Proposal for a Regulation of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures, and amending Directive 67/548/EEC and Regulation (EC) No 1907/2006 [SEC(2007) 853] [SEC(2007) 854]
Date: 2007-06-27
Institutions: European Commission
Subjects: approximation of laws, dangerous substance, environmental protection, health policy, labelling, packaging

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 27.6.2007 
COM(2007) 355 final 

2007/0121 (COD) 

Volume I 

Proposal for a 

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

on classification, labelling and packaging of substances and mixtures, and amending 
Directive 67/548/EEC and Regulation (EC) No 1907/2006 

(presented by the Commission) 

[SEC(2007) 853] 
[SEC(2007) 854] 

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EXPLANATORY MEMORANDUM 

BACKGROUND TO THE PROPOSAL 

Reasons and objectives 

This  proposal  builds  on  existing  chemicals  legislation  and  establishes  a  new  system  on 
classification and labelling of hazardous substances and mixtures by implementing in the EU 
the  international  criteria  agreed  by  the  United  Nation  Economic  and  Social  Council  (UN 
ECOSOC) for the classification and labelling of hazardous substances and mixtures, called the 
Globally Harmonised System of Classification and Labelling of Chemicals (GHS). 

Chemicals are  manufactured and traded globally,  and  their  hazards  are  the  same  around  the 
world. Therefore the description of hazards should not differ between countries if the product 
is the same. 

Enterprises will save costs if they do not have to assess hazard information for their chemicals 
against different sets of criteria. 

If the same criteria are used to identify the hazards of chemicals and the same labelling is used 
to describe them, the level of protection of human health and the environment becomes more 
consistent, transparent and comparable throughout the world. Professional users of chemicals 
and consumers all over the world benefit from such a harmonisation. 

Global Context 

In December 2002, the GHS was agreed by the UN Committee of Experts on the Transport of 
Dangerous  Goods  and  the  Globally  Harmonized  System  of  Classification  and  Labelling  of 
Chemicals (CETDG/GHS)1. It was formally adopted by UN ECOSOC
2 in July 2003 and revised3 
in  2005.  In  its  Plan  of  Implementation,  adopted  in  Johannesburg  on  4 September 2002,  the 
World Summit on Sustainable Development encouraged countries to implement the GHS 
as soon as possible, to have the system fully operational by 2008. 

EU Context 

Besides participating in the UN work to develop the GHS, the Commission announced its aim 
to propose the implementation of the GHS into Community legislation on several occasions, 
e.g. in the 2001 White Paper ‘Strategy for a future Chemicals Policy’4, and the Explanatory 
Memorandum  to  the  amendment  to  Directive 67/548/EC5,  adopted  at  the  same  time  as  the 
REACH proposal. The present proposal fulfils that commitment. 

1 
2 
3 
4 
5 

An ECOSOC subsidiary body serviced by the UNECE secretariat. 
Economic and Social Committee of the UN 
http://www.unece.org/trans/danger/publi/ghs/ghs_rev00/00files_e.html 
COM(2001) 88 final 
2003/0257(COD) 

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Current EU System and GHS 

The  current  EU  classification  and  labelling  system  for  chemicals  is  set  out  in  three  key 
instruments: 

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– 

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the Dangerous Substances Directive (67/548/EEC)6; 

the Dangerous Preparations Directive (1999/45/EC)7; 

the Safety Data Sheet Directive (91/155/EEC)8. 

They pursue internal market objectives, i.e. the establishment of a Single Market in chemicals. 
The  Directives  are  based  on  a  high  level  of  protection  concerning  health,  safety, 
environmental and consumer protection (Article 95 (3) EC Treaty). 

The  first  two  Directives  set  out  rules  on  the  classification,  packaging  and  labelling  of 
dangerous  substances  and  preparations.  The  Safety  Data  Sheet  Directive  ensures  that 
suppliers  of  substances  and  preparations  provide  information  about  the  hazards  of  their 
chemicals  and  guidance  on  safe  use  to  professional  customers.  These  provisions  have  been 
taken up in REACH

9. 

The  current  EU  system  and  the  GHS  are  conceptually  similar.  Both  cover  classification, 
packaging and hazard communication through labelling and safety data sheets. The GHS is a 
that  provides  criteria  for  harmonised  classification  and  hazard 
common  approach 
communication for different target audiences, including consumers, workers and  emergency 
responders,  and  in  transport.  Therefore,  it  includes  a  “building  block”  approach  to  enable 
countries to adopt the system having regard to the various target audiences in different legal 
areas. As the GHS provides a common system of the classification and labelling for transport, 
supply and use, this proposal aims to ensure coherence with EU transport legislation, where 
relevant. EU transport legislation will incorporate relevant GHS criteria by 2007 and 2009, in 
line with the timetable for adoption of the UNECE Model Regulation. 

This proposal addresses supply and use of chemicals and, therefore, the main target audience 
are workers and consumers, as is the case for the current EU system. 

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7 

8 

9 

Council  Directive 67/548/EEC  relating  to  the  classification,  packaging  and  labelling  of  dangerous 
substances, as amended [OJ 196, 16.8.1967, p. 1] 
Council  Directive 1999/45/EC  relating  to  the  classification,  packaging  and  labelling  of  dangerous 
preparation, as amended [OJL200, 30.7.1999, p.1] 
Council Directive 91/155/EEC relating to defining and laying down the detailed arrangements for the 
system  of  specific  information  relating  to  dangerous  preparations  and  dangerous  substances,  as 
amended [OJL 076, 22.03.1991, p. 35], repealed and replaced by Regulation (EC) No 1907/2006 as of 1 
June 2007. 
Regulation  (EC)  No  1907/2006  of  the  European  Parliament  and  of  the  Council  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/EC [OJ  L 396, 30.12.2006, 
p. 1] 

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Experts have identified the differences between the current EU system for supply and use and 
the  GHS  system10.  The  Commission  has  based  this  proposal  on  their  work.  The  number  of 
classified  substances  resulting  from  the  application  of  the  new  system  is  estimated  to  be 
approximately the same as under the current system. 

Due  to  changes  of  cut-off  values  and  calculation  methods,  more  preparations  –  now  called 
mixtures  -  will  probably  be  classified  under  the  new  system.  The  application  of  the  new 
criteria may result in a different classification compared to the current one. 

As safety data sheets are the main tool for communication under the REACH Regulation, the 
provisions on safety data sheets remain there. 

Future Development 

Two  UN  Expert  Sub-Committees  keep  the  technical  aspects  regarding  health  and 
environmental  hazards  and  physical  hazards  of  the  GHS  up-to-date.  The  Committee  of  the 
Experts  on  the  Transport  of  Dangerous  Goods  and  the  Globally  Harmonised  System  of 
Classification and Labelling of Chemicals endorses recommendations of the sub-committees 
and channels these to the UN ECOSOC, which will adopt revisions of the GHS on a biannual 
basis11. 

Coherence with other policies 

Classification  of  substances  and  preparations  triggers  other  obligations  in  EU  legislation, 
referred to as downstream legislation. 

The  Commission  services  have  assessed  the  potential  effects  of  the  implementation  of  the 
GHS  criteria  on  downstream  legislation.  Their  analysis  concludes  that  effects  are  either 
minimal or can be minimised by appropriate changes to particular downstream acts. This draft 
Regulation  includes  such  changes  to  Regulation  (EC)  No  1907/2006.  For  the  Seveso  II 
Directive12,  where  the  implementation  of  GHS  is  expected  to  have  a  substantial  impact, 
necessary  measures  have  to  be  introduced  in  a  separate  amendment.  Other  separate 
amendments  implementing  the  GHS  for  other  EU  downstream  acts  will  be  part  of  an 
upcoming Commission proposal. 

During the stakeholder consultation, some parties mentioned the lack of analysis of national 
legislation referring to EU classification. However, the assessment of the effects on national 
legislation  is  within  the  competence  of  Member  States.  It  may  be  worthwhile  for  them  to 
analyse national downstream acts along the lines of the study on EU legislation. 

10 

11 
12 

from 

Group 

Technical  Working 

ECBI/03/02:  White  Paper  Working  Group  on  Classification  and  Labelling:  Summary  of 
Recommendations 
2. 
Final  report:  Technical  Assistance  to  the  Commission  on  the  implementation  of  the  GHS.  Ökopol 
Institute for Environmental Strategies, July 2004. 
Final  project  report:  Technical  support  for  the  preparation  of  Annexes  for  the  draft  legislation 
implementing the Globally Harmonised System for Classification and Labelling of Chemicals (GHS). 
Milieu Environmental Law & Policy, January 2006. 
GHS ST/SG/AC.10/30/Rev. 1, 2005, 1.1.3.2 
Council Directive 1996/82/EC of 9 December 1996 on the control of major-accident hazards involving 
dangerous substances, as amended [OJ L 10, 14.1.1997, p. 13] 

Tasks 

and 

on 

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RESULTS OF PUBLIC CONSULTATIONS AND IMPACT ASSESSMENTS 

Public stakeholder consultation 

Internet consultation 

The  Commission  launched  a  stakeholder  consultation  on  the  internet  from  21 August  to 
21 October 2006. All responses were published on the Internet. Some 370 contributions were 
received.  82%  were  sent  by  industry  -  companies  or  associations;  of  the  254 company 
responses, 45% came from enterprises with less than 250 employees. 10 NGOs and one trade 
union responded. 

18 Member  State  governments  and/or  public  authorities  sent  comments.  Non-EU  public 
authorities  (Iceland,  Norway,  Switzerland,  Romania)  gave  input  as  well.  No  international 
organisation  sent  comments.  97%  of  the  responses  supported  the  implementation  of  the 
GHS in the EU and 96% of these by means of a Regulation. Overall the draft proposals of 
the Commission services were well appreciated by Member State authorities and industry. 

Issues raised and how they are addressed 

Scope: 59% supported not changing the level of protection in comparison with the current EU 
system,  except  to  be  consistent  with  transport  legislation  or  the  GHS.  5%  had  no  opinion, 
including  most  of  the  NGOs.  36%  favoured  a  different  approach.  Of  these,  one  group 
(governmental bodies in Denmark, Sweden, Norway, Iceland), wanted to go beyond the scope 
of the current system; the second group (associations and companies) proposed to include all 
GHS categories, but not to include the "EU left-overs" not yet part of the GHS. 

The  majority  of  respondents  supported  maintaining  the  current  level  of  protection  and  the 
Commission  has  not  changed  the  proposal  in  this  regard.  However,  flammable  gases  Cat. 2 
was included as requested by some Member States and industry. 

Transitional  period:  No  specific  comments  were  made  on  the  two  stage  structure 
(substances then mixtures) of the transitional period. A clear majority of respondents (around 
60%) supported a three-year transition period for substances after entry into force of REACH. 
This would require all enterprises to register the first wave of phase-in substances and notify 
the  classification  and  labelling  of  their  substances  to  the  Chemicals  Agency.  Fixing  the 
transition  period  for  substances  in  line  with  the  relevant  period  in  REACH  avoids  double 
work as confirmed by the impact assessment. Some stakeholders preferred a longer deadline 
allowing to postpone the work until after the last registration deadline in REACH. 

For mixtures, almost half of the responses supported the 5 year option. Nearly equal numbers 
of  the  remaining  responses  preferred  either  a  longer  period  or  a  shorter  period.  Industry 
responses were divided, with significant support for 5 years for mixtures, sometimes coupled 
with a demand for a longer period for substances. Member States looked for a shorter period, 
typically 3 years. 

The  Commission  therefore  proposes  a  transition  period  for  substances  of  three  and  a  half 
years after the entry into force of REACH. As the length of the transition period for mixtures is 
less evident and the impact assessment does not show clear enough results to give preference 
for either four or five years, a transition period of 4.5 years is proposed. 

Specific comments: Around 15% of the respondents provided specific comments. 

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A large majority of these comments from industry and Member States were technical, seeking 
more clarity and consistency. Issues repeatedly pointed out are: 

– 

– 

– 

– 

– 

– 

– 

align the definition of mixtures with that of REACH; 

describe  the  general  obligations  of  Article 4  to  classify,  label  and  package  more 
clearly; 

allow  the  use  of  an  international  chemical  name  beside  the  name  of  the  IUPAC 
Nomenclature, limit the names on a label for a mixture in line with the requirements 
of the current legislation, include a provision to allow the use of shorter names; 

clarify  that  the  content  of  the  publicly  accessible  part  of  the  classification  and 
labelling inventory is consistent with Article 119 of the REACH Regulation; 

include the specific rule of current legislation with regard to advertising mixtures; 

specify more clearly the body responsible for receiving information relating to health 
in line with the current legislation; 

reconsider  the  provision  for  small  packaging  to  counterbalance  the  bigger  space 
demand of the GHS label information. 

Another  request  from  the  majority  of  Member  States  and  downstream  users  was  the 
"translation" of the current Annex I of Directive 67/548/EEC (list of harmonised classification 
and labelling of substances) into the new Annex VI, so as to maintain the results of efforts to 
build up Annex I. 

All these points were considered and taken up in the revised proposal. 

Impact assessments 

The  impact  assessment  made  use  of  the  impact  assessment  consultant  reports  prepared  by 
RPA  and  London  Economics  as  well  as  the  responses  to  the  Internet  Consultation.  The 
responses  from  companies  on  costs  led  to  further  efforts  to  quantify  significant  cost  items. 
The overall analysis demonstrates that the implementation costs need to be kept in check so as 
to arrive at the net benefits of the GHS in the foreseeable future. 

Collection and use of expertise 

The  GHS  was  developed  by  international  organisations,  with  participation  of  various 
stakeholders.  Similarly,  in  the  EU  there  have  been  continuous  technical  discussions  with 
Member  States  and  other  stakeholders  over  the  past  years.  Following  the  publication  of  the 
White Paper “Strategy for a future Chemicals Policy”, the Commission consulted widely with 
experts. The results of the technical working group on classification and labelling convened 
13 have been taken into account in drafting this 
by the Commission in preparation for REACH

13 

ECBI/03/02:  White  Paper  Working  Group  on  Classification  and  Labelling:  Summary  of 
Recommendations from Technical Working Group on Tasks 1 and 2. 

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proposal.  Further  studies  were  carried  out14  and  an  informal  stakeholder  discussion  on  the 
implementation of the GHS in the EU took place on 18 November 2005. 

LEGAL ELEMENTS OF THE PROPOSAL 

Legal basis 

Article 95 of the EC Treaty is the appropriate legal basis. The aim is to ensure a level playing 
field for all suppliers of substances and mixtures in the internal market, as well as a high level 
of protection of health, safety, environment and consumers. 

This legal basis ensures that the requirements for substances and mixtures are harmonised and 
that  substances  and  mixtures  complying  with  them  can  move  freely  throughout  the  internal 
market. This rewards the efforts required from economic actors to reclassify substances and 
mixtures. 

Moreover, Article 95(3) requires a high level of health, safety, environmental and consumer 
protection. This Regulation falls within this remit. 

Subsidiarity and proportionality 

Subsidiarity 

Existing Directives on the classification and labelling of substances and preparations already 
set  forth  an  extensive  system.  The  new  Regulation  will  replace  the  existing  Directives. 
Classification and labelling provisions need to be exactly the same in all Member States, and 
should therefore be regulated at Community level. 

Proportionality 

The  criteria  for  the  classification  of  substances  and  mixtures  as  hazardous,  including  the 
building block approach that invites the legislator to choose the appropriate hazard classes and 
categories,  have  been  developed  at  international  level.  To  ensure  proportionality,  the 
Commission selected those hazard classes and categories which are comparable with existing 
legislation. Therefore, this proposal does not include certain categories not part of current EU 
legislation. Elements which are part of current EU legislation, but have not yet been included 
in the GHS, are also part of this proposal, e.g. “ozone depletion”. 

To be consistent with the GHS, those elements which were only subject to additional labelling 
requirements under the current EU system, but which are now part of the GHS classification 
system, will now have to be classified. However, for those hazard classes or categories which 
are added in comparison to the current EU system, no obligations should be triggered under 
other  legislation,  e.g.  REACH.  For  consistency  with  transport  legislation,  this  proposal 
incorporates  some  hazard  classes  or  categories  which  are  not  included  in  current  EU 

14 

Final  report:  Technical  Assistance  to  the  Commission  on  the  implementation  of  the  GHS.  Ökopol 
Institute for Environmental Strategies, July 2004. 
Final  project  report:  Technical  support  for  the  preparation  of  Annexes  for  the  draft  legislation 
implementing the Globally Harmonised System for Classification and Labelling of Chemicals (GHS). 
Milieu Environmental Law & Policy, January 2006. 

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legislation  for  supply  and  use,  but  are  part  of  the  existing  EU  transport  system  or  will  be 
implemented in transport legislation. 

Therefore this proposal for a Regulation is proportionate. 

Choice of legal instrument 

The  choice  of  a  Regulation  is  justified,  as  it  will  lead  to  the  direct  application  of  the  rules 
throughout the Community. It replaces 2 existing and dated Directives (with 10 Amendments 
and 30 Adaptations to Technical Progress). It also contains mainly technical details agreed at 
UN  level,  which  it  is  not  appropriate  to  change,  as  this  would  defeat  the  purpose  of  global 
harmonisation.  In  the  area  of  technical  legislation,  Regulations  are  a  widely  used  technique 
that  has  already  met  with  the  support  of  Member  States  in  other  areas15.  It  is  even  more 
justified in a Community of 27 Member States that will certainly benefit from homogeneous 
and directly applicable rules throughout its territory. 

INTRODUCTION TO THE PROPOSAL 

This Regulation sets out rules for the classification of substances and mixtures as hazardous 
and for the labelling and packaging of such hazardous substances and mixtures. 

1. 

REASONS AND OBJECTIVES 

The objective of this Regulation is to ensure a high level of protection of human health and 
the environment, while guaranteeing the free movement of substances and mixtures within the 
internal market. To this end, the Regulation takes a fivefold approach based on the GHS. 

First,  it  harmonises  the  classification,  labelling  and  packaging  rules  for  substances  and 
mixtures.  Second  and  third,  it  obliges  enterprises  to  classify  their  substances  and  mixtures 
themselves  and  to  notify  the  classifications.  Fourth,  it  establishes  a  harmonised  list  of 
substances classified at Community level in Annex VI. Finally, it establishes a classification 
and labelling inventory, made up of all notifications and harmonised classifications referred to 
above. 

2. 

