Proposal for a EUROPEAN PARLIAMENT AND COUNCIL DIRECTIVE concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations
Date: 1996-07-18
Institutions: European Commission
Subjects: approximation of laws, dangerous substance, labelling, packaging, public health

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels,  18.07.1996 
COM(96) 347  final 

96/0200 (COD) 

Proposal  for a 

EUROPEAN PARLIAMENT AND COUNCIL DIRECTIVE 

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

(presented by the Commission) 

Explanatory  Memorandum 

1. 

INTRODUCTION 

In  June  1988  the  Council  adopted  Directive  88/379/EEC1on,the  approximation  of  the 
Member  States'  laws, regulations  and  administrative  provisions  relating  to the  classification, 
packaging  and labelling of dangerous preparations.  After  adopting this Directive and  bearing 
in mind  the points  of view  expressed  in the  Council's  declarations, the  Commission  adopted 
the following  directives to complete Community legislation in this area: 

•  Commission  Directive  89/178/EEC2 of 22 February  1989 adapting  Annex  II to  Directive 

88/379/EEC to technical progress; 

•  Commission  Directive  90/35/EEC3  of  19  December  1989,  which  defines,  pursuant  to 
Article  6  of  Directive  88/379/EEC,  the  categories  of  preparations  for  which  packaging 
must be fitted  with child-resistant  fastenings  and/or bear a tactile danger warning; 

•  Commission  Directive  90/492/EEC4  of  5  September  1990  adapting  for  a  second  time 
Council  Directive  88/379/EEC  to technical  progress  and  setting  the  concentration  limits, 
expressed  in  percent  volume,  to  use  when  determining  health  effects  when  the 
conventional  method  for gaseous preparations is applied; 

•  Commission  Directive  91/442/EEC5 of  23  July  1991 concerning  the  preparations  whose 

packaging must be fitted  with child-resistant  fastenings; 

•  Commission  Directive 91/155/EEC6of  5 March  1991 that  sets down  detailed  instructions 
for  the  specific  information  system  for  dangerous  preparations  in  implementation  of 
Article  10 of Directive 88/379/EEC; and 

•  Commission  Directive  93/18/EEC7  of  5  April  1993  adapting  the  annexes  to  Directive 

88/379/EEC to technical progress for the third time. 

Moreover,  in  April  1992  the  Council  adopted  Directive  92/32/EEC8  modifying  for  the 
seventh  time  Council  Directive  67/548/EEC9 concerning  the  approximation  of  the  Member 
States'  legislation,  regulations  and  administrative  provisions  related  to  the  classification^ 
packaging  and  labelling  of  dangerous  substances.  Besides  this,  in  April  1993  the 

1 
2 
3 
4 
5 
6 
7 
8 
9 

OJ N° L187 of 16.7.1988, pl4 
OJ N° L64 of 8.3.1989, pl8 
OJ No. L 19 of 24.01.1990, p. 14. 
OJNo. L 275 of 5.10.1990, p. 35. 
OJ No. L 238 of 27.8.1991, p. 25. 
OJ No. L 76 of 22.3.1991, p. 35. 
OJ No. L 104 of 29.4.1993, p. 46. 
OJ No. L 154 of 5.6.1992, p. 1. 
OJ No. L 196 of 16.8.1967, p. 1. 

- 1 -

Commission adopted  Directive 93/21/EEC10 adapting Directive 67/548/EEC to technical 
progress for the eighteenth time. 

These last two directives have had considerable impact on Directive 88/379/EEC, especially 
as regards the introduction of a new category of hazards for environmentally  dangerous 
substances, which  is backed up by the development of classification  criteria  for 
environmental  hazards and standard risk and safety advice phrases for substance  labelling. 
As a result of these two directives the provisions of Directive 88/379/EEC concerning the 
classification  and  labelling of dangerous preparations have been broadened to include 
environmental  effects. 

Besides the directives cited, other directives concerning special preparations need to be taken 
into account. 

Directive  78/631 /EEC1 '  was introduced to harmonise the rules of classification,  packaging 
and  labelling of pesticides between the Member States. In accordance with the provisions of 
this  Directive the classification  and labelling of pesticides is based on acute toxicity and 
physico-chemical  hazards. 

When  Directive  88/379/EEC  on classification,  packaging and labelling of dangerous 
preparations was adopted the inclusion of pesticides into the scope of this Directive was 
proposed. The proposal  was rejected  by the Member States recognising the fact that the 
general  classification  and labelling system was not suitable as such to pesticides taking into 
account their special  uses. 

Directive 91/414/EEC12 harmonises the legislation of the Member States concerning the 
placing on the market of plant protection products (PPP's). The authorisation of a PPP is a 
pre-marketing  condition  and is designed to ensure a high level of protection of human and 
animal health  and  the environment. The authorisation should also ensure that protection of 
animal  and  human  health and the environment should take priority over the objective of 
improving plant  production. 

The applicant  for  a PPP is obliged to submit to the competent authority a detailed 
documentation  for  hazard  assessment and assessment carried out in the context of 
authorisation  of the  PPP. The competent authority will ensure as part of the authorisation 
process that classification  and  labelling fulfils  the requirements of a high level of protection. 
Directive 91/414/EEC refers  to Directive 78/631/EEC for classification,  packaging and 
labelling  rules. When  a PPP is authorised  in one Member  State the authorisation has to be 
recognised  under comparable  conditions by other Member  States. 

Although  no serious hurdles have been encountered  in implementing  Directive  88/379/EEC 
since  its adoption, experience  gained  since then, as well as the above-mentioned  development 

10 
11 
12 

0.1 No.  L  110 of  4.5.1993,  p.l. 
O.I  No.  L.206  of  29.7.1978,  p. 13. 
0.1 No.  L 230  of  19.S. 1991,  p.  1. 

concerning the Directive and parent (related) directives, indicates that it would be worthwhile 
to revamp the existing text, bearing in mind all the directives to which it has given rise, and to 
correct  some drawbacks that have come to light since the directive went into effect  in  1991. 

1.1. Proposal  for  the classification  and labelling of Plant Protection Products included in 
the scope of the  Directive on classification,  packaging and labelling of preparations 

The new harmonised  authorisation process laid down in Directive'91/414/EEC has brought to 
light  the need  for  updating the legislation on classification,  packaging and labelling of 
pesticides. The Member  States have considered that the approach of Directive 78/631/EEC is 
outdated. 

As a result of the discussions with the experts of Member States it is proposed that the 
classification  of PPP's should  be based on the Directive on classification,  packaging and 
labelling of preparations, but the labelling of PPP's should take into consideration  both 
classification  and assessment carried out in the context of authorisation of PPP's. This means 
that  the classification  criteria established  in Annex VI of Directive 67/548/EEC will not be 
affected  by secondary  rules derived from  risk assessment. The final  label should in principle 
include all the information  derived from  the implementation of the criteria of Annex VI of 
Directive  67/548/EEC  and the proposed Directive. Nevertheless it would be acceptable in 
well  justified  cases to modify  some information  on the label however without reducing the 
essential  information  and affecting  the level of protection. 

The adoption  of principles of classification  for PPP's in the proposed Directive improves the 
level  of protection  by covering all properties dangerous to health (not only acute toxicity) and 
by extending  the classification  to properties dangerous for the environment. 

Some  Member  States that have applied a national authorisation  system for PPP's have already 
experience  in the selection  and modification  of R- and S-phrases  for the label of PPP's on the 
basis of classification  and assessment based on use. 

This proposal  introduces only the general principle for labelling of PPP's on the basis of both 
classification  together  with assessment carried out in the context of authorisation.  Detailed 
rules for  the application  of the principle for  labelling of Plant Protection Products need to be 
developed  in accordance  with Committee procedure of the present Directive. As Directive 
78/631/EEC will  be repealed  as a consequence, the reference  in Directive 91/414/EEC  should 
be replaced  with  a reference  to the proposed  Directive. 

The requirements  on packaging of the proposed  Directive will apply to PPP's without 
prejudice  to the special  requirements on the packages of PPP's of Directive 91/414/EEC. 

The  proposed  Directive will  improve the availability  of obtaining detailed information  on 
PPP's  in the  form  of  Safety  Data Sheet (SDS) as it introduces an obligation to compile  SDS's 

1.2.  Proposal  to  include  classification  criteria  for  preparations  " dangerous  for  the 

environment" 

One  of the  main  purposes  of modifying  this  Directive  was to  include criteria  to classify  and 
label  preparations  as dangerous  to the  environment. 
This  task  was  based  on  the existing  criteria of Annex  VI to Dir.67/548/EEC  for  classifying 
substances  as dangerous  for  the environment  as well  as on the results  of a study  carried  out  by 
the  Northern  European  countries.  (Nordic  Council  of  Ministers) 

Several  existing  models  were  tested  for  the classification  of  preparations  as dangerous  to  the 
aquatic  environment. 
A  conventional  method  of calculation  was established  which essentially  followed  the  same 
philosophy  as  that  adopted  ealier  for  the development  of a conventional  method  for  health 
effects.  This  method  uses  concentration  limits for  substances  as fixed  individually  in Annex  I 
to  Dir.  67/548/EEC  or,  if not  in Annex  I, in a specific  Annex  to the revised  Directive. 
In  contrast  to  the  classification  of preparations  for  health  effects,  tests are only  allowed  in  the 
case  of  the  determination  of toxicity  to aquatic  organisms  and  under  stringent  conditions. 

To  take  into  account  important  points  such as the real  effect  on the environment  caused  by  the 
dangerous  substances  contained  in the preparation,  or the  correct  interpretation  of  the 
information  provided  to  the  users, the experts  proposed  to use new risk phrases  and  also  an 
additional  safety  advice  which  would  better reflect  the  information  needed  for  preparations 
dangerous  to  the  environment. 

The  criteria  for  the  classification  for  the hazards  to the environment  of  preparationcontaining 
ozone  depleting  substances  has  also  be dealt  with  in the Annex to the proposal  of  revision. 

1.3.  Additional  proposals 

Aside  from  the  need  to  introduce  environmental  hazard  criteria and  to include  PPP's  in  the 
scope  of  the  Directive, there  was  also  a need  to take  account  of the opinions  of the  Member 
States  which  were  consulted  about  the  revision  project.  The  following  important  points  came 
out  of  this  consultation. 

• 

• 

including  plant  protection  products  and  biocides  within the  scope  of this  Directive,  which 
garnered  strong  support  from  some  Member  States  was made, in order to  set up  a 
harmonized  classification  scheme  for  all of these  preparations. 

extending  some  of the  provisions  in  Directive  88/379/EEC  - notably  those  concerning 
packaging,  labelling  and  the  submission  of a safety  data  sheet  - to  include  explosives  and 
some  preparations  that  are  not  classified  as dangerous  under  the terms  of the'directive  but 
can  nevertheless  present  certain  dangers  for  users. 

• 

• 

• 

• 

setting  maximum  concentrations  to  be  taken  into  consideration  in  implementing  the 
directives  based  on  the  various  danger  categories  of  substances  as  defined  in  Directive 
93/21/EEC. 

revising  the  provisions  related  to  the  obligation  to perform  physico-chemical  tests  under 
Good  Laboratory  Practices  (GLP)  to  avoid  repeating  tests  for  preparations  whose 
compositions vary but slightly. 

revising  the  maximum  tolerances  for  variations  in  the  concentrations  of  a  preparation's 
ingredients for repeated toxicology trials. 

introducing  a  procedure  for  requesting  confidentiality  that  would  apply  only  to  harmful 
substances that are classified  by their acute lethal  effects. 

•  harmonizing  the  directive's  terminology  with  the  definitions  laid  down  in  Directive 

92/32/EEC. 

•  adapting the annexes to the directive to technical progress. 

1.4 Proposals  relating  to  the  derogations  for  Austria,  Finland  and  Sweden  within  the 

Treaties of Accession 

By  this  proposal  the  Commission  responds  to  the  important  commitments  given  to  the  new 
Member States in the Treaties of the Accession. 

Firstly,  by  introducing  provisions  relating  to  classification,  packaging  and  labelling  of 
pesticides  and  at  the  same  time  repealing  Directive  78/631/EEC  (see  under  point  1.1). 
Secondly,  by  extending  some  provisions  of  the  Directive  to  preparations  not  classified  as 
dangerous. 

2.  JUSTIFICATION  OF THE NEED FOR  MODIFICATIONS 

2.1. from a legislative  standpoint 

In  an attempt  to  simplify  Community  legislation  in the  area  of  classification,  packaging  and 
labelling of preparations the present proposal  on one hand brings together into one  instrument 
the principal  act  and  all  its derivated  legislation  while  at the  same time  makes  amendements 
on matters of substance for reasons of developments on technical  aspects. 

2.2. from the standpoint of Community  harmonization 

The  provisions  related  to  the  classification,  labelling  and  packaging  of  preparations  that  are 
marketed  in  the  European  Union  must  absolutely  be  implemented  in  a  harmonised  way. 

Straying  from  this  principle  would  be  highly  detrimental  to  the  free  circulation  of  the 
preparations in the Community market and thus impede its smooth functioning. 

2.3. from a safety-health-environment  standpoint 

The Community  basis for taking  measures related to human and environmental  health,  safety 
and  protection  is  a high  level  of  protection.  It thus  follows  that  all  provisions  in  line  with 
these  concerns,  such  as  the  adoption  of  classification  criteria  for  environmentally  dangerous 
preparations, should be taken into consideration. 

2.4. from an economic  standpoint 

Applying  uniform  classification  criteria to the  greatest  possible  number  of  different  types  of 
preparations  released  on  the  EU  market  by  the  chemical  sector's  extremely  diverse  array  of 
firms  should have positive consequences for Europe's economy. 

2.5. from  an editorial  standpoint 

Centralizing  all  of the  provisions  relating  to  dangerous  preparations  within  a  single  piece  of 
legislation  is  advisable  for  obvious  practical  reasons.  It  should  enable  users  to  grasp  more 
readily  the  scope  of  this  legislation  and  would  make  the  text  more  accessible  and  easier  to 
understand. 

3. 

COST-BENEFIT  ANALYSIS  OF THE DRAFT DIRECTIVE 

3.1. Additional  costs 

3.1.1.  Impact: 

The  draft  directive  can  have  effects  in two  areas  relating  to the preparations  marketed  in  the 
European Union,  namely, 

1. 

the updating of product  information  that must be provided and 

2. 

the  compiling  of 
unclassified  products. 

information  for  newly  classified  products  and  certain 

It is vital  to take account  of the fact  that updating  information  about products marketed  in the 
European  Union  is  a  constant  process  that  is  not  dependent  solely  on  the  new  directive. 
Health  risk  information  is constantly  being  modified  due to adaptations  to technical  progress 
that  may  be  made  in  the  substances  classified  as  dangerous  (Annex  I  to  Directive 
67/548/EEC)  that  may  go  into  the  products.  As  a result,  the  persons  or  entities  responsible 
for  releasing  products  on  the  market  must  keep  abreast  of  developments  in  European 
legislation  in  this  area  as  well  as  the  related  costs.  However,  it  is  clear  that  adding 
environmental  hazard  evaluation  criteria  to  the  draft  directive  will  entail  classifying  and 
labelling many  products. 

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In  the  case  of  already  labelled  products,  updating  the  information  will  simply  be  a  normal 
operation linked to the above-mentioned process. 

For newly  classified  products and certain unclassified  products, on the other hand,  providing 
such information  will be an additional cost to be taken into consideration. 

The  Commission  took  an  important  criterion  into  account  in  drawing  up  the  principles  for 
assessing environmental  hazards, namely, making certain that the number of  environmentally 
dangerous  products  classified  would  not  exceed  the  number  of  products  classified  as 
dangerous  to  human  health.  This  safeguard  should  lead  to  a fair  balance  as  regards  product 
classification  and should not lead to overlabelling. 

3.1.2. Costs 

There are several different  types of costs, to wit: 

• 

legal costs (knowledge of legislation:  'know-how'), 

• 

technical  costs  (knowledge  of  the  products  and  applicability  of  the  legislation  according 
to product type), 

the sum of the two should  allow product classification  and the development  of a labelling 
scheme and safety  data sheets (SDS). 

The costs may  be deemed  moderate  for  large companies that already  have in-house  labelling 
and  safety  data-sheet  systems  for  their  products,  sometimes  even  for  completely  safe 
preparations.  In the  case  of  SMEs  that  have their  own  product  safety  managers,  the  'know-
how'  and  production  of  safety  data  sheets  may  be  covered  in-house,  but  printing  the  labels 
and safety  data sheets and providing the right packaging will entail additional costs. 

The cost  for  adaptation  of the other enterprises  could  be more  substantial,  that  is to  say, they 
will have to find  the know-how as well as the other services. 

3.2.  Benefits 

The  obligation  to  implement  the  directive's  provisions  may  be  beneficial  on  a  number  of 
scores, for  example, 

•  when  the  manufacturer  considers  changing  his  product's  composition  to  reduce  the  risks 

for human health and the  environment; 

•  by preventing the market being flooded  with products that are considered  dangerous; 

•  by improving the use of information  systems and training in their use; 

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•  by  providing  users  with  better  information  through  the  labelling  of  dangerous  products 

and safety  data sheets. 

The  advantages  are  not  material  only;  they  can  also  be  measured  in  the  following  relative 
terms: 

• 

reduced  risks  of  accidents, thereby  lowering  costs  for  society  (social  security,  illness  and 
accidents); 

•  making users more aware of the choices they must make. 

• 

it  is  worthwhile  pointing  out  that  one  advantage  is  the  elimination  of  redundant  costs 
bound  to  existing  divergent  regulatory  constraints  and  their  impact  on  the  circulation  of 
these products 

4.  CONSULTATIONS  REQUIRED FOR THE DRAFT  REVISION 

The  draft  revision  required  numerous  meetings  of  national  experts.  Meetings  of  specialized 
experts  were  necessary  for  some  particularly  technical  matters,  such  as  safety  data  sheets, 
environmental  danger criteria and pesticides. 

Both  the  Member  States  and  other  bodies  provided  a wealth  of  information  and  contributed 
efficaciously  to the drafting.  Eager to cooperate, the new Member  States participated  actively 
with  the  Commission  in  the  development  of  the  draft  revision,  especially  when  it  came  to 
setting the classification  criteria for environmental  hazards. 

The following  bodies were consulted: 

• 

• 

the Member  States' competent  authorities 

industry, via chemical trade federations  (CEFIC, Eurométaux, etc.). 

Some  special  consumers'  associations,  such  as  associations  of  the  visually  impaired,  were 
also invited to take part in the revision process. 

5. 

