Capsule shells: functional, on-brand and regulatory compliant
Choosing the right capsule shell is a key element of product development. For contract manufacturers, this involves considering not only appearance, processing and target-group appeal, but also the regulatory compliance of the materials used. Depending on the product concept, gelatin, HPMC or pullulan capsules, for example, may be considered – each with different functional and labelling properties.
For the European market, it is crucial that all substances used in capsule shells are permitted under food law and are suitable for the respective product. Food supplements may be marketed in capsule form, among other formats. Individual components of the capsule shell may also require a more in-depth regulatory review – for example, with regard to additives, colourings or novel food ingredients.
The Novel Food Regulation (EU) 2015/2283 may also apply if a substance intended for use in or as part of the capsule shell was not used to a significant extent for human consumption in the EU before 15 May 1997. The current Novel Food framework has been in effect since 1 January 2018. Whether a substance is to be classified as novel is assessed on a case-by-case basis. The European Commission's Novel Food Catalogue provides guidance, although it is not legally binding.
Furthermore, the additives used in capsule shells are particularly relevant. A well-known example is titanium dioxide (E 171), which is no longer approved as a food additive in the EU. This is a crucial consideration for formulation, purchasing and product design, especially for white or opaque capsule shells.
We support you in selecting the right capsule solution, not only from a technical perspective but also from a regulatory one. As early as the development phase, we work with you to determine which capsule materials best suit your product, target group and brand positioning, what the labelling requirements are, and whether individual components require a separate regulatory assessment. This provides greater certainty throughout development, procurement and market launch.
Our approach to contract manufacturing is to think holistically about capsule solutions: from material selection and processing properties to marketability and labelling. This results in products that are functionally convincing and compliant with regulatory requirements.
Are you planning a capsule product for the EU market?
We'll help you select the right capsule shell – tailored to your formula, target group, positioning and regulatory requirements.