Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Council Directives 92/58/EEC, 92/85/EEC, 94/33/EC, 98/24/EC and Directive 2004/37/EC of the European Parliament and of the Council , in order to align them to Regulation (EC) No. 1272/2008 on classification, labelling and packaging of substances and mixtures
Date: 2013-02-26
Institutions: European Commission
Subjects: classification, dangerous substance, labelling, occupational safety, packaging, public health

EUROPEAN 
COMMISSION 

Brussels, 26.2.2013  
COM(2013) 102 final 

2013/0062 (COD) 

Proposal for a 

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

amending Council Directives 92/58/EEC, 92/85/EEC, 94/33/EC, 98/24/EC and Directive 
2004/37/EC of the European Parliament and of the Council , in order to align them to 
Regulation (EC) No. 1272/2008 on classification, labelling and packaging of substances 
and mixtures 

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EXPLANATORY MEMORANDUM 

1. 

CONTEXT OF THE PROPOSAL 

Grounds for and objectives of the proposal 

Article 153(1)(a) of the Treaty on the Functioning of the European Union (hereinafter TFEU) 
stipulates that ‘the Union shall support and complement the activities of the Member States in 
improvement  of  the  working  environment  to  protect  workers’  health  and  safety’.  Under 
Article  153(2)  of  the  TFEU,  the  Commission  may  propose  directives  which  lay  down 
minimum  requirements  for  gradual  implementation,  having  regard  to  the  conditions  and 
technical rules obtaining in each of the Member States. 

On  the  basis  of  these  legal  provisions,  an  appropriate  occupational  safety  and  health 
framework has been adopted with a view to protecting workers’ health and safety from risks 
due to exposure to chemicals at the workplace. Following the adoption of Regulation (EC) No 
1272/2008  of  the  European  Parliament  and  of  the  Council  on  classification,  labelling  and 
packaging  (CLP)  of  substances  and  mixtures1,  in  order  to  implement,  within  the  European 
Union,  the  United  Nations  Globally  Harmonised  System  of  Classification  and  Labelling  of 
Chemicals (hereinafter GHS)2, certain aspects of this legal framework need to be adapted. 
Directives  92/58/EEC3,  92/85/EEC4,  94/33/EC5,  98/24/EC6  and  2004/37/EC7  contain 
references  to  EU  chemical  classification  and  labelling  legislation.  If  these  Directives  are  to 
remain effective, they need to be aligned to the new legislation in this area. Thus, the aim of 
the present Directive is to update references and terminology of the five aforesaid Directives 
to  bring  them  into  line  with  the  applicable  EU  chemical  classification  and  labelling 
legislation.  In  doing  so,  no  changes  to  the  scope  or  level  of  protection  provided  by  these 
Directives are required. 

1 

2 

3 

4 

5 
6 

7 

Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on 
classification, labelling and packaging of substances and mixtures, amending and repealing Directives 
67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 216, 20.8.1994, p. 
12)(hereafter the CLP Regulation). 
The Globally Harmonised System of Classification and Labelling of Chemicals provides a harmonised 
basis for globally uniform physical, environmental and health and safety information on  hazardous 
chemical  substances  and  mixtures.  With  its  Plan  of  Implementation,  adopted  in  Johannesburg  on  4 
September  2002,  the  World  Summit  on  Sustainable  Development  encouraged  countries  to  implement 
the harmonised system as soon as possible, with a view to making it fully operational by  2008. 
Council Directive 92/58/EEC of 24 June 1992 on the minimum requirements for the provision of safety 
and/or health signs at work (ninth individual Directive within the meaning of Article 16 (1) of Directive 
89/391/EEC) (OJ L 245, 26.8.1992, p. 23). 
Council  Directive  92/85/EEC  of  19  October  1992  on  the  introduction  of  measures  to  encourage 
improvements  in  the  safety  and  health  at  work  of  pregnant  workers  and  workers  who  have  recently 
given  birth  or  are  breastfeeding  (tenth  individual  Directive  within  the  meaning  of  Article  16  (1)  of 
Directive 89/391/EEC) (OJ L 348, 28.11.1992, p. 1). 
Council Directive 94/33/EC on the protection of young people at work (OJ L 216, 20.8.1994, p. 12). 
Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from 
the  risks  related  to  chemical  agents  at  work  (fourteenth  individual  Directive  within  the  meaning  of 
Article 16(1) of Directive 89/391/EEC )( OJ L 131, 5.5.1998, p. 11). 
Directive 2004/37/EC of the European Parliament and of the Council of 29 April 2004 on the protection 
of  workers  from  the  risks  related  to  exposure  to  carcinogens  or  mutagens  at  work  (Sixth  individual 
Directive within the meaning of Article 16(1) of Council Directive 89/391/EEC) (OJ L 158, 30.4.2004, 
p. 50). 

