Introduction
Jurisdictional and regulatory issues
Controversial substances
Strengths and weaknesses of the regulatory approach
Solutions - Introduction
Efficiency
Substitution
Redesign
Financing the transition
Introduction
Although many additives and processing aids improve safety, freshness, taste, texture, or appearance, they have also been essential parts of the shift from fresh and whole foods to more highly processed ones, distributed across long-distance supply chains. It has often been said that if processed foods were consumed in a short period of time after manufacture, many of these substances would be less necessary. Many facilitate convenient use, for most of the population an advantage but not a necessity, however for some with reduced ability to manipulate foods and their packages, such advantages are important. Many substances and processes are of questionable value, even impeding, the transition to a new food system. Some have facilitated the use of low quality ingredients and highly manipulative processing techniques. As such, many substances and packing materials do not contribute to the accessibility of healthy food products, even if they themselves are not unsafe. They have frequently helped to create distorted expectations regarding the ease, accessibility and taste of less healthy options. Many have been part of improving food cosmetics, essentially a way to fool consumers. In this way, they have contributed to the food deskilling of the population, prioritizing convenience and value added for processors over nutritional quality and cooking skill. Their use is often deeply cultural (e.g., bleached flour, brightly coloured foods), sometimes with links to our colonial history.
Originally derived from natural products, now most food additives and processing aids are synthesized, which typically reduces costs and facilitates high throughput, mechanized manufacturing for processors. It is not that natural origin automatically equates with safety, but rather that humans have a longer history of consuming them and adapting them to diets, often through trial and error with mistakes, but ultimately determining how to consume with some degree of safety (for a deep history see, for example, Johns, 1990). Humans have limited history consuming many of today's additives, so in a certain way the regulatory approval process has to compensate for this lack of experience with these new substances. Food additives have been in the spotlight in Canada since at least the 1970s (Pim, 1979). History is filled with food additives first permitted then removed (see CSPI for an historical overview of additives banned in the US after first being used and / or officially approved).
Part of the difficulty is that people have different levels of sensitivity to different substances, some relatively well characterized, others not. For example, it is know that many are sensitive to products like MSG and sulphites. More controversially, a number of additives may contribute to hyperactivity in some children, including a number of dyes and preservatives.
This is not just a domestic processing issue since Canada is such a significant importer of manufactured foods. Import monitoring programs don't necessarily catch problems, given that lax rules around additives and fraud in other jurisdictions can result in elevated levels of problematic substances.
There are also significant controversies surrounding some packaging materials. Packaging is obviously important for food safety and efficient transport, but the environmental problems associated with food packaging are now very significant (discussed under Goal 5, Food packaging changes). This section examines the safety of the materials used in food packaging.
Jurisdictional and regulatory issues
As with the regulation of other substances, the Criminal Law power of the Constitution provides federal authority to regulate food additives, processing aids and packaging materials to assure safety. Environmental aspects of packaging are discussed under Goal 5 Food packaging changes. The main relevant legislation are the Food and Drugs Act and the Safe Food for Canadians Act. The federal government has the authority to conduct pre - market assessment and post-market surveillance and to impose labelling requirements.
Food Additives
Food additives are regulated primarily under Division 16 of the Food and Drugs Regulations. Under the regulations, the following frequently consumed substances are not considered additives:
- Food ingredients such as salt, sugar and starch.
- Vitamins, minerals and amino acids.
- Spices, seasonings and flavouring preparations.
- Agricultural chemicals (these are considered residues and are regulated under other provisions, such as the Pest Control Products Act and the Food and Drugs Act, see Goal 4 Pesticides)
- Veterinary drug residues (see Goal 4, Veterinary Health Products)
- Food packaging materials.
Under section B.01.001 of the Regulations, and excluding the substances listed above, a "food additive" is a "substance the use of which results, or may reasonably be expected to result, in it or its by-products becoming a part of or affecting the characteristics of a food".
There are 15 categories of permitted food additives (see List of Permitted Food Additives). Many categories are important for food safety, others are clearly for the convenience or cost structures of processors or to facilitate product marketing and shelf extension.
