| Unipharm, Inc.
is committed to product quality and safety, and takes all
necessary measures to assure compliance with all appropriate
regulations. VITRUM®
formulas were originally developed in the U.S. in strict accordance
with U.S. government oversight, andt all VITRUM®
products marketed in the EU have been reformulated, when necessary,
to meet the requirement of the European Union.
 A
complex matrix of food labeling requirements were gradually
introduced in Europe, beginning in 1979, and these were finally
consolidated into a single Directive
2000/13/EC by the European Parliament and the Council of 20
March 2000.
Specifically with respect to vitamins and minerals, the Directive
90/496/EEC stated that information on vitamins and minerals
shall also be expressed as a percentage of reference values
(RDA). The Directive 2002/46/EC of the European Parliament
and of the Council of 10 June 2002 addresses the laws of the
Member States relating to food supplements. To enhance informed
consumer choice and safety, the European Commission's Directive
on Food Supplements establishes a harmonized set of rules
for the sale of vitamins and minerals as dietary supplements,
which specifies the vitamins and minerals that be used in
the manufacture of food supplements, how they should be labeled
and in what forms they are allowed. The Directive is now generally
in force throughout the EU, and Member States are responsible
for ensuring that food supplements are marketed within the
Community only if they comply with the rules laid down in
this Directive.
The objective of the most recent directive is two-fold. First,
it stipulates a general framework of safety rules for vitamins
and minerals in the European Union, including an authorized
list of chemical substances for use in the production process,
in accordance with the assessment by the Scientific Committee
for Food. Only vitamins and minerals that constitute the normally
healthy diet are to be present in food supplements. Secondly,
it mandates detailed labeling information to be readily available
for consumers - including a daily dose recommendation, a warning
against possible health risks from excess use, and a reminder
that pills are no substitute for a varied diet.
All VITRUM® products marketed by Unipharm,
Inc. in EU countries comply, in every detail, with all
EU requirements for food supplements.
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