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General context 

The GHS is a United Nations system for identifying hazardous chemicals and informing users 
about the related hazards by means of standard symbols and phrases on packaging labels, and 
safety data sheets. 

Following  successful  negotiations  on  the  Commission’s  proposal,  the  European  Parliament 
and the Council adopted the CLP Regulation on 16 December 2008. This Regulation aligns 
the  existing  EU  legislation  to  the  GHS  and  was  published  in  the  Official  Journal  on  31 
December 2008. 

The CLP Regulation entered into force on 20 January 2009. The deadlines for classification in 
accordance  with  the  new  rules  are  1  December  2010  for  substances  and  1  June  2015  for 
mixtures.  The  CLP  Regulation  will  ultimately  replace  the  current  rules  on  classification, 
labelling  and  packaging  of  substances  (Directive  67/548/EEC)  and  preparations  (Directive 
1999/45/EC) after the transitional period provided for in its Article 61. 

The CLP Regulation is expected to facilitate global trade and harmonised communication of 
information  on  hazards  posed  by  chemicals  and  to  promote  regulatory  efficiency.  It  will 
complement the ‘REACH Regulation’8. 

Implementation  of  the  GHS  in  the  European  Union  via  the  CLP  Regulation  will  require 
companies to  classify,  label and package their substances and  mixtures  appropriately  before 
placing  them  on  the  market  after  a  transitional  period  during  which  the  two  systems,  CLP 
Regulation and the combination of the substances and preparations directives, will apply side 
by side. The aim is to protect workers, consumers and the environment by means of labelling 
and indicating any potential hazardous effects of chemicals. 

The safety data sheets provided by suppliers of chemicals are a major source of information 
for  employers  and  workers.  Transitional  arrangements  will  also  apply  to  the  legislative 
requirements  governing  safety  data  sheets  which  are  now  regulated  in  Article  31  of  the 
REACH Regulation. 

The aforementioned five Directives need to be amended in order to update the references to 
the EU chemical classification and labelling legislation described above, without any changes 
to the scope or level of protection provided by these Directives. 

Consistency with other European Union policies and objectives 

This proposal relates to the key action on quality of work and working conditions identified in 
the Flagship initiative ‘An agenda for new skills and jobs9’ 

It is consistent with the objectives of other policies of the European Union, in particular those 
aiming  at  improvement  of  the  regulatory  framework  in  order  to  develop  a  clear, 

8 

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Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 
concerning  the  Registration,  Evaluation,  Authorisation  and  Restriction  of  Chemicals  (REACH), 
establishing  a  European  Chemicals  Agency,  amending  Directive  1999/45/EC  and  repealing  Council 
Regulation  (EEC)  No  793/93  and  Commission  Regulation  (EC)  No  1488/94  as  well  as  Council 
Directive  76/769/EEC  and  Commission  Directives  91/155/EEC,  93/67/EEC,  93/105/EC  and 
2000/21/EC. 
Communication  from  the  Commission  to  the  European  Parliament,  the  Council,  the  European 
Economic  and  Social  Committee  and  the  Committee  of  the  Regions  – An  Agenda for new skills  and 
jobs: A European contribution towards full employment, COM(2010) 682. 

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understandable, up-to-date and user-friendly body of secondary EU legislation, in the interests 
of citizens and economic operators. 

