L 144/72 Official Journal of the European Union 30.4.2004 EN 
COMMISSION RECOMMENDA TION 
of 29 April 2004 
on the results of the risk evaluation and the risk reduction strategies for the substances: 
Acetonitrile; Acrylami de; Acrylonitrile; Acryli c acid; Butadiene; Hydrogen fl uoride; 
Hydrogen peroxide; Methacryli c acid; Methyl methacrylate; Tol uene; Trichlorobenzene 
(notifi ed under document number C(2004) 1446)
(Text with EEA relevance) 
(2004/394/EC) 
THE COMM ISSIO N OF THE EU ROPEAN  COMMU NITIES, 
Having regard to the Treaty establi shing the European Communi ty 
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 partic ular Arti cle 11(2 ) thereof,  
Wherea s: 
(1) 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 desi gnates for t hose substan ces the followi ng rapporteu r Member St ates: 
– Acetoni trile, rapport eur Membe r State : Spai n, 
– Acrylami de, rapport eur Membe r State : the United Kingdom, 
– Acrylonit rile, rapporteu r Member St ate: Ireland,  
– Acrylic acid, rapporteur Member Stat e: Germany, 
– Butadiene, rapporteur Member Sta te: the Unit ed Kingdom, 
– Hydrogen fluoride, rapporteur Member State: the  Netherlands, 
– Methacrylic acid, rapport eur Member State: Germa ny, 
1OJ L 8 4, 5.4.1993, p . 1. 
2OJ L 1 31, 2 6.5.9 4, p. 3. 
30.4.20 04 Official Journal of the European Union L 144/73 EN 
– Methyl methacrylat e, rapporteur Member State:  Germany. 
(2) In the framework of Council Regulation (EEC) No 793/93 the following substances 
have been identifi ed 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 designate s for those substances the followi ng rapporteu r 
Memb er States: 
– Hydrogen peroxide, ra pporteur Me mber St ate: Finland; 
– Toluen e, rapport eur Membe r State : Denma rk; 
– Trichl orobenzene, ra pporteur Me mber St ate: Denmark;  
(3) Those rapporteu r Member State s have compl eted all the risk evalua tion 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). 
(4) The Scientific Committee on Toxicity, Ecotoxicity and the Environment (CSTEE) has 
been consu lted and has issued  an opinion with respect to the risk evaluations carried 
out by the Member State s rapporteurs. 
(5) The results of the risk eval uation are set out  in the Annex. 
(6) 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 
evalua tion and implement  the relevant recommendati ons, 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  measur es to w hich pr iority s hould b e give n. 
(7) The measur es provide d for in this recommend ation are in accord ance with the opinion 
of the Committee set up pursuant to Article 15 of Regulation (EEC) No 793/93, 
HEREBY  RECOM MEND S: 
1. All sector s importing , produ cing, transp orting,  storing , formu lating into a preparation  
or other processing, using, dispo sing or recov ering  the f ollow ing substances : 
(1) A cetonitrile; 
CAS N o 75- 05-8 
Einecs N o 200- 835-2  
3OJ L 2 31, 2 8.9.1 995, p. 18. 
4OJ L 1 61, 2 9.6.1 994, p. 3. 
L 144/74 Official Journal of the European Union 30.4.2004 EN 
(2) A crylamide; 
CAS No 7 9-06-1 
Einecs No 201-1 73-7 
(3) A crylonitrile; 
CAS N o 107- 13-1 
Einecs N o 203- 466-5  
(4) A crylic acid; 
CAS No 7 9-10-7 
Einecs No 201-1 77-9 
(5) B utadiene; 
CAS N o 106-99 -0 
Einecs No 203-450- 8 
(6) H ydrogen  fluoride; 
CAS No  7664-39- 3 
Einecs No 23 1-634 -8 
(7) H ydrogen  peroxide ; 
CAS No  7722-84- 1 
Einecs No 23 1-765 -0 
(8) M ethacrylic acid; 
CAS N o 79- 41-4 
Einecs N o 201- 204-4  
(9) M ethyl methacrylate; 
CAS N o 80- 62-6 
Einecs N o 201- 297-1  
(10) Toluene; 
CAS No 108- 88-3 
Einecs No 203- 625- 9
(11) Trichlo robenzene;  
CAS No 120-82-1 
Einec s No 204-428-0 
shoul d take into account the results of the risk evaluation set out in the Section Risk 
assess ment of parts  1 to 11 of  the Annex  for each  of the s ubstances 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 recommendati on should be implem ented. Where it 
is considered that no risks are expected, the information should be used to ensure the 
current risk reduction m easures are maintai ned. 
This Recommendat ion 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 t he Member States.  
30.4.20 04 Official Journal of the European Union L 144/75 EN 
Done at Brussels, 29 April 2004. 
For the Commission 
Margot WALLSTRÖM 
Member of the Commission 
_______ 
L 144/76 Official Journal of the European Union 30.4.2004 EN 
ANN EX
PART ONE 
CAS-NO. 75-05- 8 Einecs-No. 200-835-2 
Struct ural F ormul a: CH 3−C ≡ N  
Einecs N ame: Acetonitrile
IUPAC Name:  Aceto nitrile 
Rapporteur: S pain 
Classificati on 5: F: R11  
Xn: R20/21 /22 
Xi: R 36 
The risk assessmen t is based on current  practices related to the life cycle of the substance  
produced in or import ed into the European Commu nity as described  in the comprehensive 
Risk Asses sment Report forwar ded 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  
labora tories. It was not possibl e to obtai n inform ation on the use of the total volum e of 
substance produced in or imported into the European Communit y, therefore, some uses may 
exist which are not covered by this risk assessment. 
The risk assessment has identi fied other sources of exposure of the substance to man and the  
environment, i n particular, t he substance is produced during biomass burning and is present in 
automobil e exhaust, which do not result from the  life-cycle of the substance produce d in or 
imported i nto the European Com munity. 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 Mem ber State Rapporteur does however provide 
informat ionabout these risks.
5The classification of the substanc es is estab lished by Commiss ion Directive 2000 /32/EC of 19 May 
2000  adaptin g to techni cal progr ess for the 26th time Council  Directive 67/548/EEC on the 
approximation of the laws, regulatio ns and adminis trative provis ions relating to the classifica tion, 
packaging and labelling o f dangerous substances (OJ L 136, 8.6..2000, p. 1). 
6The compre hensive Risk Assessment Report, as well as a summ ary thereof, can be found on the internet 
site o f the Europ ean Chemica ls Bure au: http://ecb.j rc.it/existing-substanc es/.
30.4.20 04 Official Journal of the European Union L 144/77 EN 
RISK ASSESSMEN T 
A. Human health 
The conclusions of the eval uation 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 a s a solven t and as a n inte rmedi ate. 
The conclusions of the eval uation of the risks to  
CONSUMERS and HUMANS E XPOS ED VI A THE  ENVI RONMENT  
is that there is at present no need for furth er infor mation and/or  testing or for risk reduction 
measures beyo nd those which are being applied. This conclusion is reach ed because: 
– the risk assessment shows that risks are not expected. Risk reduction measures 
already being applied are co nsidered suff icient 
The conclusions of the evaluation of the r isks to  
HUMAN H EALTH  (physicochemical properties) 
is that there is at present no need for further information and/or testing or for risk reduction 
measures beyo nd those which are being applied. This conclusion is reach ed because: 
– the risk assessment shows that risks are not expected. Risk reduction measures 
already being applied are co nsidered suff icient 
B. Environment 
The conclusions of the evaluation of the r isks to the environment for 
ATMOSP HERE 
is that there is at present no need for further information and/or testing or for risk reduction 
measures beyo nd those which are being applied. This conclusion is reach ed 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 suf ficient. 
L 144/78 Official Journal of the European Union 30.4.2004 EN 
The conclusions of the eval uation of the risks to t he environment for 
AQUATI C ECOSYSTEM and TERRESTRIAL ECOSYSTE M 
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 pha rmaceutica l industry. 
The conclusions of the eval uation of the risks to t he environment for 
MICRO-ORGANISMS IN THE S EWAGE 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 consequen ce of exposure arisin g 
from the use of the substanc e in the pharmaceutical industry . 
STRATE GY FOR  LIMITING RISKS 
The risk assessmen t has ident ified other  sources of acetonitri le emissions (eg burning of fossil 
fuels). This is outside the scope of Council Regulation (EEC) 793/93 and has not been 
considered in the Ri sk Reduction Strat egy. 
for WORKERS 
The legislation for workers protection currently in force at Communit y level is considered to 
give an adequat e framework to limit the risks of the substanc e to the extent  needed and shall 
apply.  
