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					                     EUROPEAN COMMISSION
                     DIRECTORATE GENERAL JRC
                     JOINT RESEARCH CENTRE
                     Institute for Health and Consumer Protection
                     Unit: Toxicology and Chemical Substances -
                     European Chemicals Bureau




                                                                               ECBI/42/01 Rev. 4
                                                                                24 January 2002


                                        SUMMARY RECORD


             Meeting of the Commission Working Group on the
           Classification and Labelling of Dangerous Substances


                            ECB Ispra, 30 May – 1 June 2001

Elisabet Berggren and Eva Reinhard chaired the meeting, except agenda point 2.5
“Criteria for Persistent, Bioaccumulating and Toxic substances”, chaired by Mario
Nichelatti, agenda point 6. “New Chemicals Policy, chaired by Jörg Lebsanft, DG ENV
and agenda point 9.4 “Annex I entries with R67” chaired by Nicholas Burge, DG ENTR. A
copy of the participants’ list is attached.


1     Adoption of the Draft Agenda
      ECBI/02/01 - Rev. 2      Revised draft agenda, CMR WG meeting 30 May – 1 June 2001 / room doc

F mentioned the necessity to discuss the glycol ethers. Some of the substances were
problematic and gained a lot of interest in the media lately. All glycol ethers should be
discussed together, they belonged to the same family. DK requested discussion of
agenda point 9.1 “Revision of Nota M”, in view of the fact a draft Directive had been put
forward by DG ENT. ECB informed that the 29th and the 30th ATP were going to be
worked on in parallel. The 29th ATP would solely include newly inserted or revised Annex I
entries, while the 30th ATP would be a consolidated version of Annex I. Furthermore, a
database was available, including the 28th ATP. It was planned to link it to the home page
at the end of the year. UK asked whether the timeframe of the 29th ATP was in
accordance with the work plan of DG ENV. ECB replied that the work on the white paper
might delay the next ATP. DG ENV was aware of the problem.



2.    Previous Meetings
                                                                                                   2


2.1    Adoption of the draft summary record of the CMR WG meeting JRC Ispra, 9 –
       12 May 2000
       ECBI/51/00 - Rev. 2   Revised draft summary record, CMR WG meeting, 9 – 12 May 2000

Adopted



2.2    Adoption of the draft summary record of the CMR WG meeting JRC Ispra, 15
       – 17 November 2000
       ECBI/76/00 - Rev. 2   Revised draft Summary Record, CMR WG meeting, 15-17 November 2000

ECB apologised that comments from DK and S had not been included in the revised
summary record. It would be updated and sent out again, to be adopted at the next
meeting.
UK felt that resources could be saved in ECB as the minutes were too long and too
detailed. Lists of documents and summaries of previous meetings were not necessary.
FIN requested detailed minutes. They were so far the only “tool” available to obtain
information on the reasoning for a specific classification. NL and D supported FIN. UK
disagreed. The minutes did not allow to understand the reasoning for classification.
Substances for which the classification was clear were not discussed, e.g. there was no
record on which or how many studies the classification was based on. Several Member
States welcomed a short summary of reached conclusions and follow-up actions shortly
after the meeting.



2.3    Summary record of the Specialised Experts meeting, Arona, 6-8 September
       2000
       ECBI/59/00 - Add. 1 Rev. 2 Summary Record - Meeting of Specialised Experts, 6-8 September 2000

Tetrachloroethylene: NL thought that the report gave a non-consistent picture of whether
the Specialised Experts felt that category 2 or 3 was right, based on the animal data
(compare p. 11 and 12). UK expressed a general concern about the Specialised Experts
meeting. The original concept was that specialised experts would reach consensus. The
meetings were not transparent enough and the kind of consensus needed in the CMR
group for making a decision was not reached. Quality signs were missing. The experts
should be chosen very carefully. DK did not agree. The Specialised Experts were very
helpful in giving a scientific advice in relation to classification. NL said that the Specialised
Experts should not be used to decide on a classification, but to discuss and correlate
different scientific data. S did not fully agree with NL. The Specialised Experts should
weigh evidence. In the case of tetrachloroethylene the problem was the criteria and not
the judging of data.

Conclusion:
ECB proposed to postpone the issue to the September meeting. UK might write a
document as basis for further discussions.



2.4    Meeting of Experts in preparation of the Committee for the 28th Adaption to
       Technical Progress of Directive 67/548/EEC, Brussels 25 January 2001
                                                                                                      3




ECB informed that the Newsletter was now available on Internet.



2.5.   Ad-hoc Meeting on the development of criteria for Persistent,
       Bioaccumulating and Toxic Substances (PBT), Ispra 12 December 2000

       ECBI/75/00 Rev. 2

Mario Nichelatti, currently dealing with problems concerning classification and labelling
for environmental end-points at the ECB, informed the group on activities on PBTs. The
Environment group had kept an ad-hoc meeting to discuss classification criteria for PBTs
and vPvBs (very persistent and very bioaccumulating substances). The group had then felt
that it would be quite straightforward to set up such criteria. However activities concerning
the same type of substances with respect to the risk assessment side and the
development of the TGD would be awaited. A general strategy how to handle the PBTs
had been discussed by an ad-hoc group on initiative by DG ENV and chaired by FIN
during the Spring. How to tackle the problem with the PBTs would further be discussed at
the CA meeting in Stockholm, at the end of June. It was however awaited that the C&L
working group soon would continue their part of the work and it would then be necessary
to consult also the CMR group primarily on CMR properties of those substances as well as
their toxicity. The chair said that it could be necessary to arrange another ad-hoc meeting
the following year with both environment and health experts present. However, first the
Environment group would reconsider the new criteria as soon as this would be timely in
relation to the other activities ongoing within other working groups of the Commission.



3.     Classification of substances from the Risk Assessment Group

3.1    Continued discussion

3.1.1 Substances listed in Annex I

Tetrachloroethylene (S206), (602-028-00-4).
Rapporteur: UK.
       ECBI/21/96 - Add. 2   I, Garlanda, proposal to apply R64
       ECBI/21/96 - Add. 3   ECB, Note for the File for discussion of R64: Requirements for application
       ECBI/21/96 - Add. 4   S, Swedish comments on criteria for labelling with R64 -
                             pentabromodiphenyl ether, PBDPE (U044)
       ECBI/21/96 - Add. 5   S, proposal for classification of tri- and tetrachloroethylene with R64
       ECBI/41/98            UK, tetrachloroethylene, summary of health C&L issues
       ECBI/41/98 - Add. 1   FIN, tetrachloroethylene, carcinogenicity
       ECBI/41/98 - Add. 2   Published paper, study of colour vision loss in exposed workers
       ECBI/41/98 - Add. 3   Published paper, study of effects on rat brain proteins
       ECBI/41/98 - Add. 4   FIN, Tetrachloroethylene (S206), two epidemiology studies (Vaughan et al.
                             1997, Walker et al. 1997)
       ECBI/41/98 - Add. 5   D, Tetrachloroethylene, information on German Research Project relating to
                             carcinogenicity
       ECBI/41/98 - Add. 6   S, Tetrachloroethylene, metabolites in urine of exposed humans (study by
                             Birner et a. 1996)
       ECBI/41/98 - Add. 7   UK, tetrachloroethylene (S206), epidemiology study Doyle et al. 1997
       ECBI/41/98 - Add. 8   UK, tetrachloroethylene (S206), ESR substance, update
                                                                                                       4


       ECBI/41/98 - Add. 9    S, tetrachloroethylene (S206), publication Voelkel et al. 1998:
                              Biotransformation of Perchloroethylene in rats and humans
       ECBI/41/98 - Add. 10   S, tetrachloroethylene (S206), two published articles related to
                              carcinogenicity: Voelkel et al. 1998; Paehler et al., 1999
       ECB4/21/99             ECB, WA 4 (ESR), draft summary record of ad-hoc sub-group meeting on
                              carcinogenicity and mutagenicity of tetrachloroethylene, 20-21 October 1998
       ECBI/59/00 – Rev. 2    Conclusions of the Meeting of Specialised Experts, 6-8 September 2000

The substance is on the 2nd ESR Priority List with UK as rapporteur. The current Annex I
classification is Carc. Cat. 3; R40 : N; R51-53. Concentration limit > 1%: Xn; R40
(12./22.ATP).
The Group agreed to maintain the present classification with concern to environment in
September 1997.

In July 1998, the Group indicated that ultimately tetrachloroethylene would be referred to the
Specialised Experts, anticipating difficulties in the discussion of carcinogenicity and reproductive
toxicity classification.
The Group noted that strong concern on the basis of human evidence for developmental toxicity,
by itself not considered sufficient to allocate the substance in Category 1, had led a relative
majority of the Specialised Experts to recommend classification in Category 2.

Conclusion from the November 2000 CMR meeting:
The Group confirmed classification of tetrachloroethylene with Carc. Cat. 3; R40 : Xi; R38 : R67,
agreed not to classify for fertility effects, agreed to postpone the final decision on classification for
effects on development until the details of the Specialised Experts discussions would be
available, and wanted to continue discussions on the justification of R64 at a future meeting, in a
more general context.


UK could not accept the minutes of the specialised experts meeting and suggested not to
classify tetrachloroethylene for reproductive toxicity. F, IRL and NL felt that the
epidemiology was not strong enough to classify tetrachloroethylene for developmental
toxicity Cat.2. Animal experiments could be interpreted as Category 0 – 3. Therefore, the
proposal was Cat.3. S stated that there was conclusive evidence for effects in human.
Clearly, the abortion rate in human was increased, as shown by 2 epidemiological studies.
Thus, because of “other relevant data” Cat.2 was possible. In summary, UK, F, IRL, NL,
B, EL, and I voted for Repr. Cat.3; R63. S, DK, D, ES, A, P, FIN and N voted for Repr.
Cat.2; R61. ECB decided that no agreement could be reached in this group.
Tetrachloroethylene would not be discussed again in the CMR group but had to be looked
at with colleagues in DG ENV. IND was disappointed and concerned that no decision was
being made. The data clearly did not allow a classification stronger than Cat.3. One study
only assumed an exposure. Furthermore, the Group decided not to classify
tetrachloroethylene with R64.

Conclusion:
The Group confirmed classification of tetrachloroethylene with Carc. Cat. 3; R40 : Xi; R38
: R67 and decided not to classify with R64. No consensus could be reached for Repr.
Cat.3; R63 or Repr. Cat.2; R61. Tetrachloroethylene would be discussed with DG ENV
and the resulting proposal put into a future ATP.


Hydrogen peroxide solution...% (M007), (008-003-00-9).
Rapporteur: FIN.
                                                                                                          5


       ECBI/45/99 - Add. 10   FIN, hydrogen peroxide (M007), ESR substance, classification proposal for
                              health effects
       ECBI/45/99 - Add. 12   CEFIC, hydrogen peroxide (M007), comment on classification proposal for
                              health effects
       ECBI/45/99 - Add. 14   N, hydrogen peroxide (M007), Opinion of SCCNFP relating to possible
                              cancer hazards of hydrogen peroxide "Hydrogen (carbamide) peroxide in
                              tooth whitening products" adopted 17.02.99
       ECBI/45/99 - Add. 15   FIN, Hydrogen peroxide (M007), clarification concerning concentration limits
                              for irritation to skin
       ECBI/45/99 - Add. 16   Swedish Natl. Inspectorate of Explosives and Flammables, Hydrogen
                              peroxide (M007), oxidising properties, conc. limit footnote (decrease to 40%)
       ECBI/45/99 - Add. 17   CEFIC, hydrogen peroxide (M007), classification proposal oxidising
                              properties (delete conc. limit) and Annex I entry of solution only required
       ECBI/45/99 - Add. 18   CEFIC/HPO Subgroup, hydrogen peroxide (M007), comment on
                              classification proposal for phys-chem. properties
       ECBI/45/99 - Add. 20   CEFIC, Peroxygens Sector Group, hydrogen peroxide (M007), classification
                              proposal for phys-chem. properties
       ECBI/45/99 - Add. 22   Parts I, II, III and IV
       ECBI/45/99 - Add. 23   FIN, hydrogen peroxide (M007), physico-chemical properties and acute
                              toxicity by inhalation
       ECBI/45/99 - Add. 24   CEFIC, hydrogen peroxide (M007) – consolidated classification proposal by
                              industry
       ECBI/45/99 - Add. 25   CEFIC, Peroxygens, theoretical vapor saturation concentrations
       ECBI/45/99 - Add. 26   CEFIC, hydrogen peroxide, CTL, study detail

Hydrogen peroxide is on the 2nd ESR Priority List with FIN as Rapporteur. The current
Annex I entry (12. ATP) is: hydrogen peroxide solution …%, classified with O; R8 : C; R34.
Note B. Specific concentration limits: C > 20%: C; R34 : 5% < C < 20%: Xi; R36/38.
Footnote: C > 60%: O; R8.
In September 1999 the Environment Group agreed not to classify for dangers to the
environment.

Conclusion from the November 2000 CMR meeting:
The Group confirmed classification of hydrogen peroxide solution ...% with O; R8 : Xn; R22 : C;
R35 and provisionally agreed to classify with T; R23. Specific concentration limits were
[provisionally] agreed as (listed per classification endpoint):
Xn; R22                   C > 10% Xn; R22.
[T; R23]                  C > 35% [T; R23] : 3% < C < 35% [Xn; R20].
C; R35                    C > 50% C; R35 : 35% < C < 50% C; R34 : 10% < C < 35% Xi; R37/38-41
                          : 5% < C < 10% Xi; R41 : 3% < C < 5% Xi; R36.
Footnote                  C > 40% O; R8,
                          with 40% agreed unless new data from Industry necessitate a re-visit.
                          ECB to turn to DG ENV for advice on the legal status of the footnote.


Concentration limits T; R23 vs. Xn; R20:
FIN explained that hydrogen peroxide solutions above 90% were commercially available,
necessitating an adaptation of the classification by applying R5 to cover the hazard of
explosion for solutions over 70%. Acute toxicity studies had been performed using
aerosols and vapours. Aerosols rendered unrealistic scenarios of droplet exposure and
should not be taken as basis for classification and labelling (mouse studies, 70% and 90%
solutions). Deaths were due to secondary effects, caused by the highly concentrated,
corrosive solutions. Several studies were available using vapour, rendering more realistic
scenarios. One of these studies, performed in 1961 with mice, was problematic. It was
based on 90% solution for vapour generation and could be used to argue for classification
with T; R23. However, two rat studies had been performed, using 50% and 90% solutions
                                                                                            6


for vapour generation. There, no death occurred, irritations only, were found in the
respiratory tract. Therefore, FIN proposed Xn; R20 for C > 70% and Xn; R37 for C > 50%.
S did not accept Xn; R20 for C > 70% and wanted to take the mouse study into account.
UK, DK and N supported S. All data, including the aerosol studies should be taken into
consideration. I, D, A, F, IRL, ES, B, and P considered the FIN proposal acceptable, even
thus some concern was expressed that the mouse data should not be ignored completely.
The Group concurred that Xn; R20 and not T; R23 was applied for solutions with C > 70%.

Specific vs. general concentration limits:
UK, , F, IRL and S favoured the use of the standard limits for the application of Xn; R20.
Very corrosive solutions had to follow the general dilution procedure and no strong
arguments were available to change the general limits for hydrogen peroxide solution. FIN
mentioned that in the vapour studies with rats performed with 50% and 90% solutions, only
irritancy of the respiratory tract was seen. IND reinforced that the dose response curve
was safe. It was very clear that deaths were only seen in areas where aerosols of high
concentration, 70% and 90%, had been used. It was possible to draw a limit at 70% in
inhalation experiments.
The Group agreed to use the general concentration limits for Xn; R20.

O; R8
S asked to consider a cut off level of 40%. IND replied that several experts regarded a cut
off level of 50% better than 40%. H2O2 was not an appropriate substance for the test.
Experimental data should go over standard estimations.

