Today’s food supplement consumers are seeking out safe, clean label options to support both their health and their sustainability goals. As such, they are increasingly seeking food supplement products made from unambiguous ingredients. A 2020 consumer research study commissioned by Lonza revealed that 88 percent of European food supplement consumers cited “unquestionable safety” in their top three prerequisites for purchasing supplements, next to scientific proof of effectiveness and price.1 Even further, 78 percent indicated that natural sourcing was among their top ten purchasing influences.2
As the market evolves and expectations continue to rise, regulatory agencies are reviewing requirements and what might have been considered ‘safe’ five years ago is now being re-evaluated. Manufacturers and brand owners need to consider the balance needed for effective food supplement solutions. They must comply not only with the latest regulatory requirements, but also with consumer demand for safe products that meet preferences around swallowability, convenience, appearance and feel, as well as religious or dietary requirements.
Changing regulations
Regulatory changes can affect every product component, including food colorants. Harmonized EU legislation allows the use of specific authorized colorants, described as food additives, in food supplements. The food additive titanium dioxide (TiO2, E171), an opaque white pigment, has been used as an authorized colorant to achieve a visually appealing capsule for more than 40 years. However, recent studies have raised questions regarding its safety and impact on human health, owing to the presence of potentially cell-damaging nanoparticles.3 Although the evidence on orally consumed food-grade titanium dioxide is not yet conclusive, and conflicting information has surfaced,4 these findings have inevitably sparked a public debate which has seen titanium dioxide come under considerable scrutiny. This ongoing debate saw France suspend the use of TiO2 as a food additive from January 1, 2020. Further assessment by the European Food Safety Authorization (EFSA) concluded that titanium dioxide can no longer be considered safe when used as a food additive, and in May 2021, the EU Commission’s expert group on food additives achieved unanimity in its decision to ban the use of titanium dioxide as a food additive, although the transition period remains to be defined. In light of EFSA’s assessment of TiO2 and the resulting ban across Europe, many manufacturers are now reformulating their products and the hunt is on to find a white opacifier that makes a viable alternative to titanium dioxide.
Assessing the titanium dioxide alternatives
Titanium dioxide is an opacifier with many advantages for manufacturers. Its opacity enables effective masking of the capsule fill and protection of ingredients from light degradation, while the distinctive bright whiteness helps brand owners to establish a unique visual identity. An alternative opacifier needs to carry the same functionality, without compromising the stability or robustness of the capsule, and all while meeting the consumer clean label imperative. As such, finding a suitable replacement is essential 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 colorant calcium carbonate (E-170). 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, where the need for a compliant high-performance solution was always highest priority, that a carefully selected, food-grade calcium carbonate was chosen for Capsugel® Vcaps® Plus White Opal® HPMC capsules, based on particle size, distribution and shape. This semi-opacifier is used in combination with the thermogelling technology featured in the Capsugel® Vcaps® Plus HPMC capsule portfolio, which allows for the offering of a gelatin-like dissolution profile, while also providing light protection, opacity and brand differentiation thanks to its natural look.
Diverse demands, compliant solutions
As consumer needs grow more complex and sophisticated, so, too, do the needs of food supplement manufacturers, which must find solutions which balance a wider range of considerations. Today, industry regulation is not only important in helping to streamline and safeguard product development, but is also playing an increasingly instrumental role in shaping and influencing innovation. This, in turn, has created new opportunities for dosage form manufacturers to support the needs of brand owners, enabling them to achieve the right standards.
For more information, visit www.capsugel.com
White Opal® is a registered trademark in the EU.
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Julien Lamps
Product Manager, Lonza Capsules and Health Ingredients Lonza Capsules & Health Ingredients is the preferred global partner to the pharmaceutical, biotech and nutrition markets. We work to prevent illness and enable a healthier world by supporting our customers to deliver new and innovative medicines that help treat a wide range of diseases. We achieve this by combining technological insight with world-class manufacturing, scientific expertise and process excellence. These enable our customers to commercialize their discoveries and innovations in the healthcare sector. Lonza’s industry-leading Capsugel® capsules and encapsulation technologies, formulation know-how and science-backed ingredients combined with our customer-focused services, provide unique and innovative solutions for nutraceutical companies. |
References:
[1] NMI SORD 2020, Food Supplement Consumers in Germany, Poland, Denmark, France, Italy and the UK, Base: 1000 consumers in each country.
[2] Ibid.
[3] 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,” (2017) https://www.nature.com/articles/srep40373
[4] L. Blevins et al., “Evaluation of immunologic and intestinal effects in rats administered an E 171-containing diet, a food grade titanium dioxide (TiO2),” (2019) https://pubmed.ncbi.nlm.nih.gov/31473338/
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