
I. Background:
Regulation (EC) No. 768/2008/EC of the European Parliament and of the Council of July 9, 2008 establishes requirements for certification and market surveillance in connection with the marketing of products. According to the Regulation, the EU Declaration of Conformity, or "DoC" for short, should follow the exemplary structure set out in Annex III. Manufacturers shall include in the Declaration of Conformity the elements specified in the relevant modules of Annex II and update them on an ongoing basis. By publishing the EC Declaration of Conformity, the manufacturer assumes responsibility for the conformity of the product.
II. Policy:
Traders should be aware of and comply with the relevant regulatory requirements to ensure that the Declaration of Conformity complies with all applicable requirements in order to guarantee the conformity of their products on the European market and to protect human health and the environment.
TEMU reserves the right to take a series of measures against non-compliant products, including but not limited to actively responding to the requirements of the regulatory authorities, issuing risk alerts to buyers, removing the products from the shelves, and notifying buyers or other relevant parties to destroy/return the products.
III. Answers to DoC Frequently Asked Questions:
1. What is DoC?
DoC stands for EU Declaration of Conformity and is a formal document drawn up and signed by the manufacturer himself, stating that his product complies with all relevant product safety requirements before entering the European market.The DoC Declaration of Conformity document is mandatory. The DoC Declaration of Conformity document is mandatory and must be translated into the language or languages required by the country in which the product is to be sold.
2、What is the range of products for which DoC is applicable?
Applies to all harmonized legislation under the Framework Directive, including but not limited to toys, electronics, personal protective equipment, mechanical equipment, construction goods, gas equipment, recreational and private boats, pressure equipment, and measuring equipment.
- Toy: means a product suitable for use in play or specially designed for children under 14 years of age, subject to harmonized standards ref: https://ec.europa.eu/docsroom/documents/54139
- Construction Product: means any product or set of equipment produced and placed on the market for permanent installation in a building work or its component parts, the performance of which affects the performance of the building work, in order to satisfy the essential requirements of the building work. Reference to harmonized standards to be met: https://ec.europa.eu/docsroom/documents/56834
- Personal Protective Equipment (PPE): means equipment designed and manufactured to be worn or held by an individual for the purpose of protecting the individual's health or safety from one or more hazards. Reference for harmonized standards to be met: https://ec.europa.eu/docsroom/documents/57175
- Electrical and electronic equipment: means equipment which depends for its normal operation on electric currents or electromagnetic fields, and equipment for generating, transmitting and measuring such currents and electromagnetic fields, and which is designed for use with voltage ratings not exceeding 1 000 volts alternating current (AC) and 1 500 volts direct current (DC). Harmonized standards to be met by electrical and electronic products subject to the Electromagnetic Compatibility Directive (e.g. remote control vehicles) can be found at: https://ec.europa.eu/docsroom/documents/51314
Harmonized standards to be met by electrical and electronic products subject to the Low Voltage Directive (e.g. laptops): https://ec.europa.eu/docsroom/documents/57244
Radio equipment means an electrical or electronic product that is intended to transmit and/or receive radio waves for the purpose of radio communications and/or radio measurements, or an electrical or electronic product that must be equipped with an accessory such as an antenna in order to be intended to transmit and/or receive radio waves for the purpose of radio communications and/or radio measurements. Reference for harmonized standards to be met: https://ec.europa.eu/docsroom/documents/57117
Hazardous substances in electrical and electronic equipment (e.g. batteries), harmonized standards to be met refer to: https://ec.europa.eu/docsroom/documents/41284 - MECHANICAL EQUIPMENT: Components fitted or intended to be fitted with a drive system (other than by direct action of human or animal power), consisting of interconnected parts or components, at least one of which is movable, which are connected together for a specific purpose. Harmonization criteria to be fulfilled refer to: https://ec.europa.eu/docsroom/documents/55576
- Pressure Equipment: means vessels, piping, safety accessories and pressure accessories including, where applicable, components connected to pressurized parts such as flanges, nozzles, couplings, brackets, lugs. Reference for harmonized standards to be met: https://ec.europa.eu/docsroom/documents/51457,
- Recreational and private boating: a "recreational boat" means any type of watercraft, excluding a personal watercraft, used for sport and recreational purposes, with a hull length between 2.5 m and 24 m, irrespective of the means of propulsion; a "personal watercraft" means a watercraft with a hull length of less than 4 m used for sport and recreational purposes. It uses a water jet pump as the primary propulsion and is designed to be operated by a person sitting, standing or kneeling on the hull and not within the confines of the hull. Harmonized standards to be met refer to: https://ec.europa.eu/docsroom/documents/57434
- 測量設備:是指具有歐洲議會和理事會2014年2月26日第2014/32/EU號指令第2(1)條所述測量功能的任何裝置或系統。需滿足的協調標準參考:https://single-market-economy.ec.europa.eu/document/download/8ec76f63-2544-4903-9c44-2d141c140d23_en?filename=2014_32_EU%20Measuring%20Instruments_Summary%20list%20of%20harmonised%20standards_Generated%20on%2031.08.2021.pdf
*The above relevant categories are for reference only, please refer to the EU website for more information. (Link: https://single-market-economy.ec.europa.eu/single-market/european-standards/harmonised-standards_en)
3、What is the relationship between DoC and CE marking?
The CE marking is a safety mark for the entry of goods into the European Common Market and is a sign for manufacturers to declare that their products comply with the relevant EU directives. Before placing a product on the market, the manufacturer must ensure that the product is designed and manufactured in accordance with the regulatory requirements. According to the relevant provisions, the manufacturer shall carry out or has carried out the applicable conformity assessment procedures to verify the conformity of the product. If the product passes the conformity assessment procedure and complies with the requirements, the manufacturer shall draw up an EU Declaration of Conformity in accordance with the regulations and affix the CE marking to the product. The manufacturer is obliged to keep the EU Declaration of Conformity for 10 years after the product has been placed on the market, in order to be prepared for examination and supervision by the relevant regulatory authorities.
4、How to write a DoC file?
Before completing the DoC, the trader must first identify the type of product, which EU harmonization legislation it needs to meet and the corresponding conformity assessment required by the regulation. According to the conformity assessment procedure carried out for the goods, follow the Declaration of Conformity template given by the regulation, fill in the relevant information faithfully and sign the declaration.
When writing a Declaration of Conformity, merchants need to ensure that they include all the necessary information required by the regulation, and that all the requirements of multiple harmonized legislation are met if multiple harmonized legislation is applicable at the same time.
The following is an example of a product declaration of conformity and a sample label for toys (for reference only).
①Unique identification of the product (product name/model number #):
(ii) The object of the declaration of the name and address of the manufacturer or its authorized representative (product identification allowing traceability): may include color images that are sufficiently clear to allow identification of the product, where appropriate;
③ The purpose of the Declaration of Conformity is to comply with the relevant EU harmonized legislation (e.g. 2009/48/EU: Toy Safety Directive):
④ Cite the relevant harmonized standards (e.g., EN71-1: Machinery xxx) that are relevant to the declaration of conformity:
⑤ When applicable: The reporting organization (name, number) has implemented (standard) and issued a certificate, signed by a representative (general manager/quality manager).