Corrosivity / Irritation
FIN proposed to apply R38 instead of R34 for solutions of 35-50%. At the last meeting the
argument for R34 was “delayed necrosis”. However, the effect was limited to the
epidermis, no full thickness necrosis was seen. The scores do not fulfil the criteria for R38.
The FIN proposal for irritancy and corrosivity equals the IND proposal except that 5%
instead of 6% was chosen as the lowest concentration limit. UK was worried, since the
concentration irritating skin and eye was different from the concentration irritating the
respiratory tract. R37 should be applied down to 35%. 35% was the cut off value for skin,
8% the cut off value for serious damage to eyes. IND explained that worker studies had
been performed. No irritation was seen. Neither stable aerosols nor stable vapour could be
generated for concentrations below 50%. NL remarked that the stability of peroxide and
the decomposition of the substance had to be considered. IND informed that hydrogen
peroxide was decomposing and that vapours were predominantly composed of water. D
reminded the group that R34 should not be applied together with R37, unless the
substance evaporated easily.

Footnote
UK doubted whether the footnote was the best thing to do. It might have been better to
have 3 different entries with individual properties for HH. ECB responded that perchloric
acid set the precedence for putting physical chemical properties into footnotes. Footnotes
had the same legal status as the rest of an Annex I entry.
FIN stressed the need to finalise hydrogen peroxide at this meeting.

Conclusion:
The Group agreed to provisionally accept the FIN proposal for classification of hydrogen
peroxide solution …% with: R5 : O; R8 : C; R35 : Xn; R20/22 and the specific
concentration limits:
                                                                                                      7


      C > 70%: C; R20/22-35
50% < C < 70%: C; R20/22-34
35% < C < 50%: Xn; R22-38-41
 8% < C < 35%: Xn; R22-41
 5% < C < 8%: Xi; R36

Footnote:
        C > 70%: R5, O; R8
50% < C < 70%: O; R8;
Note B
IND would send additional studies. Member States decided during the Follow-up action
period whether hydrogen peroxide had to be rediscussed at the next meeting.

Follow-up action:
The Group agreed on the above listed classification. Symbols O; C. R-phrases 5-8-20/22-
35. S-phrases(1/2-)17-26-28-36/37/39-45. The substance would be sent to DG ENV for
possible inclusion in a future TPC.
(S has a potential reservation)


Toluene (S207/U022), (601-021-00-3).
Rapporteur: DK
       ECBI/22/00           DK, toluene, ESR RAR based classification proposal health effects
       ECBI/22/00 – Add. 1  CONCAWE, toluene, comment on the classification proposal from DK
       ECBI/22/00 – Add. 2  ERA, toluene, comment on Danish classification proposal
       ECBI/22/00 – Add. 3  CONCAWE, toluene, comment on the DK proposal to classify with R48/20
       ECBI/22/00 – Add. 4  D, toluene, BK Toxikologie Rationale for Cat. 3; R62, effects on fertility
       ECBI/22/00 – Add. 5  S, comment in support of R48/20
       ECBI/59/00 – Rev. 2  Conclusions of the Specialised Experts on developmental toxicity, meeting in
                            Arona, 06-08 September 2000
       ECBI/22/00 – Add. 6 Concawe/APA comments on proposed classification for Cat.3 Fertility
       ECBI/22/00 – Add. 7 ERA: Classification and labelling of toluene with R62….
       ECBI/22/00 – Add. 8 IND: Classification and labelling of toluene as R48/20
       ECBI/22/00 – Add. 9 DK: Comment on classification with R62
       ECBI/22/00 – Add. 10 D: Rational of classification with Cat.3, fertility impairment
       ECBI/22/00 – Add. 11 (Room doc.) ERA: Reply to ECBI/22/00 Add. 10

The substance is on the 2nd ESR Priority List with DK as rapporteur. Toluene is currently
classified in Annex I with F; R11 : Xn; R20 : No Note : Specific conc. limits: C > 12.5 % :
Xn; R20 (12. ATP). This substance was last discussed in April 1996, July 1997 and
October 1997, with the conclusion to postpone further discussions until the Danish RAR
would be available.
In September 2000 the majority of Specialised Experts recommended that toluene ought
to be classified with Category 3; R63 for effects on development.
In September 2000 the Environment Group reached final agreement not to classify
toluene as dangerous for the environment.

Conclusion from the November 2000 CMR meeting:
The Group agreed to classify toluene with F; R11 : Repr. Cat. 3; R63 : Xn; R48/20-65 : Xi; R38 :
R67, and confirmed deletion of Xn; R20 and the associated specific concentration limit. A decision
related to the D proposal to classify for effects on fertility was postponed. In addition, the detailed
proposal for a specific higher concentration limit concerning classification for developmental
toxicity, announced by CONCAWE, will be tabled at the next meeting.
                                                                                                      8




Fertility
Member States agreed not do support the D proposal for classification with Repr. Cat.3;
R62.

Concentration limits
CONCAWE withdrew the proposal for a specific higher concentration limit for
developmental toxicity. Reviewing the data revealed no justification for the approach.

Conclusion:
The Group agreed to classify toluene with F; R11 : Repr. Cat. 3; R63 : Xn; R48/20-65 : Xi;
R38 : R67 : Notes 4 and 6. Symbols F; Xn. R-phrases 11-38-48/20-63-65-67. S-phrases
(2-)36/37(-62). The substance would be sent to DG ENV for possible inclusion in a future
TPC.


2-Furaldehyde (U027), (605-010-00-4).
Rapporteur: NL.
       ECBI/28/00            NL, 2-furaldehyde (U027), ESR substance, RAR based classification
                             proposal health effects
       ECBI/28/00 – Add. 1   S, Classification of furaldehyde (U027) for mutagenicity

The substance is on the 2nd ESR Priority List with NL as rapporteur. The substance is
currently classified in Annex I (24. ATP) with Carc. Cat. 3; R40 : T; R23/25 : Xn; R21 : Xi;
R36/37; No Note. Specific conc. limits: C > 25% T; R21-23/25-36/37-40 : 20% < C < 25%
T; R23/25-36/37-40 : 5% < C < 20% T; R23/25-40 : 1% < C < 5% Xn; R20/22-40. –
In September 2000 the Environment Group reached agreement not to classify this
substance as dangerous for the environment.

Conclusion from the November 2000 CMR meeting:
The Group agreed to classify 2-furaldehyde with T; R23/25 : Xn; R21 : Xi; R36/37/38. The Group
wanted to continue the discussion of mutagenicity [Muta. Cat. 3; R68], carcinogenicity [Carc. Cat.
3; R40] and specific concentration limits when the result of the transgenic mouse assay is
available.


Transgenic mouse assay
NL informed that the results from the transgenic mouse assay were expected at the end of
the year. UK remarked that the outcome of the study would show whether 2-furaldehyde
was mutagenic. A Carc. Cat.2 classification could be conceived.

Conclusion
The Group confirmed to classify 2-furaldehyde with T; R23/25 : Xn; R21 : Xi; R36/37/38
and wanted to continue the discussion of mutagenicity [Muta. Cat.3; R68], carcinogenicity
[Carc. Cat.2; R45] [Carc. Cat.3; R40] and specific concentration limits when the result of
the transgenic mouse assay was available.


Aniline (A036), (612-008-00-7).
Rapporteur: D.
       ECBI/64/00 – Add. 1   D, aniline (A036), ESR substance, RAR based classification proposal health
                             effects
       ECBI/64/00 – Add. 2   CEFIC, aniline (A036), comment on proposal T; R48/23/24/25
                                                                                                        9




The substance is on the 1st ESR Priority List with D as rapporteur. Aniline is currently
classified in Annex I (21. ATP) with Carc. Cat.3; R40 : T; R48/23/24/25 : Xn; R20/21/22 :
N; R50. No Note. Specific concentration limits C > 1%: T; R20/21/22-40-48/23/24/25 :
0.2% < C < 1%: Xn; R48/20/21/22.
In September 2000 the Environment Group confirmed classification of this substance
with N; R50.

Conclusion from the November 2000 CMR meeting:
The Group agreed to classify aniline with Muta. Cat. 3; R68 : T; R23/24/25 – 48/23/24/25 : Xi; R41
: R43, and to continue the discussion of carcinogenicity [Carc. Cat. 3; R40] at the next meeting.
Mutagenicity would be revisited, pending the results of the mechanistic studies announced by IND.


Mutagenicity / Carcinogeniciy
IND reported that 2 new studies were finished. 1st, a new micronucleus test showed
negative results in rat. 2nd, a 28 days study in rat showing strong haematotoxicity leading
to cell damage in the spleen. A mouse study was still ongoing. There, the intention was to
identify whether micronuclei are formed by genotoxic mechanisms. The results of the
study were needed to understand whether the spleen tumors are a consequence of
genotoxicity or systemic toxicity, e.g. necessitating classification in category 2 or 3. The
results would be available for the September meeting. S mentioned that negative studies
would not overcome positive ones. Enough evidence was available to classify aniline with
Cat.2. UK, D, F, B and IRL felt that the outcome of the announced study might have an
influence on classification and wished to postpone a further discussion to the September
meeting. IND remarked that if a substance was clearly genotoxic and showed positive
results in animals classification could be upgraded. However, if the genotoxic effects and
the tumors did not correspond, an upgrade was not necessarily the result in the past.

Conclusion:
The Group confirmed classification of aniline with T; R23/24/25 – 48/23/24/25 : Xi; R41 :
R43. Mutagenicity [Muta. Cat.3; R68] and carcinogenicity [Carc. Cat.3; R40] would be
discussed and finalised at the September meeting, based on the new study announced by
IND.



3.1.1 Substances not listed in Annex I

Benzyl butyl phthalate; BBP (W044), (EC No 201-622-7, CAS No 85-68-7, Index No
607-…).
Rapporteur: N.
       ECBI/37/99 – Add. 19 Rev. 1 N, benzyl butyl phthalate (W044), ESR substance, health classification
                             proposal, Revision of Enclosure 1
       ECBI/37/99 – Add. 20 CEFIC, benzyl butyl phthalate (W044), comment on classification proposal
                             health effects
       ECBI/37/99 – Add. 26 CEFIC / ECPI, benzyl butyl phthalate (W044), comment on classification
                             proposals for reproduction toxicity, on-going studies
       ECBI/37/99 – Add. 27 ECPI: Interim report on the 2-generation study and comment on the
                             classification of BBP
       ECBI/37/99 – Add. 28 (room doc.) N: Classification proposal for BBP and additional information on
                             reprotoxicity
       ECBI/37/99 – Add. 29 CEFIC / ECPI: Benzyl butyl phthalate (W044), cat. 2 not justified
                                                                                                   10


       ECBI/37/99 – Add. 29-App.1    CEFIC / ECPI: Benzyl butyl phthalate (W044), BBP Metabolism
                             Species Differences

The substance is on the 3rd ESR Priority List with N as rapporteur. The substance is
currently not included in Annex I.

Moreover, evidence from older investigations both with benzyl butyl phthalate and the metabolite
butyl phthalate, the common metabolite of both BBP and DBP - suspected to be responsible for the
same effects - were sufficient to conclude that Repr. Cat. 2; R61 is warranted. S added the
observations of 84% malformed offspring in investigation by Gray et al., after exposure to from
gestation day 14 to postnatal day 3. Industry had no information on the completion of a Japanese
reprotoxicity study, hence it should be deleted as a basis for classification.
Referring to the N criticism of the new study design, D was concerned about the implications if
standard reproduction toxicity studies are not deemed sufficient anymore.

Conclusion from the November 2000 CMR meeting:
The Group provisionally agreed to classify benzyl butyl phthalate with Repr. Cat. 3; R62 : Repr.
Cat. 2; R61, and to finalise the discussions when the result of the new two-generation study is
available.


Development
IND apologised for the late documents and explained that they related to a human
volunteer study, performed at the UK ministry of agriculture. They considered the new
documents to be important for classification. N stressed that the proposal to classify with
Repr. Cat.2; R61 was based on several studies that showed clear effects on development,
including a decrease in testis weight, decreased number of sperm cells, etc. N presented a
room document ECBI/37/99 Add.28 (part I and II) with additional information to the
classification proposal. Recent studies were described that clearly indicated effects on
development of the reproductive organs in male rats i.e., malformed testis development,
decreased anogenital distance and histopathological changes in the testis after exposure
to BBP “in utero”. Furthermore, after exposure to one of the major metabolites of BBP in
rats, MBuP, effects on testis descendent were reported in rats. N also informed that the
pattern of developmental toxicity reported after exposure to the major metabolites of BBP,
MBuP or MBeP may be responsible for the embryonic and/or teratogenic effects of BBP in
rats. IND emphasised that the Japanese study showed clear effects at top dose only. No
effects, neither for liveability nor for development, were seen in male and female rats older
than two generations. An interim report was available. DK and F clarified that the interim
report revealed no new findings that would contradict the provisional agreement from the
last meeting.

Fertility
F put forward that BBP showed similar effects on fertility as DEHP [Bis(2-
ethylhexyl)phthalate] that had been classified with Cat.2; R60. Decisions should be
coherent from one meeting to the other. D explained that the decrease in fertility was
dependent on the way of administration. When given by diet, the effect was solely seen at
very high doses. When given by gavage (bolus) effects were already seen at 500 mg.
Which form should be taken into account for classification? A explained that the
Specialised Experts recommended to take gavage data. N informed that the Japanese
study administered BBP by gavage, while IND used diet. N did not consider the
differences to be that big. UK mentioned that the proposed Cat.3; R62 was also taking the
metabolites into account. UK asked for more toxicokinetic data and more information on
the effects in mice.
                                                                                                       11




NL, B and IRL felt that a consistent data base was available. However, they liked to
rediscuss the substance at the next meeting when they would have studied the new
documents more carefully, especially in respect to metabolites.

Conclusion:
The provisional agreement from the last meeting to classify benzyl butyl phthalate with
Repr. Cat.3; R62 : Repr. Cat.2; R61 was confirmed. Member States decide during the
Follow-up action period whether BBP had to be rediscussed at the next meeting.

Follow-up action:
BBP will be rediscussed at the September meeting, with the aim to be concluded.


Bis(pentabromophenyl) ether (U045/F023), (EC No 214-604-9, CAS No 1163-19-5,
602-…).
Rapporteur: F.
       ECBI/07/99 – Add. 1   F, diphenyl ether, decabromo deriv. (F023/U045), proposal not to classify for
                             carcinogenicity
       ECBI/07/99 – Add. 2   F, diphenyl ether, decabromo deriv. (F023/U045), proposal not to classify for
                             health effects (summary on all endpoints)
       ECBI/07/99 – Add. 2   Rev. 1
       ECBI/07/99 – Add. 5   ECBI/07/99 – Add. 2        F, diphenyl ether, decabromo deriv. (F023/U045),
                             proposal not to classify for health effects (summary on all endpoints)
       ECBI/07/99 – Add. 7   D, Comments on the classification of bis-(pentabromophenyl)ether
       ECBI/07/99 – Add. 8   F, bis-(pentabromophenyl)ether, extract RA report, developmental effects
                             (Follow-up actions)
       ECBI/07/99 – Add. 9   F, bis-(pentabromophenyl)ether, extract RA report II (Follow-up actions)

The substance is on the 1st ESR Priority List with jointly F (health) and UK (environment)
as rapporteurs. The substance is currently not included in Annex I.
Proposal: [no classification for health effects] : [Carc. Cat. 3; R40].

Conclusion from the November 2000 CMR meeting:
The Group agreed to continue the discussion of carcinogenicity when the German rationale would
be available in English, and wanted to wait for the results from the new developmental toxicity
study before taking a final decision.


Background information
S familiarised the group with information about the metabolism of bis(pentabromophenyl)
ether, obtained at an international workshop on flame retardants in Stockholm, in May
2001. Absorption was highly dependent on the vehicle used and could go up to 65%,
compared 0.3% in the NTP study and 6% in the Risk Assessment Report, where corn oil
was used. Bis(pentabromophenyl) ether dissolved poorly in corn oil. The studies had been
performed with corn oil, thus the toxicological effect of a higher absorption was not known.
F informed that the 6% given in the Risk Assessment Report was based on calculation
from the NTP study as well. The vehicle was not the determining factor but the calculation
used, e.g. is the uptake in the introgastroal tract considered.

