Canada Legislation
Introduction Schematic view of procedure Recycling
Guidelines for Determining the Acceptability and Use of Recycled Plastics
Because of the increasing demand from government agencies and
the public to reduce the amount of solid waste into landfill
sites, more efforts have been directed to solid waste management
by reduction, recycling and reuse. As a result, there is an
increasing need for the plastics industry to meet the challenge
in reducing the amount of solid waste disposals by resorting to
the use of recycled materials in the fabrication of products.
The purpose of these guidelines is to assist manufacturers of
food packaging in determining the acceptability and use of
materials which contain post-consumer recycled food-contact
plastics intended for use in food packaging applications.
The suggestions provided herewith are for guidance purposes
only and apply to the recycling and re-use of post-consumer
food-contact plastics. They are not to be construed as legal
requirements. The use of recycled plastics, as with any other
plastic materials, in food packaging applications must comply
with the provisions of the Food and Drugs Act and Regulations.
Recycled materials such as glass, metal and aluminum have
historically been used for food packaging applications. These
materials are quite impervious to chemical contaminants and are
not likely to pose any health concern as they can be easily
cleaned.
Due to the permeable nature of plastics, the possibility that
chemical contaminants resulting from post-consumer misuse or
abuse remain in the recycled materials and migrate into food is
one of the major concerns regarding the safety of recycled
plastics used in food packaging applications. Other issues of
plastics recycling, such as microbial contamination and
structural integrity of the packaging, are important but will
not be discussed in detail. Because the processing of recycled
plastic materials involves high temperatures and the use of
sanitizers and cleaning agents which would effectively eliminate
any level of microbial organisms in the material, exposure to
microbial contaminants should not be of concern. Manufacturers
of recycled plastic materials made for use in food packaging
must test the physical properties of recycled plastics in the
same manner as virgin materials to ensure that the recycled
materials are of similar specifications as virgin plastics and
meet the technical requirements for their functional purposes.
The use of a recycled material as a non-food contact layer in a multilayered food package is a potential application for recycled plastics. Recycled plastics separated by an effective barrier made of an acceptable virgin plastic or other appropriate material such as aluminum would present no concern with respect to migration of potential contaminants into food. The effectiveness of the functional barrier depends on the chemical nature and thickness of the barrier, and the conditions of use. In some applications, the use of the functional barrier in the construction of the package will make it obvious that migration of non-food contact material into food is not possible under the conditions of use. In other applications involving more severe conditions of use, the effectiveness of the functional barrier to protect food from migration of contaminants should be demonstrated with scientific data. For instance, recyclers/manufacturers could intentionally incorporate a known concentration of contaminants into the recycled resin and, using a non-recycled material (plastic or other) as a barrier, perform extraction studies with food-simulating solvents to demonstrate the effectiveness of the barrier layer. Alternatively, manufacturers may design or develop other suitable techniques, in lieu of extraction studies, to establish the impermeability of a given barrier material under the intended conditions of use.
The recycling process of used plastics from food applications generally involves collection, sorting, reclamation and fabrication of finished products. Recyclers will have to develop a comprehensive source control program to monitor collection, baling and sorting. Appropriate source control measures may include but are not limited to the following:
documenting and maintaining records of all sources of recycled materials, from related batch numbers through to production lots of finished products;
limiting the source of collection to food-contact plastics. For example, only polystyrene cups, plates, cutlery from school cafeterias;
promoting the use of collection sites for plastics containers designated with the label "for food-contact use only";
sorting procedures to limit the plastic resin type;
implementing visual inspection systems and other devices
to detect and reject containers that may contain potential hazardous or
toxic substances;
Process efficacy which refers to the ability of the recycled
process to remove contaminants from recycled materials is the
determining factor in the use of recycled materials for food
packaging applications. In cases where plastic food containers
may have been used by consumers for secondary purposes (such as
storing motor oil, pesticides, etc.), a protocol which
demonstrates the efficacy of a clean-up process can be
established by exposing plastic packaging (either in container
form or as flaked or pelletized resin) to selected surrogate
contaminants. The material would then be subjected to the
recycling process. Subsequent analysis of the resulting material
for the levels of the residual contaminants would demonstrate
the efficacy of the recycling process. The choice of model
contaminants should be made up of a concoction of compounds
which reflect the anticipated commercial contaminants available
to consumers (automotive fuels and oils, solvents, pesticides,
toxic organic salts involving heavy metals, antifreeze,
household cleaners, etc.).
