Annexes to COM(1976)556 - Approximation of Member States' laws, regulations and administrative provisions on the protection of the health of workers occupationally exposed to vinyl chloride monomer (submitted to the Council by the Commission) - Main contents
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dossier | COM(1976)556 - Approximation of Member States' laws, regulations and administrative provisions on the protection of the health of workers ... |
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document | COM(1976)556 ![]() |
date | June 29, 1978 |
1. Owing to differences in definition, the recommended values for the permissible atmospheric concentration substances injurious to health at the workplace currently vary from country to country.
This Directive is concerned with a new, statistically-defined reference value - the technical long-term limit value - which should be regarded as a mean annual value.
2. The limit values for shorter reference periods are based on data obtained by extensive measurement of vinyl chloride monomer concentrations in the vinyl chloride polymer industry. These measurements accord with the data resulting from observations both on other substances injurious to health and for other sectors of industry.
The data can be summarized as follows: (a) the distributions of concentrations of substances injurious to health can be represented log normally;
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3. Assuming these data, a mean ratio of the limit values for shorter reference periods to the technical long-term limit value can be established: >PIC FILE= "T0013208">
4. The above limit values for reference periods shorter than one year must have a maximum 5 % probability of being exceeded when the annual arithmetic mean of atmospheric vinyl chloride monomer concentrations is three parts per million.
ANNEX II GUIDELINES FOR THE MEDICAL SURVEILLANCE OF WORKERS (Article 10 (2))
1. Current knowledge indicates that over-exposure to vinyl chloride monomer can give rise to the following disorders and diseases: - sclerodermatous skin disorders,
- circulatory disorders in the hands and feet (similar to Raynaud's syndrome),
- acro-osteolysis (affecting certain bone structures, particularly the phalanges in the hand),
- liver and spleen fibroses (similar to perilobular fibrosis, known as Banti's syndrome),
- lung function disorders,
- thrombocytopenia,
- hepatic angiosarcoma.
2. Medical surveillance of the workers should take account of all symptoms and syndromes, with particular emphasis on the area of greatest risk. As far as is known at present, no symptoms occurring separately or in combination have been identified as precursors or transitional stages of hepatic sarcoma. As no specific methods of preventive analysis are known for this disease, medical action shall include at least the following measures as minimum requirements: (a) records of the workers's medical and occupational history,
(b) clinical examination of the extremities, the skin and the abdomen,
(c) X-ray of the hand bones (every two years).
Further tests, particularly laboratory tests, are desirable. These should be decided by the competent doctor in the light of the most recent developments in industrial medicine.
The following laboratory tests are suggested at present for prognostic epidemiological surveys: - urinalysis (glucose, proteins, salts, bile pigments, urobilinogen),
- erythrocyte sedimentation rate,
- blood platelet count,
- determination of total bilirubin level,
- determination of transaminase levels (SGOT, SGPT),
- determination of gamma glutamyl transferase (GT) level,
- thymol turbidity test,
- alkaline phospatase level,
- determination of cryoglobulin.
3. As in the case of all biological examinations, the results of the tests shall be interpreted in the light of the laboratory techniques used and their normal values. Generally speaking, the significance of a functional disorder is assessed after joint consideration of the results obtained from various examinations and by developments in the anomalies observed. As a general rule, abnormal results shall be investigated and, if necessary, additional specialist examinations carried out.
4. The competent doctor shall decide in each case whether a worker is suitable for a working area.
The competent doctor shall also decide what contra-indications apply. The most important of these are: - typical vascular and neurovascular lesions,
- lung function disorders,
- clinical or biological hepatic insufficiency,
- diabetes,
- chronic renal insufficiency,
- thrombocytopenia and hemorrhagic disorders,
- certain chronic skin diseases such as scleroderma,
- abuse of alcohol and/or addiction to drugs.
This list, which is intended merely for guidance, has been drawn up using pathological data obtained from previous retrospective studies.