The meeting was chaired by Prof. Dayan

Opening

The secretary of the Committee made an introduction where he took the opportunity to welcome the members to the first meeting of the Committee under DG XXIV. He also apologized for the very short notice given to members. The Committee was informed that the Plenary meeting scheduled for the second day (26 June) would provide members with an opportunity to obtain more precise information on the ongoing restructuring process of the management of scientific committees.

1. Approval of the draft agenda

The draft agenda was adopted.

2. Apologies for absence (if any)

Apologies were received from Profs Wennig, Vilanova, Foa, Rueff and Fournier. Prof Schuman also sent an apology on behalf of Prof Forth.

3. Approval of the minutes of the previous (62nd) meeting (CSTE/97/4/V)

The minutes were approved.

4. Discussion on the subject 'Nickel in Euro coins'

(i) Introduction. Background

The secretary made an introduction to the subject summarizing the background to the problem. He also presented the other two Commission officials present and involved in the subject: Mme P. Brunko and Mr T. Vissol.

Mr Vissol started off presenting himself in his capacity as Head of Unit in DG XXIV in charge with the change-over of the consumer to the Euro. Mr Vissol has been involved in the activities of the so called 'Mint Directors Working Group' which has responsibilities in the area of the definition of the Euro coins technical characteristics.

He explained that the activities on the EMU started way back in 1992. By then the discussion already addressed the composition of the future Euro coins. Results were reached before the accession of Sweden [it is to be reminded here that Sweden, namely via the studies by Lidén et al, has been the Member State that has played the most significant role contesting the inclusion of nickel in some of the Euro coins in spite of the fact that some Swedish coins have nickel in its composition (75% copper and 25% nickel)].

Mr Vissol also gave a brief historical account of the inclusion of nickel in coins in general. This metal started being used in coins in the beginning of the century. It has the advantages of being a low cost metal and one with good electromagnetic characteristics (good for vending machines). The three layers techniques of nickel alloys renders counterfeiting of coins more difficult and the striking of the metallic pieces is also easier. Among existing alternatives to nickel security coinage he mentioned the alloy 'matinox', based on steel.

In mentioning the consequences of choosing an alternative to nickel a reference was made to the likely consequences on the nickel market. Since large quantities of the metal are required to produce new coins, choosing an alternative to nickel will have as a consequence upsetting significantly the nickel market, particularly if one adds the fact that the recovery of nickel from existing national coins which are to be withdrawn would contribute to compounding the problem.

On the other hand the cost of nickel free coins could be lower if made of steel for instance. The main difference would stem from the fact that steel is harder. Tools to strike the metal would have to be replaced more frequently but this would be a comparatively cheap consequence.

In summary the factors forcing an alternative with nickel are:

1. Length of time it took to reach a decision (difficult to go back now).

2. Nickel is easier to work and has excellent coinage characteristics.

3. Wish not to affect nickel market.

4. Three layers techniques with nickel alloys are excellent for 'security coins' (of more value) to be produced in big quantities.

The final decision by the Council will have to be taken before the end of the year 1997, (the European Parliament must give its advice, Art. 189C procedure) and the current Commission proposal, which accepts nickel in the coins of 1 and 2 Euros, may be revised on the basis of the Committee (CSTE) advice.

Some of these considerations were contested on the assumption that in trying to find an answer to the problem one should concentrate on health issues alone.

(ii) Analysis of the available evidence

The Committee discussed the validity of the pilot study by Dr Lidén et al but was divided as to their significance. Some were of the view that the data were indicative of a certain sensitizing potential of coins whereas others considered that the results were inconclusive because of their lack of statistical significance, hence, as an argument, they were not considered good enough to warrant an outright ban of nickel from coins. It was also said that the conclusions were hardly surprising considering the conditions of some of the experiments.

Copies of a EPI-DERM survey which indicated a given number of reported nickel related cases of contact dermatitis were distributed to the participants. According to that survey the only people surveyed apparently affected had been catering and bar staff but no link could be established with the handling of coins as the reporting dermatologists had simply listed nickel as the suspected agent. Besides, according to the chairman, during the last five years, only one person in Britain had been granted a pension on the basis of proved nickel dermatitis, a jewellery worker.

