and  7  with  respect  to

— the  criteria  for  classification  and  labelling  of  preparations  containing  carcinogenic  substances

classified  on  the  basis  of  criteria  in  point  4.2.1  of  Annex  VI  to  Directive  67/548/EEC,

— labelling of preparations classified as carcinogenic, category 3, with a special R-phrase instead of

R-phrase  40.

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Appendix  1

Substances  referred  to  in  Annex  VIII  Part  C  point  2  (Austria)

Name  of  the  substance

Index  number  in  Annex  I
to  Directive  67/548/EEC

Linuron

Trichlorosilan

Phosphorus  trichloride

Phosphorus  pentachloride

Phosphorus  oxychloride

Sodium  polysulphides

Disulphur  dichloride

Thionyl chloride

Calcium  hypochlorite

Potassium  hydroxide

2-Dimethylaminoethanol

2-Diethylaminoethanol

Diethanolamine

N-Methyl-2-ethanolamine

2-Ethylhexan-1,3-diol

Isophorone

6-Methyl-1,3-dithiolo(4,5-b)chinoxalin-2-one

Acetic anhydride

Methyl  formate

Ethyl  formate

Acrylic acid

Chloroacetyl chloride

Nitrofen

Quintozen;  Pentachloronitrobenzol

Dichlofluanid

Cumene  hydroperoxide

Monocrotophos

Edifenphos

Triazophos

Methanol

Trifenmorph;  4-Tritylmorpholin

Diuron

Fenbutanin  oxide

1-Butanol,  2-Butanol,  iso-Butanol

006-021-00-1

014-001-00-9

015-007-00-4

015-008-00-X

015-009-00-5

016-010-00-3

016-012-00-4

016-015-00-0

017-012-00-7

019-002-00-8

603-047-00-0

603-048-00-6

603-071-00-1

603-080-00-0

603-087-00-9

606-012-00-8

606-036-00-9

607-008-00-9

607-014-00-1

607-015-00-7

607-061-00-8

607-080-00-1

609-040-00-9

609-043-00-5

616-006-00-7

617-002-00-8

015-072-00-9

015-121-00-4

015-140-00-8

603-001-00-X

613-052-00-X

006-015-00-9

050-017-00-2

603-004-00-6

Appendix  2

Substances  referred  to  in  Annex  VIII  Part  C  point  3  (Sweden)

Name  of  the  substance

Index  number  in  Annex  I
to  Directive  67/548/EEC

Acetone

Butanone

Amyl  formate

Ethyl  acetate

n-Butylacetate

606-001-00-8

606-002-00-3

607-018-00-3

607-022-00-5

607-025-00-1

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Name  of  the  substance

Index  number  in  Annex  I
to  Directive  67/548/EEC

sec-Butylacetate

tert-Butylacetate

iso-Butylacetate

Butylformate

Cyclohexane

1,4-Dimethylcyclohexane

Diethyl  ether

Ethyl  methyl  ether

Amyl acetate

Ethyl lactate

Amyl  propionate

2,4-Dimethylpentan-3-one

Di-n-propylether

Di-n-propyl  ketone

Ethyl  propionate

Heptane

Hexane  (mixture  of  isomers)  containing  less  than  5 %
n-hexane)

Isopropyl  acetate

Isopropyl  alcohol

4-Methoxy-4-methylpentane-2-one

Methyl acetate

Methyl cyclohexane

5-Methylhexane-2-one

Methylacetate

4-Methylpentan-2-one

Methyl  propionate

Octane

Pentane

Pentan-3-one

Propan-1-ol

Propyl  acetate

Propyl  formate

Propyl  propionate

Sodium  bisulphite  =  polysulphite

Toluene-2,4-diisocyanate

Toluene-2,6-diisocyanate

Cadmiumfluoride

1,2-Epoxy-3(tolyloxy)-propane
Diphenylmethane-2,29-diisocyanate
Diphenylmethane-2,49-diisocyanate
Diphenylmethane-4,49-diisocyanate
Hydroquinone

