Proposal for a Decision of the European Parliament and of the Council amending Council Directive 76/769/EEC as regards restrictions on the marketing and use of certain dangerous substances and preparations 2-(2-methoxyethoxy)ethanol, 2-(2-butoxyethoxy)ethanol, methylenediphenyl diisocyanate, cyclohexane and ammonium nitrate (amendment of Council Directive 76/769/EEC) {SEC(2007) 1237} {SEC(2007) 1238}
Date: 2007-10-02
Institutions: European Commission
Subjects: chemical product, dangerous substance, health risk, marketing restriction, paints and varnishes

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COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 2.10.2007 
COM(2007) 559 final 

2007/0200 (COD) 

Proposal for a 

DECISION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL  

amending Council Directive 76/769/EEC as regards restrictions on the marketing and 
use of certain dangerous substances and preparations 2-(2-methoxyethoxy)ethanol, 2-(2-
butoxyethoxy)ethanol, methylenediphenyl diisocyanate, cyclohexane and ammonium 
nitrate 

(amendment of Council Directive 76/769/EEC) 

(presented by the Commission) 

{SEC(2007) 1237} 
{SEC(2007) 1238} 

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EXPLANATORY MEMORANDUM 

1. 

CONTEXT OF THE PROPOSAL 

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 marketing and 
use of certain dangerous substances and preparations establishes a framework for harmonised 
rules  throughout  the  European  Union  concerning  the  placing  on  the  market  and  use  of 
dangerous substances and preparations. 

Directive 76/769/EEC is used to manage the risks to human health and the environment from 
dangerous substances. Dangerous substances and preparations listed in Annex I to Directive 
76/769/EEC may only be placed on the market and used under specified conditions. 

It is proposed to manage risks on the following five substances by listing them in Annex I of 
Directive 76/769/EEC: 

– 

– 

– 

– 

– 

2-(2-methoxyethoxy)ethanol (DEGME) 

2-(2-butoxyethoxy)ethanol (DEGBE) 

methylenediphenyl diisocyanate (MDI) 

cyclohexane 

ammonium nitrate (AN). 

Risk assessments in the framework of Regulation (EEC) No 793/93 of 23 March 1993 on the 
evaluation and control of the risks of existing substances, have been carried out for DEGME, 
DEGBE,  MDI  and  cyclohexane.  The  risk  assessments  identified  risks  to  human  health  for 
consumers  when  using  preparations  containing 
these  four  substances.  Commission 
Recommendations  1999/721/EC1and  2007/xxx/EC2  adopted  within  the  framework  of 
Regulation  (EEC)  No  793/93,  recommended  marketing  and  use  restrictions  at  Community 
level under Council Directive 76/769/EEC as the most appropriate strategy to limit the risks 
for consumers. 

Ammonium nitrate is a substance that can act as an oxidant and the risk to be addressed arises 
from  its  ability  to  explode  when  mixed  with certain  other  substances.  Ammonium  nitrate  is 
widely  used  as  a  fertiliser  in  the  EU  and  ammonium  nitrate  fertilisers  should  meet  certain 
minimum safety standards before being placed on the market. 

1.1. 

Introduction to the chemical substances (chemical identities and uses) 

1Commission Recommendations 1999/721/EC of 12 October 1999 on the results of the risk evaluation and on 
2-(2-
the 

for 
the 
methoxyethoxy)ethanol; Alkanes, C10-13, chloro; Benzene, C10-13-alkyl derivs. 

2-(2-butoxyethoxy)ethanol; 

substances: 

reduction 

strategies 

risk 

2Commission  Recomendations  on  the  results  of  the  risk  evaluation  and  the  risk  reduction  strategies  for  the 
substances:  Piperazine;  Cyclohexane;  Methylenediphenyl 
diisocyanate;  But-2yne-1,4-diol; 
Methyloxirane;  Aniline;  2-Ethylhexylacrylate;  1,4-Dichlorobenzene;  3,5-dinitro-2,6-dimethyl-4-tert-
butylacetophenone;  Di-(2-ethylhexyl)phthalate;  Phenol;  Bis(pentabromophenyl)ether;  5-tert-butyl-
2,4,6-trinitro-m-xylene2. To be published 

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1.1.1. 

2-(2-methoxyethoxy)ethanol (DEGME) 

2-(2-methoxyethoxy)  ethanol  (DEGME)  belongs  to  the  group  of  glycol  ethers,  which  are 
mainly used as co-solvents in a wide variety of applications. The substance is identified by the 
CAS number 111-77-3 and the EINECS number 203-906-6. 

The  main  use  of  DEGME  is  as  anti-icing  agent  in  jet  fuel.  DEGME  is  further  used  as 
chemical  intermediate,  basic  chemical  (processing  solvent)  and  solvent  in  paints  and 
varnishes, paint strippers, cleaning agents, self-shining emulsions, floor sealants, windscreen 
washer liquids, skin-cleaning products (soap) and skin-care products3. 

1.1.2. 

2-(2-butoxyethoxy)ethanol (DEGBE) 

2-(2-butoxyethoxy)ethanol (DEGBE) belongs to the group of glycol ethers, which are mainly 
used as co-solvents in a wide variety of applications. The substance is identified by the CAS 
number 112-34-5 and the EINECS number 203-961-6. 

DEGBE is used in paints, dyes, inks, detergents and cleaners. The major function of this agent 
is to dissolve various components of mixtures in both aqueous and non-aqueous systems4. 

