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Product safety and CE marking

Product safety and CE marking

The page was last modified: 2018-11-14

All products you sell in the EU, Norway, Iceland and Liechtenstein (the EEA area) have to be safe- Many products are covered be specific rules, like requirements for CE marking.

If there are no specific rules for your product, the rules about general product safety are applicable if your product is sold to consumers. You are also covered by rules about product liability and liability to report dangerous products that you have sold on the market.

Products that have to be CE-marked

You may only sell products with a CE-marking if they are on the EU Commission’s list of products that have to be CE-marked. If your product is inaccurately marked you can not sell it. Through the CE-marking the manufacturer guarantees that certain requirements have been met. Toys and personal protective equipment are examples of products that have to be CE-marked. On the contrary, strollers and pacifiers are products that can not be CE-marked.

Read about products covered by CE-marking on the website of the European Commission

CE-marking and harmonised European standards

Harmonised European standards make it easier for you as a manufacturer to meet EU regulatory requirements concerning CE-marking. If you follow such standards when you manufacture your product, it is considered to meet EU technical requirements concerning CE-marking.

As a rule, using harmonised standards is voluntary. So you can choose other solutions. But you are always liable for all the statutory requirements being met.

To be allowed to put a CE-marking on your product there are several things you must do:

Find out whether your product must be assessed by what is called a notified body (swedac.se) (in Swedish).
If your product does not need to be assessed by a notified body, you have to perform your own controls that it meets the technical requirements and document any risks in using it.
Produce technical documentation proving that the product meets the technical requirements.
Write and sign a declaration that your product meets all the requirements set in the relevant EU rules; this is called a declaration of conformity. You have to state what these rules are. In certain cases you also have to state which standards you have used and which notified bodies have assessed the product.

Other compulsory marking requirements

In addition to CE marking there are also other compulsory marking requirements, such as

the energy label for white goods and TVs
the EU leaf for organic food products
the wheel mark for marine equipment
the explosion protection marking of equipment for potentially explosive atmospheres
the PI marking for transportable pressure equipment
the 3 marking for aerosol dispensers.

Products that must not be CE marked

If you do not have to CE-mark your product under EU rules, then you must not place a CE-marking on it. Products that must not bear CE marking have to meet national product requirements when these exist or the general requirements of the Product Safety Act. The Act applies to products and services sold to consumers.

To the Product Safety Act on the website of the Riksdag (Swedish Parliament) (in Swedish)

The liability of importers and distributors for CE marking and product safety

If you import products or distribute imported products in the EEA market, you are liable for the products meeting EU requirements concerning product safety and CE marking.

If you import a product that has to have a CE marking but that does not have one, you can only place a CE marking on the product if, as the importer, you are counted as the manufacturer. Otherwise it is only the manufacturer that can place a CE marking on a product.

On the website of the Swedish Consumer Agency you can read more about product safety and CE marking. You can also read about what liability you have as an importer or distributor.

Product liability and the control of product safety

As a business operator, you are obliged to report dangerous products that you have sold on the market to the responsible authorities.

Under the Product Liability Act you may, as a manufacturer, importer or distributor, be liable financially if a product causes an injury or damage if it is not as safe as it should be.

Certain authorities can carry out controls and prohibit products that do not meet the existing requirements. The Swedish Customs also cooperates with the control authorities to stop dangerous products at the border.

Product requirements when exporting to non-EEA countries

When you export to countries outside the EU, Norway, Iceland and Liechtenstein (the EEA area), you can assume that these countries want to protect their population from dangerous products with the aid of general product safety rules, special rules for certain product groups, various marking requirements, product liability and a surveillance system for products sold on their market.

Even if your product follows an international standard, there may be national regulations that deviate from it. You should contact public authorities in the country concerned. Business Sweden can also help you to find out what rules apply.

When you do business with certain countries, you can certify your product in Sweden against a standard in order to meet the regulatory requirements in these countries. This certification can then be approved in the other countries in accordance with international agreements.

There are different kinds of international agreements that apply to different countries.

Voluntary certification

You can also certify your products and services in relation to voluntary marking Examples include:

You will find the most common forms of environmental and sustainability labelling in the labelling guide of Hallå Konsument, the Swedish Consumer Agency’s information service.

Product safety and chemicals

It is your responsibility to know what your products contain, and to inform your customers about this in certain cases. If your product contains certain chemicals, you must also report this to the EU register of chemicals.

Responsible: Swedish Agency for Economic and Regional Growth