GENERAL ISSUES 

The  Regulation  applies  to  substances  and  mixtures.  However,  since  the  physical  hazards  of 
substances or mixtures are to some extent influenced by the way in which they are released, 
the  Regulation  also  covers  release  by  aerosols  through  a  specific  hazard  class.  Radioactive 
substances are excluded from the scope, as they are covered by  other rules.  Substances and 
mixtures  subject  to  customs  supervision  are  also  excluded,  subject  to  certain  conditions,  as 
they  are  not  supplied  in  the  EU.  Non-isolated  intermediates  are  not  included  for  the  same 
reason.  Substances  and  mixtures  for  scientific  research  and  development  not  placed  on  the 
market are also excluded when used under controlled conditions minimising exposure. 

15 

See  Regulation  (EC)  No  178/2002  on  Food  Law  [OJ  L  31,  1.2.2002,  p.  1,  Regulation  (EC)  No 
2003/2003  on  Fertilisers  [OJ  L  304,  21.11.2003,  p.  1],  Regulation  (EC)  No  273/2004  on  Drug 
Precursors  [OJ  L  47,  18.2.2004,  p.  1]  and  Regulation  (EC)  No  648/2004  on  Detergents  [OJ  L  104, 
8.4.2004, p. 1]. 

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The  essential  terms  are  defined.  Following  the  GHS,  the  term  “preparation”  is  replaced  by 
“mixture”. 

Annex I  lists  the  hazard  classes  of  the  GHS,  as  well  as  the  relevant  hazard  categories  and 
criteria. If a substance or a mixture fulfils the criteria for any hazard class, it is hazardous. The 
Commission is empowered to update Annex I and to include new hazard classes agreed at UN 
level. The concept of “dangerous” is also laid down, in order to allow minimising effects on 
downstream legislation. 

Before a substance or mixture is marketed, the supplier must classify it. This means he must 
identify and describe its hazards, evaluate this information and compare it with the criteria of 
the Regulation. Suppliers may define other concentration limits which differ from the generic 
concentration limits in justified cases, unless Annex VI contains specific concentration limits. 
However,  where  harmonised  classifications  for  a  hazard  class  or  differentiation  within  a 
hazard  class  are  included  in  this  Regulation  for  a  substance,  the  supplier  must  classify  in 
accordance with that entry, and must not deviate from it on the basis of available information. 

Distributors  must  ensure  that  they  pass  on  the  relevant  information,  either  by  keeping  the 
labels on the substances or mixtures they receive or by applying the rules of this Regulation 
themselves. 

The procedure for identifying information relevant for hazard classification is described. No 
new  testing  needs  to  be  done  for  the  purpose  of  classification  only.  Thus,  available 
information  from  public  sources  and  information  generated  under  other  EU  legislation  like 
REACH, the transport, biocides or plant protection product legislation, may be used. 

If  the  supplier  generates  new  information,  certain  quality  conditions  must  be  met,  to  ensure 
that classification is based on sound data. International standards are accepted as well as data 
that fulfil the requirements of REACH or other legislation. Testing on animals must be avoided 
wherever possible and alternative methods always must be considered first. Animal tests must 
comply  with  the  relevant  Directive16.  Testing  on  humans  is  not  permitted;  only  available 
experience on effects on humans may be used. 

For  mixtures,  there  is  a  general  obligation  to  use  available  test  data  on  the  mixtures 
themselves,  except  for  mixtures  containing  substances  with  e.g.  CMR  properties.  For  the 
latter,  the  classification  of  the  mixtures  is  normally  based  on  the  information  on  those 
substances.  If  no  test  data  are  available  on  the  mixtures  themselves,  Annex I  specifies 
“bridging principles”, which enable suppliers to derive a sound classification of mixtures. If 
the available information is not sufficient for the application of those principles, the individual 
chapters of Annex I specify what needs to be done. 

The identified relevant information needs to be evaluated for the purpose of classification, by 
comparing it with the criteria in Annex I. 

The classification of mixtures must take account of all available information about potential 
occurrence  of  synergistic  and  antagonistic  effects  among  the  ingredients.  Cut-off  values 
ensure  that  the  system  is  workable  and  proportionate.  A  new  hazard  evaluation  is  required 

16 

Directive 86/609/EEC, OJ L 358, 18.12.1986, p. 1. 

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when the composition of a mixture is changed outside specified limits, unless it is evident that 
the change has no effect on the classification. 

Agreed classifications must be respected, unless the supplier has sufficient evidence to justify 
a different classification. 

3. 

LABELLING 

The label elements from the GHS are specified, i.e. the name, address and telephone number 
of  the  supplier,  product  identifiers,  hazard  pictograms,  signal  words,  hazard  statements  and 
precautionary statements. To maintain the level of protection of current EU law, supplemental 
information on hazards not yet included in the GHS must also be mentioned. Furthermore, as 
is the case today, the nominal quantity in the package, as placed on the market to the general 
public, has to be indicated. To protect confidential business information, it is possible, as is 
the  case  today,  to  apply  for  permission  to  use  a  name  that  does  not  reveal  the  substance’s 
chemical  identity.  The  Agency  established  by  the  REACH  Regulation  will  decide  on  such 
applications. 

Principles of precedence for labelling are specified.. 

The supplier has to update the label after changes to the classification, unless the labels are 
part of an approval decision concerning a biocide or a plant protection product. In the latter 
case, the applicable special legislation has to be complied with. 

To ensure that customers notice hazard information, there are rules on the colours and format 
of labels and on the location of information on labels. 

To reduce the burden on enterprises and to avoid the duplication of transport labels, there are 
provisions determining which labels to use in case of inner and outer packages. 

4. 

PACKAGING 

Safety measures for containers and other packages are set out. 

5. 

HARMONISATION  OF  CLASSIFICATION  AND  LABELLING  OF  SUBSTANCES;  THE 
CLASSIFICATION AND LABELLING INVENTORY 

The  provisions  of  Title XI  of  the  REACH  Regulation  are  moved  to  this  Regulation,  with 
certain technical changes. 

5.1. 

Establishing harmonised classification and labelling of substances 

For  specific  hazard  classes  harmonised  classifications  can  be  included  in  Annex VI,  while 
harmonisation  of  other  hazard  classes  is  possible  if  there  is  a  need  for  Community  wide 
action. The applicable procedure is set out, ensuring that expert opinion is taken into account 
and that stakeholders may comment. 

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5.2. 

Notification  to  the  Agency  and  establishing  the  classification  and  labelling 
inventory 

Specific  information  must  be  provided  for  inclusion  of  a  substance  in  the  inventory.  As 
classification  and  labelling  data  are  part  of  the  information  needed  for  registration  under 
REACH, there is no need to notify the information if a registration has been submitted. 

If the classification is changed, as a result of REACH or otherwise, the entry must be updated. 
It is anticipated that for some substances the classifications will vary. Over time, it is expected 
that notifiers and registrants will agree on a single entry. 

Where  the  entries  differ,  enterprises  must  make  every  effort  to  agree  a  single  entry.  This 
reflects the principle of industry self-responsibility and enables authorities to focus resources 
on substances with properties of very high concern. 

The  information  to  be  included  in  the  inventory  is  set  out.  It  will  be  widely  available  as  a 
source of information on substances and will encourage industry to come to agreed entries. 

6. 

COMPETENT AUTHORITIES AND ENFORCEMENT 

Member  States  must  to  appoint  the  authorities  for  the  application  and  enforcement  of  this 
Regulation. Good cooperation between all competent authorities is essential. 

To bundle information on human health, as under current legislation, one body per Member 
State is responsible for receiving health-related information. 

Member  States  are  to  take  all  measures  necessary  to  ensure  correct  application  of  this 
Regulation. To enhance the exchange of practical experience, the Agency’s Forum established 
by the REACH Regulation shall also exchange enforcement information under this Regulation. 

Finally, Member States have to establish proportionate sanctions for non-compliance. 

7. 

COMMON AND FINAL PROVISIONS 

There are special rules on advertising, to avoid misleading customers. 

To be able to retrace their decisions taken in applying this Regulation, suppliers must keep the 
relevant  information,  together  with  any  information  they  are  required  to  keep  under  the 
REACH Regulation. Authorities may request this information. 

Similar to its role under REACH, the Agency’s Secretariat is to prepare guidance and tools for 
industry as well as guidance for authorities. 

Free movement of substances and mixtures that comply with the provisions of the Regulation 
is  guaranteed,  while  Member  States  are  enabled  to  address  risks  to  human  health  and  the 
environment by appropriate provisional measures. 

The  Commission  is  empowered  to  adapt  all  annexes  as  well  as  a  number  of  Articles  to 
technical  progress  through  a  Committee  procedure,  as  they  relate  to  scientific  and  technical 
matters and do not touch the fundamental rules of the Regulation. The Committee established 

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by  the  REACH  Regulation  shall  also  assist  the  Commission  under  this  Regulation.  The 
regulatory procedure with scrutiny has to be applied for adaptations to technical progress. For 
confirmation or refusal of the provisional measures taken under the safeguard clause and for 
fees,  the  ordinary  regulatory  procedure  will  be  applied,  as  such  decisions  do  not  involve 
changes to the Regulation. 

The findings of the analysis of the potential effects of the GHS Regulation on EU downstream 
legislation are reflected in the proposal. Directives 67/548/EEC and 1999/45/EC are replaced 
by this Regulation at the end of the last transitional period set out. References in Community 
legislation  to  those  Directives  and  their  provisions  and  classifications  will  be  replaced  by 
references  to  this  Regulation  through  separate  acts.  The  Regulation  specifies  which  hazard 
classes or categories trigger obligations under REACH; by doing so, it leaves the current scope 
of REACH intact. 

The obligations under this Regulation apply to the supply of substances. Not all duties apply 
when the Regulation first enters into force. As the classification of mixtures depends on the 
classification of substances, the new criteria will have to be applied first to substances, before 
they are applied to mixtures. 

The  deadline  for  mixtures  strikes  a  balance  between  avoiding  too  much  confusion  from  the 
use of a dual system during the transitional period and the need to allow enterprises sufficient 
time  to  manage  the  new  workload  arising  from  reclassifying  substances  and  mixtures  that 
have already been on the market in addition to those that are newly supplied. 

For  the  transitional  period,  maximum  flexibility  is  given  to  enterprises:  they  are  free  to  use 
either of the two systems. This will encourage enterprises to align to the new system in the 
most efficient way. 

For  some  hazard  classes  and  hazard  categories,  during  the  transitional  period  the  table  of 
equivalence which is provided may serve as a first orientation for the results that might follow 
from the application of the new criteria. 

Guidance provided to assist operators in fulfilling the obligations under this Regulation will 
include a table with references to the specific categories of danger and risk phrases according 
to  Directive 67/548/EEC  which  should  be  read  as  references  to  specific  hazard  classes, 
differentiations and hazard categories in this Regulation. 

8. 

ANNEXES 

Annex I 

Annex I includes a General Introduction (part 1), the hazard classes and criteria for physical, 
health 
replacing  Annex VI  of 
Directive 67/548/EEC, except for ozone depletion, which is placed in part 5. 

environmental  hazards 

(parts 2,  3 

and 4) 

and 

Annex II 

Part 1 includes the extra labelling provisions from Annex VI to Directive 67/548/EEC not yet 
covered by the GHS; part 2 contains special rules for labelling certain substances or mixtures, 
mainly from Annex V to Directive 1999/45/EC. Part 3 provides for child-proof fastenings and 

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tactile warnings retained from the current EU system. Part 4 contains a special labelling rule 
for plant protection products. 

Annex III 

The  list  of  hazard  statements  is  similar  to  Annex III  of  Directive 67/548/EEC.  Additional 
hazard statements are required for hazards not currently part of the GHS; thus, R-phrases from 
the current EU scheme were added as “EUH-statements”. 

Annex IV 

Rules for applying precautionary statements are given. The list of precautionary statements is 
similar to Annex IV of Directive 67/548/EEC. 

Annex V 

reproduces 
This 
Directive 67/548/EEC. 

the  GHS  hazard  pictograms  and 

is  similar 

to  Annex II  of 

Annex VI 

Part 3  is  a  list  of  substances  with  harmonised  classifications  for  specific  hazard  class(es)  or 
differentiation(s)  and  hazard  category/ies.  As  authorities  should  focus  on  substances  of  the 
highest  concern,  mainly  substances  classified  for  carcinogenicity,  germ  cell  mutagenicity  or 
reproductive toxicity Cat. 1A or 1B, and for respiratory sensitisation will be added, but other 
effects  can  be  added  if  justified.  Table 3.1  of  the  Annex  includes  the  entries  in  Annex I  of 
Directive 67/548/EEC, adapted where necessary to the GHS classification criteria, Table 3.2 
contains the unadapted entries taken over from Annex I of Directive 67/548/EEC. 

Annex VII 

This includes ”translation” tables for suppliers of substances and mixtures already evaluated 
under the current rules for those hazard categories where a simple equivalence exists. 

These tables provide an option for suppliers to fulfil their new obligations without having to 
make  an  ab  initio  reclassification  of  their  currently  self-classified  substances  and  mixtures. 
Should  a  supplier  choose  not  to  use  the  table,  he  must  re-evaluate  the substance  or  mixture 
using the criteria laid down in parts 2 to 5 of Annex I. 

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2007/0121 (COD) 

Proposal for a 

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

on classification, labelling and packaging of substances and mixtures, and amending 
Directive 67/548/EEC and Regulation (EC) No 1907/2006 

(Text with EEA relevance) 

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, 

Having  regard  to  the  Treaty  establishing  the  European  Community,  and  in  particular 
Article 95 thereof, 

Having regard to the proposal from the Commission17 

Having regard to the opinion of the European Economic and Social Committee18, 

Acting in accordance with the procedure laid down in Article 251 of the Treaty19, 

Whereas: 

(1) 

(2) 

(3) 

(4) 

This  Regulation  should  ensure  a  high  level  of  protection  of  human  health  and  the 
environment as well as the free movement of chemical substances and mixtures, while 
enhancing competitiveness and innovation. 

The  efficient  functioning  of  the  internal  market  for  substances  and  mixtures  can  be 
achieved only if requirements for substances and mixtures do not differ significantly 
from Member State to Member State. 

A high level of human health and environmental protection should be ensured in the 
approximation  of  legislation  on  classification  and  labelling  of  substances  and 
mixtures, with the goal of achieving sustainable development. 

Trade in substances and mixtures is not only an issue of the internal market, but also 
of  the  global  market.  Enterprises  should  therefore  benefit  from  the  global 
harmonisation of rules for the classification and labelling of substances and mixtures 
and  from  consistency  between,  on  the  one  hand,  the  rules  for  classification  and 
labelling for supply and use and, on the other hand, those for transport. 

(5)  With  a  view  to  facilitating  worldwide  trade  while  protecting  human  health  and  the 
environment,  harmonised  criteria  for  classification  and  labelling  of  substances  and 
mixtures  have  been  carefully  developed  over  a  period  of  12 years  within  the  United 

17 
18 
19 

OJ C 
OJ C 
OJ C 

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(6) 

(7) 

(8) 

Nations (UN) structure, resulting in the Globally Harmonised System of Classification 
and Labelling of Chemicals, hereinafter “the GHS”. 

This  Regulation  follows  various  declarations  whereby  the  Community  confirmed  its 
intention  to  contribute  to  the  global  harmonisation  of  criteria  for  classification  and 
labelling  for  substances  and  mixtures,  not  only  at  UN  level,  but  also  through  the 
incorporation of the internationally agreed GHS criteria into Community law. 

The  benefits  for  enterprises  will  increase  as  more  countries  in  the  world  adopt  the 
GHS  criteria  in  their  legislation.  The  Community  should  be  at  the  forefront  of  this 
process to encourage other countries to follow and to provide a competitive advantage 
to industry in the Community. 

Therefore it is essential to harmonise the provisions for the classification and labelling 
of  substances  and  mixtures  within  the  Community,  taking  into  account  the 
classification  criteria  and  labelling  rules  of  the  GHS,  but  also  by  building  on  the  40 
years  of  experience  obtained  through  implementation  of  existing  Community 
chemicals  legislation  and  maintaining  the  level  of  protection  achieved  through  the 
system  of  harmonisation  of  classification  and  labelling,  through  Community  hazard 
classes  not  yet  part  of  the  GHS  as  well  as  through  current  labelling  and  packaging 
rules. 

(9) 

This  Regulation  is  without  prejudice  to  the  full  and  complete  application  of  the 
Community competition rules. 

(10)  The  objective  of  this  Regulation  is  to  determine  which  properties  of  substances  and 
mixtures  should  lead  to  a  classification  as  hazardous,  in  order  for  suppliers  of 
substances  and  mixtures  to  properly  identify  and  communicate  the  hazards  of  their 
substances  and  mixtures.  Such  properties  should  include  physical  hazards  as  well  as 
hazards to human health and to the environment, including hazards for the ozone layer. 

(11)  This  Regulation  should,  as  a  general  principle,  apply  to  all  substances  and  mixtures 
supplied  in  the  Community,  except  where  other  Community  legislation  lays  down 
more specific rules on classification and labelling, such as Directive 76/768/EEC of 27 
July 1976 on the approximation of the laws of the Member States relating to cosmetic 
products20,  Council  Directive  82/471/EEC  of  30  June  1982  concerning  certain 
products used in animal nutrition21, Council Directive 88/388/EEC of 22 June 1988 on 
the approximation of the laws of the Member States relating to flavourings for use in 
foodstuffs  and  to  source  materials  for  their  production22,  Council  Directive 
89/107/EEC  of  21  December  1988  on  the  approximation of  the  laws of the  Member 
States concerning food additives authorized for use in foodstuffs intended for human 
consumption23, Council Directive 90/385/EEC of 20 June 1990 on the approximation 
of  the  laws  of  the  Member  States  relating  to  active  implantable  medical  devices24, 

20 

21 

22 
23 
24 

OJ  L  262,  27.9.1976.  Directive  as  last  amended  by  Commission  Directive  2005/80/EC  (OJ  L  303, 
22.11.2005, p. 32). 
OJ L 213, 21.7.1982, p. 8. Directive as last amended by Commission Directive 2004/116/EC (OJ L 379, 
24.12.2004, p. 81). 
OJ L 184, 15.7.1988, p. 61. Directive as last amended by Regulation (EC) No 1882/2003. 
OJ L 40, 11.2.1989, p. 27. Directive as last amended by Regulation (EC) No 1882/2003. 
OJ L 189, 20.7.1990, p. 17. 

