2004/394/EC:Commission Recommendation of 29 April 2004 on the results of the risk evaluation and the risk reduction strategies for the substances: Acetonitrile; Acrylamide; Acrylonitrile; Acrylic acid; Butadiene; Hydrogen fluoride; Hydrogen peroxide; Methacrylic acid; Methyl methacrylate; Toluene; Trichlorobenzene (Text with EEA relevance) (notified under document number C(2004) 1446)
Date: 2004-04-29
Institutions: European Commission
Subjects: EU Member State, dangerous substance, environmental protection, evaluation method, exchange of information, health risk, public health

L 144/72 

EN 

Official Journal of the European Union

30.4.2004 

COMMISSION RECOMMENDATION 

of 29 April 2004 

on the results of the risk evaluation and the risk reduction strategies for the substances: 
Acetonitrile; Acrylamide; Acrylonitrile; Acrylic acid; Butadiene; Hydrogen fluoride; 
Hydrogen peroxide; Methacrylic acid; Methyl methacrylate; Toluene; Trichlorobenzene 

(notified under document number C(2004) 1446)

(Text with EEA relevance) 

(2004/394/EC) 

THE COMMISSION OF THE EUROPEAN COMMUNITIES, 

Having regard to the Treaty establishing the European Community 

Having regard to Council Regulation (EEC) No 793/93 of 23 March 1993 on the evaluation 
and control of the risks of existing substances (1) and in particular Article 11(2) thereof, 

Whereas: 

(1)

– 

– 

– 

– 

– 

– 

– 

1

2

In  the  framework  of  Council  Regulation  (EEC)  No  793/93  the  following  substances 
have  been  identified  as  priority  substances  for  evaluation  in  accordance  with 
Commission Regulation (EC) No 1179/94 of 25 May 1994 concerning the first list of 
priority substances as foreseen under Council Regulation (EEC) No 793/93 (2), which 
also designates for those substances the following rapporteur Member States: 

Acetonitrile, rapporteur Member State: Spain, 

Acrylamide, rapporteur Member State: the United Kingdom, 

Acrylonitrile, rapporteur Member State: Ireland, 

Acrylic acid, rapporteur Member State: Germany, 

Butadiene, rapporteur Member State: the United Kingdom, 

Hydrogen fluoride, rapporteur Member State: the Netherlands, 

Methacrylic acid, rapporteur Member State: Germany, 

OJ L 84, 5.4.1993, p. 1. 
OJ L 131, 26.5.94, p. 3. 

30.4.2004

EN 

Official Journal of the European Union

L 144/73 

– 

(2)

– 

– 

– 

(3)

(4)

(5)

(6)

Methyl methacrylate, rapporteur Member State: Germany. 

In  the  framework  of  Council  Regulation  (EEC)  No  793/93  the  following  substances 
have  been  identified  as  a  priority  substances  for  evaluation  in  accordance  with 
Commission  Regulation  (EC)  No  2268/95  of  28  September  1995  concerning  the 
second  list  of  priority  substances  as  foreseen  under  Council  Regulation  (EEC)  No 
793/93  (3),  which  also  designates  for  those  substances  the  following  rapporteur 
Member States: 

Hydrogen peroxide, rapporteur Member State: Finland; 

Toluene, rapporteur Member State: Denmark; 

Trichlorobenzene, rapporteur Member State: Denmark; 

Those rapporteur Member States have completed all the risk evaluation activities with 
regard to man and the environment for those substances and have suggested a strategy 
for  limiting  the  risks  in  accordance  with  Commission  Regulation  (EC)  No  1488/94 
of  28  June  1994  laying  down  the  principles  for  the  assessment  of  risks  to  man  and 
the environment of existing substances in accordance with Council Regulation (EEC)            
No 793/93 (4). 

The Scientific Committee on Toxicity, Ecotoxicity and the Environment (CSTEE) has 
been consulted and has issued an opinion with respect to the risk evaluations carried 
out by the Member States rapporteurs. 

The results of the risk evaluation are set out in the Annex. 

On the basis of the measures recommended by the rapporteur, the Member States and 
the  interested  sector  should  where  appropriate  take  into  account  the  agreed  risk 
evaluation  and  implement  the  relevant  recommendations,  to  ensure  risk  to  human 
health  and  the  environment  is  controlled  for  each  of  the  substances  for  which  a  risk 
assessment  has  been  carried  out.  The  Commission  has  also  listed  community 
legislative measures to which priority should be given. 

(7)

The measures provided for in this recommendation are in accordance with the opinion 
of  the  Committee  set  up  pursuant  to  Article  15  of  Regulation  (EEC)  No  793/93, 

HEREBY RECOMMENDS: 

1. 

All sectors importing, producing, transporting, storing, formulating into a preparation 
or other processing, using, disposing or recovering the following substances: 

(1) 

Acetonitrile; 
CAS No 75-05-8 
Einecs No 200-835-2 

3

4

OJ L 231, 28.9.1995, p. 18. 
OJ L 161, 29.6.1994, p. 3. 

L 144/74 

EN 

Official Journal of the European Union

30.4.2004 

(2) 

(3) 

(4) 

(5) 

(6) 

(7) 

Acrylamide; 
CAS No 79-06-1 
Einecs No 201-173-7 

Acrylonitrile; 
CAS No 107-13-1 
Einecs No 203-466-5 

Acrylic acid; 
CAS No 79-10-7 
Einecs No 201-177-9 

Butadiene; 
CAS No 106-99-0 
Einecs No 203-450-8 

Hydrogen fluoride; 
CAS No 7664-39-3 
Einecs No 231-634-8 

Hydrogen peroxide; 
CAS No 7722-84-1 
Einecs No 231-765-0 

(8)  Methacrylic acid; 
CAS No 79-41-4 
Einecs No 201-204-4 

(9)  Methyl methacrylate; 

CAS No 80-62-6 
Einecs No 201-297-1 

(10)  Toluene; 

CAS No 108-88-3 
Einecs No 203-625-9

(11)  Trichlorobenzene; 
CAS No 120-82-1 
Einecs No 204-428-0 

should take into account the results of the risk evaluation set out in the Section Risk 
assessment of parts 1 to 11 of the Annex for each of the substances mentioned.  

2. 

The  strategy  for  limiting  risks  set  out  in  the  Section  Strategy  for  limiting  risks  of 
Parts 1 to 11 of the Annex to this recommendation should be implemented. Where it 
is considered that no risks are expected, the information should be used to ensure the 
current risk reduction measures are maintained. 

This Recommendation is addressed to all sectors importing, producing, transporting, 
storing,  formulating  into  a  preparation  or  other  processing,  using,  disposing  or 
recovering the following substances and to the Member States.  

30.4.2004

EN 

Official Journal of the European Union

L 144/75 

Done at Brussels, 29 April 2004. 

For the Commission 
Margot WALLSTRÖM 
Member of the Commission 

_______ 

L 144/76 

EN 

Official Journal of the European Union

30.4.2004 

ANNEX

PART ONE 

CAS-NO. 75-05-8 

Einecs-No. 200-835-2 

Structural Formula: 

Einecs Name: 

CH3−C ≡ N 

Acetonitrile

IUPAC Name: 

Acetonitrile 

Rapporteur: 

Spain 

Classification 5: 

F: R11 
Xn: R20/21/22 
Xi: R36 

The  risk  assessment  is  based  on  current  practices  related  to  the  life  cycle  of  the  substance 
produced  in  or  imported  into  the  European  Community  as  described  in  the  comprehensive 
Risk  Assessment  Report  forwarded  to  the  Commission  by  the  Member  State  Rapporteur  6. 
The risk assessment has, based on the available information, determined that in the European 
Community  the  substance  is  mainly  used  as  an  intermediate  for  synthesis  of  industrial 
chemicals,  pharmaceuticals  and  pesticides,  and  in  the  manufacturing  of  photographic  film. 
Other uses include as a solvent in various extraction processes and in research and analytical 
laboratories.  It  was  not  possible  to  obtain  information  on  the  use  of  the  total  volume  of 
substance produced in or imported into the European Community, therefore, some uses may 
exist which are not covered by this risk assessment. 

The risk assessment has identified other sources of exposure of the substance to man and the 
environment, in particular, the substance is produced during biomass burning and is present in 
automobile exhaust, which do not result from the life-cycle of the substance produced in or 
imported into the European Community. The assessment of the risks arising from these 
exposures are not part of this risk assessment. The comprehensive Risk Assessment Reports 
as forwarded to the Commission by the Member State Rapporteur does however provide 
information about these risks.

5

6

The  classification  of  the  substances  is  established  by  Commission  Directive  2000/32/EC  of  19  May 
2000  adapting  to  technical  progress  for  the  26th  time  Council  Directive  67/548/EEC  on  the 
approximation  of  the  laws,  regulations  and  administrative  provisions  relating  to  the  classification, 
packaging and labelling of dangerous substances (OJ L 136, 8.6..2000, p. 1). 
The comprehensive Risk Assessment Report, as well as a summary thereof, can be found on the internet 
site of the European Chemicals Bureau: http://ecb.jrc.it/existing-substances/.

30.4.2004

EN 

Official Journal of the European Union

L 144/77 

RISK ASSESSMENT 

A. Human health 

The conclusions of the evaluation of the risks to  

WORKERS  

is  that  there  is  a  need  for  specific  measures  to  limit  the  risks.  This  conclusion  is  reached 
because of: 

– 

concerns for general  systemic  toxicity  as a  consequence  of dermal  exposure arising 
from use as a solvent and as an intermediate. 

The conclusions of the evaluation of the risks to  

CONSUMERS and HUMANS EXPOSED VIA THE ENVIRONMENT 

is that there is at present no need for further information and/or testing or for risk reduction 
measures beyond those which are being applied. This conclusion is reached because: 

– 

the  risk  assessment  shows  that  risks  are  not  expected.  Risk  reduction  measures 
already being applied are considered sufficient 

The conclusions of the evaluation of the risks to  

HUMAN HEALTH (physicochemical properties) 

is that there is at present no need for further information and/or testing or for risk reduction 
measures beyond those which are being applied. This conclusion is reached because: 

– 

the  risk  assessment  shows  that  risks  are  not  expected.  Risk  reduction  measures 
already being applied are considered sufficient 

B. Environment 

The conclusions of the evaluation of the risks to the environment for 

ATMOSPHERE 

is that there is at present no need for further information and/or testing or for risk reduction 
measures beyond those which are being applied. This conclusion is reached because: 

– 

the risk assessment shows that risks related to the environmental spheres mentioned 
above  are  not  expected.  Risk  reduction  measures  already  being  applied  are 
considered sufficient. 

L 144/78 

EN 

Official Journal of the European Union

30.4.2004 

The conclusions of the evaluation of the risks to the environment for 

AQUATIC ECOSYSTEM and TERRESTRIAL ECOSYSTEM 

is  that  there  is  a  need  for  specific  measure  to  limit  the  risks.  The  conclusion  is  reached 
because of: 

– 

concerns  for  the  aquatic  and  terrestrial  ecosystems  as  a  consequence  of  exposure 
arising from use of the substance in the pharmaceutical industry. 

The conclusions of the evaluation of the risks to the environment for 

MICRO-ORGANISMS IN THE SEWAGE TREATMENT PLANT 

is  that  there  is  a  need  for  specific  measures  to  limit  the  risks.  This  conclusion  is  reached 
because of: 

– 

concerns for effects on sewage treatment plants as a consequence of exposure arising 
industry. 
from 

pharmaceutical 

substance 

use 

the 

the 

the 

of 

in 

STRATEGY FOR LIMITING RISKS 

The risk assessment has identified other sources of acetonitrile emissions (eg burning of fossil 
fuels).  This  is  outside  the  scope  of  Council  Regulation  (EEC)  793/93  and  has  not  been 
considered in the Risk Reduction Strategy. 

for WORKERS 

The legislation for workers protection currently in force at Community level is considered to 
give an adequate framework to limit the risks of the substance to the extent needed and shall 
apply. 

