---
title: "What the EU requires before you can sell a product"
description: "The seven layers of EU product compliance a non-EU company must satisfy: the rules that apply, the technical file and declaration of conformity, CE marking, labelling and traceability, chemicals, producer responsibility, and the importer's duties — each linked to the regulation page."
type: "page"
url: "https://www.conphora.com/sell-in-europe/requirements/"
markdown: "https://www.conphora.com/sell-in-europe/requirements.md"
locale: "en"
language: "en"
updated: "2026-09-10"
author: "Conphora compliance team"
publisher: "Conphora"
tags: ["sell-in-europe", "non-EU", "GPSR"]
license: "Free to quote with attribution and a link to the page"
---

# What the EU requires before you can sell a product

> The seven layers of EU product compliance a non-EU company must satisfy: the rules that apply, the technical file and declaration of conformity, CE marking, labelling and traceability, chemicals, producer responsibility, and the importer's duties — each linked to the regulation page.

Seven layers, from the acts that apply to the duties your importer takes on. Nothing here is asserted that the linked regulation page does not carry.

## In short

A non-EU company selling a product in the EU must satisfy seven layers: the EU acts that apply to the product, a technical file and an EU declaration of conformity, CE marking where a CE act applies, labelling and traceability including an EU responsible person, chemicals restrictions, producer-responsibility registrations for packaging, batteries and electrical equipment per country, and — where an EU dealer or distributor imports — that importer's own duties.

- The GPSR covers every consumer product, and sector acts such as LVD, EMC, RED, TSD, MDR and PPE add their own requirements and CE marking.
- Manufacturers draw up technical documentation before placing a product on the market and keep it for 10 years; importers keep a copy.
- Instructions and safety information must be in the language determined by each Member State where the product is made available.
- Producer responsibility for packaging, batteries and electrical equipment is organised per country.

## The seven layers

Work through them in order; each layer produces the evidence the next one needs.

### 1. The rules that apply

The GPSR applies to every consumer product placed or made available on the EU market, whoever sells it. Products covered by sector acts follow those acts for the risks they cover and the GPSR for the rest. Which acts apply depends on the product's category, materials, function and use — typically several at once.

Regulations: GPSR, LVD, EMC, RED, TSD, MDR, PPE, IVDR, ATEX

- [Free compliance checker](https://www.conphora.com/compliance-check/)
- [All regulations](https://www.conphora.com/regulations/)

### 2. The technical file and the declaration of conformity

Before a product is placed on the market the manufacturer carries out a risk analysis and draws up technical documentation, keeps it up to date and holds it for 10 years; importers check that this was done and keep a copy for the same period. Under a CE act the manufacturer also signs the EU declaration of conformity and thereby assumes responsibility for the product's compliance.

Regulations: GPSR

- [Glossary: technical file](https://www.conphora.com/research/glossary/technical-file/)
- [Glossary: declaration of conformity](https://www.conphora.com/research/glossary/declaration-of-conformity/)

### 3. CE marking where a CE act applies

CE marking is the manufacturer's statement that the product conforms to all applicable EU harmonisation legislation that provides for it; only the manufacturer or its authorised representative may affix it. Toys, electrical equipment, radio equipment, PPE, medical devices, pressure equipment and more are CE acts. Products outside every CE act carry no CE marking and are governed by the GPSR.

Regulations: LVD, EMC, RED, TSD, PPE, MDR, PED, RoHS

- [Glossary: CE marking](https://www.conphora.com/research/glossary/ce-marking/)

### 4. Labelling, traceability and the responsible person

The product must carry a type, batch or serial number, the manufacturer's name and postal and electronic address, and the importer's details where there is one; where the product cannot carry them, they go on the packaging or an accompanying document. Instructions and safety information follow in the language determined by each Member State. The EU responsible person's name and contact details go on the product, its packaging, the parcel or an accompanying document, and on every online listing when the manufacturer is outside the EU.

Regulations: GPSR, TexR

- [The EU responsible person](https://www.conphora.com/sell-in-europe/eu-responsible-person/)

### 5. Chemicals and substances

RoHS restricts ten substances in electrical and electronic equipment and is proven with CE marking; the POPs Regulation bans or restricts persistent organic pollutants in products; REACH restricts substances in articles and gives duties on substances of very high concern. Test reports are the evidence — a supplier's assurance is not.

Regulations: RoHS, POPs

- [Knowledge: the REACH regulation](https://www.conphora.com/knowledge/reach-regulation/)
- [Glossary: REACH](https://www.conphora.com/research/glossary/reach/)

### 6. Environment and producer responsibility

Extended producer responsibility makes the producer pay for the waste stage of its products through national schemes for packaging, batteries and electrical equipment. WEEE requires registration in each Member State where you sell; the Batteries Regulation's producer-responsibility chapter has applied since 18 August 2025; the PPWR applies from 12 August 2026. Representatives for these registrations are appointed under those acts, separately from the product-safety mandate.

Regulations: WEEE, BattR, PPWR

- [Glossary: extended producer responsibility](https://www.conphora.com/research/glossary/extended-producer-responsibility/)

### 7. The importer's duties when an EU company imports

When a dealer, distributor or customer in the EU places your product on the market, it becomes the importer: it may only do so after verifying that you have met your obligations, it must put its own name and address on the product, keep a copy of the technical documentation and cooperate with the authorities. Expect a questionnaire before the first order — and expect to be refused without a complete file.

Regulations: GPSR

- [Glossary: importer](https://www.conphora.com/research/glossary/importer/)
- [Distributors and importers](https://www.conphora.com/sell-in-europe/route-to-market/#distributors)

## Customs and tax: pointers, not guidance

Product compliance is one gate; the border is another. These are the official starting points — Conphora does not provide customs, VAT or EORI services.

### EORI number and import procedures

Every importer into the EU needs an EORI number; Access2Markets shows the procedures, documents and duties per product and country.

### Tariff classification

TARIC is the EU's integrated customs tariff — the code decides duties and border measures.

### VAT on distance sales (IOSS/OSS)

Sales to EU consumers from outside the EU use the Import One-Stop Shop or the One-Stop Shop; the official EU pages are linked from Access2Markets.

### Incoterms with your importer

Agree who is the importer of record and who carries duties and risk before the first shipment; it decides who the responsible person is.

- [Next: the EU responsible person](https://www.conphora.com/sell-in-europe/eu-responsible-person/)
## How Conphora helps

### Free to read

Regulation pages, the glossary, this guide and the free compliance checker. No account.

[Open](https://www.conphora.com/regulations/)

### Free account

The Academy track, downloads and Radar follow. Never a card.

Create a free account

### Subscription

The compliance engine, every tool and 20 products included.

[See plans and pricing](https://www.conphora.com/pricing/)

### Managed

We run the whole route for you, with a named contact.

[Talk to us about Managed](https://www.conphora.com/sell-in-europe/managed/)

_Reviewed 2026-09-10 by Conphora compliance team_
