EIGA at ADR/RID/ADN Joint Meeting

EIGA members and staff attended the ADR/RID/ADN Joint Meeting, virtually in Bern this month. We again submitted several papers:

• ECE/TRANS/WP.15/AC.1/2021/9 (EIGA) & INF.24 (France) – on the use of DOT cylinders in Europe and the USA

Both papers were adopted for publication in version ADR 2023. This is a major achievement !...after more than a decade of perseverance of EIGA, we finally achieved that the Multilateral Agreement between Europe and USA, M318 valid till June’23, no longer needs to be extended as the text will appear in January’23 in the ADR regulations.

Thanks to the USA delegations and CGA, the DOT already published a final ruling, i.e. law 49CFR, allowing the transport, filling and use of European Pi-marked cylinders. Vice versa, with this last EIGA paper our proposed text in the ADR 2023 also allows similar import and export of DOT cylinders in Europe. The exact new text of this carriage of gases of Class 2 refillable pressure receptacles in ADR can be obtained from your WG-1 member.

• INF.30 EIGA RID/ADR 4.1.6.8 and 4.1.6.15 – Requirements for valve protection

With the support from the German Authority, our paper was adopted, clarifying in the regulations the difference between cylinder valve, guard, cap and shroud.

EIGA further supported a number of other papers, such as the INF.39 from Portugal on a list of abbreviations. As result “ EIGA” now appears under this list, because it is referred to in ADR/RID.

The paper INF.8 (Germany) on RID/ADR 6.2.3.1.5, not allowing any pressure relief devices on non-UN acetylene cylinders, was adopted with EIGA’s support.

Info 16/21 - Fires in Cylinder Regulators in Industrial Oxygen in Service

(Revision of Info 16/12) EIGA receives reports of incidents involving fires in oxygen gas cylinder regulators.

This Safety Information is intended to raise awareness of these incidents and to provide the basic recommendations and rules to safely operate and maintain oxygen gas cylinder regulators.

The Safety Information should be read by all those who are involved in the purchasing, use and maintenance of oxygen gas cylinder regulators.

Doc 174/21 - Guidelines for the Safe Installation and Use of Cryogenic Food Freezing and Chilling Equipment

(revision of Doc 174/20) This publication has been prepared to cover the safety requirements and best practices for the installation and use of equipment for the chilling and freezing of food using liquefied cryogenic gases (liquid nitrogen) or refrigerated liquefied gases (liquid carbon dioxide) as the cooling medium. The purpose is to provide guidelines on the design, installation and operation of chilling and freezing equipment so that they can be operated safely.

Doc 179/21 – Liquid Oxygen Nitrogen and Argon Cryogenic Tanker Loading Systems

(Harmonised publication, revision of Doc 179/13) This publication covers cryogenic liquid oxygen, liquid nitrogen, and liquid argon tanker loading systems for loading by gravity, pressure, or pump filling. It covers the design of the tanker loading systems and the period of time and activities between when a tanker enters the filling area and when it departs from the filling area.

This publication focuses on the factors affecting the transfer of oxygen, nitrogen, and argon as cryogenic liquids between a source and appropriately designed tankers used for the transportation of these products. The source can be either a storage tank or directly from the plant.

Doc 235/21 – Industrial Gas Pipeline Integrity Management

(Harmonised publication) Operation and maintenance guidelines for transmission pipelines are an important requirement due to the hazardous nature of certain gases and the presence of the pipelines through the public domain.

This publication covers the integrity of industrial gas transmission pipelines for gaseous nitrogen, oxygen, argon, helium, hydrogen, carbon monoxide, and Syngas. This publication addresses the integrity of industrial gas pipelines in the public domain including maintenance and operation as appropriate.

Doc 901/21 – Working Group Expert Guide

(EIGA Members' area, Revision of Doc 913/13) This publication provides guidance for the EIGA Working Groups, on the structure and organisation of EIGA and its Working Groups.

EIGA and the World Health Organisation (WHO)

The WHO have initiated activities around COVID-19, in particular on medical gases. In order to offer those countries in the world which do not have their own guidelines on medical gases, they have drafted documents open for public consultation. As result, EIGA have prepared and submitted comments on :

• WHO’s published Guidance on ‘’Oxygen sources and distribution for COVID-19 treatment centres- interim guidance 4 April 2020. It is a valuable document summarizing the possibilities of oxygen supply for treatment centers and EIGA have commented on the different aspects of medical oxygen production from PSA’s. We also referred to our Doc 195 Safe design and operation of on-site generation of oxygen 95% for medical use, which provides good insights into this topic, based on worldwide industry experience.