Cancerogenicity
D informed that the German “Advisory Group for Toxicology on CMR effects” regarded the
occurrence of neoplastic cancer in the rat liver as being sufficient for classification with
Car. Cat.3; R40. The effect might be due to cell toxicity, since a genotoxic effect was
                                                                                                       12


missing. S thought it was a borderline case, but supported D. DK supported D and S. UK,
IRL and NL stressed that substances that produced neoplasms or adenomas in mice liver
had never been classified. More studies would be needed to proof that neoplasms led to
real tumours.
The Group agreed to not classify bis(pentabromophenyl) ether for carcinogenicity.

Development
DK wished to discuss developmental toxicity. F explained that the study was old and the
effects were not related to the dose, rendering the effects not relevant for classification. S
mentioned that in the short summary obtained from F and from IND, effects could be seen
at high doses. Considering the problem with the corn oil mentioned before, there was no
guarantee that exposure was to the molecule and not to crystals. NL agreed with S, more
information was needed. F promised to send a more detailed report.

Endocrine disruption
DK remarked that bis(pentabromophenyl) ether was listed on the EU-strategy list of
Endocrine Disrupter. It should flagged for future work, since the white paper foresees that
endocrine disrupters should be picked up by the different existing EU-legislation on
chemicals.

Conclusion:
Member States look into the paper from F and decide during the follow-up action period
whether Bis(pentabromophenyl) ether had to be rediscussed in September.

Follow-up action:
The Group agreed on “No classification” for Bis(pentabromophenyl) ether, there will be no
Annex I entry.


Diphenyl ether, octabromo derivative (U046/F024), (EC No 251-087-9, CAS No 32536-
52-0, Index No 602-…).
Rapporteur: F.
       ECBI/07/99 - Add. 3   F, diphenyl ether, octabromo deriv. (F024/U046), RAR based classification
                             proposal health effects
       ECBI/07/99 - Add. 4   D, BK Toxikol.: diphenyl ether, octabromo deriv. (F024/U046), classification
                             proposal for developmental toxicity, Repr. Cat. 2; R61
       ECBI/07/99 - Add. 6   CEFIC, octabromodiphenylether (F024/U046), comment from Albermarle on
                             classification

The substance is on the 1st ESR Priority List with, jointly, F (health) and UK (environment)
as rapporteurs. The substance is currently not included in Annex I.
In September 1999 agreement has been reached not to classify this substance for
dangers to the environment.

Conclusion from the November 2000 CMR meeting:
The proposal was: [Repr. Cat. 3; R63] [Repr. Cat. 2; R61] : [R64]. The Group agreed to postpone
the discussion of this substance until results from the new sub-chronic toxicity study would be
available.


Development
F explained that while bis(pentabromophenyl) ether showed no effect on development,
octabromodiphenyl ether was positive in animal experiments, even thus, not consistently.
                                                                                          13


Therefore, classification with Repr. Cat.3; R63 was proposed. D expressed the view of the
German “Advisory Group for Toxicology on CMR effects” that classification with Repr.
Cat.2; R61 was justified due to embryotoxic effects (reduced body weight gain, delayed
ossification, increase in the number of resorptions etc.) even in dose ranges which are not
yet identifiable as being maternally toxic. DK and S supported D. Cat. 2 was justified
because of rat and rabbit studies. At least one study showed lethal effects at 25 mg/kg,
which could not be explained with maternal toxicity. NL, IRL and UK mentioned that it was
a borderline case between Cat.2 and Cat.3. Two rat studies showed diverging results. The
rabbit study was not particularly helpful. Abortion in rabbits was not rare and it was not
considered in former cases. However, when there were effects, they were severe.
Therefore, Repr. Cat.2; R61 could be accepted. NL would have liked to see the inhalation
studies.
The Group agreed to classify diphenyl ether, octabromo derivative with Repr. Cat 2; R61,
as proposed by D.

R64
IND emphasised that R64 should be used according to the criteria. bis(pentabromophenyl)
ether was found in the mother milk at very low doses. It was secreted rapidly, in
unchanged form. In contrary, isomer mixtures such as hepta- and penta-isomers could
cause damage by feeding of the child. F referred to document ECBI/07/99 Add.6. No
penta bromodyphenyl ether was found in commercial mixtures. Absorption from the
gastrointestinal tract was said to be 2%. F thought absorption might be higher. The
product contained brom. F wondered whether brom could be split off. IND explained that
only one study was available dealing with this issue. IND offered to ask the company to
answer the question. S informed about what they had heard at the workshop in
Stockholm. Octabromo derivative contained heptabromo, that could be found in breast
milk. D referred to document ECBI/07/99 Add.4. Brom can be split from the product,
resulting in an increased bromid content in the serum. Apart from that, there was not
sufficient data to justify classification with R64. No toxic effects were seen in breast fed
new-borns. In summary, D, FIN, UK, I, EL, and P voted against R64. S, A, (N) and IRL
voted for a classification with R64. NL, F, DK and B considered it to be a borderline case.
The Group decided not to classify diphenyl ether, octabromo derivative with R64.

Conclusion
The Group provisionally agreed to classify diphenyl ether, octabromo derivative with
Repr. Cat.2; R61. F would send the inhalation studies. Member States decided during the
Follow-up action period whether diphenyl ether, octabromo derivative had to be
rediscussed at the next meeting, concerning development.

Follow-up action:
The Group agreed to classify diphenyl ether, octabromo derivative with Repr. Cat.2; R61.
Symbols T. R-phrase 61. S-phrases 53-45. The substance would be sent to DG ENV for
possible inclusion in a future TPC.
(F has not yet submitted the inhalation studies. S has a potential reservation)



3.2   First discussion

3.2.1 Substances listed in Annex I
                                                                                                        14


But-2-yne-1,4-diol (D017), (EC No 203-788-6, CAS No 110-65-6, Index No 603-076-00-
9).
      ECBI/24/01             D, Classification proposal
      ECBI/24/01 Add. 1      D, Rationale for Classification of but-2-yne-1,4-diol (revision)

But-2-yne-1,4-diol is currently classified in Annex I (26. ATP) with C; R34 : T; R23/25 : Xn;
R21-48/22. Note D. Specific concentration limits C > 50%: T; R21-23/25-34-48/22 : 25% <
C < 50%: T; R21-23/25- 36/38-48/22 : 10% < C < 25%: Xn; R20/22-48/22 : 3% < C < 10%:
Xn; R20/22
Proposal: in addition to Annex I, R43


Sensitisation
D referred to ECBI/24/01 Add. 1 and informed that 10 persons volunteered to be patch
tested, 4 turned out to be positive. In addition, in a recent paper by Blaschke et al. 2001
sensitisation on exposure had been reported. The human data alone would not be
sufficient but in combination with the animal data, enough evidence was present to
warrant R43. Up to 2% of But-2-yne-1,4-diol was found in cleansing agents for consumer
products. Since no problems were reported so far, no specific concentration limits were
proposed. UK inquired whether affected workers really were exposed to the particular
substance only. D answered that there was no doubt. Exposure was accidentally, but for
sure to But-2-yne-1,4-diol. UK added that since the substance was corrosive, patch
testing was not easy to perform, rendering the arguments for R43 weak. However, UK
could agree on precautionary ground.
The Group agreed to classify But-2-yne-1,4-diol with R43.

Specific concentration limits
D preferred to keep the standard limits, but add the 1% limit with R43.

Conclusion
The Group agreed to add R43 to the current Annex I classification of But-2-yne-1,4-diol. It
will be classified with C; R34 : T; R23/25 : Xn; R21-48/22 : R43 : Note D. Specific
concentration limits C > 50%: T; R21-23/25-34-48/22-43 : 25% < C < 50%: T; R21-23/25-
36/38-48/22-43 : 10% < C < 25%: Xn; R20/22-48/22-43 : 3% < C < 10%: Xn; R20/22-43 :
1% < C < 3%: R43. Symbols C; T. R-phrases 21-23/25-34-43-48/22. S-phrases (1/2-25-
)26-36/37/39-45(-46). The substance would be sent to DG ENV for possible inclusion in a
future TPC.


Phenol (U054), (604-001-00-2).
      ECBI/68/00            UK, five substance data sheets plus classification proposals, health effects,
                            incl. phenol (U054, revision)
      ECBI/23/01            D, Classification proposal
      ECBI/23/01 Add 1 / Add 1 – rev. 1       D, Phenol, proposal for conc. limits

Phenol is currently classified in Annex I (12. ATP) with T; R24/25 : C; R34. No Note.
Specific concentration limits C > 5%: T; R24/25-34 : 1% < C < 5%: Xn; R21/22-36/38.
Proposals from UK and D: [Muta. Cat. 3; R68] : [T; R23/24/25] : [Xn; R21/22-
48/20/21/22] : [C; R34].

November 2000 CMR meeting:
                                                                                                         15


Due to time constraints the UK proposal for a revised classification for health effects was not
discussed.


Mutagenicity
UK proposed Muta. Cat.3: R68 based on positive test results. Neither the dose nor the
potency was considered. There was clear concern that phenol had genetic effects. D was
suggesting not to classify for mutageniciy, based on the same database as UK, with only
one study less. A mechanistic study would be favourable. B, DK, EL, ES, F, IRL, N, NL,
AT, P, FIN, S, and UK favoured to classify with Cat.3.
The Group agreed to classify phenol with Muta. Cat.3; R68.

Acute Toxicity
D introduced their proposal. The effect of phenol upon skin contact in humans should be
classified with T. Short term exposure showed strong effects, without a significant impact
of the dose. Phenol was very difficult to remove from skin, leading to fatal consequences.
Classification with T might not be in line with the criteria but was justified by its effect. UK
supported D for precautionary reasons. IND asked to consider that phenol was a solid
substance that became liquid at 65 C . They further asked that it should be noted that this
would be a case where the classification was based on its properties during normal
handling and use, i.e. in the molten state and not on its intrinsic properties in its normal
state as a solid.
The Group agreed to classify phenol with T; R23/24/25.

Repeated dose toxicity
D suggested to classify with R48/20/21. UK advised to add R22, in addition. IND pointed
out an inconsistency in the D paper. In a repeated gavage study, the effects described in
the D paper were not seen. Effects were seen on much higher level. UK explained that
their proposal was based on a different study than the one referred to by IND. NL
preferred to classify solely with R48/20.
The Group agreed to classify phenol with Xn; R48/20/21/22.

The Group agreed to classify phenol with C; R34.

Specific concentration limits
S suggested not to raise the limit to 5 % for precautionary reasons for the consumers. 1%
and 10% led to corrosion, specific concentration limits should be considered. D had not
thought about that but would send in a proposal for the next meeting.

Conclusion
The Group agreed to classify phenol with Muta.Cat.3; R68 : T; R23/24/25 : Xn;
R48/20/21/22 : C; R34 and to discuss specific concentration limits at the September
meeting.


Naphthalene (D047/P396), (EC No. 202-049-5, Index No 601-052-00-2).
Rapporteur: UK.
       ECBI/42/98            UK, classification proposal and discussion document
       ECBI/42/98 – Add. 1   D, naphthalene D047/P396, comment, classification as carc. cat. 3
       ECBI/42/98 – Add. 2   CEFIC, naphthalene, comment on D proposal to classify for carcinogenicity
       ECBI/42/98 – Add. 3   Ruetgers VFT AG, naphthalene, comment on D classification proposal
       ECBI/42/98 – Add. 4   UK, naphthalene, update on health effects and classification proposal
                                                                                                           16


       ECBI/26/01          UK, five substance data sheets plus classification proposals, health effects,
                           incl. phenol (U054, revision)
       ECBI/26/01          UK, Classification proposal for naphtalene
       ECBI/26/01 – Add. 1 Concawe, Comments to ECBI/26/01 - classification of naphtalene

The substance is on the 1st ESR Priority List with UK as rapporteur. The substance is
currently not in Annex I.

Conclusion from the November 1999 CMR meeting:
The Group agreed to classify naphthalene with Xn; R22 : N; R50-53. Symbols Xn; N. R-phrases
22-50/53. S-phrases (2-)36/37-60-61. No Nota, no specific concentration limits. The proposal
would be sent to DG ENV for possible inclusion in a future TPC.


New UK Proposal: Carc. Cat. 3; R40, in addition to agreed classification.

Carcinogenicity
UK informed that the new information obtained after the Risk Assessment would justify
Carc. Cat.3; R40. The evidence would not be sufficient to classify with Cat.2. Possibly, the
substance was also genotoxic. S, B, and NL agreed with UK. F pointed out that two
species show positive results, the tumours were clearly increasing with dose and Cat.2
should be considered.

Conclusion
The Group agreed to classify naphthalene with Carc. Cat.3; R40 : Xn; R22 : N; R50-53.
Symbols Xn; N. R-phrases 22-40-50/53. S-phrases (2-)36/37(-46)-60-61. No Nota, no
specific concentration limits. The proposal would be sent to DG ENV for possible inclusion
in a future TPC.


Diphenylmethyl-2,2’-diisocyanates (Q033), (615-005-00-9).
    ECBI/43/95 - Add. 29          S, classification proposals for Q029, Q033 and Q034
    ECBI/43/95 - Add. 35          BASF, naming and nomenclature of diisocyanates: TDI, MDI and
                                  derivatives (615-005-01-6)
    ECBI/43/95 - Add. 39          ECB, nomenclature of entries 615-005-00-9, 615-005-01-6, 615-006-00-
                                  4
    ECBI/43/95 - Add. 48          ISOPA, comments on the classification of 615-005-00-9 and 615-006-
                                  00-4
    ECBI/43/95 - Add. 62          N, Proposals for specific concentration limits for MDI and TDI.
    ECBI/40/96 - Add. 21          CEFIC, comments on MDI/TDI
    ECBI/40/96 - Add. 22          DE, information on MDI
    ECBI/22/01                    S, Classification proposal
    ECBI/22/01 – Add.1            Comments by the advisory group for toxicology on the hazardous
                                  substances committee

This substance is problematic for S (Accession Treaty). The present entry in Annex I is
classified as: Xn; R20 : Xi; R36/37/38 (both from the 1st ATP) : R42 (3rd ATP) and
concentration limits of 25%, 5% and 1% included in the 12th ATP. The proposal from S
includes three isomers, all of which are included in EINECS. An additional substance, the
mixture of isomers (EC No. 247-714-0) should be added to the entry. At the Environment
meeting in June 1997, it was agreed not to classify this entry for dangers to the
environment. In January 1998, the Group confirmed its agreement to classify the entry
with T; R23: Xi; R36/37/38: R42/43: symbol T: R-phrases: 23-36/37/38-42/43, S-phrases:
(1/2-)26-28-38-45 and NOTA C. Concentration limits
                                                                                                  17


C > 25%                  T; R23-36/37/38-42/43
3% < C < 25%             Xn;R20-36/37/38-42/43
1% < C < 3%              Xn; R42/43
0.1% < C < 1%            Xn; R42 (with NOTA 2).

CEFIC had questioned the classification with T; R23 and preferred the current Xn; R20. Given the
new data provided by CEFIC, NL, IT, B, IRL and DE requested that the issue of acute inhalational
toxicity be discussed again.

Conclusion from the July 1998 CMR meeting:
The Group agreed to classify the entry with Xn; R20 : Xi; R36/37/38: R42/43. Symbol Xn. R-
phrases: 20-36/37/38-42/43. S-phrases: (/2-)23-36/37-45. Nota C.
Concentration limits:
C > 25%                Xn; R20-36/37/38-42/43
3% < C < 25%           Xn; R36/37/38-42/43
1% < C < 3%            Xn; R42/43
0.1% < C < 1%          Xn; R42.                    Nota 2
The proposal would be sent to DG XI for possible inclusion in a future TPC.


B informed that on-going studies were important for the decision and requested to
postpone the discussion to the September meeting.


4,4’-isopropylidenediphenol, Bisphenol A (K007), (604-030-00-0).
        ECBI/36/01            UK, Classification of bisphenol A
        ECBI/36/01 – Add. 3   CEFC, Bisphenol A (CAS 80-05-7), Industry Position on UK Proposal

Bisphenol A is currently classified in Annex I (19. ATP) with Xi; R36/37/38 : R43.
At the Environment meeting in September 2000, it was agreed not to classify this entry for
dangers to the environment.
New Proposal: [Repr. Cat. 2; R60] : [Xi; R37-41] : [R43]


Irritation, Sensitisation
UK introduced the substance and explained that R43 was not really supported by data
and that there was no strong evidence in human. Thus, they hesitated to classify with
R43. NL agreed that there was low evidence but still supported to classify with R43.
The Group agreed to classify bisphenol A with Xi; R37-41 : R43.

