Parafilm M® Barrier Film
Use in the European Community
Sometimes we are asked, by our customers in EC countries, for a
"European Health Usage Certificate". We are in essence being asked about
whether Parafilm is recommended for the manufacturing of food commodities
and toys. The basis for that request is guideline 90/128/EWG.
If a product is approved by the US Food and Drug Administration (FDA),
there is usually no need for further certifications in Europe. However,
Parafilm has not been submitted to FDA for this kind of application.
Sometimes customers are confused by the new IVD Directive, which shall be
applied by member states from June 7, 2000. According to that directive,
all "in-vitro diagnostic medical devices" should be marked with the CE sign
in the European Community. This directive is only applicable for products
which are especially designed for in-vitro examinations and has no effect
on products for general laboratory applications.
Parafilm M is a laboratory sealing film for general applications and
therefore is offered without CE markings.
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Friday July 04, 2008
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