Withdrawal of products from the market and sanctions: violation of the CE marking

As is known, the CE certification it is an indispensable element for the marketing of certain types of products on the European market. It is defined by the application of standards and directives which certify the conformity of the product with all the provisions of the European Community in terms of health protection, safety and environmental protection.

Obtaining – and maintaining – CE certification presents a number of issues specific obligations for the different economic operators involved. The fulfillment of these obligations - and therefore the conformity of the marking - is assessed by the Member States through notified bodies, capable of carrying out the process of verifying the constancy of conformity of the product with the provisions.

In the event of non-conformity being detected (and the economic operator concerned not taking decisive action to put an end to the non-conformity itself), various scenarios open up for the product and the operators involved in its marketing. One of these is the withdrawal of products from the market.

In the event of failure to comply with the CE certification, in fact, the competent authorities "adopt appropriate measures to limit or prohibit the placing of the product on the market or to guarantee its withdrawal from the market, at the expense of the person responsible for placing the equipment on the market".

Sanctions: construction products

In addition to the adoption of restrictive measures such as the ban on movement and withdrawal, there are financial and custodial sanctions, well defined - in the case of construction products - by Legislative Decree no. 106/2017. The sanctions represented can be categorized as:

  • pecuniary criminal sanctions (with minimum and maximum fines);
  • criminal custodial sanctions (with provision for arrest);
  • joint criminal sanctions (with provision of arrest and fine);
  • administrative pecuniary sanctions.

Specifically, the manufacturer that violates the general principles and provisions relating to the use of the CE Marking - and the rules and conditions provided for in Article 9 of Regulation (EU) no. 305/2011 – is punished with an administrative fine ranging from 4,000 euros to 24,000 euros; the same act is punished with imprisonment of up to 6 months and with a fine ranging from 10,000 euros to 50,000 euros if the products in question are intended for structural or fire-fighting use.

Products awaiting inspectionSanctions: electromagnetic compatibility

To regulate other matters compared to Legislative Decree no. 106/2017, we find Art. 15. of Legislative Decree 6 November 2007, n. 194 for the implementation of Directive 2004/108/EC. The article defines the sanctions regarding electromagnetic compatibility of equipment, appliances and systems, outlining that:

• Anyone who places equipment on the market that does not comply with the protection requirements is subject to the administrative sanction of paying a sum from 4,000 euros to 24,000 euros. Anyone who makes modifications to equipment with the required CE marking which results in non-compliance with the protection requirements is subject to the same sanction.

• Anyone who places on the market, markets, distributes in any form or installs equipment which, although compliant with the protection requirements, does not have the required CE marking and technical documentation, is subject to the administrative sanction of paying a sum from 2,000 euros to 12,000 euros.

Furthermore, the sanctions also concern anyone who affixes marks that could be confused with the CE marking (or limit their visibility and readability): in this case the administrative fine amounts to a sum from 1,000 euros to 6,000 euros.

Likewise, anyone who promotes advertising for equipment that does not comply with the provisions of the legislative decree is subject to an administrative fine of a sum from 2,500 euros to 15,000 euros.

Conclusions

The examination of these two regulations - and the focus on the sanctioning aspect of the same - is aimed at encouraging reflection on the need to apply standards and directives in full compliance with the laws. By interpreting the rules incorrectly - with the aim of not subjecting the equipment to all the appropriate conformity checks - one incurs measures which, on an economic as well as productive level, have a decisive impact on the marketing of the products on the market.

Sicom Testing offers a complete service for CE certification of the products.

To request further information on this topic, write to info@sicomtesting.com
or call +39 0481 778931.

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14 thoughts on “Ritiro dei prodotti dal mercato e sanzioni: la violazione della marcatura CE”

  1. With my purchase I received the CE certificate of conformity. However, the code it refers to (EN 12101-2:2003-09) has been withdrawn and appears to be replaced by EN 12101-2:2017. Does this invalidate the Certificate of Conformity? What about the product being “not fit for purpose”?

    Reply
    • Good morning,
      Although the EN 12101-2:2017 standard has been published, the EN 12101-2:2003 standard is still indicated in the list of harmonized standards, published in the Official Journal of the European Union, relating to regulation 305/2011 for construction products. which therefore still guarantees the presumption of conformity under the regulation, compliance with the requirements of the regulation can be guaranteed using the 2003 version of the standard. The presumption of conformity is valid until the publication of a new standard or a corresponding amendment in the Official Journal of the European Union.
      Best regards
      Sicom Test

      Reply
    • Good morning,
      Medium voltage electrical devices (greater than 1000 Vac or 1500 Vdc) do not fall under any European directive or regulation and do not require CE marking; the exception is transformers that fall under regulation 548/2014/EU (ecodesign), in this case the CE marking is necessary.
      Best regards
      Sicom Test

      Reply
  2. Good morning.

