title: 2004/394/EC:Commission Recommendation of 29 April 2004 on the results of the risk evaluation and the risk reduction strategies for the substances: Acetonitrile; Acrylamide; Acrylonitrile; Acrylic acid; Butadiene; Hydrogen fluoride; Hydrogen peroxide; Methacrylic acid; Methyl methacrylate; Toluene; Trichlorobenzene (Text with EEA relevance) (notified under document number C(2004) 1446)

text:
L 144/72           EN               Official Journal of the European Union                30.4.2004
                               COMMISSION RECOMMENDATION
                                             of 29 April 2004
 on the results of the risk evaluation and the risk reduction strategies for the substances:
   Acetonitrile; Acrylamide; Acrylonitrile; Acrylic acid; Butadiene; Hydrogen fluoride;
Hydrogen peroxide; Methacrylic acid; Methyl methacrylate; Toluene; Trichlorobenzene
                          (notified under document number C(2004) 1446)
                                        (Text with EEA relevance)
                                               (2004/394/EC)
THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Community
Having regard to Council Regulation (EEC) No 793/93 of 23 March 1993 on the evaluation
and control of the risks of existing substances (1) and in particular Article 11(2) thereof,
Whereas:
(1)      In the framework of Council Regulation (EEC) No 793/93 the following substances
         have been identified as priority substances for evaluation in accordance with
         Commission Regulation (EC) No 1179/94 of 25 May 1994 concerning the first list of
         priority substances as foreseen under Council Regulation (EEC) No 793/93 (2), which
         also designates for those substances the following rapporteur Member States:
–          Acetonitrile, rapporteur Member State: Spain,
–          Acrylamide, rapporteur Member State: the United Kingdom,
–          Acrylonitrile, rapporteur Member State: Ireland,
–          Acrylic acid, rapporteur Member State: Germany,
–          Butadiene, rapporteur Member State: the United Kingdom,
–          Hydrogen fluoride, rapporteur Member State: the Netherlands,
–          Methacrylic acid, rapporteur Member State: Germany,
1
         OJ L 84, 5.4.1993, p. 1.
2
         OJ L 131, 26.5.94, p. 3.
 ---pagebreak--- 30.4.2004        EN                 Official Journal of the European Union                L 144/73
–         Methyl methacrylate, rapporteur Member State: Germany.
(2)     In the framework of Council Regulation (EEC) No 793/93 the following substances
        have been identified as a priority substances for evaluation in accordance with
        Commission Regulation (EC) No 2268/95 of 28 September 1995 concerning the
        second list of priority substances as foreseen under Council Regulation (EEC) No
        793/93 (3), which also designates for those substances the following rapporteur
        Member States:
–         Hydrogen peroxide, rapporteur Member State: Finland;
–         Toluene, rapporteur Member State: Denmark;
–         Trichlorobenzene, rapporteur Member State: Denmark;
(3)     Those rapporteur Member States have completed all the risk evaluation activities with
        regard to man and the environment for those substances and have suggested a strategy
        for limiting the risks in accordance with Commission Regulation (EC) No 1488/94
        of 28 June 1994 laying down the principles for the assessment of risks to man and
        the environment of existing substances in accordance with Council Regulation (EEC)
        No 793/93 (4).
(4)     The Scientific Committee on Toxicity, Ecotoxicity and the Environment (CSTEE) has
        been consulted and has issued an opinion with respect to the risk evaluations carried
        out by the Member States rapporteurs.
(5)     The results of the risk evaluation 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
        evaluation and implement the relevant recommendations, to ensure risk to human
        health and the environment is controlled for each of the substances for which a risk
        assessment has been carried out. The Commission has also listed community
        legislative measures to which priority should be given.
(7)     The measures provided for in this recommendation are in accordance with the opinion
        of the Committee set up pursuant to Article 15 of Regulation (EEC) No 793/93,
HEREBY RECOMMENDS:
1.        All sectors importing, producing, transporting, storing, formulating into a preparation
          or other processing, using, disposing or recovering the following substances:
          (1)     Acetonitrile;
                  CAS No 75-05-8
                  Einecs No 200-835-2
3
        OJ L 231, 28.9.1995, p. 18.
4
        OJ L 161, 29.6.1994, p. 3.
 ---pagebreak--- L 144/74        EN                Official Journal of the European Union                30.4.2004
         (2)     Acrylamide;
                 CAS No 79-06-1
                 Einecs No 201-173-7
         (3)     Acrylonitrile;
                 CAS No 107-13-1
                 Einecs No 203-466-5
         (4)     Acrylic acid;
                 CAS No 79-10-7
                 Einecs No 201-177-9
         (5)     Butadiene;
                 CAS No 106-99-0
                 Einecs No 203-450-8
         (6)     Hydrogen fluoride;
                 CAS No 7664-39-3
                 Einecs No 231-634-8
         (7)     Hydrogen peroxide;
                 CAS No 7722-84-1
                 Einecs No 231-765-0
         (8)     Methacrylic acid;
                 CAS No 79-41-4
                 Einecs No 201-204-4
         (9)     Methyl methacrylate;
                 CAS No 80-62-6
                 Einecs No 201-297-1
         (10)    Toluene;
                 CAS No 108-88-3
                 Einecs No 203-625-9
         (11)    Trichlorobenzene;
                 CAS No 120-82-1
                 Einecs No 204-428-0
         should take into account the results of the risk evaluation set out in the Section Risk
         assessment of parts 1 to 11 of the Annex for each of the substances mentioned.
2.       The strategy for limiting risks set out in the Section Strategy for limiting risks of
         Parts 1 to 11 of the Annex to this recommendation should be implemented. Where it
         is considered that no risks are expected, the information should be used to ensure the
         current risk reduction measures are maintained.
         This Recommendation is addressed to all sectors importing, producing, transporting,
         storing, formulating into a preparation or other processing, using, disposing or
         recovering the following substances and to the Member States.
 ---pagebreak--- 30.4.2004      EN               Official Journal of the European Union   L 144/75
Done at Brussels, 29 April 2004.
                                                For the Commission
                                                Margot WALLSTRÖM
                                                Member of the Commission
                                              _______
 ---pagebreak--- L 144/76            EN                Official Journal of the European Union                       30.4.2004
                                                    ANNEX
                                                  PART ONE
CAS-NO. 75-05-8                                                        Einecs-No. 200-835-2
Structural Formula:                CH3−C ≡ N
Einecs Name:                       Acetonitrile
IUPAC Name:                        Acetonitrile
Rapporteur:                        Spain
Classification 5:                  F: R11
                                   Xn: R20/21/22
                                   Xi: R36
The risk assessment is based on current practices related to the life cycle of the substance
produced in or imported into the European Community as described in the comprehensive
Risk Assessment Report forwarded to the Commission by the Member State Rapporteur 6.
The risk assessment has, based on the available information, determined that in the European
Community the substance is mainly used as an intermediate for synthesis of industrial
chemicals, pharmaceuticals and pesticides, and in the manufacturing of photographic film.
Other uses include as a solvent in various extraction processes and in research and analytical
laboratories. It was not possible to obtain information on the use of the total volume of
substance produced in or imported into the European Community, therefore, some uses may
exist which are not covered by this risk assessment.
The risk assessment has identified other sources of exposure of the substance to man and the
environment, in particular, the substance is produced during biomass burning and is present in
automobile exhaust, which do not result from the life-cycle of the substance produced in or
imported into the European Community. The assessment of the risks arising from these
exposures are not part of this risk assessment. The comprehensive Risk Assessment Reports
as forwarded to the Commission by the Member State Rapporteur does however provide
information about these risks.
5
         The classification of the substances is established by Commission Directive 2000/32/EC of 19 May
         2000 adapting to technical progress for the 26th time Council Directive 67/548/EEC on the
         approximation of the laws, regulations and administrative provisions relating to the classification,
         packaging and labelling of dangerous substances (OJ L 136, 8.6..2000, p. 1).
6
         The comprehensive Risk Assessment Report, as well as a summary thereof, can be found on the internet
         site of the European Chemicals Bureau: http://ecb.jrc.it/existing-substances/.
 ---pagebreak--- 30.4.2004         EN              Official Journal of the European Union                 L 144/77
                                      RISK ASSESSMENT
A. Human health
The conclusions of the evaluation of the risks to
WORKERS
is that there is a need for specific measures to limit the risks. This conclusion is reached
because of:
–         concerns for general systemic toxicity as a consequence of dermal exposure arising
          from use as a solvent and as an intermediate.
The conclusions of the evaluation of the risks to
CONSUMERS and HUMANS EXPOSED VIA THE ENVIRONMENT
is that there is at present no need for further information and/or testing or for risk reduction
measures beyond those which are being applied. This conclusion is reached because:
–         the risk assessment shows that risks are not expected. Risk reduction measures
          already being applied are considered sufficient
The conclusions of the evaluation of the risks to
HUMAN HEALTH       (physicochemical properties)
is that there is at present no need for further information and/or testing or for risk reduction
measures beyond those which are being applied. This conclusion is reached because:
–         the risk assessment shows that risks are not expected. Risk reduction measures
          already being applied are considered sufficient
B. Environment
The conclusions of the evaluation of the risks to the environment for
ATMOSPHERE
is that there is at present no need for further information and/or testing or for risk reduction
measures beyond those which are being applied. This conclusion is reached because:
–         the risk assessment shows that risks related to the environmental spheres mentioned
          above are not expected. Risk reduction measures already being applied are
          considered sufficient.
 ---pagebreak--- L 144/78           EN                  Official Journal of the European Union                       30.4.2004
The conclusions of the evaluation of the risks to the environment for
AQUATIC ECOSYSTEM and TERRESTRIAL ECOSYSTEM
is that there is a need for specific measure to limit the risks. The conclusion is reached
because of:
–          concerns for the aquatic and terrestrial ecosystems as a consequence of exposure
           arising from use of the substance in the pharmaceutical industry.
