Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the classification, packaging and labelling of dangerous preparations
Date: 2012-01-26
Institutions: European Commission
Subjects: classification, dangerous substance, labelling, marketing standard, packaging

EUROPEAN COMMISSION 

Brussels, 26.1.2012 
COM(2012) 8 final 

2012/0007 (COD) 

Proposal for a 

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

on the classification, packaging and labelling of dangerous preparations 

(Recast) 

 
 
  
 
1. 

2. 

3. 

4. 

5. 

EXPLANATORY MEMORANDUM 

On 1 April 1987 the Commission decided1 to instruct its staff that all acts should be 
codified  after  no  more  than  ten  amendments,  stressing  that  this  is  a  minimum 
requirement  and  that  departments  should  endeavour  to  codify  at  even  shorter 
intervals the texts for which they are responsible, to ensure that their provisions are 
clear and readily understandable. 

The  codification  of  Directive 1999/45/EC  of  the  European  Parliament  and  of  the 
Council of 31 May 1999 concerning the approximation of the laws, regulations and 
administrative  provisions  of  the  Member  States  relating  to  the  classification, 
packaging  and  labelling  of  dangerous  preparations2  has  been  initiated  by  the 
Commission.  The  new  Directive  was  to  have  superseded  the  various  acts 
incorporated in it3. 

In  the  meantime  the  Lisbon  Treaty  entered  into  force.  Article 290  of  the  Treaty  on 
the  Functioning of the European Union  (TFEU) allows the legislator to delegate to 
the  Commission  the  power  to  adopt  non-legislative  acts  of  general  application  to 
supplement or amend certain non-essential elements of a legislative act. Acts adopted 
by the Commission in this way are referred to in the terminology used by the TFEU 
as "delegated acts" (Article 290(3)). 

Directive 1999/45/EC contains a provision with regard to which such a delegation of 
power would be opportune. It is therefore appropriate to transform the codification of 
Directive 1999/45/EC 
the  necessary 
amendments. 

into  a  recast 

incorporate 

in  order 

to 

The  recast  proposal  was  drawn  up  on  the  basis  of  a  preliminary  consolidation, 
in 22 official  languages,  of  Directive 1999/45/EC  and  the  instruments  amending  it, 
carried  out  by  the  Publications  Office  of  the  European  Union,  by  means  of 
a data-processing  system.  Where  the  Articles  have  been  given  new  numbers,  the 
correlation  between  the  old  and  the  new  numbers  is  shown  in  a  table  set  out  in 
Annex IX to the recast Directive. 

1 
2 
3 

COM(87) 868 PV. 
OJ L 200, 30.7.1999, p. 1. 
See Annex VIII, Part A to this proposal. 

EN 

2 

   EN 

 
                                                 
(cid:208) 1999/45/EC (adapted) 

2012/0007 (COD) 

Proposal for a 

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

on the classification, packaging and labelling of dangerous preparations 

(Recast) 

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, 

Having  regard  to  the  Treaty  on  the  Functioning  of  the  European  Union,  and  in  particular 
Article ⌦ 114 ⌫ thereof, 

Having regard to the proposal from the European Commission, 

After transmission of the draft legislative act to the national Parliaments, 

Having regard to the opinion of the European Economic and Social Committee4, 

Acting in accordance with the ordinary legislative procedure5, 

Whereas: 

(cid:216) new 

(1) 

(2) 

Directive 1999/45/EC of the European Parliament and of the Council of 31 May 1999 
concerning the approximation of the laws, regulations and administrative provisions of 
the Member States relating to the classification, packaging and labelling of dangerous 
preparations6  has  been  substantially  amended  several 
times7.  Since  further 
amendments are to be made, it should be recast in the interests of clarity. 

The approximation of the rules existing in the Member States relating to classification, 
packaging and labelling of certain dangerous preparations is essential for setting equal 
competition conditions and the functioning of the internal market. 

(3)  Measures for the approximation of the provisions of the Member States affecting the 
functioning  of  the  internal  market  ⌦ should ⌫,  in  so  far  as  they  concern  health, 

(cid:208) 1999/45/EC recital 3 (adapted) 

4 
5 
6 
7 

OJ C […], […], p. […]. 
OJ C […], […], p. […]. 
OJ L 200, 30.7.1999, p. 1. 
See Annex VIII, Part A. 

EN 

3 

   EN 

 
 
 
 
                                                 
(4) 

(5) 

safety and protection of man and the environment, adopt a high level of protection as a 
basis. This Directive ⌦ should ⌫, at the same time, ensure protection for the general 
public, and, in particular, persons who come into contact with dangerous preparations 
in the course of their work or in the pursuit of a hobby, protection for consumers and 
for the environment. 

(cid:208) 1999/45/EC recital 8 (adapted) 

The  number  of  animals  used  for  experiments  should  be  reduced  to  a  minimum,  in 
accordance  with  the  provisions  of  ⌦ Directive  2010/63/EU  of  the  European 
Parliament and of the Council of 22 September 2010 on the protection of animals used 
for  scientific  purposes ⌫8.  ⌦ Pursuant  to  Article  4(1)  of  that  Directive  Member 
States  are  to  ensure  that,  wherever  possible,  a  scientifically  satisfactory  method  or 
testing strategy, not entailing the use of live animals, are used instead of a procedure 
within the meaning of that Directive, defined as any use, invasive or non-invasive, of 
an  animal  for  experimental  or  other  scientific  purposes,  with  known  or  unknown 
outcome,  or  educational  purposes,  which  may  cause  the  animal  a  level  of  pain, 
suffering,  distress  or  lasting  harm  equivalent  to,  or  higher  than,  that  caused  by  the 
introduction  of  a  needle  in  accordance  with  good  veterinary  practice. ⌫  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. 

(cid:208) 1999/45/EC recital 14 (adapted) 

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. It is therefore necessary as part of a transparent information process 
to classify them ⌦ in accordance with this Directive ⌫ and assign to them a safety 
data  sheet  in  accordance  with  ⌦ Regulation  (EC)  No 1907/2006  of  the  European 
Parliament  and  of  the  Council  of  18 December  2006  concerning  the  Registration, 
Evaluation,  Authorisation  and  Restriction  of  Chemicals  (REACH),  establishing  a 
European Chemicals Agency, amending Directive 1999/45/EC and repealing Council 
Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as 
Council  Directive  76/769/EEC  and  Commission  Directives 91/155/EEC,  93/67/EEC, 
93/105/EC  and  2000/21/EC9, ⌫  and  also  to  label  them  in  accordance  with  the 
international rules used for the transport of dangerous goods. 

(6)  ⌦ Regulation  (EC)  No  1107/2009  of  the  European  Parliament  and  of  the  Council 
of 21 October 2009 concerning the placing of plant protection products on the market 
repealing  Council  Directives  79/117/EEC  and  91/414/EEC ⌫10  and 
and 
Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 

(cid:208) 1999/45/EC recital 12 (adapted) 

8 
9 
10 

OJ L ⌦ 276, 20.10.2010, p. 33 ⌫. 
OJ L 396, 30.12.2006, p. 1. 
OJ L ⌦ 309, 24.11.2009, p. 1 ⌫. 

EN 

4 

   EN 

 
 
 
 
                                                 
concerning  the  placing  of  biocidal  products  on  the  market11,  in  contrast  to  the 
provisions applicable to chemical preparations covered by this Directive, provide for 
an authorisation procedure for each product on the basis of a dossier presented by the 
applicant  and  an  assessment  carried  out  by  the  competent  authority  in  each  Member 
State. Furthermore, that authorisation procedure includes a control relating specifically 
to the classification, packaging and labelling of each product before it is placed on the 
market.  It  is  appropriate,  as  part  of  a  clear  and  transparent  information  process,  to 
classify and label plant protection products ⌦ and biocidal products ⌫ according to 
the provisions of this Directive, and also to provide instructions for use in accordance 
with the results of the evaluation carried out in the framework of ⌦ Regulation (EC) 
No 1107/2009 and Directive 98/8/EC ⌫ and to ensure that the labelling satisfies the 
high  level  of  protection  sought  by  both  this  Directive  and  ⌦ Regulation (EC) 
No 1107/2009  or  Directive  98/8/EC  respectively ⌫.  In  addition,  a  safety  data  sheet 
has  to  be  established  for  plant  protection  products  ⌦ and  biocidal  products ⌫  in 
accordance with ⌦ Regulation (EC) No 1907/2006 ⌫. 

(cid:208) 1999/45/EC recital 5 (adapted) 

is  necessary 

to  provide  ⌦ for ⌫  concentration 
It 
volume/volume percentage in the case of preparations marketed in gaseous form. 

limits  expressed  as  a 

(cid:208) 1999/45/EC recital 9 

It  is  necessary  to  define  what  human  experience  might  be  considered  for  the 
evaluation of the health hazards of a preparation. If clinical studies may be accepted, it 
is  taken  as  given  that  such  studies  comply  with  the  Helsinki  Declaration  and  the 
Guidelines for Good Clinical Practice of the Organisation for Economic Co-operation 
and Development. 

(7) 

(8) 

(cid:208) Corrigendum 1907/2006 
recital 57 
(OJ L 136, 29.5.2007, p. 3) 
(adapted) 

(9) 

As the existing safety data sheet is already being used as a communication tool within 
the  supply  chain  of  substances  and  preparations,  ⌦ has  been  developed ⌫  further 
and  ⌦ has  been  made ⌫  an  integral  part  of  the  system  established  by  Regulation 
⌦ (EC) No 1907/2006, it should be removed from this Directive ⌫. 

(cid:208) Corrigendum 2006/121/EC 
recital 1 
(OJ L 136, 29.5.2007, p. 281) 
(adapted) 

(10)  ⌦ Due 

to ⌫ 

(EC)  No 1907/2006,  Council 
Directive 67/548/EEC of 27 June 1967 on the approximation of the laws, regulations 
and administrative provisions relating to the classification, packaging and labelling of 

the  adoption  of  Regulation 

11 

OJ L 123, 24.4.1998, p. 1. 

EN 

5 

   EN 

 
 
 
 
 
                                                 
dangerous substances12 ⌦ has  been ⌫ adapted  and its rules on  the  notification and 
risk  assessment  of  chemicals ⌦ have  been ⌫ deleted. ⌦ This  Directive  should  be 
adapted accordingly. ⌫ 

(cid:208) 440/2008 recital 2 (adapted) 

(11)  Annex V  to  Directive  67/548/EEC,  ⌦ setting  out  methods  for  the  determination  of 
the  physico-chemical  properties, 
toxicity  and  ecotoxicity  of  substances  and 
preparations, ⌫  has  been  deleted  by  Directive 2006/121/EC  of  the  European 
Parliament  and  of  the  Council13  with  effect  from  1 June  2008. ⌦ The  references  to 
that Annex in this Directive should be adapted accordingly. ⌫ 

(cid:208) 1272/2008 recital 53 (adapted) 

(12) 

In  order  to  take  full  account  of  the  work  and  experience  accumulated  under 
Directive 67/548/EEC, including the classification and labelling of specific substances 
listed  in  Annex  I  ⌦ to  that ⌫  Directive,  all  existing  harmonised  classifications 
should  be  converted  into  new  harmonised  classifications  using  the  new  criteria. 
Moreover,  as  the  applicability  of  Regulation  (EC)  No 1272/2008  of  the  European 
Parliament  and  of  the  Council  of  16 December  2008  on  classification,  labelling  and 
packaging of substances and mixtures, amending and repealing Directives 67/548/EEC 
and  1999/45/EC,  and  amending  Regulation (EC)  No 1907/200614  is  deferred  and  the 
harmonised classifications in accordance with the criteria of Directive 67/548/EEC are 
relevant for the classification of substances and mixtures during the ensuing transition 
period, all existing harmonised classifications should also be placed unchanged in an 
annex  to  ⌦ that ⌫  Regulation.  By  subjecting  all  future  harmonisations  of 
classifications to ⌦ that ⌫ Regulation, inconsistencies in harmonised classifications 
of the same substance under the existing and the new criteria should be avoided. 

(cid:208) 2006/8/EC recital 1 (adapted) 

(13)  Preparations composed of more than one substance being classified in ⌦ Table 3.2 of 
Part 3 of Annex VI to Regulation (EC) No 1272/2008 ⌫ as carcinogenic, mutagenic 
and/or toxic for reproduction ⌦ had to ⌫ be labelled with risk phrases (R phrases) to 
indicate  both  category 1  or  2  and  category 3  classification.  However,  providing  both 
R phrases sends a conflicting message. Preparations should therefore only be classified 
and labelled with the higher category. 

(14)  ⌦ The  references  to  R  phrase  R40  in  Directive  67/548/EEC  were  amended  by ⌫ 
Commission  Directive  2001/59/EC15  when  ⌦ R  phrase  R40  was ⌫  assigned  to 
carcinogens  of  category  3.  Consequently,  the  old  wording  of  R  phrase  R40 
⌦ became ⌫ R68 and ⌦ was used ⌫ for mutagens of category 3 and for certain 

(cid:208) 2001/60/EC recital 2 (adapted) 

12 
13 
14 
15 

OJ 196, 16.8.1967, p. 1. 
OJ L 396, 30.12.2006, p. 850. 
OJ L 353, 31.12.2008, p. 1. 
OJ L 225, 21.8.2001, p. 1. 

EN 

6 

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substances with non-lethal irreversible effects. ⌦ The references to R phrase R40 in 
this Directive should be adapted accordingly. ⌫  

(15)  Annex VI to Directive 67/548/EEC ⌦ as amended by Directive 2001/59/EC gives ⌫ 
clear advice on the classification of substances and preparations for corrosive effects. 
⌦ In this Directive, preparations should therefore be classified ⌫ accordingly.  

(cid:208) 2001/60/EC recital 3 (adapted) 

(16) 

It  is  known  that  cement  preparations  containing  chromium  (VI)  may  cause  allergic 
reactions  in  certain  circumstances.  Such  preparations  ⌦ should ⌫  display  ⌦ the 
relevant ⌫ warning label. 

(cid:208) 2001/60/EC recital 4 (adapted) 

(17)  ⌦ Directive  67/548/EEC  as  amended  by ⌫  Commission  Directive  98/98/EC16 
provides  for  new  criteria  and  a  new  R phrase  (R67)  for  vapours  which  may  cause 
drowsiness  and  dizziness.  ⌦ Preparations  should  be  classified  and 
labelled 
accordingly ⌫. 

(cid:208) 2001/60/EC recital 1 (adapted) 

(cid:208) 1999/45/EC recital 7 (adapted) 

(18)  Criteria  developed  for  classifying  and  labelling  substances  dangerous  for  the 
environment were introduced ⌦ together with the appropriate symbols, indications of 
danger,  risk  phrases  and  safety  advice  required  to  appear  on  labelling, ⌫  by 
⌦ Council  Directive 92/32/EEC  of  30 April  1992  amending  for  the  seventh  time 
Directive 67/548/EEC on the approximation of the laws, regulation and administrative 
provisions  relating  to  the  classification,  packaging  and  labelling  of  dangerous 
substances17  and  by  Commission  Directive  93/21/EEC  of  27 April  1993  adapting  to 
the 
technical  progress  for 
approximation  of  the  laws,  regulation  and  administrative  provisions  relating  to  the 
classification,  packaging  and  labelling  of  dangerous  substances18. ⌫  Provisions 
⌦ are  required ⌫  at  ⌦ Union ⌫  level  on  the  classification  and  labelling  of 
preparations  to  take  account  of  their  effects  on  the  environment,  and  it  is  therefore 
necessary  to  ⌦ provide  for ⌫  a  method  for  assessing  the  hazards  of  a  given 
preparation for the environment either by a calculation method, or by determining the 
ecotoxicological properties by test methods under certain conditions. 

the  18th time  Council  Directive  67/548/EEC  on 

(19)  For substances very toxic to the aquatic environment (classified as N) and assigned the 
R  phrases  R50  or  R50/53,  specific  concentration  limits  (SCLs)  are  applied  to 
substances listed in Table 3.2 of Part 3 of Annex VI to Regulation (EC) No 1272/2008 

(cid:208) 2006/8/EC recital 2 (adapted) 

16 
17 
18 

OJ L 355, 30.12.1998, p. 1. 
OJ L 154, 5.6.1992, p. 1. 
OJ L 110, 4.5.1993, p. 20. 

EN 

7 

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in  order  to  avoid  an  underestimation  of  the  hazard.  This  measure  creates  distortions 
to 
between  preparations  containing  substances 
which SCLs are applied, and those preparations containing substances not yet included 
in  ⌦ that ⌫  Annex,  but  classified  and  labelled  provisionally  in  accordance  with 
Article 6 of Directive 67/548/EEC and to which no SCLs are applicable. It is therefore 
necessary  to  ensure  that  SCLs  are  applied  in  the  same  way  to  all  preparations 
containing substances very toxic to the aquatic environment. 

in  ⌦ that ⌫  Annex, 

listed 

(20)  Directive 2001/59/EC revised the criteria in Annex VI to Directive 67/548/EEC for the 
classification and labelling of ozone depleting substances. The revised Annex III now 
only  provides  for  the  assignment  of  the  symbol  N  in  addition  to  R  phrase  R59. 
⌦ Preparations should be classified and labeled accordingly. ⌫ 

(cid:208) 2006/8/EC recital 3 (adapted) 

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

(cid:208) 1999/45/EC recital 20 

(cid:208) 1999/45/EC recital 16 (adapted) 

(22)  The label constitutes a basic tool for users of the dangerous preparations in so far as it 
provides them with the initial essential concise information. It nevertheless needs to be 
supplemented by a two-fold system of more detailed information, consisting firstly of 
the  safety  data  sheet  intended  for  professional  users  ⌦ as  provided  for  in 
Regulation (EC)  No 1907/2006 ⌫  and  secondly  of  the  bodies  appointed  by  the 
Member  States  which  are  responsible  for  the  provision  of  information  solely  for 
medical purposes, both preventive and curative. 