For a recycling process which involves initially the chemical
depolymerization of the recycled plastic (e.g. PET), followed by
regeneration and purification of the resulting monomers (or
oligomers) used to produce the new polymer, the efficacy of this
process may be demonstrated by an analytical protocol which
involves "spiking" the material with known levels of model
contaminants and subjecting it to the same depolymerization
process. The levels of the residual contaminants will be
measured by appropriate analytical methodology.
Exposure to microbial contaminants resulting from the use of recycled plastics should not be of concern by reasons discussed above. However, it is possible, that traces of chemical contaminants could be carried through the recycling process, become a part of the packaging and migrate into food in contact with the packaging. Recyclers/manufacturers must ensure that the recycling process is able to remove, neutralize or reduce the contaminants to insignificant levels which will not be injurious to the health of the consumer of the food packaged therein. In order to develop criteria in deciding what levels of contaminants in the recycled materials would be acceptable and not compromise the health of consumers, the Health Protection Branch takes the position that a probable daily intake (PDI) of 25 ng/kg b.w. or less of a contaminant in food arising from recycled food contact articles will generally be of negligible risk to consumers. This dietary exposure can in most cases be estimated on the basis of the residual level of the contaminant in the finished article and taking into consideration such factors as the density and thickness of the article, the ratio of food to contact surface, the consumption factor, the recycled resin content of the article and if appropriate, market penetration. In these calculations, complete (i.e.100%) migration of the contaminant from the food contact material to the food is assumed.
All packaging materials used in the sale of foods are subject
to the provisions of Division 23 of the Food and Drug
Regulations. While there is no specific prohibition against the
use of recycled materials for food packaging under these
Regulations, Section B23.001 prohibits the sale of foods in
packaging materials that may impart harmful substances to their
contents. Due to the general nature of Division 23, the Health
Protection Branch provides a service to packaging material
suppliers by conducting evaluations on the chemical safety of
products which are voluntarily submitted by manufacturers. If
the Branch considers a product to be acceptable, a No
Objection Letter is then issued to the packaging supplier
for some specified food packaging end use. The No Objection
Letter may then be presented to prospective food
manufacturing customers. The responsibility for compliance with
Section B.23.001 still rests with the food seller.
A No Objection Letter does not constitute an
approval of the product under the Food and Drugs Act and
Regulations. It is simply an opinion expressed by the Branch on
the acceptability of the product, based on the information
available at the time of its evaluation. Issuance of a No
Objection Letter does not relieve the product user (food
processor) of his responsibility under the Food and Drug Acts
and Regulations.
An essential element of the information required by the Health Protection Branch to evaluate the safety of a given food packaging material is an accurate characterization of its chemical composition. Chemical characterization of a virgin plastic material is relatively straightforward since the chemical identity of the plastic resin and the functional additives used in the manufacture of the packaging material can be readily ascertained from the suppliers. Chemical characterization of a recycled plastic material from post-consumer use is a more difficult proposition because contamination by any number of substances such as automotive fuel/oils, pesticides, disinfectants, etc., is possible. Manufacturers of recycled plastic materials seeking a No Objection Letter from the Health Protection Branch for use of their product in food packaging applications must be able to demonstrate that any contaminants are removed, neutralized or reduced to levels that will be safe to the consumer of the food packaged therein.
The following are the initial requirements1 for manufacturers of recycled plastics in the submission to the Health Protection Branch:
1. A submission covering letter:
Identifying the product by its manufacturer, trade name and code number, if applicable.
Clearly indicating the types of food, conditions (temperatures/time) and intended use of the product;
Describing the structure and dimensions of the product. For multilayered film, indicate the layer which may come in direct contact with food.
Describing in detail the chemical composition of the product, in the form of a complete quantitative list of all the ingredients used in its manufacture. Each ingredient should be identified by its chemical name, trade name and supplier.
