1. Welcoming address, apologies for absence, declarations of interest

No declarations of interest relative to the agenda points of this 23rd CSTEE plenary were submitted by any CSTEE member.

2. Adoption of the draft agenda

The draft agenda was adopted.

3. Approval of the draft minutes of the 22nd CSTEE plenary meeting

The approval of the draft minutes was deferred because the secretariat had been unable to prepare a draft due to work overload. The CSTEE chairman undertook to raise the issue of resources of the CSTEE secretariat with the Commission services.

4. Regulation 793/93 on Existing substances (ESR):

A. Status reports/opinions (Human health & Environment) on:

a) Dibutyl Phthalate - for opinion

A draft text had already been discussed at the occasion of the previous CSTEE plenary. The working group chairman reviewed this draft considering comments sent on the environmental part. The CSTEE had requested more information for the environmental risk assessment allowing for a risk for the atmospheric compartment, the need to better assess local PEC in surface waters and the requirement of information on endocrine disrupting effects on aquatic organisms. Other aspects of the RAR addressed were the carcinogenicity section, the exposure scenario and ED effects. The draft opinion was adopted. It is available in:
/food/fs/sc/sct/outcome_en.html

b) Methyl oxirane (propylene oxide)

Given the need to cancel the 2nd day of this plenary (initially foreseen to last two days) the discussion on this chemical was postponed as the adoption of an opinion on this chemical was not urgent.

c) Toluene

Same comment as for b).

d) 1,2,4-Trichlorobenzene

Same comment as for b).

e) Acrylic acid

Same comment as for b).

f) Methyl-tert-Butyl Ether - for opinion

A discussion had already taken place at the previous CSTEE plenary on the environmental part of the draft, on which the CSTEE had agreed with only partially with the overall conclusion of the RAR. Taking into consideration that atmosphere is the most exposed compartment, the CSTEE expressed the view that there is a need for more information on the effects of MTBE on terrestrial plants and animals through air exposure. Subsequently the discussion focussed on the human health part.

The draft CSTEE opinion on Methyl-tert-Butyl Ether was adopted. It is available in:
/food/fs/sc/sct/outcome_en.html

B. State of play regarding other substances evaluated under the ESR

There was no update to provide on this point.

C. Input of the CSTEE into the revision of the 'Technical Guidance Document' in support of Regulation 793/93

Same comment as in 4.B.

5. Presentation of JRC report on results of the validation of methodologies for determining the release of DINP from toys and childcare articles

A JRC representative attended this CSTEE plenary in view of presenting the JRC report on "Validation of methodologies for the release of Di-isononylphthalate (DINP) in saliva simulant from toys" and its provisional conclusions.

CSTEE members commented on the report and asked questions to which the JRC representative answered. In principle the report will be finalised soon and the comments made by some CSTEE members will be taken into account. In principle this should be done quickly and it was expected that at the occasion of the June CSTEE plenary the report would be finalised and terms of reference submitted by the Commission service, DG Enterprise. It is this Commission service that will be able to use its conclusions for regulatory purposes (Directive 76/769 on limitations of marketing and use of certain dangerous substances and preparations).

6. Evaluation of sludge treatments for pathogen reduction - for opinion

The last version of the draft was described and discussed. The CSTEE considered that the bibliography was sufficient for covering major pathogens and effectiveness of treatments. The report was deemed an acceptable basis for the Commission to propose appropriate treatments and user restrictions for the land spreading of sludges that will minimise risk. However there may still be important risks, especially to operators, in the transportation and storage of sludges and these should be given some consideration. The draft CSTEE opinion on 'Evaluation of sludge treatments for pathogen reduction' was adopted with some modifications. It is available in:
/food/fs/sc/sct/outcome_en.html

7. (i) Carcinogenic and non-carcinogenic effects of Cadmium and Arsenic in ambient air - progress report

The draft texts presented were discussed in detail and it was agreed that, with some substantial changes still to be made, the rapporteurs for each should finalise them, hopefully in time for an adoption by written procedure. The need to resort to this process of adoption was because the requester Commission service would need the CSTEE opinions by 17 May 2001, date when a WG meeting of the DG Environment 'Air quality' working group would take place.

(ii) Derivation of limit values for PAH in ambient air - progress report

Same comment as for 7.(i).