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Council Directive 93/42/EEC of 14 June 1993 concerning medical devices25, Directive 
98/79 of the European Parliament and of the Council of 27 October 1998 on in vitro 
diagnostic medical devices26, Commission Decision 1999/217/EC of 23 February 1999 
adopting  a  register  of  flavouring  substances  used  in  or  on  foodstuffs  drawn  up  in 
application  of  Regulation  (EC)  No  2232/96  of  the  European  Parliament  and  of  the 
Council of 28 October 199627, Directive 2001/82/EC of the European Parliament and 
of  the  Council  of  6  November  2001  on  the  Community  code  relating  to  veterinary 
medicinal  products28,  Directive  2001/83/EC  of  the  European  Parliament  and  of  the 
Council of 6 November 2001 on the Community code relating to medicinal products 
for human use29, Regulation (EC) No 178/2002 of the European Parliament and of the 
Council  of  28  January  2002  laying  down  the  general  principles  and  requirements  of 
food  law,  establishing  the  European  Food  Safety  Authority  and  laying  down 
procedures  in  matters  of  food  safety30  and  Regulation  (EC)  No  1831/2003  of  the 
European Parliament and of the Council of 22 September 2003 on additives for use in 
animal nutrition31 or where substances and mixtures are transported and governed by 
Council Regulation (EEC) No 3922/91 of 16 December 1991 on the harmonisation of 
technical  requirements  and  administrative  procedures  in  the  field  of  civil  aviation32, 
Council Directive 94/55/EC of 21 November 1994 on the approximation of the laws of 
the Member States with regard to the transport of dangerous goods by road33, Council 
Directive 96/49/EC of 23 July 1996 on the approximation of the laws of the Member 
States  with  regard  to  the  transport  of  dangerous  goods  by  rail34  or  Directive 
2002/59/EC  of  the  European  Parliament  and  of  the  Council  of  27  June  2002 
establishing  a  Community  vessel  traffic  monitoring  and  information  system  and 
repealing Council Directive 93/75/EEC35. 

(12)  Although  ammunitions  are  not  covered  by  this  Regulation,  explosives  marketed  to 
produce an explosive or pyrotechnic effect may, through their chemical composition, 
present hazards to health. It is therefore necessary as part of a transparent information 
process  to  classify  them  in  accordance  with  the  provisions  of  the  Regulation,  as  this 
will  also  allow  to  label  them  in  accordance  with  the  international  rules  used  for  the 
transport of dangerous goods. 

(13)  The  terms  used  in  this  Regulation  should  be  consistent  with  those  set  out  in 
Regulation (EC) No 1907/2006  of  the  European  Parliament  and  of  the  Council  of 

25 

26 
27 

28 
29 
30 
31 

32 

33 

34 

35 

OJ  L  169,  12.7.1993,  p.  1.  Directive  as  last  amended  by  Regulation  (EC)  No  1882/2003  (OJ  L  284, 
31.10.2003, p. 1). 
OJ L 331, 7.12.1998, p. 1. Directive as last amended by Regulation (EC) No 1882/2003. 
OJ  L  84,  27.3.1999,  p.  1.  Decision  as  last  amended  by  Commission  Decision  2006/22/EC  (OJ  L  91, 
29.3.2006, p. 48). 
OJ L 311, 28.11.2001, p. 1. 
OJ L 311, 28.11.2001, p. 67. 
OJ L 31, 1.2.2002, p. 1. 
OJ L 268, 18.10.2003, p. 29. Regulation as last amended by Commission Regulation (EC) No 378/2005 
(OJ L 59, 5.3.2005, p. 8). 
OJ L 373, 31.12.1991, p. 4. Regulation as last amended by Regulation (EC) No 1899/20069 (OJ L 377, 
27.12.2006, p. 1). 
OJ L 319, 12.12.1994, p.7. Directive as last amended by Commission Directive 2006/89/EC (OJ L 305, 
4.11.2006, p. 4). 
OJ L 235, 17.9.1996, p. 25. Directive as last amended by Commission Directive 2006/90/EC (OJ L 305, 
4.11.2006, p. 6). 
OJ L 208, 5.8.2002, p. 10. 

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18 December 2006  concerning 
the  Registration,  Evaluation,  Authorisation  and 
Restriction  of  Chemicals  (REACH),  establishing  a  European  Chemicals  Agency, 
amending  Directive 1999/45/EC  of  the  European  Parliament  and  of  the  Council  and 
repealing  Council  Regulation  (EEC) No 793/93  and  Commission  Regulation  (EC) 
and  Commission 
No 1488/94 
Directives 91/155/EEC,  93/67/EEC,  93/105/EC  and 2000/21/EC36  and  with  the 
definitions specified at UN level in the GHS, in order to ensure maximum consistency 
in  the  application  of  chemicals  legislation  within  the  Community  in  the  context  of 
global  trade.  The  hazard  classes  specified  in  the  GHS  should  be  set  out  in  this 
Regulation for the same reason. 

as  Council  Directive 76/769/EEC 

as  well 

(14) 

It is especially appropriate to include those hazard classes defined in the GHS which 
specifically take account of the fact that the physical hazards which may be exhibited 
by substances and mixtures are to some extent influenced by the way in which they are 
released. 

(15)  This Regulation should replace 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  dangerous  substances37  as  well  as 
Directive 1999/45/EC of the European Parliament and of the Council of 31 May 1999 
concerning the approximation of the law, regulations and administrative provisions of 
the Member States relating to the classification, packaging and labelling of dangerous 
preparations38.  It  should  maintain  the  overall  current  level  of  protection  of  human 
health  and  the  environment  provided  by  those  Directives.  Therefore,  some  hazard 
classes  which  are  covered  by  those  Directives  but  are  not  yet  included  in  the  GHS, 
should  be  maintained  in  this  Regulation.  It  is  also  necessary  to  maintain  in  this 
Regulation the concept of “dangerous” as defined by those Directives, which does not 
include  those  hazard  classes  which  are  part  of  the  GHS  but  are  not  covered  by 
Directives  67/548/EEC  and  1999/45/EC,  to  minimise  effects  on  other  pieces  of 
Community legislation referring to that concept. 

(16)  Responsibility  for  the  identification  of  hazards  of  substances  and  mixtures  and  for 
deciding on their classification should mainly lie with the suppliers of those substances 
or mixtures, regardless of whether they are subject to the requirements of Regulation 
(EC) No 1907/2006. However, there should be a possibility to provide for harmonised 
classifications of substances for hazard classes of the highest concern which should be 
applied  by  all  suppliers  of  such  substances  and  of  mixtures  containing  such 
substances. 

(17) 

In  cases  of  a  decision  to  harmonise  the  classification  of  a  substance  for  a  specific 
hazard class or differentiation within a hazard class by including or revising an entry 
for  that  purpose  in  part  3  of  Annex VI  to  this  Regulation,  the  supplier  should  apply 
this  harmonised  classification,  and  only  self-classify  for  the  remaining,  non-
harmonised hazard classes or differentiations within the hazard class. 

36 
37 

38 

OJ L 396, 30.12.2006, p. 1. 
OJ  196,  16.8.1967,  p.  1.  Directive  as  last  amended  by  Regulation  (EC)  No  807/2003  (OJ  L  122, 
16.5.2003, p. 36). 
OJ  L  200,  30.7.1999,  p.  1.  Directive  as  amended  by  Commission  Directive 2001/60/EC  (OJ  L  226, 
22.8.2001, p. 5). 

EN 

17 

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(18)  To ensure that customers receive information on the hazards, manufacturers, importers 
and downstream users should package and label substances and mixtures according to 
the  classification  derived,  and  distributors  should  ensure  that  they  transfer  the 
information  received  by  either  leaving  the  labelling  unchanged  or  by  labelling  in 
accordance  with  this  Regulation  themselves.  Where  distributors  modify  the  label  or 
the packaging of substances or mixtures, they should also be subject to the obligation 
to  classify  the  substance  or  mixture  in  accordance  with  the  provisions  of  this 
Regulation. 

(19)  To  ensure  information  on  hazardous  substances  when  they  are  included  in  mixtures, 
mixtures  should  also  be  labelled,  where  appropriate,  when  they  contain  at  least  one 
substance  that  is  classified  as  hazardous,  even  if  the  mixtures  themselves  are  not 
classified as hazardous. 

(20)  While the supplier of any substance or mixture should not be obliged to generate new 
information  for  the  purpose  of  classification,  he  should  identify  all  relevant 
information available to him on the hazards of the substance or mixture and evaluate 
its  quality;  in  doing  so,  the  supplier  should  also  take  into  account  historical  human 
data,  such  as  epidemiological  studies  on  exposed  populations,  accidental  or 
occupational exposure and effect data and clinical studies. That information should be 
compared with the criteria for the different hazard classes and differentiations in order 
for him to arrive at a conclusion as to whether or not the substance or mixture should 
be classified as hazardous. 

(21)  While the classification of any substance or mixture may be carried out on the basis of 
available  information,  the  available  information  to  be  used  for  the  purposes  of  this 
of 
Regulation 
Regulation (EC) No 1907/2006,  transport  provisions  or  international  principles  or 
procedures for the validation of information, so as to ensure quality and comparability 
of the results and consistency with other requirements at international or Community 
level. The same should apply where the supplier chooses to generate new information. 

comply  with 

provisions 

preferably 

relevant 

should 

(22)  To  facilitate  the  hazard  identification  of  mixtures,  suppliers  should  base  this 
identification  on  the  data  for  the  mixture  itself,  where  available,  except  for  mixtures 
with  carcinogenic,  germ  cell  mutagenic,  reproductive  toxic  substances  or  sensitising 
properties  or  where  the  biodegradation  or  bioaccumulation  properties  in  the  hazard 
class  hazardous  to  the  aquatic  environment  are  evaluated.  In  those  cases,  as  the 
hazards of the mixture cannot be assessed sufficiently based on the mixture itself, the 
data for the individual substances of the mixture should normally be used as a basis for 
the hazard identification of the mixture. 

(23) 

If  sufficient  information  is  available  on  similar  tested  mixtures,  including  relevant 
ingredients of the mixtures, it is possible to determine the hazardous properties of an 
untested mixture by applying certain rules known as “bridging principles.” Those rules 
allow characterisation of the hazards of the mixture without performing tests on it, but 
rather by building on the available information on similar tested mixtures. Where no 
test  data  are  available  for  the  mixture  itself,  suppliers  should  therefore  follow  the 
bridging principles to ensure adequate comparability of results of the classification of 
such mixtures. 

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(24)  The protection of animals falling within the scope of Council Directive 86/609/EEC of 
24 November 1986  on  the  approximation  of  laws,  regulations  and  administrative 
provisions  of  the  Member  States  regarding  the  protection  of  animals  used  for 
experimental and other scientific purposes39 is of high priority. Accordingly, where the 
supplier chooses to generate information for the purposes of this Regulation, he should 
first  consider  means  other 
the  scope  of 
Directive 86/609/EEC.  

testing  on  animals  within 

than 

(25)  New information as regards physical hazards should always be necessary, except if the 

data are already available or if a derogation is foreseen in part 2. 

(26)  For the purpose of classification, data should not be generated by means of testing on 
humans  and  non-human  primates.  Available,  reliable  epidemiological  data  and 
experience  with  regard  to  the  effects  of  substances  and  mixtures  on  humans  (e.g. 
occupational data and data from accident databases) should be taken into account and 
be  given  priority  over  data  derived  from  animal  studies  when  they  demonstrate 
hazards not identified from those studies. Results of animal studies should be weighed 
against results of data from humans and expert judgement should be used to ensure the 
best protection of human health when evaluating both the animal and human data. 

(27)  Testing that is carried out for the sole purpose of this Regulation should be carried out 
on  the  substance  or  mixture  in  the  form  in  which  it  is  used  or  reasonably  can  be 
expected  to  be  used.  It  should,  however,  be  possible  to  use,  for  the  purpose  of  this 
Regulation,  the  results  of  tests  that  are  carried  out  to  comply  with  other  regulatory 
requirements, including those laid down by third countries, even if the tests were not 
carried  out  on  the  substance  or  mixture  in  the  form  in  which  it  is  used  or  can 
reasonably be expected to be used. 

(28)  The  criteria  for  classification  in  different  hazard  classes  and  differentiations  are  set 
forth in Annex I, which also contains additional provisions as to how the criteria may 
be met. 

(29)  Recognising  that  the  application  of  the  criteria  for  the  different  hazard  classes  to 
information is not always straightforward and simple, suppliers should apply weight of 
evidence determinations involving expert judgment to arrive at adequate results. 

(30)  Specific  concentration  limits  should  be  assigned  to  a  substance  by  a  supplier  in 
accordance with the criteria referred to in this Regulation, provided the supplier is able 
to  justify  the  limits  and  informs  the  European  Chemicals  Agency,  hereinafter  “the 
Agency”, accordingly. Guidance should be provided by the Agency for the purpose of 
setting  the  specific  concentration  limits.  In  order  to  ensure  uniformity,  specific 
concentration  limits  should  also  be  included,  where  appropriate,  in  cases  of 
harmonised classifications. Specific concentration limits should take precedence over 
any other concentration limit for the purpose of classification. 

(31)  For  reasons  of  proportionality  and  workability,  generic  cut-off  values  should  be 
defined,  both  for  impurities,  additives  and  individual  constituents  of  substances  and 

39 

OJ L 358, 18.12.1986, p.1. Directive as last amended by Directive 2003/65/EC (OJ L 230, 16.9.2003, 
p. 32). 

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for substances in mixtures, specifying when information on these should be taken into 
account in determining the hazard classification of substances and mixtures. 

(32)  To ensure adequate classification of mixtures, available information on synergistic and 

antagonistic effects should be taken into account for the classification of mixtures. 

(33)  Suppliers  should  re-evaluate  their  classifications  of  mixtures  if  they  change  the 
composition  of  their  mixtures  to  ensure  that  the  classification  is  based  on  up-to-date 
information,  unless  there  is  sufficient  evidence  that  the  classification  would  not 
change. Suppliers should also update the labels accordingly. 

(34)  Substances  and  mixtures  classified  as  hazardous  should  be  labelled  and  packaged 
according to their classification, so as to ensure appropriate protection and to provide 
essential information to their recipients, by drawing the attention to the hazards of the 
substance or mixture. 

(35)  The two components used to communicate the hazards of substances and mixtures are 
labels and the safety data sheets provided for in Regulation (EC) No 1907/2006. The 
label is the only tool for communication to consumers, but it may also serve to draw 
attention of workers to the more comprehensive information on substances or mixtures 
provided in safety data sheets. Since the provisions on safety data sheets are included 
in  Regulation (EC) No 1907/2006  which  uses  the  safety  data  sheet  as  the  main 
communication  tool  within  the  supply  chain  of  substances,  it  is  appropriate  not  to 
duplicate the same provisions in this Regulation. 

(36)  Workers and consumers worldwide would benefit from a globally harmonised hazard 
communication tool in the form of labelling. Therefore, the elements to be included in 
labels  should  be  specified  in  accordance  with  the  hazard  pictograms,  signal  words, 
hazard  statements  and  precautionary  statements  which  form  the  core  information  of 
the GHS system. Other information included in labels should be limited to a minimum 
and should not call into question the main elements. 

(37) 

It is essential that the substances and mixtures placed on the market be well identified, 
however,  the  Agency  should  allow  enterprises,  where  necessary,  to  describe  the 
chemical identity in a way that does not put the confidential nature of their businesses 
at risk. 

(38)  The  International  Union  of  Pure  and  Applied  Chemistry  (IUPAC)  is  a  long  standing 
global  authority  on  chemical  nomenclature  and  terminology.  Identification  of 
substances by their IUPAC name is widespread practice worldwide and provides the 
standard basis for identifying substances in an international and multilingual context. 
It is therefore appropriate to use these names for the purposes of this Regulation. 

(39)  The  Chemical  Abstracts  Service  (CAS)  provides  a  system  whereby  substances  are 
added to the CAS Registry and are assigned a unique CAS Registry Number.  Those 
CAS  numbers  are  used  in  reference  works,  databases,  and  regulatory  compliance 
documents  throughout  the  world  to  identify  substances  without  the  ambiguity  of 
chemical  nomenclature.  It  is  therefore  appropriate  to  use  the  CAS  numbers  for  the 
purposes of this Regulation. 

EN 

20 

   EN 

 
(40)  To  limit  the  information  on  the  label  to  the  most  essential  information,  principles  of 
precedence  should  determine  the  most  appropriate  label  elements  for  cases  in  which 
substances or mixtures possess several hazardous properties. 

(41)  The  labelling  rules  in  this  Regulation  should  be  without  prejudice  to  Council 
Directive 91/414/EEC  concerning  the  placing  of  plant  protection  products  on  the 
market40  and  Directive 98/8/EC  of  the  European  Parliament  and  of  the  Council 
concerning the placing of biocidal products on the market41. 

(42)  Rules  for  the  application  of  labels  and  the  location  of  information  on  labels  are 
necessary to ensure that the information on labels can be easily understood. Statements 
such as “non-toxic”, “non-harmful”, “non-polluting”, “ecological” or other statements 
inconsistent with the classification are therefore inappropriate and are not to appear on 
the labels of hazardous substances or mixtures. 

(43)  This  Regulation  should  set  general  packaging  standards,  in  order  to  ensure  the  safe 

supply of hazardous substances and mixtures. 

(44)  Resources of the authorities should be focused on substances of the highest concern. 
Provision  should  therefore  be  made  to  enable  competent  authorities  or  suppliers  to 
submit  proposals  to  the  Agency  for  a  harmonised  classification  of  substances 
classified  for  carcinogenicity,  germ  cell  mutagenicity  or  reproductive  toxicity 
categories 1A  or  1B,  for  respiratory  sensitisation,  or  in  respect  of  other  effects  on  a 
case-by-case  basis.  The  Agency  should  give  its  opinion  on  the  proposal  while 
interested  parties  should  have  an  opportunity  to  comment.  The  Commission  should 
decide on the final classification. 

(45) 

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  of  Directive  67/548/EEC,  all  existing  harmonised  classifications  should  be 
converted into new harmonised classifications using the new criteria. Moreover, as the 
applicability  of  this  Regulation  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  this 
Regulation. By subjecting all future harmonisations of classifications to the provisions 
of this Regulation, inconsistencies in harmonised classifications of the same substance 
under the existing and the new criteria should be avoided. 

(46) 

In order to achieve the functioning of the internal market for substances and mixtures, 
while  at  the  same  time  ensuring  a  high  level  of  protection  for  human  health  and  the 
environment,  rules  should  be  established  for  a  classification  and  labelling  inventory. 
The  classification  and  labelling  for  any  substance  placed  on  the  market  should 
therefore be notified to the Agency to be included in the inventory. 