1.1.3.  methylenediphenyl diisocyanate (MDI) 

Methylenediphenyl  diisocyanate  (MDI)  refers  to  a  number  of  isomeric  compounds  with  the 
chemical formula C15H10N2O2. The material defined by EINECS number 247-714-0 and CAS 
number  26447-40-5,  encompasses  all  isomeric  mixtures  and  also  all  of  the  specific  isomers 
even if those isomers have specific CAS or EINECS numbers. 

MDI is mainly used in the industrial production of rigid polyurethane foams with world wide 
use.  Many  other  uses  are  in  the  fields  of  paints  and  coatings,  adhesives,  sealants  (including 
weather  resistant  sealing  material),  elastomers,  and  footwear.  There  is  use  also  in  the 
production  of  particle  board  (for  the  bonding  of  wood)  and  mould  cores  for  the  foundry 
industry5. 

1.1.4. 

cyclohexane 

Cyclohexane is a cyclic alkane with the molecular formula C6H12. It is identified by the CAS 
number 110-82-7 and the EINECS number 203-806-2. 

The main use as a solvent is in adhesives (cyclohexane combined with other solvents). These 
are mostly “neoprene” (polychloroprene) based adhesives used in the leather industry (shoes), 
the  construction 
industry. 
Cyclohexane adhesives products are mainly used by craftsmen but also by the general public 
in household and “do-it-yourself” products6. 

industry  (floor  coatings)  and 

the  automobile  equipment 

3 

4 

5 

6 

Risk  assessment  report  under  Council  Regulation  (EEC)  793/93  published  in  1999,  available  at: 
http://ecb.jrc.it/esis/ 
Risk  assessment  report  under  Council  Regulation  (EEC)  793/93  published  in  1999,  available  at: 
http://ecb.jrc.it/esis/ 
Risk  assessment  report  under  Council  Regulation  (EEC)  793/93  published  in  2005,  available  at: 
http://ecb.jrc.it/ esis/ 
Rrisk  assessment  report  under  Council  Regulation  (EEC)  793/93  published  in  2004,  available  at: 
http://ecb.jrc.it/ esis/ 

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1.1.5. 

ammonium nitrate (AN) 

Ammonium  nitrate,  molecular  formula  NH4NO3  has  the  CAS  number  6484-52-2  and  the 
EINECS number 229-347-8. Although it is not formally classified as an oxidising substance, 
it can have strong oxidising properties under certain conditions. 

Ammonium nitrate is widely used throughout the EU as a fertiliser, but it is also constitutes 
the  main  ingredient  in  the  commercial  blasting  agent  ANFO  (ammonium  nitrate  fuel-oil). 
Ammonium  nitrate  is  used  in  fertiliser  both  alone,  and  in  blends  with  other  nutrient 
substances. In the terminology of the fertiliser industry, these two categories are referred to as 
straight  and  compound  fertilisers,  whereas  the  equivalent  terminology  in  the  chemicals 
legislation is substances and preparations. Fertilisers containing more than 28% nitrogen are 
known as high-nitrogen ammonium nitrate fertilisers. 

1.2. 

Risk evaluation and risk management measures 

1.2.1. 

2-(2-methoxyethoxy)ethanol (DEGME) 

The risk assessment carried out in accordance with Council Regulation (EEC) No 793/93 by 
Netherlands concluded that there was a need for limiting the risks for human health (workers 
and  consumers).  Health  risks  for  consumers  were  expected  during  the  use  of  DEGME  in 
paints or paint strippers. 

The  risk  assessment  report  was  submitted  to  the  Scientific  Committee  on  Toxicity, 
Ecotoxicity and the Environment (CSTEE) which adopted its opinion during the 6th plenary 
meeting  of  27  November  19987.  Apart  from  general comment on the derived  Health Based 
Occupational  Reference  Values  which  were  not  fully  supported  by  CSTEE,  the  risk 
assessment report was considered of good quality. 

The Commission Recommendation 1999/721/EC8, contained a strategy to limit the risks for 
consumers in order to prevent dermal exposure to DEGME in paints and paint strippers. For 
workers the legislation already in force under Council Directive 98/24/EC9 was considered to 
give adequate protection against the risks of DEGME. 

According  to  a  survey  carried  out  by  the  European  Council  of  the  Paint,  Printing  Ink  and 
Artists’  Colours  Industry  (CEPE)  in  2000,  there  was  only  a  negligible  use  of  DEGME  in 
paints sold to the general public. CEPE had recommended its member companies to replace 
DEGME  by  alternatives  in  all  consumer  paints  and  they  do  not  longer  intentionally  use 
DEGME in paints for the consumer market. 

In  December  2006,  the  Commission  contacted  European  paint  strippers  manufacturers  who 
confirmed that they no longer sell DEGME for consumer uses. 

1.2.2. 

2-(2-butoxyethoxy)ethanol (DEGBE) 

7 
8 
9 

Opinion available at: http://ec.europa.eu/health/ph_risk/committees/sct/sct_opinions_en.htm 
OJ, L292, 13.11.1999 p 42. 
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 

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The risk assessment carried out in accordance with Council Regulation (EEC) No 793/93 by 
Netherlands concluded that there was a need for limiting the risks for human health (workers 
and consumers). The conclusions of a need to limit the risk for consumers were based on the 
risks from the use of DEGBE in paint spraying applications. 

The  risk  assessment  report  was  submitted  to  the  Scientific  Committee  on  Toxicity, 
Ecotoxicity and the Environment (CSTEE), which adopted its opinion during the 6th plenary 
meeting of 27 November 199810. Apart from general comments on the derived Health Based 
Occupational  Reference  Values,  which  were  not  fully  supported  by  CSTEE,  the  risk 
assessment report was considered of good quality. 

