CE marking

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CE mark

With the CE marking , the manufacturer , distributor or EU authorized representative declares, in accordance with EU regulation 765/2008, "that the product meets the applicable requirements that are stipulated in the Community harmonization legislation on its affixing."

The CE marking is therefore not a quality seal , but a marking that is to be applied by the distributor at his own discretion and by means of which he expresses that he knows the special requirements of the product he sells and that the same corresponds to them.

If the conformity of a product has been assessed and confirmed by a notified body , the complete marking also includes the four-digit identification number assigned by the notifying body in addition to the CE mark.

Designation and meaning "CE"

The original spelling of the acronym CE is ambiguous and is not specified in the official regulations. According to the responsible standardization institute CENELEC , it now stands for Conformité Européenne ( French for "European conformity"). At the time of its introduction, however, CE was also the usual abbreviation for the European Community in four of the nine official languages ​​at the time, and the mark was usually still called the EC mark in German official documents of that time , which is why it can also have its origin here. Until 1993, the CE mark was still called the "CE mark"; the official name has since been "CE marking". This designation was introduced for all harmonization directives that have already been adopted by Council Directive 93/68 / EEC of July 22, 1993 amending the directives

  • 87/404 / EEC (simple pressure vessel)
  • 88/378 / EEC (safety of toys)
  • 89/106 / EEC (construction products)
  • 89/336 / EEC (electromagnetic compatibility)
  • 2006/42 / EG ( machines )
  • 89/686 / EEC (personal protective equipment)
  • 90/384 / EEC (non-automatic weighing instruments)
  • 90/385 / EEC (active implantable medical devices)
  • 90/396 / EEC (gas appliances)
  • 91/263 / EEC (telecommunications terminal equipment)
  • 92/42 / EEC (new hot water boilers filled with liquid or gaseous fuels) and
  • 73/23 / EEC (electrical equipment for use within certain voltage limits) (published in OJ EC No. L 220/1 of 30 August 1993).

For the medical device sector , the correct designation was "CE marking" from the start (see Art. 17 and Annex XII of Directive 93/42 / EEC).

Due to the official language of the European Commission , Directorate-General for Enterprise and Industry (regulatory policy), the stylized combination of letters has been a graphic symbol since 1994.

According to information from the European Commission, the symbol "CE" no longer has a literal meaning, but is a symbol of the free market in the EU.

Development and function

By affixing the CE mark, the manufacturer or distributor confirms that the product complies with the product-specific European directives (since December 1, 2009, with the entry into force of the "Lisbon Treaty": EU directives ). The CE mark alone does not allow any conclusions to be drawn as to whether the product has been checked for compliance with the guidelines by independent bodies. However, if a four-digit identification number (identification number) is attached after the CE mark, this indicates that a notified body has been included. The CE mark is legally not a seal of approval (quality mark ), but documents compliance with the minimum legal requirements.

The CE mark was primarily created to guarantee the end consumer safe products within the European Economic Area comprising 30 signatory states, including the European Community (EC), today: European Union (EU). The CE marking is often referred to as a “ passport ” for the European internal market.

EU directives in accordance with Art. 288 Paragraph 3 TFEU (so-called internal market or harmonization directives) define safety and health requirements as minimum requirements for numerous products , which must not be undercut. A product may only be placed on the market for the first time and put into operation for the first time if it complies with the basic requirements of all applicable EU directives and if a conformity assessment procedure according to the procedures in Annex II of Decision No. 768 / 2008 / EC of the European Parliament and of the Council of 9 July 2008 on a common legal framework for the marketing of products and repealing Council Decision 93/465 / EEC (OJ L 218/82).

As part of the new concept for product regulation and the overall concept for conformity assessment, regulations were created which are intended to serve technical harmonization within the EU internal market.

