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GuidelinesRegulatory updates2026.11.07

PPWR Packaging Change Control — A Decision Table on Whether Reassessment Is Needed When a Label, Adhesive or Supplier Changes

Packaging changes do not arise only when a bottle or box is replaced outright. More often the adhesive, coating, component weight or supplier changes while the product name stays the same. Based on the change consideration and reassessment provision in Article 15(4), the continuous updating of the declaration in Article 39(2) and the provision on who makes changes in Article 21, this guide sets out an impact decision table by change type, change request items, a method for linking stock and orders to document versions, and completion criteria.

Key takeaway — Change control asks two questions: ‘what has changed’ and ‘can it affect compliance’. Article 15(4) requires reassessment under the Article 38 procedure where compliance may be affected, and Article 39(2) requires the declaration to be kept continuously up to date. Impact can only be judged by comparing the before and after specifications, not the name of the change (‘design revision’).

This article is based on Regulation (EU) 2025/40 (PPWR) and Commission Notice C/2026/3084 (implementation guidance), as checked on 6 October 2026. For the specification sheet that records the pre-change specification, see packaging specification sheet and supplier document requests, and for the declaration to be revised after a change, see the EU declaration of conformity guide.

Compare before and after specifications rather than the name of the change

Article 15(4) requires the manufacturer to have procedures in place so that series production of packaging remains in conformity with the Regulation, to take due account of changes in packaging design or characteristics and of changes in the harmonised standards, common specifications or other technical specifications applied, and to carry out a reassessment under the Article 38 conformity assessment procedure where it considers that compliance may be affected. To check whether a material or adhesive layer change is hidden under the heading ‘design revision’, record the following on the change request.

Change request item What to record
Packaging number and layer Packaging number from the specification sheet; sales, grouped or transport
Component changed Which of bottle, cap, label, box, cushioning
Old and new part numbers Supplier part number and our part number
Attribute changing Material, thickness or weight, coating, adhesive or ink, joining structure, supplier, printed content
Application point From which order or lot
Reason for change Cost, supply discontinuation, design, regulatory response
Impact review owner and result Conclusion from the decision table below

This request form is our own working format. It does not replace statutory technical documentation; it is used as the input needed for the impact review.

Impact decision table by change type

The requirements that may be affected differ for each packaging, and not every requirement applies right now. The table below is our own proposal summarising, by change type, which requirements' evidence needs revisiting.

Change type Requirements to review for impact Check whether existing evidence remains valid Starting point for the reassessment decision
Change of main material Article 6 recyclability (distinguish application dates), Article 7 recycled content (plastic, not yet applicable), Article 12 labelling Whether material-based test and assessment data covered the new material If the material differs, existing evidence is a subject mismatch
Change of coating, adhesive or ink Component assessment under Article 6(9), separation conditions Whether the data specified the adhesive or coating Impact possible if separation conditions or component joining change
Change of thickness or weight Article 6, packaging protective performance Thickness tested If the thickness differs from that tested, review applicability
Change of supplier (same specification claimed) Supplier information under Article 16 Whether the new supplier's documents match the existing specification on paper If there is no evidence of a match, start by obtaining documents
Change of printing or artwork Article 12; identification and manufacturer marking under Article 15(5) and (6); importer marking under Article 18(3) Whether marking items are omitted or obscured Confirm the application date of each marking requirement
Change of joining structure (integrated component added or removed) Article 6(9) Whether the assessment unit changes Impact possible if the integrated or separate component distinction changes
Change of brand or selling party Article 3(1)(13), Article 21 Whether the manufacturer determination changes If the role changes, start with the responsible party in the documents

Section 6 of the Commission guidance explains that the recyclability principle in Article 6(1) applies from 12 August 2026, that the design-for-recycling criteria in Article 6(2)(a) apply from 1 January 2030 or 24 months after the delegated act enters into force, whichever is later, and that until the delegated act enters into force there is no need to carry out the conformity assessment under Article 38 and Annex VII for recyclability. So do not close the before-and-after assessment on the strength of a supplier's ‘recycled material’ wording alone, but do not assume either that detailed criteria not yet applicable must be assessed now.

Fictional example: changing the adhesive on a removable label

This is a fictional example for illustration. Suppose the removable label on a household product bottle is kept but only the adhesive supplier changes. Even if the label size and printing are the same, check the new specification and evidence for any difference in separation conditions or the material to which it applies. If the existing report covered the old adhesive, a review is needed as to whether the data support the new combination. This example does not mean that an adhesive change always requires a specific test; the assessment method and whether further testing is needed are decided by the impact judgement.