ANALYSIS  OF  THE  CHANGES  WITH  REGARD  TO  DIRECTIVE 
88/379/EEC 

It  must  stressed  that  the  proposal  for  revision  was  guided  by  the  same  philosophy  as  that 
which  had  inspired  Directive  88/379/EEC, which means that the principles  that were  adopted 
previously  have not been  challenged. 

The  draft  revision  comprises  twenty-five  articles.  It  contains  a  table  of  repealed  Directives 
taking  transposition  deadlines  into  account  and  also  an  Annex  with  a  table  of  correlation 
between the Directive  88/379/EEC and the new proposal. 

The main changes made in the parent directive are outlined below. 

Changes in Directive  88/379/EEC 

Article 1 

Paragraph  1 

The  scope  is  broadened  to  include  certain  preparations  that  may  present  a  danger  for  users, 
even  if  these  preparations  are  not  classified  as  dangerous  according  to  the  definitions  laid 
down in this Directive. 

Paragraph  3 

These  preparations  are  governed  only  by  the  provisions  of  Articles  9  and  10  the 
corresponding  annexes thereto and the provisions of Article  16. 

The article recognizes that a certain number of preparations that are not considered  dangerous 
as  defined  by  this  Directive  may  nevertheless  present  a  danger  for  man  because  of  their 
specific  properties  and the user's risks of exposure to them.  Consequently,  safety  data  sheets 
must be provided  for  such preparations in compliance with Article 16. 

Paragraph  4 

The  exemptions  granted  to  pesticides  have'been  dropped,  meaning  that  these  products  are 
included  in the scope of the new directive.  However, only some of the provisions, rather than 
the  entire  directive,  apply  to  these  preparations.  The  grounds  therefor  are  given  in  the 
corresponding  articles. 

Inclusion  of Plant protection  products 

Without  prejudice  to  the  provisions  laid  down  in  Directive  91/414/EEC,the  classification, 
packaging  and  labelling  of  plant  protection  products  are  covered  by  the  new  Directive 
(see §1.1.). 

Explosives 

The  Member  States  wanted  explosive  preparations  to  be  covered  by  safety  data  sheets.  We 
must  also  point  out  that  ammunition,  which  was  previously  included  under  Directive 
88/379/EEC, is not covered  by the new directive, since ammunition  is considered  articles, not 
preparations. 

Article 3 

Paragraph 1 

The  determination  of  a  preparation's  dangerousness  has  been  broadened  to  allow  for 
environmental  hazards. 

Paragraph 2 

To make certain  that the person/entity responsible  for releasing products on the market  takes 
all  of  the  dangerous  substances  in  a  preparation  into  account,  a  list  of  the  statuses  of  these 
substances has been included in the text. 

Paragraph 3 

This text replaces the text of Article 3(6) of Directive  88/379/EEC  and  sets the  concentration 
limits  to  take  into  consideration  for  dangerous  substances  based  on  the  different  danger 
categories as defined  in Directive 93/21/EEC. 

Article 5 

This article replaces Article  3(2) of Directive  88/379/EEC  and concerns the determination  of 
physico-chemical  properties. 

Paragraph  1, 2nd hyphen 

The assays need not be repeated when the preparation's composition  is modified  only  slightly. 

Examples of the types of justification  that must be provided include: 

proving one is outside the limits of explosiveness 

proving that a change in the composition produces no change in the flash  point, etc. 

Paragraph  1, 3rd hyphen 

The  text  was  updated  in  line  with  the  new  provisions  of  the  Aerosol  Directive  (Directive 

94/1/EC).13 

Paragraphs 2 

Reference  is made to some exemptions to testing covered  in Annex I to the  project 

13 

OJ  No.  L 23 of  28.1.1994,  p. 28. 

10 

Paragraphs 3 

Reference  is made to the methods of calculation described in Annex I to the present  Directive 
for certain special preparations such as gaseous mixtures.  This addition  is in conformity  with 
Annex VI to Directive 67/548/EEC (labelling guide). 

Paragraph 4 

The principle of classification  laid down in this Directive applies to plant protection products. 
Thus, the physico-chemical  dangers presented by these products  are assessed  by the  methods 
given  in  Annex  V  to  Directive  67/548/EEC  (see  the  preambles  to  Annex  III  to  Directive 
91/414/EEC).  However,  Directive  91/414/EEC  stipulates  that  Good  Laboratory  Practices 
(GLP) must be followed  when assaying such products.  This requirement has been dropped  in 
this Directive (see  1  hyphen 2).  That is why this paragraph was redrafted  accordingly. 

Remark: 

If methods  other  than  those  given  in Annex V to  Directive  67/548/EEC  are  used,  this  raises 
no  problems,  since  the  preamble  to  Annex  V  authorizes  such  a  situation  under  the  same 
conditions as Directive 91/414/EEC. 

Article 6 

This  article  replaces  Article  3(3)  and  (4)  of  Directive  88/379/EEC.  As  Article  3(5)  of  this 
directive  describes  the conventional  method,  it has been transferred  to  Part A of Annex  II to 
the  draft. 

Paragraphs  1 and 2 

The  principles  for  the  determination  of  properties  affecting  health  are  laid  down  in  these 
paragraphs 

Paragraph  3 

As the same principles apply to both industrial preparations and plant protection products and 
that  good  laboratory  principles  must  be  used  in  both  cases  (see  Directive  91/414/EEC)  a 
specific  reference  to  applying  GLP  to toxicity  testing  and  protecting  laboratory  animals  has 
been included,  should assessment of hazards of toxicity be based on such testing. 

Remark: 

This  also  implies  that  carcinogenicity-mutagenicity-toxic  for  reproduction  (CMR)  tests  are 
not permitted  for  plant  protection  products.  However,  there  is no  demand  for  CMR  tests  for 
these preparations  (see Amiex III to Directive 91/414/EEC). 

11 

Paragraph 4 

The  tolerances  on  the  variations  in  the  concentrations  of  a  preparation's  constituents  have 
been  revised  for  repeated  toxicity  trials.  However,  this  provision  does  not  apply  to  the 
products covered by Directive 91/414/EEC. 

Article 7 

Paragraphs  1 and 2 

The principles  for the determination  of properties of danger to the environment  are laid down 
in these paragraphs 

These articles and the corresponding annexes are the most important new developments  in the 
draft  Directive.  The  aim is to  include provisions relating to the assessement  of the danger of 
preparations  for the  environment. 

The  article  basically  adheres  to  the  same  philosophy  as  that  underlying  the  assessment  of 
effects  on  health,  that  is,  one  may  either  use  a  conventional  method  based  on  the 
concentration  limits  on  the  substances  of  which  the  preparation  is  composed  or,  under 
conditions specified  in Annex III C, conduct tests on living organisms. 

Remark 

Pending  development  of  criteria  for  the  terrestrial  environment  in  Annex  VI  to  Directive 
67/548/EEC, in the case of Plant Protection Products, the provisions of Directive 91/414/EEC 
must  be  taken  into  account,  since  this  Directive  refers  to  dangerous  properties  for  the 
terrestrial  environment. 

Article 8 

This  article  replaces  Article  5  of  Directive  88/379/EEC  and  contains  the  following 
modifications: 

Paragraph  3 

Two new indents have been  added to specify  the type of documentation  that the person/entity 
responsible  for  placing the products  on the market  must keep to prove the Directive  has been 
complied  with  fully. 

Paragraph  4 

This  paragraph  allows 
the  Member  States'  national 
authorities.  The  aim  of  this  provision  is to  facilitate  the  management  of  and  verification  of 
compliance with this Directive. 

information  exchanges  between 

12 

Article 9 

This  article  replaces  Article  6  of  the  directive.  It  was  updated  in  conformity  with  similar 
provisions  in Directive  92/32/EEC  and refers  to Annex  IV to this directive, which  sets  forth 
the instructions  applicable  to the packaging  of certain preparations  that  are offered  or  sold  to 
the public at large such as defined  in Directives 90/35/EEC and 91/442/EEC. 

Article 10 

This article replaces Article 7 of Directive  88/379/EEC and contains the following  changes: 

Paragraph  1.1 

It  is  stipulated  that  minimum  labelling  requirements  apply  to the  preparations  referred  to  in 
Article  1(3) of this Directive. 

Paragraph  1.2. 

This  paragraph  adresses  the  principle  for  labelling  plant  protection  products  on  the  basis  of 
the  competent authorities' conclusions using both the results of the classification  scheme  that 
complies  with  this  proposed  Directive  and  the  results  of  the  assessment  deriving  from  the 
authorisation  procedure  such  as  provided  for  in  Directive  91/414/EEC.  Detailed  rules  for 
labelling  of  plant  protection  products  will  be  developed  in  accordance  with  the  Committee 
procedure of the present Directive. 

Paragraph  2.3:  chemical names 

The  provisions  of  Article  7  of  Directive  88/379/EEC  have  been  kept  in  this  proposal. 
However,  the  following  change  have  been  made;  the  names  of  substances  which  must  be 
clearly  specified  on the  label  are indicated  by reference  to their danger  categories  and  not by 
reference  to specific  R phrases. 

Paragraph 2.3.4 

This  paragraph  describes  the  names  of  the  substances  that  do  not  necessarily  have  to  be 
specified  by danger  category. 

Paragraph  2.3.5:  confidentiality 

This  paragraph  has  been  changed  slightly  to  define  the  only  substances  for  which 
confidentiality  may  be  requested  and  to refer  to  Article  11, which  defines  the  procedures  for 
making this request. 

13 

Paragraphs 2.5 and 2.6:  R and S phrases 

Provisions  relating  to  the  R  and  S  phrases  for  preparations  that  are  dangerous  for  the 
environment  have  been  added.  The  number  of phrases  to  be  printed  has  been  changed  and 
raised to six in both cases. 

Paragraph 3 

Introduction  of  a  feasibility  clause  allowing  certain  preparations  classified  as  dangerous  for 
the environment  and  covered  by Annex  V to this Directive to be  labelled  differently.  These 
particulars will also be included  in the said Annex V. 

Paragraph 4 

Changes  concerning  125-ml packages:  The R phrase  and  safety  advice  (S phrase)  will  have 
to be printed  on  the  labels  of  preparations  classified  X{ that  have been  assigned  phrase  R41 
('Risk  of serious damage to eyes.'). 

Article 11 

This  article  has  been  added  to  Directive  88/379/EEC.  It  concerns  the procedures  governing 
the  request  for  confidentiality  for  a  dangerous  substance  entering  into  a  preparation's 
composition  that  has  been  classified  'harmful'  on  the  basis  of  its  acute  lethal  effects.  This 
article also refers to Annex VI of this Directive for more ample technical  information. 

Article 12 

This  article  has  also  been  added  to  Directive  88/379/EEC. 
It  lays  down  an  information 
exchange  procedure  for  the  Member  States'  authorities  and  then  between  the  latter  and  the 
Commission as regards requests for  confidentiality. 

Article 13 

This  is basically  the  same as Article  8 of Directive  88/379/EEC  brought  in  line with  the  text 
of Directive  92/32/EEC.  However,  the minimum  label  size  specifications  have  been  moved 
to Annex VI to Directive 67/548/EEC (labelling guide). 

Article 14 

Paragraph 3 

This  article  is  a  modified  version  of  Article  9  of  Directive  88/379/EEC.  It  has  also  been 
brought  in line with the corresponding article of Directive 92/32/EEC. 

It  states  that  certain  preparations  -  notably  explosives  and  specific  preparations  defined  in 
Annex VII to this Directive - may derogate from  the labelling provisions. 

-  14 -

Article 15 

This article solves the following  problem: 

A customer  must  always have  the possibility  of refusing  to  buy  a product  if the  information 
given  on the  label  shows  that  the  product  is  dangerous,  especially  in  the  case  of  mail-order 
purchases.  It thus  seems useless to mention the danger  or dangers  in product  advertisements 
in  all  cases,  unless  the  recipient  is  bound  to  the  purchase  agreement  without  having  had  a 
chance to read the label. 

Article 16 

This  article  is  completely  new.  It provides  that  the  person/entity  responsible  for  placing  on 
the  market  a  dangerous  preparation  for  industrial  use  must  provide  a  safety  data  sheet  with 
the first delivery. 

This  provision  also  applies  to  preparations  that  are  not  classified  as  dangerous  by  virtue  of 
Articles  5,  6  and  7  of  the  directive  but  contain  at  least  one  dangerous  substance  in  a 
concentration  greater  than  or equal  to  1% w/w  or  0.2%  v/v.  However,  in this  case, the  data 
sheet shall be provided only if requested by the recipient. 

Articles  17,18,19, 20 and 21 

These  articles  have  been  brought  into  line  with  the  corresponding  articles  of  Directive 
92/32/EEC. 

Article 22 

Standard article used in the context of a recast of a Directive. 

Articles 23 to 25 

These articles are relating to the entry into force  of the Directive with an exact date. However, 
it  is  foreseen  that  5  years  between  the  date  of  adoption  and  the  date  of  entry  into  force  is 
needed  for  practical  reasons  to  allow  enough  time  for  the  industry  to  adapt  to  the  new 
legislation. 

Annexes 

Annex I 

concerns  the  assessment  of  the  preparation's  physico-chemical  properties 
pursuant to Article 5. 

Annex II,  A & B 

concerns  the  assessment- of  preparations'  effects  on  health. 
corresponds to Annex I of Directive  88/379/EEC. 

Part  B 

-  15 -

Annex III, A, B & C  concerns the assessment of dangers for the environment 

Annex III, D & E  concerns 

the 

labelling  criteria  for  preparations  dangerous  for 

the 

environment 

Annex  IV 

Annex  V 

concerns  safety  closure devices and tactile warnings  (taken  from  Directive 
91/442/EEC) 

concerns  particular  labelling  provisions  for  some  special  preparations. 
This annex corresponds to Annex II to Directive 88/379/EEC. 

Annex  VI,  A & B  concerns  the  procedures  for  requesting  confidentiality  for  an  ingredient 
that  is  classified  as  a  harmful  substance  solely  on  the  basis  of  its  acute 
lethal  effects. 

Annex  VII 

concerns specific  preparations covered by Article  14 of this Directive. 

Annex  VIIIA 
B 

repealed  Directives 
deadline for  transposition 

Annex  IX 

Correlation, table 

6. 

LEGAL  BASE 

The  proposed  revision  is  aiming  at  the  realisation  of  the  Internal  Market  by  ensuring  free 
circulation  of  goods  and  high  level  of protection  of human  health  and the  environment.  As a 
consequence  it is based on Article  100 A paragraph 3 of the Treaty. 

7. 

CONSULTATION  OF  THE  EUROPEAN  PARLIAMENT  AND  ECONOMIC 
AND SOCIAL  COMMITTEE 

In  accordance  with  Article  100A  of  the  Treaty,  the  co-decision  procedure  applies.  The 
Economic and  Social  Committee must also be consulted. 

16 

Proposal for an European Parliament and Council Directive concerning the 
approximation  of the laws, regulations and administrative  provisions of the 
Member States relating to the classification,  packaging and labelling of dangerous 
preparations 

THE EUROPEAN  PARLIAMENT AND THE COUNCIL OF THE EUROPEAN  UNION, 

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

Having regard to the proposal  of the Commission1, 

Having regard to the opinion of the Economic and  Social  Committee2 

Acting  in accordance with the procedure  laid down in Article  189 b of the Treaty1 

(1)  Wliereas  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  preparations4  has  been  amended  on  several  occasions; 
whereas  on  the  occasion  of further  amendments, the  said  Directive  should,  for  reasons  of  clarity 
be recast; 

(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 
establishment  and  functioning  of the  internal  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, 
of  persons  who  come  into  contact  with  dangerous  preparations  in the  course  of their  work  or  in 
the pursuit of a hobby, of consumers, and also 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,  due  to  their  composition,  present  a danger  for  children;  whereas  the  packaging  of 
such preparations  should therefore  be equipped  with child  resistant  fastening; 

(5)  Whereas  it  is  necessary  to  provide  concentration  limits  in  the  case  of  preparations  marketed  in 
gaseous  form;  whereas  concentration  limits  expressed  as  a  volume/volume  percentage  are 
therefore  inserted  into Annex 11; 

2 
3 
4 OJ n° L 187 of  16.7.1988 p. 14 -Directive as last amended by Commission Directive 93/18/EEC (OJ n° LI04 

of 29.4.1993, p.46) 

4i 

(6)  Whereas  Annex  V  to  this  Directive  contains  special  labelling  provisions  applicable  to  certajn 
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 Article  1.3, may present a danger to the user; 

(7)  Whereas  in April  1992 the Council  adopted  Directive  92/32/EEC amending  for  the  seventh  time 
Council  Directive  67/548/EEC  on  the  approximation  of the  laws, regulations  and  administrative 
provisions  relating  to  the  classification,  packaging  and  labelling  of  dangerous  substances5  6; 
whereas  in  April  1993  the  Commission  adopted  Directive  93/21/EEC  adapting  to  technical 
progress for the eighteenth  time Council  Directive 67/548/EEC on the approximation  of the laws, 
regulations and administrative  provisions relating to the classification,  packaging and  labelling of 
dangerous  substances7;  whereas  new  criteria  developed  for  classifying  and  labelling  substances 
dangerous for the environment  were introduced  by these Directives with the appropriate  symbols, 
indication  of  danger,  risk  phrases  and  safety  advices  for  labelling  requirement;  whereas 
provisions  should  be  adopted  at  Community  level  on  the  classification  and  labelling  of 
preparations  to  take  account  of  their  effects  on  the  environment  and  whereas  it  is,  therefore, 
necessary  to  introduce  a  method  for  assessing  the  hazards  of  a  preparation  to  the  environment 
either by a calculation  method, or by determining  the ecotoxicological  properties  by test  methods 
under certain  conditions; 

(8)  Whereas  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  laws, regulations and administrative  provisions of the Member  States  regarding 
the  protection  of  animals  used  for  experimental  and  other  scientific  purposes8;  whereas  Article 
7(2)  of  the  above-mentioned  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; 

(9)  Whereas  classification,  packaging  and  labelling  of plant  protection  products  covered  by  Council 
Directive  78/63 1/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)9 
require  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 market10 ; 

(10)  Whereas Council  Directive 91/414/EEC  and Council  Directive  .../../EC11 on  biocides,  in  contrast 
to  chemical  preparations  covered  by  the  present  Directive,  provides  for  an  authorization 
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,  and  furthermore  that 
to  the  classification, 
this  authorization  procedure  includes  a  control  relating  specifically 
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  plant  protection 

5 OJ n° L  196 of  16.8.1967, p.l.  Directive as last amended  by Commission  Directive 94/69/EC (OJ  n°L381  of 

31.12.1994,  p.l) 