The Group considered R48, but decided that it was not justified.

Mutagenicity
UK explained that the tests were not completely negative, there were some bits of positive
evidence.
The Group agreed not to classify bisphenol A for mutagenicity.

Carcinogenicity
UK informed that they preferred not to classify for carcinogenicity, despite the fact that
certain tumour types were seen more frequently.
The Group agreed not to classify bisphenol A for carcinogenicity.

Fertility
                                                                                          18


UK informed that clear signs of defects could be seen in two species. The new Japanese
study talked about testicular effects, indicating that bisphenol A could produce direct
effects on fertility. However, the mechanism was not understood and no studies were
available. Nevertheless, UK proposed Repr. Cat.2; R60. The findings could not be
explained by toxicity only. If toxicity was the reason for the loss of body weight, some
signs of toxicity should have been seen in organs. A discussion of their interpretation of
the criteria would be welcome. NL explained that the effects in the rat could be discussed.
The 2-generation study was not convincing, the 3-generation study showed effects only at
the highest dose, in combination with maternal toxicity. In the mouse there was true
evidence. It was a borderline case between Cat.2 and Cat.3, with NL preferring Cat.2. B
and E agreed that it was a borderline case but preferred Cat.3 on the basis of the criteria.
S, DK, FIN, N, F, and IRL thought that due to the mouse study Cat.2 was warranted. IND
asked to bring a specialist to the next meeting to explain the study.
The Group agreed to provisionally classify bisphenol A with Repr.Cat.2; R60.

Development
S, N, and DK referred to the effects seen with low doses. Even thus the results were
conflicting they would like to discuss development at the next meeting.
The Group agreed to discuss development in September, based on a document
describing new relevant studies, sent by S.

Conclusion
The Group agreed to classify bisphenol A with Xi; R37-41 : R43, to provisionally classify
with Repr. Cat.2; R60 and to discuss fertility and development in the September meeting.
The aim is to conclude bisphenol A in September.


Cadmium oxide (C106), (048-002-00-0).
      ECBI/

Cadmium oxide is currently classified in Annex I (15./19. ATP) with Carc. Cat.2;R49 : T;
R48/23/25 : Xn; R22 : Note E.

Discussion postponed , awaiting studies.


Cadmium sulphide, (048-010-00-4).
      ECBI/25/01           (Parts I and II); N, Carcinogenicity of cadmium sulphide

Cadmium sulphide it not a risk assessment substance. It is currently classified in Annex I
(19. ATP) with Carc. Cat. 3; R 40 : T; R 48/23/25 : Xn; R 22 : Spec. conc. limits: C >= 10%
: T; R 22-40-48/23/25 : 1% <= C < 10% : Xn; R 40-48/20/22 : 0,1% <= C < 1% : Xn; R
48/20/22 : Nota 1. N asked to rediscuss Cadmium sulfphide together with other Cadmium
substances.
New proposal N: [Carc. Cat. 2]

Discussion postponed to discuss together with other Cadmium substances.


Cadmium (EC No. 231-152-8).
Proposal N: [], [].
                                                                                                       19


      ECBI/25/0

Cadmium is currently not in Annex I.

Discussion postponed to discuss together with other Cadmium substances.



4.    Continuation of discussion of the following substances

4.1   Substances not listed in Annex I

4,4'-Bis(dimethylamino)benzophenone; Michler’s ketone (D094), (EC No 202-027-5,
CAS No 90-94-8, Index No 606-...).
Proposal: Carc. Cat. 2; R45 : Muta. Cat. 3; R68 : [Xi; R41].
      ECBI/59/98 - Add. 2   D, C.I. Basic Violet 3 (D083), comments by the German „Advisory Group for
                            Toxicology“ on CMR effects of 4,4’-Bis-(dimethylamino)benzophenon) -
                            impurity
      ECBI/68/00            UK, five substance data sheets plus classification proposals, health effects,
                            incl. Michler's ketone (D094)
      ECBI/59/98 – Add. 2   D, C.I. Basic Violet 3, comments by the German „Advisory Group for
                            Toxicology“ on CMR effects of 4,4’-Bis-(dimethylamino)benzophenon) -
                            impurity

In January 2000 the Group supported the D classification proposal, based on tumours
observed in the rat and mouse liver meriting Carc. Cat. 2; R45, and in vivo genotoxicity in
somatic cells leading to Muta. Cat. 3; R40.

November 2000 CMR meeting:
Due to time constraints the additional data and classification proposal from UK were not
discussed.

Damage to eyes
The Group agreed to classify the substance with Xi; R41.

Conclusion
The Group agreed to classify Michler’s ketone with Carc.Cat.2; R45 : Muta.Cat.3; R68 :
Xi; R41. Symbol, T. R-phrases 45-41-68. S-phrases 53-45. The proposal would be sent to
DG ENV for possible inclusion in a future TPC.


C.I. Basic Violet 3 (D083), (EC No 208-953-6, CAS No 548-62-9, Index No 612-...).
Proposal: [Carc. Cat. 3; R40] [Carc. Cat. 2; R45] : Xn; R22[-48/22] : Xi; R41 : N; R50-
           53.
      ECBI/59/98            D, new classification proposals (D083-D092)
      ECBI/59/98 - Add. 2   D, C.I. Basic Violet 3 (D083), comments by the German „Advisory Group for
                            Toxicology“ on CMR effects of 4,4’-Bis-(dimethylamino)benzophenon) –
                            impurity
      ECBI/59/98 - Add. 8   D, Basic Violet 3 (D083), clarification on impurity Michler's ketone
      ECBI/68/00            UK, five substance data sheets plus classification proposals, health effects,
                            incl. Michler's ketone (D094)

In September 99 C.I. Basic Violet 3 was agreed to classify with N; R50-53 for dangers to
the environment.
                                                                                              20


May 2000 meeting
The Group confirmed that C.I. Basic Violet 3 should be classified with Xn; R22 : X; R41 : N; R50-
53. The discussion of repeated dose oral toxicity and of carcinogenicity was postponed until the
joint UK/D data sheet on Michler’s ketone would be available.


Non CMR endpoints
D felt that R22 was clearly warranted, due to two studies. Also R41 was no problem,
based on the non-reversible effects to eyes. The problem was repeated dose toxicity. The
sensitivity of the pregnant animals might be due to antimicrobial effects. D was not sure
what to propose; clearly, R48 would not solve the problem.
The Group agreed to classify C.I. Basic Violet 3 with Xn; R22, Xi; R41 and not to classify
with Xn; R48/22.

Cancerogenicity
D felt there was no evidence for genotoxicity, the effect was rather systemic. Rats and
mice showed increased tumour rates. However, their occurrence was above the
maximally tolerated dose and occurred only towards the end of the treatment. Some
tumour-rates were within the historical control data. One study was old and the
nomenclature not updated, rendering the tumour-types unidentifiable. Therefore, D had
forwarded a proposal for Cat.3. S preferred Cat. 2. Dose-related tumour-formation was
seen in different organs in two species. In the original paper the effect was described as
significant. Furthermore, clear genotoxic activity was demonstrated in vitro, including a
positive chromosomal aberration test. A agreed that the data justified Cat.2. Furthermore,
it should be considered that the impurity, typically above 0.1 % could be cancerogenic. NL
added that impurities higher than 0.1 % would lead to a classification with Cat.2 after the
criteria. D replied that problems with impurities should be solved over the preparation
directive. Products were on the market with different amounts of impurities. They should
be labelled differently. DK proposed to have no entry for the pure substance but to have
an entry for substances with impurities over 0.1%. UK did not agree. Tumour formation
was due to crystal violet. Historical control values were needed. The dose response was
not clear, the tumours not defined. UK proposed to classify Crystal violet with Cat.3 and
Michler’s ketone with impurities over 0.1% with Cat.2. S replied that the contribution of
Michler’s ketone to tumour-formation might be true in some cases, but not in others. S
would send the original paper for the next meeting. A and B noted that if the reevaluation
did not warrant Cat.2, two entries should be formulated. F favoured Carc. Cat.3. For
mutagenicity F underlined that the validity of the in vivo essays was questionable. NL
preferred to have the experiments repeated using substances without impurities.

Conclusion
The Group decided to postpone further discussion of cancerogenicity to the next meeting
when S had sent in the original data supporting Cat.2, F had sent a written concern for
mutagenicity and the ECB had formulated a proposal for a split entry.



5.     First discussion of new proposals for substances

5.1    Revision of Annex I entries

Tributyl phosphate           (U051), (015-014-00-2).
                                                                                                        21


      ECBI/55/00            UK, five substance data sheets plus classification proposals, health effects,
                            incl. tributyl phosphate (U051, also environm. effects, revision)

Tributyl phosphate is currently classified in Annex I (12. ATP) with Xn; R22. No Note. No
specific concentration limits. – In September 2000 a decision on the UK proposal not to
classify for dangers to the environment was postponed.
New Proposal: [Carc. Cat. 3; R40] : [Xn; R22] : [Xi; R38].


Non CMR endpoints
The Group agreed to classify tributyl phosphate with Xn; R22 : Xi; R38.

Carcinogenicity
UK proposed to classify with Cat.3. Mechanistic studies were available that showed that
the crystals were not the cause of tumours. The effect was not species specific. B thought
it was a borderline case but could accept Cat.3. IND noted that it was not a genotoxic
mechanism and that the osmolarity was high. The mechanism might be rat specific and
not relevant for human.

Conclusion
The Group agreed to classify tributyl phosphate with Carc. Cat.3; R40 : Xn; R22 : Xi; R38.
Symbol Xn. R-phrases 22-38-40. S-phrases (2-)36/37(-46). The proposal would be sent to
DG ENV for possible inclusion in a future TPC when the Environment group had finished
their discussion. The pesticide group would be informed about the decision.


2-nitrotoluene (D095), (609-006-00-3).
      ECBI/65/00            D, 2-nitrotoluene (D095), data sheet and classification proposal health and
                            environmental effects, revision
      ECBI/65/00 – Add. 7   D, 2-nitrotoluene (D095), TR-504; Toxicology and carcinogenesis studies of
                            o-nitrotoluene in F344/N rats and B6C3F1 mice (feed studies), draft
                            technical report reviewed by NTP.

2-Nitrotoluene is currently classified in Annex I (21. ATP) with T; R23/24/25 : R33 : N;
R51-53. No Note. No specific concentration limits.
New Proposal: [Carc. Cat. 2; R45] : [Muta. Cat. 3; R68] : [Repr. Cat. 3; R62] : [Xn;
                R20/22] : [N; R51-53].


Non CMR endpoints
D introduced the substance. The substance had a low potential for methemoglobinemia
based on a cat study. Therefore, the proposal was R 22. Despite the fact that no mortality
was seen at maximal vapour pressure, R20 was proposed in addition. Several studies
were performed to analyse irritation. For skin and eye irritation, the effects were low and
fully reversible. Therefore, no classification was proposed. Also for repeated dose toxicity,
several studies were available. 200 mg administered over 24 weeks did not show signs of
toxicity. Therefore, no classification was proposed. A explained that there was no data
available that justified allocation of R20 and therefore should be omitted. R33 should also
be removed from the original classification.
The Group agreed to classify 2-nitrotoluene with Xn; R22.

Mutagenicity
                                                                                                       22


UK asked why the proposal was not Cat.2. The substance could reach the germ cells. D
answered that the DNA-binding assay was positive, while the in vitro assays were
negative. Direct evidence for germ cell damage was missing. The substance would have
an effect on testis. In summary, classification with Cat.2 was possible. NL noted that the in
vitro activity was not clear. In addition, there was not much evidence for in vivo DNA-
binding. Normally, in vitro data would be followed by in vivo data and then the data on
germ cells would be taken into account. This was a borderline case. NL preferred
classification with Cat. 3. B agreed with NL. UK illustrated that DNA adduct formation was
not the only positive test. The substance was activated in the gut, which might be the
reason for the negative in vitro tests. The criteria stated that if germ cells were reached
and testicles were affected, Cat.2 was warranted. Cat. 2 for mutagenicity should go along
with Cat.2 for cancerogenicity. A Cat.3 for mutagenicity would ask for a Cat.3 for
cancerogenicity. NL added that Cat.2 would only be justified when taking the
precautionary principle into consideration, without further testing. D informed that the NTP
2-year study was finished and the results would be available at the September meeting.

Reprotoxicity
D explained the effect on reproductiv organs in the rat. Systemic effects could not explain
these effects. Therefore, Cat.3 was proposed.
The Group agreed to classify 2-nitrotoluene with Repr. Cat.3; R62.

Conclusion
The Group agreed to classify 2-nitrotoluene with Repr. Cat.3; R62 : Xn R22 and to
discuss mutagenicity and carcinogenictiy at the next meeting, when the NTP-study report
from D was available.


3-chloropropene (A002), (602-029-00-X).
      ECBI/68/00           UK, five substance data sheets plus classification proposals, health effects,
                           incl. 3-chloropropene (A002, revision)

3-Chloropropene is currently classified in Annex I (21. ATP) with F; R11 : T+; R26 : N;
R50. Note D. No specific concentration limits.
New Proposal: [F; R11] : [Carc. Cat. 3; R40] : [Muta. Cat. 3; R68] : [Xn; R20/21/22-
48/20] : [Xi; R36/37/38] : N; R50.

Non CMR endpoints
UK explained the substance. Acute toxicity was straight forward and needed no
discussion.
The Group agreed to classify 3-chloropropene with F; R11 : Xn; R20/21/22-48/20 : Xi;
R36/37/38

Mutagenicity
UK explained the evidence. In vitro results were positive, in vivo results were negative.
Thus, some effect was seen in liver, rendering the negative results in vivo somewhat
questionable. Bone marrow was tested and was negative. However, bone marrow was not
a target and therefore the wrong tissue. There was one positive test for skin that was
unfortunately not a standard test. UK felt that if the right tests were performed they would
be positive. There was not enough evidence to classify with Cat.2. Cat. 3 seemed to be
justified. NL agreed. Better in vivo tests should be performed. It could not be excluded that
the dose tested was too low in the available in vivo tests. Cat.3 was acceptable. B
disagreed. The scientific data was not sufficient for Cat.3. Even thus the alkylating
                                                                                         23


properties were clear, the precautionary approach was not indicated in this case. UK and
IRL reconfirmed that the in vivo data was not negative, rather “not useful”. They agreed
that alkylating substances were not classified so far, when there was no additional data.
But this was not the case here.
The Group agreed to classify 3-chloropropene with Muta. Cat. 3; R68.

Cancerogenicity
UK explained that the mechanism of tumour-formation was not clear. Possibly,
genotoxicity could play a role. The disposition of the substance in human was different
from animals. However, the forestomach tumours indicated that epithelial tissue was a
target. It was a borderline case. Nevertheless, UK thought that if the study was performed
according to the guidelines the forestomach tumours would still be seen. NL doubted that
there was sufficient evidence for Cat.3. The study was of poor quality and the data not
relevant for human. The scientific evidence was borderline but they could go along with
Cat.3. IRL mentioned that for consistency reasons with other substances that produced
similar tumours 3-chloropropene should be classified with Cat.3.
The Group agreed to classify 3-chloropropene with Carc. Cat.3; R40.
B put a reservation forward.

R31 was discussed by the Group, but considered to be unnecessary.

Conclusion
The Group agreed to classify 3-chloropropene with F; R11 : Carc.Cat.3; R40 : Muta.Cat.3;
R68 : Xn; R20/21/22-48/20 : Xi; R36/37/38 : N; R50. Symbols F : Xn : N. R-phrases 11-
20/21/22-36/37/38-40-48/20-50. S-phrases (2-)16-26-36/37(-46)-60-61. The proposal
would be sent to DG ENV for possible inclusion in a future TPC.


