Proposal for a Regulation of the European Parliament and of the Council amending Regulation (EC) No 648/2004 in order to adapt it to Regulation (EC) No … on Classification, Labelling and Packaging of Substances and Mixtures, and amending Directive 67/548/EEC and Regulation (EC) No 1907/2006 {SEC(2007) 1337} {SEC(2007) 1338}
Date: 2007-10-17
Institutions: European Commission
Subjects: budget, chemical product, dangerous substance, impact study, labelling, packaging

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 17.10.2007 
COM(2007) 613 final 

2007/0213 (COD) 

Proposal for a 

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

amending Regulation (EC) No 648/2004 
in order to adapt it to Regulation (EC) No … 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) 1337} 
{SEC(2007) 1338} 

EN 

   EN 

 
 
 
  
 
 
TABLE OF CONTENTS 

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending 
Regulation (EC) No 648/2004 in order to adapt it to Regulation (EC) No … on Classification, 
Labelling and Packaging of Substances and Mixtures, and amending Directive 67/548/EEC 
and Regulation (EC) No 1907/2006........................................................................................... 1 

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 .................................................................................................. 4 

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

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

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

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

Proportionality............................................................................................................................ 5 

Choice of legal instrument ......................................................................................................... 5 

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

1. 

2. 

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

Detailed provisions....................................................................................................... 6 

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending 
Regulation (EC) No 648/2004 in order to adapt it to Regulation (EC) No … on Classification, 
Labelling and Packaging of Substances and Mixtures, and amending Directive 67/548/EEC 
and Regulation (EC) No 1907/2006........................................................................................... 7 

LEGISLATIVE FINANCIAL STATEMENT......................................................................... 10 

EN 

2 

   EN 

 
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, 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  Regulation  aims  to  make  such  changes  to  such  a  downstream  act,  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  Decision 
aiming  to  make  changes  in  order  to  address  the  effects  of  the  proposal  on  classification, 
labelling and packaging for six existing Directives. 

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  Regulation  proposes  such  changes  to  the 
provisions of Regulation (EC) No 648/2004. 

A proposal for a Regulation concerning the placing on the market of plant protection products 
is currently under discussion in the European Parliament and the Council. Once this proposal 
is  adopted,  the  present  proposal  for  a  Regulation  on  amending  EU  downstream  legislation 
should  be  revised  in  order  to  include  also  the  Plant  Protection  Products  Regulation,  or  a 
separate amending proposal should be presented, if appropriate. 

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.  To  the  extent  this  proposal 
addresses an existing Regulation, it does not require transposition at Member State level. 

1 

COM(2007) 355 final. 

EN 

3 

   EN 

 
                                                 
RESULTS OF PUBLIC CONSULTATIONS AND IMPACT ASSESSMENTS 

Public stakeholder consultation 

Internet consultation 

The  Commission  launched  a  public  stakeholder consultation  on  the  proposal  for  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  proposed  Regulation  on  classification, 
labelling and packaging of substances and mixtures. Regulation (EC) 648/2004 does not base 
any additional obligation on the classification of substances and mixtures. 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 

EN 

4 

   EN 

 
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 is based on Article 95 of the EC Treaty. This legal basis is appropriate for this 
proposed  Regulation  because  it  adapts  an  existing  Regulation,  which  is  itself  based  on 
Article 95  of  the  EC  Treaty,  to  the  proposed  Regulation  on  classification,  labelling  and 
packaging of substances and mixtures. 

Subsidiarity and proportionality 

Subsidiarity 

An existing Regulation in the field of detergents already contains substantive legal provisions. 
The proposed Regulation will amend the existing Regulation to adapt it 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  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 and the rules on the 
labelling and packaging of hazardous substances and mixtures are contained in the proposal 
for  a  Regulation  on  classification,  labelling  and  packaging  of  substances  and  mixtures.  To 
ensure legal certainty and clarity of the obligations of the operators concerned, the provisions 
of  Regulation  (EC) 648/2004  should  be  amended  to  reflect  the  new  situation.  This  is 
especially  important  as  Regulations  are  directly  applicable  in  the  Member  States  and 
operators should be in no doubt as to the obligations which apply to them.  