6  OJn°L  154 of 5.6.1992, p.l 
7O J n °L  110of4.5.1993,p.20 
8O J n ° L 3 5 8 of  18.12.1986, p.l 
9OJ  n° L 206 of 29.7.1978 , p. 13. Directive as last amended  by Council  Directive 92/32/EEC  ( cf 5) 
10 OJ n° L 230 of  19.8.1991, p.l.  Directive  as last amended  by Commission  Directive 94/79/EC  (OJ  n°L 354 of 

31.12.1994,  p. 16) 

11  OJn°L 

% 

products according to the provisions of this Directive, to label them by taking  into account both 
the  classification  and  labelling  rules  of  the  present  Directive  and the  results  of  the  evaluation 
carried  out  in the  framework  of  Council  Directive  91/414/EEC  and to  ensure  that  the  labelling 
satifies  the  high  level  of  protection  sought  by  both  this  Directive  and  Directive  91/414/EEC; 
whereas  also  a  safety  data  sheet  has  to  be  established  in  accordance  with  this  Directive  but 
subject to the authorization  procedure of the Directive on plant protection products; 

(11)  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  such 
preparations; 

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

(13)  Whereas the  label  constitutes a basic tool for  users of the dangerous  preparations  by giving them 
the  initial  essential  concise  information;  whereas  it nevertheless  needs to  be  supplemented  by a 
two-fold  system  of  more  detailed  information,  one,  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  in implementation  of Article  10 of Directive  88/379/EEC12 and the other 
the  bodies  appointed  by  the  Member  States  and  whose  responsibility  is  to  give  information 
reserved  solely for  medical purposes, both curative and preventive; 

(14)  Whereas  the  confidentiality  for  certain  substances  contained  in  the  preparations  should  be 
guaranteed  and  whereas  it  is,  therefore,  necessary  to  institute  a  system  which  allows  the 
manufacturer  to request confidentiality  for such substances; 

(15)  Whereas  the  provisions  of  this  Directive  are  without  prejudice  to  the  commitment  entered  into 
by  the  Community  and  its  Member  States,  in  accordance  with  the  goals  set  under  Agenda 21, 
Chapter  19, at  the  UNCED  conference  of  June  1992  in  Rio  de  Janeiro,  to  strive  for  the  future 
harmonization  of systems for the classification  of dangerous substances and preparations; 

(16)  Whereas the  Commission  should  be  given  the powers  necessary  to adapt all the Annexes  to  this 

Directive to technical  progress; 

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

HAVE  ADOPTED  THIS  DIRECTIVE: 

12OJn°L76of22.3.1991,p.35 

Directive last amended by Commission  Directive 93/112/EEC (OJ No L314, 16.12.1993, p.38) 

A<\ 

TABLE  OF  CONTENTS 

Article 1 

Objectives  and scope 

Article 2 

Definitions 

Article 3 

Article 4 

Article 5 

General  principles  for  the  determination  of 
dangerous  properties 

General  principles  of  classification 
labelling 

and 

Evaluation  of  the  hazards  deriving 
physico-chemical  properties 

from 

Article 6 

Evaluation  of health hazards 

Article 7 

Evaluation  of environmental  hazards 

Article 8 

Article 9 

Obligations and duties of the Member  States 

Packaging 

Article  10 

Labelling 

Article  11 

Article  12 

Confidentiality  of  the  identity  of  a  chemical 
name: procedures and details 

Exchange  of  information  concerning  requests 
for  confidentiality  between  he  Commission 
and the Member  States 

Article  13 

Implementation  of the labelling  requirements 

Article  14 

Exemptions  from  the  labelling  and  packaging 
requirements 

Article  15 

Advertisements 

Article  16 

Safety  data sheet 

Article  17 

Article  18 

Rights  of  Member  States  regarding  safety  of 
workers 

Bodies  responsible  for  receiving  information 
relating to health 

Article  19 

Free movement  clause 

Article 20 

Safeguard  clause 

Article 21 

Procedure  for adaptation  to technical  progress 

oU> 

Article 23 

Implementation  of the Directive 

Annex I 

Methods 
the  evaluation  of  physico-
chemical  properties  in accordance with Art. 5 

for 

Annex II part A 

Method of evaluation  of health  hazards 

Annex II part B 

Concentration 
conventional method  Art.6 

limits  to  be  used  for 

the 

Annex III part A 

Method  of  evaluation  of  the  environmental 
hazards 

Annex III part B 

Concentration 
conventional  method  Art.7 

limits 

to  be  used  for 

the 

Annex III part C 

Test  methods  for 
hazards for the aquqtic  environment 

the  evaluation  of 

the 

Annex III part D 

Indications  concerning 
phrases) 

special 

risks 

(R 

Annex III part E 

Indications  concerning 
phrases) 

safety  advice 

(S 

Annex IV 

Special  provisons  for  containers  containing 
preparations  offered  or  sold  to  the  general 
public 

Annex V part A 

Special  provisions  for  the  labelling  of  certain 
preparations A 

Annex V part B 

Special  provisions  for  the  labelling  of  certain 
preparations B 

Annex V part C 

Special  provisions  for  the  labelling  of  certain 
preparations C 

Annex VI part A 

Information 
request for  confidentiality 

to  be  communicated 

in 

the 

Annex VI part B 

Lexicon 
establishing 
alternative designations (generic  names) 

-  guide 

for 

the 

Annex VII 

Preparations covered  by Article  14(2) 

AnnexVlll  part A 

Repealed  Directives 
Article 22 

in  accordance  with 

AnnexVlll  part B 

Deadlines 
application  in accordance with Article 22 

transposition 

and 

for 

for 

Annex IX 

Correlation  table 

o fc  ^ 

Objectives and  scope 

Article 1 

1.  This  Directive  aims  at the  approximation  of the  laws, regulations  and  administrative  provisions 

of the Member  States concerning: 

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

2.  This Directive  shall  apply to preparations  which: 

- contain at least one dangerous substance within the meaning of Article 2 
and 
- are considered  dangerous within the meaning of Articles 5, 6 or 7. 

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  16 
of this  Directive  shall  also  apply  to  preparations  which  are not  considered  dangerous  within  the 
meaning of Articles  5, 6 or 7 but may nevertheless present a hazard to the user. 

4.  Without  prejudice  to  the  provisions  of  Directive  91/414/EEC  concerning  the  placing  of  plant 
protection  products  on  the  market,  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)  medicinal  products  for  human  or  veterinary  use,  as  defined 

in  Council  Directive 

65/65/EEC(b); 

(b)  cosmetic  products  as defined  in Council Directive 76/768/EEC 
(c)  mixtures  of  substances  which,  in  the  form  of  waste,  are  covered  by  Council  Directives 

; 

75/442/EEC(15) and  78/319/EEC (16); 
foodstuffs, 

(d) 
(e)  animal  feedingstuffs, 
(f)  preparations  containing  radioactive substances as defined  by Directive  80/836/Euratom 
(g)  medical  devices  covered  by  Directives  90/385/EEC  \  and  93/42/EEC 
intended  to be implanted,  invasive or used  in direct contact with the body. 

, 

,  which  are 

(13)OJ No L 22, 09.02.1965, p. 369/65. 

Directive last amended by Directive 93/39/EEC (OJ No L214, 24.08.1993, p.22) 

(14)OJ No L262, 27.09.1976, p.169. 

Directive last amended by Directive 93/47/EEC (OJ No L203, 13.08.1993, p.24) 

(15)OJ No L194, 25.07.1975, p.39: 
(16)OJ No L84, 31.03.1978, p.43. 
(l7)OJNoL46,  17.09.1980, p.l. 
(18)OJ No L189, 20.7.1990, p.17. 
(19)OJNoL169,12.7.1993,p.l. 

h 

In addition, 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. 

Definitions 

Article 2 

The definitions  appearing  in Article 2 of Directive 67/548/EEC, with the exception  of the definition  in 
paragraph  1  (d) thereof, shall apply to this Directive. 

Article 3 

General  principles  for the determination  of dangerous properties of  preparations 

1.  The evaluation  of the hazards of a preparation  shall be based on the determination  of : 

- 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 of this Directive. 
Where  laboratory  tests  are  conducted,  they  must  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  of  this  Directive,  all  dangerous  substances  within  the  meaning  of  Article  2  of  Directive 
67/548/EEC 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  labelled  provisionally  by the person responsible  for  placing on the market  in  accordance 

with Article  6 of Directive  67/548/EEC 

-  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 labelled  in accordance with Article  13(2) of Directive  67/548/EEC 

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

& 

For  preparations  covered  by  this  Directive,  dangerous  substances  such  as  defined  in  paragraph .2 
above  which  are  classified  dangerous  on  the  basis  of  their  health  effects  and  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. 

Category  of danger 

of the substance 

Concentration  to take  into consideration  for 

gaseous preparations 
% vol/vol 

other  preparations 
% w/w 

Very Toxic  T+  R26, R27, R28, 
R39 

Toxic  T R23, R24, R25, 
R39, R48 

Carcinogenic  Care. Cat.  1  or 2 
R45, R49 

Mutagenic  Muta. Cat.  1  or 2 
R46 

Toxic for  reproduction  Cat.  1  or 2 
R60 Fertility or 
R61  Development 

Harmful  Xn R20, R21,  R22 

R40, R48 

Harmful  Xn R65 

Corrosive  C, R35, R34 

Irritant  Xi R41, 

R36, R37, R38 

> 0  02 

> 0  02 

> 0 02 

> 0 02 

^ °>02 

> 0  2 

- 

> 0,02 

>02 

Sensitizing  R42, R43 

> 0,2 (R42) 

Carcinogenic  Care. Cat. 3 
R40 
Mutagenic  Muta. Cat.3 
R40 
Toxic  for reproduction  Cat. 3 
R62 Fertility  or 
R63  Development 

> 0 2 

> 0 2 

> Q 2 

Dangerous  for  environment  aquatic  N, R50, 
R51,R53 

Dangerous  for environment  ozone  N, R59 

> Q j 

Dangerous for  environment 
aquatic  R52, R53 

Dangerous  for environment 
ozone  R59 

Dangerous  for environment 
other  R54,  R55, R56/R57,  R58 

> Q  J 

lb 

> 0  1 

>01 

> 0 1 

> 0 1 

^<U 

>\ 

> 1 

> 1 

> 1 

> 1 

> 1 

> 1 

>  j 

> Q j 

>0.\ 

>  j 

> Q. I 

> Q. ] 

General  principles of classification  and  labelling 

Article 4 

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

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

Evaluation  of the hazards  deriving  from  physico-chemical  properties 

Article 5 

1.  The  hazards  of  a preparation  deriving  from  its physico-chemical  properties  shall  be  assessed  by 
determining,  by means  of the methods  specified  in part  A of Annex  V to Directive  67/548/EEC, 
the  physico-chemical  properties  of  the  preparation  necessary  for  appropriate  classification  and 
labelling  in accordance  with the criteria of Annex VI to that  Directive. 

By way of derogation  from  the preceding: 

the  determination  of  the  explosive,  oxidising,  extremely  flammable,  highly  flammable,  or 
flammable  properties  is not necessary provided, however, 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  (20) as last amended  by Directive  94/1/EC(21) 

2.  For certain  cases  for  which  the  methods  of  Part  A  of  Annex  V to  Directive  67/548/EEC  are  not 
appropriate, alternative calculation  methods referred  to in Annex I part B to this Directive. 
3.  Some  exemptions  to  the  application  of  the  methods  of  Part  A  of  Annex  V  to  Directive 

67/548/EEC  are referred  to part A to Annex I to this Directive. 

4.  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  for  appropriate  classification  in  accordance  with  criteria  of  Annex  VI  to  Directive 
67/548/EEC.  These  physico-chemical  properties  will  be  determined  by  means  of  the  methods 
laid  down  in  part  A  of  Annex  V  to  Directive 67 / 548 / EEC  unless  other  internationally 
recognized  methods  are  acceptable  in  accordance  with  the  provisions  of  Annexes  II  and  III  to 
Directive  91/414/EEC. 

(20)OJ  No  L  147, 09.06.1975, p. 40 
(21)OJ  No  L 23, 28.01.1994, p. 28. 

OH 

Article 6 

Evaluation  of health  hazards 

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

procedures: 

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

concentration  limits; 

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

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

more of the following  procedures : 

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

concentration  limits; 

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

3.  When  a toxicological  property  is established  by method  1(b) or 2(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(22) and with the provisions of Directive  86/609/EEC. 

Any  of the toxicological  properties  of the preparation  which  are  not  assessed  by the  method  set 
out in  1(b) or 2(b) above shall be assessed  in accordance with the conventional  method. 

Where  a  toxicological  property  has  been  established  by  both  the  methods  above,  the  result  of 
method  1(b)  or  2(b)  shall  be  used  for  classifying  the  preparation  except  in  the  case  of 
carcinogenic,  mutagenic  effects  and  toxic  effects  for  reproduction  for  which  only  the 
conventional  method  described  in Annex II applies. 

Furthermore, where  it can  be demonstrated  that : 

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

-  owing  to  effects  such  as  potentiation  a  conventional  assessment  would  underestimate  the 

toxicological  hazard, these effects  shall be taken  into account  in classifying  the  preparation, 

( 2 2 )OJNoL  15, 17.01.1987, p. 29. 

35 

-  owing  to  effects  such  as  antagonism,  a  conventional  assessment  would  overestimate  the 

toxicological  hazard, these effects  shall be taken  into account in classifying  the preparation. 

For  preparations  of  a  known  composition  with  the  exception  of  those  covered  by  Directive 
91/414/EEC, classified  in accordance with method  1(b) above a new evaluation  of health  hazard 
either by method  1(a) or  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  manufacturer, 
in accordance with the following  table : 

Initial concentration 
range of the constituent 

Permitted variation in 
initial concentration of 
the constituent 

< 2,5 % 

>2,5<  10% 

>  10 <  25% 

>  25 < 100% 

± 30 % 

± 2 0% 

±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  of  this  Directive, 
are introduced  by the  manufacturer. 

This will apply  unless there  is valid  scientific justification  for considering  that a re-evaluation  of 
the hazard will not result in a change of  classification. 

In  accordance  with  paragraph  l.a)  and  2.a), the  health  effects  of  a preparation  shall  be  assessed 
by  the  conventional  method  described  in  Parts  A  and  B  of  Annex  II  to  this  Directive,  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 Annex II to this Directive, 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 Annex  II to this  Directive, the concentration  limits  shall  be 
assigned  in accordance with the specifications  in Part B of Annex II to this Directive. 

& 

Article 7 

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  Parts  A  and  B  of  Annex  III  to  this  Directive  using 

concentration  limits, 

(b)  by  determining,  by  means  of  the  methods  specified  in  Part  C  of  Annex V  to  Directive 
67/548/EEC,  the  hazards  of  a  preparation  for  the  environment  necessary  for  appropriate 
classification  and  labelling  in  accordance  with  the  criteria  defined  in  Annex  VI  to  that 
Directive.  The  conditions  of  application  of  the  test  methods  specified  above  shall  be  as 
described  in Annex  III  Part Cto  this Directive. 

2.  The  environmental  hazards  of  a preparation  covered  by  Directive  91/414/EEC  shall  be  assessed 

by one or more of the following  procedures : 

(a)  by  a  conventional  method  described  in  Parts  A and  B of  Annex  III  to  the  present  Directive 

using concentration  limits 

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

When an ecotoxicological  property  is established  by method  l.(b)  or 2.(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  by  both  the  procedures  mentioned  above, 
the  results  of  the  methods  referred  to  in  l.(b)  or  2.(b)  shall  be  used  for  classifying  the 
preparation. 

For  preparations  of  a  known  composition  with  the  exception  of  those  covered  by  Directive 
91/414/EEC  classified  in accordance with method  l.(b)  above a new evaluation  of  environmental 
hazard  either  by method  1 .(a) or  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  manufacturer, 
in accordance  with the following; table : 

& 

Initial  concentration 
range of the constituent 

Permitted variation in 
initial concentration  of 
the constituent 

< 2,5 % 

>2,5<  10% 

>  10 <  2 5% 

>  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  of  this  Directive, 
are  introduced  by  the  manufacturer. 

This  will  apply  unless  there  is valid  scientific  justification  for  considering  that  a  re-evaluation  of 
the  hazard  will  not  result  in  a change  of  classification. 

5. 

In  accordance  with  paragraphs  l.(a)  and  2.(a)  above,  the  environmental  hazards  of  a  preparation 
shall  be  assessed  by  the  conventional  method  described  in  Parts  A  and  B  of  Annex  III  to  this 
Directive,  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  Annex  III  to  this  Directive,  these  concentration  limits  must  be  used. 

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

the  concentration 

Obligations  and  duties  of  the  Member  States 

Article  8 

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  therewith. 

2. 

If  there  is  any  doubt  with  regard  to  the  compliance  referred  to  in  paragraph  1, the  authorities  of 
the  Member  States  may  request  information  on  the  composition  of  the  preparation  and  any  other 
pertinent  information  from  any  person  responsible  for  placing  on  the  market. 

3.  Without  prejudice  to  Article  8.2,  the  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, 
-  any  pertinent  information  relating  to  packaging  requirements  according  to  Article  9,  paragraph 
1  (3),  including  the  test  certificate  issued  in  accordance  with  Part  A  of  Annex  IX  to  Directive 
67/548/EEC, 

- t he  data  used  for  establishing  the  safety  data  sheet,  in  accordance  with  Article  16  of  this 

Directive. 

S 

4.  The  Member  States  shall  inform  the  Commission  of  the  name  and  full  address  of  the  national 
authorities responsible for communicating and exchanging  information relating to the management 
of this Directive. 

The Commission  shall publish the list in the Official  Journal. 

Article 9 

Packaging 

Member  States shall take all necessary measures to ensure that : 

1.1.  preparations  within  the  meaning  of  Article  1.2.  and  those  defined  in  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 the contents, or liable to form  dangerous compounds with the contents; 

-  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; 

-  containers  fitted  with  replaceable  fastening  devices  shall  be  so  designed  that  the  packaging 

can be refastened  repeatedly without the contents escaping; 

1.2.  containers  which  contain  preparations  within  the  meaning  of  Article  1.2.  and  those  defined  in 

Annex IV pursuant to Article  1.3. offered  or sold to the general public do not have : 

-  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  human  and  animal  foodstuffs,  or medicinal  or 

cosmetic products. 

1.3.  containers which  contain  certain  preparations offered  or sold to the general  public and defined  in 

Annex IV to this Directive: 

-  are fitted  with child-resistant  fastenings 

and/or 

-  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. 

X 

Article 10 

Labelling 

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

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 Part A of Annex V to this Directive. 

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 
paragraphs  2.1  and  2.2  hereunder  and the specific  provisions  of Parts  B and  C of Annex  V to 
this  Directive. 