Within this framework it is recommended: 

– 

to  consider  revising  the  current  occupational  exposure  limit  value  adopted  under 
Commission  Directive  91/322/EEC  7 to  provide  an  indication that  dermal  exposure 
can make a contribution to the worker body burden. 

for ENVIRONMENT 

– 

7

8

that  the  European  Commission  should  consider  the  inclusion  of  acetonitrile  in  the 
priority  list  of  Annex  X  to  Council  and  Parliament  Directive  2000/60/EC  8  (Water 
Framework Directive) during the next review of this Annex. 

Commission  Directive  91/322/EEC  on  establishing  indicative  limit  values  by  implementing  Council 
Directive  80/1107/EEC  on  the  protection  of  workers  from  the  risks  related  to  exposure  to  chemical, 
physical and biological agents at work (OJ L 177, 5.7.1991, p. 22). 
Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a 
framework for Community action in the field of water policy, (OJ L 327, 22.12.2000, p. 1). 

30.4.2004

EN 

Official Journal of the European Union

L 144/79 

– 

– 

to  facilitate  permitting  under  Council  Directive  96/61/EC  9  (Integrated  Pollution 
Prevention  and  Control)  this  substance  should  be  included  in  the  ongoing  work  to 
develop  guidance  on  ‘Best  Available  Techniques’  (BAT).  It  is  recommended  that 
Member  States  should  carefully  monitor  the  implementation  of  BAT  by  permitting 
and  report any important developments to the Commission in the framework of the 
exchange of information on BAT. 

local  emissions  to  the  environment  should,  where  necessary,  be  controlled  by 
national rules to ensure that no risk for the environment is expected. 

9

Council  Directive  96/61/EC  of  24  September  1996  concerning  integrated  pollution  prevention  and 
control (OJ L 257, 10.10.1996, p. 26). 

L 144/80 

EN 

Official Journal of the European Union

30.4.2004 

ANNEX

PART TWO 

CAS-NO. 79-06-1 

Einecs-No. 201-173-7 

Structural Formula: 

CH2 ═ CH−CONH2

Einecs Name: 

Acrylamide

IUPAC Name: 

2-propenamide 

Rapporteur: 

United Kingdom 

Classification 10: 

Carc.Cat.2:R45 
Muta.Cat.2:R46 
Repro.Cat.3:R62 
T:R25 
T:R48/23/24/25 
Xn:R20/21 
Xi:R36/38 
R43 

The risk assessment is based on current practices related to the life-cycle of the substance 
produced in or imported into the European Community as described in the comprehensive Risk 
Assessment Report forwarded to the Commission by the Member State Rapporteur 11. 

The risk assessment has, based on the available information, determined that in the European 
Community the substance is mainly used as an intermediate in the chemical industry for the 
production of polyacrylamide. Other uses are as on-site preparation of polyacrylamide gels and 
as grouting agents. The main uses of polyacrylamide are in waste water treatment, paper and 
pulp processing and mineral processing; minor uses include as cosmetic additives and as soil 
conditioners. It was not possible to obtain information on the use of the total volume of 
substance produced in or imported into the European Community, therefore some uses may 
exist which are not covered by this risk assessment. 

10

11

The  classification  of  the  substance  is  established  by  Commission  Directive  2001/59/EC  of  6  August, 
adapting to technical progress for the 28th time Council Directive 67/548/EEC on the approximation of 
the laws, regulations and administrative provisions relating to the classification, packaging and labelling 
of dangerous substances (OJ L 225, 21.8.2001, p. 1). 
The comprehensive Risk Assessment Report, as well as a summary thereof, can be found on the internet 
site of the European Chemicals Bureau: http://ecb.jrc.it/existing-substances/.

30.4.2004

EN 

Official Journal of the European Union

L 144/81 

RISK ASSESSMENT 

A. Human health 

The conclusions of the evaluation of the risks to 

WORKERS 

is that there is a need for specific measures to limit the risks. This conclusion is reached 
because of: 

– 

– 

concerns for mutagenicity and carcinogenicity as a consequence of exposure arising 
from production of the substance, use as an intermediate in the chemical industry for 
the production of polyacrylamide, use of polyacrylamide, use of polyacrylamide gels 
for  electrophoresis  and  use  of  acrylamide  based  grouts  (small  and  large  scale 
applications). 

concerns  for  neurotoxicity  and  reproductive  toxicity  as  a  consequence  of  exposure 
arising from the small and large scale use of acrylamide based grouts. 

The conclusions of the evaluation of the risks to 

CONSUMERS 

– 

is that risks can not be excluded at any exposure, as the substance is identified as a 
non-threshold  carcinogen.  The  adequacy  of existing  controls  and  the  feasibility and 
practicability  of  further  specific  measures  should  be  considered.  However,  the  risk 
assessment  indicates  that  risks  are  already  low.  This  should  be  taken  into  account 
when  considering  the  adequacy  of  existing  controls  and  the  feasibility  and 
practicability of further specific risk reduction measures. 

The conclusions of the evaluation of the risks to 

HUMANS EXPOSED VIA THE ENVIRONMENT 

is  that  there  is  a  need  for  specific  measures  to  limit  the  risks.  This  conclusion is reached 
because of: 

– 

concerns  for  neurotoxicity,  reproductive  toxicity,  mutagenicity  and  carcinogenicity 
as  a  consequence  of  exposure  resulting  from  the  use  of  acrylamide  based  grouts  in 
large scale construction applications. 

In addition to the conclusion given above, risks cannot be excluded considering the remaining 
uses,  as  the  substance  is  identified  as  a  non-threshold  carcinogen.  The  adequacy  of  existing 
controls  and  the  feasibility  and  practicability  of  further  specific  measures  should  be 
considered. However, the risk assessment indicates that risks are already low. This should be 
taken into account when considering the adequacy of existing controls and the feasibility and 
practicability of further specific risk reduction measures. 

L 144/82 

EN 

Official Journal of the European Union

30.4.2004 

The conclusion of the assessment of the risks to 

HUMAN HEALTH (physicochemical properties) 

is that there is at present no need for further information and/or testing or for risk reduction 
measures beyond those which are being applied. This conclusion is reached because: 

– 

the  risk  assessment  shows  that  risks  are  not  expected.  Risk  reduction  measures 
already being applied are considered sufficient. 

B. Environment 

The conclusions of the evaluation of the risks to the environment for 

AQUATIC ECOSYSTEM

is that there is a need for specific measures to limit the risks. The conclusion is reached because 
of: 

– 

concerns  for  the  aquatic  ecosystem  as  a  consequence  of  exposure  arising  from  the 
use of acrylamide based grouts in construction applications, and to indirect exposure 
of other organisms through contaminated water from the same use. 

The conclusion of the assessment of the risks to the 

ATMOSPHERE 

is that there is at present no need for further information and/or testing or for risk reduction 
measures beyond those which are being applied. This conclusion is reached because: 

– 

the risk assessment shows that risks related to the environmental spheres mentioned 
above  are  not  expected.  Risk  reduction  measures  already  being  applied  are 
considered sufficient. 

The conclusion of the assessment of the risks to the 

TERRESTRIAL ECOSYSTEM 

is  that  there  is  a  need  for  further  information  and/or  testing.  This  conclusion  is  reached 
because of: 

– 

– 

concerns  for  use  of  acrylamide-based  grouts  in  construction  applications.  The 
information and/or testing requirement is: 

information to refine the risk evaluation for the environment. 

The need to obtain this information was re-evaluated in light of the risk reduction strategy and 
is no longer required (see section II Strategy for limiting risks). 

30.4.2004

EN 

Official Journal of the European Union

L 144/83 

The conclusion of the assessment of the risks to the 

MICRO-ORGANISMS IN THE SEWAGE TREATMENT PLANT 

is that there is at present no need for further information and/or testing or for risk reduction 
measures beyond those which are being applied. This conclusion is reached because: 

– 

the risk assessment shows that risks related to the environmental spheres mentioned 
above  are  not  expected.  Risk  reduction  measures  already  being  applied  are 
considered sufficient. 

STRATEGY FOR LIMITING RISKS 

for HUMAN HEALTH and the ENVIRONMENT

It is recommended: 

– 

– 

– 

to  consider  at Community level marketing and use restrictions in Council Directive 
76/769/EEC  12 for  the  use  of  acrylamide  13  in  grouts  for  small  and  large-scale 
applications. 

Further work may be necessary to determine if derogations can be justified 

The  marketing  and  use  restrictions  proposed  will  eliminate  the  need  for  more 
information to refine the risk evaluation for the environment 

for WORKERS

The  legislation  for  worker  protection  currently  in  force  at  Community  level  is  generally 
considered  to  give  an  adequate  framework  to  limit  the  risks  of  the  substance  to  the  extent 
needed and shall apply. 

Within this framework it is recommended: 

– 

to establish at community level occupational exposure limit values for acrylamide. 

for CONSUMERS

– 

12

13

The  existing  legislative  measures  for  consumer  protection,  in  particular  the 
provisions  under  Directive  76/769/EEC  (Marketing  and  Use  Directive)  as  regards 
substances  that  are  carcinogenic,  mutagenic  and  toxic  to  reproduction  (CMR 

OJ L 262, 27.9.1976, p. 201. 
N-methylolacrylamide-based  grouts  are  also  a  potential  source  of  free  acrylamide  in  the  grouting 
process and consideration should be given to examining the risks from this chemical. 

L 144/84 

EN 

Official Journal of the European Union

30.4.2004 

substances),  and  Council  Directive  2001/95/EC  (General  Product  Safety)  14  as 
regards products are considered sufficient to address the risks identified. 

14

OJ L 11, 15.1.2002, p. 4. 

30.4.2004

EN 

Official Journal of the European Union

L 144/85 

ANNEX

PART THREE 

CAS-NO. 107-13-1 

Einecs-No.203-466-5 

Structural Formula: 

CH2 ═ CH − C ≡ N 

Einecs Name: 

Acrylonitrile 

IUPAC Name: 

2-propenenitrile 

Rapporteur: 

Ireland 

Classification 15 

F:R11 
Carc.Cat.2:R45 
T:R23/24/25 
Xi:R37/38 
R41 
R43 
N:R51/53 

The  risk  assessment  is  based  on  current  practices  related  to  the  lifecycle  of  the  substance 
produced  in  or  imported  into  the  European  Community  as  described  in  the  comprehensive 
Risk Assessment Report forwarded to the Commission by the Member State rapporteur 16. 

The risk assessment has, based on the available information, determined that in the European 
Community  the  substance  is  mainly  used  as  a  monomer  in  the  production  of  polymeric 
materials, primarily acrylic and modacrylic fibres, acrylonitrile-butadiene-styrene plastics and 
styrene-acrylonitrile plastics. Other uses are as a monomer in the synthesis of novel polymeric 
materials, production of acrylamide, adiponitrile, fatty amines and fatty alcohols. 

