Highlights of WG activity since Jan 2020.

The main recent activities of the 8 Work Groups under IGC are summarised below:

o Transport (WG-1)

o Published Documents:

o Doc 63: “Prevention of Tow away incidents”(republished)

o Doc 81 “Road Vehicle Emergency and Recovery” (rev) and its corresponding Training Package TP 08 (rev)

o BN 18: “Connecting Packages to Customer Processes by Vehicles Crew members” (rev)

o Doc 173 : “ADR Transport Security Guidelines”(rev)

o SA 44: “Load Securing of Gas Receptacles for Transport” (new)

o New Work item:

-Fuel cell/fully electric powered trucks for Transportation of Dangerous Goods. (Those vehicles are not yet explicitly mentioned or allowed by ADR, while LNG, CNG and LPG powered vehicles were specifically added in 2017 through UN regulation 105)

o Other items in progress worth mentioning:

o BLEVE meetings (lessons learnt from Bologna 08/2018 propane accident): ADR will incorporate some new requirements metal mudguards…but the requirements regarding new road safety technology will be made mandatory in Europe for all heavy vehicles (and not specific to ADR)

o 15 years periodic inspection of tubes in battery vehicles: delayed due position of ECMA(European Cylinder Manufacturers Association)

o UN TDG has created a new WG between authorities, experts and industry (to review regulatory changes to come such as ADR 2021). Two members of EIGA WG1 will represent EIGA in this UN WG.

o Cylinders & Valves (WG-2)

o Published documents:

§ Doc 100/20 “Hydrogen cylinders and transport vessels” (rev)

§ Info 25/20 “Crane Transport of cylinder and package” (rev)

§ TB 05/20 “Recommended method for the Determination of Hydrocarbons on Gas” (rev)

§ TB 07/20 “Cylinders that Reach the End of Retest Period or Service Life at Customer side” (rev)

§ Doc 78 “Leak Detection Fluids Cylinder Package” (rev)

§ SI 22 “Potential Hazards of Quick Release Cylinder Valves Used with Firefighting Gases” (rev)

§ TB 13 “Safe Design and Use of Cylinder Pallets” (rev)

§ TB 16 “-40 °C” Mark on Cylinders/Valves” (rev)

§ TP 58/20 “Safe Design and Handling of Filling Connectors” (new)

§ TB 35 “COVID-19 - Multilateral Agreement M326 - Periodic Inspection and Test of Pressure Receptacles for the Carriage of Gases of Class 2” (new)

o Other items in progress worth mentioning

§ REACH: Declaration of lead content > 0,1% (w/w): a paper was prepared by WG-9 and reviewed by WG-2.

o Atmospheric Gases Process & Equipment (WG-3)

o WG-3 worked together with CGA to develop an Industry position with respect to Sumitomo brazed aluminium heat exchanger case:

§ PP 44, “Sumitomo Precision Products Fabricated Brazed Aluminium Heat Exchangers” (new)

§ BN 28, “Sumitomo Precision Products Fabricated Brazed Aluminium Heat Exchangers Operating under the PED” (new)

o Other revised and new documents published (5 of them harmonized with CGA)

§ DOC 65, “Safe Operation of Reboiler/Condensers in Air Separation Units” (rev)

§ DOC 144 “Safe Use of Aluminium-Structured Packing for Oxygen Distillation” (rev)

§ DOC 147 “Safe practices guide for cryogenic air separation plants” (rev)

§ DOC 13 “Oxygen Pipeline and Piping System” (rev)

§ DOC 127 “Bulk Liquid Oxygen, Nitrogen and Argon Storage Systems at Production Sites” (rev)

§ DOC 234 “Internal Inspection of Decommissioned Flat Bottom Tanks” (new)

o Other item: WG-3 is keeping an eye on EN-14620 revision in case its scope would be extended to cryogenic storage of air gases.

o Specialty Gases (WG-4)

o Published documents:

§ DOC 188 “Safe Transfer of Toxic Liquefied Gases was finalised” (rev)

§ DOC 30 “Disposal of gases” (rev)

o The work on IGC Doc. 030 Disposal of gases was finally closed at the end of April. (Two previous JWG meetings with CGA scheduled last December and February were cancelled because the quorum was not met. This raises potentially an issue for the work on future harmonized documents in the field of Specialty Gases. In both EIGA and CGA dedicated work groups, there are only a few member companies and the recent merger in the industry will put future work at risk).