All legal provisions that concern the CE marking are within the scope of the “ New Legislative Framework ” (addition and specification of the “New Concept”) in Regulation (EC) No. 765/2008 and Decision No. 768/2008 / EC , both of July 9, 2008, have been re-regulated:

EC Regulation No. 765/2008
  • Recitals 37 and 38 (CE marking as the 'only' conformity marking),
  • Chapter IV (= Article 30: "General principles - rules and conditions for affixing the CE marking"),
  • Annex II ("CE marking" - typeface)

and

EC Decision No. 768/2008
  • Article R 11: "General principles of CE marking" with reference to Article 30 of EC Regulation No. 765/2008 and
  • Article R 12: “Rules for affixing the CE marking”.

Article R 12 paragraph 4 reads (identical in content to Article 30 paragraph 6 of EC Regulation 765/2008):

“The EU Member States build on existing mechanisms to ensure the correct implementation of the CE marking system and take appropriate steps in the event of misuse. The Member States are also introducing sanctions for violations which, in the case of serious violations, may be criminal in nature. "

For the first time since the introduction of the CE marking, its misuse by means of symbols that can be confused with graphics or content is sanctioned or made a criminal offense - cf. Section 9 (1) sentence 2 of the Medical Devices Act - MPG:

"All other signs may be affixed to the medical device, the packaging or the instructions for use of the medical device, provided they do not impair the visibility, legibility and meaning of the CE marking."

With the CE marking, the manufacturer indicates the conformity of the product with the "Basic Requirements" to be met depending on the applicable harmonization directive. The manufacturer of the product is usually responsible for this marking . The obligations are subordinate to his agent in the EU, ultimately to the distributor .

Legal peculiarities for medical devices

In contrast to other industrial products , medical products must not only be safe according to the "basic requirements" of Directive 93/42 / EEC (Appendix I) and Directive 90/385 / EEC (Appendix 1), but also within the scope of the intended medical and technical purpose specified by the manufacturer be efficient.

Section 19 of the Medical Devices Act (MPG) requires, as a prerequisite for market access / marketability of medical devices, proof of their suitability for the medical use foreseen according to their intended purpose. This evidence therefore includes the usefulness of the product for the patient if the product is properly selected and used within the scope of its medical indication . This fact is sometimes ignored by media representatives.

The legal requirements are usually verified within the framework of a certified quality management system according to EN ISO 13485 , title: Medical devices - Quality management systems - Requirements for regulatory purposes (DIN EN ISO 13485: 2012). EN ISO 13485 is the sectoral harmonized successor standard to the ISO 9001 standards, identical to EN 29001 (referenced in the "module decision" 1993) and the old EN 46001. Compliance with it and compliance with the basic legal requirements leads to the presumption of conformity.

If external notified bodies are involved in the conformity assessment of medical devices, the certificates of conformity issued by them are valid for a maximum of five years, after which a new certification audit takes place, which sets the respective state of the art as the benchmark. In addition, six-monthly to annual repeat audits of the quality management system are carried out by the notified body. It is different z. B. in the USA, where a medical device that has been approved by the Food and Drug Administration (FDA) is not viewed and tested a second time.

The "basic requirements" legally determined in the EU directives, e. B. the sterility and the biological safety of medical devices, are described in detail in European harmonized standards, which the EU Commission commissioned (mandated) and reviewed. All harmonized standards are published in the EU Official Journal and are revised every five years at the latest and adapted to the latest state of the art.

Legal specifics for construction products

According to the European law prohibition of market hindrances, it will no longer be possible to impose additional requirements on construction products with CE marking from mid-October 2016 following a decision of the European Court of Justice .

Important features of the CE marking

  • Products to which one or more of the EU directives apply due to their type or composition must be provided with the CE mark before they are placed on the market or put into operation for the first time. All applicable guidelines must be observed.
  • Manufacturers of technical products are responsible for checking which EU directives they have to apply during production.
  • The product may only be placed on the market and put into operation if it complies with the provisions of all currently applicable directives and provided the conformity assessment has been carried out in accordance with all applicable directives.
  • The manufacturer creates an EU declaration of conformity and affixes the CE mark to the product.
  • If required, a notified body must be involved for the conformity assessment .
  • In addition to the CE marking, no other marks or quality seals are permitted that could call into question the statement of the "CE". (There are always discussions about the German GS mark , which does not include the scope of the CE mark in terms of content).
  • The CE mark confirms full compliance with the "basic (safety) requirements" that are specifically defined in EU directives.
  • Exceptions to this rule only exist if special guidelines provide otherwise.
  • The risk assessment is an important part of the conformity assessment procedure. This is currently carried out in accordance with the harmonized European standard EN ISO 12100: 2010. This is a basic safety standard (A standard). As an alternative to this general procedure, if a special product standard (C standard) exists for special machine types (e.g. press construction, ...), there is the option of carrying out the risk assessment according to the C standard.

