EIGA Summer Session in Valencia
2022 06 07
A very successful in-person Summer Session !
My warm thanks to all of the 100+ participants that made this EIGA Summer Session a success !
See here for a short after-movie or here for lots of pictures of the Summer Session.
The EIGA Summer Sessions bring together senior management of our members to discuss statutes, budgets and strategies for the association. It is meant for members only as an ideal opportunity to engage at high level and feel the vibrant energy which drives our industrial gases sector. In just few days a busy schedule of meetings is being worked through, with meetings of the Board and of the Chairs of the four Councils and Board Taskforces.
Important decisions were taken, including a membership fee rise. See the draft minutes here (after login to the EIGA extranet).
Philippe Cornille, Gen.Sec. EIGA
Being highly safety and technology oriented, EIGA helps maintain focus on safety and stimulates its members in their continuous safety efforts by granting awards. It is both impressive and rewarding to see how many great safety innovations and improvement projects are being implemented. The very best of this fine selection are awarded an EIGA Award.
This year's awards (click to expand list of winners) were formally handed over to the winners at EIGA's Safety Awards Dinner at the EIGA Summer Session. Congratulations to the award winners !
Please follow EIGA on LinkedIn (click here ) to receive more details on individual awards in the coming weeks. There sure are learnings or inspiration in these projects.
The Peter Jackson Award is to commemorate Peter Jackson, who was an active participant and supporter of the safety work in EIGA and its Member Companies.
The award is based on the lost time accident reports submitted by the member companies in the Work Injury Statistics Tool (WIST), and the award winner is the company with the best improvement of the safety performance in 5 years. The winner of the 2021 Peter Jackson Award is NIPPON GASES NORGE AS.
EIGA has over 250 experts from Member Companies participating in more than 50 Work Groups. The Working Group Award is given to the Working Group or Ad Hoc Group in recognition of its achievements in quality, effectiveness and team work.
This year, Work Group 17, on Transport Safety won the Working Group Award. Their drive to improve safety is an example to all EIGA members and working groups. WG-17 has been very active developing EIGA’s Transport Safety Information publications, aimed at sharing knowledge and information around transport operations including technical aspects such as rollover prevention, driver recruitment and training, behavioural aspects of driving such as Distraction Management, Managing Driver Fatigue and Driver Health and Wellness. The library is key to sharing best practices to all in the industry so that we can improve our safety record.
The Safety Innovation Award shall recognise innovative best health and safety practices and is intended to encourage EIGA member companies to look to promote best practice, learn and adopt new ideas that benefit their business, the health and safety of their employees, contractors and customers and the communities they work in. The topic for 2021 was “Contractor Management”, for which 13 applications were received.
All applications were evaluated against each of the selection criteria. The Safety Advisory Council (SAC) and the Board of Directors unanimously concluded that NIPPON GASES ITALIA S.R.L deserves the Safety Innovation Award for their “Remote Job safety Observations” project.
One other project had a score very close to the winning score. SAC decided to nominate this project as the Safety Innovation Award runner-up: Sol SpA : “Artificial Intelligence Survey System for Contractor’s Man Down and Alarm for Forbidden Areas Features”
The Environmental Award recognises best environmental practice and is also designed to encourage EIGA member companies to look to promote best practice, learn and adopt new ideas that benefit their business, the environment and the communities they work in.
15 applications were evaluated against each of the selection criteria. The Safety Advisory Council (SAC) and the Board of Directors unanimously concluded that NIPPON GASES NETHERLANDS B.V. deserves the Environmental Award for their “CO2 Recovery in Dry-Ice Plant Dordrecht” project.
However, the quality of many applications was so high that the SAC decided to nominate runner-ups that scored very close to the winning project. These runner-ups are, in alphabetical order:
Air Liquide ALBI - ALBI Climate Ambassador's Network
Air Liquide Espana - Air Gas Mobile Tank Vaporiser conditioned with Solar Panel
Linde REE - Linde Green Gases
The Company Safety Awards are assigned in 3 categories. Per category, the member company which has the lowest recorded employee recordable work injury rate shall receive an award for this achievement
Category 1 NIPPON GASES EURO-HOLDING, S.L.U.
