Product safety checklist for manufacturers

What does a manufacturer do?

A manufacturer is responsible for designing and making a product, or having a product made. The manufacturer sells the product directly to consumers or trades the product, often through an importer or distributor.

Use the decision tree to determine your role per product

You are also considered a manufacturer by law when you sell a product under your name or trademark. Do you change an existing product? Then by law, you are seen as a manufacturer for the part that has changed. Or for the whole product if the change affects the safety of the product.

1. Check if your product is already banned in the EU

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

2. Design and manufacture your product according to safety requirements

You should design, manufacture, and test your product according to the standards and guidelines that apply to your product. For instance, the guidelines for toys, cosmetics, or electrical appliances. Different safety rules apply to each product category (in Dutch).

If your product consists of different parts, the product may fall under more than 1 category. For example, a toy that has a battery comes under both the requirements for toys and the requirements for electrical appliances.

3. Create a technical file

You must keep a technical file that contains all important information about the product. Make sure the dossier is up to date. And keep it for 10 years after the product has been made available on the market. The technical dossier contains information on, for example:

• use of the product
• the design
• markings, labels, and user information
• risk assessments
• checks carried out and test reports

You must show this file to the supervising authorities during an inspection or check. You may decide on the form of the technical file. You can also make your technical file available online.

4. Put important information on the product, packaging or in a document

Your products should be traceable if there is something wrong with them. Therefore, you should provide important information to consumers and supervising authorities. Put this information on the product, its packaging or in an enclosed document:

• your name, trade name, address and contact details on the product
• clear instructions, safety information and warnings
• a type, batch or serial number, or other means of identification

The information should be easy to understand and in a language that consumers understand.

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. In it, you also put products you have recalled. And what other measures you took.

6. Set up a compliance system

You should summarise 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 what role and obligations. Do you only have one or a few products? Then you can comply with this more easily than if you have an extensive range.
• Who you buy products from and what the conditions are for this. 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 consulting firm.

7. CE marking and EU declaration of conformity

You must affix CE marking to certain products. This is how you declare that your product has been checked and meets the product safety requirements. See an overview of product groups which must have a CE marking (in Dutch) at the Netherlands Enterprise Agency (RVO). Is CE marking mandatory? Then see how to apply CE marking with the step-by-step guide CE marking (in Dutch).

As a manufacturer, you must also draw up and sign an EU declaration of conformity. With this document you declare that your product meets EU requirements and that you are responsible for it. You must translate the EU declaration of conformity into the (required) language(s) in the EU country where your product is sold. For the Netherlands, this is in Dutch.

After this step, you can bring the product to the market.

8. Monitor the safety of your product through a quality system

Make sure that all products you make continue to meet the requirements in the technical file. To do so, set up a quality system. In it, you record moments in the business process when you monitor the quality and safety of the products. For example, the fixed moments when you take random samples. And check whether the product is still safe (conformity). This allows you to recall unsafe products if necessary.

You can hire a consultant to help you implement a quality system.

9. Keep track of changes for product requirements

Every product must comply with product legislation at the time you put it on the market. To put on the market means: making a product available on the EU market for the first time. So, make sure you can prove at what point you market which product. You show this by using a traceability system.

Are you bringing a new batch, or series onto the market? Then you must check (or have it checked) whether legislation and product standards have changed. If so, your product must comply with these new laws and standards.

10. Take immediate action in case of an unsafe product

Do you discover that a product is unsafe? Then take these measures immediately:

• Make a report via the EU platform Safety Gate. This way, you provide information to supervising authorities about the risks, the number of products concerned and the measures you have taken.
• Inform consumers and other market participants, such as distributors and online marketplace providers. Explain the situation and the risk.
• Recall the unsafe products.
• Adjust the unsafe products.