2. 

CONSULTATION OF INTERESTED PARTIES AND IMPACT ASSESSMENT 

Consultation of interested parties 

-  Consultation  of  the  Advisory  Committee  on  Safety  and  Health  at  Work  (ACSHW),  in 
accordance  with  the  Council  Decision  of  22  July  2003  setting  up  that  Committee10.  The 
Committee adopted its opinion on 1 December 2011. 

- Consultation of the social partners in accordance with Article 154(2) and (3) of the TFEU. 
The  first-stage  consultation  (Article  154(2)  of  the  TFEU)  took  place  between  9  December 
2009 and 26 March 2010. The second-stage consultation (Article 154(3) of the TFEU) took 
place between 17 January and 17 March 2011. 

The results can be summarised as follows: 

• 

• 

• 

• 

Five  out  of  six  social  partners  which responded agree  with  the  content  of  the 
envisaged regulatory initiative. 

The majority of the respondents agree with the approach of a single amending 
Directive.  One  of  the  workers’  representatives  suggested  that  the  required 
amendments should be done separately and not by means of a single amending 
Directive, as two of the five Directives in question are currently under review 
for other reasons. 

An  approach  that  includes  maintaining  a  formal  link  to  the  EU  chemical 
classification system (the CLP Regulation) is commonly preferred. 

The social partners are in favour of  additional non-binding measures that  can 
help  employers  and  workers  to  understand  occupational  safety  and  health 
issues arising from the new requirements for chemical classification, labelling 
and  packaging.  Explanatory  guidance,  in  particular  for  SMEs,  would  be 
considered  useful.  The  Commission,  in  cooperation  with  the  ACSHW,  has 
prepared guidance material which will be published in the near future. 

• 

None of the social partners wished to initiate a dialogue on the matter. 

Impact assessment 

The  proposed  amendments  to  the  five  aforesaid  Directives  maintain  the  current  level  of 
worker  protection  with  no  additional  requirements  being  introduced.  Thus,  the  proposed 
changes do not create any significant impact that would require a formal impact assessment to 
be carried out. 

A  full  impact  assessment  for  the  primary  piece  of  legislation,  the  European  Parliament  and 
Council  Regulation  (EC)  No  1272/2008  on  classification,  labelling  and  packaging  of 
substances and mixtures, was presented during 200711. 

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11 

Council Decision of 22 July 2003 setting up an Advisory Committee on Safety and Health at Work (OJ 
C 218, 13.9.2003, p. 1). 
Proposal for a Regulation of the European Parliament and of the Council on classification, labelling and 
packaging  of  substances  and  mixtures,  and  amending  Directive  67/548/EEC  and  Regulation  (EC)  No 
1907/2006. Impact Assessment; COM(2007) 355 final. 

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3. 

LEGAL ELEMENTS OF THE PROPOSAL 

Summary of the proposed measures 

The proposal amends the relevant articles and annexes of Directives 92/58/EEC, 92/85/EEC, 
94/33/EC,  98/24/EC  and  2004/37/EC,  in  order  to  achieve  the  objectives  mentioned  under 
point 1 above. 

Legal basis 

Article 153(2) of the TFEU. 

Subsidiarity principle 

The subsidiarity principle applies in so far as the proposal concerns a field – protection of the 
health and safety of workers at work – which does not fall under the exclusive competence of 
the European Union. 

The  objectives  of  the  proposal  cannot  be  achieved  sufficiently  by  the  Member  States 
themselves, as the provisions of Directives cannot be amended or repealed at national level. 

The objectives of the proposal can be achieved only by Union action, entailing amendment of 
an  act  of  EU  law  that  is  currently  in  force,  which  cannot  be  done  by  the  Member  States 
themselves. 

The principle of subsidiarity is respected in as much as the proposal amends existing Union 
legislation. 

Proportionality principle 

The proposal complies with the proportionality principle. The minimum EU action necessary 
to ensure the continued effectiveness of existing policy will be taken, without introducing any 
additional requirements. 

Choice of instrument 

Proposed instrument: Directive. 

