Regulatory and compliance · EU market entry

Which EU representative does your product need?

Almost every EU rule for products, data and imports names a company that must be established in the EU. The names differ: responsible person, authorised representative, only representative, importer, operator, declarant, fiscal representative. This page lists them all, with the date the rule applies and whether your own Dutch company can take the role.

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In short

A company outside the EU that sells products, software or services in Europe needs, for almost every product type, a named company established in the EU that is responsible for it. The role can be a service provider, a distributor or your own European subsidiary. The table on this page shows for each rule which role is required, since when, and what the role does. Holdwise sets up the Dutch company that can hold most of these roles at the same time, and coordinates the specialist partners that do the licence and product work.

Read the table first. Then read the sector page for your product: each row links to it.

13 Dec 2024

every non-food consumer product needs an EU responsible person (GPSR)

1 Jan 2026

importing more than 50 tonnes of steel, aluminium, cement, fertilisers or hydrogen needs an authorised CBAM declarant in the EU

2 Dec 2027

high-risk AI systems need an authorised representative in the EU

The table: one EU role per rule

Product or activity	EU role required	The rule and the date	Own Dutch company?
Any non-food consumer product: toys, electronics, textiles, furniture, sports goods, household goods	Responsible person in the EU: the manufacturer, the importer, an authorised representative or a fulfilment service provider. Name and address on the product or packaging.	General Product Safety Regulation (GPSR), since 13 December 2024. For CE-marked products the same duty exists since 16 July 2021 under the market surveillance regulation.	Yes, as importer or authorised representative. Consumer products page
Machinery, electrical equipment, radio equipment, connected products	Importer or authorised representative established in the EU behind the CE marking; for connected products the manufacturer reports vulnerabilities and the importer checks compliance.	Market surveillance regulation since 16 July 2021; Machinery Regulation from 20 January 2027; Cyber Resilience Act reporting since 11 September 2026, full application 11 December 2027.	Yes. Machinery and electronics page
Cosmetics: skincare, haircare, make-up, perfume	Responsible person in the EU: by default the importer, or another EU company with a written mandate. Keeps the product file, notifies in the CPNP, named on the label.	Cosmetics Regulation (EC) 1223/2009, in force since 2013.	Yes. Cosmetics page
Medical devices and in vitro diagnostics	Authorised representative in the EU, plus an importer in the EU. Both registered in EUDAMED with a single registration number.	MDR and IVDR; EUDAMED registration mandatory since 28 May 2026.	Yes, both roles in one company with a person responsible for regulatory compliance. Medical devices page
Medicines	Marketing authorisation holder in the EU or EEA, a qualified person for pharmacovigilance living in the EU or EEA, an importer with a manufacturing and importation authorisation and a qualified person for batch release, and a licensed wholesaler.	Directive 2001/83/EC and Regulation (EC) 726/2004.	Yes for the holder, the importer and the wholesaler; the qualified persons are employed or contracted. Pharmaceuticals page
Clinical trials with medicines or devices	Legal representative in the EU for a sponsor established outside the EU.	Clinical Trials Regulation (EU) 536/2014, all trials under it since January 2025; MDR for device studies.	Yes. Clinical trials page
Chemicals: substances, mixtures, articles that release a substance	Only representative in the EU for a manufacturer outside the EU, or a registration by each EU importer. Also: poison centre notification by the EU importer.	REACH (EC) 1907/2006 at one tonne a year or more; CLP (EC) 1272/2008 at any volume for hazardous products.	Yes, with a person who knows the practical handling of substances. Chemicals page
Artificial intelligence: general-purpose models and high-risk systems	Authorised representative in the EU for a provider established outside the EU.	AI Act (EU) 2024/1689 as amended in July 2026: models since 2 August 2025; high-risk systems from 2 December 2027; embedded high-risk AI from 2 August 2028.	Yes. AI Act page
Personal data of people in the EU, processed by a company outside the EU	Representative in the EU, in a country where the data subjects are.	GDPR, Article 27, since 25 May 2018. Exception for occasional, low-risk processing.	Yes, often the same company as the AI Act representative.
Food, drinks and food supplements	Food business operator in the EU on the label: the company under whose name the food is sold, or the EU importer.	Regulation (EU) 1169/2011 on food information; general food law (EC) 178/2002.	Yes. Food and supplements page
Packaging around any product you sell	The company that first places the packaged product on the market in a country registers for producer responsibility there; a company from another country appoints an authorised representative for it in that country.	Packaging and Packaging Waste Regulation (PPWR), applies since 12 August 2026; Dutch packaging scheme (Verpact).	Yes for the Netherlands; for other countries the Dutch company appoints a representative there. PPWR page
Batteries, electrical and electronic equipment	Producer registered for extended producer responsibility in each country of sale; a company from another country appoints an authorised representative in that country.	Battery Regulation (EU) 2023/1542; WEEE Directive 2012/19/EU.	Yes for the Netherlands; per other country a representative.
Cocoa, coffee, soy, palm oil, rubber, cattle, wood and products made from them	Operator: the first company established in the EU that places the product on the EU market files the due diligence statement.	EU Deforestation Regulation (EUDR) 2023/1115; applies from 30 December 2026 for large and medium companies, 30 June 2027 for small ones.	Yes. EUDR page
Steel, iron, aluminium, cement, fertilisers, hydrogen, electricity	Authorised CBAM declarant, established in the EU, for imports above 50 tonnes a year.	CBAM Regulation (EU) 2023/956 as amended by (EU) 2025/2083; definitive period since 1 January 2026; first declaration and certificates by 30 September 2027.	Yes. CBAM page
Any import: the customs declaration	Importer of record established in the EU, or an indirect customs representative established in the EU that declares in its own name. Every declarant needs an EU customs number (EORI).	Union Customs Code (EU) 952/2013.	Yes: the Dutch company is the importer of record with its own EORI number. Import and distribution page
VAT on imports and sales in the EU	A VAT registration; a company outside the EU often needs a fiscal representative for it, and always for the Dutch import VAT deferment licence (Article 23).	VAT Directive 2006/112/EC and the Dutch VAT Act.	Yes: an own Dutch company registers for VAT in its own name and applies for Article 23 itself. Fiscal representation
Payments, e-money, crypto-asset services	A licensed EU entity with its head office in the EU country of the licence.	PSD2, the e-money directive and MiCA (EU) 2023/1114.	Yes, as the licensed entity, supervised by DNB and the AFM. Payments page and MiCA page

