Beyond titanium dioxide: Balancing consumer needs with compliance

As consumer needs grow more complex and detailed, so too do the needs of food supplement manufacturers who must find solutions that align consumer preferences with regulatory requirements. Lonza's Stephane Vouche explains

With a wealth of options and information at their fingertips, today’s food supplement consumers are more health-conscious and better informed than ever, with an increasing awareness of the impact of their purchasing decisions on their well-being and their planet.

As such, cleaner and clearer labels have become a high priority as consumers increasingly seek out food supplement products made from natural, recognisable and easy-to-understand ingredients.

Research commissioned by Lonza shows, for instance, that 43% of supplement consumers in France are looking for products with no preservatives, whereas 42% want to know the source of the ingredients in the food supplement products they buy.

For most of these consumers, a requirement for safety is an obvious corollary: Lonza’s research also found that 59% of French shoppers insist on “unquestionable safety” when choosing supplement products. As such, for a product to truly meet the demands of today’s consumers, an ethos of safety, sustainability and traceability must apply at every stage in the product journey — from the ingredient and the dosage form right through to regulatory compliance.

As the market evolves and expectations rise, manufacturers and brand owners need to continually balance the need for a robust, effective food supplement solution with consumer demands for clean label credentials, as well as other diverse criteria such as swallowability, convenience, look and feel and religious or dietary requirements.

Although it is important to align with such preferences, there are also a number of formulation drivers — including ingredient compatibility and the desired release profile — to take into consideration when looking to develop a successful food supplement product. Finally, and crucially, a food supplement product must be fully compliant with the latest regulatory requirements.

Changing regulation

Regulatory changes have the power to shape the conversation around every product component including, for example, food colourants. Harmonised EU legislation allows the use of specific authorised colourants, described as food additives, in foodstuffs such as food supplements.

Capsules, in particular, have long been one of the world’s most popular dosage forms for food supplements, offering a convenient and easy-to-use delivery method. For supplement manufacturers, this technology offers additional benefits, including the opportunity to add colour; indeed, white capsules have proven to be particularly popular thanks to their bright, distinctive appearance and wider functional properties.

Traditionally, the food additive titanium dioxide (E171) has been used as a colourant to achieve capsules with this highly sought-after aesthetic. Titanium dioxide is an opaque white pigment that has been an authorised food additive for more than 40 years. Recent studies have, however, raised questions about the safety of titanium dioxide and its impact on human health, owing to the presence of potentially cell-damaging nanoparticles.1

Although the evidence on orally consumed food grade titanium dioxide is not yet conclusive and conflicting information has surfaced, these findings have inevitably sparked a public debate that has seen titanium dioxide come under considerable scrutiny.2

In the EU, the European Food Safety Agency (EFSA) is currently conducting a re-evaluation of the safety of titanium dioxide, taking the latest data into account, including new toxicological studies. The outcome is expected by mid-2020 and many EU member states await these results to clarify their own position towards titanium dioxide.

In the meantime, the marketing of foodstuffs containing titanium dioxide has been suspended in France from January 2020; this unilateral suspension can legally remain in force until a decision is made at a European level.

With no formal decision on the ongoing use of titanium dioxide, such uncertainty has continued to fuel confusion and negative public perception. Many manufacturers are reformulating their products accordingly. For many supplement brands, the hunt is on to find a white opacifier that makes a viable alternative to titanium dioxide.

Reassessing the value of titanium dioxide

Titanium dioxide is an opacifier with a lot of advantages for manufacturers. The opacity it delivers enables highly effective masking of the capsule fill and the protection of ingredients from light degradation. At the same time, the distinctive bright whiteness it delivers helps brand owners to establish a unique visual identity that supports market differentiation and enhances product understanding and compliance for consumers.

These qualities are derived from the high refractive index of titanium dioxide, which is not matched by any other food-grade ingredient.

In addition, titanium dioxide is chemically inert, insoluble in water and highly stable in variable heat and light conditions. As such, finding a viable alternative has been a challenge for the industry as it has the potential to significantly impact the manufacturing process and shelf-life of capsules.

In the quest for an alternative opacifier, the performance of a wide variety of substances has been assessed. Most fall short in one essential aspect or another, but one option offering semi-opaque whiteness for masking properties is the food additive calcium carbonate (E170).

To further explore the efficacy of calcium carbonate, Lonza has rigorously tested more than 30 components in the search for an alternative opacifier that offers the broadest spectrum of benefits to both manufacturers and consumers.

It is through this testing process, whereby the need for a compliant high-performance solution was always the highest priority, that a carefully selected, food-grade calcium carbonate was chosen for Lonza’s new Vcaps Plus White Opal capsules, based on particle size, distribution and shape.

This ensures that the plant-based Vcaps Plus White Opal capsules offer a high-performance solution with high machinability and excellent mechanical robustness, whilst also providing light protection, opacity and brand differentiation thanks to its natural look.

Diverse demands, compliant solutions

As consumer needs grow more complex and detailed, so too do the needs of food supplement manufacturers who must find solutions that balance a wider range of considerations.

Indeed, current industry regulation is not only important in helping to streamline and safeguard product development, but is now also playing an increasingly instrumental role in shaping and influencing innovation. This, in turn, has created a need for dosage form solutions that enable brand owners to remain aligned with relevant standards.

With its Capsugel Vcaps Plus White Opal capsules, Lonza has proven that a compliant solution does exist that can meet consumer and manufacturer needs. Extensive and rigorous regulatory and quality evaluation has paved the road towards the use of a carefully selected grade of calcium carbonate.

This selected semi-opacifier is used in combination with the Vcaps Plus technology platform and offers many of the benefits of titanium dioxide. As a clean label option, Vcaps Plus White Opal capsules are vegetarian, vegan and consist of only two ingredients: plant-based hypromellose and the food grade opacifier calcium carbonate.

Thanks to the Vcaps Plus technology platform, no gelling agent is required; yet, the capsule offers a gelatin like dissolution profile that not only meets regulatory requirements but also fulfils the needs of increasingly discerning and demanding consumers.

References

  1. S. Bettini, et al., “Food-Grade TiO2 Impairs Intestinal and Systemic Immune Homeostasis, Initiates Preneoplastic Lesions and Promotes Aberrant Crypt Development in the Rat Colon,” www.nature.com/articles/srep40373 (2017).
  2. L. Blevins, et al., “Evaluation of Immunologic and Intestinal Effects in Rats Administered an E171-Containing Diet, a Food Grade Titanium Dioxide (TiO2),” www.sciencedirect.com/science/article/pii/S0278691519305836 (2019).

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