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Consumer Safety

Industrial enzymes are normally used as processing aids and are generally not present as active ingredient in consumer products. However in certain products like detergent products enzymes can be present as active ingredients. Within the pharmaceutical industry there are a limited number of enzymes used therapeutically, however these are not in the scope of AMFEP.

Enzyme respiratory sensitization is not associated with consumer products, and enzymes have for instance a long history of safe use within detergent products [1].

Nevertheless, it is important that an adequate risk assessment is made whenever a new enzyme containing consumer product is developed.

The Soap and Detergent Association, SDA, (American Cleaning Institute, ACI, as of 2010) in collaboration with the enzyme manufacturers has developed a document on “Risk assessment guidance for enzyme-containing products” (SDA, 2005). Of course, this document focuses on how to make risk assessments on enzyme containing consumer products within the laundry and cleaning industry. However, the principles described in this document are generally applicable to all industries, and Amfep strongly encourages that the appropriate risk assessment process is conducted prior to the introduction of enzymes in consumer products.

Enzymes in consumer products do not lead to skin problems upon normal use. Enzymes are not skin sensitizers, as explained in the AMFEP Position Paper “Lack of Skin Sensitisation Potential”. Mild irritation could in theory occur when handling products containing high concentrations of protease, however there is evidence that for detergent products enzymes are not responsible for skin complaints [2].

If enzymes are to be used in personal care or cosmetics applications special attention in regards to risk assessment is needed. The enzyme manufacturers (AMFEP together with the Enzyme Technical Association in the USA, published a Position Paper “AMFEP And ETA Position On Consumer Risk Assessments For Enzyme-Containing Personal Care Products And Cosmetics” to help manufacturers perform a specific risk assessment for this enzyme use.

Special attention should also be given to the risk assessment of enzyme containing consumer products that are applied via pump sprays. A protocol for the risk assessment  of such products is made available by AISE.

If enzymes are included in products for cleaning of medical devices the users should be instructed not to create aerosols for instance by open process ultrasonic cleaning. If ultrasonic cleaning is applied the equipment must be closed and kept closed for at least 5 minutes after cessation of the ultrasonic treatment, allowing aerosols to settle before opening the equipment.

Enzymes from plant or animal sources are naturally present in fresh food and are consumed every day. Similar enzymes derived from both fungal and bacterial sources have a long history of safe use in the food industry. As stated in a review by the US Food and Drug Administration FDA (Olempska-Beer et al , 2006) [3].Enzymes are degraded and metabolized after ingestion like other dietary proteins, and enzymes naturally present in the human diet have not been associated with toxicity and are considered intrinsically safe. Ingestion of food enzymes in general is also not a concern with regard to food allergy (Bindslev-Jensen et al., 2006) [4].

Enzyme suppliers can advise or provide more detailed information and support related to the specific enzyme preparation and consumer use situation.

 

[1] Basketter B, Berg N, Broekhuizen C, Fieldsend M, Kirkwood S, Kluin C, Mathieu S and Rodriguez C, Enzymes in Cleaning Products: An Overview of Toxicological Properties and Risk Assessment/Management, Regul Toxicol Pharmacol. 2012 Oct;64(1):117-23. Epub 2012 Jun 26.

[2] Basketter DA, English JS, Wakelin SH, White IR., Enzymes, detergents and skin: facts and fantasies. Br J Dermatol. 2008 Jun;158(6):1177-81

[3] Olempska-Beer ZS, Merker RI, Ditto MD, DiNovi MJ., Food-processing enzymes from recombinant microorganisms--a review., Regul Toxicol Pharmacol 2006 Jul; 45(2):144-158.

[4] Bindslev-Jensen C, Skov PS, Roggen EL, Hvass P, Brinch DS., Investigation on possible allergenicity of 19 different commercial enzymes used in the food industry., Food Chem Toxicol 2006 Nov;44(11):1909-15