Proposal for a European Parliament and Council Directive amending for the 18th time Directive 76/769/EEC on the approximation of the laws, regulations and administrative provisions of the Member States relating to restrictions on the marketing and use of certain dangerous substances and preparations
Date: 1998-01-07
Institutions: European Commission
Subjects: approximation of laws, carcinogenic substance, consumer protection, dangerous substance, marketing

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels,  07.01.1998 
COM(97) 738  final 

98/ 0005 (COD) 

Proposal  for  a 

EUROPEAN  PARLIAMENT  AND  COUNCIL  DIRECTIVE 

amending for the  18th 
time Directive 76/769/EEC  on the approximation  of the laws, 
regulations and administrative provisions of the Member States relating to 
restrictions  on the marketing and use of certain dangerous substances  and 
preparations 

(presented  by  the  Commission) 

EXPLANATORY  MEMORANDUM 

1. 

INTRODUCTION  AND  CONTEXT 

European  Parliament  and  Council  Directive  94/60/EC1  amending  for  the  14th  time  of 
Directive  76/769/EEC2  (on the approximation  of the laws, regulations and  administrative 
provisions  of  the  Member  States  relating  to  restrictions  on  the  marketing  and  use  of 
certain  dangerous  substances  and  preparations)  adds  a  list  of  substances  classified  as 
category  1 or  2  carcinogens,  mutagens  or  substances  toxic  to  reproduction  (c/m/r)  to 
Annex  I of  Directive  76/769/EEC.  It  stipulates  that these  substances  may  not  be  used  in 
substances or preparations placed  on the market  for  sale to the general public. The c/m/r-
classification  of these substances  has been  defined  in Annex  I of Directive  67/548/EEC3 
on  classification,  packaging  and  labelling  of  dangerous  substances.  This  Annex  is 
regularly updated by way of adaptation to technical progress. 

Directive  94/60/EC  also  imposes  on  the  Commission  the  obligation  to  submit  further 
proposals  to the  European  Parliament  and  Council  to  add  additional  c/m/r substances  to 
Annex  I  of  Directive  76/769  no  later  than  six  months  after  the  publication  of  new 
classifications  as  c/m/r  (categories  1  and  2)  in  the  framework  of  Council  Directive 
67/548/EEC.  The  European  Parliament  and  Council  Directive  97/.../EC4,  16th 
amendment  to  Directive  76/769/EEC,  updates  and  consolidates  the  Appendix  of  c/m/r-
substances to Annex I to the Directive. 

Commission  Directive  96/54/EC5  (22nd  adaptation)  added  16  new  c/m/r  substances  to 
Annex I of Directive 67/548/EEC. Out of these substances  14 are category 2 carcinogens, 
7 are  category  2 mutagens,  one  is category  1 toxic to reproduction  substance  and  one  is 
category  2  toxic  to  reproduction  substance.  The  appendix  to  points  29,  30  and  31  is 
proposed to be supplemented by these substances. 

1 
2 

3 

4 
5 

OJ No L 365, 31.12.1994, p. 1. 
OJ No L 262, 27.9.1976, p. 201,  Directive as last amended  by Directive 94/60/EC (OJ No L 365, 
31.12.1994,  p.l). 
OJ No  196,  16.8.1967, p.  1/67,  Directive as last amended by Commission  Directive  94/69/EC (OJ 
NoL381,31.12.1994, p.l). 
OJ No L 
OJ No L 248, 30.9.1996, p. 1. 

<*£ 

2. 

JUSTIFICATION  FOR PROPOSAL AND CONSIDERATIONS  OF 
SUBSIDIARITY 

What are the objectives  of the proposal in relation to the Community's obligations ? 

In the context of the programme 'Europe against cancer' an action plan has been  launched 
by the  Council  (Decisions  90/238/Euratom, ECSC, EEC6 and  93/362/EEC7)  to  focus  the 
attention  on  substances  and  preparations  considered  to  be  carcinogens.  Due  to  the  fact 
that  use  of  chemicals  by  consumers  cannot  be  controlled  safety  can  only  be  ensured  by 
prohibiting  use  by  consumers  of  c/m/r  substances  and  preparations.  Following  the 
adoption  of  the  Directive  94/60/EC  the  Commission  is  required  to  propose  Directives 
prohibiting use by consumers of substances newly classified  as c/m/r categories  1  or 2. 

The  objectives  of  the  proposal  are  to  preserve  the  Internal  Market  and  to  protect  the 
health of the consumers. 

Does  the  initiatives  arise  out  of  an  exclusive  Community  competence  or  a  shared 
competitiveness? 

