Packaging materials, information

Specimen or facsimile of each of the packaging materials. —Information concerning overprinted mentions or labels. 

Packaging Similarly, information on the closure/packaging systems must be provided in terms of material specification, suitability/compatibility with the pharmaceutical product, dimensional specifications, water impermeability, and so on. Defence against microbial contamination should be discussed in the context of either packaging of sterile product or use of preservatives as appropriate. 

A system of documentation should exist such that the history of each batch of the product, including details of starting materials, packaging materials, and intermediate, bulk and finished products, may be determined. Distribution records must be kept. This information is of paramount importance should a defective batch need to be recalled. 

The enforcement in Denmark of EU Directives on food packaging materials is discussed. Enforcement activities considered include studies of total migration from food contact materials, migration from kitchen-and tableware made of melamine plastics and migration of di(2-ethylhexyl)adipate from plasticised PVC films. Activities which need to be undertaken to increase the effectiveness of enforcement activities in the field of migration are described, including development of selfinspection programmes in industry, European network of enforcement, more rapid analysis and provision of information to the consumer. 2 refs. 

Data and information about a substance submitted as part of the procedures for establishing a tolerance for unavoidable contaminants in food and food-packaging materials, described in parts 109 and 509. 

JFSSG (1999a) Survey of retail paper and board food packaging materials for polychlorinated biphenyls (PCBs), Food Surveillance Information Sheet 174, available from the Food Standards Agency, Room 303b, P.O. Box 31037, London SW1P 3WG, Tel. No. +44 (0)20 7238 6245/6150, fax +44 (0)20 7238 6330 or email informationcentre foodstandards.gsi.gov.uk. 

Styrene can cause off-flavors in food products packed in polystyrene packaging materials. Each food product has a different sensitivity to styrene off-flavors and thus each food package system needs to be evaluated individually. The formation of styrene off-flavor in a given package/product system can be estimated a priori given the styrene threshold concentration in the food, the initial residual styrene monomer concentration in the packaging material and the desired shelf life. If this information is not readily available then accelerated storage tests followed by a sensory comparison can be carried out to evaluate the potential of off-flavor formation in the product. 

A description of the packaging material (Give the common or IUPAC names, molecular or ionic formulae, and structural diagrams for the packaging materials. Include recycling information.)... 

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