Information Requirements For Food Packaging Submissions

Packaging materials^{Footnote 1} 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.

2) Specific constituents/single additives (raw material suppliers)

Four elements of information are required for a submission on a new additive or a single constituent in a food contact material. They include information on the product's identity, its proposed usage, data on its extractability characteristics and toxicological data. The information to be included under each of these four elements is as follows:

a) Product identity

• Chemical name
• Chemical formula (empirical and structural)
• Molecular weight
• Manufacturing process (including a detailed description and a schematic diagram)
• Purity specifications (residual reactants, by products, etc)
• Chemical and physical properties

b) Proposed usage

• Intended technical effect or purpose (e.g. antioxidant, stabilizer, ultraviolet absorber, etc.)
• Types of substrates or polymers
• Maximum use level in each type of polymer
• Efficacy data to demonstrate that the additive will do what it is intended to do at the proposed use levels
• Types of foods involved
• Conditions of use (time, temperature, etc. to which the packaging material will be exposed, whether during processing, transport or handling by consumers)

c) Migration/extraction data

Extraction studies data are required to identity and quantify the potential contaminants in foods. These studies are usually conducted using food simulants under conditions that reflect as close as possible those of the proposed end-use applications. HPFB accepts 95% aqueous ethanol as a fatty food simulant so that most manufacturers now conduct extraction studies using only two different food simulants namely, 10% aqueous ethanol and 95% ethanol. The first is suitable for aqueous, acidic and low alcoholic foods while the second is acceptable for high alcoholic foods and fatty foods. However, while extraction data obtained with 10% and 95% ethanol are acceptable, any extraction data submitted from studies using the more traditional food simulants such as distilled water, 3% acetic acid, 15% ethanol, heptane and/or HB 307 (a synthetic triglyceride) are also considered valid. The final report must provide all the parameters used in the study (i.e. volumes of food simulants, surface area exposed, time, temperature, etc.). It must also contain the full details of the analytical methodology employed for measuring the levels of migrants in the food simulants, including validation data and an estimate of its limit of detection.

d) Toxicological data

The submitted toxicological data should provide the basis for the petitioner's safety determination for the packaging material constituent under the proposed conditions of use. The toxicological studies recommended by HPFB for its safety assessment are based on levels of concern that are determined by the level of dietary exposure. Dietary exposures that fall below 0.025 ug/kg bw are considered to be below the threshold of toxicological concern and toxicological data need not be submitted. The four levels of concern and recommended toxicological data are described below and summarized in Tables I and II. Nevertheless, HPFB may identify a need for additional studies and request that these be submitted in order to complete its safety assessment. Consequently, HPFB encourages the submission of all unpublished and published studies relevant to the safety assessment of the packaging material constituent regardless of level of dietary exposure. When unpublished studies are submitted, full reports complete with the primary data should be included when available. Sufficient details should also be provided in order to ascertain that study protocols conform with the testing guidelines published by the Organization for Economic Co-operation and Development and were conducted according to good laboratory practice.

• Concern Level 1 ("very low") - 0.025 - 0.1 µg/kg b.w. - Requires data for structure activity of the substance, in accordance with structure categories listed in the U.S. FDA Red Book and/or other methods
• Concern Level 2 ("low") 0.1 - 2.5 µg/kg b.w. - Requires the submission of the information specified under Concern Level 1 plus two short term genotoxicity studies and a 28-day feeding study in rodents. The two genotoxicity studies normally required are an Ames test and a chromosomal aberration assay, either in vitro or in vivo, in mammalian cells.
• Concern Level 3 ("medium") 2.5 - 25 µg/kg b.w. - Requires the submission of the studies specified in Concern Level 1, two short term genotoxicity studies as specified in Concern Level 2 plus a 90-day feeding study in rodents, a multi generation study in rodents and a teratology study also in rodents. At this concern level, the 28-day rat study required under Concern Level 2 is replaced by a 90-day rat study.
• Concern Level 4 ("high") > 25 µg/kg b.w. - Requires the submission of the studies specified under Concern Level 3 plus a 1-year feeding study in non-rodents and a chronic toxicity/oncogenicity study in two rodent species.

3) Contacts

Completed submissions may be forwarded to:

Food Packaging Materials & Incidental Additives Section
Chemical Health Hazard Assessment Division
Health Canada
251 Sir Frederick Banting Driveway
Postal Locator 2201C
Ottawa, Ontario, K1A 0K9
Canada
Email: hc.fpmia-meaai.sc@canada.ca

¹Probable Daily Intake