Regulation secondary packaging

Clauses (a) and (b) clearly do not apply to secondary packaging materials. It is clause (c) which is more applicable materials and articles. ..which...can reasonably be expected to... transfer their constituents to foods. Thus, although the title of the Regulation indicates that it applies to materials and articles intended to come into contact with food , Article 1 can be taken to include secondary packaging materials. 

Thus the provisions of Articles 1 and 3 of the EC Regulation give a clear indication that all those involved in the food packaging chain need to consider whether the secondary packaging materials they use comply with the Regulation. 

Although the types of test procedure will broadly continue to follow the stages identified in this and other chapters, the ultimate intensity of the procedure must be related to (and vary with) the type of product and the route by which it is administered etc. The use of a declared food grade plastic is usually the minimum standard that would be used for a pharmaceutical product, either for a secondary packaging component or where extraction between product (solid items) and the plastic may seem unlikely. Reference to toy regulations may also provide useful information, especially where coloured materials are employed. 

FDA regulations for ophthalmic liquids allow the use of unpreserved multidose packaging if the product is packaged and labeled in such a manner as to afford adequate protection and minimize the hazards resulting from contamination during use (21 CFR 200.50). Thus, the same unit-dose containers can be modified to use a resealable cap and the labehng modified to limit the usage to a minimum number of doses such as to discard after 12 hours from initial use and limit the content volume to the expected number of doses with only a small overfill if necessary. It may be necessary to use a secondary... 

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