Issue 50 June 2017 THE ZETTE - eiga.eu · Many other documents are in preparation and should be completed in the ... IGC Chair’s Report 1 MGC Chair’s ... SAC Chair’s Report

Industrial Gases Council (IGC)

Andrea Mariotti, 2016-2017 Chair

It is with pleasure that I write my fourth and last report about the activities of

the Industrial Gases Council. Towards the end of the year I will transfer my

responbilities to Iñaki Uriarte of Praxair who will be the IGC chairman for the

next two years (2018 and 2019).

In the past six months, improvements at the highest levels of the safety and

health of our employees and contractors and environment compliance of our

industry have been accomplished, thanks to the extraordinary efforts of our

experts who are the members of our permanent Working Groups and

temporary Ad-Hoc Groups (AHG) and Joint Working Groups (JWG). It is

useful to be reminded that the AHGs and JWGs are created by EIGA Councils

to work on one specific task (such as a new document or, for the JWGs, a

harmonisation project) and once their task is completed these groups are

closed. As always you will find the list of new or revised publications that

have been published since the last edition of the EIGAzette and the news of

each Working Group in the sections that follow in this publication.

Many other documents are in preparation and should be completed in the

second half of the year. Among these I would particularly like to mention the

revision of two harmonised documents Doc 146 Perlite Management and Doc

179 Safe Design and Operation of Cryogenic Enclosures. The two documents

are in many ways bound together. In past years and even more recently, there

have been several incidents resulting in sudden eruptions and massive

releases of perlite from Air Separation Plant coldboxes. The effects of such

releases can be dramatic for the people affected and in some cases the

dispersion of the perlite to spread outside the boundary limits of the plants has

raised the unwanted attention of neighbours and authorities. The documents

already address most of the concerns but these risks and the possible

preventive measures are to be emphasised in a more precise way.

Another task that should be completed by the end of 2017 is the harmonisation

of the publication Doc 33 Cleaning of Equipment for Oxygen Service. It is well

known that in addition to correct design and material compatibility the

cleanliness of all equipment to be used for oxygen service is fundamental to

reduce the risk of ignition and combustion propagation. However, even though

this cleanliness requirement is known, incidents still occur because

contamination of materials in contact with oxygen has been reduced but not

eliminated. The new document will support companies in implementing a

management system to assure cleanliness starting from the manufacturing of

equipment by our suppliers, the packaging and storage at site, during the

installation and during maintenance. The new harmonised document will help

us and our suppliers to guarantee this fundamental requirement for the safe

operation of our plants and the safety of our workers and our clients. After the

success of the EIGA Seminar 2017 on Human Factors held in Brussels in

January, with many interesting, useful and appreciated presentations and with

a high level of attendance, a new Seminar Organising Committee is already

Contents

IGC Chair’s Report 1

MGC Chair’s Report 2

REC Chair’s Report 2

SAC Chair’s Report 3

EIGA Office News 4

Publications 4

Working Group News 5

Transport (WG-1) 5

Gas Cylinders and Pressure

Vessels (WG-2) 5

Atmospheric Gasses Process

and Equipment (WG-3) 6

Special Gases (WG-4) 6

Environment (WG-5) 7

Cryogenic Vessels (WG-6) 8

Medicinal Gases (WG-7) 8

Food Gases (WG-8) 9

Classification, Labelling &

SDS (WG-9) &

LISAM (TF-9.1) 9

Homecare (WG-10) 10

Hydrogen Energy (WG-11) 10

Acetylene (WG-12) 11

Security (WG-13) 11

Medical Equipment (WG-15) 12

Issue 50 June 2017

EUROPEAN INDUSTRIAL GASES ASSOCIATION AISBL Avenue des Arts 3-5 • B – 1000 Brussels

Phone : + 32 2 217 70 98 • Fax: + 32 2 219 85 14

E-mail : [email protected] • www.eiga.eu

THE ZETTE

© EIGA 2017 2 EIGAzette No 50 – June 2017

working to prepare the 2018 Seminar, focused on the

theme of Transport Safety. Safety during the

transportation of our products is one of the most

challenging operations for the gas industry not only for

the distribution of bulk gases in road tankers and of

compressed gases in cylinders but also for all the

activities that are related to homecare business. These

transport activities, and in general all the activities on the

road, are the ones that usually register the highest number

of fatalities and severe injuries, not only of our personnel

and sub-contractors but even more frequently, of the

third parties that are involved in traffic accidents.

Sometimes these road accidents are not caused by us but

several of them could be avoided or their severity

mitigated. The 2018 Seminar will be in Brussels on 24th

and 25th January 2018: make a note in your agenda to

attend and reserve the date.

For more information, please contact Mr Andrea Mariotti, IGC

Chair, at SOL Group (Italy)

Medical Gases Council (MGC)

Kenth Drott, 2016-2017 Chair

Although most readers of the EIGAzette would agree

that the work EIGA is doing is very important for our

industry it is often difficult to put a value on it. EIGA is

developing excellent documents, guidelines and position

papers which require significant effort by the experts

from the member companies. The cost for the industry

can be measured, but what about the value, is it worth it?

The value can be defined on one hand in terms of

improved patient and employee safety and on the other

in terms of minimising the regulatory cost burden for

member companies resulting from new laws and

regulations. In this edition of the EIGAzette I would like

to highlight two achievements for MGC during 2016

which helped avoid additional cost whilst ensuring no

impact on patient and employee safety.

The first achievement is related to the new regulation for

“Falsified Medicines”. New regulations within the EU

will require certain medicines to be fully traceable to

avoid falsified medicines being placed on the market.

Through engagement with the Commission, EIGA

managed to have medical gases included on a list of

exempted products. This means that EIGA members will

not have to invest in additional systems to demonstrate

the traceability of medical gases. This represents

significant cost avoidance savings to the industry as well

as demonstrating that regulators have confidence in our

industry.

The second achievement concerns the so-called “Fir

tree” connector which has been the subject of an effort

within international standardisation for several years.