With in this frame work i t is reco mme nded : 
– to consi der revising the current occupational  exposu re limit value adop ted under 
Commission Directive 91/322/EEC 7 to provide an indicati on that dermal exposure 
can make a con tribution to the wo rker bod y burd en. 
for E NVIRONMEN T 
– that the European Commission should consider the inclusion of acetonitri le in the 
priority list of Annex  X to Council and Parliament  Directive  2000/60/EC 8 (Wate r 
Fram ework Direc tive) du ring the next  review of this Anne x. 
7Comm ission Directive 91/322/EEC on establishing indicative limit values by implementing Coun cil 
Directive 80/1107/EEC on the protection of worke rs from the risks related to exposure to chemica l, 
physical a nd biologica l agents at work (OJ L 177, 5.7.1991, p. 22). 
8Directive 2000 /60/EC of the European Parliament and of the Counc il of 23 Octobe r 2000  establishing a 
framewor k for Com munity action in the field of  water  policy, (OJ L 327, 22. 12.2000,  p. 1) . 
30.4.20 04 Official Journal of the European Union L 144/79 EN 
– to facilitate permi tting under Counci l Direct ive 96/61/ EC 9 (Integrated Pollut ion 
Preventi on and Control ) this substance should be includ ed in the ongoing work to 
develop guidance on ‘Best Availabl e Techniq ues’ (BAT). It is recomme nded that 
Member States should carefull y monit or the implement ation of BAT by permit ting 
and report  any important  developments to the Commission in the framework of the 
excha nge o f info rmation on  BAT. 
– local emissions  to the environment should, where necessary, be controlled by 
national rul es to ensure that no risk for the envi ronment is expected. 
9Coun cil Directive 96/61/EC  of 24 Septemb er 1996 concerning integrated pollution preven tion and 
control (OJ L  257, 10.10.1996, p. 26). 
L 144/80 Official Journal of the European Union 30.4.2004 EN 
ANN EX
PART TWO  
CAS-N O. 79-0 6-1 Einecs-No. 2 01-173-7 
Structural F ormula: CH 2 ═ CH−CONH 2
Einecs N ame: Acrylamide
IUPAC Name:  2 -propenam ide 
Rapporte ur: United Ki ngdom 
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:R 36/38 
R43 
The risk  assessment is  based  on cur rent pr actices re lated to the life -cycle of the s ubstance  
produc ed in or  imported into  the Euro pean Commun ity as d escribed  in the comp rehens ive Risk 
Assessment Report for warded to the Commission by  the Member S tate Ra pporteur 11. 
The ris k assessment has, based on the available inf ormation, determined that in the European  
Community the  subs tance is mainly us ed as an intermed iate in the chemical indus try for the 
produc tion of p olyacry lamide. Other  uses are as  on-site prepar ation of p olyacry lamide gels  and 
asgrouting agents.The main us es of polyac rylamide a re in w aste w ater treatment,  paper and 
pulp pro cessing  and miner al proces sing; mino r uses include as cos metic additives a nd as soil 
conditioners. It was not pos sible to obtain information on the use of the total volume of 
substan ce prod uced in o r imported into the Eur opean Co mmunity, ther efore some us es may  
exist w hich are not cover ed by  this ris k ass essment. 
10The classi fication of the subst ance is establ ished by Comm ission Directive 2001/ 59/EC of 6 August, 
adapti ng to technical progress for the 28th time Counc il Directive 67/548 /EEC on the approximation of 
the laws,  regulations and admi nistrative provisions relating to the classif ication, packagi ng and labelling 
of dangerou s substances (OJ  L 225, 21.8.2001, p. 1). 
11The compr ehensi ve Risk Assessment  Report , as well as a summ ary thereof, can be found on the internet 
site o f the Europ ean Chemica ls Bure au: http://ecb.j rc.it/existing-substanc es/.
30.4.20 04 Official Journal of the European Union L 144/81 EN 
RISK ASSESSMEN T 
A. Human health 
The conclusions of the eval uation of the risks to 
WORKERS 
is tha t there is a ne ed for speci fic me asures to l imit the risks. Thi s conclusion isreached 
because of: 
– concerns  for mutagenicit y and carcinogenicit y as a consequence of exposure arising 
from production of the substance, use as an intermedi ate 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 
appli cations). 
– 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 eval uation of the risks to 
CONSUMERS 
– is that risks can not be excluded at any exposure, as the substance is identifi ed as a 
non-threshold carcinogen. The adequacy of existing controls and the feasibilit y and 
practicabil ity 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 feasibilit y and 
practicabil ity of further specific risk reducti on measures. 
The conclusions of the eval uation of the risks to 
HUMANS EX POSED VI A THE  ENVI RONMENT  
is that there is a need for specific measu res to limit the risks. This conclusion isreached 
because of: 
– concerns  for neurotoxicity, reproductive toxicity, mutagenicit y and carcinogenicity 
as a consequence of exposure resulting from the use of acrylamide based grouts in 
large scal e constru ction appli cations. 
In addition to the conclusion given above, risks cannot be excluded considering the remaining 
uses, as the substance is identifi ed as a non-threshold carcinogen. The adequacy of existing 
controls and the feasibilit y and practicabil ity 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 feasibilit y and 
practicabil ity of further specific risk reducti on measures. 
L 144/82 Official Journal of the European Union 30.4.2004 EN 
The conclusion of the a ssessment of the risks to 
HUMAN HEALT H (physicochemical propert ies) 
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. T his conclusion is reached bec ause: 
– the risk assessment shows that risks are not expected. Risk reduction measures 
already being applied are consi dered sufficient. 
B. Environment 
The conclusions of the eval uation of the risks to t he environment for 
AQUAT IC ECOSYS TEM
is that the re is a need for specific me asures to limit th e risks. The c onclus ion is  reached becau se 
of: 
– concerns for the aquatic ecosystem as a consequence of exposure arising from the 
use of acrylamide based grouts in construction applicati ons, and to indirect exposure 
of other organisms through contaminat ed water from the same use. 
Theconclus ionofthe assessment of the risks to the 
ATMOSP HERE 
is that there is at present no need for furth er infor mation and/or  testing or for risk reduction 
measures beyond those w hich are being app lied. This c onclusion is reached bec ause: 
– 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 a ssessment of the risks to the 
TERRESTRIAL ECOSYST EM 
is that there is a need for further information and/or testing. This conclusion is reached 
because o f: 
– concerns for use of acrylamide-based grouts in construction applicati ons. The 
inform ation and/o r testi ng require ment  is: 
– inform ation to refi ne the  risk eval uation for the  environ ment . 
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 lim iting risks). 
30.4.20 04 Official Journal of the European Union L 144/83 EN 
The conclusion of the a ssessment of the risks to the 
MICRO-ORGANISMS IN THE S EWAGE TREATMENT  PLANT 
is that there is at present no need for furth er infor mation and/or  testing or for risk reduction 
measures beyond those w hich are being app lied. This c onclusion is reached bec ause: 
– 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. 
STRATE GY FOR  LIMITIN G RISK S 
for HUMAN HE ALTH and the ENVI RONMENT
It is rec omme nded: 
– to conside r at Comm unity level  marketing and use restrictions in Council Directive 
76/769/EEC 12for the use of acryla mide 13 in grouts for small and large-scale 
appli cations. 
– Further work may be necessary to determine i f derogations can be justifi ed 
– The market ing and use restric tions proposed will eliminate the need for more 
inform ation to refi ne the  risk eval uation for the  environ ment  
for W ORKER S
The legislation for work er protection curren tly in force at Community level is gener ally 
considered to give an adequate framework to limit the risks of the substance to the extent 
needed and shall apply. 
Within this framework it i s recommended: 
– to establish at com munity level  occupational exposure lim it values for acrylamide. 
for CON SUME RS
– 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 
12OJ L 262 , 27.9 .1976 , p. 2 01. 
13N-met hylol acrylam ide-based grout s are also a potenti al source of free acrylam ide in the grout ing 
process and considerati on should be giv en to exami ning the ri sks from t his chemi cal. 
L 144/84 Official Journal of the European Union 30.4.2004 EN 
substances), and Council Directive 2001/95/EC (General Product Safety) 14 as 
regards pr oduct s are c onside red suffi cient to addre ss the risks i denti fied. 
14OJ L 11,  15.1 .2002 , p. 4 . 