The  risk  assessment  has  identified  other  sources  of  exposure  to  the  substance,  relevant  for 
man and the environment, which do not result from the life cycle of the substance produced in 
or  imported  into  the  European  Community,  in  particular,  the  substance  is  produced  during 
combustion of fossil fuels. The  assessment of the risks arising from these exposures are not 
part of this risk assessment. The comprehensive Risk Assessment Report, as forwarded to the 

15

16

The classification of the substance is established by Commission Directive 2000/32/EC of 19 May 2000 
adapting to technical progress for the 26th time Council Directive 67/548/EEC on the approximation of 
the laws, regulations and administrative provisions relating to the classification, packaging and labelling 
of dangerous substances (OJ L 136, 8.6.2000, p.1). 
The comprehensive Risk Assessment Report, as well as a summary thereof, can be found on the internet 
site of the European Chemicals Bureau: http://ecb.jrc.it/existing-substances/.

L 144/86 

EN 

Official Journal of the European Union

30.4.2004 

Commission  by  the  Member  State  Rapporteur,  does  however  provide  information  which 
could be used to assess these risks. 

30.4.2004

EN 

Official Journal of the European Union

L 144/87 

RISK ASSESSMENT 

A. Human health

The conclusions of the evaluation of the risks to  

WORKERS  

is  that  there  is  a  need  for  specific  measures  to  limit  the  risks.  This  conclusion  is  reached 
because of: 

– 

concerns  for  general  systemic  effects  and  carcinogenicity  as  a  consequence  of 
exposure arising during the production and processing of the substance. 

The conclusions of the evaluation of the risks to  

CONSUMERS and HUMANS EXPOSED VIA THE ENVIRONMENT

are  that  there  is  a  need  for  specific  measures  to  limit  the  risks.  This  conclusion  is  reached 
because : 

– 

Risks  can  not  be  excluded  for  all  exposure  scenarios,  as  the  substance  is  currently 
regarded  as  a  non-threshold  carcinogen.  The  adequacy  of  existing  controls  and  the 
feasibility  and  practicability  of  further  specific  measures  should  be  considered. 
However,  the  risk  assessment  indicates  that  risks  are  already  low.  This  should  be 
taken  into  account  when  considering  the  adequacy  of  existing  controls  and  the 
feasibility and practicability of further specific risk reduction measures. 

The conclusion of the assessment of the risks to  

HUMAN HEALTH (physicochemical properties) 

is that there is at present no need for further information and/or testing or for risk reduction 
measures beyond those which are being applied. This conclusion is reached because: 

– 

the risk assessment shows that risks are not expected. Risk reduction measures 
already being applied are considered sufficient. 

B. Environment

The conclusions of the evaluation of the risks to the environment for 

AQUATIC ECOSYSTEM 

is  that  there  is  a  need  for  specific  measure  to  limit  the  risks.  The  conclusion  is  reached 
because of: 

– 

concerns for effects on the local aquatic sphere as a consequence of exposure arising 
from production of acrylic fibres at a particular site. 

L 144/88 

EN 

Official Journal of the European Union

30.4.2004 

The conclusion of the assessment of the risks to the  

ATMOSPHERE and TERRESTRIAL ECOSYSTEM

is that there is at present no need for further information and/or testing or for risk reduction 
measures beyond those which are being applied. This conclusion is reached because: 

– 

the risk assessment shows that risks related to the environmental spheres mentioned 
above  are  not  expected.  Risk  reduction  measures  already  being  applied  are 
considered sufficient. 

The conclusion of the assessment of the risks for 

MICRO-ORGANISMS IN THE SEWAGE TREATMENT PLANT 

is that there is at present no need for further information and/or testing or for risk reduction 
measures beyond those which are being applied. This conclusion is reached because: 

– 

the  risk  assessment  shows  that  risks related  to  the  environmental  sphere  mentioned 
above  are  not  expected.  Risk  reduction  measures  already  being  applied  are 
considered sufficient 

STRATEGY FOR LIMITING RISKS 

The  risk  assessment  has  identified  other  sources  of  acrylonitrile  emissions  (e.g.  burning  of 
fossil fuels). This is outside the scope of Council Regulation (EEC) 793/93 and has not been 
considered in the Risk Reduction Strategy. 

for WORKERS

The  legislation  for  workers  protection  currently  in  force  at  Community  level  is  generally 
considered  to  give  an  adequate  framework  to  limit  the  risks  of  the  substance  to  the  extent 
needed and shall apply. 

Within this framework it is recommended: 

– 

to establish at community level occupational exposure limit values for Acrylonitrile 

for CONSUMERS and HUMANS EXPOSED VIA THE ENVIRONMENT 

– 

The  existing  legislative  measures  for  the  protection  of  consumers  and  humans 
exposed via the environment, in particular the provisions under the Council Directive 
76/769/EEC  (Marketing  and  Use  Directive)  as  regards  CMR  substances,  Council 
Directive  2001/95/EC  (General  Product  Safety)  as  regards  products,  and  Council 
Directive  96/61/EC  (Integrated  Pollution  Prevention  and  Control)  are  considered 
sufficient to address the risks identified. 

for the ENVIRONMENT 

– 

to  facilitate  permitting  under  Council  Directive  96/61/EC  (Integrated  Pollution 
Prevention  and  Control)  this  substance  should  be  included  in  the  ongoing  work  to 

30.4.2004

EN 

Official Journal of the European Union

L 144/89 

guidance 

(BAT). 
develop 
It is recommended that Member States should carefully monitor the implementation 
of BAT by permitting and report any important developments to the Commission in 
the framework of the exchange of information on BAT. 

Techniques’ 

Available 

‘Best 

on 

– 

local  emissions  to  the  environment  should,  where  necessary,  be  controlled  by 
national rules to ensure that no risk for the environment is expected. 

L 144/90 

EN 

Official Journal of the European Union

30.4.2004 

ANNEX

PART FOUR 

CAS NO. 79-10-7 

Einecs-No.201-177-9 

Structural Formula: 

CH2 ═ CH−COOH 

Einecs Name: 

Acrylic Acid 

IUPAC Name: 

 2-propenoic acid 

Rapporteur: 

 Germany 

Classification 17 

C:R35 
Xn:R20/21/22 
R10 
N:R50 

The  risk  assessment  is  based  on  current  practices  related  to  the  life  cycle  of  the  substance 
produced  in  or  imported  into  European  Community  as  described  in  the  comprehensive Risk 
Assessment Report forwarded to the Commission by the Member State rapporteur 18. 

The risk assessment has, based on the available information, determined that in the European 
Community  the  substance  is  mainly  used  as  an  intermediate  in  the  production  of  poly-
acrylates.  Other  uses  are  as  an  ingredient  in  adhesives  and  its  occurrence  as  a  residual 
monomer in adhesives, paints, binding agents, printing inks, sanitary towels, panty-liners and 
nappy  pants.  Polyacrylates  are mainly used as co-builders in phosphate free washing agents, 
in  flocculating  agents  and  for  treatment  of  drinking  and  waste  water.  It  was  not  possible  to 
obtain information on the use of the total volume of substance produced in or imported into 
the European Community, therefore, some uses may exist which are not covered by this risk 
assessment. 

The  risk  assessment  has  identified  other  sources  of  exposure  to  the  substance,  relevant  for 
man and the environment, in particular, during the use of acrylate based grouting agents, as a 
decomposition product during the production of printed circuit boards and during the removal 
of paints using gas flames, which do not result from the life-cycle of the substance produced 

17

18

The classification of the substance is established by Commission Directive 2000/32/EC of 19 May 2000 
adapting to technical progress for the 26th time Council Directive 67/548/EEC on the approximation of 
the laws, regulations and administrative provisions relating to the classification, packaging and labelling 
of dangerous substances (OJ L 136, 8.6.2000, p.1). 
The comprehensive Risk Assessment Report, as well as a summary thereof, can be found on the internet 
site of the European Chemicals Bureau: http://ecb.jrc.it/existing-substances/.

30.4.2004

EN 

Official Journal of the European Union

L 144/91 

in or imported into the European Community. The assessment of the risks arising from these 
exposures are part of this risk assessment. 

RISK ASSESSMENT 

A. Human health

The conclusion of the assessment of the risks to 

WORKERS 

is  that  there  is  a  need  for  specific  measures  to  limit  the  risks.  This  conclusion  is  reached 
because of: 

– 

– 

– 

concerns  for  respiratory  tract  irritation  and  corrosivity  as  a  consequence  of  single 
inhalation exposure arising from production and processing, production of adhesives 
containing the substance and use of adhesives containing the substance, 

concerns  for  local  effects  as  a  consequence  of  repeated  inhalation  exposure  arising 
from  production  of  adhesives  containing  the  substance  and  use  of  adhesives 
containing the substance, 

concerns  for  general  systemic  toxicity  as  a  consequence  of  repeated  inhalation 
exposure arising from production and use of adhesives containing the substance. 

The conclusion of the assessment of the risks to 

CONSUMERS and HUMANS EXPOSED VIA THE ENVIRONMENT

is that there is at present no need for further information and/or testing or for risk reduction 
measures beyond those which are being applied. This conclusion is reached because: 

– 

the  risk  assessment  shows  that  risks  are  not  expected.  Risk  reduction  measures 
already being applied are considered sufficient. 

The conclusion of the assessment of the risks to 

HUMAN HEALTH (physicochemical properties) 

is that there is at present no need for further information and/or testing or for risk reduction 
measures beyond those which are being applied. This conclusion is reached because: 

– 

the  risk  assessment  shows  that  risks  are  not  expected.  Risk  reduction  measures 
already being applied are considered sufficient. 

B. Environment

The conclusions of the evaluation of the risks to the environment for 

AQUATIC ECOSYSTEM 

L 144/92 

EN 

Official Journal of the European Union

30.4.2004 

is  that  there  is  a  need  for  specific  measures  to  limit  the  risks.  The  conclusion  is  reached 
because of: 

– 

concerns  for  effects  on  the  local  aquatic  ecosystem  as  a  consequence  of  exposure 
arising  from  wet  polymerisation  processes  including  wet  production  of  super 
absorber polymers and the use of acrylate based grouts. 

The conclusion of the assessment of the risks to the 

ATMOSPHERE and TERRESTRIAL ECOSYSTEM 

is that there is at present no need for further information and/or testing or for risk reduction 
measures beyond those which are being applied. This conclusion is reached because: 

– 

the  risk  assessment  shows  that  risks  are  not  expected.  Risk  reduction  measures 
already being applied are considered sufficient. 

The conclusion of the assessment of the risks to 

MICRO-ORGANISMS IN THE SEWAGE TREATMENT PLANT 

is  that  there  is  a  need  for  further  information  and/or  testing.  This  conclusion  is  reached 
because 

– 

there is a need for better information to adequately characterise the risk to municipal 
waste  water  treatment  plants  as  a  consequence  of  exposure  from  the  use  of  the 
substance  for  wet  polymerisation  including  the  production  of  super  absorber 
polymers. 

The information and/or test requirements are 

– 

Further data reflecting integrity of native ciliate populations in sewage. 

for WORKERS 

STRATEGY FOR LIMITING RISKS 

The  legislation  for  workers’  protection  currently  in  force  at  Community  level  is  generally 
considered  to  give  an  adequate  framework  to  limit  the  risks  of  the  substance  to  the  extent 
needed and shall apply. 

Within this framework it is recommended: 

– 

– 

to establish at community level occupational exposure limit values for acrylic acid. 

that  employers  using  adhesives  containing  acrylic  acid  should  take  note  of  the 
practical  non-binding  guidance,  to  be  developed  by  the  Commission  as  foreseen 
under  Article  12(2)  of  Council  Directive  98/24/EC  19 (Chemical  Agents Directive), 

19

OJ L 131, 5.5.1998, p. 11. 