The connector, commonly known as a nipple or barbed

hose or fir-tree connector, and through which a flow of

oxygen is delivered to the patient from oxygen cylinders

equipped with VIPRs (Valve with Integrated Pressure

Regulator) as well as being found on many other medical

devices such as flow-meters or portable liquid oxygen

systems, was "threatened" with replacement by a new

connector (called a “small-bore connector”). This had

been designed for the same purpose by another

standardisation committee with the goal of preventing

misconnections with other applications in the patient

environment. EIGA pointed out in early discussions that

the new connector was not well adapted to our devices

delivering oxygen and characterised by a long life time

and use in sometimes severe environments. In addition,

a close analysis showed that the new connector was not

bringing any additional safety to the patient. MGC

successfully influenced the outcome in a way to avoid

replacement costs whilst still achieving the patient safety

related goal the group aimed for.

These are two excellent examples of the type of work that

is increasingly required within EIGA for us to be

successful. Not only do we need to have our industry

experts working on standards and guidelines for use in

our industry. We also need to participate in other

international standardisation committees, to monitor

changes in the regulatory framework, make impact

assessments and to build relationships and networks with

relevant stakeholders so that we can influence new

regulations as early as possible. With our competences,

our solid reputation and with a proactive approach, EIGA

is well positioned to continue to be successful in

improving patient safety and in minimising the

regulatory burden for member companies.

For more information, please contact Mr Kenth Drott, MGC Chair,

at Linde (United Kingdom)

Regulatory Environment Council (REC)

Christian Beck, 2017 – 2018 Chair

For many months now a REC Ad-Hoc Group, together

with our public affairs consultant FleishmanHillard, has

been working hard to place amendments in developing

legislation to remove the uncertainty around treatment of

outsourced hydrogen and syngas under Phase 4 of the

Emissions Trading Scheme (ETS). In February of this

year the European Parliament and European Council

finalised their respective amendments to the original text

of the European Commission. The EU Commission,

Council and Parliament texts now go into the “Trilogue”

process in which amendments and compromises are

agreed and the respective texts are integrated.

Neither the Council nor the Parliament text included the

explicit assurances we were looking for. It is clear that

the European Commission, which is present in all the

discussions that matter, is trying hard to resist changes to

its original text. However, wording has been added to

the Council and Parliament texts that goes some way

towards supporting our ultimate objective.

The Ad-Hoc Group continues to engage with Member

States and MEPs, proposing changes to fit into the final


text that will provide the additional confidence that we

are looking for. In its latest position paper (March 17)

EIGA states again the importance of a level playing field

for independent hydrogen and syngas production and

points out that the risk of competitive distortion could

lead to closures of production facilities and thereby

undermining greenhouse gas reduction objectives. These

arguments are now supported by the well-respected

consultant company Ecofys. They have carried out a

study commissioned by EIGA that compares the

environmental impact of outsourced and insourced

production. Ecofys concluded that “distortion might end

and reverse the current trend towards the outsourcing of

industrial gases, consequently causing economic and

ecological damage in the form of overcapacities and

additional emissions”. EIGA will continue its efforts to

ultimately prevent this scenario.

For more information, contact Mr Christian Beck, REC Chair, at Praxair

(Germany)

Safety Advisory Council (SAC)

Rainer Wysotzki, 2016-2017 Chair

EIGA Safety Performance

Part of SAC’s mission is to maintain EIGA’s accident

databases and accident statistics, with the aim of

monitoring the industry’s safety performance. The SAC

Data Bank is used to improve the analysis of the

incidents and SAC has introduced flags for:

Seveso Directive relevant incidents.

PSIF incidents (incidents with actual or potential for

severe injury or fatality).

Looking at how the gas industry has been doing recently,

safety figures for 2016 showed an adverse increase in the

relevant KPIs.

In 2016 the number of Lost Time Injuries (LTIs)

increased from 140 to 163 which resulted in an increase

of the LTI.

Frequency Rate (number of injuries per million hours

worked) from 1,8 LTI per million man-hours worked to

2,1. There is a big difference between the company

Membership Categories. While Category A member

companies remain at an LTI Frequency rate of 1,2, the

rate increases for Category B (from 1,5 to 1,8) and for

Category C (from 3,6 to 4,6) member companies. An

increase is also observed in the case of the Recordable

Working Injuries (RWI) from 3,5 to 4,1 RWIs per

million hours worked.

Human error or human failure is still seen as a major

cause of injuries, the same conclusion as in previous

years. Can we fight against this type of cause by only

issuing new documents and sharing best practices? I

believe we can do more by tackling human factors,

human behaviour or human reliability (for employees

and contractors) and, closely related of course,

leadership is industry’s main challenge in improving

safety performance. This is the reason why we selected

Human Factors as the topic for the Winter Seminar 2017

back in January this year.

The topic for the next Winter Seminar will be Transport

Safety. Sadly, in 2016 several transport related fatalities

were reported by member companies. Safety in the

transport of gases, which closely relates to contractors, is

the industry’s second safety challenge.

SAC work at a glance

SAC meetings are a place to exchange information and

experience on recent gas industry-related incidents, as

well as analysing their causes and preparing incident

resume reports. I would like to draw your attention again

to the quarterly publication Training Package – Recent

Incidents. SAC’s ambition is to use these to provoke

discussion and so develop new ideas on how to improve

safety in our industry.

In 2015 a new award was created, the Safety Innovation

Award. Each year a special theme is to be selected by the

EIGA Board of Directors and for 2016 this was

“Transport Safety”. The winner of the award has been

identified and will be announced at the Summer Session

in June 2017 in Manchester.

The theme for the next Safety Innovation award has

already been agreed and will cover the next main area of

concern, “Human Factors”. Award submissions will be

requested after the Summer Session, so please start to

think whether any projects or initiatives in your company

might be suitable.

You can find reports of the SAC Working Groups in the

following pages of this edition of EIGAzette. Other Ad-

Hoc Groups under SAC are busy developing materials to

support improvements in process safety, health and

hygiene, product safety and worker safety. Additionally,

the Ad-Hoc Group on REACH is closely monitoring the

development of the REACH legislation to verify,

influence or initiate changes.

As the transport of gases in private vehicles has been

recognised as a widely underestimated hazard, SAC

decided to create a new Ad-Hoc Group that has been

working on developing new guidelines for the gas

industry and will shortly publish a range of Safety

Leaflets and Training Packages on this topic.

