What is CE Marking?

 WHAT IS CE MARKING?

The European Union (EU) was formed in the year 1993 to establish a common internal market without trade restrictions to guarantee free movement of goods, personnel, services and capital. The EU presently comprises of 27 nations and it, along with Iceland, Liechtenstein and Norway form, what is called as the European Economic Area (EEA) also referred to as the Community Market. In order to enable free movement of goods, within the EEA, the CE Marking regulation was implemented wherein all goods manufactured inside the EEA as well as those imported to the EEA, must bear the CE Marking to demonstrate compliance with all relevant EU laws regarding health, safety and environment.

An interesting feature of the CE Marking is that it is “self-declaration” where-in the manufacturers themselves declare that their product complies with all relevant EU laws called Directives. This declaration called as “Declaration of Conformity(DoC)” is all that is required to demonstrate compliance. 

However, the manufacturer (or importer, if the manufacturer is non-European) remains fully responsible for the CE Marking and hence he/she has the obligation to ensure that the product bearing the CE Marking conforms to all the requirements of the relevant Directives.  

A wide range of items are eligible for CE Marking including household appliances, IT products, tools, industrial electrical equipment, toys, medical gadgets, personal protective equipment (PPE) etc.

WHY DO WE NEED CE MARKING?

Indian manufacturers require CE marking only to export their products to the European Economic Area (EEA). It is not compulsary for sale in India per se. However, such has been the impact of CE marking that even if they are not aiming for the European market, some Indian businesses may decide to voluntarily get CE marking for their products. Mainly, two factors may lead Indian businesses to choose CE marking:

1.  Access to the European Market:  Considering that the EEA is the world’s largest single trading block consisting of over 500 million consumers and that the CE marking permits lawful sale of products on the European market, tapping this market can give a big boost to product sales and can be highly profitable in the long run.

2.  Global Recognition and Credibility: The CE marking, which denotes adherence to European safety and quality standards, is widely recognized. Regardless of the exact target market, Indian businesses may improve the stature and reputation of their products by gaining CE marking.

Since it is the manufacturer who is ultimately responsible if he/she marks the product CE, understanding the laws, technical requirements, testing processes and certification criteria pertinent to their product category and target market is vital for an Indian firm thinking about exporting items to the EEA and acquiring CE marking.

Considering the legal nature of the CE marking, working with competent specialists and seasoned consultants who are familiar and competent with CE marking process and regulatory requirements is absolutely essential to smoothly navigate this regulatory landscape and to ensure that there are no legal complications when the product is ultimately placed in the European market.

HOW TO GET CE MARKING?

The following actions are typically taken in order to achieve CE marking:

1.  Decide Which Directives Are Relevant: Since a product may give rise to different hazards (like electrical, electro-magnetic, mechanical, environmental etc) more than one Directive may be applicable to a particular product. The first step is to accurately determine which specific EU Directive(s) are relevant to your product as skipping a Directive may lead to legal complications at a later stage or choosing an irrelevant Directive may lead to overcompliance and cost over-runs.

2. Notified Body (if applicable): A notified body (third party conformity assessment body) may be necessary ONLY in  specific circumstances involving higher-risk items (like medical devices). A notified body is a laboratory based inside the EU, that has received permission from the European government to do a 3rd party conformity assessment. Each directive dictates whether conformity assessment is to be done by a Notified Body or not. If only EMC, LVD and RoHS directives are applicable then services from Notified Bodies are NOT mandatory.

3.  Product Compliance Assessment and Conformity Verification:  Within the scope each applicable Directive, identify relevant European (EN) standard(s) and evaluate/test the product as per these standards.  Conformance to the tests prescribed by the EN standards generates objective evidence (i.e a test report) and this by far remains the most acceptable way to prove conformance to Directives Although, for simpler products, technical justification (without testing) may also be sufficient.

4.  Technical Documentation Compilation: Compile a detailed technical file that documents the entire conformity assessment process along with test/evaluation reports. The documentation also describes the features of your product’s design, construction, schematics, working, manufacture, performance, test reports etc. It also documents the compulsory risk assessment carried out for the product for all risks it poses.

5. Declaring conformity: Sign a Declaration of Conformity (DoC) -a statement through which the manufacturer declares the product’s compliance to the pertinent EU directives. Authorities or consumers should be able to access the DoC upon request.

6. CE Certificate (Attestation Certificate): Since CE is self-declaration through the DoC, the manufacturer may get the entire CE process attested by a competent specialist or a competent laboratory/certification body through the CE attestation certificate.

7.  Affixing the CE Mark: After you’ve taken all the necessary actions, put the CE marking on your product and, if necessary, its packaging and related paperwork. The directives provide guidelines regarding the nature, size and placement of the CE marking which need to be adhered to.

ADDITION REQUIREMENTS

A business must meet specific conditions in order to receive CE marking approval. For businesses looking to obtain CE marking approval, the following criteria are essential:

Risk Assessment: Carry out a comprehensive risk assessment and demonstrate how potential hazards and risks posed by the product have been identified, analysed, evaluated and mitigated. This is a new requirement in addition to test/evaluation report to demonstrate that potential hazards arising out of the product  have been minimized or eliminated. This risk assessment form a part of the technical documentation.

Provide a Clear Instruction Manual: Make a user-centric manual in the language understandable by the end-users adeptly defining product’s underlying objectives, imperative safety precautions, precise operating instructions, instructions for repair and maintenance. This ensures a safe and hazard free operation minimizing potential risks and avoids consequent legal hassles and damages.

Product Marking, Traceability and Identification: Product should be affixed with a name-plate to allow tracing the history of the product and to enable market surveillance authorities to find the liable economic operators. It facilitates surveillance authorities to trace unsafe or non-compliant products up the distribution chain. It should bear the name, trademark and address of the manufacturer. If the manufacturer is non-European, the address of the importer should also be mentioned.

Requirements for Imported Products: For products imported into the EU from outside, every link in the supply chain—importers, distributors, assemblers and employers wherever applicable—must be aware of their corresponding to roles and responsibilities.