Hydroxypropylacrylate

Turpentine

Butyl  methyl  ketone  (2-Hexanone)

Hexane

Vanadium  pentoxide

Sodium  nitrate

Zinc  oxide

607-026-00-7

607-026-00-7

607-026-00-7

607-017-00-8

601-017-00-1

601-019-00-2

603-022-00-4

603-020-00-3

607-130-00-2

607-129-00-7

607-131-00-8

606-028-00-5

603-045-00-X

606-027-00-X

607-028-00-8

601-008-00-2

601-007-00-7

607-024-00-6

603-003-00-0

606-023-00-8

607-021-00-X

601-018-00-7

606-026-00-4

607-092-00-7

606-004-00-4

607-027-00-2

601-009-00-8

601-006-00-1

606-006-00-5

603-003-00-0

607-024-00-6

607-016-00-2

607-030-00-9

016-010-00-3

615-006-00-4

615-006-00-4

048-006-00-2

603-056-00-X

615-005-00-9

615-005-00-9

615-005-00-9

604-005-00-4

607-108-00-2

650-002-00-6

606-030-00-6

601-007-00-7

023-001-00-8

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ANNEX  IX

CORRELATION  TABLE

This Directive

88/379/EEC

Article  1

Article  1

1.1

1.2

1.3

1.4

1.5

Article  2

Article  3

Article  4

Article  5

5.1

5.1  3rd  indent

5.2  to  5.3

5.4

Article  6

6.1

6.2

6.3

6.4

6.5

Article  7

Article  8

8.1

8.2

8.3

8.4

Article  9

9.1

9.2

9.3

Article  10

10.1.1  to  1.2

10.2

10.2.3

10.2.4

10.2.5

Article  11

1.1

1.2

1.3

Article  2

Article  3(6)

Article  3(1)

Article  4

Article  3(2)

3.2

3.2  paragraph  3(b)

Article  3(3)

3.3  paragraphs  (a)  and  (b)

3.3  paragraphs  3  and  4

3.4

3.5  paragraphs  1  to  3

Article  5

5.1

5.2

5.3

Article  6

6.1  paragraph  (a)

6.1  paragraph  (b)

6.2  and  6.3  second  paragraph

Article  7

7.1

7.1  paragraph  (c)

7.1  paragraph  (d)

7.4

Article  8

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This Directive

88/379/EEC

Article  12

Article  13

Article  14

Article  15

Article  16

Article  17

Article  18

Article  19

Article  20

Article  21

Article  22

Article  23

Article  24

Article  9

Article  10

Article  7

Article  11

Article  12

Article  13

Article  14

Article  15

Article  16

Article  16(3)

Article  17

CORRELATION  TABLE

This Directive

88/379/EEC

90/35/EEC

91/442/EEC

93/18/EEC

Annex  I.A

Article  3(2)(2)

Annex  I  Introduction

Annex  I.B

Annex  II.A
Introduction
Paragraphs  1  to  3

Annex  II.A
Introduction  (4)

Annex  II.A.1

Article  3(5)(a)

Annex  II.A.1.1.1

Article  3(5)(a)(i)

Annex  II.A.1.1.2

Article  3(5)(a)(ii)

Annex  II.A.1.2

Article  3(5)(a)(iii)

Annex  II.A.2

Article  3(5)(b)

Annex  II.A.2.1.1

Article  3(5)(b)(i)

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This Directive

88/379/EEC

90/35/EEC

91/442/EEC

93/18/EEC

Annex  II.A.2.1.2

Article  3(5)(b)(ii)

Annex  II.A.2.2

Article  3(5)(b)(iii)

Annex  II.A.2.3

Article  3(5)(b)(iv)

Annex  II.A.3

Article  3(5)(c)

Annex  II.A.3.1.1

Article  3(5)(c)(i)