Check that the technical documentation and the declaration cover the right subject

Point 2 of Annex VII requires the technical documentation to include a description of the packaging, design and manufacturing drawings and component materials, a list of the standards and specifications applied, and test reports, and point 3 requires the manufacturing process and its monitoring to ensure conformity with the technical documentation and the requirements. When there is a change, compare the drawings, materials and assessment evidence with the actual order specification and, where needed, reflect new evidence and reassessment results. Because the declaration must also be kept continuously up to date under Article 39(2), confirm the packaging covered and the content of the change.

Changing only the modification date of a document file is no substitute for the review. Recording the reason for and impact of the change, the evidence used and the parts updated lets the scope of the earlier judgement be found at the next change.

Where old-specification stock and new-specification receipts overlap, link the documents to each shipping configuration. Marking in internal records and in the material sent to the importer from which order or lot the changed packaging is used reduces the mixing of two versions under the same product name. Article 18(2) requires the importer to verify the manufacturer's technical documentation and accompanying documents before placing on the market, so record which version was delivered to the importer as well.

Whether stock may be supplied is judged by the relevant requirement, the time of placing or making available on the market and the transitional provisions. Article 15(8) requires the manufacturer that considers packaging it has placed on the market not to comply with the applicable requirements to take corrective measures, withdrawal or similar immediately and to inform the market surveillance authorities, and paragraph (9) provides an exception for reusable packaging placed on the market before 11 February 2025. Do not assume that stock is always permitted, or that it must all be destroyed, merely because it is stock.

Completion criteria: five things to close before the next order

  • Have the before and after specifications been identified at part number and revision date level?
  • Have the conclusion and evidence of the impact review been recorded?
  • Has the new evidence needed been obtained, or the reassessment completed?
  • Do the technical documentation and the declaration point to the post-change specification?
  • Is the version marked on the applicable order or lot and on the material sent to the importer?

Change procedures for human-use medical devices are covered in the medical device change approval, change certification and change notification guide and assessing the scope of a model addition change. If medical device packaging changes, handle that change control and PPWR change control in the same change record.

Common misunderstandings

Common explanation What the legal text provides What to check
It is a design revision, so it has nothing to do with the Regulation Article 15(4) requires changes in design and characteristics to be taken into account. List of attributes changed
Every change needs retesting Reassessment applies where compliance is considered possibly affected. Impact judgement record
The supplier said it is the same specification, so we are done A documentary match must be confirmed using Article 16 information. New supplier's documents
Changing the file date makes it current Keeping up to date under Article 39(2) means updating the content. Content updated and evidence
All stock has to be destroyed The legal text does not provide a blanket rule. Requirement, timing, transitional provisions

Documents that speed up the review if prepared before enquiring

  • Before and after specifications (part number, material, adhesive, weight, drawing revision date)
  • Reason for the change and the order in which it is planned to apply
  • Current list of technical documentation and declaration version
  • Specification covered by existing test reports

Please mention PPWR packaging in your message when you use the PPWR change review enquiry. Based on the documents you hold, we will indicate the impacts and document scope needing further confirmation. The scope and cost of the review are advised individually after we have confirmed the packaging configuration and the content of the change.

Prepared and sources checked: 2026-10-06. Sources: Regulation (EU) 2025/40 recital 14, Article 3(1)(13), Article 6(9), Article 15(4) to (9), Article 16, Article 18(2) and (3), Article 21, Article 39(2), Annex VII points 2 and 3 · Commission Notice C/2026/3084 Section 6 (timing of recyclability application). The change request form, decision table, completion criteria and fictional example are our own practical tools and do not replace a compliance judgement on individual packaging.

Frequently asked questions

Q. Does every packaging change require reassessment?
No. Article 15(4) requires the manufacturer to take due account of changes in packaging design or characteristics and changes in the standards or technical specifications applied, and to carry out a reassessment under the Article 38 conformity assessment procedure where it considers that the compliance of the packaging may be affected. Judging whether there is an impact, and recording that judgement, comes first.
Q. Only the supplier has changed and the specification is said to be the same. What do we check?
Obtain the new supplier's documents under Article 16 to support the claim that the specification is the same, and compare them with the existing documents. Check whether the material, layer structure, coating, adhesive and weight are the same on paper and whether there is a basis for the existing test report applying to the new supply; if they differ, move to an impact review.
Q. Can stock made before the change still be shipped as it is?
The legal text neither permits nor prohibits stock across the board. Recital 14 explains that packaging already placed on the market and held in distributors' stock before the application date of the relevant requirements need not comply with those requirements, but that is an explanation tied to application dates; judging stock after a specification change must be done separately by the relevant requirement, the time of placing or making available on the market and the content of the change. The starting point is to record from which order or lot the changed packaging is used.
Q. If an EU distributor alters our packaging and sells it, who is responsible?
Under Article 21, where an importer or distributor modifies packaging already placed on the market in a way that may affect compliance, that importer or distributor is considered a manufacturer and the obligations in Article 15 apply. Because a change in who makes the change can change who bears the obligations, write change notification and the permitted scope into the contract.

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