The questions we get most, answered briefly.

Who signs the packaging declaration of conformity?

The manufacturer of the packaging signs it — meaning whoever sells the packed product under their own brand, not the glassworks or the box maker. Articles 3 and 21 of Regulation (EU) 2025/40 define the manufacturer as whoever designs or has packaging designed and places it on the market under their own name or trademark.

Component suppliers answer for their materials and must provide information under Article 16, but the declaration for the finished packaging belongs to the brand owner.

Since when is the PPWR declaration of conformity mandatory?

Since 12 August 2026, with no transition period for packaging placed on the market from that date. Regulation (EU) 2025/40 applies directly in every Member State without national transposition.

How many declarations does one wine bottle need?

One per packaging type, not one per component. A bottle with closure, capsule and labels is a single primary type and therefore one declaration; the six-bottle carton is a secondary type with its own; the pallet is a tertiary type with its own. A winery with three formats, a gift box and a carton typically reaches eight to ten declarations.

When does the PPWR micro-enterprise exemption actually apply?

Only when all three conditions are true together: fewer than 10 employees, turnover or balance sheet not above €2 million counted across the whole group, and packaging designed and produced by a supplier established in the same Member State. A single foreign supplier — a Portuguese cork, a French capsule — removes the exemption.

Do non-EU brands need a PPWR declaration?

Yes, if the packaging reaches the EU market under your brand. Non-EU manufacturers have the same obligations, and importers must verify that the declaration exists before placing the goods on the market. In practice EU importers are already asking their non-EU suppliers for the document.

Is there a CE marking for packaging?

No. The PPWR provides for no CE marking on packaging: it requires an EU declaration of conformity and technical documentation held by the manufacturer. Anyone offering CE certification of packaging is selling something that does not exist.

When does the EU Machinery Regulation 2023/1230 apply?

From 20 January 2027, replacing Machinery Directive 2006/42/EC. There is no transition period for machinery placed on the market from that date. As a regulation rather than a directive, it applies identically across the EU without national transposition.

Does a technical file compliant with the Machinery Directive still work?

Not automatically. The required contents are listed in Annex IV of Regulation (EU) 2023/1230 and differ from Annex VII of the directive, particularly on software performing safety functions, cybersecurity and digital instructions. An existing good file is a starting point to be re-mapped, not restarted.

What are the penalties for a missing machinery technical file in Italy?

Article 15 of Italian Legislative Decree 17/2010 currently applies: €2,000–12,000 for a manufacturer who fails to produce the technical documentation when the surveillance authority requests it, and €4,000–24,000 for placing a machine on the market that does not meet the essential requirements. Italy's decree adapting to Regulation 2023/1230 is not yet published.

Can machinery instructions be digital only?

Regulation (EU) 2023/1230 allows instructions to be supplied in digital format, but on the user's request the manufacturer must also provide them on paper, at no extra cost and without delay. Instructions must remain accessible for the expected lifetime of the machine.

When does a modification make a machine 'new' under the regulation?

When it is a substantial modification: a change not foreseen by the manufacturer that creates a new hazard or significantly increases an existing risk. Whoever performs it becomes the manufacturer of the modified machine, with a new risk assessment, technical file and declaration. This mainly affects retrofitters and line integrators.

We manufacture outside the EU. Do we need an authorised representative?

If your machinery is placed on the EU market, you generally need an authorised representative established in the Union, appointed by written mandate, who keeps the declaration and technical documentation available to market surveillance authorities and cooperates with them.