30.4.20 04 Official Journal of the European Union L 144/85 EN 
ANN EX
PART THREE 
CAS-NO. 107-13- 1 Einecs-No.203-466-5 
Struct ural F ormul a: CH 2 ═ CH − C ≡ N 
Einec s Name: Acryloni trile 
IUPAC Name: 2-propenenit rile 
Rapporteu r: Ireland 
Classification 15 F :R11 
Carc. Cat.2:R 45 
T:R23/2 4/25 
Xi:R37 /38 
R41 
R43 
N:R5 1/53 
The risk assessment is based on current  practices related to the lifecycle of the substance  
produced in or import ed into the European Commu nity as described  in the comprehensive 
Risk As sessment Rep ort forw arded to the Co mmission by the  Member S tate 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-acry lonitrile plastics. Other uses are as a monomer in the synthesis of novel polymeric 
materi als, producti on of acrylamid e, adiponi trile, fatty ami nes and fatty alc ohols. 
The risk assessment has identified other sources of exposure to the substance, relevant for 
man and the environme nt, 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 
15The classification of the substance is established by Commission Directi ve 2000/32/EC of 19 May 2000 
adapting  to techni cal progr ess for the 26th time Council  Directive 67/548/EEC on the approximatio n of 
the laws, regulations and admi nistrative provisions relating to the classif ication, packagi ng and labelling 
of dangerou s substances (OJ  L 136, 8.6.2000, p.1). 
16The compr ehensi ve Risk Assessment  Report , as well as a summ ary thereof, can be found on the internet 
site o f the Europ ean Chemica ls Bure au: http://ecb.j rc.it/existing-substanc es/.
L 144/86 Official Journal of the European Union 30.4.2004 EN 
Commission by the Member State Rapporteur, does however provide information which 
could be used to assess these risks. 
30.4.20 04 Official Journal of the European Union L 144/87 EN 
RISK ASSESSMEN T 
A. Human health
The conclusions of the eval uation 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 carcinogenicit y as a consequence of 
exposure arising during the production and processing of the substance. 
The conclusions of the eval uation of the risks to  
CONSUMERS and HUMANS  EXPO SED VI A THE  ENVI RONMENT
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 exposu re scenarios , as the substance is currently 
regard ed as a non-thres hold carcinogen . The adequacy of existing controls and the 
feasibility and practicability of further specific measures should be considered.  
Howev er, the risk assess ment indicates that risks are already low. This should be 
taken into account when considering  the adequacy of existing controls and the 
feasibilit y and practicabil ity of further specific risk reducti on measures. 
The conclusion of the a ssessment of the risks to  
HUMAN HEALT H (physicochemical propert ies) 
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. T his conclusion is reached bec ause: 
– the risk assessment shows that risks are not expected. Ri sk reduction measures 
already being applied are consi dered sufficient. 
B. Environment
The conclusions of the eval uation of the risks to t he environment for 
AQUATI C 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 fi bres at a particul ar site. 
L 144/88 Official Journal of the European Union 30.4.2004 EN 
The conclusion of the a ssessment of the risks to the  
ATMOSPHE RE and TERR ESTRIAL ECOSYST EM
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. T his conclusion is reached bec ause: 
– 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 a ssessment of the risks for 
MICRO-ORGANISMS IN THE S EWAGE 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. T his conclusion is reached bec ause: 
– 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 
STRATE GY FOR  LIMITIN G RISK S 
The risk assessment has identifi ed other sources of acrylonitrile  emissio ns (e.g. burning of 
fossil fuels ). This is outsid e the scope of Counc il Regu lation (EEC)  793/93 and has not been 
considered in the Ri sk Reduction Strat egy. 
for WORKERS
The legislation for workers protection currently in force at Communit y level is generally 
conside red to give an adequat e framework to limit the risks of the substanc e to the extent  
needed and shall appl y. 
Withi n this fr amework i t is rec omme nded: 
– to est ablish at com munit y level  occupat ional  exposure li mit values fo r Acrylonit rile 
for CONSUMERS and HU MANS EXP OSED  VIA T HE EN VIRONMEN T 
– The existing legislative  measures for the protection of consumers and humans 
exposed via the environme nt, in particul ar 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 ri sks identified. 
for the ENVI RONMENT  
– to facilit ate permitt ing under Council Directive 96/61/EC (Integrated Pollution 
Prevention and Control) this substance should be included in the ongoing  work to 
30.4.20 04 Official Journal of the European Union L 144/89 EN 
develop guidance on ‘Best Available Techniques’ (BAT). 
It is recomm ended that Member States should carefully monitor the implementati on 
of BAT by permitting and repor t any important developmen ts 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 rul es to ensure that no risk for the envi ronment is expected. 
L 144/90 Official Journal of the European Union 30.4.2004 EN 
ANN EX
PART FOUR 
CAS NO. 79-10-7 Einecs-No.201-177-9 
Struct ural F ormul a: CH 2 ═ CH−COO H 
Einec s Name: Acrylic Acid 
IUPAC Name:  2-propenoic acid 
Rapporteur:  Germany 
Classi fication 17 C :R35 
Xn:R20 /21/2 2 
R10 
N:R50 
The risk assessmen t is based on current  practices related to the life cycle of the substance  
produced in or import ed into European Commu nity as described  in the comprehensive Risk 
Asses sment Report f orward ed to the Commission by the M ember State rapp orteur 18. 
The risk assessment has, based on the available  information, determined that in the European 
Communit y the substance is mainly used as an intermedi ate in the production of poly-
acrylates. Other uses are as an ingredient in adhesives and its occurrence  as a residu al 
monom er in adhesi ves, paint s, bindi ng agents,  printing inks, sanita ry towels, panty-li ners and 
nappy pants. Polyacrylat es are mainl y used as co-buil ders in phosphate  free washing agents, 
in floccul ating agents and for treatment of drinkin g and waste water. It was not possible  to 
obtai n inform ation on the use of the total volum e of substanc e produced in or impor ted into 
the European Communit y, therefore, some uses may exist which are not covered by this risk 
assessment. 
The risk assessment has identifi ed 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 
decompositi on 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 
17The classification of the substance is established by Commission Directi ve 2000/32/EC of 19 May 2000 
adapting  to techni cal progr ess for the 26th time Council  Directive 67/548/EEC on the approximatio n of 
the laws, regulations and admi nistrative provisions relating to the classif ication, packagi ng and labelling 
of dangerou s substances (OJ  L 136, 8.6.2000, p.1). 
18The compr ehensi ve Risk Assessment  Report , as well as a summ ary thereof, can be found on the internet 
site o f the Europ ean Chemica ls Bure au: http://ecb.j rc.it/existing-substanc es/.
30.4.20 04 Official Journal of the European Union L 144/91 EN 
in or imported into the European Communit y. The assessment of the risks arising from these 
exposures are part of this risk assessment. 
RISK ASSESSMEN T 
A. Human health
The conclusion of the a ssessment 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 irritati on and corrosivity as a consequence of single 
inhalati on exposure arising from production and processing, production of adhesives 
containing the substanc e and use of adhesives containi ng the substance, 
– concerns for local effects as a consequence of repeated inhalati on exposure arising 
from production of adhesives containing the substance and use of adhesives 
contai ning the  substanc e, 
– concerns for general systemic toxicity as a consequence of repeated inhalati on 
exposure arising from production and use of adhesives containi ng the substance. 
The conclusion of the a ssessment of the risks to 
CONSUMERS and HUMANS  EXPO SED VI A THE  ENVI RONMENT
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. T his conclusion is reached bec ause: 
– the risk assessment shows that risks are not expected. Risk reduction measures 
already being applied are consi dered sufficient. 
The conclusion of the a ssessment of the risks to 
HUMAN HEALT H (physicochemical propert ies) 
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. T his conclusion is reached bec ause: 
– the risk assessment shows that risks are not expected. Risk reduction measures 
already being applied are consi dered sufficient. 
B. Environment
The conclusions of the eval uation of the risks to t he environment for 
AQUATI C ECOSYSTEM 
L 144/92 Official Journal of the European Union 30.4.2004 EN 
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 a ssessment of the risks to the 
ATMOSPHE RE and TERRESTRIAL ECOSYST EM 
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. T his conclusion is reached bec ause: 
– the risk assessment shows that risks are not expected. Risk reduction measures 
already being applied are consi dered sufficient. 
The conclusion of the a ssessment of the risks to 
MICRO-ORGANISMS IN THE S EWAGE 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 inform ation to adequat ely charact erise the risk to munic ipal 
waste water treatment  plants as a consequen ce of exposure from the use of the 
substance for wet polymerisa tion includin g the production of super absorber 
polymers.  