No other instrument would have been suitable. The aim is to amend five EU Directives and 
the only way to do this is to adopt another Directive. 

4. 

BUDGETARY IMPLICATIONS 

The proposal has no implications for the Union budget. 

5. 

ADDITIONAL INFORMATION 

Simplification 

The  proposal  contributes  to  the  simplification  of  the  legislative  framework  by  introducing 
appropriate proportionality and flexibility. 

Repeal of existing legislation 

Not applicable. This proposal contains only amendments to existing Directives. 

European Economic Area 

This draft instrument is concerned with a subject covered by the  EEA  Agreement  and  must 
therefore extend to the European Economic Area. 

Detailed explanation of the proposal by article 

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Articles  1  to  5  introduce  the  required  changes  to  the  relevant  provisions  of  Directives 
92/58/EEC,  92/85/EEC,  94/33/EC,  98/24/EC  and  2004/37/EC,  in  order  to  align  them  to  the 
references  to  the  European  Parliament  and  Council  Regulation  (EC)  No  1272/2008  on 
classification, labelling and packaging of substances and mixtures. 

Regarding  the  non-exhaustive  list  of  agents  mentioned  in  the  Annex,  Part  I,  Section  3  of 
Directive  94/33/EC,  an  exact  correlation  between  the  pre-existing  and  new  chemical 
classification systems cannot be achieved. The proposal therefore presents an alignment that 
may  result  in  a  limited  number  of  additional  substances  coming  within  the  scope  of  the 
Annex.  However,  the  proposed  changes  are  designed  to  maintain  the  policy  objective  of 
Article 7 of this Directive, which remains unchanged. 

Articles 6 and 7 concern the transposition, entry into force and application of the Directive. 

Article 8 is a standard article reflecting the legal nature of a Directive. 

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2013/0062 (COD) 

Proposal for a 

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

amending Council Directives 92/58/EEC, 92/85/EEC, 94/33/EC, 98/24/EC and Directive 
2004/37/EC of the European Parliament and of the Council , in order to align them to 
Regulation (EC) No. 1272/2008 on classification, labelling and packaging of substances 
and mixtures 

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, 

Having  regard  to  the  Treaty  on  the  Functioning  of  the  European  Union,  and  in  particular 
Article 153(2) thereof, 

Having regard to the proposal from the European Commission, 

After transmission of the draft legislative act to the national Parliaments, 
Having regard to the opinion of the European Economic and Social Committee12, 
Having regard to the opinion of the Committee of the Regions13, 

Acting in accordance with the ordinary legislative procedure, 

Whereas: 

(1) 

(2) 

(3) 

According to Article 153 of the Treaty, the European Parliament and the Council may 
adopt, by means of directives, minimum requirements for encouraging improvements, 
especially  in  the  working  environment,  to  ensure  a  better  level  of  protection  of  the 
health  and  safety  of  workers.  Such  directives  must  avoid  imposing  administrative, 
financial  and  legal  constraints  in  a  way  which  would  hold  back  the  creation  and 
development of small and medium-sized undertakings. 

Article  31(1)  of  the  Charter  of  Fundamental  Rights  of  the  European  Union  provides 
that every worker has the right to working conditions which respect his or her health, 
safety and dignity. 

Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 
December  2008  on  classification,  labelling  and  packaging  of  substances  and 
mixtures14 established a new system for the classification and labelling of substances 
and  mixtures  within  the  Union,  based  on  the  Globally  Harmonised  System  of 
Classification  and  Labelling  of  Chemicals  (GHS)  at  international  level,  within  the 
United Nations Economic Commission for Europe structure. 

(4) 

Council Directives 92/58/EEC of 24 June 1992 on the minimum requirements for the 
provision  of  safety  and/or  health  signs  at  work15,  92/85/EEC  of  19  October  1992  on 

12 
13 
14 
15 

OJ C , , p. . 
OJ C , , p. . 
OJ L 353, 31.12.2008, p. 1. 
OJ L 245, 26.8.1992, p. 23. 