The conclusions of the evaluation of the risks to the environment for
MICRO-ORGANISMS IN THE SEWAGE TREATMENT PLANT
is that there is a need for specific measures to limit the risks. This conclusion is reached
because of:
–          concerns for effects on sewage treatment plants as a consequence of exposure arising
           from the use of the substance in the pharmaceutical industry.
                                STRATEGY FOR LIMITING RISKS
The risk assessment has identified other sources of acetonitrile emissions (eg burning of fossil
fuels). This is outside the scope of Council Regulation (EEC) 793/93 and has not been
considered in the Risk Reduction Strategy.
for WORKERS
The legislation for workers protection currently in force at Community level is considered to
give an adequate framework to limit the risks of the substance to the extent needed and shall
apply.
Within this framework it is recommended:
–          to consider revising the current occupational exposure limit value adopted under
           Commission Directive 91/322/EEC 7 to provide an indication that dermal exposure
           can make a contribution to the worker body burden.
for ENVIRONMENT
–          that the European Commission should consider the inclusion of acetonitrile in the
           priority list of Annex X to Council and Parliament Directive 2000/60/EC 8 (Water
           Framework Directive) during the next review of this Annex.
7
         Commission Directive 91/322/EEC on establishing indicative limit values by implementing Council
         Directive 80/1107/EEC on the protection of workers from the risks related to exposure to chemical,
         physical and biological agents at work (OJ L 177, 5.7.1991, p. 22).
8
         Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a
         framework for Community action in the field of water policy, (OJ L 327, 22.12.2000, p. 1).
 ---pagebreak--- 30.4.2004         EN                 Official Journal of the European Union                   L 144/79
–         to facilitate permitting under Council Directive 96/61/EC 9 (Integrated Pollution
          Prevention and Control) this substance should be included in the ongoing work to
          develop guidance on ‘Best Available Techniques’ (BAT). It is recommended that
          Member States should carefully monitor the implementation of BAT by permitting
          and report any important developments to the Commission in the framework of the
          exchange of information on BAT.
–         local emissions to the environment should, where necessary, be controlled by
          national rules to ensure that no risk for the environment is expected.
9
        Council Directive 96/61/EC of 24 September 1996 concerning integrated pollution prevention and
        control (OJ L 257, 10.10.1996, p. 26).
 ---pagebreak--- L 144/80            EN                 Official Journal of the European Union                             30.4.2004
                                                     ANNEX
                                                   PART TWO
CAS-NO. 79-06-1                                                         Einecs-No. 201-173-7
Structural Formula:                 CH2 ═ CH−CONH2
Einecs Name:                        Acrylamide
IUPAC Name:                         2-propenamide
Rapporteur:                         United Kingdom
Classification 10:                  Carc.Cat.2:R45
                                    Muta.Cat.2:R46
                                    Repro.Cat.3:R62
                                    T:R25
                                    T:R48/23/24/25
                                    Xn:R20/21
                                    Xi:R36/38
                                    R43
The risk assessment is based on current practices related to the life-cycle of the substance
produced in or imported into the European Community as described in the comprehensive Risk
Assessment Report forwarded to the Commission by the Member State Rapporteur 11.
The risk assessment has, based on the available information, determined that in the European
Community the substance is mainly used as an intermediate in the chemical industry for the
production of polyacrylamide. Other uses are as on-site preparation of polyacrylamide gels and
as grouting agents. The main uses of polyacrylamide are in waste water treatment, paper and
pulp processing and mineral processing; minor uses include as cosmetic additives and as soil
conditioners. It was not possible to obtain information on the use of the total volume of
substance produced in or imported into the European Community, therefore some uses may
exist which are not covered by this risk assessment.
10
         The classification of the substance is established by Commission Directive 2001/59/EC of 6 August,
         adapting to technical progress for the 28th time Council Directive 67/548/EEC on the approximation of
         the laws, regulations and administrative provisions relating to the classification, packaging and labelling
         of dangerous substances (OJ L 225, 21.8.2001, p. 1).
11
         The comprehensive Risk Assessment Report, as well as a summary thereof, can be found on the internet
         site of the European Chemicals Bureau: http://ecb.jrc.it/existing-substances/.
 ---pagebreak--- 30.4.2004         EN                Official Journal of the European Union                   L 144/81
                                        RISK ASSESSMENT
A. Human health
The conclusions of the evaluation of the risks to
WORKERS
is that there is a need for specific measures to limit the risks. This conclusion is reached
because of:
–         concerns for mutagenicity and carcinogenicity as a consequence of exposure arising
          from production of the substance, use as an intermediate in the chemical industry for
          the production of polyacrylamide, use of polyacrylamide, use of polyacrylamide gels
          for electrophoresis and use of acrylamide based grouts (small and large scale
          applications).
–         concerns for neurotoxicity and reproductive toxicity as a consequence of exposure
          arising from the small and large scale use of acrylamide based grouts.
The conclusions of the evaluation of the risks to
CONSUMERS
–         is that risks can not be excluded at any exposure, as the substance is identified as a
          non-threshold carcinogen. The adequacy of existing controls and the feasibility and
          practicability of further specific measures should be considered. However, the risk
          assessment indicates that risks are already low. This should be taken into account
          when considering the adequacy of existing controls and the feasibility and
          practicability of further specific risk reduction measures.
The conclusions of the evaluation of the risks to
HUMANS EXPOSED VIA THE ENVIRONMENT
is that there is a need for specific measures to limit the risks. This conclusion is reached
because of:
–         concerns for neurotoxicity, reproductive toxicity, mutagenicity and carcinogenicity
          as a consequence of exposure resulting from the use of acrylamide based grouts in
          large scale construction applications.
In addition to the conclusion given above, risks cannot be excluded considering the remaining
uses, as the substance is identified as a non-threshold carcinogen. The adequacy of existing
controls and the feasibility and practicability of further specific measures should be
considered. However, the risk assessment indicates that risks are already low. This should be
taken into account when considering the adequacy of existing controls and the feasibility and
practicability of further specific risk reduction measures.
 ---pagebreak--- L 144/82           EN                Official Journal of the European Union                  30.4.2004
The conclusion of the assessment of the risks to
HUMAN HEALTH        (physicochemical properties)
is that there is at present no need for further information and/or testing or for risk reduction
measures beyond those which are being applied. This conclusion is reached because:
–         the risk assessment shows that risks are not expected. Risk reduction measures
          already being applied are considered sufficient.
B. Environment
The conclusions of the evaluation of the risks to the environment for
AQUATIC ECOSYSTEM
is that there is a need for specific measures to limit the risks. The conclusion is reached because
of:
–         concerns for the aquatic ecosystem as a consequence of exposure arising from the
          use of acrylamide based grouts in construction applications, and to indirect exposure
          of other organisms through contaminated water from the same use.
The conclusion of the assessment of the risks to the
ATMOSPHERE
is that there is at present no need for further information and/or testing or for risk reduction
measures beyond those which are being applied. This conclusion is reached because:
–         the risk assessment shows that risks related to the environmental spheres mentioned
          above are not expected. Risk reduction measures already being applied are
          considered sufficient.
The conclusion of the assessment of the risks to the
TERRESTRIAL ECOSYSTEM
is that there is a need for further information and/or testing. This conclusion is reached
because of:
–         concerns for use of acrylamide-based grouts in construction applications. The
          information and/or testing requirement is:
–         information to refine the risk evaluation for the environment.
The need to obtain this information was re-evaluated in light of the risk reduction strategy and
is no longer required (see section II Strategy for limiting risks).
 ---pagebreak--- 30.4.2004          EN                 Official Journal of the European Union                     L 144/83
The conclusion of the assessment of the risks to the
MICRO-ORGANISMS IN THE SEWAGE TREATMENT PLANT
is that there is at present no need for further information and/or testing or for risk reduction
measures beyond those which are being applied. This conclusion is reached because:
–         the risk assessment shows that risks related to the environmental spheres mentioned
          above are not expected. Risk reduction measures already being applied are
          considered sufficient.
                                STRATEGY FOR LIMITING RISKS
for HUMAN HEALTH and the ENVIRONMENT
It is recommended:
–         to consider at Community level marketing and use restrictions in Council Directive
          76/769/EEC 12 for the use of acrylamide 13 in grouts for small and large-scale
          applications.
–         Further work may be necessary to determine if derogations can be justified
–         The marketing and use restrictions proposed will eliminate the need for more
          information to refine the risk evaluation for the environment
for WORKERS
The legislation for worker protection currently in force at Community level is generally
considered to give an adequate framework to limit the risks of the substance to the extent
needed and shall apply.
Within this framework it is recommended:
–         to establish at community level occupational exposure limit values for acrylamide.
for CONSUMERS
–         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
12
         OJ L 262, 27.9.1976, p. 201.
13
         N-methylolacrylamide-based grouts are also a potential source of free acrylamide in the grouting
         process and consideration should be given to examining the risks from this chemical.
 ---pagebreak--- L 144/84           EN              Official Journal of the European Union             30.4.2004
                                                                                14
          substances), and Council Directive 2001/95/EC (General Product Safety)             as
          regards products are considered sufficient to address the risks identified.
14
         OJ L 11, 15.1.2002, p. 4.
 ---pagebreak--- 30.4.2004          EN                  Official Journal of the European Union                             L 144/85
                                                     ANNEX
                                                  PART THREE
CAS-NO. 107-13-1                                                         Einecs-No.203-466-5
Structural Formula:                CH2 ═ CH − C ≡ N
Einecs Name:                       Acrylonitrile
IUPAC Name:                        2-propenenitrile
Rapporteur:                        Ireland
Classification 15                  F:R11
                                   Carc.Cat.2:R45
                                   T:R23/24/25
                                   Xi:R37/38
                                   R41
                                   R43
                                   N:R51/53
The risk assessment is based on current practices related to the lifecycle of the substance
produced in or imported into the European Community as described in the comprehensive
Risk Assessment Report forwarded to the Commission by the Member State rapporteur 16.
The risk assessment has, based on the available information, determined that in the European
Community the substance is mainly used as a monomer in the production of polymeric
materials, primarily acrylic and modacrylic fibres, acrylonitrile-butadiene-styrene plastics and
styrene-acrylonitrile plastics. Other uses are as a monomer in the synthesis of novel polymeric
materials, production of acrylamide, adiponitrile, fatty amines and fatty alcohols.
