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- Practical Guide -
Page 128 of 153
SECTION 14
PARAFFIN WAXES AND MICROCRYSTALLINE WAXES
EU legislation
Paraffin waxes are not yet regulated at EU level by a specific Directive and, therefore, the
general provisions of the Framework Directive 89/109/EEC [A11] apply.
2.
Wax (REF. N. 95859) and oils (REF.N. 95883)
The Directive 2002/72/EC [A29] contains some specifications of waxes, refined and white
mineral oils, paraffinic.
Other information can be found:
a)
For waxes in par. 172.886(b) of the Code of Federal Register of the US FDA
b)
For white mineral oils in the European Pharmacopoeia as "Paraffinum Liquidum"
Nota bene 1
Since some of the waxes are also used as direct food additives, evaluations from the SCF can be found for
certain qualities of waxes (specified by the EU directives).
Nota bene 2
The term "highly", used in the SCF opinion does not appear in the current specifications because it is too
generic and unnecessary for the definition of the product. In fact, the product should comply with the
specifications appearing in the SCF opinion as well as with that of this document.