1.2.  Member  States, through  the authorities  designated  in Article 9(1) of Directive 91/414/EEC, shall 
take  all  necessary  measures  to  ensure  that  the  preparations  covered  by  the  above-mentioned 
Directive  are  labelled  on the  basis  first  of the classification  criteria  in this  Directive  and  second 
the assessment  conclusions  in accordance  with the provisions  of the above-mentioned  Directive, 
without reducing the  level of protection 

2.  The following  information  shall be clearly and indelibly marked on any package: 

2.1.  the trade name or designation  of the preparation; 

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

2.3.  the chemical  name(s) 

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

2.3.1.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,  Annex II  B of this 
Directive have to be taken  into consideration 

2.3.2.for  preparations  classified  C in accordance with  Article  6, only the  substances  C present  in 
concentration  equal  to or  greater  than  the  lowest  limit  (limit  Xi)  laid  down  in Annex  I of 
Directive  67/548/EEC  or,  failing  that,  Annex  II  B of  this  Directive  have  to  be  taken  into 
consideration 

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

As  a  general  rule  a  maximum  of  four  chemical  names  shall  suffice  to  identify  the 
substances  primarily  responsible  for the  major  health  hazards which  have given  rise to the 

5o 

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

carcinogen  category  1, 2 or  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  : 
- 
-  mutagen  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 
- 
sensitizing 
- 

toxic  for  reproduction  category  1, 2 or  3 

shall  be  mentioned  on  the  label. 

The  chemical  name  shall  be  one  of  the  designations  listed  in  Annex  I  to  Directive 
67/548/EEC  or  an  internationally  recognised  designation  if  it  is not  yet  listed  therein. 

2.3.4.As  a  consequence  of  the  above  provisions  the  name  of  the  substance(s)  which  led  to  the 

classification  of the  preparation  in  the  following  danger  categories: 

extremely  flammable 

- 
explosive 
-  oxidising 
- 
-  highly  flammable 
- 
- 
-  dangerous  for  the  environment 

flammable 
irritant 

need  not  be  mentioned  on  the  label  unless  the  substance(s)  has  (have)  already  been 
mentioned  pursuant  to  2.3.1.  or  2.3.2. 

2.3.5.Where  the  disclosure  on  the  label  of  the  chemical  identity  of  a  harmful  or  harmful  in 
combination  with  one  of  the  properties  mentioned  in  2.3.4  presenting  acute  lethal  effects 
alone  will  put  at  risk  the  confidential  nature  of  his  property,  the  person  responsible  for 
placing  the  preparation  on  the  market  may  request  the  application  of  the  procedure  of 
Article  11 with  a view  to  using  an  alternative  name. 

2.4.  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  Annex  II  and  the 
provisions  of  Annex  VI  to  Directive  67/548/EEC  and  shall  be  applied  in  accordance  with  the 
evaluation  of  the  hazards  in  accordance  with  Annexes  I, II  and  III  to  this  Directive. 

Where  more  than  one  danger  symbol  has  to  be  assigned  to  a preparation  : 

- 

- 
- 
- 

the  obligation  to  apply  the  symbol  T  shall  make  the  symbols  C  and  X  optional  unless 
otherwise  specified  in  Annex  I to  Directive  67/548/EEC 
the  obligation  to  apply  the  symbol  C  shall  make  the  symbol  X  optional 
the  obligation  to  apply  the  symbol  E shall  make  the  symbols  F and  O  optional 
if  the  symbol  Xn  and  the  indication  of  danger  "harmful"  are  assigned,  the  symbol  Xj  and 
indication  of  danger  "irritant" arc  optional. 

31 

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

2.5.  the risk phrases (R phrases) 

The  indications  concerning  special  risks  (R  phrases)  shall  conform  to  the  wording  in  Annex  III 
and  the  provisions  of  Annex  VI  to  Directive  67/548/EEC  and  shall  be  assigned,  in  accordance 
with the results of the hazards evaluation  in accordance with Annex  I, II, and  III to this Directive. 

The  indications  concerning  special  risks (R phrases)  for  preparations  classified  as dangerous  for 
the  environment  shall  conform  to  the  wording  of  Annex  III  D  of  this  Directive  and  shall  be 
assigned  in  accordance  with  the  results  of  the  hazards  evaluation  in  accordance  with  Annex  III 
A, B and C to this Directive. 

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,  these  standard 
phrases  must  cover  all the  principal  hazards  associated  with the  preparation.  In  some  cases  more 
than six R phrases may be necessary. 

The standard  phrases "extremely  flammable"  or "highly  flammable"  need  not be indicated  where 
they describe an  indication  of danger used  in accordance with  paragraph  2.4. 

2.6. the safety  advice (S phrases) 

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

The  indications  giving  safety  advice  six  (S  phrases)  for  preparations  classified  as  hazardous  to 
the environment  shall  conform  to the  wording  of  Annex  III  E of the  present  Directive  and  shall 
be assigned  in accordance  with the results of the hazards evaluation  in accordance with  Annex III 
A, B and C 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. 

2.7.  the  nominal  quantity  (nominal  mass  or  nominal  volume)  of  the  contents  in  the  case  of 

preparations  sold to the general  public. 

3.  By  way  of  derogation  to  2.4,  2.5  and  2.6,  exemptions  to  certain  provisions  on  labelling  in  the 
articles  mentioned  or specific  provisions  on  labelling replacing  those  may  be  indicated  in  Annex 
V A and  B for  certain  preparations  classified  as  dangerous  within  the  meaning  of  Article  7 and 
defined  in Annex  V to this  Directive. 

3X 

4. 

If the contents of the package do not exceed  125 ml : 

- 

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

- 

in  the  case  of  flammable  preparations  there  is  no  need  to  indicate  the  safety  advice 
(S phrases). 

5. 

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

Article 11 

Confidentiality  of the identity of a chemical  name : procedures and details 

1.  Where the  person  responsible  for  placing a dangerous  preparation  within the  meaning  of  Article 
1.2.  on the market  avails  himself of the provisions of Article  10 paragraph  2.3.5. he shall  make a 
request  for  confidentiality  to the  competent  authority  of one of the Member  States  in which  the 
preparation  is to be placed  on the market. 

2.  This  request  must  provide  the  information  required  in  the  form  in  Part  A  of  Annex  VI  to  this 
Directive, without prejudice to further  information  requested by the competent authority from the 
person  responsible  for  placing  the  preparation  on  the  market  if  it appears  necessary  to  evaluate 
the validity of the  request. 

It  shall  include  a  proposal  of  alternative  generic  name,  using  a generic  name  that  identifies  the 
most  important  chemical  groups  in accordance with the  lexicon  presented  in Annex VI Part B to 
this Directive. 

3.  Member  States  shall  designate to the  Commission,  at the  latest by the date of entry  into  force  of 
this  Directive,  the  authority  or  authorities  responsible  for  receiving  requests  for  confidentiality 
and examining their conformity  with this Directive. 

4.  The  authority  of  the  Member  State  receiving  a  request  for  confidentiality  shall  verify  its 

admissibility  and  inform  the applicant of its decision  within a maximum  of (45) days. 

If the request  is rejected  or further  information  is required, the competent  authority  shall  give  its 
reasons  therefor. 

Confidential  information  brought to the knowledge of the authorities of the Member  States  or of 
the Commission  shall be dealt with  in accordance with Article  19 (4) of Directive  67/548/EEC. 

5.  Anyone  other  than  the  person  responsible  for  placing  the  preparation  on  the  market,  who 
modifies  only  the  designation  or  commercial  name  of  a  preparation  the  labelling  of  which 
contains  one  or more  alternative  designations  protecting  the chemical  identity  or  identities,  shall 
inform  on  the  one  hand  the  authorities  of  the  Member  States  where  this  preparation,  together 
with  its  new  designation  or  commercial  name,  is  placed  on  the  market  for  the  first  time  and  on 
the other hand  the  Commission. 

35 

This information  shall  include : 

—  the old designation  or commercial  name, 
— the new designation or commercial  name, 
— the alternative designation(s)  employed. 

The alternative designations  shall not be  modified. 

Article 12 

Exchange  of  information  concerning  requests  for  confidentiality  between  the  Commission  and 
the Member States. 

1. 

In  the  event  of  a  favourable  decision,  the  responsible  authority  shall  forward  a  copy  of  its 
decision  and the request to the Commission  as soon as possible. 

2.  The  Commission  shall  forward  this  decision  and  the  request  file  as  soon  as  possible  to  the 

responsible authorities of the other Member States. 

3.  Where  one or  more  authorities  referred  to  in paragraph  2, enters  an  objection  it shall  inform  the 
Commission  thereof  within  one  month.  The  Commission  shall  consult  the  Member  States  as 
soon as possible and shall take an appropriate decision  in accordance with Article 21. 

4.  At  the  latest  by  the  date  of  entry  into  force  of  this  Directive,  each  Member  State  shall 
communicate  to  the  Commission  the  list  of  commercial  names  of  preparations  in  respect  of 
which  it has  been  informed  under  Directive  88/379/EEC of the  use of  an  alternative  name  for  a 
harmful  substance. 

5.  The Commission  shall communicate each of the lists to the other Member states. 

Implementation  of the  labelling  requirements 

Article  13 

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  the  said  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 are intended  solely for provision  of the information  required  by this 
Directive and  if necessary of any supplementary health  or safety  information. 

2.  A  label  is not  required  when  the particulars  are clearly  shown  on the package  itself,  as  specified 

in paragraph  1. 

3.  The colour and  presentation  of the  label  - or,  in the case of paragraph  2, of the package  - shall  be 

such that the danger  symbol  and  its background  stand out clearly from  it. 

4.  The  information  required  on  the  label  under  Article  10  shall  stand  out  clearly  from 

its 

background  and  shall  be of such  size and spacing as to be easily read. 

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

3M 

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

6.  For the  purpose  of this  Directive,  labelling  requirements  shall  be deemed  to be  satisfied: 

(a) 

in the  case  of  an  outer  package  containing  one  or more  inner  packages,  if the  outer  package 
is  labelled  in  accordance  with  international  rules  on  the  transport  of  dangerous  preparations 
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  preparations  and  with  Article  10 (2)  2.1, 2.2,  2,3, 2.5, and  2.6,  or  ; 

-  where  appropriate,  for  particular  types  of  packaging  such  as  mobile  gas  cylinders,  in 
to 
requirements 

in  Annex  VI 

referred 

specific 

to 

accordance  with 
the 
Directive  67/548/EEC. 

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  preparations. 

Exemptions  from  the  labelling  and  packaging  requirements 

Article  14 

1.  Articles  9,  10 and  13 shall  not  apply  to  the  provisions  relating  to  explosives  placed  on  the  market 

with  a view  to  obtaining  an  explosive  or  pyrotechnic  effect. 

2. 

For  certain  dangerous  preparations  within  the  meaning  of Articles  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  13 shall  not  apply. 

3.  Member  States  may  : 

(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  for  labelling  in  accordance 
with  Article  13  ( l ) a n d ( 2 ); 

(b)  by  way  of  derogation  from  Articles  10  and  13,  permit  the  packaging  of  dangerous 
preparations  which  are  not  explosive,  very  toxic  or  toxic  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)  where  packages  are  too  small  for  the  labelling  provided  for  in  Articles  10  and  13  and  there 
is  no  reason  to  fear  any  danger  to  persons  handling  such  preparations  or  to  other  persons,  by 
way  of  derogation  from  the  above  provisions,  permit  the  packaging  of  explosive,  very  toxic 
or  toxic  preparations  to  be  labelled  in some  other  appropriate  way. 

This  derogation  does  not  permit  use  of  symbols,  indications  of  danger,  risk  (R)  phrases  or  safety 
(S)  phrases  different  from  those  laid  down  in this  directive. 

55 

If  a  Member  State  makes  use  of  the  options  provided  for  in  paragraph  3,  it  shall  inform  the 
Commission  thereof  forthwith. 

Advertisements 

Article 15 

Any  advertisement  for  a preparation  within  the meaning  of this  Directive  communicated  exclusively 
by  correspondence  or  catalogue  which  imposes  an  obligation  on  the  buyer  shall  be  prohibited  if  no 
mention  is made therein  of the type or types of hazard  indicated on the  label. 

Article 16 

Safety data sheet 

Member  States shall  take all the necessary measures to ensure that : 

1. 

the  person  responsible  for  placing on the market a preparation  within  the meaning  of Article  1.2. 
must provide, at the  latest on first delivery, a safety  data sheet. 

2.  The person  responsible  for  placing on the marked  a preparation  provides  on request  a safety  data 
sheet  for  preparations  not  classified  as dangerous  within  the  meaning  of  Articles  5,  6 and  7 but 
containing  in an  individual  concentration  of > 1  %  by weight for  non-gaseous  preparations  and > 
0,2 % by volume  for  gaseous preparations  at least : 

-  one substance  posing health hazards or 
-  one substance  for  which there are Community exposure limits at the workplace. 

3.  By  way  of  derogation  from  paragraphs  1  and  2,  the  applicant  for  authorization  of  a  plant 
protection  product  must  provide  to  the  authorities  designated  in  Article  9(1)  of  Directive 
91/414/EEC  a  safety  data  sheet  attached  to  the  application  for  authorization  of  the  plant 
protection  product. 

4.  Safety  data  sheets  must  comply  with the provisions of Directive  91/155/EEC 

as  last  amended 

by Directive  93/112/EEC(24)-

5.  This  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. 

6.  The  necessary  amendments  required  to adapt to technical  progress  Directive  91/155/EEC  as  last 
amended  by  Directive  93/112/EEC  shall  be adopted  in accordance  with  the  procedure  laid  down 
in Article  21 of this  Directive. 

7.  The  safety  data  sheet  may  be  communicated  on  paper  or  electronically  provided  that  the 

addressee  has the  necessary  means of receiving it. 

(23)  OJ. No  L76, 22.03.1991, p35. 
(24)  O.J.NoL314,  16.12.1993, p38. 

% 

Rights of Member states regarding safety of workers 

Article 17 

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

Bodies  responsible  for receiving information  relating to health 

Article 18 

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

Member  States  shall  take  the  necessary  steps  to  ensure  that  the  appointed  bodies  provide  all  the 
requisite guarantees  for  maintaining the confidentiality  of the information  received.  Such  information 
may  only  be  used  to  meet  any  medical  demand  by  formulating  preventive  and  curative  measures,  in 
particular  in emergencies. 

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

Member  States  shall  ensure  that  the  appointed  bodies  shall  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 . 

Free  movement  clause 

Article  19 

Member  States  may  not  prohibit,  restrict  or  impede  the  placing  on  the  market  of  preparations  which 
comply with the requirements of this Directive. 

Article 20 

~~ 

Safeguard  clause 

1.  Where  a  Member  State  has  detailed  evidence  that  a  preparation,  although  satisfying  the 
requirements  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  Sates  of  such  action  and  give  reasons  for  its 
decision. 

2. 

In the  case  referred  to  in  paragraph  1, the  Commission  shall  consult  the  Member  States  as  soon 
as possible. 

2* 

The  Commission  shall  take  a decision  in accordance  with  the  procedure  laid  down  to  in  Article 
21 of this Directive. 

Article 21 

Procedure for adaptation to technical  progress 

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

Article 22 

The Directives  listed  in Annex VIII, part A are hereby repealed, without  prejudice  to the obligation  of 
the  Member  states  concerning  the deadlines  for  transposition  into  national  law and  for  application  of 
the Directives  indicated  in Annex VIII, part B. 
References  to the  repealed  Directives  shall  be constitued  as reference  to  this  Directive  and  should  be 
read  in accordance  with the correlation  table set out  in Annex IX. 

Article 23 

Member  States  shall  bring  into  force  the  laws,  regulations  and  administrative  provisions 
necessary  to comply  with  this  Directive  by  .... 2003  at the  latest. They  shall  immediately  inform 
the Commission  thereof. 

When  Member  States  adopt  these  provisions,  these  shall  contain  a reference  to this  Directive  or 
shall  be  accompanied  by  such  reference  at  the  time  of  their  official  publication.  The  procedure 
for  such reference  shall be adopted  by the Member  States. 

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

Article 24 

This  Directive  is addressed  to the Member States. 

Article.25 

5X 

ANNEX I 

Methods  for the evaluation  of physico-chemical  properties of preparations  in accordance with 
Article 5 

PART A 

Exemption  to test methods of Annex V - Part A to Directive  67/548/EEC 

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

PART B. 

Alternative  calculation  methods 

Bl.  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  67/548/EEC 

B2.  Gaseous  preparations 

1.  Method  for the determination  of oxidising  properties 

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

2.  Method  for the  determination  of flammability  properties 

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

Anl  - 1 

ANNEX II 

Methods for the evaluation of health hazards of  preparations 
in accordance with Article 6 

PART A: METHOD  OF EVALUATION 

Introduction 

This  conventional  method  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 classification  of the substance  is 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  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 the conventional  method are those set out in Part B of this Annex. 

Anil  - 1 

Conventional  method  for the evaluation of health  hazards 

1.  The following  preparations shall  be classified  as very toxic: 

1.1.  owing to their acute  lethal effects  and assigned the risk phrases R26, R27 or R28. 