(cid:208) 1999/45/EC recital 4 

(23)  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. Certain preparations not falling within these categories of danger 
may  nevertheless,  owing  to  their  composition,  present  a  danger  for  children.  The 
packaging  of  such  preparations  should  therefore  be  equipped  with  child-resistant 
fastenings. 

(24) 

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  ⌦ that ⌫  certain  provisions  of  this  Directive  cover  such 
preparations. 

(cid:208) 1999/45/EC recital 15 (adapted) 

EN 

8 

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(cid:208) 1999/45/EC recital 6 (adapted) 

(25)  This Directive contains special labelling provisions applicable to certain preparations. 
To  ensure  an  adequate  level  of  protection  for  man  and  the  environment,  special 
labelling  provisions ⌦ should ⌫  also  be ⌦ laid  down ⌫  for  certain  preparations 
which, although not dangerous within the meaning of this Directive, may nevertheless 
present a danger to the user. 

(cid:208) 1999/45/EC recital 19 (adapted) 

(26) 

In  the  case  of  preparations  classified  as  dangerous  within  the  meaning  of  this 
Directive, it is appropriate to permit Member States to allow certain derogations with 
respect  to  labelling  where  the  packaging  is  too  small,  or  otherwise  unsuitable  for 
labelling,  or  where  such  small  packaging  or  such  small  quantities  are  involved  that 
there  is  no  reason  to  fear  any  danger  to  man  or  the  environment.  In  such  cases 
appropriate  consideration  should  also  be  given  to  the  approximation  of  the  relevant 
provisions at ⌦ Union ⌫ level.  

(27) 

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

(cid:208) 1999/45/EC recital 13 

(cid:216) new 

(28) 

In order to supplement or amend certain non-essential elements of this Directive, the 
power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of 
the European Union should be delegated to the Commission in respect of determining 
exemptions to certain provisions on environmental labelling, deciding on measures in 
the  framework  of  the  special  provisions  on  the  labelling  of  certain  preparations  and 
adapting  the  Annexes  to  technical  progress.  It  is  of  particular  importance  that  the 
Commission carry out appropriate consultations during its preparatory work, including 
at expert level.  

The  Commission,  when  preparing  and  drawing-up  delegated  acts,  should  ensure  a 
simultaneous,  timely  and  appropriate  transmission  of  relevant  documents  to  the 
European Parliament and Council. 

(29) 

In  order  to  ensure  uniform  conditions  for  the  implementation  of  this  Directive, 
implementing powers should be conferred on the Commission. Those powers should 
be  exercised  in  accordance  with  Regulation  (EU)  No  182/2011  of  the  European 
Parliament and of the Council of 16 February 2011 laying down the rules and general 
principles concerning mechanisms for control by Member States of the Commission’s 
exercise of implementing powers19. 

19 

OJ L 55, 28.2.2011, p. 13. 

EN 

9 

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(30)  This  Directive  should  be  without  prejudice  to  the  obligations  of  the  Member  States 
relating to the time-limits for transposition into national law of the Directives set out in 
Annex VIII, Part B, 

HAVE ADOPTED THIS DIRECTIVE: 

(cid:208) 1999/45/EC 

Article 1 

Objectives and scope 

1.  This  Directive  aims  at  the  approximation  of  the  laws,  regulations  and  administrative 
provisions  of  the  Member  States  relating  to  the  classification,  packaging  and  labelling  of 
dangerous  preparations,  and  to  the  approximation  of  specific  provisions  for  certain 
preparations  which  may  present  hazards,  whether  or  not  they  are  classified  as  dangerous 
within the meaning of this Directive, when such preparations are placed on the market of the 
Member States. 

2. This Directive shall apply to preparations which: 

(a) 

contain at least one dangerous substance within the meaning of Article 2; ⌦ and ⌫ 

(cid:208) 1999/45/EC (adapted) 

(b) 

are considered dangerous within the meaning of Article 5, 6 or 7. 

(cid:208) 1999/45/EC 

(cid:208) 1999/45/EC (adapted) 

3.  The  specific  provisions  set  out  in  Article 9  and  Annex IV,  ⌦ and  those  set  out ⌫  in 
Article 10 and Annex V shall also apply to preparations which are not considered dangerous 
within the meaning of Article 5, 6 or 7 but which may nevertheless present a specific hazard. 

4. Without prejudice to ⌦ Regulation (EC) No 1107/2009 ⌫, the articles on classification, 
packaging ⌦ and ⌫ labelling of this Directive shall apply to plant protection products. 

(cid:208) 1999/45/EC 

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

(a) 

veterinary  medicinal  products  and  medicinal  products  for  human  use,  as  defined  in 
Directives 2001/82/EC20  and  2001/83/EC21  of  the  European  Parliament  and  of  the 
Council respectively;  

20 

OJ L 311, 28.11.2001, p. 1. 

EN 

10 

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(b) 

(c) 

(d) 

(e) 

(f) 

(g) 

cosmetic products as defined in Council Directive 76/768/EEC22; 

mixtures  of  substances  which, 
Directive 2008/98/EC of the European Parliament and of the Council23; 

form  of  waste,  are  covered  by 

the 

in 

foodstuffs; 

animal feedingstuffs; 

preparations 
containing 
Directive 96/29/Euratom24; 

radioactive 

substances 

as  defined  by  Council 

(cid:208) 1999/45/EC (adapted) 

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

6. This Directive shall not apply to: 

(cid:208) 1999/45/EC  

(a) 

(b) 

the carriage of dangerous preparations by rail, road, inland waterway, sea or air; 

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

Article 2 

Definitions 

1. For the purposes of this Directive ⌦ , the following definitions shall apply ⌫: 

(cid:208) 1999/45/EC (adapted) 

(cid:208) 1999/45/EC 

(a) 

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

(b) 

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

21 
22 
23 
24 

OJ L 311, 28.11.2001, p. 67. 
OJ L 262, 27.9.1976, p. 169. 
OJ L 312, 22.11.2008, p. 3. 
OJ L 159, 29.6.1996, p. 1. 

EN 

11 

   EN 

 
 
 
 
 
                                                                                                                                                         
(c) 

(d) 

(e) 

(f) 

(g) 

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

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

(cid:208) 1999/45/EC (adapted) 

(cid:208) 1999/45/EC 

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

includes 

it 

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

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

(cid:208) 1999/45/EC (adapted) 

2. The following are ‘dangerous’ within the meaning of this Directive: 

(cid:208) 1999/45/EC 

(a) 

(b) 

(c) 

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

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

extremely flammable substances and preparations: liquid substances and preparations 
having an extremely low flash-point and a low boiling-point and gaseous substances 
and preparations which are flammable in contact with air at ambient temperature and 
pressure; 

EN 

12 

   EN 

 
 
 
 
 
(d) 

highly flammable substances and preparations: 

(i) 

(ii) 

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

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

(iii) 

liquid substances and preparations having a very low flash-point; or 

(iv)  substances and preparations which, in contact with water or damp air, evolve 

extremely flammable gases in dangerous quantities; 

flammable substances and preparations: liquid substances and preparations having a 
low flash-point; 

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

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

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

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

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

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

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

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

substances  and  preparations  which  are  toxic  for  reproduction:  substances  and 
preparations which, if they are inhaled or ingested or if they penetrate the skin, may 

(e) 

(f) 

(g) 

(h) 

(i) 

(j) 

(k) 

(l) 

(m) 

(n) 

EN 

13 

   EN 

 
produce,  or  increase  the  incidence  of,  non-heritable  adverse  effects  in  the  progeny 
and/or an impairment of male or female reproductive functions or capacity; 

(o) 

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

Article 3 

Determination of dangerous properties of preparations 

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

(a) 

(b) 

(c) 

physico-chemical properties; 

properties affecting health; 

environmental properties. 

Those different properties shall be determined in accordance with Articles 5, 6 and 7.  

(cid:208) 1999/45/EC (adapted) 

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

(cid:208) 1999/45/EC 

(cid:208) 1999/45/EC (adapted) 
(cid:206)1 1272/2008 Art. 56 pt. 1 
(adapted) 

2.  Where  the  determination  of  dangerous  properties  is  carried  out  in  accordance  with 
Articles 5, 6 and 7, all dangerous substances within the meaning of Article 2 and in particular 
⌦ the  following  shall  be  taken  into  consideration  in  accordance  with  the  provisions  laid 
down in the method used ⌫: 

(a)  ⌦ substances ⌫ 
No 1272/2008 ; 

listed 

in  (cid:206)1 Part  3  of  Annex VI 

to  Regulation 

(EC) 

(b)  ⌦ substances ⌫ classified and labelled provisionally by the person responsible for 

the placing on the market in accordance with Article 6 of Directive 67/548/EEC. 

(cid:208) 1999/45/EC 
(cid:206)1 1272/2008 Art. 56 pt. 2(a) 

3.  For  preparations  covered  by  this  Directive,  dangerous  substances  as  referred  to  in 
paragraph 2  which  are  classified  as  dangerous  on  the  basis  of  their  health  and/or 
environmental effects, whether they are present as impurities or additives, shall be taken into 
consideration  when  their  concentrations  are  equal  to,  or  greater  than,  those  defined  in  the 

EN 

14 

   EN 

 
 
 
 
 
following table unless lower values are given in (cid:206)1 Part 3 of Annex VI to Regulation (EC) 
No 1272/2008 , or in Part B of Annex II to this Directive or in Part B of Annex III thereto, 
unless otherwise specified in Annex V to this Directive. 

Category of danger of the substance 

Concentration to take into consideration for 

gaseous preparations 
% vol/vol 

other preparations 
% w/w 

Very toxic 

Toxic 

Carcinogenic 
Category 1 or 2 

Mutagenic 
Category 1 or 2 

Toxic for reproduction 
Category 1 or 2 

Harmful 

Corrosive 

Irritant 

Sensitising 

Carcinogenic 
Category 3 

Mutagenic 
Category 3 

Toxic for reproduction 
Category 3 

Dangerous for the environment N 

Dangerous for the environment 
ozone 

Dangerous for the environment 

≥ 0,02 

≥ 0,02 

≥ 0,02 

≥ 0,02 

≥ 0,02 

≥ 0,2 

≥ 0,02 

≥ 0,2 

≥ 0,2 

≥ 0,2 

≥ 0,2 

≥ 0,2 

≥ 0,1 

≥ 0,1 

≥ 0,1 

≥ 0,1 

≥ 0,1 

≥ 0,1 

≥ 1 

≥ 1 

≥ 1 

≥ 1 

≥ 1 

≥ 1 

≥ 1 

≥ 0,1 

≥ 0,1 

≥ 1 

EN 

15 

   EN 

 
 
 
Article 4 

General principles of classification and labelling 

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

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

Evaluation of the hazards deriving from physico-chemical properties 

Article 5 

(cid:208) 1999/45/EC (adapted) 

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  the  Annex  to 
Council  Regulation  (EC)  No 440/200825,  the  physico-chemical  properties  of  the  preparation 
necessary for appropriate classification and labelling in accordance with the criteria laid down 
in Annex VI to Directive ⌦ 67/548/EEC ⌫. 

(cid:208) 1999/45/EC 

2.  By  way  of  derogation  from  paragraph 1,  the  determination  of  the  explosive,  oxidising, 
extremely  flammable,  highly  flammable,  or  flammable  properties  is  not  necessary  provided 
that: 

(a) 

(b) 

(c) 

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 8(1a) of Council Directive 75/324/EEC26. 

3.  For  certain  cases  for  which  the  methods  laid  down  in  Part A  of  the  Annex  to 
Regulation (EC)  No 440/2008  are  not  appropriate,  alternative  calculation  methods  are  laid 
down in Part B of Annex I to this Directive. 

25 
26 

OJ L 142, 31.5.2008, p. 1. 
OJ L 147, 9.6.1975, p. 40. 

EN 

16 

   EN 

 
 
 
                                                 
4. Certain exemptions from the application of the methods laid down in Part A of the Annex 
to Regulation (EC) No 440/2008 are referred to in Part A of Annex I to this Directive. 

(cid:208) 1999/45/EC (adapted) 

5.  The  hazards  deriving  from  the  physico-chemical  properties  of  a  preparation  covered  by 
⌦ Regulation (EC) No 1107/2009 ⌫ shall be assessed by determining the physico-chemical 
properties  of  the  preparation  necessary  for  appropriate  classification  in  accordance  with  the 
criteria set out in Annex VI to Directive 67/548/EEC. Those properties shall be determined by 
means  of  the  methods  laid  down  in  Part A  of  the  Annex  to  Regulation  (EC)  No 440/2008 
unless  other  internationally  recognised  methods  are  acceptable  in  accordance  with  the 
provisions of ⌦ Commission Regulations (EU) No 544/201127 and (EU) No 545/201128 ⌫. 

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) 

(b) 

by a conventional method described in Annex II; 

in  accordance  with 

by  determining  the  toxicological  properties  of  the  preparation  necessary  for 
appropriate  classification 
to 
Directive 67/548/EEC.  Those  properties  shall  be  determined  by  means  of  the 
methods laid down in Part B of the Annex to Regulation (EC) No 440/2008, unless, 
in the case of plant protection products, other internationally recognised methods are 
acceptable in accordance with  the provisions of ⌦ Regulations (EU) No 544/2011 
and (EU) No 545/2011 ⌫. 

in  Annex VI 

the  criteria 

2.  Without  prejudice  to  the  requirements  of  ⌦ Regulation (EC)  No 1107/2009 ⌫,  only 
where  it  can  be  scientifically  demonstrated  by  the  person  responsible  for  placing  the 
preparation on the market that the toxicological properties of the preparation cannot correctly 
be determined by the method outlined in point (a) of paragraph 1, or on the basis of existing 
test  results  on  animals,  the  methods  outlined  in  point (b)  of  paragraph 1  may  be  used, 
provided 
of 
specifically 
are 
Directive 86/609/EEC. 

under  Article 12 

authorised 

justified 

they 

or 

When  a  toxicological  property  is  established  by  the  methods  outlined  in  point (b)  of 
paragraph 1 to obtain new data, the test shall be conducted in compliance with the principles 
of good laboratory practice provided for in Directive 2004/10/EC of the European Parliament 
and the Council29 and the provisions of Directive 86/609/EEC, in particular Articles 7 and 12 
thereof. 

Subject to the provisions of paragraph 3, where a toxicological property has been established 
on the basis of both the methods outlined in points (a) and (b) of paragraph 1, the results from 

27 
28 
29 

OJ L 155, 11.6.2011, p. 1. 
OJ L 155, 11.6.2011, p. 67. 
OJ L 50, 20.2.2004, p. 44. 

EN 

17 

   EN 

 
 
                                                 
the methods outlined in point (b) of paragraph 1 shall be used for classifying the preparation, 
except in the case of carcinogenic, mutagenic or toxic effects for reproduction for which only 
the method outlined in point (a) of paragraph 1 shall be used. 

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

3.  Furthermore,  where  it  can  be  demonstrated  by  epidemiological  studies,  by  scientifically 
valid  case  studies  as  specified  by  Annex VI  to  Directive 67/548/EEC  or  by  statistically 
backed  experience,  such  as  the  assessment  of  data  from  poison  information  units  or 
concerning occupational diseases: 

– 

– 

– 

that  toxicological  effects  on  man  differ  from  those  suggested  by  the  application  of 
the  methods  outlined  in  paragraph 1,  then  the  preparation  shall  be  classified 
according to its effects on man, 

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

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

4.  For  preparations  of  a  known  composition,  with  the  exception  of  those  covered  by 
⌦ Regulation (EC) No 1107/2009 ⌫, classified in accordance with point (b) of paragraph 1, 
a new evaluation of health hazard by the methods outlined in either point (a) or point (b) of 
paragraph 1 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 % 

± 20 % 

± 10 % 

± 5 % 

– 

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

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

EN 

18 

   EN 

 
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) 

(b) 

by a conventional method described in Annex III ; 

by  determining  the  hazardous  properties  of  the  preparation  for  the  environment 
necessary  for  appropriate  classification  in  accordance  with  the  criteria  set  out  in 
Annex VI to Directive 67/548/EEC. Those properties shall be determined by means 
of  the  methods  laid  down  in  Part C  of  the  Annex  to  Regulation  (EC)  No 440/2008 
unless,  in  the  case  of  plant  protection  products,  other  internationally  recognised 
methods  are  acceptable  in  accordance  with  the  provisions  of  ⌦ Regulations (EU) 
No 544/2011  and  (EU)  No 545/2011 ⌫.  Without  prejudice 
testing 
requirements ⌦ laid down in or pursuant to Regulation (EC) No 1107/2009 ⌫, the 
conditions for application of the test methods are described in Part C of Annex III to 
this Directive. 

the 

to 

2.  Where  an  ecotoxicological  property  is  established  by  one  of  the  methods  outlined  in 
point (b) of paragraph 1 to obtain new data, the test shall be conducted in compliance with the 
principles  of  good  laboratory  practice  provided  for  in  Directive  2004/10/EC  and  with  the 
provisions of Directive 86/609/EEC. 

