WRITTEN QUESTION E-1462/00

by Jillian Evans (Verts/ALE) to the Commission

(10 May 2000)

Subject: Effects on health of calcium sulphate

What information does the Commission have on the long term effects of exposure to calcium sulphate on human health and what measures if any have been taken to minimise the risks of exposure?

Answer given by Mr Byrne on behalf of the Commission

(19 July 2000)

Calcium sulphate is a chemical compound which is used in many different areas. It is mainly used in the production of cement and as a building material. The substance has an irritating effect on air passages and eyes. Little is known of the long-term harmful effects. The exposure of workers to dangerous chemicals is covered by Council Directive 98/24/EC of 7 April 1998, on the protection of the health and safety of workers from the risks related to chemical agents at work(1) which provides for specific prevention measures based on risk assessment.

Calcium sulphate is authorised for use as a food additive (EC number E 516). Based on the opinion of the scientific committee for food, it has not been assigned a specified acceptable daily intake (ADI). This means that it is not necessary to set a maximum level to ensure safety of the use of this substance in food. Therefore in this area of use, no further measure is needed.

It is also used as an implant, such as in bone substitutes, and is in that case covered by Council Directive 93/42/CEE of 14 June 1993, on medical devices(2). Impurities may cause problems in the use of calcium sulphate, but there are well known procedures for cleaning the materials and well-accepted USP (US Pharmacopoeia) and NF (National Formulary) guidelines in place (Pharmacology standards). Long term adverse effects of use in bone substitutes are not known.

(1) OJ L 131, 5.5.1998.

(2) OJ L 169, 12.7.1993.