Economic operators' obligations

For the marketing of products, the regulations from Decision No. 768/2008 / EC of the European Parliament and of the Council apply, in which the obligations of economic operators are specified and the terms used are defined. These include (Chapter R2, Article R1):

  • "Making available on the market": any supply of a product, whether in return for payment or free of charge, for distribution, consumption or use on the Community market in the course of a commercial activity
  • "Placing on the market" means the making available of a product on the Community market for the first time
  • "Manufacturer": any natural or legal person who manufactures a product or has a product designed or manufactured, and who markets this product under his own name or brand
  • "Importer": any natural or legal person established in the Community who places a product from a third country on the Community market
  • "Distributor": any natural or legal person in the supply chain who makes a product available on the market, with the exception of the manufacturer or the importer

There are different obligations for the individual actors (Chapter R2, Articles R2, R4 and R5), such as:

  • The manufacturers prepare the necessary technical documents and carry out the applicable conformity assessment procedure or have it carried out.
  • Manufacturers guarantee that their products bear a type, batch or serial number or some other identifier for their identification or, if this is not possible due to the size or nature of the product, that the required information is on the packaging or in the Documents attached to the product.
  • The manufacturers indicate their name, registered trade name or registered trade mark and the address at which they can be contacted either on the product itself or, if this is not possible, on the packaging or in the documents accompanying the product. The address must contain a central point at which the manufacturer can be contacted.
  • Manufacturers shall ensure that the product is accompanied by instructions for use and safety information, made available in a language easily understood by consumers and other end-users, as decided by the Member State concerned.
  • Importers only place compliant products on the Community market.
  • Importers shall indicate their name, registered trade name or registered trade mark and the address at which they can be contacted on the product itself or, if this is not possible, on the packaging or in a document accompanying the product.
  • Importers shall ensure that the product is accompanied by instructions for use and safety information made available in a language easily understood by consumers and other end-users, as decided by the Member State concerned.
  • Before making a product available on the market, distributors check that the product bears the required conformity mark (s), that it is accompanied by the instructions for use and safety information in a language that consumers and other end-users use in the Member State in which the product is to be made available on the market can be easily understood and whether the manufacturer and importer have complied with the requirements of Articles [R2 (5) and (6)] and [Article R4 (3)].

Affixing the CE mark

Directive-compliant representation of the CE mark
Non-compliant display of the CE mark (incorrect proportions) on a Cherry keyboard
  • The CE marking is only valid for products which are put on the market after May 7, 1985, the date of the Council resolution on a new conception in the field of technical harmonization and standardization (OJ No. C 136/1) were brought.
  • The manufacturer or his authorized representative located in the Community must affix the CE marking to the product or to the label attached to it in a clearly visible, legible, unmistakable and permanent manner. The size must be at least 5 mm; If the CE marking is reduced or enlarged, the proportions must be observed. If the type of product does not allow this or gives no reason to do so, it will be affixed to the packaging (if present) and the accompanying documents, provided that the relevant directive provides for such documents.
  • If a notified body is involved in the course of production monitoring in accordance with the applicable guidelines, the identification number of the notified body must appear next to the CE mark. The notified body is responsible for affixing the identification number by the manufacturer or his authorized representative based in the Union .
  • The CE marking may only be carried out if all EU directives that apply to the corresponding product have been met.

Area of ​​application

The CE mark is a prerequisite for the initial placing on the market (or commissioning) of products for which a CE mark is required in accordance with the following EU directives, namely in all participating states of the European Economic Area (EEA). The EEA comprises the EU member states and the EFTA states with the exception of Switzerland . This means that CE marking is not required when placing on the market in Switzerland. There are many special conformity marks, but the CE mark according to EU directives is recognized.

