Manufacturer, importer or distributor: how to establish the role

Whoever manufactures packaging is a manufacturer. But so is whoever produces none of it at all, and places it on the market under its own name.

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The manufacturer

This is the role with full obligations. Article 15 assigns it the carrying out of the conformity assessment procedure, the drawing up of the technical documentation under Annex VII, and the signing of the EU declaration of conformity, for each type of packaging.

Retention is added to these: five years from placing on the market for single-use packaging, ten for reusable packaging.

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The importer

Article 18 concerns whoever places packaging from third countries on the Union market without applying its own trademark to it.

It does not draw up the declaration, but before placing the packaging on the market it must ensure that the manufacturer has carried out the conformity assessment procedure under Article 38 and drawn up the technical documentation under Annex VII, that the packaging is labelled in accordance with Article 12, that it is accompanied by the required documents, and that the manufacturer has met the requirements of Article 15(5) and (6).

If it considers, or has reason to believe, that the packaging is not compliant, it does not place it on the market until it has been brought into conformity.

It must also indicate its name and the registered trade name or trademark on the packaging, together with the postal address at which it can be contacted.

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The distributor

Article 19 concerns whoever makes available on the market packaging already placed there by others, without applying its own trademark and without modifying it.

It does not draw up the declaration. It verifies that the upstream obligations have been fulfilled, retains the information, and cooperates with the national authority in any action taken to remedy cases of non-conformity with the requirements of Articles 5 to 12.

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The fulfilment service provider

A role often overlooked. Article 20 provides that fulfilment service providers must ensure that the conditions for storage, handling, packaging, addressing or dispatch do not compromise the conformity of the packaging they handle, whether empty or containing a product.

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When importers and distributors become manufacturers

This is the provision that reclassifies the largest number of undertakings. Article 21, verbatim:

"Where an importer or distributor places packaging on the market under its own name or trademark or modifies packaging already placed on the market in such a way that compliance with the applicable requirements of this Regulation may be affected, that importer or distributor shall be considered a manufacturer for the purposes of this Regulation and shall be subject to the obligations of the manufacturer under Article 15."

Two alternative conditions: either one is enough.

The most frequent case is the first. An undertaking that buys wrapping, boxes and labels from third parties and sells its own product packaged under its own trademark is the manufacturer of that packaging. It did not produce it, it did not design it, and it is answerable for it all the same.

The second case is modification: relabelling, repackaging, substitution of materials, if it affects compliance.

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The exemption for microenterprises

The second subparagraph of Article 21 shifts the obligation upstream in a specific case:

"Where an importer or distributor referred to in the first subparagraph is a microenterprise as defined in Recommendation 2003/361/EC as applicable on 11 February 2025, and the natural or legal person supplying the packaging to the importer or distributor is located in the Union, that natural or legal person supplying the packaging shall be considered the manufacturer for the purposes of Article 15."

Both conditions are required:

1. the undertaking is a microenterprise: fewer than 10 employees and annual turnover, or balance sheet total, not exceeding EUR 2 million;
2. the packaging supplier is located in the Union.

The exemption looks at the origin of the packaging, not of the product. A microenterprise that imports goods from third countries but buys its own boxes from a European supplier falls within it. The same undertaking that also imports the packaging does not.

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The role can differ for different packaging

It is not a status carried around: it is assessed item by item.

The same undertaking can be the manufacturer of the wrapping bearing its own trademark, and a mere distributor of a product it resells in the producer’s original packaging. The two positions coexist, and the census must be carried out with that in mind.

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The obligation that applies to everyone, whatever the role

Article 22 requires every economic operator to be able to tell the market surveillance authorities, on request:

• the identity of any economic operator that has supplied it with packaging or packaged products;
• the identity of any economic operator to which it has supplied them.

For five years in the case of single-use packaging and for ten in the case of reusable packaging, from the date of supply.

It admits no size-based exemptions and also applies to those who draw up no declaration at all.

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The six questions that settle the doubt

1. Does the undertaking manufacture the packaging, or commission its manufacture to its own design?
2. Does it place packaged products on the market under its own name or trademark?
3. Does it import packaging or packaged products from third countries?
4. Does it modify packaging already placed on the market in a way that affects its compliance?
5. Does it market, under its own name or trademark, packaging manufactured by third parties?
6. Is some of the packaging intended for contact with food?

An affirmative answer to the first leads to the role of manufacturer under the very definition in Article 3(1), point 13. The second, the fourth and the fifth lead to the same outcome through Article 21.

The third, on its own, does not. Importing from third countries without applying its own trademark and without modifying the packaging carries the obligations of Article 18, not those of the manufacturer. The importer reaches manufacturer status only if the second, fourth or fifth also applies.

The sixth does not concern the role, but determines the application of the PFAS restrictions.

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References

Regulation (EU) 2025/40 of the European Parliament and of the Council of 19 December 2024 on packaging and packaging waste, in OJ L of 22 January 2025. Applicable from 12 August 2026.

• Art. 15 · obligations of manufacturers
• Art. 17 · authorised representatives
• Art. 18 · obligations of importers
• Art. 19 · obligations of distributors
• Art. 20 · obligations of fulfilment service providers
• Art. 21 · cases in which the obligations of manufacturers apply to importers and distributors
• Art. 22 · identification of economic operators
• Annex VII · conformity assessment procedure

Official text: http://data.europa.eu/eli/reg/2025/40/oj