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Directorate-General for Health and Food Safety
The meeting was chaired
by Prof. Klein.
1. Approval of the draft agenda
The draft agenda was adopted.
2. Apologies for absence (if any)
Apologies were received from Prof. Brandt, Dr Canton and Prof. Silva Fernandes.
3. Discussion on the subject 'Dutch request to apply article 100a(4) - Cadmium'
The Secretary of the CSTE made an introduction to this agenda item. He drew the attention of the Ecotoxicology section members to the fact that some of the documents sent as working documents for the discussion (docs. 3, 4, 5 and 6 of the 2nd list of documents for the meeting) should be discarded as they were not of a scientific nature.
As regards the reason proper for the Commission to have decided to consult the CSTE on this, it was noted that there was one fundamental reason. The 'new' Directorate General XXIV, given its new responsibilities in the field of consumer health, has to take a much more proactive role in the defence of the interests of the consumer. Having been consulted by DG III (Industry, 'chef de file' for this dossier) on the adequacy of their proposed action to deal with it, DG XXIV wanted to have the best information possible before giving an answer. Given that the CSTE is now under its responsibility, it was DG XXIV's view that the CSTE should be consulted on the matter before.
The representative of Directorate General III of the European Commission, Mr Berend, gave an overview of the problem which goes back to 1992 when the Dutch authorities first notified the Commission of their intention to have article 100a(4) applied to deal with their 'cadmium problem'. In practice what the Dutch authorities wanted were two things which would make their legislation (the so called 'Cadmium decree') differ from the Cadmium Directive (91/338/EEC); they are:
- Set a limit value of 50 p.p.m. instead of 100 p.p.m. as in the Directive.
- Ban cadmium in pigments and stabilisers for plating in more applications than those foreseen in the Directive.
To ascertain whether such a request was founded, DG III requested an economic and a scientific study which allowed for the following conclusions: the Dutch decree does not appear to be a means of arbitrary discrimination or of a restriction to trade and, as the study allowed to conclude, the Dutch provisions did not seem to be justified as far as health and environmental effects are concerned.
Generally, members of the Ecotoxicology section thought that giving an opinion on the basis of the evidence made available to the CSTE was very difficult because the data was considered very poor. The 'scientific' data submitted to the CSTE was considered insufficient since it does not contain any statistical analysis. This cannot be compensated for, it was said, by general statements about levels where the word 'significant' is occasionally used without substantiation.
One of the shortcomings which members of the Ecotoxicology section mentioned was the lack of data on body burdens. The representative of DG III said that these were not considered in the study commissioned by DG III because, in making their request, the Dutch authorities did not consider them either. It was nevertheless emphasized by members of the CSTE that, in trying to come up with proper conclusions on a problem such as this, that kind of data was of the utmost importance. The same comment was made in respect of data on animal body burdens.
It was acknowledged that the CSTE is not necessarily bound by the nature of the papers distributed to it. It can draw on other forms of knowledge to which its members have access. It was also acknowledged that, in spite of the fact that the reports are not ideal, it does not mean that they do not have any value. It was mentioned that all that the ERM report does is reinterpret the data in the Dutch report, and that it does it in a sufficient way.
It was mentioned that the CSTE had already in the past issued opinions on cadmium levels (in 1981 and 1989) which were considered to be still valid. However the section was reminded that the question put before them was now different. The put the present problem in the right perspective the form of words chosen and sent to members of the CSTE in the convocation letter was also reminded.
In discussing the pertinence of taking into consideration the specificities of the Dutch circumstances, it was suggested that, at the preparatory stages of the so called 'Cadmium directive', specific circumstances such as the Dutch ones had also been taken into consideration. This has to mean that the 100 p.p.m. value in the 'Cadmium directive' already addresses less favourable realities such as the Dutch ones.
During the discussion it was mentioned that the problem with national data is that it does not take necessarily into account regional data. Comparisons on a country to country basis can be misleading. If regional data were made available a different picture would emerge, some said. Others said that, legalistically, what is necessary is to compare country to country data and regional differences, no matter how much sense they may make, should not be accounted for.
Others believed, as suggested in the references to the decision that led to the 100 p.p.m. level, that regional differences had been already accounted for at the drafting stages of the 'Cadmium directive' and, as such, the Dutch authorities would have some difficulties in making their case. The case of the 'Po valley' in Italy was mentioned. This might be a case even worse than the Dutch one and in spite of this, this is a region which is not entitled to any particular derogation foreseen under EU legislation.
To counter this argumentation some said that the situation today might be different from the one on the basis of which the 'Cadmium directive' was drafted but this could not be proved.
It was finally agreed that comparisons with averages do not make sense since we will always have cases above and below that average. If this were to be the logic to be pursued, cases that would loose out could always claim to be entitled to a derogation.
In the end, and in spite of the shortcomings already pointed out, the Ecotoxicology section of the CSTE agreed to issue an opinion. The text was discussed and the one that was finally agreed was to be completed at the Plenary meeting with the inclusion of one extra sentence recognizing that, in making the request to apply Article 100a (4), on this particular occasion the Dutch authorities failed to make their case.
5. Date of next meeting
To be decided at the Plenary meeting in the afternoon.
6. Any other business
Without any other business the meeting was closed at 12H30.
LIST OF PARTICIPANTS
CSTE:
Prof. Bro-Rasmussen
Prof. Calow
Prof. Chambers
Prof. Jouany
Prof. Klein (chairman)
Prof. Persoone
Prof. Scoullos
Prof. Vighi
European Commission:
DG XXIV:
Mr. Costa-David
Mr. Lainas
DG III:
Mr. Berend
DGXI:
Mrs. Fidalgo
Mr. Jesus-González
1. Approval of the draft agenda
The draft agenda was adopted.