8. Proposed health standards for a revised bathing water directive - for opinion

A working group meeting had taken place on 30 March 2001 and subsequently a draft has been circulated for comments. The rapporteur presented the most recent draft. The two studies taken into consideration by the Commission are recognised as scientifically sound. However, the CSTEE suggested that use should be made of all available information. The CSTEE also recommended assaying together Escherichia coli with intestinal enteroccoci in both fresh and coastal waters. The draft CSTEE opinion on 'Proposed health standards for a revised bathing water directive' was adopted. It is available in: /food/fs/sc/sct/outcome_en.html

9. Health effects of Radio Frequency and Electromagnetic fields - progress report

The first meeting of the Working Group had taken place on 23 April. The plenary was an opportunity for the CSTEE to be informed of conclusions reached by means of a brief oral account made by the WG chairman. The composition of the WG was again revised and proposals for membership put forward. These had been endorsed by the secretariat and the necessary contacts would be established.

10. Assessment of the risks to human health posed by azo colorants in toys, writing inks and paper products, and analysis of the advantages and drawbacks of restrictions on their marketing and use (LGC report ETD/99/502495) - progress report

The draft prepared by the rapporteur was discussed in detail. He took the task of producing a new version in the light of comments/new information. Depending on how quickly this would be done the adoption of the draft could be considered by written procedure or later at the June CSTEE plenary.

11. Review of a draft CPMP discussion paper on Environmental Risk assessment of medicinal products.

A first draft was presented by the rapporteur and discussed. The need to proceed with the finalisation of the composition of the working group was also underlined. As indicated in the cover letter accompanying the CPMP paper the EMEA are expecting comments before the end of July 2001 and therefore a working group meeting should be organised before the June CSTEE plenary; the rapporteur undertook to produce a new draft in the light of the numerous comments made both on the CPMP document and on the draft itself.

12. Participation of the CSTEE in activities/working groups of other scientific committees of the Commission

a) Toxicity of minerals such as Cu and Zn in animal feed regarding the possible environmental impact of these minerals

This SCAN activity having not started yet the involvement of the CSTEE representatives in the respective WG did not take place either.

b) Other

There were no other ones on which to report at this stage.

13. Strategies for dealing with emerging issues identified by the SSC and for which the CSTEE is the 'lead' committee:

a) Endocrine disruption (Human health)

The discussion on this subject centred on how focussed the future CSTEE opinion should be. It was suggested that issues such as links with developments under the OECD programme, the 6th framework research programme, future EU chemicals policy, EC activity on list of priority substances, etc. should be established. The issue of low dose effects should be devoted some considerable attention. The WG chairman took the task of checking the composition of the WG and already a new name was added to the existing CSTEE working group.

b) Indoor climate

The WG chairman presented a table of contents. The 1st vice-chairman informed that he would participate in a workshop in Vienna, due to take place on 27 April 2001, where he would make a presentation. He would subsequently inform the CSTEE of conclusions/information obtained from that meeting.

Subsequently a discussion took place on the table of contents presented and its complexion was changed somewhat to accommodate comments that would bring the purported draft more in line with the mandate and the nature of the concerns that this topic poses. The WG chairman undertook to change the draft table of contents. A scoping analysis should perhaps be carried out to try and identify which items were priorities on this subject.

14. Strategies for dealing with additional opinion requests submitted by other DGs of the Commission

a) Submissions under article 95 of the Treaty.

We have been informed that submissions under article 95 of the Treaty (which are normally requests from M. States for derogations to the EU legislation), have been sent to the Commission. They concern TBT and Creosote. So far only the latter, on Creosote, has reached the CSTEE secretariat. The CSTEE secretariat had sent the respective data pack to the committee. It included a good background note and the draft questions. It was decided that the former CSTEE 'Creosotes' working group should tackle this opinion request which is an urgent one given the obligation on the part of the Commission to respond to the M. State concerned within a period of 6 months, failing which the measures announced in a notification are deemed approved. The WG chairman took the task of producing quickly a first draft for comments.

b) Other

There were no other ones pending currently. However a representative of DG Health and Consumer Protection informed the committee that an opinion request might be submitted soon on the subject of TBT. Given that another one on the same chemical could be submitted soon [see 14.a)], it was thought best to address the problem concomitantly and therefore the concerned Commission services should co-ordinate positions for a single submission. As this will involve the SCF the issue is to be addressed also under agenda point 16.b).

15. Feedback from the relevant services of the Commission on the follow up to the opinions adopted previously by the CSTEE

No information was provided on any specific opinion request adopted by the CSTEE that might have been the object of a Commission proposal recently.

16. Update on the latest meetings of the Scientific Steering Committee on matters of interest to the CSTEE

a) Harmonisation of Risk Assessment Task Force and working groups

The chairman informed that three working groups had been set up to address the issues under this 'umbrella' subject; one on 'Environment', another on 'Biological effects' and a third one on 'Chemicals and Physical factors'. Their remits were described. The 1st and the 3rd are chaired by two CSTEE members.

b) Cross committee's collaboration

The CSTEE will likely be involved in some opinion requests submitted to the SCF. As from the last information obtained they should concern TBTs and PAH. As for the PAH opinion request submitted to the CSTEE (ambient air) the SCF expressed the view that it is perhaps a bit late in the process for them to be involved in a useful way. They have however been sent copies of the opinion request and of the most recent CSTEE draft.

