I import products from non-EU countries: do I have to issue the packaging declaration of conformity?

The notion of manufacturer adopted by the regulation is broader than the everyday one: it does not coincide with whoever physically produces the packaging.

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The rule, verbatim

Article 21 of Regulation (EU) 2025/40, headed "Cases in which the obligations of manufacturers apply to importers and distributors":

"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, then. Either one is enough.

First: the packaging is placed on the market under the undertaking’s name or trademark. A product imported and sold in the undertaking’s packaging, carrying its label, makes the undertaking the manufacturer of that packaging, even with no relationship whatsoever to the plant that produced it.

Second: it modifies packaging already placed on the market in a way that affects its compliance. Relabelling, repackaging, substitution of materials.

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What this entails

The obligations are those under Article 15: carrying out the conformity assessment procedure, drawing up the technical documentation under Annex VII, and signing the EU declaration of conformity under Annex VIII, for each type of packaging.

The documentation must be retained and made available to the national authorities for five years from the placing on the market of single-use packaging and for ten years in the case of reusable packaging (Annex VII, point 4).

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What if I import without applying my own trademark?

In that case the undertaking remains an importer, and Article 18 applies. The declaration is not drawn up by the importer, but before placing the packaging on the market the undertaking must ensure that:

• the manufacturer has carried out the conformity assessment procedure under Article 38 and drawn up the technical documentation under Annex VII;
• the packaging is labelled in accordance with Article 12;
• the packaging is accompanied by the required documents;
• the manufacturer has met the requirements of Article 15(5) and (6).

If the importer considers, or has reason to believe, that the packaging does not meet the requirements of the regulation, it cannot place it on the market until it has been brought into conformity.

Article 18 also requires the importer’s name and the registered trade name or trademark to be indicated on the packaging, together with the postal address at which the importer can be contacted.

Verifying that a manufacturer established outside the Union has drawn up the technical documentation under Annex VII involves a burden no smaller than drawing it up. In practice, the importer often ends up having to reconstruct it.

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The exemption for microenterprises

The second subparagraph of Article 21 provides for a case in which the obligation shifts upstream:

"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."

For it to apply, both conditions are required:

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

If both are met, it is the supplier that is considered the manufacturer and that answers to Article 15.

The exemption looks at the origin of the packaging, not of the product. A microenterprise that imports the product from a third country but buys the packaging from a supplier located in the Union falls within the exemption. The same microenterprise that also imports the packaging does not.

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The obligation that applies to everyone regardless

Regardless of qualification, 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.

This is a traceability obligation that admits no size-based exemptions: it also applies to those who draw up no declaration at all.

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What to do, in order

1. Establish the qualification. Placing on the market under its own trademark, modifying the packaging, the exemption for microenterprises: everything else depends on this.
2. Take stock of the packaging. Not just the product’s own packaging: shipping packaging, tape, filler material and labels too.
3. Obtain the information from suppliers. Composition, materials, heavy metals concentration, and for packaging intended for contact with food, the PFAS values.
4. Draw up the technical documentation and the declaration, under Annexes VII and VIII.
5. Retain everything for the prescribed period, and be able to produce it on request.

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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. 18 · Obligations of importers
• Art. 21 · Cases in which the obligations of manufacturers apply to importers and distributors
• Art. 22 · Identification of economic operators
• Art. 38 · Conformity assessment procedure
• Annex VII · Conformity assessment procedure, Module A
• Annex VIII · Template for the EU declaration of conformity

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