• WHO propose a modification of their monograph on 99.5% oxygen by enlarging the purity range from 90% to 99.5%, in order to cover the oxygen produced by PSA’s. Both EIGA and the ISO TC 121 Anaesthetic and respiratory equipment, recommended to not do this, but instead keep their 99.5% monograph on oxygen from cryogenic distillation of ambient air unchanged and create a new one on 93% Oxygen from PSA’s, like it exist in Europe and America. Also our international colleague associations CGA and AIGA commented in a similar manner.

• WHO’s propose a new guidance on Good Manufacturing Practice for Medical Gases. EIGA and CGA, submitted comments. WHO’s draft GMP is very similar to what already exist in Europe and the Americas, hence we were able to focus on improvements or propose alternative requirements. Matter a fact, EIGA plans to use our comments to also convince the EMA (European Medicines Agency) to further improve the European GMP Annex 6 Manufacture of Medicinal Gases.

SA 45/21 - Hazard of Oxygen-Enriched Atmospheres in Healthcare Facilities

The potential hazards associated with oxygen-enriched atmospheres are well known and several EIGA publications provide personnel working with oxygen with details of the fire and explosion hazards associated with these conditions.

Moreover, during the COVID-19 pandemic patients receive High-Flow Nasal Oxygen (HFNO) as an effective means of treatment, capable of delivering an oxygen flow rate of up to 60 litres per minute. As more wards are equipped for oxygen treatment and HFNO treatment, it is possible the ventilation systems will not be able to maintain atmospheres that are not oxygen enriched.

Please click here to download SA 45 (EIGA Members' area)

TB 38/21 - Home Care Service Providers’ Obligations under the Medical Devices Regulation

The Medical Device Regulation (MDR) becomes applicable as of the 26th of May 2021.

The objective of this Technical Bulletin is to give guidance on the interpretation of this regulation for Home Care Service Providers (HSP) and to provide recommendations on how to implement the requirements of this regulation.

TP 24/21 - EIGA Good Homecare for Oxygen Therapy

The provision of Homecare respiratory services by EIGA members is an important area where EIGA members serve the community. Click here to view the publication (EIGA Members' area) .

Info 40/21 - Medicinal Oxygen Production and Supply during Pandemic Situations

During the entire COVID-19 pandemic situation, EIGA members remained adhering strictly to quality and safety requirements for medical 99.5% oxygen to the well-established and validated European Monograph 0417. Click here to download Info 40/21

Doc 128/21 - Design and Operation of Vehicles Used in Medical Oxygen Homecare Deliveries

(revision of Doc 128/12) This document describes the basic design principles and safe operation of purpose designed vehicles, recommended for Homecare Service Providers for delivering all modes of supply of medical oxygen and associated therapy equipment.

It has been prepared by industry experts building on best practices used by EIGA member companies. As well as being adopted by EIGA members, the document is already used by a number of national authorities for guidance.

Doc 901/21 – Working Group Expert Guide

(EIGA Members' area, Revision of Doc 913/13) This publication provides guidance for the EIGA Working Groups, on the structure and organisation of EIGA and its Working Groups.

EIGA appointed member of the High Level Group on Energy Intensive Industries

EIGA was admitted as active member to the High Level expert Group on energy-intensive industries (see here for more detail, or contact p.cornille@eiga.eu).

This will allow EIGA to better advise the European Commission in the preparation of policy initiatives relating to energy-intensive industries such as ours.

European Parliament endorses position on Carbon Border Adjustment Mechanism

The European Parliament has supported the implementation of a CBAM, while at the same time not explicitly ruling out some continuation of free allowances. The CBAM is intended to replace free allowances to protect from carbon leakage, and thus could significantly affect the impact of the ETS on industrial gases.

UK ETS to begin auctions on 19 May

The UK ETS, which has been established to mirror the EU ETS, will begin auctions on 19 May. While this will formally commence the scheme, there remain many variables which are yet to be clarified by the UK government. The latest information can be found here.

Doc 901/21 – Working Group Expert Guide

(EIGA Members' area, Revision of Doc 913/13) This publication provides guidance for the EIGA Working Groups, on the structure and organisation of EIGA and its Working Groups.

BN 15/21 - Harmonisation of Information for Poison Centres

(revision of BN 15/18) Regulation (EU) 2017/542 was published in March 2017 amending the CLP by adding an Annex VIII on “harmonised information relating to emergency health response”.

Annex VIII meets part of EIGA’s original concerns by excluding mixtures classified only for the hazard “gases under pressure” from its scope but fails to exclude “flammable gas mixtures” and “oxidising gas mixtures” for the same obvious reason “explosive mixtures” (non-gaseous) have also been excluded.

Starting 2018 the remaining concerns of EIGA have been shared with the consultant, contracted by the Commission to make a workability study. A change of scope to exclude flammable and oxidizing gas mixtures was not accepted. EIGA still strongly believes that submitting pieces of information which are in practice not useful to emergency health responders does not bring any added value to either users or industry and will continue to defend this position.