Corroborating this apparent lack of data (specifically of conditions attributable to nickel in coins) was the example provided by the fact that the Austrian authorities had been asked to provide data clearly attributable to nickel in coins but no cases had been registered, as indicated by the Austrian mint.

It was clear that there is very little information in the literature. Available articles relate more to observations from individual medical doctors than to classical clinical studies. Some members contended that this meant there was no real problem; however, it was argued by others that nickel sensitization was a recently emerging problem and that this could explain the paucity of the data.

One unavoidable conclusion is that there are really no good data about the problem, particularly if one considers that there is a difference between the incidence of sensitization and incidence of clinical disease. The interpretation of this absence of cases with well identified cause and effect relationships was rather controversial. Some thought that should there be any scientific evidence we would have it by now because evidence usually emerges over a number of years and its absence apparently indicates that there is no problem. To this it was answered that 'absence of evidence is not evidence of absence'.

(iii) Practical and methodological considerations

To fill the information gaps the suggestion was made to carry out tests of nickel release but questions were asked on how to interpret the data. A discussion ensued on the measurement of nickel release. In carrying out such measurements it was said that possible contaminations (e.g. nickel in pockets) may have to be brought into the equation because conclusions could be questioned if it could be demonstrated that, in practice, significant quantities of nickel came from sources other than coins. The possibility of using artificial sweat as a surrogate of 'real' sweat raised some doubts among the members.

The debate on the significance of the defined threshold for testing proved to be controversial. Members seemed to differ in the interpretation/significance attributed to it depending on whether consideration was being given to non-sensitized people only or whether including people previously sensitized. The reason, as some put it, was due to the fact that in pre-sensitized people it does not make sense to consider thresholds since a reaction can be elicited even with quantities well below the indicated level; the advocates of this view were of the opinion that a threshold can be set for sensitization in non sensitised people but not in pre-sensitized people.

One of the documents distributed for the meeting seemed to corroborate this view because it indicated responses at extremely low levels. However some also thought that the indicated level need not in general lead to exacerbation in pre-sensitized people.

In this respect it was remembered that 20% of women are allergic and a significant proportion to nickel in particular. If one bears in mind that cashiers in supermarkets are practically always women the significance of the potential problem among the 'professional handlers' of coins gains a different significance.

It was suggested that the threshold of 0.5µg/cm2/week should be accepted as this figure had been arrived at on people not previously sensitized, hence its value as a guide. To put things in perspective the average dietary intake of nickel was mentioned (3µg/kg/day) but it was also suggested that comparisons with the oral route do not make sense.

It was agreed that the problem of primary sensitization is one which is practically impossible to solve. To further substantiate this view one Committee member confirmed that having contacted Prof. Lidén she had said that the problem is not so much to do with causing allergies in non allergic people but in that it could be a problem in pre-sensitized people.

Some members considered the ultimate objective of this exercise to be that of protecting people, in which case the threshold argument does not make sense. One can only be 100% sure of no effects if nickel is excluded from coins. This, some suggested, in spite of the terms of the nature of the questions specifically asked to the Committee, which talked about 'effects on the average consumer' and on the 'professional handler' of coins. This conclusion is even more pressing if one considers the hypothesis of contamination and its unpredictable nature because of the diversity of confounding factors (objects containing nickel likely to get in touch with the hands) some of which at least are difficult to control. By way of example it was mentioned that a diagnosis in the ears is easy but in the hands it is much more complicated because people handle lots of things.

It was said that once the sensitizing effect was induced there is no possibility of escaping it, and if coins are to have an eliciting effect there is no way one can escape the mechanism because everybody will handle coins in one way or another.

For nickel allergic people there is only one way of getting rid of the problem. With jewellery, people have an option not to use it but for coins people have to use them everyday, there is no such option. Coins in pockets mean that thresholds will be meaningless in this case because of prolonged contact.