The submission requirements of additive manufacturers for approval of new additives are provided in the Guide for food additive submissions. The requirements follow a similar approach to other substances, with similar critiques as provided in this action area. Notably, the Guide acknowledges that while most additives are designed for the benefit of food manufacturers, they should also be of value to consumers - "The benefits should be documented with supporting data and information. Depending on the purpose or function of the additive, examples of such data include evidence for an improvement in shelf life, maintenance of nutritional quality, reduction of wastage, or correction for natural variations in colour, flavour, or texture of foods." and "Health Canada's Food Directorate may not respond favorably to any submission in which there is evidence that the proposed use of an additive could encourage faulty or careless handling and processing, causing a reduction in nutritive quality of the food or making the food appear deceptively better or of greater value than it really is." (section 2.3.1).
Important as these observations are, there are clearly some limitations regarding Health Canada's understanding of food and consumers. Health Canada has clearly accepted the dominant model of food production, processing and distribution, with a technological understanding of food waste. They have accepted the idea that natural variations in colour, flavour and texture should be avoided, even though such variation is biologically and ecologically natural. In other words, they have accepted the idea that control over the natural processes of food is important for consumer purchasing (see Goal 3, Public research for the roots of this mentality). Uniformity of texture, colour and flavour is important to manufacturers at large scale, as it facilitates production, packaging and distribution, but such an approach contributes to consumer deskilling, something in theory that Health Canada should be trying to avoid.
Processing Aids
The distinction between a processing aid and an additive is not always clear, so Health Canada has put out a guidance, Differentiating food additives from processing aids. "A food processing aid is a substance that is used for a technical effect in food processing or manufacture, the use of which does not affect the intrinsic characteristics of the food and results in no or negligible residues of the substance or its by-products in or on the finished food." The guidance provides some examples. The distinction between additive and aid is sometimes determined by the processing and food itself. In other words, a processing aid can also be a food additive in some circumstances.
A processing aid is not usually directly regulated. Pre-clearance of processing aids is not normally required because the aid is thought not to be present in the end product, or is at negligible levels. Health Canada, upon request with a submission package (Guide for Preparing Food Processing Aid Submissions) will provide opinions on the acceptability of processing aids. There is also a list of antimicrobial processing aids used in meat processing for which letters of no objection have previously been issued. Use of processing aids does not have labelling requirements.
This approach is consistent with the Canadian regulatory assumption that the process by which a food is produced is not the focus, but rather the end product itself. We know that processing often reduces the nutritional value of a product (and sometimes it enhances absorption of certain constituents). This is often necessary to make certain foods available for longer periods of time, but in many cases it is really about extending shelf life and profitability. How processing aids and processing techniques themselves might contribute to nutritional decline is not directly regulated unless it can be demonstrated that the "intrinsic characteristics" of the food are affected, in which case, regulatory consideration as an additive may be triggered. But given the range of processed foods on the market and the degree of manipulation of foods and food constituents, it is clear that the regulatory system is not designed to minimize such negative impacts. One exception would be certified organic processing regulations which restrict certain techniques, additives and aids that are thought to excessively reduce the nutritional value of a product (see Goal 5, Sustainable Food). Presumably, regulators believe the marketplace will determine whether a food is acceptable by consumers, but given the lack of consumer information on processing and processing aids, it is not clear how consumers would have the knowledge to make such decisions.
Packaging Materials
Packaging in contact with food (primary packaging) is regulated for safety under Division 23 of the Food and Drugs Act and Regulations. Essentially, it is illegal to use packaging that imparts contaminants to food. Until 2014, food packaging had to be pre-approved and listed before it could be released to the market, but now such pre-market assessments are voluntary. The CFIA provides industry guidance.
The Safe Food for Canadians Act and Regulations (which incorporates some of the provisions of the earlier Canadian Consumer Packaging and Labelling Act) sets out operational requirements for food packing and packaging. These provisions are primarily about food safety and fraud prevention. Although the Act was passed in 2012, not all of its provisions may yet be in force.
Controversial substances
A number of controversial additives, processing aids and packaging materials remain on the Canadian market, even though there is some evidence of harm associated with them. This evidence has been sufficient in many cases for other jurisdictions to remove them. For example, the following are some of the substances banned in Europe, but allowed in the US, highlighting once again the differences between a more precautionary approach in Europe and a probabilistic approach in in the US (and Canada). Allowed in Canada on the list are titanium dioxide and Sunset Yellow (Yellow 6) (colourants) used in a wide range of products, azodicarbonamide (a bleaching agent and dough conditioner) used in bread and flour products, and BHA and BHT (oil and fat preservatives). In Europe, foods containing some dyes must include the statement, "may have adverse effects on activity and attention in children" (Beck, 2019).