30.4.2004

EN 

Official Journal of the European Union

L 144/93 

and  of  any  sector  specific  guidance  developed  at  national  level  based  on  this 
guidance. 

for ENVIRONMENT

it is recommended that: 

– 

– 

– 

– 

– 

– 

– 

– 

for Acrylic Acid released from chemical grouts: 

to  establish  a  harmonised  European  testing  and  assessment  scheme  for  chemical 
grouts. 

to  regulate  general  conditions  for  use  of  chemical  grouts  at  EU  level,  including 
requirements  on  comprehensive  training  of  planners  and  field  personnel,  whereas 
local aspects should be considered by the respective local supervisory authorities. 

local  emissions  to  the  environment  should,  where  necessary,  be  controlled  by 
national rules to ensure that no risk for the environment is expected. 

for  Acrylic  Acid  used  in  wet  polymerisation  processes  at  downstream  user  sites 
(processing capacity > 500 t/a) and in SAP production: 

that  the  European  Commission  should  consider  the  inclusion  of  acrylic  acid  in  the 
priority  list  of  Annex  X  to  Directive  2000/60/EC  (Water  Framework  Directive) 
during  the  next  review  of  this  Annex  and  should  consider  measures  such  as 
harmonised  requirements  for  prior  authorisation  of  discharges  and  emissions  into 
water for the respective plants.  

to  facilitate  permitting  under  Council  Directive  96/61/EC  (Integrated  Pollution 
Prevention  and  Control)  this  substance  should  be  included  in  the  ongoing  work  to 
develop  guidance  on  ‘Best  Available  Techniques’  (BAT).  It  is  recommended  that 
Member  States  should  carefully  monitor  the  implementation  of  BAT  by  permitting 
and  report any important developments to the Commission in the framework of the 
exchange of information on BAT. 

local  emissions  to  the  environment  should,  where  necessary,  be  controlled  by 
national rules to ensure that no risk for the environment is expected. 

L 144/94 

EN 

Official Journal of the European Union

30.4.2004 

ANNEX

PART FIVE 

CAS-NO. 106-99-0 

Einecs-No. 203-450-8 

Structural Formula: 

CH2 = CH – CH = CH2

Einecs Name: 

Butadiene 

IUPAC Name: 

1,3-Butadiene 

Rapporteur: 

UK 

Classification 20 

F+:R12 
Carc.Cat.1:R45 
Muta.Cat.2:R46 

The  risk  assessment  is  based  on  current  practices  related  to  the  life  cycle  of  the  substance 
produced  in  or  imported  into  the  European  Community  as  described  in  the  comprehensive 
Risk Assessment Report forwarded to the Commission by the Member State Rapporteur 21

The risk assessment has, based on the available information, determined that in the European 
Community  the  substance  is  mainly  used  as  an  intermediate  in  the  polymer  industry.  The 
major  uses  of  1,3-butadiene  are  in  the  manufacture  of  synthetic  rubber  such  as  styrene-
butadiene rubber (SBR) and polybutadiene rubber, thermoplastic resins such as acrylonitrile-
butadiene-styrene  (ABS),  and  styrene-butadiene  latex.  It  is  also  used  as  a  chemical 
intermediate in the production of neoprene for automotive and industrial rubber goods, in the 
production  of  methylmethacrylate-butadiene-styrene  (MBS)  polymer,  which  is  used  as  a 
polyvinyl chloride (PVC) reinforcing agent, and for producing adiponitrile, a nylon precursor. 
It was not possible to obtain information on the use of the total volume of substance produced 
in  or imported into the European Community, therefore, some uses may exist which are not 
covered by this risk assessment. 

20

21

The  classification  of  the  substance  is  established  by  Commission  Directive  2001/59/ECof  6  August, 
adapting to technical progress for the 28th time Council Directive 67/548/EEC on the approximation of 
the laws, regulations and administrative provisions relating to the classification, packaging and labelling 
of dangerous substances (OJ L 225, 21.8.2001, p. 1). 
The comprehensive Risk Assessment Report, as well as a summary thereof, can be found on the internet 
site of the European Chemicals Bureau: http://ecb.jrc.it/existing-substances/.

30.4.2004

EN 

Official Journal of the European Union

L 144/95 

RISK ASSESSMENT 

A. Human health

The conclusions of the evaluation of the risks to WORKERS  

is  that  there  is  a  need  for  specific  measures  to  limit  the  risks.  This  conclusion  is  reached 
because of: 

– 

concerns for mutagenicity and carcinogenicity as a consequence of exposure arising 
from production and use as an intermediate in the polymer industry.  

The conclusions of the evaluation of the risks to  

CONSUMERS and HUMANS EXPOSED VIA THE ENVIRONMENT 

is that there is a need to limit the risks. This conclusion is reached because: 

– 

Risks can not be excluded for all exposure scenarios, as the substance is identified as 
a non-threshold carcinogen. The adequacy of existing controls and the feasibility and 
practicability  of  further  specific  measures  should  be  considered.  However,  the  risk 
assessment  indicates  that  risks  are  already  low.  This  should  be  taken  into  account 
when  considering  the  adequacy  of  existing  controls  and  the  feasibility  and 
practicability of further specific risk reduction measures. 

– 

The conclusion of the assessment of the risks to  

HUMAN HEALTH (physicochemical properties) 

is that there is at present no need for further information and/or testing or for risk reduction 
measures beyond those which are being applied. This conclusion is reached because: 

– 

the  risk  assessment  shows  that  risks  are  not  expected.  Risk  reduction  measures 
already being applied are considered sufficient. 

B. Environment

The conclusions of the evaluation of the risks to the environment for 

ATMOSPHERE, AQUATIC ECOSYSTEM and TERRESTRIAL ECOSYSTEM  

is that there is at present no need for further information and/or testing or for risk reduction 
measures beyond those which are being applied. This conclusion is reached because: 

– 

the risk assessment shows that risks related to the environmental spheres mentioned 
above  are  not  expected.  Risk  reduction  measures  already  being  applied  are 
considered sufficient. 

The conclusions of the evaluation of the risks to the environment for 

MICRO-ORGANISMS IN THE SEWAGE TREATMENT PLANT 

L 144/96 

EN 

Official Journal of the European Union

30.4.2004 

is that there is at present no need for further information and/or testing or for risk reduction 
measures beyond those which are being applied. This conclusion is reached because: 

– 

the  risk  assessment  shows  that  risks  are  not  expected.  Risk  reduction  measures 
already being applied are considered sufficient. 

STRATEGY FOR LIMITING RISKS 

for WORKERS 

The  legislation  for  workers’  protection  currently  in  force  at  Community  level  is  generally 
considered  to  give  an  adequate  framework  to  limit  the  risks  of  the  substance  to  the  extent 
needed and shall apply. 

Within this framework it is recommended: 

– 

to establish at community level occupational exposure limit values for butadiene . 

for CONSUMERS and HUMANS EXPOSED VIA THE ENVIRONMENT 

– 

the  existing  legislative  measures  for  the  protection  of  consumers  and  humans 
exposed via the environment, in particular the provisions under the Council Directive 
76/769/EEC  (Marketing  and  Use  Directive)  as  regards  CMR  substances,  Council 
Directive  2001/95/EC  (General  Product  Safety)  as  regards  products,  and  Council 
Directive  96/61/EC  (Integrated  Pollution  Prevention  and  Control)  are  considered 
sufficient to address the risks identified. 

30.4.2004

EN 

Official Journal of the European Union

L 144/97 

ANNEX

PART SIX 

CAS-NO. 7664-39-3 

Einecs-No.231-634-8 

Structural Formula: 

HF 

Einecs Name: 

Hydrofluoric acid, anhydrous hydrofluoric acid

IUPAC Name: 

Hydrogen fluoride 

Rapporteur: 

Netherlands 

Classification 22 

T+:R26/27/28 
C: R34 

The  risk  assessment  is  based  on  current  practices  related  to  the  life  cycle  of  the  substance 
produced  in  or  imported  into  the  European  Community  as  described  in  the  comprehensive 
Risk Assessment Report forwarded to the Commission by the Member State rapporteur 23. 

The risk assessment has, based on the available information, determined that in the European 
Community the substance is mainly used as an intermediate in the chemical industry for the 
synthesis of organofluoride compounds and inorganic fluorides. Other uses are as a pickling 
Other  uses  are  agent  for  metal  surfaces,  an  etching  agent  for  glass  surfaces  and  surface 
cleaning. It was not possible to obtain information on the use of the total volume of substance 
produced in or imported into the European Community, therefore, some uses may exist which 
are not covered by this risk assessment. 

The risk assessment has identified other sources of exposure of the substance to man and the 
environment,  in  particular,  releases  of  hydrogen  fluoride  from  iron/steel  and  aluminium 
industry, glass, ceramic and brick industry, power plants and phosphate chemical producers, 
which  does  not  result  from  the  life-cycle  of  the  substance  produced  in  or  imported  into  the 
European Community. The assessment of the risks arising from these exposures are not part 
of  this  risk  assessment.  The  risk  assessment  forwarded  to  the  Commission  by  the  Member 
State Rapporteur does however provide information which could be used to assess these risks. 

22

23

The  classification  of  the  substance  is  established  by  Commission  Directive  2000/32/EC  of  19  May 
2000,  adapting  to  technical  progress  for  the  26th  time  Council  Directive  67/548/EEC  on  the 
approximation  of  the  laws,  regulations  and  administrative  provisions  relating  to  the  classification, 
packaging and labelling of dangerous substances (OJ L 136, 8.6.2000, p. 1). 
The comprehensive Risk Assessment Report, as well as a summary thereof, can be found on the internet 
site of the European Chemicals Bureau: http://ecb.jrc.it/existing-substances/.

L 144/98 

EN 

Official Journal of the European Union

30.4.2004 

RISK ASSESSMENT 

A. Human health

The conclusions of the evaluation of the risks to WORKERS  

is  that  there  is  a  need  for  specific  measures  to  limit  the  risks.  This  conclusion  is  reached 
because of: 

– 

– 

– 

– 

concerns for skin, eye and respiratory tract irritation and/or corrosivity, depending on 
the  concentration,  as  a  consequence  of  repeated  exposure  to  gaseous  hydrogen 
fluoride at production and use as an intermediate in the chemical industry and use of 
aqueous solutions of the substance, 

concerns  for  general  systemic  toxicity  as  a  consequence  of  repeated  inhalatory 
exposure arising from the use of aqueous solutions of the substance, 

concerns  for  skin  irritation  and/or  corrosivity,  depending  on  concentration,  as  a 
consequence of single exposure to the hydrogen fluoride liquid arising from the use 
of aqueous solutions of the substance, 

for 

respiratory 

irritation  and/or  corrosivity,  depending  on 
concerns 
concentration,  as a  consequence  of single  exposure to  gaseous hydrogen fluoride  at 
production  and  use  as  an  intermediate  in  the  chemical  industry  and  at  the  use  of 
aqueous solutions of the substance. 

tract 

The conclusion of the evaluation of the risks to  

CONSUMERS 

is  that  there  is  a  need  for  specific  measures  to  limit  the  risks.  This  conclusion  is  reached 
because of: 

– 

concerns  for  skin  irritation  and/or  corrosivity,  depending  on  concentration,  as  a 
consequence of single and repeated exposure to the hydrogen fluoride liquid arising 
from the consumer use of preparations containing the substance. 

The conclusions of the evaluation of the risks to 

HUMANS EXPOSED VIA THE ENVIRONMENT 

is  that  there  is  a  need  for  specific  measures  to  limit  the  risks.  This  conclusion  is  reached 
because of: 

– 

concerns  for  general  systemic  toxicity  due  to  repeated  inhalatory  exposure  in  the 
vicinity of production and processing sites of the substance. 