Something different applies to the "medical devices" business sector:

The Switzerland (then "EC") signed with the EU on 21 June 1999 an international legal "agreement on the mutual recognition of conformity assessment", which provides in Annex 1, sectoral chapter 4 ( "medical devices") that Swiss manufacturers CE - Apply labeling to medical devices yourself in accordance with EU law. Conversely, Switzerland accepts the import of medical devices with CE marking into its own country (reference: OJ No. L 114/369 of April 30, 2002). Comparable third country agreements exist between the EU and Australia, New Zealand and Canada. In the USA, on the other hand, medical devices with CE marking require separate approval from the FDA in order to be allowed to be sold. The CE marking does not accelerate this approval. Attempts to implement uniform approval by the Global Harmonization Task Force (GHTF) failed in 2012 and will be continued at industry level.

Decision No. 1/95 of the EC-Turkey Association Council of December 22, 1995 on the implementation of the final phase of the customs union (OJ No. L 35/1 of February 13, 1996) provides for Turkey's quasi-inclusion in the EU Internal market for medical devices.

Affected product groups or technical areas

Internal WLAN module of a printer with CE marking

For the following product groups there are European directives or regulations based on the principles of the "New Concept" as the basis for CE marking:

Product group / technical area Current directive / regulation

(End of validity)

To be replaced by directive / regulation (beginning of validity) Outdated directives / regulations
Environmentally friendly design of energy-related products 2009/125 / EC 96/57 / EC (until July 23, 2009)
Electrical equipment (low voltage directive) 2014/35 / EU 73/23 / EEC, 93/68 / EEC, 2006/95 / EC
Simple pressure vessels 2014/29 / EU 2009/105 / EC
toy 2009/48 / EC
Building products (EU) 305/2011 89/106 / EEC (until July 1, 2013)
Electromagnetic compatibility of equipment 2014/30 / EU 89/336 / EEC, 2004/108 / EC
Personal safety equipment (EU) 2016/425 89/686 / EEC
Non-automatic weighing instruments 2014/31 / EU 2009/23 / EC (until April 20, 2016), 90/384 / EEC (until June 5, 2009)
Active implantable medical devices (EU) 2017/745 90/385 / EEC (amended by 93/42 / EEC; June 14, 1993, 93/68 / EEC; August 30, 1993, Regulation (EC) 1882/2003; September 29, 2003 and 2007/47 / EC; 21. March 2010)

until May 26th, 2020

Gas appliances (EU) 2016/426 90/396 / EEC
Hot water boiler 92/42 / EEC
Explosives for civil use 2014/28 / EU 93/15 / EEC (until February 26, 2014)
Pyrotechnic items 2013/29 / EU 2007/23 / EC (until July 1, 2015; various transition periods until 2017)
93/42 / EEC (amended by 2007/47 / EC; March 21, 2010) Regulation (EU) 2017/745 on medical devices (mandatory implementation after a transition period from May 26, 2020)
Devices and protective systems for the intended use in potentially explosive areas 2014/34 / EU 94/9 / EG (amended by 2014/34 / EU; until April 20, 2016)
Sport boats (see also CE seaworthiness classification ) 2013/53 / EU 94/25 / EG (amended by 2003/44 / EG; August 26, 2003; until June 18, 2016)
Elevators 2014/33 / EU 95/16 / EG (until April 20, 2016)
Pressure equipment 2014/68 / EU 97/23 / EG (amended by 1882/2003; September 29, 2003 and AB1. L265; September 27, 1997)
machinery 2006/42 / EG (amended by 596/2009; June 18, 2009 and 2009/127 / EG; 20/20/2009 and AB1. L76; March 16, 2007) 98/37 / EG (until December 29, 2009)
In-vitro diagnostics Directive 98/79 / EC (amended by 1882/2003; 09/29/2003, 596/2009; June 18, 2009 and 2011/100; December 20, 2011)
Telecommunications terminal equipment 1999/5 / EC; 99/005 / EG (both until June 13, 2016)
Radio systems 2014/53 / EU 1999/5 / EG (see telecommunications terminal equipment)
Cable cars for passenger transport (EU) 2016/424
Measuring device 2014/32 / EU (Annex III amended by 2015/13 / EU; October 31, 2014) 2004/22 / EC (amended by 2009/137 / EC; November 10, 2009; until April 20, 2016)
Noise emissions into the environment 2000/14 / EC (amended by 2005/88 / EC; December 27, 2005, 219/2009; March 31, 2009) 79/113 / EWG, 84/532 / EWG, 84/533 / EWG, 84/534 / EWG, 84/535 / EWG, 84,536 / EWG, 84/637 / EWG, 84/538 / EWG, 86/662 / EEC; all until July 3, 2001
Directive on the restriction of the use of certain hazardous substances in electrical and electronic equipment (RoHS) 2011/65 / EU , amended by directives (EU) 2015/863 and 2017/2102 2002/95 / EG (RoHS 1) until January 3, 2013