I want to thank all members of the SAC working groups

and Ad-Hoc Groups for contributing a huge effort to

develop and revise new and existing documents.

As already mentioned, EIGA is preparing for a Seminar

on “Transport Safety” in January 2018. Be a part of this

EIGA project and contribute your share to our common

cause.


SAC challenges for 2017 are:

In compliance with the EIGA strategic priorities to

find a way to identify consistently bad performers and

to help these companies to improve their safety

performance;

Further develop guidance on transport safety;

Improve contractor management;

Further develop strategies on how to influence human

behaviour;

Encourage National Associations to interact more

closely with SAC. For more information, please contact Mr Rainer Wysotzki, SAC chair, at

Praxair (Germany)

EIGA Office News

EIGA Board Members

At the Board Meeting in January, Eduardo Gil Elejoste

of Praxair replaced Daniel Yankowski as Board

Representative for Praxair for the term of office 2017 and

2018.

EIGA Council Members

At their meeting in January, the EIGA Board of Directors

Meeting approved the new nominations of the Chairmen

and Vice-Chairmen of some of our Councils as follows:

• Christian Beck, Praxair was nominated as Chairman

of the Regulatory Environment Council (REC) for

2017 and 2018.

• Dr Horst Debus, Messer Group, replacing Frank

Hopfenbach of Messer Group was nominated as

Vice-Chairman of REC for 2017 and 2018.

• Marco Salvoni, Air Liquide was nominated to

complete the term of office of Jesus Gomez, Air

Liquide as Vice-Chairman of the Safety Advisory

Council (SAC) for 2016 and 2017.

The Vice-Chairmen will automatically become

Chairmen of the respective Councils at the end of these

terms.

Later in 2017, EIGA will launch the nomination and

election process for EIGA’s independent member

companies to elect representatives of Category 2 and

Category 3 Companies on the Board of Directors and all

four EIGA Councils for terms of office 2018 and 2019.

EIGA Winter Session 2017

In January, EIGA welcomed delegates to the Human

Factors Seminar 2017. The event attracted nearly 200

delegates from over 60 organisations with a very wide

range of roles within our industry. They came from more

than 25 countries, including visitors from Australia,

Europe, the Middle East and the USA; both members and

non-members.

Over the course of two days, 26 industry and external

experts provided guidance and perspective on a range of

different aspects of human factors and on how people

should be communicating the issues. The objective of the

Seminar was to promote the understanding of human

factors and behaviours and their application in taking our

industry safety performance to the highest possible level.

Topics covered included what is meant by Human

Factors, safety culture and the importance of human

factors in leadership.

The speakers also presented some proven tools and

techniques and experience in implementing them in

individual companies.

Feedback on the event was very positive and we hope

that the delegates were motivated to take back to their

companies and implement with conviction the

knowledge they acquired.

The next EIGA Seminar, in January 2018 (see EIGA

Events below for details) will be on the theme of

Transport Safety.

National Associations

The annual National Associations meeting was held in

Mechelen, near Brussels, on 12th and 13th April 2017 and

included a full day joint session with the Working Group

Chairmen to discuss the activities of the Working

Groups. The National Associations meeting was

attended by 13 representatives from 11 out of EIGA’s 23

National Association affiliates as well as the Council

Chairmen. The participants joined in active discussions

on some of the key issues impacting our industry at a

national level and shared experience from these issues

and from incidents.

International Harmonisation Council (IHC)

The IHC and observers from the IOMA Global

Committee companies met in Bangkok, Thailand in

March to review the progress on current projects and the

resources required to complete projects in development.

In 2016, ten harmonisation projects were closed, i.e. all

the associations published their version of the same

document.

CGA and EIGA agreed and have both published an

additional four harmonised publications in 2016 and two

to date in 2017.

EIGA Events

For your diaries:

EIGA Summer Session 2017, 1st – 3rd June 2017,

Manchester, United Kingdom.

EIGA National Associations’ Meeting, 20th November

2017, Net Meeting.

EIGA Winter Seminar 2018, 24th – 25th January 2018,

Brussels – Transport Safety Seminar.

EIGA National Associations’ Meeting, 21st and 22nd

March 2018, Belgium.

E-mail EIGA office: [email protected]

mailto:[email protected]


Publications

Please visit www.eiga.eu to download the following

publications (new since the last issue of the EIGAzette):

EIGA Documents

Doc 70: Carbon Dioxide Food and Beverages Grade,

Source Qualification, Quality Standards and Verification (WG-8)

Doc 73: Use of Non-Metallic Materials in High

Pressure Oxygen Breathing Gas Applications

(WG-15)

Doc 99 Part 2: Good Manufacturing Practice Guide

Part II for Medical Gases: Basic Requirements for

Active Substances Used as Starting Materials

(WG-7)

Doc 149: Safe Installation and Operation of PSA and

Membrane Oxygen and Nitrogen Generators (WG-3)

Doc 166: Guidelines on Management of Waste Gas

Cylinders (WG-5)

Doc 189: The Calculation of Harm and No-Harm

Distances for the Storage and Use of Toxic Gases in

Transportable Containers (WG-4)

Doc 207: Safe Operation and Maintenance of

Furnaces Insulated with Refractory Ceramic Fibres

(RCF) (TF-I.11-1)

Doc 208: Safety in Storage, Handling and Distribution of Cryogenic Ethylene (WG-6)

EIGA Office Publications (for EIGA members

only)

EIGA 926: Fraud and Fraudulent Behaviour (WG-

13)

EIGA 927: Risk Assessment for Liquid Oxygen

Releases from Flat Bottom Tanks (WG-3)

EIGA 928: Failure Frequency Values for Cryogenic

Flat Bottom Tanks (WG-3)

Safety Alerts (for EIGA members only)

SA 32: Chemical Products (SAC)

SA 33: Pressure Testing (SAC)

Safety Information

Info 17: Prevention of Accidents due to Overheated or Burning Tyres (WG-1)

Safety Information – Human Factors

Info HF 01: Human Factors - "An Overview" (SAC)

Training Packages (for EIGA members only)

TP 50: The Legal Framework in Europe for the Transport of Gases (WG-1)

