Effective 1 January—31 December 2021

Temperature Control
Regulations
Edition 9
COVID-19
Resources for Airlines
and Air Transport Professionals
In response to the unprecedented challenges currently facing the industry, IATA is strongly
advocating for ICAO’s Takeoff Plan to restart aviation. The plan is designed to ease potential
concerns associated with flying and encourage governments to reopen borders through a
globally harmonized approach.
Working with global experts like the ICAO Council’s Aviation Recovery Taskforce (CART) and the
World Health Organization (WHO), IATA has put together industry guidance covering airports,
aircraft, passengers, crew and cargo, as well as analyses and forecasts of the economic
impact of COVID-19 on the industry, and summaries of the relief measures being rolled out by
governments around the globe.
This information is being updated often as conditions evolve and regulations change, so consult
the iata.org resources often!

INDUSTRY GUIDANCE
www.iata.org/covid-19

CART/IATA Guidance: Crew

● ICAO Guidelines
Airport
● Guidance for crew health precautions during pandemic
● ICAO Guidelines
● IATA Guidance for Managing Pilot Training & Licensing during
● Ground handling return to service
COVID
● Guidance for ground handling during COVID-19

● Ground Handling – information about conducting ground

Cargo
operations in time of COVID-19 ● ICAO Guidelines

● Regulatory Approval Status for Mobile Boarding Pass, Electronic ● Carriage of cargo in the passenger cabin

Bag Tag, Home Printed Bag Tag ● Guidance for Operators of Dangerous Goods during COVID-19

● Air Cargo comprehensive FAQ on cargo operations

Aircraft
● ICAO Guidelines
● Aircraft cleaning & disinfection during & post-pandemic
● Guidance for cabin operations during & post-pandemic also
available in Spanish
● Guidance for Flight Operations during and Post Pandemic
● Airline Air Cargo Operations Status: this section covers over 370
airlines worldwide, to capture the Operational Status, current
Cargo Restrictions, Passenger to Cargo (“P2C”) & Cargo In
Cabin (“CIC”) information
● Country Air Cargo Operations Status: this section covers over 200
countries, to capture the current Cargo Restrictions, Cargo In
Cabin (“CIC”) and other important updates to regulations
● Air Cargo Schedules: this section will be released soon (planned
Q4 2020)

Passenger
● Latest COVID-19 travel documentation requirements and health
restrictions from around the world updated in real time:
www.iata.org/timatic
● Instant updates of travel restrictions via Timatic COVID-19
Alerts www.iata.org/timatic-alerts
● Interactive COVID-19 Travel Regulations Map provides the
latest travel restrictions per country via the IATA TravelCentre:
www.iatatravelcentre.com/map
Government Measures Industry Impact
● Access the Government measures related to COVID-19 to learn Data & Economic Analysis
out more about the entry/exit requirements as aviation heads
into a re-start phase (listed per country). Analysis of COVID-19 impacts on the financial and traffic
performance and outlook for the global air transport industry.
● COVID-19 Dashboard on state & airport restrictions (NOTAM
and AIS data) Economics
● COVID-19 Contingency related differences (CCRD) presenting ● All reports on COVID-19 published by IATA Economics
alleviations in safety operational measures
COVID-19 media kit
Relief Measures for Airlines ● Press Releases & Speeches
IATA is appealing to governments for relief measures to support ● Financial impact
the industry in the face of collapsing travel demand, owing to
the COVID-19 pandemic and mandated border closures and ● Traveler Advice

restrictions on mobility. See below areas of action: ● Professional resources

Airline Taxes COVID-19 news – a collection of news stories from airlines

● Governments ticket tax change measures - tax relief measures and airports as well as government relief measures.
and payment deferrals

Airport Infrastructure & Charges

● Airport charges reduction - temporary reduction of airport
charges for airlines - per country, collected in our Aviation
Charges Intelligence Center (ACIC)COVID 19:Slots - to find out
the latest IATA’s position in the are of slots
Relief Measures News
● COVID-19 news a collection of news stories on government
relief measures as well as airport and airline news
Comms Materials
Communication Assets for Industry’s Re-Start
As the industry moves into the re-start phase following the
COVID-19 pandemic, IATA has developed infographics, visuals,
and videos to help restore the travel confidence. Any industry
stakeholder can download, use, and promote these assets
through their own communication channels as images are
copyright free.

