Proposal for a Decision of the European Parliament and of the Council amending Council Directives 76/768/EEC, 88/378/EEC, 1999/13/EC and Directives 2000/53/EC, 2002/96/EC and 2004/42/EC in order to adapt them to Regulation (EC) … on Classification, Labelling and Packaging of Substances and Mixtures, and amending Directive 67/548/EEC and Regulation (EC) No 1907/2006 [SEC(2007) 1334] [SEC(2007) 1335]
Date: 2007-10-16
Institutions: European Commission
Subjects: EU law - national law, chemical product, consumer protection, dangerous substance, environmental policy, labelling, packaging, product safety, toy industry

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 16.10.2007 
COM(2007) 611 final 

2007/0212 (COD) 

Proposal for a 

DECISION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

amending Council Directives 76/768/EEC, 88/378/EEC, 1999/13/EC and 
Directives 2000/53/EC, 2002/96/EC and 2004/42/EC in order to adapt them to 
Regulation (EC) … 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) 1334] 
[SEC(2007) 1335] 

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TABLE OF CONTENTS 

EXPLANATORY MEMORANDUM ....................................................................................... 3 

Background to the proposal........................................................................................................ 3 

Reasons and objectives............................................................................................................... 3 

Coherence with other policies .................................................................................................... 3 

Results of public consultations and impact assessments............................................................ 4 

Public stakeholder consultation.................................................................................................. 4 

Internet consultation................................................................................................................... 4 

Issues raised and how they are addressed .................................................................................. 4 

Impact assessments .................................................................................................................... 4 

Collection and use of expertise .................................................................................................. 5 

Legal elements of the proposal................................................................................................... 5 

Legal basis.................................................................................................................................. 5 

Subsidiarity and proportionality................................................................................................. 5 

Subsidiarity................................................................................................................................. 5 

Proportionality............................................................................................................................ 6 

Choice of legal instrument ......................................................................................................... 6 

Introduction to the proposal ....................................................................................................... 6 

1. 

2. 

Reasons and Objectives................................................................................................ 6 

Detailed provisions....................................................................................................... 7 

DECISION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending 
Council Directives 76/768/EEC, 88/378/EEC, 1999/13/EC and Directives 2000/53/EC, 
2002/96/EC and 2004/42/EC in order to adapt them to Regulation (EC) … on Classification, 
Labelling and Packaging of Substances and Mixtures, and amending Directive 67/548/EEC 
and Regulation (EC) No 1907/2006........................................................................................... 8 

LEGISLATIVE FINANCIAL STATEMENT......................................................................... 15 

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EXPLANATORY MEMORANDUM 

BACKGROUND TO THE PROPOSAL 

Reasons and objectives 

This  proposal  accompanies  the  Commission  proposal  for  a  Regulation  of  the  European 
Parliament  and  of  the  Council  on  classification,  labelling  and  packaging  of  substances  and 
mixtures1. The latter proposal builds on existing chemicals legislation and establishes a new 
system  on  classification,  labelling  and  packaging  of  hazardous  substances  and  mixtures  by 
implementing in the EU the international criteria agreed by the United Nations 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). 

Classification  of 
applicable 
Directives 67/548/EEC  and  1999/45/EC  triggers  other  obligations  in  EU  legislation, 
hereinafter referred to as downstream legislation. 

and  preparations  under 

substances 

currently 

the 

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 
proposed  Decision  aims  to  make  such  changes  to  a  number  of  downstream  acts,  through 
amendments which take account of the effects of the proposal on classification, labelling and 
packaging  of  substances  and  mixtures.  It  is  presented  together  with  a  proposed  Regulation 
aiming  to  make  changes  in  order  to  address  the  effects  of  the  proposal  on  classification, 
labelling and packaging for an existing Regulation. 

Coherence with other policies 

The analysis of the potential effects of the implementation of the GHS criteria on downstream 
legislation  concluded  that  effects  are  either  minimal  or  can  be  minimised  by  appropriate 
changes  to  particular  downstream  acts.  This  draft  Decision  proposes  such  changes  to  the 
provisions  of  Directives 76/768/EEC,  88/378/EEC,  1999/13/EC,  2000/53/EC,  2002/96/EC 
and 2004/42/EC. 

During  the  stakeholder  consultation  which  was  held  on  the  proposal  for  a  Regulation  on 
classification, labelling and packaging of substances and mixtures and which also addressed 
potential  effects  on  downstream  legislation,  some  parties  mentioned  the  lack  of  analysis  of 
national legislation referring to the EU classification criteria. However, the assessment of the 
effects on national legislation is within the competence of Member States. The Commission 
would  encourage  Member  States  to  analyse  national  downstream  acts  along  the  lines  of  the 
study on EU legislation. 

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COM(2007) 355 final. 

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RESULTS OF PUBLIC CONSULTATIONS AND IMPACT ASSESSMENTS 

Public stakeholder consultation 

Internet consultation 

The Commission launched a public stakeholder consultation on the proposal for a Regulation 
on  classification,  labelling  and  packaging  of  substances  and  mixtures  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 responded. 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  support  the  implementation  of  the 
GHS  in  the  EU.  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: A majority of respondents (59%) supported neither extending nor lowering the level 
of  protection  in  comparison  with  the  current  EU  system,  except  where  necessary  to  ensure 
consistency with transport legislation or with 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" which are not yet part of the GHS. 

Impact assessments 

The  Commission’s  overall  impact  assessment  for  the  proposed  Regulation  on  classification, 
labelling and packaging of substances and mixtures and its consequential changes to related 
downstream  legislation  made  use  of  the  consultant  reports  prepared  by  RPA  and  London 
Economics  as  well  as  the  responses  to  the  stakeholder  consultation.  Specifically,  the 
responses from companies on the costs have 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. 

The  measures  set  out  in  this  proposal  provide  for  an  adaptation  of  the  references  to  the 
classification  rules  and  terminology  according  to  the  proposal  for  a  Regulation  on 
classification,  labelling  and  packaging  of  substances  and  mixtures  for  all  downstream  acts 
covered  by  the  current  proposed  Decision.  For  Directives 76/768/EEC,  88/378/EEC, 
2000/53/EC and 2002/96/EC, potential effects are minimised by covering, in the reference to 
dangerous  substances  and  mixtures  according  to  the  proposed  Regulation  on  classification, 
labelling  and  packaging  of  substances  and  mixtures,  those  endpoints  which  are  already 
referred  to  under  the  current  EU  regime  on  classification  and  labelling,  while  not  adding 
further endpoints.  