o Ad hoc Group AHG-4.10 ISO/TC 158 is involved in the development of ISO 6142-2 Gas analysis — Preparation of calibration gas mixtures - Part 2: Gravimetric method for Class II mixtures. Good progress in establishing a common position. A new ISO work item needs to be created because date was expired.

o Cryogenic Vessels (WG-6)

o Published documents: (all rev)

§ DOC 224 – “Static Vacuum Insulated Cryogenic Vessels Operation and Inspection”

§ DOC 87 – “Conversion of Cryogenic Transport Tanks to Oxygen Service”

§ Info 27- “Operation of Transportable Vacuum Insulated Containers for Industrial and Medical Gases”

§ DOC 909 – “EIGA Cryogenic Gases Couplings for Tanker Filling”

§ Doc 102 part 9, “Audit Guidelines for Customer installations Regular inspection of cryogenic tanks at customer premises”.

§ Technical Bulletin 11, “Recommendations for the Prevention of Brittle Failure of the Outer Jacket of Vacuum Insulated Cryogenic Storage Tanks”

§ Harmonized DOC 164 (CGA G-6.7) – “Safe Handling of Liquid Carbon Dioxide Containers that have lost pressure”

o Ongoing contribution to ISO/TC 220 “Cryogenic vessels” and CEN/TC 268 “Cryogenic vessels” including and CEN/TC 268/WG5 “Specific hydrogen technologies applications”

o Food Gases & CO₂ (WG-8)

o Published documents: (all rev)

§ DOC 67: “CO2 cylinders at users' premises”

§ DOC 125: “Guide to the Supply of Gases for Use in Foods”

§ DOC 126: “Minimum Specifications for Food Gas Applications”

§ DOC 174: “Guidelines for the Safe Installation and Use of Cryogenic Food Freezing and Cooling Equipment”.

o Ongoing work on Food Contact Material (FCM) by Ad-Hoc Group AHG-8.4 who will liaise with AHG-M16 “cylinders internal quality”

o Hydrogen Energy (WG-11)

WG-11 activity is focusing on building common positions within industrial gas companies and other players in the hydrogen (or H₂) infrastructure industry, in order to present a common industry view to the various standardisation and regulation bodies. The players involved in the H₂ infrastructure extend beyond the traditional panel of gas companies. WG-11 regularly includes guests such as Shell, Daimler, BMW, Toyota, Honda, Ford and other players in the field of H₂ mobility to support this activity.

The ongoing topics (dealt with at ISO and CEN level) are:

Hydrogen quality specifications for Hydrogen Energy

Hydrogen refuelling stations

Hydrogen refuelling protocols and risk assessment => topic of communication/ non-communication refuelling

Another topic being worked on is Hydrogen CO2 footprint (e.g. in the case of carbon capture)

o Acetylene (WG-12)

WG-12 has undertaken the task of revising the comprehensive Doc 123 “Code of Practice – Acetylene” and re-publish its EIGA acetylene library in a set of more manageable shorter documents.

o Published documents: (all rev)

§ DOC 231: “Response to Operational Issues in Acetylene Plants”

§ TB 34: “Acetylene Plant Safe Operating Pressures and Temperatures”

§ Doc 102 part 6, “Safety Audit / Assessment Tool – Acetylene Plant and Cylinder Filling”.

o Other topics:

§ Regulatory Watch on DMF Restriction (AHG-12.1) - ongoing

o HyCO Plants (WG-14)

o This work group is working well as a combined working group with CGA.

§ Doc 230: “Safe Catalyst Handling in HYCO Plants” (new)

Key objectives and initiatives for 2020, industry impact

o Continue activity for EIGA and industry experts in their involvement with ADR and UN TDG regulations; ISO and CEN work on cylinders, valves, vessels, special gases analytical work and hydrogen energy.

o Ensure best practices as detailed in the documents produced are effectively disseminated and implemented.

o Identify gas industry synergies.

o Continue to learn lessons from accidents/incidents.

o Ensure backlog of documents to be revised is controlled and efficiently managed by each WG.

Issues requiring Board guidance

o Hydrogen landscape:

In the framework of revisiting the management of the Hydrogen related topics within EIGA, IGC is considering widening the scope of WG-14 “HyCO” to incorporate other H2 production technologies and other elements of the Hydrogen value chain.

o Nitrous oxide:

Considering the fact that N2O production and distribution have specificities and do not fit well in any existing WG (WG-3 “atmospheric gases”) used to be the “custodian” of the N2O documents, IGC is proposing to set-up a permanent workgroup in which the few “subject matter experts” available in the companies could work together on developing further the safe practices.

