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
(EU) 2016/1413 : Meal Replacements for Weight Control
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:
Total replacement of meals (450-800 kcal / day):
Total replacement of meals (600-1200 kcal / day):
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.