As to Directive 1999/13/EC, no further adaptation of reference to the classification criteria is 
made  because  potential  effects  are  deemed  irrelevant  for  the  scope  of  the  Directive. 

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Directive 2004/42/EC  does  not  base  any  additional  obligation  on  the  classification  of 
substances and mixtures. 

For each of the EU downstream Directives which are proposed for amendment by the current 
proposed Decision, there is therefore no need for further analysis beyond that set out in the 
overall impact assessment referred to above. 

Collection and use of expertise 

The  GHS  was  developed  by  international  organisations,  with  participation  of  a  variety  of 
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 
2 have been taken into account in drafting this 
by the Commission in preparation for REACH
proposal.  Further  studies  were  carried  out3  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 

This proposal has a double legal basis consisting of both Article 95 and Article 175 (1) of the 
EC  Treaty.  This  double  legal  basis  is  the  appropriate  legal  basis  for  this  proposed  Decision 
because  it  minimises  the  effects  for  six  existing  Directives  which  would  result  from  the 
proposal  for  a  Regulation  on  classification,  labelling  and  packaging  of  substances  and 
mixtures.  Three  of  those  Directives  are  based  on  Article 175 (1)  of  the  EC  Treaty,  three  of 
them  are  based  on  Article 95  of  the  EC  Treaty.  Both  legal  bases  rely  on  the  co-decision 
procedure laid down in Article 251 of the EC Treaty and they are therefore compatible from a 
procedural  viewpoint.  A  double  legal  basis  comprising  both  aforementioned  Articles  was 
recently  used  by  the  European  Parliament  and  the  Council  for  the  Regulation  on  certain 
fluorinated greenhouse gases4. 

Subsidiarity and proportionality 

Subsidiarity 

Six existing Directives in the fields of cosmetic products, safety of toys, emissions of volatile 
organic compounds, end-of-life vehicles and waste electric and electronic equipment already 
contain  substantive  legal  provisions.  The  proposed  Decision  will  amend  the  existing 
Directives to adapt them to the classification rules set forth in the proposal for a Regulation on 
classification, labelling and packaging of substances and mixtures. Those amendments need to 

2 

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4 

ECBI/03/02:  White  Paper  Working  Group  on  Classification  and  Labelling:  Summary  of 
Recommendations from Technical Working Group on Tasks 1 and 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. 
OJ L 161, 14.6.2006, p. 1. 

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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 are contained in the 
proposal  for  a  Regulation  on  classification,  labelling  and  packaging  of  substances  and 
mixtures. In that proposal, some hazard classes and categories are added in comparison to the 
current  EU  system,  leading  to  classification  of  substances  and  mixtures  which  previously 
were  not  classified.  To  ensure  proportionality,  there  should  be  no  change  in  the  scope  of 
downstream legislation, so as not to trigger new obligations. The proposed Decision aims to 
ensure this, by including in six Directives a reference to the concept of “dangerous” which is 
found  in  Article 3 (2)  of  the  proposal  for  a  Regulation  on  classification  and  labelling  of 
substances and mixtures and which is in line with the current EU system. 

Therefore this proposal for a Decision is proportionate. 

Choice of legal instrument 

The  choice  of  a  Decision  is  justified.  On  the  one  hand,  this  proposal  amends  six  existing 
Directives which have been transposed into Member State legislation and whose legal nature 
is not affected by the proposal for a Regulation on classification, labelling and packaging of 
substances and mixtures. The amendments introduced by this Decision in turn will have to be 
transposed  in  Member  State  legislation.  It  is  therefore  appropriate  to  choose  an  instrument 
that is not directly applicable, but that is addressed to the Member States instead. On the other 
hand, the majority of the amendments contained in this proposal are only intended to become 
applicable  several  years  from  the  adoption  of  the  amending  act,  namely  from  1  December 
2010  and  from  1  June  2015  respectively.  This  would  either  require  different  transposition 
dates  to  be  set  for  the  different  provisions  depending  on  the  relevant  dates,  which  is 
unorthodox wording for a Directive from a legal perspective, or a single date of transposition, 
which would require Member States to adopt national legislation with a deferred applicability 
for some provisions, which is unusual for a Directive. A Decision is more efficient in laying 
down clearly the obligations of Member States in this regard and is therefore to be preferred. 

INTRODUCTION TO THE PROPOSAL 

This Decision amends six existing Directives to adapt them to the criteria for the classification 
and  labelling  of  substances  and  mixtures  laid  down  in  the  proposal  for  a  Regulation  on 
classification, labelling and packaging of substances and mixtures. 

1. 

REASONS AND OBJECTIVES 

The  main  objective  of  this  Decision  is  to  address  the  effects  of  the  introduction  of  new 
classification  criteria  for  substances  and  mixtures  for  six  Directives  which  refer  to 
classification  of  substances  or  mixtures,  so  as  to  prevent  undesired  changes  in  scope  and 
obligations.  Where  necessary,  it  adapts  the  provisions  of  those  Directives  to  the  new 
terminology resulting from the new criteria and the new hazard statements introduced by the 
proposal  on  classification,  labelling  and  packaging.  The  term  “mixture”  is  introduced  to 
replace  the  term  “preparation”,  in  line  with  the  proposal  on  classification,  labelling  and 
packaging of substances and mixtures.  

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Where the Directives refer in general to the test methods laid down in Directive 67/548/EEC, 
this  proposal  updates  this  reference  in  line  with  the  recently  adopted  Regulation 1907/2006 
(REACH) which foresees a Commission Regulation containing these methods.  

For  Directive 1999/13/EC,  this  proposal  contains  a  change  which  is  consequential  to  the 
replacement  of  the  former  risk  phrase  R40  by  two  new  risk  phrases  called  R40  and  R68, 
operated by Directive 2001/59/EC. This replacement had until now not been reflected in the 
wording  of  Directive 1999/13/EEC.  It  is  appropriate  to  make  this  change  now  to  ensure  a 
correct  transition  to  the  corresponding  hazard  phrases  foreseen  in  the  proposal  on 
classification, labelling and packaging of substances and mixtures. 