Regulated product areas without CE marking

There are regular guidelines for the following product groups, according to which, however, no CE marking is required or for which other conformity marks are provided:

  • Packaging and packaging waste (94/62 / EC),
  • Interoperability of the rail system in the Community (2008/57 / EC) to replace Directives 96/48 / EC (interoperability of the trans-European high-speed rail system) and 2001/16 / EC (interoperability of the conventional trans-European rail system)
  • Marine equipment (96/98 / EC); Conformity mark: symbolized steering wheel (wheel mark)
  • Technical work equipment and consumer products (2001/95 / EC), if no other directive with labeling requirements applies to one of these products

Misuse

There is improper use if

  • a CE mark has been affixed to a product without it fulfilling the conformity requirements, or
  • the label was attached to a product for which the ordinance does not require labeling.

In this case, the importer who imports the article into the European Union is the distributor and is legally treated as if he were the manufacturer or dealer. The distributor is legally responsible for the compliance of the products with the applicable legal requirements.

In a parliamentary question in 2008, the EU Commission confirmed that there is such abuse. As with any brand, abuse cannot be prevented, regardless of whether products with improper labeling were manufactured in China or elsewhere. The monitoring of the market and the removal of products that do not comply with the regulations are the responsibility of the member states. The Commission is also in constant discussions with the Chinese authorities to ensure that exports from there to the EU comply with the relevant Community legislation.

Legal implications

With an appeal judgment of January 30, 2014 (Az. 4 U 66/13), the Zweibrücken Higher Regional Court defined the legal liability of the CE marking in connection with a complaint against Poly Implant Prothèse for poor quality as follows:

“In terms of liability, such labels do not even contain a guarantee promise from which the buyer of the product can assert contractual claims for compensation against the manufacturer in the event of quality defects (cf. BGH NJW 1974, 1503). If such marks are not relevant to the manufacturer under liability law, this applies even more to the certifying notified body , which only has to check the manufacturer's quality management system. "

Time and again, products come onto the European market whose construction is not based on an EU declaration of conformity. They therefore wrongly carry the CE mark. The CE marking of a product or the issuing of declarations of conformity without a conformity assessment being carried out violates applicable law and may also result in criminal proceedings.

Different markings can also be illegal. The 6th civil senate of the Frankfurt Higher Regional Court (judgment of June 21, 2012, Az. 6 U 24/11) determined that the indication "CE-tested" for a product was anti-competitive and misleading:

" The ... advertising is misleading (§ 5 UWG) because the indication " CE-tested " - regardless of the question of advertising with self-evident - gives the addressed traffic the impression that the advertised toys have been checked by a manufacturer independent body subjected. This impression is incorrect, because the user with the CE mark only confirms the conformity of his product with the relevant regulations. "

The LG Stendal already commented on November 13th, 2008 on the legal meaning of the CE mark and the different information "CE-tested":

“ ... The CE mark is not a quality mark, but a kind of goods pass. It signals neither a special safety nor a quality of the product, but represents a simple assertion by the manufacturer. Information about official and official tests and approvals are to a high degree suitable to convince the traffic of the quality and usability of a product. ... By using the phrase “CE-tested” next to the product shown, the uninhibited viewer gets the impression that a neutral body has carried out a test without it being important in which direction this test was carried out. ... "