The conclusion of the assessment of the risks to  

HUMAN HEALTH (physicochemical properties) 

30.4.2004

EN 

Official Journal of the European Union

L 144/99 

is that there is at present no need for further information and/or testing or for risk reduction 
measures beyond those which are being applied. This conclusion is reached because: 

– 

the  risk  assessment  shows  that  risks  are  not  expected  although  concerns  for  risks 
related to the violent behaviour of the concentrated substance on contact with water 
and the potential formation of hydrogen on reaction of less than 65 % solutions of the 
substance with metals have been raised. 

B. Environment

The conclusions of the evaluation of the risks to the environment for 

AQUATIC ECOSYSTEM and ATMOSPHERE 

is  that  there  is  a  need  for  specific  measures  to  limit  the  risks.  This  conclusion  is  reached 
because of: 

– 

concerns  for  effects  on  local  aquatic  and  atmospheric  environmental  spheres  as  a 
consequence  of  exposure  arising  from  some  production  and  use  sites  of  the 
substance. 

The conclusion of the assessment of the risks to the  

TERRESTRIAL ECOSYSTEM  

is that there is at present no need for further information and/or testing or for risk reduction 
measures beyond those which are being applied. This conclusion is reached because: 

– 

the risk assessment shows that risks related to the environmental spheres mentioned 
above  are  not  expected.  Risk  reduction  measures  already  being  applied  are 
considered sufficient. 

The conclusion of the assessment of the risks for  

MICRO-ORGANISMS IN THE SEWAGE TREATMENT PLANT 

is that there is at present no need for further information and/or testing or for risk reduction 
measures beyond those which are being applied. This conclusion is reached because: 

– 

the risk assessment shows that risks related to the environmental spheres mentioned 
above  are  not  expected.  Risk  reduction  measures  already  being  applied  are 
considered sufficient. 

STRATEGY FOR LIMITING RISKS 

for WORKERS

The  legislation  for  workers’  protection  currently  in  force  at  Community  level  is  generally 
considered  to  give  an  adequate  framework  to  limit  the  risks  of  the  substance  to  the  extent 
needed. 

L 144/100

EN 

Official Journal of the European Union

30.4.2004 

Within this framework it is recommended: 

– 

– 

to  consider  at  the  Community  level  prohibition  of  the  use  in  building  surface 
cleaning (including floors) at work of hydrogen fluoride by including it in Annex III 
of Directive 98/24/EC (Chemical Agents Directive);  

that  the  Commission  Scientific  Committee  on  Occupational  Exposure  Limits 
(SCOEL)  review  the  new  information  contained  in  the  risk  assessment  report  and 
recommend whether there is a need to revise the current occupational exposure limit 
(OEL). 

for CONSUMERS 

It is recommended: 

– 

to  remove  hydrogen  fluoride  preparations  classified  as  corrosive  or  toxic  from  the 
consumer  market  24These  products  do  not  comply  with  the  general  safety 
requirement of the Directive 92/59/EEC on General Product Safety  25and should be 
immediately  withdrawn.  Member  States  should  carry  out  an  active  and  effective 
market  surveillance  of  the  situation  in  their  territories  concerning  the  presence  of 
hydrogen fluoride containing consumer products, to remove these products from the 
market  as  being  unsafe  under  the  general  safety  obligation  provisions  of  the 
Directive 92/59/EEC (General Product Safety) and to notify the Commission through 
the Rapid Alert System of Directive 92/59/EEC.

24

25

Minutes  of  the  meeting  of  2  April  2003  of  the  Emergencies  Committee  of  Directive  92/59/EEC 
(General Product Safety). 
OJ L 228, 11.8.1992, p. 24. 

30.4.2004

EN 

Official Journal of the European Union

L 144/101 

for the ENVIRONMENT

– 

– 

to  facilitate  permitting  under  Council  Directive  96/61/EC  (Integrated  Pollution 
Prevention  and  Control)  this  substance  should  be  included  in  the  ongoing  work  to 
develop  guidance  on  ‘Best  Available  Techniques’  (BAT).  It  is  recommended  that 
Member  States  should  carefully  monitor  the  implementation  of  BAT  by  permitting 
and  report any important developments to the Commission in the framework of the 
exchange of information on BAT. 

local  emissions  to  the  environment  should,  where  necessary,  be  controlled  by 
national rules to ensure that no risk for the environment is expected. 

L 144/102

EN 

Official Journal of the European Union

30.4.2004 

ANNEX

PART SEVEN 

CAS-NO. 7722-84-1 

Einecs-No. 231-765-0 

Structural Formula: 

H2O2

Einecs Name: 

Hydrogen peroxide 

IUPAC Name: 

Hydrogen peroxide 

Rapporteur: 

Classification 26 

Finland 

O:R8 
C:R35  

The  risk  assessment  is  based  on  current  practices  related  to  the  life  cycle  of  the  substance 
produced  in  or  imported  into  the  European  Community  as  described  in  the  comprehensive 
Risk Assessment Report as forwarded to the Commission by the Member State Rapporteur 27. 

The risk assessment has, based on the available information, determined that in the European 
Community  the  substance  is  mainly  used  as  in  pulp  bleaching  and  chemicals  manufacture. 
Other  uses  are  in  textile  bleaching,  disinfection  in  the  foods  processing  industry,  etching  in 
the  electronics  industry,  metal  plating,  degrading  of  proteins,  tooth  bleaching,  professional 
hair  dyeing  and  bleaching,  treatment  of  drinking  water  and  waste  water,  in  numerous 
consumer  products  for  hair  dyeing  and  bleaching,  household  textile  bleaching  products, 
cleaning agents, contact lens disinfection, and tooth bleaching products. 

26

27

The  classification  of  the  substance  is  established  by  Commission  Directive  91/325/EEC  of  1  March 
1991,  adapting  to  technical  progress  for  the  12th  time  Council  Directive  67/548/EEC  on  the 
approximation  of  the  laws,  regulations  and  administrative  provisions  relating  to  the  classification, 
packaging and labelling of dangerous substances (OJ L180, 8. 7. 1991, p. 1). 
The comprehensive Risk Assessment Report, as well as a summary thereof, can be found on the internet 
site of the European Chemicals Bureau: http://ecb.jrc.it/existing-substances/.

30.4.2004

EN 

Official Journal of the European Union

L 144/103 

RISK ASSESSMENT 

A. Human health

The conclusions of the evaluation of the risks to 

WORKERS  

is  that  there  is  a  need  for  specific  measures  to  limit  the  risks.  This  conclusion  is  reached 
because of: 

– 

– 

– 

– 

concerns for skin, eye and respiratory tract irritation and/or corrosivity, depending on 
concentration, as a consequence of exposure arising from loading operations.  

concerns  for  skin  and  eye  irritation  and/or  corrosivity,  depending  on  concentration, 
as  a  consequence  of  exposure  arising  from  bleaching  of  textiles  (batch  process), 
aseptic  packaging  (old  types  of  immersion  bath  machines),  peracetic  acid  use  in 
breweries,  etching  of  circuit  boards  (old  process),  metal  plating,  degrading  of 
proteins. 

concerns  for  eye  irritation  and/or  corrosivity,  depending  on  concentration,  as  a 
consequence of exposure arising from hairdresser’s work.  

concerns for repeated inhalation toxicity in loading operations and aseptic packaging 
(all  machines  types),  etching  of  circuit  boards  (old  process)  and  waste  water 
treatment. 

The conclusions of the evaluation of the risks to  

CONSUMERS 

is  that  there  is  a  need  for  specific  measures  to  limit  the  risks.  This  conclusion  is  reached 
because of: 

– 

– 

concerns for eye irritation as a consequence of exposure arising from hair dying and 
bleaching  and  concerns  for  eye  irritation/corrosivity  in  use  of  textile  bleaches  and 
cleaning agents, if the actual concentration ofhydrogen peroxide is >5 %. 

concerns  for  specific  adverse  effects  on  tooth  pulp  and  teeth  as  a  consequence  of 
exposure arising from tooth bleaching with 35% of hydrogen peroxide by a dentist.

The conclusions of the evaluation of the risks to 

HUMANS EXPOSED VIA THE ENVIRONMENT 

is that there is at present no need for further information and/or testing or for risk reduction 
measures beyond those which are being applied. This conclusion is reached because: 

– 

the  risk  assessment  shows  that  risks  are  not  expected.  Risk  reduction  measures 
already being applied are considered sufficient. 

L 144/104

EN 

Official Journal of the European Union

30.4.2004 

The conclusion of the assessment of the risks to  

HUMAN HEALTH (physicochemical properties) 

is that there is a need for specific measures to limit the risks (applies to the workers and to the 
consumers) This conclusion is reached because: 

– 

concerns for the risk of fire hazard caused by spills of the more concentrated (>25 %) 
hydrogen peroxide solutions on combustible materials. 

B. Environment

The conclusions of the evaluation of the risks to the environment for 

ATMOSPHERE and TERRESTRIAL ECOSYSTEM  

is that there is at present no need for further information and/or testing or for risk reduction 
measures beyond those which are being applied. This conclusion is reached because: 

– 

the risk assessment shows that risks related to the environmental spheres mentioned 
above  are  not  expected.  Risk  reduction  measures  already  being  applied  are 
considered sufficient. 

The conclusion of the assessment of the risks to the  

AQUATIC ECOSYSTEM  

is  that  there  is  a  need  for  specific  measures  to  limit  the  risks.  This  conclusion  is  reached 
because of: 

– 

concerns for effects on aquatic ecosystem as a consequence of exposure arising from 
four production sites and use in manufacture of other chemicals. 

The conclusion of the assessment of the risks for  

MICRO-ORGANISMS IN THE SEWAGE TREATMENT PLANT 

is that there is at present no need for further information and/or testing or for risk reduction 
measures beyond those which are being applied. This conclusion is reached because: 

– 

the risk assessment shows that risks related to the environmental spheres mentioned 
above  are  not  expected.  Risk  reduction  measures  already  being  applied  are 
considered sufficient. 

for WORKERS 

STRATEGY FOR LIMITING RISKS 

The legislation for workers’ protection currently in force at Community level is generally 
considered to give an adequate framework to limit the risks of the substance to the extent 
needed and shall apply. 

30.4.2004

EN 

Official Journal of the European Union

L 144/105 

Within this framework it is recommended that: 

– 

– 

employers  review  any  risk  assessments  produced  according  to  Directive  98/24/EC 
(Chemical  Agents  Directive)  to  take  into  account  the  information  contained  in  the 
risk  assessment  and  risk  reduction  strategy  for  hydrogen  peroxide  produced  under 
Regulation (EEC) 739/93, and take any necessary measures that are required.  

employers  using  hydrogen  peroxide  for  the  uses  identified  as  a  concern  in  the  risk 
assessment  (part  I)  should  take  note  of  the  practical  non-binding  guidance,  to  be 
developed by the Commission as foreseen under Article 12(2) of Directive 98/24/EC, 
and  of  any  sector  specific  guidance  developed  at  national  level  based  on  this 
guidance. 

for CONSUMERS  

It is recommended that: 

– 

– 

– 

in the framework of Commission Directive (EC) 2003/83 28 regarding the maximum 
acceptable percentage of hydrogen peroxide for tooth bleaching products used under 
supervision of a dentist, a concentration limit of up to 6 % hydrogen peroxide should 
be considered, provided appropriate conditions of use and warning are printed on the 
label. 

textile  bleaching  agents  and  cleaning  agents  which  contain  ≥  5  %  of  hydrogen 
peroxide should  be  formulated  so  that  the  risk  of  eye  irritation/corrosivity  is 
diminished  (e.g.  viscous  suspensions,  cream).  In  the  instructions,  the  risk  of  eye 
irritation/corrosivity should be emphasised and the percentage of H2O2 in the product 
should  be  indicated.  For  hair  dyes/bleaches  the above mentioned recommendations, 
including  the  percentage  limit,  should  be  considered  within  the  framework  of 
Community legislation on cosmetic products. 

the  requirement  for  child-resistant  fastenings 
the  Directive  1999/45/EC 
(Dangerous  Preparations  Directive)  should  be  extended  to  all  household chemicals, 
which may be accessible to children and contain hydrogen peroxide. 

in 

for ENVIRONMENT

It is recommended that: 

– 

to  facilitate  permitting  under  Directive  96/61/EC  (Integrated  Pollution  Prevention 
and  Control)  this  substance  should  be  included  in  the  ongoing  work  to  develop 
guidance  on  ‘Best  Available  Techniques’  (BAT).  It  is  recommended  that  Member 
States should carefully monitor the implementation of BAT by permitting and report 
any important developments to the Commission in the framework of the exchange of 
information on BAT. 