2. 

DETAILED PROVISIONS 

Articles 1  to  6  introduce  the  required  changes  to  Directives 76/768/EEC,  88/378/EEC, 
1999/13/EC,  2000/53/EC,  2002/96/EC  and  2004/42/EC  in  line  with  the  findings  of  the 
analysis  of  the  potential  effects  of  the  proposal  for  a  Regulation  on  classification,  labelling 
and packaging of substances and mixtures on EU downstream legislation and the objectives 
discussed under the previous section. 

The staggered dates of entry into effect of the changes reflect the phased entry into effect of 
the  aforementioned  proposal  for  a  Regulation.  This  is  logical,  as  the  Decision  introduces 
changes which are consequential to the adoption of that Regulation. 

Article 7 is a standard article which is required due to the legal nature of a Decision. 

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2007/0212 (COD) 

Proposal for a 

DECISION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

amending Council Directives 76/768/EEC, 88/378/EEC, 1999/13/EC and 
Directives 2000/53/EC, 2002/96/EC and 2004/42/EC in order to adapt them to 
Regulation (EC) … 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 and Article 175(1) thereof, 

Having regard to the proposal from the Commission5,  

Having regard to the opinion of the European Economic and Social Committee6, 

Acting in accordance with the procedure laid down in Article 251 of the Treaty7, 

Whereas: 

(1) 

Regulation  (EC) No …  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  1907/20068  provides  for  the 
harmonisation of the classification and labelling of substances and mixtures within the 
Community.  That  Regulation  will  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 substances9 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 preparations10. 

(2) 

Regulation  (EC) …  builds  on 
the  experience  of  Directives 67/548/EEC  and 
1999/45/EC and incorporates the criteria for classification and labelling of substances 

5 
6 
7 
8 
9 

10 

OJ C 
OJ C 
OJ C 
OJ L  
OJ 196, 16.8.1967, p. 1. Directive as last amended by Directive 2006/121/EC (OJ L 396, 30.12.2006, p. 
850). 
OJ  L  200,  30.7.1999,  p.  1.  Directive  as  amended  by  Regulation  (EC)  No  1907/2006  (OJ  L  396, 
30.12.2006, p. 1). 

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and mixtures  provided  for  by  the  Globally Harmonised System of Classification  and 
Labelling  of  Chemicals  (GHS)  which  has  been  adopted  at  the  international  level, 
within the United Nations structure. 

Certain provisions on classification and labelling laid down in Directives 67/548/EEC 
and  1999/45/EC  also  serve  for  the  purpose  of  the  application  of  other  Community 
legislation,  such  as  Council  Directive 76/768/EEC  of  27  July  1976  on  the 
approximation  of  the  laws  of  the  Member  States  relating  to  cosmetic  products11, 
Council  Directive 88/378/EEC  of  3  May  1988  on  the  approximation  of  laws  of  the 
Member  States  concerning  the  safety  of  toys12,  Council  Directive 1999/13/EC  of 
11 March 1999  on  the  limitation  of  emissions  of  volatile  organic  compounds  due  to 
installations13, 
the  use  of  organic 
the  Council  of 
Directive 2000/53/EC  of 
18 September 2000  on  end-of-life  vehicles14,  Directive 2002/96/EC  of  the  European 
Parliament  and  of  the  Council  of  27 January 2003  on  waste  electrical  and  electronic 
equipment15 and Directive 2004/42/EC of the European Parliament and of the Council 
of 21 April 2004 on the limitation of emissions of volatile organic compounds due to 
the  use  of  organic  solvents  in  certain  paints  and  varnishes  and  vehicle  refinishing 
products and amending Directive 1999/13/EC16. 

solvents 
certain 
the  European  Parliament  and  of 

activities 

and 

in 

The  incorporation  of  the  GHS  criteria  into  Community  legislation  leads  to  the 
introduction of new hazard classes and categories only partially corresponding to the 
classification and labelling arrangements provided for by Directives 67/548/EEC and 
1999/45/EC. An analysis on the potential effects of the transition from the old to the 
new system  of  classification and labelling has led to the  conclusion that by  adapting 
the  references  to  the  classification  criteria  in  Directives 76/768/EEC,  88/378/EEC, 
2000/53/EC and 2002/96/EC to the new system introduced by Regulation (EC) No …, 
the scope of the respective acts should be maintained. 

It is also necessary to adapt Directive 76/768/EEC to take into account the adoption of 
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/EC17. 

OJ  L  262,  27.9.1976, p.  169.  Directive  as last  amended by  Commission  Directive 2007/22/EC  (OJ L 
101, 18.4.2007, p. 11). 
OJ L 187, 16.7.1988, p. 1. Directive as last amended by Directive 93/68/EEC (OJ L 220, 30.8.1993, p. 
1). 
OJ L 85, 29.3.1999, p. 1. Directive as last amended by Directive 2004/42/EC (OJ L 143, 30.4.2004, p. 
87). 
OJ L 269, 21.10.2000, p. 34. Directive as last amended by Decision 2005/673/EC (OJ L 254, 30.9.2005, 
p. 69). 
OJ L 37, 13.2.2003, p. 24. Directive as amended by Directive 2003/108/EC (OJ L 345, 31.12.2003, p. 
106). 
OJ L 143, 30.4.2004, p. 87.  
OJ L 396, 30.12.2006, p. 1. 

(3) 

(4) 

(5) 

11 

12 

13 

14 

15 

16 
17 

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(6) 

(7) 

It is appropriate to bring Directive 1999/13/EC into line with the replacement of risk 
phrase R40 by two new risk phrases R40 and R68 under Directive 67/548/EEC, so as 
to  ensure  the  correct  transition  to  the  hazard  statements  laid  down  in  Regulation 
(EC) No … 

The transition from the criteria for classification contained in Directives 67/548/EEC 
and 1999/45/EC will be fully completed on 1 June 2015. Manufacturers of cosmetics, 
toys,  paints,  varnishes,  vehicles  refinishing  products,  vehicles  and  electric  and 
electronic  equipment  are  manufacturers,  importers  or  downstream  users  within  the 
meaning of  Regulation (EC) No …, as are the operators whose activities are covered 
by  Council  Directive  1999/13/EC.  All  of  them  should  be  enabled  to  design  their 
timeframe  as  under 
transition  strategy  under 
Regulation (EC) No …. 

this  Decision 

in  a  similar 

(8) 

Directives 76/768/EEC,  88/178/EEC,  1999/13/EC,  2000/53/EC,  2002/96/EC  and 
2004/42/EC should be amended accordingly. 