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the  introduction  of  measures  to  encourage  improvements  in  the  safety  and  health  at 
work  of  pregnant  workers  and  workers  who  have  recently  given  birth  or  are 
breastfeeding 16, 94/33/EC on the protection of young people at work17, and 98/24/EC 
on the protection of the health and safety of workers from the risks related to chemical 
agents  at  work18,  and  Directive  2004/37/EC  of  the  European  Parliament  and  of  the 
Council  of  29  April  2004  on  the  protection  of  workers  from  the  risks  related  to 
exposure  to  carcinogens  or  mutagens  at  work  19  contain  references  to  the  previous 
classification and labelling system. They should therefore be amended in order to align 
them to the new system laid down in Regulation (EC) No 1272/2008. 

Those amendments are necessary to ensure the continued effectiveness of the above-
mentioned Directives. 

Section  I  point  2  and  Section  II  point  1  of  the  Annex  to  Directive  94/33/EC  contain 
references to repealed Directives 90/679/EEC of 26 November 1990 on the protection 
of  workers  from  risks  related  to  exposure  to  biological  agents  at  work20  and 
90/394/EEC  of  28  June  1990  on  the  protection  of  workers  from  the  risks  related  to 
exposure to carcinogens at work21. Those references should therefore be replaced by 
references  to  the  relevant  provisions  of  Directive  2000/54/EC  of  the  European 
Parliament  and  of  the  Council  of  18  September  2000  on  the  protection  of  workers 
from risks related to exposure to biological agents at work22 and Directive 2004/37/EC 
of the European Parliament and of the Council of 29 April 2004 on the protection of 
workers from the risks related to exposure to carcinogens or mutagens at work23. 

In  accordance  with  Article  154  of  the  Treaty,  the  Commission  consulted  the  social 
partners on the possible direction of Union action in this field. 

Following  this  consultation,  the  Commission  considered  that  Union  action  was 
desirable and consulted the social partners on the content of the envisaged proposal, in 
accordance with Article 154 of the Treaty. 

Following this second phase of consultation, the social partners did not wish to initiate 
the process which could lead to the conclusion of an agreement, as set out in Article 
154 of the Treaty, 

(5) 

(6) 

(7) 

(8) 

(9) 

HAVE ADOPTED THIS DIRECTIVE: 

Article 1  
Amendments to Directive 92/58/EEC 

Directive 92/58/EEC is amended as follows: 

(1) 

Article 1(2) is replaced by the following: 

‘2.  This  Directive  shall  not  apply  to  signs  for  the  placing  on  the  market  of  hazardous 
substances  and  mixtures,  and  dangerous  products  and/or  equipment,  unless  other  Union 
provisions make specific reference thereto.’ 

16 
17 
18 
19 
20 
21 
22 
23 

OJ L 348, 28.11.1992, p. 1. 
OJ L 216, 20.8.1994, p. 12. 
OJ L 131, 5.5.1998, p. 11. 
OJ L 158, 30.4.2004, p. 50. 
OJ L 374, 31.12.1990, p.1. 
OJ L 196, 23.7.1990, p.1. 
OJ L 262, 17.10.2000, p. 21. 
OJ L 158, 30.4.2004, p. 50. 

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(2) 

In  Annex  I,  Section  12,  the  word  ‘dangerous’  is  replaced  by  ‘hazardous’  and  the 
word ‘preparations’ by ‘mixtures’. 

(3) 

Annex III is amended as follows: 

(a) Section 1 is replaced by the following: 

‘1.  Containers  used  at  work  for  chemical  substances  or  mixtures  classified  as  hazardous 
according to the criteria for any of the hazard classes or categories 2.1 to 2.4, 2.6 and 2.7, 2.8 
types A and B, 2.9, 2.10, 2.12, 2.13 categories 1 and 2, 2.14 categories 1 and 2, 2.15 types A 
to  F,  3.1  to  3.6,  3.7  adverse  effects  on  sexual  function  and  fertility  or  on  development,  3.8 
effects  other  than  narcotic  effects,  3.9  and  3.10  in  accordance  with  Regulation  (EC)  No 
1272/2008  of  the  European  Parliament  and  of  the  Council  on  classification,  labelling  and 
packaging of substances and mixtures, and containers used for the storage of such hazardous 
substances  or  mixtures,  together  with  the  visible  pipes  containing  or  transporting  hazardous 
substances  and  mixtures,  must  be  labelled  with  appropriate  pictograms  in  accordance  with 
that Regulation.’ 