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

3.  For  preparations  of  a  known  composition,  with  the  exception  of  those  covered  by 
⌦ Regulation (EC) No 1107/2009 ⌫, classified in accordance with the method outlined in 
point (b)  of  paragraph 1,  a  new  evaluation  of  environmental  hazard  either  by  the  method 
outlined  in  point (a)  of  paragraph 1  or  that  outlined  in  point (b)  of  paragraph 1  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 % 

± 20 % 

± 10 % 

± 5 % 

EN 

19 

   EN 

 
– 

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

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

(cid:208) 1999/45/EC  

Article 8 

Obligations and duties of the Member States 

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

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

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

(a) 

(b) 

(c) 

the data used for the classification and labelling of the preparation; 

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

the data used for establishing the safety data sheet, in accordance with Article 31 of 
Regulation (EC) No 1907/2006. 

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

Article 9 

Packaging 

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

(a) 

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

(i) 

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

EN 

20 

   EN 

 
 
(ii) 

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; 

(iii)  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; 

(iv)  containers  fitted  with  replaceable  fastening  devices  shall  be  so  designed  that 
the packaging can be refastened repeatedly without the contents escaping; 

(b) 

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

(i) 

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

(ii) 

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

(c) 

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

(cid:208) 1999/45/EC (adapted) 
(cid:206)1 1272/2008 Art. 56 pt. 2(b) 

(i) 

are fitted with child-resistant fastenings; ⌦ and/or ⌫ 

(ii) 

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. 

2. The packaging of preparations shall be deemed to satisfy the requirements of points (a)(i), 
(ii)  and  (iii)  of  paragraph 1  if  it  complies  with  the  requirements  for  carriage  of  dangerous 
goods by rail, road, inland waterway, sea or air. 

Article 10 

Labelling 

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

(a) 

(b) 

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

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 

EN 

21 

   EN 

 
 
satisfies the requirements of points (a) and (b) of paragraph 3 of this Article and the 
specific provisions of Parts B and C of Annex V. 

2. With respect to plant protection products subject to ⌦ Regulation (EC) No 1107/2009 ⌫, 
the  labelling  requirements  in  accordance  with  this  Directive  shall  be  accompanied  by  the 
following wording: 

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

This  labelling  shall  be  without  prejudice  to  the  information  required  in  accordance  with 
Article ⌦ 65 ⌫ of ⌦ Regulation (EC) No 1107/2009 ⌫ and ⌦ Annexes I and III ⌫ to 
⌦ Commission Regulation (EU) No 547/201130 ⌫. 

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

(a) 

(b) 

(c) 

the trade name or designation of the preparation; 

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

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

(i) 

(ii) 

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 (cid:206)1 Part 3 of Annex VI to 
Regulation (EC)  No 1272/2008   or,  failing  that,  Part B  of  Annex II  to  this 
Directive have to be taken into consideration; 

for  preparations  classified C  in  accordance  with  Article 6,  only  C  substances 
present  in  concentrations  equal  to,  or  greater  than,  the  lowest  limit  (limit  Xi) 
laid down in (cid:206)1 Part 3 of Annex VI to Regulation (EC) No 1272/2008  or, 
failing  that,  Part B  of  Annex II  to  this  Directive  have  to  be  taken  into 
consideration; 

(iii) 

the  name  of  the  substances  which  have  given  rise  to  the  classification  of  the 
preparation  in  one  or  more  of  the  following  danger  categories  ⌦ shall  be 
mentioned on the label ⌫: 

– 

– 

– 

– 

carcinogen category 1, 2 or 3, 

mutagen category 1, 2 or 3, 

toxic for reproduction category 1, 2 or 3, 

very  toxic,  toxic  or  harmful  due  to  non-lethal  effects  after  a  single 
exposure, 

30 

OJ L 155, 11.6.2011, p. 176. 

EN 

22 

   EN 

 
                                                 
– 

toxic  or  harmful  due  to  severe  effects  after  repeated  or  prolonged 
exposure, 

– 

sensitising. 

The  chemical  name  shall  be  one  of  the  designations  listed  in  (cid:206)1 Part 3  of 
Annex VI 
internationally 
recognised chemical nomenclature if no corresponding designation is yet listed 
in that Annex; 

to  Regulation  (EC)  No 1272/2008   or  an 

(iv) 

the name of any substance which led to the classification of the preparation in 
the following danger categories ⌦ need not be mentioned on the label, unless 
the substance has to be mentioned pursuant to points (i), (ii) or (iii) ⌫: 

– 

– 

– 

– 

– 

– 

– 

explosive, 

oxidising, 

extremely flammable, 

highly flammable, 

flammable, 

irritant, 

dangerous for the environment; 

(v) 

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

(d)  ⌦ 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 Annexes II and VI to Directive 67/548/EEC 
and shall be applied in accordance with the evaluation of the hazards carried out in 
accordance with Annexes I, II and III to this Directive. 

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

(i)  T  shall  make  the  symbols C  and  X  optional  unless  otherwise  specified  in 

(cid:206)1 Part 3 of Annex VI to Regulation (EC) No 1272/2008 ; 

(ii)  C shall make the symbol X optional; 

(iii)  E shall make the symbols F and O optional; 

(iv)  Xn shall make the symbol Xi optional. 

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

EN 

23 

   EN 

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

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

The standard phrases ‘extremely flammable’ or ‘highly flammable’ need not be used 
where they describe an indication of danger used in accordance with point (d) of this 
paragraph; 

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

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

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

(g) 

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

(cid:208) 1999/45/EC (adapted) 
(cid:206)1 1137/2008 Art. 1 and Annex, 
point 3.5.1 (adapted) 
(cid:214) new 

4.  (cid:206)1 In  relation  to  certain  preparations  classified  as  dangerous  within  the  meaning  of 
Article 7, by way of derogation from points (d), (e) and (f) of paragraph 3 of this Article, the 
Commission  may  (cid:214) shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article 20  for  the  purpose  of  determining   determine  exemptions  to  certain  provisions  on 
environmental labelling or specific provisions in relation to environmental labelling, where it 
can  be  demonstrated  that  there  would  be  a  reduction  in  the  environmental  impact.  Those 
measures,  designed  to  amend  non-essential  elements  of  this  Directive  by  supplementing  it 
shall  be  adopted  in  accordance  with  the  regulatory  procedure  with  scrutiny  referred  to  in 
Article 20a(3).   Those  exemptions  or  specific  provisions  are  defined  and  laid  down  in 
Part A or B of Annex V.  

EN 

24 

   EN 

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

(cid:208) 1999/45/EC 

(a) 

(b) 

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

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

(cid:208) 1999/45/EC (adapted) 

6.  Without  prejudice  to  ⌦ point  3  of  Annex  I  to  Regulation  (EU)  No  547/2011 ⌫, 
indications  such  as  ‘non-toxic’,  ‘non-harmful’,  ‘non-polluting’,  ‘ecological’  or  any  other 
statement indicating that the preparation is not dangerous or likely to lead to underestimation 
of the dangers of the preparation in question shall not appear on the packaging or labelling of 
any preparation subject to this Directive. 

(cid:208) 1999/45/EC  

Article 11 

Implementation of the labelling requirements 

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

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

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

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. 

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

EN 

25 

   EN 

 
 
 
 
6. For the purposes 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 goods and the inner package or packages are labelled in accordance with 
this Directive; 

(b) 

in the case of a single package: 

(i) 

if  such  a  package  is  labelled  in  accordance  with  international  rules  on  the 
transport  of  dangerous  goods  and  with  points (a),  (b),  (c),  (e)  and  (f)  of 
Article 10(3); for preparations classified according to Article 7, the provisions 
of  Article 10(3)(d)  shall  additionally  apply  with  respect  to  the  property  in 
question when it has not been so identified on the label; or 

(ii)  where  appropriate,  for  particular  types  of  packaging  such  as  mobile  gas 
to 
requirements 

in  Annex VI 

referred 

to 

if 

cylinders, 
Directive 67/548/EEC are complied with. 

the  specific 

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

Article 12 

Exemptions from the labelling and packaging requirements 

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

3. Member States may also: 

(a) 

(b) 

(c) 

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 11(1) and (2); 

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

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

EN 

26 

   EN 

 
(cid:208) 1999/45/EC (adapted) 
(cid:206)1 1137/2008 Art. 1 and Annex, 
point 3.5.2 (adapted) 
(cid:214) new 

(d) 

by  way  of  derogation  from  Articles 10  and  11  permit  the  packaging  of  dangerous 
preparations which are not mentioned in points (b) or (c) to be labelled in some other 
appropriate  way,  if  the  packages  are  too  small  for  the  labelling  provided  for  in 
Articles 10 and 11 and there is no reason to fear any danger to persons handling such 
preparations or to other persons. 

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

4. If a Member State makes use of the options provided for in paragraph 3, it shall forthwith 
inform the Commission and Member States thereof. (cid:206)1 The Commission may decide (cid:214) shall 
be  empowered  to  adopt  delegated  acts  in  accordance  with  Article  20  for  the  purpose  of 
amending   upon  measures  in  the  framework  of  Annex  V  (cid:214) on  the  basis  of  such 
information . Those measures, designed to amend non-essential elements of this Directive 
by  supplementing  it,  shall  be  adopted  in  accordance  with  the  regulatory  procedure  with 
scrutiny referred to in Article 20a(3).  

Article 13 

Distance selling 

Any  advertisement  for  a  preparation  within  the  meaning  of  this  Directive  which  enables  a 
member of the general public to conclude a contract for purchase without first having sight of 
the  label  for  that  preparation  ⌦ shall ⌫  make  mention  of  the  type  or  types  of  hazard 
indicated  on  the  label.  This  requirement  is  without  prejudice  to  Directive 97/7/EC  of  the 
European Parliament and of the Council31. 

Article 14 

Confidentiality of chemical names 

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

– 

– 

irritant with the exception of those assigned R41 or irritant in combination with one 
or more of the other properties mentioned in point (c)(iv) of Article 10(3), or 

harmful or harmful in combination with one or more of the properties mentioned in 
point (c)(iv) of Article 10(3) presenting acute lethal effects alone 

31 

OJ L 144, 4.6.1997, p. 19. 

EN 

27 

   EN 

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

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

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

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

Confidential information brought to the attention of the authorities of a Member State or of 
the Commission shall be ⌦ kept secret ⌫. 

In all cases such information: 

(cid:216) new 

– 

– 

may  be  brought  to  the  attention  only  of  the  competent  authority  or  authorities 
responsible  for  receiving  the  information  necessary  for  evaluating  the  foreseeable 
risks which the preparations may entail for man and the environment, and examining 
its conformity with the requirements of this Directive, 

may,  however,  be  divulged  to  persons  directly  involved  in  administrative  or  legal 
proceedings involving sanctions which are undertaken for the purpose of controlling 
substances placed on the market and to persons who are to participate or be heard in 
legislative proceedings. 

(cid:208) 1999/45/EC 

Article 15 

Rights of Member States regarding safety of workers 

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

EN 

28 

   EN 

 
 
 
Article 16 

Bodies responsible for receiving information relating to health 

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

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 case of emergency. 

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

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

(cid:208) 1999/45/EC (adapted) 

Article 17 

Free movement clause 

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

(cid:208) 1999/45/EC 

Article 18 

Safeguard clause 

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

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

EN 

29 

   EN 

 
 
 
(cid:208) 1137/2008 Art. 1 and Annex, 
point 3.5.3 
(cid:214) new 

3.  The  Commission  shall  (cid:214) decide  by  means  of  implementing  acts.   take  a  decision 
(cid:214) Those  implementing  acts  shall  be  adopted   in  accordance  with  the  (cid:214) examination  
regulatory procedure referred to in Article 21(2). 

(cid:208) 1137/2008 Art. 1 and Annex, 
point 3.5.4 (adapted) 
(cid:214) new 

Article 19 

⌦ Adaptation to technical progress ⌫ 

The Commission shall (cid:214) adopt delegated acts in accordance with Article 20 for the purpose 
of  adapting   adapt  Annexes I  to  VII  to  technical  progress.  Those  measures,  designed  to 
amend  non-essential  elements  of  this  Directive,  shall  be  adopted  in  accordance  with  the 
regulatory procedure with scrutiny referred to in Article 20a(3).  

(cid:216) new 

Article 20 

Exercise of the delegation 

1. The power to adopt delegated acts is conferred on the Commission subject to the conditions 
laid down in this Article.  

2. The power to adopt delegated acts referred to in Article 10(4), Article 12(4) and Article 19 
shall be conferred for an indeterminate period of time from the [date of entry into force of this 
Directive] 

(cid:208) 1137/2008 Art. 1 and Annex, 
point 3.5.4 (adapted) 
(cid:214) new 

3. The delegation of powers referred to in Article 10(4), Article 12(4) and Article 19 may be 
revoked at any time by the European Parliament or by the Council. A decision to revoke shall 
put an end to the delegation of the power specified in that decision. It shall take effect the day 
following the publication of the decision in the Official Journal of the European Union or at a 
later  date  specified  therein.  It  shall  not  affect  the  validity  of  any  delegated  acts  already  in 
force. 

4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the 
European Parliament and to the Council. 

EN 

30 

   EN 

 
 
 
 
 
5. A delegated act adopted pursuant to Article 10(4), Article 12(4) and Article 19 shall enter 
into force only if no objection has been expressed either by the European Parliament or the 
Council within a period of two months of notification of that act to the European Parliament 
and  the  Council  or  if,  before  the  expiry  of  that  period,  the  European  Parliament  and  the 
Council  have  both  informed  the  Commission  that  they  will  not  object.  That  period  shall  be 
extended by one month at the initiative of the European Parliament or of the Council. 

(cid:208) 1137/2008 Art. 1 and Annex, 
point 3.5.5 (adapted) 
(cid:214) new 

Article 21 

⌦ Committee ⌫ 

1.  The  Commission  shall  be  assisted  by  the  committee  established  by  Article 29(1)  of 
Directive  67/548/EEC.  (cid:214) That  Committee  shall  be  a  Committee  within  the  meaning  of 
Regulation (EU) No 182/2011.  

2. Where reference is made to this paragraph, (cid:214) Article 5 of Regulation (EU) No 182/2011 
shall  apply.   Articles 5  and  7  of  Decision  1999/468/EC  shall  apply,  having  regard  to  the 
provisions of Article 8 thereof. 

The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months. 

3.  Where  reference  is  made  to  this  paragraph,  Article 5a(1)  to  (4)  and  Article 7  of 
Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. 

(cid:216) new 

Article 22 

Repeal 

Directive  1999/45/EC,  as  amended  by  the  Acts  listed  in  Part A  of  Annex VIII,  is  repealed, 
without  prejudice  to  the  obligations  of  the  Member  States  relating  to  the  time-limits  for 
transposition into  national  law  of  the  Directives  set  out  in  Part B  of  Annex VIII  to  the 
repealed Directive and in Part B of Annex VIII to this Directive.  

References  to  the  repealed  Directive  shall be  construed  as  references  to  this  Directive  and 
shall be read in accordance with the correlation table in Annex IX. 

EN 

31 

   EN 

 
 
 
(cid:208) 1999/45/EC (adapted) 

Article 23 

Entry into force 

This Directive shall enter into force on the ⌦ twentieth ⌫ day ⌦ following that ⌫ of its 
publication in the Official Journal of the European Union. 

Article 24 

Addressees 

This Directive is addressed to the Member States. 

Done at Brussels, 

For the European Parliament 
The President 

For the Council 
The President 

EN 

32 

   EN 

 
 
(cid:208) 1999/45/EC 

ANNEX I 

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

PART A 

Exemptions to test methods of Part A of the Annex to Regulation (EC) No 440/2008 

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

PART B 

Alternative calculation methods 

B.1. 

Non-gaseous preparations 

1. 

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

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

B.2. 

Gaseous preparations 

1. 

Method for the determination of oxidising properties 

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

2. 

Method for the determination of flammability properties 

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

_____________ 

EN 

33 

   EN 

 
 
(cid:208) 1999/45/EC 
(cid:206)1 1272/2008 Art. 56 pt. 2(c) 

ANNEX II 

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

INTRODUCTION 

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

1. 

2. 

3. 

4. 

5. 

6. 

acute lethal effects; 

non-lethal irreversible effects after a single exposure; 

severe effects after repeated or prolonged exposure; 

corrosive effects, irritant effects; 

sensitising effects; 

carcinogenic effects, mutagenic effects, toxic effects for reproduction. 

