Cold chain: essentials about EN12830 and EN13486 standards

Published on 24 janv. 2020 In: Trend

  • Reading time08 min.
  • LevelBeginner

Cold chain traceability has been a major issue for carriers and logistics specialists of temperature-sensitive goods over many years. The development of interconnected temperature sensors offers an increased range of temperature recorders. To be compliant, your equipment must meet EN12830 and EN13486 standards. This article provides the needed field of application related information, as well as an overview of current regulations and legal requirements.

Cold chain: essentials about EN12830 and EN13486 standards

Temperature control and monitoring throughout the cold chain are crucial issues in terms of product quality. There are a number of standards to meet in order to ensure that foodstuffs and medicines are stored at the right temperatures, and to monitor these temperatures on an ongoing basis.

These include the use of regulation-compliant temperature recorders, which must be checked on a regular basis. Both these cold-chain monitoring aspects are regulated by standards, referred to as EN12830 for recorders, and EN13486 for monitoring.

This article focuses on both above-mentioned standards, their scope of application and the legal obligations resulting there from.

Regulation scope? Key players? Purposes?

In a globalized environment, the storage, transport and distribution of temperature sensitive products shall meet different country-specific regulations. This article focuses on regulations applicable to the European territory. Many different industries have to comply with cold chain traceability regulations, therefore you need to verify the standards applicable to your specific branch of activity.

EN 12830 standard provides an example of the identified fields of activity:
"Typical categories of temperature sensitive goods with transport, storage and distribution temperatures comprised between -80 C and +85 C apply to refrigerated, frozen and deep-frozen foodstuffs, ice cream, fresh and hot dishes, pharmaceuticals, blood, organs, chemicals, biomaterials, electronics and mechanical devices, flowers, plants, bulbs, raw materials and liquids, animals, art works and furnishings.

This regulation has a very broad scope of application, but our focus remains on 2 major industries for transport and logistics covered by this regulation:

  • Storage and transportation of chilled, frozen and deep-frozen perishables.
  • Storage and transportation of medical products such as pharmaceuticals, blood, organs and medical samples.

Standards to be met?

To fully understand your obligations, you might want to get a little technical background... EU regulations require the use of compliant recorders that are regularly monitored. To this end, you must use recorders which meet the two following standards: EN12830 and EN13486.

EN12830: for temperature recorders

EN12830 is the first applicable standard for the recorder you are using. EN 12830 provides the technical and functional requirements for air temperature data recorders used for monitoring product transportation, storage and sales. This applies to temperature recorders, in order to ensure that temperatures are adequately maintained and recorded. The latest version is dated 2018, with the previous version dating back to 1999. The 2018 version applies nowadays and very clearly defines the recorders safety and integrity requirements.

Dedicated or open system?

Many ways can be used to address these security and integrity issues, but two approaches are essential:

  • The first one is to ensure data security and integrity through a dedicated system. That is to say starting from the sensor down to the visualization application system. In such a case, standard compliance may prove easier, as the system is handled at application level, providing significant calculating facilities. Nevertheless, this approach requires the exclusive use of the full manufacturer's solution: from the temperature sensor until the final application, through all manufacturers’ specific communication layers.
  • The second approach intends to ensure data security and integrity through an open system. The temperature sensor itself is designed to meet the standards safety and integrity requirements. Standards compliance is more difficult to achieve in this case, as this feature needs to be monitored at sensor level, offering a limited amount of computing resources. However, this approach allows more flexibility for manufacturers to use any independent system, while ensuring compliance with EN12830 standard requirements.

Where to find out whether a recorder complies with EN12830 standard?