Many offers on Internet trading platforms from third countries for consumers are misused or do not have a CE mark. This often results from the lack of "instructions for use and safety information in a language [...] that can be easily understood by consumers and other end-users in the Member State in which the product is to be made available on the market" ( Usually the instructions for this must be available in the national language). If the shipment is from a third country, consumers (who are considered to be "importers" in the sense of) must expect the customs authorities to prohibit the importation of the relevant products during an inspection and destroy them without compensation (possibly subject to a fee) or return them to the sender (the is considered to be the distributor). Dealers can import goods and carry out a conformity test themselves and then create a declaration of conformity and label the goods before they put the goods on the market.

"China Export"

In connection with improper use, rumors are often circulating about an allegedly almost indistinguishable label "China Export" from the original CE label, in which only the distance between the symbols C and E is smaller. These are "fake" markings which importers and consumers are supposed to believe are CE markings without actually being one.

On this subject has Zuzana Roithová (Deputy European Affairs Committee of International Trade) filed in November 2007 by the European Commission a parliamentary question (P-5938/07).

In his answer of January 9, 2008, Industry Commissioner Günter Verheugen stated that this was a misconception (in the original text "misconception"). The Commission had no evidence of the existence of a “China Export” marking similar to the CE marking. The example presented is rather a CE marking that does not adhere to the intended proportions. Such markings with incorrect proportions can also be found on products that meet the conformity requirements.

According to Article 30 (5) of Regulation (EC) No. 765/2008, the affixing of markings, signs or inscriptions is prohibited, the meaning or design of which can be confused by third parties with the meaning or design of the CE marking.

literature

Web links

Commons : CE Marking  - collection of pictures, videos and audio files

Individual evidence

  1. ↑ CE marking - European Commission
  2. ↑ a b c d Decision No. 768/2008 / EC of the European Parliament and of the Council of 9 July 2008 on a common legal framework for the marketing of products and for the repeal of Decision 93/465 / EEC of the Council (text relevant to the EEA) . In: European Union (Ed.): Official Journal of the European Union . August 13, 2008 ( europa.eu [accessed June 16, 2019] Article R12, Paragraph 3).
  3. ↑ FAQs. CENELEC, accessed on September 19, 2019 .
  4. ^ Proposal for a guideline of the council for the approximation of the laws of the member states for simple pressure vessels . In: Official Journal of the European Communities . C 89, April 15, 1986 ( europa.eu [PDF; accessed September 19, 2019]).
  5. ↑ EC marking for manufacturers - European Commission
  6. ↑ New building law could endanger people and the environment , Federal Environment Agency (UBA), July 21, 2016
  7. ^ New Approach Standardization in the Internal Market
  8. ↑ a b c Answer given by Mr Verheugen on behalf of the Commission (English, accessed on November 22, 2009)
  9. ↑ CE marking for importers and dealers - European Commission
  10. ↑ http://www.landesrecht.rlp.de/jportal/portal/t/7qe/page/bsrlpprod.psml?pid=Dokumentbeispiel&showdoccase=1&doc.id=KORE202842014&doc.part=L Full text Az. 4 U 66/13, quoted by juris GmbH, Section Reasons , Paragraph 41, accessed on Apr. 4, 2019.
  11. ↑ cited in [1] , accessed on Apr. 4, 2019.
  12. ↑ https://openjur.de/u/30743.html LG Stendal judgment of November 13, 2008 AZ 31 O 50/08, accessed on April 4, 2019 from openjur.
  13. ↑ Zuzana Roithová: Written question - Parasitic use of the good reputation of the European Conformité Européenne (CE) marking through the symbol China Export (CE) - P-5938/200. November 27, 2007, accessed on June 24, 2013 (translation, original language of the question: Czech).
  14. ↑ Regulation (EC) No. 765/2008 of the European Parliament and of the Council of 9 July 2008 on the regulations for accreditation and market surveillance in connection with the marketing of products and for the repeal of Regulation (EEC) No. 339/93 of the Councils (text with EEA relevance). August 13, 2008, accessed May 28, 2019 .