Several artificial sweeteners are controversial. Clearly sweeteners themselves are problematic in excess (see Goal 4, Reducing consumption of nutrients of concern), but rather than address the way the processing sector has used sugars to create consumer demand for their products, much of the attention has been on the development of artificial sweeteners. Although clearly important for people with certain health conditions, their widespread use in many cases may have other health problems, including paradoxically encouraging consumption of more calories (i.e., I had a diet soda, now I can eat cake). While the evidence is not definitive, and regulators have dismissed most of the studies as methodologically problematic, there are questions particularly about aspartame (for an overview, see Tandel, 2011). The International Agency for Research on Cancer (IARC) has named aspartame a possible carcinogen.
Nitrates and nitrites are still permitted as preservatives in processed meats and some cheeses. Nitrates and nitrites are naturally occurring in many plant foods, but the controversy surrounds their use in cured meats because cooking at high temperature in close proximity to high levels of protein in meat creates more opportunity for conversion to other problematic substances such as nitrosamines. This is much less likely to happen in vegetables (Dowden, 2019). In addition to questions about their direct safety in cured meat, nitrates/nitrites are also implicated in facilitating the ubiquitous sale of low quality meat, high consumption of which can result in a range of health problems beyond nitrate/nitrite exposure. Given controversies about their use, many manufacturers have been shifting to more natural plant alternatives, although some of these may be no better because of the high heat issue.
A number of packaging materials are also problematic. Bisphenol A, an alkyl phenol used in plastic drinking water jugs and in plastic liners of cans, is implicated as a hormone disruptor due to its estrogen-like activity in experimental animals (cf. Nagel et al., 1997). It is still permitted in Canada but under the Canadian Consumer Product Safety Act, it is not permitted in baby bottles. The federal government also claims to have successfully worked with industry to phase out BPA-containing packaging for liquid infant formula products. Other packaging materials that may be hormone disruptors include phthalates (in plastic film) and styrenes (styrofoam). In 2018 the European Food Safety Agency named 4 phthalates as hormone disruptors.
In particular, there are significant questions about the implications of human consumption of microplastics, many of which are associated with all stages of food systems, and especially consumer food and beverage packaging and paper receipts that most of us handle several times a week while food shopping (and of course other purchases). Micro-plastics and larger plastics have been deemed CEPA toxic (see Goal 5, Reducing food packaging). They are ubiquitous global contaminants (cf. Bujaczek et al., 2020; Ross et al., 2021), with direct impacts on humans associated with their consumption from numerous sources including food (cf. Smith and Lourie, 2010; Schwabl et al., 2019; Smith, 2020) and indirect impacts associated with their negative effects on marine and terrestrial ecosystems and the foods we consume from them. The implications are not entirely clear yet for human health, but it is likely that regular ingestion amounts to hundreds of thousands of particles and plastics pass through our guts and end up in our cleansing organs, such as the liver, spleen and lymph nodes. Tests on non-human species have concluded that microplastics can suppress appetite and reproduction (Smith, 2020). And microplastics carry with them substances that are hormone disruptors (Ragusa et al., 2021). Waste management processes are also a significant direct and indirect source of contamination (cf. Mitrano and Wohlleben, 2020 for some of the issues regarding policy intervention).
There are questions about paper takeout containers, bakery and deli paper treated with per- and poly-fluorinated alkyl substances (PFAS, grease-proofing agent used in paper packaging), ortho phenyl-phenol in aluminum cans, benzophenone in milk and juice containers, heavy metals, perchlorate (anti-static agent used in plastic for dry food and in food handling equipment, and some ingredients / contaminants in printer inks. The Food Safety Alliance for Packaging, an industry association, is cautioning its members to minimize use of these and other materials.