40 

41 

OJ L 230, 19.8.1991, p. 1. Directive as last amended by Commission Directive 2007/6/EC (OJ L 43, 
15.2.2007, p. 13). 
OJ L 123, 24.4.1998, p. 1. Directive as last amended by Commission Directive 2006/140/EC (OJ L 414, 
30.12.2006, p. 78). 

EN 

21 

   EN 

 
                                                 
(47)  Different suppliers of the same substance should make every effort to agree on a single 
classification for that substance except for hazard classes and differentiations subject 
to a harmonised classification for that substance. 

(48)  To  ensure  a  harmonised  protection  for  the  general  public,  and,  in  particular,  for 
persons who come into contact with certain substances, and the proper functioning of 
other  Community  legislation  relying  on  classification  and  labelling,  an  inventory 
should  record  the  classification  in  accordance  with  this  Regulation  agreed  by 
manufacturers  and  importers  of  the  same  substance,  if  possible,  as  well  as  decisions 
taken  at  Community  level  to  harmonise  the  classification  and  labelling  of  some 
substances. 

(49)  The  information  included  in  the  classification  and  labelling  inventory  should  benefit 
from  the  same  degree  of  accessibility  and  protection  as  that  afforded  by  Regulation 
(EC) No 1907/2006, especially with regard to information which, if disclosed, risks to 
jeopardise the commercial interests of those concerned. 

(50)  Member  States  should  appoint  the  competent  authority  or  competent  authorities 
responsible  for  proposals  for  harmonised  classification  and  labelling  and  for  the 
enforcement of the obligations set out in this Regulation. Member States should put in 
place  effective  monitoring  and  control  measures  in  order  to  ensure  compliance  with 
this Regulation. 

(51) 

(52) 

In  order  for  the  system  established  by  this  Regulation  to  operate  effectively,  it  is 
important  that  there  should  be  good  co-operation  and  co-ordination  between  the 
Member States, the Agency and the Commission. 

In order to provide focal points for information on hazardous substances and mixtures, 
Member States should appoint bodies responsible for receiving information relating to 
health in addition to the competent authorities for the application and enforcement of 
this Regulation. 

(53)  Regular  reports  by  the  Member  States  and  the  Agency  on  the  operation  of  this 
Regulation  will  be  an  indispensable  means  of  monitoring  the  implementation  of 
chemicals legislation as well as trends in this field. Conclusions drawn from findings 
in  the  reports  will  be  useful  and  practical  tools  for  reviewing  the  Regulation  and, 
where necessary, for formulating proposals for amendments. 

(54)  The Forum for the exchange of information on enforcement in the Agency, established 
by  Regulation (EC) No 1907/2006,  should  also  exchange  information  about  the 
enforcement of this Regulation. 

(55) 

In  order  to  ensure  transparency,  impartiality  and  consistency  in  the  level  of 
enforcement activities by Member States, it is necessary for Member States to set up 
an  appropriate  framework  with  a  view  to  imposing  effective,  proportionate  and 
dissuasive penalties for non-compliance with this Regulation, as non-compliance can 
result in damage to human health and the environment. 

(56)  Rules should be laid down requiring advertisements for substances meeting the criteria 
for  classification  according  to  this  Regulation  to  mention  the  associated  hazards,  in 
order  to  protect  recipients  of  substances,  including  consumers.  Advertisements  for 

EN 

22 

   EN 

 
mixtures  classified  as  hazardous  should  mention  the  type  of  hazards,  for  the  same 
reason. 

(57)  A safeguard procedure should be foreseen to address situations where a substance or a 
mixture  constitutes  a  risk  for  human  health  or  the  environment,  even  if  it,  in 
compliance  with  this  Regulation,  is  not  classified  as  hazardous.  Should  such  a 
situation occur, action at the UN level may be necessary, in view of the global nature 
of trade in substances and mixtures. 

(58)  While  many 

of 

the 

obligations 

by 
Regulation (EC) No 1907/2006 are triggered by classification, this Regulation should 
not  alter  the  scope  and  impact  of  that  Regulation.  To  ensure  this,  this  Regulation 
maintains  the  concept  of  “dangerous”  as  defined  by  Directives 67/548/EEC  and 
1999/45/EC. 

established 

enterprises 

on 

(59) 

It  is  appropriate  to  provide  for  a  deferred  applicability  of  this  Regulation  so  that  a 
smooth transition to the new system may be ensured. Moreover, this should allow all 
parties involved, authorities, enterprises as well as stakeholders, to focus resources in 
the  preparation  for  new  duties  at  the  right  times.  Therefore,  and  because  the 
classification  of  mixtures  depends  on  the  classification  of  substances,  the  provisions 
for the classification of mixtures should only be applied after the reclassification of all 
substances.  If  operators  choose  to  apply  the  classification  criteria  contained  in  this 
Regulation earlier on a voluntary basis, this should be allowed, but to avoid confusion 
the labelling should in that case comply with the provisions of this Regulation instead 
of the provisions of Directives 67/548/EEC or 1999/45/EC. 

(60)  To  avoid  unnecessary  burdens  on  enterprises,  substances  and  mixtures  which  are 
already  going  through  the  supply  chain  when  the  labelling  provisions  of  this 
Regulation become applicable to them, should not be required to be relabelled. 

(61)  Since  the  objectives  of  this  Regulation,  namely  harmonising  the  classification, 
labelling and packaging rules for substances and mixtures, providing an obligation to 
classify and establishing a harmonised list of substances classified at Community level 
as  well  as  a  classification  and  labelling  inventory  cannot  be  sufficiently  achieved  by 
the  Member  States  and  can  therefore  be  better  achieved  at  Community  level,  the 
Community  may  adopt  measures,  in  accordance  with  the  principle  of  subsidiarity  as 
set out in Article 5 of the Treaty. In accordance with the principle of proportionality, 
as set out in that Article, this Regulation does not go beyond what is necessary in order 
to achieve those objectives. 

(62)  The  Regulation  observes 

the  fundamental  rights  and  principles  which  are 
acknowledged  in  particular  in  the  Charter  of  Fundamental  Rights  of  the  European 
Union42. 

(63)  The measures necessary for the implementation of this Regulation should be adopted 
in  accordance  with  Council  Decision 1999/468/EC  of  28 June 1999  laying  down  the 
procedures for the exercise of implementing powers conferred on the Commission43. 

42 

OJ C 364, 18.12.2000, p. 1. 

EN 

23 

   EN 

 
                                                 
(64) 

In particular, power should be conferred on the Commission to adapt this Regulation 
to  technical  progress,  including  incorporating  amendments  made  at  UN  level  to  the 
GHS.  In  carrying  out  such  adaptations  to  technical  progress  the  biannual  working 
rhythm at UN level should be considered. Furthermore, powers should be conferred on 
the  Commission  for  the  purpose  of  deciding  on  the  harmonised  classification  and 
labelling  of  specific  substances.  Since  those  measures  are  of  general  scope  and  are 
designed to amend non-essential elements of this Regulation, they should be adopted 
in accordance with the regulatory procedure with scrutiny provided for in Article 5a of 
Decision 1999/468/EC. 

(65)  When,  on  imperative  grounds  of  urgency,  the  normal  time-limits  for  the  regulatory 
procedure with scrutiny cannot be complied with, the Commission should be able to 
use the urgency procedure provided for in Article 5a (6) of Decision 1999/468/EC for 
the adoption of adaptations to technical progress. 

(66)  The  Commission  should  also  for  the  purposes  of  this  Regulation  be  assisted  by  the 
Committee  established  by  Regulation (EC) No 1907/2006,  with  a  view  to  ensuring  a 
consistent approach to the updating of chemicals legislation, 

HAVE ADOPTED THIS REGULATION: 

TITLE I 
GENERAL ISSUES 

Article 1 
Subject matter and Scope 

1. 

This  Regulation  is  to  ensure  a  high  level  of  protection  of  human  health  and  the 
environment as well as the free movement of substances and mixtures as defined in 
points 1  and  2  of  Article 3  in  Regulation (EC) No 1907/2006  by  providing  for  the 
following: 

(a) 

harmonising  the  classification  of  substances  and  mixtures,  and  the  rules  on 
labelling and packaging for hazardous substances and mixtures; 

(b)  providing an obligation for suppliers to classify substances and mixtures; 

(c) 

providing  an  obligation  for  suppliers  to  notify  such  classifications  and  for 
registrants  to  submit  such  classifications  as  part  of  their  registrations  to  the 
European Chemicals Agency, hereinafter the Agency;  

(d) 

establishing  a  list  of  substances  with  their  harmonised  classifications  and 
labelling at Community level in part 3 of Annex VI; 

43 

OJ  L  184,  17.7.1999,  p.  23.  Decision  as  amended  by  Decision  2006/512/EC  (OJ  L200,  22.7.2006, 
p. 11). 

EN 

24 

   EN 

 
                                                                                                                                                         
(e) 

establishing  a  classification  and  labelling  inventory,  which  is  made  up  of  all 
notifications,  submissions  and  harmonised  classifications  referred  to  in 
points (c) and (d). 

2. 

This Regulation shall not apply to the following: 

(a) 

(b) 

(c) 

(d) 

radioactive  substances  and  mixtures  within 
Directive 96/29/Euratom44; 

the  scope  of  Council 

substances  and  mixtures  which  are  subject  to  customs  supervision,  provided 
that  they  do  not  undergo  any  treatment  or  processing,  and  which  are  in 
temporary  storage,  or  in  a  free  zone  or  free  warehouse  with  a  view  to  re-
exportation, or in transit; 

non-isolated 
Regulation (EC) No 1907/2006; 

intermediates  as  defined 

in  point 15(a)  of  Article 3 

in 

substances and mixtures for scientific research and development, which are not 
placed on the market, provided they are used under such controlled conditions 
minimising  exposure  as  if  they  were  classified  as  carcinogenic,  germ  cell 
mutagenic  or  toxic  to  reproduction  (CMR)  category 1A  or  1B  according  to 
Annex I. 

3. 

4. 

Waste  as  defined  in  Directive 2006/12/EC  of  the  European  Parliament  and  of  the 
Council45 is not a substance, mixture or article within the meaning of paragraph 1. 

This  Regulation  shall  not  apply  to  substances  and  mixtures  in  the  following  forms, 
which are in the finished state, intended for the final user: 

(a)  medicinal products as defined in Directive 2001/83/EC; 

(b)  veterinary medicinal products as defined in Directive 2001/82/EC; 

(c) 

cosmetic products as defined in Directive 76/768/EEC; 

(d)  medical  devices  as  defined  in  Directives 90/385/EEC  and  93/42/EEC,  which 
are  invasive  or  used  in  direct  physical  contact  with  the  human  body,  and  in 
Directive 98/79/EC; 

(e) 

food  or  feedingstuffs  as  defined  in  Regulation (EC) No 178/2002  including 
when they are used: 

(i) 

a 

food 
as 
Directive 89/107/EEC; 

additive 

in 

foodstuffs  within 

the 

scope 

of 

(ii) 

as  a  flavouring  in  foodstuffs  within  the  scope  of  Directive 88/388/EEC 
and Decision 1999/217/EC; 

44 
45 

OJ L 159, 29.6.1996, p. 1. 
OJ L 114, 27.4.2006, p. 9. 

EN 

25 

   EN 

 
                                                 
(iii)  as 

an 

additive 
Regulation (EC) No 1831/2003; 

in 

feeding 

stuffs  within 

the 

scope 

of 

(iv) 

in animal nutrition within the scope of Directive 82/471/EEC. 

5. 

Save where Article 19 applies, this Regulation shall not apply to cases governed by 
Regulation (EEC) No 3922/91, 
or 
Directive 2002/59/EC. 

Directive 94/55/EC, 

Directive 96/49/EC 

Article 2 
Definitions 

For the purpose of this Regulation, the definitions in points 1 to 14, the introductory phrase in 
point 15 and (a) of that point, points 23 and 24 of Article 3 of Regulation (EC) No 1907/2006 
shall apply.  

In addition, the following definitions shall apply: 

(1) 

(2) 

(3) 

(4) 

hazard class means the nature of the physical, health or environmental hazard; 

hazard  category  means  the  division  of  criteria  within  each  hazard  class,  specifying 
hazard severity; 

supplier means a manufacturer, importer, downstream user or distributor placing on 
the market a substance or a mixture; 

competent  authority  means  the  authority  or  authorities  or  bodies  established  by  the 
Member States to carry out the obligations arising from this Regulation. 

Alloys  as  defined  in  point 41  of  Article 3  in  Regulation (EC) No 1907/2006  shall  be 
considered as mixtures for the purposes of this Regulation. 

Article 3 
Hazardous substances and mixtures and specification of hazard classes 

1. 

A  substance  or  a  mixture  fulfilling  the  criteria  relating  to  physical  hazards,  health 
hazards or environmental hazards, laid down in parts 2 to 5 of Annex I is hazardous 
and shall be classified in relation to the respective hazard classes provided for in that 
Annex. 

Where,  in  the  case  of  the  hazard  classes  referred  to  in  sections 3.1,  3.4,  3.7,  3.8 
and 4.1  of  Annex I,  those  classes  are  differentiated  on  the  basis  of  the  route  of 
exposure or the nature of the effects, the substance or mixture shall be classified in 
accordance with such differentiation.  

2. 

A substance or mixture fulfilling the criteria for any of the following hazard classes 
or categories set out in Annex I is dangerous: 

(a) 

hazard classes 2.1 to 2.4, 2.6 and 2.7, 2.8 types A and B, 2.9, 2.10, 2.12, 2.13 
categories 1 and 2, 2.14 categories 1 and 2, 2.15 types A to F; 

EN 

26 

   EN 

 
(b)  hazard classes 3.1 to 3.6, 3.7 adverse effects on sexual function and fertility or 

on development, 3.8 effects other than narcotic effects, 3.9 and 3.10; 

(c) 

hazard class 4.1; 

(d)  hazard class 5.1. 

The Commission may develop further differentiations for hazard classes on the basis 
of  the  route  of  exposure  or  the  nature  of  the  effects  and  shall  amend  the  second 
subparagraph  of  paragraph 1  as  a  result.  Those  measures,  designed  to  amend  non-
essential  elements  of  this  Regulation,  shall  be  adopted  in  accordance  with  the 
regulatory procedure with scrutiny referred to in Article 54 (3). 

Article 4 
General obligation to classify, label and package 

Manufacturers, importers and downstream users shall classify substances or mixtures 
in accordance with Title II before placing them on the market. 

Where  a  substance  or  mixture  is  classified  as  hazardous,  it  shall  be  labelled  and 
packaged in accordance with Titles III and IV. 

For the purposes of this Regulation, the articles referred to in section 2.1 of Annex I 
shall be classified, labelled and packaged in accordance with the rules for substances 
and mixtures. 

Manufacturers,  producers  of  articles  and  importers  shall,  in  addition  to  the 
classification  provided  for  in  paragraph 1,  classify  substances  in  accordance  with 
Title II where 

(a)  Articles 6, 7 (1) or (5), 17 or 18 of Regulation (EC) No 1907/2006 provide for 

registration of a substance; 

(b)  Articles 7 (2) or 9 of Regulation (EC) No 1907/2006 provide for notification. 

Where a distributor modifies the original label or packaging provided by any of the 
actors  referred  to  in  paragraph 1  for  the  purpose  of  placing  a  substance  or  mixture 
classified as hazardous on the market, the distributor shall fulfil the requirements set 
out in Titles II, III and IV. 

In all other cases, the distributor shall ensure that the labelling or packaging provided 
by those operators is correct and unchanged. 

A mixture referred to in part 2 of Annex II not classified as hazardous but containing 
at  least  one  substance  classified  as  hazardous,  shall  not  be  placed  on  the  market, 
unless it is labelled in accordance with Title III. 

If a substance is subject to harmonised classification and labelling in accordance with 
Title V  through  an  entry  in  part 3  of  Annex VI,  the  supplier  shall  classify  that 
substance  in  accordance  with  that  entry,  and  a  classification  of  the  substance  in 

3. 

1. 

2. 

3. 

4. 

5. 

6. 

EN 

27 

   EN 

 
accordance  with  Title  II  shall  not  be  performed  for  the  hazard  classes  or 
differentiations covered by that entry. 

However,  where  the  substance  also  falls  within  one  or  more  hazard  classes  or 
differentiations  not  covered  by  an  entry  in  part 3  of  Annex VI,  classification  under 
Title II shall be carried out for those hazard classes or differentiations. 

TITLE II 
HAZARD CLASSIFICATION 

Chapter 1 
Identification and examination of Information 

Article 5 
Identification and examination of available information on substances 

1. 

The supplier of a substance shall identify the relevant available information for the 
purposes  of  determining  whether  the  substance  entails  a  physical,  health  or 
environmental hazard as set out in Annex I, and, in particular, the following: 

(a) 

data  generated  in  accordance  with  any  of  the  methods  referred  to  in 
Article 8 (3); 

(b) 

epidemiological data and experience on the effects on humans; 

(c) 

any  other  information  generated  in  accordance  with  section 1  of  Annex XI  to 
Regulation (EC) No 1907/2006. 

The  information  shall  relate  to  the  form  or  physical  state  in  which  the  substance  is 
used or can reasonably be expected to be used after it is placed on the market. 

The  supplier  shall  examine  the  information  referred  to  in  paragraph 1  to  ascertain 
whether  it  is  adequate  and  reliable  for  the  purpose  of  the  evaluation  pursuant  to 
Chapter 2. 

Article 6 
Identification and examination of available information on mixtures 

The  supplier  of  a  mixture  shall  identify  the  relevant  available  information  for  the 
purposes  of  determining  whether  the  mixture  entails  a  physical,  health  or 
environmental hazard as set out in Annex I, and, in particular, the following: 

(a) 

(b) 

data  generated  in  accordance  with  any  of  the  methods  referred  to  in 
Article 8 (3) on the mixture itself or the substances contained in it; 

epidemiological data and experience on the effects on humans for the mixture 
itself or the substances contained in it; 

2. 

1. 

EN 

28 

   EN 

 
(c) 

any  other  information  generated  in  accordance  with  section 1  of  Annex XI  to 
Regulation (EC) No 1907/2006  for  the  mixture  itself  or  the  substances 
contained in it. 

The information shall relate to the form or physical state in which the mixture is used 
or can reasonably be expected to be used after it is placed on the market. 

Subject to paragraphs 3 and 4, where the information referred to in paragraph 1(a) is 
available for  the  mixture  itself, and  the supplier has ascertained that information to 
be  adequate  and  reliable,  he  shall  use  that  information  for  the  purposes  of  the 
evaluation pursuant to Chapter 2. 

