Information Requirements For Food Packaging Submissions
Packaging materials1 intended for use with foods
in Canada may be submitted voluntarily to
the Health Products and Food Branch (HPFB) for a pre-market
assessment of their chemical safety and subsequent issuance
of an advisory opinion on their acceptability in relation to
Section B.23.001 of the Food and Drugs Act and Regulations
dealing with the potential transfer of harmful chemicals to
foods. Any type of material, whether it is in the form of a
finished product such as a laminated film, a container, etc.
or a formulated product such as a plastic resin, a colour
concentrate, etc. may be submitted to the Branch for a
pre-market assessment. In addition, suppliers of single
additives like antioxidants, ultra violet absorbers, etc. may
also independently request letters of opinion for their own
products before selling them to formulators or converters.
Thus, in terms of data requirements, food packaging
submissions may be divided into two distinct categories
namely, those on formulated products and finished
articles which are normally submitted by converters
and formulators and those on specific constituents or
single additives which usually originate from raw
material suppliers.
The following information is provided as a guide to the food
packaging industry to assist in the preparation of
submissions to HPFB.
1) Formulated products & finished articles
(formulators/converters)
Two elements of information are required
initially for a formulated product or a
finished packaging article namely, the product's identity
and its intended food packaging uses. The information to be
provided under each element is as follows:
a) Product identity
-
Trade name and number (mostly for records purposes)
-
Structure (eg. laminate)
-
Composition (in the form of a quantitative listing of all
components in which each one is identified by proper
chemical name and/or trade name, grade and supplier)
-
Specifications
-
Chemical/physical properties relative to proposed use
b) Proposed usage
-
Form of finished package (eg. bottle, film, casing, etc.)
-
Dimensions of package (volume, wall thickness, etc.)
-
Packaging ratio, i.e. weight of food/unit area of
packaging material (g/in2)
-
Conditions (time, temperature) to which packaging article
will be exposed during packaging, distribution and use by
consumers
-
Estimate of projected market penetration
Other sources of information or items which are not essential
but may sometimes be useful for evaluation purposes include
Material Safety Data Sheets, Technical Data Sheets, Product
Literature and even sometimes a sample of the finished
article.
Should this initial evaluation of a formulated or finished
product reveal the presence of one or more new components,
the safety of which has not been evaluated by HPFB, the
ingredients so identified will then fall into category 2) and
will require the submission of all data outlined below for
specific constituents or single additives. The advisory
opinion for the formulated product or finished article will
then be withheld pending completion of the safety assessment
of the new constituents.
1On a trade name basis, not by generic name
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