28

OJ L 238 25.9.2003, p. 27. 

L 144/106

EN 

Official Journal of the European Union

30.4.2004 

ANNEX

PART EIGHT 

CAS-NO.79-41-4 

Einecs-No. 201-204-4 

Structural Formula: 

CH2 = C(CH3) -COOH 

Einecs Name: 

Methacrylic acid (MAA) 

IUPAC Name: 

2-Propenoic acid, 2-methyl 

Rapporteur: 

Classification 29: 

Germany 

C: R35 
Xn: R21/22 

The  risk  assessment  is  based  on  current  practices  related  to  the  lifecycle  of  the  substance 
produced  in  or  imported  into  the  European  Community  as  described  in  the  comprehensive 
Risk Assessment Report forwarded to the Commission by the Member State rapporteur 30

The risk assessment has, based on the available information, determined that in the European 
Community  the  substance  is  mainly  used  as  an internal  and  external  intermediate  in  the 
chemical industry for the production of methacrylic acid esters and as co-monomer in different 
kinds of polymers. Other uses are as an ingredient in adhesives and its occurrence as a residual 
monomer in paints and products for textile processing. It was not possible to obtain information
on  the  use  of  the  total  volume  of  substance  produced  in  or  imported  into  the  European 
Community, therefore, some uses may exist which are not covered by this risk assessment. 

The  risk  assessment  has  identified  other  sources  of  exposure  to  the  substance,  relevant  for 
man and the environment, in particular during the use of methacrylate based grouts, which do 
not  result  from  the  life-cycle  of  the  substance  produced  in  or  imported  into  the  European 
Community. The  assessment  of  the  risks  arising  from  these  exposures  are  part  of  this  risk 
assessment.  

29

30

The  classification  of  the  substance  is  established  by  Commission  Directive  2001/59/EC  of  19  August 
2001  adapting  to  technical  progress  for  the  28th  time  Council  Directive  67/548/EEC  on  the 
approximation  of  the  laws,  regulations  and  administrative  provisions  relating  to  the  classification, 
packaging and labelling of dangerous substances (OJ L 225, 21.8.2001, p. 1). 
The comprehensive Risk Assessment Report, as well as a summary thereof, can be found on the internet 
site of the European Chemicals Bureau: http://ecb.jrc.it/existing-substances/.

30.4.2004

EN 

Official Journal of the European Union

L 144/107 

RISK ASSESSMENT 

A. Human health

The conclusion of the assessment of the risks to 

WORKERS 

is  that  there  is  a  need  for  specific  measures  to  limit  the  risks.  This  conclusion is reached 
because of: 

– 

– 

concerns  for  respiratory  tract  irritation  as  a  consequence  of  short  term  inhalation 
exposure arising from the production, further processing as a chemical intermediate 
in the chemical industry, the manufacture of adhesives in the industrial area and the 
industrial and skilled trade use of adhesives, 

concerns  for  local  respiratory  effects  as  a  consequence  of  repeated  inhalation 
exposure arising from manufacture and use of adhesives. 

The conclusion of the assessment of the risks to 

CONSUMERS and HUMANS EXPOSED VIA THE ENVIRONMENT

is that there is at present no need for further information and/or testing or for risk reduction 
measures beyond those which are being applied. This conclusion is reached because: 

– 

the  risk  assessment  shows  that  risks  are  not  expected.  Risk  reduction  measures 
already being applied are considered sufficient. 

The conclusion of the assessment of the risks to 

HUMAN HEALTH (physicochemical properties) 

is that there is at present no need for further information and/or testing or for risk reduction 
measures beyond those which are being applied. This conclusion is reached because: 

– 

the  risk  assessment  shows  that  risks  are  not  expected.  Risk  reduction  measures 
already being applied are considered sufficient. 

B. Environment 

The conclusion of the assessment of the risks to the environment for 

AQUATIC ECOSYSTEM 

is that there is a need for specific measures to limit the risks. The conclusion is reached because 
of: 

– 

concerns for effects  on  the  aquatic  ecosystem  as a consequence of exposure arising 
from the use of acrylate based grouting agents. 

L 144/108

EN 

Official Journal of the European Union

30.4.2004 

The conclusion of the assessment of the risks to the 

ATMOSPHERE and TERRESTRIAL ECOSYSTEM

is that there is at present no need for further information and/or testing or for risk reduction 
measures beyond those which are being applied. This conclusion is reached because: 

– 

the  risk  assessment  shows  that  risks  are  not  expected.  Risk  reduction  measures 
already being applied are considered sufficient. 

The conclusion of the assessment of the risks to 

MICRO-ORGANISMS IN THE SEWAGE TREATMENT PLANT 

is that there is at present no need for further information and/or testing or for risk reduction 
measures beyond those which are being applied. This conclusion is reached because: 

– 

the  risk  assessment  shows  that  risks  are  not  expected.  Risk  reduction  measures 
already being applied are considered sufficient.

for WORKERS 

STRATEGY FOR LIMITING RISKS 

The  legislation  for  workers’  protection  currently  in  force  at  Community  level  is  generally 
considered  to  give  an  adequate  framework  to  limit  the  risks  of  the  substance  to  the  extent 
needed and shall apply. 

Within this framework it is recommended:

– 

– 

to  establish  at  community  level  occupational  exposure  limit  values  for  Methacrylic 
acid. 

that  employers  using  adhesives  containing  methacrylic  acid  should  take  note  of the 
practical  non-binding  guidance,  to  be  developed  by  the  Commission  as  foreseen 
under  Article  12(2)  of  Directive  98/24/EC  (Chemical  Agents  Directive)  and  of  any 
sector specific guidance developed at national level based on this guidance . 

for ENVIRONMENT 

For methacrylic acid released from chemical grouts it is recommended: 

– 

– 

– 

to  establish  a  harmonised  European  testing  and  assessment  scheme  for  chemical 
grouts. 

to  regulate  general  conditions  for  use  of  chemical  grouts  at  EU  level,  including 
requirements  on  comprehensive  training  of  planners  and  field  personnel,  whereas 
local aspects should be considered by the respective local supervisory authorities. 

local  emissions  to  the  environment  should,  where  necessary,  be  controlled  by 
national rules to ensure that no risk for the environment is expected. 

30.4.2004

EN 

Official Journal of the European Union

L 144/109 

ANNEX

PART NINE 

CAS-NO.80-62-6 

Einecs-No.201-297-1 

Structural Formula: 

CH2 = C(CH3) – COOCH3

Einecs Name: 

Methyl methacrylate (MMA) 

IUPAC Name: 

2-methyl-propenoic acid, methyl ester 

Rapporteur: 

Classification 31 

Germany 

F:R11 
Xi:R37/38  
R43  

The risk  assessment  is based on current practices related to the lifecycle of the substance as 
described  in  the  risk  evaluation  forwarded  to  the  Commission  by  the  Member  State 
rapporteur 32. 

The risk assessment has, based on the available information, determined that in the European 
Community  the  substance  is  mainly  used  as  an  intermediate  in  production  of  polymers, 
copolymers,  adhesives,  reactive  resins,  in  transesterification  and  in  cast  sheet  production. 
Other uses are in the production of emulsion, dispersion and solvent polymers, acrylic sheet 
type  polymers,  as  an  ingredient  in  reactive  adhesives  and  embedding  resins,  floor  coatings, 
casting  resins  used  for  dental  and  medical  applications  and  the  substance occurs as residual 
monomer  in  paints,  as  well  as  in  other  polymers  used  for  consumer  products.  It  was  not 
possible  to  obtain  information  on  the  use  of  the  total  volume  of  substance  produced  in  or 
imported  into  the  European  Community,  therefore,  some  uses  may  exist  which  are  not 
covered by this risk assessment. 

The  risk  assessment  has  identified  other  sources  of  exposure  to  the  substance,  relevant  for 
man  and  the  environment,  in  particular,  as  a  decomposition  product  during  the  thermal 
processing  of  polymethyl  methacrylate  (PMMA),  which  do  not  result  from  the  life-cycle  of 
the substance produced in or imported into the European Community. The assessment of the 
risks arising from these exposures are part of this risk assessment. 

31

32

The classification of the substance is established by Commission Directive 2000/32/EC of 19 May 2000 
adapting to technical progress for the 26th time Council Directive 67/548/EEC on the approximation of 
the laws, regulations and administrative provisions relating to the classification, packaging and labelling 
of dangerous substances (OJ L 136, 8.6.2000, p. 1). 
The comprehensive Risk Assessment Report, as well as a summary thereof, can be found on the internet 
site of the European Chemicals Bureau: http://ecb.jrc.it/existing-substances/.

 
L 144/110

EN 

Official Journal of the European Union

30.4.2004 

RISK ASSESSMENT 

A. Human health 

The conclusion of the assessment of the risks to 

WORKERS 

is that there is a need for specific measures to limit the risks. This conclusion is reached 
because of: 

– 

– 

– 

– 

concerns for respiratory tract irritation and corrosivity as a consequence of inhalation 
exposure arising from cast sheet production, production of reactive resins, production 
and  use  of  adhesives,  production  of  paints,  skilled  trade  area:  floor  coating,  use  of 
casting  resins  in  medical  applications  and  in  orthopaedic  workshops,  dental 
laboratories and surgeries as well as in ornamental decoration, 

concerns  for  skin  sensitisation  as  a  consequence  of  dermal  exposure  arising  from 
production of methyl methacrylate, polymethyl methacrylate, transesterification, cast 
sheet  production,  production  of  adhesives  and  reactive  resins  in  chemical  industry, 
production  of  adhesives,  casting  resins  and  floor  coating  materials,  production  of 
paints and varnishes, use of adhesives in plastics, electronics and glass industry, use 
of adhesives and floor coating in skilled trade area, use of casting resins in medical 
applications,  orthopaedic  workshops,  dental 
surgeries, 
manufacturing of lenses and ornamental decoration, 

laboratories 

and 

concerns  for  local  effects  as  a  consequence  of  repeated  inhalation  exposure  arising 
from  cast  sheet  production,  production  of  reactive  resins,  production  and  use  of 
adhesives  and  as  well  as  production  of  paints,  use  of  casting  resins  in  orthopaedic 
workshops and dental laboratories and surgeries, 

concerns for general systemic effects as a consequence of inhalation exposure arising 
from  cast  sheet  production,  production  of  adhesives,  production  of  paints,  skilled 
trade  area:  floor  coating,  use  of  casting  resins  in  orthopaedic  workshops  and  in 
ornamental decoration. 