SA 05/21 - Disguised Transportable Gas Cylinders

Info 16/21 - Fires in Cylinder Regulators in Industrial Oxygen in Service

(Revision of Info 16/12) EIGA receives reports of incidents involving fires in oxygen gas cylinder regulators.

This Safety Information is intended to raise awareness of these incidents and to provide the basic recommendations and rules to safely operate and maintain oxygen gas cylinder regulators.

The Safety Information should be read by all those who are involved in the purchasing, use and maintenance of oxygen gas cylinder regulators.

Doc 75/21 - Methodology for Determination of Safety and Separation Distances

(revision of Doc 75/07) The primary objective of this document is to define a philosophy to determine suitable separation distances for all equipment, pipework and storage to allow member companies to develop consistent standards across the industry.

Doc 102.10/21 - Safety Audit / Assessment Tool – Transport of Gas Cylinders

The former Appendix 9 of Doc 102 – Safety Audit / Assessment Tool for Transport of Gas Cylinders – has been reviewed and published as Doc 102.10. All annexes of Doc 102 are listed in Doc 102.01.

Doc 155/21 - Best Available Techniques for Hydrogen Production by Steam Methane Reforming

Doc 169/20 - Classification, and Labelling Guide in accordance with EC Regulation 1272/2008 (CLP Regulation)

(revision of Doc 169/19) EIGA Doc 169 known as the « Classification and Labelling Guide » is updated regularly in order to take into account the changes in the CLP Regulation and the changes in the classification of gases due to the REACH registration of substances that have occurred.

Doc 181/21 - Gas Cylinders Compliance with the Revised Packaging Waste Directive

(revision of Doc 181/13) This publication provides guidance to EIGA members on compliance of gas cylinders with Directive 94/62/EC on packaging and packaging waste (as amended) on the prevention of packaging waste.

The publication provides guidance to EIGA members on the consistent and practical implementation of the packaging waste directive and to help ensure that member states’ implementation does not duplicate or conflict with existing regulations concerning the management of gas cylinders.

Doc 186/21 – Guideline for Process Safety Management

(Harmonised publication, revision of Doc 186/14) Process Safety Management (PSM) is of interest to many organisations looking to adopt an integrated and systematic approach to assuring the integrity of their operations. The publication is intended to provide a design basis for the development of a process safety management system where an organisation does not have one. It may also be used as a common basis for benchmarking existing process safety management systems. The elements of the process safety management framework set out the key aspects to assure the integrity of operations. Each element contains an overview which states its intent and a number of requirements which define what organisations should address.

Doc 901/21 – Working Group Expert Guide

(EIGA Members' area, Revision of Doc 913/13) This publication provides guidance for the EIGA Working Groups, on the structure and organisation of EIGA and its Working Groups.

Doc 903/21 – EIGA Safety and Environmental Award Schemes

(Revision of Doc 903/20) Following a review of the EIGA Safety Awards, the EIGA Safety Advisory Council has proposed a number of changes to ensure that the Awards continue to support EIGA’s safety mission. The changes and revised definitions are detailed in the revised version of Doc 903 Safety and Environmental Award Schemes.

The principle changes are as follows:

Zero Accident Award – Location

The qualification for the award has been changed from “no lost time injury” to “no recordable injury”.

An application for a Zero Accident Award shall be deferred for one year if an incident with a potential for severe injury or fatality (PSIF) has occurred during the 12 months prior to the submission date for an award nomination to EIGA.

Safety Innovation Award

The criteria have been slightly modified and the application form has been updated accordingly.

Doc 913/21 – Transport Security Guidance for EIGA Members

(Revision of Doc 913/13) This document (EIGA Members' area) contains tools and resources that maybe used when assessing security issues related to the transport of dangerous goods. It provides guidance for compliance with European regulations and the current editions of international transport agreements such as those for road and rail.

The implementation of the information contained in this document, plus the specific ways of managing security and risks will vary when taking into account the raw materials and products being transported, the mode and route of transportation and the vulnerability/risk profile.

This document is intended to provide additional information to that given in EIGA Doc 173, ADR Transport Security Guidelines.

Doc 919/20 – Guidelines for the Preparation of Safety Data Sheets

(EIGA Members' area, Revision of Doc 919/19) EIGA 919 “Guidelines for the preparation of Safety Data Sheets” known as the “SDS Guide” is updated regularly in order to take into account new data and new risk management measures submitted by gas producers during the REACH registration of gases and communicated in their revised SDSs. Changes in the library of phrases are highlighted in the document.

National legislations are not considered in this document. References to national legislation should be added in the relevant sections of the SDS by the gas supplier, preferably in coordination with the other EIGA members in the relevant National Gas Association.