EIGA Newsletter

19 May 2025

EIGA NEWS

Nitrous Oxide and waste incinarators

On 6 May, EIGA had a constructive and insightful meeting with representatives from the European Commission (DG GROW and DG ENVI) to clarify some key distinctions between the packages used for nitrous oxide.

This is a very topical issue. Indeed, Single-use packages (canisters, cartridges) containing nitrous oxide (N2O) are creating issues in waste incinerators by explosion. The European Commission is considering how to address the problem, and EIGA needed to make sure that there would be no new requirements on cylinders, which are distributed by EIGA members but not found in waste incinerators.

Technical Manager Els Vandererven explained the differences between single use packages and Refillable gas cylinders. She further explained why EIGA sees no need nor benefit to change the current practice of PRDs on refillable N2O cylinders. This was very well understood by the European Commission which confirmed that their intention was not to put any additional burden on the industrial gases industry in this regard.

EIGA is also liaising with the European Waste Management Association (FEAD).

PUBLICATIONS

COM 11/25 - Medical Oxygen in Healthcare Facilities - All you need to know about supply sources for medical gas pipeline systems

This White Paper on medicinal oxygen provides a comprehensive overview of the use of oxygen, its properties, historical significance, and its various applications, specifically in the medical field. Its prime purpose is to consider the different medical oxygen supply sources used for Medical Gas Pipeline Systems (MGPS) in Healthcare Facilities (HF), but to also include information about the development of oxygen as a medicinal product and an overview of its physical properties.

Doc 51/25 - Management of Change

(Revision of Doc 51/17)

Management of Change (MOC) process forms an important element of a Process Safety Management System as well as other management systems. The introduction of any change to a process, process equipment, or component and associated premises, if not appropriately managed, can significantly increase the levels of personal, environmental, security, reliability and process safety risk or impact product quality.

Management shall ensure that risks arising from any form of change are systematically identified, assessed and managed.

Doc 118/25 - Safe Management of Contractors

(Revision of Doc 118/12)

This document is intended for use by EIGA member Companies to provide recommendations on how to plan and safely execute contracted work and should be used by anyone involved in the selection, management and assessment of contractors.
The document has undergone an extensive revision.

Doc 143/25 - Guide to Carbide Lime Applications

(Revision of Doc 143/17)

This publication describes some of the beneficial uses of carbide lime and is intended for use by EIGA members as a guide to which applications of carbide lime can be used to demonstrate that the carbide lime can be used directly without further processing and should not be considered a waste. The publication has been revised to ensure consistent use of terminology for the product. New sections have been added for carbide lime as a by-product and for transport of carbide lime.

Doc 209/25 - Quality of Delivered Product from Medicinal Gas Cylinders

(Revision of Doc 209/17)

EIGA have conducted analytical tests in order to measure metallic elements, that could be present in medicinal gases. This publication provides the test results, which conclude that impurities measurements are below the detectability levels as well as below ICH Q3D requirements.

Doc 213/25 - Description of the Pressure Test Methods Used during Cylinder Manufacture

(Revision of Doc 213/18)

This publication explains the historical background of the pressure test methods used during the manufacture of high-pressure seamless aluminium alloy and seamless steel cylinders. The publication is based on Technical Information TI 001, Description of the pressure test methods used during cylinder manufacture, prepared by the European Cylinder Makers Association, ECMA.

Doc 214/25 - Development of Calculation Formulae for Cylinder Wall Thickness

(Revision of Doc 214/18)

This publication explains the historical background to the formulae used to calculate the minimum design wall thickness of seamless steel and aluminium alloy cylinders and the differences between them. The publication is based on Technical Information TI 002, Development of calculation formulas for cylinder wall thickness prepared by the European Cylinder Makers Association, ECMA.

Doc 216/25 - ICH Q3D Risk Assessment Report Elemental Impurities in Medicinal Gases

(Harmonised publication)
(Revision of Doc 216/20)

From the information given in this report and a risk assessment, the view of the EIGA companies is that the levels of elemental impurities within the lincensed medicinal gases that they supply for patient treatment are well below the limits set out in ICH Q3D.

Doc 222/25 - Guidelines for Cleaning Externally Contaminated Medical Gas Containers

(Harmonised publication)
(Revision of Doc 222/19)

Guide on the removal of external contamination from medical gas containers so that the process does not damage the container or its accessories and protects personnel handling medical gas containers.

SI 2/25 - Handling of Full Metal and Composite Gas Cylinders During and After Exposure to Excessive Heat or Fire

(Revision of SI 2/21)

All gas cylinders, whatever the gas content, are potentially dangerous when exposed to fire or excessive heat. Excessive heat exposure can weaken the cylinder and, in extreme cases, result in the failure of the cylinder.

TB 4/25 - Lifetime of pre-1930 Steel Cylinders

(Revision of TB 4/18)

The Technical Bulletin deals with an issue raised by a cylinder maker who recommended the discontinuation of the use of carbon steel cylinders manufactured before 1930, the so-called "first generation" cylinders. Following a review by EIGA of data for cylinders produced before 1930, EIGA rejected the recommendation and this Technical Bulletin gives details of the review and the decision.

TB 8/25 - ATB Cylinders

(Revision of TB 8/18)

This Technical Bulletin is intended for anyone who is involved in the maintenance activities of high-pressure gas cylinders and who may be inspecting cylinders from ATB.

TB 30/25 - Classification of Medical Device Gases According to European Medical Device Regulations

(Revision of TB 30/24)

To establish a harmonised approach and to avoid different interpretations of rules and risk classes across the different EU member states.

The European Industrial Gases Association (EIGA)

EIGA ? is a safety and technically oriented organisation representing the vast majority of European and also non-European companies producing and distributing industrial, medical and food gases. The member companies closely co-operate in technical and safety matters to achieve the highest level of safety and environmental care in the handling of gases. EIGA is in frequent touch with Standardisation and Regulatory Organisations and Authorities as well as trade and industrial organisations. EIGA?s membership comprises European companies that produce or distribute industrial and/or medical gases. As such, EIGA itself does not produce or market industrial or medical gases.

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