HAVE ADOPTED THIS DECISION: 

Article 1 
Amendment to Directive 76/768/EEC 

Directive 76/768/EEC is amended as follows: 

(1) 

the  word  « preparation »  or  “preparations”  within  the  meaning  of  Article 3(2) of 
Regulation (EC) No 1907/2006 in its version of 30 December 2006 is replaced by the 
word « mixture » or “mixtures” respectively throughout the text; 

(2) 

in Article 4a, point d of paragraph 1 is replaced by the following: 

“(d)  the  performance  on  their  territory  of  animal  testing  of  ingredients  or 
combinations  of  ingredients  in  order  to  meet  the  requirements  of  this  Directive,  no 
later  than  the  date  on  which  such  tests  are  required  to  be  replaced  by  one  or  more 
validated  methods  listed  in  Commission  Regulation  […*  on  test  methods]**,  or  in 
Annex IX to this Directive.  
____________________________________________________________________ 

* OJ L … 
** OJ L 396, 30.12.2006, p. 1.” 

(3) 

from  1 December 2010,  Article 4b  of  Directive 76/768/EEC  is  replaced  by  the 
following: 

“Article 4b 

The  use  in  cosmetic  products  of  substances  classified  as  carcinogenic,  germ  cell 
mutagenic  or  toxic  for  reproduction,  of  category 1A,  1B  and  2,  under  part 3  of 
Annex VI of Regulation (EC) No … of the European Parliament and of the Council 
of  …  on  Classification  and  Labelling  of  Substances  and  Mixtures***  shall  be 
prohibited.  To  that  end  the  Commission  shall  adopt  the  necessary  measures  in 

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accordance with the procedure referred to in Article 10 (2). A substance classified in 
category 2  may  be  used  in  cosmetics  if  the  substance  has  been  evaluated  by  the 
SCCNFP and found acceptable for use in cosmetic products. 

*** OJ L …” 

(4) 

from 1 December 2010, in Article 7a(1), the last sentence of the second subparagraph 
of point (h) is replaced by the following: 

“The quantitative information required under (a) to be made publicly accessible shall 
be limited to dangerous substances within the meaning of Article 3(2) of Regulation 
(EC) No ….”; 

(5) 

in Annex IX, the first sentence is replaced by the following: 

“This  Annex  lists  the  alternative  methods  validated  by  the  European  Centre  on 
Validation of Alternative Methods (ECVAM) of the Joint Research Centre available to 
meet the requirements of this Directive and which are not listed in Regulation [..].” 

Article 2 
Amendment to Directive 88/378/EEC 

Directive 88/378/EEC is amended as follows: 

(1) 

(2) 

the  word  « preparation »  or  “preparations”  within  the  meaning  of  Article 3(2)  of 
Regulation (EC) No 1907/2006 in its version of 30 December 2006 is replaced by the 
word « mixture » or “mixtures” respectively throughout the text; 

from  1 June 2015,  in  section 2  of  part II  of  Annex II,  point (b)  is  replaced  by  the 
following: 

“(b)  Toys  which,  for  reasons  essential  to  their  functioning,  contain  dangerous 
substances or mixtures within the meaning of Article 3 (2) of Regulation (EC) No … 
of the European Parliament and of the Council of … on Classification and Labelling 
of  Substances  and  Mixtures*,  in  particular  materials  and  equipment  for  chemistry 
experiments, model assembly, plastic or ceramic moulding, enamelling, photography 
or  similar  activities,  must  not  contain,  as  such,  substances  or  mixtures  which  may 
become flammable due to the loss of non-flammable volatile components. 

* OJ L …” 

(3) 

from 1 June 2015, in section 3 of part II of Annex II, the first paragraph of point 3 is 
replaced by the following: 

“3. Toys must not contain dangerous substances or mixtures within the meaning of 
Article 3(2)  of  Regulation  (EC) No …  in  amounts  which  may  harm  the  health  of 
children  using  them.  At  all  events  it  is  strictly  forbidden  to  include,  in  a  toy,  such 
dangerous  substances or mixtures  if they are intended to be used as such while the 
toy is being used.” 

EN 

11 

   EN 

 
 
 
 
(4) 

from 1 June 2015, in section 4 of Annex IV, the title and point (a) are replaced by the 
following: 

“4. Toys containing inherently dangerous substances or mixtures. Chemical toys 

(a)  Without  prejudice  to  the  application  of  the  provisions  laid  down  in  Regulation 
(EC) No …,  the  instructions  for  use  of  toys  containing  inherently  dangerous 
substances  or  mixtures  within  the  meaning  of  Article 3 (2)  of  that  Regulation  shall 
bear  a  warning  of  the  dangerous  nature  of  these  substances  or  mixtures  and  an 
indication  of  the  precautions  to  be  taken  by  the  user  in  order  to  avoid  hazards 
associated with them, which shall be specified concisely according to the type of toy. 
The first aid to be given in the event of serious accidents resulting from the use of 
this type of toy shall also be mentioned. It shall also be stated that the toys must be 
kept out of reach of very young children.” 

Article 3 
Amendment to Directive 1999/13/EC 

Directive 1999/13/EC is amended as follows: 

(1) 

the  word  « preparation »  or  “preparations”  within  the  meaning  of  Article 3(2)  of 
Regulation (EC) No 1907/2006 in its version of 30 December 2006 is replaced by the 
word « mixture » or “mixtures” respectively throughout the text; 

(2) 

Article 5 is amended as follows: 

(a) 

from 1 June 2015, paragraph 6 is replaced by the following: 

“6. Substances or mixtures which, because of their content of VOCs classified 
as  carcinogens,  mutagens  or  toxic  to  reproduction  under  Regulation  (EC)  No 
…  of  the  European  Parliament  and  of  the  Council*  are  assigned  or  need  to 
carry  the  hazard  statements  H340,  H350,  H350i,  H360D  or  H360F  shall  be 
replaced,  as  far  as  possible  and  by  taking  into  account  the  guidance  as 
mentioned  in  Article 7 (1),  by  less  harmful  substances  or  mixtures  within  the 
shortest possible time. 