Category 2 AIR LIQUIDE ITALIA SPA
Category 3 LINDE PORTUGAL, LDA
The Road Safety Awards are assigned in 4 categories. The company obtaining the lowest preventable road vehicle accidents frequency rate for the period January to December will receive the appropriate category of the EIGA Annual Road Safety Award
AIR LIQUIDE DEUTSCHLAND GMBH for Bulk Vehicles, annually driven more than 5 million km
LINDE GAS AS for Bulk Vehicles, annually driven 1 million – 5 million km
LINDE FRANCE SA for Cylinder Vehicles, annually driven more than 2 million km
CARBAGAS for Cylinder Vehicles, annually driven 0.5 million - 2 million km
EIGA issues Safety Awards to Member Company sites achieving the number of worked hours, or a certain number of consecutive years, without a recordable work injury to any of its employees or contractors
This year, 61 so called Zero Accident Award – Location were awarded for 8 groups of companies .
Air Liquide with 7 awards
Air Products with 17 awards
Linde with 9 awards
Messer with 15 awards
Nippon Gases with 6 awards
Sapio with 2 awards
SIAD with 4 awards
SOL with 1 award
Each semester, the EIGAzette provides a detailed status report on the achievements of the Councils and different (ad-hoc) Working Groups. The below reports are grouped per Council and should update you on all relevant activities from the last 6 months.
NA - National Associations
1. Last Meeting
EIGA Joint Session – National Associations & Working Group and Council Chairs – March 23rd, 2022
EIGA NAM – NAs only – March 24th, 2022
→ Virtual Meeting
2. Hot Topics
• ENERGY & NATURAL GAS – COST & SUPPLY
Biggest worry for nearly all NAs
Already worrying before the Russian War in Ukraine – but has been now greatly exacerbated
Status as an energy-intensive sector for industrial gases is not safe in all countries (e.g., Spain, Portugal)
Political lobbying is hard since governments are also not in the position to do something about the situation + IG sector has to fight for compensations/support with all the other industrial sectors in a country
• NA COMMUNICATION: MATRIX OF COMMON INTEREST
It was decided to keep the Matrix on, also because as it was the Board’s request
Attendees agreed to fill out the Matrix before the meeting on June 10th
the Matrix will be available on the NA Microsoft Teams Platform for participants to fill in the Matrix and alter their entries anytime by themselves
• TOPIC FOR THE NEXT NA-MEETING
Next meeting for NAs is a One-topic-conference call
Selection of Topic was discussed extensively
→ Review/Status (& complete) the Matrix of Common Issues of Interest
→ EIGA’s 100-year anniversary – looking ahead at the role of associations in the future
3. Other Topics
• Interesting: ÖIGV (Austria) reported on new OXYTOP activities
Reminder: OXYTOP had been trying to put internal coating for oxygen cylinders on the market a few years ago and tried to convince authorities that this would make oxygen “safer” – thanks to the work EIGA AHG M6 the issue could be put to rest
now OXYTOP is asking Austrian gas companies to fill such cylinders for them which were coated maybe outside Austria/in other countries and bring them onto the market
ÖIGV’s position: each gas company in Austria should decide independently if it would fill such cylinders together with their mother companies – no agreement to avoid such a filling or coordinate activities against OXYTOP
Austrian cylinder manufacturer Worthington Cylinders advised against such fillings due to bad experiences
• Still: Developing hydrogen strategies and trying to get a foot in the political discussion about hydrogen
• COVID-19: everything is good in Europe
4. Communication documents
Matrix Issues of Common Interest
In 2022 there will be some changes in the IGC, two of these have already happened:
- François de Bussy, Air Liquide, and Didier Miniscloux took over;
- Christoph Herrmann, Linde, and Nikos Larass took over;
- Johann Ringhofer, Messer, will retire in the year.
The main themes discussed are highlighted in the next chapter and a detailed overview of the themes emerged in the meetings is reported in the chapter: “Themes under attention of the Working Groups”.
In addition to these elements, some other topics has been discussed in the IGC meetings: connection with other Councils; minutes structure; incident requiring special attention.
The first theme highlights how it is necessary to recover moments of information exchange between the Councils. Unfortunately, this point has weakened due to the pandemic which prevented face-to-face meetings, but the exchange of information will be restored, or improved, with the new normality. It was highlighted how, for some issues, it might be appropriate to have a dedicated exchange, for example for incidents of particular importance or for procedures that may touch the topics of different Councils.
Emerging themes from the WGs (short summary of the main critical items of the WGs)
IGC is covering eight WGs. The documents and themes of these WGs involve a lot of aspect in gas field. Up to now, 10 new or revised document was produced in 2022 (see chapter Documents issued, at the end of the document).
- WG1, Impact of BLEVE legislation of vehicles;
- WG2, Impact on cylinders testing (Brexit);
- WG3, Safety location of vent distances;
- WG4, Harmonized documents;
- WG6, Documents to be revised;
- WG8, Impact on valves or pipes or fittings;
- WG11, Resources for standardisation activities/e.g. refuelling standardisation;
- WG12, DMF restriction uses;
- WG14, Hydrogen safety production;
- WG18, Knowledge to be found on incidents.