1,2-Dimethoxyethane; EGDME (F025), (603-031-00-3).
       ECBI/01/01         F, Classification proposal

1,2-Dimethoxyethane; EGDME is currently classified in Annex I (19. ATP) with R10 : R19
and Xn; R20.
New Proposal: [R11-R19] ; [T; Repro. Cat. 2; R61] : [Xn; Repro. Cat. 3; R62] : [Xn;
R20]

Non-CMR endpoints
No discussion was necessary for most endpoints. UK suggested to classify in addition
with R36. Several of the glycol ethers seemed to be eye irritants. There were no tests
available for that substance showing that there was no concern for eye irritation. The
substance should be compared to the effects seen with DEGEE.
The Group agreed to classify 1,2-dimethoxyethane with F; R11 : R19 : Xn; R20.
During the Follow-up Actions Member States decided not to classify with R36, since
structural relationship is not appropriate for this endpoint.

Fertility
F briefly presents existing epidemiological data on glycol ethers related to reprotoxic
effects, referring to INSERM (Institut National de la Santé et de la Recherche Médicale)
expert evaluation: there is some information from professional exposure, however, it is
quite uneasy to impute the observed effects to glycols ethers exclusively because of co-
exposure to other solvents. However, it seems that there is a link between male infertility
                                                                                          24


and occupational exposure to some glycol ethers. Abnormalities in women both, in fertility
and in the menstruation cycle had been observed after professional exposure in the most
exposed areas to glycol ethers.

In the mouse study, clear effects were seen in testis. Due to these concerns Repr. Cat.3:
R62 had been proposed. S, DK, N and NL thought that the drastic loss in testis weight
warranted classification with Cat.2.
The Group agreed to classify 1,2-dimethoxyethane with Repro. Cat. 2; R60.

Development
F explained that the same metabolite caused developmental problems in several glycol
ethers. Foetal lethality was observed in rat and mice at doses that caused no maternal
toxicity, warranting classification with Cat.2.
The Group agreed to classify 1,2-dimethoxyethane with Repro. Cat. 2; R61.

Conclusion
The Group agreed to classify 1,2-dimethoxyethane; EGDME with F; R11 : R19 : T; Repro
Cat.2, R60 : T; Repro Cat.2, R61 : Xn; R20. Symbols F : T. R-phrases 60-61-11-19-20. S-
phrases 53-45.The proposal would be sent to DG ENV for possible inclusion in a future
TPC, when the Environment group had finished their discussion.



5.2    Substances not listed in Annex I

2-(2-ethoxyethoxy)ethanol: DEGEE (F027), (EC No 203-919-7; CAS No 111-90-0)
       ECBI/01/01          F, Classification proposal

The substance is currently not classified in Annex I.
Proposal: [Xn; Repro. Cat. 3; R62] : [Xi; R36]


Irritation
F explained that the substance caused conjunctival reddening in cats and irritation in
rabbit eyes. Therefore, R36 was proposed. D mentioned a new study that was performed
according to the guidelines and did not show eye irritation. Only old studies that were not
performed according to the guidelines would show irritations. Therefore, R36 was not
warranted.
Based on the new study the Group agreed not to classify for irritation.

Fertility
F introduced the available studies. They were old and might not be useful for
classification. Cat.3 was however proposed. NL, B, and D did not think that classification
was warranted, based on the available studies. S and DK were worried that relevant
studies were missing. It had to be expected that the same metabolites were formed as for
other glycol ethers. IND promised to make some recent studies available.
The Group decided to not classify 2-(2-ethoxyethoxy)ethanol for fertility. Objections to the
decision could be put forward during the Follow-actions.

Conclusion
                                                                                                        25


The Group agreed on “No classification” for 2-(2-ethoxyethoxy)ethanol: DEGEE, there will
be no Annex I entry.



5.3    Annex I entries in 28th ATP: open issues – future procedures
Octamethylcyclotetrasiloxane (Y009), (EC No 209-136-7, CAS No 556-67-2, Index No
014-018-00-1).
Draft Annex I entry, 28.ATP: Repr. Cat. 3; R62 : R53.
Proposal: [Repr. Cat. 2; R60] : R53.
      ECBI/37/98           Centre Europ.d.Silicones, classification proposal for D4 /
                           Octamethylcyclotetrasiloxane, Y009
      ECBI/37/98 - Add. 1  Centre Europ.d.Silicones, classification proposal for D4, Y009, paper form
                           dated 23.6.98
      ECBI/37/98 - Add. 2  Centre Europ.d.Silicones, classification proposal for D4, Y009, CES position
                           statement dated 31.3.98
      ECBI/37/98 - Add. 3  Centre Europ.d.Silicones, classification proposal for D4, Y009, Scientific
                           Position Paper dated 23.6.98
      ECBI/37/98 - Add. 4  S, Y009, Organosiloxanes and Female Reproductive System, Publication
                           J.F. Hayden and S.A. Barlow (1972)
      ECBI/37/98 - Add. 5  ES, IUCLID-export file Octamethylcyclotetrasiloxane (D4) (Y009, CAS No
                           556-67-2)
      ECBI/37/98 - Add. 6  CES, D4 / Cyclotetrasiloxane, Y009, classification for toxicity to reproduction,
                           scientific position papers
      ECBI/37/98 - Add. 7  S, Y009, octamethylcyclotetrasiloxane and reproduction toxicity
      ECBI/37/98 - Add. 8  CES, D4 / octamethylcyclotetrasiloxane, Y009, discussion paper on the
                           classification for toxicity to reproduction
      ECBI/37/98 - Add. 9  CES, D4 (Y009), information on further investigations (fertility effects, mode
                           of action) and time-plan
      ECBI/37/98 – Add. 10 CES, octamethylcyclotetrasiloxane, Y009, comment and study results on
                           mode of action, toxicity to reproduction
      ECBI/33/00 - Rev. 2  ECB, Note for the file, revised second part of planned entries for 28.ATP

Discussions leading up to the proposed inclusion of the substance in Annex I through the
28. ATP:
The classification proposal was sent by CEFIC / Centre Europeen des Silicones.
In September 1998 it was agreed to classify with R53 for environmental concerns.


Hormonal effects
DK stressed that they were not happy to put the substance into the 28. ATP. There was
no evidence that the effects seen in animals would not be relevant for humans. IND was
already classifying voluntarily with Cat.3. DK offered to produce a summary for the
Specialised Experts Group with the help of IND and proposed to schedule a specialised
experts meeting for substances with hormonal effects. UK emphasised that it was not
necessary to have another scientific debate, the decision had been made. All Member
States would classify for reprotoxicity. S and IRL welcomed a discussion by the
Specialised Experts. UK was worried that some Member States would like to change the
criteria for endocrine disrupters. If that was the case the discussion should be held in the
open, e.g. this Group should discuss the changes first. There was a wide variation in how
different Member States interpreted the criteria for the endpoint. NL proposed that a
position paper could be created, analysing the problem and pointing out the
consequences changes would have on classification. D supported the proposal. However,
it should be considered that enlarging the criteria for reprotoxicity for the new effects
meant a long way to go, including discussion with the OECD. S, DK and IRL agreed with
                                                                                                         26


a general discussion of the problem but stressed the need to go forward with the
substance and preferred to send it to the Specialised Experts for the December meeting.
B and UK doubted whether the Specialised Experts would be helpful to solve the problem.

Conclusion
ECB concluded that the decision whether octamethylcyclotetrasiloxane was sent to the
Specialised Expert Group together with other substances would be taken at a later
meeting.

Nonylphenol [1]; 4-nonylphenol, branched [2] (U047 and U048), (EC Nos 246-672-0
[1]; 284-325-5 [2], CAS Nos 25154-52-3 [1]; 84852-15-3 [2], Index No 601-053-00-8).
Rapporteur: UK.
       ECBI/48/99            UK, nonylphenol (U047) and 4-nonylphenol, branched (U048), ESR
                             substances, classification proposal health effects
       ECBI/48/99 – Add. 1   S, comments on reproductive toxicity and repeated dose toxicity of
                             nonylphenol (U047 and U048), classification proposal
       ECBI/33/00 - Rev. 2   ECB, Note for the file, revised second part of planned entries for 28.ATP

Both substances/groups of substances are on the 2nd ESR Priority List with UK as
rapporteur. They are presently not included in Annex I.
Draft Annex I entry, 28.ATP: Xn; R22 : C; R34 : N; R50-53.
Proposal: [Repr. Cat. 3; R63] : Xn; R22 : C; R34 : N; R50-53.

In April 1998 the Environment Group agreed to classify the substances with N; R50-53.

In January 2000 the Group agreed to classify nonylphenol and nonylphenol, branched, with Xn;
R22 : C; R34 : N; R50-53.
In May 2000 S, supported by DK and N, introduced arguments in support of classification of
nonylphenols (U047 and U048) with Repr. Cat. 3; R63 in addition to the agreed classification in
January 2000, which was to go forward to the next TPC. The Group agreed discussion at the next
meeting.


The Group decided to discuss the addition of Repr. Cat.3; R63 to the agreed classification
for nonylphenol [1]; 4-nonylphenol, branched [2] at the September meeting, together with
bisphenol A. Both substances showed similar effects at different dose levels.



5.4  New proposal of revision of Annex I entry
Diaminotoluene, (EC No 246-910-3, CAS No 25376-45-8, Index No 612-151-00-5).
Annex I entry, .ATP:.
       ECBI/21/01            Parts I, II, III, IV,
                                                                                                    27


Diaminotoluene is currently classified in Annex I (. ATP) with Carc. Cat.2; R45 : T ….
N; R51/53D explained the problem with the Annex I entry for diaminotoluene. The entry
evoked the impression that it was valid for all isomers not specifically listed in Annex I. In
reality, it was meant to cover very specific mixtures only that had to be labelled over the
preparation directive. D proposed to delete the entry from Annex I, since there was not
enough data to create specific entries for individual substances. UK asked for a document
before having to make a decision. UK would not like to delete the entry and give the
impression that there was no concern, if there was no data. A explained that the
substance had an EC- number, thus had to be classified.

Conclusion
D agreed to put together the available data for the isomers for the next meeting. A
possibility would be to better specify the entry with footnotes.

Follow-up action
A proposed to put the explanations in square brackets instead of using footnotes. Square
brackets were not considered to belong to the nomenclature (s. 23 ATP).


Comment on an agreed classification to be included in a future ATP:
    Boric acid (K073), (EC Nos. 233-139-2; 234-343-4; Cas Nos. 10043-35-3; 11113-
    50-1, Index No 005-...)
       ECBI/04/99     DK, boric acid (K073) and borax (K074), evaluation of toxicity to reproduction
       ECBI/04/99 – Add. 1 F, boric acid (K073), classification dossier and proposal
       ECBI/04/99 – Add. 2 DK, boric acid (K073), classification dossier and proposal
       ECBI/04/99 – Add. 3 DK, borax (K074), classification dossier and proposal
       ECBI/04/99 – Add. 4 Borax Europe, comment on classification proposals for boric acid (K073) and
                             borax (K074)
       ECBI/04/99 – Add. 5 F, boric acid (K073), classification for the environment
       ECBI/04/99 – Add. 6 CEFIC, comment on classification proposals for boric acid (K073) and borax
                             (K074)
       ECBI/04/99 – Add. 7 CEFIC, boric acid (K073) and borax (K074), announcement of further
                             information plus published article F.J. Murray, 1998 (comparative
                             pharmacokinetics)
       ECBI/04/99 – Add. 8 FIN, published article: Assessment of boric acid and borax using the IEHR
                             evaluative process for reprotoxicity; J.A. Moore and Exp.Sci. Comm. 1997
       ECBI/04/99 – Add. 9 BORAX Europe, borates and effects on fertility, studies on exposed humans:
                             M.D. Whorton, 1994; Sayli et al., 1998; comment on classification proposal
       ECBI/04/99 – Add. 10 BORAX Europe , comments on issues raised by the EU C&L WG
       ECBI/04/99 – Add. 11 BORAX Europe, study M.V. Pahl, April 2000: The Effect of Pregnancy on
                             Renal Clearance of Boron in Humans
       ECBI/04/99 – Add. 12 BORAX Europe, study N.D. Vaziri, and F. Oveisi, April 2000: Evaluation of
                             the Renal Clearance of Boric Acid in Non-pregnant and Pregnant Sprague-
                             Dawley Rats (plus two attachments)
       ECBI/04/99 – Add. 13 CEFIC, boric acid (K073), borates (K074), Case Against Classification of
                             Boric Acid: Comments from Borax Europe Ltd - October, 2000
       ECBI/04/99 – Add. 14 CEFIC, boric acid (K073), borates (K074), Details of a Study Commissioned
                             by Borax Europe
       ECBI/04/99 Add 15

Classification proposals for boric acid, which is not yet included in Annex I, were received from DK
and F.
In September 99 it was agreed not to classify for dangers to the environment.

The Chair remarked that boron compounds on the third (sodium perborate) and fourth (boric acid,
borax) ESR Priority Lists with Austria as evaluating rapporteur meant a revisit by the C&L Group
                                                                                               28


in the near future. The Chair had a strong preference to conclude the boron compounds on the
agenda with Repr. Cat. 3; R62-63 for the timebeing in order to provide for a warning until
announced results were available from new Industry investigations, considered helpful by Member
States for clarification as to open questions of relevance for classification.

Conclusion November 2000 CMR meeting:
The Group agreed that boric acid would be sent to DG ENV for possible inclusion in a future TPC,
with the classification Repr. Cat. 3; R62-63. Symbol Xn. R-phrases 62-63. S-phrases (2-)36/37-46.
No Note. No specific concentration limits.


ECB informed the Group that there was no time to discuss boric acid again. It would be
put in the next ATP, as agreed at the last meeting. DK and S expressed their
dissatisfaction. Both Member States wanted the substance to be discussed by the
Specialised Experts. UK mentioned that care would need to be taken over Annex I entries
to properly cover the correct range of substances. IND announced new studies were
about to be performed. . ECB concluded that the new studies would be taken into account
in the Risk Assessment Report and boric acid and the related substances could be
referred back to the C&L Group if necessary, when the risk assessment would be finalised
in a few years time. It would also then be timely to discuss whether to ask the Specialised
Experts for advice, as the full package of studies would be available. However it was now
of concern to introduce the new entry into Annex I by the next ATP as the substances not
so far were listed into Annex I.
                                                                                                         29


Due to time constraints the following substances on the agenda were not
discussed:

5.1    Revision of Annex I entries

2-aminoethanol (U050), (603-030-00-8)..
       ECBI/55/00            UK, five substance data sheets plus classification proposals, health effects,
                             incl. 2-aminoethanol (U050, revision)

Sulphuryl difluoride (P467), (009-015-00-7).
       ECBI/55/00            UK, five substance data sheets plus classification proposals, health effects,
                             incl. sulfuryl difluoride (P467, revision)

Ethylene (D096), (601-010-00-3).
       ECBI/65/00 - Add. 1   D, ethylene (D096), proposal to revise classification for health effects
       ECBI/65/00 - Add. 6   CEFIC / LOSG, ethylene (D096), comment on Muta. classification proposal
                             and data sheet

2-(propyloxy)ethanol; EGPE (F026), (603-095-00-2).
       ECBI/01/01            F, Classification proposal

1,1-dichloroethylene, (602-025-00-8).
       ECBI/01/01

1-chloro-4-nitrobenzene, (610-005-00-5).
       ECBI/01/01            D, Classification proposal
       ECBI/01/01 – Add.1    Extract from “Occupational Toxicants, Critical data evaluation for MAK
                             values and classification of carcinogens”

Tert-butyl acrylate, (607-245-00-8).
       ECBI/27/01            Ind, Rationale for classification (revision)

Salts of thiocanic acid, (615-004-00-3).
       ECBI/08/96 – Add.17

Fluorosilicates, (009-013-00-6).
       ECBI/08/96 – Add.18



5.2.   Substances not listed in Annex I

2-hexyloxyethanol; ethylene glycol monohexyl ether (U052), (EC No 203-951-1, CAS
No 112-25-4, Index No 603-…).
       ECBI/55/00            UK, five substance data sheets plus classification proposals, health effects,
                             incl. ethylene glycol monohexylether (U052, new entry)

6-methoxy-m-toluidine; p-cresidine (U053), (EC No 204-419-1, CAS No 120-71-8,
Index No 612-…).
       ECBI/55/00            UK, five substance data sheets plus classification proposals, health effects,
                             incl. p-cresidine (U053, new entry)
                                                                                                            30