    I purchased a professional cavitation and radio frequency device from Amazon, and it came with a seal on the back of the device that made me assume it was CE certified. What happens is that the seller has not sent any technical data sheet of the device or documentation that can prove the veracity of the CE certification.
    So will it be valid? Will I be able to have such a device at a beauty centre?

    Thank you!!

    Reply
    • Good morning,
      The device in question must be considered a medical device (even if used for aesthetics), according to REGULATION (EU) 2017/745 a CE marked medical device must be registered in the "EUDAMED" medical device database and have a UDI code ( indicated in the device documentation) through which you can verify that the device is registered.
      Best regards
      Sicom Test

      Reply
  3. I purchased a brush cutter from a French manufacturer for my 1.6 TB mini excavator, who confirmed that they complied with the safety regulations. The device disintegrated after a few hours of use. I found out that it is not CE certified and the instructions for use are incomplete. Luckily and only luckily the driver was not hit by the blade holder which had become a flying saucer. The manufacturer confirmed to me that CE certification is not mandatory for its product. This product seems very dangerous to me. I want this manufacturer to take back his car and warn his customers.

    Reply
    • Good morning,
      A brush cutter must comply with the machinery directive and therefore must have the CE mark (which can be affixed after having verified compliance with the regulations); if it does not comply with the regulations it cannot be placed on the market.
      Best regards
      Sicom Test

      Reply
  4. Good morning
    I wanted to ask you a question. To market a product in the EU, it must have a visible CE marking on the product.
    In the case of mobile phones, so far, we are buying it with the CE mark and with the digital certificate in the phone's software.
    Is this CE marking mandatory in all countries to be sold?
    When we buy mobile phones from other countries, are we responsible for them having the CE marking and is it also necessary for them to come with a declaration of conformity?
    In the case of mobile devices, if they just have the certificates in the phone's software, is that enough?
    Is it mandatory in Spain for the phone to have that CE mark on the back of the phone? How should a cell phone be certified?
    And finally, what is the legislation/regulation that applies to the mobile equipment to be certified?
    Thanks for your attention

    Reply
    • Good morning,
      -The CE marking must be affixed visibly, legibly and indelibly on the radio equipment or on the relevant plate, unless this is not possible or necessary due to the nature of the radio equipment. The CE marking must be affixed visibly and legibly on the packaging.
      -The CE marking is mandatory in all countries of the European Economic Area.
      -All radio devices placed on the market in the European Economic Area must have both the CE marking and the declaration of conformity.
      -Spain is part of the European Economic Area so all radio devices marketed in Spain must have the CE mark
      -The requirements for certifying a radio device are set out in the Radio Equipment Directive 2014/53/EU.
      Best regards

      Reply
  5. HI,
    I'm thinking of making a wall mounted bike rack. I understand that CE marking or self-certification would not be necessary. I hope to comply with the General Product Safety Directive, would anything else be mandatory? Any advice to take into consideration?

    Thank you very much and regards

    Reply
    • Good morning.
      We understand that for this product it is sufficient to apply the General Product Safety Directive.
      Greetings from Sicom Testing

      Reply
  6. Greetings,
    I would like to import a small portable sterilizer with UV-C LED lights from China.
    The Chinese supplier provided me with CE+Rohs certifications, but since it is a "very low voltage" product I cannot understand whether CE certification is necessary or not. Furthermore, if the certifications received are sufficient to affix the CE mark on the product.
    Can you help me?
    A thousand thanks
    Beccalossi Luca

    Reply
    • Good morning.
      The product must be certified for the European market and the general product safety directive GPSD 2001/95/EC will probably apply for safety aspects. If it contains electronic parts, the product also falls under the electromagnetic compatibility directive 2014/30/EU, and in this case the CE mark must be affixed. The RohS directive also applies to this type of equipment.
      Sicom testing can provide a complete service for this type of product, which starts from evaluating the documentation made available by the supplier and identifying the most economical path to place the product on the market in accordance with the regulations, also having all the capacity to carry out any required tests.
      Greetings from Sicom Testing

      Reply

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