Gelatin

Grades and forms

Gelatin is a protein made by partial hydrolysis of collagen from animal skin, hide or bone. In food-supplement manufacturing it is a functional material. It forms hard and soft capsule shells, sets gummies and binds or coats particles. Manufacturers specify gelatin powder on four points.

• Source. Commercial gelatin comes mainly from porcine skin, bovine hide and bone, or fish skin. The source affects labelling and dietary suitability more than technical behaviour.
• Type. Type A is made by acid pretreatment, usually from pigskin. Type B is made by alkaline pretreatment, usually from bovine material. They differ in isoelectric point, which matters next to charged ingredients.
• Bloom strength. Bloom is the standard measure of gel strength. Higher Bloom grades set firmer and faster. Lower grades give softer textures and lower viscosity at the same concentration.
• Particle size. Fine powders hydrate quickly. Coarser granules disperse with less lumping.

Capsule shells and gummies usually call for different Bloom and viscosity grades. Bloom, viscosity, particle size and microbiological limits are stated on the specification sheet. SoleChem sends it, with the certificate of analysis, alongside its quote. State the source, type and Bloom range you need in the quote form.

Gelatin is not the same material as hydrolyzed collagen. Further hydrolysis shortens the chains, so collagen peptides dissolve in cold water and do not gel. Choose gelatin when the product needs gel structure or film formation.

EU regulatory status

In the EU, gelatin is treated as a food ingredient, not a food additive. Its use is therefore not governed by the Union list of additives in Annex II of Regulation (EC) No 1333/2008.

Gelatin is a food of animal origin. Its production for human consumption is subject to the specific hygiene requirements of Regulation (EC) No 853/2004, Annex III, Section XIV.

Directive 2002/46/EC defines food supplements and lists permitted vitamin and mineral forms. It does not regulate shell or carrier materials such as gelatin.

Under Regulation (EU) No 1169/2011, gelatin appears in the list of ingredients, including when it forms the capsule shell. Fish is a listed allergen in Annex II of that Regulation. Annex II sets out specific exceptions for fish gelatine, including its use as a carrier for vitamin or carotenoid preparations; check the exact wording of Annex II before relying on an exception. See the labelling guide for the full requirements.

Formulation notes

Hydration and setting. Gelatin swells in cold water and dissolves when warmed. On cooling it sets into a thermoreversible gel that melts again on heating. Disperse the powder into cold water first to avoid lumps.

Heat and acid. Prolonged heating lowers gel strength, and low pH speeds this up. In gummies, add acids and heat-sensitive actives late, after cooking.

Enzymes. Proteases such as bromelain and papain break down gelatin. Do not combine active proteolytic enzymes with gelatin in water-containing systems such as gummies.

Reducing sugars. Gelatin takes part in Maillard reactions with reducing sugars. In sugar-based gummies this can cause browning during storage, so include colour in stability testing.

Capsule shells. Gelatin shells hold moisture. Very dry storage makes them brittle and humid storage softens them. Hygroscopic fills can draw water from the shell. Aldehydes and some reactive excipients cross-link gelatin and slow shell dissolution, so test fill compatibility in stability studies. The guides to capsules and softgels cover shell selection. For products that must exclude animal-derived material, HPMC is the usual capsule-shell alternative.

Taste and handling. Gelatin is largely neutral in taste. Odour and colour vary by grade and are covered by the specification sheet. Other carriers, binders and flow aids are listed under excipients.