* OJ L …” 

(b)  paragraph 8 is amended as follows: 

(i) 

the words “the risk phrase R40” are replaced by “the risk phrases R40 or 
R68”; 

(ii) 

the  words  “the  labelling  R40”  are  replaced  by  “the  labelling  R40  or 
R68”; 

(iii)  from 1 June 2015, the words “the risk phrases R40 or R68” are replaced 

by “the hazard statements H341 or H351”; 

EN 

12 

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(iv)  from 1 June 2015, the words “the labelling R40 or R68” are replaced by 

“the hazard statements H341 or H351”; 

(c) 

from 1 June 2015, in paragraph 9, the words “risk phrases” are replaced by the 
words “hazard statements”; 

(d)  paragraph 13 is amended as follows: 

(i) 

the  words  “the  labelling  R40,  R60  or  R61”  are  replaced  by  “the  risk 
phrases R40, R68, R60 or R61”; 

(ii) 

from 1 June 2015, the words “the risk phrases R40, R68, R60 or R61” are 
replaced by “the hazard statements H341, H351, H360F or H360D”. 

Article 4 
Amendment to Directive 2000/53/EC 

From 1 December 2010, in Article 2 of Directive 2000/53/EC, paragraph 11 is replaced by the 
following: 

“11. ‘hazardous substance’ means any substance which is considered to be dangerous within 
the meaning of Article 3(2) of Regulation (EC) No … of the European Parliament and of the 
Council*; 

* OJ L …” 

Article 5 
Amendment to Directive 2002/96/EC 

Directive 2002/96/EC is amended as follows: 

(1) 
from 1 June 2015, the word “preparation” or “preparations” within the meaning 
of Article 3(2) of Regulation (EC) No 1907/2006 in its version of 30 December 2006 
is replaced by the word “mixture” or “mixtures” respectively throughout the text; 

(2) 

from 1 June 2015, in Article 3, point (l) is replaced by the following:  

“ (l) ‘dangerous substance or mixture’ means any substance or mixture which has to 
be  considered  dangerous  within  the  meaning  of  Article 3(2)  of  Regulation 
(EC) No … of the European Parliament and of the Council*; 

* OJ L…” 

(3) 

in section 1 of Annex II, the thirteenth indent is replaced by the following: 

EN 

13 

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“-  components  containing  refractory  ceramic  fibres  as  described  in  part 3  of 
Annex VI to Regulation (EC) No … of the European Parliament and of the Council*; 
__________________________________________________________ 

* OJ L …” 

Article 6 
Amendment to Directive 2004/42/EC 

Article 2 of Directive 2004/42/EC is amended as follows: 

(a) 

(b) 

in paragraph 3, the word « preparation » is replaced by « mixture »; 

in paragraph 8, the word “preparation” is replaced by “mixture”. 

Article 7 

This Decision is addressed to the Member States. 

Done at Brussels,  

For the European Parliament 
The President 

For the Council 
The President 

EN 

14 

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LEGISLATIVE FINANCIAL STATEMENT 

Policy area(s): 02 – ENTERPRISE 

Activit(y/ies): 04 – GETTING STILL MORE FROM THE INTERNAL MARKET 

TITLE  OF  ACTION:  PROPOSAL  FOR  A  GLOBALLY  HARMONISED  SYSTEM  FOR 

CLASSIFICATION AND LABELLLING OF CHEMICALS 

1. 

PART 1: BUDGET LINES 

1.1. 

Budget  lines  (operational  lines  and  related  technical  and  administrative 
assistance lines (ex- B.A lines)) including headings: 

Not applicable. 

1.2. 

Duration of the action and of the financial impact: 

Not applicable 

For  reasons  explained  under  Section 3.1  of  this  document,  there  are  no  direct 
additional costs related to this legislative proposal on the Community budget.  

Costs,  which  relate  to  the  work  with  Technical  Committees  required  for  this 
legislation  will  be  borne  by  the  European  Chemicals  Agency  (budget 
line 02 03 03), to be established under Commission proposal COM (2003) 644. 

These  costs,  however,  will  not  be  different  from  the  costs  related  to  the 
management  of  existing  legislation  for  the  classification  and  labelling  of 
substances  and  preparations.  This  regulation  replaces  two  other  pieces  of 
Legislation18 at no additional costs to the Community budget. 

1.3. 

Budgetary characteristics (add rows if necessary) 

Budget 
line 

Type of expenditure 

New 

EFTA 
contribution 

Contributions 
from applicant 
countries 

Heading in 
financial 
perspective 

Not applicable 

18 

Council Directive 67/548/EEC relating to the classification, packaging and labelling of dangerous 
substances, as amended [OJ 196, 16.8.1967, p.1] and Council Directive 1999/45/EEC relating to 
the  classification,  packaging  and  labelling  of  dangerous  preparations,  as  amended  [OJL  200, 
30.7.1999, p.1] 

EN 

15 

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2. 

PART 2: SUMMARY OF RESOURCES 

2.1. 

Financial Resources 

2.1.1. 

Summary of commitment appropriations (CA) and payment appropriations (PA) 

Expenditure type 

Section 
no. 