The conclusion of the assessment of the risks to 

CONSUMERS 

is that there is at present no need for further information and/or testing or for risk reduction 
measures beyond those which are being applied. This conclusion is reached because: 

– 

the  risk  assessment  shows  that  risks  are  not  expected.  Risk  reduction  measures 
already being applied are considered sufficient. 

The conclusion of the assessment of the risks to 

HUMANS EXPOSED VIA THE ENVIRONMENT 

30.4.2004

EN 

Official Journal of the European Union

L 144/111 

is that there is at present no need for further information and/or testing or for risk reduction 
measures beyond those which are being applied. This conclusion is reached because: 

– 

the  risk  assessment  shows  that  risks  are  not  expected.  Risk  reduction  measures 
already being applied are considered sufficient. 

The conclusion of the assessment of the risks to 

HUMAN HEALTH (physicochemical properties) 

is that there is at present no need for further information and/or testing or for risk reduction 
measures beyond those which are being applied. This conclusion is reached because: 

– 

the  risk  assessment  shows  that  risks  are  not  expected.  Risk  reduction  measures 
already being applied are considered sufficient. 

B. Environment 

The conclusion of the assessment of the risks to the 

AQUATIC ECOSYSTEM 

is  that  there  is  a  need  for  specific  measures  to  limit  the  risks.  The  conclusion  is  reached 
because of: 

– 

concerns  for  effects  on  the  local  aquatic  ecosystem  as  a  consequence  of  exposure 
arising from wet polymerisation processes. 

The conclusion of the assessment of the risks to the 

ATMOSPHERE and TERRESTRIAL ECOSYSTEM 

is that there is at present no need for further information and/or testing or for risk reduction 
measures beyond those which are being applied. This conclusion is reached because: 

– 

the  risk  assessment  shows  that  risks  are  not  expected.  Risk  reduction  measures 
already being applied are considered sufficient. 

The conclusion of the assessment of the risks to 

MICRO-ORGANISMS IN THE SEWAGE TREATMENT PLANT 

is that there is at present no need for further information and/or testing or for risk reduction 
measures beyond those which are being applied. This conclusion is reached because: 

– 

the  risk  assessment  shows  that  risks  are  not  expected.  Risk  reduction  measures 
already being applied are considered sufficient. 

STRATEGY FOR LIMITING RISKS 

for WORKERS

L 144/112

EN 

Official Journal of the European Union

30.4.2004 

The  legislation  for  workers’  protection  currently  in  force  at  Community  level  is  generally 
considered  to  give  an  adequate  framework  to  limit  the  risks  of  the  substance  to  the  extent 
needed and shall apply. 

Within this framework it is recommended: 

– 

– 

to  establish  at  community  level  occupational  exposure  limit  values  for  methyl 
methacrylate 

that employers using methyl methacrylate for the uses identified as a concern in the 
risk assessment (part I) should take note of the practical non-binding guidance to be 
developed  by  the  Commission  as  foreseen  under  Article  12(2)  of  98/24/EC 
(Chemical  Agents  Directive),  and  of  any  sector  specific  guidance  developed  at 
national level based on this guidance. 

for ENVIRONMENT

for  Methyl  methacrylate  used  in  wet  polymerisation  processes  at  downstream  user  sites 
(processing capacity > 5000 t/a) it is recommended: 

– 

– 

– 

that  the  European  Commission  should  consider  whether  to  include  methyl 
methacrylate  on  the  priority  list  of  Annex  X  to  Directive  2000/60/EC  (Water 
Framework  Directive)  during  the  next  review  of  this  Annex  and  should  consider 
measures such as harmonised requirements for prior authorisation of discharges and 
emissions into water for the respective plants. 

to  facilitate  permitting  under  Council  Directive  96/61/EC  (Integrated  Pollution 
Prevention  and  Control)  this  substance  should  be  included  in  the  ongoing  work  to 
develop  guidance  on  ‘Best  Available  Techniques’  (BAT).  It  is  recommended  that 
Member  States  carefully  monitor  the  implementation  of  BAT  by  permitting  and 
report  any  important  developments  to  the  Commission  in  the  framework  of  the 
exchange of information on BAT 

local  emissions  to  the  environment  should,  where  necessary,  be  controlled  by 
national rules to ensure that no risk for the environment is expected. 

30.4.2004

EN 

Official Journal of the European Union

L 144/113 

ANNEX

PART TEN 

CAS-NO. 108-88-3

Einecs-No. 203-625-9

Structural Formula: 

C6H5 – CH3

Einecs Name: 

IUPAC Name: 

Rapporteur: 

Classification 33 

Toluene 

Toluene 

Denmark 

F:R11 
Xn:R20  

The  risk  assessment  is  based  on  current  practices  related  to  the  lifecycle  of  the  substance 
produced  in  or  imported  into  the  European  Community  as  described  in  the  comprehensive 
Risk Assessment Report forwarded to the Commission by the Member State rapporteur 34. 

The risk assessment has, based on the available information, determined that in the European 
Community the substance is mainly used as an intermediate for synthesis of other chemicals, in 
solvents,  and  adhesives,  paints,  lacquers,  varnishes  and  in  the  mineral  oil,  fuel  and  polymer 
industries.  Other  uses  reported  are  in  the  pulp,  paper  and  board  industry,  textile  industry, 
agricultural industry and electrical and electronic industry. 

The risk assessment has identified other sources of exposure of the substance to man and the 
environment, in particular the use and combustion of petroleum products, which do not result 
from the life-cycle of the substance produced in or imported into the European Community. 
The assessment of the risks arising from these exposures is not part of this risk assessment. The 
comprehensive Risk Assessment Reports as forwarded to the Commission by the Member State 
Rapporteur does however provide information that could be used to assess these risks. 

33

34

The  classification  of  the  substance  is  established  by  Commission  Directive  91/325/EEC  of  1  March 
1991,  adapting  to  technical  progress  for  the  12th  time  Council  Directive  67/548/EEC  on  the 
approximation  of  the  laws,  regulations  and  administrative  provisions  relating  to  the  classification, 
packaging and labelling of dangerous substances (OJ L 180, 8. 7. 1991, p. 1). 
The comprehensive Risk Assessment Report, as well as a summary thereof, can be found on the internet 
site of the European Chemicals Bureau: http://ecb.jrc.it/existing-substances/.

L 144/114

EN 

Official Journal of the European Union

30.4.2004 

RISK ASSESSMENT 

A. Human health 

The conclusions of the evaluation of the risks to WORKERS 

is that there is a need for specific measures to limit the risks. This conclusion is reached 
because of: 

– 

– 

– 

– 

– 

– 

– 

– 

concerns  for  acute  toxicity  as  a  consequence  of  dermal  exposure  arising  from 
spraying painting or the use of adhesives, 

concerns  for  acute  toxicity  (headache,  dizziness,  feeling  of  intoxication,  sleepiness 
and  impaired  functional  performance)  as  a  consequence  of  inhalation  exposure 
arising  from  production  and  use  as  an  intermediate,  production  of  products 
containing the substance and use of products containing the substance, 

concerns for eye irritation as a consequence of exposure arising from production of 
products containing the substance and use of products containing the substance in the 
sectors  of  manual  cleaning,  use  of  adhesives,  printing  and  painting  (mechanical 
coating), 

concerns  for  general  systemic  toxicity  as  a  consequence  of  inhalation  exposure 
arising  from  production  of  products  containing  the  substance  and  use  of  products 
containing the substance in the sectors of manual cleaning, use of adhesives, printing 
and painting (mechanical coating), 

concerns for general  systemic  toxicity  as a  consequence  of dermal  exposure arising 
from use of products containing the substance in the sectors of manual cleaning, use 
of adhesives and spray painting, 

concerns for general systemic toxicity as a consequence of the combined dermal and 
inhalatory  exposure  arising  the  use  of  products  containing  the  substance  in  the 
sectors of manual painting, 

concerns  for  specific  organ  toxicity  (auditory  system  toxicity)  as  a  consequence  of 
inhalation exposure arising from production of products containing the substance and 
use  of  products  containing  the  substance  in  the  sectors  of  manual  cleaning,  use  of 
adhesives, printing and painting (mechanical coating), 

concerns  for  fertility  and  developmental  effects  and  spontaneous  abortions  as  a 
consequence  of  inhalation  exposure arising  from  production  of products  and  use of 
toluene  containing  products  in  the  sectors  of  manual  cleaning,  use  of  adhesives, 
printing and painting (mechanical coating). 

The conclusions of the evaluation of the risks to 

CONSUMERS 

30.4.2004

EN 

Official Journal of the European Union

L 144/115 

1. 

– 

2. 

– 

is  that  there  is  a  need  for  specific  measures  to  limit  the  risks.  This  conclusion  is 
reached because of: 

concerns  for  acute  toxicity  (headache,  dizziness,  feeling  of  intoxication,  sleepiness 
and  impaired  functional  performance)  and  eye  irritation  as  a  consequence  of 
inhalation  exposure  or  eye  exposure  to  vapours  arising  from  spray  painting  and 
carpet laying. 

is  that  there  is  a  need  for  further  information  and/or  testing.  This  conclusion  is 
reached because 

concerns for effects on reproduction as a consequence of inhalation exposure. 

The information and/or test requirement is: 

– 

information on the relationship between the observed effects on reproduction and the 
duration of the exposure leading to these effects. 

The need to obtain this information was re-evaluated in light of the risk reduction strategy and 
is no longer required (see section II Strategy for limiting risks). 

The conclusions of the evaluation of the risks to 

HUMANS EXPOSED VIA THE ENVIRONMENT 

is  that  there  is  a  need  for  specific  measures  to  limit  the  risks.  This  conclusion  is  reached 
because of: 

– 

concerns  for  effects  on  humans  due  to  the  contribution  of  commercial  product 
toluene to the formation of ozone and other harmful substances, i.e., smog formation. 

The conclusion of the assessment of the risks to  

HUMAN HEALTH (physicochemical properties) 

is that there is at present no need for further information and/or testing or for risk reduction 
measures beyond those which are being applied. This conclusion is reached because: 

– 

the  risk  assessment  shows  that  risks  are  not  expected.  Risk  reduction  measures 
already being applied are considered sufficient. 

B. Environment

The conclusions of the evaluation of the risks to the environment for 

AQUATIC ECOSYSTEM  

is  that  there  is  a  need  for  specific  measures  to  limit  the  risks.  This  conclusion  is  reached 
because of: 

L 144/116

EN 

Official Journal of the European Union

30.4.2004 

– 

concerns for the aquatic ecosystem as a consequence of exposure arising from some 
sites of production and combined production and processing of the substance, as well 
as exposure arising from processing and the use sectors of basic chemicals (including 
processing aid, “extraction” agent and solvent), processing and formulation, mineral 
oil  and  fuel  formulation,  formulation  of  polymers,  formulation  of  paints and  textile 
processing. 

The conclusion of the assessment of the risks to the  

TERRESTRIAL ECOSYSTEM  

is  that  there  is  a  need  for  specific  measures  to  limit  the  risks.  This  conclusion  is  reached 
because of: 

– 

concerns  for  terrestrial  ecosystem  as  a  consequence  of  exposure  arising  from 
processing  as  well  as  exposure  arising  from  the  use  sectors  of  basic  chemicals 
(including  processing  aid,  “extraction”  agent  and  solvent),  processing  and 
formulation, mineral oil and fuel formulation, formulation of polymers, formulation 
of paints and textile processing. 

The conclusion of the assessment of the risks for  

ATMOSPHERE 

is  that  there  is  a  need  for  specific  measures  to  limit  the  risks.  This  conclusion  is  reached 
because of: 

– 

concerns for the contribution of the commercial product toluene to the formation of 
ozone and other harmful substances, i.e. smog formation. 