The question of the body area where a reaction can be induced in respect of where a previous sensitization took place was also mentioned. Given that immunological mechanisms are at stake reactions are not necessarily linked to the place of pre-sensitization and can be elicited elsewhere in the body (the example of earpiercing, which induces a strong immunological response, was given). Of course one has to take account of the thickness of the skin and this varies in different parts of the body.

The so called 'Nickel Directive' (94/27/EC) was mentioned. When it was drafted coins were certainly not intended to be included under its scope, in spite of the phraseology specifying the kind of objects to which it should apply not being absolute. 'Revising' the directive to make it also specifically applicable to coins was suggested as a 'legalistic' solution to the problem; on the other hand some also thought that the consequences of the 'Nickel directive' could mean by now a reduction of the levels of nickel sensitization among the European population.

However, neither mechanism is likely to provide a solution because, the Committee was reminded, the directive is in fact not still in force. Its entering into force was made dependent on the adoption by CEN of the necessary test methods and these have not yet been agreed because of problems linked to the determination of the surface of the objects to which the directive is supposed to apply. This is of course difficult given the wide variability of such objects (coins however do not pose this problem since their surface is easily measurable). It was estimated that given these constraints the nickel directive won't be in force before 3 to 5 years.

(iv) Action to take

Initially it was suggested that a small working group should be set up. One of its main tasks should be to get information from trade unions and banks. This idea was later dropped.

One important advantage of testing samples of the Euro coins is that it may clarify their level of nickel release. In either case we will have data, i.e. in the absence of other data, if it shows that the levels of nickel release are high we will have reasons for concern as more people are revealing to be sensitized everyday. If the release is low it may make lead us to question the significance of the putative risk and of course one has to be reminded that the level of acceptable risk is a political decision. A shortcoming of tests is that they are not predictors of the real circumstances of coin use.

To compensate for the shortcomings of information it was suggested that more info on the elicitation of a response in pre-sensitized people and in the triggering of an allergic response was needed although it was recognized that we may not obtain data which will allow us to make a clear statement.

An attempt was made at preparing what could be the opinion of the Committee but it stayed at the stage of the second draft. Members thought that it would be preferable to wait till more data was made available, particularly that which could be obtained from dermatologists and occupational health professionals although some were of the opinion that the data to be obtained from occupational health services is likely to be scarce because there is always the possibility that people are not going to complain of such a disorder for fear of losing their jobs. If data is to be obtained it is more likely that this is available from medical doctors than from such services.

Apart from initiatives that Committee members are welcome to take in trying to obtain data from occupational health physicians/health managers of major banks and retail stores as well as from trade unions, the European Environmental and Contact Dermatitis Research Group will be contacted to ascertain:

1. What evidence, if any, do they have of cases of nickel sensitization or of allergic dermatitis of hands due to coins in both 'ordinary' people and those occupationally exposed, focusing on number of cases, special circumstances and nature of proof of nickel from coins as etiological agent.

2. Whether they have information on the prevalence of nickel dermatitis of hands in groups occupationally exposed to coins.

3. What is their expert opinion about the magnitude of the risk, if any, of using nickel alloys in coins of 1 and 2 Euros assuming release rates above and below 0.5µg/cm2/week.

In the meantime further literature references will be gathered and made available to the Committee. Dr Lison, mentioned the existence of literature data which he could make available to the Committee before the next meeting. Other members were invited to do the same.

Tests will be conducted to assess the nickel release from samples of coins of 1 and 2 Euros. In response to some Committee members who argued that there was not yet agreement on this testing method the Commission representatives explained that the only disagreement related to the calculation of the surface of the object under study. This was relevant for jewellery where the surface was difficult to estimate; for coins, the calculation of the surface was not a problem. The results will allow the Committee to have a better idea of the risks involved. Apart from the JRC, the European Commission made contact with several laboratories to carry out the tests.

The Committee did not feel necessary to set up a specific working group to deal with the issue but the chairman of the Committee will centralize the data and prepare a draft opinion to be made available by its next meeting, scheduled for 3/4 September 1997.

