Bromelain

Grades and forms

Bromelain is a mixture of cysteine proteases extracted from pineapple (Ananas comosus), mainly from the stem. Manufacturers buy bromelain powder by enzyme activity, not by weight alone. The activity unit and the activity per gram on the specification therefore define the grade. It belongs to the enzymes category alongside papain, the other plant cysteine protease used in supplements.

Activity is measured against a reference substrate. Each unit system uses its own method, so results do not convert exactly from one system to another.

Grades also differ in source material, stem or fruit bromelain, and in whether a carrier dilutes the enzyme to a set activity. A carrier-free grade gives the most activity per milligram of powder. A diluted grade can make small inclusion rates easier to blend evenly.

Three points usually decide the choice:

• the activity per serving your finished-product specification requires;
• the capsule fill or tablet mass you have available;
• the unit system your label, customers and auditors expect.

SoleChem sends the specification sheet and certificate of analysis with its quote. These state the activity, the unit, the assay method and any carrier. Name the unit and minimum activity you need in the quote form.

EU regulatory status

Bromelain is neither a vitamin nor a mineral, so Annexes I and II of Directive 2002/46/EC do not apply to it. The directive’s definition of a food supplement also covers other substances, but the EU has not harmonised which ones may be used. Member states set these rules nationally. Some keep positive lists or conditions of use, others rely on notification and case-by-case assessment.

National authorities may also judge, product by product, whether a bromelain product is a food supplement or falls under medicinal-product rules. Check the position in each target market with its competent authority before launch.

Under Article 8 of Regulation (EC) No 1925/2006, the Commission can restrict or prohibit substances other than vitamins and minerals. Check Annex III of that regulation for any entry covering bromelain.

Novel food status under Regulation (EU) 2015/2283 must be confirmed for the source and production process of the grade you buy. Our novel food guide explains how to check.

When bromelain is used as a processing aid in food manufacture, separate EU legislation on food enzymes applies. That framework is distinct from the rules for bromelain as a declared ingredient of a food supplement.

Any claim on the label must comply with Regulation (EC) No 1924/2006. Check the EU Register of nutrition and health claims and our health claims guide. For declaring the amount per daily portion, see labelling a food supplement in the EU.

Formulation notes

Bromelain is a protein. Its activity falls with heat, moisture and time, so most formulation decisions aim to keep it dry and cool.

• Capsules. Dry blends fill well into hard capsules. Control humidity during blending and encapsulation. Formulators choose between gelatin and HPMC shells on product grounds; see ingredients for capsules.
• Tablets. Wet granulation exposes the enzyme to water and drying heat. Direct compression or dry granulation keeps exposure lower. Check activity after compression and coating; see ingredients for tablets.
• Flow. A glidant such as silicon dioxide is a common addition when a fine enzyme powder flows poorly.
• Gelatin systems. Bromelain hydrolyses gelatin in the presence of water. This is why fresh pineapple stops gelatin from setting. Avoid it in gelatin gummies and other wet gelatin systems.
• Protein-containing products. In liquids or reconstituted powders, bromelain can break down other proteins in the formula, such as hydrolyzed collagen or whey. Keep such products dry until use.
• Shelf life. Plan for activity loss over the product’s life. Base any overage on your own stability data; the overage calculator handles the arithmetic.
• Handling. Enzyme powders are handled as respiratory sensitisers. Follow the safety data sheet for dust control, extraction and protective equipment.