CE

 

CE Registration / Certification

• CE is “Communaute Europeenne” in French and means “European Community.”
• CE is a unified product certification recognized by the EU and EFTA countries.
• CE registered or certified means that the manufacturers of the products has evaluated its conformity in accordance with the essential
  requirements of the EU Council Regulations or Directives and meets the essential requirements for the safety and the health of consumers.
• The products with CE Mark, Declaration of Conformity (DOC) or Certificate of Conformity (COC) can only be sold in the European Market.
• Products that are subject to CE Registration or Certification are Safety, Health, and Environment related products and include all products such as children’s toys, electronics, construction equipment, medical devices, cosmetics, agricultural products, etc.

Advantages of CE Registration / Certification

1. Safely export your products to Europe.

1. CE Registration / Certification can prevent potential problems in the Customs in Europe, such as product classification errors, labelling
   problems, and delays in customs clearance.

2. Effectively cope with EU regulations.

1. The European Commission has been tightening its regulations in order to protect the health of European consumers, and you can
   respond quickly to new regulatory measures in the EU.

3. Quickly increase market shares by improving consumer awareness.

1. Since the CE mark is enforced by the EU Commission, all export products to EU must be attached and can be participated in public procurement bidding of each country. In addition, price competitiveness can be secured by improving consumer recognition in the Middle East or Asia.

Categories of CE Registration / Certification

CE Registration or Certification means that the manufacturers check the Directives/Regulations of EU and are granted the CE Mark, DOC or COC.

• • 1. CE Mark
    • The CE Mark is a the typical CE registration, and means that the manufacturers have issued Declaration of Constitution (DOC) in
      accordance with the Directives/Regulations of EU or have been granted Certificate of Conformity (COC) issued by the Notified Body (NB) appointed by EU Council.
    • The CE Mark is a Certification Mark to ensure the safety of products in the European market, and the CE Mark must be attached to products related to the Health, Safety, and Environment of consumers in the EU.
    • CE Mark ensures that all products, from children’s toys to construction equipment, meet the EU safety standards.
  • 2. DOC (Declaration of Conformity) Also known as a self-conformity declaration, it declares that the manufacturer has made a conformity assessment in accordance with the essential requirements of the Regulations or Directives of the EU.
  • 3. COC (Certificate of Conformity) It refers to the Certificate of Notified Body as official evaluation agencies appointed by the CE and is called CE Certification or CE Approval depending on the contents in COC.

Verification of NB
https://webgate.ec.europa.eu/single-market-compliance-space/#/notified-bodies/by-legislation

CE Conformity Assessment in Modules

1. The CE Conformity Assessment procedure is basing on “Procedures for assessing the Conformity” in the CE Directives and Regulations and
   performs CE Mark or Certification with the required modules.

1. The “CE Conformity Assessment Procedure” consists of one module or a combination of various modules, such as Module A and Module B, depending on product characteristics and CE Directives/Regulations, and the modules may be applied to product design stage, production stage, or both design / production stages.

CE MODULES

Module	Directives / Regulation	Stage
Module A Production Management	Manufacturer’s design and production safety management	Design Production Management Production
Module B Type Inspection	Submission and inspection of design data and samples to the NB	Design
Module C Type Suitability	NB approval of continuous production guarantee under Module B	Production
Module D Quality Guarantee	NB approval of production process, and quality test procedures under Module B	Production
Module E Product Guarantee	NB approval of final inspection and quality test procedures under Module B	Production
Module F Continuous Application	Type inspection and approval of NB for continuous application under Module B	Production
Module G Unit Inspection Guarantee	Full inspection and approval of NB for all unit products	Design Unit Inspection Guarantee Production
Module H Entire Process Guarantee	Design Unit Inspection Guarantee Production	Design Entire Process Guarantee Production

Procedure of CE Registration / Certification

The Procedure below is a typical Procedure, and additional procedures such as safety verification documents and NB tests are carried out for special ingredients or special safety evaluation products.