The info rmation and /or test requiremen ts are 
– Furth er data reflecting integ rity of native ciliate popu lations  in sewag e. 
STRATE GY FOR  LIMITING RISKS 
for WORKE RS 
The legislation for workers’ protection currently in force at Communit y level is generally 
conside red to give an adequat e framework to limit the risks of the substanc e to the extent  
needed and shall appl y. 
Withi n this fr amework i t is rec omme nded: 
– to est ablish at com munit y level  occupat ional  exposure li mit values fo r acryli c 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), 
19OJ L 131, 5.5. 1998, p. 11. 
30.4.20 04 Official Journal of the European Union L 144/93 EN 
and of any sector specifi c guidance  developed at national level based on this 
guidan ce. 
for ENVIRONM ENT
it is recommended that: 
– for Acrylic Acid released from chemic al 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 , inclu ding 
requirem ents on comprehe nsive traini ng of planners and field personnel,  whereas 
local aspects should be c onsidered by the respective l ocal supervisory authoritie s. 
– local emissions to the environment should, where necessary, be controlled by 
national rul es to ensure that no risk for the envi ronment 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 pla nts.  
– to facilitate permi tting under Counci l Direct ive 96/61/ EC (Integrat ed Pollu tion 
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 implem entation of BAT by permitt ing 
and report any impor tant developments to the Commission in the framework of the 
excha nge o f info rmation on  BAT. 
– local emissions  to the environment should, where necessary, be controlled by 
national rul es to ensure that no risk for the envi ronment is expected. 
L 144/94 Official Journal of the European Union 30.4.2004 EN 
ANN EX
PART FIVE 
CAS-NO. 106-99- 0 Einecs-No. 203-450-8 
Struct ural F ormul a: CH 2 = CH – CH = CH 2
Einecs N ame: Buta diene  
IUPAC Name: 1,3-Butadi ene 
Rapporteu r: UK 
Classification 20 F +:R12 
Carc.Cat .1:R45 
Muta.Cat .2:R46 
The risk assessment is based on current practic es relate d to the life cycle of the substance 
produced in or import ed into the European Commun ity as described in the comprehen sive 
Risk Assess ment Report forwarded to the Commission by the Member State Rapporteur 21
The risk assessment has, based on the avail able informat ion, determi ned that in the European 
Commun ity the substance is mainl y used as an interm ediat e 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  
intermedi ate in the production of neoprene for automoti ve and industrial rubber goods, in the 
production of methylmet hacrylate-butadie ne-styrene (MBS) polymer, which is used as a 
polyvinyl chloride (PVC) reinforcing agent, and for producing adiponitri le, a nylon precursor. 
It was not possibl e to obtai n inform ation on the use of the total volum e of substanc e produced  
in or imported into the European Communit y, therefore, some uses may exist which are not 
covered by this risk assessment. 
20The classifi cation of the substance is establish ed by Commission  Directive 2001/59/ECo f 6 Augu st, 
adapting to technica l progress for the 28th time Council Direc tive 67/548/EEC on the approximatio n of 
the laws, regulations and admi nistrative provisions relating to the classif ication, packagi ng and labelling 
of dangerou s substances (OJ  L 225, 21.8.2001, p. 1). 
21The compr ehensi ve Risk Assessment  Report , as well as a summ ary thereof, can be found on the internet 
site o f the Europ ean Chemica ls Bure au: http://ecb.j rc.it/existing-substanc es/.
30.4.20 04 Official Journal of the European Union L 144/95 EN 
RISK ASSESSMEN T 
A. Human health
The conclusions of the eval uation of the risks to W ORKERS  
is that there is a need for specific measures to limit the risks. This conclusion is reached 
because of: 
– concerns  for mutagenicit y and carcinogenicit y as a consequence of exposure arising 
from production and use as an int ermediate i n the polymer industry.  
The conclusions of the eval uation of the risks to  
CONSUMERS and HUMANS E XPOS ED VI A THE  ENVI RONMENT  
is that the re is a need to limit the risks. This  conclusio n is reached becau se: 
– Risks can not be excluded for all exposure scenarios , as the substance is identif ied as 
a non-thres hold carcin ogen. The adequ acy of existing contr ols and the feasibility and 
practic ability of furth er specific measu res should be considered . How ever,  the risk 
assessment indicates that risks are already low. This should be taken into account 
when considering the adequacy of existing controls and the feasibilit y and 
practicabil ity of further specific risk reducti on measures. 
– The conclusion of the a ssessment of the risks to  
HUMAN HEALT H (physicochemical propert ies) 
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. T his conclusion is reached bec ause: 
– the risk assessment shows that risks are not expected. Risk reduction measures 
already being applied are consi dered sufficient. 
B. Environment
The conclusions of the eval uation of the risks to t he environment for 
ATMOSPHE RE, AQUATIC ECOSYST EM and TERRESTRIAL ECOSYSTE M  
is thatthere is at present no need for further information and/or testing or for risk reduction 
measures beyond those which are being applied. T hisconclu sion is re ached be cause:  
– 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 eval uation of the risks to t he environment for 
MICRO-ORGANISMS IN THE S EWAGE TREATMENT  PLANT 
L 144/96 Official Journal of the European Union 30.4.2004 EN 
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. T his conclusion is reached bec ause: 
– the risk assessment shows that risks are not expected. Risk reduction measures 
already being applied are consi dered sufficient. 
STRATE GY FOR  LIMITIN G RISK S 
for WORKERS 
The legislation for workers’ protection currently in force at Communit y level is generally 
conside red to give an adequat e framework to limit the risks of the substanc e to the extent  
needed and shall appl y. 
Withi n this fr amework i t is rec omme nded: 
– to est ablish at com munit y level  occupat ional  exposure li mit values fo r butadi ene . 
for CONSUMERS and HUMANS E XPOS ED VI A THE  ENVI RONMENT  
– the existing legislative  measures for the protection of consumers and humans 
exposed via the environme nt, in particul ar 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 ri sks identified. 
30.4.20 04 Official Journal of the European Union L 144/97 EN 
ANN EX
PART SIX  
CAS-N O. 7664- 39-3 Einecs-No.23 1-634-8 
Structural F ormula: HF 
Einecs Name: Hydrofluori c acid, anhydrou s hydr ofluoric acid
IUPA C Name: Hydro gen fluoride 
Rapporteur: Netherlands 
Classificat ion 22 T +:R26/2 7/28 
C: R34 
The risk assessment is based on current practic es relate d to the life cycle of the substance 
produced in or import ed into the European Commun ity as described in the comprehen sive 
Risk Assess ment Report forwarded to the Commission by the Member State rapporteur 23. 
The risk assessment has, based on the avail able informat ion, determi ned that in the European 
Commun ity the substance is mainl y used as an interm ediat e in the chemi cal 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 
cleani ng. 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 identifi ed other sources of exposure of the substance to man and the 
environ ment , in particular,  releases of hydrog en fluoride from iron/steel and aluminium 
industr y, glass , ceramic and brick industr y, power  plants and phosphate chemica l producers , 
which does not result from the life-cycle of the substanc e produced  in or imported into the 
European Community. The assess ment of the risks arising from these exposu res are not part 
of this risk assess ment. The risk assess ment forwar ded to the Commission by the Member 
State Rapporteur  does ho wever p rovide infor mation which could be used to assess  these risk s. 
22The classifi cation  of the substance  is establ ished by Comm ission Directive 2000/ 32/EC of 19 May 
2000, adapti ng to technical progress for the 26th time Counc il Directive 67/548 /EEC on the 
approximation of the laws, regulations and administrati ve provisions relating to the classification, 
packa ging and labelling of d angerous  subs tances  (OJ L 1 36, 8.6.2 000, p. 1). 
23The comprehensive Risk Asses sment Repo rt, as well as a summary thereof, can be found on the internet 
site of the European Chemicals B ureau: http:/ /ecb.jrc.it/existin g-substances /.
L 144/98 Official Journal of the European Union 30.4.2004 EN 
RISK ASSESSMEN T 
A. Human health
The conclusions of the eval uation of the risks to W ORKERS  
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 irritati on and/or corrosivity, depending on 
the concentration, as a consequence of repeated exposure to gaseous hydrogen 
fluori de at product ion and use as an intermedi ate in the chemi cal indust ry 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 irritati on 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, 
– concerns for respiratory tract irritati on and/or corrosivity, depending on 
concentration, as a consequence of single exposure to gaseous hydrogen fluoride at 
product ion and use as an intermedi ate in the chemi cal indust ry and at the use of 
aqueous solutions of the substance. 