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

(a) 

(b) 

where the dangerous substances listed in (cid:206)1 Part 3 of Annex VI to Regulation (EC) 
No 1272/2008   are  assigned  concentration  limits  necessary  for  the  application  of 
the  method  of  assessment  described  in  Part A  of  this  Annex,  these  concentration 
limits must be used; 

where  the  dangerous  substances  do  not  appear  in  (cid:206)1 Part 3  of  Annex VI  to 
Regulation  (EC)  No 1272/2008   or  appear  there  without  the  concentration  limits 
necessary for the application of the method of evaluation described in Part A of this 
Annex,  the  concentration  limits  must  be  assigned  in  accordance  with  the 
specifications in Part B of this Annex. 

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

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

– 

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

EN 

34 

   EN 

 
 
– 

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

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

Where they are not given in (cid:206)1 Part 3 of Annex VI to Regulation (EC) No 1272/2008 , the 
concentration limits to be taken into account for the application of this conventional method 
are those set out in Part B of this Annex. 

(cid:208) 1999/45/EC 
(cid:206)1 1272/2008 Art. 56 pt. 2(d), 
first indent 

PART A 

Procedure for evaluation of health hazards 

The evaluation proceeds stepwise as follows: 

1. 

The following preparations are to be classified as very toxic: 

1.1. 

owing  to  their  acute  lethal  effects  and  assigned  the  symbol  ‘T+’,  the  indication  of 
danger ‘very toxic’ and the risk phrases R26, R27 or R28: 

1.1.1. 

preparations containing one or more substances classified as very toxic that produce 
such effects, in individual concentrations equal to or greater than: 

(a) 

(b) 

either the concentration specified in (cid:206)1 Part 3 of Annex VI to Regulation (EC) 
No 1272/2008  for the substance or substances under consideration, or 

the concentration specified at point 1 in Part B of this Annex (Table 1 and 1a) 
where the substance or substances do not appear in (cid:206)1 Part 3 of Annex VI to 
Regulation (EC) No 1272/2008  or appear in it without concentration limits; 

1.1.2. 

preparations  containing  more  than  one  substance  classified  as  very  toxic  in  lower 
individual concentrations than the limits specified in point 1.1.1(a) or (b) if: 

∑

⎛
⎜⎜
⎝

P
T
L
T

+

+

⎞
1≥⎟⎟
⎠

EN 

35 

   EN 

 
 
 
where: 

PT+  = 

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

LT+  = 

is the very toxic limit specified for each very toxic substance, expressed 
as a percentage by weight or by volume; 

(cid:208) 1999/45/EC 
(cid:206)1 1272/2008 Art. 56 pt. 2(d), 
second indent 

1.2. 

owing to their non-lethal irreversible effects after a single exposure and assigned the 
symbol ‘T+’, the indication  of danger ‘very  toxic’ and the risk phrase R39/route of 
exposure. 

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

(a) 

(b) 

either the concentration specified in (cid:206)1 Part 3 of Annex VI to Regulation (EC) 
No 1272/2008  for the substance or substances under consideration, or 

the concentration specified at point 2 in Part B of this Annex (Table 2 and 2a) 
where the substance or substances do not appear in (cid:206)1 Part 3 of Annex VI to 
Regulation (EC) No 1272/2008  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  symbol  ‘T’,  the  indication  of 
danger ‘toxic’ and the risk phrases R23, R24 or R25; 

(cid:208) 1999/45/EC 
(cid:206)1 1272/2008 Art. 56 pt. 2(d), 
third indent 

2.1.1. 

preparations containing one or more substances classified as very toxic or toxic that 
produce such effects in individual concentrations equal to or greater than: 

(a) 

(b) 

either the concentration specified in (cid:206)1 Part 3 of Annex VI to Regulation (EC) 
No 1272/2008  for the substance or substances under consideration, or 

the concentration specified at point 1 in Part B of this Annex (Table 1 and 1a) 
where the substance or substances do not appear in (cid:206)1 Part 3 of Annex VI to 
Regulation (EC) No 1272/2008  or appear in it without concentration limits; 

2.1.2. 

preparations containing more than one substance classified as very toxic or toxic in 
lower individual concentrations than the limits specified in point 2.1.1(a) or (b) if: 

EN 

⎛
P
∑ +
T
⎜⎜
L
⎝
T

+

P
T
L
T

⎞
1≥⎟⎟
⎠

36 

   EN 

 
 
 
 
where: 

PT+  = 

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

PT 

= 

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

LT 

= 

is  the  respective  toxic  limit  specified  for  each  very  toxic  or  toxic 
substance, expressed as a percentage by weight or by volume; 

(cid:208) 1999/45/EC 
(cid:206)1 1272/2008 Art. 56 pt. 2(d), 
fourth indent 

2.2 

owing to their non-lethal irreversible effects after a single exposure and assigned the 
symbol  ‘T’,  the  indication  of  danger  ‘toxic’  and  the  risk  phrase  R39/route  of 
exposure. 

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

(a) 

(b) 

either the concentration specified in (cid:206)1 Part 3 of Annex VI to Regulation (EC) 
No 1272/2008  for the substance or substances under consideration, or 

the concentration specified at point 2 in Part B of this Annex (Table 2 and 2a) 
where the substance or substances do not appear in (cid:206)1 Part 3 of Annex VI to 
Regulation (EC) No 1272/2008  or appear in it without concentration limits; 

(cid:208) 1999/45/EC 
(cid:206)1 1272/2008 Art. 56 pt. 2(d), 
fifth indent 

2.3. 

owing  to  their  long-term  effects  and  assigned  the  symbol  ‘T’,  the  indication  of 
danger ‘toxic’ and the risk phrase R48/route of exposure. 

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

(a) 

(b) 

either the concentration specified in (cid:206)1 Part 3 of Annex VI to Regulation (EC) 
No 1272/2008  for the substance or substances under consideration, or 

the concentration specified at point 3 in Part B of this Annex (Table 3 and 3a) 
where the substance or substances do not appear in (cid:206)1 Part 3 of Annex VI to 
Regulation (EC) No 1272/2008  or appear in it without concentration limits. 

3. 

The following preparations shall be classified as harmful: 

3.1. 

owing to their acute lethal effects and assigned the symbol ‘Xn’ and the indication of 
danger ‘harmful’ and the risk phrases R20, R21 or R22; 

EN 

37 

   EN 

 
 
 
(cid:208) 1999/45/EC (adapted) 
(cid:206)1 1272/2008 Art. 56 pt. 2(d), 
sixth indent 

3.1.1. 

preparations  containing  one  or  more  substances  classified  as  very  toxic,  toxic  or 
harmful and that produce such effects in individual concentrations equal to or greater 
than: 

(a) 

(b) 

either the concentration specified in (cid:206)1 Part 3 of Annex VI to Regulation (EC) 
No 1272/2008  for the substance or substances under consideration, or 

the concentration specified at point 1 in Part B of this Annex (Table 1 and 1a) 
where the substance or substances do not appear in (cid:206)1 Part 3 of Annex VI to 
Regulation (EC) No 1272/2008  or appear in it without concentration limits; 

3.1.2. 

preparations  containing  more  than  one  substance  classified  as  very  toxic,  toxic  or 
harmful in lower individual concentrations than the limits specified in point 3.1.1(a) 
or (b) if: 

⎛
P
∑ +
⎜⎜
T
L
⎝

Xn

+

P
T
L

Xn

+

P
L

Xn

Xn

⎞
1≥⎟⎟
⎠

where: 

PT+ 

= 

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

PT 

= 

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

PXn 

= 

is the percentage by weight or by volume of each harmful substance in 
the preparation, 

LXn 

= 

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 symbol ‘Xn’, 
and the indication of danger ‘harmful’ and the risk phrase R65. 

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

(cid:208) 1999/45/EC 
(cid:206)1 2001/60/EC Art. 1 pt. 1, 
first indent 

3.3. 

owing to their non-lethal irreversible effects after a single exposure and assigned the 
symbol ‘Xn’, the indication of danger ‘harmful’ and the risk phrase (cid:206)1 R68 /route 
of exposure. 

EN 

38 

   EN 

 
 
 
 
(cid:208) 1999/45/EC 
(cid:206)1 1272/2008 Art. 56 pt. 2(d), 
seventh indent 

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

(a) 

(b) 

either the concentration specified in (cid:206)1 Part 3 of Annex VI to Regulation (EC) 
No 1272/2008  for the substance or substances under consideration, or 

the concentration specified at point 2 in Part B of this Annex (Table 2 and 2a) 
where the substance or substances do not appear in (cid:206)1 Part 3 of Annex VI to 
Regulation (EC) No 1272/2008  or appear in it without concentration limits; 

(cid:208) 1999/45/EC 
(cid:206)1 1272/2008 Art. 56 pt. 2(d), 
eighth indent 

3.4. 

owing  to  their  long-term  effects  and  assigned  the  symbol  ‘Xn’,  the  indication  of 
danger ‘harmful’ and the risk phrase R48/route of exposure. 

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

(a) 

(b) 

either the concentration specified in (cid:206)1 Part 3 of Annex VI to Regulation (EC) 
No 1272/2008  for the substance or substances under consideration, or 

the concentration specified at point 3 in Part B of this Annex (Table 3 and 3a) 
where the substance or substances do not appear in (cid:206)1 Part 3 of Annex VI to 
Regulation (EC) No 1272/2008  or appear in it without concentration limits. 

4. 

The following preparations are to be classified as corrosive: 

4.1. 

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

(cid:208) 1999/45/EC 
(cid:206)1 1272/2008 Art. 56 pt. 2(d), 
ninth indent 

4.1.1. 

preparations  containing  one  or  more  substances  classified  as  corrosive  to  which  is 
assigned the phrase R35 in individual concentrations equal to or greater than: 

(a) 

either the concentration specified in (cid:206)1 Part 3 of Annex VI to Regulation (EC) 
No 1272/2008  for the substance or substances under consideration, or 

EN 

39 

   EN 

 
 
 
 
(b) 

the concentration specified at point 4 in Part B of this Annex (Table 4 and 4a) 
where the substance or substances do not appear in (cid:206)1 Part 3 of Annex VI to 
Regulation (EC) No 1272/2008  or appear in it without concentration limits; 

4.1.2. 

preparations containing more than one substance classified as corrosive to which is 
assigned  phrase R35  in  lower  individual  concentrations  than  the  limits  specified  in 
point 4.1.1(a) or (b) if: 

∑

⎛
⎜
⎜
⎝

P
RC
,
L

RC
,

35

35

⎞
⎟
≥⎟
⎠

1

where: 

PC, R35  = 

LC, R35  = 

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

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

(cid:208) 1999/45/EC 
(cid:206)1 1272/2008 Art. 56 pt. 2(d), 
tenth indent 

4.2.1. 

preparations  containing  one  or  more  substances  classified  as  corrosive  to  which  is 
assigned the phrase R35 or R34 in individual concentrations equal to or greater than: 

(a) 

(b) 

either the concentration specified in (cid:206)1 Part 3 of Annex VI to Regulation (EC) 
No 1272/2008  for the substance or substances under consideration, or 

the concentration specified at point 4 in Part B of this Annex (Table 4 and 4a) 
where the substance or substances do not appear in (cid:206)1 Part 3 of Annex VI to 
Regulation (EC) No 1272/2008  or appear in it without concentration limits; 

4.2.2. 

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

∑

⎛
⎜
⎜
⎝

P
RC
,
L

RC
,

35

34

+

P
RC
,
L
RC
,

34

34

⎞
⎟
≥⎟
⎠

1

where: 

PC, R35  = 

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

PC, R34  = 

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

EN 

40 

   EN 

 
 
 
 
LC, 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 are to be classified as irritants: 

5.1. 

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

(cid:208) 1999/45/EC 
(cid:206)1 1272/2008 Art. 56 pt. 2(d), 
eleventh indent 

5.1.1. 

preparations  containing  one  or  more  substances  classified  as  irritant  to  which  is 
assigned phrase R41 in individual concentrations equal to or greater than: 

(a) 

(b) 

either the concentration specified in (cid:206)1 Part 3 of Annex VI to Regulation (EC) 
No 1272/2008  for the substance or substances under consideration, or 

the concentration specified at point 4 in Part B of this Annex (Table 4 and 4a) 
where the substance or substances do not appear in (cid:206)1 Part 3 of Annex VI to 
Regulation (EC) No 1272/2008  or appear in it without concentration limits; 

5.1.2. 

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

∑

⎛
⎜
⎜
⎝

P
RC
,
L

RXi
,

35

+

41

P
RC
,
L

RXi
,

34

+

41

P
RXi
,
L

RXi
,

41

41

⎞
⎟
≥⎟
⎠

1

where: 

PC, R35 

= 

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

PC, 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, 

LXi, R41  = 

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

5.2. 

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

EN 

41 

   EN 

 
 
 
(cid:208) 1999/45/EC 
(cid:206)1 1272/2008 Art. 56 pt. 2(d), 
twelfth indent 

5.2.1. 

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

(a) 

(b) 

either the concentration specified in (cid:206)1 Part 3 of Annex VI to Regulation (EC) 
No 1272/2008  for the substance or substances under consideration, or 

the concentration specified at point 4 in Part B of this Annex (Table 4 and 4a) 
where the substance or substances do not appear in (cid:206)1 Part 3 of Annex VI to 
Regulation (EC) No 1272/2008  or appear in it without concentration limits; 

5.2.2. 

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

∑

⎛
⎜
⎜
⎝

P
RC
,
L

RXi
,

35

+

36

P
RC
,
L

RXi
,

36

34

+

P
L

RXi
,

RXi
,

+

41

36

P
RXi
,
L

RXi
,

36

36

⎞
⎟
≥⎟
⎠

1

where: 

PC, R35 

= 

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

PC, 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, 

PXi, R36  = 

is the percentage by weight or by volume of each irritant substance to 
which is assigned phrase R36 in the preparation, 

LXi, R36  = 

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

5.3. 

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

EN 

42 

   EN 

 
 
 
(cid:208) 1999/45/EC 
(cid:206)1 1272/2008 Art. 56 pt. 2(d), 
thirteenth indent 

5.3.1. 

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

(a) 

(b) 

either the concentration specified in (cid:206)1 Part 3 of Annex VI to Regulation (EC) 
No 1272/2008  for the substance or substances under consideration, or 

the concentration specified at point 4 in Part B of this Annex (Table 4 and 4a) 
where the substance or substances do not appear in (cid:206)1 Part 3 of Annex VI to 
Regulation (EC) No 1272/2008  or appear in it without concentration limits; 

5.3.2. 

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

∑

⎛
⎜
⎜
⎝

P
RC
,

35

L

RXi
,

38

+

P
RC
,

34

L

RXi
,

38

+

P

RXi
,

38

L

RXi
,

38

⎞
⎟
≥⎟
⎠

1

where: 

PC, R35 

= 

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

PC, R34 

= 

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

PXi, R38  = 

is the percentage by weight or by volume of each irritant substance to 
which is assigned phrase R38 in the preparation, 

LXi, R38  = 

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

5.4. 

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

(cid:208) 1999/45/EC 
(cid:206)1 1272/2008 Art. 56 pt. 2(d), 
fourteenth indent 

5.4.1. 

preparations containing one or more substances classified as irritant and to which is 
assigned phrase R37 in individual concentrations equal to or greater than: 

(a) 

either the concentration specified in (cid:206)1 Part 3 of Annex VI to Regulation (EC) 
No 1272/2008  for the substance or substances under consideration, or 

EN 

43 

   EN 

 
 
 
 
(b) 

the concentration specified at point 4 in Part B of this Annex (Table 4 and 4a) 
where the substance or the substances do not appear in (cid:206)1 Part 3 of Annex VI 
to  Regulation  (EC)  No 1272/2008   or  appear  in  it  without  concentration 
limits; 

5.4.2. 

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

∑

⎛
⎜
⎜
⎝

P
RXi
,
L

RXi
,

37

37

⎞
⎟
≥⎟
⎠

1

where: 

PXi, R37  = 

LXi, R37  = 

is the percentage by weight or by volume of each irritant substance to 
which is assigned phrase R37 in the preparation, 

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

5.4.3. 

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

∑

⎛
⎜
⎜
⎝

P
RC
,
L

RXi
,

35

+

37

P
RC
,
L

RXi
,

37

34

+

P
RXi
,
L

RXi
,

37

37

⎞
⎟
≥⎟
⎠

1

where: 

PC, R35 

= 

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

PC, R34 

= 

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

PXi, R37  = 

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

LXi, R37  = 

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

EN 

44 

   EN 

 
 
 
6. 

The following preparations are to be classified as sensitising: 

(cid:208) 1999/45/EC 
(cid:206)1 1272/2008 Art. 56 pt. 2(d), 
fifteenth indent 

6.1. 

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

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

(a) 

(b) 

either the concentration specified in (cid:206)1 Part 3 of Annex VI to Regulation (EC) 
No 1272/2008  for the substance or substances under consideration, or 

the concentration specified at point 5 in Part B of this Annex (Table 5 and 5a) 
where the substance or substances do not appear in (cid:206)1 Part 3 of Annex VI to 
Regulation (EC) No 1272/2008  or appear in it without concentration limits; 

(cid:208) 1999/45/EC 
(cid:206)1 1272/2008 Art. 56 pt. 2(d), 
sixteenth indent 

6.2. 