The risk assessment has identified other sources of exposure to the substance, relevant for
man and the environment, which do not result from the life cycle of the substance produced in
or imported into the European Community, in particular, the substance is produced during
combustion of fossil fuels. The assessment of the risks arising from these exposures are not
part of this risk assessment. The comprehensive Risk Assessment Report, as forwarded to the
15
        The classification of the substance is established by Commission Directive 2000/32/EC of 19 May 2000
        adapting to technical progress for the 26th time Council Directive 67/548/EEC on the approximation of
        the laws, regulations and administrative provisions relating to the classification, packaging and labelling
        of dangerous substances (OJ L 136, 8.6.2000, p.1).
16
        The comprehensive Risk Assessment Report, as well as a summary thereof, can be found on the internet
        site of the European Chemicals Bureau: http://ecb.jrc.it/existing-substances/.
 ---pagebreak--- L 144/86        EN               Official Journal of the European Union   30.4.2004
Commission by the Member State Rapporteur, does however provide information which
could be used to assess these risks.
 ---pagebreak--- 30.4.2004         EN               Official Journal of the European Union                L 144/87
                                       RISK ASSESSMENT
A. Human health
The conclusions of the evaluation of the risks to
WORKERS
is that there is a need for specific measures to limit the risks. This conclusion is reached
because of:
–         concerns for general systemic effects and carcinogenicity as a consequence of
          exposure arising during the production and processing of the substance.
The conclusions of the evaluation of the risks to
CONSUMERS      and HUMANS EXPOSED VIA THE ENVIRONMENT
are that there is a need for specific measures to limit the risks. This conclusion is reached
because :
–         Risks can not be excluded for all exposure scenarios, as the substance is currently
          regarded as a non-threshold carcinogen. The adequacy of existing controls and the
          feasibility and practicability of further specific measures should be considered.
          However, the risk assessment indicates that risks are already low. This should be
          taken into account when considering the adequacy of existing controls and the
          feasibility and practicability of further specific risk reduction measures.
The conclusion of the assessment of the risks to
HUMAN HEALTH        (physicochemical properties)
is that there is at present no need for further information and/or testing or for risk reduction
measures beyond those which are being applied. This conclusion is reached because:
–         the risk assessment shows that risks are not expected. Risk reduction measures
          already being applied are considered sufficient.
B. Environment
The conclusions of the evaluation of the risks to the environment for
AQUATIC ECOSYSTEM
is that there is a need for specific measure to limit the risks. The conclusion is reached
because of:
–         concerns for effects on the local aquatic sphere as a consequence of exposure arising
          from production of acrylic fibres at a particular site.
 ---pagebreak--- L 144/88          EN               Official Journal of the European Union               30.4.2004
The conclusion of the assessment of the risks to the
ATMOSPHERE      and TERRESTRIAL ECOSYSTEM
is that there is at present no need for further information and/or testing or for risk reduction
measures beyond those which are being applied. This conclusion is reached because:
–         the risk assessment shows that risks related to the environmental spheres mentioned
          above are not expected. Risk reduction measures already being applied are
          considered sufficient.
The conclusion of the assessment of the risks for
MICRO-ORGANISMS IN THE SEWAGE TREATMENT PLANT
is that there is at present no need for further information and/or testing or for risk reduction
measures beyond those which are being applied. This conclusion is reached because:
–         the risk assessment shows that risks related to the environmental sphere mentioned
          above are not expected. Risk reduction measures already being applied are
          considered sufficient
                             STRATEGY FOR LIMITING RISKS
The risk assessment has identified other sources of acrylonitrile emissions (e.g. burning of
fossil fuels). This is outside the scope of Council Regulation (EEC) 793/93 and has not been
considered in the Risk Reduction Strategy.
for WORKERS
The legislation for workers protection currently in force at Community level is generally
considered to give an adequate framework to limit the risks of the substance to the extent
needed and shall apply.
Within this framework it is recommended:
–         to establish at community level occupational exposure limit values for Acrylonitrile
for CONSUMERS and HUMANS EXPOSED VIA THE ENVIRONMENT
–         The existing legislative measures for the protection of consumers and humans
          exposed via the environment, in particular the provisions under the Council Directive
          76/769/EEC (Marketing and Use Directive) as regards CMR substances, Council
          Directive 2001/95/EC (General Product Safety) as regards products, and Council
          Directive 96/61/EC (Integrated Pollution Prevention and Control) are considered
          sufficient to address the risks identified.
for the ENVIRONMENT
–         to facilitate permitting under Council Directive 96/61/EC (Integrated Pollution
          Prevention and Control) this substance should be included in the ongoing work to
 ---pagebreak--- 30.4.2004         EN               Official Journal of the European Union              L 144/89
          develop       guidance        on         ‘Best         Available Techniques’ (BAT).
          It is recommended that Member States should carefully monitor the implementation
          of BAT by permitting and report any important developments to the Commission in
          the framework of the exchange of information on BAT.
–         local emissions to the environment should, where necessary, be controlled by
          national rules to ensure that no risk for the environment is expected.
 ---pagebreak--- L 144/90            EN                  Official Journal of the European Union                            30.4.2004
                                                      ANNEX
                                                   PART FOUR
CAS NO. 79-10-7                                                          Einecs-No.201-177-9
Structural Formula:                  CH2 ═ CH−COOH
Einecs Name:                         Acrylic Acid
IUPAC Name:                          2-propenoic acid
Rapporteur:                          Germany
Classification 17                   C:R35
                                    Xn:R20/21/22
                                    R10
                                    N:R50
The risk assessment is based on current practices related to the life cycle of the substance
produced in or imported into European Community as described in the comprehensive Risk
Assessment Report forwarded to the Commission by the Member State rapporteur 18.
The risk assessment has, based on the available information, determined that in the European
Community the substance is mainly used as an intermediate in the production of poly-
acrylates. Other uses are as an ingredient in adhesives and its occurrence as a residual
monomer in adhesives, paints, binding agents, printing inks, sanitary towels, panty-liners and
nappy pants. Polyacrylates are mainly used as co-builders in phosphate free washing agents,
in flocculating agents and for treatment of drinking and waste water. It was not possible to
obtain information on the use of the total volume of substance produced in or imported into
the European Community, therefore, some uses may exist which are not covered by this risk
assessment.
The risk assessment has identified other sources of exposure to the substance, relevant for
man and the environment, in particular, during the use of acrylate based grouting agents, as a
decomposition product during the production of printed circuit boards and during the removal
of paints using gas flames, which do not result from the life-cycle of the substance produced
17
         The classification of the substance is established by Commission Directive 2000/32/EC of 19 May 2000
         adapting to technical progress for the 26th time Council Directive 67/548/EEC on the approximation of
         the laws, regulations and administrative provisions relating to the classification, packaging and labelling
         of dangerous substances (OJ L 136, 8.6.2000, p.1).
18
         The comprehensive Risk Assessment Report, as well as a summary thereof, can be found on the internet
         site of the European Chemicals Bureau: http://ecb.jrc.it/existing-substances/.
 ---pagebreak--- 30.4.2004        EN               Official Journal of the European Union                 L 144/91
in or imported into the European Community. The assessment of the risks arising from these
exposures are part of this risk assessment.
                                      RISK ASSESSMENT
A. Human health
The conclusion of the assessment of the risks to
WORKERS
is that there is a need for specific measures to limit the risks. This conclusion is reached
because of:
–         concerns for respiratory tract irritation and corrosivity as a consequence of single
          inhalation exposure arising from production and processing, production of adhesives
          containing the substance and use of adhesives containing the substance,
–         concerns for local effects as a consequence of repeated inhalation exposure arising
          from production of adhesives containing the substance and use of adhesives
          containing the substance,
–         concerns for general systemic toxicity as a consequence of repeated inhalation
          exposure arising from production and use of adhesives containing the substance.
The conclusion of the assessment of the risks to
CONSUMERS      and HUMANS EXPOSED VIA THE ENVIRONMENT
is that there is at present no need for further information and/or testing or for risk reduction
measures beyond those which are being applied. This conclusion is reached because:
–         the risk assessment shows that risks are not expected. Risk reduction measures
          already being applied are considered sufficient.
The conclusion of the assessment of the risks to
HUMAN HEALTH       (physicochemical properties)
is that there is at present no need for further information and/or testing or for risk reduction
measures beyond those which are being applied. This conclusion is reached because:
–         the risk assessment shows that risks are not expected. Risk reduction measures
          already being applied are considered sufficient.
B. Environment
The conclusions of the evaluation of the risks to the environment for
AQUATIC ECOSYSTEM
 ---pagebreak--- L 144/92          EN                Official Journal of the European Union               30.4.2004
is that there is a need for specific measures to limit the risks. The conclusion is reached
because of:
–         concerns for effects on the local aquatic ecosystem as a consequence of exposure
          arising from wet polymerisation processes including wet production of super
          absorber polymers and the use of acrylate based grouts.
The conclusion of the assessment of the risks to the
ATMOSPHERE and TERRESTRIAL ECOSYSTEM
is that there is at present no need for further information and/or testing or for risk reduction
measures beyond those which are being applied. This conclusion is reached because:
–         the risk assessment shows that risks are not expected. Risk reduction measures
          already being applied are considered sufficient.
The conclusion of the assessment of the risks to
MICRO-ORGANISMS IN THE SEWAGE TREATMENT PLANT
is that there is a need for further information and/or testing. This conclusion is reached
because
–         there is a need for better information to adequately characterise the risk to municipal
          waste water treatment plants as a consequence of exposure from the use of the
          substance for wet polymerisation including the production of super absorber
          polymers.
          The information and/or test requirements are
–         Further data reflecting integrity of native ciliate populations in sewage.
                                STRATEGY FOR LIMITING RISKS
for WORKERS
The legislation for workers’ protection currently in force at Community level is generally
considered to give an adequate framework to limit the risks of the substance to the extent
needed and shall apply.