The conclusion of the e valuation of t he 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 irritati on 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 cont aining the substance. 
The conclusions of the eval uation of the risks to 
HUMANS EX POSED VI A THE  ENVI RONMENT  
is that there is a need for specific measu res to limit the risks. This conclu sion is reach ed 
becau se of: 
– concerns for general systemic toxicity due to repeated inhalatory exposure in the 
vicinity of production and proces sing sites of the substance. 
The conclusion of the ass essment of the risks  to  
HUMAN H EALTH  (physicochemical properties) 
30.4.20 04 Official Journal of the European Union L 144/99 EN 
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. T his conclusion is reached bec ause: 
– the risk assessment shows that risks are not expected although concerns for risks 
related to the viole nt behavi our of the concent rated substanc e on contac t with water 
and the potential  formation of hydrogen on reaction of less than 65 % solutions of the 
substance with meta ls have been raised. 
B. Environment
The conclusions of the eval uation of the risks to t he environment for 
AQUATI C 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 a ssessment of the risks to the  
TERRESTRIAL ECOSYST EM  
is thatthere is at present no need for further information and/or testing or for risk reduction 
measures beyond those which are being applied. T hisconclu sion is re ached be cause:  
– 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 a ssessment of the risks for  
MICRO-ORGANISMS IN THE S EWAGE TREATMENT  PLANT 
is thatthere is at present no need for further information and/or testing or for risk reduction 
measures beyond those which are being applied. T hisconclu sion is re ached be cause:  
– 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. 
STRATE GY FOR  LIMITIN G RISK S 
for WORKERS
The legislation for workers’ protection currently in force at Communit y level is generally 
conside red to give an adequat e framework to limit the risks of the substanc e to the extent  
needed. 
L 144/100 Official Journal of the European Union 30.4.2004 EN 
Withi n this fr amework i t is rec omme nded: 
– to conside r at the Comm unity level  prohibit ion of the use in buildi ng surface 
cleaning (including floors) at work of hydrogen fluoride by including it in Annex III 
of Directi ve 98/24/ EC (Chem ical Agents Direct ive);  
– that the Commi ssion Scient ific Commi ttee on Occupational Exposure Limit s 
(SCOEL) review the new information contained in the risk assess ment report and 
recommend whether there is a need to revise the current occupational  exposu re limit 
(OEL).  
for C ONSUMERS 
It is recommended: 
– to remov e hydrogen fluor ide prepar ations class ified as corrosi ve or toxic  from the 
consum er mark et 24These products do not compl y with the general safety 
requi reme nt of the Direc tive 92/59/EEC on Genera l Produc t Safet y 25and should be 
immediat ely withdrawn. Member State s should carry out an active and effecti ve 
mark et survei llance of the situation in their territories conce rning the presen ce 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 Ra pid Ale rt System  of Direct ive 92/ 59/EE C.
24Minutes of the meeting of 2 April 2003 of the Emergencies Committ ee of Directi ve 92/59/EEC 
(General P roduct Safety). 
25OJ L 228 , 11.8 .1992 , p. 2 4. 
30.4.20 04 Official Journal of the European Union L 144/101  EN 
for the ENVIRONM ENT
– to facilitate permitting under Council Directive 96/61/EC (Integrated Pollution 
Preven tion 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 implem entation of BAT by permitt ing 
and report any impor tant developments to the Commission in the framework of the 
excha nge o f info rmation on  BAT. 
– local emissions  to the environment should, where necessary, be controlled by 
national rul es to ensure that no risk for the envi ronment is expected. 
L 144/102 Official Journal of the European Union 30.4.2004 EN 
ANN EX
PART SEVEN 
CAS-NO. 7722-84- 1 Einecs-No. 231-765-0 
Struct ural F ormul a: H2O2
Einecs N ame: Hydro gen peroxide 
IUPAC Name:  H ydrogen  peroxide  
Rapporteur: Finland 
Classification 26 O :R8 
C:R35  
The risk asses sment is based on current practices related to the life cycle of the substanc e 
produced  in or imported into the European Communit y as described in the comprehensive 
Risk As sessment Rep ort as fo rwarde d to the Commission b y the Membe r State Rappor teur 27. 
The risk assessment has, based on the available  information, determined that in the European 
Communit y the substance is mainly used as in pulp bleaching and chemical s manufacture. 
Other uses are in textile bleaching, disinfection in the foods process ing industry,  etching  in 
the electronics industry, metal plating, degrading of proteins, tooth bleaching, professional 
hair dyeing and bleaching, treatment  of drinkin g water and waste water, in numerous 
consumer products for hair dyeing and bleach ing, household  textile bleaching products, 
cleaning agents, contact lens disinfection, and  tooth bleaching products. 
26The classificat ion of the substance is established by Commission Directive 91/325/EE C of 1 March 
1991, adapting to technical  progre ss for the 12th time Council  Directive 67/548/EEC on the 
approximation of the laws, regulatio ns and adminis trative provis ions relating to the classifica tion, 
packaging and labelling o f dangerous substances (OJ L180, 8. 7. 1991, p. 1). 
27The comprehensi ve Risk Assessment Report, as well as a summar y thereof, can be found on the internet 
site of th e European Chemi cals Bureau:  http: //ecb.jr c.it/existi ng-subst ances/.
30.4.20 04 Official Journal of the European Union L 144/103  EN 
RISK ASSES SME NT 
A. Human health
The conclu sions of the e valuation of  the risk s 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 irritati on and/or corrosivity, depending on 
concentration, a s a consequence of exposure arising from loading operations.  
– concerns for skin and eye irritati on 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 irritati on and/or corrosivity, depending on concentration, as a 
consequence of exposure arising from hairdresser’s work.  
– concerns for repeated inhalati on toxicity in loading operations and aseptic packaging 
(all machines types), etching of circuit boards (old process) and waste water 
treatment . 
The conclusions of the eval uation 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 irritati on as a consequence of exposure arising from hair dying and 
bleaching and concerns for eye irritati on/corrosivity in use of textile bleaches and 
cleaning agents, if the ac tual concent ration 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 eval uation of the risks to 
HUMANS EX POSED VI A THE  ENVI RONMENT  
is that there is at present no need for furth er infor mation and/or  testing or for risk reduction 
measures beyo nd those which are being applied. This conclusion is reach ed because: 
– the risk assessment shows that risks are not expected. Risk reduction measures 
already being applied are co nsidered suff icient. 
L 144/104 Official Journal of the European Union 30.4.2004 EN 
The conclusion of the a ssessment of the risks to  
HUMAN HEALT H (physicochemical propert ies) 
is that there is a need for specific measures to limit the risks (applies to the workers and to the 
consumers ) This conc lusion is re ached becaus e: 
– concerns  for the risk of fire hazard caused by spills of the more concentrated (>25 %) 
hydrogen peroxide solutions on combustible m aterials. 
B. Environment
The conclusions of the eval uation of the risks to t he environment for 
ATMOSPHE RE and TERRESTRIAL ECOSYST EM  
is thatthere is at present no need for further information and/or testing or for risk reduction 
measures beyond those which are being applied. T hisconclu sion is re ached be cause:  
– 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 a ssessment of the risks to the  
AQUATI C 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 m anufacture of other chemi cals. 
The conclusion of the a ssessment of the risks for  
MICRO-ORGANISMS IN THE S EWAGE TREATMENT  PLANT 
is thatthere is at present no need for further information and/or testing or for risk reduction 
measures beyond those which are being applied. T hisconclu sion is re ached be cause:  
– 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. 
STRATE GY FOR  LIMITIN G RISK S 
for WORKERS 
The legislati on for workers’ protection currently in force at Com munity level  is generally 
considered to give an adequat e framework to limi t the risks of the substance t o the extent 
needed and shall appl y. 
30.4.20 04 Official Journal of the European Union L 144/105  EN 
Within this framework it is recommended that: 
– employers review any risk assessmen ts produce d accord ing to Direct ive 98/24 /EC 
(Che mical Agents Directive) to take into account the information contained in the 
risk assess ment 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 identifi ed 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 specifi c guidance  developed at national level based on this 
guidan ce. 
for CONSU MERS  
It is recommended that: 
– in the framew ork of Commission  Directive  (EC) 2003/83 28regar ding the maximum 
acceptable percentag e of hydrogen perox ide for tooth bleaching  products used under 
supervisi on of a denti st, a concent ration  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 irritati on/corrosivity is 
dimini shed (e.g. viscous suspensions, cream). In the instructions, the risk of eye 
irritati on/corrosivity should be emphasised and the percentage of H2O2 in the product 
should be indicated. For hair dyes/bleaches the above mentioned recommendati ons, 
including the percentage limit, should be considered within the framewor k of 
Communit y legislation on cosmeti c products. 