In the next scheme the main themes that can have an impact on our business are visualised.
All topics are considered to be under the control of the WG member.
Of these points, the focus is, according to the IGC, on the themes of WG3 and WG 11:
- Safe location of oxygen and inert vents
- Resources for standardisation activities/ refuelling standardisation.
The risk to our business could arise from an external decision by the legislator or institutions.
There is a strong work by the members of the working group to follow what happens in the table of this institutions to try, when possible, to address the decision.
This "external" work is becoming more and more important and requires resources that are not always available.
In general, this last point seems to increase in importance as not being present at the tables where decisions are made could have some impact on our business.
This point, that is to always ensure the presence at external meetings, is difficult to resolve due to the low number of people who can participate, but it must still be addressed.
A visual impact of the main items for each WG is represented in the below picture. The picture reports the estimated magnitude of the themes. More detailed information on the work of the working groups is provided in the next chapter.
Themes under attention of the Working Groups
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. After the push by regulators to get battery electrical (BEV) entered into ADR 2023, it now looks like for the 2023 regulation there may be a restriction to BEVs for non-flammable, non-toxic products
BLEVE: No further meetings held since previous IGC meeting. For now, it is unclear what ADR will request. However, the proposals seem difficult to be implemented as the chairman of the Joint Meeting wants a design that avoids tire fires from spreading to “any other part of the vehicle”, which currently seems technically impossible.
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 not relevant to the industrial gases industry since all of its equipment has safety valves in line with regulations anyway. This is only relevant for liquefied gas tanks (e.g. LPG).
Automatic closing stop-valves in vapour phase of refrigerated liquefied tanks: EIGA proposed to avoid additional automatic closing valve on liquid hydrogen trailers (on the vapour phases). The proposal has been accepted. However, for new designs, it is necessary to include an automatic valve on the vapour phase.
Other ADR theme
Extra-large tank containers (tanks larger than 40,000 L geometrical volume with liquid chemicals): the changes in the new ADR will be applicable to all tank containers while before the text referred to tanks > 40,000L used for rail transport. It means that LHe and LH2, which are prohibited from rail transport, are affected. WG-1 members will be requested to check the implications now that this definition and the proposed new text is applicable to our equipment.
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.
WG-4 has drafted an new paper and WG-1 did not have any further comments. To be submitted through WG-4.
Note: Motivation was to disallow disilane for air transport.
In-house Cylinder Retesting
There was discussion in the 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. Many national delegates seem to be in favour of EIGA’s position. EIGA will remain vigilant on this item.
The theme has not been placed on the agenda of the next TPED NoBo working group meeting yet. EIGA will keep observing this closely. We now have two members in the Type B NoBo Group (AL and Messer). So we can listen in to everything concerning Type B bodies. However, we’re still fairly blind in the Type A body meetings and have to rely on Type A bodies friendly to us to keep us informed and argue in our favour, which may or may not happen.
Empty uncleaned cylinders
The Competent Authority is again protesting the gases industry taking back cylinders from customers. They are of the opinion that these should be handled as full cylinders, especially if they are equipped with pressure gauges. EIGA still believes that the actual procedure is good and safe and will argue accordingly.
It has been discussed to replace EN 13530 (Cryogenic vessels - Large transportable vacuum insulated vessels) -with ISO 20421. The ISO standard is more recent and ISO does not have the same lack of resources. However, there would be technical implications for the design of our tanks in Europe, which is why WG-1 is reluctant to support the change.
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. For what concerns the wall thickness allowance, there has been an agreement with ECMA on the 2% allowance. The paper has been presented but not yet approved
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.
Consideration of tubes trailers external corrosion: ECMA states could be external corrosion between cylinders. We have performed a study of the receptacles rejected during the last 5 to 20 years; this study is based on result provided by 4 companies operated in 6 countries, meaning a sample of about 300 battery vehicles and 60.000 receptacles.
For what concerns the changes in the ADR regulation, it is proposed that in the 2023 version of ADR there will be a concept about how to work with DOT cylinders. Wolfgang Doerner presented a document showing the DOT text for TPED cylinders under DOT regulation and his interpretation and the ADR text for DOT cylinder under ADR regulation. WG2 supports this work item and proposed to create a technical bulletin, which WG have done and is available in TB folder on EIGA MS Teams side.
There was considerable discussions about the implications transportable pressure equipment covered by TPED as well as static pressure equipment covered by PED. The solution is not simple. The CGA is finalizing a document on the guide for the gas manufactures on cylinder testing. EIGA will just refer to this document. The change may affect the existing cylinders.