IATA Position Papers

● Temperature Screening: A Public Health Responsibility

● Collection of Self-Declared Passenger Health Data

● Harmonization of Health Declaration Form/Data Set

Other Guidance Materials

Safety & Flight Operations
● Guidance for managing aircraft airworthiness for operations
during and post pandemic Ed.1, 12 June 2020
● IOSA Guidance for Safety Monitoring under COVID-19 Ed.2

IATA has launched a service for its member airlines that

addresses operational reports, questions and information
related to COVID restart operations: COVID Reporting Process
for Member Airlines

Customer Vouchers Initiatives

● Airline vouchers & ticket exchange policies repository
Effective 1 January—31 December 2021

Temperature Control
Regulations
Edition 9

International Air Transport Association

Montreal—Geneva
 NOTICE
DISCLAIMER. The information contained in this
publication is subject to constant review in the
light of changing government requirements and
regulations. No subscriber or other reader should
act on the basis of any such information without
referring to applicable laws and regulations and/
or without taking appropriate professional advice.
Although every effort has been made to ensure
accuracy, the International Air Transport Associa-
tion shall not be held responsible for any loss or
damage caused by errors, omissions, misprints
or misinterpretation of the contents hereof. Fur-
thermore, the International Air Transport Asso-
ciation expressly disclaims any and all liability to
any person or entity, whether a purchaser of this
publication or not, in respect of anything done
or omitted, and the consequences of anything
done or omitted, by any such person or entity
in reliance on the contents of this publication.

© International Air Transport Association. All

Rights Reserved. No part of this publication may
be reproduced, recast, reformatted or trans-
mitted in any form by any means, electronic or
mechanical, including photocopying, record-
ing or any information storage and retrieval sys-
tem, without the prior written permission from:

Senior Vice President

Airport, Passenger, Cargo and Security
International Air Transport Association
800 Place Victoria
P.O. Box 113
Montreal, Quebec
CANADA H4Z 1M1

Temperature Control Regulations, 9th Edition

Material No.: 9893-09
ISBN 978-92-9264-127-6
© 2020 International Air Transport Association. All rights reserved.
Montreal—Geneva
 Table of Contents
PREFACE ................................................................................................................................................................................. v

INTRODUCTION ..................................................................................................................................................................... vii

Reference Marks................................................................................................................................................................. vii

ACKNOWLEDGEMENT .......................................................................................................................................................... ix

GLOSSARY ............................................................................................................................................................................. xi

Chapter 1—Application of these Regulations ..................................................................................................................... 1

1.1 Contractual Considerations.......................................................................................................................................... 1
1.2 Shipper Responsibilities............................................................................................................................................... 2
1.3 Carrier Responsibilities ................................................................................................................................................ 3
1.4 Special Conditions ....................................................................................................................................................... 3
1.5 Cargo Services Conference Resolutions..................................................................................................................... 3
1.6 Compliance .................................................................................................................................................................. 4
1.7 Relationship of the Language Editions ........................................................................................................................ 4

Chapter 2—Government Regulations................................................................................................................................... 5

2.1 Compliance .................................................................................................................................................................. 5
2.2 Government Regulatory Agencies and Food Laws ..................................................................................................... 5
2.3 Specific Variations by Countries .................................................................................................................................. 6

Chapter 3—Carrier Regulations ............................................................................................................................................ 7

3.1 General Airline Information .......................................................................................................................................... 7
3.2 Specific Airline Variations .......................................................................................................................................... 13

Chapter 4—Pharmaceutical Products Facts and Types ................................................................................................... 19

4.1 Air Transport Industry ................................................................................................................................................ 19
4.2 Types of Pharmaceutical Products ............................................................................................................................ 20
4.3 Market Trends............................................................................................................................................................ 26

Chapter 6—Packaging.......................................................................................................................................................... 27
6.1 General Knowledge ................................................................................................................................................... 27
6.2 Air Shipment Requirements....................................................................................................................................... 27
6.3 Package Categories................................................................................................................................................... 31

Chapter 7—Documentation and Labelling ......................................................................................................................... 37

7.1 Air Waybill .................................................................................................................................................................. 37
7.2 Cargo Handling Codes .............................................................................................................................................. 37
7.3 Aircraft Documents .................................................................................................................................................... 37
7.4 Special Load Notification to Captain.......................................................................................................................... 38
7.5 Government Documents ............................................................................................................................................ 43
7.6 Labelling..................................................................................................................................................................... 43
7.7 Marking ...................................................................................................................................................................... 43
7.8 WHO Documentation and Labelling for Vaccines ..................................................................................................... 45
 Temperature Control Regulations

Chapter 8—Acceptance and Control .................................................................................................................................. 47

8.1 General Knowledge ................................................................................................................................................... 47
8.2 Hazard Analysis Critical Control Point ....................................................................................................................... 47
8.3 Cold Chain Management ........................................................................................................................................... 54
8.4 Load Acceptance ....................................................................................................................................................... 55
8.5 Signs of Abnormal Loads........................................................................................................................................... 56
8.6 Tips and Check List ................................................................................................................................................... 56