1.1.1.  preparations  containing  one  or  more  substances  classified  as  very  toxic  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  (Table  I and  I a)  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  individual 

concentrations  not exceeding the  limits specified  under  1.1.1  a) or b) 

if: 

where: P-p+ is the percentage by weight or by volume of each  very toxic substance  in the 

preparation, 
Lj+  is 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 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  (Table  II  and  II  a)_where  the 
substance  or  substances  do  not  appear  in  Annex  I  to  Directive  67/548/EEC  or  appear  in  it 
without concentration  limits; 

2.  The  following  preparations  shall  be classified  as toxic: 

2.1.  owing to their- acute  lethal effects,  and assigned  the risk phrases R23, R24 or R25 

2.1.1.  preparations  containing  one  or  more  substances  classified  as  very  toxic  or  toxic  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 

Anil  - 2 

b) the concentration  specified  at point  1 in Part  B of this Annex (Table  I and  I a) 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 
individual concentrations not exceeding the limits specified  under 2.1.1.a) or b)  if: 

( P 

E 

p ^ 

>1 

where:  P-r+  is  the  percentage  by  weight  or  by  volume  of  each  very  toxic  substance  in  the 

'  preparation, 
Pj  is the percentage by weight or by volume of each toxic substance  in the  preparation, 
L'Y  is  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  risk 

phrases 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  (Table  II  and  II  a)  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 risk phrases R38 / 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  (Table  III  and  III  a)  where  the 
substance  or  substances  do  not  appear  in  Annex  I  to  Directive  67/548/EEC  or  appear  in  it 
without concentration  limits; 

Anil  - 3 

3.  The following  preparations shall be classified  as  harmful: 

3.1.  owing to their acute lethal effects  and assigned the risk phrases R20, R21 or R22 

3.1.1.  preparations  containing one or more substances classified  as very toxic, toxic or  harmful 

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  (Table  I and  I a)  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  individual  concentrations  not exceeding  the  limits  specified  under  3.1.1.a) or 
b) 

if: 

(  Pr 

E 

PT 

PY  ^ 

>1 

T+ 

| 

x  T 

! 

x  Xn 

where:  P-p+ is the  percentage  by weight  or  by volume  of  each  very  toxic  substance  in 

V  ^Xn 

^Xn 

^Xn  J 

is  the  percentage  by  weight  or  by  volume  of  each  toxic  substance  in  the 

the  preparation, 
?j 
preparation, 
PXn *s t ne  percentage by weight or by volume of each  harmful  substance  in the 
preparation, 
L)(n  is  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 risk phrases R65 

3.2.1.  preparations  containing  one  or  more  substances  classified  as  harmful  and  assigned  the 

risk  phrase  R65 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  (Table  I  )  where  the 
substance  or  substances  do not  appear  in Annex  I to  Directive  67/548/EEC  or  appear 
in it without concentration  limits; 

3.2.2.  preparations  containing  more  than  one  substance  classified  as  harmful  and  assigned  the 
risk  phrase  R65  in  individual  concentrations  not  exceeding  the  limits  specified  under 
3.2.1.a) orb) 

if: 

f  P 

I  '  Px" 

R65 

\ 

>  1 

^  Xn 

,  R 
,R65 

J 

Anil  - 4 

where: 

is  the  percentage  by  weight  of  each  harmful  substance  to  which  is 

P ^n  ^5 
assigned  the  risk  phrase  R65  in the  preparation, 
L xn  R65  's  t ne  respective  harmful  limit  specified  for  each  harmful  substance 
to  which  is assigned  the  risk  phrase  R65, expressed  as  percentage  by  weight. 

3.3.  owing  to  their  non-lethal  irreversible  effects  after  a  single  exposure,  and  assigned  the  risk 

phrases  R40  /  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  (Table  II  and  II  a)  where  the 
substance  or  substances  do  not  appear  in  Annex  I  to  Directive  67/548/EEC  or  appear  in  it 
without  concentration  limits; 

3.4.  owing  to  their  long-term  effects,  and  assigned  the  risk  phrases  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  (Table  III  and  III  a)  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  shall  be  classified  as  corrosive: 

4.1.  and  assigned  the  risk  phrase  R35, 

4.1.1. 

preparations  containing  one  or  more  substances  classified  as  corrosive  and  to  which  is 
assigned  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  (Table  IV  and  IV  a) 
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  and  to  which  is 
assigned  phrase  R35  in  individual  concentrations  not  exceeding  the  limits  specified 
under  4.1.1.a)  or  b) 

if: 

Anil  - 5 

I  rC,R35 

V ^C,R35  J 

>1 

where:  Pc  R35  is the  percentage  by weight  or by volume  of each  corrosive  substance 

which  is assigned  phrase  R35 in the preparation, 

LQ  p35  is  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 risk phrase R34, 

4.2.1.  preparations  containing  one  or  more  substances  classified  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  (Table  IV  and  IV  a) 
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  and  to 
which  is  assigned  phrase  R35  or  R34  in  individual  concentrations  not  exceeding  the 
limits specified  under 4.2.1 .a) or b) 

if: 

z 'p 

1  C,R35 

A 

p 
l  ÇR34 

>1 

^C,R34  J 
where:  Pc  ^35  is the  percentage  by weight  or by volume  of  each  corrosive  substance 

V ^C,R34 

to which  is assigned  phrase  R35 in the preparation, 

VQ R34  is the  percentage  by weight  or by volume  of  each  corrosive  substance 
to which  is assigned  phrase  R34 in the preparation, 

LQ  R34  is  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 

5.  The  following  preparations  shall  be classified  as  irritants: 

5.1 

liable to cause serious eye damage and assigned  the risk phrase R41, 

5.1.1.  preparations  containing  one  or  more  substances  classified  as  irritant  and  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 

Anil  - 6 

b)  the concentration  specified  at point  4  in Part  B of this  Annex  (Table  IV and IV- a) 
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 in  individual  concentrations  not  exceeding  the  limits 
specified  under  5.1.1.a) or b) or classified  as corrosive  and to which  is assigned  phrase 
R35orR34  if: 

f  R ÇR35 

Z 

\^Xi,R4\ 

P 
1  ÇR34 

+ 

^Xi,R4\ 

+ 

\ 

Xi,R4\ 

P 
L 
'Xi,R4\  J 

>1 

where: 

?Q  R35 is the percentage by weight or by volume of each  corrosive  substance 
to which  is-assigned phrase  R35 in the preparation, 

?Q  R34 is the percentage by weight or by volume of each  corrosive  substance 
to which  is assigned  phrase  R34 in the preparation, 

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

resPective  irritant  limit  R41  specified  for  each  corrosive 

LXi R41  's  me 
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 risk phrase R36, 

5.2.1.  preparations containing one or more substances classified  as corrosive and 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  (Table  IV and IV  a) 
where  the  substance  or  substances  do  not  appear  in  Annex  I  lo  Directive 
67/548/EEC or appear in it without concentration  limits; 

5.2.2.  preparations  containing  more  than  one of the  substances  classified  as irritant  and  to 
which  is assigned  phrase  R41 or R36 in individual  concentrations  not exceeding the 
limits specified  under 5.2.1  a) or b) or classified  as corrosive and to which  is assigned 
phraseR35orR34 

if: 

z  p 

J  C,R35 
f

i

p 
iC./?34 

p 
,  -l  Xi.R4\ 

ll 

p 
l  Xi,R36 

, 

^ 

>1 

R36  J 

where:  Pc  R35  is  the  percentage  by  weight  or  by  volume  of  each  corrosive 

substance to which  is assigned  phrase  R35 in the preparation, 

A n i l -7 

Pc  R34  's 
substance  to  which  is assigned  phrase  R34  in the  preparation, 

t ne  percentage  by  weight  or  by  volume  of  each  corrosive 

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

Pxi,R36  's  t ne  percentage  by  weight  or  by  volume  of  each  irritant  substance 
to  which  is assigned  phrase  R36  in the  preparation, 

Lxj  R36  is  die  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  risk  phrase  R38, 

5.3.1.  preparations  containing  one  or  more  substances  classified  as  corrosive  and  to  which  is 
assigned  phrase  R35  or  R34  or  as  irritant  and  to  which  is  assigned  phrase  R38  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  (Table  IV  and  IV  a) 
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  corrosive  and  to 
which  is assigned  phrase  R35  or  R34  or  as  irritant  and  to  which  is  assigned  phrase  R38  in 
individual  concentrations  not  exceeding  the  limits  specified  under  5.3.1.a)  or  b) 

if: 

(  p 

1  CJU5 

Z 

p 
1  C.R34 

1 

p 
ÂXi,R3& 

I 

\ 
>1 

.\7.rt38 

,\7,/?38 

^A7,/?38  j 

where: 

Pc  R35  is  the  percentage  by  weight  or  by  volume  of  each  corrosive  substance 
to  which  is assigned  phrase  R35  in the  preparation, 

?Q  R34  is  t ne  percentage  by  weight  or  by  volume  of  each  corrosive  substance 
to  which  is assigned  phrase  R34  in the  preparation, 

F^Xi 1^3g  is  the  percentage  by  weight  or  by  volume  of  each  irritant  substance  to 
which  is assigned  phrase  R38  in  the  preparation, 

for  each  corrosive 
L \j  R3$  is  the  respective 
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 

limit  R38  specified 

irritant 

5.4 

irritant  to  respiratory  system  and  assigned  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: 

Anl 

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  (Table  IV  and  IV  a) 
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  individual  concentrations  not  exceeding  the  limits  specified 
under 5.4.1.a) or b) 

if: 

1' p 

Z 

1  Xi,R31 

^ 

>1 

where:  Pxj  R37  is  the  percentage  by  weight  or  by  volume  of  each  irritant  substance  to 

which  is assigned  phrase R37 in the preparation, 

V ^Xi,R31  J 

Lxi  R37  is the  irritant  limit R37 specified  for  each  irritant  substance  to which  is 
assigned  phrase R37, expressed  as percentage by weight or by volume 

Anil  - 9 

6.  The following  preparations shall be classified  as sensitising  : 

6.1  by skin contact and assigned 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  V  a)  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  by inhalation  and assigned the risk phrase R42, 

preparations  containing  at  least  one  substance  classified  as  sensitising  and  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  V  a)  where  the 
substance  or  substances  do  not  appear  in  Annex  I  to  Directive  67/548/EEC  or  appear  in  it 
without concentration  limits; 

Remark  : if a preparation  contains  a substance to which  is assigned  phrases  R42/43  the  effects  are  to 

be considered  in accordance with 6.1 - 6.2 above. 

7.  The following  preparations  shall  be classified  as  carcinogenic: 

7.1.  those of category  1  or 2, and assigned  phrase R 45 or R 49 

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 category 1 
and category 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  (Table  VI  and  VI  a)  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, and assigned  phrase R 40 

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 n i l-  10 

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  (Table VI and  VI  a)  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 shall be classified  as mutagenic: 

' 

8.1.  those of category  1  or 2 and assigned  phrase R 46, 

preparations  containing  at  least  one  substance  producing  such  effects,  classified  as  mutagenic 
and  to  which  is  assigned  phrase  R46  which  denotes  mutagenic  substances  in  category  1 and 
category 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 (Table  VI  and  VI  a)  where  the 
substance  or  substances  do  not  appear  in  Annex  I  to  Directive  67/548/EEC  or  appear  in  it 
without concentration  limits; 

8.2.  those of category  3 and assigned  phrase R 40, 

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  (Table  VI  and  VI  a)  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  shall  be classified  as toxic for reproduction: 

_ 

9.1.  those of category  1  or 2 and  assigned  R 60 (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 category  1 and category 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 (Table  VI  and  VI  a) where  the 
substance  or  substances  do  not  appear  in  Annex  I  to  Directive  67/548/EEC  or  appear  in  it 
without concentration  limits; 

Anil  -  11 

9.2.  those of category 3 and assigned  R 62 (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  (Table  VI  and  VI  a) 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 and assigned  R 61 (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 category  1  and category 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  (Table  VI  and  VI  a)  where  the 
substance  OF  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 and assigned  R 63 (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  (Table  VI  and  VI  a)  where  the 
substance  or  substances  do  not  appear  in  Annex  I  to  Directive  67/548/EEC  or  appear  in  it 
without  concentration  limits; 

A n i l-  12 

PARTB 

ANNEX  II 

CONCENTRATION  LIMITS TO BE USED IN APPLYING THE CONVENTIONAL  METHOD OF 
ASSESSING  HEALTH HAZARDS IN ACCORDANCE  WITH ARTICLE 6 

An  assessment  must  be  made  of  all  the  health  hazards  that  the  use  of  a  substance  might  entail.  For 
that purpose the dangerous  health  effects  have been 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 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  (Tables  A)  where 
they  are  expressed  as  a  volume/volume  percentage  and  in  conjunction  with  the  classification  of  a 
substance. 

The classification  of the substance  is 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  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. 

1.  Acute lethal  effects 

1.1.  Non-gaseous  preparations 

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. 

Classification 
of the  substance 

TABLE I 

Classification  of the  preparation 

T+ 

T 

XrT 

T+  with  R26, R27,  R28 

concentration  >  7% 

1%  < concentration  < 7  % 

0,1  %  < concentration  <  1 % 

T  with  R23, R24,  R25 

Xnw i t h R 2 0,  R21.R22 

Xn  with  R65 

concentration  > 25  % 

3 %  < concentration  <  25  % 

concentration  > 25  % 

concentration  >  10  % 

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 abovcmcnlioned  R phrases according to the classification  used, 

- 

in general, the  R phrases  selected  should  be those  applicable to tne substancc(s) present  in the concentration  which  gives  rise to 
the most severe  classification. 

Anil  -  13 

1.2.  Gaseous  preparations 

The  concentration  limits  expressed  as  a  volume/volume  percentage  in  Table  1  A  below 
determine  the  classification  of  the  gaseous  preparations 
individual 
concentration of the gas(es) present whose classification  is also shown. 

in  relation  to  the 

TABLE IA 

Classification 
of the substance  (gas) 

Classification  of the gaseous  preparation 

T+ 

T 

^n 

T+  with  R26, R27, R28 

concentration  > 1 % 

0,2% < concentration  <  1 % 

0,02  % < concentration  < 0,2 % 

T with  R23, R24, R25 

XnwithR20,  R21,R22 

concentration  > 5 % 

0,5% < concentration  < 5 % 

concentration  > 5 % 

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.  Non-gaseous  preparations 

For  substances  that  produce  non-lethal  irreversible  effects  after  a single  exposure  (R 39/route  of 
exposure,  R  40/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. 

Classification 
of the  substance 

T+  with  R39/route  of 
exposure 

Twith  R 39/route  of 
exposure 

Xn  with  R 40/route  of 
exposure 

TABLE II 

Classification  of the  preparation 

T+ 

T 

*n 

concentration  > 10 % 
R 39 (*) obligatory 

1 % < concentration  <  10 % 
R 39 (*)  obligatory 

0,1 % < concentration  <  1 % 
R 40 (*) obligatory 

concentration  >  10 % 
R 39 (*)  obligatory 

1 % < concentration  <  10 % 
R 40 (*) obligatory 

concentration  >  10 % 
R 40  ("Obligatory 

(*)  In order  to  indicate  the  route  of  administration/exposure  (r of exp)  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)  shall  be used. 

2.2.  Gaseous  preparations 

For  gases  that  produce  non-lethal  irreversible  effects  after  a  single  exposure  (R 39/route  of 
exposure,  R  40/route  of  exposure),  the  individual  concentration  limits  specified  in  Table  II  A, 
expressed  as a volume/volume  percentage, determine,  when  appropriate, the  classification  of the 
preparation. 

A n i l-  L' 

TABLE IIA 

Classification 
of the substance  (gas) 

T+  with  R39/route  of 
exposure 

T with  R 39/route  of 
exposure 

X„ with  R 40/route of 
exposure 

Classification  of the gaseous  preparation 

T+ 

T 

*n 

concentration >  I  % 
R 39 (*)  obligatory 

0,2 % < concentration <  1  % 
R 39 (*) obligatory 

0,02 % < concentration < 0,2 % 
R 40 (•) obligatory 

concentration > 5  % 
R 39 (*) obligatory 

0,5 % < concentration  < 5  % 
R 40 (*) obligatory 

concentration  > 5  % 
R40  (*) obligatory 

(*)  In order to  indicate  the  route  of administration/exposure (r of exp)  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) shall  be used. 

3.  Severe effects  after  repeated  or prolonged  exposure 

3.1.  Non-gaseous  preparations 

For  substances  that  produce  severe  effects  after  repeated  exposure  (R  48/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. 

Classification 

of the substance 

T with  R 48/route  of 
exposure 

Xn  with  R 48/route  of 
exposure 

TABLE III 

Classification  of the  preparation 

y 

X 

concentration  > 10 % 
R 48 (*) obligatory 

1  % < concentration  <  10 % 
R 48 (*)  obligatory' 

concentration  >  10 % 
R 48 (*)  obligatory 

(*)  In  order  to  indicate  the  route  of  administration/exposure  (r of  exp)  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)  shall  be used. 

3.2.  Gaseous  preparations 

For  gases  that  produce  severe  effects  after  repeated  or  prolonged  exposure  (R 48/route  of 
exposure),  the  individual  concentration  limits  specified  in  Table  III  A  below,  expressed  as  a 
volume/volume  percentage, determine, when appropriate, the classification  of the  preparation. 

Classification 

of the substance («as) 

T with  R 48/route  of 
exposure 

Xn  with  R 48/route  o\' 
exposure 

TABLE III A 

Classification  of the gaseous  preparation 

T 

concentration > 5 % 
R 48 (*) obligatory 

V 

0,5  % < concentration  < 5 % 
R 48 (*)  obligatory 

concentration  > 5 % 
R 48 (*) obligator} 

(*)  In  order  to  indicate  the  route  of  administration/exposure  (r of  exp)  the  combined  R phrases  listed  under  points  3.2.1,  3.2.2  and 

3.2.3  of the  labellin»  «uidc (Annex  VI to Directive  67/548/EEC)  shall  be  used. 

A n i l-  15 

4.  Corrosive and irritant effects  including serious damage to eye 

4.1.  Non-gaseous  preparations 

For substances  that  produce  corrosive  effects  (R  34, R 35)  or  irritant  effects  (R  36,  R 37,  R  38, 
R41),  the  individual  concentration  limits  specified  in  Table  IV,  expressed  as  a  weight/weight 
percentage, determine, when appropriate, the classification  of the preparation. 

Classification 
of the substance 

C with  R 35 

C with  R 34 

Xj\vithR41 

Xjwith 
R36,  R37,  R38 

TABLE IV 

Classification  of the preparation 

C with R 35 

C with  R 34 

XjwithR41 

X; with  R36,R37,R38 

concentration  >  10 % 
R 35 obligatory 

5 % < concentration  <  10 % 
R 34 obligatory 

concentration  >  10 % 
R 34 obligatory 

C)  5  % 

(*)J0% 

1 % < concentration  < 5 % 
R 36/38 obligatory' 

5 % < concentration  <  10 % 
R 36/38  obligatory 

concentration  >  10 % 
R 41 obligatory 

5 % concentration  <  10 % 
R 36 obligatory 

concentration  > 20 % 
R 36, R 37, R 38 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  R  35  or  R  34  must  also  be 
considered  as  being  assigned  phrase  R 41.  Consequently,  if the preparation  contains  corrosive  substances  with  R 35  or  R 34  below  the  concentration 
limits  for  a  classification  of  the  preparation  as  corrosive,  such  substances  can  contribute  to  a  classification  of  the  preparation  as  irritant  (R  41)  or 
irritant (R 36). 

4.2.  Gaseous  preparations 

For  gases  that  produce  such  effects  (R  34,  R  35  or  R  36,  R  37,  R  38,  R  41),  the  individual 
concentration  limits  specified  in  Table  IV  A  below,  expressed  as  a  volume/volume  percentage 
determine, when  appropriate, the classification  of the  preparation. 