Two documents published:
- DOC 908/22 “300 Bar Residual Pressure Valve Filling Connectors”
- DOC 15. Gaseous H2 Stations: the document has been approved and published as TB42.
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. One member requests to keep the document in the library and to review it.
DOC 154: Safe location of oxygen and inert vents
AHG 3.34: is working on and there will be a major rewrite based on Vent Jet calculation. Safety distances now seem more realistic (the numbers are bigger). The document covers only Oxygen and Inert gases vents. These changes will impact members of EU and USA and it will impact only new installations.
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
Documents under revisions:
- Doc 39 “The Safe preparation of gas mixtures (Harmonized)”. The document was sent for publication approval, to be published in March/April.
- IGC Doc 80 “Handling gas container emergencies. Expected publication at the end of April.
- Doc 139 The Safe preparation of compressed / oxidant gas mixtures (Harmonized).
- The document was sent for IGC approval, to be published in May.
- GC Doc 160/15 “Code of Practice – Silane” (Harmonized)
- International Standardization: there has been a proposal to create UN Numbers for pyrophoric gases and add criteria for pyrophoric gases in Division 2.1 submitted by CGA and EIGA to the UN TDG sub-Committee in 2017.
- IGC Doc 161 “Gas compatibility with aluminium alloy cylinders”: the revision is due for 2023, and it may involve a collaboration with WG-2.
WG-6: Cryogenic Vessels
Documents under revision
- The document EIGA Doc 66/08 - Refrigerated Carbon Dioxide Storage at Users Premises has been published.
- The WG is working on the following documents (the IGC will receive work item request):
Installation of indoor CO2 vessels,
Manufacturing inspection of liquid CO2 trailers
Static high pressure CO2 vessel operation and inspection.
- Discussion regarding ambient vaporizers installed on customer installation sites, related to a certain manufacturing type and its possible damage following repetitive operations (freezing and defrosting). However, it is not clear what is expected from the document. Not a conclusion yet on the next steps. More information will be given.
WG-8: Food Gases and CO2
Materials in contact whit food gases.
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” Ongoing Work with AHG 8.4. The document is almost finalized and then will be passed to WG8 to finalize the work.
The CGA Food Gases Committee Task force investigating assessment sampling for FSSC certification. EIGA has kept in touch with FSSC22000/ISO22000 organization but for the time being there is no possibility to introduce the EIGA/CGA request
Harmonized document Doc 174-21 “Guidelines for the safe installation and use cryogenic food freezing and cooling equipment”.
It was established a task force with EIGA and CGA members. Two meetings have been held in which the work on the document revision has started.
WG-11: Hydrogen Energy
Hydrogen quality specification
There are several 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 are defining the way to fill cars or other vehicles from a refueling station. They are one of the key factors for safe efficient and competitive 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 standardization 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.
CCU - CO2 as a co-product of H2
CCU - CO2 as a co-product of H2: Promoting the Emitter Payer Principle.
Pending decision from REC & IGC on how to proceed on this topic.
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.
Work request regarding the standardization of the HRS: Establish an industry position about Standardization of the Interface between Tube trailer and H2 Refuelling Station.
Document under revision:
1. DOC 2XX – Purification, Compression and Drying of Acetylene
2. DOC 2XX – Safe Filling of Acetylene Cylinders
3. DOC 2XX – Blowing Down Acetylene Cylinders
4. DOC 196 – CALCIUM CARBIDE STORAGE AND HANDLING
5. DOC 205 – CALCIUM CARBIDE SPECIFICATIONS
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).
1. Safety of Hydrogen HyCO Production and Carbon Capture - Approaching completion.
2. Hydrogen Production Overview – In earlier stages of preparation.
Much interest on the addition of H2 to existing pipeline systems.
All the hydrogen documents are public. The purpose of the work item request is to reduce the number from three to one document and keeping the ASME code as primary source for design these systems.
Additionally, we ask to WG-14 to produce two new documents, in order to show that EIGA is the expert on the topic of hydrogen safety. One document will show to the external stakeholders that we are designing the process safely. The second is about an overview of all the kind of commercial producing technologies.
A new ad hoc group will be created. It will work on a third (new) public document, which will deal with hydrogen logistic and applications.
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.
The document on N2O proceeds. Some tests on the hypergolic reaction are under the attention of the working group.