The 1st vice-chairman commented on his recent involvement on 'Dioxins', subject on which a SCF working group had been formed, a working group meeting taken place, in which he had participated. He described succinctly the major conclusions of the meeting.

17. Arrangements for the next (24th) plenary meeting of the CSTEE

No special arrangements are expected. Date is confirmed for 12/ June 2001. It will be a one-day meeting only.

18. Any other business

There was none .

AGENDA (rev. 2 - 10/4/2001) -

1. Welcoming address, apologies for absence, declarations of interest
2. Adoption of the draft agenda
3. Approval of the draft minutes of the 22nd CSTEE plenary meeting
4. Regulation 793/93 on Existing substances (ESR):
A. Status reports/opinions (Human health & Environment) on:
a) Dibutyl Phthalate
b) Methyl oxirane (propylene oxide);
c) Toluene;
d) 1,2,4-Trichlorobenzene;
e) Acrylic acid;
f) Methyl-tert-Butyl Ether.
B. State of play regarding other substances evaluated under the ESR
C. Input of the CSTEE into the revision of the 'Technical Guidance Document' in support of Regulation 793/93
5. Presentation of JRC report on results of the validation of methodologies for determining the release of DINP from toys and childcare articles
6. Evaluation of sludge treatments for pathogen reduction - for opinion
7. (i) Carcinogenic and non-carcinogenic effects of Cadmium and Arsenic in ambient air - for opinion
(ii) Derivation of limit values for PAH in ambient air - for opinion
8. Proposed standards for a revised bathing water directive - for opinion
9. Health effects of Radio Frequency and Electromagnetic fields - progress report
10. Assessment of the risks to human health posed by azo colorants in toys, writing inks and paper products, and analysis of the advantages and drawbacks of restrictions on their marketing and use (LGC report ETD/99/502495) - progress report/opinion.
11. Review of a draft CPMP discussion paper on Environmental Risk assessment of medicinal products.
12. Participation of the CSTEE in activities/working groups of other scientific committees of the Commission
a) Toxicity of minerals such as Cu and Zn in animal feed regarding the possible environmental impact of these minerals - activity of the SCAN
b) Other
13. Strategies for dealing with emerging issues identified by the SSC and for which the CSTEE is the 'lead' committee:
a) Endocrine disruption (Human health)
b) Indoor pollution
14. Strategies for dealing with additional opinion requests submitted by other DGs of the Commission
a) Submissions under article 95 of the Treaty.
b) Other
15. Feedback from the relevant services of the Commission on the follow up to the opinions adopted previously by the CSTEE
16. Update on the latest meetings of the Scientific Steering Committee on matters of interest to the CSTEE
a) Harmonisation of Risk Assessment Task Force and Working groups
b) Cross committee's collaboration
17. Arrangements for the next (24th) plenary meeting of the CSTEE
18. Any other business

LIST OF PARTICIPANTS

CSTEE:

Prof. James BRIDGES, Prof. Peter CALOW, Prof. Giorgio CANTELLI FORTI, Prof. Wolfgang DEKANT, Prof. Erik DYBING, Prof. Helmut A. GREIM, Prof. Colin JANSSEN, Prof. Bo O. JANSSON, Prof. Soterios A. KYRTOPOULOS, Dr. Claude LAMBRÉ, Prof. Amadeu SOARES, Dr. José V. TARAZONA, Prof. Benedetto TERRACINI, Prof. Janneche UTNE-SKÅRE, Prof. Cornelis Van LEEUWEN, Prof. Katarina VICTORIN, Prof. Marco VIGHI, Prof. Joseph G. VOS.

European Commission:

HEALTH AND CONSUMER PROTECTION DG:

Messrs. Jorge COSTA-DAVID, Panagiotis DASKALEROS and Marc SEGUINOT

ENTERPRISE DG:

Mrs. Lena PERENIUS, Mr Dirk Hedrich

ENVIRONMENT DG:

Messrs. Bert van MAELE and Luca MARMO, Mrs Marion WICHMANN-FIEBIG

EMPLOYMENT AND SOCIAL AFFAIRS DG:

Mrs. Kyriakoula ZIEGLER-SKYLAKAKIS.

JOINT RESEARCH CENTRE:

Mrs. Elke ANKLAM, Mrs. Catherine SIMONEAU.