Commission Recommendation 1999/721/EC defined a risk reduction strategy for DEGBE11. 
The strategy recommended not making available to consumers paints containing DEGBE that 
are intended to be sprayed. Furthermore, paints containing DEGBE placed on the market for 
supply  to  the  general  public  should  clearly  indicate  that  they  should  not  be  sprayed.  For 
workers  the  legislation  already  in  force  under  Council  Directive  98/24/EC  of  7  April  1998 
was considered to give adequate protection against the risk of DEGBE. 

In  October  2001,  the  Commission  conducted  a  study  on  “the  advantages  and  drawbacks  of 
introducing  Community-wide  restrictions  on  the  marketing  and  use  of  DEGBE”.  The  study 
examined  the  advantages  associated  with  the  possible  restrictions  and  their  drawbacks 
(economic or otherwise), the suitability of substitute chemicals and the implications for small 
and  medium  enterprises.  Consideration  was  given  during  the  study  to  a  number  of  possible 
risk  reduction  measures  that  could  be  adopted  such  as  a  ban  of  preparations  containing 
DEGBE in spray painting or additional labelling requirements. A threshold for the maximum 
allowable  concentration  of  DEGBE  in  paints  was  considered  an  appropriate  measure  to 
eliminate the risks for consumers in spray painting applications. 

In  February  2007,  after  the  discussion  of  the  Working  Group  of  the  Competent  Authorities 
responsible  for  the  implementation  of  Directive  76/769/EEC  (Limitations  Working  Group), 
the  Oxygenated  Solvents  Producers  Association  (OSPA)  provided  new  information  on  the 
toxicity  and  exposure  to  DEGBE12  which  was  evaluated  by  the  Rapporteur  of  the  EU  risk 
assessment,  the  Netherlands.  Using  this  information  from  a  drinking  water  study,  the  lung 
effects  found  in  an  inhalation  study  were  assessed  as  of  local  acute  character  rather  than 
systemic, and based on conservative assumptions with regard to the respirable fraction and the 
particle  size  distribution  of  aerosols  it  was  concluded  that  the  safe  concentration  limit  of 
DEGBE  in  spray  paints  is  3%.  A  similar  evaluation  was  also  conducted  for  other  paints 
containing DEGBE and the exposure to DEGBE vapour from surfaces painted with a brush or 
a  roller  was  not  of  toxicological  concern.  Consequently,  no  risks  were  identified  from 
brushing and rolling applications. 

1.2.3.  methylenediphenyl diisocyanate (MDI) 

The risk assessment, carried out in accordance with Council Regulation (EEC) No 793/93 by 
Belgium, concluded that there is a need for limiting the risks for human health (workers and 
consumers). 

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12 

Opinion available at: http://ec.europa.eu/health/ph_risk/committees/sct/sct_opinions_en.htm 
OJ, L 292, 13.11.1999 p 42. 
Statement  from  the  “Oxygenated  Solvents  Producers Association,  OSPA”,  May  2007  provided  to  the 
Commission and the Members of the Limitations Working Group. 

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The  risk  assessment  report  was  submitted  to  the  Scientific  Committee  on  Toxicity, 
Ecotoxicity and the Environment (CSTEE), which adopted its opinion during the 41st plenary 
meeting of 8 January 200413. The CSTEE confirmed the conclusions of the risk assessment. 

A human health risk reduction strategy for MDI was prepared by ECOLAS on behalf of the 
Belgian Rapporteur in November 2004. The conclusions of this study recommended personal 
protection equipment and sufficient instructions for preparations containing MDI sold to the 
general public. 

A study was conducted by BIPRO on behalf of the Belgian Rapporteur in June 2006, on the 
advantages and drawbacks of various possible measures restricting the marketing and use of 
MDI.  The  conclusions  of  this  study  recommended  restricting  marketing  and  use  of 
preparations  containing  MDI  which  are  sold  to  the  general  public  to  those  being  sold  with 
adequate personal protection equipment, as well as additional handling and use instructions. 

Commission  Recommendation  2007/xxx/EC  defined  a  strategy  for  limiting  the  risks  for 
MDI14.The strategy considers that it is necessary to adopt marketing and use restrictions for 
the use of MDI in consumer products. For workers the strategy recommended to establish at 
Community  level  occupational  exposure  limit  values  for  MDI  in  accordance  with  Council 
Directive 98/24/EC. 

1.2.4. 

cyclohexane 

The risk assessment was carried out in accordance with Council Regulation (EEC) No 793/93 
by  France  which  concluded  that  there  was  a  need  for  limiting  the  risks  for  human  health 
(workers  and  consumers)  due  to  the  exposure  arising  from  use  of  adhesives  containing 
cyclohexane.  Adhesives  containing  cyclohexane  are  considered  the  main  consumer  use  and 
the  risk  assessment  was  focused  specifically  on  carpet  laying  applications  for  which  the 
highest exposure was expected.  

The  risk  assessment  report  was  submitted  to  the  Scientific  Committee  on  Toxicity, 
Ecotoxicity and the Environment (CSTEE), which adopted its opinion during the 29th plenary 
meeting of 9 January 200215. The CSTEE confirmed the conclusions of the risk assessment. 

Commission  Recommendation  2007/xxx/EC16  defined  a  strategy  for  limiting  the  risk  for 
consumers and it recommended marketing and use restrictions for the use of cyclohexane in 
neoprene based adhesives intended for consumer use. For workers the legislation already in 
force  under  Council  Directive  98/24/EC  of  7  April  1998  was  considered  to  give  adequate 
protection against the risks of cyclohexane during industrial uses. 