For information:

o IGC is taking part to the CGA lead YIMA task force to expedite incorporation of lessons learnt into changes to existing harmonized documents specifically:

§ CGA P8/ EIGA Doc 147 “Safe practices guide for cryogenic air separation plants”

§ CGA P8.8/ EIGA Doc 170 “Safe Design and Operation of Cryogenic Enclosures”

§ CGA P8.3/ EIGA Doc 146 “Perlite Management”

During the first part of 2020, all the efforts of the MGC and of related groups were made to help our Industry to cope with the Coronavirus pandemic.

The quiet summer has let us thinking that the worse was over, nevertheless the activity of MGC continued to focus also on Covid-related activities.

In 2020, 18 conference calls were set up just for MGC meetings.

1. Key achievements from the last report, industry impact.

Answers to Letters from a Cylinder Manufacturer

A First letter sent to EIGA expressed concerns on the content of EIGA - BN25 with regard to the use of industrial cylinders for medicinal gases.

--> EIGA answered, confirming that companies make their own internal validation and controls before using industrial cylinders

The manufacturer sent a second letter to EIGA and to GMP inspectorate in Poland attaching also a picture of a terrible internal surface of a cylinder. This generated an alert from the inspectorate to MAHs to stress the need for strong controls.

MGC helped in the preparation and in the strategy of the answer to this cylinder manufacturer: the picture did not represent the state of cylinders normally filled at members’ sites. Furthermore, the conditions of service and usage of the cylinder was not known.

Finally MGC suggested that in their answer, EIGA should encourage the manufacturer to contact EIGA and/or the Cylinders Manufacturers Association in case of issues with medical/food cylinders before to take individual actions.

From this experience, MGC created a new AHG M.16 to write an all-encompassing EIGA document to answer to queries arising on internal cylinder quality from authorities, customer, cylinder manufacturers etc

Lesson learned

An internal document with the main items of what went well and what could be better was prepared.

Actions for EIGA and EIGA members were reported.

Analysis of WHO document: Oxygen sources and distribution for COVID-19 treatment centres

This document, shared also in 9G group in Pharmacopoeia, contains information that may be misleading or inaccurate, especially concerning the use of concentrators during Covid-19 Pandemic.

WG7 is preparing a proposal to revise the document. The aim is to cooperate with the WHO in drafting a more accurate document and introducing themselves as Industry experts

Code of Practice

MGC considers a special Code of Practice to be used only during pandemic situation in which companies, with the only interest of public health, have the need to exchange information, but is double checking compliance with competition law.

Medical writer budget

For the new doc on N2O Best Clinical Practice, the MGC, needs to effectively reach the target audience: Healthcare Professionals, scientific journals and Institutions. Therefore, MGC asked for a 5k€ budget to allow a professional medical writer to write the draft based on info given by the members. EIGA has agreed, on an exceptional basis to absorb this in EIGA’s 2020 budget. MGC deems that could be useful to avail of these professional writers and estimates the maximum need in two documents per year

WG7: Medical Gases

Pandemic issue heavily impacted the work in WG7. Two different TelCos have been indeed dedicated to COVID-19. Quoting WG7 Chair, “sharing the information was and is a key to manage this crisis well”

However WG7 is continuing:

- the very important work on review of Annex 6 “Manufacture of Medicinal Gases” of GMP that should further improve the EU rules on manufacturing of medicinal gases;

- the preparation of proposal to change the Pharmacopoeia analytical method for water in nitric oxide

Achievements:

ICH Q3D Risk Assessment Report – Elemental Impurities in Medicinal Gases (Harmonized)

Doc. 216/20 ICH Q3D Risk Assessment Report – Elemental Impurities in Medicinal Gases (Harmonized)

WG7 and EIGA have successfully led the harmonisation of this document.

Working Group 10, Homecare

Achievements:

- Revision of Good Homecare Practice -TP24: final editorial revision.

- Design and operation of vehicles used in medical oxygen homecare deliveries -Doc 128/12 & Homecare Vehicle Fires (in corporating SA 29): ready for publication approval

- Answer to the doubts on “TB 36/20 Analysis of Fire Incidents in Homecare Oxygen Therapy Based on Data Review and Literature” expressed from a firebreak Manufacturer

Working Group 15, Medical Devices

Current work items

• • • VIDEO on VIPRs Use ; a short educational cartoon/video to be watched before any specific training on a gas cylinder fitted with VIPRs

    • VIPR lifetime management ; clarifying the responsibilities of VIPRs manufacturers and the gas manufacturers regarding the maintenance, the withdrawal of service and the usability of medical gas package.

