What is CE Marking?
A definitive guide to CE marking in Europe. Discover what a CE marking is, what products require a CE mark, and why a CE mark is required on the EU market.
Many products are not specifically regulated by a dedicated regulation or directive. In such cases, the General Product Safety Directive (GPSD) and future Regulation apply.
Examples of products falling under the GPSD include low-voltage products falling below 50V, candles, hair and beauty accessories, brushes and mirrors, jewellery, household as well as general consumer goods.
EU Legislation on General Products
Until the publication of the General Product Safety Directive 2001/95/EC on December 3, 2001 and the subsequent 3-year transition period, the General Product Safety Directive 92/59/CEE was the reigning legal framework for general product safety products.
On January 15, 2004, the General Product Safety Directive became fully applicable in the EU as the only legal framework for general consumer products. Any product made available on the EU market (either via e-commerce or in physical stores) must comply with the essential safety requirements set out by this Directive.
Some key information on GPSD products:
- Non-EU manufacturers wishing to place their products on the EU market should appoint a professional Authorised Representative.
- CE Marking is not applicable for products falling under the GPSD – improper application of the CE Marking will serve as a red flag for the Competent Authorities in the process of their surveillance activities.
- Intervention of a Notified Body is not required for any conformity assessment procedures described in this Directive.
Products which fail to comply with the essential general safety requirements may be subject to fines, publication on Safety Gate, recall of the products off the EU market and total destruction of the products.
Finally, each EU Member State may pose additional national requirements for the compliance of certain GPSD products.
Objective of the Directive is to ensure that products placed on the European market are safe. Accordingly, the GPSD aims at protecting consumers from unsafe products.
The safety essential requirements must be ensured for products to be lawfully placed in the European Economic Area.
Article 2 of the GPSD defines a safe product as “any product which, under normal or reasonably foreseeable conditions of use [..], does not present any risk or only the minimum risks compatible with the product’s use, considered to be acceptable and consistent with a high level of protection for the safety and health of persons [..]. A safety evaluation must be performed concerning the relevant product and the below must be taken into account:
- “The characteristics of the product, including its composition, packaging, instructions for assembly and, where applicable, for installation and maintenance,
- The effect on other products,
- The presentation of the product, the labelling, any warnings and instructions for its use and disposal and any other indication or information regarding the product,
- The categories of consumers at risk when using the product, in particular children and the elderly.” (Art. 2 par.B).
Under certain conditions, if a product is deemed to be unsafe, the European Commission can ban the marketing of it, recall it from customers and withdraw it from the market.
EU Member State enforce the GPSD requirements and are entitled to request all necessary information to the involved parties and take samples and perform safety checks of any product on the EU market.
The directive provides an alert system, the Safety Gate system, which ensures the exchange of information about risk assessments, dangerous products and scientific development amongst other aspects necessary for control of safety of products.
The General Product Safety Directive is a “horizontal” directive applying to all those products addressed to general consumers which do not have more specific EU legislation setting out safety requirements.
Manufacturers need to determine the applicable standards for the product, at European, international, and national level, and then identify the appropriate conformity assessment module according to the product characteristics. The technical documentation to be compiled per product type should include the following:
- Safety Evaluation and Risk Assessment Report,
- Complete (exhaustive) list of standards your product is currently complying with (EN, international or nationals),
- Declaration of Conformity of the product,
- Quality Management System in place or ISO Certificate,
- Instructions of Use including any relevant warning concerning the correct use of the product and explanation of any possible risks your product expose the end user to,
- Labeling: labels should clearly mention both manufacturer’s name and complete details (address, tel., fax, email address) and the European Authorised Representative complete details (name, address, email address),
- Vigilance and traceability activities such as tracking any complaints reported by the users.
Non-compliant products enter the EU Market everyday – whether manufacturer knowingly does so or due to a lack of control from the EU importer/distributor on the compliance requirements of products.
Each Competent Authorities of Member State focus on conducting systematic surveillance of products which are being made available on the market. This can include pulling products off of shelves, stopping products at customs or even deploying bots online to identify non-EU based e-commerce shops which mention that they ship to the EU Market. In the case that a product is found to be non-complaint, the main consequences include, but are not limited to:
- Being publicly reported to Safety Gate
- Warehousing Fees
- Requested Withdrawal
- Mandated Withdrawal
- Product Recall (from end-users and/or the market)
- Complete ban on marketing of the product
- Destruction of the product
- Fines
- Revocation of the CE Marking
The professionalism and expertise of the appointed Authorised Representative in dealing with various Competent Authorities and handling post-market surveillance cases play a vital role in the successful recovery of your brand in the EU Market.
The manufacturer is responsible to continue to collect information related to use of their products after they have been made available to consumers as well as to ensure that they continue to be compliant as the legislation applicable to their products evolves. Post-Marketing surveillance activities include, but are not limited to:
- Staying up-to-date on new requirements or legislative changes
- Continual updating of the technical file as modifications are made to the product
- Reporting of any incidents related to the product use
- Removal of non-compliant batches from EU economics operators and end-user
- Keeping technical file available for 10 years after the last batch entered the EU market
Working with a professional Authorised Representative will help to ensure that the necessary actions are taken to ensure continued compliance and proper post-market surveillance.
Explore our Authorised Representative services for low-voltage products. Contact us for inquiries.