– the requirement for child-resistant fastenings in the Directive 1999/45/EC 
(Dang erous Preparations  Directive ) should be exten ded to all household chemica ls, 
which  may be ac cessible to childr en an d con tain hy drogen pe roxide. 
for ENVIRONM ENT
It is recommended that: 
– to facilit ate permitt ing 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 implem entation of BAT by permitt ing and report 
any important  developments to the Commission in the framework of the exchange of 
information on BAT. 
28OJ L 238 25 .9.2003 , p. 27.  
L 144/106 Official Journal of the European Union 30.4.2004 EN 
ANN EX
PART EIGHT 
CAS-NO.79-41- 4 Einecs-No. 201-204-4 
Struct ural F ormul a: CH 2 = C(CH 3)-COO H 
Einecs Na me: Methacrylic acid  (MAA) 
IUPA C Name: 2-Propenoic acid, 2- methyl 
Rappor teur: German y 
Classification 29: C: R35 
Xn: R2 1/22 
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 A ssessment Rep ort fo rwarded to the Commiss ion by  the Me mber Sta te rapp orteur 30
The risk assessment has, based on the available information, determined that in the European 
Community the substance is mainly used as anintern al and exter nal intermed iate in the 
chemica l indus try for the production of methacr ylic acid esters and as co-mo nomer  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 possi ble to obtain inform ation
on the use of the total volume of substa nce produc ed in or imported  into the European 
Community, therefo re, some u ses may  exist w hich are not co vered by  this risk a ssess ment. 
The risk assess ment 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-cycl e of the substance produced in or importe d into the European 
Communi ty.The asses sment of the risks arising  from these exposures are part of this risk 
assessment .  
29The classifi cation of the substance is establish ed by Commission  Directive 2001/59/EC of 19 Augu st 
2001 adaptin g to techni cal progr ess for the 28th time Council  Directive 67/548/EEC on the 
approximation of the laws, regulatio ns and adminis trative provis ions relating to the classifica tion, 
packaging and labelling o f dangerous substances (OJ L 225, 21.8.2001, p. 1). 
30The comprehensi ve Risk Assessment Report, as well as a summar y thereof, can be found on the internet 
site of th e European Chemi cals Bureau:  http: //ecb.jr c.it/existi ng-subst ances/.
30.4.20 04 Official Journal of the European Union L 144/107  EN 
RISK ASSES SME NT 
A. Human health
The conclu sion of  the ass essment o f the r isks to 
WORKE RS 
is that there is a need for specif ic measur es to limit the risks. This conclusion isreached 
because of: 
– concerns  for respiratory tract irritati on as a consequence of short term inhalati on 
exposure arising from the production, further processing as a chemical  intermediat e 
in the chemi cal indust ry, the manufa cture of adhesiv es in the indust rial area and the 
indust rial a nd skil led trade use of a dhesive s, 
– concerns for local respiratory effects as a consequence of repeated inhalati on 
exposure arising from manufacture and use of adhesives. 
The conclu sion of  the ass essment o f the r isks to 
CON SUMERS and HUMANS  EXPOSED VIA THE ENVIRONME NT
is that there is at present no need for furth er infor mation and/or  testing or for risk reduction 
measures beyond those w hich are being app lied. This c onclusion is reached bec ause: 
– the risk assessment shows that risks are not expected. Risk reduction measures 
already being applied are consi dered sufficient. 
The conclusion of the a ssessment of the risks to 
HUMAN HEALT H (physicochemical propert ies) 
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. T his conclusion is reached bec ause: 
– the risk assessment shows that risks are not expected. Risk reduction measures 
already being applied are consi dered sufficient. 
B. Environment 
The conclusion of the a ssessment of the risks to the environm ent for 
AQUATI C ECOSYSTEM 
is that there is a need for specific measu res to limit the risks. The conclu sion is reach ed becau se 
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 Official Journal of the European Union 30.4.2004 EN 
The conclusion of the a ssessment of the risks to the 
ATMOSPHE RE and TERR ESTRIAL ECOSYST EM
is that there is at present no need for furth er infor mation and/or  testing or for risk reduction 
measures beyond those w hich are being app lied. This c onclusion is reached bec ause: 
– the risk assessment shows that risks are not expected. Risk reduction measures 
already being applied are consi dered sufficient. 
The conclusion of the a ssessment of the risks to 
MICRO-ORGANISMS IN THE S EWAGE TREATMENT  PLANT 
is that there is at present no need for furth er infor mation and/or  testing or for risk reduction 
measures beyond those w hich are being app lied. This c onclusion is reached bec ause: 
– the risk assessment shows that risks are not expected. Risk reduction measures 
already being applied are consi dered sufficient.
STRATE GY FOR  LIMITIN G RISK S 
for WORKERS 
The legislation for workers’ protection currently in force at Communit y level is generally 
conside red to give an adequat e framework to limit the risks of the substanc e to the extent  
needed and shall appl y. 
Withi n this fr amework i t is rec omme nded:
– to establ ish at comm unity level  occupational exposure limit values for Methacrylic 
acid. 
– that employer s 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 spe cific guidance  develo ped at n ational level ba sed on th is guidan ce . 
for ENVI RONMENT  
For me thacry lic acid  relea sed from chemical grouts it is recommend ed: 
– to establish a harmonis ed Euro pean 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 cons idered by the res pective local supervisory author ities. 
– local emissions to the environment should, where necessary , be controlled by 
national rules to ensure that no risk f or the environment is expected. 
30.4.20 04 Official Journal of the European Union L 144/109  EN 
ANNEX
PART  NINE  
CAS-N O.80-62 -6  E inecs -No.201-297-1 
Structural Fo rmula: CH 2 = C(CH3) – COOCH 3
Einecs N ame: Meth yl met hacrylate  (MMA) 
IUPAC Name:  2 -methyl -propenoic  acid, methyl  ester 
Rapporte ur: Germany 
Classification 31 F :R11 
Xi:R37 /38  
R43  
The risk assessmen t is based on current  practices related to the lifecycle of the substance  as 
described in the risk evaluat ion forwarded to the Commi ssion by the Member State 
rapporteur 32. 
The risk assessme nt has, based on the available inform ation, determined that in the European 
Communit y the substance is mainly used as an intermedi ate 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 informat ion 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 identifi ed other sources of exposure to the substance, relevant for 
man and the environ ment , in particular,  as a decom posit ion product  during the thermal 
process ing of polymethyl methacrylate (PMMA ), which do not result from the life-cycle of 
the substance produced in or imported into the European Communit y. The assessment of the 
risks ar ising fr om these ex posures  are part o f this risk  asses sment. 
31The classifi cation  of the substance  is establ ished by Comm ission Directive 2000/ 32/EC of 19 May 2000 
adapt ing to technical progre ss for the 26th time Council  Directive 67/548/EEC on the approximatio n of 
the laws, regulations and admi nistrative provisions relating to the classif ication, packagi ng and labelling 
of dangerou s substances (OJ  L 136, 8.6.2000, p. 1 ). 
32The compr ehensi ve Risk Assessment  Report , as well as a summ ary thereof, can be found on the internet 
site o f the Europ ean Chemica ls Bure au: http://ecb.j rc.it/existing-substanc es/.
L 144/110 Official Journal of the European Union 30.4.2004 EN 
RISK ASSESSMEN T 
A. Human health 
The conclusion of the a ssessment of the risks to 
WORKERS 
is tha t there is a ne ed for speci fic me asures to l imit the risks. Thi s conclu sion is re ached 
because o f: 
– concerns for respiratory tract irritati on and corrosivity as a consequence of inhalati on 
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 applicati ons and in orthopaedic workshops, dental 
laboratories and surgeries as well as in orname ntal decorati on, 
– concerns for skin sensitisation as a consequence of dermal exposure arising from 
product ion of meth yl meth acrylat e, polyme thyl meth acrylat e, transest erific ation, cast 
sheet production, production of adhesives and reactive resins in chemical  industry, 
production of adhesives, casting resins and floor coating material s, 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 
applicati ons, orthopaedic workshops, dental laboratories and surgeries, 
manufacturing of lenses and ornament al decoration, 
– concerns for local effects as a consequence of repeated inhalati on 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 inhalati on 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 
orname ntal decorat ion. 
The conclusion of the a ssessment 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. T his conclusion is reached bec ause: 
– the risk assessment shows that risks are not expected. Risk reduction measures 
already being applied are consi dered sufficient. 