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

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

(a) 

(b) 

either the concentration specified in (cid:206)1 Part 3 of Annex VI to Regulation (EC) 
No 1272/2008  for the substance or substances under consideration, or 

the concentration specified at point 5 in Part B of this Annex (Table 5 and 5a) 
where the substance or substances do not appear in (cid:206)1 Part 3 of Annex VI to 
Regulation (EC) No 1272/2008  or appear in it without concentration limits. 

7. 

The following preparations are to be classified as carcinogenic: 

7.1. 

those  of  category 1  or  2  which  are  assigned  the  symbol  ‘T’  and  the  phrase R45  or 
R49. 

(cid:208) 1999/45/EC 
(cid:206)1 1272/2008 Art. 56 pt. 2(d), 
seventeenth indent 

EN 

45 

   EN 

 
 
 
 
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) 

(b) 

either the concentration specified in (cid:206)1 Part 3 of Annex VI to Regulation (EC) 
No 1272/2008  for the substance or substances under consideration, or 

the concentration specified at point 6 in Part B of this Annex (Table 6 and 6a) 
where the substance or substances do not appear in (cid:206)1 Part 3 of Annex VI to 
Regulation (EC) No 1272/2008  or appear in it without concentration limits; 

(cid:208) 1999/45/EC 
(cid:206)1 1272/2008 Art. 56 pt. 2(d), 
eighteenth indent 

7.2. 

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

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

(a) 

(b) 

either the concentration specified in (cid:206)1 Part 3 of Annex VI to Regulation (EC) 
No 1272/2008  for the substance or substances under consideration, or 

the concentration specified at point 6 in Part B of this Annex (Table 6 and 6a) 
where the substance or substances do not appear in (cid:206)1 Part 3 of Annex VI to 
Regulation (EC) No 1272/2008  or appear in it without concentration limits. 

8. 

The following preparations are to be classified as mutagenic: 

(cid:208) 1999/45/EC 
(cid:206)1 1272/2008 Art. 56 pt. 2(d), 
nineteenth indent 

8.1. 

those of category 1 or 2 which are assigned the symbol ‘T’ and the phrase R46. 

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

(a) 

(b) 

either the concentration specified in (cid:206)1 Part 3 of Annex VI to Regulation (EC) 
No 1272/2008  for the substance or substances under consideration, or 

the concentration specified at point 6 in Part B of this Annex (Table 6 and 6a) 
where the substance or substances do not appear in (cid:206)1 Part 3 of Annex VI to 
Regulation (EC) No 1272/2008  or appear in it without concentration limits; 

EN 

46 

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(cid:208) 1999/45/EC 
(cid:206)1 2001/60/EC Art. 1 pt. 1, 
second indent 

8.2. 

those of category 3 which are assigned the symbol ‘Xn’ and the phrase (cid:206)1 R68 . 

Preparations containing at least one substance, producing such effects, classified as 
mutagenic  and  to  which  is  assigned  phrase (cid:206)1 R68   which  denotes  mutagenic 
substances in category 3, in individual concentrations equal to or greater than: 

(cid:208) 1999/45/EC 
(cid:206)1 1272/2008 Art. 56 pt. 2(d), 
twentieth indent 

(a) 

(b) 

either the concentration specified in (cid:206)1 Part 3 of Annex VI to Regulation (EC) 
No 1272/2008  for the substance or substances under consideration, or 

the concentration specified at point 6 in Part B of this Annex (Table 6 and 6a) 
where the substance or substances do not appear in (cid:206)1 Part 3 of Annex VI to 
Regulation (EC) No 1272/2008  or appear in it without concentration limits. 

9. 

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

(cid:208) 1999/45/EC 
(cid:206)1 1272/2008 Art. 56 pt. 2(d), 
twenty-first indent 

9.1. 

those  of  category 1  or  2  which  are  assigned  the  symbol  ‘T’  and  the  phrase R60 
(fertility). 

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

(a) 

(b) 

either the concentration specified in (cid:206)1 Part 3 of Annex VI to Regulation (EC) 
No 1272/2008  for the substance or substances under consideration, or 

the concentration specified at point 6 in Part B of this Annex (Table 6 and 6a) 
where the substance or substances do not appear in (cid:206)1 Part 3 of Annex VI to 
Regulation (EC) No 1272/2008  or appear in it without concentration limits; 

(cid:208) 1999/45/EC 
(cid:206)1 1272/2008 Art. 56 pt. 2(d), 
twenty-second indent 

9.2. 

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

Preparations  containing  at  least  one  substance  producing  such  effects,  classified  as 
toxic for reproduction and to which is assigned phrase R62 which denotes substances 

EN 

47 

   EN 

 
 
 
 
 
toxic for reproduction of category 3, in individual concentrations equal to or greater 
than: 

(a) 

(b) 

either the concentration specified in (cid:206)1 Part 3 of Annex VI to Regulation (EC) 
No 1272/2008  for the substance or substances under consideration, or 

the concentration specified at point 6 in Part B of this Annex (Table 6 and 6a) 
where the substance or substances do not appear in (cid:206)1 Part 3 of Annex VI to 
Regulation (EC) No 1272/2008  or appear in it without concentration limits; 

(cid:208) 1999/45/EC 
(cid:206)1 1272/2008 Art. 56 pt. 2(d), 
twenty-third indent 

9.3. 

those  of  category 1  or  2  which  are  assigned  the  symbol  ‘T’  and  the  phrase R61 
(development). 

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

(a) 

(b) 

either the concentration specified in (cid:206)1 Part 3 of Annex VI to Regulation (EC) 
No 1272/2008  for the substance or substances under consideration, or 

the concentration specified at point 6 in Part B of this Annex (Table 6 and 6a) 
where the substance or substances do not appear in (cid:206)1 Part 3 of Annex VI to 
Regulation (EC) No 1272/2008  or appear in it without concentration limits; 

(cid:208) 1999/45/EC 
(cid:206)1 1272/2008 Art. 56 pt. 2(d), 
twenty-fourth indent 

9.4. 

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

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

(a) 

(b) 

either the concentration specified in (cid:206)1 Part 3 of Annex VI to Regulation (EC) 
No 1272/2008  for the substance or substances under consideration, or 

the concentration specified at point 6 in Part B of this Annex (Table 6 and 6a) 
where the substance or substances do not appear in (cid:206)1 Part 3 of Annex VI to 
Regulation (EC) No 1272/2008  or appear in it without concentration limits. 

EN 

48 

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(cid:208) 1999/45/EC (adapted) 
(cid:206)1 1272/2008 Art. 56 pt. 2(e) 

PART B 

Concentration limits to be used in evaluation of health hazards 

For  each  health  effect,  the  first  table  (Tables 1  to  6)  sets  out  the  concentration  limits 
(expressed  as  a  weight/weight  percentage)  to  be  used  for  non-gaseous  preparations  and  the 
second table (Tables 1a to 6a) sets out the concentration limits (expressed as a volume/volume 
percentage)  to  be  used  for  gaseous  preparations.  These  concentration  limits  are  used  in  the 
absence of specific concentration limits for the substance under consideration in (cid:206)1 Part 3 of 
Annex VI to Regulation (EC) No 1272/2008 . 

1. 

Acute lethal effects 

1.1. 

Non-gaseous preparations 

The concentration limits fixed in Table 1, 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 

Classification of the substance 

Classification of the preparation 

T+ 

T 

Xn 

T+ with R26, R27, R28 

concentration 
≥ 7 % 

T with R23, R24, R25 

Xn with R20, R21, R22 

1 % ≤ 
concentration 
< 7 % 

concentration 
≥ 25 % 

0,1 % ≤ 
concentration 
< 1 % 

3 % ≤ 
concentration 
< 25 % 

concentration 
≥ 25 % 

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

– 

– 

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

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

EN 

49 

   EN 

 
 
 
 
 
1.2. 

Gaseous preparations 

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

Classification of the substance 
(gas) 

T+ with R26, R27, R28 

T with R23, R24, R25 

Xn with R20, R21, R22 

Table 1a 

Classification of the gaseous preparation 

T+ 

T 

Xn 

concentration 
≥ 1 % 

0,2 % ≤ 
concentration 
< 1 % 

concentration 
≥ 5 % 

0,02 % ≤ 
concentration 
< 0,2 % 

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. 

(cid:208) 1999/45/EC (adapted) 
(cid:206)1 2001/60/EC Art. 1 pt. 2, 
first indent 
(cid:206)2 2001/60/EC Art. 1 pt. 2, 
second indent 

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 
(R39/route of exposure, (cid:206)1 R68 /route of exposure), the individual concentration 
limits  specified  in  Table 2,  expressed  as  a  weight/weight  percentage,  determine, 
when appropriate, the classification of the preparation. 

EN 

50 

   EN 

 
 
 
 
 
Classification of the substance 

Table 2 

Classification of the preparation 

T+ 

T 

Xn 

T+ with R39/route of 
exposure 

concentration 
≥ 10 % 
R39 (*) obligatory

T with R39/route of 
exposure 

Xn with (cid:206)1 R68 /route 
of exposure 

1 % ≤ 
concentration 
< 10 % 
R39 (*) 
obligatory 

concentration 
≥ 10 % 
R39 (*) 
obligatory 

0,1 % ≤ 
concentration 
< 1 % 
(cid:206)1 R68  (*) 
obligatory 

1 % ≤ 
concentration 
< 10 % 
(cid:206)1 R68  (*) 
obligatory 

concentration 
≥ 10 % 
(cid:206)1 R68  (*) 
obligatory 

(*) 

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

2.2. 

Gaseous preparations 

For  gases  that  produce  non-lethal  irreversible  effects  after  a  single  exposure 
(R39/route of exposure, (cid:206)2 R68 /route of exposure), the individual concentration 
limits  specified  in  Table 2a,  expressed  as  a  volume/volume  percentage,  determine, 
when appropriate, the classification of the preparation. 

EN 

51 

   EN 

 
 
 
 
Classification of the substance 
(gas) 

T+ with R39/route of 
exposure 

T with R39/route of 
exposure 

Xn with (cid:206)2 R68 /route 
of exposure 

Table 2a 

Classification of the gaseous preparation 

T+ 

T 

Xn 

concentration 
≥ 1 % 
R39 (*) obligatory

0,2 % ≤ 
concentration 
< 1 % 
R39 (*) 
obligatory 

concentration 
≥ 5 % 
R39 (*) 
obligatory 

0,02 % ≤ 
concentration 
< 0,2 % 
(cid:206)2 R68  (*) 
obligatory 

0,5 % ≤ 
concentration 
< 5 % 
(cid:206)2 R68  (*) 
obligatory 

concentration 
≥ 5 % 
(cid:206)2 R68  (*) 
obligatory 

(*) 

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

3. 

Severe effects after repeated or prolonged exposure 

3.1. 

Non-gaseous preparations 

For  substances  that  produce  severe  effects  after  repeated  or  prolonged  exposure 
(R 48/route  of  exposure),  the  individual  concentration  limits  specified  in  Table 3, 
expressed  as  a  weight/weight  percentage,  determine,  when  appropriate,  the 
classification of the preparation. 

Classification of the substance 

T with R48/route of 
exposure 

Xn with R48/route of 
exposure 

Table 3 

Classification of the preparation 

T 

Xn 

concentration ≥ 10 % 
R48 (*) obligatory 

1 % ≤ concentration 
< 10 % 
R48 (*) obligatory 

concentration ≥ 10 % 
R48 (*) obligatory 

(*) 

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

EN 

52 

   EN 

 
 
 
 
 
3.2. 

Gaseous preparations 

For  gases  that  produce  severe  effects  after  repeated  or  prolonged  exposure 
(R48/route  of  exposure),  the  individual  concentration  limits  specified  in  Table 3a, 
expressed  as  a  volume/volume  percentage,  determine,  when  appropriate,  the 
classification of the preparation. 

Table 3a 

Classification of the 
substance 
(gas) 

Classification of the gaseous preparation 

T 

Xn 

T with R48/route 
of exposure 

concentration ≥ 5 % 
R48 (*) obligatory 

0,5 % ≤ concentration < 5 % 
R48 (*) obligatory 

Xn with R48/route 
of exposure 

concentration ≥ 5 % 
R48 (*) obligatory 

(*) 

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

4. 

Corrosive and irritant effects including serious damage to the eye 

4.1. 

Non-gaseous preparations 

For  substances  that  produce  corrosive  effects  (R34,  R35)  or  irritant  effects  (R36, 
R37,  R38,  R41),  the  individual  concentration  limits  specified  in  Table 4,  expressed 
as a weight/weight percentage, determine, when appropriate, the classification of the 
preparation. 

Classification of 
the substance 

C with R35 

C with R34 

Table 4 

Classification of the preparation 

C with R35 

C with R34 

Xi with R41 

concentration 
≥ 10 % 
R35 
obligatory 

5 % (*) 

10 % (*) 

5 % ≤ 
concentration 
< 10 % 
R34 
obligatory 

concentration 
≥ 10 % 
R34 
obligatory 

Xi with R36, R37, 
R38 

1 % ≤ 
concentration 
< 5 % 
R36/38 
obligatory 

5 % ≤ 
concentration 
< 10 % 
R36/38 
obligatory 

EN 

53 

   EN 

 
 
 
Xi with R41 

Xi with R36, 
R37, R38 

concentration 
≥ 10 % 
R41 
obligatory 

5 % ≤ 
concentration 
< 10 % 
R36 obligatory 

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

(*) 

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

NB: 

Simple  application  of  the  conventional  method  to  preparations  containing  substances  classified  as 
corrosive  or  irritant  may  result  in  under-classification  or  over-classification  of  the  hazard,  if  other 
relevant factors (e.g. pH of the preparation) are not taken into account. Therefore, in classifying for 
corrosivity, consider the advice given in point 3.2.5 of Annex VI to Directive 67/548/EEC and in the 
second and third indents of Article 6(3), of this Directive. 

(cid:208) 2001/60/EC Art. 1 pt 3 

4.2. 

Gaseous preparations 

(cid:208) 1999/45/EC (adapted) 

For  gases  that  produce  such  effects  (R34,  R35  or  R36,  R37,  R38,  R41),  the 
individual concentration limits specified in Table 4a, expressed as a volume/volume 
percentage determine, when appropriate, the classification of the preparation. 

EN 

54 

   EN 

 
 
 
 
 
 
 
 
Classification 
of the 
substance 
(gas) 

C with 
R35 

C with 
R34 

Xi with 
R41 

Xi with 
R36, R37, 
R38 

Table 4a 

Classification of the gaseous preparation 

C with R35 

C with R34 

Xi with R41 

Xi with R36, R37, R38 

concentration 
≥ 1 % 
R35 obligatory

0,2 % ≤ 
concentration 
< 1 % 
R34 obligatory

0,2 % (*) 

concentration 
≥ 5 % 
R34 obligatory

5 % (*) 

0,02 % ≤ 
concentration 
< 0,2 % 
R36/37/38 
obligatory 

0,5 % ≤ 
concentration 
< 5 % 
R36/37/38 
obligatory 

concentration 
≥ 5 % 
R41 
obligatory 

0,5 % ≤ 
concentration 
< 5 % 
R36 obligatory 

concentration 
≥ 5 % 
R36, R37, R38 
obligatory as 
appropriate 

(*) 

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

NB: 

Simple  application  of  the  conventional  method  to  preparations  containing  substances  classified  as 
corrosive  or  irritant  may  result  in  under-classification  or  over-classification  of  the  hazard,  if  other 
relevant factors (e.g. pH of the preparation) are not taken into account. Therefore, in classifying for 
corrosivity, consider the advice given in point 3.2.5 of Annex VI to Directive 67/548/EEC and in the 
second and third indents of Article 6(3), of this Directive. 

(cid:208) 2001/60/EC Art. 1 pt. 3 

EN 

55 

   EN 

 
 
 
 
 
 
 
 
(cid:208) 1999/45/EC (adapted) 
(cid:206)1 2001/60/EC Art. 1 pt. 2, 
third indent 

5. 

Sensitising effects 

5.1. 

Non-gaseous preparations 

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

– 

– 

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

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

individual  concentration 

in  Table 5,  expressed  as  a 
limits  specified 
The 
weight/weight  percentage,  determine,  when  appropriate,  the  classification  of  the 
preparation. 

Table 5 

Classification of the preparation 

Classification of the substance 

Sensitising with R42 

Sensitising with R43 

Sensitising with R42 

concentration ≥ 1 % 
R42 obligatory 

Sensitising with R43 

5.2. 

Gaseous preparations 

concentration ≥ 1 % 
R43 obligatory 

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

– 

– 

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

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

individual  concentration 

The 
in  Table 5a,  expressed  as  a 
limits  specified 
volume/volume  percentage,  determine,  when  appropriate,  the  classification  of  the 
preparation. 

