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Safety of low-calorie sweeteners

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  • Are they safe to use?
  • All approved sweeteners are safe for use by the consumer. Safety is the number one concern of low-calorie sweetener manufacturers, food and beverage producers, regulatory bodies and consumers. A newly discovered sweetener goes through years of costly research and development to make sure that it's safe.
  • What is the approval procedure?
  • Before a sweetener comes to market and is available to consumers, it must get the approval of regulatory authorities (governments). In giving approval, these authorities rely on the safety evaluations of independent scientific advisory bodies such as the European Food Safety Authority (EFSA), previously the European Commission's Scientific Committee for Food (SCF), the United States Food and Drug Association (FDA), and the United Nations' Joint FAO/WHO Expert Committee on Food Additives (JECFA) and subsequently allow its consumption. The independent experts who serve on these advisory bodies scrutinize and evaluate the data about the sweetener and its uses to make sure they are safe.

    The approval process is lengthy. Safety studies may take from seven to fifteen years, and the regulatory process may take a further four to seven years.
  • What is the ADI?
  • The Acceptable Daily Intake (ADI), expressed on a body weight basis, is the amount of a sweetener and any other food additive that can safely be consumed on a daily basis over a person's lifetime. The concept was developed by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) and it was later endorsed by the Scientific Committee for Food (SCF) of the European Commission, now the European Food Safety Authority.

    JECFA defines ADI levels as: "An estimate of the amount of a food additive, expressed on a body weight basis that can be ingested daily over a lifetime without appreciable health risk".
    The ADI is usually derived from long-term animal feeding studies. First, the so-called NOAEL (No-Observed-Adverse-Effect Level) is determined. This is the greatest amount of additive, which can be fed to animals on a daily basis over a lifetime without any adverse effect. The NOAEL is then divided by a large safety factor, usually 100, and the resulting value is the ADI for humans. For example, if the NOAEL in an animal study is observed to be 100 mg/kg bodyweight, this is then converted to an ADI of 1 mg/kg bodyweight for humans. The safety factor takes into account the difference between animals and humans and the variability between individuals, including age, nutrition, pregnancy etc.

    The ADI is in fact a safe intake level. If an individual occasionally exceeds the ADI, this is of no consequence if balanced by periods when the ADI is not consumed. Individuals who persistently exceed the ADI have a lower yet adequate margin of safety. For example, someone who constantly consumed twice the ADI would still benefit of a safety factor of 50 instead of 100. Therefore the ADI should be regarded as a workable benchmark to evaluate exposure and for regulators to establish permitted use levels of food additives.
  • How much is safe?
  • Sweeteners as used in foods and drinks today are safe. When approving a sweetener for use in foods and drinks, the regulator takes into account the estimated overall intake as well as the Acceptable Daily Intake (ADI) which includes a typical safety factor of 100.

    This means that even if people occasionally consume more sweeteners than the ADI, it is still safe, as the ADI expresses the amount that a person can consume every day during lifetime.
    To make sure that the levels of intake do not exceed the acceptable level, consumption studies are carried out by governments and industry. Sweeteners are the substances for which probably the greatest number of such studies has been carried out throughout the world. These studies have shown that consumers generally do not exceed the ADI and that only some consumers exceed it marginally and on rare occasions. However, exceeding the ADI occasionally presents no health concern.

  • How is the use of low-calorie sweeteners regulated?
  • Regulatory approval differs from country to country. But the goal of "safety" is the same in all countries. To achieve this goal, governments use the safety evaluations of their own scientific advisory bodies or the United Nations' Joint FAO/WHO Expert Committee on Food Additives (JECFA). For example, the European Commission relies on the advice of the European Food Safety Authority (EFSA) – previously the European Scientific Committee for Food (SCF) – and the United States relies on the US Food and Drug Administration (FDA).

    Approval is the authorisation by regulatory authorities for a specific non-calorie or low-calorie sweetener to be used by the consumer as either a table-top sweetener or an ingredient in specific foods at specified maximum amounts. Approval must be obtained before a sweetener can be sold for use in foods or beverages.

    Approval is granted on the basis of safety assessments and the proof of technological need. It is granted only when regulators are satisfied that the product is safe. Regulators also establish levels of acceptable daily intake (ADI). Low-calorie sweeteners are among the most thoroughly tested food additives in use today.

    For example, the European Sweeteners Directive (94/35/EC), a regulation adopted in 1994 by the European Council and Parliament and now applied in all 25 Member States of the European Union (EU), identifies the sweeteners that are approved for use in the EU, the foodstuffs in which they can be used and their maximum use level. To be approved, food additives such as low-calorie sweeteners must perform a useful purpose and be safe.