The CE marking is a mandatory conformity mark for many products sold and marketed in the European Union (EU). However, they exist products which are excluded from the obligation to affix the CE mark according to EU product guidelines. In this article, we will explore which products are not subject to CE marking, the product directives involved and the importance of preparing a technical file to demonstrate the conformity and safety of these products.
Products not subject to CE marking
The CE marking is a conformity mark that indicates that a product meets the essential safety, health and environmental protection requirements established by the EU product directives. Products subject to CE marking can include electronic devices, industrial machinery, toys, medical equipment, construction products and more.
However, some products are excluded from the obligation to affix the CE mark because they do not fall within the specific product directives that require marking. These products can still be sold in the EU, but other relevant regulations and requirements must be met.
European General Safety Directive
There Directive 2001/95/EC on general product safety sets out the general rules for the safety of products intended for consumers in the EU. This directive applies to all products intended for consumers, regardless of the CE marking requirement. The directive establishes that products must be safe and not present risks to the health and safety of consumers.
European Hazardous Substances Directive
There RoHS directive (Restriction of Hazardous Substances Directive) applies to all electrical and electronic products marketed in the European Union (EU). It was introduced to reduce the environmental impact caused by the presence of dangerous substances in these products and to promote the protection of public health and the environment.
The RoHS Directive restricts the use of certain hazardous substances, such as lead, mercury, cadmium, hexavalent chromium, polychlorinated bromines (PBBs) and polybrominated biphenyls (PBDEs), in electrical and electronic products.
Technical file and compliance report
Even if i products not subject to CE marking they don't require branding, it's still important demonstrate the compliance and safety of such products. To this end, it is good practice to prepare a technical file that documents all the information relating to the product, including the analyzes and safety assessments carried out.
The technical file should contain details on the design, production and use of the product, as well as testing and analysis of compliance with the relevant standards. Furthermore, for products subject to Directive 2001/95/EC, it is necessary to draw up a conformity report which certifies compliance with the safety requirements established by the directive.
Application of specific Directives
Also for products not subject to CE marking, some manufacturers voluntarily choose to apply specific directives to demonstrate compliance and acquire greater certification for your product. For example, a manufacturer of electronic devices could choose to follow the LVD (Low Voltage Safety) Directive even for products operating at very low voltage and for which it is not required. Other times we have been asked to apply the Machinery Directive to cover particular risks not mentioned in the LVD Directive, for example for the risks of electronic control units installed on motorways falling.
L'affixing of the CE mark, foreseen by the specific directives, represents a image advantage for the product, as it tells consumers that the product has passed certain safety and compliance standards.
Another interesting case are the equipment intended for the army and police. These are excluded from the product certification guidelines, however, as already discussed in a previous article, today certification is often required for compliance with workplace safety standards. The application of these exclusion rules today is believed to be done in a targeted manner only in strictly necessary cases.
While some products are not subject to CE marking, it is essential to ensure that all products sold in the EU are safe and comply with current regulations. Preparing a technical file and including the necessary compliance reports helps demonstrate that the product complies with safety and consumer protection requirements.
Although affixing the CE mark to products not subject to the obligation is a violation of the rules of the European market, many manufacturers still choose to adopt specific directives to improve the safety and quality of their products. Regulatory compliance and attention to safety are key to building consumer trust and ensuring success in the European market.
To request further information on this topic, write to firstname.lastname@example.org
or call +39 0481 778931.