After successfully overturning some potentially problematic EU regulatory developments, TDMR - the European association for manufacturers and distributors of formula diet products - is aligning the industry once again to request an amendment to a recently imposed regulation imposing increased protein requirements.
The recent regulatory development causing a stir in the EU diet food sector is the European Commission’s formal adoption of the Delegated Regulation amending Regulation 2017/1798 on TDRs.
The 2017 Delegated Act, which included a five year transition period and therefore became formally adopted on October 27th, suggested that TDRs for weight control must contain at least 75g of protein, 11g linoleic acid and 1.4 g alpha-linolenic acid and not contain more than 250 mg of magnesium, for the total daily ration.
The regulation was based on a 2015 EFSA opinion which was considered highly controversial by the industry. These changes would lead to "serious sensory issues", according to TDMR, who hosted a targeted campaign explaining these concerns to commissioners, member states’ representatives and MEPs.
These efforts led the commission to ask EFSA to review its 2015 scientific opinion on TDRs. And as a result, EFSA’s “Statement on additional scientific evidence in relation to the essential composition of total diet replacement for weight control”, published in April 2021, saw the minimum requirements lowered for ALA and LA and an increase in the maximum permitted magnesium content.
The Commission then updated the composition requirements for essential fatty acids (EFAs) and magnesium to bring them in line with the 2021 EFSA recommendations.
The regulation was therefore amended to state that the alpha-linolenic acid contained in such products shall not be less than 0.8 g and shall not contain more than 350 mg of magnesium for the total daily ration.
TDMR says the industry is please with these changes but the protein issue remains problematic so it is aligning once more to make a new request to amend protein requirements.
Speaking about the suggested increased protein content, Prof Anthony Leeds, the Chair of TDMR Europe, told NutraIngredients: "They are deeply problematic because they impact the palatability, texture and price of the products as it is a massive increase in protein from the previous requirements set in Directive 96/8 which simply stated that the protein content in the products shall provide not less than 25% and not more than 50 % of the total energy of the product."
He warned that the suggested changes could lead to consumers turning away from these products due to increased price and reduced palatability.
"Indeed, there is sufficient new evidence suggesting a full review of the protein requirements for TDRs is required," adds Prof Leeds, "The necessary and scientifically indicated changes to the Delegated Regulation 2017/1798 on TDR is yet another example of the need to increase knowledge of specialist nutrition products among policy makers and clearly highlights industry’s contribution as very necessary to ensure that policymakers and regulators receive up to date information and develop fit for purpose regulations."
He adds that the requirement to actively engage with the EU regulatory process is increased in the formula diet products sector due to policy makers’ growing interest in tackling the obesity epidemic.
"Businesses in the sector need to keep an eye on policy developments and work together to help decision makers gain a better understanding of their products and their efficacy in helping bring down the incidence of obesity as well as to ensure that the regulation of slimming foods is based on sound and contemporary information."