Annex  II.A.3.1.2

Article  3(5)(c)(ii)

Annex  II.A.3.2

Article  3(5)(c)(iii)

Annex  II.A.3.3

Article  3(5)(c)(iv)

Annex  II.A.4

Article  3(5)(d)

Annex  II.A.4.1.1

Article  3(5)(d)(i)

Annex  II.A.4.1.2

Article  3(5)(d)(ii)

Annex  II.A.4.2.1

Article  3(5)(e)(i)

Annex  II.A.4.2.2

Article  3(5)(e)(ii)

Annex  II.A.5

Article  3(5)(f)

Annex  II.A.5.1.1

Article  3(5)(f)(i)

Annex  II.A.5.1.2

Article  3(5)(f)(ii)

Annex  II.A.5.2.1

Article  3(5)(h)(i)

Annex  II.A.5.2.2

Article  3(5)(h)(ii)

Annex  II.A.5.3.1

Article  3(5)(g)(i)

Annex  II.A.5.3.2

Article  3(5)(g)(ii)

Annex  II.A.5.4.1

Article  3(5)(i)(i)

Annex  II.A.5.4.2

Article  3(5)(i)(ii)

Annex  II.A.6

Annex  II.A.6.1

Article  3(5)(g)(iii)

Annex  II.A.6.2

Article  3(5)(c)(v)

Annex  II.A.7.1

Article  3(5)(j)

Annex  I.6

Annex  II.A.7.2

Article  3(5)(k)

Annex  II.A.8.1

Article  3(5)(l)(m)

Annex  II.A.8.2

Article  3(5)(n)
Article  3(5)(o)(p)

Annex  II.A.9.1  to  9.4

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This Directive

88/379/EEC

90/35/EEC

91/442/EEC

93/18/EEC

Annex  II.B  Introduction

Annex  I  Introduction

Annex  II.B.1

Annex  II.B.1.1

Annex  II.B.1.2

Annex  II.B.2

Annex  II.B.2.1

Annex  II.B.2.2

Annex  II.B.3

Annex  II.B.3.1

Annex  II.B.3.2

Annex  II.B.4

Annex  II.B.4.1

Annex  II.B.4.2

Annex  II.B.5

Annex  II.B.5.1

Annex  II.B.5.2

Annex  II.B.6

Annex  II.B.6.1

Annex  II.B.6.2

Annex  III.A

Annex  III.B

Annex  III.C

Annex  IV.B

Annex  IV.A.1

Annex  IV.A.2

Annex  IV.A.3

Annex  V.A.1

Annex  V.A.2

Annex  V.A.3

Annex  V.A.4

Annex  V.B.1

Annex  I.1

Annex  I.1.1

Annex  I.1.2

Annex  I.2

Annex  I.2.1

Annex  I.2.2

Annex  I.3

Annex  I.3.1

Annex  I.3.2

Annex  I.4

Annex  I.4.1

Annex  I.4.2

Annex  I.5

Annex  I.5.1

Annex  I.5.2

Annex  I.6

Annex  I.6.1

Annex  I.6.2

Annex  II.A.1

Annex  II.A.2

Annex  II.A.3

Annex  II.A.4

Annex  II.B.1

Articles  1  and  2

Article  1(1)

Article  2;  Annex  (a)

Article  1;  Annex  (b)

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This Directive

88/379/EEC

90/35/EEC

91/442/EEC

93/18/EEC

Annex  II.B.2

Annex  II.B.3

Annex  II.B.4

Annex  II.B.5

Annex  II.B.6

Annex  V.B.2

Annex  V.B.3

Annex  V.B.4

Annex  V.B.5

Annex  V.B.6

Annex  V.B.7

Article  3.2(3)(b)

Annex  V.B.8

Article  3.5(4)

Annex  V.C

Annex  VI

Annex  VII

Annex  VIII

Annex  IX

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C 360/65

STATEMENT  OF  THE  COUNCIL’S  REASONS

I.

