Sep.2026 09
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Economic Operator Obligations Articles 38-46: Manufacturer, Importer and Distributor Checklist
Introduction
Each actor in the chain carries distinct duties. Paper A separates manufacturer, cell supplier, importer and distributor obligations so an EU buyer knows exactly what a NiMH factory must provide.
Details

economic operator obligations articles 38 to 46 manufacturer importer distributor checklist

Regulation (EU) 2023/1542 assigns explicit, different duties to every actor in the battery chain: manufacturers, producers, cell and module suppliers, importers, distributors, fulfilment-service providers and second-life operators. Articles 38–46 define those duties, and non-EU factories need to understand them because their European customers will ask for exactly the documents the law places on the importer. This paper separates the roles and builds the supplier-side checklist for nickel-metal hydride (NiMH).

The Manufacturer and Producer Duties

The manufacturer (Article 39) is the entity that manufactures or designs a battery, or has it designed or manufactured and markets it under its name. Its duties are comprehensive: design compliant with substance, performance, safety and labeling requirements; complete the conformity-assessment procedure; draw up the technical documentation and EU Declaration of Conformity; affix CE; keep records for ten years; implement compliant-series production with change control; label with name, trade mark and contactable address; operate complaint handling, corrective action and recall procedures; and cooperate with market-surveillance authorities. The producer definition for extended-producer-responsibility purposes additionally triggers per-country registration and take-back financing — a separate duty covered in our EPR paper.

animated flow of responsibility from cell maker through pack factory importer distributor to user

Importer and Distributor: Verification Before Placement

The importer (Article 42) places a non-EU battery on the EU market and must, before doing so, verify that conformity assessment was completed, that technical documentation exists, that CE marking and required labels/instructions are present, and that the manufacturer's contact details appear. The importer must state its own name and postal/electronic address on the battery or packaging, keep a copy of the DoC available for ten years, and suspend placement where it finds non-conformity, notifying the manufacturer and authority. The distributor (Article 43) must check the visible compliance elements — CE mark, labels, instructions, importer identification — before making a battery available, and ensure storage and transport do not compromise compliance. Fulfilment-service providers (Article 44) assume manufacturer-like obligations when they handle batteries for sellers without an EU establishment.

The Cell and Module Supplier's Special Position

Article 38 and the related provisions recognise that pack manufacturers depend on cell and module suppliers: the upstream supplier must provide the technical information and compliance evidence needed for the downstream operator to meet its obligations — composition, test data, carbon and recycled-content inputs where relevant, and due-diligence information. In a NiMH value chain this means the cell factory is effectively the evidence originator: the pack builder, the brand and the importer all re-use the cell maker's substance reports, IEC 62133-1 results, IEC 61951 performance data and nickel due-diligence records. Missing upstream evidence cannot be recreated downstream, which is why importers audit the factory rather than the trading company.

animated layers of documents the NiMH factory hands the EU importer

Authorised Representatives and the Non-EU Factory

A manufacturer without an EU establishment may appoint an authorised representative in writing (Article 40) to hold the DoC and technical documentation, cooperate with authorities and perform specified tasks; the manufacturer remains responsible for compliant products regardless. Where no authorised representative exists, the importer carries the manufacturer's obligations — a reason importers either demand an EU representative or a very complete supplier dossier. NiMH exporters should understand that "FOB shipping" does not end their regulatory exposure: their name appears in the technical file, their test reports justify the CE mark, and recall or non-conformity notices flow back to them contractually.

The Supplier-Side Compliance Checklist

A NiMH factory ready for Articles 38–46 audits holds: category classification per product; Annex VIII technical file index; signed Annex IX DoC templates; Article 13 label artwork files; IEC 61951/62133-1 and UN 38.3 reports; REACH and Annex I declarations; Annex III/IV durability data; due-diligence policy and verification; ten-year record control; change-control and CAPA procedures; lot traceability from cell to shipment; and an importer handoff pack translated as required. Each item maps to a specific article, which lets the importer close its own checklist in days rather than weeks.

Weijiang Power

Weijiang Power operates as the evidence originator EU importers need: a per-product Article 38–46 handoff pack containing technical file, DoC, labels, test reports, durability data and due-diligence records, with lot traceability and change control. Request our importer checklist and we will map each of your destination-market obligations to the exact document we supply, including the information your authorised representative must hold.

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