What does the quantity of declared nutrients according to established practice mean?

It is well recognized that nutrient(s) added or present in foods when measured may differ from amounts declared on labels. This is due to uncertainty in measurement and influencing ecosystems. With this foreknowledge, the nutrition labelling regulation 2008, stated that “compliance to the number of declared nutrients on the label would be according to the established practices”. The regulator may have taken a broad view until specific guidance could be worked out in due course. Meanwhile, businesses declared nutrient values as “approximate or typical”, citing Indian food composition tables, and other databases. These databases were used for compliance purposes, as tolerances were yet to be set. Tolerances are set so that measured values are not too wide of the declared value. However, this is not the same as “approximate or typical”.

The word tolerance, and its true meaning, entered regulatory texts quite recently. Over several years closely related expressions were used but the term tolerance was never explicitly stated. Iodized salt, under a product standard (15.01:PFA), requires 150μg of iodine per 10g to be delivered to the consumer. To ensure this will happen (enforcement), the package should have no less than 30 ppm at entry to the market. This could be read as a tolerance limit “which includes an overage” in order to meet 100% of the declared amount; during product shelf life. However, declaring the amount as “iodine >15ppm” makes one wonder if this was meant to be a beneficial nutrient message for the consumer or merely a product specification.

Then there is the case of fortified foods [FSS(FF) 2018] where the language is tricky. Regulation 4(1) requires any manufacturer who fortifies any food to ensure that the level of added micronutrients does not fall below the “minimum level” specified in Schedule-I. Where a minimum value is specified, it must meet 100% of the declared amount to stay in compliance. For example, would the lower limit of a “± 20 % tolerance be applicable to a vegetable oil product declaring 600 μg of vitamin A (minimum level) per 100g? Interestingly, there is a reason for most oil brands declaring a mid-range amount of 750 μg. A review of these regulatory texts ought to be done before any guidance on tolerance is taken up.

Declare nutrient amounts for informed consumer choice

Labelling is a pre-purchase information opportunity for consumers to examine and/or compare product value. The thinking must be clear when declarations are required to avoid label clutter. Edible oil product labels typically provide 12-14 nutrient declarations, three of which are zero. When nutrient(s) is negligible or insignificant, these may not be declared. FSS (LD) 2020, is the general regulation that specifies nutrients to be declared in the nutrition information panel. Given that FSS(HSN) 2016 addresses comprehensively the supplement category – delivered in tablets, capsules, pills, liquids, and such forms – provisions under FSS(LD) 2020 do not apply. Instead, “the amount of the nutrients vitamins or minerals or substances with a nutritional or physiological effect” contained in the product are declared in the nutrition information panel or as supplement facts. Nutrition labelling becomes mandatory when nutrition and health claims are made. When claims are made the nutrient or substance must be at the threshold levels prescribed; these minimum amounts are given in annexures under FSS(AC)2018. Nutrient declarations are not attracted except when specified. This prevents clutter.

What is “established practice”

Regulatory texts on tolerances include terms such as rounding of numerals, overages, tolerance criteria, and finally compliance to declared amounts. Tolerances expressed in a numerical form of “maximum minus 10 percent”, first appeared in the labelling regulation (LD 2020), thereafter amended to “± 20 percent”. A change within 2 years raises the question of whether these are ad hoc or arrived at after considering ‘. Rounding is one such factor.

Rounding guidelines on the number of significant figures or decimal places to be declared should be set to avoid implying a level of precision that is untrue. Neither is it reproducible nor likely to impress a consumer. The rounding of a declared value is taken into account in determining tolerance between the laboratory test result of the competent authority and the declared amount. Rounding benefits consumers most for easier recall, while keeping numbers close to the true value. There are several guidance documents, such as an EU Commission (1), for reference. Secondly in establishing tolerance ranges, due recognition needs to be given to measurement uncertainty and nutrient stability. All factors such as nutrient concentration, food matrices, method of analysis, applicability, sensitivity, precision, repeatability, reproducibility, and limits of detection and determination, taken together contribute to measurement uncertainty.