1.2.5. 

ammonium nitrate (AN) 

The possibility of accidental explosion for AN fertilisers exists only if the ammonium nitrate 
content,  or  more  precisely  the  total  nitrogen  content,  exceeds  a  critical  value.  Such  high-

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Opinion available at: 
http://ec.europa.eu/health/ph_risk/committees/sct/sct_opinions_en.htm 
OJ, C […], […],p. […] 
Opinion available at: 
http://ec.europa.eu/health/ph_risk/committees/sct/sct_opinions_en.htm 
OJ, C […], […], P.[…] 

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nitrogen  AN  fertilisers  are  defined  in  Regulation  (EC)  No  2003/2003  on  fertilisers  as  those 
containing more than 28% by mass of nitrogen in relation to ammonium nitrate. Ammonium 
nitrate based fertilisers containing less that 28% nitrogen are not considered to pose a risk of 
explosion under normal conditions of handling and use. 

To  circulate  freely  on  the  internal  market,  fertilisers  with  a  high  ammonium  nitrate  content 
must  comply  with  a  test  for  resistance  to  detonation  as  specified  in  Regulation  (EC)  No 
2003/2003.  They  must  also  meet  a  number  of  technical  requirements  concerning  their 
porosity, particle size, pH and impurity content. 

However,  Regulation  (EC)  No  2003/2003  is  only  applicable  to  fertilisers  falling  within  its 
scope, and that are marketed as “EC fertiliser”, so that it cannot be used to impose measures 
on non-EC fertilisers. Manufacturers of non-EC fertilisers can comply with the Regulation on 
a voluntary basis. 

For fertilisers intended for sale only within a single Member State, manufacturers may choose 
to conform only to requirements existing at national level. Therefore these fertilisers may not 
conform with the safety requirements set at the European level. To ensure a uniform level of 
safety  within  the  EU,  all  ammonium  nitrate  fertilisers  should  conform  to  the  same  safety 
requirements. 

In  addition  to  the  risk  of  detonation  under  conditions  of  normal  handling  and  use  in 
agriculture,  AN  fertilisers  have  also  been  used  by  terrorists  to  manufacture  explosives.  To 
make  acquisition  of  high  nitrogen  AN  fertilisers  for  deliberate  misuse  more  difficult,  the 
nitrogen content of fertilisers sold to the general public should be limited to the lower limit of 
20%. 

1.3. 

Intended effects of EU legislation  

Due to the fact that there is a need for limiting the risks for consumers and in particular for 
ensuring adequate protection during the “Do-It-Yourself” uses, certain restrictions should be 
applied for preparations containing DEGME, DEGBE, MDI or cyclohexane which are placed 
on the market for supply to the general public. 

The present Decision would amend Annex I to Directive 76/769/EEC by adding the following 
chemical  substances:  DEGME,  DEGBE,  MDI  and  cyclohexane.  The  placing  on  the  market 
for supply to the general public of preparations containing these substances will be restricted 
for certain applications. 

Relevant  measures,  such  as  maximum  concentration  of  the  substance  (e.g.  DEGME  and 
DEGBE),  package  size  reduction  (e.g.  cyclohexane),  mandatory  sale  of  gloves  with  the 
product  (e.g.  MDI)  and  additional  instructions  on  the  product  (e.g.  DEGBE,  MDI, 
cyclohexane)  should  be  applied  under  the  provisions  of  the  present  Decision  in  order  to 
reduce the possible risks to consumers when using preparations containing these substances. 

In order to ensure a uniform high level of safety for farmers and distributors within the EU for 
all ammonium nitrate fertilisers, and to limit access to high nitrogen fertilisers to agricultural 
professionals  the  Annex  I  to  Directive  76/769/EEC  should  also  be  amended  to  impose  the 
same safety requirements on all ammonium nitrate fertilisers marketed in the EU, and to limit 
the nitrogen content of the ammonium nitrate fertilisers that are sold to the general public. 

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2. 

RESULTS  OF  CONSULTATIONS  WITH  THE  INTERESTED  PARTIES  AND 
IMPACT ASSESSMENTS 

2.1. 

Consultations 

For DEGBE, DEGME, MDI and cyclohexane, in addition to the various studies mentioned in 
the previous chapter, advice on the preparation of the proposal was sought through a number 
of  meetings  of  the  Working  Group  of  the  Competent  Authorities  responsible  for  the 
implementation  of  Directive  76/769/EEC.  Experts  from  industry,  the  European  Chemical 
Industry  Council  (Cefic)  and  other  industry  organisations  were  consulted,  as  was  the 
European Consumers Organisation (BEUC). 

For ammonium nitrate, advice on the preparation of the proposal was sought at a meeting on 
24 March 2006 of the Commission’s Working Group on Fertilisers involving experts from the 
Competent  Authorities  and  Industry,  represented  by  EFMA17,  which  concluded  that:  “…  a 
number  of  actions  that  should  be  considered  to  improve  the  safety  of  ammonium  nitrate 
fertilisers in normal use. … use of 76/769/EEC should be considered to bring all ammonium 
nitrate fertilisers within the scope of the Fertiliser Regulation, which currently addresses only 
“EC fertilisers”. 

2.2. 

Impact Assessment 

A detailed impact assessment has been prepared and was sent to the Impact Assessment (IA) 
Board on 29 May 2007 which expressed its opinion on 15 June 2007 after the Board meeting 
on 13 June 2007. 

All the comments of the Board (IA quality checklist and final opinion) have been included in 
the final impact assessment version18. 

The main findings of the impact assessment are as follows. 

2.2.1.  Conclusions of the Impact assessment 

For DEGME: 

A  total  ban  of  the  placing  on  the  market  paints  and  paint  strippers  containing  DEGME  for 
consumer use is an effective and efficient measure to eliminate the risks for consumers. From 
the analysis conducted there are no additional costs for industry, therefore this measure will 
be proportionate. 