The table shows the rules as they apply in September 2026. Roles marked as authorised representative or responsible person can be taken by a service company; the last column says whether your own Dutch subsidiary can take the role instead.

Service company or your own company: the pattern

The pattern is the same in every sector. A service company works for a first test of the market: a fee per product or per year, the service company’s name on the label, their address in the registrations. When sales are real, the roles move into your own European subsidiary: your name on the label, the files and the registrations in your group, the contracts with distributors, marketplaces and customers signed by a company you own, stock in Europe, and import VAT deferred through the Dutch licence.

One Dutch company can hold most of the roles in the table at the same time: responsible person for consumer goods and cosmetics, authorised representative for devices and AI, only representative for chemicals, food business operator, importer of record, VAT registration, CBAM declarant and EUDR operator. The specialist knowledge each role asks for, such as a person responsible for regulatory compliance or a REACH specialist, is employed or contracted. Holdwise sets up and runs the company; the partners do the product and licence work; you keep one contact.

What the Dutch company looks like

A Dutch private limited company, the BV, is set up by power of attorney: the parent company is the shareholder, the notary checks the identity of the directors by video call, and nobody travels. The company gets its KVK number, tax number, VAT number and EORI customs number. It has a registered office, its own bank account and its own books in the Netherlands, which is what banks, authorities and the tax treaties expect.

The company pays 19% corporate tax on the first €200,000 of profit and 25.8% above that. Dividends to a parent company in a treaty country usually go out without Dutch dividend tax. With the Article 23 licence, import VAT is reported in the VAT return and nothing is paid at the border. Read setting up a subsidiary in Europe for the full picture, and the document check for the papers your country needs to provide.