TP 51: Pre-Fill Inspection of Gas Cylinders (WG-2)

Training Packages - Recent Incidents (for EIGA

members only)

TP INC 25: Recent Incidents in the Industrial and

Medical Gases Industry - SAC 148 (SAC)

TP INC 26: Recent Incidents in the Industrial and

Medical Gases Industry - SAC 149 (SAC)

TP INC 27: Recent Incidents in the Industrial and Medical Gases Industry - SAC 150 (SAC)

Technical Bulletins

TB 19: Safety Considerations in Case of Fire of

Composite Cylinders or Tubes Used in Trailers (WG-2)

Safety Leaflets

SL 01: Dangers of Asphyxiation (WG-1)

SL 04: The Safe Transport, Use and Storage of Acetylene Cylinders (WG-12 & SAC)

Working Group News

Transport (WG-1)

Further to the report in the last EIGAzette, the initiative

to introduce amendments to ADR and to the US Code of

Federal Regulations, to allow importation and emptying

of European and US DOT cylinders into the other’s

market continues.

At the last International Maritime Organisation (IMO)

meeting in London, EIGA submitted a proposal for the

introduction of battery vehicles into the International

Maritime Dangerous Goods (IMDG) Regulations which

will permit the transportation of these vehicles by sea

without the need of derogation from the competent

authorities.

Another recent success is the approval by the authorities

of the EIGA position on the marking of bundles. When

not compliant with EN-ISO 10961 or EN 13769, the

bundles should be marked with the original technical

standard. This position is very helpful for bundles built

before the publication of these standards.

EIGA has published a Training Package, TP 50/17 The

Legal Framework in Europe for the Transport of Gases,

which gives an overview of the regulations applicable to

our industry. Doc 184 Methods to Prevent the Premature

Activation of Relief Devices on Transport Tanks has been

recently updated by WG-1 and will be published soon.

Finally, harmonised publication Doc 41 Guidelines for

Transport by Sea of Multiple Element Gas Containers

(MEGCS) and Portable Tanks for Gases is under

revision.

For more information, please contact Mr Christophe di Giulio, Chair of

WG-1, at Air Liquide (France)

Gas Cylinders and Pressure Vessels (WG-2)

Working Group Activities

WG-2 has a steady programme for revising existing

EIGA documents. We are also in intensive discussions

with the other regional gases associations on harmonised

http://www.eiga.eu/


publications and work in partnership with ECMA

(European Cylinder Makers Association).

Current harmonisation and international work includes

cooperation with CGA to submit a “Petition for

Rulemaking” to the United States Department of

Transportation and submission of proposed changes

within ADR for DOT cylinders to allow importation and

emptying of European and US DOT cylinders in the

other’s market

The harmonised publication Doc 72 Water corrosion of

composites with AA6061 liners is currently starting its

revision process.

For EIGA publications, Doc 86 Gas Cylinders and

Valves with Restricted use in EU was reissued with a new

Appendix added to cover Italy.

The following drafts are in preparation for publication or

have been published recently:

TP 51 Prefill Inspection of Gas Cylinders. This

Training Package covers the general pre-fill

inspection guidance for cylinders and bundles of

cylinders with specific requirements for aluminium

alloy and composite cylinders.

TB 19: Safety Considerations in Case of Fire of

Composite Cylinders or Tubes Used in Trailers

A new revision of Doc 915 Datasheets for Failed

Cylinders and Valves

A new document Overview and Development of the

15 Years Retest Issue for Cylinders

Common papers are being developed with ECMA in

several areas. To ensure knowledge about specific issues

for design, operation and testing of gas cylinders is

retained within our associations, EIGA and ECMA are

working on several common publications. These will be

published by EIGA as Technical Bulletins on:

Recommended method for determination of loose

particles in gas cylinders.

Description of the pressure test methods used during

cylinder manufacture.

Development of calculation formulas for cylinder

wall thickness.

WG-2 is currently revising 6 documents in total, has

started to produce an overview document on definition

of cylinder and valve parameters in standards and is

developing advice on safe cooling and heating of

cylinders.

For more information, please contact Dr. Wolfgang Dörner, Chair of

WG-2, at Linde AG (Germany)

Atmospheric Gases Process and Equipment

(WG-3)

Recently published documents include a revised version

of the harmonised Doc 149 Safe Installation and

Operation of PSA and Membrane Oxygen and Nitrogen

Generators (published at beginning of this year). One

outstanding comment on Doc 10 Reciprocating

Compressors for Oxygen Service has been resolved and

so this revision of the harmonised publication is expected

soon.

The harmonised documents Doc 146 Perlite

Management and Doc 179 Safe Design and Operation of

Cryogenic Enclosures have been revised through several

Joint Working Group conference calls in co-operation

with members of CGA. It is expected that the revised

documents will be published later this year.

CGA has started to develop a new document on Vacuum

Jacketed Piping in Cryogenic Service. Due to lack of

availability of WG-3 experts it will initially be a non-

harmonised document. It is intended to make it a

harmonised document in the future.

AHG-I.21 is still very busy developing a new

harmonised publication Cleaning for Oxygen Service.

The new publication combines and updates the

information in the existing EIGA and CGA publications

and is expected to be completed by the end of 2017.

Plant integrity in general is becoming an increasingly

important issue of focus. After clarification of the

detailed scope with industry experts, a Joint Working

Group is now being established to develop a harmonised

publication on Pipeline Integrity Management.

In the latest version of Doc 154 Safe location of Oxygen

and Inert Gas Vents removed tables related to low

pressure/velocity vents were removed because they were

found not to be accurate enough. CGA has now initiated

a task force on dispersion modelling evaluation to

research behaviour of low pressure/velocity vents. EIGA

has participation in this through individual company

experts who are also on our Working Group.

For more information, please contact Mr Dirk Reuter, Chair of WG-3, at

Messer Group (Germany)

Special Gases (WG-4)

Jean-Francois Lefevre of Air Products has recently

joined WG-4 and replaces Esteban Elias.

Esteban remains as the chair of AHG-4.10 ISO TC 158.

This group continues to work on the development of a

draft ISO 6142-2 standard which details the production

of gravimetrically prepared calibration mixtures. An ISO

TC158 WG-3 ‘Gravimetric Methods’ meeting will

review the latest draft during its May 2017 meeting in

Sweden.