Year 
n 

n + 1 

n + 2 

n + 3 

n + 4 

n + 5 
and 
later 

Total 

EUR million (to 3 decimal places) 

Operational expenditure 

Commitment 
Appropriations (CA) 

6.1 

Payment  Appropriations 
(PA) 

a 

b 

Not applicable 

Administrative expenditure within reference amount 

Technical 
& 
administrative  assistance 
(NDA) 

6.2.4 

c 

Not applicable 

TTOOTTAALL  RREEFFEERREENNCCEE  AAMMOOUUNNTT  

Commitment 
Appropriations 

Payment 
Appropriations 

a+c 

b+c 

Not applicable 

Administrative expenditure not included in reference amount 

Human 
associated 
(NDA) 

resources 

and 
expenditure 

Administrative  costs,  other 
than  human  resources  and 
associated 
not 
included in reference amount 
(NDA) 

costs, 

6.2.5 

d 

0.351  0.351 

0.351 

0.351 

0.351 

0.351 

2.106 

6.2.6 

e 

-- 

-- 

-- 

-- 

-- 

-- 

-- 

Total indicative financial cost of intervention 

TOTAL  CA 
cost 
Resources 

of 

TOTAL  PA 
cost 
Resources 

of 

including 
Human 

including 
Human 

a+c
+d+
e 

b+c
+d+
e 

0.351  0.351 

0.351 

0.351 

0.351 

0.351 

2.106 

-- 

-- 

-- 

-- 

-- 

-- 

-- 

EN 

16 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
  
  
  
  
  
  
 
 
 
 
 
 
 
Co-financing details 

If the proposal involves co-financing by Member States, or other bodies (please 
specify which), an estimate of the level of this co-financing should be indicated 
in the table below (additional lines may be added if different bodies are foreseen 
for the provision of the co-financing): 

Co-financing body 

Year 
n 

n + 1 

n + 2 

n + 3 

n + 4 

n + 5 
and 
later 

Total 

EUR million (to 3 decimal places) 

TOTAL CA including co-
financing 

f 

a+c
+d+
e+f 

Not applicable 

2.1.2.  Compatibility with Financial Programming 

X 

(cid:133) 

(cid:133) 

Proposal is compatible with existing financial programming. 

Proposal will entail reprogramming of the relevant heading in the financial 
perspective. 

Proposal may require application of the provisions of the Interinstitutional 
Agreement  (i.e.  flexibility  instrument  or  revision  of  the  financial 
perspective). 

2.1.3.  Financial impact on Revenue 

X 

(cid:133) 

Proposal has no financial implications on revenue 

Proposal has financial impact – the effect on revenue is as follows: 

Budge
t line 

Revenue 

EUR million (to one decimal place) 

Situation following action 

[Yea
r n] 

[n+1] [n+2] [n+3

] 

[n+4]  [n+5]

19

Prior to
action 
[Year 
n-1] 

a) Revenue in absolute terms 

Not applicable 

b) Change in revenue 

 Δ 

(Please  specify  each  revenue  budget  line  involved,  adding  the  appropriate 
number of rows to the table if there is an effect on more than one budget line.) 

19 

Additional columns should be added if necessary i.e. if the duration of the action exceeds 6 years. 

EN 

17 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
2.2. 

Human Resources FTE (including officials, temporary and external staff) – 
see detail under point 6.2.1. 

Annual requirements  Year n  n + 1 

n + 2 

n + 3 

n + 4 

n + 5 
and 
later 

Total 
number 
human resources 

of 

3 

3 

3 

3 

3 

3 

The  needs  for  human  and  administrative  resources  shall  be  covered  within  the 
allocation granted to the managing DGs (co-responsibility of ENTR and ENV) 
in the framework of the annual allocation procedure. 

3. 

PART 3: CHARACTERISTICS AND OBJECTIVES 

Details  of  the  context  of  the  proposal  are  required  in  the  Explanatory 
Memorandum.  This  section  of  the  Legislative  Financial  Statement  should 
include the following specific complementary information: 

3.1. 

Need to be met in the short or long term 

As explained in 3.2 below, this proposal replaces existing legislation with almost 
the same scope. 

DG  ENV  is  responsible  for  the  existing  legislation  on  the  classification  of 
dangerous  substances  which  is  largely  managed  by  the  European  Chemicals 
Bureau  (ECB)  in  Ispra  under  a  special  agreement  with  DG  ENV;  whereas 
DG ENTR has the responsibility to manage the existing legislation on dangerous 
preparations. While the ECB runs most of the complex Technical Committees, 
which  are  responsible  for  the  preparatory  work,  it  is  the  Commission’s  task  to 
take  the  recommendations  from  the  Technical  Committees  and  manage  the 
associated  Comitology  procedure.  For  this  purpose,  staff  is  maintained  in 
DG ENV and DG ENTR. 

Under  the  new  proposal,  the  work  with  the  Technical  Committees  will  be 
transferred from the ECB to the new European Chemicals Agency in Helsinki. 
The  opinions,  which  the  Committees  of  the  Agency  will  produce,  will  be 
forwarded  to  the  Commission  which  will  then  manage  the  associated 
Comitology procedure. 

Estimates are that the human resources requirements at the Commission will not 
change  with  the  introduction  of  the  new  legislation.  Therefore,  this  legislative 
proposal  does  not  trigger  any  additional  (compared  to  existing  legislation) 
resource requirements. 

EN 

18 

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3.2. 

Value-added  of  Community  involvement  and  coherence  of  the  proposal 
with other financial instruments and possible synergy 

Currently,  there  are  a  large  number  of  different  classification  and  labelling 
(C&L)  systems  for  chemicals  (substances  and  preparations,  GHS  term: 
mixtures)  in  force  in  different  jurisdictions  across  the  world  (e.g.  European 
Union, USA, Canada, Japan, China, Korea, Australia). As a consequence, C&L 
systems  are  different  and  so  is  the  resulting  Health  and  Safety  (H&S) 
information  for  the  same  type  of  substances  and  mixtures  that  originate  in 
different countries. 

In 1992, the UN Conference on Environment and Development (UNCED) in Rio 
de  Janeiro  identified  the  harmonisation  of  classification  and  labelling  systems 
for chemicals as one of its action programmes. 

As  a  result,  a  new  system  has  been  developed  in  co-operation  with  various 
international  organisations.  EU  Member  States, 
the  Commission  and 
stakeholders were heavily involved in this development work. 

In  December 2002,  this  new  system,  the  Globally  Harmonised  System  of 
Classification  and  Labelling  of  Chemicals  (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)  in  Geneva.  The  GHS  was  then  formally  adopted  by  UN 
ECOSOC20 in July 2003 and became available for implementation. 

Despite  the  non-binding  nature  of  the  agreement  the  new  GHS  system  is  a  de 
facto  international  standard.  Besides  participating  in  the  work  to  develop  the 
GHS at UN level, the Commission has announced on several occasions its aim 
to  implement  the  GHS  into  Community  legislation.  On  29 October 2003,  the 
Commission  stated  in  the  explanatory  memorandum  to  the  amendment  to 
67/548/EC, adopted at the same time as the REACH proposal, that: 

“it is the intention of the Commission to propose inclusion of the internationally 
agreed GHS into Community law as soon as possible” 

and, more specifically that: 

“the Commission will come forward with the necessary proposals for having it 
adopted at the same time as the final adoption of the REACH legislation”. 