The conclusion of the a ssessment of the risks to 
HUMANS EX POSED VI A THE  ENVI RONMENT  
30.4.20 04 Official Journal of the European Union L 144/111  EN 
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. T his conclusion is reached bec ause: 
– the risk assessment shows that risks are not expected. Risk reduction measures 
already being applied are consi dered sufficient. 
The conclusion of the a ssessment of the risks to 
HUMAN HEALT H (physicochemical propert ies) 
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. T his conclusion is reached bec ause: 
– the risk assessment shows that risks are not expected. Risk reduction measures 
already being applied are consi dered sufficient. 
B. Environment 
The conclusion of the a ssessment of the risks to the 
AQUATI C 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 polymerisati on processes. 
The conclusion of the a ssessment of the risks to the 
ATMOSPHE RE and TERRESTRIAL ECOSYST EM 
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. T his conclusion is reached bec ause: 
– the risk assessment shows that risks are not expected. Risk reduction measures 
already being applied are consi dered sufficient. 
The conclusion of the a ssessment of the risks to 
MICRO-ORGANISMS IN THE S EWAGE 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. T his conclusion is reached bec ause: 
– the risk assessment shows that risks are not expected. Risk reduction measures 
already being applied are consi dered sufficient. 
STRATE GY FOR  LIMITIN G RISK S 
for WORKERS
L 144/112 Official Journal of the European Union 30.4.2004 EN 
The legislation for workers’ protection currently in force at Communit y level is generally 
conside red to give an adequat e framework to limit the risks of the substanc e to the extent  
needed and shall appl y. 
Withi n this fr amework i t is rec omme nded: 
– to establ ish at comm unity level  occupational exposure limit values for methyl 
methacrylate 
– that employer s 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 
nationa l level  based on this guidanc e. 
forENV IRONME NT
for Methyl methacrylate used in wet polymerisation processes  at downstream user sites 
(processing capac ity > 5000 t/a)  it is recomme nded: 
– that the European Commission should consider whether to include methyl 
methacr ylate on the prior ity list of Annex X to Directive 2000 /60/EC (Water 
Framew ork Directive) durin g the next review  of this Annex and should consider 
measures such as harmoni sed requirem ents for prior authori sation of discharges and 
emissi ons int o water for t he respect ive pl ants. 
– to facilitate permitting under Council Directive 96/61/EC (Integrated Pollution 
Preven tion and Control)  this substance should be included in the ongoing work to 
develop guidance on ‘Best Available Techniques’ (BAT). It is recommended that 
Member State s careful ly monit or the implement ation of BAT by permi tting and 
report any impor tant developments to the Commission in the framework of the 
excha nge o f info rmation on  BAT 
– local emissions  to the environment should, where necessary, be controlled by 
national rul es to ensure that no risk for the envi ronment is expected. 
30.4.20 04 Official Journal of the European Union L 144/113  EN 
ANNEX
PART  TEN 
CAS-NO. 108-88-3 Einecs-No.  203 -625-9
Structural Formula: C6H5 – CH 3
Einecs N ame: Toluene 
IUPAC Name:  T oluene 
Rapporteur: Denmark 
Classi fication 33 F :R11 
Xn:R20   
The risk assessmen t is based on current  practices related to the lifecycle of the substance  
produced in or import ed into the European Commu nity as described  in the comprehensive 
Risk As sessment Rep ort forw arded to the Co mmission by the  Member S tate rapporteur  34. 
The risk assessment has, based on the available information, determined that in the European 
Community the substance is mainly used asan 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 h as identified  other s ources  of ex posur e of the  subs tance to man and the 
environmen t, in particu lar the us e and co mbustion o f petro leum produ cts, w hich do n ot resu lt 
from the life-cycle of the subs tance produced in or imported into the European Community. 
The ass essment o f the r isks ar ising f rom these  expo sures  is not p art of this risk  assessment. The 
comprehen sive Risk  Assessment R eports as forwarded to the Commission by the Member State 
Rapporteu r does  howe ver pr ovide info rmation that co uld be us ed to as sess these r isks. 
33The classification of the substance is established by Commission Directi ve 91/325/EEC of 1 March 
1991, adapting to technical progress for the 12th time Council Directi ve 67/548/EEC on the 
approxim ation of the laws, regul ations and admini strative provi sions relating to the classifi cation, 
packaging and labelling of dangerous substances (OJ L 180 , 8. 7. 1991, p.  1). 
34The comprehensi ve Risk Assessment Report, as well as a summar y thereof, can be found on the internet 
site of th e European Chemi cals Bureau:  http: //ecb.jr c.it/existi ng-subst ances/.
L 144/114 Official Journal of the European Union 30.4.2004 EN 
RISK ASSESSMEN T 
A. Human health 
The conclusions of the eval uation of the risks to W ORKERS 
is tha t there is a ne ed for speci fic me asures to l imit the risks. Thi s conclu sion is re ached 
because o f: 
– 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 intoxicati on, sleepiness 
and impaired functional performance) as a consequence of inhalati on exposure 
arising from production and use as an intermedi ate, production of products 
containing the substanc e and use of products containing the substanc e, 
– concerns for eye irritati on 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 inhalati on 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 (mecha nical coat ing), 
– 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 paint ing, 
– concerns for specific organ toxicity (auditory system toxicity) as a consequence of 
inhalati on 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 paint ing (mechanical  coating), 
– concerns for fertilit y and developmenta l effects and spontaneous abortions as a 
consequence of inhalati on exposure arising from production of products and use of 
toluene containing products in the sectors of manual cleaning, use of adhesives, 
printing and paint ing (mechanical  coating). 
The conclusions of the eval uation of the risks to 
CONSUMERS 
30.4.20 04 Official Journal of the European Union L 144/115  EN 
1. is that there is a need for specific measures to limit the risks. This conclusion is 
reached beca use of: 
– concerns  for acute toxicity (headache, dizziness, feeling of intoxicati on, sleepiness 
and impaired functional performance) and eye irritati on as a consequence of 
inhalati on exposure or eye exposure to vapours arising from spray painting and 
carpet laying. 
2. 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 inhal ation exposure. 
The in format ion and /or te st requi rement  is: 
– information on the relationship between the observed effects on reproduction and the 
duration of the exposure leading to t hese 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 lim iting risks). 
The conclusions of the eval uation of the risks to 
HUMANS EX POSED VI A THE  ENVI RONMENT  
is that there is a need for specific measu res to limit the risks. This conclu sion is reach ed 
becau se of: 
– concerns for effects on humans due to the contri bution  of comme rcial product 
tolue ne to t he format ion of ozone  and oth er harmful  substance s, i.e., sm og formati on. 
The conc lusion o f the assessm ent of t he risks t o  
HUMAN HEALTH (physicochem ical properti es) 
is that there is at present no need for further informa tion and/or testing or for risk reducti on 
measures be yond those whi ch are be ing appl ied. T his concl usion is reached b ecause:  
– the risk assessment shows that risks are not expected. Risk reduction measures 
already being applied are consi dered sufficient. 
B. Environment
The conclusions of the eval uation of the risks to t he environment for 
AQUATI C ECOSYSTEM  
is that there is a need for specific measures to limit the risks. This conclusion is reached 
because of: 
L 144/116 Official Journal of the European Union 30.4.2004 EN 
– 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 chemical s (including 
processing aid, “extraction” agent and solvent), processing and formulation, mineral 
oil and fuel formul ation, formul ation of polyme rs, formul ation of paint s and textile 
processing. 
The conclusion of the a ssessment of the risks to the  
TERRESTRIAL ECOSYST EM  
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 chemical s 
(including processing aid, “extraction” agent and solvent), processing and 
formul ation, mine ral oil and fuel formul ation, formul ation of polyme rs, formul ation 
of paints and textil e processing. 
The conclusion of the a ssessment of the risks for  
ATMOSPHE RE 
is that there is a need for specific measures to limit the risks. This conclusion is reached 
because of: 
– concerns for the contributi on of the commercial  product tolue ne to the formati on of 
ozone and other harmful substances, i.e. smog formation. 
The conclusion of the assessment of the risks for  
MICRO-ORGANISMS IN T HE SEWAGE T REATMENT P LANT  
is that there is a need for specifi c measures to limit the risks. This conclusi on is reached 
because of:  
– concerns for sewage treatment  plants as a consequen ce of exposure arisin g from 
processing of the substance as well as in the use secto rs of indus try use as basic  
chemicals. 
