ADDITIVE SELECTION IN FOOD-CONTACT AND MEDICAL MATERIALS

摘要

The paper reviews the current regulatory position relating to selection of additives for medical and food contact materials. Regulations and recommendations discussed include; a) The 2002/72/EC Directive on Food-contact plastics b) The European Pharmacopoeia c) Specifications and information required in support of applications for marketing authorizations relating to primary packaging materials for new medicinal products for human and veterinary medicinal products. d) FDA Regulations e) The Council of Europe Resolution on Rubber Particular emphasis is placed on antioxidants/stabilisers and antistatic agents. Brief details are given of LC-MS and GC x GC TOF identification of additives.