Introduction

In January 2022 the chair of IGC changed from Air Liquide (François de Bussy) to SIAD (Giorgio Bissolotti) . In 2022 there will be some changes in the IGC as three people have announced their retirement.

In 2021 WG-14 was re-titled to Hydrogen production (previously HyCO) and WG-18, Nitrous Oxide was created.

Themes emerging from the WGs (short summary of the main critical items of the WGs)

Items that could have a business direct impact are connected to the retesting of cylinders or battery vehicles (see WG-1 and WG-2). For cylinders there was a positive news relating to the agreement on the mutual recognition, which enter in force in the 2023, between Europe and the United States (DOT).

The items that need attention for the future relate to hydrogen regulation (see WG-11 and WG- 14) and, in general, the presence of EIGA members in the associations that prepare the standards/norms. The specification relating to hydrogen used in fuel cells which, thanks to the work of the WG-11, has been positively influenced according to the ideas in our sector.

The start of the work of some WGs (WG-14 and 18) and the quantity of technical documents produced by many working groups should also be highlighted.

WG-1: Transport

DOT Cylinders

DOT cylinders: changes in progress in the code of Federal Regulations 49 CFR. DOT cylinders will enter into ADR 2023 which is a very good news. The next step should be to recognise worldwide EU (ADR) and DOT cylinders. No news since last report, but still under observation of WG-1.

Cylinder periodic inspection of tubes in battery vehicles

More work is required to achieve the 15 years periodic inspection of tubes in battery vehicles. A specific WG should be created with stakeholders.

UN Disilane Air Transport

Creation of UN number for disilane: EIGA has withdrawn its original paper upon the request of CGA who were not in line with the EIGA position. CGA will prepare a new paper for a later UN meeting in coordination with EIGA. On hold for now.

Fuel Cell/Fully Electric Trucks ADR Task Force for Transportation of Dangerous Goods.

EIGA representatives participate in the meetings with competent authorities, manufacturers and other interested parties. It is not believed that Battery Electrical Vehicles (BEV) or Fuel Cell Electrical Vehicles (FCEV) with enter ADR before 2025.

BLEVE Meetings

Consequences of BLEVE meetings: three measures will enter ADR in order to mitigate BLEVE incidents. These are fire resistant mudguards, engine fire suppression system and safety valves for tanks. Safety valves on tanks are less relevant to the industrial gases industry since all of its equipment has safety valves in line with regulations anyway. Currently it is still unclear if the two relevant measures will also apply to compressed gases.

In-house Cylinder Retesting

There was discussion in the Tanks WG on the scope of work to be allowed for in-house inspection services (IS). There is a proposal to restrict their capabilities only to pressure receptacles that they own themselves. This would make retesting more expensive without added value. EIGA argued accordingly and submitted an INF document which was discussed.

WG-2: Gas Cylinders and Pressure Vessels

Cylinder wall thickness to reject cylinders

EIGA and ECMA agree to allow isolated pits and to allow a percentage below minimum wall thickness. However, different positions exist on the wall thickness to reject cylinders.

Tubes trailers 15 years retest regime (on going). Inert gases, H2 and He.

There was not a common position between WG2 and ECMA to increase the testing interval up to 15 years. It was decided to create an EIGA+ECMA informal working group to discuss the provisions under which an extension of the retest up to 15 years could be eventually accepted. Informal Working Group will start end of January 2022.

WG-3: Atmospheric Gases Process & Equipment

DOC 43-Cryogenic carbon absorbers.

Cryogenic carbon absorbers, DOC 43. It was proposed to archive the document as there was no real interest to update document.

WG-4: Special Gases

Availability of experts in specialty gases

Availability of experts in specialty gases seems to be a problem due to its scarcity.

Harmonisation of EIGA documents with CGA documents

The work method is being optimised.

WG-6: Cryogenic Vessels

There is a large number of documents under revision

WG-8: Food Gases and CO2

Materials in contact whit food gases.