The  action  to  preserve  the  Internal  Market  for  dangerous  substances  falls  within  the 
exclusive  competence  of  the  Community.  This  competence  was  established  by  Council 
Directive  76/769/EEC. 

What are the courses of action available to the  Community? 

The  only  course  of  action  available  is  a  proposal  for  an  amendment  to  Directive 
76/769/EEC,  the  eighteenth  amendment,  providing  for  harmonised  rules  on  the  use  of 
substances and preparations classified  as category  1  or 2 c/m/r's. 

Are uniform  rules necessary? Is it not sufficient  to establish targets to be implemented  by 
Member  States? 

The proposed  18th amendment  establishes uniform  rules for the circulation  of  substances 
and  preparations  classified  as c/m/r. It also  guarantees  high  level  of protection  of  health 
and  safety  of  consumers.  The  proposed  18th  amendment  is  the  only  way  to  meet  these 
goals. Targets would be  insufficient. 

3.  RATIONALE OF THE PROPOSAL 

The proposed  18th amendment  would  extend the appendix  of c/m/r  substances  to  Annex 
1 to Directive  76/769 by adding the substances  classified  as c/m/r  category  1 or  category 
2  in  the  22nd  adaptation  to  technical  progress  of  Directive  67/548/EEC.  Use  by 
consumers of all these substances is thus prohibited. 

6 
7 

OJ No L  137, 30.5.1990, p.  31. 
OJ No L  150, 22.6.1993, p. 43. 

3 

4. 

COSTS AND BENEFITS 

4.1 

Costs 

None of the  16 substances  are known to be placed  on the market  for  consumer  uses. The 
proposed  Directive should not pose any problems to the industry or trade. 

4.2  Benefits 

The  proposed  ban  will  ensure  that  the  carcinogenic  substances  and  preparations  are  not 
placed  on  the  market  for  consumer  use  either  now  or  in  the  future.  The  benefit  of  the 
proposal is to protect the health of consumers. 

5. 

PROPORTIONALITY 

The  18th amendment would yield benefits  in terms of protecting the health of consumers. 
This would be achieved at no costs. 

6. 

CONSULTATIONS  PERFORMED IN PREPARING  THE DRAFT  18TH 
AMENDMENT 

Advice on the preparation of the proposal was sought through several meetings  involving 
experts  from  Member  States  and  industry.  Industry,  represented  CEFIC  (European 
Chemical  Industry  Council)  and  ETAD  (Ecological  and  Toxicological  Association  of 
Dyes and Organic Pigments Manufacturers)  did not present any remarks on the proposal. 

7.  CONFORMITY WITH THE TREATY 

This  proposal  is  intended  to  facilitate  a  high  level  of  protection  of  health  of  the 
consumers and is therefore  in conformity  with Article  100 A § 3 of the Treaty. 

The proposal  does not call for any  special  provisions of the kind referred  to in Article  7 c 
of the Treaty. 

It is in conformity  with Article 3 b. 

8. 

CONSULTATION  OF THE EUROPEAN  PARLIAMENT AND THE 
ECONOMIC AND SOCIAL  COMMITTEE 

In  compliance  with  Article  100  A  of  the  Treaty,  the  Codecision  Procedure  with  the 
European  Parliament  is  applicable.  The  Economic  and  Social  Committee  has  to  be 
consulted. 

^ 

Proposal  for an European Parliament and Council Directive amending for the 18th 
time Directive 76/769/EEC on the approximation  of the laws, 
regulations  and administrative provisions  of the Member States relating to 
restrictions on the marketing and use of certain dangerous substances  and 
preparations 

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN 
UNION, 

Having  regard  to  the  Treaty  establishing  the  European  Community,  and  in  particular 
Article  100 a thereof, 

Having regard to the proposal from the  Commission1, 

Having regard to the opinion of the Economic and Social  Committee2, 

Acting in accordance with the procedure referred  to in Article  189 b of the Treaty  3, 

Whereas  measures  should  be  adopted  for  the  smooth  operation  of  the  internal  market; 
whereas  the  internal  market  comparises  an  area  without  internal  frontiers  in  which  the 
free  movement  of goods, persons, services and capital is ensured; 

Whereas the operation of the internal market should also gradually  improve the quality of 
life,  health  protection  and  consumer  safety;  whereas  the  measures  proposed  by  this 
Directive are in line with the Council Resolution  of 9 November  1989 on future  priorities 
for relaunching  consumer protection  policy4; 

Whereas the  Council  and the Representatives  of the  Governments  of the Member  States, 
meeting  within  the  Council, adopted  Decision  90/238/Euratom, ECSC, EEC5  concerning 
a  1990 to  1994 action plan in the context of the 'Europe against Cancer' programme; 