EN 

56 

   EN 

 
 
 
 
Table 5a 

Classification of the substance 
(gas) 

Classification of the gaseous preparation 

Sensitising with R42 

Sensitising with R43 

Sensitising with R42 

concentration ≥ 0,2 % 
R42 obligatory 

Sensitising with R43 

concentration ≥ 0,2 % 
R43 obligatory 

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 6,  expressed  as  a  weight/weight  percentage,  shall  determine,  where 
appropriate,  the  classification  of  the  preparation.  The  following  symbol  and  risk 
phrases are assigned: 

Carcinogenic categories 1 and 2: 

T; R45 or R49 

Carcinogenic category 3: 

Mutagenic categories 1 and 2: 

Xn; R40 

T; R46 

Mutagenic category 3: 

Xn; (cid:206)1 R68  

Toxic for reproduction fertility categories 1 and 2: 

T; R60 

Toxic for reproduction development categories 1 and 2:  T; R61 

Toxic for reproduction fertility category 3: 

Toxic for reproduction development category 3: 

Xn; R62 

Xn; R63 

EN 

57 

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(cid:208) 2006/8/EC Art. 1 and Annex, 
pt. 1(a) 

Classification of the 
substance 

Table 6 

Classification of the preparation 

Categories 1 and 2 

Category 3 

Carcinogenic 
substances of 
category 1 or 2 
with R45 or R49 

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

Carcinogenic 
substances of 
category 3 with 
R40 

Mutagenic 
substances of 
category 1 or 2 
with R46 

Mutagenic 
substances of 
category 3 with 
R68 

Concentration ≥ 0,1 % 
mutagenic 
R46 obligatory 

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

Concentration ≥ 0,5 % 
toxic for reproduction 
(fertility) 
R60 obligatory 

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

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

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

Concentration ≥ 0,5 % 
toxic for reproduction 
(development) 
R61 obligatory 

Concentration ≥ 1 % 
carcinogenic 
R40 obligatory (unless already 
assigned R45 (*)) 

Concentration ≥ 1 % 
mutagenic 
R68 obligatory (unless already 
assigned R46) 

Concentration ≥ 5 % toxic for 
reproduction (fertility) 
R62 obligatory (unless already 
assigned R60) 

Concentration ≥ 5 % toxic for 
reproduction (development) 
R63 obligatory (unless already 
assigned R61) 

EN 

58 

   EN 

 
 
 
 
 
 
 
 
 
 
(*) 

In  cases  where  the  preparation  is  assigned  R49  and  R40,  both  R  phrases  shall  be  kept, 
because  R40  does  not  distinguish  between  the  exposure  routes,  whereas  R49  is  only 
assigned for the inhalation route. 

(cid:208) 1999/45/EC 
(cid:206)1 2001/60/EC Art. 1 pt. 2, 
fifth indent 

6.2. 

Gaseous preparations 

For gases which produce such effects, the concentration limits laid down in Table 6a, 
expressed  as  a  volume/volume  percentage,  shall  determine,  where  appropriate,  the 
classification of the preparation. The following symbol and risk phrases are assigned: 

Carcinogenic categories 1 and 2: 

T; R45 or R49 

Carcinogenic category 3: 

Mutagenic categories 1 and 2: 

Xn; R40 

T; R46 

Mutagenic category 3: 

Xn; (cid:206)1 R68  

Toxic for reproduction fertility categories 1 and 2: 

T; R60 

Toxic for reproduction development categories 1 and 2:  T; R61 

Toxic for reproduction fertility category 3: 

Toxic for reproduction development category 3: 

Xn; R62 

Xn; R63 

EN 

59 

   EN 

 
 
(cid:208) 2006/8/EC Art. 1 and Annex, 
pt. 1(b) 

Classification of the 
substance 

Table 6a 

Classification of the preparation 

Categories 1 and 2 

Category 3 

Carcinogenic 
substances of 
category 1 or 2 
with R45 or R49 

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

Carcinogenic 
substances of 
category 3 with 
R40 

Mutagenic 
substances of 
category 1 or 2 
with R46 

Mutagenic 
substances of 
category 3 with 
R68 

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

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

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

Concentration ≥ 0,1 % 
mutagenic 
R46 obligatory 

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

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

Concentration ≥ 1 % 
carcinogenic 
R40 obligatory (unless already 
assigned R45 (*)) 

Concentration ≥ 1 % 
mutagenic 
R68 obligatory (unless already 
assigned R46) 

Concentration ≥ 1 % toxic for 
reproduction (fertility) 
R62 obligatory (unless already 
assigned R60) 

EN 

60 

   EN 

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

Concentration ≥ 1 % toxic for 
reproduction (development) 
R63 obligatory (unless already 
assigned R61) 

(*) 

In  cases  where  the  preparation  is  assigned  R49  and  R40,  both  R  phrases  shall  be  kept, 
because  R40  does  not  distinguish  between  the  exposure  routes,  whereas  R49  is  only 
assigned for the inhalation route. 

_____________ 

EN 

61 

   EN 

 
 
(cid:208) 1999/45/EC (adapted) 
(cid:206)1 1272/2008 Art. 56 pt. 2(f) 
(cid:206)2 Corrigendum 1999/45/EC 
(OJ L 6, 10.1.2002, p. 70) 
(cid:206)3 1272/2008 Art. 56 pt. 2(g), 
first indent 

ANNEX III 

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

INTRODUCTION 

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

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

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

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

(a) 

(b) 

Where the dangerous substances listed in (cid:206)1 Part 3 of Annex VI to Regulation (EC) 
No 1272/2008   are  assigned  concentration  limits  necessary  for  the  application  of 
the  method  of  assessment  described  in  Part A  of  this  Annex,  these  concentration 
limits must be used. 

Where  the  dangerous  substances  do  not  appear  in  (cid:206)1 Part 3  of  Annex VI  to 
Regulation  (EC)  No 1272/2008   or  appear  there  without  the  concentration  limits 
necessary for the application of the method of evaluation described in Part A of this 
Annex,  the  concentration  limits  shall  be  assigned  in  accordance  with  the 
specification in Part B of this Annex. 

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

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PART A 

Procedure for the evaluation of environmental hazards 

(a) 

Aquatic environment 

I. 

Conventional method for the evaluation of hazards to the aquatic environment 

The  conventional  method  for  the  evaluation  of  hazards  to  the  aquatic  environment 
(cid:206)2 takes  into  account  all  the  hazards  that  a  preparation  may  entail   for  this 
medium according to the following specifications. 

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

1. 

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

1.1.  preparations containing one or more substances classified as dangerous to the 
environment  and  to  which  is  assigned  phrases  R50-53  in  individual 
concentrations equal to or greater than: 

(a) 

(b) 

the  concentration  specified 

either 
to 
Regulation (EC) No 1272/2008  for the substance or substances under 
consideration, or 

in  (cid:206)3 Part 3  of  Annex VI 

the  concentration  specified  in  Part B  of  this  Annex  (Table  1)  where  the 
substance  or  substances  do  not  appear  in  (cid:206)3 Part 3  of  Annex VI  to 
Regulation (EC) No 1272/2008  or appear in it without concentration 
limits; 

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

∑

⎛
⎜
⎜
⎝

P
RN
,
L

RN
,

50

−

53

50

−

53

⎞
⎟
≥⎟
⎠

1

where: 

PN, R50—53 

= 

is  the  percentage  by  weight  of  each  substance  dangerous 
for  the  environment  to  which  is  assigned  phrases  R50–53 
in the preparation, 

LN, R50—53 

= 

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

2. 

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

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(cid:208) 1999/45/EC (adapted) 
(cid:206)1 1272/2008 Art. 56 pt. 2(g), 
second indent 

2.1.  preparations containing one or more than one substance classified as dangerous 
to  the  environment  and  to  which  is  assigned  phrases  R50–53  or  R51–53  in 
individual concentrations equal to or greater than: 

(a) 

(b) 

the  concentration  specified 

either 
to 
Regulation (EC) No 1272/2008  for the substance or substances under 
consideration, or 

in  (cid:206)1 Part 3  of  Annex VI 

the  concentration  specified  in  Part  B  of  this  Annex  (Table 1)  where  the 
substance  or  substances  do  not  appear  in  (cid:206)1 Part 3  of  Annex VI  to 
Regulation (EC) No 1272/2008  or appear in it without concentration 
limits; 

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

where: 

PN, R50—53  = 

is the percentage by weight of each substance dangerous for 
the environment to which is assigned phrases R50–53 in the 
preparation, 

PN, R51—53  = 

is the percentage by weight of each substance dangerous for 
the environment to which is assigned phrases R51–53 in the 
preparation, 

LN, R51—53  = 

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

3. 

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

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(cid:208) 1999/45/EC (adapted) 
(cid:206)1 1272/2008 Art. 56 pt. 2(g), 
third indent 

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

(a) 

(b) 

the  concentration  specified 

either 
to 
Regulation (EC) No 1272/2008  for the substance or substances under 
consideration, or 

in  (cid:206)1 Part 3  of  Annex VI 

the  concentration  specified  in  Part B  of  this  Annex  (Table 1)  where  the 
substance  or  substances  do  not  appear  in  (cid:206)1 Part 3  of  Annex VI  to 
Regulation (EC) No 1272/2008  or appear in it without concentration 
limits; 

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 lower individual concentrations than the limits specified 
in point I.3.1(a) or (b) if: 

where: 

PN, R50—53  = 

is the percentage by weight of each substance dangerous for 
the environment to which is assigned phrases R50–53 in the 
preparation, 

PN, R51—53  = 

is the percentage by weight of each substance dangerous for 
the environment to which is assigned phrases R51–53 in the 
preparation, 

PR52—53 

= 

is the percentage by weight of each substance dangerous for 
the environment to which is assigned phrases R52–53 in the 
preparation, 

LR52—53 

= 

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

4. 

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

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(cid:208) 1999/45/EC (adapted) 
(cid:206)1 1272/2008 Art. 56 pt. 2(g), 
fourth indent 

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) 

(b) 

the  concentration  specified 

either 
to 
Regulation (EC) No 1272/2008  for the substance or substances under 
consideration, or 

in  (cid:206)1 Part 3  of  Annex VI 

the  concentration  specified  in  Part B  of  this  Annex  (Table 2)  where  the 
substance  or  substances  do  not  appear  in  (cid:206)1 Part  3  of  Annex VI  to 
Regulation (EC) No 1272/2008  or appear in it without concentration 
limits; 

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

∑

⎛
⎜
⎜
⎝

P
RN
,
L

RN
,

50

50

⎞
⎟
≥⎟
⎠

1

where: 

PN, R50 

= 

is  the  percentage  by  weight  of  each  substance  dangerous  for 
the  environment  to  which  is  assigned  phrase  R50  in  the 
preparation, 

LN, R50 

= 

is  the  limit  R50  for  each  substance  dangerous  for  the 
environment  to  which  is  assigned  phrase  R50,  expressed  as 
percentage by weight; 

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

where: 

PN, R50 

= 

is the percentage by weight of each substance dangerous for 
the  environment  to  which  is  assigned  phrase  R50  in  the 
preparation, 

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PN, R50—53  = 

is the percentage by weight of each substance dangerous for 
the environment to which is assigned phrases R50–53 in the 
preparation, 

LN, R50 

= 

is  the  perspective  limit  R50  for  each  substance  dangerous 
for  the  environment  to  which  is  assigned  phrases  R50  or 
R50–53, expressed as percentage by weight; 

5. 

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

(cid:208) 1999/45/EC (adapted) 
(cid:206)1 1272/2008 Art. 56 pt. 2(g), 
fifth indent 

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) 

(b) 

the  concentration  specified 

to 
either 
Regulation (EC) No 1272/2008  for the substance or substances under 
consideration, or 

in  (cid:206)1 Part 3  of  Annex VI 

the  concentration  specified  in  Part B  of  this  Annex  (Table 3)  where  the 
substance  or  substances  do  not  appear  in  (cid:206)1 Part 3  of  Annex VI  to 
Regulation (EC) No 1272/2008  or appear in it without concentration 
limits; 

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

∑

⎛
⎜⎜
⎝

P
R
L
R

52

52

⎞
≥⎟⎟
⎠

1

where: 

PR52  = 

LR52  = 

is the percentage by weight of each substance dangerous for the 
environment to which is assigned phrase R52 in the preparation, 

the 

limit  R52  for  each  substance  dangerous  for 

is 
the 
environment  to  which  is  assigned  phrase  R52,  expressed  as 
percentage by weight; 

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6. 

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

(cid:208) 1999/45/EC (adapted) 
(cid:206)1 1272/2008 Art. 56 pt. 2(g), 
sixth indent 

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) 

(b) 

the  concentration  specified 

either 
to 
Regulation (EC) No 1272/2008  for the substance or substances under 
consideration, or 

in  (cid:206)1 Part 3  of  Annex VI 

the  concentration  specified  in  Part B  of  this  Annex  (Table 4)  where  the 
substance  or  substances  do  not  appear  in  (cid:206)1 Part 3  of  Annex VI  to 
Regulation (EC)  No 1272/2008   or  appear  in  it  without  concentration 
limits; 

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

∑

⎛
⎜⎜
⎝

P
R
L

R

53

53

⎞
≥⎟⎟
⎠

1

where: 

PR53  = 

LR53  = 

is  the  percentage  by  weight  of  each  substance  dangerous  for  the 
environment to which is assigned phrase R53 in the preparation, 

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

6.3.  preparations  containing  one  or  more  than  one  of  the  substances  classified  as 
dangerous  for  the  environment  and  to  which  is  assigned  phrase  R53  not 
meeting  the  criteria  in  point  I.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: 

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where: 

PR53 

= 

is  the  percentage  by  weight  of  each  substance  dangerous 
for the environment to which is assigned phrase R53 in the 
preparation, 

PN, R50—53 

= 

is  the  percentage  by  weight  of  each  substance  dangerous 
for the environment to which is assigned phrase R50–53 in 
the preparation, 

PN, R51—53 

= 

is  the  percentage  by  weight  of  each  substance  dangerous 
for the environment to which is assigned phrase R51–53 in 
the preparation, 

PR52—53 

= 

is  the  percentage  by  weight  of  each  substance  dangerous 
for the environment to which is assigned phrase R52–53 in 
the preparation, 

LR53 

= 

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 
weight. 

(b) 

(1) 

I. 

Non-aquatic environment 

OZONE LAYER 

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

The  following  preparations  ⌦ shall  be ⌫  classified  as  dangerous  for  the 
environment: 

1. 

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

(cid:208) 1999/45/EC 
(cid:206)1 1272/2008 Art. 56 pt. 2(h) 

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

(a) 

(b) 

the  concentration  specified 

either 
to 
Regulation (EC) No 1272/2008  for the substance or substances under 
consideration, or 

in  (cid:206)1 Part 3  of  Annex VI 

the  concentration  specified  in  Part B  of  this  Annex  (Table 5)  where  the 
substance  or  substances  do  not  appear  in  (cid:206)1 Part 3  of  Annex VI  to 
Regulation (EC) No 1272/2008  or appear in it without concentration 
limits. 

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(2) 

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 

R55 

R56 

R57 

R58 

Toxic to flora 

Toxic to fauna 

Toxic to soil organisms 

Toxic to bees 

  May cause long-term adverse effects in the environment. 

PART B 

Concentration limits to be used for the evaluation of environmental hazards 

I. 

For the aquatic environment 

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

(cid:208) 2006/8/EC Art. 1 and Annex, 
pt. 2(b) 

Table 1a 

Acute aquatic toxicity and long-term adverse effects 

Classification of the substance 

N, R50-53 

N, R51-53 

R52-53 

Classification of the preparation 

N, R50-53 

N, R51-53 

R52-53 

see Table 1b 

see Table 1b 

see Table 1b 

Cn ≥ 25 % 

2,5 % ≤ Cn< 25 % 

Cn ≥ 25 % 

Preparations  containing  a  substance  classified  with  N,  R50–53,  the  concentration 
limits and the resulting classification given in table 1b are applicable. 

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Table 1b 

Acute aquatic toxicity and long-term adverse effects of substances very toxic to the 
aquatic environment 

LC50 or EC50 value (‘L(E)C50’) 
of substance classified as N, 
R50–53 (mg/l) 

0,1 < L(E)C50 ≤ 1 

Classification of the preparation 

N, R50-53 

N, R51-53 

R52-53 

Cn ≥ 25 % 

2,5 % ≤ Cn< 
25 % 

0,25 % ≤ Cn< 
2,5 % 

0,01 < L(E)C50 ≤ 0,1 

Cn ≥ 2,5 % 

0,25 % ≤ Cn< 
2,5 % 

0,025 % ≤ Cn< 
0,25 % 

0,001 < L(E)C50 ≤ 0,01 

Cn ≥ 0,25 % 

0,025 % ≤ Cn< 
0,25 % 

0,0025 % ≤ Cn< 
0,025 % 

0,0001 < L(E)C50 ≤ 0,001 

Cn ≥ 0,025 % 

0,0025 % ≤ Cn< 
0,025 % 

0,00025 % ≤ Cn< 
0,0025 % 

0,00001 < L(E)C50 ≤ 
0,0001 

Cn ≥ 0,0025 % 

0,00025 % ≤ 
Cn< 0,0025 % 

0,000025 % ≤ Cn< 
0,00025 % 

For  preparations  containing  substances  with  a  lower  LC50  or  EC50  value  than  0,00001 mg/l,  the 
corresponding concentrationlimits are calculated accordingly (in factor 10 intervals). 

