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Description of key information

The ability of enzymes to elicit respiratory sensitization is well known and the classification of enzymes as respiratory sensitizers is widely accepted. However, when exposure is controlled and limited, experience demonstrates that enzymes can be used safely. 

Additional information

The ability of enzymes to elicit respiratory sensitisation is well known. Occupational surveillance programs have identified occupational enzyme allergy cases, however, mostly resulting from exposure to dusty enzymes prior to modern advancements in product formulation (encapsulation) and industrial hygiene (ref. 1).

For enzymes, it is also well known that the sensitizing dose level is lower than the dose that elicits symptoms (ref. 2). This means that a dose level which does not sensitise the exposed people will not elicit any allergy-related clinical reactions in already sensitized individuals. From the studies of consumer exposure it is possible to identify exposure levels to enzymes that do not lead to sensitisation. The exposure that leads to sensitisation in the occupational setting is an unknown combination of exposure level, exposure duration, exposure interval (i.e. frequency) and individual susceptibility (ref. 1). For the occupational exposure, a derived minimal effect level (DMEL) of 60 ng/m3 has been provided (ref. 1). For consumers, a DMEL of 15 ng/m3 has been proposed (ref. 1). Application of the two effect levels has been shown to lead to safe occupational environment and safe consumer use of enzymes (ref. 1, 2). 

 

References:

1. Basketter D.A., C. Broekhuizen, M. Fieldsend, S. Kirkwood, R. Mascarenhas, K. Maurer, C. Pedersen, C. Rodriguez, and H.E. Schiff, 2010. Defining occupational and consumer exposure limits for enzyme protein respiratory allergens under REACH. Toxicology , 268:165–170.

2. Sarlo, K., Kirchner, D.B., 2002. Occupational asthma and allergy in the detergent industry: new developments. Curr. Opin. Allergy Clin. Immunol. 2, 97–101.