    • Electronic gauge for VIPRs ; developing new standards for the Industry

    • CO2 class III follow up ; trying to avoid the heavy requirements for a Class III medical device

    • CO2 General Safety Performance Requirements ; evaluating applicable requirements and establishing common answers helping Industry in the preparation of Medical Device Technical File

Achievements:

EIGA has obtained the status of Observer at EUDAMED

Two experts from WG15 Medical Equipment were accepted to participate as Observer in the EUDAMED sub-group of the Medical Device Coordination Group (MDCG) for a period of five years starting from 1 September 2020.

IMPACT: This working group will assist and advise the MDCG on policy and technical matters related to the establishment, management and maintenance of the European Database on Medical Devices (EUDAMED), including the implementation and application of the relevant provisions of the MDR and IVDR. In doing so, the Subgroup will support the development process of the necessary specifications and technical functionalities related to EUDAMED

AHG M5 - N2O clinical best practice

Achievements:

Alignment of all members on:

• • Document detailed content

  • Supportive references

  • Common matters in SmPCs

  • On site hospital survey to obtain data on the conditions of use of N2O/O2 50%/50%

AHG-M8: ISO TC 121 Mirror group

AHG-M8 is a small group of experts following up the standardisation activities of ISO/TC 121, Anaesthetic and Respiratory Equipment with a more specific focus in ISO/TC 121/SC 6, Medical gas supply systems. The goal is to develop an EIGA view on topics related to ISO TC121 and coordinate actions, since several members of the AHG are representatives of their country in this SubCommittee.

In 2020, the activities of ISO /TC 121/SC 6 have been drastically reduced, due to the COVID-19 pandemics: the two annual meetings have been cancelled and all standardisation projects have been put on hold for 6 months.

AHG M12 Microbiological contamination

Achievements:

- TB 02/20 - Microbiological Quality of Medical, Pharmaceutical and Food Grade Gases

(revision of TB 02/12)

This Technical Bulletin details EIGA’s position concerning the microbiological quality of gases used in medical, pharmaceutical and food applications and is based on literature data.

Analysis studies, carried out by the gases industry, have shown that that the microbiological quality of gases are well below the European Pharmacopeia acceptance criteria

- Doc 232/20 - Microbiologiocal Quality of Medical and Food Gases Review - Scientific Report

This scientific report supports with literature data the matching Technical Bulletin TB02

IMPACT: Based on the above documents it is not required to monitor the microbiological quality of gases compared to the acceptance limits of the European Pharmacopoeia.

AHG-M.14 “9G Mirror”

The ADG-M.14 started its activities in October 2019.

Achievements:

New monograph Oxygen (98 per cent):

• • Set-up of a strategy for EIGA members

  • Definition of an appropriate risk management framework to evaluate the proposed monograph requirements, including the drafting of descriptive material, the FMECA chart and the most appropriate measuring scales for severity and probability.

AHG-M.15, impact of MDR on HSP

Medical Device Regulation (MDR) specifies requirements for distributors besides those for manufacturers. These requirements need to be fulfilled by Homecare Service Providers (HSP).

The purpose of this AHG is to analyse the impact of the respective articles of the MDR relevant for distributors and to evaluate the consequences for HSP´s.

Intended output:

• • Technical Bulleting following the impact on the HSP structured according to the supply chain steps of the HSP will be drafted before implementation date of MDR

2. Working Groups and Ad Hoc Groups created

AHG-M.16 Cylinder Internal Quality

Brand new group created to have an all-encompassing EIGA Document addressing solutions and responses to queries/complaints by authorities, Notified Bodies, customers, etc. around contamination of ‘’residuals’’ in cylinders

First meeting in July 2020. Goal is having an EIGA published document open for the public by the next year.

3. Working Groups and Ad Hoc Groups closed

AHG M11 Firebreaks

Achievements:

Publication of the technical bulletin “TB 36/20 Analysis of Fire Incidents in Homecare Oxygen Therapy Based on Data Review and Literature”. This Technical Bulletin provides advice to Homecare Service Providers on the mitigation of fires in homecare oxygen therapy based on both a literature review and an analysis of the occurrences of oxygen fire incidents at homecare patients recorded by EIGA members.

IMPACT: The technical bulletin shows that there is no significant difference in terms of incidents between countries where fire breaks are mandatory and countries where they are not. So the real difference is made by patients' awareness of the risks of oxygen therapy

4. Key objectives and initiatives the coming two years

MGC

• Continue actively to act as EMA stakeholder for any impact on our industry

• Position EIGA as a recognized stakeholder by relevant Authorities, such as the work done with European Medicine Agency (EMA)

• Anticipate and integrate changes in regulations that could impact or modify significantly the medical gases sector.

