Proposal for a Directive of the European Parliament and of the Council relating to restrictions on the marketing and use of nonylphenol, nonylphenol ethoxylate and cement (twenty-sixth amendment of Council Directive 76/769/EEC)
Date: 2002-08-16
Institutions: European Commission
Subjects: approximation of laws, cement, chemical product, consumer protection, dangerous substance, environmental protection, marketing restriction

COMMISSION OF THE EUROPEAN COMMUNITIES

Brussels, 16.8.2002
COM(2002) 459 final

2002/0206 (COD)

Proposal for a

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

relating to restrictions on the marketing and use of nonylphenol, nonylphenol ethoxylate
and cement (twenty-sixth amendment of Council Directive 76/769/EEC)

(presented by the Commission)

EXPLANATORY MEMORANDUM

1.

INTRODUCTION AND CONTEXT

Nonylphenol  (NP)  is  used  as  an  intermediate  in  the  production  of  nonylphenol  ethoxylates
(NPE) (e.g. for use in detergents and paints), in the production of resins, plastics, stabilisers in
the polymer industry, in the manufacture of phenolic oximes, and in some speciality paints.

The risks to  the health  and  environment  of  NP  and  NPE  have  been  assessed  under  Council
Regulation  (EEC) 793/93  of  23 March 1993  on  the  evaluation  and  control  of  the  risks  of
existing  substances 1.  The  risk  assessment  identified  a  need  for  reducing  the  risks  from  NP
and  NPE  to  the  environment.  In  its  opinion  of  6/7 March 2001,  the  CSTEE  confirmed  the
conclusions of the assessment and the need to reduce risks to the environment.

The  Commission  adopted  on  7 November 2001  a  Recommendation  in  the  framework  of
Regulation  (EEC) 793/93  on  a  risk  reduction  strategy  for  NP  and  NPE  providing  for
restrictions on marketing and use to control risks to the environment2.

On  the  basis  of  the  risk  assessments  and  recommended  risk  reduction  strategies  in  the
framework  of  Regulation (EEC) 793/93,  the  Commission  proposes  to  restrict  the  marketing
and use of NP and NPE and of preparations containing them.

Cement  is  widely  used  in  the  construction  industry.  It  can  contain  small  amounts  of  water-
soluble  chromium VI,  which  is  classified  as  carcinogenic  and  sensitising.  Chromium VI  in
cement  can  induce  painful,  disabling,  allergic  eczema  in  people  exposed  to  wet  cement
preparations.  A  technique  for  reducing  chromium VI  is  available  and  has  been  shown  to
reduce  the  adverse  health  effect.  In  Member  States  where  this  technique  has  already  been
introduced,  the  number  of  eczema  cases  resulting  from  exposure  to  cement  has  been
dramatically  reduced.  In  its  opinion  of  27 June 2002,  the  CSTEE  confirmed  the  scientific
findings. On the basis of existing scientific evidence, the Commission proposes to restrict the
marketing and use of cement containing more than 2 ppm chromium VI.

The proposed Directive would introduce harmonised provisions on the marketing and use of
NP, NPE and cement.

2.

JUSTIFICATION FOR THE PROPOSAL

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

The objective of the proposal is to introduce harmonised provisions with regard to NP, NPE
and cement and thus preserving the Internal Market, as required by Article 95 of the Treaty.
The  objective  is  also,  as  set  out  in  Article 95(3)  of  the  Treaty,  to  ensure  a  high  level  of
protection to health and the environment.

When  Member  States  adopt  national  provisions  restricting  the  marketing  and  use  of
dangerous substances and preparations there will be obstacles to trade because of differences
in legislation between Member States. The Draft Proposal aims to improve the conditions for

1

2

OJ L 84, 5.4.1993, p. 1.
OJ L 319, 4.12.2001, p. 30.

2

                                                
the  functioning  of  the  Internal  Market  to  the  benefit  of  the  protection  to  health  and  the
environment.

What are the courses of action available to the Community?

The  only  course  of  action  available  is  to  make  a  proposal  for  an  amendment  to
Directive 76/769/EEC,  the  twenty-sixth  amendment,  providing  for  harmonised  rules  on  the
use of NP, NPE and cement.

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

Member States?

