Templates and records · ISO 22716 · Clause 7.3

ISO 22716 cosmetic packaging and filling record

Packaging is where most mix-ups happen: one container or label from the previous product is enough to mix two products. The record shows the line was cleared and each unit carries the right batch.

In one sentence

The packaging and filling record captures line clearance, the packaging materials used with their batches, the coding assigned to the finished product, in-line and in-process controls, and reconciliation of units and materials, because ISO 22716 recommends packaging according to defined documentation, checking before starting that no materials from the previous operation remain and assigning a batch number to each unit (7.3), which Regulation 1223/2009 requires on the label (Article 19(1)(d)).

Content reviewed on 17 October 2026

Where the standard requires it: ISO 22716 · Clause 7.3 Chapters are those of ISO 22716:2007, the only edition published, confirmed by ISO in 2022. It is a guidelines standard: it recommends; the obligation comes from Article 8 of Regulation (EC) 1223/2009.
Type of information: Mandatory record ISO 22716 recommendation (7.3), enforceable through Article 8 of Regulation 1223/2009
Who fills it in: Packaging line leader With clearance verified by a second person and a final quality review
When: For every packaging order Clearance at the start; controls at the defined frequency; reconciliation at the end
How long it is kept: Defined by the company ISO 22716 asks for the archiving period to be set according to applicable legislation (17.5.2). As a reference, the product information file is kept for ten years after the last batch was placed on the market (Article 11(1) of Regulation 1223/2009).

What the standard requires

What ISO 22716 demands and what it leaves to your judgement

The packaging documentation must state the equipment, the product's list of packaging materials and the filling, closing, labelling and coding operations. Before starting, the area must be cleared, the documentation and materials must be to hand, and you must check that the equipment is clean and the coding is defined.

Each unit of finished product carries a batch number that can be linked to that of the bulk. The line must be identified at all times with its name, the product and the batch, and in-line control equipment, such as code readers or checkweighers, is checked to a defined programme.

Where filling and labelling are not continuous, the intermediate product must be segregated and identified to avoid mix-ups (7.3.8).

Read it in context: Production and quality control, in the ISO 22716 Academy

Structure

Fields the template should include

Finished product, format and batch number
Bulk batch of origin
Packaging line and equipment
Line clearance: verified by whom and when
Packaging materials with their batch: container, cap, label, carton
Coding: batch and date of minimum durability or period after opening printed
Check of in-line control equipment
In-process controls: weight, closure, labelling, appearance
Reconciliation of units and printed material
Incidents and their reference

Example

Example: packing the cream in 50 ml jars

Company, people and figures are fictitious: the example only shows what a properly completed record looks like.

Field	Content
Product	Moisturising cream CH-30 · 50 ml jar · batch 26-0418-A
Bulk	Batch 26-0418 · IBC-14
Clearance	Line L-3 free of the previous product · verified by two people · 20 April, 06:50
Materials	Jar batch T-2602 · lid batch TP-2611 · label version 4, batch E-0388 · carton batch ES-0921
Coding	Batch 26-0418-A and date of minimum durability 04/2029 checked on the first unit
In-line control	Checkweigher tested with reference weights at start-up and every 2 hours
Controls	Net weight every 30 min: 50.4 to 51.2 g (minimum 50.0 g)
Reconciliation	7,820 jars filled · 7,792 conforming · 28 rejected on weight · 30 spare labels destroyed

At the audit

Mistakes auditors commonly flag

Line clearance is signed without being checked, and labels from the previous product turn up.
The batch numbers of packaging materials are not recorded.
Coding is not checked at start-up or after stoppages.
Spare printed material returned to the warehouse unidentified.
Reconciliation with unexplained differences in units.

In Kimobox

How this record is kept in Kimobox

1Each packaging order is linked to its bulk batch and to the batches of materials used.
2In-process controls are recorded against the batch, with their criteria.
3An incident on the line is opened as a nonconformity linked to the batch.
4Traceability of the finished batch can be followed back to the raw materials and forward to the shipments.

Frequently asked questions

What people ask us before getting started

What is line clearance?

The check, before starting, that no product, container, label or document from the previous operation remains on the line or in the area. It is the control that prevents mix-ups, the most common cause of labelling recalls.

Is a batch number mandatory on every unit?

Yes. Regulation 1223/2009 requires the batch number or reference identifying the product on the container and the packaging (Article 19(1)(d)), and ISO 22716 recommends assigning it to each unit of finished product.

What is reconciliation for?

To detect when something does not add up: missing units, too many or too few labels. An unexplained difference in printed material may mean labels have ended up on another product.

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Sources

Where each figure comes from

References to the official text in force. If a standard is revised, this page is updated and the review date says so.

ISO 22716:2007 — Cosmetics. Good Manufacturing Practices (GMP). Guidelines on Good Manufacturing Practices ISO · 2007 ed., confirmed in 2022
Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products EUR-Lex · 30 November 2009, consolidated text