For DEGBE: 

Setting a limit value of 3% for DEGBE in spray paints to be sold to the general public is an 
effective  and  efficient  measure  to  eliminate  the  risks  to  consumers.  This  measure  will  not 
cause high costs to industry as the content of DEGBE in most spray paints is already around 
or below 3%. The additional instruction “Do not use in paint spraying equipment” on all other 
paints containing DEGBE above the limit of 3% will avoid misuse by consumers. The costs 

17 
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European Fertilizer Manufacturers Association 
Commission 
document: 
http://ec.europa.eu/enterprise/chemicals/studies_en.htm 

Staff  working 

“Impact 

assessment 

report” 

available 

at: 

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for  industry  for  a  change  in  labelling  are  limited  and  can  be  reduced  through  a  longer 
transition period before the measure will have to be implemented. Therefore this measure will 
be proportionate. 

For MDI: 

A  requirement  to  add  polyethylene  gloves  and  specific  warnings  and  use  instructions  to  all 
products  containing  MDI  sold  to  the  general  public  are  effective  and  efficient  measure  to 
reduce the health risks to consumers. Consumers can reduce dermal exposure and will be well 
informed to avoid misuse during the application of MDI products. The costs of polyethylene 
gloves  are  low  compared  to  the  product  price  and  the  costs  for  change  in  labelling  can  be 
reduced  if  a  longer  transition  period  is  foreseen  before  the  measure  will  have  to  be 
implemented.  Therefore  the  additional  requirement  of  gloves  and  more  specific  instructions 
on the products will be proportionate measures. 

During the Limitations Working Group meetings, the Member States Competent Authorities, 
the Stakeholder and the Commission agreed that a study to collect more data on possible cases 
of  respiratory  allergy  due  to  products  containing  MDI.  The  study  will  involve  specialised 
centres and will be agreed by the Commission. Based on the results of this study and further 
analysis  of  cost-benefits  if  the  risks  for  consumers  will  be  confirmed,  further  protective 
measures will have to be considered. 

For Cyclohexane: 

Additional labelling “Do not use for carpet laying" and “Do not use under conditions of poor 
ventilation"  as  well  as  a  reduced  package  size  to  650g  for  neoprene-based  adhesives 
containing cyclohexane and sold to the general public are effective and efficient measures to 
reduce the risks for consumers. The costs for industry for changing the labelling are not very 
high and can be reduced if a longer transition period is foreseen before the measure will have 
to be implemented. Therefore these measures will be also proportionate. 

For Ammonium Nitrate (AN): 

Restricting  the  marketing  of  AN  fertilisers  in  such  a  way  that  placing  on  the  market  of 
fertilisers  with  a  nitrogen  content  >  28%  is  only  possible  when  they  meet  the  safety 
requirements of Regulation (EC) No 2003/2003, is the most effective and cost efficient option 
to  ensure  that  all  AN  fertilisers  would  meet  harmonised  and  recognised  safety  standards: 
currently  Member  States  apply  different  measures  for  national  fertilisers.  This  measure  is 
needed to cover the gap in the current legislation which allows the sale of national fertilisers 
in parallel with the sale of “EC fertilisers” under Regulation (EC) No 2003/2003. Sale to the 
general public will be restricted to fertilisers containing <20% nitrogen. The loss of sales to 
the  general  public  of  fertiliser  containing  more  than  20%  nitrogen  is  negligible  and  will  be 
compensated through sales of other fertiliser types of equivalent performance at similar cost. 

3. 

LEGAL ELEMENTS OF THE PROPOSAL 

3.1. 

Legal basis 

The legal basis of the proposal is Article 95 of the Treaty. 

The present Decision would provide harmonised rules for the placing on the market and use 
of DEGME, DEGBE, MDI and cyclohexane preparations for supply to the general public. It 

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would also provide harmonised rules for the placing on the market of AN as a substance and 
in preparations for use as a fertiliser. 

The present Decision would establish uniform rules for the circulation of the products and it 
would  avoid  obstacles  to  trade  because  of  differences  in  legislation  between  the  Member 
States. This proposed amendment to the Directive 76/769/EEC would improve the conditions 
for the functioning of the Internal Market and it would guarantee a high level of protection of 
human health. 

3.2. 

Subsidiarity and proportionality principles 

Council Directive 76/769/EEC relating to restrictions on the placing on the market and use of 
certain dangerous substances and preparations, seeks to establish harmonised rules throughout 
the EU and to avoid divergent national legislation, which is liable to cause barriers to intra-
community  trade.  This  cannot  be  achieved  by  leaving  the  responsibility  to  act  solely  to  the 
Member States. 

The  measures  proposed  in  the  present  Decision  are  proportionate  insofar  as  they  do  not  go 
beyond what it required to achieve the aim of improving the protection of human health whilst 
the economic costs to industry and society at large for all the specific applications are limited. 

3.3. 

Choice of instruments 

The Commission has chosen Council Directive 76/769/EEC as the best instrument to preserve 
the Internal Market and at the same time ensure a high level of protection of human health and 
the environment. It is therefore in conformity with Article 95(3) of the Treaty. 

Directive 76/769/EEC will be repealed on 1 June 2009 by 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.  The  amendments  to  be  made  to  Annex  I  of  Directive 
76/769/EEC  by  this  Decision  will  be  applied  after  1  June  2009  and  will  be  introduced  in 
Annex XVII of Regulation (EC) No 1907/2006. 