• Continue the publication of documents related to the safe design, manufacturing, operation and use of the products.

• Ensure a regular communication and an active collaboration between medical working groups and ad-hoc groups.

• Promote synergies with the WGs and AHGs under the other Councils.

• Pursue the development of the relationship and synergies with National Associations and sharing EIGA/MGC views on the current topics.

Working Group 7, Medical Gases

Harmonization & alignment with other associations and authorities:

• • Lobbying for a review of EMA Guideline on Medicinal Gases and Annex 6

  • Preparation of GDP (Good Distribution Practice) Guideline

  • Preparation of Guideline on Pharmaceutical Data Integrity

  • Pharmacopeia Comparison Document Review

Working Group 10, Homecare

Define Standards & Best Practices

• • Forward to publication approval of Doc 128 and TP 24

  • Review of Doc 141 – Planning Oxygen supplies for Respiratory Patients when travelling (target completion date 2021)

  • Start work on replacement document for Hygienic reprocessing (revised Doc 157)

  • Review of Doc 193 (2014) – Guidance on safety and reliability of Oxygen Self fill systems

  • Start review of Doc 198 (2015) – Security and Safety for Home Care Personnel

Working Group 15, Medical Devices

Define Standards & Best Practices

• • BP: Preparation of technical files (MDR)

  • BP: Guideline for vigilance / post-market / PSUR

Regulatory Affairs, promoting our industry and influencing

• • document on new NO generating devices

  • TB on classification of CO2 and mix for in vitro cell cultures

Developing new standards

• • Medical device gas standard and specification (one by gas)

  • VIPR handling device / protector (EIGA then ISO)

Communication with "todays" means

• • Informative / Educative videos

  • EIGA YouTube channel

  • Wikipedia (identification of the subject that we should follow/create)

AHG M5 - N2O clinical best practice

Produce communication material (Brochure, press release, publication) on the clinical best practices of use to mitigate the potential safety risks related to the human exposure to N2O and N2O mixtures

AHG-M.14 “Pharmacopoeia 9G group Mirror”

The key objectives are the following items:

• • New Oxygen 98 monograph: data evaluation and refining of the proposed monograph;

  • PID analysis of medical gases on oil, starting with Medicinal Air or Oxygen 98 (refer to the above for explanations);

  • Stability of gases at molecular level;

  • Proposal to include the capacitive hygrometer as European Pharmacopeia method for determining water in gases (starting proposal was to apply it to Nitric Oxide).

Key achievements in 2020, industry impact.

In 2021, REC will celebrate its 10 years of existence! All along this period, REC has defended the Industrial Gases business model, constantly recalling the importance of industrial gases in the European Industry value chain (economic and environmental efficiency) and in the decarbonization of industry (green and low-carbon technologies). REC has been able to secure level playing field, amongst others, in 2010 (ETS phase 3 directive), in 2012 (ETS phase 3 state aid guidelines), in 2014 (Environmental protection & Energy State Aid Guidelines – EEAG), in 2018 (ETS phase 4 directive) and in 2020 (ETS phase 4 state aid guidelines).

Overall achievements

The EU green deal, launched by the Commission at the end of 2019, aims to make Europe climate neutral by 2050 with a new ambitious objective: reducing by 55% the 2030 GHG emissions, compared to 1990. The EU Green Deal will bring new opportunities for the Industrial gases sector, but also new regulatory risks for the IG business model.

In 2020, REC, with Ad Group R3 and R4, has focused its activities to secure the current Climate directives (ETS phase 4 directive, Monitoring & Reporting Regulation (MRR), ETS state aid guidelines, RED II) and prepare the grounds for 2021 advocacy works on the revision of all the current Climate directives and the adoption of the Sustainable Finance Taxonomy (“regulatory revision tsunami”), with the constant aim of defending the level playing field between outsourced and insourced activities and the need to support green and low carbon technologies developed by IG sector (e.g.: green and low-carbon Hydrogen and Oxygen solutions).

Ad Hoc Group R3

1) EU ETS directive phase 4 (Implementing regulations) – ETS State aid Guidelines – RED II

The ETS phase 4 will start on January 1^st, 2021. The EU carbon market has been amended in 2018 to be aligned with the objective of 40% emissions reduction in 2030. The two last Implementing regulations (MRR/AVR and the draft ETS Benchmarks), required for the complete transposition of the Directive, have been published in December 2020. The new version of MRR/ARV will enter into force from January 1^st, 2021 while the draft ETS Benchmarks has to be adopted formally by the EU after a consultation ending January 4^th, 2021. The new version of ETS state aid Guidelines should also enter into force from 01/01/2021.