International Harmonisation

WG-4 continues to work on the development of

internationally harmonised documents with AIGA, CGA

and JIMGA. A series of net-meetings has been held with

the other Associations to address comments received on

the following harmonised publications.


Current activities are focussed on Doc 162 Code of

Practice: Phosphine and Doc 163 Code of Practice:

Arsine where the final technical reviews have all been

completed and EIGA is waiting for the completion of

final editing by AIGA/JIMGA and approval to publish

the documents.

Doc 140 Code of Practice: Fluorine and Fluorine

Mixtures has received some late technical comments

from CGA and a Joint Working Group meeting has been

arranged in May to address the comments.

Doc 92 Code of Practice: Nitrogen Trifluoride has been

sent to IGC and the other associations for final approvals

prior to publication.

A series of net meetings were held with the other

Associations in February and April to develop a matrix

of Special Gases hazards and publications that address

them, to identify any gaps. The Gap Analysis will

establish areas for future work. Further net meetings are

envisaged.

A joint CGA/EIGA review of the classification

parameters detailed in ISO 10156:2010 Gases and gas

mixtures – Determination of fire potential and oxidizing

ability for the selection of cylinder valve outlets is

underway and following experimental work

commissioned by CGA an industry position will be

developed with a view to revision of the standard.

EIGA Publications

Doc 189 The Calculation of Harm and No-Harm

Distances for the Storage and Use of Toxic Gases in

Transportable Containers has been amended and

republished.

Five yearly reviews of EIGA publications Doc 129

Pressure Receptacles with Blocked or Inoperable Valves

and Doc 130 Principles for the Safe Handling and

Distribution of Highly Toxic Gases and Gas Mixtures

have been completed and sent to IGC for technical

comments and review. Doc 129 has undergone a

significant re-write.

International Standardisation – ISO Standards

WG-4 continues to participate in the development and

review of several ISO Standards, including:

ISO 11114-1:2012: Gas cylinders - Compatibility of

cylinder and valve materials with gas contents - Part 1:

Metallic materials.

Following the submission of EIGA comments an

amendment to the 2012 standard was published in

January 2017.

ISO 13338: 1995 (classification for corrosivity)

Determination of tissue corrosiveness of a gas or gas

mixture.

The standard was reviewed at the ISO TC58 SC2/WG-7

meeting in January 2017 and the revised DIS will be sent

for publication.

ISO 101298: 2010 Determination of toxicity of a gas or

gas mixture.

This standard was also reviewed at the January meeting

and a draft prepared for the DIS enquiry stage.

ISO 10156: 2010 (classification for flammability and

oxidizing potential): Gases and gas mixtures -

Determination of fire potential and oxidizing ability for

the selection of valve outlets.

Comments arising from the DIS document were

reviewed and agreed at the January meeting of ISO TC

58 SC2 WG-7. When published, the revised standard

will be proposed for reference in the UN Model

Regulations (TDG and GHS).

ISO 5145: 2014 Cylinder valve outlets for gases and gas

mixtures – Selection and dimensioning.

Currently a DIS has been sent for review and EIGA have

submitted comments relating to the limit for pyrophoric

gas mixtures, namely that the limit under which no

testing is required for them to be classified as non-

pyrophoric should be 1% rather than 1.4%. For more information, please contact Dr Kevin Cleaver, Chair of

WG-4, at BOC Gases (United Kingdom)

Environment (WG-5)

As with incidents and accidents that impact safety or

health, human factors play an important role as causes of

environmental incidents. The recent presentation at the

EIGA 2017 Human Factors Seminar identified the key

issues and some tools and techniques that can be used to

prevent environmental incidents by reducing human

factors causes. WG-5 will be publishing a Newsletter on

this subject.

Legislation - Circular Economy

EIGA continues the process to amend the Packaging

Directive to exempt reusable gas cylinders through the

current EU initiatives on the Circular Economy. We are

pushing for an exemption from packaging legislation for

reusable gas cylinders, on the basis that our cylinder

operating model supports the objectives of the circular

economy. The Commission is supporting stronger

wording on the support of reusable systems and we are

meeting with some Member State Permanent

Representatives to push our case.

Industrial Emission Directive BREFs

The BREFs (Best available technique REFerence

document) define the best available techniques to

prevent and reduce emissions for the ‘most polluting”

industrial processes. BREFs are defined in very broad

sectors and industrial gas process such as hydrogen or

acetylene plants are included in a wider BREF at

European level.

EIGA’s BREF publications Doc 155 on hydrogen plants

and Doc 83 on HyCO plants are an input to the process

and Doc 155 is referenced in the refineries BREF

(section 2.4 and reference 56).


The IPPC Bureau publishes the BREF, consistent with

the EIGA documents, and then the Commission

publishes the BAT conclusions containing the emission

limit values (ELV).

EIGA documents provide the basis on which we work as

an industry and highlight the relevant BATs. The goal is

to make sure they are cross reference in the BREF

documents and the ELVs are also consistent with what

we can achieve.

WG-5 continues to work on the new acetylene cylinder

BREF and welcomes feedback from members on how

the authorities view publications Doc 155 and Doc 183.

EIGA Environmental Awards

WG-5 have produced a Newsletter summarising the

lessons from the EIGA Environmental Award winners

which will be published shortly.

Recently Publications

The publication Doc 166 Management of Waste Gas

Cylinders covers how to deal with cylinders at the end of

their operational life.

Publications in progress

A Technical Bulletin on baseline reports as a guide for

the industrial emissions directive IED is in preparation

and four Environmental Newsletters are in draft.

Doc 107 on environmental management systems has

been revised, including the changes required for ISO

14001 2015 and will soon be ready for publication.

We are updating documents on noise (Doc 85),

environmental auditing (Doc 135) and the four

environmental impacts documents for ASUs (Doc 94),

transport (Doc 113), customer installations (Doc 117)

and hydrogen plants (Doc 122).

EIGA WG-5 Environment monitors, and, seeks to

influence current and proposed legislation, exchange

information on environmental incidents/events and

develops and recommends environmental best practice

and indicators. WG-5 typically meets 3-4 times per year

and has reduced our carbon footprint by adopting the

virtual meeting guidelines.