Chapter 9—Traceability and Tracking ................................................................................................................................ 59

9.1 General Knowledge ................................................................................................................................................... 59
9.2 RFID........................................................................................................................................................................... 60

Chapter 10—Perishable Handling Procedures .................................................................................................................. 69

10.1 Effects of Handling Operations on Perishables Quality........................................................................................... 69
10.2 Incompatible Loads and Segregation ...................................................................................................................... 71

Chapter 12—Airport Ground Operations: Terminal and Ramp Side ...............................................................................73

12.1 General Knowledge ................................................................................................................................................. 73
12.2 Weather and Geographical Locations ..................................................................................................................... 73

Chapter 13—Perishable Handling Facilities....................................................................................................................... 79

13.1 General Knowledge ................................................................................................................................................. 79
13.2 Cold Room and Freezers......................................................................................................................................... 80

Chapter 17—Air Transport Logistics for Time and Temperature Sensitive Healthcare Products ...............................83
17.1 Applicability .............................................................................................................................................................. 83
17.2 Purpose.................................................................................................................................................................... 83
17.3 Air Transport Logistics Overview ............................................................................................................................. 84
17.4 Service Levels.......................................................................................................................................................... 84
17.5 Product Temperature Ranges ................................................................................................................................. 86
17.6 Packaging Technology............................................................................................................................................. 87
17.7 Key Risk Factors...................................................................................................................................................... 89
17.8 Critical Control Points .............................................................................................................................................. 89
17.9 Temperature Mapping Recommendations .............................................................................................................. 98
17.10 Package Labeling for Healthcare Products ......................................................................................................... 100
17.11 Training Programs ............................................................................................................................................... 103
17.12 Quality Management Systems............................................................................................................................. 105
17.13 Additional Environmental Considerations ............................................................................................................ 107
17.14 Further Reading ................................................................................................................................................... 108

Appendix A—Ventilation, Heating and Cooling Capability of Airbus and Boeing Aircraft .........................................109

Appendix B—General Design Requirements for Thermal, Insulated and Refrigerated Containers ..........................113

Appendix C—Example of a Process Flow of Time and Temperature Healthcare and Pharmaceutical Shipments
with their Possible Applicable IATA Special Handling Codes ....................................................................................... 115

Appendix D—Guidelines for Center of Excellence for Independent Validators (CEIV) for Perishables Logistics
Audit Checklist.................................................................................................................................................................... 119
PREFACE
This is the 9th edition of the IATA Temperature Control Regulations (TCR), an industry recognized standard for the efficient
and adequate shipping of time and temperature sensitive goods. The former TCR editions were based on the
requirements stated in the IATA Perishable Cargo Regulations (PCR) manual and replicated the chapter dealing with the
packaging, labelling, handling of pharmaceutical products and mainly the chapter on healthcare logistics (PCR Chapter
17), which was a result of the work undertaken by a cross industry working group comprising of representatives from the
pharmaceutical industry, the air transport industry and their service providers.
This edition came about as a result of the pharmaceutical industry requiring a standalone healthcare regulation. The
Temperature Control Regulations (TCR) is its own specialized publication. Therefore the 16th edition 2017 of the IATA
Perishable Cargo Regulations (PCR) extracted all content related to the handling of pharmaceuticals from the PCR into
the standalone TCR.
Cargo handlers and airline staff will need to be made aware of special handling requirements at the time when shipments
are being planned, ideally through SOP's and service level agreements. That is way in advance of their reservation with
the carrier.
In developing this manual, IATA has drawn on its extensive experience to give special attention to the format and wording
to ensure that the Regulations are a readily understandable and easy-to-use manual.
This 9th edition of the IATA Temperature Control Regulations (TCR) has introcuded some important changes, such as:
• In the handling section 17.8.4.2 the IATA Acceptance Checklist for Time and Temperature Sensitive Healthcare
Shipments was modified to avoid any misinterpretation related to shipments delivered on temperature controlled truck.
• The Center of Excellence for Independent Validators in Pharmaceutical Logistics (CEIV Pharma) checklist and
guidelines have been amended with the aim to align the wording with the other CEIV quality driven standard for the
air transportation industry. CEIV Pharma is available as a new Appendix D.
Important: application of this manual.
Cargo Services Resolution 624
1. The acceptance, packing and handling of perishables for transportation by air shall be in accordance with the
principles and provisions of the IATA Temperature Control Regulations (TCR).
2. Notwithstanding the foregoing, Members may accept consignments of pharmaceuticals and healthcare cargo
according to criteria different from, but of no less a standard than, those in this manual, for the type of cargo to be
transported.
This Manual will constantly be reviewed by the IATA Live Animals and Perishables Board (LAPB) as well as the Time and
Temperature Working Group (TTWG) and is updated on an annual basis.
IATA, by means of the LAPB and the Time and Temperature Working Group, continues its long term commitments
towards the Commercial, Safety and efficiency requirements of civil aviation, whilst considering trade developments,
scientific progress and consumer demands. In particular, the focus in terms of time and temperature management is on
supply chain logistics from the original manufacturer to the end of the distribution process. Identifying minimum mandatory
requirements the industry needs to comply with is critical.
The current edition has been updated in line with comments received from the industry and its various stakeholders and
incorporates the new requirements.