INTRODUCTION

1. On  18  July  1996  the  Commission  sent  the  Council  a  proposal,  based  on  Article  100a
of  the  EC  Treaty,  on  the  approximation  of  the  laws,  regulations  and  administrative
provisions  of  the  Member  States  relating  to  the  classification,  packaging  and  labelling
of  dangerous  preparations.

2. The  European  Parliament  delivered its first reading opinion on 26 June 1997. Further
to  that  opinion,  the  Commission  submitted  an  amended  proposal  on  23  September
1997.

The  Economic  and  Social  Committee  delivered  its  opinion  on  20  March  1997.

3. On  24  September  1998,  the  Council  adopted  by  unanimity  its  common  position  in

accordance  with  Article  189b  of  the  Treaty.

II. OBJECTIVE

4. The  Commission  proposal  recasts  Directive  88/379/EEC  to  provide  a  more  consistent
approach across the sectors; to rationalise and update existing Community legislation;
to simplify the processes for adaptation to technical progress; and to address the issues
concerning  the  Accession  Member  States.  In  doing  so  the  draft  proposal:

— extends  the  scope  of  the  current  Directive  to  encompass  plant  protection  products
(i.e.  pesticides)  which  are  currently  subject  to  separate  legislation  which  would  be
repealed  by  this  proposal,

— extends  the  scope  to  include  provisions  for  environmental  classification  and

labelling,

— extends  certain  requirements  to  preparations  containing  levels  of  dangerous
substances  below  that  where  normal  hazard  classification  would  be  triggered.

III. ANALYSIS  OF  THE  COMMON  POSITION

5. The  proposal  has  been  examined  in  the  Council  since  1996.  Compared  to  the

Commission’s  amended  proposal  the  text  has  been  changed  in  various  points.

Many  of  the  amendments  suggested  by  the  European  Parliament  have  been
incorporated  in  the  common  position.  As  regards  other  amendments  the  Council  has
either accepted these amendments in principle or has taken them into consideration in
its  common  position.

6. As  regards  Amendment  1  (accepted  by  the  Commission)  concerning  a  Commission
report  and,  if  appropriate,  necessary  Commission  proposals,  related  to  labelling
requirements  on  dangerous  preparations  (recital  17),  the  Council  welcomes  this
amendment and has incorporated it in a reworded form in the common position. The
Council  notes  that  the  Commission  is,  by  accepting  this  recital,  committing  itself  to
launch,  as  soon  as  possible,  a  study  on  the  comprehensibility  of  labels  to  the  users.

7. Furthermore,  the  Council  has  accepted  Amendment  2  (Article  1(1))  concerning  a
clarification  of  the  objectives  and  scope  (this  amendment  is  also  accepted  by  the
Commission).  Along  the  same  lines  the  Council  has  also  accepted  Amendment  3

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(Article  1(3))  specifying  that  the  scope  covers  non-dangerous  preparations  which  may
present  a  specific  hazard  (this  amendment  is  accepted  by  the  Commission).  However,
Amendments  2  and  3  have  been  integrated  into  the  text  in  a  slightly  reworded  form.

8. Concerning Amendment 5 (Article 4(2)) the Council has in a reworded form accepted
labelling  (the

this  clarification  of  the  general  principles  of  classification  and 
Commission  has  accepted  this  amendment).

9. The  Council  accepts  in  principle  Amendment  6  (Article  6(2))  introducing  relevant
restrictions  on  animal  testing  in  cases  where  alternative  methods  are  available.  The
amendment  also  clarifies  that  tests  in  question  shall  be  conducted  in  compliance  with
the  principles  of  good  laboratory  practice  and  protection  of  animal  welfare  (the
Commission  has  accepted  the  amendment  in  a  reworded  form).