Based on the regulations named in the table, as applied in September 2026. Dates come from the Official Journal of the European Union; sector details from the pages linked in the table.

Who does what

Holdwise sets up and runs the Dutch company and stays your single point of contact. Specialist partners do the licence and product work. You keep one contact, one file and one invoice.

You

Your company

Own the product, the documentation and the intellectual property
Decide the countries, the channels and the price
Provide the technical files, certificates and label artwork
Sign the power of attorney and the mandates

Holdwise

The Dutch base

Sets up the Dutch company (a BV), by power of attorney, with the notary
Registered office, KVK number, tax number, VAT number, EORI number
Bank account, the Article 23 licence, bookkeeping and VAT returns
Annual accounts, corporate tax, payroll where you employ staff
Single point of contact for every specialist partner

Specialist partner, via Holdwise

Licences and product rules

Regulatory affairs per sector: cosmetics, devices, medicines, chemicals, AI, food
Notifications and registrations: CPNP, EUDAMED, ECHA, poison centres, EU databases
Producer responsibility registrations for packaging, batteries and electronics
Customs clearance, CBAM declarations, EUDR due diligence statements
Warehousing and fulfilment for the EU from the Netherlands

The route, step by step

What happens from your first question to the day your first product is on the European market.

One question. You tell us what you sell, where it is made and which countries you want. We answer in writing with the roles your product needs, the structure that fits and one written proposal.
The Dutch company. The notary sets up the BV by power of attorney with the parent as shareholder. You receive the KVK number, the tax number, the VAT number and the customs number. The bank file starts on day one.
The roles. The Dutch company takes the roles from the table that your product needs. The specialist partner drafts the mandates and the registrations.
The label. The Dutch name and address go on the product, the packaging or the documentation, as each rule requires.
The registrations. Product notifications, producer responsibility schemes, customs and VAT, all in the name of your own company.
Operations. Stock in the Netherlands, sales across the EU from your own company, bookkeeping and VAT done. One monthly overview, one point of contact.

Related guides

The other parts of the route to Europe, on the same site.

Entering the EU market: the hub

Setting up a subsidiary in Europe

EU responsible person or your own entity: the choice

The documents your country needs to provide

Corporate services: address, bookkeeping, VAT and payroll

Fiscal representation and the Article 23 licence

Common questions

What is the difference between a responsible person and an authorised representative? +

Both are companies established in the EU that are responsible for a product from outside the EU. The name depends on the law: the cosmetics regulation and the product safety regulation say responsible person, the medical device rules and the AI Act say authorised representative, REACH says only representative. The duties are similar: hold the documentation, be named, answer the authorities, and in some cases share the liability.

Can one company be the representative for several product types? +

Yes. One Dutch company can be the responsible person for your consumer goods, the authorised representative for your devices, the only representative for your chemicals and the food business operator for your supplements. Each role needs its own mandate and, where the law asks for it, a person with the right qualification.

Do I need the representative if I sell only through Amazon? +

Yes. Amazon checks that a responsible person exists for consumer goods and cosmetics and shows it to buyers. The marketplace can be the fulfilment service provider under the product safety rules, but the responsible person is a separate role that you appoint.

Is a distributor in Germany enough? +

A distributor that imports your product becomes the importer under most of these rules and takes the responsibility with it. That works until the distributor changes, and it puts your registrations, your label and your market knowledge in someone else’s company. Brands with real sales keep the roles in their own subsidiary and let distributors distribute.

Can a company outside the EU be the importer of record for customs? +

Under the Union Customs Code the declarant must be established in the EU, apart from a few exceptions such as transit. A company outside the EU imports through an indirect customs representative in the EU, or through its own EU company with an EORI number.

Does Holdwise take these roles itself? +

Holdwise sets up and runs the Dutch company that takes the roles, and coordinates the specialist partners that do the product and licence work. The roles are held by your own company. You keep one contact: us.

Ask about your own situation

Tell us what you make or sell, where your company is and which countries you want to sell in. You get a written answer. Where a Dutch company fits, we write down what it would look like and what it costs.

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