Monitoring, Reporting & Verification rules (MRR/AVR) (14/12/2020 – enter into force 01/01/2021)

The MRR/AVR defined the emissions accounting rules for ETS. The new version of this implementing regulation does not impact the CO2 merchant market, which was a concern for EIGA, nor modify the CCS/CCU reporting scheme. The latter is expected not before 2023. The main changes of the current version are specific to biomass (only applicable from 01/01/2022 after the complete transposition of RED II):

1. zero rating for biomass used as energy source depending on the sustainability and GHG saving criteria in article 29 §2-7 and §10 of RED II.

2. rules for determining the biomass fraction of biogas (e.g.: purchase records combined with guarantee of origin and connected to the same grid)

ETS benchmark values for free allocation of emission allowances for 2021/2025 (draft)

The draft Implementing regulation on ETS Benchmarks confirms the expected Hydrogen benchmark value of 6.73 t CO2/t H2, in line with the refinery benchmark reduction rate of 24% and ensures the level playing field between insourced and outsourced hydrogen production. In 2021, the reduction of free allowances related to the new benchmark values is likely to be offset by the revision of the Cross Sectoral Correction Factor.

It worth noting that the methodology for attributing emissions to different sub-installations has changed. For the H2 and Syngas, the emissions allocated to the heat exported from installation implied a net reduction of the emissions allocated to hydrogen production. Based on this new method, the Commission has extrapolated the theoretical average value of the 10% most efficient Hydrogen installations (4,02 t CO2 /t H2) and Syngas installations (0 t CO2/ t Syngas); these unrealistic figures underscore the value of having H2 & syngas benchmarks tied to the refinery benchmark.

ETS State Aid Guidelines post 2021 (21/09/2020 – enter into force 01/01/2021)

The EU ETS state aid guidelines provide for partial relief from indirect emissions costs for sectors included in a specific list of exposed sectors, a list that is different from the carbon leakage list applicable to free allocation of EUAs. The Commission has published the new version of the ETS state aid guidelines post 2021 on 21 September 2020. As expected, the number of eligible sectors has been reduced and the Industrial gases sector remained excluded. However, EIGA has managed to keep the level playing field between outsourced and insourced production and has achieved that electricity consumption for the production of hydrogen and syngas will be eligible for compensation, for the first time, in Phase 4. It will be possible to understand better the impact when will be published the annexes of the guidelines, in particular the Electricity Efficiency Benchmarks.

Renewable Energy Directive - RED II (transposition by 30 June 2021)

As the other climate directives, RED has been reviewed to be aligned with the soon-to-be-superseded 40% emissions reduction objective in 2030. RED II establishes a binding target of a share of at least 32% of renewable energy in 2030 at EU level (RED I: 20% in 2020). IG sector may be impacted by RED II through the definition of renewable, biomass/biogas and Guarantee of Origin schemes. EIGA is monitoring the expert works on the delegated acts, in particular all the detailed definitions regarding biomass/biogas and the methodology setting out detailed rules on how electricity input to H2 production etc. could be counted as renewable, expected by the end of 2021.

2) The EU Green deal: Climate directives revision

After a series of consultations from the Commission all along the year and the publication of the target 2030 impact assessment (17/09/2020), the EU Council agreed with Commission proposal to raise the EU 2030 emissions-cutting goal to 55%, on 11 December 2020. It is now highly likely that the EU Council and Parliament will arrive at a common 2030 objective of 55% and will find a compromise on the Climate Law.

The next step in 2021 will be the revision of all the climate directives which were recently adopted in 2018. The revision of the 2030 emission target, from 40 % to likely 55 %, will impact significantly the climate directives and all the Industry sectors as the IG sector (see details in Target 2030 impact assessment).

Since the EU Green deal announcement, EIGA has always expressed its support to the Europe’s climate ambitions recalling the key role that IG sector should play in the energy transition with an appropriate regulatory framework encouraging renewable and low-carbon hydrogen and air gases technologies while securing an adequate level playing field between

insourced and outsourced production.