The  proposed  twenty-sixth  amendment  establishes  uniform  rules  for  the  circulation  of  NP,
NPE and cement. It also guarantees a high level of protection of health and the environment.
The proposed twenty-sixth amendment is the only way to meet these goals. Targets would be
insufficient.

3.

RATIONALE OF THE PROPOSAL

The  proposed  twenty-sixth  amendment  would  extend  Annex I  to  Directive 76/769/EEC  by
adding the NP, NPE and cement. The use of NP, NPE and cement is thus restricted.

4.

COSTS AND BENEFITS

4.1.

Costs

The proposed Directive should pose only minor problems to the industry or trade, as the use
of  NP  and  NPE  is  declining.  In  fact,  companies  have  already  developed  substitutes  or
alternative  techniques.  With  regard  to  the  chromium  VI  in  cement,  the  proposed  Directive
should  pose  only  minor  problems  to  the  industry  or  trade  as  the  technology  for  reducing
chromium  VI  is  available  at  low  costs  and  is  already  applied  by  numerous  enterprises  in
several Member States.

4.2.

Benefits

The benefits of the proposal are to establish an  Internal Market as well  as to  protect human
health and the environment. The proposed ban will ensure that for certain uses which pose a
risk to human health or to the environment NP, NPE, and cement containing more than 2 ppm
chromium VI, are no longer on the market.

5.

PROPORTIONALITY

The  twenty-sixth  amendment  would  yield  benefits  in  terms  of  protecting  human  health  and
environment. This will be achieved at little cost.

3

6.

CONSULTATIONS PERFORMED IN PREPARING THE DRAFT TWENTY-
SIXTH AMENDMENT

Advice  on  the  preparation  of  the  proposal  was  sought  through  meetings  involving  experts
from  Member  States,  the  European  Chemical  Industry  Council  (CEFIC),  Eurométaux,  the
European Cement Association, the European Federation of Building and Woodworkers. The
European Consumers’ Organisation BEUC also gave its opinion.

7.

CONFORMITY WITH THE TREATY

This proposal is intended to preserve the Internal Market and at the same time ensure a high
level  of  protection  of  health  and  the  environment,  and  is  therefore  in  conformity  with
Article 95(3) of the Treaty.

8.

EUROPEAN 
COMMITTEE

PARLIAMENT  AND  ECONOMIC  AND 

SOCIAL

In  compliance  with  Article 95  of  the  Treaty,  the  Codecision  Procedure  with  the  European
Parliament is applicable. The Economic and Social Committee has to be consulted.

4

2002/0206 (COD)

Proposal for a

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

relating to restrictions on the marketing and use of nonylphenol, nonylphenol ethoxylate
and cement (twenty-sixth amendment of Council Directive 76/769/EEC)

(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 Commission 3,

Having regard to the opinion of the Economic and Social Committee 4,

Acting in accordance with the procedure laid down in Article 251 of the Treaty5,

Whereas:

(1)

(2)

(3)

(4)

The risks posed to the environment by nonylphenol (NP) and nonylphenol ethoxylate
(NPE) have been assessed in accordance with Council Regulation (EEC) No 793/93 of
23 March 1993 on the evaluation and control of the risks of existing substances6. The
assessment  identified  a  need  to  reduce  those  risks  and, 
in  its  opinion  of
6/7 March 2001, the Scientific Committee on Toxicity, Ecotoxicity and the Environment
(CSTEE) confirmed that conclusion.

Commission  Recommendation 2001/838/EC7,  adopted  within  the  framework  of
Regulation (EEC) No  793/93,  proposed  a  risk  limitation  strategy  for  NP  and  NPE,
recommending in particular that restrictions be placed on their marketing and use.

In order to protect the environment, it therefore appears necessary that the placing on
the market and the use of NP and NPE should be restricted to specific uses.

Scientific studies have also  shown  that cement  preparations  containing  chromium VI
may cause allergic reactions in certain circumstances, if there is direct and prolonged
contact with the human skin.

(5)

The CSTEE has confirmed the adverse health effects of chromium VI in cement.

3

4

5

6

7

OJ C .
OJ C .
OJ C …
OJ L 84, 5.4.1993, p. 1.
OJ L 319, 4.12.2001, p. 30.