10. The Council accepts Amendment 7 (Article 9(2)) which lays down the practice already
existing  between  transport  and  supply  packages  (Amendment  7  is  accepted  by  the
Commission).  This  amendment  has  been  slightly  reworded  by  the  Council.

11. The Council has accepted the principles expressed in Amendment 14 (this amendment
is  accepted  by  the  Commission)  related  to  labelling  requirements  applicable  to
preprations  classified  as  dangerous  for  the  environment,  when  they  are  supplied  in
small packages (Article 10(4)). However the Council has further clarified the European
Parliament  amendment;  to  ensure  that  where  the  warning  symbol  is  not  required  the
appropriate  R-phrase  is  given  instead.

12. Finally,  as  regards  labelling  requirements,  the  Council  has  incorporated  with  minor
editorial  modifications  Amendment  15  (accepted  by  the  Commission)  prohibiting  the
use  of  information  on  the  label  such  as  ‘ecological’  which  might  lead  to  an
underestimation  of  the  hazards.  In  addition  the  Council  has  clarified  the  text  by
making a reference to provisions on plant protection products, which will continue to
allow  ‘positive’  environmental  labelling  like  ‘not  dangerous  to  bees’  (Article  10(5)).

13.

In relation to safety data sheets (Article 14), this provision has been modified to make
clear  that  safety  data  sheets  are  principally  intended  for  professional  users.  For
non-classified  preparations,  the  Council  has  considered  that  information  provided  on
safety  data  sheets  for  such  products  should  be  proportionate  to  risks.  It  has  also
accepted Amendment 40 of the European Parliament, extending provisions concerning
non-dangerous preparations to cover preparations which contain substances dangerous
to  the  environment  (which  was  not  accepted  by  the  Commission).  The  Council  has
also  thought  it  appropriate  to  require  safety  data  sheets  for  plant  protection
products.

14. As  regards  the  Annexes,  the  following  amendments  have  been  accepted  by  the

Council:

— Amendment  18  introducing  to  Annex  III,  Part  B,  Table  V,  a  lower  concentration
limit  (0,1 %  instead  of  0,5 %)  for  classification  of  preparations  containing
ozone-depleting  substances  (the  amendment  is  also  accepted  by  the  Commission),

— Amendment  19  (which  was  also  accepted  by  the  Commission),  introducing  an
editorial improvement of the introduction of Annex III (methods for the evaluation
of  the  environmental  hazards  of  preparations  in  accordance  with  Article  7),

— Amendment 21 concerning Annex IV, Part B (accepted by the Commission) which
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).

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15. The  Council  accepts  Amendment  27  suggesting  that  the  reference  to  Directive
96/65/EC  should  be  added  to  the  list  of  Directives  that  need  to  be  repealed  (this
amendment  was  accepted  by  the  Commission).

16. The  following  amendments  were  not  accepted  by  the  Council:

— Amendment  4  (Article  3(3));  the  Council  does  not  find  it  appropriate  introducing
changes  to  the  application  of  the  conventional  methods,  and  it  fears  that  this
amendment  eventually  will  lead  to  unnecessary  animal  testing  because  the
conventional  method  would  be  unworkable  (the  European  Parliament  amendment
is  not  accepted  by  the  Commission),

— Amendments 8, 9, 11 and 12 (Article 10); the Council feels that these amendments
would  not  improve  the  level  of  protection  of  the  user  (the  Commission  has  not
accepted  those  amendments),

— Amendment  16  (Article  13);  it  is  the  Council’s  opinion  that  this  provision  should
only  apply  to  the  specific  situation  of  offering  a  product  for  sale  on  the  market
through the so-called ‘distance selling’. The Article has been reworded to bring it in
line  with  the  provisions  of  Directive  97/7/EC  on  distance  contracts  (the
Commission  has  not  accepted  this  amendment),

— Amendment 17 (Article 20) concerning the type of committee procedure applicable
when  adaptation  to  technical  progress  is  taking  place  within  the  Commission.
However, the European Parliament suggests a type IIIa — committee procedure (1).
The  Council  thinks  some  parts  of  the  adaptation  to  technical  progress  would
involve highly sensitive political questions, and on this basis it considers that a type
IIIb  —  committee  is  more  appropriate  (Amendment  17  has  been  accepted  by  the
Commission  who  wants  a  IIIa  —  committee).