Classification 
of the substance  (gas) 

C with  R 35 

C with  R 34 

Xj with  R 41 

Xj with 
R36,  R37.  R38 

TABLE IV A 

Classification  of the gaseous  preparation 

C with  R 35 

C with  R 34 

XjWithR41 

Xj with  R 36.R 37,R  38 

concentration  >  1  % 
R 35 obligatory 

0,2 % < concentration  <  1  % 
R 34 obligatory 

" 

0,2%(») 

0.02 %  concentration < 0.2 % 
R 37 obligatory' 

concentration  > 5 % 
R 34 obligatory 

5 % C) 

0,5  % < concentralion  < 5 % 
R 37 obligatory 

concentration  > 5 % 
R 41 obligatory 

0,5  % concentration  < 5 % 
R 36 obligatory 

concentration  > 5 % 
R 36, R 37. R 38 obligatory  as 
appropriate 

(*)  According  to  the  labelling  guide  (Annex  VI  to  Directive  67/548/EEC),  corrosive  substances  assigned  risk  phrases  R  35  or  R  34  must  also  be 
considered  as being  assigned  phrase  R -11.  Consequently,  if the  preparation  contains  corrosive  substances  with  R 35  or  R 34  below  the  concentration 
limits  for  a  classification  of  the  preparation  as  corrosive,  such  substances  can  contribute  to  a  classification  of  the  preparation  as  irritant  (R  41)  or 
irritant  (R 36). 

A n i l-  16 

5.  Sensitising  effects 

5.1.  Non-gaseous  preparations 

Preparations that produce such effects  are classified  as sensitising and assigned : 
the symbol Xn  and phrase R 42 if this effect  can be produced  by inhalation, 
- 
- 
the symbol  Xj and phrase R 43 if this effect  can be produced  through contact with 
skin, 

the 

The  individual  concentration 
percentage, determine, when  appropriate, the classification  of the preparation. 

limits  specified 

in  Table  V,  expressed  as  a  weight/weight 

TABLE V 

Classification 

of the substance 

sensitising  with  R 42 

sensitising with  R 43 

Classification  of the  preparation 

sensitising with R 42 

sensitising with  R 43 

concentration  >  1  % 
R42  obligatory 

concentration  >  1  % 
R 43  obligatory 

5.2  Gaseous  preparations 

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

- 

the symbol  Xn  and phrase R 42 if this effect  can be produced  by  inhalation, 

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

TABLE V A 

Classification 

of the substance (gas) 

sensitising with  R 42 

Classification  of the gaseous  preparation 

sensitising with  R 42 

concentration  > 0,2 % 
R 42 obligatory 

Anil  -  17 

6.  Carcinogenic/mutagenic/toxic  effects  for  reproduction 

6.1  Non-gaseous 

preparations 

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: 

Carcinogenic  cat.  1 and  2: 
Carcinogenic  cat.  3: 
Mutagenic  cat.  1 and  2: 
Mutagenic  cat.  3: 
Toxic  for  reproduction  fertility  cat.l  and  2: 
Toxic  for  reproduction  development  cat.l  and  2: 
Toxic  for  reproduction  fertility  cat.3: 
Toxic  for  reproduction  development  cat.  3: 

T;  R45,  R49 

Xn;  R40 
T;R46 
Xn;  R40 
T;R60 

Xn;  R62 

T;R6; 

Xn;  R63 

TABLE  VI 

Classification 

of the substance 

Classification  of the preparation 

Categories  1  and 2 

I 

Category 3 

carcinogenic substances  of 
category  1  or 2 with  R 45 or R 
49 

> 0,1 % 
carcinogenic 
R 45, R 49 obligatory as 
appropriate 

carcinogenic substances of 
category  3 with  R 40 

mutagenic substances  of 
category  1  or 2 with  R 46 

mutagenic  substances of 
category  3 with  R 40 

> 0,1  % 
mutagenic 
R 46 obligatory 

> 1  % 
carcinogenic 
R 40 obligatory 

>  1  % 
mutagenic 
R 40 obligatory 

substances  "toxic  for 
reproduction"  of category  1  or 2 
with  R 60 (fertility) 

> 0,5 % 
toxic for reproduction  (fertility) 
R 60 obligatory 

substances  "toxic  for 
reproduction"  of category  3 with 
R 62 (fertility) 

substances  "toxic for 
reproduction"  of category  1  or 2 
with  R 61 (development) 

substances  "toxic  for 
reproduction"  of category  3 with 
R 63 (development) 

> 0,5 % 
toxic for  reproduction 
(development) 
R 61 obligatory 

— 

> 5 % 
toxic for reproduction  (fertility) 
R 62 obligatory 

> 5 % 
toxic for  reproduction 
(development) 
R 63 obligatory 

Anil-  18 

6.2.  Gaseous 

preparations 

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

T; R45,  R49 
Carcinogenic  cat.  1 and  2: 
Xn;  R40 
Carcinogenic  cat.  3: 
T;  R46 
Mutagenic  cat.  1 and  2: 
Xn;  R40 
Mutagenic  cat.  3: 
Toxic  for  reproduction  fertility  cat.l  and  2: 
T;  R60 
Toxic  for  reproduction  development  cat. 1 and  2:  T;  R61 
Toxic  for  reproduction  fertility  cat.3: 
Toxic  for  reproduction  development  cat.3  : 

Xn;  R62 
Xn;  R63 

TABLE  VI  A 

Classification 

Classification  of the gaseous  preparation 

of the substance (gas) 

Categories  1  and 2 

I 

Category 3 

carcinogenic substances of 
category  1  or 2 with R 45 or 
R 49 

> 0 , 1% 
carcinogenic 
R 45, R 49 obligatory as 
appropriate 

carcinogenic substances of 
category  3 with R 40 

mutagenic substances of 
category  1  or 2 with  R 46 

mutagenic substances of 
category  3 with  R 40 

> 0,1 % 
mutagenic 
R 46 obligatory 

substances  "toxic for 
reproduction" of category  1  or 2 
with  R 60 (fertility) 

> 0,2 % 
toxic for reproduction  (fertility) 
R 60 obligatory 

substances  "toxic  for 
reproduction"  of category  3 with 
R 62 (fertility) 

substances  "toxic for 
reproduction"  of category  1  or 2 
with R 61 (development) 

substances  "toxic for 
reproduction"  of category  3 with 
R 63 (development) 

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

>  1  % 
carcinogenic 
R 40  obligatory 

>  1  % 
mutagenic 
R 40  obligatory 

>  1  % 
toxic for reproduction  (fertility) 
R 62  obligatory 

>  1  % 
toxic for  reproduction 
(development) 
R 63 obligatory 

Anil-  19 

ANNEX III 

Methods for the evaluation  of the environmental hazards of preparations in accordance to 
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 : METHODS  OF  EVALUATION 

a)  Aquatic  environment 

I.  Conventional  method  for  the evaluation  of hazards to the aquatic  environment 

The  conventional  method  for  the  evolution  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  shall  be classified  as dangerous  for  the  environment 

1.1.  and  assigned  the  risk  phrases  R50  and  R53  (R50-53):  very  toxic  to  aquatic  organisms  and 

may cause long-term  adverse  effects  in the aquatic  environment 

1.1.1.  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; 

1.1.2.  preparations  containing  more  than  one  substance  classified  as  dangerous  for  the  environment 
and  to which  is  assigned  phrases  R50-53  in  individual  concentrations  not  exceeding  the  limits 
specified  under  1.1.1 a) or b)  if: 

Z (  p 

1  N,R50-53 

^ 

>1 

y ^N,R50-53 

J 

AnIII-1 

where: 

P N , R 5 0 - 53
environment  to  which  is assigned  phrases  R50-53  in the  preparation, 

t ne  percentage  by  weight  of  each  substance  dangerous  for  the 

ls 

LN,R50-53  ls  t ne  u r mt  R50-53  for  each  substance  dangerous  for  the  environment 
to  which  is assigned  the  phrases  R50-53, expressed  as  percentage  by  weight 

1.2. 

and  assigned  the  risk  phrases  R51  and  R53  (R51-53):  toxic  to  aquatic  organisms  and  may 
cause  long-term  adverse  effects  in  the  aquatic  environment 

1.2.1.  preparations  containing  one  or  more  than  one  substance  classified  as  dangerous 

the 
environment  and  to  which  is  assigned  phrases  R50-53  or  R51-53  in  individual  concentrations 
equal  to  or  greater  than: 

to 

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; 

1.2.2.  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  individual  concentrations 
not  exceeding  the  limits  specified  under  1.2.la) or  b)  if: 

z f p 

1  .\,R50-53 

V 

A\'.#51-53 
,Y.#51-53 

p 
L  .V.#51-53 

\ 

I 

Av. 
^.Y.#51-53  J 

>1 

where: 

P]\j  R50-53 
environment  to  which  is  assigned  phrases  R50-53  in  the  preparation, 

t ne  percentage  by  weight  of  each  substance  dangerous  for  the 

's 

PNR51-53 
environment  to  which  is assigned  phrases  R51-53  in  the  preparation, 

t ne  Pe r c e nt a ge  by  weight  of  each  substance  dangerous  for  the 

'S 

L]sj  R5i_53 
environment 
percentage  by  weight 

is  the  respective  limit  R51-53  for  each  substance  dangerous  for  the 
expressed  as 

is  assigned  phrases  R50-53  or  R51-53, 

to  which 

1.3. 

and  assigned  the  risk  phrases  R52  and  R53  (R52-53):  harmful  to  aquatic  organisms  and 
may  cause  long-term  adverse  effects  in  the  aquatic  environment 

1.3.1.  preparations  containing  one  or  more  than  one  substance  classified  as  dangerous 

the 
environment  and  to  which  is  assigned  phrases  R50-53  or  R51-53  or  R52-53  in  individual 
concentrations  equal  to  or  greater  than: 

to 

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  1  to  Directive  67/548/EEC  or  appear  in  it  without 
concentration  limits: 

AnIlI-2 

 
1.3.2.  preparations  containing  more  than  one  of  the  substances  classified  as  dangerous  for  the 
environment  and  to  which  is  assigned  phrases  R51-53  or  R50-53  or  R52-53  in  individual 
concentrations  not exceeding the limits specified  under 1.3.la) or b)  if: 

z *N,R50-53 

V  A?52-53 

.  *N,R5\-53 

.  ^ 5 2 - 53 

>1 

A?52-53 

A?52-53 J 

where:  P]sj R50-53  is  the  percentage  by  weight  of  each  substance  dangerous  for  the 

environment  to which  is assigned  phrases R50-53  in the preparation, 

^NR51-53 
environment to which  is assigned  phrases R51-53 in the preparation, 

t ne  Percentage  by  weight  of  each  substance  dangerous  for 

's 

the 

PR52-53  ls  t ne  percentage  by weight  of each  substance  dangerous  for  the  environment 
to which  is assigned  phrases R52-53  in the preparation, 

LR52-53  is  me  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 

1.4. 

and assigned  the risk phrase R^O: very toxic to aquatic  organisms 

1.4.1.  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; 

1.4.2.  preparations  containing  more  than  one  substance  classified  as  dangerous  for  the  environment 
and  to  which  is  assigned  phrase  R50  in  individual  concentrations  not  exceeding  the  limits 
specified  under 1.4.la) or b)  if: 

z 'p 

1  A', #50 

A 

>1 

where:  P]^ R50  is the percentage  by weight of each  substance dangerous  for the environment  to 

V ^A',#50 J 

which  is assigned  phrases R50 in the preparation, 

L]s] R50  is the  limit  R50 for  each  substance  dangerous  for  the  environment  to  which  is 
assigned  phrases R50, expressed  as percentage by weight 

1.4.3.  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  1.4.1  or 1.4.2. 

AnIII-3 

and containing one or more than one substance classified  as dangerous  for the environment  and 
to which  is assigned  phrases R50-53  if: 

z 1  N,R50 

V Av,/?50 

rN,R50-53 

>1 

Av,/?50  J 

where: P^f  J ^Q  is the percentage by weight of each substance dangerous for the environment  to 

which  is assigned  phrases R50 in the preparation, 

**N R50-53 
environment  to which  is assigned  phrases R50-53  in the  preparation, 

t ne  percentage  by  weight  of  each  substance  dangerous  for.  the 

is 

Ljsj R5o  is 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 

1.5. 

and assigned  the risk phrase R52: harmful  to aquatic  organisms 

1.5.1.  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; 

1.5.2.  preparations  containing  more  than  one  substance  classified  as  dangerous  for  the  environment 
and  to  which  is  assigned  phrase  R52  in  individual  concentrations  not  exceeding  the  limits 
specified  under 1.5.la) or b)  if: 

A?52 J 

where:  PR52  is the  percentage  by  weight  of  each  substance  dangerous  for  the  environment  to 

which  is assigned  phrase  R52  in the  preparation, 

LR52  's  t ne  'i'11'*  R52  for  each  substance  dangerous  for  the  environment  to  which  is 

assigned  phrase R52, expressed  as percentage by weight 

AnIII-4 

1.6. 

and  assigned  the  risk  phrase  R53:  may  cause  long-term  adverse  effects  in  the  aquatic 
environment, 

1.6.1.  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 

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; 

1.6.2.  preparations  containing  more than  one substance  classified  as  dangerous  for  the  environment 
and  to  which  is  assigned  phrase  R53  in  individual  concentrations  not  exceeding  the  limits 
specified  under 1.6.la) or b)  if: 

z 'p 

rR53 

^ 

>1 

where:  PR53  is the  percentage  by  weight  of  each  substance  dangerous  for  the  environment  to 

V A?53 J 

which  is assigned  phrase R53 in the  preparation, 

LR53  is  die  limit  R53  for  each  substance  dangerous  for  the  environment  to  which  is 
assigned  phrase R53, expressed  as percentage by weight 

1.6.3.  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  1.6.2.  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: 

VI  ^#53 

[  ^Y.#50-53  Av.#51-53 

^#52-53 

A?53 

A?53 

A?53 

A?53 

>1 
/ 

where:  PR53  is  the  percentage  by  weight  of  each  substance  dangerous  for  the  environment  to 

which  is assigned  phrase  R53 in the  preparation, 

P]sj RS0-53  is t ne  percentage  by weight  of each  substance  dangerous for the environment 
to which  is assigned  phrase R50-53  in the preparation, 

P^i R5 ] _53 is the percentage  by weight of each  substance dangerous for the environment 
to which  is assigned  phrase R51-53 in the  preparation, 

PR50-53  'S  t ne  Pe r c e n*age  by weight of each  substance dangerous for the environment to 
which  is assigned  phrase  R52-53  in the  preparation, 

L R 53  is  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 
weieht 

AnIII-5 

b) 

Non-aquatic  environment 

bl)  Ozone layer 

I. 

Conventional  method  for the evaluation of preparations dangerous  for the ozone  layer 

The following  preparations shall  be classified  as dangerous for the environment 

1.1. 

and  assigned  the  symbol  N,  the  indication  of  danger  and  the  risk' phrase  R59:  Dangerous  for 
the ozone  layer 

1.1.1.  preparations  containing  one or more  substances  classified  as dangerous  to the environment  and 
to which  is assigned  phrase (N) 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; 

1.1.2.  preparations  containing  more  than  one  substance  classified  as  dangerous  for  the  environment 
and  to  which  is  assigned  phrase  (N)R59  in  individual  concentrations  not  exceeding  the  limits 
specified  under 1.1.1 a) or b) 

if: 

I 'p 

1  N,R59 

A 

>1 

where:  P]sj R59 is the percentage by weight or by volume of each  substance  dangerous  for  the 

environment  to which  is assigned  phrase (N)R59  in the  preparation, 

V A'„/?59  J 

L^j ^59  is  the  limit  (N)R59  for  each  substance  dangerous  for  the  environment  to 
which  is assigned  phrase (N)R59, expressed  as percentage by weight or by volume 

1.2. 

and assigned  the risk  phrase R59: Dangerous  for  the ozone  layer 

1.2.1.  preparations  containing  one or more  substances  classified  as dangerous  to the environment  and 
to  which  is  assigned  phrase  (N)  R59  or  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; 

1.2.2.  preparations  containing  more  than  one  of  the  substances  classified  as  dangerous  for  the 
environment  and  to  which  is  assigned  phrase  (N)R59  or  R59  in  individual  concentrations  not 
exceeding the  limits specified  under 1.2.la) or b)  if: 

AnIII-6 

z (p 

*  N,RS9 
\  LR59 

\ 
>1 

p 
rR59 
I>R&) 

where:  P]sj R59  is the  percentage  by weight or by volume of each  substance  dangerous  for  the 

environment to which  is assigned  phrase (N)R59 in the preparation, 

PR59  IS  t ne  percentage  by  weight  or  by  volume  of  each  substance  dangerous  for  the 
environment to which  is assigned  phrase R59 in the preparation, 

LR59  is t ne  respective  limit  R59  for  each  substance  dangerous  for  the  environment  to 
which  is  assigned  phrase  (N)R59  or  R59,  expressed  as  percentage  by  weight  or  by 
volume 

b2)  Terrestrial  environment 

I. 

Evaluation  of  preparations  dangerous  for  the terrestrial  environment 

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 
Toxic to  fauna 
R55 
Toxic to soil  organisms 
R56 
Toxic to bees 
R57 
May cause  long-term  adverse effects  in the environment. 
R58 

AnIII-7 

ANNEX III 

PART B: TABLE OF CONCENTRATION  LIMITS 

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 
N,  R50-53 
N, R51-53 
R52-53 

N, R50-53 
Cn >25% 

Classification  of the preparation 
N,R51-53 
2.5% < Cn < 25% 
Cn >25 % 

R52-53 
0.25% < Cn < 2.5% 
2.5% < Cn < 25% 
Cn  >25% 

Table 2. : Acute aquatic toxicity 

Classification 
of the substance 
N, R50 
N, R50-53 

Classification  of the preparation 
N, R50 
Cn  > 25% 
Cn>25% 

j 

Table 3.  : Aquatic  toxicity 

Classification 
of the substance 

Classification  of the preparation 
R52 

R52 

Cn > 25% 

Table 4.  : Lone-term  adverse  effects 

Classification 
of the substance 

Classification  of the preparation 
R53 

R53 
N,  R50-53 
N,  R51-53 
R52-53 

j 

Cn > 25% 
Cn > 25% 
Cn > 25% 
Cn > 25% 

AnIII-8 

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 

Classification  of preparation 

of the substance 

I  N, R59 

N, R59 

C > 0.5% 

Classification 

Classification  of preparation 

of the substance 

S  N,.R59  R59 

R59 

C > 0.5% 

AnIII-9 

ANNEX  HI 

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  result  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  shall  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. 