Within this framework it is recommended:
–         to establish at community level occupational exposure limit values for acrylic acid.
–         that employers using adhesives containing acrylic acid should take note of the
          practical non-binding guidance, to be developed by the Commission as foreseen
          under Article 12(2) of Council Directive 98/24/EC 19 (Chemical Agents Directive),
19
         OJ L 131, 5.5.1998, p. 11.
 ---pagebreak--- 30.4.2004         EN               Official Journal of the European Union                 L 144/93
          and of any sector specific guidance developed at national level based on this
          guidance.
for ENVIRONMENT
it is recommended that:
–         for Acrylic Acid released from chemical grouts:
–         to establish a harmonised European testing and assessment scheme for chemical
          grouts.
–         to regulate general conditions for use of chemical grouts at EU level, including
          requirements on comprehensive training of planners and field personnel, whereas
          local aspects should be considered by the respective local supervisory authorities.
–         local emissions to the environment should, where necessary, be controlled by
          national rules to ensure that no risk for the environment is expected.
–         for Acrylic Acid used in wet polymerisation processes at downstream user sites
          (processing capacity > 500 t/a) and in SAP production:
–         that the European Commission should consider the inclusion of acrylic acid in the
          priority list of Annex X to Directive 2000/60/EC (Water Framework Directive)
          during the next review of this Annex and should consider measures such as
          harmonised requirements for prior authorisation of discharges and emissions into
          water for the respective plants.
–         to facilitate permitting under Council Directive 96/61/EC (Integrated Pollution
          Prevention and Control) this substance should be included in the ongoing work to
          develop guidance on ‘Best Available Techniques’ (BAT). It is recommended that
          Member States should carefully monitor the implementation of BAT by permitting
          and report any important developments to the Commission in the framework of the
          exchange of information on BAT.
–         local emissions to the environment should, where necessary, be controlled by
          national rules to ensure that no risk for the environment is expected.
 ---pagebreak--- L 144/94            EN                 Official Journal of the European Union                             30.4.2004
                                                     ANNEX
                                                   PART FIVE
CAS-NO. 106-99-0                                                        Einecs-No. 203-450-8
Structural Formula:                 CH2 = CH – CH = CH2
Einecs Name:                        Butadiene
IUPAC Name:                         1,3-Butadiene
Rapporteur:                         UK
Classification 20                   F+:R12
                                    Carc.Cat.1:R45
                                    Muta.Cat.2:R46
The risk assessment is based on current practices related to the life cycle of the substance
produced in or imported into the European Community as described in the comprehensive
Risk Assessment Report forwarded to the Commission by the Member State Rapporteur 21
The risk assessment has, based on the available information, determined that in the European
Community the substance is mainly used as an intermediate in the polymer industry. The
major uses of 1,3-butadiene are in the manufacture of synthetic rubber such as styrene-
butadiene rubber (SBR) and polybutadiene rubber, thermoplastic resins such as acrylonitrile-
butadiene-styrene (ABS), and styrene-butadiene latex. It is also used as a chemical
intermediate in the production of neoprene for automotive and industrial rubber goods, in the
production of methylmethacrylate-butadiene-styrene (MBS) polymer, which is used as a
polyvinyl chloride (PVC) reinforcing agent, and for producing adiponitrile, a nylon precursor.
It was not possible to obtain information on the use of the total volume of substance produced
in or imported into the European Community, therefore, some uses may exist which are not
covered by this risk assessment.
20
         The classification of the substance is established by Commission Directive 2001/59/ECof 6 August,
         adapting to technical progress for the 28th time Council Directive 67/548/EEC on the approximation of
         the laws, regulations and administrative provisions relating to the classification, packaging and labelling
         of dangerous substances (OJ L 225, 21.8.2001, p. 1).
21
         The comprehensive Risk Assessment Report, as well as a summary thereof, can be found on the internet
         site of the European Chemicals Bureau: http://ecb.jrc.it/existing-substances/.
 ---pagebreak--- 30.4.2004         EN                Official Journal of the European Union               L 144/95
                                        RISK ASSESSMENT
A. Human health
The conclusions of the evaluation of the risks to WORKERS
is that there is a need for specific measures to limit the risks. This conclusion is reached
because of:
–         concerns for mutagenicity and carcinogenicity as a consequence of exposure arising
          from production and use as an intermediate in the polymer industry.
The conclusions of the evaluation of the risks to
CONSUMERS and HUMANS EXPOSED VIA THE ENVIRONMENT
is that there is a need to limit the risks. This conclusion is reached because:
–         Risks can not be excluded for all exposure scenarios, as the substance is identified as
          a non-threshold carcinogen. The adequacy of existing controls and the feasibility and
          practicability of further specific measures should be considered. However, the risk
          assessment indicates that risks are already low. This should be taken into account
          when considering the adequacy of existing controls and the feasibility and
          practicability of further specific risk reduction measures.
–         The conclusion of the assessment of the risks to
HUMAN HEALTH        (physicochemical properties)
is that there is at present no need for further information and/or testing or for risk reduction
measures beyond those which are being applied. This conclusion is reached because:
–         the risk assessment shows that risks are not expected. Risk reduction measures
          already being applied are considered sufficient.
B. Environment
The conclusions of the evaluation of the risks to the environment for
ATMOSPHERE, AQUATIC ECOSYSTEM and TERRESTRIAL ECOSYSTEM
is that there is at present no need for further information and/or testing or for risk reduction
measures beyond those which are being applied. This conclusion is reached because:
–         the risk assessment shows that risks related to the environmental spheres mentioned
          above are not expected. Risk reduction measures already being applied are
          considered sufficient.
The conclusions of the evaluation of the risks to the environment for
MICRO-ORGANISMS IN THE SEWAGE TREATMENT PLANT
 ---pagebreak--- L 144/96          EN               Official Journal of the European Union               30.4.2004
is that there is at present no need for further information and/or testing or for risk reduction
measures beyond those which are being applied. This conclusion is reached because:
–         the risk assessment shows that risks are not expected. Risk reduction measures
          already being applied are considered sufficient.
                             STRATEGY FOR LIMITING RISKS
for WORKERS
The legislation for workers’ protection currently in force at Community level is generally
considered to give an adequate framework to limit the risks of the substance to the extent
needed and shall apply.
Within this framework it is recommended:
–         to establish at community level occupational exposure limit values for butadiene .
for CONSUMERS and HUMANS EXPOSED VIA THE ENVIRONMENT
–         the existing legislative measures for the protection of consumers and humans
          exposed via the environment, in particular the provisions under the Council Directive
          76/769/EEC (Marketing and Use Directive) as regards CMR substances, Council
          Directive 2001/95/EC (General Product Safety) as regards products, and Council
          Directive 96/61/EC (Integrated Pollution Prevention and Control) are considered
          sufficient to address the risks identified.
 ---pagebreak--- 30.4.2004          EN                Official Journal of the European Union                        L 144/97
                                                   ANNEX
                                                  PART SIX
CAS-NO. 7664-39-3                                                     Einecs-No.231-634-8
Structural Formula:               HF
Einecs Name:                      Hydrofluoric acid, anhydrous hydrofluoric acid
IUPAC Name:                       Hydrogen fluoride
Rapporteur:                       Netherlands
Classification 22                 T+:R26/27/28
                                  C: R34
The risk assessment is based on current practices related to the life cycle of the substance
produced in or imported into the European Community as described in the comprehensive
Risk Assessment Report forwarded to the Commission by the Member State rapporteur 23.
The risk assessment has, based on the available information, determined that in the European
Community the substance is mainly used as an intermediate in the chemical industry for the
synthesis of organofluoride compounds and inorganic fluorides. Other uses are as a pickling
Other uses are agent for metal surfaces, an etching agent for glass surfaces and surface
cleaning. It was not possible to obtain information on the use of the total volume of substance
produced in or imported into the European Community, therefore, some uses may exist which
are not covered by this risk assessment.
The risk assessment has identified other sources of exposure of the substance to man and the
environment, in particular, releases of hydrogen fluoride from iron/steel and aluminium
industry, glass, ceramic and brick industry, power plants and phosphate chemical producers,
which does not result from the life-cycle of the substance produced in or imported into the
European Community. The assessment of the risks arising from these exposures are not part
of this risk assessment. The risk assessment forwarded to the Commission by the Member
State Rapporteur does however provide information which could be used to assess these risks.
22
        The classification of the substance is established by Commission Directive 2000/32/EC of 19 May
        2000, adapting to technical progress for the 26th time Council Directive 67/548/EEC on the
        approximation of the laws, regulations and administrative provisions relating to the classification,
        packaging and labelling of dangerous substances (OJ L 136, 8.6.2000, p. 1).
23
        The comprehensive Risk Assessment Report, as well as a summary thereof, can be found on the internet
        site of the European Chemicals Bureau: http://ecb.jrc.it/existing-substances/.
 ---pagebreak--- L 144/98         EN              Official Journal of the European Union                   30.4.2004
                                     RISK ASSESSMENT
A. Human health
The conclusions of the evaluation of the risks to WORKERS
is that there is a need for specific measures to limit the risks. This conclusion is reached
because of:
–        concerns for skin, eye and respiratory tract irritation and/or corrosivity, depending on
         the concentration, as a consequence of repeated exposure to gaseous hydrogen
         fluoride at production and use as an intermediate in the chemical industry and use of
         aqueous solutions of the substance,
–        concerns for general systemic toxicity as a consequence of repeated inhalatory
         exposure arising from the use of aqueous solutions of the substance,
–        concerns for skin irritation and/or corrosivity, depending on concentration, as a
         consequence of single exposure to the hydrogen fluoride liquid arising from the use
         of aqueous solutions of the substance,
–        concerns for respiratory tract irritation and/or corrosivity, depending on
         concentration, as a consequence of single exposure to gaseous hydrogen fluoride at
         production and use as an intermediate in the chemical industry and at the use of
         aqueous solutions of the substance.
