BACKGROUND:
The regulatory void left by the ongoing BREXIT implementation had made it difficult for UK wellness brands to identify clear guidelines for their ever popular LCD and VLCD products. Ensuring that sound guidelines are used in the formulation and utilization of such products is a growing concern amongst brands seeking compliance during such transitory times. The following decision chart aims at summarizing the regulatory classifications available as per FAO's CODEX and EU's directives, as well as the basis of their selection:
REGULATORY REFERENCES TAKEN INTO ACCOUNT:
(EU) 2017/1798 : Total Diet Replacement for Weight Control
UK relevance:
Still listed as adopted in UK legislation: https://www.legislation.gov.uk/eur/2017/1798/contents/adopted
Validity: Takes effect Oct 2022
Framework:
Foods specially formulated to replace the whole daily diet, for use in energy restricted diets intended for weight reduction, when used as instructed by the food business operator.
Reference:
https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R1798&from=DE
(FAO) CODEX CXS 203-1995: Standard for Formula Foods for Use in Very Low Energy Diets for Weight Reduction
UK relevance:
Being the de-facto world reference for total replacement VLCD, many UK brands are referring to this standard while awaiting for UK-specific guidelines.
Validity: Since 1995
Framework: A formula food for use in very low energy diets is a food specially prepared to supply a minimum amount of carbohydrates and the daily requirements of the essential nutrients in 450-800 kcal which represents the sole source of energy intake.
Reference: https://www.fao.org/input/download/standards/296/CXS_203e.pdf
(EU) 2016/1413 : Meal Replacements for Weight Control
UK relevance:
Still listed as adopted in UK legislation: https://www.legislation.gov.uk/eur/2016/1413/contents
Validity: Since 2016
Framework: Foods specially formulated to replace 1 or 2 daily meals in conjunction with other foods. For use in energy restricted diets intended for weight reduction, when used as instructed by the food business operator.
DECISION TREE:
Partial substitution of meals- With Weight-Loss Claim :
(EU) 2016/1413
Substituting 1 main daily meal as a weight maintenance
Substituting 2 main daily meals for the purpose of weight loss
Product requirements:
200-250 kcal/meal
Fat : less than 30% of calories
at least 1g linoleic acid
Protein: 25-50% of calories
Vit/mineral: 30% of reference values 1169/2011
(does not apply to fluoride, chromium, chloride and molybdenum)
Notes:
Strict context for composition and weight-loss claim
Ideal for retail self-serve products and integration with food-based meal programs.
Supplementing of meals - Without Weight-Loss Claim:
Refer to foodstuff regulations
Typical composition:
Supplementing daily food intake, provides protein and added vitamins and minerals, with 0.75g linoleic acid. Fortified foods used as tools to reinforce a program.
Typically 135-150 kcal/ serving
Notes: Notes: Commonly used in conjunction with a food-based meal program.
Total replacement of meals (450-800 kcal / day):
CODEX CXS 203-1995
Product requirements:
450-800 kcal/day
Fat : less than 30% of calories
at least 3g linoleic acid, 0.5g alpha-linoleinc acid
Protein: 50g or more
Carbohydrates: 50g or more
Vit/mineral: 100% of ref. values in Codex 1995
Notes: Commonly used by UK brands as reference for VLCD products
Must be labelled as : "Formula Food for Use in Very Low Energy Diets"
Total replacement of meals (600-1200 kcal / day):
(EU) 2017/1798
Product requirements:
600-1200 kcal/day
(VLCD <800 kcal, LCD< 1200 kcal)
at least 11g linoleic acid, 1.4 g a-linolenic acid
Protein: 75 to 105g
Carbohydrates: 30g or more
Vit/mineral: 100% of ref. values in Table 1 + specific Na/K requirements
Notes: Common usage is to break down daily ration into 4-5 meals, allowing flavour variety and controlled satiety.
As European manufacturers we provide :
- If weight-loss claims are needed:
Product lines of EU MR/MRP (1 or 2 portions/ meal)
- If a complete replacement of food intake comes from your products:
EU TDR lines.
- If no weight-loss claims are needed:
Fortified products are available within the context of a balanced food-based
meal plan, Codex CXS 203-1995 compliant products are available.
These products are available as part of our product catalogue and we look forward to further discussing this with you.
Regardless of the products, the following should be noted:
-Regular medical supervision should always apply to weight-loss programs.
-Strict adhesion to health/ weight-loss claims according to the regulations
- We always recommend referring to local regulatory authorities for a product compliance confirmation.
- Should regulatory requirements evolve , we are available for formulation updates
-CODEX CXS 203-1995 is recognized as the predecessor to numerous MR regulations
worldwide.