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The Directive on Dangerous Substances

Collection of Information on Enzymes

Enzymes are chemical substances with a wide range of applications; there are technical enzymes, food enzymes, feed enzymes, enzymes used in cosmetics and in pharmaceuticals and enzymes used in research, to name a few.

The majority of enzymes is manufactured from micro-organisms. With the new genetic engineering techniques, enzymes from almost any source in nature, exhibiting enhanced enzyme properties, are becoming accessible. Potential applications are expanding rapidly.

Under the EU chemical legislation, new enzymes have to be notified as "new substances", which means that a predefined set of information has to be supplied by the manufacturer. The notification procedure is however not uncontested: opinions differ as to what methodology should be used to characterise and test the different enzymes and establish potential hazards.

The report "Collection of Information on Enzymes" is the result of a study commissioned by the Environment Directorate General of the European Commission. It provides an in-depth view of enzymes, their production, use and properties, as well as enzyme regulation in some non-EU countries. It also outlines potential hazards to the environment and human health and gives recommendations as to how enzymes could be regulated in future.

Full text of the Report (pdf ~2.8 MB)

Executive Summary (pdf ~75K)