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CE marking

CE marking is a mark that must be affixed to certain commercial products to indicate that the manufacturer or importer affirms the goods' conformity with European health, safety, and environmental protection standards.

Overview
The CE mark on a product indicates that the manufacturer or importer of that product affirms its compliance with the relevant EU legislation and the product may be sold anywhere in the European Economic Area (EEA). It is a criminal offence to affix a CE mark to a product that is not compliant or to offer such a product for sale. For example, most electrical products must comply with the Low Voltage Directive and the EMC Directive, among others; toys must comply with the Toy Safety Directive. (The Low Voltage Directive is about electrical safety; EMC or Electromagnetic Compatibility means the device will work as intended without interfering with, or being affected by, the use or function of any other device.) The CE mark indicates compliance with as many norms (directives and regulations) as apply at the time of the declaration of compliance (see below). In the case of electrical products, several later norms such as the Restriction of Hazardous Substances Directive (RoHS) and Waste Electrical and Electronic Equipment Directive (WEEE) are relevant in addition to the Low Voltage Directive and EMC Directive. The exact significance of the CE mark therefore depends on when it was applied to a specific unit. The marking does not indicate EEA manufacture or that the EU or another authority has approved a product as safe or conformant. The EU requirements may include safety, health, and environmental protection. If stipulated in any EU product legislation, assessment by a Notified Body or manufacture according to a certified production quality system may be required. Where relevant, the CE mark is followed by the registration number of the notified body involved in conformity assessment. Not all products need CE marking to be traded in the EEA; only product categories subject to relevant directives or regulations are required (and allowed) to bear CE marking. Most CE-marked products can be placed on the market subject only to an internal production control by the manufacturer (Module A; see Self-certification, below), with no independent check of the conformity of the product with EU legislation; ANEC has cautioned that, amongst other things, CE marking cannot be considered a "safety mark" for consumers. ==Countries requiring CE marking==
Countries requiring CE marking
CE marking is mandatory for certain product groups intended for sale within the European Union, the European Free Trade Association (EFTA), and Turkey. As Northern Ireland (a region of the UK) remains aligned to the European Single Market under the Northern Ireland Protocol, CE marking remains mandatory for products placed on the market there, and the British UKCA mark is not required. CE marking was not required by countries of the Central European Free Trade Agreement (CEFTA), but CEFTA members Albania, North Macedonia, Serbia, and Montenegro had applied for membership of the European Union, and were adopting many of its standards within their legislation, as had most Central European former member countries of CEFTA that joined the EU, before joining. , the United Kingdom government "intends to extend recognition of the CE marking for placing most goods on the market in Great Britain, indefinitely, beyond December 2024", with "different rules for medical devices, construction products, cableways, transportable pressure equipment, unmanned aircraft systems, rail products, marine equipment and ecodesign". ==Rules underlying CE marking==
Rules underlying CE marking
The formal legal status of the CE mark is set out in various EU Directives and Regulations. The underlying principles are explained in the Commission's "Blue Guide". ==Self-certification==
Self-certification
Depending on the level of risk of the product, the CE marking is affixed to a product by the manufacturer or authorized representative who needs to ensure that the product meets all the CE marking requirements. In some cases, if a product has minimal risk, it can be self-certified by a manufacturer making a declaration of conformity and affixing the CE marking to their own product. Self-certification exists only for products that have a minimal risk for their use, and this is clearly foreseen in the relevant directive and regulation according to the product "category". In order to certify, the manufacturer must do several things: • Investigate whether the product needs to have a CE marking. The product must conform to all Directives and Regulations that apply to the product. • Choose the conformity assessment procedure from the modules called out by the directive or the regulation for the product according to each category (level of risk) involved. There are several modules available for the Conformity Assessment Procedures, but only a few of them involve self-certification. The most of these procedure require a "type Approval" and a Production conformity assessment by a Notified Body. All procedures (modules) of certification are as listed below which are derivered from Article 5.1.7 of "Blue Guide". ==EU declaration of conformity==