The conclusion of the evaluation of the risks to
CONSUMERS
is that there is a need for specific measures to limit the risks. This conclusion is reached
because of:
–        concerns for skin irritation and/or corrosivity, depending on concentration, as a
         consequence of single and repeated exposure to the hydrogen fluoride liquid arising
         from the consumer use of preparations containing the substance.
The conclusions of the evaluation of the risks to
HUMANS EXPOSED VIA THE ENVIRONMENT
is that there is a need for specific measures to limit the risks. This conclusion is reached
because of:
–        concerns for general systemic toxicity due to repeated inhalatory exposure in the
         vicinity of production and processing sites of the substance.
The conclusion of the assessment of the risks to
HUMAN HEALTH      (physicochemical properties)
 ---pagebreak--- 30.4.2004         EN              Official Journal of the European Union                 L 144/99
is that there is at present no need for further information and/or testing or for risk reduction
measures beyond those which are being applied. This conclusion is reached because:
–         the risk assessment shows that risks are not expected although concerns for risks
          related to the violent behaviour of the concentrated substance on contact with water
          and the potential formation of hydrogen on reaction of less than 65 % solutions of the
          substance with metals have been raised.
B. Environment
The conclusions of the evaluation of the risks to the environment for
AQUATIC ECOSYSTEM and ATMOSPHERE
is that there is a need for specific measures to limit the risks. This conclusion is reached
because of:
–         concerns for effects on local aquatic and atmospheric environmental spheres as a
          consequence of exposure arising from some production and use sites of the
          substance.
The conclusion of the assessment of the risks to the
TERRESTRIAL ECOSYSTEM
is that there is at present no need for further information and/or testing or for risk reduction
measures beyond those which are being applied. This conclusion is reached because:
–         the risk assessment shows that risks related to the environmental spheres mentioned
          above are not expected. Risk reduction measures already being applied are
          considered sufficient.
The conclusion of the assessment of the risks for
MICRO-ORGANISMS IN THE SEWAGE TREATMENT PLANT
is that there is at present no need for further information and/or testing or for risk reduction
measures beyond those which are being applied. This conclusion is reached because:
–         the risk assessment shows that risks related to the environmental spheres mentioned
          above are not expected. Risk reduction measures already being applied are
          considered sufficient.
                             STRATEGY FOR LIMITING RISKS
for WORKERS
The legislation for workers’ protection currently in force at Community level is generally
considered to give an adequate framework to limit the risks of the substance to the extent
needed.
 ---pagebreak--- L 144/100          EN                Official Journal of the European Union                30.4.2004
Within this framework it is recommended:
–         to consider at the Community level prohibition of the use in building surface
          cleaning (including floors) at work of hydrogen fluoride by including it in Annex III
          of Directive 98/24/EC (Chemical Agents Directive);
–         that the Commission Scientific Committee on Occupational Exposure Limits
          (SCOEL) review the new information contained in the risk assessment report and
          recommend whether there is a need to revise the current occupational exposure limit
          (OEL).
for CONSUMERS
It is recommended:
–         to remove hydrogen fluoride preparations classified as corrosive or toxic from the
          consumer market 24These products do not comply with the general safety
          requirement of the Directive 92/59/EEC on General Product Safety 25and should be
          immediately withdrawn. Member States should carry out an active and effective
          market surveillance of the situation in their territories concerning the presence of
          hydrogen fluoride containing consumer products, to remove these products from the
          market as being unsafe under the general safety obligation provisions of the
          Directive 92/59/EEC (General Product Safety) and to notify the Commission through
          the Rapid Alert System of Directive 92/59/EEC.
24
         Minutes of the meeting of 2 April 2003 of the Emergencies Committee of Directive 92/59/EEC
         (General Product Safety).
25
         OJ L 228, 11.8.1992, p. 24.
 ---pagebreak--- 30.4.2004        EN                Official Journal of the European Union          L 144/101
for the ENVIRONMENT
–         to facilitate permitting under Council Directive 96/61/EC (Integrated Pollution
          Prevention and Control) this substance should be included in the ongoing work to
          develop guidance on ‘Best Available Techniques’ (BAT). It is recommended that
          Member States should carefully monitor the implementation of BAT by permitting
          and report any important developments to the Commission in the framework of the
          exchange of information on BAT.
–         local emissions to the environment should, where necessary, be controlled by
          national rules to ensure that no risk for the environment is expected.
 ---pagebreak--- L 144/102          EN                Official Journal of the European Union                       30.4.2004
                                                   ANNEX
                                                PART SEVEN
CAS-NO. 7722-84-1                                                     Einecs-No. 231-765-0
Structural Formula:               H 2O 2
Einecs Name:                      Hydrogen peroxide
IUPAC Name:                       Hydrogen peroxide
Rapporteur:                       Finland
Classification 26                 O:R8
                                  C:R35
The risk assessment is based on current practices related to the life cycle of the substance
produced in or imported into the European Community as described in the comprehensive
Risk Assessment Report as forwarded to the Commission by the Member State Rapporteur 27.
The risk assessment has, based on the available information, determined that in the European
Community the substance is mainly used as in pulp bleaching and chemicals manufacture.
Other uses are in textile bleaching, disinfection in the foods processing industry, etching in
the electronics industry, metal plating, degrading of proteins, tooth bleaching, professional
hair dyeing and bleaching, treatment of drinking water and waste water, in numerous
consumer products for hair dyeing and bleaching, household textile bleaching products,
cleaning agents, contact lens disinfection, and tooth bleaching products.
26
        The classification of the substance is established by Commission Directive 91/325/EEC of 1 March
        1991, adapting to technical progress for the 12th time Council Directive 67/548/EEC on the
        approximation of the laws, regulations and administrative provisions relating to the classification,
        packaging and labelling of dangerous substances (OJ L180, 8. 7. 1991, p. 1).
27
        The comprehensive Risk Assessment Report, as well as a summary thereof, can be found on the internet
        site of the European Chemicals Bureau: http://ecb.jrc.it/existing-substances/.
 ---pagebreak--- 30.4.2004        EN                Official Journal of the European Union                  L 144/103
                                       RISK ASSESSMENT
A. Human health
The conclusions of the evaluation of the risks to
WORKERS
is that there is a need for specific measures to limit the risks. This conclusion is reached
because of:
–         concerns for skin, eye and respiratory tract irritation and/or corrosivity, depending on
          concentration, as a consequence of exposure arising from loading operations.
–         concerns for skin and eye irritation and/or corrosivity, depending on concentration,
          as a consequence of exposure arising from bleaching of textiles (batch process),
          aseptic packaging (old types of immersion bath machines), peracetic acid use in
          breweries, etching of circuit boards (old process), metal plating, degrading of
          proteins.
–         concerns for eye irritation and/or corrosivity, depending on concentration, as a
          consequence of exposure arising from hairdresser’s work.
–         concerns for repeated inhalation toxicity in loading operations and aseptic packaging
          (all machines types), etching of circuit boards (old process) and waste water
          treatment.
The conclusions of the evaluation of the risks to
CONSUMERS
is that there is a need for specific measures to limit the risks. This conclusion is reached
because of:
–         concerns for eye irritation as a consequence of exposure arising from hair dying and
          bleaching and concerns for eye irritation/corrosivity in use of textile bleaches and
          cleaning agents, if the actual concentration ofhydrogen peroxide is >5 %.
–         concerns for specific adverse effects on tooth pulp and teeth as a consequence of
          exposure arising from tooth bleaching with 35% of hydrogen peroxide by a dentist.
The conclusions of the evaluation of the risks to
HUMANS EXPOSED VIA THE ENVIRONMENT
is that there is at present no need for further information and/or testing or for risk reduction
measures beyond those which are being applied. This conclusion is reached because:
–         the risk assessment shows that risks are not expected. Risk reduction measures
          already being applied are considered sufficient.
 ---pagebreak--- L 144/104         EN               Official Journal of the European Union                 30.4.2004
The conclusion of the assessment of the risks to
HUMAN HEALTH        (physicochemical properties)
is that there is a need for specific measures to limit the risks (applies to the workers and to the
consumers) This conclusion is reached because:
–         concerns for the risk of fire hazard caused by spills of the more concentrated (>25 %)
          hydrogen peroxide solutions on combustible materials.
B. Environment
The conclusions of the evaluation of the risks to the environment for
ATMOSPHERE and TERRESTRIAL ECOSYSTEM
is that there is at present no need for further information and/or testing or for risk reduction
measures beyond those which are being applied. This conclusion is reached because:
–         the risk assessment shows that risks related to the environmental spheres mentioned
          above are not expected. Risk reduction measures already being applied are
          considered sufficient.
The conclusion of the assessment of the risks to the
AQUATIC ECOSYSTEM
is that there is a need for specific measures to limit the risks. This conclusion is reached
because of:
–         concerns for effects on aquatic ecosystem as a consequence of exposure arising from
          four production sites and use in manufacture of other chemicals.
The conclusion of the assessment of the risks for
MICRO-ORGANISMS IN THE SEWAGE TREATMENT PLANT
is that there is at present no need for further information and/or testing or for risk reduction
measures beyond those which are being applied. This conclusion is reached because:
–         the risk assessment shows that risks related to the environmental spheres mentioned
          above are not expected. Risk reduction measures already being applied are
          considered sufficient.
                             STRATEGY FOR LIMITING RISKS
for WORKERS
The legislation for workers’ protection currently in force at Community level is generally
considered to give an adequate framework to limit the risks of the substance to the extent
needed and shall apply.
 ---pagebreak--- 30.4.2004          EN               Official Journal of the European Union             L 144/105
Within this framework it is recommended that:
–         employers review any risk assessments produced according to Directive 98/24/EC
          (Chemical Agents Directive) to take into account the information contained in the
          risk assessment and risk reduction strategy for hydrogen peroxide produced under
          Regulation (EEC) 739/93, and take any necessary measures that are required.
–         employers using hydrogen peroxide for the uses identified as a concern in the risk
          assessment (part I) should take note of the practical non-binding guidance, to be
          developed by the Commission as foreseen under Article 12(2) of Directive 98/24/EC,
          and of any sector specific guidance developed at national level based on this
          guidance.
for CONSUMERS
It is recommended that:
–         in the framework of Commission Directive (EC) 2003/83 28 regarding the maximum
          acceptable percentage of hydrogen peroxide for tooth bleaching products used under
          supervision of a dentist, a concentration limit of up to 6 % hydrogen peroxide should
          be considered, provided appropriate conditions of use and warning are printed on the
          label.