(cid:208) 2006/8/EC Art. 1 and Annex, 
pt. 2(c) 

Table 2 

Acute aquatic toxicity 

LC50 or EC50 value (‘L(E)C50’) of substance 
classified either as N, R50 or as N, R50-53 (mg/l) 

Classification of the preparation N, R50 

0,1 < L(E)C50 ≤ 1 

0,01 < L(E)C50 ≤ 0,1 

0,001 < L(E)C50 ≤ 0,01 

0,0001 < L(E)C50 ≤ 0,001 

0,00001 < L(E)C50 ≤ 0,0001 

Cn ≥ 25 % 

Cn ≥ 2,5 % 

Cn ≥ 0,25 % 

Cn ≥ 0,025 % 

Cn ≥ 0,0025 % 

For  preparations  containing  substances  with  a  lower  LC50  or  EC50  value  than  0,00001 mg/l,  the 
corresponding concentration limits are calculated accordingly (in factor 10 intervals). 

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(cid:208) 1999/45/EC (adapted) 

Table 3 

Aquatic toxicity 

Classification of the substance 

Classification of the preparation R52 

R52 

Cn ≥ 25 % 

Table 4 

Long-term adverse effects 

Classification of the substance 

Classification of the preparation R53 

R53 

N, R50—53 

N, R51—53 

R52—53 

Cn ≥ 25 % 

Cn ≥ 25 % 

Cn ≥ 25 % 

Cn ≥ 25 % 

II. 

For the non-aquatic environment 

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

(cid:208) 2006/8/EC Art. 1 and Annex, 
pt. 2(d) 

Table 5 

Dangerous for the ozone layer 

Classification of the substance 

Classification of the preparation N, R59 

N with R59 

Cn ≥ 0,1 % 

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(cid:208) 1999/45/EC (adapted) 

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  the  Annex  to ⌫ 
Regulation (EC) No 440/2008 have been complied with. 

Furthermore, the tests are to be carried out on all 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 or a test result was already available before this Directive entered 
into force. 

_____________ 

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ANNEX IV 

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

PART A 

Containers to be fitted with child-resistant fastenings 

1. 

2. 

3. 

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,  are  to  ⌦ be ⌫  fitted 
with child-resistant fastenings. 

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

Containers  of  whatever  capacity,  having  at  least  one  of  the  substances  mentioned 
below  present  in  a  concentration  equal  to  or  greater  then  the  maximum  individual 
concentration specified, 

No 

1 

2 

Identification of the substance 

Concentration limit 

CAS-Reg No 

Name 

Einecs No 

67-56-1  Methanol 

2006596 

75-09-2 

Dichloromethane 

2008389 

≥ 3 % 

≥ 1 % 

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

PART B 

Containers to be fitted with a tactile warning of danger 

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

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

_____________ 

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(cid:208) 2006/8/EC Art. 1 and Annex, 
pt. 3 
(cid:206)1 1272/2008 Art. 56 pt. 2(i) 
(cid:206)2 Corrigendum 2006/8/EC 
(OJ L 43, 15.2.2007, p. 42) 
(cid:206)3 1272/2008 Art. 56 pt. 2(j) 

ANNEX V 

SPECIAL PROVISIONS CONCERNING THE LABELLING OF CERTAIN 
PREPARATIONS 

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

Preparations sold to the general public 

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

A. 

1. 

1.1. 

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

2. 

Preparations intended for use by spraying 

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

3. 

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

When a preparation contains at least one substance assigned the phrase R33, the label 
on the packaging 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 (cid:206)1 Part 3 of Annex VI to Regulation (EC) No 1272/2008 . 

4. 

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

When a preparation contains at least one substance assigned phrase R64, the label on 
the packaging 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 
(cid:206)1 Part 3 of Annex VI to Regulation (EC) No 1272/2008 . 

EN 

75 

   EN 

 
 
B. 

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

1. 

Preparations containing lead 

1.1. 

Paint and varnishes 

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

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

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

‘Warning! Contains lead’. 

2. 

Preparations containing cyanoacrylates 

2.1. 

Adhesives 

The  label  on  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. 

Preparations containing isocyanates 

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

‘Contains isocyanates. 

See information supplied by the manufacturer’. 

EN 

76 

   EN 

 
4. 

Preparations containing epoxy constituents with an average molecular weight ≤ 700 

The  label  on  the  packaging  of  preparations  containing  epoxy  constituents  with  an 
average molecular weight ≤ 700 must bear the following inscriptions: 

‘Contains epoxy constituents. 

See information supplied by the manufacturer’. 

5. 

Preparations sold to the general public which contain active chlorine 

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

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

6. 

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

The  label  on  the  packaging  of  the  above  mentioned  preparations  must  bear  the 
following inscription printed in clearly legible and indelible characters: 

‘Warning! Contains cadmium. 

Dangerous fumes are formed during use. 

See information supplied by the manufacturer. 

Comply with the safety instructions’. 

7. 

Preparations available as aerosols 

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

8. 

Preparations containing substances not yet tested completely 

Where  a  preparation  contains  at  least  one  substance  which,  in  accordance  with 
Directive 67/548/EEC, bears the inscription (cid:206)2 ‘Caution — substance not yet fully 
tested’,  the label on the packaging 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 %. 

EN 

77 

   EN 

 
9. 

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

The  label  on  the  packaging  of  preparations  containing  at  least  one  substance 
classified  as  sensitising  and  being  present  in  a  concentration  equal  to  or  greater 
than 0,1 %  or  in  a  concentration  equal  to  or  greater  than  that  specified  under  a 
specific  note  for  the  substance  in  (cid:206)3 Part 3  of  Annex VI  to  Regulation  (EC) 
No 1272/2008  must bear the inscription: 

‘Contains (name of sensitising substance). May produce an allergic reaction’. 

10. 

Liquid preparations containing halogenated hydrocarbons 

For liquid preparations which show no flashpoint or a flashpoint higher than 55 °C 
and  contain  a  halogenated  hydrocarbon  and  more  than  5 %  flammable  or  highly 
flammable substances, the label on the packaging must bear the following inscription 
as appropriate: 

‘Can become highly flammable in use’ or ‘Can become flammable in use’. 

11. 

Preparations  containing  a  substance  assigned  phrase  R67:  vapours  may  cause 
drowsiness and dizziness 

When  a  preparation  contains  one  or  more  substances  assigned  the  phrase  R67,  the 
label on the packaging of the preparation must carry the wording of this phrase as set 
out  in  Annex III  to  Directive  67/548/EEC,  when  the  total  concentration  of  these 
substances present in the preparation is equal to or higher than 15 %, unless: 

– 

– 

the  preparation  is  already  classified  with  phrases  R20,  R23,  R26,  R68/20, 
R39/23 or R39/26, 

or the preparation is in a package not exceeding 125 ml. 

12. 

Cements and cement preparations 

The  label  on  the  packaging  of  cements  and  cement  preparations  containing  more 
than 0,0002 %  soluble  chromium  (VI)  of  the  total  dry  weight  of  the  cement  must 
bear the inscription: 

‘Contains chromium (VI). May produce an allergic reaction’ 

unless  the  preparation  is  already  classified  and  labelled  as  a  sensitiser  with 
phrase R43. 

C. 

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

1. 

Preparations not intended for the general public 

The label on the packaging of preparations referred to in Article 31(3)(a) and (c) of 
Regulation (EC) No 1907/2006 must bear the following inscription: 

‘Safety data sheet available for professional user on request’. 

EN 

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78 

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(cid:208) 1999/45/EC (adapted) 
(cid:206)1 1272/2008 Art. 56 pt. 2(k) 

ANNEX VI 

CONFIDENTIALITY FOR THE CHEMICAL IDENTITY OF A SUBSTANCE 

PART A 

Information to be communicated in the request for confidentiality 

Introductory notes 

A. 

B. 

C. 

D. 

Article 14  indicates  the  conditions  in  which  the  person  responsible  for  placing  a 
preparation on the market may avail himself of the confidentiality. 

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. 

The  alternative  designation  used on the label must be the same as that given under 
Heading 3 
to 
Regulation (EC) No 1907/2006. 

ingredients’  of  ⌦ Annex II ⌫ 

‘Composition/information  on 

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

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

Request for confidentiality 

In  accordance  with  Article 14  the  request  for  confidentiality  must  obligatorily  contain  the 
following information: 

1. 

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

EN 

79 

   EN 

 
 
2. 

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

CAS No 

Einecs No 

Chemical name according to international 
nomenclature and classification 
((cid:206)1 Part 3 of Annex VI to Regulation (EC) 
No 1272/2008  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. 

4. 

5. 

Justification for confidentiality (probability — plausibility). 

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

Is the designation or commercial name the same for all the ⌦ Union ⌫? 

YES 

NO 

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

(cid:208) 2006/96/EC Art. 1 and Annex, 
pt. G 

Belgium: 

Bulgaria: 

Czech Republic: 

Denmark: 

Germany: 

Estonia: 

Ireland: 

Greece: 

Spain: 

France: 

Italy: 

EN 

80 

   EN 

 
 
 
 
 
 
 
 
 
 
 
Cyprus: 

Latvia: 

Lithuania: 

Luxembourg: 

Hungary: 

Malta: 

Netherlands: 

Austria: 

Poland: 

Portugal: 

Romania: 

Slovenia: 

Slovakia: 

Finland: 

Sweden: 

United Kingdom: 

(cid:208) 1999/45/EC (adapted) 
(cid:206)1 1272/2008 Art. 56 pt.2(l) 
(cid:206)2 1272/2008 Art. 56 pt. 3 
(cid:206)3 1272/2008 Art. 56 pt. 4 

6. 

7. 

8. 

9. 

Composition of the preparation(s) defined in Heading 3 of Annex II to Regulation (EC) 
No 1907/2006. 

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

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

Intended uses for the preparation(s). 

10. 

Safety data sheet(s) conforming to Regulation (EC) No 1907/2006. 

EN 

81 

   EN 

 
 
Lexicon guide for establishing the alternative designations (generic names) 

PART B 

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  (cid:206)1 Part 3  of 
Annex VI to Regulation (EC) No 1272/2008 . 

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

The families are defined in the following manner: 

– 

– 

inorganic  or  organic  substances  whose  properties  are  identified  by  having  a 
common  chemical  element  as  their  chief  characteristic.  The  family  name  is 
derived from the name of the chemical element. These families are identified 
as  in  (cid:206)2 Part 3  of  Annex VI  to  Regulation  (EC)  No 1272/2008   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  (cid:206)2 Part 3  of 
Annex VI to Regulation (EC) No 1272/2008  (601—650). 

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

2. 

Establishing the generic name 

General principles 

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

(i) 

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

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

important functional groups and chemical elements. 

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

EN 

82 

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3. 

Division of substances into families and sub-families 

Family No 
(cid:206)1 Part 3 of Annex VI to 
Regulation (EC) 
No 1272/2008  

Families 

Sub-families 

001 

Hydrogen compounds 

002 

003 

004 

005 

Hydrides 

Helium compounds 

Lithium compounds 

Beryllium compounds 

Boron compounds 

Boranes 

Borates 

006 

Carbon compounds 

Carbamates 

Inorganic carbon compounds 

Salts of hydrogen cyanide 

Urea and derivatives 

007 

Nitrogen compounds 

Quaternary ammonium compounds 

Acid nitrogen compounds 

Nitrates 

Nitrites 

Oxygen compounds 

Fluorine compounds 

Inorganic fluorides 

Neon compounds 

Sodium compounds 

008 

009 

010 

011 

EN 

83 

   EN 

 
 
 
 
 
 
012 

Magnesium compounds 

Organometallic magnesium derivatives 

013 

Aluminium compounds 

Organometallic aluminium derivatives 

014 

Silicon compounds 

Silicones 

Silicates 

015 

Phosphorus compounds 

Acid phosphorus compounds 

Phosphonium compounds 

Phosphoric esters 

Phosphates 

Phosphites 

Phosphoramides and derivatives 

016 

Sulphur compounds 

Acid sulphur compounds 

Mercaptans 

Sulphates 

Sulphites 

017 

Chlorine compounds 

018 

019 

020 

021 

022 

Chlorates 

Perchlorates 

Argon compounds 

Potassium compounds 

Calcium compounds 

Scandium compounds 

Titanium compounds 

84 

   EN 

EN 

 
 
 
 
 
 
 
023 

024 

025 

026 

027 

028 

029 

030 

031 

032 

033 

034 

035 

036 

037 

038 

039 

040 

041 

042 

043 

044 

045 

046 

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 

EN 

85 

   EN 

 
 
 
047 

048 

049 

050 

051 

052 

053 

054 

055 

056 

057 

058 

059 

060 

061 

062 

063 

064 

065 

066 

067 

068 

069 

070 

071 

Silver compounds 

Cadmium compounds 

Indium compounds 

Tin compounds 

Organometallic tin derivatives 

Antimony compounds 

Tellurium compounds 

Iodine compounds 

Xenon compounds 

Caesium compounds 

Barium compounds 

Lanthanum compounds 

Cerium compounds 

Praseodymium compounds 

Neodymium compounds 

Promethium compounds 

Samarium compounds 

Europium compounds 

Gandolinium compounds 

Terbium compounds 

Dysprosium compounds 

Holmium compounds 

Erbium compounds 

Thulium compounds 

Ytterbium compounds 

Lutetium compounds 

EN 

86 

   EN 

 
 
072 

073 

074 

075 

076 

077 

078 

079 

080 

081 

082 

083 

084 

085 

086 

087 

088 

089 

090 

091 

092 

093 

094 

095 

Hafnium compounds 

Tantalum 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 

Actinium compounds 

Thorium compounds 

Protactinium compounds 

Uranium compounds 

Neptunium compounds 

Plutonium compounds 

Americium compounds 

EN 

87 

   EN 

 
 
 
096 

097 

098 

099 

100 

101 

102 

103 

601 

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 

EN 

88 

   EN 

 
 
 
 
Glycols and polyols 

604 

Phenols and derivatives 

Halogenated phenol derivatives (*) 

(*) 

Specify  according 
halogen. 

to 

the  family  corresponding 

to 

605 

Aldehydes and derivatives 

Aliphatic aldehydes 

Aromatic aldehydes 

Alicyclic aldehydes 

Aliphatic acetals 

Aromatic acetals 

Alicyclic acetals 

606 

Ketones and derivatives 

Aliphatic ketones 

Aromatic ketones (*) 

Alicyclic ketones 

(*) 

Quinones included. 

607 

Organic acids and derivatives 

Aliphatic acids 

Halogenated aliphatic acids (*) 

Aromatic acids 

Halogenated aromatic acids (*) 

Alicyclic acids 

Halogenated alicyclic acids (*) 

Aliphatic acid anhydrides 

Halogenated aliphatic acid anhydrides (*) 

Aromatic acid anhydrides 

EN 

89 

   EN 

 
 
 
 
 
 
 
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 
halogen. 

Nitriles and derivatives 

Nitro compounds 

to 

the  family  corresponding 

to 

Chlornitrated compounds 

Azoxy and azo compounds 

608 

609 

610 

611 

EN 

90 

   EN 

 
612 

Amine compounds 

Aliphatic amines and derivatives 

Alicyclic amines and derivatives 

Aromatic amines and derivatives 

Aniline and derivatives 

Benzidine and derivatives 

613 

Heterocyclic bases and derivatives 

Benzimidazole and derivatives 

Imidazol and derivatives 

Pyrethrinoids 

Quinoline and derivatives 

Triazine and derivatives 

Triazole and derivatives 

614 

Glycosides and alkaloids 

Alkaloid and derivatives 

Glycosides and derivatives 

615 

Cyanates and isocyanates 

Cyanates 

Isocyanates 

616 

Amides and derivatives 

Acetamide and derivatives 

617 

647 

648 

Anilides 

Organic peroxides 

Enzymes 

Complex coal derivatives 

Acid extract 

Alkaline extract 

EN 

91 

   EN 

 
 
 
 
 
 
 
Anthracene oil 

Anthracene oil extract residue 

Anthracene oil fraction 

Carbolic oil 

Carbolic oil extract residue 

Coal liquids, liquid solvent extraction 

Coal liquids, liquid solvent extraction solvents 

Coal oil 

Coal tar 

Coal tar extract 

Coal tar solids residue 

Coke (coal tar) low temperature, high temperature 
pitch 

Coke (coal tar), high temperature pitch 

Coke (coal tar), mixed coal high temperature pitch 

Crude benzole 

Crude phenols 

Crude tar bases 

Distillate bases 

Distillate phenols 

Distillates 

Distillates (coal), liquid solvent extraction, primary 

Distillates (coal), solvent extraction, hydrocracked 

Distillates (coal), solvent extraction, hydrocracked 
hydrogenated middle 

Distillates (coal), solvent extraction, hydrocracked 
middle 

Extract residues (coal), low temperature coal tar 

EN 

92 

   EN 

 
alkaline 

Fresh oil 

Fuels, diesel, coal solvent extraction, hydrocracked, 
hydrogenated 

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

Gasoline, coal solvent extraction, hydrocracked 
naphtha 

Heat treatment products 

Heavy anthracene oil 

Heavy anthracene oil redistillate 

Light oil 

Light oil extract residues, high boiling 

Light oil extract residues, intermediate boiling 

Light oil extract residues, low boiling 

Light oil redistillate, high boiling 

Light oil redistillate, intermediate boiling 

Light oil redistillate, low boiling 

Methylnaphthalene oil 

Methylnaphthalene oil extract residue 

Naphtha (coal), solvent extraction, hydrocracked 

Naphthalene oil 

Naphthalene oil extract residue 

Naphthalene oil redistillate 

Pitch 

Pitch redistillate 

Pitch residue 

Pitch residue, heat treated 

EN 

93 

   EN 

 
Pitch residue, oxidised 

Pyrolysis products 

Redistillates 

Residues (coal), liquid solvent extractions 

Tar brown coal 

Tar brown coal, low temperature 

Tar oil, high boiling 

Tar oil, intermediate boiling 

Wash oil 

Wash oil extract residue 

Wash oil redistillate 

649 

Complex oil derivatives 

Crude oil 

Petroleum gas 

Low boiling point naphtha 

Low boiling point modified naphtha 

Low boiling point cat-cracked naphtha 

Low boiling point cat-reformed naphtha 

Low boiling point thermally cracked naphtha 

Low boiling point hydrogen treated naphtha 

Low boiling point naphtha — unspecified 

Straight-run kerosine 

Kerosine — unspecified 

Cracked gas oil 

Gas oil — unspecified 

Heavy fuel oil 

Grease 

EN 

94 

   EN 

 
 
Unrefined or mildly refined base oil 

Base oil — unspecified 

Distillate aromatic extract 

Distillate aromatic extract (treated) 

Foots oil 

Slack wax 

Petrolatum 

650 

Various substances 

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

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 

generic name 

– 

butanol 

family 603 

sub-family 

generic name 

: 

: 

: 

: 

: 

– 

2-Isopropoxyethanol 

family 603 

sub-family 

generic name 

: 

: 

: 

phenols and derivatives 

phenol derivatives 

alcohols and derivatives 

aliphatic alcohols 

aliphatic alcohol 

alcohols and derivatives 

glycolethers 

glycolether 

95 

EN 

   EN 

 
 
– 

methacrylate 

family 607 

sub-family 

generic name 

: 

: 

: 

organic acids and derivatives 

acrylates 

acrylate 

4.2. 