5

                                                
(6)

(7)

(8)

(9)

In order to protect human health, it therefore appears necessary to restrict the placing
on the market and the use of cement. In particular, the placing on the market and the
use  of  cement  or  cement  preparations  containing  more  than  2 ppm  chromium VI
should  be  restricted  in  the  case  of  manual  activities  where  there  is  a  risk  of  contact
with the skin.

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  and  preparations8  should
therefore be amended accordingly.

The  objective  of  this  Directive  is  to  introduce  harmonised  provisions  with  regard  to
NP, NPE and cement, thus preserving the internal market whilst ensuring a high level
of protection for health and the environment, as required by Article 95 of the Treaty.

This  Directive  does  not  affect  the  Community  legislation  laying  down  minimum
requirements for the protection of workers, such as Council Directive 89/391/EEC of
12 June 1989 on the introduction of measures to encourage improvements in the safety
and health of workers at work 9, and individual directives based thereon, in particular
Council Directive 90/394/EEC 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] 10 and Council Directive 98/24/EC
on the protection of the health and safety of workers from the risks related to chemical
agents at work.

HAVE ADOPTED THIS DIRECTIVE:

Annex I to Directive 76/769/EEC is hereby amended as set out in the Annex to this Directive.

Article 1

Article 2

Member  States  shall  adopt  and  publish  the  laws,  regulations  and  administrative  provisions
necessary to comply with this Directive no later than xx xx 200x [one year after the date of its
entry into force]. They shall forthwith inform the Commission thereof.

They shall apply those provisions from xx xx 200x [eighteen months after the entry into force
of this Directive].

When Member States adopt those provisions, the provisions 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.

8

9

10

OJ L 262, 27.9.1976, p. 201.
OJ L 183, 29.6.1989, p. 1.
OJ L 196, 26.7.1990, p. 1.

6

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

Article 3

Article 4

This Directive is addressed to the Member States.

Done at Brussels,

For the European Parliament
The President

For the Council
The President

7

ANNEX

The following points [XX] and [XX] are added to Annex I of Directive 76/769/EEC:

“[XX]

(1) 

(2) 

Nonylphenol C6H4(OH)C9H19

Nonylphenol ethoxylate
(C2H4O)nC15H24O

May not be  placed on  the  market  or  used as  a substance  or
constituent of preparations in concentrations equal or higher
than  0,1 %  by  mass  nonylphenol  or  1 %  by  mass
nonylphenol ethoxylate for the following purposes:

(1) 

industrial and institutional cleaning except:

–  controlled  closed  dry  cleaning  systems  where
the washing liquid is recycled or incinerated,

–  cleaning  systems  with  special  treatment  where
the washing liquid is recycled or incinerated;

domestic cleaning;

textiles and leather processing except:

–  processing with no release into waste water and
where  the  NPE  is  fully  bound  in  the  polymer
matrix 
textile  printing,
dyestuffs),

(finishing  agents, 

–  systems  with  special 

treatment  where 

the
process  water  is  pre-treated  to  remove  the
organic  fraction  completely  prior  to  biological
waste  water 
of
treatment 
sheepskin);

(degreasing 

emulsifier in agricultural teat dips;

metal working except:

–  uses  in  controlled  closed  systems  where  the

washing liquid is recycled or incinerated;

manufacturing of pulp and paper;

cosmetics including shampoos;

other personal care products except:

–  spermicides.

(2) 

(3) 

(4) 

(5) 

(6) 

(7) 

(8) 

[XX]. Cement

May not be  placed on  the  market  or  used as  a substance  or
constituent of preparations, if it contains more than 0,0002 %
soluble chromium VI  of  the  total  dry  weight  of  the  cement,
for manual activities, where there is a risk  of contact  to  the
skin.

In  addition,  if  ferrous  sulphate  is  used  as  a  reducing  agent,
then without prejudice to the application of other Community
provisions  on  the  classification,  packaging  and  labelling  of
dangerous  substances  and  preparations,  the  packaging  of
cement or cement preparations shall be legibly and indelibly
marked  with  information  on  the  packing  date  and  storage
period  during  which  the  content  of  soluble  chromium VI  is
below 0,0002 % of the total dry weight of the cement.”

8