It is more appropriate to amend the Annex I of Directive 76/769/EEC using a Decision rather 
than  a  Directive  as  transposition  of  the  proposed  restrictions  into  national  law  would  be 
accomplished only a few months before the Directive 76/769/EEC is repealed. Transposition 
will therefore not serve any useful purpose. In this situation a Decision is a more appropriate 
legal act than a Directive.  

4. 

BUDGETARY IMPLICATION 

There are no budgetary implications arising from the present Decision. 

EN 

10 

   EN 

 
2007/0200 (COD) 

Proposal for a 

DECISION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL  

amending Council Directive 76/769/EEC as regards restrictions on the marketing and 
use of certain dangerous substances and preparations 2-(2-methoxyethoxy)ethanol, 2-(2-
butoxyethoxy)ethanol, methylenediphenyl diisocyanate, cyclohexane and ammonium 
nitrate 

(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 Commission1, 

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

Acting in accordance with the procedure laid down in Article 251 of the Treaty3, 

Whereas: 

(1) 

(2) 

1 
2 
3 
4 

5 

(DEGBE),  methylenediphenyl  diisocyanate 

The  risks  posed  to  human  health  by  2-(2-methoxyethoxy)ethanol  (DEGME),  2-(2-
butoxyethoxy)ethanol 
(MDI)  and 
cyclohexane  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 
substances4. The risk assessment for all these chemical substances identified the need 
to reduce the risks posed to human health. Those conclusions were confirmed by the 
Scientific Committee on Toxicity, Ecotoxicity and the Environment (CSTEE). 

Commission Recommendations 1999/721/EC of 12 October 1999 on the results of the 
risk  evaluation  and  on  the  risk  reduction  strategies  for  the  substances:  2-(2-
butoxyethoxy)ethanol;  2-(2-methoxyethoxy)ethanol;  Alkanes,  C10-13,  chloro; 
Benzene, C10-13-alkyl derivs.5 and 2007/xxx/EC on the results of the risk evaluation 
and  the  risk  reduction  strategies  for  the  substances:  Piperazine;  Cyclohexane; 
Methylenediphenyl  diisocyanate;  But-2yne-1,4-diol;  Methyloxirane;  Aniline;  2-

OJ C , , p. . 
OJ C , , p. . 
OJ C , , p. . 
OJ  L  84,  5.4.1993,p.  1.  Regulation  as  amended  by  Regulation  (EC)  No  1882/2003  (OJ  L  284, 
31.10.2003, p. 1). 
OJ L 292, 13.11.1999, p. 42 

EN 

11 

   EN 

 
 
                                                 
1,4-Dichlorobenzene; 

Ethylhexylacrylate; 
3,5-dinitro-2,6-dimethyl-4-tert-
butylacetophenone;  Di-(2-ethylhexyl)phthalate;  Phenol;  Bis(pentabromophenyl)ether; 
5-tert-butyl-2,4,6-trinitro-m-xylene6,  adopted  within  the  framework  of  Regulation 
(EEC)  No  793/93,  proposed  a  strategy  for  limiting  the  risks  for  DEGME,  DEGBE, 
MDI  and  cyclohexane  respectively,  recommending  that  restriction  measures  under 
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 preparations7 must be applied 
for  preparations  containing  these  substances  placed  on  the  market  for  supply  to  the 
general public. 

In order to protect the consumers, it therefore appears necessary to restrict the placing 
on  the  market  and  the  use  of  preparations  containing  DEGME,  DEGBE,  MDI  and 
cyclohexane during specific applications. 

DEGME is no longer used as a constituent of consumer paints and paint strippers. The 
aforementioned  risk  assessment  has  shown  that  there  is  a  risk  to  the  health  of 
consumers through dermal exposure to paints and paint-strippers containing DEGME. 
Preparations  containing  DEGME  used  in  paints  and  paint  strippers  should  therefore 
not be placed on the market for supply to the general public. A limit value of 0.1% of 
DEGME in preparations should be adopted for market surveillance purposes. 

DEGBE  is  used  as  a  constituent  of  paints.  The  aforementioned  risk  assessment  for 
DEGBE has shown that there is a risk to the health of consumers through inhalation 
exposure during spray painting application. A derived safe concentration limit of 3% 
for  DEGBE  in  spray  paints  should  be  introduced  to  prevent  the  risk  of  inhalation 
exposure for consumers. 

For  other  paints  than  spray  paints,  a  warning  against  using  such  paints  in  spraying 
equipment  should  be  required  where  those  paints  contain  a  DEGBE  concentration 
limit which is equal to or more than 3%. 

In  order  to  ensure  an  appropriate  phase  out  of  paints  not  meeting  the  concentration 
limits  for  DEGBE,  different  dates  should  be  fixed  for  the  applicability  of  the 
restriction in respect of the first placing on the market and the final sale for DEGBE in 
spray paints. 

The risk assessment for MDI has shown that there is a need to limit the risks during 
consumer  applications  of  preparations  containing  MDI  due  to  concerns  from 
inhalation and dermal exposure. To prevent and eliminate these risks, the placing on 
the market for supply to the general public of preparations containing MDI should be 
permitted only under certain conditions such as the mandatory supply of polyethylene 
gloves to the packaging and additional instructions to the packaging. As the provision 
of  the  protective  equipment  and  the  printing  of  relevant  instructions  will  require 
specific efforts by producers, a longer period of transition should be provided. 