{{anchor|EU declaration of performance}}EU declaration of conformity
Under the General Product Safety Regulation (EU) 2023/988 (GPSR), the EU declaration of conformity is a mandatory legal document in which the manufacturer or authorised representative declares that a product complies with all applicable safety requirements. The EU declaration of conformity must include: • Manufacturer’s or authorised representative’s name and full business address. • Product identification (type, model, serial or batch number). • A statement that the signatory accepts full responsibility for compliance with the applicable EU legislation. • Traceability information (e.g., photograph or drawing of the product). • Reference to relevant regulations (e.g., GPSR, and if applicable CE‑directives) and harmonised standards used. • Identification of any notified body involved, with its name and identification number, if applicable. • Place and date of issue. • Name and position of the person authorised to sign on behalf of the manufacturer or authorised representative. • A legally binding signature. Additional requirements: • The declaration must be drafted before placing the product on the EU market and retained for at least 10 years thereafter by the manufacturer, importer, or authorised representative. • It must be translated into the official language(s) of each EU country where the product is sold. The declaration is part of the product’s technical documentation and must be submitted to competent authorities on request. ==Product groups==
Product groups
The norms (directives and regulations) requiring CE marking affect the following product groups: • Active implantable medical devices (excludes surgical instruments) • Appliances burning gaseous fuels • Cableway installations designed to carry persons • Construction products according to Regulation (EU) No. 305/2011 under specific rules • Eco-design of energy related products • Electrical and electronic equipment, including radio equipment • Equipment and protective systems intended for use in potentially explosive atmospheres • Explosives for civil uses • Fertilizers Regulation (EU) No. 1009/2019 • Hot-water boilers • In vitro diagnostic medical devices • LiftsMachinery • Measuring instruments • Medical devices • Noise emission in the environment • Non-automatic weighing instruments • Personal protective equipmentPressure equipmentPyrotechnics • Recreational craft • Restriction of the use of certain hazardous substances in electrical and electronic equipment (RoHS) • Toys • Simple pressure vessels ==Mutual recognition of conformity assessment==
Mutual recognition of conformity assessment
There are numerous 'Agreements on Mutual Recognition of Conformity Assessment' between the European Union and other countries such as the US, Japan, Canada, Australia, New Zealand and Israel. Consequently, CE marking is now found on many products from these countries. Japan has its own marking known as the Conformity Mark. Switzerland and Turkey (which are not members of the EEA) also require products to bear CE marking as an affirmation of conformity. ==Characteristics of CE marking==
Characteristics of CE marking
• The CE marking has to be affixed by the manufacturer or its authorized representative in the European Union according to its legal format visibly, legibly and indelibly to the product • When a manufacturer puts the CE marking on a product it implies that it complies with all the Essential Health and safety requirements from all the directives and regulations that applies to its product. • For example, for a machine, generally the Machinery directive applies, but often also: • Low voltage directive • EMC directive • sometimes other directives or regulations, e.g. ATEX directive • and sometimes other legal requirements, e.g. for food contact materials. When the manufacturer of a machine puts the CE marking, it engages itself and guarantees, that it makes all the tests, assessments and evaluation on the product to conform to all the requirements of all the norms that apply to its product. • CE marking has been introduced by the COUNCIL DIRECTIVE 93/68/EEC of 22 July 1993 amending Directives 87/404/EEC (simple pressure vessels), 88/378/EEC (safety of toys), 89/106/EEC (construction products), 89/336/EEC (electromagnetic compatibility), 89/392/EEC (machinery), 89/686/EEC (personal protective equipment), 90/384/EEC (non-automatic weighing instruments), 90/385/EEC (active implantable medicinal devices), 90/396/EEC (appliances burning gaseous fuels), 91/263/EEC (telecommunications terminal equipment), 92/42/EEC (new hot-water boilers fired with liquid or gaseous fuels), 93/42/EEC (medical devices) and 73/23/EEC (electrical equipment designed for use within certain voltage limits). • The size of the CE marking must be at least 5 mm, if enlarged its proportions have to be kept. • If the appearance and workmanship of a product do not allow for the CE marking to be affixed on the product itself, the marking has to be affixed to its packaging or accompanying documents. • If a norm requires the involvement of a Notified Body in the conformity assessment procedure, depending on the legislation, an identification number may need to be put behind the CE logo. This is done under the responsibility of the Notified Body. ==Misuse==
