2020 09 23
EIGA has moved
The new EIGA address is Rue de l'Astronomie 30, B-1210 Brussels.
For the majority of visitors arriving by metro : the new offices are nearby to the same "Madou"metro-station you are familiar with.
Visitors arriving by car can call EIGA to check the availability of the few parking spaces we have in the basement of the new building.
Experts staying overnight usually stay in the Crowne Plaza hotel. The walk from the hotel has now become a bit shorter.
Phone numbers and other contact details remain unchanged.
02Welcome !
The new location is better equipped to welcome the Working Group experts. The EIGA staff is looking forward to welcome you as soon as Covid will allow it.
Did you know we can now accommodate you (outside of the Working Group meetings) with a place to work whenever you are in Brussels between meetings or waiting for your train or flight. Just give us a call.
EIGA Councils
IGC
Feedback from the ADR/RID/AND Joint Meeting
Some EIGA members and staff attended virtually meeting, between 10th and 18th September. EIGA, with the input from WG1, submitted several formal and informal papers. Please find a brief summary of results on the main papers:
Paper 2020/1 on Periodic & intermediate inspection of tanks or refrigerated liquefied gases: proposing no intermediate inspection before the first periodic inspection of tanks for refrigerated liquefied gases. Our paper was adopted and ADR/RID will be amended in that sense.
In addition, all the countries were in line with the French proposal (2020/7) to remove "at the request of the competent authority" for the intermediate inspection of tank containers (right column in 6.8.3.4.6). This means that this inspection should become mandatory.
Paper ECE/TRANS/WP.15/AC.1/2020/9 Test periods for battery vehicles filled in accordance with P200: Most delegations that took the floor expressed their view that more work is needed on the proposal by EIGA. They felt that it is too premature to already decide on an extended test period to 15 year for battery-vehicles and that more data is needed for such a decision. The Joint Meeting suggested establishing an informal working group also on this subject and requested the representative of EIGA to prepare the draft terms of reference for that group for consideration and decision at the March 2021 session. Interested delegates should contact the representative of EIGA.
Paper 2020/52 on the newly appointed “Joint Meeting Standards Advisor” was also adopted. This person is verifying CEN standards to assure compliance with ADR. This person is paid by the EIGA, LGE and ECMA associations.
Paper 2020/63 on the deletion of a note in ADR which rejects cylinders with lower than minimum design wall thickness of cylinders. The new technology of ultrasonic testing allows to detect much more cylinder imperfections than visual and hydro inspection. Although there is an ISO Technical Report with validated data on this matter, our paper was not supported by the delegations. We will have to discuss between EIGA experts if and how we can further pursue this subject with the Joint Meeting and/or UN Subcommittee Transport.
04Doc 173/20 - ADR Transport Security Guidelines
(Revision of Doc 173/13) There is a requirement within ADR for those transporting dangerous goods to take account of security provisions, and in particular for certain "high consequence dangerous goods".
This document gives guidance on the issues to be considered and precautions to be taken for transporting gases when complying with the security requirements of ADR Chapter 1.10. Within Appendix 1 there is an example of a security plan which can be used as a template to assist transporters of dangerous goods to prepare a security plan.
The document is intended to be used by those involved in the transport of dangerous goods by road and who are responsible for the preparation or administration of the security provisions of ADR.
05Doc 174/20 - Guidelines for the Safe Installation and Use of Cryogenic Food Freezing and Cooling Equipment
(Revision of Doc 174/12) This publication has been prepared to cover the safety requirements and best practices for the installation and use of equipment for the chilling and freezing of food using liquefied cryogenic gases (liquid nitrogen) or refrigerated liquefied gases (liquid carbon dioxide) as the cooling medium. The purpose is to provide guidelines on the design, installation and operation of chilling and freezing equipment so that they can be operated safely.
The publication is intended for any person or organisation that is involved in the design, installation, operation and maintenance of cryogenic food freezing equipment.
06Doc 234/20 - Internal Inspection of Decommissioned Flat Bottom Tanks
This publication aims to give recommendations for inspections of decommissioned cryogenic flat bottom tanks. It also aims to build a library of inspections available to EIGA members that will demonstrate the absence of aging mechanisms in this type of equipment and allow continued operation of the equipment without periodic internal inspection.
