Healthcare Nutrition

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  • Europe & Russia

    Foods for Special Medical Purposes

    • This is a regulated sector across the EU states and Russia
    • Regulations applying to foods for special medical purposes denote nutritional, compositional and labelling requirements for these foods
    • Products are to be used under medical supervision
    • Product Definitions:
      • Nutritionally complete foods with a standard nutrient formulation, which may constitute the sole source of nourishment
      • Nutritionally complete foods with a nutrient-adapted formulation specific for a disease, disorder or medical condition which may constitute the sole source of nourishment for the persons for whom they are intended
      • Nutritionally incomplete foods with a standard formulation or a nutrient-adapted formulation specific for a disease, disorder or medical condition, which are not suitable to be used as the sole source of nourishment

    Russia has specific categories e.g. therapeutic dietary food products, preventative dietary food products, food products for enteral nutrition, food products without (or with the low content of) specific amino acids etc.

    Consumers in this category are:

    Patients with a limited, impaired or disturbed capacity to take, digest, absorb, metabolise or excrete ordinary foodstuffs or certain nutrients contained therein or metabolites, or with other medically-determined nutrient requirements, whose dietary management cannot be achieved only by modification of the normal diet.

    There are special nutritional compositions for products for infants which differ to the requirements set out for other age groups.

    Notable exceptions are:
    • Germany has its own regulation, the Diatverordung
    • Differences exist across in the EU in terms of what foods are considered ‘foods for special medical purposes’
    Potential regulation changes currently underway:

    The EU Framework on Foods for Particular Nutritional Uses has been repealed with effect from July 20th 2016. Foods for special medical purposes are now considered under ‘foods for specific groups’. In line with this change, a new delegated Regulation on food for special medical purposes has been published. This new legislation has changes in composition and labelling rules and sets pesticide limits for medical foods for infants. The new legislation will apply from 2019.

    Updated July 22, 2016

    Foods for Weight Control

    This is a regulated sector across the EU states and Russia. Regulations applying to foods for products for weight reduction denote nutritional, compositional and labelling requirements for these foods.

    Product Definitions:

    • Products presented as a replacement for the whole of the daily diet
    • Products presented as a replacement for one or more meals of the daily diet

    Consumers in this category are part of the general population.

    Notable exceptions to above are:
    • EU legislation does not have rules for diets less than 800kcals (so called very low calorie diets)
    • Germany also has its own regulation, the Diatverordung
    Potential regulation changes currently underway:
    • The EU framework on ‘foods for particular nutritional uses’ has been repealed with effect from July 20th 2016, and such products are are now considered under ‘foods for specific groups’. Foods for specific groups will include total diet replacements for weight control however, meal replacement for weight control will be regulated under nutrition and health claims legislation. Although the new delegated act on total diet replacement for weight control was due to be published by July 2015 it is still in discussion at EU level. As mentioned above there will be a change in scope with the new legislation and it is expected that there will be compositional and labelling changes compared to the existing legislation.
    Labelling considerations:
    • Health claims which make reference to the rate or amount of weight loss which will occur are not permitted

    Updated July 22, 2016

  • Middle East & Africa

    Foods for Medical Uses

    • This is a regulated sector across the Gulf Cooperation Council (GCC)
    • Regulations applying to foods for medical uses denote nutritional, compositional and labelling requirements for these foods
    • Products are to be used under medical supervision

    These products are not generally regulated in African countries. Consumers in this category are:

    • Those with particular dietary requirements: physical or physiological conditions and/or specific diseases and disorders
    • Includes foods for infants and children

    Foods for Weight Control

    • This is a regulated sector across the GCC
    • Regulations applying to foods for products for weight reduction denote nutritional, compositional and labelling requirements for these foods
    • Product Definitions:
      • Formula foods for use in very low energy diets for weight reduction
      • Foods for use in weight control diets:
        • Replacement for all meals of the daily diet
        • Replacement for one or more meals of the daily diet

    These products are not generally regulated in African countries. Egypt, however, has standards on a number of low calorie foods e.g. low calorie bread, low calorie jam.

