State of the Union: Five key takeaways from Ursula Von der Leyen
17 September 2020
Key points from von der Leyen's state of the union speech [caption id="attachment_14822" align="alignnone" width="640"]...
Whether it is displayed on everyday items such as mobile phones, gas appliances and toys, or on medical and other specialised equipment, the "CE" marking is widely known throughout Europe.
In use since 1993, the marking is a key indicator of a product's compliance with EU legislation and enables the free movement of products that comply with legislation. By affixing the CE marking on a product, a manufacturer declares , on his own responsibility, conformity with all of the legal requirements to achieve CE marking. The marking applies to a wide range of products sold within the European Economic Area (EEA), meaning the 27 EU Member States, Iceland, Liechtenstein and Norway.
What the CE marking does is provide an indication that products carrying the marking comply with legislation applicable to them. It also helps manufacturers, distributors and importers to do business on a level playing field. It does not mean that a product was made in the EU or necessarily has been tested by a government agency. And it does not apply to all products sold within the EEA.
The system works this way: before a product can be sold within the EEA, the manufacturer must find out whether it is covered by any EU legislation providing for CE marking. The manufacturer must conduct checks according to the provisions of the relevant legislation to ensure the product complies with the legislative requirements. For example, children's toys are tested for cancer-causing chemicals, while machinery is tested to ensure operators are not physically imperilled. Following a successful check, the manufacturer affixes the CE marking on the product. Products not covered by legislation providing for CE marking may not carry the marking but still have to be checked according to the provisions of the legislation applying to them.
For products with a lower impact on health and safety and with a simple design, the manufacturer does the checking himself. However, if the product carries a higher level of potential risk – such as medical devices and gas-burning appliances – independent checking must be done by an authorised third party. In each case, the manufacturer conducts risk assessments and drafts technical documentation for the product.
Products from third countries that fall within the scope of legislation providing for CE marking and which will be sold within the EEA must also bear the CE marking. While manufacturers are responsible for ensuring product compliance and affixing the CE marking, importers and distributors also play an important role in making sure that only products which comply with the legislation and bear the CE marking are placed on the market. Not only does this help to reinforce the EU's health and safety protection requirements, it also supports fair competition with all players being held accountable to the same rules.
When goods are produced in third countries and the manufacturer is not represented in the EEA, importers must make sure that the products they place on the market comply with the applicable requirements and do not present a risk to the European public. The importer has to verify that the manufacturer outside the EU has taken the necessary steps and that the documentation is available upon request.
Further along the supply chain, distributors play an important role in ensuring that only compliant products are on the market. The distributor must also have a basic knowledge of the legal requirements – including which products must bear the CE marking and the accompanying documentation – and should be able to identify products that are clearly not in compliance.
Given the significance of CE marking, it is important that the system is backed up by credible and consistent enforcement. Therefore, EU member states have their own "market surveillance authorities" that can check and test manufacturers', distributors' and importers' products. If a product fails to comply with EU legislation or in case of misuse of CE marking, measures are taken. These may include recalling and destroying of a product. Responsible parties can be fined and, in grievous cases, imprisoned. In minor cases, violators can be given a second chance to comply with EU legislation.
Taken together, the CE marking system provides all stakeholders with means to promote the marketing of safe products within the European market.
For more information about CE marking, the products falling into the scope of legislation providing for CE marking, guidance for consumers and instructions for manufacturers, importers and distributors, please refer to the European Commission's Directorate-General for Enterprise and Industry's CE marking website, at: http://ec.europa.eu/cemarking.
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