Technical Construction File ; TCF

The general contents of TCF is as follows, and additional materials are required in accordance with product characteristics and CE Directives/Regulations.

• 1. Product Info : Product Function Category (PFC), Name, Components
• 2. CE Directive / Regulation for Products
• 3. Intended Use
• 4. Manufacturing Process Drawing
• 5. Certificate of Analysis : Components 100%,
• 6. Raw Materials : CAS No., Component Material Category (CMC) 등
• 7. User Manual
• 8. Manufacturer’s info. : Name, Address, Origin, etc.
• 9. Label : Name, Components, Weight, Warning, etc.
• 10. Design : Electronic Devices, Medical Devices, etc.
• 11. Manufacturing Drawings & Components
• 12. Description of the Design Specifications
• 13. Safety Assessment Data of : issued by Official Labs.
• 14. Assessment of the Risk
• 15. Manufacturer’s Instruction and Information
• 16. Essential Health & Safety Requirements
• 17. Test Reports
• 18. QC Files
• 19. Certificates : ISO, etc. 20. CE Mark
• 21. DOC
• 22. NB Certificates : COC

Q & A

We want to export Cosmetics to Europe. Do we need to get CE Registration or Certification ?

1. General cosmetics such as skin lotion can be exported to Europe by registering CE and attaching CE Mark. However, sunscreens and other functional cosmetics must be certified by NB and obtained COC.

How do we get CE Certification for sunglasses and Goggles ?

1. According to Directive 2016/425 (Personal Protective Equipment Directive 89/686/EEC), Sunglasses and Goggles are considered as Personal Protective Equipments (PPE), meaning that “a tool or device designed to be worn or carried by an individual to protect a user from one or more risks that threaten health and safety”. Thus, CE certification must be carried out with (1) Application to NB (2) Grade Determination (3) DOC or COC issuance under the PPE Directive.

What is the Grade Standard for PPE (Personal Protective Equipment) ?

PPE is applied to CE Directive 2016/425 (PPE), the Personal Protective Equipment Directive (89/686/EEC), Personal Protective Equipment (PPE) is classified as follows.

1. • Category 1 : Minimum Protection / Simple Design Goggles, Sunglasses, Cleaning Gloves
   • Category 2 : Intermediate Protection Helmets, Welding Goggles, PU-coated Gloves, etc.
   • Category 3 : Maximum Protection / Complex Design Respirators, Harness, Slings, Oxygen Mask such as Equipment having a significant impact on the human body

Check Points for CE Registration / Certification

1. DOC or COC Certification on accurate product classification

1. EU Directives/Regulations should be checked according to the purpose of use, active ingredients, etc., and products should be accurately classified and proceed with the CE Conformity Evaluation Procedure by NB, the official certification body appointed by CE, for DOC or COC.

2. Compliance with labeling requirements

1. Labeling requirements must be accurately followed to review the risks of allergic induction and side effects and to demonstrate Safety Assessment.

3. Necessary measures, such as attaching a warning, etc.

1. If hazardous substances are detected or suspected, even if they are below the standard level, a warning of potential physical hazards must be affixed.

Inquiry of Registration / Certification of FDA / CE / KFDA

DaeHan Public Administrative Attorney’s Office has specialized in the Certification on KFDA/CE/FDA/, Foreign Invested Corporations (FIC)
including Branches and Liaison Offices, Immigration on Public Bond Investment and Real Estate Investment, and has provided Immigration &
Investment Solutions, Consulting on D8, D7 Visa, Tax and Marketing. We submit applications for licenses or permits on the behalf of clients.

Please contact us for the following issues. (1) Certification on KFDA/CE/ FDA (2) Establishment of FIC, Branches & Liaison Offices (3) Immigration on Public Bond Investment and Real Estate Investment (4) Visa Consulting on D8, D7, F5, F2, F1 (5) M&A & Technology Outsourcing (6) Stock Market Investment (8) Marketing & Tax Consulting.