Lot Traceability: What It Is and How Lot Tracking Works

Lot traceability is the ability to follow a specific lot of a product through every step of the supply chain - from the supplier you bought the raw material from, through production and storage, to the customer who received the finished goods. Each lot is identified by a unique lot number, and every movement of that lot is recorded so it can be traced backwards and forwards at any time.

Lot traceability is a legal requirement for food companies in the EU and a core part of Good Distribution Practice for medicines. In practice, it is what decides whether a recall affects one pallet or your entire production week.

Lot tracking vs. lot tracing

The two terms are often used interchangeably, but they describe two different directions:

• Lot tracking (forward traceability) follows a lot downstream: where did this lot go, which products was it used in, and which customers received it?
• Lot tracing (backward traceability) follows a lot upstream: where did this finished product come from, which raw material lots went into it, and who supplied them?

A complete lot traceability system does both. Tracking tells you who to contact in a recall. Tracing tells you what caused the problem.

What does EU law require?

For food and feed, the baseline is Article 18 of Regulation (EC) No 178/2002, the General Food Law. It requires every food business to be able to identify who supplied them and which businesses they supplied - the so-called “one step back, one step forward” principle. Article 19 adds the obligation to withdraw or recall unsafe food. Read more about traceability of food.

For food of animal origin, Commission Implementing Regulation (EU) No 931/2011 goes further and specifies which information must be recorded for each delivery:

• A description of the food and its quantity
• Name and address of the business the food was dispatched from and dispatched to
• A reference identifying the lot, batch or consignment
• The date of dispatch

Directive 2011/91/EU requires prepacked food to carry a lot marking, usually preceded by the letter “L”. The lot marking can be left out if the best-before or use-by date states at least the day and month.

For medicines, the EU guidelines on Good Distribution Practice (2013/C 343/01) require distributors to keep a record of every transaction - including the batch number, at least for medicines bearing safety features - so that recalls can be carried out quickly and effectively.

Internal traceability: the part the law doesn’t spell out

“One step back, one step forward” only covers what enters and leaves the company. What happens inside - which raw material lots went into which production batch - is called internal traceability, and the General Food Law does not prescribe how to do it.

Most food standards do. BRCGS Food Safety, for example, requires a traceability test at least once a year, where full traceability must be achieved within four hours. IFS Food and FSSC 22000 likewise require tested traceability systems. And without internal traceability, a problem with a single raw material lot forces you to recall everything produced in the period, not just the products that actually contain it.

How lot traceability works in practice

Lot traceability is built from four events, each of which must be recorded at the moment it happens:

1. Receipt. Incoming goods are registered with the supplier’s lot number, or given a new internal lot number, along with quantity, date and best-before date.
2. Transformation. When raw materials are used in production, the system links the consumed input lots to the new batch being produced. This is the link that makes internal traceability possible.
3. Splitting and repacking. When a lot is divided - into smaller packs, different pallets or different customers - each new lot keeps a reference to its parent lot.
4. Shipment. Every sales order and delivery records exactly which lots were sent to which customer and in what quantity.

When all four are recorded, tracing becomes a lookup rather than an investigation. You can answer “which customers received products containing supplier lot 4471?” in minutes.

Example: one raw material lot, three customers

A bakery receives 500 kg of hazelnuts from a supplier as lot H-2210. Over two weeks, the hazelnuts are used in three production batches of cookies. Those batches are packed into nine lots of finished goods and delivered to three retailers.

The supplier then reports a possible aflatoxin issue with lot H-2210. With lot traceability in place, the bakery can see immediately that three batches are affected, that four of the nine finished lots are still in stock, and which five deliveries went to which three retailers. The recall is limited to exactly those products. Without it, the bakery would have to recall every hazelnut product made in the period. See also how to find a faulty batch in minutes, not days.

Lot traceability vs. serialisation

Lot traceability tracks a group of identical units. Serialisation gives each individual unit its own serial number. In the EU, prescription medicines must carry a unique identifier under the Falsified Medicines Directive (2011/62/EU) and Delegated Regulation (EU) 2016/161. That identifier contains a serial number, but also the batch number and expiry date - so serialisation is built on top of lot traceability, not instead of it.

Why spreadsheets break down

Many smaller companies start with lot traceability in spreadsheets, production logs and delivery notes. It works until the day it has to work fast. The weak points are almost always the same:

• Lot numbers are entered after the fact, and some are missed.
• Production consumption is recorded per day or per shift, not per batch.
• Data lives in several places that have to be cross-referenced manually during a recall.

An ERP system with built-in lot management records lot numbers as part of the normal workflow - receiving, producing, picking and shipping - so traceability is a by-product of daily work rather than a separate task. Lot management is therefore a core feature of both a food ERP and a pharma ERP.

Frequently asked questions

What is the difference between lot traceability and batch traceability?

In everyday use, nothing - both refer to tracing products by the group they were produced or handled in. Some systems distinguish between a batch (the output of one production run) and a lot (a quantity of identical product handled as one unit). See batch number vs. lot number for the details.

Is internal traceability required by law?

Not by the EU General Food Law, which only requires one step back and one step forward. It is, however, required by food safety standards such as BRCGS, IFS and FSSC 22000, and in practice by most retail customers.

How fast should a traceability test be?

BRCGS Food Safety requires full traceability within four hours. Companies with a system-based lot traceability setup can typically answer the question in minutes.

Does every product need a lot number?

Prepacked food sold in the EU must carry a lot marking under Directive 2011/91/EU, unless the best-before or use-by date states at least the day and month. Medicines must always carry a batch number.

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Last updated: November 06, 2026