After several years of work by the experts of Group 16 (Plastic materials, plastic containers and closures), three new general chapters on plastic materials were adopted by the European Pharmacopoeia Commission at its 180th session in November 2024. These general chapters – Cyclo-olefin polymers (3.1.16), Cyclo-olefin copolymers (3.1.17) and Styrene block copolymers (3.1.18) – are the first new texts to be published in section 3.1. Materials used for the manufacture of containers since Polyethylene terephthalate (3.1.15) in 2001, when the European Pharmacopoeia (Ph. Eur.) was in its 4th edition. They are also the first texts in section 3.1 to refer to the general chapter on Extractable elements in plastic materials for pharmaceutical use (2.4.35), published in September 2024.

The three new general chapters cover important plastic materials already used for several medicinal products in Europe and will help standardise analytical procedures and specifications for these widely employed substances. They are rendered legally binding through cross-references in the general monograph on Pharmaceutical preparations (2619) and in the dosage form monographs in section 7 of the Ph. Eur. All three texts will be published in issue 12.1 of the Ph. Eur. in July 2025, with an implementation date of 1 January 2026.

With the addition of cyclo-olefin polymers, cyclo-olefin copolymers and styrene block copolymers, the Ph. Eur. now covers a total of 14 different materials used in the manufacture of containers for pharmaceutical uses.

See also:

• Outcome of the 180th session of the European Pharmacopoeia Commission, November 2024
• The European Pharmacopoeia Commission
• Groups of Experts and Working Parties