To advocate its position, EIGA decided to respond to all the consultations (Inception Impact Assessment -IIA- and public consultation/questionnaire with a potential impact on IG activities) in order to be considered as a stakeholder in the future discussions:

• Review of the target 2030 (IIA response on 15/04/2020, Public consultation 23/06/2020)

• Energy Taxation Directive (IIA 30/03/2020, Public consultation 14/10/2020)

• Carbon Border Adjustment Mechanism (IIA 30/03/2020, Public consultation 28/10/2020)

• Smart Sector Integration Strategy (8/06/2020)

• Hydrogen Strategy (8/06/2020)

• Climate directives, revision to new 55% emissions reduction target:

  • Renewable Energy Directive (IIA 21/09/2020, Public consultation 9/02/2021)

  • ETS (IIA 26/11/2020, Public consultation 05/02/2021)

  • No responses have been sent to date on Energy Efficiency Directive and Effort Sharing Regulation revision (minor impact for IG sector)

• State Aid Guidelines

  • EEAG (IIA 10/12/2020, Public consultation 7/01/2021)

Based on the stakeholder responses, the Commission intends to publish the draft revisions of the Climate directives mid-2021 with the intention to conclude the legislative process by end 2023. The state Aid Guidelines for Environmental protection and Energy (EEAG) should be finalized by end 2021.

The main messages developed in all the consultations are aligned with the EIGA positions on the EU Green deal:

- ETS - the revision of the cap and possible extensions of the ETS should not weaken EU industry competitiveness, the existing protection against carbon leakage should be maintained (free allowances to eligible sectors for the period 2021 to 2030), ETS revenues should be applied for industry decarbonization projects including CAPEX but also OPEX requirements.

- RED II – need to promote the use of renewable electricity, renewable and low-carbon hydrogen energy and feedstock sources, synthetic fuels; need to clarify and extend accounting and traceability schemes (e.g. Guarantees of Origin) to renewable and low-carbon fuels avoiding any distortion between certification mechanisms.

- EEAG – continue to support renewable electricity, introduce new support mechanisms (e.g. Carbon Contracts for Difference) for renewable and low-carbon hydrogen, synthetic fuels and CCUS technologies; to maintain the same criteria for the sectors exposed to carbon leakage and ensure a level playing field between outsourcing and insourcing production.

- Hydrogen Strategy – to secure a technology-neutral (renewable and low-carbon technology) and cost-efficient pathway (without impairing existing assets and private long-term commercial contracts) to the hydrogen economy, supporting the move to low-carbon production in traditional industrial markets (steel, refinery, chemicals) and in emerging markets (energy, mobility); harmonize definitions around low-carbon hydrogen; provide necessary funding mechanisms and state aid.

Ad Hoc Group R4

Sustainable Finance/Taxonomy

After the publication of the final Technical Expert Group report on Sustainable Taxonomy in March 2020, the Commission has developed and published its own proposal as a draft delegated act on November 20, 2020. A public consultation was launched by the Commission (deadline 18/12/2020) in order to finalize its proposal which will be submitted for scrutiny to the Council and EU parliament early next year (for a delegated act, the council and the parliament have only a right to veto).

In the draft delegated act, EIGA’s request to eliminate possible distortions between hydrogen production under the categories “Manufacture of hydrogen” and “Manufacture of other organic basic chemicals” has been accepted. However, IG sector is still not listed as sustainable activity with the exception of hydrogen for which the provided threshold has been drastically reduced from 5.8 to 2.25 tCO2/t hydrogen (cf. ETS benchmark of 6.73).

The Commission, in its attempts to accelerate the decarbonization of the EU economy, considered that the criteria should be tightened for all “sustainable” activities and, consequently, arrived at the above threshold for sustainable hydrogen (calculated as 80% below a comparable well-to-gate fossil fuel hydrogen production figure of 11.25 tCO2/t hydrogen). This “deep green” approach has raised a lot of concern among the industry sectors and Member States. In particular, EIGA is concerned that due to the reduced threshold several forms of low-carbon hydrogen production (Natural Gas SMR with CCS and even electrolysis when fed by renewable electricity supplied via the grid) will be excluded and warns against potential distortion between insourced (transitional activity) and outsourced hydrogen production (sustainable activity).

EIGA/REC sent a response to the draft delegated act consultation asking (1) to amend the definition of sustainable hydrogen as 60% reduction compared to the fossil fuel hydrogen benchmark, based on EU standards as the CertifHy method, (2) to include the IG sector activities in the future development of the taxonomy and (3) to provide sufficient transition time until the taxonomy would be applied in other contexts and legislations.

Key objectives and initiatives for 2020, industry impact.