9th Edition, January 2021 v

 Temperature Control Regulations

Any comment or suggestion for improvement should be addressed to:

The Secretary, Live Animals & Perishables Board
International Air Transport Association
Cargo Department
33 Route de l'Aéroport
P.O. Box 416
1215 Geneva 15 Airport
Switzerland
+41 22 770 2525
+41 22 798 3553
E-mail: larper@iata.org
Web: http://www.iata.org/pharma
The Link above also provides access to IATA TCR training leading to a certificate of competency; a requirement towards
obtaining the Air Cargo Operations diploma. Different training courses such as the Temperature Controlled Cargo
Operations course or the Audit, Quality and Risk Management for Temperature Controlled Cargo course are available. For
further information on training, including distance learning or self-study, classroom schedule and location as well as in-
company (Customized) training visit: https://www.iata.org/en/training/courses/.
Companies involved in time and temperature sensitive goods at large whether with a particular interest in advertizing, or in
showing their products or otherwise become involved with IATA activities, can do so by means of a detailed but concise
email to the aforementioned email address. More information about IATA cargo can be found at: https://www.iata.org/
cargo/.

vi 9th Edition, January 2021

INTRODUCTION
The IATA Temperature Control Regulations (TCR) is a comprehensive guide designed to enable stakeholders involved in
the transport and handling of pharmaceutical products to safely meet the requirements.
Air transport makes just in time possible and in that respect Time and Temperature sensitive goods and their end
consumers have probably benefited the most from the advantages the air mode offers. Keeping speed and well controlled
conditions, in the movement of pharmaceuticals, is what this business is all about. Air transport ensures life saving drugs
reach patients worldwide and therefore contributes to the search for healthier lives. Through increased and global market
access, shippers around the world benefit from using air transport for the global movement of their products.
In order to cope with market growth and consumer needs, airlines and shippers have worked together to develop efficient
handling techniques and packaging methods to ensure the delivery of Time and Temperature sensitive goods is always in
first class condition. Concepts in terms of time and temperature management, the movement of goods from the Healthcare
sector, quality management systems, service level agreements etc. as well as other trends have been further developed in
this manual and in continuation of the previous editions. Freight forwarders and other service providers find operating
procedures for the movement of goods from the healthcare sector.
Many airlines have distinct product and service offerings when it comes to Time and Temperature sensitive goods. We
invite you to discover them in section 3.1.
The content of this Manual is based on the experience of the airlines and scientific data supplied by research institutions.
Readers should bear in mind that the guidelines published in this Manual are binding to IATA members and should be
considered jointly with the specific conditions imposed by national authorities.
The IATA Temperature Control Regulations is published annually under the authority of the IATA Cargo Services
Conference, and is updated by the Live Animals and Perishables Board (LAPB) in conjunction with input from the Time
and Temperature Working Group (TTWG).
It is anticipated that this Regulation will prove useful not only to airlines and shippers but also to primary producers or
manufacturers, their associations and others participating in the transportation of Time and Temperature sensitive
commodities. IATA welcomes input from readers on the contents of this publication. Refer to the preface for contact
details.
Note:
The Temperature Control Regulations (TCR) was an extract of the Perishable Cargo Regulations (PCR) and only
includes sections which were relevant to the transport of temperature sensitive healthcare products. The
numbering sequence of the TCR followed the Perishable Cargo Regulations (PCR) 15th Edition 2015. However, in
response to the pharmaceutical industry’s need and request, all content related to the handling of
Pharmaceuticals has been removed from the Perishable Cargo Regulations (PCR) 16th Edition to the standalone
Temperature Cargo Regulations (TCR).
Note:
The Temperature Control Regulations (TCR) is being revamped to ensure proper numbering and enhanced
standards as well as industry best practices.

Reference Marks
The following symbols placed against any portion of these Regulations indicate a change from the previous edition:
Symbol Meaning
 Addition of new item.
 Change to an item.
 Cancellation of an item.
+ Indicates an IATA requirement illustrated by means of a small symbol on the left, a hand with a pointing
finger.

9th Edition, January 2021 vii