Documents issued in 2022
DOC 80 / 22 - Handling Gas Container Emergencies
DOC 132 / 22 - Unmanned Airgas Plants: Design and Operation
TB 43 / 22 - Secondary Identification of H2 Vehicle at Dispenser
DOC 39 / 22 - The Safe Preparation of Gas Mixtures
TB 42 / 22 - Welded Gaseous Storage Vessels and Hydrogen Compatibility
DOC 66 / 22 - Refrigerated CO2 Storage at Users' Premises
DOC 138 / 22 - PTFE Used as a Sealant for Cylinder/Valve Connections
DOC 908 / 22 - 300 Bar Residual Pressure Valve Filling Connectors
DOC 240 / 22 - Commodity Specification Acetylene
DOC 62 / 22 - Methods to Avoid and Detect Internal Gas Cylinder Corrosion of Gas Cylinders and Tubes
Key topics from the last report
See the MGC house depicted above.
European Medicines Agency (EMA) initiatives: EIGA as stakeholder
During Covid-19 pandemic, the awareness at EMA and National Health Authorities level of our industry has increased, as result EIGA was invited to attend stakeholder meetings:
Multistakeholder workshop on EMA’s extended mandate in crisis preparedness and management for medicinal products and medical devices, which took place on April 1st. Outcome: there will be a list of critical medicines and medical devices for COVID crisis (oxygen and nitric oxide may be on it – list will be published in August this year). In order to increase safety of supply, industry of critical medicines will be asked to supply info’s on supply capacity and stocks etc. EIGA may need to harmonize the approach so that all members answer in a similar way.
QWP (Quality Working Party): EIGA was invited to provide a 15 min presentation in the meeting that took place on May 3rd. WG7 has given the reasons why we think it is necessary to amend the outdated EMA Guideline on Medicinal Gases. Outcome: EMA QWP supports EIGA’s request to revise the Guideline and agrees to include it in their 3-year Work Programme.
Industry Stakeholders Standing Group (ISG) to be created during 2022 with inclusion of all EMA Industry eligible organisations. EMA intention is to have direct and regular meeting interaction with the industry.
Medical Device Regulation: Gases and mixtures for in-vitro applications:
WG 15 has agreed on their classification and results have been published as an amendment of TB 30 “Classification of Medical Device Gases According to European Medical Device Regulations”. It includes gases used in incubators and in vitro applications. Objective: uniform application of regulatory requirements.
Video on VIPRs use
A video was created by WG15 to provide best practices on VIPRs lifetime management to users. This activity was initially requested by the UK Heath Authorities MHRA. The external supplier has provided the final version. Currently under revision by WG15.
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. WG-20 (the WG on Communication) will no longer be implicated in this project since EIGA considers the document should not be communicated as a press release but a communication to very specific stakeholders, e.g medical associations. Currently working on the document to be disseminated. List of stakeholders will be provided directly by AHG M.5 members.
Temperature/Humidity monitoring for compressed & liquefied gases
Environmental control and monitoring for medicinal gas cylinders, especially control of temperature in storage and distribution, is in some EU countries a special burden that the gas industry has to fulfil. WG-7 has prepared a Technical Bulletin to explain scientifically why it is not necessary to perform any environmental controls and monitoring for medicinal gases and gas mixtures during storage and transportation for high-pressure cylinders. The final document was approved in April 2022. This document should be the basis for any discussions with National Health Authorities during inspection and other contacts for all the EIGA member companies to be achieve waivers for environmental controls and monitoring.
WG 10_ Documents published in the past semester:
Doc 141 Travelling with Oxygen review: update and clarifications
Doc 157 Hygienic Reprocessing: rescope and update to a world including Covid
Doc 193 Guidance on self-fill systems: simple update
Technical Bulletin 39: “Impact on EIGA Members by the ongoing Field Safety Notice of Philips-Respironics”. Trying to manage expectations on an inherently very difficult topic
EU Pharmacopoeia Monographs
A new monograph Oxygen 98 % was issued by the EU Pharmacopoeia for comments, including the online measurement of the oxygen content, and the continuous analysis of impurities CO, CO2, moisture (as a minimum). Still waiting to analyse comments (being translated), many of which apparently were received from France.
MGC proposed a meeting between Chairs of 9G Mirror group and APHARGAZ which took place in April 2022. Objective: to better understand the process in France regarding decision taken at Ph.Eur. Level, to build a deeper understanding of the APHARGAZ ongoing initiatives and to help to strengthen the relationship between APHARGAZ and French Pharmacopeia. APHARGAZ Chair will participate in the next EIGA AHG M.14 "Pharmacopoeia Mirror" meeting, to ensure a better alignment on the purposes and ongoing initiatives around oxygen 98 percent.