STRATE GY FOR  LIMITING RISKS 
The risk assessmen t has ident ified 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 Ri sk Reduction Strat egy. 
for WORKERS
The legislation for workers’ protection currently in force at Communit y level is generally 
conside red to give an adequat e framework to limit the risks of the substanc e to the extent  
needed and shall appl y. 
30.4.20 04 Official Journal of the European Union L 144/117  EN 
Within this framework it is recommended: 
– that the Commission Scientifi c Commit tee on Occupational Exposure Limit s 
(SCOEL) review the new information contained in the risk assess ment report and 
recommend wh ether there is a need to rev ise the curr ent OEL. 
for CON SUME RS
It is recommended: 
– to consider at Communit y 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 market ing and use restric tions proposed will eliminate the need for more 
information on reproduct ion as a consequence of inhalat ion exposure. 
for ENV IRONMENT and HUMANS EX POSED VI A THE  ENVI RONMENT  
It is recom mended:  
– 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 meantim e, toluene should be 
conside red as a releva nt List II substance in Council  Directive  76/464/EEC 35 on 
polluti on caused by certain dangerous substances discharged into the aquatic 
environ ment  of the Commu nity, thus requiri ng the establ ishment  of natio nal quali ty 
object ives, monit oring and eventua l reducti on measures, as to ensure that 
concentrations in surface water systems do not exceed the quality objecti ve. 
– to facilitate permit ting 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 implem entation of BAT by permitt ing 
and report any impor tant developments to the Commission in the framework of the 
excha nge o f info rmation on  BAT. 
– local emissions  to the environment should, where necessary, be controlled by 
national rul es to ensure that no risk for the envi ronment is expected. 
35OJ L 129 , 18.5 .1976 , p 23.
L 144/118 Official Journal of the European Union 30.4.2004 EN 
The proposal  from the Commi ssion to limit the content  of solvent s in certai n products would 
further l imit the ri sk from tol uene to m an via t he enviro nment  36
36Proposal 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 fina l).  
30.4.20 04 Official Journal of the European Union L 144/119  EN 
ANNEX
PART  ELEVE N 
CAS-NO . 120-82-1 Einecs-No.  204-428-0 
Structural Formula: C6H3Cl3
Einecs N ame: 1,2,4-Trichlor oben zene (TCB)
IUPAC Name:  1 ,2,4-Trichlorobenzene 
Rapporteur: Denmark 
Classi fication 37 X n:R22 
Xi:R38 
N:50-53 
The risk assessment  is based on current  practices related to the lifecycle of the substance  
produced in or import ed into European Commu nity as described  in the comprehensive Risk 
Asses sment Report f orward ed to the Commission by the M ember State rapp orteur 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 synthes is of herbicides and as 
aprocesssolventinclosed system s.Other uses reported include as a solvent, dye carrier in 
textile industry, additive in dielectric fluids and corro sion inhibitor. It was not possible to obtain 
information on the use of the total volume of substance produced in or imported into the 
European Communit y, therefore, some uses may exist which are not covered by this risk 
assessment. 
The risk asses sment has identified other sourc es of expos ure of the substan ce to man and the 
environment, in particular, from certai n 1,2,4-tri chlorobe nzene contai ning dielectric fluids still 
in use in existing electric al equipme nt and envir onmenta l forma tion of 1,2,4-tric hloro benzene as 
a decomp osition  product of other, more compl ex organo-chlori ne compoun ds, which do not
result from the life-cycle of the substance produced in or imported into the European 
Communit y.The asses sment of the risks arising  from these exposures are not part of this risk 
assessment .  
The comprehe nsive Risk Assessment Reports as forwarded to the Commi ssion by the Member 
State  Rapport eur does howev er provide  informa tion t hat cou ld be use d to assess t hese risks. 
37The classifi cation of the substance is establish ed by Commission  Directive 2001/59/ECo f 6 Augu st, 
adapting to technica l progress for the 28th time Council Direc tive 67/548/EEC on the approximatio n of 
the laws, regulations and admi nistrative provisions relating to the classif ication, packagi ng and labelling 
of dangerou s substances (OJ  L 225, 21. 8.2001, p. 30). 
38The compr ehensi ve Risk Assessment  Report , as well as a summ ary thereof, can be found on the internet 
site o f the Europ ean Chemica ls Bure au: http://ecb.j rc.it/existing-substanc es/.
L 144/120 Official Journal of the European Union 30.4.2004 EN 
The risk assessment indicat es that it  should be further investigate d if the substance should be 
considered in relat ion to nati onal or internat ional programmes addressing persistent organic 
pollu tants. 
RISK ASSESSMEN T 
A. Human health 
The conclusions of the eval uation of the risks to  
WORKERS  
is that the re is a need for further informati on and/or testing. Thi s conclusion is reached 
because:  
– concerns for effects as a consequence exposure 
The in format ion and /or te st requi rement s are 
– information on occupational  exposu re during the use of the substan ce as a dye carrier 
and as a process solven t, during product ion of product s conta ining the substan ce in 
the secto r of product ion of dielectric fluids and during the use of product s conta ining 
the su bstanc e in the se ctor of produ ction of wi re and  cabling. 
The need to obtai n this inform ation was re-eva luated in light of the risk reducti on strategy and 
is no l onger require d (see sect ion II St rategy for li miting 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 inhalati on 
exposure arising from drumming activit ies in the production of the substance, from 
the product ion of product s contai ning the substanc e in the sector of pigmen t 
production and from the use of products containing the substance in the sector of 
spray painting, 
– concerns for eye and respiratory tract irritati on as a consequence of repeated 
exposure to the vapour of the substance arising from the production of products 
contai ning the substanc e in the sector of pigmen t product ion and from the use of 
products containing the  substance in the sector of product ion of plastic pel lets, 
– 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 painti ng, dismantling transformers and poli shing, 
The conclusions of the eval uation of the risks to 
CONSUMERS 
is that there is a need for specific measures to limit the risks. This conclusion is reached 
because of: 
30.4.20 04 Official Journal of the European Union L 144/121  EN 
– 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 aris ing from spr ay painting and car po lishing. 
The conclusions of the evaluation of the r isks to  
HUMANS  EXP OSED VI A THE  ENVI RONMENT  
is that there is a need for specific measu res to limit the risks. This conclu sion is reach ed 
becau se of: 
– concerns for indirect exposure as calculat ed exposures can exceed WHO TDIs, and 
WHO g uideline val ues in drinking water for local use scenarios. 
The conclusion of the a ssessment of the risks to  
HUMAN HEALT H (physicochemical propert ies) 
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. T his conclusion is reached bec ause: 
– the risk assessment shows that risks are not expected. Risk reduction measures 
already being applied are consi dered sufficient. 
B. Environment
The conclusions of the eval uation of the risks to t he environment for 
AQUATI C ECOSYST EM and T ERRESTRIAL  ECOSYSTEM is that there  is a need for speci fic 
measu res to l imit the risks.  This concl usion i s reache d beca use 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, addit ive in diel ectric flui ds and a corrosion inhibitor). 
The conclusion of the a ssessment of the risks to the  
ATMOSPHE RE 
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. T his conclusion is reached bec ause: 
– the risk assessment shows that risks are not expected. Risk reduction measures 
already being applied are consi dered sufficient 
The conclusion of the a ssessment of the risks to 
MICRO-ORGANISMS IN THE S EWAGE TREATMENT  PLANT  
is that there is a need for specific measures to limit the risks. This conclusion is reached 
because of: 
L 144/122 Official Journal of the European Union 30.4.2004 EN 
– concerns for sewage treatment  plants as a consequen ce of exposure arisin g from use 
as an intermediate, as well as from the use sectors  of basic chemi cals as a solvent , 
textile industry as dye carrier and other downstream uses. 
STRA TEGY FOR  LIMITI NG RI SKS 
for WORKERS
The legislation for workers’ protection currently in force at Community level and in particular 
the provisions under Commission Directive 2000/39/E C 39 establ ishing a fi rst list  of indic ative  
exposure limit values are generall y considere d to give an adequat e 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 healt h (workers) and eliminate  the need for more information on the occupational  
exposu re scenar ios. 
for CONS UMERS, the ENV IRON MENT and HU MANS E XPO SED VIA  THE  ENV IRON MENT  
It is recom mended:  
– to consider marketing and use restrictions at Communit y level in Council Directive 
76/769/EEC for all uses of TCB except as an intermedi ate to protect the environment 
and to reduce the indirect exposu re via the environment. Where appropriate, 
marketing and use res trictions of ar ticles containing TCB  should als o be cons idered. 
39OJ L 142, 16.6.20 00, p. 47.