This publication provides guidance for inspections when a cryogenic flat bottom tank is decommissioned. However, in some exceptional cases, an internal inspection can be required, for example after an overfill or overpressure incident, tank contamination, or after repairs / refurbishment.
MGC
Doc 216/20 - ICH Q3D Risk Assessment Report – Elemental Impurities in Medicinal Gases
(Harmonised publication) (Revision of Doc 216/19) The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) has developed a harmonised guideline for elemental impurities, Q3D in pharmaceutical products which includes medical gases, referred to as ICH Q3D. This is an adopted guideline from the European Medicines Agency.
ICH Q3D recommends a science and risk-based approach to evaluate the potential for introduction of elemental impurities, into the drug product and to determine if additional controls need to be included in the overall control strategy to ensure product quality and safety.
To determine whether medicinal gases are likely to contain any elemental impurities, specified in ICH Q3D, EIGA members performed a risk assessment which considered which elemental impurities could theoretically be present in the licenced drug products. The maximum daily dosages were also calculated for each medicinal gas to determine which medicinal gases were at the highest risk.
Although the method of production is unique for each medicinal gas, the method of filling and packaging the gases is common across all products. The same basic equipment and procedures are used to fill these products and the container closure systems used are similar for all products. This led to a conclusion that the potential elemental impurities present was common for all medicinal gases.
For those high risk elemental impurities that were identified as potentially being present in the gases, appropriate test procedures were set up to determine their levels in the finished product.
The test method sampling system took product from the container closure system so as to represent the gas that would be delivered to the patient for treatment. This was considered to be the worst-case scenario for all medicinal gases and gas mixtures, to determine whether the elemental impurities would be within the permitted daily exposure limits detailed in ICH Q3D.
From the information given in this report, the view of the EIGA companies is that the levels of elemental impurities within the medicinal gases that they supply for patient treatment are well below the limits set out in ICH Q3D.
This publication is intended for all those you are involved in the supply of medical gases.
The publication is part of the programme to develop Globally Harmonised publications amongst Regional Gas Associations.
REC
An intense legislative agenda on the energy and climate front for the next months
European Commission President Ursula von der Leyen gave her first State of the European Union (SOTEU) to the European Parliament. Amongst the most important announcements, she proposed to raise the climate ambition to a new -55% GHG target for 2030 compared to 1990 levels, up from the previous -40%, to use the crisis as an opportunity to rebuild the EU economy in a greener way. This announcement was then followed by the 2030 Climate Target Plan, which includes an extensive and comprehensive revision of existing legislation, including the Emission Trading System the Energy Taxation Directive (ETD) and the Carbon Border Adjustment Mechanism (CBAM).
In the ‘fit for 55’ package, the revision of the Renewable Energy Directive (RED II) will hopefully provide a clearer framework and set of definition for new fuels, such as hydrogen. Hydrogen was indeed identified as a key sector to drive the EU’s economy decarbonisation and two strategies on smart sector integration (to link production sector and end-users mainly) and specifically on hydrogen were released in June. In particular, the Clean Hydrogen Alliance has been launched in the context of the Hydrogen Strategy and this will require in the next months and years the engagement of all the stakeholders interested to create a prosperous market for hydrogen (see also below).
The new climate ambitions will also have an impact on the revision of the State Aid Guidelines for Environmental and Energy products (EEAG) which are expected to be adopted by the end of 2021. While the new State Aid Guidelines for the indirect costs of ETS should to be adopted by the end of 2020 and ensure that the cost of the electricity used to produce hydrogen can be compensated by Member States, when electrolysis is used as production method.
In this framework, President von der Leyen also called for the EUR 750 billion Next Generation EU (NGEU) recovery instrument to be spent on the EU’s twin green and digital priorities. She also committed to issue 30% of NGEU bonds as green bonds. This specific point raises concerns that the current discussion on the Green Taxonomy as part of the Sustainable Finance portfolio will influence the market of products and substances like hydrogen. In turn, the Sustainable Finance agenda will also be impacted by the increased ambitions, with the planned revision of the transition criteria possibly becoming more stringent as a result of the increased targets.
As you can see, EIGA faces challenging times ahead in this field.