17. As  regards  the  annexes,  the  following  amendments  were  not  accepted:

— as  regards  Amendment  13  (Article  10(2)  point  3.5)  concerning  the  labelling  of
chemical  names  primarily  responsible  for  health  hazards,  the  Council  has  not
accepted  this  amendment  (this  amendment  is  not  accepted  by  the  Commission).

— Amendment 20 (Annex III, Part C) provides that the existing test results should be
applicable for the assessment of effects dangerous for the environment. Since this is
already  the  case,  the  Council  considers  this  amendment  superfluous  (the
Commission  has  not  accepted  this  amendment),

— Amendment  22  (Annex  V,  Part  B)  concerns  the  specific  warning  on  the  label  on
sensitising  effects  to  persons.  The  Council  has  modified  this  warning  which  now
states  that  the  allergic  effect  due  to  low  concentrations  of  sensitisers  may  be
expected 
in  persons  already  sensitised  (the  Commission  has  accepted  this
amendment),

— Amendment 24 (Annex V, Part C) dealing with the availability of safety data sheets
(SDS). The Council does not find it appropriate to specify the type of preparations
for  which  the  obligation  to  provide  a  SDS  is  applied.  Furthermore,  the  Council
wants  to  specify  that  SDS  is  available  for  professional  users  on  request  (the
Commission  accepted  this  amendment  in  a  slightly  modified  form),

— Amendment  25  (Annex  V,  Part  D)  related  to  labelling  provisions  on  plant
protection  products  (PPP).  The  Council  has  not  accepted  this  amendment  because
labelling requirements on PPP’s have been further elaborated in the legal text itself
(Article  10(1)(2)).  Article  10(1)(2)  states  that  the  label  of  a  PPP  must  bear  an

(1) OJ  L  197,  18.7.1987,  p.  33.

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inscription  specifying  that  risk  to  man  and  the  environment  can  be  avoided  when
the  user  complies  with  the  instructions  for  use.  The  label  will  also  have  normal
hazard  information  and  the  symbols  indicating  danger  (the  Commission  accepted
this  amendment),

— Amendment 26 (Annex V, Part D) concerning labelling provisions on biocides. The
Council  does  not  find  it  appropriate  to  include  a  specific  provision  on  biocides  in
the  present  Directive  because  such  specific  provisions  are  laid  down  in  Directive
98/8/EC  on  biocides  (the  Commission  has  not  accepted  this  amendment).

18.

In  addition,  the  Council  has  introduced  new  provisions  on:

— Articles  6  and  7  concerning  evaluation  of  health  hazards  and  evaluation  of
environmental  hazards;  this  provision  would  make  it  possible  to  introduce  into
Annexes  II  and  III  other  conventional  methods.  This  might  be  necessary  for
alloys,

— Article 15 concerning confidentiality of chemical names; this provision now covers
both  labelling  and  safety  data  sheets,  and  the  Council  has  introduced  a  less
bureaucratic  notification  procedure,

— Article  21  concerning  Accession  Treaty  arrangements;  this  provision  allows
Sweden, Finland and Austria not to transpose the existing (old) Community acquis
in  the  beginning  of  1999.

IV. CONCLUSION

19. The  Council  considered  that,  in  view  of  the  above  objective,  it  has  endeavoured  to
retain  and  strengthen  the  provisions  which  guarantee  a  high  level  of  health  and
environmental  protection.

In  trying  to  achieve  this  the  Council  has  included  many  of  the  European  Parliament
amendments  and  has  taken  into  consideration  other  amendments.