The  current  proposal  will  replace  2  existing  European  Directives21  including 
more  than  10  Amendments  and  30  Adaptations  to  Technical  Progress.  As  this 

20 
21 

Economic and Social Committee of the United Nations 
Council Directive 67/548/EEC relating to the classification, packaging and labelling of dangerous 
substances, as amended [OJ 196, 16.8.1967, p.1] and Council Directive 1999/45/EEC relating to 

EN 

19 

   EN 

 
                                                 
area was already legislated at European level and it is related to the introduction 
of  an  international  standard  with  the  objective  of  achieving  a  high  level  of 
harmonisation, the Community involvement is justified. 

3.3. 

Objectives,  expected  results  and  related  indicators  of  the  proposal  in  the 
context of the ABM framework 

The  objective  of  the  proposal  is  to  contribute not  only  to the  harmonisation  of 
the internal market but to better protect human health and the environment and 
at  the  same  time  promote  sustainable  development  and  facilitate  international 
trade. 

In  this  context  it  must  be  stated  that  the  existing  situation,  namely  having 
different hazard descriptions for the same substance, does not contribute to the 
protection  of  human  health  nor  does  it  facilitate  international  trade  as  industry 
has to apply different labels for the same substance depending on the region to 
which it wants to export. 

For  the  expected  results  of  the  proposal,  see  the  final  Report  of  the  Impact 
Assessment  of  this  proposal  which  has  made  extensive  use  of  the  detailed 
studies  of  RPA  and  London  Economics  and  also  of  the  responses  to  the 
Stakeholder  Consultation.  Specifically,  the  responses  from  companies  on  the 
costs  have  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. This requires 
a transition period of appropriate length, viz. for substances 3 years to align with 
the  deadline  of  the  classification  and  labelling  inventory,  and  for  mixtures  of 
around  4.5  years  so  as  to  avoid  the  costs  and  risks  of  significant  workability 
bottleneck related with overly short and too long periods. 

Any additional studies regarding the establishment of a base-line scenario or the 
definition  of  indicators  to  measure  the  impact  of  the  proposed  legislation  are 
deemed  to  be  not  proportionate  and  are  therefore  not  being  carried  out.  The 
reasons why such studies are deemed to be not proportionate are the following: 

– 

– 

This legislative proposal relates to the implementation of an international 
agreement.  Even  a  negative  ex-ante  evaluation  would  not  result  in  the 
Commission  not  putting  forward  such  a  legislative  proposal  since  other 
policy options do not exist 

A  negative  ex-post  evaluation  would  not  induce  the  Commission  to 
withdraw  from  its  commitment  to  implement  the  internationally  agreed 
system of Classification and Labelling 

the  classification,  packaging  and  labelling  of  dangerous  preparations,  as  amended  [OJL  200, 
30.7.1999, p.1] 

EN 

20 

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3.4.  Method of Implementation (indicative) 

Show below the method(s) chosen for the implementation of the action. 

X 

Centralised Management 

X  Directly  by  the  Commission  (in  co-operation  with  the  European 

Chemicals Agency, please see below) 

ٱ 

Indirectly by delegation to: 

ٱ 

X 

ٱ 

Executive Agencies 

Bodies set up by the Communities as referred to in Art. 185 of 
the  Financial  Regulation  (European  Chemicals  Agency  to  be 
set up under Commission proposal COM (2003) 644) 

National  public-sector  bodies/bodies  with  public-service 
mission 

ٱ 

Shared or decentralised management 

ٱ 

ٱ 

With Member states 

With Third countries 

ٱ 

Joint management with international organisations (please specify) 

Relevant comments: 

4. 

PART 4: MONITORING AND EVALUATION 

4.1.  Monitoring system 

The Commission services will align the monitoring and evaluation activities on 
the Regulation with the corresponding efforts at UN level and those for REACH.  

UNITAR and OECD will review the extent of convergence of the C&L systems 
over  the  world  as  realised  by  the  GHS,  firstly  to  see  whether  the  expected 
benefits  of  harmonisation  are  realized  and  also  to  identify  the  appropriate  next 
steps towards even more uniform C&L requirements. The Commission services 
will  provide  their  expert  input  to  this  review  work,  based  on  the  GHS 
classifications as registered in the REACH classification and labelling inventory.  

EN 

21 

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4.2. 

Evaluation 

4.2.1.  Ex-ante evaluation 

Based  on  the  five-yearly  reports  from  the  Member  States  (as  required  by 
Article 46 of the Regulation), the Commission will evaluate to which extent the 
Regulation  is  applied  correctly  and  whether  there  are  bottlenecks  in  the 
application.  

The first evaluation (i.e. the one after five years) will focus on the transition of 
substance  classifications  towards  GHS  with  a  view  on  the  then  ongoing 
transition  of  mixture  classifications  and  also  informing  the  review  of  REACH 
foreseen at seven years after entry into force.  

The  second  evaluation  (i.e.  the  one  after  ten  years)  will  be  able  to  assess  the 
complete transition period. Both evaluations can use a sample of chemicals with 
their  “old”  and  “new”  classifications  so  as  to  check  whether  any  significant 
change  of  scope  has  occurred,  and  to  assess  the  (change  in)  quality  of  the 
classifications and labelling. 

4.2.2.  Measures  taken  following  an  intermediate/ex-post  evaluation  (lessons  learned 

from similar experiences in the past) 

Not applicable. 

4.2.3.  Terms and frequency of future evaluation 

Please see 4.2.1 

5. 

PART 5: ANTI-FRAUD MEASURES 

As  this  proposal  does  not  contain  or  result  in  the  management  of  financial 
resources this section is not applicable. 

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22 

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6. 

PART 6: DETAILS OF RESOURCES 

6.1. 