09Renewable Energy Directive - (RED II)
The European Commision will review how far EU renewable energy rules in RED II (Directive 2018/2001/EU) can contribute to a higher EU climate ambition, and wants to explore how to accelerate the transition to a more integrated energy system as outlined in the energy system integration & hydrogen strategies.
To that end, the European Commission opened up for feedback. The EIGA ad-hoc-group submitted feedback (that can be consulted here).
10Sector Integration – Regulatory Framework for Hydrogen
A workshop was organised, and EIGA called to put forward a regulatory and market framework which:
allows the private sector to continue to compete and to invest in green and low-carbon solutions without putting long-term commercial contracts at risk and without impairing existing assets.
justifies new infrastructure in a market-driven approach and in a cost-effective way
develops the internal energy market in line with the principles of the Third Energy Package, preventing distortion that may be caused by cross-subsidies and regulatory intervention
secures a technology-neutral and cost-efficient pathway to the hydrogen economy, supporting the move to low-carbon production in traditional industrial markets (steel, refineries, chemicals) and in emerging markets (circular economy, mobility, heating), whilst ensuring a level playing field between renewable and low-carbon hydrogen (CCS/CCU)
harmonizes definitions around low-carbon hydrogen (e.g. green/blue hydrogen, guarantees of origin, additionality)
provides the necessary funding mechanisms and state aid (e.g. contract for difference) needed to finance the transition towards a sustainable integrated low-carbon energy market.
Energy Taxation Directive
The revision of the Energy Taxation Directive (ETD) forms part of a group of policy reforms to deliver on this increased ambition and achieve climate neutrality by 2050. EIGA participated in the consultation and made the point that low carbon hydrogen produced through methane reforming in combination with carbon capture should be treated on equal footing to hydrogen produced through other processes.
EIGA stressed that the ETD must promote the use of low carbon hydrogen whether produced by other means such as water electrolysis (‘green’ hydrogen) or derived from natural gas (‘blue’ hydrogen). Either way, low carbon hydrogen will allow meaningfully reduction of emissions from industrial processes regardless of the underlying technologies.
SAC
Safety Innovation Award
This is a reminder that applications for the EIGA Safety Innovation Award 2020 can be sent to the EIGA office before 13th October 2020.
The EIGA Safety Innovation Award recognises best practices. The theme for 2020 is “Safety excellence in maintenance”.
The one-page application form is can be found here. More detail can be found in Doc 903 (after login).
The award is open to all EIGA member companies. Please feel free to share with your colleagues.
13Doc 233/20 - Emergency Response Planning
Companies are required to take reasonable measures to prevent emergency situations such as fires or leaks from happening, but emergencies are still possible on any site. Every site should therefore have an emergency plan and the necessary resources in place: designated spaces, equipment and people organised to manage the potential emergencies to reduce harm to employees, the public and the environment or damage to facilities.
This publication describes the key elements of a robust emergency management system to formally assure preparedness using an emergency plan.
14Doc 108/20 - Environmental Legislation Applicable to Industrial Gases Operations Within the EU
(Revision of Doc 108/14) The EIGA Environmental Legislation Guide covers environmental legislation originating from the European Union. Whilst there is a wide variety of environmental legislation in each member state, the main driving forces come from the European Union with over 400 legislative instruments put in place since 2001. This publication provides guidance on how European legislation concerns the main environmental aspects relevant to the Industrial Gases Industry. In all cases the relevant national legislation should be consulted for specific implementation in each country or region.
The publication has been revised to update information and references in the guide. The publication is intended for use by all those involved in the management of the environmental aspects of industrial and medical gas operations
15TP 28/20 - Safe Driving in Bad Weather Conditions
(Revision of TP 28/12) (For EIGA Members only: log in to download this Training Package)
Adverse weather conditions significantly increase the risks to drivers. If drivers are aware of the hazards associated with bad weather, they will be more likely to be able to avoid hazardous driving situations.
This Training Package has been prepared to assist in ensuring all drivers working in the industry:
- are aware of the increased risk of driving in bad weather conditions;
- understand the reaction of the vehicle in various weather conditions;
- can apply safe driving procedures and adjust their driving to suit the adverse conditions.
The Training Package should be communicated to anyone who drives a vehicle of any type, including passenger cars