The Commission representatives insisted on the need to have an opinion by September.

5. Discussion on Tri and Tetrachloroethylene. Status of the opinion

The representative of the Commission service ('Water quality' unit - XI/D/1) that requested the opinion of the CSTE on this agenda item made the remark that in the draft minutes of the previous meeting of the CSTE, in point 5.1 the term 'parameters' should be replaced by the term 'limit-values'. Nobody objected to this request.

Mr Papadopoulos went on to make a brief historical account of the reasons that led to the request for an opinion presently being discussed. The requester of the opinion followed the advice of the CSTE back in 1994. However, the European Parliament (EP) suggested the values were too high, meaning not restrictive enough. The EP suggested instead a global limit-value of 10µg/l but were unable to justify it.

It was also explained that the requester needs a CSTE opinion by the first week of September 1997. If this is not available then, the Council may decide, politically, something that is based, at least apparently, on no scientific data whatsoever. Clearly the requester would prefer to propose something with a valid scientific backing and a sound opinion of the CSTE would serve that purpose.

In respect of Trichloroethylene the chairman asked members whether they agreed with the reclassification of IARC (upon reconsideration of epidemiological data) of this substance as a group 2 carcinogen and whether, in the light of this, they were willing to stick to the limit-value they had suggested before.

The chairman commented that the limit-value of 10 µg/l suggested by the EP relates to 5 chemicals not all of which have much in common and this proves the point that there is a lack of logic in the EP proposal.

In favour of the IARC evaluations it was mentioned that the experiments on which they based their conclusions, which have revealed kidney cancers by trichloroethylene metabolites, imply a mechanism known to be present in man as well. For this reason the IARC conclusions should be supported. Countering this view some said that there are probably striking metabolic differences between man and mice.

On the other hand the Henschler study was a cluster (group formed because of common factor of kidney cancer), and there was exposure to unbelievable high amounts of trichloroethylene. In a 2nd study since carried out it was impossible to exclude the effects of other products such as arsenic.

Problems with the extrapolation of data were also mentioned. If the CSTE accepts IARC's view that this is a group 2 carcinogen does this also mean that it should be considered a genotoxic carcinogen? The question could not be answered.

It was apparent that the data available to the Committee at the meeting was not considered convincing enough and in particular there was no apparent reason for accepting the limit-values suggested by the EP. It was finally agreed to postpone an opinion till the next meeting in September. By then the CSTE will have had a chance of looking at a document which, it was suggested, might lead members to accept limit-values as stringent if not more as those proposed by the EP. The document in question is called 'Evaluation of health hazards by exposure to trichloroethylene; An estimation of quality criteria in soil and drinking water' and was prepared by Paul Bo Larsen of the Institute of Toxicology of the National Food Agency (January 1995).

As a matter of fact the document was made available during the meeting but its was considered to be more appropriate to give the CSTE a chance of taking a more careful look at it before trying to issue an opinion. Let already be said here that the recommended limit value in drinking water suggested therein is even more stringent (1µg/l).

The chairman is now going to prepare a paper on tri and tetrachloroethylene in drinking water for circulation to the CSTE members with a view to have an opinion finally available in September in time for the requester to use in their reply to the EP.

6. Information on the doc. 'Interactions between chemicals in the workplace' (Dr. Lison)

This agenda item was not taken for lack of time.

7. Date(s) of next meeting(s)

Decided at the Plenary meeting (26 June 1997, 14H00).

8. Any other business

None. The meeting was closed at about 10H00 of 26 June 1997 (it had continued into that day).

LIST OF PARTICIPANTS

CSTE:

Prof. Dayan (chairman)

Prof. G. De Mik

Dr. Schümann

Prof. Kyrtopoulos

Prof. Ladefoged

Dr. Lison

Prof. Oskarsson

Prof. Pelkonen

Dr. Pugh

Prof. Turnheim

Prof. Jouany

European Commission:

DG XXIV:

Mrs. Brunko

Mr. Costa-David

Mr. Vissol

Mr. Lainas

DG XI:

Mr. Bell

Mr. Papadopoulos