(3) 

(4) 

(5) 

(6) 

(7) 

(8) 

6 
7 

OJ C , , p. . 
OJ L 262, 27.9.1976 p. 201. Directive as last amended by Commission Decision 2006/139/EC (OJ L 
384, 29.12.2006, p. 94) 

EN 

12 

   EN 

 
                                                 
(9)  MDI is widely used in consumer products such as One Component Foam (OCF). The 
incidence of cases of respiratory allergy among consumers is still unquantified. There 
is a need to collect more data on possible cases of persons suffering from respiratory 
allergy as a consequence of exposure to preparations containing MDI. The data should 
be  collected  in  accordance  with  a  study  protocol  agreed  by  the  Commission  that 
should  involve  specialised  centres  of  respiratory  allergy.  Where  new  data  has  been 
collected and it is demonstrated that there is a further need for restriction measures, the 
procedure laid down under Article 69 (1) and (3) of 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/EC8 should apply and be based on 
those data. 

(10)  The risk assessment for cyclohexane focused on the exposure of consumers during the 
use  of  preparations  containing  cyclohexane  for  carpet  laying,  and  concluded  that 
restriction  measures  were  necessary  to  reduce  the  risk  for  consumers  during  such 
applications. Neoprene-based adhesives containing cyclohexane should therefore only 
be placed on the market for supply to the general public with a reduced package size. 
Harmonised  instructions  provided  to  the  product  should  prevent  consumers  from  the 
use  under  inappropriate  conditions,  i.e.  poor  ventilation  or  inappropriate  application 
such as carpet laying. 

(11)  Ammonium  nitrate,  which  is  widely  used  throughout  the  Community  as  a  fertiliser, 
can act as an oxidising agent. In particular, it has the ability to explode when mixed 
with  certain  other  substances.  Ammonium  nitrate  fertilisers  should  therefore  meet 
certain  requirements  when  placed  on  the  market  to  ensure  that  they  are  safe  against 
accidental detonation. 

(12)  Regulation (EC) No 2003/2003 of the European Parliament and of the Council of 13 
October 2003  relating to fertilisers9 provides for harmonised  requirements, including 
the  safety  requirements,  for  ammonium  nitrate  fertilisers.  Fertilisers  complying  with 
those  requirements  may  be  labelled  “EC  fertiliser”  and  may  circulate  freely  on  the 
internal market. 

(13)  For fertilisers intended for sale only within a single Member State, manufacturers may 
choose  to  conform  only  to  requirements  existing  at  national  level.  Therefore  those 
fertilisers  may  not  comply  with  the  safety  requirements  set  at  Community  level.  To 
ensure  a  uniform  level  of  safety  within  the  Community,  all  ammonium  nitrate 
fertilisers should therefore conform to the same safety requirements. 

(14)  Regulation  (EC)  No  2003/2003,  in  its  Annex  III,  specifies  a  test  of  resistance  to 
detonation for ammonium nitrate fertilisers containing more than 28% nitrogen. It also 
specifies  a  number  of  physical  characteristics  and  limits  on  the  chemical  impurity 

8 
9 

OJ L 396, 30.12.2006, p. 1. 
OJ L 304, 21.11.2003, p. 1. Regulation as last amended by Commission Regulation (EC) No 162/2007 
(OJ L 51, 20.2.2007, p. 7). 

EN 

13 

   EN 

 
                                                 
content  for  such  fertilisers  in  order  to  minimise  the  risk  of  detonation.  Ammonium 
nitrate  fertilisers  that  comply  with  those  requirements,  or  that  contain  less  than  28% 
nitrogen, are accepted by all Member States as being safe for use in agriculture. 

(15)  All ammonium nitrate fertilisers sold within the Community should therefore conform 

to the safety requirements as set out in Regulation (EC) No 2003/2003. 

(16)  Ammonium  nitrate  fertilisers  have  been  misused  for  the  illicit  manufacture  of 
explosives. Fertiliser types that can be used for this purpose have a nitrogen content as 
low  as  20%.  Access  to  those  fertiliser  types  should  be  limited  to  professional 
agricultural  use  by  imposing  a  limit  of  less  than  20%  of  the  nitrogen  content  in 
ammonium nitrate preparations sold to the general public. 

(17)  Directive 76/769/EEC should be amended accordingly, 

for 

requirements 

(18)  This  Decision  is  without  prejudice  to  the  Community  legislation  laying  down 
the  protection  of  workers,  such  as  Council 
minimum 
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 10 and individual Directives 
based thereon, in particular 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)  (codified  version)11  and 
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)12, 

HAVE ADOPTED THIS DECISION: 

Article 1 

Annex I to Directive 76/769/EEC is amended in accordance with the Annex to this Decision. 

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

Article 2 

This Decision is addressed to the Member States. 

Article 3 

10 

11 
12 

OJ L 183,  29.6.1989,  p. 1.  Directive  as  amended  by  Regulation  (EC)  No  1882/2003  of  the  European 
Parliament and of the Council (OJ L 284, 31.10.2003, p. 1). 
OJ L 158, 30.4.2004, p. 50. 
OJ L 131, 5.5.1998, p. 11. 

EN 

14 

   EN 

 
                                                 
Done at Brussels,  

For the European Parliament 

For the Council 

For the European Parliament 
The President 

For the Council 
The President 

EN 

15 

   EN 

 
 
 
In Annex I to Directive 76/769/EEC, the following points 53 to 57 are added: 

ANNEX  

(53) 

2-(2-methoxyethoxy)ethanol 
(DEGME) 

CAS N°: 111-77-3 

EINECS N°: 203-906-6 

(54) 

2-(2-butoxyethoxy)ethanol (DEGBE) 

CAS N°: 112-34-5 

EINECS N°: 203-961-6 

Shall  not  be  placed  on  the  market  after  [18 
months  after  the  entry  into  force  of  the 
Decision],  for  supply  to  the  general  public, 
as  a  constituent  in  paints  and  in  paint 
strippers in concentrations equal to or higher 
than 0.1% by mass. 