(b) In Section 5 the word ‘dangerous’ is replaced by ‘hazardous’ and the word ‘preparations’ 
by ‘mixtures’. 

Article 2  
Amendments to Directive 92/85/EEC 

Annex I to Directive 92/85/EEC is amended as follows: 

(1) 

Section A, point 2, is replaced by the following: 

‘2. Biological agents 
Biological agents of risk groups 2, 3 and 4 within the meaning of Article 2 numbers 2, 3 and 4 
of Directive 2000/54/EC24, in so far as it is known that such agents or the therapeutic 
measures necessitated by them endanger the health of pregnant women and the unborn child, 
and in so far as they do not yet appear in Annex II.’ 

(2) 

Section A, point 3(a), is replaced by the following: 

‘(a) chemical agents labelled as carcinogen category 1A, 1B, germ cell mutagen category 1A 
or 1B, toxic to reproduction category 1A or 1B, or toxic to reproduction with effects on or via 
lactation in accordance with Regulation (EC) No 1272/2008 of the European Parliament and 
of the Council on classification, labelling and packaging of substances and mixtures in so far 
as they do not yet appear in Annex II;’ 

(3) 

Section A, point 3(b), is replaced by the following: 

‘(b) chemical agents in Annex I to Directive 2004/37/EC’ 

(4) 

Section B is replaced by the following: 

‘B PROCESSES 

Industrial processes listed in Annex 1 to Directive 2004/37/EC.’ 

Article 3  
Amendments to Directive 94/33/EC 

Directive 94/33/EC is amended as follows: 

24 

OJ L 262, 17.10.2000, p. 21. 

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(1) 

Point (a) of Section I.2 of the Annex is replaced by the following:  

‘Biological  agents  belonging  to  groups  3  and  4  within  the  meaning  of  Article  2,  second 
paragraph  of  Directive  2000/54/EC  of  the  European  Parliament  and  of  the  Council  of  18 
September  2000  on  the  protection  of  workers  from  risks  related  to  exposure  to  biological 
agents at work (seventh individual directive within the meaning of Article 16(1) of Directive 
89/391/EEC)25’ 

(2) 

(a) 

Section I.3 of the Annex is amended as follows: 

point (a) is replaced by the following: 

‘(a) substances and mixtures classified in accordance with Regulation (EC) No 1272/2008 of 
the  European  Parliament  and  of  the  Council  on  classification,  labelling  and  packaging  of 
substances and mixtures: 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

(b) 

(c) 

(d) 

acute toxicity, category 1, 2, 3 

skin corrosion, category 1A, 1B, 1C 

flammable gas, category 1, 2 

flammable liquid, category 1, 2 

explosive, category ‘unstable explosive’, or divisions 1.1, 1.2, 1.3, 1.5 

specific target organ toxicity (single exposure), category 1, 2 

specific target organ toxicity (repeat exposure), category 1 

respiratory sensitiser, category 1 

skin sensitiser, category 1 

carcinogen, category 1A, 1B 

germ cell mutagen, category 1A, 1B 

toxic to reproduction, category 1A, 1B 

eye damage, category 1’ 

point (b) is deleted. 

point (c) is deleted. 

point (d) is replaced by the following: 

‘(d)  Substances  and  mixtures  referred  to  in  Article  2(a)(ii)  of  Directive  2004/37/EC  of  the 
European Parliament and of the Council of 29 April 2004 on the protection of workers from 
the risks related to exposure to carcinogens or mutagens at work (Sixth individual Directive 
within the meaning of Article 16(1) of Council Directive 89/391/EEC);’ 

(3) 

Section II.1 of the Annex is replaced by the following: 

‘1. Processes at work referred to in Annex I to Directive 2004/37/EC.’ 