–         textile bleaching agents and cleaning agents which contain ≥ 5 % of hydrogen
          peroxide should be formulated so that the risk of eye irritation/corrosivity is
          diminished (e.g. viscous suspensions, cream). In the instructions, the risk of eye
          irritation/corrosivity should be emphasised and the percentage of H2O2 in the product
          should be indicated. For hair dyes/bleaches the above mentioned recommendations,
          including the percentage limit, should be considered within the framework of
          Community legislation on cosmetic products.
–         the requirement for child-resistant fastenings in the Directive 1999/45/EC
          (Dangerous Preparations Directive) should be extended to all household chemicals,
          which may be accessible to children and contain hydrogen peroxide.
for ENVIRONMENT
It is recommended that:
–         to facilitate permitting under Directive 96/61/EC (Integrated Pollution Prevention
          and Control) this substance should be included in the ongoing work to develop
          guidance on ‘Best Available Techniques’ (BAT). It is recommended that Member
          States should carefully monitor the implementation of BAT by permitting and report
          any important developments to the Commission in the framework of the exchange of
          information on BAT.
28
         OJ L 238 25.9.2003, p. 27.
 ---pagebreak--- L 144/106          EN                 Official Journal of the European Union                      30.4.2004
                                                    ANNEX
                                                 PART EIGHT
CAS-NO.79-41-4                                                          Einecs-No. 201-204-4
Structural Formula:                CH2 = C(CH3) -COOH
Einecs Name:                       Methacrylic acid (MAA)
IUPAC Name:                        2-Propenoic acid, 2-methyl
Rapporteur:                        Germany
Classification 29:                 C: R35
                                   Xn: R21/22
The risk assessment is based on current practices related to the lifecycle of the substance
produced in or imported into the European Community as described in the comprehensive
Risk Assessment Report forwarded to the Commission by the Member State rapporteur 30
The risk assessment has, based on the available information, determined that in the European
Community the substance is mainly used as an internal and external intermediate in the
chemical industry for the production of methacrylic acid esters and as co-monomer in different
kinds of polymers. Other uses are as an ingredient in adhesives and its occurrence as a residual
monomer in paints and products for textile processing. It was not possible to obtain information
on the use of the total volume of substance produced in or imported into the European
Community, therefore, some uses may exist which are not covered by this risk assessment.
The risk assessment has identified other sources of exposure to the substance, relevant for
man and the environment, in particular during the use of methacrylate based grouts, which do
not result from the life-cycle of the substance produced in or imported into the European
Community. The assessment of the risks arising from these exposures are part of this risk
assessment.
29
        The classification of the substance is established by Commission Directive 2001/59/EC of 19 August
        2001 adapting to technical progress for the 28th time Council Directive 67/548/EEC on the
        approximation of the laws, regulations and administrative provisions relating to the classification,
        packaging and labelling of dangerous substances (OJ L 225, 21.8.2001, p. 1).
30
        The comprehensive Risk Assessment Report, as well as a summary thereof, can be found on the internet
        site of the European Chemicals Bureau: http://ecb.jrc.it/existing-substances/.
 ---pagebreak--- 30.4.2004         EN                Official Journal of the European Union                 L 144/107
                                        RISK ASSESSMENT
A. Human health
The conclusion of the assessment of the risks to
WORKERS
is that there is a need for specific measures to limit the risks. This conclusion is reached
because of:
–         concerns for respiratory tract irritation as a consequence of short term inhalation
          exposure arising from the production, further processing as a chemical intermediate
          in the chemical industry, the manufacture of adhesives in the industrial area and the
          industrial and skilled trade use of adhesives,
–         concerns for local respiratory effects as a consequence of repeated inhalation
          exposure arising from manufacture and use of adhesives.
The conclusion of the assessment of the risks to
CONSUMERS      and HUMANS EXPOSED VIA THE ENVIRONMENT
is that there is at present no need for further information and/or testing or for risk reduction
measures beyond those which are being applied. This conclusion is reached because:
–         the risk assessment shows that risks are not expected. Risk reduction measures
          already being applied are considered sufficient.
The conclusion of the assessment of the risks to
HUMAN HEALTH        (physicochemical properties)
is that there is at present no need for further information and/or testing or for risk reduction
measures beyond those which are being applied. This conclusion is reached because:
–         the risk assessment shows that risks are not expected. Risk reduction measures
          already being applied are considered sufficient.
B. Environment
The conclusion of the assessment of the risks to the environment for
AQUATIC ECOSYSTEM
is that there is a need for specific measures to limit the risks. The conclusion is reached because
of:
–         concerns for effects on the aquatic ecosystem as a consequence of exposure arising
          from the use of acrylate based grouting agents.
 ---pagebreak--- L 144/108         EN               Official Journal of the European Union               30.4.2004
The conclusion of the assessment of the risks to the
ATMOSPHERE      and TERRESTRIAL ECOSYSTEM
is that there is at present no need for further information and/or testing or for risk reduction
measures beyond those which are being applied. This conclusion is reached because:
–         the risk assessment shows that risks are not expected. Risk reduction measures
          already being applied are considered sufficient.
The conclusion of the assessment of the risks to
MICRO-ORGANISMS IN THE SEWAGE TREATMENT PLANT
is that there is at present no need for further information and/or testing or for risk reduction
measures beyond those which are being applied. This conclusion is reached because:
–         the risk assessment shows that risks are not expected. Risk reduction measures
          already being applied are considered sufficient.
                             STRATEGY FOR LIMITING RISKS
for WORKERS
The legislation for workers’ protection currently in force at Community level is generally
considered to give an adequate framework to limit the risks of the substance to the extent
needed and shall apply.
Within this framework it is recommended:
–         to establish at community level occupational exposure limit values for Methacrylic
          acid.
–         that employers using adhesives containing methacrylic acid should take note of the
          practical non-binding guidance, to be developed by the Commission as foreseen
          under Article 12(2) of Directive 98/24/EC (Chemical Agents Directive) and of any
          sector specific guidance developed at national level based on this guidance .
for ENVIRONMENT
For methacrylic acid released from chemical grouts it is recommended:
–         to establish a harmonised European testing and assessment scheme for chemical
          grouts.
–         to regulate general conditions for use of chemical grouts at EU level, including
          requirements on comprehensive training of planners and field personnel, whereas
          local aspects should be considered by the respective local supervisory authorities.
–         local emissions to the environment should, where necessary, be controlled by
          national rules to ensure that no risk for the environment is expected.
 ---pagebreak--- 30.4.2004          EN                  Official Journal of the European Union                            L 144/109
                                                     ANNEX
                                                   PART NINE
CAS-NO.80-62-6                                                          Einecs-No.201-297-1
Structural Formula:                CH2 = C(CH3) – COOCH3
Einecs Name:                       Methyl methacrylate (MMA)
IUPAC Name:                        2-methyl-propenoic acid, methyl ester
Rapporteur:                        Germany
Classification 31                  F:R11
                                   Xi:R37/38
                                   R43
The risk assessment is based on current practices related to the lifecycle of the substance as
described in the risk evaluation forwarded to the Commission by the Member State
rapporteur 32.
The risk assessment has, based on the available information, determined that in the European
Community the substance is mainly used as an intermediate in production of polymers,
copolymers, adhesives, reactive resins, in transesterification and in cast sheet production.
Other uses are in the production of emulsion, dispersion and solvent polymers, acrylic sheet
type polymers, as an ingredient in reactive adhesives and embedding resins, floor coatings,
casting resins used for dental and medical applications and the substance occurs as residual
monomer in paints, as well as in other polymers used for consumer products. It was not
possible to obtain information on the use of the total volume of substance produced in or
imported into the European Community, therefore, some uses may exist which are not
covered by this risk assessment.
The risk assessment has identified other sources of exposure to the substance, relevant for
man and the environment, in particular, as a decomposition product during the thermal
processing of polymethyl methacrylate (PMMA), which do not result from the life-cycle of
the substance produced in or imported into the European Community. The assessment of the
risks arising from these exposures are part of this risk assessment.
31
        The classification of the substance is established by Commission Directive 2000/32/EC of 19 May 2000
        adapting to technical progress for the 26th time Council Directive 67/548/EEC on the approximation of
        the laws, regulations and administrative provisions relating to the classification, packaging and labelling
        of dangerous substances (OJ L 136, 8.6.2000, p. 1).
32
        The comprehensive Risk Assessment Report, as well as a summary thereof, can be found on the internet
        site of the European Chemicals Bureau: http://ecb.jrc.it/existing-substances/.
 ---pagebreak--- L 144/110         EN                Official Journal of the European Union                 30.4.2004
                                        RISK ASSESSMENT
A. Human health
The conclusion of the assessment of the risks to
WORKERS
is that there is a need for specific measures to limit the risks. This conclusion is reached
because of:
–         concerns for respiratory tract irritation and corrosivity as a consequence of inhalation
          exposure arising from cast sheet production, production of reactive resins, production
          and use of adhesives, production of paints, skilled trade area: floor coating, use of
          casting resins in medical applications and in orthopaedic workshops, dental
          laboratories and surgeries as well as in ornamental decoration,
–         concerns for skin sensitisation as a consequence of dermal exposure arising from
          production of methyl methacrylate, polymethyl methacrylate, transesterification, cast
          sheet production, production of adhesives and reactive resins in chemical industry,
          production of adhesives, casting resins and floor coating materials, production of
          paints and varnishes, use of adhesives in plastics, electronics and glass industry, use
          of adhesives and floor coating in skilled trade area, use of casting resins in medical
          applications, orthopaedic workshops, dental laboratories and surgeries,
          manufacturing of lenses and ornamental decoration,
–         concerns for local effects as a consequence of repeated inhalation exposure arising
          from cast sheet production, production of reactive resins, production and use of
          adhesives and as well as production of paints, use of casting resins in orthopaedic
          workshops and dental laboratories and surgeries,
–         concerns for general systemic effects as a consequence of inhalation exposure arising
          from cast sheet production, production of adhesives, production of paints, skilled
          trade area: floor coating, use of casting resins in orthopaedic workshops and in
          ornamental decoration.