AnIII-10 

ANNEX III 

PART D: INDICATIONS  CONCERNING  SPECIAL RISKS (R PHRASES) 

Preparations  classified  as  dangerous  for  the  environment  within  the  meaning  of  Article  7  and  in 
accordance  with  the  provisions  of Annex III A, B and  C shall  be assigned  the  following  risk  phrases 
in accordance with the table below: 

Classification  and  preparation 

Risk phrases which  must appear  on the  label 

N, R50 - 53 

Very toxic to aquatic organisms 

Contains  substances  which  are  dangerous  for  the  aquatic 
environment 

N, R50 

N, R51 - 53 

Very toxic to aquatic organisms 

Toxic to aquatic organisms 

R52 - 53 

Harmful  to aquatic organisms 

Contains  substances  which  are  dangerous  for  the  aquatic 
environment 

R52 

R53 

Contains  substances  which  are  dangerous  for  the  aquatic 
environment 

Harmful  to aqaatic organisms 

Contains  substances  which  may  be  dangerous  for  the  aquatic 
environment 

N, R59, R59 

Contains substances which deplete the ozone layer 

AnIII-11 

ANNEX III 

PART E: INDICATIONS  CONCERNING  SAFETY ADVICE (S PHRASES) 

Preparations classified  as dangerous for the environment within the meaning of Article 7 and in 
accordance with the provisions of Annex III A, B and C shall be assigned the following  safety  advice. 

"Follow the manufacturer's  instructions regarding use and  disposal" 

The following  S phrases must also be taken  into consideration 

556 

Dispose  this product  and its container to a dangerous or special  waste collection  point 

Applicability: 
preparations  which  are dangerous  for the environment 

Criteria  for  use: 
recommended  for  preparations  to  which  the  symbol N  has  been  assigned  and  which  are  likely  to  be 
used by the general  public 

557 

Use appropriate  containment  to avoid environmental contamination 

Applicability: 
preparations to which the symbol N has been assigned 

Criteria  for  use: 
normally  limited  to preparations not  likely to be used by the general  public 

S59 

Refer  to manufacturer/supplier  on information on  recovery/recycling 

Applicability: 
preparations which  are dangerous for the environment 

Criteria  for  use: 
- obligatory  for  substances  dangerous  for the ozone layer 
-  recommended  for  preparations  to  which  the  symbol  N  has  been  assigned  and  for  which 

recovery/recycling  is recommended 

AnIII-12 

S60 

This material  and/or its container must be disposed  of as hazardous  waste 

Applicability: 
preparations which  are dangerous for the environment 

Criteria for use: 
recommended  for  preparations  to which  the  symbol  N  has  been  assigned  which  are  not  likely  to  the 
used by the general  public 

S61 

Avoid  discharge  into the environment: consult the special  instructions, safety  data  sheets 

Applicability: 
preparations which  are dangerous  for the  environment 

Criteria for use: 
- normally  used for  preparations  for which the symbol N has been  assigned 
- recommended  for  all  preparations classified  as dangerous  for the environmentnot  covered  above 

Anil I-13 

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, shall be fitted  with child-resistant  fastenings. 

2.  Containers  of  whatever  capacity,  containing  liquid  preparations  having  a  cinematic  viscosity 
measured  by  rotative  viscosity  in  accordance  with  ISO  3219  (edition  of  15 December  1977)  of 
less than  7x10"  m2/sec at 40° C and containing aliphatic and/or aromatic hydrocarbons  in a total 
concentration  equal  to  or  greater  than  10  %  with  the  exception  of  preparations  placed  on  the 
market  in the  form  of aerosols  or  in a container  fitted  with  a sealed  spray  attachment,  which  are 
offered  or sold to the general  public shall be fitted with child-resistant  fastening. 

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, 

Identification  of the substance 

N° 

1 

2 

CAS Reg N° 

67-56-1 

75-09-2 

Name 

Methanol 

Dichloromethane 

EINECS N° 

2006596 

2008389 

Concentration  limit 

> 3% 

>  1  % 

which  are offered  or sold to the general public shall  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, shall  carry a tactile warning of danger. 

AnIV- 1 

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.  P r e p a r a t i o ns  sold  to  the  g e n e r al  p u b l ic 

1.1.  The  labels  on  packages  containing  such  preparations,  in  addition  to  the  specific  safety  advice, 
must  bear  the  relevant  safety  advice  S  1, S 2,  S 45  or  S 46  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  gi-ve 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.  P r e p a r a t i o ns  i n t e n d ed  for  use  by  s p r a y i ng 

The  package  label  containing  such  preparations  must  compulsorily  bear  the  safety  advice  S 23 
accompanied  by  safety  advice  S  38  or  S  51  assigned  to  it  in  accordance  with  the  criteria  laid 
down  in Annex VI to Directive 67/548/EEC. 

3.  P r e p a r a t i o ns  c o n t a i n i ng  a  s u b s t a n ce  a s s i g n ed  p h r a se  R  3 3:  D a n g er  of 

c u m u l a t i ve  e f f e c ts 

When  a  preparation  contains  at  least  one  substance  assigned  the  phrase  R  33, 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.  P r e p a r a t i o ns  c o n t a i n i ng  a  s u b s t a n ce  a s s i g n ed  p h r a se  R  6 4:  May  c a u se 

harm  to  b r e a s t f ed  b a b i es 

_ 

When  a  preparation  contains  at  least  one  substance  assigned  phrase  R  64,  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 
hieher than  1  %, unless different  values are set in Annex I to Directive 67/548/EEC. 

AnV  - 1 

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

1.  P r e p a r a t i o ns  c o n t a i n i ng 

lead 

1.1.  Paint and  varnishes 

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  12.5 millilitres, the particulars  may  be 
as follows. 

"Warning. Contains  lead". 

2.  P r e p a r a t i o ns  c o n t a i n i ng  c y a n o a c r y l a t es 

2.1  Adhesives 

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. 

3.  P r e p a r a t i o ns  c o n t a i n i ng 

i s o c y a n a t es 

The  package 
prepolymers, etc., or as mixtures thereof)  must bear the following  inscriptions: 

labels  of  preparations  containing 

isocyanates 

(as  monomers,  oligomers, 

"Contains  isocyanates. 
See information  supplied  by the  manufacturer." 

4.  P r e p a r a t i o ns  c o n t a i n i ng  e p o xy  c o n s t i t u e n ts  with  an  a v e r a ge  m o l e c u l ar 

w e i g ht  <  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." 

AnV  - 2 

5.  P r e p a r a t i o ns  sold  to  t he  g e n e r al  p u b l ic  w h i ch  c o n t a in  a c t i ve  c h l o r i ne 

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.  P r e p a r a t i o ns  c o n t a i n i ng  c a d m i um 

( a l l o y s)  and 

i n t e n d ed 

to  be  u s ed 

for 

b r a z i ng  or  s o l d e r i ng 

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.  P r e p a r a t i o ns  a v a i l a b le  as  a e r o s o ls 

Without  prejudice  to the  provisions  of this  Directive,  preparations  available  as  aerosols  are  also 
subject  to  the  labelling  provisions  in  accordance  with  point  2.2.  and  2.3.  of  the  Annex  to 
Directive  75/324/EEC  as last amended  by Directive 94/1/EC. 

8.  P r e p a r a t i o ns  c o n t a i n i ng  s u b s t a n c es  not  yet  t e s t ed  c o m p l e t e ly 

Where  a  preparation  contains  at  least  one  substance  which,  in  accordance  with  Article  13.3  of 
Directive  67/548/EEC,  bear  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  % 

AnV  - 3 

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

least one dangerous  substance 

1.  P r e p a r a t i o ns 

least  one  d a n g e r o us 
c l a s s i f i ed  w i t h in  the  m e a n i ng  of  A r t i c l es  5,  6  and  7. 

c o n t a i n i ng 

at 

s u b s t a n ce 

but 

not 

The  label  on  the  packaging  of  preparations  containing  at  least  one  substance  classified  as 
sensitising  and  accompanied  by  a  specific  note  under  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" 

2.  P r e p a r a t i o ns  not  i n t e n d ed  for  the  g e n e r al  p u b l ic 

The  label on the packaging  of the preparations  referred  to  in Article  16.2 must  bear the  following 
inscription: 

"Safety  data sheet available on  request". 

AnV  - 4 

ANNEX VI 

Request for confidentiality  for the chemical  identity of a harmful  substance 
presenting only acute lethal  effects. 

PART A:  INFORMATION  TO  BE  COMMUNICATED 

IN  THE  REQUEST  FOR 

CONFIDENTIALITY 

Introductory notes: 

A.  Article  10 paragraph  2.3.4. indicates the conditions  in which the person  responsible  for  placing a 

preparation  on the market may avail himself of the confidentiality  request, namely:  -

—the substance  whose chemical  identity  he wishes  to protect  must  be classified  only  harmful  on 
the basis  of  its acute  lethal  effects  (Xn,  R 20, R 21, R 23) possibly  in combination  with  one  or 
more of the properties referred  to in Article  10 paragraph  2.3.4. of this Directive; 

—the  person  responsible  for  placing  the  preparation  on  the  market  must  demonstrate  that  the 
disclosure  of the chemical  identity of a harmful  substance on the label of a preparation  will  put 
at risk the confidential  nature of his property. 

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  under  heading  2 
'Composition/information  on  ingredients' of the Annex to Directive  91/155/EEC  as  last  amended 
by Directive  93/112/EEC. 

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

AnVI 

Request for  confidentiality 

In  accordance  with  Article  11, 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 
importer  or 

who  is  responsible  for  placing  the  preparation  on  the  market  (manufacturer, 
distributor). 

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

designation. 

CASN0 

EINECS N° 

Chemicar 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. 

3. 

Justification  for  confidentiality  (probability  - plausibility) 

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

5. 

Is this 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: 

AnVI  - 2 

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  as 

last modified  by Directive 93/112/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  as  last  amended  by  Directive 

93/112/EEC. 

AnVI  -  ': 

PART P:  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 topirective  67/548/EEC. 

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 

The family  name is derived  from  the functional  group name. 

These families  are identified  by the conventional  number found  in Annex I (601 to 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 below  in the form  of a non-restrictive  list. 

AnVI  - 4 

3.  Division of substances  into families  and  sub-families 

Family N° 
Annex I to Directive 67/548/EEC 

Families 

Sub-families 

001 

002 

003 

004 
005 

006 

Hydrogen  compounds 

Hydrides 

Helium  compounds 

Lithium  compounds 

Beryllium  compounds 
Boron  compounds 

Boranes 
Borates 

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 

010 

011 

012 

013 

014 

015 

Oxygen  compounds 

Fluorine compounds 

Inorganic  fluorides 

Neon  compounds 

Sodium  compounds 

Magnesium  compounds 

Organometallic  magnesium  derivatives 

Aluminium  compounds 

Organometallic aluminium  derivatives 

Silicon  compounds 

Silicones 
Silicates 

Phosphorus  compounds 

__ 

Acid phosphorus  compounds 
Phosphonium  compounds 
Phosphoric esters 
Phosphates 
Phosphites 
Phosphoramides and  derivatives 

j 

016 

Sulphur  compounds 

Acid  sulphur compounds 
Mercaptans 
Sulphates 
Sulphites 

AnVI  - 5 

017 

018 

019 

020 

021 

022 

023 

024 

025 

026 

027 

028 

029 

030 

031 

032 

033 

034 

035 

036 

037 

038 

039 

040 

041 

042 

043 

044 

045 

046 

047 

048 

049 

050 

Chlorine compounds 

Chlorates 
Perch lorates 

Argon  compounds 

Potassium  compounds 

Calcium  compounds 

Scandium  compounds 

Titanium  compounds 

Vanadium  compounds 

Chromium  compounds 

Chromium  VI compounds 

Manganese compounds 

Iron compounds 

Cobalt compounds 

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 

05 1 

Antimony  compounds 

Organometallic tin  derivatives 

AnVI  - 6 

052 

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 

079 

080 

081 

082 

083 

084 

085 

086 

087 

088 

Tellurium  compounds 

Iodine compounds 

Xenon compounds 

Caesium  compounds 

Barium  compounds 

Lanthanum  compounds 

Cerium  compounds 

Praseodymium  compound 

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 

Tantalium  compounds 

Tungsten  compounds 

Rhenium  compounds 

Osmium  compounds 

Iridium  compounds 

Platinum  compounds 

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 

A n V I-  7 

089 

090 

091 

092 

093 

094 

095 

096 

097 

098 

099 

100 

101 

102 

103 

601 

Actinium  compounds 

Thorium  compounds 

Protactinium  compounds 

Uranium  compounds 

Neptunium  compounds 

Plutonium  compounds 

Americum  compounds 

Curium  compounds 

Berkelium  compounds 

Californium  compounds 

Einsteinium  compounds 

Fermium  compounds 

Mendelevium  compounds 

Nobelium  compounds 

Lawrencium  compounds 

Hydrocarbons 

Aliphatic  hydrocarbons 
Aromatic  hydrocarbons 
Alicyclic  hydrocarbons 
Polycyclic aromatic hydrocarbons  (PAH) 

602 

Halogenated  hydrocarbons  (*) 

Halogenated  aliphatic hydrocarbons  (*) 
Halogenated aromatic hydrocarbons  (*) 
Halogenated  alicyclic hydrocarbons  (*) 

(*) specify according to the family  corresponding  to  halogen 

603 

Alcohols and  derivatives 

Aliphatic  alcohols 
Aromatic alcohols 
Alicyclic  alcohols 
Alcanolamines 
Epoxy derivatives 
Ethers 
Glycolethers 
Glycols and  polyols 

604 

605 

Phenols and derivatives 

Halogenated  phenol  derivatives  (*) 
(*) specify according to the family  corresponding  to  halogen 

Aldehydes and  derivatives 

Aliphatic  aldehydes 
Aromatic  aldehydes 
Alicyclic  aldehydes 
Aliphatic  acetals 
Aromatic  acetals 
Alicyclic  acetals 

AnVI  - 8 

606 

Ketones and derivatives 

Aliphatic Ketones 
Aromatic Ketones  (*) 
Alicyclic Ketones 

(*) Quinones included 

607 

Organic acids and  derivatives 
Aliphatic acids 
Halogenated  aliphatic acids  (*) 
Aromatics acids 
Halogenated aromatic acids  (*) 
Alicyclic acids 
Halogenated  alicyclic acids  (*) 
Aliphatic acid  anhydrides 
Halogenated  aliphatic acid anhydrides  (*) 
Aromatic acid  anhydrides 
Halogenated  aromatic acid anhydrides  (*) 
Alicyclic acid  anhydrides 
Halogenated  alicyclic acid anhydrides  (*) 
Salts of aliphatic acid 
Salts of halogenated  aliphatic acid  (*) 
Salts of aromatic acid 
Salts of halogenated aromatic acid  (*) 
Salts of alicyclic acid 
Salts of halogenated  alicyclic acid  (*) 
Esters of aliphatic acid 
Esters of halogenated  alicyclic acid  (*) 
Esters of aromatic acid 
Esters of halogenated  aromatic acid  (*) 
Esters of alicyclic acid 
Esters of halogenated  alicyclic acid  (*) 
Esters of glycol ether 
Acrylates 
Methacrylates 
Lactones 
Acyl halogenides 

(*) specify according  to the family  corresponding  to halogen 

608 

609 

610 

61 

612 

Nitriles and  derivatives 

Nitrated  derivatives 

Chloronitrated  derivatives 

Azoxy and azoic derivatives 

Aminated  derivatives 

Alphatic amines and  derivatives 
Alicyclic amines and dérivâtes 
Aromatic amines and  derivatives 
Aniline and  derivatives 
Benzidine and  derivatives 

AnVI  - 9 

613 

Heterocyclic bases and derivatives 

Benzimidazole and  derivatives 
Imidazol and derivatives 
Pyrethrinoids 
Quinoline and  derivatives 
Triazine and  derivatives 
Triazole and derivatives 

Glucosides and  alcaloids 

Alcaloid and  derivatives 
Glucosids and  derivatives 

Cyanates and  isocyanates 
Cyanates 
Isocyanates 

Amides and  derivatives 

Acetamide and  derivatives 
Anilides 

Organic  Peroxides 

Various  substances 
Do not use this family.  Instead, use the families  or sub 
families  mentioned  above 

614 

615 

616 

617 

650 

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 

A n V I-  10 

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-trichIorophenylacetic 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 

N.B. :  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 

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

sodium  hydrosulphite 
family  016: sulphur  compounds 
generic  name: inorganic  sulphur  compound 

AnVI  -  11 

(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). 

AnVI-  12 

ANNEX VII 

Preparations covered  by Article  14(2) 

Examples of preparations classified  within the meaning of Article 6: 

Alloys 
Preparations containing  polymers 
Preparations containing  elastomers 

AnVI I - 1 

ANNEX VIII 

PART A .Repealed Directives in accordance with Artricle 22 

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

Directive 90/35/EEC  defining  in accordance with  Article 6 of Directrive  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 on dangerous preparations the packaging of which must be fitted  with  child-
resistant  fastenings 

AnVIII  - 1 

PART B: Deadlines  for transposition  and for application  in accordance with Article 22 

Directive 

Deadline for 
transposition 

Deadline  for 
application 

-78/631/EEC (OJ no L206 of 29/7/1978, pl3)  1  January  1981  1  January  1981 
-88/379/EEC  (OJ no Li87  of  16/7/1988, p  14)7 June  1991 
-89/178/EEC (OJ no L64 of 8/3/1989; pl8) 
-90/492/EEC (OJ no L275 of 5/10/1990, p35)  1  June  1991 
-93/18/EEC  (OJ no L104 of 29/4/1993, p46  1  July  1994 
-90/35/EEC  (OJ no LI9 of 24/1/1990, pi4) 
1  August  1992 
-91/442/EEC(OJ  no L238 of 27/8/1991, p25)  1  August  1992 

7 June  1991 
1  June  1991 
8 June  1991 
1  July  1994 

1  November  1992 
1  November  1992 

1  December  1990 

AnVIII  - 2 

Correlation  table 

ANNEX IX 

This 
Directive 
Article  1 
1.1 
1.2 
1.3 
1.4 
1.5 
Article 2 
Article 3 
Article 4 

Article  5 
5.1 
5.13rdindt 
5.2-5.3 
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 
10.1.1-1.2 
10.2 
10.2.3. 
10.2.4. 
10.2.5. 