In ensuring this, this proposal for a Regulation is proportionate. 

Choice of legal instrument 

The choice of a Regulation is justified, as it amends an existing Regulation. 

2 

3 

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. 

EN 

5 

   EN 

 
                                                 
 
INTRODUCTION TO THE PROPOSAL 

This proposed Regulation amends an existing Regulation to the provisions of the proposal for 
a Regulation on classification, labelling and packaging of substances and mixtures which will 
repeal and replace Directives 67/548/EEC and 1999/45/EC. 

1. 

REASONS AND OBJECTIVES 

The  objective  of  this  Regulation  is  to  reflect  the  introduction  of  a  new  Regulation  on 
classification, labelling and packaging of substances and mixtures and of new terminology for 
a Regulation which refers to classification of substances or mixtures. The term “mixture” is 
introduced  to  replace  the  term  “preparation”,  in  line  with  the  proposal  on  classification  and 
labelling of substances and mixtures.  

2. 

DETAILED PROVISIONS 

Article 1  introduces  the  required  changes  to  Regulation (EC) No 648/2004  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  in  the  previous  section.  As  far  as  Regulation 
(EC) No 648/2004  makes  general  references  to  Directives 67/548/EEC  and  1999/45/EC, 
which  will  be  repealed  by  the  Regulation  on  classification,  labelling  and  packaging  of 
substances and mixtures, it needs to be updated so as to refer to that Regulation. 

The staggered dates of entry into effect of the changes reflect the phased entry into effect of 
the aforementioned proposal for a Regulation. 

EN 

6 

   EN 

 
2007/0213 (COD) 

Proposal for a 

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

amending Regulation (EC) No 648/2004 
in order to adapt it to Regulation (EC) No … 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 Commission4, 

Having regard to the opinion of the European Economic and Social Committee5, 

Acting in accordance with the procedure laid down in Article 251 of the Treaty6, 

Whereas: 

(1) 

the  European  Parliament  and  of 

and  Regulation (EC) No 1907/20067  provides 

Regulation (EC) No …  of 
the  Council  on 
classification,  labelling  and  packaging  of  substances  and  mixtures,  and  amending 
the 
Directive 67/548/EEC 
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 substances8 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 preparations9. 

for 

(2) 

Regulation (EC) No …  builds  on  the  experience  of  Directives 67/548/EEC  and 
1999/45/EC and incorporates the criteria for classification and labelling of substances 

4 
5 
6 
7 
8 

9 

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  last  amended  by  Regulation  (EC)  No  1907/2006  (OJ  L  396, 
30.12.2006, p. 1). 

EN 

7 

   EN 

 
                                                 
(3) 

(4) 

(5) 

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 Regulation (EC) No 648/2004 of the European Parliament and of 
the Council of 31 March 2004 on detergents10. 

An  analysis  of  the  potential  effects  of  replacing  Directives 67/548/EEC  and 
1999/45/EC  and  the  introduction  of  the  GHS  criteria  led  to  the  conclusion  that  by 
adapting the references to those Directives in Regulation (EC) No 648/2004, the scope 
of that act should be maintained. 

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 detergents 
the  meaning  of 
importers  or  downstream  users  within 
are  manufacturers, 
Regulation (EC) No …  and  should  be  given  the  possibility  under  this  Regulation  to 
adjust  to  that  transition  within  a  similar  timeframe  as  that  provided  for  in 
Regulation (EC) No …. 

(6) 

Regulation (EC) No 648/2004 should be amended accordingly. 

HAVE ADOPTED THIS REGULATION: 

Article 1 
Amendment to Regulation (EC) No 648/2004 

Regulation (EC) No 648/2004 is amended as follows: 

(1) 

the  word  “preparation”  or  “preparations”  within  the  meaning  of  Article 3(2)  of 
Regulation  (EC) 1907/2006  of  the  European Parliament and  of the Council11, in its 
version  of  30  December  2006,  is  replaced  by  the  word  « mixture »  or  “mixtures” 
respectively throughout the text; 

(2) 

in paragraph 1 of Article 9, the introductory phrase is replaced by the following: 

“Without  prejudice  to  Article 45  of  Regulation  (EC) No …  of  the  European 
Parliament and of the Council*, manufacturers placing on the market the substances 
and/or  mixtures  covered  by  this  Regulation  shall  hold  at  the  disposal  of  the 
competent authorities of the Member States:; 

_________________________________________________________________

* OJ L …” 

(3) 

in Article 11, paragraph 1 is replaced by the following: 

10 

11 

OJ L 104, 8.4.2004, p. 1. Regulation as amended by Commission Regulation (EC) No 907/2006 (OJ L 
168, 21.6.2006, p.5). 
OJ L 396, 30.12.2006, p. 1. 

