The CE marking, like any other marking or norm, is sometimes misappropriated. For instance, it is occasionally employed on products that fail to meet the requisite conditions for its application or become subject to counterfeiting and imitation.
The CE marking, in effect since 1993, serves the purpose of attesting to the compliance of products with prevailing European Community regulation before their introduction into the European Economic Area (EEA). Nonetheless, it is imperative to underline that while the marking should “identify non-compliant products,” this by no means infers that these products have undergone safety validation by the EU or any other competent authority. The product’s manufacturer is merely supposed to declare its compliance viz./CE’s requirements, thereby enabling the use of the EC marking, and to retain its technical documentation in case such documentation is requested.
Compliance is of the essence, as only specific categories of products necessitate antecedent scrutiny by “conformity assessment bodies.” A restricted inventory has been delineated, and with a marked reduction in the number of certified companies, manufacturers face heightened demand and protracted lead times, thereby constituting a potential competitive hurdle.
Initial conditions can engender misconduct or deviations on the part of producers, manufacturers, importers, and distributors. Consequently, the European Union has devised a hierarchical system of liability.
Despite past rumors that subsequently proved unfounded, efforts to combat the misuse and fraudulent applications of the CE marking have only been reinforced.
THE CE MARK IS NOT NECESSARILY A GUARANTEE OF QUALITY.
THE FRAUD OFFENSE IN THE USE OF THE CE MARK: TOWARDS FALSE CE MARKING?
Despite the “filtering” and “chain of responsibility” system established by the EU and implemented by member states in each own legislation, the CE marking is not immune to misuse and cannot provide an absolute guarantee of safety, health, and environmental compliance.
This observation came to light in the Poly Implant Prothesis (PIP) case. In this instance, the founder, Dr. X , was directly implicated in the production of PIP breast implants, which led to the demise of several consumers and the onset of sixteen cases of breast cancer. To mount his defense, Dr. X implicated four additional potentially responsible entities.
One of the entities designated subsequent to the manufacturer was the certifying/notifying body. “Each manufacturer selects from a roster of 70 notifying bodies responsible for inspecting the manufacturer’s documentation from the outset and awarding the CE certification.”
PIP had chosen the German company TÜV Rheinland. Subsequently, TÜV Rheinland came under scrutiny as of November 2010 when the principal victims’ association filed a complaint against it. TÜV Rheinland, however, claimed to have been deceived by the manufacturer. It asserted that during its inspections at the facility, PIP had presented compliant gel, only to replace it as soon as the inspection concluded. Furthermore, European directives on medical devices did not require it to inspect the implants themselves, leading it to focus solely on the gel. TÜV Rheinland subsequently renewed its CE certification.
This underscores that certification or the CE marking may have been applied even though the product exhibited irregularities, which would have precluded CE certification had they been discovered earlier.
To safeguard consumers, most of the Consumer Codes provide for penalties for the offense of fraud:
“Any person, whether or not party to the contract, who has misled or attempted to mislead the other party, by any means or through any medium, even by a third party:
- As to the nature, kind, origin, substantial qualities, composition, or useful properties of any merchandise;
- As to the quantity of the things delivered or their identity by delivering merchandise other than the thing specified in the contract;
- As to fitness for use, inherent risks, controls performed, instructions for use, or precautions to be taken.
The French Supreme Court under Article L.231-I of the Consumer Code, ruled that: “The presence of the CE marking on the product does not relieve the importer, responsible for the initial introduction into the national market, from ensuring the conformity of the goods with the applicable requirements.”
Another issue regarding false CE marking may appear more anecdotal. Nevertheless, it warrants consideration, as if left unchecked, it can also pose hazards.
IMITATIONS AND COUNTERFEITS OF THE CE MARK.
Formal requirements for affixing the CE marking (visible/graphic/indelible)
“The ‘CE’ logo has a precise graphic design that must be adhered to by the manufacturer,” explains Etienne Mignolet of the SPF économie.
The CE marking must be affixed by the manufacturer (or by a representative authorized by the European Union) in accordance with the format stipulated by the law, ensuring that it is legible and indelible. It must measure at least 5 mm and maintain its proportions in case of enlargement. If the characteristics of the product or its manufacturing process prevent the direct application of the CE marking, it must be affixed to the packaging or accompanying documentation. If the laws require a conformity attestation from a certified third-party organization, the organization’s identification number must be affixed adjacent to the CE marking, under the responsibility of the moral entity itself.
In exceptional circumstances, when products are small in size, directives may provide for exemptions. These exemptions pertain to:
- Personal protective equipment
- Equipment and systems for use in explosive atmospheres
- Medical devices (including in vitro diagnostic devices and active implantable devices)
- Safety components for elevators
- Terminal equipment for radio and telecommunications.
Color and method of affixation
The color of the logo and the affixation method are at the discretion of the manufacturer, provided that the logo remains legible, visible, and indelible.
PRODUCTS WITH FALSE CE MARKINGS USED UNINTENTIONALLY
In response to the Czech representative, the Commission acknowledged that it was “aware that the CE marking is sometimes misused, as is the case with any other logo. Additionally, there are instances where products that fully comply with European standards bear a logo that does not meet European marking requirements regarding form, dimensions, and proportions.” In other words, certain companies mistakenly apply an incorrect logo.
COMBATING AND CONTROLLING FALSE CE MARKINGS
The absence of the CE marking or the presence of a “false marking” can lead to administrative and criminal proceedings.
Fighting and Prophylaxis
The directives of this period, which have only recently begun given the time required for directive development, are primarily characterized by:
– The mandatory reference to two “upstream” documents:
1) Regulation (EC) No 765/2008 of the European Parliament and of the Council – Defines rules for the accreditation of conformity assessment bodies, the monitoring of products placed on the market, and control of products from third countries, as well as the general principles of CE marking.
2) Decision No 768/2008/EC of the European Parliament and of the Council – Establishes common principles and reference provisions intended for application across sectoral legislation, to provide a consistent basis for the revision or recasting of this legislation.
– Extended responsibility from the manufacturer (or importer) to the entire logistics chain.
– A new redefinition of the role and responsibilities of notifying bodies to address past abuses.
Various methods exist to verify the correct use of the CE marking.
It falls to the public authorities of each member state to monitor products bearing the CE marking, in collaboration with the European Commission. If there is suspicion of CE marking abuse, citizens have the right to contact the competent authorities in their respective countries.
Administrative and Criminal Sanctions for False CE Marking
Depending on the severity of the offense, economic operators may face penalties ranging from fines to imprisonment.
Civil penalties include a ruling by the French Supreme Court on November 21, 2006, which held that the sales contract could be terminated at the request of the purchaser for a product lacking the “CE marking.” This reaffirms the public nature of the September 12, 1989 decree, which cannot be circumvented and may involve the payment of damages
Administrative penalties may encompass product withdrawal from the market and consignment of goods to the company’s warehouse. Furthermore, criminal penalties may involve fines and imprisonment.
Controls are conducted by the Directorate for the Repression of Fraud. When a product fails to meet the imposed standards, the seller or importer is liable for the offense of deception.
Therefore, a product lacking a “CE marking” cannot be placed on the market, as the marking presumes compliance with essential safety and health requirements for consumers.
BB&A Law Firm has provided advice to numerous businesses for regulation purposes & administrative proceedings, contracts, or litigation related to CE marking and is available to address any questions on this matter.