Misuse
The European Commission is aware that CE markings, like other certifications marks, are misused. A test of 27 electrical chargers with UK sockets in 2008 found that all the eight legitimately branded ones with a reputable name met safety standards, but none of those unbranded or with minor names did, despite bearing the CE mark; However, the European Commission says that this is a misconception. The matter was raised at the European Parliament in 2008. The Commission responded that it was unaware of the existence of any "Chinese Export" mark and that, in its view, the misunderstanding had arisen because a producer had failed to respect the precise dimensions and proportions of the mark as prescribed in the legislation. In March 2017, another question was put to the European Commission on the statistics of the fraudulent use of the CE mark, reasserting the "China Export" myth. In reply, the Commission notes that it is the responsibility of Member States to take legal action on infringements; the Commission does not have statistics on the penalties that were imposed by Member States for the improper use of the CE marking. In an IEEE conference paper studying the origins and evolution of the claim, the author concludes there seems to exist no evidence of existence of a fraudulent "China Export" sign. In addition, similar "fraudulent" marking can be found in many European and American made products which do not show apparent noncompliance. Typesetting C and E too near to each other is probably just a typesetting mistake. The possibly earliest mention of "China Export" can be found on a Finnish fishing-themed discussion forum on year 2004. The author suspects the origins start from a joke: someone has invented a funny meaning for the abbreviation CE, from which the claim has evolved as oral history and turned into a widespread myth. Repeating the myth as a European parliamentary question has reinforced the credibility of the myth. Domestic plugs and sockets Directive 2014/35/EU, the "Low Voltage Directive", specifically excludes (amongst other things) plugs and socket outlets for domestic use which are not covered by any Union norm and therefore should not be CE marked. Throughout the EU, as in other jurisdictions, the control of plugs and socket outlets for domestic use is subject to national regulations. It is fairly common to see domestic sockets (and adaptors) that have an inbuilt 5 volt USB-A power supply socket in addition to conventional 'two-pin + earth' AC sockets. These sockets must be CE marked, but the CE mark applies to the 5 volt converter only and not the rest of the socket or adaptor. This is comparable to dedicated 5 volt power supplies. Legal implications There are mechanisms in place to ensure that the CE marking is put on products correctly. Controlling products bearing CE marking is the responsibility of public authorities in member states, in cooperation with the European Commission. Citizens may contact national market surveillance authorities if the misuse of the CE marking is suspected or if a product's safety is questioned. In the UK, sale of any product that carries a CE mark that is not so approved, or outside the scope of approval is a specific offence under Section 1 of the Trade Descriptions Act 1968. The seller of such an article is as equally guilty as the manufacturer or importer. Ignorance as to the true status of the sold item is no defence against a prosecution (strict liability). Under the Act, the misrepresentation is that the sold item conforms to a specification that it does not or that there is no such specification to which it can conform. The procedures, measures and sanctions applying to counterfeiting of the CE marking vary according to the respective member state's national administrative and penal legislation. Depending on the seriousness of the crime, economic operators may be liable to a fine and, in some circumstances, imprisonment. However, if the product is not regarded as an imminent safety risk, the manufacturer may be given an opportunity to ensure that the product is in conformity with the applicable legislation before being forced to take the product off the market. ==Use in computer systems==
Use in computer systems
The mark does not have a Unicode code point. According to the Unicode principles, rendering the mark is a computer font design choice for the two ordinary upper-case letters, C and E, with a specific kerning arrangement. The exact geometry that constitutes the mark is provided in the vector graphics files available from the European Commission. ==Meaning of CE==
Meaning of CE
Although it has been suggested that the CE letter pair is an abbreviation of (as used, for example, ==See also==
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