The conclusion of the assessment of the risks to
CONSUMERS
is that there is at present no need for further information and/or testing or for risk reduction
measures beyond those which are being applied. This conclusion is reached because:
–         the risk assessment shows that risks are not expected. Risk reduction measures
          already being applied are considered sufficient.
The conclusion of the assessment of the risks to
HUMANS EXPOSED VIA THE ENVIRONMENT
 ---pagebreak--- 30.4.2004        EN               Official Journal of the European Union                L 144/111
is that there is at present no need for further information and/or testing or for risk reduction
measures beyond those which are being applied. This conclusion is reached because:
–         the risk assessment shows that risks are not expected. Risk reduction measures
          already being applied are considered sufficient.
The conclusion of the assessment of the risks to
HUMAN HEALTH       (physicochemical properties)
is that there is at present no need for further information and/or testing or for risk reduction
measures beyond those which are being applied. This conclusion is reached because:
–         the risk assessment shows that risks are not expected. Risk reduction measures
          already being applied are considered sufficient.
B. Environment
The conclusion of the assessment of the risks to the
AQUATIC ECOSYSTEM
is that there is a need for specific measures to limit the risks. The conclusion is reached
because of:
–         concerns for effects on the local aquatic ecosystem as a consequence of exposure
          arising from wet polymerisation processes.
The conclusion of the assessment of the risks to the
ATMOSPHERE and TERRESTRIAL ECOSYSTEM
is that there is at present no need for further information and/or testing or for risk reduction
measures beyond those which are being applied. This conclusion is reached because:
–         the risk assessment shows that risks are not expected. Risk reduction measures
          already being applied are considered sufficient.
The conclusion of the assessment of the risks to
MICRO-ORGANISMS IN THE SEWAGE TREATMENT PLANT
is that there is at present no need for further information and/or testing or for risk reduction
measures beyond those which are being applied. This conclusion is reached because:
–         the risk assessment shows that risks are not expected. Risk reduction measures
          already being applied are considered sufficient.
                             STRATEGY FOR LIMITING RISKS
for WORKERS
 ---pagebreak--- L 144/112        EN                Official Journal of the European Union              30.4.2004
The legislation for workers’ protection currently in force at Community level is generally
considered to give an adequate framework to limit the risks of the substance to the extent
needed and shall apply.
Within this framework it is recommended:
–         to establish at community level occupational exposure limit values for methyl
          methacrylate
–         that employers using methyl methacrylate for the uses identified as a concern in the
          risk assessment (part I) should take note of the practical non-binding guidance to be
          developed by the Commission as foreseen under Article 12(2) of 98/24/EC
          (Chemical Agents Directive), and of any sector specific guidance developed at
          national level based on this guidance.
for ENVIRONMENT
for Methyl methacrylate used in wet polymerisation processes at downstream user sites
(processing capacity > 5000 t/a) it is recommended:
–         that the European Commission should consider whether to include methyl
          methacrylate on the priority list of Annex X to Directive 2000/60/EC (Water
          Framework Directive) during the next review of this Annex and should consider
          measures such as harmonised requirements for prior authorisation of discharges and
          emissions into water for the respective plants.
–         to facilitate permitting under Council Directive 96/61/EC (Integrated Pollution
          Prevention and Control) this substance should be included in the ongoing work to
          develop guidance on ‘Best Available Techniques’ (BAT). It is recommended that
          Member States carefully monitor the implementation of BAT by permitting and
          report any important developments to the Commission in the framework of the
          exchange of information on BAT
–         local emissions to the environment should, where necessary, be controlled by
          national rules to ensure that no risk for the environment is expected.
 ---pagebreak--- 30.4.2004          EN                Official Journal of the European Union                       L 144/113
                                                   ANNEX
                                                 PART TEN
CAS-NO. 108-88-3                                                      Einecs-No. 203-625-9
Structural Formula:               C6H5 – CH3
Einecs Name:                      Toluene
IUPAC Name:                       Toluene
Rapporteur:                       Denmark
Classification 33                 F:R11
                                  Xn:R20
The risk assessment is based on current practices related to the lifecycle of the substance
produced in or imported into the European Community as described in the comprehensive
Risk Assessment Report forwarded to the Commission by the Member State rapporteur 34.
The risk assessment has, based on the available information, determined that in the European
Community the substance is mainly used as an intermediate for synthesis of other chemicals, in
solvents, and adhesives, paints, lacquers, varnishes and in the mineral oil, fuel and polymer
industries. Other uses reported are in the pulp, paper and board industry, textile industry,
agricultural industry and electrical and electronic industry.
The risk assessment has identified other sources of exposure of the substance to man and the
environment, in particular the use and combustion of petroleum products, which do not result
from the life-cycle of the substance produced in or imported into the European Community.
The assessment of the risks arising from these exposures is not part of this risk assessment. The
comprehensive Risk Assessment Reports as forwarded to the Commission by the Member State
Rapporteur does however provide information that could be used to assess these risks.
33
        The classification of the substance is established by Commission Directive 91/325/EEC of 1 March
        1991, adapting to technical progress for the 12th time Council Directive 67/548/EEC on the
        approximation of the laws, regulations and administrative provisions relating to the classification,
        packaging and labelling of dangerous substances (OJ L 180, 8. 7. 1991, p. 1).
34
        The comprehensive Risk Assessment Report, as well as a summary thereof, can be found on the internet
        site of the European Chemicals Bureau: http://ecb.jrc.it/existing-substances/.
 ---pagebreak--- L 144/114         EN                Official Journal of the European Union                 30.4.2004
                                        RISK ASSESSMENT
A. Human health
The conclusions of the evaluation of the risks to WORKERS
is that there is a need for specific measures to limit the risks. This conclusion is reached
because of:
–         concerns for acute toxicity as a consequence of dermal exposure arising from
          spraying painting or the use of adhesives,
–         concerns for acute toxicity (headache, dizziness, feeling of intoxication, sleepiness
          and impaired functional performance) as a consequence of inhalation exposure
          arising from production and use as an intermediate, production of products
          containing the substance and use of products containing the substance,
–         concerns for eye irritation as a consequence of exposure arising from production of
          products containing the substance and use of products containing the substance in the
          sectors of manual cleaning, use of adhesives, printing and painting (mechanical
          coating),
–         concerns for general systemic toxicity as a consequence of inhalation exposure
          arising from production of products containing the substance and use of products
          containing the substance in the sectors of manual cleaning, use of adhesives, printing
          and painting (mechanical coating),
–         concerns for general systemic toxicity as a consequence of dermal exposure arising
          from use of products containing the substance in the sectors of manual cleaning, use
          of adhesives and spray painting,
–         concerns for general systemic toxicity as a consequence of the combined dermal and
          inhalatory exposure arising the use of products containing the substance in the
          sectors of manual painting,
–         concerns for specific organ toxicity (auditory system toxicity) as a consequence of
          inhalation exposure arising from production of products containing the substance and
          use of products containing the substance in the sectors of manual cleaning, use of
          adhesives, printing and painting (mechanical coating),
–         concerns for fertility and developmental effects and spontaneous abortions as a
          consequence of inhalation exposure arising from production of products and use of
          toluene containing products in the sectors of manual cleaning, use of adhesives,
          printing and painting (mechanical coating).
The conclusions of the evaluation of the risks to
CONSUMERS
 ---pagebreak--- 30.4.2004         EN              Official Journal of the European Union                L 144/115
1.        is that there is a need for specific measures to limit the risks. This conclusion is
          reached because of:
–         concerns for acute toxicity (headache, dizziness, feeling of intoxication, sleepiness
          and impaired functional performance) and eye irritation as a consequence of
          inhalation exposure or eye exposure to vapours arising from spray painting and
          carpet laying.
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 inhalation exposure.
The information and/or test requirement is:
–         information on the relationship between the observed effects on reproduction and the
          duration of the exposure leading to these effects.
The need to obtain this information was re-evaluated in light of the risk reduction strategy and
is no longer required (see section II Strategy for limiting risks).
The conclusions of the evaluation of the risks to
HUMANS EXPOSED VIA THE ENVIRONMENT
is that there is a need for specific measures to limit the risks. This conclusion is reached
because of:
–         concerns for effects on humans due to the contribution of commercial product
          toluene to the formation of ozone and other harmful substances, i.e., smog formation.
The conclusion of the assessment of the risks to
HUMAN HEALTH       (physicochemical properties)
is that there is at present no need for further information and/or testing or for risk reduction
measures beyond those which are being applied. This conclusion is reached because:
–         the risk assessment shows that risks are not expected. Risk reduction measures
          already being applied are considered sufficient.
B. Environment
The conclusions of the evaluation of the risks to the environment for
AQUATIC ECOSYSTEM
is that there is a need for specific measures to limit the risks. This conclusion is reached
because of:
 ---pagebreak--- L 144/116         EN               Official Journal of the European Union              30.4.2004
–         concerns for the aquatic ecosystem as a consequence of exposure arising from some
          sites of production and combined production and processing of the substance, as well
          as exposure arising from processing and the use sectors of basic chemicals (including
          processing aid, “extraction” agent and solvent), processing and formulation, mineral
          oil and fuel formulation, formulation of polymers, formulation of paints and textile
          processing.
The conclusion of the assessment of the risks to the
TERRESTRIAL ECOSYSTEM
is that there is a need for specific measures to limit the risks. This conclusion is reached
because of:
–         concerns for terrestrial ecosystem as a consequence of exposure arising from
          processing as well as exposure arising from the use sectors of basic chemicals
          (including processing aid, “extraction” agent and solvent), processing and
          formulation, mineral oil and fuel formulation, formulation of polymers, formulation
          of paints and textile processing.