Article  11 
Article  12 
Article  13 
Article  14 
Article  15 
Article  16 
Article  17 

88/379/EEC 

Article 1 
1.1 
1.2 

L3 
Article 2 
(Art 3.6.) 
Article 3.1 
Article 4 
Article 3.2. 
3.2 
3.2 para 3(b) 

Article  3.3 
3.3  para a & b 

3.3para3&4 
3.4 
3.5 para  1  to 3 

Article 5 
5.1 
5.2 
5.3 

Article 6 
6.1(a) 
6.1(b) 
6.2 + 6.3 2nd  para 
Article 7 

7.1 
7.1.(c) 
7.1.(d) 
7.4 

Article 8 
Article 9 

Article  10 
Article 11 

An IX -3 

Article  18 
Article  19 
Article 20 
Article 21 
Article 22 
Article 23 
Article 24 
Article 25 

I Article  12 
Article  13 
Article  14 
Article  15 

Article  16 
Article  16 para 3 
Article  17 

An IX -3 

Table of correspondence 
This  Directive 

88/379 

90/35 

91/442 

93/18 

Art 3.2  para 2 

Art 3.5  (a) 
Art 3.5(a)(i) 
Art3.5(a)(ii) 
Art3.5(a)(iii) 
Art 3.5(b) 
Art 3.5  (b)(i) 
Art 3.5  (b)(ii) 
Art3.5(b)(iii) 
Art 3.5  (b)(iv) 
Art 3.5  (c) 
Art 3.5  (c)(i) 
Art 3.5  (c)(ii) 
Art 3.5  (c)(iii) 
Art 3.5  (c)(iv) 
Art 3.5(d) 
Art3.5(d)(i) 
Art 3.5  (d)(ii) 
Art 3.5  (e)(i) 
Art 3.5  (e)(ii) 
Art  3.5(0 
Art 3.5  (0(i) 
Art  3.5(00') 
Art 3.5  (h)(i) 
Art3.5(h)(ii) 
Art3.5(g)(i) 
Art 3.5  (g)(ii) 
Art 3.5  (i)(i) 
Art 3.5  (i)(ii) 

Art 3.5  (g)(iii) 
Art 3.5  (c)(v) 
Art 3.5  0) 
Art 3.5 (k) 
Art 3.5(1),  (m) 
Art 3.5 (n) 
Art3.5(o),(p) 

Annex  I.A 
Annex I.B 
Annex 
II.A.foreword 
para  1-3 
Annex 
II.A.foreword 
para 4 
Annex II.A.1 
Annex II.A. 1.1.1 
Annex II.A.1.1.2 
Annex  II.A. 1.2 
Annex  II.A.2 
Annex H.A.2.1.1 
Annex II.A.2.1.2 
Annex II.A.2.2 
Annex II.A.2.3 
Annex  II.A.3 
Annex II.A.3.1.1 
Annex II.A.3.1.2 
Annex II.A.3.2 
Annex II.A.3.3 
Annex II.A.4 
Annex II.A.4.1.1 
Annex II.A.4.1.2 
Annex II.A 4.2.1 
Annex II.A 4.2.2 
Annex II.A.5 
Annex II.A 5.1.1  ! 
Annex II.A.5.1.2 
Annex II.A.5.2.1 
Annex II.A.5.2.2 
Annex H.A.5.3.1 
Annex II.A.5.3.2 
Annex II.A.5.4.1 
Annex  II.A.5.4.2 
Annex  II.A.6 
Annex  II.A.6.1 
Annex II.A.6.2 
Annex II.A.7.1 
Annex II.A.7.2 
Annex H.A.8.1 
Annex II.A.8.2 

Annex II.A.9.1-9.4 
Annex 
II.B.foreword 
Annex  II.B.l 
Annex  II.B. 1.1 
Annex II.B.1.2 
Annex  I1.B.2 
Annex II.B.2.1 
Annex  11. B.2.2 
Annex  II.B.3 
Annex II.B.3.1 
Annex  II.B.3.2 
Annex 11.B.4 
Annex  II.B.4.1 
Annex  Il.B.4.2 
Annex  II.B.5 
Annex  II.B.5.1 
Annex  II.B.5.2 
Annex  II.B.6 

Annex I foreword 

Annex 1.6 

Annex  I.foreword 

Annex 1.1 
Annex 1.1.1 
Annex 1.1.2 
Annex  1.2 
Annex 1.2.1 
Annex 1.2.2 
Annex 1.3 
Annex  1.3.1 
Annex 1.3.2 
Annex 1.4 
Annex 1.4.1 
Annex 1.4.2 
Annex 1.5 
Annex 1.5.1 
Annex 1.5.2 
Annex 1.6 

An IX -3 

88/379 

90/35 

91/442 

Art  1  and 2 
Art  1  para 1 

Art 2; Annex (a) 
Art  I ; Annex (b) 

Art 3.2  para 3 (b) 
Art 3.5  para 4 

93/18 
Annex 1.6.1 
Annex 1.6.2 

Annex II.A.1 
Annex  II.A.2 
Annex  II.A.3 
Annex  II.A.4 
Annex  II.B. I 
Annex  II.B.2 
Annex  II.B.3 
Annex  II.B.4 
Annex II.B.5 
Annex  II.B.6 

This  Directive 
Annex II.B.6.1 
Annex II.B.6.2 
Annex HI.A 
Annex III.B 
Annex III.C 
Annex III.D 
Annex III.E 
Annex  IV B 
Annex  IV.A.l 
Annex  IV.A.2 
Annex 1V.A.3 
Annex V.A. 1 
Annex  V.A.2 
Annex  V.A.3 
Annex  V.A.4 
Annex  V.B.I 
Annex  V.B.2 
Annex  V.B.3 
Annex  V.B.4 
Annex  V.B.5 
Annex  V.B.6 
Annex  V.B.7 
Annex  V.B.8 
Année V.C 
Annex VI 
Annex VII 
Annex VIII 
Annex  IX 

An IX -3 

FINANCIAL  STATEMENT 

1. 

TITLE OF OPERATION 

Proposal  for  a  European  Parliament  and  Council  Directive  on  the  approximation  of  the 
laws,  regulations  and  administrative  provisions  of  the  Member  States  relating  to  the 
classification,  packaging and labelling of dangerous preparations. 

2. 

BUDGET HEADINGS INVOLVED: 

- A  1178: 
- A 2510: 

- A 5010: 

Technical and administrative assistance in support of different  activities 
Expenditure on meetings of committees whose consultation is compulsory 
on the procedure for drafting  Community  legislation 
Departmental data processing 

3. 

4. 

LEGAL BASIS: Article  100 A of the EU Treaty 

DESCRIPTION OF OPERATION 

4.1. General  Objective 

The  present  proposal,  by  replacing  and  consolidating  existing  legislation  on  dangerous 
preparations1  will  ensure  that  the  provisions  relating  to  classification,  packaging  and 
labelling of dangerous preparations are harmonized. 

In addition to replacing and consolidating existing legislation the proposal will 
also include new provisions: 

-updating the existing provisions of the directive to take account of  modifications 
and adaptations to technical progress of the parent directives. 
-extending of certain provisions of the directive to phyto pharmaceutical  -
products and explosives, and to preparations which, although not dangerous 
within the meaning of the directive, can present a hazard to the user 
-introducing provisions relating to preparations which are dangerous for the 
environment 

4.2 

Duration Unlimited 

'Council Directive  88/379/EEC  on the class, pack, and  lab. of dang, preps, as adapted  3 times to technical 
progress and  implemented  through  specific  implementing  directives. 

& 

5. 

CLASSIFICATION OF EXPENDITURE OR REVENUE 

5.1 

Non - compulsory  expenditure 

5.2 

Non differentiated  appropriations 

5.3 

No revenue is expected 

6. 

TYPE OF EXPENDITURE OR REVENUE 
See point  10 "Administrative expenditure" 

7. 

FINANCIAL IMPACT 
No financial  impact on appropriation for operations 

8. 

FRAUDE PREVENTION  MEASURES 

None 

9. 

ELEMENTS  OF COST-EFFECTIVENESS  ANALYSIS 

9.1. Specific  and quantified  objectives; target population 

Specific  objectives: 
The  aim  of  the  proposed  operation  are firstly,  to harmonise the rules relating  to  the 
classification,  labelling  and  packaging  of  dangerous  preparations  placed  in  the 
European  market  so  as  to  avoid  creating  obstacles  to  trade  and  secondly,  to 
guarantee a high level of protection for health and the environment. 
The  obligation  to  implement  the  directive's  provisions  will  be  beneficial  on  a 
number of scores: 
-  when the manufacturer  considers changing his products composition to reduce the 

risk for human  health and the environment; 

-  by  preventing  the  market  from  being  flooded  with  products  that  are  considered 

dangerous; 

-  by improving the use of information  systems and training in their use; 
-  by  providing  users  with  better  information  through  the  labelling  of  dangerous 

products and  safety  data sheet; 
-  by reducing the risks of accident; 
-  by making users aware of the choices they must make 

In  addition,  applying  uniform  classification  criteria  to the  greatest  possible  number 
of different  types  of preparations  released on the EU market by the chemical  sectors 

4o 

extremely  diverse  array  of  firms  should  have  positive  consequences  for  Europe's 
economy. 

Target  population:  Chemical  industry  (producers,  importers,  distributors)  general 
public (consumers), national authorities. 

9.2.  Grounds for the operation 

9.2.1  Community  harmonization 

The provisions related to the classification,  labelling and packaging of 
dangerous preparations that are marketed in the European Union 
absolutely  must be implemented in an harmonized fashion.  Straying 

labelling 
highly 

from  this  principle  could  lead  to  distortions  in  the  preparation's 
or the  provision  of  suitable  information  for  users.  This  would  be 

detrimental  to the smooth functioning  of the Community  market. 

9.2.2  Safety-health-environment 

The Community basis for taking measures related to human and 
environmental  health, safety  and protection is a high level of protection. 
It thus follows  that all provisions in line with these objectives, such as the 
adoption of classification  criteria for environmentally  dangerous 
preparations, should be taken into consideration. 

9. 3.  Monitoring and evaluation  of the operation. 

fhe  implementation  of  this  Directive  will  be  monitored  by  the  committee  set  up 
under Directive 88/379/EEC. 

<tf 

10.  ADMINISTRATIVE EXPENDITURE (SECTION EOT, PART A OF THE BUDGET) 

Actual  mobilisation  of  the  necessary  administrative  resources  will  depend  on  the 
Commission's  annual  decision  on  the  allocation  of  resources;  taking  into  account  the 
number of staff and additional amounts authorised by the budget authority. 

10.1.  Effect  on the number of posts 

Type of post 

Staff to be assigned to 
managing the operation 
Permanent 
posts 

Temporarv 
post? 

Source 

Duration 

Additional 
resources 

Existing 
resources 
in DG or 
department 
concerned 

Official 
Temporar 
y 
Staff 

A 
B 

C 

Other resources 
Total 

IB 

s 

1 

2 
3 

(2 man.Year) 

unlimited 

from 

as 
1997 
1997 

10.2. Overall financial  impact of additional human  resources 

Amounts 

ECU 
Method of calculation 

Officials 
Temporary  staff 
Other resources : 

Total 

The  expenses  related  to  human  resources  required  for  the completion  of this  action 
will  be made available  upon mobilisation of existing resources and are as follows: 

Officials  (Titles A1,A2, A4, A5) 

Technical assistance (A  1178): 
establishment  of a data base 

ECU 
90.000 

195.000(1) 

Total  285.000 

( 1 ) As from  1999 and  onwards  provisions  must  be made for the costs of adapting the 

data base to any changes (  15 % of  195.000 Ecus) 

*

•• 

tft 

10.3.  Increase in other administrative expenditure as result of the operation 

Amounts 
Budget heading 
A  5010:  Equipment  (Computer  100.000 
services  "informatique") 

A 2510: Meetings  (Article 21) 

105.000 

Total 1  205.000 

(2) in  1997 
(3) yearly as from  1999 

ECU 
Method of calculation 
(2) 

2 plenary meeting (30 experts) 
695 x 30 x 2 = 41.700/ year (3) 
6 working parties (15 experts) 
695x15x6  = 62.550/year (3) 
| 

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IMPACT  ON  COMPETITIVENESS  AND  EMPLOYMENT 

I.  The  proposal  for  a  Directive 

The  proposal  for  a  revision  of  the  Directive  relating  to  the  classification,  packaging  and 
labelling  of dangerous  preparations  is  intended: 

on  the  one  hand,  to  rework  existing  legislative texts concerning  the  classification, 
packaging  and  labelling  of dangerous  preparations,  i.e. the base  Directive 
88/379/EEC  and  its adaptation  to technical  progress, as well  as derived  directives 
in the  interests  of user-friendliness,  particularly  with regard  to  SMEs  and  SMIs 
and 
on the  other  hand, 

• 
• 

• 

to  include  provisions  on  environmentally  dangerous  preparations, 
to  extend  certain  provisions  of  the  Directive  to  cover  plant  protection  products, 
explosives  and  preparations  which, while  not dangerous  within  the  meaning  of  the 
Directive,  may  present  certain  dangers  for  users, 
to  update  certain  provisions  of  this  Directive  so  as  to  take  account  of  the 
amendments  and  their  adaptation  to technical  progress, 

This  proposal  must: 

harmonize  the  rules  on  the  classification,  packaging  and  labelling  of  dangerous 
preparations, 
ensure  that  the  internal  market  functions  correctly, 
ensure  a high  level  of protection  for  health  and  the  environment. 

Given  its  aims  and  definition,  this  proposal  cannot  be  carried  out  by  the  Member  States, 
but  requires  action  at  Community  level. 

II.  The  impact  on  businesses 

The  measures  concerned  relate  to  the  whole  of  the  chemicals  industry,  from 
companies  down  to  small  and  medium-sized  enterprises  (SMEs). 

large 

Under  these  provisions,  the  person  or  entity  responsible  for  placing  on  the  market  a 
preparation  covered  by  the  Directive  is  obliged  to  use  labelling  and  the  safety  data  sheet 
to  provide  information  relating  to the protection  of health  and  the  environment. 

The  costs  arising  from  these  measures  will  affect  different  types  of  company  in  different 
ways.  In  the  case  of  major  chemical  groups,  these  measures  are  already  partly  in  force 
and  the  extra  costs  can  readily  be  absorbed  without  having  any  significant  effect  on  the 
sale  price  of  the  product.  In  the  case  of  SMEs,  and  especially  small  businesses,  the  costs 
will  be  more  considerable  and  will  be reflected  in the price to the  consumer. 

* 

Costs: 

A distinction can be made between different  types of costs: 
(knowledge of the legislation:  "know-how") 
- legal 
(knowledge of products and applications of the legislation according to 
- technical 
type of product). 

The  sum  of these  two  types  of  cost  should  enable  an  appropriate  labelling  system  and  a 
safety  data sheet (SDS) to be classified  and developed. 

Costs  will  presumably  be  lower  for  large  businesses  which  already  use  SDS  labelling 
systems for their products, even for non-dangerous preparations. 

For  SMEs  with  a head  of product  safety,  the  "know-how"  and  safety  data  sheets  can  be 
developed  within  the enterprise.  However,  the printing  of labels and  the SDSs  as  well  as 
the development  of suitable packaging will incur additional costs. 

For other businesses, the cost of adjusting  may be greater. 

III.  What  must  businesses  do to comply with the proposal? 

First,  it  must  be  borne  in  mind  that  the  process  of  classifying  dangerous  substances  is 
constantly  changing,  entailing frequent  amendments to Annex I to Directive  67/548/EEC 
and.  consequently,  changes  to  the  preparations  which  contain  these  substances.  To 
comply  with  the  draft  Directive,  therefore,  the  persons  responsible  for  placing  products 
on  the  market  must,  where  appropriate,  update  the  labelling  of  their  products  and  apply 
the  new criteria  for  classifying  environmentally  dangerous  substances.  This new type  of 
classification  will  supplement  the  present  system  of  classifying  products  according  to 
their  effects  on  health  and  their  physical  and  chemical  properties.  It  should  not  lead  to 
preparations  being  classified  in  too  high  a category  simply  on  the  grounds  of  the  threat 
the); may pose to the  environment. 

Moreover,  these  provisions  on  classifying  environmentally  dangerous  substances  should 
not  mean  that  more  information  has to be supplied  on the  safety  data sheets, because  the 
data  which  must  appear  on  these  sheets  has  already  been  laid  down  in  Directive 
91/155/EEC, as last amended by Directive 93/112/EEC. 

Businesses  will  have  time  to  make  the  necessary  adjustments  in  the  time  it  takes  to 
implement the  legislation. 

The  sectors  of  industry  concerned  have  been  informed  and  have  not  objected  to  a 
minimum  two-year  period for  implementing the Directive in the Member States. 

ks 

IV.  What are the likely economic effects of the proposal? 

IV. 1  Effects  on  competition 

Competitiveness  will  be  affected  differently  from  one  firm  to  another. 
In  the 
longer  term,  the  measures  will  mean  an  increase  in  the  sale  price  of  products 
placed  on  the  market  by  SMEs.  However,  the  persons  responsible  for  placing 
products  on  the  market  can  improve  their  firm's  competitiveness  by  orienting 
production  towards less dangerous products. 

IV.2  Effects  on  employment 

The  measures  concerned  will  lead  to  increased  employment,  possibly  benefiting 
the  persons  recruited  by  firms  to  handle  this  work  but  also  the  providers  of 
services who are in a position to meet the requirements of this Directive. 

V.  Consultation 

A  number  of  professional  and  trade  associations  represented  by  the  Council  of  the 
European  Federation  of  the  Chemical  Industry  (CEFIC)  have  been  consulted  and  have 
been  closely  involved  in  producing  the  draft  Directive.  Some  particular  industries  have 
also  been  involved  - e.g.  the  European  Industrial  Gas Association  (EIGA), the  European 
Confederation  of  Associations  of  Paint  and  Printing  Ink  Manufacturers  (CEPE)  and  the 
International  Association of Soap and Detergent Manufacturing  Industries (AIS). 
Without  altering  the  thinking  behind  the  Directive,  the  Commission  and  the  Member 
States  have  given  a  positive  response  to  the  concern  expressed  by  industry  over  some 
measures which  might  have major  financial  repercussions: 

Safety  data  sheets  are  to  be  supplied  oniy  on  request  in  the  case  of  preparations 
which  are not dangerous within the meaning of the Directive but which contain at 
least  one  dangerous  substance  in a concentration  exceeding  that  laid  down  in  the 
Directive: 
Physical  and  chemical  data  are  exempted  from  laboratory  testing  under  certain 
conditions and exempted  from  the compulsory  implementation  of good  laboratory 
practices; 
Firms  will  be  free  to  choose  the  concentration  limits  deemed  acceptable  when 
the  conventional  method  of  assessing  environmentally  dangerous 
applying 
properties  which do not involve excessive  labelling. 

In  general, the professional  and  trade associations  consider  that  their concerns  have  been 
taken  into consideration  and that a reasonable balance has been struck. 

% 

ISSN 0254-1475 

COM(96) 347  final 

DOCUMENTS 

EN 

15  14  10 

Catalogue number  :  CB-CO-96-346-EN-C 

ISBN 92-78-06643-5 

Office for Official Publications of the European Communities 

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