For more information or if you have any feedback on these subjects,

please contact Mr Stephen Bradley, Chair of WG-5, at Air Products

(United Kingdom)

Cryogenic Vessels (WG-6)

Doc 208 Safety in storage, Handling and Distribution of

Cryogenic Ethylene was published at the end of March

2017.

Current activities are focused on the development and

revision of the following documents:

Doc 06 Safety in Storage, Handling and Distribution of

Liquid Hydrogen. The document is under final review

and will be sent to IGC for approval.

Doc 24 Vacuum Insulated Cryogenic Storage Tank

Systems Pressure Protection Devices. This document has

been revised following discussions at WG-6 and has

been sent to IGC for technical review.

Doc 87 Conversion of Cryogenic Transport Tanks to

Oxygen Service, will be revised (this document used to

be assigned to WG-1).

A new document, on operation and inspection of static

vacuum insulated cryogenic vessels, which is a

compilation of Doc 114 Operation of Static Cryogenic

Vessels, Doc 115 Storage of Cryogenic Air Gases at

User’s Premises, Doc 119 Periodic Inspection of Static

Insulated Vessels, and takes into account ISO 21009-2,

Cryogenic vessels – static vacuum insulated vessels –

Part 2: Operational requirements, is under discussion at

WG-6 and should be finalised during the WG-6 meeting

in November 2017.

The harmonised document Doc 164 covering safe re-

pressurisation of carbon dioxide vessels has been

modified to include both EN and ASME design codes

and to allow use the of quick re-pressurisation method

for the EN code. The document has been agreed by the

joint working group.

Activity under CEN TC 268

The target for approval of the new standards on

refuelling stations (including filling protocols) and

hydrogen quality is very short to meet the requirements

of the EU Alternative Fuels Directive on hydrogen

fuelling. Members of WG-6 are requested to support

their WG-11 colleagues in approval of these documents

providing relevant expertise on PED.

The scope of EN 1626 cryogenic valves is being opened

to LNG.

A new working group (CEN/TC 268/WG-6) will be

created to cover helium cryostats.

Activity under ISO TC 220

The ISO TC 220 and associated working groups will

meet in Houston from June 12th June till 14th June, 2017.

During those meetings, several standards on cryogenic

vessels, including material aspects, accessories and

operations will be developed.

For more information, please contact Mr Hervé Barthélémy, Chair of


Medical Gases (WG-7)

Internal condition of medical cylinders

An Ad-Hoc Group has developed a testing protocol and

performed a series of tests in order to analyse and

determine the presence of any metal impurities in the

medicinal gas supply from cylinders that might originate

from the internal surface of the cylinder.


The testing project is being carried out by EIGA with the

participation of the Austrian National Association

ÖIGV.

ICH Q3D

Q3D, the Guideline for Elemental Impurities published

by the International Council for Harmonisation of

Technical Requirements for Pharmaceuticals for Human

Use (ICH) is going to come into effect in December 2017

for all authorised medicinal products, so the group is

working on the definition of risk analysis, testing

protocol, test performance and analysis of the results in

preparation for the application deadline.

Patient Information Leaflet

EU Directive 2001/83 stipulates that medicinal products

shall be accompanied by a Patient Information Leaflet.

EIGA fully supports this legislation as a method to

enhance patient safety, however, considering progress in

communications technology, EIGA wishes to propose

alternative methods of delivering Patient Information

Leaflets for medicinal gases. The reason for this is the

unique nature of medicinal gases and how they are

packaged, delivered and administered. EIGA’s proposal

is to make the Patient Information Leaflet electronically

available and not attach it to the package. WG-7 is

drafting a document with an appropriate rationale to

support this position.

For more information, please contact Mrs Stefania Mariani, Chair of

WG-7, at SOL (Italy)

Food Gases (WG-8)

Several new members have joined the Working Group.

Nathalie Brixi (Praxair) (in replacement of Javier

Campo), Jim Fieret (Linde) and David Hopper (Air

Liquide) have all become permanent members of WG-8.

Publications

A revised version of Doc 70 Carbon Dioxide Food and

Beverages Grade, Source Qualification, Quality

Standards and Verification has been published.

The main amendments are related to fermentation

sources, ethanol and biogas plants with additional

requirements on specifications for different standards or

sources and control frequency changes. The publication

describes how to perform a raw gas analysis before the

design of a purification plant so that seasonal variations

in the composition of the raw gas stream and any

variability in the agricultural feedstock are taken care of.

Ethanol sources must take the variability of soil type,

vegetable matter, water supply, fertilizer and pesticides

into consideration.

For biogas sources (methane and carbon dioxide) from

anaerobic digestion processes, from energy crops or

waste matter, an extensive risk analysis of the process

must account for any chemical and biochemical issues to

ensure compliance with beverage carbon dioxide

specifications (on-line or complete batch analysis)

before customer supply. For sources from municipal

landfills, a more extensive risk assessment and analysis

is required to know if the feedstock is acceptable. The

anaerobic digestion plants and feedstocks shall be

compliant with the EU regulations EC 1069/2009, EC

1774/2002, EC 142/2011 and any local regulatory

restrictions. Application of ISO 22000 to the carbon

dioxide plants is strongly recommended.

Compliance, Standards

1935/2004 EC Directive compliance:

An EU Standardisation Request on Food Contact

Materials was issued in January 2017 under the EU

Commission standardisation process, to draft

harmonised standards regarding analytical testing

methods used to determine the transfer of substances that

are components of materials to the food they are in

contact with. The Commission expects drafting after

consultation with a wide group of interested parties,

including consumers, small and medium-sized

companies, industry associations and EU countries. In

due course we will provide a contribution from EIGA.

These standards would concern oligomer migration and

different methods and testing for specific substances.

Regulatory Watch

Plant Protection Regulation (1107/2009/EC):

The dossier for the renewal of this Active Substance

should be submitted by end of February 2018. A

consortium agreement between the involved gas

companies has now been established and a pre-

submission meeting with ANSES, the French Authority

in charge of this EU Dossier, was held in March 2017. For more information, please contact Mr Philippe Girardon, Chair of


Classification, Labelling, SDS (WG-9) and

LISAM (TF-9.1)

The mission of WG-9 is to monitor, and influence when

needed, new and revised legislation on classification and

labelling of pressure receptacles and the preparation of

Safety Data Sheets (SDSs) and to publish

recommendations on how to comply with the relevant

legislation.

