Other external experts could be selected by the members of the group. She explained that the group of DG III working in this subject had encountered a lot of problem in responding to certain questions, and requested that the Committee help her to find the appropriate responses. A member of the Committee said that for the Committee it would be easier to give responses because these will be only from a scientific point of view, and would not take account of non-scientific element. Concerning Leachable Proteins, these have been used as an indication of the allergen levels. Concerning chemicals, several chemicals that are commonly used during the NR device manufacturing process have been identified as causing type IV allergy.
Medical devices differ concerning the types and amounts of chemicals added.
The standard EN 455-3 requires the manufacturer to disclose, upon request, information about sensitising chemicals present in glove products. Concerning alternative products, several are discussed, in particular chlorinated latex gloves as alternative to powdered latex gloves. Dr. W.De Jong, as chairman, Prof. D. Williams, Prof. J. Descotes and Dr. A.H. Pettersen. He said that the complete report and opinion will be available in next few days, when typographical amendments were complete. The representative of the EMEA said that the report of the Agency will be finalised in July 1999.