Key objectives and initiatives the coming two years
The leading objective of MGC is to consolidate its position towards Health Authorities and other EU Regulators, taking advantage of the gas industry’s visibility gained throughout the Covid-19 pandemic. To achieve this goal, MGC will work to:
Consolidate its position as a recognized stakeholder by relevant European Authorities
Continue actively to act as European Medicines Agency and WHO stakeholder for any impact on Public Health
Promote the collaboration in the industry on Vigilance initiatives regarding medicinal and medical device products, especially considering the strict MDR requirements
Anticipate and integrate changes in regulations that could impact or modify significantly the medical gases sector.
Publish white papers on specific areas to spread out our view and best practices in a proactive way
Continue the publication of documents related to the safe design, manufacturing, operation and use of medical products
Ensure a regular communication and synergies between medical and non-medical working groups, ad-hoc groups and with National Associations.
Working Group 7- Medical Gases
Define Standards & Best Practices
White Paper on Medicinal Oxygen: EIGA’s activity can often be described as “reactive”. The objective is to create a “proactive” white paper to provide information on production, controls, supply chain, liability and environmental aspects of both ASU and Hospital PSA. Target audience: managers and engineering staff at hospital facilities. The goal of publication is end of this year.
Working Group 10 - Homecare
Define Standards & Best Practices
Documents that currently under review to be published during 2022:
Doc 198 – Security and Safety for Home Care field personnel
Doc 98 – Medical Oxygen Systems for Home Care Supply
Possible integration of both documents
Document 198 is to be proposed for archiving. Part of lone worker activity to be discussed with WG16, if it is not better included in their scope.
Zeolite leakage from sieve beds: drafting a letter to oxygen concentrator Manufacturers with our concerns on the zeolite leakage inside concentrators. Draft letter to suppliers finalised and sent for legal check. Each company to contact the manufacturers they work with for their opinion.
Working Group 15 - Medical Devices
Define Standards & Best Practices
CO2 list of applicable requirements for MDR. Objective: uniform application of regulatory requirements. TB completed to be published shortly.
N2: The WG is working on the list of MDR applicable requirements for N2. Objective: uniform application of regulatory requirements
Pipeline systems: the most appropriate rules of classification for pipeline systems to be defined by the WG.
Drug generating devices: The WG will define in collaboration with WG7 the most appropriate route for the approval of this kind of devices - regulatory status identification)
The best practices on VIPRs lifetime management: under revision by WG15 to ensure alignment with new requirement of ISO/FDIS 22434.
AHG M.8 - ISO TC 121 Mirror Group
Define Standards & Best Practices
High contribution on the new standards on proportioning units, air compressors and PSA O2 93 % generators) for medical gas supply systems. Leading the drafting of:
ISO 7396-3, Medical gas pipeline systems — Part 3: Proportioning units for the production of synthetic medical air
ISO 7396-4, Medical gas pipeline systems — Part 4: Air Compressor Units
ISO 7396-5, Medical gas pipeline systems — Part 5: Oxygen Concentrator Units
The documents for final approval are expected by Q1/2023, for a publication Q2/2023
- Leading the drafting of:
ISO 18777-1, Transportable liquid oxygen systems for medical use — Particular requirements — Part 1: Base units
ISO 18777-2, Transportable liquid oxygen systems for medical use — Particular requirements — Part 1: Portable units
The documents for final approval are expected by Q2/2023, for a publication Q4/2023
Close monitoring of the relationships between ISO 10297 (cylinder valves), used for PI marking, and ISO 10524-3 (VIPRs), used for CE marking. Leading the review of ISO 10524-3 -Pressure regulators for use with medical gases — Part 3: Pressure regulators integrated with cylinder valves (VIPRs):
Objective is to find a consensus on the clauses to be amended and study the request for alignment from ISO/TC 58/SC 2 with the industrial VIPRs standard (ISO 22435) and the valve standard (ISO 10297).
AHG M.8 will provide its recommendations by the end of Q3/2022 for decision at the next ISO TC 211/SC 6 plenary meeting.
AHG-M.14 - Pharmacopoeia 9G Mirror group
The key objectives for next year are the following:
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%. The adoption will probably be in a new Eu. Pharm. General Chapter.
Evaluation of different methods for determining water in gases:
The proposal is to build a chapter with different analytical procedures adapting to the different gases and different contents of water to be determined. The idea is not to replace the existing method in monographs, but to make alternative procedures available. Validated procedures will be proposed, so that for specific gases the validation work for users could be limited;
Evaluation of the capacitive hygrometer, chilled mirror, oscillating quartz and possibly other methods, as European Pharmacopeia method for determining water in gases;
Considerations around the different analytical techniques for determining water in gases.