1,2-benzenedicarboxylic acid, dipentylester, branched and linear [1]; diisopentyl
phthalate [2]; dipentyl phthalate [3] (D097), (EC Nos 284-032-2 [1]; 210-088-4 [2]; 205-
017-9 [3], CAS Nos 84777-06-0 [1]; 605-50-5 [2]; 131-18-0 [3], Index No 607-…).
      ECBI/65/00 - Add. 2    D, 1,2-benzenedicarboxylic acid, dipentylester, branched and linear [1],
                             diisopentyl phthalate [2], dipentyl phthalate [3] (D097), classification proposal
                             health effects (new Annex I entry)

5-nitro-o-toluidine [1]; 5-nitro-o-toluidine hydrochloride [2] (D098), (EC Nos 202-765-
8 [1]; 256-960-8 [2], CAS Nos 99-55-8 [1]; 51085-52-0 [2], Index No 612-…).
      ECBI/65/00 - Add. 3    D, 5-nitro-o-toluidine and -hydrochloride (D098), classification proposal
                             health effects (new Annex I entry)

4-chloro-o-toluidine [1]; 4-chloro-o-toluidine hydrochloride [2] (D099), (EC Nos 202-
441-6 [1]; 221-627-8 [2], CAS Nos 95-69-2 [1]; 3165-93-3 [2], Index No 612-…).
      ECBI/65/00 - Add. 4 Rev.1 D, 4-chloro-o-toluidine and hydrochloride (D099), revised classification
                            proposal health effects (new Annex I entry)

2,4,5-trimethylaniline [1]; 2,4,5-trimethylaniline hydrochloride [2] (D100), (EC Nos
205-282-0 [1]; - [2], CAS Nos 137-17-7 [1]; 21436-97-5 [2], Index No 612-…).
      ECBI/65/00 - Add. 5    D, 2,4,5-trimethylaniline and -hydrochloride (D100), classification proposal
                             health effects (new Annex I entry)

4,4'-thiodianiline (U055), (EC No 205-370-9, CAS No 139-65-1, Index No 612-…).
      ECBI/68/00             UK, five substance data sheets plus classification proposals, health effects,
                             incl. 4,4’-thiodianiline (U055, new)

4,4'-oxydianiline (U056), (EC No 202-977-0, CAS No 101-80-4, Index No 612-…).
      ECBI/68/00             UK, five substance data sheets plus classification proposals, health effects,
                             incl. 4,4’-oxydianiline (U056, new)

4-methoxy-m-phenylenediamine, (EC No 210-406-1)
Proposal: [] : [] :
      ECBI/

2-(2-hexyloxyethoxy)ethanol: DEGHE (F028), (EC No 203-988-3; CAS No 112-59-4)
      ECBI/01/01             F, Classification proposal

2-[2-(2-methoxyethoxy)ethoxy]ethanol: TEGME (F029), (EC No 203-962-1; CAS No
112-35-6)
      ECBI/01/01             F, Classification proposal

1,2-Bis(2-methoxyethoxy)ethane: TEGDME (F030), (EC No 203-977-3; CAS No 112-
49-2)
      ECBI/01/01             F, Classification proposal

2-[2-(2-butoxyethoxy)ethoxy]ethanol: TEGBE (F031), (EC No 205-592-6; CAS No 143-
22-6)
      ECBI/01/01             F, Classification proposal

1-ethoxypropan-2-ol; 2PG1EE (F032), (EC No 216-374-5; CAS No 1569-02-4)
      ECBI/01/01             F, Classification proposal
                                                                                          31


General discussion points that were not discussed due to time constraints and
were postponed to a future meeting, have been removed from the summary record.
(The agenda is attached)


6.    New Chemicals Policy: Implications for the C&L Working Group

J. Lebsanft, DG ENV introduced the topic and pointed out the relevance for the C&L
Working Group. There was no reason for concern that the C&L Working Group was not
needed anymore in the future. It was foreseen in the White paper that only the most
relevant endpoints would be dealt with in the group, the others would be covered by IND.
The group was not limited in the endpoints they wanted to deal with by themselves.
Industry should maintain a list with substances and endpoints they were responsible for.
The details still had to be determined. However, IND so far gave positive signs.
Furthermore, GHS would have an important impact on the future.
It was planned to establish working groups dealing with particular issues, e.g. how to test
and register substances above 100 tones, what kind of risk assessments down stream
users had to do, sanctions, central entity, etc. A working group for PBP had already been
started. The input of the Member States was very important. In a next step the
commission would decide on the proposals. Writing the legislation would be the third and
final step. It was planned to present proposals to the council at the end of this, beginning
of next year. Possibly, ATPs and TPCs had to be slowed down because of the work on
the White Paper.

UK mentioned the importance of the transition period. A group should set out a strategy,
including the focus of the C&L Working Group and GHS. The “central entity”-working
group should take the existing groups into account. J. Lebsanft explained that
reclassification had to be done or, the requirements for GHS could not be fulfilled.
However, this had not first priority. Not a lot had been done so far concerning the central
entity. Probably, this would be dealt with by a standing committee together with the
working groups. DK noted that the C&L Working Group should focus on endpoints of
concern. DK would like to include sensitisation. Furthermore, endocrine disruptors, as well
as environmental and terrestrial concerns should not be forgotten. N. Burge, DG ENTR
cautioned that the list of endpoints of concern should not be too long, otherwise the
present situation would not be changed. UK mentioned that a proper exchange of
information between the groups for C&L, occupational health, environmental waste, etc.
had to be guaranteed. NL asked for a confinement of the role of IND.
Discussion of the New Chemicals Policy will be continued in September.
                                                                                                      32


7.     Continuation of discussion on MMV Fibers
       ECBI/12/97 – Add. 4    IRNS, MMMF transposition of 23th atp in France, suggestion of coordination at
                              European level
       ECBI/12/97 – Add. 5    I, comments/ questions concerning man made fibres
       ECBI/12/97 – Add. 6    UK, MMVF, 23.ATP, comments on urgent problems to be solved
       ECBI/12/97 – Add. 7    ECFIA, background documentation for MMMF discussion
       ECBI/12/97 – Add. 8    EURIMA, statement on classification of Mineral Wool as skin irritant
       ECBI/12/97 – Add. 9    D, MMVF, information related to DE derogation on classif. of MMVF (reasons
                              and SCTEE opinion, 8.10.99)
       ECBI/12/97 – Add. 10   IRL, announcement of proposals for individual inclusion of two new MMVF in
                              Annex I
       ECBI/12/97 – Add. 11   ECFIA, MMVF, labelling as irritant
       ECBI/12/97 – Add. 12   UK, MMVF, letter to ECB (Mr. Riego-Sintes) on in vitro testing, information
                              on method development and regulatory strategies
       ECBI/12/97 – Add. 13   ECFIA, classification proposal announcement, Annex 1 entry for a vitreous
                              silicate fibre (CMS wool)
       ECBI/12/97 – Add. 14   ECFIA, Annex 1 entry for a vitreous silicate fibre (CMS wool)

The Chair informed the Group of details on the state of progress with testing (Note Q), received
from by Mr. Juan Riego-Sintes, ECB, who was not able to attend. Accordingly, ring-testing with
the 90d-inhalation method had to be divided in two parts. The first phase, which dealt with
identification of the relevance of different endpoints and influencing parameters in three different
fibre types, was nearly finalised. First phase-testing had yielded a strong influence on results by
the content of non-fibrous particles, which caused inflammation in the respiratory tract. Particle-
free fibres, glass particles and emosites were yet to be tested in the second part.
Biopersistence testing, laboratory inter-comparison to evaluate variability, had currently come to a
stand-still. Industry was yet to provide suitable fibres.

Referring to their document ECBI/12/97 – Add. 13, ECFIA said they wanted to come up with a
model for an Annex I entry concerning a non-carcinogenic group of fibres, for the testing of which
a number of Note Q-methods had been used. Lifetime testing had been negative. Six major
producers marketed this material with various trade names and would benefit from the entry. UK
HSE had helped to develop the model proposal. The envisaged Annex I entry could replace up to
30% use of refractory fibres under Index No 650-017-00-8, but substitutes are unlikely to be
practical for up to 50% of current applications for RCF.


Application for an Annex I entry
ECFIA shortly explained the basis of the proposed Annex I entry. 30% of the fibres on the
market could be covered by the entry. The fibres were extensively tested and their wish
was to cover the whole family rather than to continue individual testing. Despite the fact
the content of Ca and Mg varied between manufacturers the characteristics of the fibres
was not changed. IRL welcomed the proposal but wished to have more details on the
inhalation study described in ECBI/12/97 – Add. 13. DK and UK noted that the
characterisation and identification of the group of fibres covered by a single Annex I entry
would be essential.

Conclusion
In depth discussion of the proposed Annex I entry was postponed to the next meeting,
when more detailed studies from ECFIA are available.
                                                                                           33


8.      ATPs to Dangerous Preparations Directive (DPD) and Safety Data Sheets
        (SDS) Directive: DG ENTR Report (DPD 1st ATP; SDS ATP)

N. Burge, DG ENTR, reported that 2 ATPs (a 1st ATP of the DPD and a 2nd ATP of the
SDS Directive) would be put to the vote at the July 2 TPC.

SDS
The SDS-Directive had been changed in particular to clarify the section describing the
SDS-requirements for non-classified preparations and to include environmental hazards.
In general, the text had been improved to improve the quality of the SDSs, as studies
have shown that there are too many bad quality SDS The SDS-Directive would have to be
revisited in the context of the White Paper.

DPD
Changes in the DPD included the introduction of criteria for classifying and labelling
preparations containing substances classified with R67, special labelling requirements for
cement, amended references to substances classified with R40 and a link to the new text
on corrosivity on Annex VI. In particular, preparations have to be labelled with R67 if they
contained 15% or more of a substance classified with R67. Labelling was not required if
the preparation was already labelled with R20, or if the package contained less than 125
ml. Due to the different cut-offs for R20 in Annex I and the DPD (25% vs. 15%) some
concern had been raised by the Preparations Group that some preparations containing
organic solvents may not be correctly classified and labelled for R67. This was because
substances in Annex I that met R67 criteria had not been given R67 because R20 had
already been assigned. S mentioned that it was possible to identify substances classified
with R20 and to look at their vapour pressure but it was not possible to verify that the
criteria had been fulfilled. Another possibility was to change Annex VI thus, that R67 had
to be included for preparations. D asked for a list of affected substances. NL noted that it
was a lot of work to reevaluate all substances for the relatively little difference of 10%
(25% vs. 15%). N. Burge replied that 15% remained the Commission’s proposal.

N. Burge also pointed out the problem with R67 in context of preparations. UK said that
there was no problem in fact, as the criteria in Annex VI is set up both, for substances and
preparations. R67 could and should be applied to a preparation also now. There were two
sets of criteria to assign R67, rule based and evidence based. Industry would use the
evidence-based criteria for the vast majority of problematic preparations. Therefore,
according to the UK, there was no hurry to solve the problem. N. Burge noted that there
was a list of substances that S was worried about. He suggested that S should produce
this list and check whether any of the substances on it were not covered by the two sets of
criteria. S promised to send the list to the ECB for circulation prior the next meeting.

DK welcomed the UK interpretation that the criteria from the preparation and substance
directives were complementary. They thought however it would still be difficult to apply
R67 to the preparations that are labelled evidence based because of lack of data.

I did not fully agree with UK. They though it would be difficult to apply evidence based
criteria for producers. N. Burge confirmed that it has been recognised as difficult and
therefore it might be necessary to develop more precise directives.

Conclusion
                                                                                                    34


Based on the list sent by S, the Group will evaluate whether there was concern in
practice.



9.     Classification and Annex I problems

9.1    Revision of Note M, reduction of cut-off level for marker benzo[a]-pyrene
       ECBI/18/99            W.D. Betts, creosote, comment on SCTEE opinion and Fraunhofer/ITA
                             carcinogenicity study
       ECBI/18/99 – Add. 1   W.D. Betts, creosote, updated comment on SCTEE opinion and
                             Fraunhofer/ITA carcinogenicity study
                                  th
       ECBI/18/99 – Add. 2   D, 8 SCTEE: Opinion (revised) on Cancer risk to consumers from Creosote
                             containing less than 50 ppm benzo-[a]-pyrene and/or from wood treated with
                             such Creosote and estimation of respective magnitude
       ECBI/18/99 – Add. 3   D, Evaluation of a dermal carcinogenicity study in mice with two coal-tar
                             products (by Fraunhofer Institut)
       ECBI/18/99 – Add. 4   DK, Evaluation of the Fraunhofer study on dermal carcinogenicity of
                             creosote
       ECBI/18/99 – Add. 5   DK, Note M: proposal for a reduction of the cut-off level for the marker
                             substance benz[a]pyrene
       ECBI/18/99 – Add. 6   D, Note M: proposal for a reduction of the cut-off level for the marker
                             substance benz[a]pyrene
       ECBI/18/99 – Add. 7   Intern. Tar Assoc., creosote, comment on the revised SCTEE opinion and on
                             the DK and D proposals in Adds. 5 and 6

The question was if the limit in Note M should be reduced for the whole group. DK proposal was to
reduce the limit to 0.00005% (0.5 ppm). D had adapted the T25 concept to the results from the
Fraunhofer study, to deduce their proposal for 0.0001%, the details were described in the German
document. Linearity as a base assumption had yielded a TC25 for BaP in the range of 5 ppm. As
the mixture had a higher mutagenic potency an additional factor of five had been applied to arrive
at the proposed 1 ppm.
UK referred to the appropriateness of BaP to be retained as the marker substance. While it had
been judged the most known and potent carcinogen at times of the 21. ATP, more potent PaH
carcinogens in creosote had become known in the meantime.
S felt that the Fraunhofer study had been satisfactorily performed, also according to the SCTEE,
and the conclusions were clear: Creosote has a five times higher carcinogenic potency than BaP,
and BaP is an appropriate indicator for carcinogenicity in creosote. The SCTEE conclusion was
that 50 ppm is too high and the linear dose relationship for carcinogenicity due to the genotoxic
potential was clearly supportive of lowering the limit to the range proposed by DK and D.

The Group agreed that BaP should be retained as the marker substance for pragmatic reasons,
and the concentration cut-off in Note M should be reduced. As a starting point for national
consultations, the Chair proposed to set the reduced cut-off in Note M to 1 ppm.

UK expressed their view that the existing limit is problematic. The current limits could not
be defended by science, but better limits could not be proposed on scientific data. D
referred to discussions held by the SCTEE and the MAK commission. In summary, BaP
was obsolete for creosote. PaHs should be better characterised. DK reminded the group
that BaP was a potent and often detected marker in tar and was therefore picked as
marker. It was difficult to find better ones. DK welcomed to look also at other markers.
However, this would not change the fact that the limit for BaP was set too high at the
moment. S agreed. The Fraunhofer study should be taken as basis for the decision. D did
not want to rediscuss the inclusion of other markers as proposed by IND in the discussion.
IND rejected that before. Fact was, that the limit for BaP was to high at the moment and
had to be lowered. UK proposed to take in addition to the Fraunhofer study also other
                                                                                              35


studies into account, that orally administered BaP. The Fraunhofer study administered
BaP topically, in a vehicle, UK did not support. It should be clarified whether only skin
cancer is of concern. DK commented that the method of skin painting is recognised for
identifying carcinogens. B mentioned that they had no problem with the current limit and
proposed to change the entries for the creosotes only. F and IRL agreed with B to modify
the entry for creosote and not the note M. DK, D, EL (provisionally), N (provisionally, A,
FIN and S supported to lower the limit to 1ppm. UK, P and I wanted to lower the limit but
were not sure yet to what level. UK added that it should not be forgotten that Note M
applied to many more substances than creosote.

Conclusion
The Group provisionally agreed to set the reduced cut-off in Note M to 1 ppm. The issue
would be discussed again at the next meeting, when a proposal for inclusion in a future
ATP would have been formulated by the ECB.