For  the  evaluation  of  mixtures  pursuant  to  Chapter 2  in  relation  to  the  ‘germ  cell 
mutagenicity’, ‘carcinogenicity’ and ‘reproductive toxicity’ hazard classes referred to 
in  sections 3.5.3.1,  3.6.3.1  and  3.7.3.1  of  Annex I,  the  supplier  shall  only  use  the 
relevant  available  information  referred  to  in  paragraph 1  for  the  substances  in  the 
mixture. 

Further, in cases where the available test data on the mixture itself demonstrate germ 
cell  mutagenic,  carcinogenic  or  toxic  to  reproduction  effects  which  have  not  been 
identified from the information on the individual substances, those data shall also be 
taken into account. 

the  evaluation  of  mixtures  pursuant 

the 
For 
‘biodegradation and bioaccumulation’ properties within the ‘hazardous to the aquatic 
environment’ hazard class referred to in section 4.1.2.8 of Annex I, the supplier shall 
only  use  the  relevant  available  information  referred  to  in  paragraph 1  for  the 
substances in the mixture. 

to  Chapter 2 

in  relation 

to 

Where  no  test  data  on  the  mixture  itself  of  the  kind  referred  to  in  paragraph 1  are 
available, the supplier shall use other available information on individual substances 
and similar tested mixtures which may also be considered relevant for the purposes 
of  determining  whether  the  mixture  is  hazardous,  provided  that  he  has  ascertained 
that  information  to  be  adequate  and  reliable  for  the  purpose  of  the  evaluation 
pursuant to Article 9(4). 

Article 7 
Animal and human testing 

Where new tests are carried out for the purposes of this Regulation, tests on animals 
within  the  meaning  of  Directive 86/609/EEC  shall  be  undertaken  only  where  no 
other alternatives are possible. 

Tests on humans and non-human primates shall not be performed for the purposes of 
this Regulation. 

2. 

3. 

4. 

5. 

1. 

2. 

EN 

29 

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1. 

2. 

3. 

Article 8 
Generating new information for substances and mixtures 

For the purposes of determining whether a substance or a mixture entails a health or 
environmental  hazard as  set  out in Annex I, the supplier may, provided that he  has 
exhausted all other means of generating information including by applying the rules 
provided  for  in  section 1  of  Annex XI  to  Regulation (EC) No 1907/2006,  perform 
new tests. 

For the purposes of determining whether a substance or a mixture entails any of the 
physical hazards referred to in part 2 of Annex I, the supplier shall perform the tests 
required in that part, unless the data resulting from those tests are already available. 

The tests referred to in paragraphs 1 and 2 shall be conducted in accordance with one 
of the following methods: 

(a) 

the  test  methods  in  the  fourth  revised  edition  of  the  United  Nations 
Recommendations on the Transport of Dangerous Goods (UN RTDG) Manual 
of Tests and Criteria ST/SG/AC.10/11/Rev.446; 

(b) 

the test methods referred to in Article 13 (3) of Regulation (EC) No 1907/2006; 

(c) 

in  respect  of  health  and  environmental  hazards  as  set  out  in  parts 3  and  4  of 
Annex I,  internationally  recognised  scientific  principles  or  methods  validated 
according to international procedures. 

Where  the  supplier  carries  out  new  ecotoxicological  or  toxicological  tests  and 
in  compliance  with  Article 13(4)  of 
analyses, 
Regulation (EC) No 1907/2006. 

they  shall  be  carried  out 

4. 

Tests that are carried out for the purposes of this Regulation, shall be carried out on 
the substance or on the mixture in the form in which it is used or reasonably can be 
expected to be used after it is placed on the market. 

Chapter 2 
Evaluation of Hazard Information and Decision on Classification 

Article 9 
Evaluation of hazard information for substances and mixtures 

The supplier of a substance or a mixture shall evaluate the information identified in 
accordance  with  Chapter 1  by  applying  to  it  the  criteria  for  classification  for  each 
hazard  class  or  differentiation  in  parts 2  to  5  of  Annex I,  so  as  to  ascertain  the 
hazards associated with the substance or mixture. 

OJ […] The text of the fourth revised edition of the UN RTDG Manual of Tests and Criteria will be 
published as soon as it is available in all official languages of the Community. 

1. 

46 

EN 

30 

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2. 

3. 

4. 

In  evaluating  available  test  data  for  a  substance  or  a  mixture  which  have  been 
obtained from test methods other than those referred to in Article 8 (3), the supplier 
shall compare the test methods employed with those indicated in that Article in order 
to determine whether the use of those test methods affects the evaluation referred to 
in paragraph 1. 

Where the criteria cannot be applied directly to available identified information, the 
supplier shall carry out an evaluation by applying a weight of evidence determination 
using  expert  judgement  in  accordance  with  section 1.1.1  of  Annex I,  weighing  all 
available  information  having  a  bearing  on  the  determination  of  the  hazards  of  the 
substance  or  the  mixture,  and  in  accordance  with  section 1.2  of  Annex XI  of 
Regulation (EC) No 1907/2006. 

Where only the information referred to in Article 6(5) is available, the supplier shall 
apply the bridging principles referred to in section 1.1.3 and in each section of parts 3 
and 4 of Annex I for the purposes of the evaluation. 

However,  where  that  information  does  not  permit  the  application  of  the  bridging 
principles, the supplier shall evaluate the information by applying the other method 
or methods described in each section of parts 3 and 4 of Annex I. 

Article 10 
Specific concentration limits and multiplying factors for classification of substances and 
mixtures 

1. 

2. 

3. 

Subject to paragraph 3, specific concentration limits whereby a threshold is indicated 
on or over which the presence of that substance in another substance or in a mixture 
as an impurity, additive or individual constituent may lead to the classification of the 
substance  or  mixture  as  hazardous  may  be  set  by  the  supplier  in  the  following 
situations: 

(a)  where  information  shows  that  the  hazard  of  a  substance  is  evident  when  it  is 
present at a level below the concentrations set for any hazard class in part 2 of 
Annex I  or  below  the  generic  concentration  limits  set  for  any  hazard  class  in 
parts 3 to 5 of Annex I; 

(b) 

in  exceptional  cases,  where  information  shows  that  a  substance  classified  as 
hazardous is present at a level above the concentrations set for any hazard class 
in  part 2  of  Annex I  or  above  the  generic  concentration  limits  set  for  any 
hazard  class  in  parts 3  to  5  of  that  Annex,  but  there  are  conclusive  data 
showing that the hazard of the substance is not evident. 

Subject  to  paragraph 3,  multiplying  factors,  hereinafter  referred  to  as  “m-factors”, 
describing the severity of acute aquatic toxicity shall be established by the supplier 
when the acute aquatic toxicity of the substance is below 1 mg/litre for determining 
the classification of a mixture for environmental hazards. 

Specific  concentration  limits  or  m-factors  shall  not  be  set  in  accordance  with 
paragraph 1  and  2  for  hazard  classes  or  differentiations  included  in  part 3  of 
Annex VI. 

EN 

31 

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4. 

5. 

In  setting  the  specific  concentration  limit  or  m-factor  the  supplier  shall  take  into 
account any specific concentration limits or m-factors for that substance which have 
been included in the classification and labelling inventory. 

Specific  concentration  limits  set  in  accordance  with  paragraph  1  shall  take 
precedence  over  the  concentrations  in  the  relevant  sections  of  part  2  of  Annex  I  or 
the generic concentration limits for classification in the relevant sections of parts 3 to 
5 of Annex I. 

6. 

The Agency shall provide further guidance for the application of paragraphs 1 and 2. 

Article 11 
Cut-off values 

1. 

2. 

3. 

Where  a  substance  contains  another  substance,  classified  as  hazardous  itself,  in  the 
form  of  an  impurity,  additive  or  individual  constituent,  this  information  shall  be 
taken  into  account  for  the  purposes  of  classification,  if  the  concentration  of  the 
impurity, additive or individual constituent is equal to or greater than its cut-off value 
referred to in paragraph 3. 

Where a mixture contains a substance classified as hazardous, either as a component 
or in the form of an impurity or additive, this information shall be taken into account 
for the purposes of classification, if the concentration of that substance is equal to or 
greater than its cut-off value referred to in paragraph 3. 

The  cut-off  value  referred  to  in  paragraphs 1  and  2  shall  be  the  lower  of  the 
following: 

(a) 

the generic cut-off values specified in Table 1.1 of part 1 of Annex I; 

(b) 

(c) 

any  specific  concentration  limits  set  in  part 3  of  Annex VI  or  in  the 
classification and labelling inventory referred to in Article 43; 

any concentrations in the relevant sections of part 2 of Annex I or any generic 
concentration limits for classification in the relevant sections of parts 3 to 5 of 
Annex I, where the specific concentration limits referred to in point b are not 
available. 

Article 12 
Specific cases requiring further evaluation 

Where, as a result of the evaluation carried out pursuant to Article 9, the following properties 
or  effects  are  identified,  the  supplier  shall  take  them  into  account  for  the  purposes  of 
classification: 

(a) 

where  adequate  and  reliable  information  demonstrates  that  in  practice  the  physical 
properties  of  a  substance  or  a  mixture  other  than  an  organic  peroxide  differ  from 
those shown by tests; 

EN 

32 

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(b) 

(c) 

where  conclusive  experimental  data  show  that  the  substance  or  mixture  is  not 
biologically  available  and  those  data  have  been  ascertained  to  be  adequate  and 
reliable; 

where  adequate  and  reliable  information  demonstrates  the  potential  occurrence  of 
synergistic  or  antagonistic effects among the substances  in a  mixture for which the 
evaluation  was  decided  on  the  basis  of  the  information  for  the  substances  in  the 
mixture.  

Article 13 
Decision to classify substances and mixtures 

If  the  evaluation  undertaken  pursuant  to  Article 9  and  Article 12  shows  that  the  hazards 
associated  with  the  substance  or  mixture  meet  the  criteria  for  classification  in  one  or  more 
hazard  classes  or  differentiations  in  parts 2  to  5  of  Annex I,  the  supplier  shall  classify  the 
substance or mixture in relation to the relevant hazard class or classes or differentiations by 
assigning the following: 

(a) 

(b) 

one or more hazard categories for each relevant hazard class or differentiation; 

subject  to  Article 21,  one  or  more  hazard  statements  corresponding  to  each  hazard 
category assigned in accordance with (a). 

Article 14 
Specific rules for the classification of mixtures 

1. 

The  classification  of  a  mixture  shall  not  be  affected  where  the  evaluation  of  the 
information indicates any of the following: 

(a) 

(b) 

(c) 

that  the  substances  in  the  mixture  react  slowly  with  atmospheric  gases,  in 
particular oxygen, carbon dioxide, water vapour, to form different substances; 

that the substances in the mixture react very slowly with other substances in the 
mixture to form different substances; 

that  the  substances  in  the  mixture  may  self-polymerize  to  form  oligomers  or 
polymers. 

2. 

A mixture need not be classified for explosive, oxidising, or flammable properties as 
referred to in part 2 of Annex I provided that any of the following requirements are 
met: 

(a) 

(b) 

none  of  the  substances  in  the  mixture  possesses  such  properties  and,  on  the 
basis  of  the  information  available  to  the  supplier,  the  mixture  is  unlikely  to 
present hazards of this kind; 

in the event of a change in the composition of a mixture of known composition, 
scientific  evidence  indicates  that  an  evaluation  of  the  information  on  the 
mixture will not lead to a change in classification; 

EN 

33 

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(c)  where a mixture is placed on the market in the form of an aerosol, it satisfies 

the provisions of Article 9a of Council Directive 75/324/EEC47. 

Article 15 
Review of classification for substances and mixtures 

Subject to paragraph 3, where the supplier of a substance or mixture may reasonably 
be expected to have become aware of new scientific or technical information that he 
has  ascertained  to  be  adequate  and  reliable  for  the  purposes  of  the  evaluation 
pursuant  to  this  Chapter  and  that  warrants  a  change  in  the  classification  of  the 
substance  or  mixture,  he  shall  carry  out  a  new  evaluation  of  that  information  in 
accordance with this Chapter. 

Where  the  supplier  introduces  a  change  to  a  mixture  of  a  known  composition,  that 
has been classified as hazardous, he shall carry out a new evaluation in accordance 
with this Chapter where the change is either of the following: 

(a) 

(b) 

a change in the composition of the initial concentration of one or more of the 
hazardous constituents in concentrations above the limits in Table 1.2 of part 1 
of Annex I; 

a  change  in  the  composition  involving  the  substitution  or  addition  of  one  or 
more constituents in concentrations which meet the cut-off value referred to in 
Article 11 (3). 

Where 
Directive 98/8/EC the first subparagraph shall not apply. 

the  mixture  concerned 

is  covered  by  Directive 91/414/EEC  or 

A new evaluation in accordance with paragraphs 1 and 2 shall not be required if there 
is valid scientific justification that this will not result in a change of classification. 

The  supplier  shall  adapt  the  classification  of  the  substance  or  the  mixture  in 
accordance with the results of the new evaluation. 

Article 16 
Classification of substances included in the classification and labelling inventory 

A  supplier  may  classify  a  substance  differently  from  the  classification  already 
included  in  the  classification  and  labelling  inventory,  provided  he  submits  the 
reasons  for  his  classification  to  the  Agency  together  with  the  notification  in 
accordance with Article 41. 

Paragraph 1  shall  not  apply  if  the  classification  included  in  the  classification  and 
labelling inventory is a harmonised classification included in part 3 of Annex VI. 

1. 

2. 

3. 

4. 

1. 

2. 

47 

OJ L 147, 9.6.1975, p.40. 

EN 

34 

   EN 

 
 
                                                 
TITLE III 
HAZARD COMMUNICATION IN FORM OF LABELLING 

Chapter 1 
Content of the Label 

Article 17 
General rules 

1. 

A  substance  or  mixture  classified  as  hazardous  shall  bear  a  label  including  the 
following elements: 

(a) 

the name, address and telephone number of the supplier; 

(b) 

the nominal quantity of a substance or mixture in the packages made available 
to  the  general  public,  unless  this  quantity  is  specified  elsewhere  on  the 
package; 

(c) 

product identifiers in accordance with Article 18; 

(d)  where appropriate, hazard pictograms in accordance with Article 19; 

(e)  where appropriate, signal words in accordance with Article 20; 

(f)  where appropriate, hazard statements in accordance with Article 21; 

(g)  where appropriate, precautionary statements in accordance with Article 22; 

(h)  where appropriate, a section for supplemental information in accordance with 

Article 27. 

2. 

Member  States  may  require  the  use  of  their  official  language  or  languages  on  the 
label when substances and mixtures covered by this Regulation are made available to 
the end user within their territories. 

Suppliers may use more languages on their labels than those required by the Member 
States, provided that the same particulars appear in all languages used. 

Article 18 
Product identifiers 

1. 

The  label  shall  include  details  permitting  the  identification  of  the  substance  or 
mixture, hereinafter “product identifiers”. 

The term used for identification of the substance or mixture shall be the same as that 
used  in  the  safety  data  sheet  drawn  up  in  accordance  with  Article 31  of 
Regulation (EC) No 1907/2006. 

EN 

35 

   EN 

 
2. 

The product identifier for a substance shall consist of at least the following: 

(a) 

(b) 

(c) 

if the substance is included in part 3 of Annex VI, a name and an identification 
number as given therein; 

if  the  substance  is  not  included  in  part 3  of  Annex VI,  but  appears  in  the 
classification and labelling inventory, a name and an identification number as 
given therein; 

if the substance is not included in part 3 of Annex VI nor in the classification 
and  labelling  inventory,  the  number  provided  by  the  Chemical  Abstracts 
Service, hereinafter “the CAS number”, together with the name set out in the 
nomenclature  provided  by  the  International  Union  of  Pure  and  Applied 
Chemistry,  hereinafter  “the  IUPAC  Nomenclature”,  or  the  CAS  number 
together with another international chemical name; 

(d) 

if  the  CAS  number  is  not  available,  the  name  set  out  in  the  IUPAC 
Nomenclature or another international chemical name. 

Where  the  name  in  the  IUPAC  nomenclature  exceeds  100 characters,  a  common 
name  may  be  used  provided  that  the  notification  in  accordance  with  Article 41 
includes both the name in the IUPAC Nomenclature and the common name used. 

3. 

The product identifier for a mixture shall consist of both of the following: 

(a) 

the trade name or the designation of the mixture; 

(b) 

the  identity  of  all  substances  in  the  mixture  that  contribute  to  acute  toxicity, 
skin corrosion or serious eye damage, germ cell mutagenicity, carcinogenicity, 
reproductive toxicity, respiratory or skin sensitisation, or specific target organ 
toxicity (STOT). 

Where,  in  the  case  referred  to  in  (b),  that  requirement  leads  to  the  provision  of 
multiple  chemical  names,  a  maximum  of  four  chemical  names  shall  suffice,  unless 
necessary as a consequence of the severity of the hazards. 

The chemical names selected shall identify the substances primarily responsible for 
the major health hazards which have given rise to the classification and the choice of 
the corresponding hazard statements. 

Article 19 
Hazard pictograms 

1. 

2. 

The  label  shall  include  the  relevant  hazard  pictograms  consisting  of  a  symbol 
together with other graphic elements, intended to convey specific information on the 
hazard concerned. 

Hazard pictograms shall fulfil the requirements laid down in section 1.2.1 of Annex I 
and in Annex V. 

EN 

36 

   EN 

 
3. 

4. 

The hazard pictogram relevant for each specific classification is set out in the tables 
indicating  the  label  elements  required  for  each  hazard  class  in  parts 2,  3  and  4  of 
Annex I. 

The  Commission  may  set  hazard  pictograms  for  other  hazard  classes  than  those 
referred  to  in  paragraph 3.  Those  measures,  designed  to  amend  non-essential 
elements  of  this  Regulation,  shall  be  adopted  in  accordance  with  the  regulatory 
procedure with scrutiny referred to in Article 54 (3). 

Article 20 
Signal words 

The following signal words shall be used on the label: 

(a) 

(b) 

‘danger’, indicating the more severe hazard categories; 

‘warning’, indicating the less severe hazard categories. 

Where the signal word ‘danger’ is used on the label, the word ‘warning’ shall not appear on 
the label. 

The signal word relevant for each specific classification is set out in the tables indicating the 
label elements required for each hazard class in parts 2 to 5 of Annex I. 

Article 21 
Hazard statements 

1. 

2. 

The  label  shall  include  the  relevant  hazard  statements  describing  the  nature  of  the 
hazards  of  a  hazardous  substance  or  mixture,  including,  where  appropriate,  the 
degree of hazard. 

The hazard statement relevant for each specific classification is set out in the tables 
indicating the label elements required for each hazard class in parts 2 to 5 of Annex I. 

