The packaging regulation's obligations, one question per page

Regulation (EU) 2025/40 applies from 12 August 2026. It is a regulation, not a directive: it requires no national transposition and is binding in its entirety and directly applicable in every Member State (Art. 71).

Establishing the role is the first thing to do, because everything else follows from it. The notion of manufacturer adopted by the regulation does not coincide with the everyday one.

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.

Yes, if the products are placed on the market under the undertaking’s name or trademark. In that case the regulation does not treat the undertaking as an importer: it treats it as the manufacturer of the packaging, with all the obligations that follow from that.

The request is legitimate and must be met, but it is not a form to fill in. The EU declaration of conformity is an act that the undertaking signs under its own sole responsibility, and it presupposes technical documentation that supports it.

The content is not left to the undertaking’s discretion: it is set out in Annex VII, point 2, of Regulation (EU) 2025/40. There are six points, from (a) to (f), plus the obligation to include an adequate analysis and assessment of the risks of non-conformity.

From 12 August 2026, packaging intended for contact with food products cannot be placed on the market if it contains PFAS at a concentration equal to or above three limit values.

Regulation (EU) 2025/40 does not set penalties: Article 68 leaves them to the Member States, which must adopt them by 12 February 2027. In Italy the decree has not yet been issued, and as of the update date of this page no amount is in force.

The sum of the concentrations of lead, cadmium, mercury and hexavalent chromium present in the packaging or in one of its components does not exceed 100 mg/kg. The limit is set by Article 5(4) of Regulation (EU) 2025/40 and applies from 12 August 2026.

The information needed to compile the technical documentation is almost always held by whoever produces the packaging, and Article 16 of Regulation (EU) 2025/40 places on the supplier the obligation to transmit it. The request enforces a duty, and it should be made citing the rule.

Membership of an extended producer responsibility scheme and payment of the environmental contribution do not discharge the obligations of Regulation (EU) 2025/40, and vice versa. They are two separate tracks: one concerns the management of packaging waste, the other concerns packaging as a product placed on the market.

The packaging used to ship the product is packaging in every respect, and the regulation gives it its own definition. Whoever sells online and ships under its own name draws up technical documentation and an EU declaration of conformity for the box too, not only for the product’s sales packaging.