A new document was drafted following the last conference call of the AHG 8.4 Food Contact Material a new document was drafted => Title “Guidelines for assessment of materials in contact with food gases” 

WG-11: Hydrogen Energy

Hydrogen quality specification

There are a number of new standards/norms on hydrogen:

- ISO 14687-2 « Hydrogen fuel -- Product specification -- Part 2: Proton exchange membrane (PEM) fuel cell applications for road vehicles »

- ISO 19880-8 : « Gaseous hydrogen — Fuelling stations — Part 8: Fuel quality control »

- EN 17124 « Hydrogen fuel - Product specification and quality assurance - Proton exchange membrane (PEM) fuel cell applications for road vehicles”.

WG-11 has been mandated by CEN TC268 WG-5 to propose a draft document for a European standard for H2 quality.

Refueling protocols:

Refueling Protocols are defining the way to fill cars or other vehicles from a refueling station. They are one of the key factors for safe supply of H2 to mobility applications. WG-11 has initiated work to build a common position concerning the expectations of the H2 suppliers about the next generation of refueling protocols to be implemented on cars after 2025.

Interface HRS, Tube Trailer:

Establish an industry position about standardisation of the interface between tube trailer and H2 Refueling Station – WG-11 decided to put on hold due to lack of alignment internally for each member.

Standardisation activity

Preparing standardisation activity related to new usages of Liquid H2 for H2 energy infrastructure. EIGA needed to be able to share relevant docs to prepare the work on those standards. WG-11 may develop a position.

WG-12: Acetylene

Implementation of DMF restriction uses

The restriction of DMF uses has been issued. This information will be included in the EIGA documents.

WG-14: Hydrogen production (previously HyCO)

H2 safety and handling and H2 production methods

Currently working on two new documents: the first is an overview of H2 safety and handling, the second is an overview of H2 production methods. We are mindful that there are a lot of newcomers to the H2 business, so we are starting with basics. We are also continuing with literature reviews with a plan to focus next on plugging any gaps. Plan to have meeting with WG-11 to get more familiar with their activities and to ensure we are aligned (WG-11 focus is on H2 energy and users).

WG-18: Nitrous Oxide

Analysis of the incidents

All companies listed known incidents in a table. The majority of the incidents have been analysed. For all reviewed accidents, lessons learned and a number of requirements have been listed, in order to be matched with the existing documentation in a gap analysis.

Medical Device Regulation - MDR

After one year delay due to Covid-19 pandemic, the new MDR has officially entered into force in Europe on May 26 th.

"Guidance on classification of medical devices" published in October 2021 by the Medical Device Coordination Group (MDCG) has officially included gases for insufflation as class IIa instead of class III.

Field Safety Notice (FSN) Philips Respironics on BiPAP and CPAP equipment

Respironics issued on June 2021 a FSN in Europe (and recall in the US). The degradation of the foam used mainly in sleep devices but also in some ventilators can potentially release toxic substances.

WG10 elaborated the TB 39/21 “Impact on EIGA Members by the ongoing Field Safety Notice of Philips-Respironics (Sound Abatement Foam Degradation)”.

Philips has activated the process for the replacements/repairs, and first replacement devices have been shipped. However, the FDA questioned the solution proposed by Philips – we are awaiting further news on the finalisation & continuation of the replacement/repairs process.

Once started, we can expect this exchange/repair process to continue at least during the whole year of 2022.

Safety Information

During the Covid-19 pandemic, the risk of oxygen-enriched atmospheres in healthcare facilities is higher than usual due also to the spread use of High-Flow Nasal Oxygen (HFNO).

In this respect, SAC recommended the publication of the Safety Information: SI 41/21 “Hazard of Oxygen-Enriched Atmospheres in Healthcare Facilities” based on the SA published previously.

Furthermore, WG7 elaborated a poster SL 11/21 “Health Care Facility – Oxygen Fire Safety”. It has been produced following a similar one proposed by CGA.