EN 

8 

   EN 

 
 
                                                 
“1.  Paragraphs  2  to  6  are  without  prejudice  to  the  provisions  relating  to  the 
classification,  labelling  and  packaging  of  substances  and  mixtures  in  Regulation 
(EC) No ….”. 

Article 2 
Entry into force and application 

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

Points (2) and (3) of Article 1 shall apply 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 

EN 

9 

   EN 

 
 
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), 
proposal 
COM (2003) 644. 

under  Commission 

established 

be 

to 

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 
Legislation12 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 

12 

EN 

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

[OJ  196,  16.8.1967,  p.1] 

substances, 

amended 

as 

10 

   EN

 
 
                                                 
2. 

PART 2: SUMMARY OF RESOURCES 

2.1. 

Financial Resources 

2.1.1. 

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

EUR million (to 3 decimal places) 

Expenditure type 

Section 
no. 

Year 
n 

n + 1 

n + 2 

n + 3 

n + 4 

n + 5 
and 
later 

Total 

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 

-- 

-- 

-- 

-- 

-- 

-- 

-- 

Co-financing details 

EN 

11 

   EN

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
  
  
  
  
  
  
 
 
 
 
 
 
 
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): 

EUR million (to 3 decimal places) 

Co-financing body 

Year 
n 

n + 1 

n + 2 

n + 3 

n + 4 

n + 5 
and 
later 

Total 

TOTAL CA including co-
financing 

f 

a+c
+d+
e+f 

Not applicable 

2.1.2.  Compatibility with Financial Programming 

X 

Proposal is compatible with existing financial programming. 

(cid:133) 

(cid:133) 

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

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

require  application  of 

the  provisions  of 

2.1.3.  Financial impact on Revenue 

X 

Proposal has no financial implications on revenue 

(cid:133) 

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]

13

Prior to
action 
[Year 
n-1] 

a) Revenue in absolute terms 

Not applicable 

b) Change in revenue 

 Δ 

13 

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

EN 

12 

   EN

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
(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.) 

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 

number 
Total 
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 

13 

   EN

 
 
 
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 
ECOSOC14 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 Directives15 including 
more  than  10  Amendments  and  30  Adaptations  to  Technical  Progress.  As 
this  area  was  already  legislated  at  European  level  and  it  is  related  to  the 

14 
15 

EN 

Economic and Social Committee of the United Nations 
Council  Directive 67/548/EEC  relating  to  the  classification,  packaging  and  labelling  of 
and  Council 
dangerous 
Directive 1999/45/EEC  relating  to  the  classification,  packaging  and  labelling  of  dangerous 
preparations, as amended [OJL 200, 30.7.1999, p.1] 

[OJ  196,  16.8.1967,  p.1] 

substances, 

amended 

as 

14 

   EN

 
                                                 
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: 

– 

– 

legislative  proposal  relates 

This 
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 

the 

to 

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 

3.4.  Method of Implementation (indicative) 

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

X 

Centralised Management 

EN 

15 

   EN

 
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.  

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.  

EN 

16 

   EN

 
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. 

EN 

17 

   EN

 
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.116 

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 

16 

As described under Section 5.3 

EN 

18 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
Sub-total Objective n 

TOTAL COST 

EN 

19 

 
 
 
 
 
 
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 
staff17 
(XX 01 
01) 

Staff  financed18  by 
Art. XX 01 02 

staff19 
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) 

17 
18 
19 

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 

20 

   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 agencies20 

  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 

20 

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

EN 

21 

   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 

22 

   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 

23 

   EN