9.3.   Development of a Note for Sensitisers in Preparations: DPD Annex V, Part B9

9.3.1 Index No 613-167-00-5 (MCI/MI): Specific concentration limit for elicitation
       ECBI/28/01 and Add 1 (Parts I and II), Add 2 and Add 3)

New entry 613-167-00-5, MCI/MI (3:1):
Industry had sent several letters to Member States Authorities objecting to inclusion in the next
ATP with 15 ppm as specific concentration limit for sensitising properties.
UK suggestedan alternative solution (ECBI/01/00 - Add. 16) leaning on the two procedural options
discussed at the ad-hoc Meeting on Sensitisers in June 1994 for potent sensitisers and low-
dose elicitation in humans, when precise concentrations were not known with sufficient certainty.
The following Member States indicated they wanted to continue the discussion of the UK proposal,
which they supported, at the pre-TPC meeting: B, D, E, ES, F, IRL and I.
DK, N, NL, P, FIN and S rejected a deviation from the agreed 15 ppm concentration limit.
A indicated continued support of 15 ppm and no final position on the new UK proposal.


N. Burge briefly introduced the problem of setting specific concentration limits for
sensitising properties of preparations in the context of the new Annex V B.9 of the DPD.
He suggested that a guidance document could be developed on how to set these limits.
Should the criteria distinguish induction and elicitation? NL thought that only induction
should be concentrated on. If a person was already sensitised, any concentration of the
given substance could elicit sensitisation. UK did not agree and liked to discuss the issue
with the experts at home. DK agreed with NL that induction was important and proposed
to decide on elicitation case by case. D felt that too much work was involved in setting
limits for elicitation. UK and DK stressed that further discussion had to be general and
should not consider the specific concentration limit for induction for MCI/MI again that was
concluded. IRL proposed to continue discussion in a small group. Sensitisers were last
discussed in 1995. It had to be decided now how to use the results from the new mouse
lymphnode test.

Octamer
D felt that octamer should be discussed by the New Substance Group. Only one group
should discuss a substance. ECB explained that the notifier asked to move the substance
to this group. The New Substance Group would delay discussion and only start it next
year.
                                                                                                  36




Conclusion
The Group decided to have a meeting on the issue the day before the September CMR
meeting. Members States could bring experts along that were not usually attending the
CMR meetings. The outcome of the pre-meeting will be put up for discussion in the CMR
Group. Octamer will be discussed at the CMR meeting in September. MCI/MI will not be
on the agenda again.



11.   Computer modelling as an aid for classification: Information from DK
      ECBI/81/00 and Add 1

DK gave a presentation of their database on advisory self-classifications made on the
basis of computer modelling. The Group welcomed the presentation and considered the
results to be very interesting and valuable. How the list would be updated, its voluntary
status and its possible use in context with the White Paper was commented. DK informed
that a meeting on different applications of QSAR-modelling would be held in Copenhagen
later this year.

The Group decided to re-discuss a broader use of the database when it was finished.



12.   Global Harmonisation
      ECBI/69/00             CEFIC, Thought Starter - Modifying Conditions to Classification of
                             Substances and Mixtures in the GHS (two files)

Iona Pratt (IRL), as the chair of the ILO working group on hazard communication reported
back from their meeting in Geneva the week prior this meeting. The work of this group
would now be finalised even if there still were some outstanding questions remaining. The
most important one for the EU was the symbol for chronic health hazards. The current
skull and crossbone-symbol had not be accepted, neither from US, Canada nor the
transport sector. However, the proposals put forward by the EU were not possible to agree
on, as they still included skulls and reminded of the symbol for acute health hazards. In
the final deal it was agreed that a new symbol would be developed for chronic health
hazards. This symbol should possibly be abstract and rather be an eye-catcher than
illustrating the chronic hazard in any way.

The problem was further that the symbol would be included in the final GHS document
which should be finalised by the beginning of September. The chair, E. Berggren, said
that she was willing to collect symbol proposals from the Member States during the
summer and possibly co-ordinate a EU proposal for the mid of August. She also promised
to search for some professional assistance to develop some proposals for further
consideration of the Member States.

Ms Pratt further explained that there were problems with the agreed shape of the symbol
from some parts of the transport sector. They would no longer agree to keep the square
standing on one corner (the diamond shape), why Member States were asked to co-
ordinate internally with transport colleagues and to brief them on the importance of the
current agreement in the Hazard Communication working group.
                                                                                       37


Finally Ms Pratt also reported that the currently used St Andrew’s cross would be
changed into an exclamation mark within the international system, as this was recognised
as a better understood symbol.

Also the ILO GHS co-ordination group had met in Geneva and the work on the final GHS
document had then been outlined. It should be finalised by the end of the summer to be
tabled on the second meeting of the UN subcommittee on GHS in December. There was
still some additional assistance needed for drafting of the document, as the different
chapters would take up the final outcome for different end-points from each working group
(classification criteria, mixtures and hazard communication). Several Member States and
CEFIC agreed to assist in this exercise.

It was then concluded that at the next CMR meeting this agenda item would come back. It
would then be possible to comment on the outcome of the final GHS document as well as
on the outcome of the discussion of the new symbol for chronic health hazards.



14. Any other business

UK was concerned over the electronic distribution of papers and asked for notification of
additions to the web page.


15.   Future priorities

UK suggested to set criteria for the prioritisation of substances on the agenda. A short,
focused agenda would be helpful. ECB promised that the discussion of substances will be
the priority at the September meeting and that points with in depth discussion will be
marked on the agenda.



16.   Deadlines

Deadline for new papers for the September meeting is August.
                                                                                                     38




                                                                                ECBI/02/01 Rev. 3
                                                                                     15 May 2001

                                          DRAFT AGENDA

                             Commission Working Group on the
                   Classification and Labelling of Dangerous Substances

                     Meeting on Health Effects - the CMR Working Group

                                   ECB - Ispra, 30 May - 1 June

              The meeting will start 30 May at 9.30 and finish 1 June at 13.00.


1.    Adoption of the draft agenda (ECBI/02/01 Rev. 3)


2.    Previous Meetings

     2.1   Adoption of the draft summary record of the CMR WG meeting, Ispra 9–12
           May 2000
            (ECBI/51/00 Rev. 2)

     2.2   Adoption of the draft summary record of the CMR WG meeting, Ispra 15–17
           November 2000
             (ECBI/76/00 Rev. 1)

     2.3   Summary record of the Specialised Experts meeting, Arona 6-8 September
           2000
             (ECBI/59/00 Add. 1 Rev. 2)

     2.4   Meeting of Experts in preparation of the Committee for the 28th Adaptation
           to Technical Progress of Directive 67/548/EEC, Brussels 25 January 2001

     2.5   Ad-hoc Meeting on the development of criteria for Persistent,
           Bioaccumulating and Toxic Substances (PBT), Ispra 12 December 2000
           (ECB/75/00 Rev. 2)



3.    Classification of substances from the Risk Assessment Group

     3.1   Continued discussion

       3.1.1 Substances listed in Annex I

               Tetrachloroethylene (UK), (S206), (602-028-00-4)
               ECBI/21/96 Add. 2-5, ECBI/41/98 and Add. 1–10, ECBI/59/00 Add. 1 Rev. 2, ECB4/21/99

               Hydrogen peroxide (FIN), (M007), (008-003-00-9)
                                                                                                      39


                ECBI/45/99 Add. 10, 12, 14-18, 20, 22 (Parts I, II, III and IV), 23 and 24

                Toluene (DK), (S207/U022), (601-021-00-3)
                ECBI/22/00 and Add.1-6, 7-8 (paper copies only), 9 and 10, ECBI/59/00 Add. 1 Rev. 2

                2-furaldehyde (NL), (U027), (605-010-00-4)
                ECBI/28/00 and Add. 1

                Aniline (D), (A036), (612-008-00-7)
                ECBI/64/00 Add. 1 and 2

       3.1.2 Substances not listed in Annex I

                Benzyl butyl phthalate (N), (W04), (EC No 201-622-7)
                ECBI/37/99 Add. 19 and Rev. 1 and Add. 20, 26 and 27 (Parts I and II)

                Bis(pentabromophenyl) ether; Diphenyl ether, decabromo derivative (F),
                (U045/F023), (EC No 214-604-9)
                ECBI/07/99 Add. 1, 2 Rev. 1, 5 and 7

                Diphenyl ether, octobromo derivative (F), (U046/F024), (EC No 251-087-9)
                ECBI/07/99 Add. 3, 4 and 6

     3.2     First discussion

           3.2.1 Substances listed in Annex I

                But-2-yne-1,4-diol, D017 603-076-00-9
                ECBI/24/01 and Add. 1

                Phenol, (U054), (604-001-00-2)
                ECBI/68/00, ECBI/23/01

                Naphthalene, (D047/P396), (601-052-00-2)
                ECBI/26/01 and Add. 1

                Methylenediphenyl diisocyanate, (Q033), (615-005-00-9)
                ECBI/22/01 and Add. 1

                4,4'-isopropylidenediphenol, Bisphenol A, (K007), (604-030-00-0)
                ECBI/36/01

                Cadmium oxide, (C106), (048-002-00-0)

                Cadmium sulphide, (048-010-00-4)
                ECBI/25/01 (Parts I and II)

       3.2.2 Substances not listed in Annex I

                Cadmium, (EC No 231-152-8)


4.    Continuation of discussion of the following substances
                                                                                    40




     4.1    Substances not listed in Annex I

           4,4'-bis(dimethylamino) benzophenone; Michler’s ketone, (D094), (EC No 202-
           027-5)
           ECBI/59/98 Add. 2, ECBI/19/00 Rev. 1, ECBI/68/00

           C.I. Basic Violet, D083, EC No 208-953-6
           ECBI/59/98 and Add. 2, 8 and 10



5.     First discussion of new proposals for substances

     5.1    Revision of Annex I entries

           2-aminoethanol, U050, 603-030-00-8
           ECBI/55/00

           Tributyl phosphate, (U051), (015-014-00-2)
           ECBI/55/00

           Sulphuryl difluoride, (P467), (009-015-00-7)
           ECBI/55/00

           2-nitrotoluene, (D095), (609-006-00-3)
           ECBI/65/00

           Ethylene (D096), (601-010-00-3)
           ECBI/65/00 - Adds. 1 and 6

           3-chloropropene, (A002), (602-029-00-X)
           ECBI/68/00

           1,2-Dimethoxyethane; EGDME, (F025), (603-031-00-3)
           ECBI/01/01 (EGDME)

           2-(propyloxy)ethanol; EGPE, (F026), (603-095-00-2)
           ECBI/01/01 (EGPE)

           1,1-dichloroethylene, (602-025-00-8)

           1-chloro-4-nitrobenzene, (610-005-00-5)
           ECBI/20/01, Add. 1 and 2

           Tert-butyl acrylate, (607-245-00-8)
           ECBI/27/01

           Salts of Thiocanic acid, (615-004-00-3)
           ECBI/08/96 Add. 17

           Fluorosilicates, (009-013-00-6)
           ECBI/08/96 Add. 18
                                                                                          41


5.2.    Substances not listed in Annex I

        2-hexyloxyethanol; Ethylene glycol monohexyl ether, (U052), (EC No 203-951-
        1)
        ECBI/55/00

        6-methoxy-m-toluidine; p-cresidine, (U053), (EC No 204-419-1)
        ECBI/55/00

        1,2-benzenedicarboxylic acid, dipentylester, branched and linear [1]
        Diisopentyl phthalate [2], Dipentyl phthalate [3], (D097) (EC No 284-032-2 [1];
        EC No 210-088-4 [2]; EC No 205-017-9 [3])
        ECBI/65/00 Add. 2

        5-nitro-o-toluidine [1]; 5-nitro-o-toluidine hydrochloride [2], (D098), [EC No
        202-765-8 [1], (612-025-00-X); EC No 256-960-8 [2]]
        ECBI/65/00 Add. 3

        4-chloro-o-toluidine [1]; 4-chloro-o-toluidine hydrochloride [2], (D099), (EC No
        202-441-6 [1]; EC No 221-627-8 [2])
        ECBI/65/00 Add. 4 Rev.1

        2,4,5-trimethylaniline [1]; 2,4,5-trimethylaniline hydrochloride [2], D100, (EC
        No 205-282-0 [1]; CAS No 21436-97-5 [2])
        ECBI/65/00 Add. 5

        4,4'-thiodianiline, (U055), (EC No 205-370-9)
        ECBI/68/00

        4,4'-oxydianiline, (U056), (EC No 202-977-0)
        ECBI/68/00 and Add. 1

        4-methoxy-m-phenylenediamine, (EC No 210-406-1)

        2-(2-ethoxyethoxy)ethanol; DEGEE, (F027), (EC No 203-919-7)
        ECBI/01/01 (DEGEE)

        2-(2-hexyloxyethoxy)ethanol; DEGHE, (F028), (EC No 203-988-3)
        ECBI/01/01 (DEGHE)

        2-[2-(2-methoxyethoxy)ethoxy]ethanol; TEGME, (F029), (EC No 203-962-1)
        ECBI/01/01 (TEGME)

        1,2 - Bis (2-methoxyethoxy) ethane; TEGDME, (F030), (EC No 203-977-3)
        ECBI/01/01 (TEGDME)

        2-(2-(2-butoxyethoxy)ethoxy)ethanol; TEGBE, (F031), (EC No 205-592-6)
        ECBI/01/01 (TEGBE)

        1-ethoxypropan-2-ol; 2PG1EE, (F032), (EC No 216-374-5)
        ECBI/01/01 (2PG1EE)

  5.3    Annex I entries in 28th ATP: open issues - future procedure
                                                                                         42




           Octamethylcyclotetrasiloxane, (Y009), (EC No 209-136-7 [014-018-00-1])
           ECBI/37/98 and Add. 1-10, ECBI/33/00 Rev. 2

           Nonylphenol [1]; 4-nonylphenol, branched [2], (U047, U048), (EC No 246-672-0
           [1]; EC No 284-325-5 [2]), [601-053-00-8]
           ECBI/48/99 Add. 1

     5.4    New proposal of revision of Annex I entry:

           Diaminotoluene (612-151-00-5)
           ECBI/21/01 (Parts I, II, III and IV)

     5.5    Comment on an agreed classification to be included in a future ATP:
           Boric acid (K073), (EC Nos. 233-139-2; 234-343-4, CAS Nos. 10043-35-3;
           11113-50-1)
           ECBI/04/99 Add. 15



6.    New Chemicals Policy: Implications for the C&L Working Group


7.    Continuation of discussion on MMV Fibers (ECBI/12/97 – Adds. 4 - 14)


8.    ATPs to Dangerous Preparations Directive (DPD) and Safety Data Sheets (SDS)
      Directive: DG ENTR Report (DPD 1st ATP; SDS ATP)


9.     Classification and Annex I problems

     9.1     Revision of Note M, reduction of cut-off level for marker benzo[a]-pyrene
             ECBI/18/99 and Add. 1 – 8

     9.2     Additional guidance on the criteria for application of R48: Proposal by
             Germany
             ECBI/67/00 and Add. 1

     9.3     Development of a Note for sensitisers in preparations: DPD Annex V, Part B
            9 - Specific concentration limit for elicitation

       9.3.1       Index No 613-167-00-5 (MCI/MI)
       (ECBI/28/01 and Add. 1 (Parts I and II), Add. 2 and Add. 3)

       9.3.2       New notified substance: Octamer (ECBI/35/01 And Add. 1)

     9.4     Annex I entries classified with R67: draft provisions in ATP to the DPD (DPD
             1st ATP)

     9.5    Test method addressing R44 (explosive if heated under confinement)

     9.6    Translation errors of Note R
                                                                                   43




10.   Criteria related activities

  10.1    Liquid oxidisers (ECBI/63/00)

  10.2    R-phrase wording for Category 3 mutagens, classification criteria

  10.3    Toxicity to reproduction: human evidence

  10.4    Irreversible colouration of the eyes: proposal by the New Substances
           Group (ECBI/70/00)

  10.5    Acute inhalation toxicity, aerosols: Discussion document from Industry
          (ECBI/05/01)



11.   Computer modeling as an aid for classification: Information from DK
      (ECBI/81/00 and Add. 1)



12.   Global Harmonisation (ECBI/69/00)

  12.1    GH criteria for physico-chemical properties and current EU system
          (ECBI/71/00)

  12.2    Progress on classification criteria - health effects

  12.3    Progress on mixtures

  12.4    Discussion on outcome of the Geneva meeting of the ILO Hazard
          Communication Working Group


13.   Acute toxicity classes and the outstanding Swedish problem of the 4th
      Category


14.   Any Other business

15.   Future priorities

  15.1    Consolidated version of Annex I and the next ATP

  15.2    Next CMR meeting

  15.3    Next Specialised Experts meeting


16.   Deadlines
      LIST OF PARTICIPANTS: COMMISSION WORKING GROUP ON CLASSIFICATION & LABELLING OF DANGEROUS
      SUBSTANCES