Stability of gases at molecular level;
Examination of stability, and reactivity of gases, on a molecular level. The goal is to generate a document giving an indication on the stability of gases of different categories (elemental gases, compound gases, mixtures, etc.). It is foreseen to finalise the document in 2022, then publishing it in the Scientific Notes part of Pharm Europa.
Revision of Oxygen 93 monograph: risk evaluation and redefinition of the proposed monograph.
AHG-M.16 - Cylinder Internal Quality
AHG M.16 is proposing a possible recommendation of max 0,1 g loose particle mass in a cylinder as acceptable. The 0,1 g reflects the actual conditions of cylinders handled by EIGA members when using state of the art processes. So-called ultra-fine particles will be excluded from the scope. Expected final documented to be submitted for approval in Q4 2022.
AHG-M.17 - Pharmacovigilance
AHG M.17 will work on the update of Doc 203/18 “Typical Post-Marketing Pharmacovigilance Cases in the Medical Gases Industry”. Expected to be ready in Q1/2023
WG currently working on the elaboration of a communication to EMA/PRAC with the aim to avoid the uploading of non-medicinal gases related cases (eg. industrial grade N2O related cases) in Eudravigilance (EU database).
Working Groups and Ad Hoc Groups to be created in 2022
Clinical Permanent AHG-M.19: the intention is to have the availability of a clinical dedicated, permanent though dormant, AHG that will address clinical queries from WG7, WG15 and others as and when it is required.
The work of the REC is composed of the efforts of its two Ad Hoc Groups: R.3 (Energy & environmental legislation) and R.4 (Sustainable finance, sustainability reporting and the “Taxonomy”). R.4 is about to come out of the state of “hibernation” it has been in for some months; the subject matter with which it deals has recently shown an uptick in activity.
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” which refers to the EU’s commitment to achieve 55% GHG reduction by 2030.
The addition of “REPowerEU” – and EU response to the Russian invasion of Ukraine – has increased the opportunities – and potentially the threats - for our sector; it has also added a new element of confusion in legislative processes.
EIGA continues to express its support for the EU’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 and a recognition of the sector’s expertise in critical areas.
To start with the most recent developments, readers are doubtless aware of most, if not all, of the measures proposed in the the European Commission’s “REPowerEU” communication. However, it is worthwhile to draw attention again to the ambitious expectations for renewable hydrogen, both domestically produced and imported, in the drive to reduce the EU’s dependence on Russian natural gas. How this will be achieved will include follow-up amendments to measures contained in the European Commission’s “Fit for 55” package of proposals that was published in July 2021 and which was followed later in that year by the “Hydrogen & Decarbonised Gas Market Package”. These dossiers are the responsibility of AGH-R.3.
Together, “Fit for 55” and the “Hydrogen & Decarbonised Gas Market Package” contain an extensive list of draft directives and regulations that are intended to bring EU policies into line with the target of 55% emission 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” and “ETS 4”.
Further details are provided in the final section of this report but I thought that I should take the opportunity here to clarify some terms:
The proposed recast of RED 2 is often – and mistakenly - referred to as a proposal for a new RED 3
The proposed recast of ETS 4 is often referred to as ETS 1, to differentiate from what is now being referred to as ETS 2, a parallel ETS to apply to new sectors including, inter alia, transport.
To turn to the matters addressed by AHG-R.4, currently the greatest interest is in the Taxonomy under which each activity is assessed for sustainability according to six pillars
Climate change mitigation
Climate change adaptation
Sustainable use and protection of water and marine resources
Transition to a circular economy
Pollution prevention and control
Protection and restoration of biodiversity and ecosystems.
Two “delegated acts” and technical screening criteria for the first two pillars (mitigation and adaptation) have been adopted by legislators; they applied from January 2022.
The decision on inclusion of nuclear energy and natural gas in the Taxonomy has not been made and is clearly an issue with a linkage to EU Member States’ desire to maintain energy security in the context of the Russian invasion of Ukraine.
Specifically for hydrogen, the technical screening criteria read:
“The activity complies with the life-cycle GHG emissions savings requirement of 73.4% for hydrogen [resulting in life-cycle GHG emissions lower than 3tCO2e/tH2] and 70% for hydrogen-based synthetic fuels relative to a fossil fuel comparator of 94g CO2e/MJ [...]
Delegated acts for the other 4 pillars of the Taxonomy will be adopted later in 2022.
The recent decision to bring AHG-R.4 out of hibernation is based on a belief that there may be an opportunity to have ASUs included in the Taxonomy, a goal of the REC for some time.
