Guidelines for Determining the Acceptability and Use of Recycled Plastics in Food Packaging Applications
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.
II. Points to consider:
1. The Use of Functional Barrier
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, ecyclers/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.
2. Source Control
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 "e;for food-contact use only"e;;
- 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;
3. Use Limitations:
Manufacturers and users may be in a better position to eliminate, reduce and neutralize the migration of potential chemical contaminants into foods packaged in recycled plastics by:
- restricting food type (such as use on dry foods, foods with natural protective shells, raw fruits and vegetables);
- limiting the use conditions of recycled packaging materials (such as use at room temperature or below);
- restricting use to food packaging applications where there is no or unlikely possibility of migration of potential contaminants to foods ( e.g. the wrappings of cartons of beverages which are contained in boxes, use in egg cartons, etc.);
4. Process Efficacy
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 "e;spiking"e; 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.
5. Exposure to Contaminants
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.
III. Federal regulations governing the use of packaging materials in food packaging applications
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.
IV. Information required for the evaluation of recycled plastics for use in food packaging applications
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 requirementsFootnote 1 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)Footnote 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.
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 & Incidental Additives Section
Chemical Health Hazard Assessment Division
251 Sir Frederick Banting Driveway
Postal Locator 2201C
Ottawa, Ontario, K1A 0K9
Fax Number: (613) 990-1543
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
Health Protection Branch
September 20, 2011
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