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

Examples: 

– 

chlorobenzene 

family 602 

sub-family 

family 017 

generic name 

: 

: 

: 

: 

halogenated hydrocarbons 

halogenated aromatic hydrocarbons 

chlorine compounds 

chlorinated aromatic hydrocarbon 

– 

2,3,6-trichlorophenylacetic acid 

family 607 

sub-family 

family 017 

generic name 

: 

: 

: 

: 

organic acids 

halogenated aromatic acids 

chlorine compounds 

chlorinated aromatic acid 

– 

1-chloro-1-nitropropane 

family 610 

family 601 

sub-family 

generic name 

: 

: 

: 

: 

chloronitrated derivatives 

hydrocarbons 

aliphatic hydrocarbons 

chlorinated aliphatic hydrocarbon 

– 

tetrapropyl dithiopyrophosphate 

family 015 

sub-family 

family 016 

generic name 

: 

: 

: 

: 

phosphorus compounds 

phosphoric esters 

sulphur compounds 

thiophosphoric ester 

EN 

96 

   EN 

 
NB:  In  the  case  of  certain  elements,  notably  metals,  the  name  of  the  family  or 

sub-family may be indicated by the words‘organic’ or ‘inorganic’. 

Examples: 

– 

dimercury chloride 

family 080 

:  mercury compounds 

generic name 

: 

inorganic mercury compound 

– 

barium acetate 

family 056 

generic name 

– 

ethyl nitrite 

family 007 

sub-family 

generic name 

: 

: 

: 

: 

: 

– 

sodium hydrosulphite 

barium compounds 

organic barium compound 

nitrogen compounds 

nitrites 

organic nitrite 

family 016 

generic name 

: 

: 

sulphur compounds 

inorganic sulphur compound 

(The  examples  cited  are  substances  taken  from  (cid:206)3 Part 3  of  Annex VI  to 
Regulation (EC)  No 1272/2008   in  respect  of  which  requests  for  confidentiality 
may be submitted). 

_____________ 

EN 

97 

   EN 

 
ANNEX VII 

PREPARATIONS COVERED BY ARTICLE 12(2) 

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

_____________ 

EN 

98 

   EN 

 
(cid:207)  

ANNEX VIII 

Part A 

Repealed Directive with list of its successive amendments 
(referred to in Article 22) 

Directive 1999/45/EC of  
the European Parliament and of the Council 
(OJ L 200, 30.7.1999, p. 1) 

Commission Directive 2001/60/EC 
(OJ L 226, 22.8.2001, p. 5) 

Regulation (EC) No 1882/2003 of  
the European Parliament and of the Council 
(OJ L 284, 31.10.2003, p. 1) 

Council Directive 2004/66/EC 
(OJ L 168, 1.5.2004, p. 35) 

Commission Directive 2006/8/EC 
(OJ L 19, 24.1.2006, p. 12) 

Council Directive 2006/96/EC 
(OJ L 363, 20.12.2006, p. 81) 

Regulation (EC) No 1907/2006 of  
the European Parliament and of the Council 
(OJ L 396, 30.12.2006, p. 1) 

Regulation (EC) No 1137/2008 of  
the European Parliament and of the Council 
(OJ L 311, 21.11.2008, p. 1) 

Regulation (EC) No 1272/2008 of  
the European Parliament and of the Council 
(OJ L 353, 31.12.2008, p. 1) 

Only point 90 of Annex III 

Only as regards the reference to 
Directive 1999/45/EC in Article 1 
and point I.B of the Annex 

Only as regards the reference to 
Directive 1999/45/EC in Article 1 
and section G of the Annex 

Only Article 140 

Only point 3.5 of the Annex 

Only Article 56 

EN 

99 

   EN 

 
 
 
 
 
Part B 

List of time-limits for transposition into national law 
(referred to in Article 22) 

Directive 

Time-limit for transposition 

1999/45/EC 

2001/60/EC 

2004/66/EC 

2006/8/EC 

2006/96/EC 

30 July 2002 

30 July 2002 

1 May 2004 

1 March 2007 

1 January 2007 

_____________ 

EN 

100 

   EN 

 
ANNEX IX 

CORRELATION TABLE 

Directive 1999/45/EC 

This Directive 

Article 1(1), introductory wording 

Article 1(1) 

Article 1(1), first indent 

Article 1(1), second indent 

Article 1(1), last wording 

Article 1(1) 

Article 1(1) 

Article 1(1) 

Article 1(2), introductory wording 

Article 1(2), introductory wording 

Article 1(2), first indent 

Article 1(2), second indent 

Article 1(2)(a) 

Article 1(2)(b) 

Article 1(3), introductory wording 

Article 1(3) 

Article 1(3), first indent 

Article 1(3), second indent 

Article 1(3) 

Article 1(3) 

Article 1(3), third indent 

– 

Article 1(3), last wording  

Article 1(4) 

Article 1(5) 

Article 1(3) 

Article 1(4) 

Article 1(5) 

Article 1(6), introductory wording 

Article 1(6), introductory wording 

Article 1(6), first indent 

Article 1(6), second indent 

Article 1(6)(a) 

Article 1(6)(b) 

Article 2(1), introductory wording 

Article 2(1), introductory wording 

Article 2(1)(a), (b) and (c) 

Article 2(1)(a), (b) and (c) 

Article 2(1)(d) 

Article 2(1)(e) 

Article 2(1)(f) 

Article 2(1)(g) 

– 

Article 2(1)(d) 

Article 2(1)(e) 

Article 2(1)(f) 

EN 

101 

   EN 

 
Article 2(1)(h) 

Article 2(1)(g) 

Article 2(2), introductory wording  

Article 2(2), introductory wording  

Article 2(2)(a), (b) and (c) 

Article 2(2)(a), (b) and (c) 

Article 2(2)(d), introductory wording 

Article 2(2)(d), introductory wording 

Article 2(2)(d), first indent 

Article 2(2)(d)(i) 

Article 2(2)(d), second indent 

Article 2(2)(d)(ii) 

Article 2(2)(d), third indent  

Article 2(2)(d)(iii) 

Article 2(2)(d), fourth indent 

Article 2(2)(d)(iv) 

Article 2(2)(e) to (o) 

Article 2(2)(e) to (o) 

Article 3(1), first subparagraph, 
introductory wording 

Article 3(1), first subparagraph, 
introductory wording 

Article 3(1), first subparagraph, first indent 

Article 3(1), first subparagraph, point (a) 

Article 3(1), first subparagraph, second indent  Article 3(1), first subparagraph, point (b) 

Article 3(1), first subparagraph, third indent 

Article 3(1), first subparagraph, point (c) 

Article 3(1), second and third subparagraphs  Article 3(1), second and third subparagraphs 

Article 3(2), introductory wording 

Article 3(2), introductory wording 

Article 3(2), first indent 

Article 3(2)(a) 

Article 3(2), second indent 

– 

Article 3(2), third indent 

Article 3(2)(b) 

Article 3(2), fourth indent 

Article 3(2), fifth indent 

Article 3(2), sixth indent 

– 

– 

– 

Article 3(2), last wording 

Article 3(2), introductory wording 

Article 3(3) 

Article 4 

Article 5(1) 

Article 3(3) 

Article 4 

Article 5(1) 

Article 5(2), first introductory wording 

Article 5(2), introductory wording 

EN 

102 

   EN 

 
Article 5(2), second introductory wording 

Article 5(2), introductory wording 

Article 5(2), first indent 

Article 5(2), second indent 

Article 5(2), third indent 

Article 5(2)(a) 

Article 5(2)(b) 

Article 5(2)(c) 

Article 5(3), (4) and (5) 

Article 5(3), (4) and (5) 

Article 6(1) and (2) 

Article 6(1) and (2) 

Article 6(3), introductory wording 

Article 6(3), introductory wording 

Article 6(3), first indent, first part 

Article 6(3), introductory wording 

Article 6(3), first indent, second part 

Article 6(3), first indent 

Article 6(3), second indent 

Article 6(3), second indent 

Article 6(3), third indent 

Article 6(3), third indent 

Article 6(4) 

Article 7 

Article 6(4) 

Article 7 

Article 8(1) and (2) 

Article 8(1) and (2) 

Article 8(3), introductory wording 

Article 8(3), introductory wording 

Article 8(3), first indent 

Article 8(3), second indent 

Article 8(3), third indent 

Article 8(4) 

Article 8(3)(a) 

Article 8(3)(b) 

Article 8(3)(c) 

Article 8(4) 

Article 9, point 1, introductory wording 

Article 9(1), first subparagraph, 
introductory wording 

Article 9, point 1.1, introductory wording 

Article 9(1), first subparagraph, point (a), 
introductory wording 

Article 9, point 1.1, first indent 

Article 9(1), first subparagraph, point (a)(i) 

Article 9, point 1.1, second indent 

Article 9(1), first subparagraph, point (a)(ii) 

Article 9, point 1.1, third indent 

Article 9(1), first subparagraph, point (a)(iii) 

Article 9, point 1.1, fourth indent 

Article 9(1), first subparagraph, point (a)(iv) 

EN 

103 

   EN 

 
Article 9, point 1.2, introductory wording 

Article 9(1), first subparagraph, point (b), 
introductory wording 

Article 9, point 1.2, first indent 

Article 9(1), first subparagraph, point (b)(i) 

Article 9, point 1.2, second indent 

Article 9(1), first subparagraph, point (b)(ii) 

Article 9, point 1.3, first subparagraph, 
introductory wording 

Article 9(1), first subparagraph, point (c), 
introductory wording 

Article 9, point 1.3, first subparagraph, 
first indent 

Article 9, point 1.3, first subparagraph, 
second indent 

Article 9(1), first subparagraph, point (c)(i) 

Article 9(1), first subparagraph, point (c)(ii) 

Article 9, point 1.3, second subparagraph 

Article 9(1), second subparagraph 

Article 9(2) 

Article 9(2) 

Article 10, point 1.1, introductory wording 

Article 10(1), introductory wording 

Article 10, point 1.1(a) 

Article 10, point 1.1(b) 

Article 10, point 1.2 

Article 10(1)(a) 

Article 10(1)(b) 

Article 10(2) 

Article 10, point 2, introductory wording 

Article 10(3), introductory wording 

Article 10, point 2.1 

Article 10, point 2.2 

Article 10(3)(a) 

Article 10(3)(b) 

Article 10, point 2.3, introductory wording 

Article 10(3)(c), introductory wording 

Article 10, point 2.3.1 

Article 10, point 2.3.2 

Article 10(3)(c)(i) 

Article 10(3)(c)(ii) 

Article 10, point 2.3.3, first subparagraph, 
introductory wording  

Article 10(3)(c)(iii), first subparagraph, 
introductory wording 

Article 10, point 2.3.3, first subparagraph, 
first indent 

Article 10(3)(c)(iii), first subparagraph, 
first indent 

Article 10, point 2.3.3, first subparagraph, 
second indent 

Article 10(3)(c)(iii), first subparagraph, 
second indent 

Article 10, point 2.3.3, first subparagraph, 
third indent 

Article 10(3)(c)(iii), first subparagraph, 
third indent 

EN 

104 

   EN 

 
Article 10, point 2.3.3, first subparagraph, 
fourth indent 

Article 10(3)(c)(iii), first subparagraph, 
fourth indent 

Article 10, point 2.3.3, first subparagraph, 
fifth indent 

Article 10(3)(c)(iii), first subparagraph, 
fifth indent 

Article 10, point 2.3.3, first subparagraph, 
sixth indent 

Article 10(3)(c)(iii), first subparagraph, 
sixth indent 

Article 10, point 2.3.3, first subparagraph, 
last wording 

Article 10(3)(c)(iii), first subparagraph, 
introductory wording 

Article 10, point 2.3.3, second subparagraph 

Article 10(3)(c)(iii), second subparagraph 

Article 10, point 2.3.4, introductory wording  Article 10(3)(c)(iv), introductory wording 

Article 10, point 2.3.4, first indent 

Article 10(3)(c)(iv), first indent 

Article 10, point 2.3.4, second indent 

Article 10(3)(c)(iv), second indent 

Article 10, point 2.3.4, third indent 

Article 10(3)(c)(iv), third indent 

Article 10, point 2.3.4, fourth indent 

Article 10(3)(c)(iv), fourth indent 

Article 10, point 2.3.4, fifth indent 

Article 10(3)(c)(iv), fifth indent 

Article 10, point 2.3.4, sixth indent 

Article 10(3)(c)(iv), sixth indent 

Article 10, point 2.3.4, seventh indent 

Article 10(3)(c)(iv), seventh indent 

Article 10, point 2.3.4, last wording 

Article 10(3)(c)(iv), introductory wording 

Article 10, point 2.3.5 

Article 10(3)(c)(v) 

Article 10, point 2.4, first subparagraph 

Article 10(3)(d), first subparagraph 

Article 10, point 2.4, second subparagraph, 
introductory wording 

Article 10(3)(d), second subparagraph, 
introductory wording 

Article 10, point 2.4, second subparagraph, 
first indent 

Article 10, point 2.4, second subparagraph, 
second indent 

Article 10, point 2.4, second subparagraph, 
third indent 

Article 10, point 2.4, second subparagraph, 
fourth indent 

Article 10(3)(d), second subparagraph, point (i) 

Article 10(3)(d), second subparagraph, point (ii) 

Article 10(3)(d), second subparagraph, point (iii) 

Article 10(3)(d), second subparagraph, point (iv) 

Article 10, point 2.4, third subparagraph 

Article 10(3)(d), third subparagraph 

EN 

105 

   EN 

 
Article 10, point 2.5 

Article 10, point 2.6 

Article 10, point 2.7 

Article 10, point 3 

Article 10(3)(e) 

Article 10(3)(f) 

Article 10(3)(g) 

Article 10(4) 

Article 10, point 4, introductory wording 

Article 10(5), introductory wording 

Article 10, point 4, first indent 

Article 10(5)(a) 

Article 10, point 4, second indent 

Article 10(5)(b) 

Article 10, point 5 

Article 11(1) to (5) 

Article 10(6) 

Article 11(1) to (5) 

Article 11(6), introductory wording 

Article 11(6), introductory wording 

Article 11(6)(a) 

Article 11(6)(a) 

Article 11(6)(b), first subparagraph, 
introductory wording 

Article 11(6)(b), first subparagraph, 
introductory wording 

Article 11(6)(b), first subparagraph, 
first indent 

Article 11(6)(b), first subparagraph, 
second indent 

Article 11(6)(b), first subparagraph, point (i) 

Article 11(6)(b), first subparagraph, point (ii) 

Article 11(6)(b), second subparagraph 

Article 11(6)(b), second subparagraph 

Articles 12 and 13 

Articles 12 and 13 

Article 15 

– 

Article 16 

Article 17 

Article 18 

Article 19 

Article 20 

Article 20a(1) and (2) 

Article 20a(3) 

Article 14, first to fifth paragraphs 

Article 14, sixth paragraph 

Article 15 

Article 16 

Article 17 

Article 18 

Article 19 

Article 21 

– 

EN 

106 

   EN 

 
– 

– 

Article 21 

Article 22 

Article 23 

Article 24 

Annex I–VII 

Annex VIII 

Annex IX 

– 

– 

Article 20 

Article 22 

– 

– 

Article 23 

Article 24 

Annex I–VII 

– 

– 

Annex VIII 

Annex IX 

_____________ 

EN 

107 

   EN