Packaging declaration of conformity: content, signature and template under Annex VIII
The EU declaration of conformity is the act by which the manufacturer states, under its sole responsibility, that the packaging meets the requirements of Articles 5 to 12 of Regulation (EU) 2025/40. It is due for packaging placed on the market from 12 August 2026, follows the eight-point model structure of Annex VIII and rests on the technical documentation of Annex VII, point 2.
- Legal reference
- Art. 39 · Annex VIII
- Last updated
- Official text
- Regulation (EU) 2025/40
The software for packaging compliance qualifies the role, compiles the technical documentation and the declaration. Generate your documents for free
The regulation provides no official form to download: it sets the structure. The template at the bottom of the page reproduces it with placeholder data.
The rule
Article 39 governs the declaration in five paragraphs. The second sets its form: the declaration has the model structure set out in Annex VIII, contains the elements specified in the module set out in Annex VII, and is continuously updated.
Three elements of that provision have practical consequences.
The model structure is binding: the eight points of Annex VIII are not optional.
The module referred to is Module A, internal production control. The declaration is the closing act of a conformity assessment, not its starting point.
The declaration is continuously updated: it is not signed once and filed away. Article 15(4) requires a new assessment when the design or characteristics of the packaging, or the reference standards, change.
When it is due
The regulation applies from 12 August 2026 (Article 71).
The obligation concerns packaging placed on the market from that date. Placing on the market means the first making available of packaging, empty or containing a product, on the Union market (Article 3(1), point 10).
Who signs it
The manufacturer draws it up and signs it (Article 15(2)).
The notion is defined in Article 3(1), point 13: a manufacturer is whoever manufactures packaging or packaged products, and also whoever has them designed or manufactured under its own name or trademark, regardless of whether another trademark is visible on the packaging.
Importers and distributors become manufacturers when they place packaging on the market under their own name or trademark, or modify it in a way that affects its compliance (Article 21, first subparagraph).
An importer that remains an importer does not sign the declaration, but keeps a copy of it available to the market surveillance authorities (Article 18(7)).
For micro-enterprises the regulation provides two cases, under different conditions, in which the supplier of the packaging is considered the manufacturer: Article 3(1), point 13(b), when the supplier is located in the same Member State; Article 21, second subparagraph, when the supplier is located in the Union.
The sequence is set by Article 15(2): first the conformity assessment procedure of Article 38, then the technical documentation and, only if the assessment has demonstrated that the requirements are met, the declaration.
The eight points of Annex VIII
The heading is "EU declaration of conformity No …", where the number identifies the declaration. Eight points follow.
1. Identification of the packaging
The unique identification of the packaging. It identifies the packaging, not the declaration, and links to the type, batch or serial number that Article 15(5) requires on the packaging.
2. Manufacturer
The name and address of the manufacturer and, where applicable, of its authorised representative. The conjunction is "and": where there is an authorised representative, both appear.
3. Responsibility
The statement that the declaration of conformity is issued under the sole responsibility of the manufacturer. It is a fixed formula and is reproduced word for word.
4. Object of the declaration
The identification of the packaging allowing its traceability, and its description. The description must make it possible to trace the physical packaging: material, components, format. A generic description does not allow traceability.
5. Other Union acts
The statement that the object of the declaration complies with the relevant Union harmonisation legislation, with references to the other Union acts applied. It does not concern Regulation (EU) 2025/40 itself. If no other acts apply, this is stated.
6. Standards and technical specifications
References to the relevant harmonised standards, the common specifications used or the other technical specifications in relation to which conformity is declared. Where no harmonised standards or common specifications have been applied, Annex VII, point 2(d)(v), requires the technical documentation to describe the solutions adopted. The field is justified, not left blank.
7. Notified body
Where applicable, the notified body, the intervention carried out and the certificates issued. Regulation (EU) 2025/40 provides for no notified body: Article 38 refers only to the Annex VII procedure, Module A. This point is completed only where a body has intervened under another Union act, in the case of a single declaration under Article 39(3).
8. Additional information
Followed, outside the numbered list, by the words "signed for and on behalf of", the place and date of issue, name, function and signature.
One declaration for each type of packaging
Annex VII, point 4, requires a written declaration for each type of packaging, identifying the packaging for which it has been drawn up.
Where several Union acts requiring an EU declaration of conformity apply to the packaging or packaged product, a single declaration is drawn up where appropriate, identifying the acts concerned and their publication references (Article 39(3)).
The declaration is drawn up in, or translated into, the language or languages required by the Member State in which the packaging is placed or made available on the market (Article 39(2)).
The technical documentation behind it
The declaration states that requirements are met, and this must be demonstrable. The demonstration lies in the technical documentation of Annex VII, point 2.
The 100 mg/kg limit on the sum of lead, cadmium, mercury and hexavalent chromium (Article 5(4)) and the PFAS limits for food contact packaging (Article 5(5)) are demonstrated there: Article 5(6) says so.
Data the undertaking does not hold, because it buys the packaging, lie with the supplier, and Article 16 requires the supplier to pass them on to the manufacturer.
The content of the technical documentation, point by point, and the data to request from the supplier have their own pages.
Retention and checks
The manufacturer keeps the declaration and the technical documentation for five years from the placing on the market of single-use packaging and for ten years for reusable packaging (Article 15(3)).
The declaration is not sent to any body when it is issued. A copy is made available to the competent authorities on request (Annex VII, point 4).
Each year the competent authorities check the accuracy of at least part of the declarations, following a risk-based approach, and take the measures needed to remedy non-compliance, such as withdrawing non-compliant products from the market (Article 39(5)).
The PDF template
The template reproduces the structure of Annex VIII with placeholder data and a note for each field. It shows what a declaration looks like and is not meant to be signed as it is: each field must be filled in with data supported by the technical documentation.
Download the declaration of conformity template (PDF, in Italian), no registration required.
Frequent questions
Is there an official form?
No. The regulation sets the model structure in Annex VIII, not a form. The template on this page follows that structure.
Is a notified body needed?
No. Conformity assessment follows Module A of Annex VII, internal production control, carried out by the manufacturer.
Must it be given to the customer?
The regulation requires it to be kept available to the authorities, not passed on to customers. Customers in the supply chain often ask for it: how to respond when a customer asks for the declaration.
Must importers draw it up?
Only if they place the packaging on the market under their own name or trademark, or modify it in a way that affects its compliance (Article 21, first subparagraph). Otherwise they keep a copy of the manufacturer’s declaration (Article 18(7)). The case is covered on the page for those importing from outside the EU.
Which penalties apply?
Article 68 leaves penalties to the Member States, by 12 February 2027. In Italy the regime has not yet been adopted: the penalties framework.
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. 3(1), points 10 and 13 · definitions of placing on the market and of manufacturer
- Art. 5(4), (5) and (6) · heavy metals, PFAS, demonstration in the technical documentation
- Art. 15 · obligations of manufacturers
- Art. 16 · information obligations of suppliers of packaging or packaging materials
- Art. 18(7) · copy of the declaration held by the importer
- Art. 21 · cases in which the obligations of manufacturers apply to importers and distributors
- Art. 38 · conformity assessment procedure
- Art. 39 · EU declaration of conformity
- Art. 71 · entry into force and application
- Annex VII · conformity assessment procedure, Module A
- Annex VIII · EU declaration of conformity
Official text: http://data.europa.eu/eli/reg/2025/40/oj