Objectives of the proposal in terms of their financial cost 

(Headings  of  Objectives, 
actions  and  outputs  should 
be provided) 

Type of 
output 

Av. 
cost 

Year n 

Year n+1 

Year n+2 

Year n+3 

Year n+4 

Year n+5 and 
later 

TOTAL 

No. 
outputs 

Total 
cost 

No. 
outputs 

Total 
cost 

No. 
outputs 

Total 
cost 

No. 
outputs 

Total 
cost 

No. 
outputs 

Total 
cost 

No. 
outputs 

Total 
cost 

No. 
outputs 

Total 
cost 

Commitment appropriations in EUR million (to 3 decimal places) 

Not applicable 

OPERATIONAL 
OBJECTIVE No.122 

Action 1 

-  Output 1 

-  Output 2 

Action 2 

-  Output 1 

Sub-total Objective 1 

OPERATIONAL 
OBJECTIVE No.2 1……… 

Action 1 

-  Output 1 

Sub-total Objective 2 

OPERATIONAL 
OBJECTIVE No.n 1 

22 

As described under Section 5.3 

EN 

23 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
Sub-total Objective n 

TOTAL COST 

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24 

 
 
 
 
 
 
6.2. 

Administrative Expenditure 

6.2.1.  Number and type of human resources 

Types of 
post 

Staff to be assigned to management of the action using existing and/or additional 
resources (number of posts/FTEs) 

Year n 

Year n+1 

Year n+2 

Year n+3 

Year n+4 

Year n+5 

A*/AD 

3* 

3* 

3* 

3* 

3* 

3* 

B*, 
C*/AST 

Officials 
or 
temporary 
staff23 
(XX 01 
01) 

Staff  financed24  by 
Art. XX 01 02 

staff25 
Other 
financed  by  Art. XX 
01 04/05 

Not applicable 

TOTAL 

3 

3 

3 

3 

3 

3 

* 

Currently one person DG ENV and two persons DG ENTR 

6.2.2.  Description of tasks deriving from the action 

Under  the  new  legislation  the  opinions  regarding  the  classification  and  labelling 
formulated by the Committees of the Agency will be forwarded to the Commission. 
It will then be the task of the Commission to manage the related Comitology work. 

In addition, the Commission will continue to participate in the evolutive work on the 
GHS system on the level of the United Nations. 

6.2.3. 

Sources of human resources (statutory) 

(cid:133) 

(cid:133) 

(cid:133) 

X 

Posts currently allocated to the management of the programme to be replaced 
or extended 

Posts pre-allocated within the APS/PDB exercise for year n 

Posts to be requested in the next APS/PDB procedure 

Posts  to  be  redeployed  using  existing  resources  within  the  managing  service 
(internal redeployment) 

23 
24 
25 

Cost of which is NOT covered by the reference amount 
Cost of which is NOT covered by the reference amount 
Cost of which is included within the reference amount 

EN 

25 

   EN 

 
 
 
 
                                                 
(cid:133) 

Posts required for year n although not foreseen in the APS/PDB exercise of the 
year in question 

6.2.4.  Other  Administrative  expenditure  included  in  reference  amount  (XX 01 04/05  – 

Expenditure on administrative management) 

Budget line 

(number and heading) 

EUR million (to 3 decimal places) 

Year 
n 

Year 
n+1 

Year 
n+2 

Year 
n+3 

Year 
n+4 

Year 
n+5 

and 
later 

TOTAL 

1.  Technical 

and 

administrative 
assistance  (including  related  staff 
costs) 

  Executive agencies26 

  Other 

technical  and  administrative 

assistance 

-  Intra muros 

-  Extra muros 

  Total  Technical  and  administrative 

assistance 

Not applicable 

6.2.5.  Financial cost of human resources and associated costs not included in the reference 

amount 

Type of human resources 

Year n 

Year n+1  Year n+2  Year n+3  Year n+4 

Year n+5 

and later 

EUR million (to 3 decimal places) 

Officials and temporary staff (XX 01 
01) 

Staff  financed  by  Art  XX  01  02 
(auxiliary, END, contract staff, etc.) 

(specify budget line) 

Total cost of Human Resources 
and associated costs (NOT in 
reference amount) 

0.351 

0.351 

0.351 

0.351 

0.351 

0.351 

-- 

-- 

-- 

-- 

-- 

-- 

0.351 

0.351 

0.351 

0.351 

0.351 

0.351 

26 

Reference should be made to the specific legislative financial statement for the Executive Agency(ies) 
concerned. 

EN 

26 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
Calculation – Officials and Temporary agents 

Reference should be made to Point 6.2.1, if applicable. 

It  is  assumed  that  the  average  cost  for  an  AD  official  or  temporary  agent  is  €  117.000  per 
year. 

Calculation – Staff financed under Art. XX 01 02 

Reference should be made to Point 6.2.1, if applicable. 

6.2.6 Other administrative expenditure not included in reference amount 

EUR million (to 3 decimal places) 

Year 
n 

Year 
n+1 

Year 
n+2 

Year 
n+3 

Year 
n+4 

Year 
n+5 

and 
later 

TOTAL 

XX 01 02 11 01 – Missions 

XX 01 02 11 02 – Meetings & Conferences 

XX 01 02 11 03 – Committees* 

XX 01 02 11 04 – Studies & consultations 

Not applicable 

XX 01 02 11 05 - Information systems 

2.  Total 

Other 
Expenditure (XX 01 02 11) 

Management 

3.  Other 

expenditure 

administrative 
including reference to budget line) 

nature 

of 

an 
(specify 

Total Administrative expenditure, other 
than human resources and associated 
costs (NOT included in reference 
amount) 

* 

The  Technical  Committees  required  for  this  legislative  proposal  are  Committees 
established at the level of the new European Chemicals Agency. Their tasks include 
inter alia work related to Classification and Labelling. All costs for these Technical 
Committees will be borne by the budget of the Chemicals Agency. 

EN 

27 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
* 

* 

The Comitology Committee required for the management of the new legislation will 
most  likely  be  the  same  Committee  as  the  one  required  for  the  REACH  legislation. 
Therefore, no additional costs will occur for Committee work. 

The  needs  for  human  and  administrative  resources  shall  be  covered  within  the 
allocation granted to the managing DGs (co-responsibility of ENTR and ENV) in the 
framework of the annual allocation procedure. 

Calculation - Other administrative expenditure not included in reference amount 

EN 

28 

   EN