Article 4 
Amendments to Directive 98/24/EC 

Directive 98/24/EC is amended as follows: 

25 

OJ, L 262, 17.10.2000, p.21. 

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(1) 

(a) 

Article 2b is amended as follows: 

Point (i) is replaced by the following:  

‘(i)  any  chemical  agent  which  meets  the  criteria  laid  down  in  Regulation  1272/2008  for 
classification within any of the hazard classes or categories 2.1 to 2.4, 2.6 and 2.7, 2.8 types A 
and B, 2.9, 2.10, 2.12, 2.13 categories 1 and 2, 2.14 categories 1 and 2, 2.15 types A to F, 3.1 
to 3.6, 3.7 adverse effects on sexual function and fertility or on development, 3.8 effects other 
than narcotic effects, 3.9 and 3.10, whether or not that chemical agent is classified under that 
Regulation;’ 

(b) Point (ii) is deleted. 

(c) Point (iii) is replaced by the following: 

‘(iii) any chemical agent which, whilst not meeting the criteria for classification as hazardous 
in accordance with (i) may, because of its physical, chemical or toxicological properties and 
the  way  it  is  used  or  is  present  in  the  workplace,  present  a  risk  to  the  safety  and  health  of 
workers,  including  any  chemical  agent  assigned  an  occupational  exposure  limit  value  under 
Article 3.’ 

(2) 

Article 4(1), second indent is replaced by the following: 

‘— information on safety and health that shall be provided by the supplier (e.g. the relevant 
safety data sheet in accordance with the provisions of Regulation (EC) No 1907/200626),’ 

(3) 

Article 8 (1), fourth indent is replaced by the following: 

‘— access to any safety data sheet provided by the supplier in accordance with Article 31 of 
Regulation (EC) No 1907/2006;’ 

(4) 

Article 8(3) is replaced by the following: 

‘3. Member States may take measures necessary to ensure that employers are able to obtain 
on request, preferably from the producer or supplier, all information on hazardous chemical 
agents  needed  to  apply  Article  4(1)  of  this  Directive,  insofar  as  Regulation  (EC)  No 
1272/2008 does not include any obligation to provide information.’ 

Article 5 
Amendments to Directive 2004/37/EC 

Directive 2004/37/EC is amended as follows: 

(1) 

Article 1(4) is replaced by the following: 

‘4. As regards asbestos, which is dealt with by Directive 2009/148/EC, the provisions of this 
Directive shall apply whenever they are more favourable to health and safety at work.’ 

(2) 

a) 

Article 2 is amended as follows: 

point (a) is replaced by the following: 

‘(a) carcinogen means: 

(i) a substance or mixture which meets the criteria for classification as a category 1A or 1B 
carcinogen set out in Annex I to Regulation (EC) No 1272/2008; 

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(ii)  a  substance,  mixture  or  process  referred  to  in  Annex  I  to  this  Directive  as  well  as  a 
substance or mixture released by a process referred to in that Annex;’ 

b) 

point (b) (i) is replaced by the following: 

‘(b) mutagen means: 

(i) a substance or mixture which meets the criteria for classification as a category 1A or 1B 
germ cell mutagen set out in Annex I to Regulation (EC) No 1272/2008;’ 

Article 6 
Transposition 

(1) 

Member States shall bring into force, by […] at the latest, the laws, regulations and 
administrative  provisions  necessary  to  comply  with  this  Directive.  They  shall 
forthwith communicate to the Commission the text of those provisions. 

When  Member  States  adopt  those  provisions,  they  shall  contain  a  reference  to  this 
Directive  or  be  accompanied  by  such  a  reference  on  the  occasion  of  their  official 
publication. Member States shall determine how such reference is to be made. 

(2) 

Member States shall communicate to the Commission the text of the main provisions 
of national law which they adopt in the field covered by this Directive. 

Article 7 
Entry into force and application 

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

This Directive is addressed to the Member States. 

Done at Brussels,  

Article 8 

For the European Parliament 
The President 

For the Council 
The President 

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