However, where a substance is included in part 3 of Annex VI, the hazard statement 
relevant for each specific classification covered by the entry in that part shall be used 
on the label, together with the hazard statements referred to in the first subparagraph 
for any classification not covered by that entry. 

3. 

The hazard statements shall be worded in accordance with Annex III. 

Article 22 
Precautionary statements 

1. 

The label shall include the relevant precautionary statements, whereby a description 
is  provided  in  the  form  of  a  phrase  or  pictogram  of  the  measure  or  measures 
recommended  to  minimise  or  prevent  adverse  effects  resulting  from  exposure  to  a 
hazardous substance or mixture due to its use. 

EN 

37 

   EN 

 
 
2. 

3. 

4. 

The precautionary statement relevant for each specific classification is set out in the 
tables indicating the label elements required for each hazard class in parts 2 to 5 of 
Annex I. 

However,  where  a  substance  is  included  in  part 3  of  Annex VI,  the  precautionary 
statements relevant for each specific classification covered by the entry in that part 
shall be used on the label, together with the precautionary statements referred to in 
the first subparagraph for any specific classification not covered by that entry. 

The  precautionary  statements  shall  be  selected  in  accordance  with  the  criteria  laid 
down  in  part 1  of  Annex IV  taking  into  account  the  hazard  statements  and  the 
intended or identified use or uses of the substance or the mixture. 

The  precautionary  statements  shall  be  worded  in  accordance  with  part 2  of 
Annex IV. 

Article 23 
Specific rules relating to classification in accordance with part 5 of Annex I 

Where a substance or mixture is classified in accordance with part 5 of Annex I the following 
shall apply: 

(a) 

(b) 

a hazard pictogram shall not be included on the label; 

the signal words, hazard statements and precautionary statements shall be placed in 
the supplemental information section as referred to in Article 27. 

Article 24 
Specific rules relating to mixtures not classified as hazardous 

A  mixture  not  classified  as  hazardous  but  containing  at  least  one  substance  classified  as 
hazardous shall be labelled in accordance with part 2 of Annex II. 

The statements shall be worded in accordance with part 3 of Annex III. 

The  label  shall  also  include  the  product  identifier  referred  to  in  Article 18  and  the  name, 
address  and  telephone  number  of  the  manufacturer,  importer  or  downstream  user  of  the 
mixture concerned. 

Article 25 
Specific rules relating to certain packaging and certain substances and mixtures 

1. 

The specific provisions on labelling laid down in section 1.3 of Annex I shall apply 
in respect of the following: 

(a)  mobile gas cylinders; 

(b)  gas containers intended for propane, butane or liquefied petroleum gas; 

EN 

38 

   EN 

 
 
(c) 

aerosols  and  containers  fitted  with  a  sealed  spray  attachment  and  containing 
substances classified as presenting an aspiration hazard; 

(d)  metals  in  massive  form,  alloys,  mixtures  containing  polymers,  mixtures 

containing elastomers; 

(e) 

explosives, as referred to in point (c) of section 2.1 of Annex I, placed on the 
market with a view to obtaining an explosive or pyrotechnic effect. 

The  Commission  may  add  further  packaging,  substances  or  mixtures  to  those 
referred  to  in  paragraph 1  to  which  specific  provisions  on  labelling  shall  apply. 
Those measures, designed to amend non-essential elements of this Regulation, shall 
be adopted in accordance with the regulatory procedure with scrutiny referred to in 
Article 54 (3). 

Article 26 
Request for confidentiality 

The supplier of a substance or a mixture may submit a request to the Agency to use a 
product identifier which refers to a substance or mixture either by means of a name 
that  identifies  the  most  important  functional  chemical  groups  or  by  means  of  a 
common  name,  where  he  can  demonstrate  that  the  disclosure  on  the  label  of  the 
chemical  identity  of  a  substance  or  mixture  puts  the  confidential  nature  of  his 
business, in particular his intellectual property rights, at risk  

Any  request  referred  to  in  paragraph 1  shall  be  made  in  the  format  referred  to  in 
Article 111 of Regulation (EC) No 1907/2006 and shall be accompanied by a fee. 

The level of the fees shall be determined by the Commission in accordance with the 
procedure referred to in Article 54 (2). 

The Agency may require further information from the supplier making the request if 
such information is necessary to take a decision. The Agency shall notify the person 
making  the  request of  its  decision within six weeks of the request or the receipt of 
further  required  information.  If  the  Agency  does  not  take  any  decision  within  the 
time specified, the use of the requested name is deemed to be allowed. 

Where  the  supplier  of  a  mixture,  before  1 June 2015,  has  demonstrated  under 
Article 15 of Directive 1999/45/EC  that the disclosure of the chemical identity of a 
substance puts the confidential nature of his business at risk, he can continue to use 
the approved alternative name for the purposes of this Regulation. 

Article 27 
Supplemental information on the label 

Statements shall be included in the section for supplemental information on the label 
where a substance or mixture classified as hazardous has the physical properties or 
health properties referred to in sections 1.1 and 1.2 of Annex II. 

2. 

1. 

2. 

3. 

4. 

1. 

EN 

39 

   EN 

 
2. 

3. 

The statements shall be worded in accordance with sections 1.1 and 1.2 of Annex II 
and part 2 of Annex III. 

A  statement  shall  be  included  in  the  section  for  supplemental  information  on  the 
label where a substance or mixture classified as hazardous falls within the scope of 
Directive 91/414/EEC. 

The  statement  shall  be  worded  in  accordance  with  part 4  of  Annex II  and  part 3  of 
Annex III. 

The supplier may include supplemental information in the section for supplemental 
information on the label other than that referred to in paragraphs 1 and 2, provided 
that  that  information  does  not  make  it  more  difficult  to  identify  the  label  elements 
referred to in Article 17(1) (a) to (g) and that it provides further details and does not 
contradict  or  cast  doubt  on  the  validity  of  the  information  specified  by  those 
elements. 

Article 28 
Principles of precedence as regards the hazard pictograms 

1. 

If a substance or mixture is classified within several hazard classes or within several 
differentiations of one or more hazard classes, the following shall apply in respect of 
the hazard pictograms to be applied on the label: 

(a) 

(b) 

(c) 

(d) 

if  the  hazard  pictogram  “GHS01”  applies,  the  use  of  the  hazard  pictograms 
“GHS02” and “GHS03” shall be optional; 

if the hazard pictogram “GHS06” applies, the hazard pictogram “GHS07” shall 
not appear; 

if the hazard pictogram “GHS05” applies, the hazard pictogram “GHS07” shall 
not appear for skin or eye irritation; 

if the hazard pictogram “GHS08” applies, the hazard pictogram “GHS07” shall 
not appear for skin sensitisation or for skin and eye irritation. 

2. 

If a substance or mixture is classified within several differentiations of one or more 
hazard  classes,  the  label  shall  include  the  most  severe  hazard  pictogram  for  each 
hazard class concerned.  

In  cases  where  the  entry  included  in  part 3  of  Annex VI  for  the  substance 
corresponds  to  a  less  severe  hazard  category  than  that  resulting  from  the 
classification pursuant to Title II of that substance in relation to that hazard class, the 
label  shall  include  the  hazard  pictogram  corresponding  to  the  most  severe  hazard 
category. 

EN 

40 

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Article 29 
Principles of precedence as regards the hazard statements 

If a substance or mixture is classified both within several hazard classes and differentiations 
of  a  hazard  class,  all  hazard  statements  resulting  from  the  classification  shall  appear  on  the 
label, unless there is evident duplication or redundancy.  

Article 30 
Principles of precedence as regards the precautionary statements 

1. 

2. 

Where the selection of the precautionary statements results in certain precautionary 
statements  being  redundant  or  ambiguous  or  being  clearly  unnecessary  given  the 
specific substance, mixture or packaging, such statements shall be omitted from the 
label. 

Where  the  substance  or  mixture  is  sold  to  the  general  public,  one  precautionary 
statement  addressing  the  disposal  of  that  substance  or  mixture  shall  appear  on  the 
label, where appropriate. 

In  other  cases,  a  precautionary  statement  addressing  the  disposal  shall  not  be 
required, if it is clear that the disposal of the substance or mixture or the packaging 
does not present a hazard to human health or the environment. 

3. 

Not  more  than  six  precautionary  statements  shall  appear  on  any  label,  unless 
necessary as a consequence of the severity of the hazards. 

Article 31 
Exemptions from labelling for small or otherwise unsuitable packaging 

1. 

For packaging containing 125 ml or less, hazard and precautionary statements need 
not be indicated on the label, if the substance or mixture is classified as: 

(a)  Flammable Gas of category 2; 

(b)  Flammable Liquid of category 2 or 3; 

(c)  Flammable Solid of category 1 or 2; 

(d)  Substances which in contact with water emit Flammable Gases of categories 2 

or 3; 

(e)  Oxidising Liquid of category 2 or 3; 

(f)  Oxidising Solid of category 2 or 3; 

(g)  Acutely Toxic of category 4, if the substances or mixtures are not supplied to 

the general public; 

(h)  Skin Irritant of category 2; 

(i)  Eye Irritant of category 2; 

EN 

41 

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(j)  Acutely Aquatic Hazardous of category 1; 

(k)  Chronically Aquatic Hazardous of category 1,2, 3 and 4. 

2. 

Where  the  Commission  so  requests,  the  Agency  shall  prepare  and  submit  to  the 
Commission  draft  exemptions  from  the  obligations  to  label  provided  for  in 
Articles 17 and 34 as follows: 

(a)  where the packaging is either too small or otherwise unsuitable for affixing the 

label, the conditions for applying the label elements; 

(b)  where packaging contains a quantity other than 125 ml which does not entail a 
risk  to  workers  or  human  health  or  the  environment,  the  quantities  and  the 
appropriate  exemptions  from  the  labelling  requirements  for  substances  and 
mixtures classified as follows: 

(i) 

Flammable Gases; 

(ii)  Oxidising Gases; 

(iii)  Flammable Liquids ; 

(iv)  Flammable Solids ; 

(v)  Substances which in contact with water emit Flammable Gases; 

(vi)  Oxidising Liquids; 

(vii)  Oxidising Solids; 

(viii)  Acutely Toxic of category 4; 

(ix)  Skin Irritant of category 2; 

(x)  Eye Irritant of category 2; 

(xi)  Hazardous to the Environment. 

Article 32 
Exemption from labelling for substances and mixtures sold to the general public 

Packaging destined for the general public on which it is physically impossible to apply a label 
in accordance with Article 34, shall be exempted from the obligation to bear a label, provided 
that such packaging is accompanied by precise and clear instructions for use, including, where 
appropriate, instructions for its disposal, and provided that it contains substances or mixtures 
classified in accordance with the following hazard classes and categories in Annex I: 

(a) 

(b) 

(c) 

EN 

Section 3.1, acute toxicity category 1, 2 or 3; 

Section 3.2, skin corrosion category 1; 

Section 3.8, specific target organ toxicity (STOT) – single exposure category 1; 

42 

   EN 

 
(d) 

Section 3.9, specific target organ toxicity (STOT) – repeated exposure category 1. 

Article 33 
Updating information on labels 

The supplier of a substance or a mixture shall update the label without delay following any 
change to the classification and labelling of the substance or mixture. 

The  supplier  of  a  mixture  referred  to  in  Article 24  shall  update  the  label  without  delay 
following any change to the classification of the substance and the labelling of the mixture. 

This Article shall be without prejudice to Directives 91/414/EEC and 98/8/EC. 

Chapter 2 
Application of Labels 

Article 34 
General rules for the application of labels 

1. 

2. 

3. 

4. 

5. 

1. 

2. 

Labels shall be firmly affixed to one or more surfaces of the packaging immediately 
containing  the  substance  or  mixture  and  shall  be  readable  horizontally  when  the 
package is set down normally. 

The colour and presentation of any label shall be such that the hazard pictogram and 
its background stand out clearly from it. 

The label elements referred to in Article 17 (1) shall be clearly and indelibly marked. 
They shall stand out clearly from the background and be of such size and spacing as 
to be easily read. 

The shape and the size of a hazard pictogram as well as the dimensions of the label 
shall be as set out in section 1.2.1 of Annex I. 

A label shall not be required when the label elements referred to in Article 17 (1) are 
shown clearly on the packaging itself. In such cases, the requirements of this Chapter 
applicable to a label shall be applied to the information shown on the packaging. 

Article 35 
Location of information on the label 

The hazard pictograms, signal word, hazard statements and precautionary statements 
shall be located together on the label. 

The supplier may decide the order of the hazard and precautionary statements on the 
label, unless otherwise specified. 

EN 

43 

   EN 

 
3. 

4. 

5. 

6. 

1. 

2. 

The  supplemental  information  shall  be  placed  in  the  supplemental  information 
section as referred to in Article 27 and the location of that section shall not make it 
more difficult to identify the elements specified in Article 17 (1). 

In addition to its use in hazard pictograms, colour may be used on other areas of the 
label to implement special labelling requirements. 

Label  elements  resulting  from  the  requirements  provided  for  in Annex XVII  of 
Regulation  (EC)  No  1907/2006,  Article 16  of  Directive 91/414/EEC  and  Article 20 
of  Directive 98/8/EC  shall  be  placed  in  the  section  for  supplemental  label 
information referred to in Article 27. 

The Commission may adopt measures adding to paragraph 5 other Community acts 
requiring  additional  labelling  elements.  Those  measures,  designed  to  amend  non-
essential  elements  of  this  Regulation,  shall  be  adopted  in  accordance  with  the 
regulatory procedure with scrutiny referred to in Article 54 (3). 

Article 36 
Specific rules for labelling of outer packaging, inner packaging and single packaging 

Where both an outer and an inner packaging is used and the outer packaging does not 
bear  a  pictogram  in  accordance  with  rules  on  the  transport  of  dangerous  goods 
Directive 94/55/EC, 
provided 
Directive 96/49/EC or Directive 2002/59/EC, both the outer and the inner packaging 
shall be labelled in accordance with this Regulation. 

Regulation (EEC) No 3922/91, 

for 

in 

However, if the  outer packaging bears  a  pictogram in accordance with rules on the 
transport  of  dangerous  goods,  only  the  inner  packaging  shall  be  labelled  in 
accordance with this Regulation. 

In case of a single packaging, the packaging shall be labelled in accordance with this 
Regulation and in accordance with rules on the transport of dangerous goods referred 
to in paragraph 1. However, where those rules provide for a pictogram relating to the 
same hazard, the hazard pictogram resulting from the application of this Regulation 
shall  not  appear  on  the  packaging.  Moreover,  where  those  rules  provide  for  other 
label  elements,  the  corresponding  label  elements  resulting  from  the  application  of 
this Regulation shall not appear. 

TITLE IV 
PACKAGING 

Article 37 
Packaging 

1. 

Substances and mixtures classified as hazardous shall be contained in packaging that 
shall satisfy the following requirements: 

(a) 

the  packaging  shall  be  so  designed  and  constructed  that  its  contents  cannot 
escape, except in cases where other more specific safety devices are prescribed; 

EN 

44 

   EN 

 
(b) 

(c) 

the materials constituting the packaging and fastenings shall not be susceptible 
to  damage  by  the  contents,  or  liable  to  form  dangerous  compounds  with  the 
contents; 

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

(d)  packaging  in  the  form  of  containers  fitted  with  replaceable  fastening  devices 
shall be so designed that the container can be refastened repeatedly without the 
contents escaping. 

2. 

Packaging  in  the  form  of  containers  containing a hazardous substance  or a  mixture 
sold or made available to the general public shall not have either a shape or graphic 
decoration  likely  to  attract  or  arouse  the  active  curiosity  of  children  or  to  mislead 
consumers,  or  a  presentation  or  a  designation  used  for  foodstuff  or  animal  feeding 
stuff or medicinal or cosmetic products. 

Where such containers meet the requirements in section 3.1.1 of Annex II they shall 
have a child-resistant fastening in accordance with sections 3.1.2, 3.1.3 and 3.1.4.2 of 
Annex II. 

Where such containers meet the requirements in section 3.2.1 of Annex II they shall 
bear a tactile warning of danger in accordance with section 3.2.2 of Annex II. 

TITLE V 
HARMONISATION OF CLASSIFICATION AND LABELLING OF SUBSTANCES AND 
THE CLASSIFICATION AND LABELLING INVENTORY 

Chapter 1 
Establishing Harmonised Classification and Labelling of 
Substances 

Article 38 
Harmonisation of classification and labelling of substances 

1. 

A  substance  that  fulfils  the  criteria  set  out  in  Annex I  for  the  following  may  be 
subject to harmonised classification and labelling in accordance with Article 39: 

(a) 

respiratory sensitisation, section 3.4, category 1; 

(b)  germ cell mutagenicity, section 3.5, category 1A, 1B or 2; 

(c) 

carcinogenicity, section 3.6, category 1A, 1B or 2; 

(d) 

reproductive toxicity, section 3.7, category 1A, 1B or 2; 

EN 

45 

   EN 

 
2. 

1. 

2. 

3. 

4. 

5. 

Where a substance fulfils the criteria for other hazard classes or differentiations than 
those  referred  to  in  paragraph 1,  a  harmonised  classification  and  labelling  in 
accordance with Article 39 shall be possible on a case-by-case basis, if justification 
is provided demonstrating the need for such action at Community level. 

Article 39 
Procedure for harmonisation of classification and labelling of substances 

A competent authority of a Member State may submit to the Agency a proposal for 
harmonised  classification  and  labelling  of  substances  and,  where  appropriate, 
specific concentration limits or m-factors. 

The  proposal  shall  follow  the  format  set  out in  part 2  of  Annex VI  and  contain  the 
relevant information provided for in part 1 of Annex VI. 

A  supplier  of  a  substance  may  submit  to  the  Agency  a  proposal  for  harmonised 
classification  and  labelling  of  that  substance  and,  where  appropriate,  specific 
concentration  limits  or  m-factors,  provided  that  there  is  no  entry  in  part 3  of 
Annex VI  for  such  a  substance  in  relation  to  the  hazard  class  or  differentiation 
covered by that proposal.  

The proposal shall be drawn up in accordance with the relevant parts of sections 1, 2 
and 3 of Annex I to Regulation (EC) No 1907/2006 and it shall follow the format set 
out  in  part B  of  the  Chemical  Safety  Report  of  section 7  of  that  Annex.  It  shall 
contain  the  relevant  information  provided  for  in  part 1  of  Annex VI  to  this 
Regulation. Article 111 of Regulation (EC) No 1907/2006 shall apply.  

