COUNCIL DIRECTIVE of 29 March 1977 on biological screening of the population for lead (77/312/EEC)
THE COUNCIL OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Economic Community, and in particular Article 235 thereof,
Having regard to the proposal from the Commission,
Having regard to the opinion of the European Parliament (1),
Having regard to the opinion of the Economic and Social Committee (2),
Whereas one of the essential tasks of the European Economic Community is to promote throughout the Community a harmonious development of economic activities and a continuous and balanced expansion, neither of which can be achieved without combating pollution and nuisances and improving the quality of life and the protection of the environment;
Whereas the various uses of lead are at present causing contamination of many areas of the environment by this substance;
Whereas the many environmental sources of lead make it difficult to determine the total exposure of any one individual to this pollutant and therefore the protection of human health calls for the most accurate possible monitoring of the individual's total lead absorption;
Whereas biological screening of the population for lead should be carried out and the results of this screening evaluated so that, where appropriate, new proposals may be drawn up;
Whereas it is desirable to lay down the technical procedures and biological reference levels for such screening;
Whereas measurement of blood lead level is currently the best means of assessing the quantity of lead recently received by an individual as a result of exposure to environmental lead ; whereas the enzymatic activity of delta-aminolevulinic acid dehydratase (ALAD) may be used as an indicative or supplementary test for determining exposure to lead;
Whereas the programme of action of the European Communities on the environment (3) provides for the coordination of national programmes having as their aim the improvement of the quality of life and for priority investigation into lead,
HAS ADOPTED THIS DIRECTIVE:
Article 1
The Member States shall take the necessary steps to apply a common procedure for biological screening in order to assess the exposure of the population to lead outside the working environment.
Article 2
This common procedure, the application of which shall be restricted to four years, shall be based on the measurement of blood lead levels.
As an indicative or supplementary test, the ALAD measurement may also be used in accordance with the procedures laid down in Annexes II and III. (1)OJ No C 28, 9.2.1976, p. 31. (2)OJ No C 50, 4.3.1976, p. 9. (3)OJ No C 112, 20.12.1973, p. 3.
Article 3
1. The conditions for biological screening shall be fixed by means of: - sampling and analysis procedures,
- frequency of sampling.
2. Blood sampling shall be carried out on volunteers.
Article 4
Sampling shall be carried out on: - groups of at least 100 persons in urban areas with more than 500 000 inhabitants,
- groups of at least 100 persons, in so far as this is feasible, chosen from among people exposed to significant sources of lead pollution,
- critical groups determined by the competent authorities in the Member States.
In each Member State and during each campaign the number of analyses to be performed shall be 50 or more per million inhabitants.
Article 5
The sampling of the groups referred to in Article 4 shall be carried out during at least two campaigns in each area investigated during the period of operation of the programme, separated by at least 24 months. In the second campaign, samples shall not necessarily be taken from the same persons as in the first campaign.
Article 6
In assessing the results of the biological screening for the purposes of the action provided for in Article 8, the following blood lead levels, which take into account the relationships between dose and effect given in Annex I, shall be taken together as reference levels: - a maximum of 20 ¶g of Pb/100 ml of blood for 50 % of the group of people examined,
- a maximum of 30 ¶g of Pb/100 ml of blood for 90 % of the group of people examined,
- a maximum of 35 ¶g of Pb/100 ml of blood for 98 % of the group of people examined.
Article 7
Blood lead levels shall be determined as follows: - Member States shall inform the Commission of the names of the laboratories taking part in the biological screening programme and of the methods of analysis used,
- the Commission, in conjunction with the Member States, shall organize inter-comparison programmes in which the abovementioned laboratories shall participate,
- the Commission, in conjunction with the Member States, shall examine the results of these programmes with a view to improving the comparability of the methods of analysis.
Article 8
Where the results of the analyses indicate that the reference levels set out in Article 6 have been exceeded in one or more cases Member States shall: - check the validity of the results,
- take action to trace the exposure sources responsible for the levels being exceeded ; this shall also include action on all individuals with a blood lead level over 35 ¶g/100 ml,
- take all appropriate measures at the discretion of their competent national authorities.
Article 9
1. Within six months of notification of this Directive, the Member States shall designate the competent national authorities which shall forward to the Commission: - the data relating to the biological screening of the population groups referred to in Article 4, together with details of the methods of analysis, the population groups examined and the areas in which samples have been taken ; complete anonymity shall be preserved as regards the persons examined ; the Commission and the Member States shall agree on the procedures and the method whereby these data shall be forwarded,
- information on the causes or factors presumed to have resulted in the reference levels in Article 6 being exceeded.
2. The competent national authority shall also notify the Commission of the measures taken pursuant to the third indent of Article 8.
Article 10
At least twice a year the Commission shall convene a meeting of representatives of the Governments of the Member States, which shall, in particular: - ensure that implementation of the biological screening and in particular of the provisions of Articles 4 and 5 is harmonized,
- see that the analyses carried out are comparable,
- examine the information and facilitate the exchange of information between the Member States on the results of the biological screening and on the measures taken pursuant to Article 8.
Article 11
On the basis of the information collected pursuant to Article 9, the Commission shall draw up in cooperation with the competent national authorities: - a collated annual report on the implementation of the programme, which shall be forwarded to the Member States, the Council and the European Parliament,
- a general report at the end of the programme which will form the basis for drawing up any further proposals taking account of progress made in scientific and technical knowledge.
Article 12
Member States shall take the necessary measures to enable the procedure laid down by this Directive to enter into force within 12 months following its notification and shall immediately inform the Commission thereof.
Article 13
This Directive is addressed to the Member States.
Done at Brussels, 29 March 1977.