    Consumers in this category are part of the general population.

  • North America

    Foods for Medical Uses

    • This is a regulated sector across North America
    • Regulations applying to foods for special medical purposes denote nutritional, compositional and labelling requirements for these foods
    • Product Definitions:
      • A medical food is a food which is formulated to be consumed or administered enterally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognised scientific principles, are established by medical evaluation (US)
      • In Canada, a ‘food for special dietary use’ is a food that has been specially processed or formulated to meet the particular requirements of a person in whom a physical or physiological condition exists as a result of a disease, disorder or injury
        • Formulated Liquid Diet
          • is sold for consumption in liquid form, and
          • is sold or represented as a nutritionally complete diet for oral or tube feeding of a person in whom a physical or physiological condition exists as a result of a disease, disorder or injury
    Consumers in this category are:

    Patients who are seriously ill or who require use of the product as a major component of the specific dietary management for a disease or condition.

    Foods for Weight Control

    • This is a regulated sector across Northern America
    • Regulations applying to foods products for weight reduction
    • Product Definitions:
      • “food for special dietary use” means food that has been specially processed or formulated to meet the particular requirements of a person
      • for whom a particular effect, including but not limited to weight loss, is to be obtained by a controlled intake of foods (Canada)
      • A very low energy diet is one that supplies less than 900kcal

    Consumers in this category are part of the general population.

  • Latin America

    Foods for Medical Uses

    • Regulation of this sector is inconsistent in the LATAM (Latin America) region
    • Brazil, Uruguay and Venezuela have provisions on composition and / or labelling for medical foods
    • In the absence of specific country legislation, Codex Standards should be applied
    Consumers in this category are:

    Patients who are seriously ill or who require use of the product as a major component of a disease or condition’s specific dietary management.

    Foods for Weight Control

    • Regulation of this sector is inconsistent in the LATAM region
    • Brazil, Argentina, Uruguay and Venezuela have provisions on composition and / or labelling for weight control
    • In the absence of specific country legislation, Codex Standards should be applied

    Consumers in this category are part of the general population.

    Notable exceptions to above are:
    • In Mexico, foods for weight loss or weight gain are considered medicines and are subject to registration
  • Asia Pacific

    Foods for Medical Uses

    • This is a regulated sector across Asia Pacific (APAC) countries
    • Regulations applying to foods for special medical purposes generally denote nutritional, compositional and labelling requirements for these foods
    • Product Definitions:
      • Whole nutrient formula foods

        The formula foods of special medical purpose that may be used as single nutrition source to meet the nutritional requirements of the target group

      • Specific whole nutrient formula foods

        The formula foods of special medical purpose that may be used as single nutrition source to meet the nutritional requirements of the target group of certain disease or medical state

      • Non-whole nutrient formula foods

        The formula foods of special medical purpose that may meet the partial nutritional requirements of the target group and is not applicable to be regarded as single nutrition source

    Consumers in this category are:

    Patients who are seriously ill or who require use of the product as a major component of a disease or condition’s specific dietary management (under the supervision of medical practitioners or clinical nutritionist / dietitian).

    An approval / authorisation process is in place in many APAC countries for foods for special medical purposes.

    Notable exceptions to above are:
    • Differences exist between countries in what foods are considered foods for medical uses with some having specific rules for specific conditions (e.g. Korea)
    • Some countries have specific rules for products intended for infants
    Potential regulation changes currently underway:
    • China is working on establishing British standards

    Foods for Weight Control

    • This is a regulated sector across the APAC countries
    • Regulations applying to foods for products for weight reduction denote nutritional, compositional and labelling requirements for these foods
    • Product Definitions:
      • products presented as a replacement for the whole of the daily diet
      • products presented as a replacement for one or more meals of the daily diet

    Consumers in this category are part of the general population.