                                                        Ispra, 30th May – 1st June 2001

                           Please, check (fill in where necessary) your address, telephone, fax No. and e-mail address



                                            ORGANISATION                                  ADDRESS, Tel. and Fax No.      Confirmation
NAMES
Marie-Noelle BLAUDE (B)        Scientific Institute of Public Health – LP   Rue J. Wytsman 16
                               Division Toxicology                          1050 Brussels BELGIUM
                                                                            Tel.: +32 2 642 55 87
                                                                            Fax: +32 2 642 52 24
                                                                            e-mail: blaude@iph.fgov.be
Thaly LAKHANISKY (B)           Scientific Institute of Public Health        Rue J. Wytsman 16
                                                                            B – 1050 BRUXELLES
                                                                            Tel.: +32 2 642.51.04
                                                                            Fax: +32 2 642.52.24
                                                                            e-mail: t.lakhaniski@iph.fgov.be
Ulla HASS (DK)                 Danish Veterinary and Food                   Morkhoj Bygade 19
                               Administration                               2960 Soborg DENMARK
                                                                            Tel.: +45 33 95 60 00
                                                                            Fax: +45 33 95 60 01
                                                                            e-mail: ulh@fdis.dk
Lea Stine TOBIASSEN (DK)       Danish Environmental Protection              Strandgade 29
                               Agency                                       DK - 1401 København K
                               Miljøstyrelsen                               Tel.: +45 32 66 03 16
                                                                            Fax: +45 32 66 03 69
                                                                            e-mail: lst@mst.dk
Eva Bay WEDEBYE (DK)           Danish Environmental Protection              Strandgade 29
                               Agency                                       DK - 1401 København K
                               Miljøstyrelsen                               Tel.: +45 32 66 01 00
                                                                            Fax: +45 32 66 02 61
                                                                            e-mail: ebw@mst.dk
                                                                                                                            45


                                         ORGANISATION                           ADDRESS, Tel. and Fax No.    Confirmation
NAMES
Helmut FLEIG (D)             BASF AG                               6 UPIC – BUILDING Z470
                                                                   67056 LUDWIGSHAFEN - GERMANY
                                                                   Tel.: +49 621 60 55 638
                                                                   Fax: +49 621 60 58 134
                                                                   e-mail: helmut.fleig@basf-ag.de
Elke KAHLER-JENETT (D)       Federal Institute for Occupational    Friedrich- Henkel-Weg 1-25
                             Safety and Health, Germany            D – 44149 DORTMUND - GERMANY
                                                                   Tel.: +49 231 90 71 589
                                                                   Fax: +49 231 90 71 611
                                                                   e-mail: Kahler-jenett.elke@baua.bund.de
Michael KUNDE (D)            BGVV                                  P.O BOX 33 00 13
                                                                   D – 14191 BERLIN – GERMANY
                                                                   Tel: +49 188 84 12 38 33
                                                                   Fax: +49 188 84 12 30 03
                                                                   e- mail: m.kunde@bgvv.de
Harald LINDEMANN (D)         BAYER AG, Institute for Toxicologie   P.O BOX 101709
                                                                   D- 42096 WUPPERTAL
                                                                   Tel: +49 202 36 84 38
                                                                   Fax: +49 202 36 43 20
                                                                   E mail: harald.lindemann.hl@bayer-ag.de
Ioanna ANGELOPOULOU (EL)     General Chemical State Laboratory     16, An Tsoha Str.
                             Division of Environment               Athens – GREECE
                                                                   Tel.: +301 64 79 407
                                                                   Fax: +301 64 66 917
                                                                   e-mail: gxk-environment@ath.forthnet.gr
Covadonga CABALLO (ES)       MINISTERIO DE SANIDAD Y CONSUMO       P. del Prado 18
                                                                   E – 28014 MADRID - SPAIN
                                                                   Tel.: +34 91 59 61 444
                                                                   Fax: +34 91 360 13 41
                                                                   e-mail: ccaballo@msc.es
Marta MARTINEZ CABALLERO (ES) MINISTERIO DE SANIDAD Y CONSUMO      P del Prado 18
                                                                   E – 28014 MADRID – SPAIN
                                                                   Tel: 34. 91.596.20.14
                                                                   Fax: 34. 91.360.13.41
                                                                   e-mail: mmartinezca@msc.es
                                                                                                                  46


                                        ORGANISATION                   ADDRESS, Tel. and Fax No.   Confirmation
NAMES
Nicole BONNARD (F)         INRS                           30, Rue Olivier Noyer
                                                          F – 75680 PARIS
                                                          Tel.: +33 1 40 44 31 28
                                                          Fax: +33 1 40 44 30 54
                                                          e-mail: bonnard@inrs.fr
Annie LAUDET-HESBERT (F)   INRS                           30, Rue Olivier Noyer
                                                          F – 75680 PARIS
                                                          Tel.: +33 1 40 44 30 81
                                                          Fax: +33 1 40 44 30 54
                                                          e-mail:hesbert@inrs.fr
Carole ROUSSE (F)          Ministere de la Sante          8, Avenue de Segur
                                                          75530 07 SP Paris FRANCE
                                                          Tel.: +33 1 40 56 71 08
                                                          Fax: +33 1 40 56 50 56
                                                          e-mail:carole.rousse@sante.gouv.fr
Iona PRATT (IRL)           Health & Safety Executive      10, Hogan Place
                                                          IRL – Dublin 2
                                                          Tel.: +353 1 614 71 09
                                                          Fax: +353 1 614 70 21
                                                          e-mail: iona@hsa.ie
Paola DI PROSPERO (I)      Istituto Superiore di Sanità   Viale Regina Elena, 299
                                                          I – 00161 ROMA
                                                          Tel.: +39 06 49 90 24 23
                                                          Fax: +39 06 49 38 71 70
                                                          e-mail:paola.diprospero@iss.it
Henk ROELFZEMA (NL)        MINISTRY OF HEALTH             Parnassusplein 5
                                                          2500 DEN HAAG
                                                          The Netherlands
                                                          Tel.: +31 70 340 69 65
                                                          Fax: +31 70 340 55 54
                                                          e-mail: h.roelfzema@minvws.nl
                                                                                                                        47


                                    ORGANISATION                             ADDRESS, Tel. and Fax No.   Confirmation
NAMES
Elisabeth FASSOLD (A)   Federal Environment Agency            Spittelauer Lände, 5
                                                              A – 1090 WIEN
                                                              Tel.: +43-1-31 30 45 912
                                                              Fax: +43-1-31.30 45 690
                                                              e-mail: fassold@ubavie.gv.at
Luisa PRIETO (P)        Instituto Nacional de Saude DR.       Avenida Padre Cruz 1649 – 016
                        Ricardo Jorse                         LISBOA – PORTUGAL
                                                              Tel: + 351 – 21 751 92 69
                                                              Fax: + 351 – 21 759 04 40
                                                              E mail: luisa.valente@insa.min_saude.pt
Paul KREUZER (FIN)      National Product Control Agency       P.O. Box 210
                                                              FIN - 00531 HELSINKI
                                                              Tel.: +358 9 39 67 27 65
                                                              Fax: +358 9 39 67 27 97
                                                              e-mail:paul.kreuzer@sttv.fi
Gunilla ERICSSON (S)    National Chemicals Inspectorate       P.O. Box 1384
                        (KEMI)                                S - 17127 SOLNA
                                                              Tel.: +46 8 783 11 55
                                                              Fax: +46 8 735 76 98
                                                              e-mail:gunillae@kemi.se
Malik ALTAHIR (S)       National Chemical Inspectorate (KEMI) P.O. Box 1384
                                                              S - 17127 SOLNA
                                                              Tel.: +46 8 783 11 00
                                                              Fax: +46 8 735 76 98
                                                              e-mail:malik@kemi.se
Andrew SMITH (UK)       Health and Safety Executive           Magdalen House (room 143)
                                                              Stanley Precinct
                                                              BOOTLE – Merseyside L20 3QZ
                                                              United Kingdom
                                                              Tel.: +44 151 951 34 04
                                                              Fax: +44 151 951 31 97
                                                              e-mail:andrew.smith@hse.gsi.gov.uk
                                                                                                                                    48


                                           ORGANISATION                           ADDRESS, Tel. and Fax No.          Confirmation
NAMES
Robert WARNER (UK)             Health and Safety Executive             Rose Court Southwark Bridge
                                                                       London UK SEI 9HS
                                                                       Tel: + 44 207 - 717-61 97
                                                                       Fax: + 44 207 – 717 62 21
                                                                       E mail: bob.warner@hse.gsi.gov.uk
Christine BIØRGE (N)           National Institute of Public Health     P.O BOX 4404 NYDALEN
                                                                       N- 0403 OSLO NORWAY
                                                                       Tel: + 47 22 04 22 96
                                                                       Fax: + 47 22 04 26 86
                                                                       E mail: christine.bjorge@folkehelsa.no
Eva HAUG (N)                   Directorate of Labour Inspection        P.O BOX 8103 DEP.
                                                                       0032 OSLO NORWAY
                                                                       Tel: + 47 22 95 70 00
                                                                       Fax: + 47 22 17 63 73
                                                                       E mail: eva.haug@arbeidstilsynet.dep.no
Solveig DYSVIK (N)             Norwegian Pollution Control Authority   P.O. Box 8100 Dep.
                                                                       N – 0032 OSLO
                                                                       Tel.: +47 22 57 34 00
                                                                       Fax: +47 22 67 67 06
                                                                       e-mail:solveig.dysvik@sft.no
Simon-Jan BEEKHUIZEN (CEFIC)   BAYER AG                                GEB 9115
                                                                       51368 LEVERKUSEN - GERMANY
                                                                       Tel: + 49 214 30 71 758
                                                                       Fax: +49 214 52 761
                                                                       E mail: simon-jan.beekhuizen.SB@bayer-ag.de
Josef BERNARD (IND)            ERA – European Rotogravure              Swakopmunder str. 3
                               Association                             81827 Munich GERMANY
                                                                       Tel: + 49 89 439 50 55
                                                                       Fax: + 49 89 439 41 07
                                                                       e-mail: josefbernard@era.eu.org
Aymon DE REYDELLET (ECFIA)     Saint Gobain ISOVER                     Les miroirs – 18 Avenue d’Alsace
                                                                       92 096 La Défense CEDEX FRANCE
                                                                       Tel.: + 33 1 47 62 41 79
                                                                       Fax: + 33 1 47 62 40 53
                                                                       e-mail: aymon.dereydellet@saint-gobain.com
                                                                                                                         49


                                      ORGANISATION                            ADDRESS, Tel. and Fax No.   Confirmation
NAMES
David FARRAR (CEFIC)        INEOS CHLOR LIMITED                  The Heath, Runcorn
                                                                 Cheshire, England, UK
                                                                 Tel.: +44 1928 511 741
                                                                 Fax: +44 1928 511 587
                                                                 e-mail:david.farrar@ineos.chlor.com
Sylvia JACOBI (IND)         Degussa AG, CEFIC Peroxygen Sector   PO Box 1345
                            Group                                63403 Hanau GERMANY
                                                                 Tel: + 49 6181 59 39 00
                                                                 Fax: + 49 6181 59 20 83
                                                                 e-mail: sylvia.jacobi@degussa.com
Ole KAMSTRUP (ECFIA)        ROCKWOOL INTERNATIONAL A/S           HOVEDGADEN 584
                                                                 2640 HEDEHUSENE DENMARK
                                                                 Tel: + 45 42 16 03 00
                                                                 Fax: + 45 42 16 43 33
                                                                 E mail: ole.kamstrup@rockwool.com
Melville LITCHFIELD (IND)   MELROSE CONSULTANCY                  Denmans Lane, Fontwell
                                                                 UK – ARUNDEL BN 180 SU
                                                                 Tel: + 44 1243 544 331
                                                                 Fax: + 44 1243 544 369
                                                                 E mail: mel.litchfield@btinternet.com
William MACHIN (CEFIC)      CEFIC                                Av. E. van Nieuwenhuyse 4, box 1
                                                                 1160 BRUSSELS - BELGIUM
                                                                 Tel: + 32 2 676 72 77
                                                                 Fax: + 32 2 676 73 32
                                                                 E mail: wma@cefic.be
Craig NESSEL (IND)          CONCAWE EXXONMOBIL                   Hermeslaan 2
                                                                 1831 MACHELEN
                                                                 Tel: + 32 2 722 44 94
                                                                 Fax: + 32 2 722 44 06
                                                                 E mail: craig.nessel@esso.com
                                                                                                                    50


                                  ORGANISATION                        ADDRESS, Tel. and Fax No.      Confirmation
NAMES
Anthony RILEY (IND)     CONCAWE                         c/o BP Amoco Product Stewardship Group
                                                        Chertsey Rd
                                                        Sunbury on Tames TW16 7NL
                                                        Tel: + 44 1932 76 44 86
                                                        Fax: + 44 1932 76 24 77
                                                        E mail: rileyaj@bp.com
Rob ROGGEBAND (CEFIC)   PROCTER & GAMBLE                TEMSELAAN 100
                                                        1853 STROMBEEK- BEVER BELGIUM
                                                        Tel: + 32 2 456 25 31
                                                        Fax: + 32 2 456 28 50
                                                        E mail: roggeband.r@pg.com
Werner WILDNER (IND)    CEFIC – Degussa AG (INFRACOR)   Hanau GERMANY
                                                        Tel: + 49 6181 59 34 07
                                                        Fax: + 49 6181 59 24 89/73 407
                                                        E mail: werner.wildner@degussa.com


Peter WILKINS           ECFIA                           17 Matham Road
                                                        EAST MOLESEY, SURREY KT8 O5X, UK
                                                        Tel: + 44 208 979 74 36
                                                        Fax: + 44 208 783 05 61
                                                        E mail: peter.wilkins@morgancrucible.co.uk
Robert BROWN            ECFIA                           4 Bramble Close
                                                        UPPINGHAM UK LE 15 9PH
                                                        Tel: + 44-1572.82 17 25
                                                        Fax: + 44-1572.82 32 83
                                                        E mail: bob@toxservices.demon.co.uk
Jörg LEBSANFT           EUROPEAN COMMISSION – DG ENV    Rue de la Loi 200 BU-5 2
                                                        1049 BRUSSELS – Belgium
                                                        Tel: + 32 2 299 04 02
                                                        Fax: + 32 2 295 61 17
                                                        E mail: joerg.lebsanft@cec.eu.int
                                                                                                              51


                                   ORGANISATION                    ADDRESS, Tel. and Fax No.   Confirmation
NAMES
Nick BURGE (EC)          EUROPEAN COMMISSION – DG    Rue de la Loi 200
                         ENTR/E/3                    BRUSSELS – Belgium
                                                     Tel: + 32 2 295.22.58
                                                     Fax: + 32 2 295.02.81
                                                     E mail: nicholas.burge@cec.eu.int
Elisabet BERGGREN (EC)   Joint Research Centre       T.P. 582
                         European Chemicals Bureau   I - 21020 ISPRA (Varese)
                                                     Tel.: +39 0332 78 9065
                                                     Fax: +39 0332 78 9963
                                                     e-mail: elisabet.berggren@jrc.it
Eva REINHARD (EC)        Joint Research Centre       T.P. 582
                         European Chemicals Bureau   I - 21020 ISPRA (Varese)
                                                     Tel.: +39 0332 78 5272
                                                     Fax: +39 0332 78 9963
                                                     e-mail: eva.reinhard@jrc.it
Reinhard SCHOLZ (EC)     Joint Research Centre       T.P. 582
                         European Chemicals Bureau   I – 21020 ISPRA (Varese)
                                                     Tel: + 39 0332 78 9260
                                                     Fax: + 39 0332 78 9963
                                                     E mail: reinhard.scholz@jrc.it