Where  the  proposal  of  the  supplier  concerns  the  harmonised  classification  and 
labelling of a substance in accordance with Article 38 (2), it shall be accompanied by 
the fee determined by the Commission in accordance with the procedure referred to 
in Article 54 (2). 

The  Committee  for  Risk  Assessment  of 
to 
Article 76 (1) (c)  of  Regulation (EC) No 1907/2006  shall  adopt  an  opinion  on  any 
proposal submitted pursuant to paragraphs 1 or 2 within 12 months of receipt of the 
proposal, giving the parties concerned the opportunity to comment. The Agency shall 
forward this opinion and any comments to the Commission. 

the  Agency  set  up  pursuant 

Where  the  Commission  finds  that  the  harmonisation  of  the  classification  and 
labelling  of  the  substance  concerned  is  appropriate,  it  shall,  within  6 months  of 
receipt of the opinion referred to in paragraph 4, include that substance together with 
the relevant classification and labelling elements in Table 3.1 of part 3 of Annex VI 
and, where appropriate, the specific concentration limits or m-factors. 

A corresponding entry shall be included in Table 3.2 of part 3 of Annex VI subject to 
the same conditions, until 31 May 2015. 

That measure, designed to amend non-essential elements of this Regulation, shall be 
adopted  in  accordance  with  the  regulatory  procedure  with  scrutiny  referred  to  in 
Article 54 (3).  On  imperative  grounds  of  urgency,  the  Commission  may  use  the 
urgency procedure referred to in Article 54 (4). 

EN 

46 

   EN 

 
Article 40 
Content of opinions and decisions for harmonised classification and labelling in Annex VI; 
accessibility of information 

1. 

Any opinion referred to in Article 39 (4) and any decision according to Article 39 (5) 
shall at least specify for each substance: 

(a) 

(b) 

the identity of the substance as specified in sections 2.1 to 2.3.4 of Annex VI to 
Regulation (EC) No 1907/2006; 

the  classification  of  the  substance  referred  to  in  Article 38,  including  a 
statement of reasons; 

(c) 

the specific concentration limits or m-factors, where applicable; 

(d) 

the labelling elements for the substance; 

(e) 

any  other  parameter  enabling  an  assessment  to  be  made  of  the  health  or 
environmental  hazard  of  mixtures  containing  the  hazardous  substance  in 
question or of substances containing such hazardous substances as impurities, 
additives and constituents, if relevant. 

2. 

The information referred to in Article 118(2) of Regulation (EC) No 1907/2006 shall 
not be disclosed in the opinion or in the decision referred to in Article 39(4) and (5) 
of  this  Regulation  respectively.  Article 119  of  Regulation (EC) No 1907/2006  shall 
apply. 

Chapter 2 
Notification of the Agency and Establishing the Classification and 
Labelling Inventory 

Article 41 
Obligation to notify the Agency 

1. 

Any  manufacturer  or  importer,  or  group  of  manufacturers  or  importers,  hereinafter 
“the  notifiers”,  who  places  on  the  market  a  substance  subject  to  registration  in 
accordance  with  Regulation (EC) No 1907/2006  or  a  substance  classified  as 
hazardous  on  its  own  or  in  a  mixture  above  the  concentration  limits  specified  in 
Directive  1999/45/EC  or  in  this  Regulation,  where  relevant,  which  results  in  the 
classification of the mixture as hazardous, shall notify  to the Agency the following 
information in order for it to be included in the inventory referred to in Article 43: 

(a) 

the identity of the notifier or notifiers responsible for placing the substance or 

substances  on 

the  market  as  specified 

in  section 1  of  Annex VI 

to 

Regulation (EC) No 1907/2006; 

(b) 

the identity of the substance or substances as specified in section 2.1 to 2.3.4 to 

Annex VI of Regulation (EC) No 1907/2006; 

EN 

47 

   EN 

 
(c) 

the classification of the substance or substances in accordance with Article 13; 

(d)  where  a  substance  has  been  classified  in  some  but  not  all  hazard  classes  or 

differentiations,  an 

indication  of  whether 

this 

is  due 

to 

lack  of 

data,inconclusive  data,  or  data  which  are  conclusive  although  insufficient  for 

classification; 

(e) 

specific concentration limits or m-factors, where applicable, in accordance with 

Article 10  of  this  Regulation  together  with  a  justification  using  the  relevant 

parts of sections 1, 2 and 3 of Annex I to Regulation (EC) No 1907/2006; 

(f) 

the  labelling  elements  for  the  substance  or  substances  in  accordance  with 

Title III of this Regulation. 

The information referred to in (a) to (e) shall not be notified, if it has been submitted 
to the Agency as part of a registration pursuant to Regulation (EC) No 1907/2006. 

The  manufacturer  or  importer  shall  submit  this  information  in  the  format  specified 
pursuant to Article 111 of Regulation (EC) No 1907/2006. 

2. 

3. 

The information listed in paragraph 1 shall be updated and notified to the Agency by 
the  notifier  or  notifiers  concerned  when,  pursuant  to  the  review  in  Article 15(1),  a 
decision to change the classification and labelling of the substance has been taken. 

For substances placed on the market before 1 December 2010, notifications shall be 
made in accordance with paragraph 1 before that date. 

Article 42 
Agreed entries 

Where the notification in Article 41 (1) results in different entries on the inventory referred to 
in  Article 43  for  the  same  substance,  the  notifiers  and  registrants  shall  make  every  effort  to 
come to an agreed entry to be included in the inventory. The notifiers shall inform the Agency 
accordingly. 

Article 43 
The classification and labelling inventory 

1. 

The  Agency  shall  establish  and  maintain  a  classification  and  labelling  inventory  in 
the form of a database. 

The information notified pursuant to Article 41 (1) shall be included in the inventory, 
as  well 
under 
Regulation (EC) No 1907/2006.  

registrations 

information 

submitted 

part 

as 

as 

of 

EN 

48 

   EN 

 
Information  in  the  inventory  which  corresponds  to  the  information  referred  to  in 
Article 119 (1)  of  Regulation (EC) No 1907/2006  shall  be  publicly  accessible.  The 
Agency shall grant access to the other information on each substance in the inventory 
to the notifiers and registrants who have submitted information on that substance in 
accordance with Article 29(1) of Regulation (EC) No 1907/2006. It shall grant access 
to such information to other parties subject to Article 118 of that Regulation. 

2. 

3. 

The  Agency  shall  update  the  inventory  when  it  receives  updated  information  in 
accordance with Article 41 (2) or Article 42. 

In  addition  to  the  information  referred  to  in  paragraph 1,  the  Agency  shall,  where 
appropriate, include the following information in each entry: 

(a)  whether,  in  respect  of  the  entry,  there  is  a  harmonised  classification  and 

labelling; 

(b)  whether,  in  respect  of  the  entry,  it  is  a  joint  entry  between  registrants  of  the 

same  substance  as  referred 

to 

in  Article 11 (1)  of  Regulation  (EC) 

No 1907/2006;  

(c)  whether  it  is  an  agreed  entry  of  two  or  more  notifiers  or  registrants  in 

accordance with Article 42; 

(d) 

if the entry differs from another entry on the inventory for the same substance. 

The  information  referred  to  in  (a)  shall  be  updated  where  a  decision  is  taken  in 
accordance with Article 39 (5). 

TITLE VI 
COMPETENT AUTHORITIES AND ENFORCEMENT 

Article 44 
Appointment of authorities and bodies 

Member States shall appoint the competent authority or competent authorities responsible for 
proposals  for  harmonised  classification  and  labelling  and  for  the  enforcement  of  the 
obligations set out in this Regulation. 

Member  States  shall  ensure  cooperation  and  coordination  of  all  authorities  competent  for 
legislation related to chemicals. 

EN 

49 

   EN 

 
Article 45 
Appointment of bodies responsible for receiving information relating to health 

Member States shall appoint a body or bodies responsible for receiving information 
by  the  suppliers,  including  chemical  composition  of  the  mixtures  placed  on  the 
market and classified or considered as hazardous on the basis of their health effects 
or on the basis of their physical effects. 

The  appointed  bodies  shall  provide  all  requisite  guarantees  for  maintaining  the 
confidentiality  of  the  information  received.  Such  information  may  only  be  used  to 
meet  medical  demand  by  formulating  preventative  and  curative  measures,  in 
particular in case of emergency. 

The information shall not be used for other purposes. 

The  appointed  bodies  shall  have  at  their  disposal  all  the  information  required  from 
the  suppliers  responsible  for  marketing  to  carry  out  the  tasks  for  which  they  are 
responsible. 

Article 46 
Enforcement and Reporting 

Member States shall take all necessary measures, including maintaining a system of 
official controls, to ensure that substances and mixtures are not placed on the market, 
unless  they  have  been  classified,  labelled  and  packaged  in  accordance  with  this 
Regulation. 

Member States shall submit a report to the Agency every 5 years by first July on the 
results of the official controls, and other enforcement measures taken. The first report 
shall  be  submitted  by  …  [3  years  after  entry  into  force].  The  Agency  shall  make 
those reports available to the Commission which shall take them into account for its 
report under Article 117 of Regulation (EC) No 1907/2006. 

The  Forum  referred  to  in  Article 76 (1) (f)  of  Regulation (EC) No 1907/2006  shall 
exchange information about the enforcement of this Regulation. 

1. 

2. 

3. 

1. 

2. 

3. 

Article 47 
Penalties for non-compliance 

Member  States  shall  lay  down  the  provisions  on  penalties  applicable  to  infringement  of  the 
provisions  of  this  Regulation  and  shall  take  all  measures  necessary  to  ensure  that  they  are 
implemented.  The  penalties  provided  for  must  be  effective,  proportionate  and  dissuasive. 
Member States shall notify those provisions to the Commission no later than eighteen months 
after  entry  into  force  of  this  Regulation  and  shall  notify  it  without  delay  of  any  subsequent 
amendment affecting them. 

EN 

50 

   EN 

 
TITLE VII 
COMMON AND FINAL PROVISIONS 

Article 48 
Advertisement 

1. 

2. 

1. 

2. 

1. 

Any  advertisement for  a  substance  classified as hazardous shall be prohibited if no 
mention is made therein of the hazard class or hazard category concerned. 

Any  advertisement  for  a  mixtures  classified  as  hazardous  or  covered  by  Article 24 
which  allows  a  member  of  the  general  public  to  conclude  a  contract  for  purchase 
without first being informed of those hazards through the label for that mixture shall 
mention the type or types of hazard indicated on the label. 

The  first  subparagraph  shall  be  without  prejudice  to  Directive 97/7/EC  of  the 
European Parliament and of the Council. 

Article 49 
Obligation to maintain information and requests for information 

Any  supplier  of  a  substance  or  mixture  shall  assemble  and  keep  available  all  the 
information  required  for  the  purposes  of  classification  and  labelling  under  this 
Regulation for a period of at least 10 years after he last supplied the substance or the 
mixture. 

The  supplier  shall  keep  this  information  together  with  the  information  required  in 
Article 36 of Regulation (EC) No 1907/2006. 

The competent authority of a Member State in which a supplier is established or the 
Agency  may  require  the  supplier  to  submit  any  information  referred  to  in  the  first 
subparagraph of paragraph 1 to it. 

However, where that information is available to the Agency as part of a registration 
pursuant  to  under  Regulation (EC) No 1907/2006  or  a  notification  pursuant  to 
Article 41  of  this  Regulation,  the  Agency  shall  use  that  information  and  the 
competent authority shall address itself to the Agency. 

Article 50 
Tasks of the Agency 

The Agency shall provide the Member States and the institutions of the Community 
with  the  best  possible  scientific  and  technical  advice  on  questions  relating  to 
chemicals which fall within its remit and which are referred to it in accordance with 
the provisions of this Regulation. 

2. 

The Secretariat of the Agency shall undertake the following tasks: 

(a) 

providing technical and scientific guidance and tools where appropriate for the 
operation of this Regulation by industry; 

EN 

51 

   EN 

 
(b)  providing technical and scientific guidance on the operation of this Regulation 

for Member State competent authorities. 

Article 51 
Free movement clause 

On  grounds  relating  to  the  classification,  labelling  or  packaging  of  substances  and  mixtures 
within the meaning of this Regulation, Member States shall not prohibit, restrict or impede the 
placing  on  the  market  of  substances  or  mixtures  which  comply  with  this  Regulation  and, 
where appropriate, with Community acts adopted in implementation of this Regulation. 

Article 52 
Safeguard Clause 

1. 

2. 

3. 

Where  a  Member  State  has  justifiable  grounds  for  believing  that  a  substance  or  a 
mixture, although satisfying the requirements of this Regulation, constitutes a risk to 
human  health  or  the  environment  due  to  reasons  of  classification,  labelling  or 
packaging,  it  may  take  appropriate  provisional  measures.  The  Member  State  shall 
immediately  inform  the  Commission,  the  Agency  and  the  other  Member  States 
thereof, giving the reasons for its decision. 

Within  60 days  of  receipt  of  the  information  from  the  Member  State,  the 
Commission in accordance with the regulatory procedure referred to in Article 54 (2) 
either authorise the provisional measure for a time period defined in the decision or 
require the Member State to revoke the provisional measure. 

In the case of an authorisation as referred to in paragraph 2, the competent authority 
of the Member State concerned shall in accordance with the procedure laid down in 
Article 39  submit  a  proposal  to  the  Agency  for  harmonised  classification  and 
labelling, within three months of the date of the Commission decision. 

Article 53 
Adaptations to technical progress 

The  Commission  may  adjust  and  adapt  Articles 12,  14,  23,  27  to  32  and  37 (2)  second  and 
third subparagraph and Annexes I to VII to technical progress. Those measures, designed to 
amend  non-essential  elements  of  this  Regulation,  shall  be  adopted  in  accordance  with  the 
regulatory  procedure  with  scrutiny  referred  to  in  Article 54 (3).  On  imperative  grounds  of 
urgency, the Commission may use the urgency procedure referred to in Article 54 (4). 

Article 54 
Committee procedure 

The  Commission  shall  be  assisted  by  the  Committee  instituted  by  Article 133  of 
Regulation (EC) No 1907/2006. 

Where reference is made to this paragraph, Article 5 of Decision 1999/468/EC shall 
apply, in compliance with Article 7 (3) and Article 8 thereof.  

52 

   EN 

1. 

2. 

EN 

 
3. 

4. 

The  period  provided  for  in  Article 5 (6)  of  Decision 1999/468/EC  shall  be  three 
months. 

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. 

Where  reference  is  made  to  this  paragraph,  Article 5a (1),  (2), (4)  and  (6),  and 
Article 7  of  Decision 1999/468/EC  shall  apply,  having  regard  to  the  provisions  of 
Article 8 thereof. 

Article 55 
Amendment to Directive 67/548/EEC 

Directive 67/548/EEC is amended as follows: 

(1) 

Article 4 is amended as follows: 

(a) 

paragraph 3 is replaced by the following: 

“3.  Where  an  entry  containing  the  harmonised  classification  and  labelling  for  a 
particular  substance  has  been  included  in  part 3  of  Annex VI  of  Regulation 
(EC)  No  …  of  the  European  Parliament  and  of  the  Council*,  the  substance 
shall  be  classified  in  accordance  with  that  entry  and  paragraphs 1  and  2  shall 
not apply to the danger categories covered by that entry.” 

(b)  paragraph 4 is deleted;  

* OJ L …,  

(2) 

in Article 5, paragraph 2 is replaced by the following: 

“2.  The  measures  in  the  first  subparagraph  of  paragraph 1  shall  apply  until  the 
substance  is  listed  in  part 3  of  Annex VI  of  Regulation (EC) No …  for  the  danger 
categories  covered  by  that  entry  or  until  a  decision  not  to  list  it  has  been  taken  in 
accordance with the procedure laid down in Article 39 of Regulation (EC) No ….”; 

(3) 

the text of Article 6 is replaced by the following: 

“Manufacturers,  distributors  and  importers  of  substances  which  appear  in  the 
EINECS  but  for  which  no  entry  has  been  included  in  part 3  of  Annex VI  of 
Regulation (EC) No … shall carry out an investigation to make themselves aware of 
the  relevant  and  accessible  data  which  exist  concerning  the  properties  of  such 
substances.  On  the  basis  of  this  information,  they  shall  package  and  provisionally 
label dangerous substances according to the rules laid down in Articles 22 to 25 and 
the criteria in Annex VI.”; 

(4) 

in Article 23, paragraph 2 is amended as follows: 

(a) 

in  point  (a),  the  words  “Annex I”  are  replaced  by  the  words  “part 3  of 
Annex VI to Regulation (EC) No …”; 

EN 

53 

   EN 

 
 
(b) 

(c) 

(d) 

(e) 

in  point  (c),  the  words  “Annex I”  are  replaced  by  the  words  “part 3  of 
Annex VI to Regulation (EC) No …”; 

in  point  (d),  the  words  “Annex I”  are  replaced  by  the  words  “part 3  of 
Annex VI to Regulation (EC) No …”; 

in  point  (e),  the  words  “Annex I”  are  replaced  by  the  words  “part 3  of 
Annex VI to Regulation (EC) No …”; 

in point (f), the words "Annex I" are replaced by the words “part 3 of Annex VI 
of Regulation (EC) No …”; 

(5) 

Annex I is deleted. 

Article 56 
Amendment to Regulation (EC) No 1907/2006 

Regulation (EC) No 1907/2006 is amended as follows: 

(1) 

Article 14 is amended as follows: 

(a) 

paragraph 2 is amended as follows:  

(i) 

point (b) is replaced by the following:   

"(b) the specific concentration limits and multiplying factors, hereinafter 
referred  to  as  “m-factors”,  that  have  been  set  in  part 3  of  Annex VI  to 
Regulation (EC) No …  of 
the 
Council*;”; 

the  European  Parliament  and  of 

(ii)  point (e) is replaced by the following:   

"(e)  the  specific  concentration  limits  and  m-factors  given  in  an  agreed 
entry  in  the  classification  and  labelling  inventory  established  under 
Title V of Regulation (EC) No …;”; 

(b) 

from 1 December 2010, in paragraph 4, the words "Directive 67/548/EEC" are 
replaced by "Regulation (EC) No …"; 

(c) 

from 1 June 2015, paragraph 2 is amended as follows: 

(i) 

points (a) and (b) are replaced by the following: 

“(a) 

the  applicable  concentrations  and  generic  concentration  limits 
defined  in  each  of  the  parts 1  to  5  of  Annex I  to  Regulation 
(EC) No … of the European Parliament and of the Council*;”; 

* OJ L … 

(b) 

the specific concentration limits and m-factors that have been set in 
part 3 of Annex VI to Regulation (EC) No …;”; 

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(ii)  Points (c) and (d) are deleted; 

* OJ L … 

(2) 

Article 31 is amended as follows: 

(a) 

the following paragraph 10 is added: 

“10.  From 1 December 2010 until 1 June 2015, the safety data sheets for substances 
shall  contain  the  classification  according  to  both  Directive 67/548/EEC  and 
Regulation (EC) No …. 

