Packaging technical documentation: what it must contain under Annex VII

A preliminary clarification concerns a recurring error in the summaries in circulation.

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Annex VII is not the technical documentation

Annex VII is headed "Conformity assessment procedure — Module A, Internal production control". It is the procedure, set out in five points.

The technical documentation is point 2 within that procedure. It is not a stand-alone annex, and it is not made up of "six sections": it has six points, which is a different thing, and it matters when drawing up the document.

Point 1 of the procedure sets out the principle: the manufacturer ensures and declares, under its sole responsibility, that the packaging meets the requirements of Articles 5 to 12 applicable to it.

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The content, point by point

The documentation must enable conformity to be assessed and must include an adequate analysis and assessment of the risks of non-conformity. It must specify the applicable requirements and cover, to the extent relevant to the assessment, the design, manufacture and operation of the packaging.

It must contain, where applicable, at least:

(a) a general description of the packaging and the use for which it is intended;

(b) conceptual design and manufacturing drawings and schemes of components;

(c) descriptions and explanations necessary for the understanding of the drawings referred to in point (b), the schemes and the operation of the packaging;

(d) a list showing:

• (i) the harmonised standards referred to in Article 36, applied in whole or in part;
• (ii) the common specifications referred to in Article 37, applied in whole or in part;
• (iii) the other relevant technical specifications used for measurements or calculations;
• (iv) in the case of harmonised standards or common specifications applied only in part, an indication of the parts applied;
• (v) in the case of harmonised standards or common specifications not applied, a description of the solutions adopted to meet the requirements;

(e) a qualitative description of how the assessments referred to in Articles 6, 10 and 11 were carried out, concerning recyclability, minimisation and reusability respectively;

(f) test reports.

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The relationship with the substance limits

Article 5(6) closes the loop: compliance with the heavy metals limit (paragraph 4) and the PFAS limits (paragraph 5) must be demonstrated in the technical documentation drawn up in accordance with Annex VII.

It is not enough for the values to be within threshold: this must appear from the documentation, with the supporting evidence. That is precisely the content of point (f).

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The relationship with the declaration of conformity

They are two separate acts, and they must be kept separate.

The technical documentation demonstrates. It stays with the undertaking and is produced to the authorities.

The EU declaration of conformity attests. It follows the template in Annex VIII, consists of eight points, and is drawn up for each type of packaging. It is the act that, as a rule, is transmitted to the customer who requests it.

Point 3 of Annex VIII contains the wording that defines its nature: the declaration is issued under the sole responsibility of the manufacturer.

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How long it must be retained

Annex VII, point 4. The written declaration and the technical documentation are kept available to the national authorities:

• five years from the date the single-use packaging was placed on the market;
• ten years from the date the reusable packaging was placed on the market.

A copy of the declaration is made available to the competent authorities on request.

The periods run from the placing on the market of each item of packaging, not from the date the document was drawn up. For an undertaking that places the same packaging on the market over several years, the obligation extends accordingly.

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The authorised representative

Point 5 of Annex VII allows the retention obligations to be fulfilled by the manufacturer’s authorised representative, in its name and under its responsibility, provided this is specified in the mandate.

However, the obligations under Article 15(1) and the obligation to draw up the technical documentation are excluded from the mandate: those cannot be delegated.

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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. 5(6) · conformity is demonstrated in the technical documentation
• Art. 15 · obligations of manufacturers
• Art. 17 · authorised representative
• Art. 36 · presumption of conformity, harmonised standards
• Art. 37 · common specifications
• Art. 38 · conformity assessment procedure
• Art. 39 · EU declaration of conformity
• 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