N2O Clinical Best Practices

AHG M.5 finalized the Clinical Best Practice document. Main objectives are to promote the safe usage of medicinal N2O and N2O mixtures and raise awareness on the misuse/abuse in order to mitigate the potential safety risks related to human exposure to these products.

WHO Documents

In the frame of Covid-19 pandemic, WHO is of the believe that there is an urgent need to increase the access and availability of medicinal gases for treatment, in particular oxygen and published several documents related to this topic. MGC, WG7 and AHG M.14 have elaborated comments to the International Pharmacopoeia for Oxygen and WHO GMPs.

EIGA has as well offered expertise in the creation of documents related to oxygen and other medicinal gases. Our comments have been accepted and the amendments have been included in the Rev 1 of WHO GMP document.

Cylinder Internal Quality

AHG M.16 is working to define an EIGA standard considering the lack of regulation regarding residual value definition. The AHG are elaborating a possible recommendation of max 0,1 g loose particle mass in a cylinder as acceptable. The 0,1 g reflect the actual conditions of cylinders handled by EIGA members when using state of the art processes.

EU Pharmacopoeia Monographs

New monograph Oxygen 98 per cent: EIGA submitted to the EDQM public consultation on the monograph in time prior deadline December 31st with the AHG M.14 comments, among which there are the inclusion of online measurement of the oxygen content, and the continuous analysis of impurities CO, CO2, moisture.

Monograph Air, medicinal: adoption of the PID (Photo Ionization Detector) method for the measurement of oil in gases - in progress at Pharmacopoeia table. The method appears to be a promising alternative to the unreliable detector tubes (e.g. Draeger tubes). It can be potentially required also in the future for in-line process analysis of Oxygen 93 and 98%.

Context

The work of the REC is composed of the efforts of its two Ad Hoc Groups: R3 (Energy & environmental legislation) and R4 (Sustainable finance and “Taxonomy”).

While structurally distinct and separate, the scopes of work of these Groups need to be seen together in the context of the EU’s focus on climate; “Fit for 55” refers to the EU’s commitment to achieve 55% GHG reduction by 2030.

These developments bring new opportunities for the Industrial Gases sector but also new regulatory risks for the IG business model. EIGA has always expressed its support for Europe’s climate ambitions, recalling the key role that IG sector should play in the energy transition, given a level playing field between insourced and outsourced production.

R4 is currently in temporary “hibernation” on the grounds that the status of relevant legislative development is such that there would be no purpose served by engagement with stakeholders.

Report

The most urgent issue with which REC dealt in 2021 was the Climate & Energy Aid Guidelines (“CEEAG”) which revise the preceding “EEAG” limitations on Member States’ freedom (1) to award State aid to renewable and low-carbon energy developments and (2) to compensate specific electro-intensive industries for the cost of levies intended to pay for that State aid. As initially proposed, the CEEAGs no longer included Industrial Gases in the list of sectors eligible for aid under (2) above. Had this been carried forward into the final document, the cost involved for our membership would have exceeded half a billion euros per year and there would have been a significant threat to the viability of te sector’s outsourcing business model for ASUs.

EIGA is pleased to read that the Industrial Gases sector has been added to the list of eligible sectors.

In July the European Commission’s “Fit for 55” package of proposals was published, followed more recently by the “Hydrogen & Decarbonised Gas Package”. Together, these proposals contain an extensive list of draft directives and regulations that are intended to bring EU policies into line with the target of 55% emissions reduction by 2030. Some of the proposals in the package would have significant implications, positive and negative, for our sector; this is particularly so for the proposed recasts of “RED 2”, “ETS 4” and perhaps the Energy Tax Directive “ETD”.