2. Apologies for absence (if any)
Apologies were received from Prof. Brandt, Dr Canton and Prof. Silva Fernandes.
3. Discussion on the subject 'Dutch request to apply article 100a(4) - Cadmium'
The Secretary of the CSTE made an introduction to this agenda item. He drew the attention of the Ecotoxicology section members to the fact that some of the documents sent as working documents for the discussion (docs. 3, 4, 5 and 6 of the 2nd list of documents for the meeting) should be discarded as they were not of a scientific nature.
As regards the reason proper for the Commission to have decided to consult the CSTE on this, it was noted that there was one fundamental reason. The 'new' Directorate General XXIV, given its new responsibilities in the field of consumer health, has to take a much more proactive role in the defence of the interests of the consumer. Having been consulted by DG III (Industry, 'chef de file' for this dossier) on the adequacy of their proposed action to deal with it, DG XXIV wanted to have the best information possible before giving an answer. Given that the CSTE is now under its responsibility, it was DG XXIV's view that the CSTE should be consulted on the matter before.
The representative of Directorate General III of the European Commission, Mr Berend, gave an overview of the problem which goes back to 1992 when the Dutch authorities first notified the Commission of their intention to have article 100a(4) applied to deal with their 'cadmium problem'. In practice what the Dutch authorities wanted were two things which would make their legislation (the so called 'Cadmium decree') differ from the Cadmium Directive (91/338/EEC); they are:
- Set a limit value of 50 p.p.m. instead of 100 p.p.m. as in the Directive.
- Ban cadmium in pigments and stabilisers for plating in more applications than those foreseen in the Directive.
To ascertain whether such a request was founded, DG III requested an economic and a scientific study which allowed for the following conclusions: the Dutch decree does not appear to be a means of arbitrary discrimination or of a restriction to trade and, as the study allowed to conclude, the Dutch provisions did not seem to be justified as far as health and environmental effects are concerned.
Generally, members of the Ecotoxicology section thought that giving an opinion on the basis of the evidence made available to the CSTE was very difficult because the data was considered very poor. The 'scientific' data submitted to the CSTE was considered insufficient since it does not contain any statistical analysis. This cannot be compensated for, it was said, by general statements about levels where the word 'significant' is occasionally used without substantiation.
One of the shortcomings which members of the Ecotoxicology section mentioned was the lack of data on body burdens. The representative of DG III said that these were not considered in the study commissioned by DG III because, in making their request, the Dutch authorities did not consider them either. It was nevertheless emphasized by members of the CSTE that, in trying to come up with proper conclusions on a problem such as this, that kind of data was of the utmost importance. The same comment was made in respect of data on animal body burdens.
It was acknowledged that the CSTE is not necessarily bound by the nature of the papers distributed to it. It can draw on other forms of knowledge to which its members have access. It was also acknowledged that, in spite of the fact that the reports are not ideal, it does not mean that they do not have any value. It was mentioned that all that the ERM report does is reinterpret the data in the Dutch report, and that it does it in a sufficient way.
It was mentioned that the CSTE had already in the past issued opinions on cadmium levels (in 1981 and 1989) which were considered to be still valid. However the section was reminded that the question put before them was now different. The put the present problem in the right perspective the form of words chosen and sent to members of the CSTE in the convocation letter was also reminded.
In discussing the pertinence of taking into consideration the specificities of the Dutch circumstances, it was suggested that, at the preparatory stages of the so called 'Cadmium directive', specific circumstances such as the Dutch ones had also been taken into consideration. This has to mean that the 100 p.p.m. value in the 'Cadmium directive' already addresses less favourable realities such as the Dutch ones.
During the discussion it was mentioned that the problem with national data is that it does not take necessarily into account regional data. Comparisons on a country to country basis can be misleading. If regional data were made available a different picture would emerge, some said. Others said that, legalistically, what is necessary is to compare country to country data and regional differences, no matter how much sense they may make, should not be accounted for.
Others believed, as suggested in the references to the decision that led to the 100 p.p.m. level, that regional differences had been already accounted for at the drafting stages of the 'Cadmium directive' and, as such, the Dutch authorities would have some difficulties in making their case. The case of the 'Po valley' in Italy was mentioned. This might be a case even worse than the Dutch one and in spite of this, this is a region which is not entitled to any particular derogation foreseen under EU legislation.
To counter this argumentation some said that the situation today might be different from the one on the basis of which the 'Cadmium directive' was drafted but this could not be proved.
It was finally agreed that comparisons with averages do not make sense since we will always have cases above and below that average. If this were to be the logic to be pursued, cases that would loose out could always claim to be entitled to a derogation.
In the end, and in spite of the shortcomings already pointed out, the Ecotoxicology section of the CSTE agreed to issue an opinion. The text was discussed and the one that was finally agreed was to be completed at the Plenary meeting with the inclusion of one extra sentence recognizing that, in making the request to apply Article 100a (4), on this particular occasion the Dutch authorities failed to make their case.
5. Date of next meeting
To be decided at the Plenary meeting in the afternoon.
6. Any other business
Without any other business the meeting was closed at 12H30.
LIST OF PARTICIPANTS
CSTE:
Prof. Bro-Rasmussen
Prof. Calow
Prof. Chambers
Prof. Jouany
Prof. Klein (chairman)
Prof. Persoone
Prof. Scoullos
Prof. Vighi
European Commission:
DG XXIV:
Mr. Costa-David
Mr. Lainas
DG III:
Mr. Berend
DGXI:
Mrs. Fidalgo
Mr. Jesus-González