Whereas  to  improve  health  protection  and  consumer  safety  substances  classified  as 
carcinogenic,  mutagenic  or  toxic  to  reproduction  and  preparations  containing  them 
should not be placed on the market for use by the general public; 

Whereas  Directive  94/60/EC6 of the European  Parlianment  and  Council  of 20  December 
1994  amending  for  the  14th time  Council  Directive  76/769/EEC  of  27  July  1976 on  the 
approximation  of  the  laws,  regulations  and  administrative  provisions  of  the  Member 
States  relating  to  restrictions  on  the  marketing  and  use  of  certain  dangerous  substances 

1 
2 
3 
4 
5 
6 

OJ No  c 
OJ No C 
Opinion  of the European  Parliament of.... 
OJ No C 294, 23.11.1989, p. 1. 
OJ No L  137, 30.5.1990, p. 31. 
OJNo  L 365,31.12.1994, p.  1. 

^T 

and  preparations7  introduces  a list  in the  form  of an  appendix  to points  29, 30  and  31  of 
Annex  I  to  Directive  76/769/EEC  containing  substances  classified  as  carcinogenic, 
mutagenic  or  toxic  to  reproduction  of  category  1  or  2,  whereas  such  substances  and 
preparations should no be placed on the market for use by the general public; 

Whereas  Directive  94/60/EC  foresees  that  the  Commission  will  submit  to  the  European 
Parliament  and  Council  a proposal  to extend  this  list  within  six months  after  publication 
of an adaptation  to technical  progress  if Annex  I to  Council  Directive  67/548/EEC  (8) of 
27  June  1967  containing  substances  classified  as  carcinogenic,  mutagenic  or  toxic  to 
reproduction  of category  1  or 2; 

Whereas  the  Commission  Directive  96/54/EC9  of  30  July  1996  adapting  for  the  22nd 
time  Council  Directive  67/548/EEC,  and  more particularly  Annex  I thereto,  to  technical 
progress,  contains  16 substances  newly  classified  as  carcinogenic,  mutagenic  or toxic  to 
reproduction*of  category  1 or 2; whereas  these  substances  should  be  added  to  points  29, 
30 and 31 of the Appendix to annex I to Directive 76/769/EEC. 

Whereas  the  risks  and  advantages  of  the  substances  newly  classified  as  carcinogenic, 
mutagenic and toxic to reproduction of category  1  or 2 have been taken into  account: 

Whereas  this  Directive  does  not  affect  Community  legislation  laying  down  minimum 
requirements  for  the protection  of workers  contained  in  Council  Directive  89/391/EEC10 
of  12 June  1989 on the introduction  of measures to encourage improvements  in the  safety 
and  health  of  workers  at  work,  and  individual  directives  based  thereon,  in  particular 
Council  Directive  90/394/EEC11  of  28 June  1990 on  the  protection  of  workers  from  the 
risks  related  to  exposure  to  carcinogens  at  work  (Sixth  individual  Directive  within  the 
meaning of Article  16(1) of Directive  89/391/EEC), 

7 

8 

9 
10 
11 

OJ No  L 262, 27.9.1976, p. 201, Directive as last amended by Council  Directive  94/60/EC  (OJ 
No L 365, 31.12.1994,  p.l) 
OJ No  L  196,  16.8.1967, p.  1, Directive as last amended by Directive 96/56/EC  of the  European 
Parliament  and the Council  (OJ No L 236,  18.9.1996, p.35). 
OJ No L 248, 30.9.1996, p. 1. 
OJ No  L  183,29.6.1989, p. 1. 
O J N oL  196, 26.7.1990, p. 1. 

HAVE ADOPTED THIS DIRECTIVE: 

Article 1 

The substances  listed  in the Annex to this Directive supplement those substances  listed in 
the appendix to points 29, 30 and 31 of Annex I to Directive 76/769/EEC . 

Article 2 

1.  Member  States  shall  adopt  and  publish  the  laws,  regulations  and  administrative 
provisions necessary to comply with this Directive no later than one year after  the date of 
its adoption and  shall forthwith  inform  the Commission thereof. 

They shall apply these provisions as from 

2.  When  Member  States  adopt  these  measures,  they  shall  contain  a  reference  to  this 
Directive  or  shall  be  accompanied  by  such  reference  to  the  occasion  of  their  official 
publication. The methods of making such reference  shall be laid down by Member States. 

This Directive is addressed to the Member States. 