Many readers will also be aware of the difficult discussions between the Commission and some Member States on the “Taxonomy”. The implications for industrial gases are complex but, in summary:

• The emissions threshold for compliance of hydrogen production with the “Taxonomy” is expected ultimately to become the basis for the performance targets embedded within other directives. A positive step has been the recognition that the differing technologies for hydrogen production (e.g. electrolysers v. SMRs with CCS) will be required to meet the same performance thresholds.

• Despite our efforts, ASUs are not included in the Taxonomy and REC will re-engage on this in the coming months.

EU policies are changing fast. On the one hand, these policy developments bring into sharp focus how the skills of EIGA members will become more and more critical if climate ambitions are to be met. It is clear that that REC will be busy in 2022, with its broad objectives being:

• to maintain a level playing field between insourced and outsourced industrial gases production, supported by the familiar argument that the efficiency gains from outsourced production can and do support the achievement of energy and climate ambitions;

• to highlight the benefits arising from private hydrogen networks to ensure customers that have access to the required purity and reliability of supply;

• to ensure recognition of ASUs as key underpinnings of industrial decarbonisation.

SAC Membership changes in 2021

In 2021 there have been the following changes in SAC membership:

• Holger GEUE (SOL Deutschland, Germany) joined as secretary;

• Nete FAXØE (Strandmøllen, Denmark) joined SAC as Cat 2&3 representative, together with Finbar CONSTANT, already member of SAC;

• Mark GARRETT replaced Martin SNAPE, the previous representative of Air Products who moved to a different position in the company;

• Udo KOHL joined as Messer Group representative, after Danilo RITLOP prematurely passed away in 2021.

Publications

During 2021 a significant number of documents and other publications have been published or revised by SAC or by the WGs and AHGs under the supervision of SAC. These total 29 publications, including:

• 1 Briefing Note

• 1 Safety Alert

• 1 Safety Information – Human Factors

• 2 Safety Information - Transport

• 3 Safety Information

• 4 Training Packages – Recent Incidents

• 17 Documents

Learning from Incidents

In 2021 SAC published 4 Awareness Packages on recent incidents in industrial and medical gases industry. Each event reported in these Awareness Packages is discussed within SAC to identify root causes and current best practices that could have helped to avoid negative outcomes. The best practices are included under the paragraph “discussion points”. A special attention is paid to report “Safety II” events.

Working Groups and Ad-Hoc Groups

A new Working Group was created in 2021, WG-19 “REACH”, which replaces AHG-I.11 REACh and extends its scope with regulation on Substances of Very High Concern (SVHC) in articles and requirements related to the SCIP database (Substances of Concern In articles as such or in complex objects (Products)).

No new Ad-Hoc Groups were created in 2021.

AHG S.13 (Oxygen e-learning) was closed in 2021.

The following Ad-Hoc Groups will be closed/put dormant in 2022:

• AHG S.14 (ATEX) will be closed after completion of the review of Doc. 134/2012

• AHG-S.9 (Safety Distances) will be put dormant.

• AHG-S.2 (Process Safety) will be put dormant completion of new doc on Process Safety Critical Devices

Database Upgrade/Evolution

The new WIST (Work Injuries Statistics) and RAST (Road Accidents Statistics) are fully operational. The objective of SAC is to make their use as large as possible so that they will allow for more reliable statistics and deeper analysis of the trends in our sector.

With this regard, the new RAST database allowed for the first time to track the data of 2020 and 2021. Result will be shared in the next NewsLetter.

Focus to Improve Performance: Safety I vs Safety II

SAC keeps on looking for examples and best practices to share in order to make periodical publications in this area. Examples of “Safety II” events are also added in Awareness Packages published every quarter.

Winter Seminar 2022

The EIGA Winter Seminar 2022 was developed under the patronage of the SAC with the aim of developing knowledge on ‘packaged gases’ (compressed gases). It provided an overview of current hot topics, best practices for the industry and a look to the future of what packaged gases will look like.

A big effort has been made by the SOC to allow for this event in pandemic period and to guarantee the quality of the event as it was in January 2021.