Where substances and mixtures are classified in accordance with Regulation (EC) -
 No …  during  the  period  from  its  entry  into  force  until  1 December 2010  or 
1 June 2015, that classification shall be added in the safety data sheet together with 
the  classification  in  accordance  with  Directives 67/548/EEC  and  1999/45/EC 
respectively.”; 

(b) 

from 1 December 2010, in paragraph 1, point (a) is replaced by the following: 

"(a) where a substance or mixture meets the criteria for classification as dangerous in 
accordance  with  Article 3 (2)  of  Regulation (EC) No …  or  Article 2 (2)  of 
Directive 1999/45/EC; or"; 

(c) 

from 1 June 2015, paragraphs 1 and 3 are amended as follows: 

(i) 

paragraph 1, 

in 
Directive 1999/45/EC" are deleted; 

point (a), 

the  words 

"or  Article 2(2) 

of 

(ii)  paragraph 3 is amended as follows: 

The introductory phrase is replaced by the following:   

"The supplier shall provide the recipient at his request with a safety data 
sheet  compiled  in  accordance  with  Annex II,  where  a  mixture  does  not 
meet  the  criteria  for  classification  as  dangerous  in  accordance  with 
Titles I and II of Regulation (EC) No …, but contains:"; 

- point (b) is replaced by the following: 

"(b) in an individual concentration of ≥ 0,1 % by weight for non-gaseous 
mixtures at least one substance that is carcinogenic category 2 or toxic to 
reproduction category 2 or persistent, bioaccumulative and toxic or very 
persistent  and  very  bioaccumulative  in  accordance  with  the  criteria  set 
out  in  Annex XIII  or  has  been  included  for  reasons  other  than  those 
referred  to  in  point  (a)  in  the  list  established  in  accordance  with 
Article 59(1); or"; 

(3) 

1 December 2010, 

from 
"Directive 67/548/EEC" are replaced by "Regulation (EC) No …"; 

in  Article 40, 

paragraph 1, 

in 

the  words 

(4) 

in Article 56, paragraph 6, point (b) is amended as follows: 

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(a) 

from the entry into force of this Regulation, it is replaced by the following: 

"(b) for all other substances, below the lowest of the concentration limits specified in 
Directive 1999/45/EC  or  in  part 3  of  Annex VI  to  Regulation (EC) No …  which 
result in the classification of the mixture as dangerous.”; 

(b) 

from 1 June 2015, it is replaced by the following: 

"(b)  for  all  other  substances,  below  the  cut-off  values  specified  in  Article 11 (3)  of 
Regulation (EC) No …  which  result  in  the  classification  of  the  mixture  as 
dangerous.”; 

(5) 

from 1 December 2010, in Article 57, paragraphs (a), (b) and (c) are replaced by the 
following: 

“(a)  substances  meeting 

the  hazard  class 
the  criteria  for  classification 
carcinogenicity  category 1A  or 1B  in  accordance  with  section 3.6  of  part 3  of 
Annex I to Regulation (EC) No …; 

in 

(b) 

(c) 

substances meeting the criteria for classification in the hazard class germ cell 
mutagenicity  category 1A  or 1B  in  accordance  with  section 3.5  of  part 3  of 
Annex I to Regulation (EC) No …; 

the  hazard  class 
the  criteria  for  classification 
substances  meeting 
reproductive  toxicity  category 1A  or 1B  in  accordance  with  section 3.7  of 
part 3 of Annex I to Regulation (EC) No …;”; 

in 

(6) 

in Article 59, paragraphs 2 and 3 are amended as follows: 

(a) 

in paragraph 2, the second sentence is replaced by the following: 

"The dossier may be limited, if appropriate, to a reference to an entry in part 3 
of Annex VI to Regulation (EC) No …."; 

(b) 

in paragraph 3, the second sentence is replaced by the following: 

"The dossier may be limited, if appropriate, to a reference to an entry in part 3 
of Annex VI to Regulation (EC) No …."; 

(7) 

Article 65 is amended as follows: 

(a) 

from  1 December 2010,  the  words  "Directive  67/548/EEC"  are  replaced  by 
"Regulation (EC) No …"; 

(b) 

from 1 June 2015, the words "and Directive 1999/45/EC" are deleted; 

(8) 

from 1 December 2010, Article 68 (2) is replaced by the following: 

“For a substance on its own, in a mixture or in an article which meets the criteria for 
classification  in  the  hazard  classes  carcinogenicity,  germ  cell  mutagenicity  or 
reproductive  toxicity,  category 1A  or  1B,  and  could  be  used  by  consumers  and  for 
which  restrictions  to  consumer  use  are  proposed  by  the  Commission,  Annex XVII 

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shall  be  amended  in  accordance  with  the  procedure  referred  to  in  Article 133(4). 
Articles 69 to 73 shall not apply.”; 

(9) 

in  Article 76,  in  point  (c)  of  paragraph 1,  the  words  “Title XI”  are  replaced  by 
“Title V of Regulation (EC) No …”; 

(10) 

Article 77 is amended as follows: 

(a) 

in paragraph 2, the first sentence of point (e) is replaced by the following:   

"(e) establishing and maintaining database(s) with information on all registered 
substances,  the  classification  and  labelling  inventory  and  the  harmonised 
accordance  with 
classification 
Regulation (EC) No ….;" 

established 

labelling 

and 

list 

in 

(b) 

in paragraph 3, point (a), the words “Titles VI to XI” are replaced by “Titles VI 
to X”; 

(11) 

Title XI is deleted; 

(12) 

from 1 December 2010, Article 119 paragraphs 1 and 2 are amended as follows: 

(a) 

(b) 

in  paragraph 1,  point (a),  the  words  "Directive 67/548/EEC"  are  replaced  by 
"Regulation (EC) No …"; 

in  paragraph 2,  point 
in 
"Directive 67/548/EEC" are replaced by "Regulation (EC) No …"; 

introductory  phrase, 

(g), 

the 

the  words 

(13) 

from 1 December 2010, in Article 138 (1) in paragraph 1, the second sentence of the 
introductory phrase is replaced by the following: 

“However, for substances meeting the criteria for classification in the hazard classes 
carcinogenicity, germ cell mutagenicity or reproductive toxicity, category 1A or 1B, 
in accordance with Regulation (EC) No …, the review shall be carried out by 1 June 
2014.”; 

(14) 

from 1 December 2010, Annex III is amended as follows: 

(a) 

point (a) is replaced by the following: 

“(a) substances for which it is predicted (i.e. by the application of (Q)SARs or 
other evidence) that they are likely to meet the criteria for category 1A or 1B 
classification  in  the  hazard  classes  carcinogenicity,  germ  cell  mutagenicity  or 
reproductive toxicity or the criteria in Annex XIII;”; 

(b) 

in point (b), point (ii) is replaced by the following: 

“(ii) for which it is predicted (i.e. by application of (Q)SARs or other evidence) 
that  they  are  likely  to  meet  the  classification  criteria  for  any  health  or 
environmental  hazard  classes  or  differentiations  under  Regulation  (EC)  No 
….”; 

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(15) 

from 1 December 2010, in Annex V, point 8., the words "Directive 67/548/EEC" are 
replaced by "Regulation (EC) No …"; 

(16) 

Annex VI is amended as follows: 

(a) 

from 1 December 2010, sections 4.1 and 4.2 are amended as follows: 

(i) 

Section 4.1 is amended as follows: 

– 

the first subparagraph is replaced by the following: 

"The  hazard  classification  of  the  substance(s),  resulting  from  the 
application of Title I and II of Regulation (EC) No … for all hazard 
classes and categories in that Regulation;"; 

– 

the second subparagraph is replaced by the following: 

"In  addition,  for  each  entry,  the  reasons  why  no  classification  is 
given for a hazard class or differentiation of a hazard class should 
be provided (i.e. if data are lacking, inconclusive, or conclusive but 
not sufficient for classification);"; 

(ii)  Section 4.2 is replaced by the following: 

"4.2.  The  resulting  hazard  label  for  the  substance(s),  resulting  from  the 
application of Title III of Regulation (EC) No …;"; 

(b)  From 1 June 2015, section 4.3 is replaced by the following:  

"4.3.  Specific  concentration  limits,  where  applicable,  resulting  from  the 
application of Article 10 of Regulation (EC) No …."; 

(17) 

from 1 December 2010, in Annex XIII, the second and third indents of point 1.3 are 
replaced by the following: 

– 

– 

“the  substance  is  classified  as  carcinogenic  (category 1A  or  1B),  germ  cell 
mutagenic  (category 1A  or  1B),  or  toxic  for  reproduction  (category 1A,  1B 
or 2), or 

(repeated  exposure),  category 1 

there  is  other  evidence  of  chronic  toxicity,  as  identified  by  the  classifications 
STOT 
inhalation  of 
gases/vapours,  inhalation  of  dust/mist/fume)  or  category 2  (oral,  dermal, 
inhalation  of  gases/vapours,  inhalation  of  dust/mist/fume)  according  to 
Regulation (EC) No …” 

(oral,  dermal, 

(18) 

Annex XV, sections I and II are amended as follows: 

(a) 

section I is amended as follows: 

(i) 

the first indent is deleted; 

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(ii) 

the second indent is replaced by the following:  

“-the identification of CMRs, PBTs, vPvBs, or a substance of equivalent 
concern in accordance with Article 59,”; 

(b) 

in section II, point 1 is deleted; 

(19) 

Annex XVII is amended as follows: 

(a) 

from 1 December 2010, the table is amended as follows: 

(i) 

in the column "Designation of the substance, of the groups of substances 
or of the preparation", entries 3., 28., 29., 30. and 40. are replaced by the 
following: 

"3.  Liquid  substances  or  mixtures,  which  are  regarded  as  dangerous 
according to Regulation (EC) No … and Directive 1999/45/EC.; 

28.  Substances  which  appear  in  Annex VI  to  Regulation (EC) No … 

classified as carcinogen category 1A or 1B and listed as follows : 

– 

– 

Carcinogen category 1A listed in Appendix 1 

Carcinogen category 1B listed in Appendix 2 

29.  Substances  which  appear  in  Annex VI  to  Regulation (EC) No … 
classified  as  germ  cell  mutagen  category 1A  or  1B  and  listed  as 
follows: 

–  Mutagen category 1A listed in Appendix 3 

–  Mutagen category 1B listed in Appendix 4 

30.  Substances  which  appear  in  Annex VI  to  Regulation (EC) No … 
classified as toxic to reproduction category 1A or 1B and listed as 
follows: 

– 

– 

Reproductive toxicant category 1A listed in Appendix 5 

Reproductive toxicant category 1B listed in Appendix 6 

40.  Substances  classified  as  flammable  gases  category 1,  flammable 
liquids  categories 1,  2  or  3,  flammable  solids  category 1  or  2, 
substances  and  mixtures  which,  in  contact  with  water,  emit 
flammable gases, category 1, 2 or 3, pyrophoric liquids category 1 
or pyrophoric solids category 1, regardless of whether they appear 
in part 3 of Annex VI to that Regulation or not.”; 

(ii) 

in the column " Conditions of restriction", in entry 28, the first indent of 
point 1. is replaced by the following: 

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"–  either  the  relevant  specific  concentration  limit  specified  in  part 3  of 
Annex VI of Regulation (EC) No …, or"; 

(b) 

from  1 June 2015,  the  column  "  Conditions  of  restriction"  of  the  table  is 
amended as follows: 

(i) 

in  entry 28,  the  second  indent  of  point  1.  is  replaced  by  the  following: 

"– the relevant generic concentration limit specified in part 3 of Annex I 
of Regulation (EC) No …."; 

(ii) 

in entry 30., point 2 (d) is replaced by the following:   

"(d) artists' paints covered by Regulation (EC) No …."; 

(20) 

Appendices 1 to 6 are amended as follows: 

(a) 

the Foreword is amended as follows: 

(i) 

(ii) 

(iii) 

the  section  entitled  “Substances”, 

in 
Directive 67/548/EEC”  are  replaced  by  “part 3  of  Annex VI 
Regulation …”; 

the  words  “Annex I  of 
to 

in  the  section  entitled  “Index  number”,  the  words  “Annex I  of 
Directive 67/548/EEC”  are  replaced  by  “part 3  of  Annex VI 
to 
Regulation …”; 

the 

section 

in 
Directive 67/548/EEC”  are  replaced  by  “part 3  of  Annex VI 
Regulation …”; 

“Annex I  of 
to 

the  words 

“Notes”, 

entitled 

(iv)  Note A is replaced by the following: 

“The name of the substance must appear on the label in the form of one 
of  the  designations  given  in  part 3  of  Annex VI  to  Regulation 
(EC) No …. 

In that part, use is sometimes made of a general description such as "... 
compounds"  or  "...  salts".  In  this  case,  the  manufacturer  or  any  other 
person who places such a substance on the market is required to state on 
the label the correct name, due account being taken of paragraph 1.1.1.6 
of part 1 of Annex VI of Regulation (EC) No …. 

Regulation (EC) No …  also  requires  that  the  appropriate  label  elements 
to be used for each substance shall be those shown in part 3 of Annex VI 
to that Regulation. 

For substances belonging to one particular group of substances included 
in  part 3  of  Annex VI  to  Regulation (EC) No …,  the  appropriate  label 
elements  to  be  used  for  each  substance  shall  be  those  shown  in  the 
appropriate entry in that part. 

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For substances belonging to more than one group of substances included 
in  part 3  of  Annex VI  to  Regulation (EC) No …,  the  appropriate  label 
elements to be used for each substance shall be those shown in both the 
appropriate  entries  given  in  that  part.  In  cases  where  two  different 
classifications  are  given  in  the  two  entries  for  the  same  hazard  class  or 
differentiation, the classification reflecting the more severe classification 
shall be used.” 

(v)  Note D is replaced by the following: 

“Certain substances which are susceptible to spontaneous polymerisation 
or decomposition are generally placed on the market in a stabilised form. 
It  is  in  this  form  that  they  are  listed  in  part 3  of  Annex VI  to 
Regulation (EC) No …. 

However, such substances are sometimes placed on the market in a non-
stabilised form. In this case, the manufacturer or any person who places 
such  a  substance  on  the  market  must  state  on  the  label  the  name  of  the 
substance followed by the words "non-stabilised".” 

(vi)  Note H is replaced by the following: 

“The  classification  and  label  shown  for  this  substance  applies  to  the 
hazard or hazards indicated by the hazard statement or hazard statements 
in combination with the hazard classification shown. The requirements of 
Article 4  of  Regulation (EC) No …  on  manufacturers,  distributors  and 
importers  of 
to  all  other  hazard  classes, 
differentiations and categories.   

this  substance  apply 

The final label shall follow the requirements of section 1.2 of Annex I of 
Regulation (EC) No ….” 

(vii)  Note K is replaced by the following: 

“The classification as a carcinogen or mutagen need not apply if it can be 
shown  that  the  substance  contains  less  than  0.1  %  w/w  1,3-butadiene 
(Einecs No 203-450-8). If the substance is not classified as a carcinogen 
or  mutagen,  at  least  the  precautionary  statements  (102-)210-403  should 
apply. This note applies only to certain complex oil-derived substances in 
part 3 of Annex VI to Regulation (EC) No ….” 

(viii)  Note S is replaced by the following: 

“This  substance  may  not  require  a  label  according  to  Article 17  (see 
section 1.3 of Annex I of Regulation …).” 

(b) 

in Appendix 1, the title is replaced by the following: 

“Point 28 – Carcinogens: category 1A”; 

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(c) 

in Appendix 2, the title is replaced by the following: 

“Point 28 – Carcinogens: category 1B”; 

(d) 

in Appendix 3, the title is replaced by the following: 

“Point 29 – Mutagens: category 1A”; 

(e) 

in Appendix 4, the title is replaced by the following: 

“Point 29 – Mutagens: category 1B”; 

(f) 

in Appendix 5, the title is replaced by the following: 

“Point 30 – Reproductive toxicants: category 1A”; 

(g) 

in Appendix 6, the title is replaced by the following: 

“Point 30 – Reproductive toxicants: category 1B”; 

(21) 

the  word  « preparation »  or  “preparations”  within  the  meaning  of  Article 3 (2)  of 
Regulation (EC) 1907/2006  is  replaced  by  the  word  « mixture »  or  “mixtures” 
respectively throughout the text. 

Article 57 
Repeal 

Directive 67/548/EEC and Directive 1999/45/EC are repealed with effect from 1 June 2015. 

Article 58 
Transitional provisions 

1. 

2. 

3. 

4. 

Until  1 December 2010,  substances  shall  be  classified,  labelled  and  packaged  in 
accordance with Directive 67/548/EEC. 

Until 1 June 2015, mixtures shall be classified, labelled and packaged in accordance 
with Directive 1999/45/EC. 

By  way  of  derogation  from  Article 60  and  from  paragraph 1  of  this  Article,  the 
substances  and  mixtures  classified  in  accordance  with  paragraph 1  may,  as  regards 
the  period  before  1 December 2010  and  1 June 2015  respectively,  be  classified  and 
labelled in accordance with this Regulation. In that case, the provisions on labelling 
in Directives 67/548/EEC and 1999/45/EC shall not apply. 

From  1 December 2010  until  1 June 2015,  substances  shall  be  classified  in 
accordance  with  both  Directive 67/548/EEC  and  this  Regulation.  They  shall  be 
labelled and packaged in accordance with this Regulation. 

Substances and mixtures that have been  classified  and  placed  on  the  market  before 
1 December 2010  and  1 June 2015  respectively  shall  not  be  required  to  be  labelled 
and packaged in accordance with this Regulation. 

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Article 59 
Reclassification 

Where  a  substance  has  already  been  classified  in  accordance  with  Directive 67/548/EEC 
before  1 December 2010,  the  suppliers  shall  from  that  date  reclassify  such  a  substance  in 
accordance  with  Title II  of  this  Regulation  or  may  adapt  the  classification  by  using  the 
conversion table in Annex VII. 

Article 60 
Entry into force 

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

Titles II, III and IV shall apply in respect of substances from 1 December 2010 and in respect 
of mixtures from 1 June 2015. 

This Regulation shall be binding in its entirety and directly applicable in all Member States. 

Done at Brussels,  

For the European Parliament 
The President 

For the Council 
The President 

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