The manufacturer of your recorder needs to be able to issue a Compliance Certificate on its own behalf. Furthermore, such equipment must have passed successful conformity tests carried out by a COFRAC (French Body of Accreditation) -accredited standardization laboratory. The manufacturer shall be able to provide the test report issued by this COFRAC-accredited testing laboratory. Please note that you are responsible for checking that the report refers to the current standard: in this case the EN12830 standard dated 2018 applies. Furthermore, the French Ministry of Agriculture periodically publishes a list of compliant temperature recorders, available here. Beware, this list does not provide any information on the standard version used for the declaration of conformity: either 1999 or 2018.

EN13486: testing recorder accuracy

Compliance with EN12830 is unfortunately not sufficient. You must also comply with EN13486! Please note that this standard was revised in 2002 and a European Committee for Standardization technical board has recently published a revision of this NF EN 13486 standard.

This is a well-known issue: sensors tend to drift over time, i.e. their measurement may progressively become less accurate after a few years of use. This applies to all sensors and also to temperature sensors. As such, it is necessary to carry out periodic quality checks and to comply with this requirement.

Users, i.e. forwarders as well as logistics specialists, are responsible for monitoring recorders on a periodic basis. Nevertheless, a few rules apply when conducting an EN13486 certification campaign:

  • COFRAC (French Body of Accreditation) is in charge of implementing this periodic monitoring process in France. Please ensure that the laboratory you are working with provides you with its "certificate of accreditation" issued by COFRAC, showing expiry and validity dates.
  • You need to define the reference temperature(s) for which you require periodic testing. Please bear in mind that certification cost usually corresponds to quantity of temperature values to be checked.

You must define the accuracy classification of this recurring inspection. This classification varies from one industry to another.

Which temperature values shall I comply with?

Defining the specific temperature value(s) to comply with depends on your sector of activity. The French Ministry of Agriculture publishes a summary table of required storage temperatures to help you in case perishables transportation. Click here to download this documentation.

Transportation of pharmaceutical products, blood and samples include the following three most frequently used temperature values:

  • 20C (18 up to 24C range)
  • 4C (2 up to 8C range)
  • -20C (-30 up to -18C range).

In this industry, many recorders are certified simultaneously for all 3 above-mentioned temperature values, leading to increasing certification costs. Please note that this comment is only intended to provide information, therefore it is essential to check the requirements of your specific industry.

Which temperature accuracy do I have to observe?

Defining the temperature accuracy you need to comply with depends on your specific business sector and on your own requirements. For example, when transporting perishable goods, your recorder must have an accuracy of + or - 2C. This means it must be Class 2 or superior (Class 1 for example).

Transportation of pharmaceutical products and blood requires a Class 1 (+ or - 1C accuracy) recorder temperature when it comes to negative temperature ranges, and a Class 0.5 (+ or - 0.5C accuracy) for positive temperature ranges.

Please note that you are responsible for defining which class you wish to use, and that certification costs increase with the improving accuracy of the requested class.

How often should I check my recorder?

The actual standards provides that "the monitoring frequency depends on user specific requirements, taking into account the manufacturer's specifications". Nonetheless, it contains a few recommendations such as: "However, the manufacturer or authorised workshops, or duly accredited checking services should carry out an inspection on a yearly basis, provided that the temperature recorders and thermometers have been used within this timeframe

How do I know whether my recorder complies with EN13486 standard?

The testing laboratory shall be able to provide a verification or calibration report for each recorder or sensor, including the report date. In addition, a visible statement indicating the recorder monitoring and its date of calibration must be clearly visible on the recorder unit itself.

Example of a COFRAC certified recorder

Ensure your products security through a quality-oriented approach

The range of connected temperature recorders has grown considerably along with the rise of industrial connected objects. In order to ensure a safe and reliable storage and transportation of your temperature-sensitive items, you need to make sure that your temperature recorders comply with the above-mentioned standards. In the event of an audit, you will need to prove cold chain compliance, to avoid the risk of product destruction. Meeting the applicable standards therefore is part of a successful customer quality policy.

Thank you: We would like to thank Mrs. Laure REVERSAT, Founder and President of NAOCOM, for her very valuable support in order to redact this article.