(1) 

(2) 

Shall not be placed on the market for 
the  first  time  after  [18  months  after 
the entry into force of the Decision], 
for supply to the general public, as a 
constituent  of 
in 
concentrations  equal  to  or  higher 
than 3% by mass. 

spray  paints 

to 

conforming 

Paints  not 
the 
concentration  limit  in  point  (1)  shall 
not  be  placed  on  the  market  for 
supply to the general public after [24 
months  after  the  entry  into  force  of 
the Decision]. 

(3)  Without 

to 

prejudice 

other 
Community 
legislation  concerning 
the  classification,  packaging  and 
labelling  of  dangerous  substances 
and  preparations,  paints  other  than 
spray  paints  containing  more  than 
3%  by  mass  of  DEGBE  that  are 
placed  on  the  market  for  supply  to 
the  general  public  shall  be  legibly 
and  indelibly  marked  by  [24  months 
after  the  entry  into  force  of  the 
as 
Decision] 
follows:
“Do  not  use 
in  paint  spraying 
equipment”. 

(55) 

(4) 

methylenediphenyl diisocyanate 
(MDI)  

CAS N°: 26447-40-5 

EINECS N°: 247-714-0 

Shall  not  be  placed  on  the  market 
after  [24  months  after  the  entry  into 
the  Decision],  as  a 
force  of 
constituent 
in 
preparations 
concentrations  equal  to  or  higher 
than 0.1% by mass for supply to the 
general public, unless the packaging: 

of 

EN 

16 

   EN 

 
 
(a) 

contains polyethylene gloves. 

(b) 

legibly 
and 
is  marked 
follows,  and 
indelibly  as 
to  other 
without  prejudice 
Community 
legislation 
concerning  the  classification, 
packaging  and  labelling  of 
substances  and 
dangerous 
preparations: 

– 

– 

– 

– 

“May  cause  allergic 
reactions 
to 
already 
individuals 
sensitised 
to 
other 
diisocyanates 
than MDI. 

May elicit asthma-like 
in 
reactions 
individuals 
with 
asthma. 

cause  dermal 
to 
suffering 

May 
reactions 
individuals 
from skin problems. 

Use  a  mask  with  an 
antigas  filter  (i.e.  type 
EN  14387:2004  mask 
with type of filter A1) 
under  conditions  of 
poor ventilation.” 

By  way  of  derogation,  point  (1)  (a) 
does not apply to hot melt adhesives. 

for 

the 

first 

Natural  or  legal  persons  placing  on 
the  market 
time 
preparations  containing  MDI  shall, 
within  3  years  from  the  date  of 
implementation of the restrictions set 
forth in paragraph (1), collect data on 
possible  cases  of  persons  suffering 
from  respiratory  allergy  during  the 
use  of  preparations  containing  MDI 
and make those data available to the 
Commission. Data shall be collected 
in  accordance  with  a  study  protocol 
that  shall  involve  specialised  centres 

(5) 

(6) 

EN 

17 

   EN 

 
 
(56) 

cyclohexane 

CAS N°: 110-82-7 

EINECS N°: 203-806-2 

(7) 

(8) 

(9) 

shall  be 

and 
Commission. 

agreed  by 

the 

Article  69(1)  and  (3)  of  Regulation 
(EC) No 1907/2006 of the European 
Parliament  and  of  the  Council*,  all 
apply,  unless 
the  data  collected 
demonstrates that there is no need for 
further  restriction  measures  other 
than those already applied. 

Shall not be placed on the market for 
the  first  time  after  [18  months  after 
the entry into force of the Decision], 
for supply to the general public, as a 
based 
constituent 
adhesives  in  concentrations  equal  to 
or  higher  than  0.1%  by  mass  in 
package sizes greater than 650 g. 

neoprene 

of 

Neoprene based adhesives containing 
cyclohexane  and  not  conforming  to 
(1) shall not be placed on the market 
for supply to the general public after 
[24 months after the entry into force 
of the Decision]. 

(10)  Without 

to 

prejudice 

other 
Community 
legislation  concerning 
the  classification,  packaging  and 
labelling  of  dangerous  substances 
and  preparations,  neoprene  based 
adhesives  containing  cyclohexane  in 
concentrations  equal  to  or  higher 
than 0.1% by mass that are placed on 
the  market  for  supply  to  the  general 
public  after  [24  months  after  the 
entry into force of the Decision] shall 
be  legibly  and  indelibly  marked  as 
follows: 

(57) ammonium nitrate (AN) 

(1) 

CAS No 6484-52-2 

EINECS No229-347-8 

– 

– 

“Do  not  use  under  conditions 
of poor ventilation. 

Do not use for carpet laying.” 

Shall not be placed on the market for 
the first time after [18 months after 
the entry into force of the Decision] 
as a substance, or in preparations that 
contain more than 28% by mass of 

EN 

18 

   EN 

 
 
nitrogen in relation to ammonium 
nitrate, for use as a solid fertiliser, 
straight or compound, unless the 
fertiliser complies with the technical 
provisions for ammonium nitrate 
fertilisers of high nitrogen content set 
out in Annex III to Regulation (EC) 
No 2003/2003 of the European 
Parliament and of the Council 
relating to fertilisers**. 

Shall not be placed on the market for 
supply to the general public after [18 
months after the entry into force of 
the Decision] as a substance, or in 
preparations that contain 20% or 
more by mass of nitrogen in relation 
to ammonium nitrate. 

(2) 

* OJ L 396, 30.12.2006, p.1. 

**OJ L 304, 21.11.2003. 

EN 

19 

   EN