The recurring terms, explained once.

The words you find in contracts, supplier emails and regulation texts, with the meaning they actually carry in practice.

Technical file General

The documentation set demonstrating a product's conformity. For packaging it is defined by Annex VII of Reg. (EU) 2025/40; for machinery by Annex IV of Reg. (EU) 2023/1230. It is not handed to the customer: it is retained and shown to surveillance authorities on request.

EU declaration of conformity General

The document by which the manufacturer states, under their sole responsibility, that the product meets the applicable legislation. For packaging it follows the ten items of Annex VIII of Reg. (EU) 2025/40.

Placing on the market General

The first making available of a product on the Union market. It determines which rules apply: a machine placed before 20 January 2027 stays under the previous regime.

Manufacturer General

Whoever designs or has a product designed and places it on the market under their own name or trademark, even if production is outsourced. This is the party that signs the declaration.

Authorised representative General

A person or company established in the EU, appointed by written mandate by a non-EU manufacturer, who holds the declaration and technical file and cooperates with authorities.

Packaging type Packaging

A format with a given combination of materials and components. Changing one component creates a different type, with its own file and declaration.

Primary, secondary, tertiary packaging Packaging

Primary is in contact with the product (the bottle), secondary groups it (the six-bottle carton), tertiary is for transport (the pallet). All three are packaging under the regulation and all three require documentation.

Article 16 request Packaging

The article of Reg. (EU) 2025/40 obliging packaging and material suppliers to make available to the manufacturer the information and documentation needed to demonstrate conformity.

Machine family Machinery

A group of machines sharing safety architecture and base technical file. Dimensional or trim variants belong to the same family; substantially different lines are different families.

Substantial modification Machinery

A change to a machine already on the market, not foreseen by the manufacturer, creating a new hazard or significantly increasing a risk. Whoever performs it becomes the manufacturer of the modified machine.

Notified body Machinery

A body designated by a Member State to carry out the conformity assessment procedures required for certain high-risk machinery categories. Other machinery uses internal production control.

EN ISO 12100 Machinery

The harmonised standard for risk assessment and risk reduction of machinery. It is the technical basis of the risk assessment accompanying the technical file.

Questions and answers → · Data collection and document tooling. Not legal advice. The declaration is signed by the manufacturer's legal representative, who remains responsible for it.