Overages consistent with good manufacturing practice

Apart from measurement uncertainty, there is also nutrient instability due to manufacturing, environmental, and supply chain conditions. Compensatory overages are required to ensure delivery of declared amounts. Nutra 2016 (Sch. I: Table C) provides overages for vitamins and minerals, some of which are illustrated (Fig. 2). The nutrient may exceed the declared amount, by a percent overage amount of, e.g. + 30%. The regulatory thinking is that overage values should be consistent with good manufacturing practice (scientific rationale) and should not present a health risk. Manufacturers are best placed to determine scientifically the overages required for their products/categories. An overage for vitamins and minerals may exceed the permissible limit of 1 RDA; an overage above this does not present a risk and constitutes acceptable ‘established practice’.

Determination of compliance to declared values.

EU Commission (1) describes tolerance as “the acceptable differences between the nutrient values declared on a label and those established in the course of official controls”, (emphasis added). Official controls relate to laboratory test results of the competent authorities (Public Health and/or Notified Laboratories). These lab results decide compliance with nutrient declarations on labels. Non-compliance follows when the test result of the competent authority falls outside prescribed tolerance.

Nutrient declarations – on the label – by FBOs present the best average “true value” derived from testing multiple lots over a wide time frame. Whether the scatter characteristics (bias, precision, accuracy) fall within ± 20 percent would be known (Fig 3). When tolerances are set, FBOs will know if their product will comply or not. What is however unknown is the variability of lab test results of competent authorities. Even here there is “established practice’

Each State FDA/UT makes measurements under different laboratory ecosystems. Recognizing this fact, the EU (1) and US FDA (4) provide guidance on how the regulator should deal with compatibility issues. The EU requires its Member States (MS) – comparable to Indian State FDAs – to carry out “official controls” for compliance in accordance with provisions laid down in regulations (2). Member States, on a yearly basis, are required to provide the Commission (comparable to Food Authority in India) with the number of tests performed, and food categories tested, the results of which were compared with the values declared and the decision taken, including actions taken where the measured value was outside the tolerance of the declared value (1). Based on experiences gained, the Commission and the MS discuss and agree on future modifications of the guidance document. Stakeholders will be consulted accordingly. This is active compliance enablement.

How should compliance enablement work between competent authorities and businesses? US FDA (4) assigns responsibility to the manufacturer for assuring the validity of a labelled nutrient value. The data source used to calculate nutrition label values “is the prerogative “of the manufacturer. FDA recommends that nutrient values are determined by laboratory analysis of each nutrient in the product. Such databases are collections of nutrient data compiled by a manufacturer, organization, or representative trade association. The majority of nutrition labelling databases submitted by the industry to the FDA fall into the “finished foods” category. Although FDA encourages the industry to submit databases for the purpose of nutrition labelling, it is voluntary. The agency “has not and does not intend to prescribe how an individual company is to determine nutrient content for labelling purposes”.

It is reasonable to expect that lab tests by the competent authority may yield results falling outside the tolerance range with respect to the declared value. When any product is found to be out of compliance, based on the FBO’s willingness to come into compliance, US FDA intends to work with the manufacturer and correct the problem (4). Similarly, the Canadian Food Inspection Agency (5) works to verify the label values based on industrial control systems, which include lab analysis, , and management of ingredient data, including changes, substitutions, and processing. Manufacturers must therefore ensure the food tested will comply with the true lot average. Compliance with established practice is about anticipating that implementation difficulties will arise and that equitable solutions will also be worked out, together.

Abbreviations:

FSS(LD) 2020: Food Safety and Standards (Labelling and Display) Regulations 2020.
FSS (HSN) 2016: Food Safety and Standards (Health supplements, nutraceuticals ….) Regulation 2016
FSS (AC) 2018: Food Safety and Standards (Advertisement and Claims) Regulation 2018.

References

The guidance is divided into the following sections:

– Rounding guidelines for nutrition labelling;
– Tolerances for vitamins and minerals in supplements;
– Tolerances for controlling the compliance levels of nutrients with levels specified in Regulation (EC) No 1924/2006.