The conclusion of the assessment of the risks for
ATMOSPHERE
is that there is a need for specific measures to limit the risks. This conclusion is reached
because of:
–         concerns for the contribution of the commercial product toluene to the formation of
          ozone and other harmful substances, i.e. smog formation.
The conclusion of the assessment of the risks for
MICRO-ORGANISMS IN THE SEWAGE TREATMENT PLANT
is that there is a need for specific measures to limit the risks. This conclusion is reached
because of:
–         concerns for sewage treatment plants as a consequence of exposure arising from
          processing of the substance as well as in the use sectors of industry use as basic
          chemicals.
                             STRATEGY FOR LIMITING RISKS
The risk assessment has identified other sources of toluene emissions (e.g. gasoline and crude
oil). This is outside the scope of Council Regulation (EEC) 793/93 and has not been
considered in the Risk Reduction Strategy.
for WORKERS
The legislation for workers’ protection currently in force at Community level is generally
considered to give an adequate framework to limit the risks of the substance to the extent
needed and shall apply.
 ---pagebreak--- 30.4.2004         EN                Official Journal of the European Union             L 144/117
Within this framework it is recommended:
–         that the Commission Scientific Committee on Occupational Exposure Limits
          (SCOEL) review the new information contained in the risk assessment report and
          recommend whether there is a need to revise the current OEL.
for CONSUMERS
It is recommended:
–         to consider at Community level marketing and use restrictions in Directive
          76/769/EEC for the substance as such or in preparations for use in adhesives and
          spray paint.
–         The marketing and use restrictions proposed will eliminate the need for more
          information on reproduction as a consequence of inhalation exposure.
for ENVIRONMENT and HUMANS EXPOSED VIA THE ENVIRONMENT
It is recommended:
–         that the European Commission should consider the inclusion of toluene in the
          priority list of Annex X to Directive 2000/60/EC (Water Framework Directive)
          during the next review of this Annex but that, in the meantime, toluene should be
          considered as a relevant List II substance in Council Directive 76/464/EEC 35 on
          pollution caused by certain dangerous substances discharged into the aquatic
          environment of the Community, thus requiring the establishment of national quality
          objectives, monitoring and eventual reduction measures, as to ensure that
          concentrations in surface water systems do not exceed the quality objective.
–         to facilitate permitting under Council Directive 96/61/EC (Integrated Pollution
          Prevention and Control) that this substance is included in the ongoing work to
          develop guidance on ‘Best Available Techniques’ (BAT). It is recommended that
          Member States should carefully monitor the implementation of BAT by permitting
          and report any important developments to the Commission in the framework of the
          exchange of information on BAT.
–         local emissions to the environment should, where necessary, be controlled by
          national rules to ensure that no risk for the environment is expected.
35
         OJ L 129, 18.5.1976, p 23.
 ---pagebreak--- L 144/118         EN                  Official Journal of the European Union                         30.4.2004
The proposal from the Commission to limit the content of solvents in certain products would
further limit the risk from toluene to man via the environment 36
36
        Proposal for a Directive on the limitation of emissions of volatile organic compounds due to the use of
        organic solvents in decorative paints and varnishes and vehicle refinishing products and amending
        Directive 1999/13/EC (COM(2002) 750 final).
 ---pagebreak--- 30.4.2004           EN                 Official Journal of the European Union                             L 144/119
                                                     ANNEX
                                                 PART ELEVEN
CAS-NO. 120-82-1                                                        Einecs-No. 204-428-0
Structural Formula:                 C6H3Cl3
Einecs Name:                        1,2,4-Trichlorobenzene (TCB)
IUPAC Name:                         1,2,4-Trichlorobenzene
Rapporteur:                         Denmark
Classification 37                   Xn:R22
                                    Xi:R38
                                    N:50-53
The risk assessment is based on current practices related to the lifecycle of the substance
produced in or imported into European Community as described in the comprehensive Risk
Assessment Report forwarded to the Commission by the Member State rapporteur 38.
The risk assessment has, based on the available information, determined that in the European
Community the substance is mainly used as an intermediate for synthesis of herbicides and as
a process solvent in closed systems. Other uses reported include as a solvent, dye carrier in
textile industry, additive in dielectric fluids and corrosion inhibitor. It was not possible to obtain
information on the use of the total volume of substance produced in or imported into the
European Community, therefore, some uses may exist which are not covered by this risk
assessment.
The risk assessment has identified other sources of exposure of the substance to man and the
environment, in particular, from certain 1,2,4-trichlorobenzene containing dielectric fluids still
in use in existing electrical equipment and environmental formation of 1,2,4-trichlorobenzene as
a decomposition product of other, more complex organo-chlorine compounds, which do not
result from the life-cycle of the substance produced in or imported into the European
Community. The assessment of the risks arising from these exposures are not part of this risk
assessment.
The comprehensive Risk Assessment Reports as forwarded to the Commission by the Member
State Rapporteur does however provide information that could be used to assess these risks.
37
         The classification of the substance is established by Commission Directive 2001/59/ECof 6 August,
         adapting to technical progress for the 28th time Council Directive 67/548/EEC on the approximation of
         the laws, regulations and administrative provisions relating to the classification, packaging and labelling
         of dangerous substances (OJ L 225, 21. 8.2001, p. 30).
38
         The comprehensive Risk Assessment Report, as well as a summary thereof, can be found on the internet
         site of the European Chemicals Bureau: http://ecb.jrc.it/existing-substances/.
 ---pagebreak--- L 144/120         EN                Official Journal of the European Union                30.4.2004
The risk assessment indicates that it should be further investigated if the substance should be
considered in relation to national or international programmes addressing persistent organic
pollutants.
                                        RISK ASSESSMENT
A. Human health
The conclusions of the evaluation of the risks to
WORKERS
is that there is a need for further information and/or testing. This conclusion is reached
because:
–         concerns for effects as a consequence exposure
The information and/or test requirements are
–         information on occupational exposure during the use of the substance as a dye carrier
          and as a process solvent, during production of products containing the substance in
          the sector of production of dielectric fluids and during the use of products containing
          the substance in the sector of production of wire and cabling.
The need to obtain this information was re-evaluated in light of the risk reduction strategy and
is no longer required (see section II Strategy for limiting risks).
that there is a need for specific measures to limit the risks. This conclusion is reached because
of:
–         concerns for general systemic toxicity as a consequence of repeated inhalation
          exposure arising from drumming activities in the production of the substance, from
          the production of products containing the substance in the sector of pigment
          production and from the use of products containing the substance in the sector of
          spray painting,
–         concerns for eye and respiratory tract irritation as a consequence of repeated
          exposure to the vapour of the substance arising from the production of products
          containing the substance in the sector of pigment production and from the use of
          products containing the substance in the sector of production of plastic pellets,
–         concerns for general systemic toxicity and local dermal effects as a consequence of
          repeated dermal exposure arising from the use of the products containing the
          substance in the sectors of spray painting, dismantling transformers and polishing,
The conclusions of the evaluation of the risks to
CONSUMERS
is that there is a need for specific measures to limit the risks. This conclusion is reached
because of:
 ---pagebreak--- 30.4.2004        EN               Official Journal of the European Union                   L 144/121
–         concerns for eye and respiratory tract irritation as a consequence of repeated
          exposure to vapours and general systemic toxicity as a consequence of repeated
          inhalation and dermal exposure arising from spray painting and car polishing.
The conclusions of the evaluation of the risks to
HUMANS EXPOSED VIA THE ENVIRONMENT
is that there is a need for specific measures to limit the risks. This conclusion is reached
because of:
–         concerns for indirect exposure as calculated exposures can exceed WHO TDIs, and
          WHO guideline values in drinking water for local use scenarios.
The conclusion of the assessment of the risks to
HUMAN HEALTH       (physicochemical properties)
is that there is at present no need for further information and/or testing or for risk reduction
measures beyond those which are being applied. This conclusion is reached because:
–         the risk assessment shows that risks are not expected. Risk reduction measures
          already being applied are considered sufficient.
B. Environment
The conclusions of the evaluation of the risks to the environment for
AQUATIC ECOSYSTEM and TERRESTRIAL ECOSYSTEM is that there is a need for specific
measures to limit the risks. This conclusion is reached because of:
–         concerns for the aquatic ecosystem and terrestrial ecosystem as a consequence of
          exposure arising from the use of the substance as a dye carrier and other uses
          (including as a process solvent, additive in dielectric fluids and a corrosion inhibitor).
The conclusion of the assessment of the risks to the
ATMOSPHERE
is that there is at present no need for further information and/or testing or for risk reduction
measures beyond those which are being applied. This conclusion is reached because:
–         the risk assessment shows that risks are not expected. Risk reduction measures
          already being applied are considered sufficient
The conclusion of the assessment of the risks to
MICRO-ORGANISMS IN THE SEWAGE TREATMENT PLANT
is that there is a need for specific measures to limit the risks. This conclusion is reached
because of:
 ---pagebreak--- L 144/122         EN                 Official Journal of the European Union            30.4.2004
–         concerns for sewage treatment plants as a consequence of exposure arising from use
          as an intermediate, as well as from the use sectors of basic chemicals as a solvent,
          textile industry as dye carrier and other downstream uses.
                               STRATEGY FOR LIMITING RISKS
for WORKERS
The legislation for workers’ protection currently in force at Community level and in particular
the provisions under Commission Directive 2000/39/EC 39 establishing a first list of indicative
exposure limit values are generally considered to give an adequate framework to limit the
risks of the substance to the extent needed and shall apply.
The marketing and use restrictions proposed for the environment will also reduce the risk for
human health (workers) and eliminate the need for more information on the occupational
exposure scenarios.
for CONSUMERS, the ENVIRONMENT and HUMANS EXPOSED VIA THE ENVIRONMENT
It is recommended:
–         to consider marketing and use restrictions at Community level in Council Directive
          76/769/EEC for all uses of TCB except as an intermediate to protect the environment
          and to reduce the indirect exposure via the environment. Where appropriate,
          marketing and use restrictions of articles containing TCB should also be considered.
39
         OJ L 142, 16.6.2000, p. 47.