The mission of TF-9.1 is to develop with LISAM S.A. an

SDS authoring tool that is compliant with legislation and

the recommendations of EIGA.

Legislation at UN level

New Chapter 2.18 ‘Chemicals under pressure’: no

decision has been taken by the sub-committee on the

creation of a new chapter versus the incorporation of the

requirements in Chapter. 3. To be continued in the

biennium 2017-2018.

New criteria for flammable gases: the latest proposal

from Belgium/Japan was accepted in the December 2016


session. The new criteria will be published in the 7th

revision of the GHS.

Legislation at EU level

Harmonisation of Information to submit to Poison

Centres (Art.45 of CLP):

The new regulation (EU) 2017/542 was published on

22nd March 2017. Implementation is to be done stepwise

with the following schedule:

mixtures for consumer use: 1st January 2020

mixtures for professional use: 1st January 2021

mixtures for industrial use: 1st January 2024

EIGAs achievement was to have “Gases under pressure”

exempted from the requirements. However, a modified

approach for concentration ranges was not accepted.

Details of submission are still in progress and WG-9 will

follow the development of the details of the submission

process.

Adaptations to Technical Progress (ATPs) of the CLP:

The 10th ATP for new/modified entries for the

Annex VI does not contain any gases.

The 11th ATP will contain an Annex with all

chemical names in all languages.

The 12th ATP for new/modified entries in Annex VI

will not contain any gases.

The 13th ATP will include the changes due to the

6thand 7th revision of GHS.

EIGA Publications

WG-9 has created new updates for both documents

Doc 919 and Doc 169 to be published in 2017. Doc 169

will be aligned to the requirements from the latest ATPs.

Doc 919 will be aligned with data from the European

Chemicals Agency (ECHA). Additionally, progress will

be made on structure and the content of the exposure

scenarios.

SDS Authoring Tool

A new version of the ExESS SDS authoring tool is to be

published by LISAM in May. The gas classification

module (GCM) as well as the content of the pure gas

SDS went through a substantial revision and was tested

and approved by TF-9.1. For seven gases extended SDSs

are provided which also contain the Exposure Scenarios

(ES). A database for phrases used in the ES was created

and translated into the languages of the EU member

countries.

The TF-9.1 is working on the update of ExESS to

improve some functionality and align the database with

EIGA Doc 919. Exposure Scenarios for some additional

gases are created.

For more information, please contact Mr Joachim Barbe, Chair of WG-9

at Messeer (Germany), or Mr Ewoud Beheydt, Chair of TF-9.1at Praxair

(Belgium)

Homecare (WG-10)

In January Antonio Lima was replaced by Sofia Falcão

(Praxair) as chair of WG-10. Our thanks to Antonio for

his commitment and good work in his term as chairman.

WG-10 has also welcomed Marie-Emilie Chlebna-

Vanmarcke as the new representative of Air Liquide.

In the January meeting in Brussels the Working Group

finished the revision of Doc 98 Safe Supply of

Transportable Medical Liquid Oxygen Systems by

Healthcare Service Providers, seven years after the last

revision, making its reading easier and more

understandable for application. The revised publication

will be issued soon.

In this year’s roadmap we are planning the revision of

Doc 158 Good Homecare Practice and Doc 157

Hygienic Processes for Respiratory Homecare Devices;

start work on the harmonised document concerning

handling and cleaning of externally soiled medicinal gas

containers, based on EIGA TB 03 Handling and

Cleaning Externally Soiled Medicinal Gas Containers

and the publication AIGA 077 Guidelines for handling

externally contaminated medical cylinders in a

pandemic situation and will also provide support to the

revision process of the standard ISO 18777 on

Transportable Liquid Oxygen System (TLOS).

This roadmap was presented in April in the Joint Session

of National Associations and EIGA Working Group

Chairs.

For more information, please contact Mrs Sofia Marcos Falcão, Chair of

WG-10, at Praxair (Spain)

Hydrogen Energy (WG-11)

The WG-11 activity is focusing on building common

positions within EIGA Member Companies and with

other stakeholders in the hydrogen infrastructure

industry, to present a common industry view to the

various standardisation and regulation bodies. Hydrogen

energy is a quite specific activity. The stakeholders

involved in the development of a hydrogen infrastructure

extend beyond the traditional panel of industrial gas

companies. This is the reason why WG-11 regularly

holds meetings with guests from companies such as

Shell, Daimler, BMW, Toyota, Honda, Ford and others

in the field of hydrogen mobility.

WG-11 is providing supporting work to standardisation

related to hydrogen refuelling stations, hydrogen quality

and hydrogen quality assurance in conjunction with

ongoing work at ISO TC197 WG-19,24,27,28, CEN TC6

and CEN TC 268 WG-5.

Hydrogen Vent Systems for Customer

Applications

This EIGA document gives guidelines to design vents for

small installations installed at customer sites such as


hydrogen refuelling stations. The final draft has been

issued by WG-11 for review by IGC before publication.

Safety distances: Evaluation of Sandia Lab

HYRAM Tool

WG-11 has defined a reference hydrogen refuelling

station configuration. This configuration is used to

evaluate the HYRAM probabilistic tool and compare its

results with the results obtained by the own respective

tools of the WG-11 members. Results of this evaluation

have been made available to ISO TC197.

Hydrogen Quality and Quality Assurance for

Hydrogen energy applications

WG-11 has proposed revised thresholds for several of the

contaminants listed in hydrogen quality specifications.

The new values will be introduced in the coming revision

of ISO 14687-2 and SAE 2719 defining hydrogen quality

for fuel cell road vehicles.

Green/Low Carbon Hydrogen Guarantee of

Origin

Further advocacy towards the adoption of the definitions

of the CERTIFHY project has been discussed within

WG-11. The liaison with CEN TC6 Hydrogen in Energy

Systems will be used to convey the position of industry

to the CEN TC6 WG2 working on CEN standards related

to hydrogen Guarantees of Origin.