The conclusion of the assessment of the risks for  

MICRO-ORGANISMS IN THE SEWAGE TREATMENT PLANT  

is  that  there  is  a  need  for  specific  measures  to  limit  the  risks.  This  conclusion  is  reached 
because of: 

– 

concerns  for  sewage  treatment  plants  as  a  consequence  of  exposure  arising  from 
processing  of  the  substance  as  well  as  in  the  use  sectors  of  industry  use  as  basic 
chemicals. 

STRATEGY FOR LIMITING RISKS 

The risk assessment has identified other sources of toluene emissions (e.g. gasoline and crude 
oil).  This  is  outside  the  scope  of  Council  Regulation  (EEC)  793/93  and  has  not  been 
considered in the Risk Reduction Strategy. 

for WORKERS

The  legislation  for  workers’  protection  currently  in  force  at  Community  level  is  generally 
considered  to  give  an  adequate  framework  to  limit  the  risks  of  the  substance  to  the  extent 
needed and shall apply. 

30.4.2004

EN 

Official Journal of the European Union

L 144/117 

Within this framework it is recommended: 

– 

that  the  Commission  Scientific  Committee  on  Occupational  Exposure  Limits 
(SCOEL)  review  the  new  information  contained  in  the  risk  assessment  report  and 
recommend whether there is a need to revise the current OEL. 

for CONSUMERS

It is recommended: 

– 

– 

to  consider  at  Community  level  marketing  and  use  restrictions  in  Directive 
76/769/EEC  for  the  substance  as  such  or  in  preparations  for  use  in  adhesives  and 
spray paint. 

The  marketing  and  use  restrictions  proposed  will  eliminate  the  need  for  more 
information on reproduction as a consequence of inhalation exposure. 

for ENVIRONMENT and HUMANS EXPOSED VIA THE ENVIRONMENT 

It is recommended: 

– 

– 

– 

that  the  European  Commission  should  consider  the  inclusion  of  toluene  in  the 
priority  list  of  Annex  X  to  Directive  2000/60/EC  (Water  Framework  Directive) 
during  the  next  review  of  this  Annex  but  that,  in  the  meantime,  toluene  should  be 
considered  as  a  relevant  List  II  substance  in  Council  Directive  76/464/EEC  35  on 
pollution  caused  by  certain  dangerous  substances  discharged  into  the  aquatic 
environment of the Community, thus requiring the establishment of national quality 
objectives,  monitoring  and  eventual  reduction  measures,  as  to  ensure  that 
concentrations in surface water systems do not exceed the quality objective. 

to  facilitate  permitting  under  Council  Directive  96/61/EC  (Integrated  Pollution 
Prevention  and  Control)  that  this  substance  is  included  in  the  ongoing  work  to 
develop  guidance  on  ‘Best  Available  Techniques’  (BAT).  It  is  recommended  that 
Member  States  should  carefully  monitor  the  implementation  of  BAT  by  permitting 
and  report any important developments to the Commission in the framework of the 
exchange of information on BAT. 

local  emissions  to  the  environment  should,  where  necessary,  be  controlled  by 
national rules to ensure that no risk for the environment is expected. 

35

OJ L 129, 18.5.1976, p 23.

L 144/118

EN 

Official Journal of the European Union

30.4.2004 

The proposal from the Commission to limit the content of solvents in certain products would 
further limit the risk from toluene to man via the environment 36

36

Proposal for a Directive on the limitation of emissions of volatile organic compounds due to the use of 
organic  solvents  in  decorative  paints  and  varnishes  and  vehicle  refinishing  products  and  amending 
Directive 1999/13/EC (COM(2002) 750 final).  

30.4.2004

EN 

Official Journal of the European Union

L 144/119 

ANNEX

PART ELEVEN 

CAS-NO. 120-82-1 

Einecs-No. 204-428-0 

Structural Formula: 

C6H3Cl3

Einecs Name: 

1,2,4-Trichlorobenzene (TCB)

IUPAC Name: 

1,2,4-Trichlorobenzene 

Rapporteur: 

Classification 37 

Denmark 

Xn:R22 
Xi:R38 
N:50-53 

The  risk  assessment  is  based  on  current  practices  related  to  the  lifecycle  of  the  substance 
produced  in  or  imported  into  European  Community  as  described  in  the  comprehensive Risk 
Assessment Report forwarded to the Commission by the Member State rapporteur 38. 

The risk assessment has, based on the available information, determined that in the European 
Community the substance is mainly used as an intermediate for synthesis of herbicides and as 
a process solvent in closed systems. Other  uses  reported  include  as  a  solvent,  dye  carrier  in 
textile industry, additive in dielectric fluids and corrosion inhibitor. It was not possible to obtain 
information  on  the  use  of  the  total  volume  of  substance  produced  in  or  imported  into  the 
European  Community,  therefore,  some  uses  may  exist  which  are  not  covered  by  this  risk 
assessment. 

The risk assessment has identified other sources of exposure of the substance to man and the 
environment, in particular, from certain 1,2,4-trichlorobenzene containing dielectric fluids still 
in use in existing electrical equipment and environmental formation of 1,2,4-trichlorobenzene as 
a  decomposition  product  of  other,  more  complex  organo-chlorine  compounds,  which  do  not
result  from  the  life-cycle  of  the  substance  produced  in  or  imported  into  the  European 
Community. The assessment of the risks arising from these exposures are not part of this risk 
assessment.  

The comprehensive Risk Assessment Reports as forwarded to the Commission by the Member 
State Rapporteur does however provide information that could be used to assess these risks. 

37

38

The  classification  of  the  substance  is  established  by  Commission  Directive  2001/59/ECof  6  August, 
adapting to technical progress for the 28th time Council Directive 67/548/EEC on the approximation of 
the laws, regulations and administrative provisions relating to the classification, packaging and labelling 
of dangerous substances (OJ L 225, 21. 8.2001, p. 30). 
The comprehensive Risk Assessment Report, as well as a summary thereof, can be found on the internet 
site of the European Chemicals Bureau: http://ecb.jrc.it/existing-substances/.

L 144/120

EN 

Official Journal of the European Union

30.4.2004 

The risk assessment indicates that it should be further investigated if the substance should be 
considered in relation to national or international programmes addressing persistent organic 
pollutants. 

RISK ASSESSMENT 

A. Human health 

The conclusions of the evaluation of the risks to  

WORKERS  

is that there is a need for further information and/or testing. This conclusion is reached 
because: 

– 

concerns for effects as a consequence exposure 

The information and/or test requirements are 

– 

information on occupational exposure during the use of the substance as a dye carrier 
and  as  a  process  solvent, during production of products containing the substance in 
the sector of production of dielectric fluids and during the use of products containing 
the substance in the sector of production of wire and cabling. 

The need to obtain this information was re-evaluated in light of the risk reduction strategy and 
is no longer required (see section II Strategy for limiting risks). 

that there is a need for specific measures to limit the risks. This conclusion is reached because 
of: 

– 

– 

– 

concerns  for  general  systemic  toxicity  as  a  consequence  of  repeated  inhalation 
exposure arising  from  drumming activities in the production of the substance, from 
the  production  of  products  containing  the  substance  in  the  sector  of  pigment 
production  and  from  the  use  of  products  containing  the  substance  in  the  sector  of 
spray painting, 

concerns  for  eye  and  respiratory  tract  irritation  as  a  consequence  of  repeated 
exposure  to  the  vapour  of  the  substance  arising  from  the  production  of  products 
containing  the  substance  in  the  sector  of  pigment  production  and  from  the  use  of 
products containing the substance in the sector of production of plastic pellets, 

concerns for general  systemic  toxicity  and local dermal effects as a consequence of 
repeated  dermal  exposure  arising  from  the  use  of  the  products  containing  the 
substance in the sectors of spray painting, dismantling transformers and polishing, 

The conclusions of the evaluation of the risks to 

CONSUMERS 

is  that  there  is  a  need  for  specific  measures  to  limit  the  risks.  This  conclusion  is  reached 
because of: 

30.4.2004

EN 

Official Journal of the European Union

L 144/121 

– 

concerns  for  eye  and  respiratory  tract  irritation  as  a  consequence  of  repeated 
exposure  to  vapours  and  general  systemic  toxicity  as  a  consequence  of  repeated 
inhalation and dermal exposure arising from spray painting and car polishing. 

The conclusions of the evaluation of the risks to  

HUMANS EXPOSED VIA THE ENVIRONMENT 

is  that  there  is  a  need  for  specific  measures  to  limit  the  risks.  This  conclusion  is  reached 
because of: 

– 

concerns for  indirect exposure as calculated exposures can exceed WHO TDIs, and 
WHO guideline values in drinking water for local use scenarios. 

The conclusion of the assessment of the risks to  

HUMAN HEALTH (physicochemical properties) 

is that there is at present no need for further information and/or testing or for risk reduction 
measures beyond those which are being applied. This conclusion is reached because: 

– 

the  risk  assessment  shows  that  risks  are  not  expected.  Risk  reduction  measures 
already being applied are considered sufficient. 

B. Environment

The conclusions of the evaluation of the risks to the environment for 

AQUATIC  ECOSYSTEM  and  TERRESTRIAL  ECOSYSTEM  is  that  there  is  a  need  for  specific 
measures to limit the risks. This conclusion is reached because of: 

– 

concerns  for  the  aquatic  ecosystem  and  terrestrial  ecosystem  as  a  consequence  of 
exposure  arising  from  the  use  of  the  substance  as  a  dye  carrier  and  other  uses 
(including as a process solvent, additive in dielectric fluids and a corrosion inhibitor). 

The conclusion of the assessment of the risks to the  

ATMOSPHERE 

is that there is at present no need for further information and/or testing or for risk reduction 
measures beyond those which are being applied. This conclusion is reached because: 

– 

the  risk  assessment  shows  that  risks  are  not  expected.  Risk  reduction  measures 
already being applied are considered sufficient 

The conclusion of the assessment of the risks to 

MICRO-ORGANISMS IN THE SEWAGE TREATMENT PLANT  

is  that  there  is  a  need  for  specific  measures  to  limit  the  risks.  This  conclusion  is  reached 
because of: 

L 144/122

EN 

Official Journal of the European Union

30.4.2004 

– 

concerns for sewage treatment plants as a consequence of exposure arising from use 
as  an  intermediate,  as  well  as  from  the use sectors  of  basic  chemicals  as  a  solvent, 
textile industry as dye carrier and other downstream uses. 

STRATEGY FOR LIMITING RISKS 

for WORKERS

The legislation for workers’ protection currently in force at Community level and in particular 
the provisions under Commission Directive 2000/39/EC 39 establishing a first list of indicative 
exposure  limit  values  are  generally  considered  to  give  an  adequate  framework  to  limit  the 
risks of the substance to the extent needed and shall apply. 

The marketing and use restrictions proposed for the environment will also reduce the risk for 
human  health  (workers)  and  eliminate  the  need  for  more  information  on  the  occupational 
exposure scenarios. 

for CONSUMERS, the ENVIRONMENT and HUMANS EXPOSED VIA THE ENVIRONMENT 

It is recommended: 

– 

to  consider  marketing and use restrictions at Community level in Council Directive 
76/769/EEC for all uses of TCB except as an intermediate to protect the environment 
and  to  reduce  the  indirect  exposure  via  the  environment.  Where  appropriate, 
marketing and use restrictions of articles containing TCB should also be considered. 

39

OJ L 142, 16.6.2000, p. 47.