Article 3 

^ 

Annex 

APPENDIX 

Foreword 

Explanations of column  headings 

Substances: 

The name  is the same as that used for the substance  in Annex I to Directive  67/548/EEC. 
Wherever  possible,  dangerous  substances  are  designated  by  their  Einecs  (European 
Inventory  of  Existing  Commercial  Chemical  Substances)  or  Elincs  (European  List  of 
Notified  Chemical  Substances)  names.  Entries  not  listed  in  Einecs  or  Elincs  are 
designated  using  an  internationally  recognised  chemical  name  (e.g.  ISO,  IUPAC).  An 
additional  common name is included  in some cases. 

Index number: 

The  index  number  is  the  identification  code  given  to  the  substance  in  Annex  I  to 
Directive  67/548/EEC.  Substances  are  listed  in  the  Appendix  according  to  this  index 
number. 

EC number: 

For  each  substances  listed  in the  European  Inventory  of  Existing  Commercial  Chemical 
Substances (EINECS) there is an identification  code. The code starts at 200-001-8. 

For  each  new  substance  notified  under  Directive  67/548/EEC,  an  identification  code  has 
been  defined  and  published  in  the  European  List  of  Notified  Chemical  Substances 
(ELINCS). The code starts at 400-010-9. 

CAS  number: 

Chemical  Abstract  Service  (CAS)  numbers  have  been  defined  for  substances  to  help  in 
their  identification. 

? 

Point 29 - Carcinogens:  category 2 

Substances 

Index  number 

EC  number 

CAS  number 

Potassium  dichromate 
Ammonium  dichromate 
Sodium dichromate 
Sodiumdichromate, dihydrate 
Chromyl dichloride; chromic  oxychloride 
Potassium  chromate 
Chromium (VI) compounds, with the exception  of barium 
chromate and of compounds specified  elsewhere  in this 
Annex 
Bromoethylene 
5-Allyl-l,3-benzodioxole;  safrole 
Benzidine based azo dyes; 4,4'-diarylazobiphenyl dyes, with 
the exception of those specified  elsewhere in this Annex 
Disodium 4-amino 3-[[4'-[(2,4-diaminophenyl)azo][l,l'-
biphenyl]-4-yl]azo]-5-hydroxy-6-(phenylazo)naphthalene-2,7-
disulphonate; C.I. Direct Black 38 
Tetrasodium3,3'-[[l,r-biphenyl]-4,4'-diylbis(azo)]bis[5-
amino-4-hydroxynaphthalene-2,7-disulphonate];  C.I. Direct 
Blue 6 
Disodium 3,3'-[[l,l'-biphenyl]-4,4'-diylbis(azo)]bis(4-
aminonaphthalene-1-sulphonate);  C.I. Direct  Red 28 
Toluene-2,4-diammonium  sulphate; 4-methyl-w-
phenylenediamine  sulphate 

024-002-00-6 
024-003-00-1 
024-004-00-7 
024-004-01-4 
024-005-00-2 
024-006-00-8 
024-017-00-8 

231-906-6 
232-143-1 
234-190-3 
234-190-3 
239-056-8 
232-140-5 

7778-50-9 
7789-09-5 
10588-01-9 
7789-12-0 
14977-61-8 
7789-00-6 

602-024-00-2 
605-020-00-9 
611-024-00-1 

209-800-6 
202-345-4 
-

593-60-2 
94-59-7 
-

611-025-00-7 

217-710-3 

1937-37-7 

611-026-00-2 

220-012-1 

2602-46-2 

611-027-00-8 

209-358-4 

573-58-0 

612-126-00-9 

265-697-8 

65321-67-7 

| 

Point 30 -Mutagens:  category 2 

Substances 

Index  number 

EC  number 

CAS  number 

Potassium dichromate 
Ammonium dichromate 
Sodium dichromate 
Sodiumdichromate, dihydrate 
Chromyl dichloride; chromic oxychlonde 
Potassium chromate 
l,3,5-tris(oxiranylmethyl)-l,3,5-triazine-2,4,6(l/7, 3H,  5H)-
trione; TGIC 

024-002-00-6 
024-003-00-1 
024-004-00-7 
024-004-01-4 
024-005-00-2 
024-006-00-8 
615-021-00-6 

231-906-6 
232-143-1 
234-190-3 
234-190-3 
239-056-8 
232-140-5 
219-514-3 

7778-50-9 
7789-09-5 
10588-01-9 
7789-12-0 
14977-61-8 
7789-00-6 
2451-62-9 

(5 

Point 31 -Toxic to reproduction:  category  1 

Substances 

Index  number 

EC  number 

CAS  number 

1,2-Dibromo-3-chloropropane 

602-021-00-6 

202-479-3 

96-12-8 

Point 31 -Toxic to  reproduction:  category 2 

Substances 

Index  number 

EC  number 

CAS  number 

bis(2-Methoxyethyl)phthalate 

607-228-00-5 

204-212-6 

117-82-8 

£ 

ISSN 0254-1475 

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