Due to the strong involvement of its members in the

intense standardisation activity ongoing in the hydrogen

energy sector, WG-11 has positioned EIGA as a key

partner at CEN, ISO, SAE level.

Liaisons with other organisations

WG-11 members and EIGA are in Liaison with

Clean Energy Partnership in Germany

ISO TC197 Hydrogen Technologies

CEN TC268 Cryogenic Vessels and Specific

Hydrogen Technologies Applications

CEN TC6 Hydrogen in Energy Systems

EC Sector Forum for Energy Management

First contacts initiated with ACEA - European

Automobile Manufacturers Association

For more information, please contact Mr Guy de Réals, Chair of WG-11,

at Air Liquide (France)

Acetylene (WG-12)

In the first half of 2017, WG-12 published a complete

revision of the Safety Leaflet SL 04 The Safe Transport,

Use and Storage of Acetylene Cylinders.

The new document acetylene supply systems at customer

premises is undergoing its final revision stages before

publication. Once the document is published, the new

document on acetylene plants will be the main document

to be prepared.

Another significant activity in this period is the

preparation of the new globally harmonised document on

mechanical integrity in acetylene plants, under the lead

of CGA. The first net meetings produced a draft version

that is now being reviewed.

Following the requests of Member Companies, two

Work Item Requests (WIRs) have been sent to IGC and

will be included in the activities of the second half of

2017:

to establish an EIGA internal database of porous

materials, including the old ones for which there is

not enough documentation allowing them to be

included in CEN/TR 14473:2014;

to produce a dedicated Training Package on correct

reading of acetylene stamp markings, especially for

those cases that could be misleading.

The AHG on DMF restriction process continues the

monitoring of the process. The second dossier submitted

to ECHA by Italian Competent Authorities has been

rejected. Nevertheless, the Italian authorities intend to

submit a third dossier and EIGA will be an active

supporter of this new submission.

Concerning participation in ISO standardisation

committees, no significant recent activities have been

reported by the WG-12 members.

For more information, please contact Mr Lorenzo Beretta, Chair of

WG-12, at SOL Group (Italy)

Security (WG-13)

WG-13 has increased team numbers slightly over the past

few months and this is allowing us to broaden our

perspective on the issues and business understanding and

allows us to continue to provide assistance plus support

to our Member Companies.

Our respective governments have a very difficult time

ahead as we all see the unfortunate consequences which

have taken place in the types of attacks on individuals

and against the authorities. This ‘lone wolf’ form of

violence is very difficult to predict as I am sure you will

all appreciate but if we all continue to be aware of our

surroundings we can hopefully minimise the impact.

Documents status update: we will be issuing a Security

Alert titled Security of EIGA Members Gas Transport

Vehicles. This is a short series of key points and is meant

as an aide memoire for companies and delivery drivers

when out on the road.

Whilst we continue as companies and individuals to go

about our daily business, there are clearly others who try

and prevent this and once again we ask that you remain

vigilant and report any suspicious activities.

For more information, please contact [email protected]

mailto:[email protected]


Medical Equipment (WG-15)

The activities of WG-15 are driven by two main events,

the ISO TC 121 meeting which will take place in

Boston at the end of May and the new Medical Device

Regulation (MDR) which finally comes into force on

25th May.

Standardisation

WG-15 and Ad-Hoc Group M-8 continue to actively

follow the revision of the ISO 10524 series on pressure

regulators (10524-1: Pressure regulators for cylinders,

10524-2: Line and manifold regulators and 10524-3:

VIPRs – Valves with Integrated Pressure regulators). For

VIPRs, the last DIS version agreed by the ISO TC 121

subcommittee SC6 during the November meeting in

Guildford, UK brought a lot of improvements on three

main topics:

transport regulation compliance (ADR) with the

clarification of the relationships of ISO 10524-3

with ISO 10297, the standard on cylinder valves

which is referenced in ADR,

regulatory compliance with a set of performance

tests in operational conditions, which means using

the gas intended for the VIPR (the medicinal

product) instead of a test gas, such as air or nitrogen,

and in condition simulating a cylinder gas package,

global reliability with a set of new endurance tests.

It is expected that the new round of comments made by

the different national committees and which will be

reviewed in Boston will help to fine tune the standard

without jeopardising the progress that has been made

previously.

Medical Device Regulation

We are there! The new Medical Device Regulation

(MDR) has come into force officially on 25th May and

the countdown has begun. In 3 years’ time, all the

stakeholders must be compliant with the MDR:

manufacturers and notified bodies, health authorities,

importers and distributors, support organisations such as

EUDAMED, the European database or the GMDN

agency providing the numbers and nomenclature that

will "help" to identify the medical devices.

Through this new regulation, the EU has three major

objectives:

Improving the quality, safety and reliability of

medical devices, with tighter requirements for

clinical evaluation and/or trials and the bodies

responsible for approving the marketing of

medical devices. This will have a direct impact

on our medical device gases.

Strengthening transparency of information for

consumers: information concerning medical

devices will be available to consumers on a

publicly accessible database.

Enhancing vigilance and market surveillance.

We come closer to what is already in place for

drugs and therefore gas manufacturers are

already familiar with this kind of requirement.

Nevertheless, it will require extra effort and

resources!

To help EIGA members, WG-15 is preparing a Technical

Bulletin on the implementation of the UDI, the Unique

Device Identifier, which is a system for traceability

(including labelling) and for registration of the medical

devices in the European database EUDAMED.

WG-15 is also preparing a set of documents dealing with

the regulatory status of medical device gases according

to the new regulation. The first publication will concern

gaseous carbon dioxide.

If you are a regular reader, you may have already heard

about the "Rule 21". This new classification rule for

substance-based devices (such as medical device gases)

causes the reclassification of carbon dioxide used in

colonoscopy as a class III device, the highest class of

risk, at the same level as cardiovascular stents or

defibrillators which does not make sense for a gas that

has been used safely for years and which is naturally

present in the body. WG-15 is exploring the regulatory

ways offered by the MDR to get an exemption and a fair

treatment for such gases. We will keep you informed of

our progress.

For more information, please contact Mr Benoît Marchal, Chair of