Finally, and although no additional resources will be required, it is clear that that REC will continue to be busy into 2023, 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 that the value is recognised of both green and blue hydrogen
to obtain recognition of ASUs as key underpinnings of industrial decarbonisation.
Individual policy developments addressed by AHG-R.3
1) Emissions Trading System (ETS)
The ETS 4 had effect from 1st January 2021 but is already under review. Proposals that REC will continue to address include:
De-coupling of hydrogen benchmark from the refinery benchmark, with implications for the level playing field between in- and outsourced supply of hydrogen to refineries.
The detailed mechanism by which the proposed new stand-alone hydrogen benchmark is calculated.
Definition & treatment of CCU and its implications for CO2 markets.
REC has engaged with the Commission, key MEPs and Member States. We are also seeking alignment with other relevant industry sectors.
2) Renewable Energy Directive (RED)
RED 2 was transposed into Member State legislation by 30 Jun 2021 but is already subject to review:
The proposal for recast of RED 2, sometimes referred to as “RED 3”, proposes renewable hydrogen targets for industry, beyond the current application to the transport sector.
There are implications in the proposal in terms of the how by-product CO2 will be treated in life cycle analyses (LCAs) relevant to this dossier (see further below).
At the time of writing, the implementing measures for RED 2 had not yet been published but were expected on 18th May. Their content will be critical in the definition of what is required for hydrogen produced in electrolysers to be certified as “renewable fuel of non-biological origin” (RFNBO).
3) Hydrogen and Decarbonised Gas Market Package (the “Gas Package)
As proposed, this measure would bring private hydrogen networks into the regulated domain, with third-party access as a requirement by 2030. EIGA’s position on this is as follows:
EIGA members own and operate the majority of existing hydrogen pipelines.
We recognize the importance of developing regulated infrastructure to meet future demand for hydrogen as an energy vector but hydrogen serves and will serve several additional markets including industry (as feedstock) and mobility. The level of maturity of these markets and their mid-term development perspectives call for separate policy frameworks. In the context of a future regulated public hydrogen infrastructure, there are sound technical and economic reasons for these hydrogen networks to be unregulated on the grounds that these consumers of hydrogen require higher levels of purity and reliability than can be provided by a future regulated network.
We believe that the technical and business expertise of our members provides us with the legitimacy to participate in the debate.
As with RED, there are implications in the Gas Package for the treatment of by-product CO2 under LCAs. AHG-R3 is seeking to develop an aligned position on this matter.
SAC Membership Changes in 2021
SAC has undergone some changes to its membership in 2021:
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 the SAC as Messer Group representative, after Danilo RITLOP premature-ly passed away in 2021.
Reviews and updates of new documents progress regularly; 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 30 publications.
In 2022 YTD the number of revised documents is 11.
Learning from Incidents
In 2021 SAC published 4 Training Packages on recent incidents in industrial and medical gases in-dustry; in 2022 YTD 2 Training Packages of the same type have been prepared.
A “special” Training Package to emphasize some typical situations that can be found at customer premises will be published on EIGA website in the next few weeks; the documents can be shared with the customers, to alert them about the possible results of lack of knowledge or poor risk awareness, that can lead to severe incidents or at least potentially high-risk scenarios.
Working Groups and Ad-Hoc Groups
In 2021 a new Working Group was created - WG-19 “REACH” - which replaces AHG-I.11 REACh and extends its scope.
Currently, WG16 “Workers Safety” has a long list of documents to be reviewed; in order to reduce its workload, SAC agreed to create a new AHG in 2022 for the revision of document Doc 60/15 “Seveso Guidance”; the new AHG will be established in summer 2022.
Ad-Hoc Groups: No new Ad-Hoc Groups were created in 2021.
AHG S.13 (Oxygen e-learning) was closed in 2021;
AHG-S.9 (Safety Distances), AHG-S.14 (ATEX), AHG-5.1 (Revision of BREF documents) have been put dormant.
AHG-S.2 (Process Safety) will be put dormant in 2022 after finalisation of the document they are working on.
EIGA Safety Innovation Award
The topic for 2022 EIGA Safety Innovation Award is Behavioural Safety and the mail for applica-tions has been sent by EIGA a few weeks ago.
For 2023 Safety Innovation Award, SAC proposes two possible subjects/areas:
New technics in communication and training
Life Saving Rules
Some years have passed from the publication of the Life Saving Rules in 2015; SAC is in the opin-ion that it could be the right time to check if the current Life Saving Rules are still appropriate with the incidents experienced in the last period by the gas companies and if the ways these are com-municated to employees, contractors and third parties can be improved, especially with reference to the advances in digital communication.