The Key to Expanding into Europe! How to Choose a Reliable "European Manager" and What to Look Out for

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Introduction.

For companies looking to enter the European market, product compliance is an unavoidable issue.

In many cases, the appointment of an EU Responsible Person is mandatory, especially when exporting or selling cosmetics, sundries, daily necessities, and chemical products.

The European Responsible Person is not just a documented representative, but is a very important person who is responsible for legal liability and even practical market response.

In this article, we will show you how to choose a reliable partner, including the cases in which a European Responsible Person is needed, his/her specific role, points to keep in mind when appointing him/her, and some common mistakes.

What products require a locally responsible person?

The European Union (EU) has a variety of regulations and systems in place to ensure product safety and transparency. The appointment of a local responsible person is often legally required for the following product groups

  • Cosmetics (CPNP registration required)

  • Miscellaneous and aromatic products (UFI registration required)

  • Chemical products (REACH registration)

  • Foods and supplements (pre-registration and country of origin labeling)

  • Medical device (MDR compatible)

  • Electronic equipment (CE marking compliant)

In order to distribute these products on the EU market, they must be registered, applied for, and data managed through a locally responsible person in accordance with European Commission guidelines.

Who is the local manager?

The European Responsible Person is the legal representative who ensures the safety and regulatory compliance of the product in Europe. Specifically, the following requirements must be met

  • Legal entities or individuals located in the EU

  • Possess and be able to present technical documentation on the product

  • Able to respond quickly to requests from the authorities

  • In the event of trouble, also assumes the obligation to respond to consumers locally and appear in court.

  • Clearly state this information on the product label/packaging

  • EPR (Extended Producer Responsibility) based cost sharing if necessary.

For example, in the case of cosmetics, the company is required to maintain a PIF (product information file) and to respond to inquiries, report incidents, and even update registration data; the same applies to REACH and CLP regulations, which require that technical information and application records concerning product safety be maintained.

 

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Failures in the Selection of Local Responsible Persons

Many companies attempting to expand into Europe for the first time stumble in their initial selection of local managers.
The following are examples of common mistakes.

1. choosing a company with which you have no trust

We have seen cases where a local company is made a partner and put directly in charge simply because "they have a base in Europe." However, whether these companies really fulfill their responsibilities is another matter. The following problems frequently occur

  • Delayed or neglected document submission

  • Failure to respond to consumer inquiries

  • Failure to respond to a Commission inquiry results in penalties.

  • Unable to change registration information

2. communication errors in English

Sometimes, although you thought you were communicating with a local company in English, your intentions were not conveyed correctly, resulting in misunderstandings and response errors. In addition, there are many cases where communication is slow and the response is confusing because it differs from Japanese business practices.

3. "Hostage-taking" of registered information

In the worst case scenario, you find yourself in a situation where you want to "change the responsible party" but are stuck because the existing responsible party will not cooperate in deleting or transferring the registration. This is a problem that can also occur with PIFs, UFIs, and REACH registration transfers.


 

Selection Points for Local Responsible Persons

The following points will help you identify reliable local managers.

  • Select a corporation (not an individual)

  • Hire a third-party or neutral company

  • Choose a partner that does not enter into exclusive distribution agreements.

  • Clear separation of roles without requiring annual sales performance

Particular attention should be paid to the pattern of making the distributor (sales agent) the responsible party. When sales rights and responsibilities are integrated, the following problems are likely to occur.

  • Exclusive agreements are used as a shield to restrict trade.

  • Responsible party information is fixed even though it is not sold.

  • If we can't reach you, we'll be unable to respond.

Risks can be minimized by including "obligation to delete registration in the event of default" and "consent clauses for data transfer" in the responsible party's contract.

Why Swapsss?

As a European business support company headquartered in France, our company Swapsss offers services on behalf of European managers. We have been chosen by many companies for the following reasons

  • Officially registered in the EU as a legal entity

  • Available in Japanese, English and French

  • Comprehensive support utilizing BPO functions (CS, translation, registration)

  • Bridging to a trusted third party responsible party can also be handled.

  • Collaboration with public organizations (JETRO, local government projects, etc.)

We can also act as a temporary responsible person, and if a reliable European partner is found, we have a system in place to ensure a smooth handover of registration data.

summary

When developing business in the European market, the presence of a European representative is an important factor that determines the success or failure of the business. The person in charge in Europe is not merely an "address lender," but is required to handle many practical matters, such as responding to problems and immediately responding to changes in regulations.

Swapsss is committed to helping you expand your business into Europe by providing you with a reliable third-party local contact and contractual risk hedges.

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Support for Expansion into Europe

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