• Regulatory House

Boric acid and borates used as excipients – does your PIL need a revision?

Boric acid is used as an antimicrobial preservative and is used as a buffering agent to control the pH. It can be found in products like ophthalmic preparations, ears drops and homeopathic dilutions.

There is no information about boric acid (or boron) in the Annex of the excipient guideline on ‘Excipients in the label and package leaflet of medicinal products for human use’. However, boron compounds were classified as toxic to reproduction (CMR Repr. cat. 2). Therefore, it is considered necessary to include appropriate information in the package leaflet of boron-containing medicinal products especially because they may be used by the most sensitive populations, i.e. pregnant women and children.

Proposal for updated information in the package leaflet can be found in the following link: https://www.ema.europa.eu/en/boric-acid-borates