Food Law: When ‘negligible’ means ‘zero’

Processing aids are used to fulfil certain technical purposes during the treatment or processing of food products. These include antimicrobial substances used on meat products or enzymes utilized to extract juice from fruit. In Canada, processing aids are not an express concept defined in legislation, but are defined in policy.

Health Canada’s written policies distinguish processing aids from food additives by relying on the definition of a food additive set out in the federal Food and Drug Regulations. In brief, processing aids are substances that are used for a technical effect in foods and do not fall within the definition of a food additive. In order to remain outside of this definition, Health Canada takes the position that a processing aid is a substance whose use does not affect the intrinsic characteristics of the food and results in no or negligible residues of the substance or its byproducts in or on the finished food.

Health Canada’s own policies recognize that the need to distinguish processing aids from food additives has resulted in its definition differing from the one used by the Codex Alimentarius Commission (CAC), which has been adopted by several of Canada’s trading partners, such as the United States and the European Union. In particular, the ‘no or negligible’ threshold on residue levels and references to the substance’s impact on a food’s characteristics are absent from the CAC definition.

Problematic approach

Based on recent experience, it appears as though Health Canada’s interpretation of ‘negligible’ residues is more restricted than their written policy would suggest. While Health Canada’s policy suggests processing efficacy data may be relevant when concluding that a substance is a processing aid, their recent position appears to be that the presence of a specific removal step is a critical indicator, if not singularly determinative, of the substance’s role, regardless of whether the substance remains present in any meaningful active amount. In short, regardless of residue levels remaining in a finished food, the processing aid is considered a food additive due to the absence of a removal step.

This overall approach is problematic for a number of reasons. For one, its departure from the CAC definition leads to differences in ingredient declaration requirements that may discourage companies from entering the Canadian market. Processing aids with residual levels remaining in finished foods are not required to be declared as ingredients in many jurisdictions, including the United States, but due to Health Canada’s interpretation as food additives, would require declaration. While there is no requirement that Canada regulates all substances in the same manner as its trading partners, this variation in ingredient lists is confusing to consumers and businesses alike.

Inconsistent application

The impact of this difference in approach is further complicated by Health Canada’s inconsistent application of the policy. Several common food ingredients are produced using processing aids that are not normally declared as components in Canadian and American ingredient lists. For example, ingredients such as maltodextrin, corn syrup and various plant-based proteins (e.g. rice protein) are manufactured using enzymes that, while irreversibly denatured during processing, are not specifically removed from the finished product. While these processing aids are used in low quantities, and their enzymatic activity may be completely inactivated in the finished food, Health Canada has taken the position that these ingredients are food additives, requiring declaration in the list of ingredients.

While Health Canada’s policy contemplates that the use of an enzyme in the production of a food ingredient derived from starch (such as maltodextrin) may be consistent with the definition of a processing aid, this may not be reflected in practice.

While it is normal for regulations to differ across countries, Health Canada’s own policies lead to inconsistent applications of the law in a manner that raises uncertainties and practical challenges for industry. The current interpretation also differs from their own published guidance in which ‘negligible’ is now regarded as zero. Due to these inconsistencies, it may be time for Health Canada to re-evaluate its published guidance. Without formal clarification, Canadian businesses are left guessing Health Canada’s interpretation and are uncertain about labelling requirements. Ultimately, this will lead to increased confusion among consumers due to discrepancies across product labels. 

Dr. Jon-Paul Powers is a partner and scientific advisor with Gowling WLG. Victor Zhao is a student-at-law with Gowling WLG.