Product safety checklist for importers

What does an importer do?

Under European law, you are considered an importer if you buy products from outside the EU and sell them on the European market. You must then comply with the legal obligations for importers.

Do you put your own logo or brand on the product? Or do you modify the product? If so, you are legally considered a manufacturer and must comply with the obligations for manufacturers. You can have more than one role at the same time.

Do you sell products via dropshipping? Then these rules also apply to you.

Use the decision tree to determine your role per product

1. Check if your product is already banned on EU platform Safety Gate

Check on the EU Safety Gate platform if there are known risks about the product you are going to import. Safety Gate lists products banned in the EU due to serious risks. It states the reason and which product law or standard has been violated. Don't make the same mistakes as other operators. Also check if Safety Gate lists banned products with the same properties as your product.

2. Check which safety rules apply to your product

You need to determine which safety rules apply to your product. These rules can be found in the EU directives for different product categories (in Dutch). Your product may fall under more than 1 product category. If so, you must comply with several EU directives. For example, if you import toys with a battery. Then your product must meet the safety obligations for toys, batteries, and electrical materials.

Hire a consultant

If you sell an unsafe product, there could be major consequences. For example, a supervising authority may require you to recall the product. And you may be held liable in case of damage caused by the product. Don't have specialist knowledge in this area? Are you a small or medium-sized entrepreneur? Then it is wise to hire a (commercial) consultancy firm. A consultant can help you comply with all obligations.

3. Check if the product is safe

Check if the product complies with the safety regulations. If you are not sure, you may not trade the product. For this step too, you can enlist the assistance of an adviser. There are many consultancies that specialise in this.

You or your adviser must check the following:

• has the manufacturer created a technical file (dossier)? And is this complete and up-to-date? Make sure you get a copy of the manufacturer's technical documentation.
• Is all the mandatory information on the product? Such as type, batch, or serial number and contact details. But also the CE marking if this is mandatory
• are instructions for (safe) use of the product in an understandable language included? Are they missing? If so, you must provide them before the product is sold.
• is the correct information on the label?
• Does the manufacturer comply with the rules for tracking the product?

Do you not have enough information to determine whether the product meets the obligations? Then you must request this information from the manufacturer.

4. Put your contact details on the product

Put your contact details on the packaging or in a document accompanying the product. Because you are importing products from outside the EU, you or the authorised representative, are the contact person for both the consumers and the supervising authorities.

It should be clear where the product came from and to whom you sold it (traceability). This allows you to trace a product faster and recall it if it is unsafe.

Do you resell products remotely (online) yourself? Because you need to ensure that the product is traceable, you also put these manufacturer's details on the product:

• the name, trade name or brand name
• the address and contact details
• the type, batch or serial number (or other means of identification)

5. Investigate and track complaints

You should investigate complaints about your product and handle them appropriately:

• Make sure consumers know how and where to report a complaint about your product. Or an accident or unsafe situation.
• Keep track of complaints and information about accidents or unsafe situations in a complaints register. You also record products that have been recalled there. And which measures have been taken.

6. Set up a compliance system

You should record the steps on this page in a process. In it, you keep track of how you ensure that you comply with product safety rules. This is called a compliance system. In it, you keep track of, for example:

• For which products you have which role and obligations. If you only have one or a few products, it is easier to comply than if you have an extensive product range.
• Who you buy products from and what the conditions are in that respect. Such as that the technical dossier is present.
• Where a product comes from and what logistical route it has taken. This is called tracing.
• What complaints you have received from customers (complaints registration). And how you handled a complaint.

The supervising authority may ask you to show your compliance system.

You can also use the NEN-ISO 37301 standard for compliance management for this purpose. Or you can hire a consultant.

7. Ensure safe transport and storage

You must ensure that you transport and store the imported products safely. For example, you must ensure that the products do not get too wet, dry, cold, or hot during storage or transport. This can make a safe product unsafe.

8. Keep the correct records

You must keep the documentation of your product in your records for a minimum of 10 years. Some products demand a longer retention period. For example, medical devices. If requested by a supervising authority, you must be able to share these documents:

• the technical file
• the declaration of conformity
• the details of all suppliers and other economic operators to whom you have supplied products

As an importer, you may also carry out administrative tasks on behalf of the manufacturer. The manufacturer must then appoint you as authorised representative.

9. Take immediate action if the product does not meet the obligations

Have you sold a product that does not comply with the obligations? Or do you think the product is unsafe? Then you may not sell it. And you must:

• file a report via the EU platform Safety Gate to provide information to supervising authorities about the risks
• inform consumers
• recall unsafe products
• provide supervising authorities with information on the manufacturer of the product
• request the technical file from the manufacturer if this is asked for by a supervising authority.