Strengths and weaknesses of the regulatory approach
As with most other inputs, the essential weakness of the regulatory approach is a limited ability to discern risks from low-level and chronic exposure, including possible effects such as allergies, hyperactivity in children, ADHD, neurological symptoms and skin disorders, and hormone disruption. An exception would be MSG which is recognized as problematic by the medical community, but other substances not necessarily. Given that the Canadian system is not driven by precaution, the significance of non-definitive evidence of problems is likely to be minimized.
A related problem is that estimates of risk are based on typical levels of food intake, data that are limited in Canada (see Goal 2, Demand - supply coordination). Consequently, risk estimates may be inaccurate, although regulators do apply margins of safety to address uncertainties. Whether these are sufficient is unclear.
Food additive assessments have traditionally focused on intentionally added substances and have relied mostly on in vivo studies, but there is a shift underway to in vitro rapid high-throughput testing. Although these shifts are part of advances in many aspects of food safety testing, there are still significant limitations in the areas of reproductive and developmental toxicity, neurotoxicity, genotoxicity, carcinogenicity, immunotoxicity, food allergy, and endocrine disruption. This is especially true for the unintended substances that appear as degradation products or consequences of substance interactions (Serafimova et al., 2021). "Crosstalk" among different toxicants is not well understood (see for an overview with additional citations, Gosslau, 2016). OECD testing protocols are not necessarily using the most recent advances, especially if they are more expensive and complex to administer and interpret. There is also some debate about what the new approaches bring to the table compared to older ones (see for example, blog posts on this topic by McPartland, 2011).
Nutritional safety assessment is required to ensure that the presence of an additive would not have an adverse effect on nutritional quality and safety of the food, however, this does not appear to include how the use of the additive can contribute to reducing the quality of the food supply through excessive extension of shelf-life or more manipulative processing.
The Safe Food for Canadians (SFC) Act and regulations is primarily a set of instruments that shift more responsibility to industry to self-regulate. This is particularly apparent with packaging materials. Billed as modernization, it is really about consistency with the use of HACCP as a food safety approach (for some of its problems, see Goal 4, Food Safety regimes, Challenges). An industry preventive control plan is important and necessary, but does not obviate the need for government monitoring and intervention. HACCP was really designed for processed packaged foods, but it is less applicable to raw foods such as meat and many foods offered in restaurants. It has been criticized for shifting responsibilities from inspectors to plant owners. In many cases, firms don't apply HACCP properly (cf. Wallace et al., 2014). The training organization, SQT, involved in audits, has identified 7 common problems with firm HACCP implementation, including:
- Lack of risk assessment
- Confusion about what constitutes a hazard
- Confusion about control measures
- Poor critical control point identification
Such problems are already apparent in domestic firms, and often more acute in international firms of the global south.
Food safety rules are driving producers and manufacturers to use more plastics, an advantage in contamination terms over cardboard, but not necessarily materials like glass and metals which are more impermeable. And the plastic containers are not necessarily being reused, for fear of contamination. All this runs counter to efforts to reduce the negative environmental impacts of packaging (see Goal 5, Food Packaging Reduction).
In summary, while many hazards are well characterized, understood, and managed, there are others about which we know relatively little, or have decided that what other jurisdictions consider significant, is not significant in Canada. This speaks again to the need for precaution. Because regulators view the market as the determiner of need, the number of materials in use is very high and it is essentially impossible to keep up with all the assessments required, a circumstance aggravated by extensive data gaps. While toxicologists will progressively improve assessment systems, complexity and time have to be reduced by limiting the number of substances under review. For this to occur, need has to be demonstrated and become part of the regulatory apparatus. Part of the need consideration must be connected to how the product facilitates processing that results in nutritional degradation of the product.
Financing the transition
Costs for processors will increase during the transition as systems and recipes are reconfigured. Certain product lines may be dropped if they are overly reliant on unacceptable prohibited additives, aids or packaging. Such changes are part of a larger processing sector transition to sustainable diets, an area that has been poorly researched in Canada, so the financial challenges for the sector are largely unknown at this point.
Reducing the number of additive, processing aid and packaging applications could reduce some regulatory costs, particularly staff time, though equally, the regulatory changes all require staff time investments to implement and, as proposed, some areas require greater oversight. The key unknown in transition is cost savings associated with reduced pollution, particularly of water ways contaminated with plastics (see also Goal 5 Food Packaging Reduction).
