Defects resulting in product safety issues can happen even if you have done everything right. If this should ever happen, you want to ensure that you can narrow down the safety issues to specific production runs. This can only be done if your products are labelled with batch numbers.
In this guide, we take a closer look at EU requirements concerning batch numbers, formats, and which products require these.
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What is a batch number?
A batch number indicates which particular production run a product belongs to. Batch numbers can contain letters and numbers indicating the following:
- Product model/SKU
- Material
- Variation (i.e., colour)
- Production facility or country
- Assembly line
- Purchase order date
- Production date and time
The format of the batch number is commonly decided by the company. What matters in the end is that the batch number ensures that individual products can be traced.
In some cases, it is sufficient to only trace a product to a certain purchase order or production run. That said, some companies have batch numbers that can link a product to a specific assembly line and the time of production.
Why are batch numbers necessary?
A number of years ago we worked on the production of snow toys made of PVC. It later turned out that the PVC had been accidentally contaminated by a machine lubricant, resulting in an amount of DEHP exceeding the limit of the REACH regulation. The seller decided to recall the products once they were made aware.
Luckily, the recall was limited, as the issue was only present in products that belonged to the specific production run indicated by the batch number. Without a batch number, identifying the production run would likely have been impossible – forcing them to recall tens of thousands of units sold in previous years.
As such, batch numbers can help businesses prevent larger recalls than would otherwise be the case. Batch numbers are also mandatory in the European Union for most products.
Which products require batch numbers in the EU?
Batch numbers are mentioned in EU regulations and directives applicable to electronics, toys, PPE, medical devices, cosmetics, and many other products. That being said, the General Product Safety Regulation, which covers, extends the requirement for batch numbers to other consumer products as well.
General Product Safety Regulation
The following sections from the General Product Safety Regulation explain how batch numbers are used in practice:
Article 9 – Obligations of manufacturers
5. Manufacturers shall ensure that their products bear a type, batch or serial number or other element enabling the identification of the product and which is easily visible and legible for consumers, or, where the size or nature of the product does not allow it, that the required information is provided on the packaging or in a document accompanying the product.
Article 23 – Market Surveillance
Where a dangerous product has been identified, market surveillance authorities may request from the manufacturer information on other products, produced using the same procedure, containing the same components or being part of the same production batch, which are affected by the same risk.
Article 36 also states the batch numbers must be included in recall notices to help customers check if their products are affected.
Real life examples of how batch numbers are used can be found in recall notices on the EU Safety Gate website.
Products requiring CE marking
Batch numbers are generally required for products that must be CE marked.
Toy Safety Directive
5. Manufacturers shall ensure that their toys bear a type, batch, serial or model number or other element allowing their identification, or, where the size or nature of the toy does not allow it, that the required information is provided on the packaging or in a document accompanying the toy.
Low Voltage Directive
5. Manufacturers shall ensure that electrical equipment which they have placed on the market bears a type, batch or serial number or other element allowing its identification, or, where the size or nature of the electrical equipment does not allow it, that the required information is provided on its packaging or in a document accompanying the electrical equipment.
Personal Protective Equipment Regulation
5. Manufacturers shall ensure that the PPE which they place on the market bears a type, batch or serial number or other element allowing its identification, or, where the size or nature of the PPE does not allow it, that the required information is provided on the packaging or in a document accompanying the PPE.
What is the difference between a batch and serial number?
In general, a batch number is applied to all products part of a single production run whereas a serial number is unique for each individual unit manufactured. A serial number, however, may not necessarily include information about the production run – which is what really matters in this context.
Which batch number format is required in the EU?
I am not aware of any specific batch number format that is either accepted or not accepted in the EU. That being said, the most simple form of a batch number includes the month and year of production.
As mentioned, batch numbers can also include information about the product model, colour, materials, production facility, assembly line, and a timestamp.
Example A: MM-YYYY
Example B: SKU-MM-YYYY
Example C: SKU-MM-YYYY-VN2-15
What truly matters is that you have a system in place to trace products. The granularity can vary depending on what you deem to be necessary
How should the batch number be affixed?
The batch number is normally permanently affixed on the product itself. If this is not possible then the batch must be indicated on the packaging or in the user instructions. However, it is ideal to print the batch number on the product to prevent larger recalls in the event that safety issues are found months or even years later.
Can we use a QR code instead of a batch number?
No, you cannot use QR codes as a replacement for batch numbers in the European Union. This could make it impossible to trace products in the event the seller stops operating or if the QR code is phased out.
This is explicitly stated in the GPSR:
The information about the identification of the product and of the economic operators, as well as instructions and safety information, could in addition be provided by the economic operators in a digital form by means of electronic solutions, such as a QR or data matrix code.
As such, QR codes can only be used in addition to printed information.
What can happen if we sell products without batch numbers?
Failing to print batch numbers makes it impossible to trace unsafe products to a specific production run. This could force you to recall a much larger number of products as you cannot know when the defect causing the safety issue appeared, or if it’s limited to a specific batch.