2. A complete description of the recycling process starting
from initial collection of the recycled feedstock from
post-consumer use to the final fabrication of the product.
3. A complete description of the quality control program that
will be maintained to eliminate and neutralize chemical and
microbial contaminants in the recycled materials.
4. Manufacturers may have to demonstrate the efficacy,
supported by appropriate analytical methodology, of the
recycling process in removing chemical contaminants or reducing
chemical contaminants to sufficiently low levels in order to
assure that the resulting packaging would not adulterate foods.
It should be noted here that the Health Protection Branch (HPB) has reviewed the guidelines prepared by the Plastics Recycling Task Force (PRTF)2 in the U.S. for the safe use of recycled plastics for food packaging applications and finds that they provide a suitable framework for determining the acceptability of recycled plastics in relation to Division 23 of the Food and Drug Regulations. Thus, manufacturers seeking comments from HPB on the acceptability of such materials are advised, and indeed encouraged, to use that document as guidance in preparing proper submissions.
1Use of the term "requirements" is not intended to
mean required by law.
2PRTF is an ad hoc group formed under the joint
auspices of the National Food Processors Association (NFPA) and
The Society of the Plastics Industry Inc. (SPI). Its mandate was
(1) to develop guidelines pertaining to the safe use of recycled
plastics in contact with foods and, (2) to develop methodology
that could be used to determine whether particular reclaiming
processes produce materials suitable for use in food packaging
applications. The guidelines were published in March 1995. For
copies of the guidelines, contact the Canadian Plastics Industry
Association, Suite 500, 5925 Airport Road, Mississauga, Ontario,
L4V 1W1, Tel: (905) 678-7748, fax (905) 678-0774.
Manufacturers of recycled materials wishing to have their
products evaluated by the Branch on their acceptability for use
should address their submissions to:
Food Packaging Materials and
Incidental Additives Section
Chemical Health Hazard Assessment Division
Bureau of Chemical Safety
Food Directorate
Health Protection Branch
Sir Frederick Banting Building
Postal Locator: 2201D
Ottawa, Ontario
K1A 0L2
Telephone: (613) 957-1825 or 957-1709
Fax Number: (613) 990-1543
As part of its responsibility in administering the Food and
Drugs Act and Regulations, the Health Protection Branch provides
advice to other Departments and agencies on matters concerning
the acceptability of food packaging materials for use in food
establishments (including meat and poultry processing plants
registered under the Meat Inspection Act; fruit, vegetable and
dairy product processing plants registered under the Canadian
Agricultural Product Act and fish establishments, fish vessels
and fish processing establishments subject to the Fish
Inspection Act).
Manufacturers who wish to sell products to food plants
regulated as noted above under these various Acts must make
submissions to the Canadian Food Inspection Agency (CFIA)
covering products used in fish plants as well as in meat and
poultry, fruit and vegetable and dairy product processing
plants.
For further information regarding submissions to CFIA, please
contact:
Program Officer
Non-Food Chemicals & Container Integrity
Policy Planning & Coordination Directorate
Science Division
Canadian Food Inspection Agency
ADRI
3851 Fallowfield Road
Nepean, Ontario, Canada
K2H 8P9
Telephone: (613) 228-6698 Ext. 4965
Fax Number: (613) 228-6675
Email:
jdonald@em.agr.ca
These guidelines present a general approach to assist
manufacturers of recycled plastic materials in determining the
acceptability of such material for food contact use and in
preparing submissions to the Health Protection Branch for
evaluation of these products. The primary concern in food
packaging is the safety of the food supply and thus,
manufacturers must ensure that any recycled material used for
food packaging is in compliance with the requirements of
Division 23 of the Food and Drug Regulations. Adequate source
control, consumer education, effective cleaning and
decontamination processes, and adherence to good manufacturing
practices are important factors in ensuring the safe use of
recycled materials.
Bureau of Chemical Safety
Food Directorate
Health Protection Branch
Health Canada
September 23, 1996
This information is originating from Health Canada and this reproduction is not represented as an official version of the materials reproduced, nor as having been made, in affiliation with or with the endorsement of Health Canada.