• Provide responses to ETS and RED public consultations (the EEAG response has been already sent by the end of 2020)

• On Sustainable finance/EU taxonomy, promote EIGA views (Commission, EU & National associations) in order (1) to get support from Member states on the delegated act hydrogen threshold (-60% instead of -80%) and (2) to prepare the inclusion of the other IG activities in the future version of the EU Taxonomy

• Climate directives: Monitor stakeholder processes during the elaboration of Commission proposals expected by mid 2021 (in particular ETS and RED) and be prepared for the legislative process that will start in the second part of 2021 (adoption expected end 2022)

• Monitor the EEAG revision process in order to maintain the IG sector in the carbon leakage list and get the right support for the renewable and low carbon hydrogen technologies

• Smart sector integration and Hydrogen strategy: Contribute to the revision of the gas directive (renewable and low carbon hydrogen definition, infrastructure and regulations)

• Support the EIGA H2 vision in the framework of the EU Energy Transition (TF Board 2- Decarbonization)

• Further increase REC support in local advocacy of National IG association on EU directives/delegated acts and National Energy and Climate plans.

SAC Membership Changes in 2020

Since the last board meeting there have been no changes in the SAC membership.

The elected Cat 2&3 representative for SAC for 2020/2021 is:

• Finbar CONSTANT (Irish Oxygen, Ireland)

In January 2021 Martin Snape completed 2 years as SAC chair and the responsibility has been transferred to Lorenzo Beretta, the previous vice chair. SAC proposes that Stefano Varisco (SIAD) be appointed the new vice chair.

Key achievements in 2019/20, Industry Impacts

e-learning Oxygen

In 2020 the first e-learning module has been published on the public area of the EIGA website.

The module focuses on oxygen safety (a key safety topic for the industrial gases industry) and is intended as awareness training to internal staff, users, suppliers and manufacturers.

The training features knowledge and experience from EIGA members’ foremost experts on oxygen safety and is combined into an eLearning package that can be delivered to users at a time and place of their own convenience.

Publications

During 2020 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 an impressive 46 publications, including:

· 22 Documents

· 5 Safety Alert

· 3 Safety Information

· 4 Safety Information – Human Factors

· 8 Safety Information – Transport

· 4 Awareness Packages

Learning from Incidents

One of the core activities of SAC is to capture the incidents of interest in the EIGA database to enable lessons learned to be discussed and to identify themes and work activities to make the industry safer. The training packages EIGA generates and shares from this activity is fundamental to what SAC is attempting to achieve.

In 2020 SAC published 4 of these incident training packages; following the request from the Board and the National Associations, for each reported accident/near-miss the pertinent discussion points are now included and special attention is paid to collect and include “Safety II” events in Incident Training Packages.

From November 2020, the events are reported in the new accident database, allowing for a more precise and faster classification of the events and a guided filling of all the requested information. The generation of the Training Packages is now largely automatic.

Working Groups and Ad-Hoc Groups

Working Groups: no working groups were created in 2020; no working groups were closed in 2020.

Ad-Hoc Groups: in 2020 the following ad-hoc groups were created:

• AHG S.13 on e-Learning created

• AHG S.14 to review Doc. 134/2012 (Potentially Explosive Atmospheres – ATEX Directive)

No ad-hoc groups were closed in 2020.

Key Objectives/Initiatives for SAC

Database Upgrade/Evolution

Replacement for the existing databases of WIST, RAST and the SACdb is completed:

• Road Vehicle Accident Statistics (RAST): the new system is live and the results are entered by the members. Starting from last year 2020 it is mandatory to report data of own fleet and of contractors.

• Work Injury Statistics (WIST): The new system is live and the results are entered by the members. There is a new requirement to split the incidents between employees and contractors.

• SAC Incident Database (SACdb): the new system is live and operating from the SAC meeting of November. All the required features have been implemented; the production of the Awareness Packages is now largely automatic.

These new tools will become fully operative in 2021.

Embracing Digital; e-Learning on O2

The Ad-Hoc group S.13 finalized the e-Learning module on Oxygen. The module is available on the public area of EIGA website; extremely positive feedback has been communicated to EIGA staff and SAC members.

Focus to Improve Performance: Safety I vs Safety II

After completing its first dedicated publication in this area (‘Safety II - Actions that Prevent Accidents’), SAC is looking for examples and best practices to share in order to make periodical publications in this area.

Winter Seminar 2021

The Winter Seminar 2021 was developed under the patronage of the SAC with the aim of developing knowledge and skills on human behaviour, the main factor to reduce injuries and accidents in the gas sector. A big effort has been made by SOC to allow for this event in pandemic period and to guarantee the quality of the event.