L'placing of products on the EU market requires compliance with a rigorous body of legislation, aimed at protecting health, public and private safety, as well as the environment and consumer interests. Regulation (EU) 2019/1020, which became applicable on 16 July 2021, significantly strengthened the market surveillance framework, introducing stricter rules for economic operators and extending the powers of the control authorities.
The regulatory framework of market surveillance
The Regulation (EU) 2019/1020 is the cornerstone of European market surveillance, applying to products covered by the Union harmonisation legislation listed in Annex I. The primary objective is to ensure that only compliant and safe products circulate within the territory of the Union, reinforcing the principle of free movement of goods through effective and harmonised controls.
Each Member State must designate market surveillance authority with adequate powers and resources to carry out documentary, physical and laboratory checks on products. These authorities operate with independence and impartiality, adopting a risk-based approach that takes into account the possible hazards associated with products, the non-compliance history of economic operators, and reports received from consumers, other authorities or the media.
The national authorities must also develop a comprehensive national market surveillance strategy at least every four years, identifying priority areas and ways of applying European legislation in order to reduce instances of non-compliance and ensure a coherent and integrated approach.
Economic operators: responsibilities and obligations
Regulation (EU) 2019/1020 introduces the definition of “economic operator”, This includes the manufacturer, authorised representative, importer, distributor, logistics service provider or any other natural or legal person subject to obligations relating to the manufacture, marketing or putting into service of products.
For certain product categories listed in Article 4(5) of the Regulation - which include products governed by directives such as the Machinery Directive 2006/42/EC, the Low Voltage Directive 2014/35/EU, the PPE Regulation (EU) 2016/425 and the CPR Regulation (EU) No 305/2011 - placing on the market is subject to the presence of an economic operator established in the European Union assuming specific responsibilities.
This operator must verify that the EU Declaration of Conformity has been drawn up or the declaration of performance and the technical documentation, keeping them at the disposal of the supervisory authorities for the prescribed period. At the reasoned request of the authorities, it is obliged to provide all information and documentation necessary to demonstrate the conformity of the product, in an easily understandable language. If he considers that a particular product presents a risk, he must inform the competent authorities. Finally, it is required to cooperate fully with the authorities guaranteeing the adoption of appropriate corrective actions to remedy non-conformities or mitigate the risks presented by the product.
The name, trade name or registered trade mark and contact details of the economic operator must be indicated on the product, its packaging or in an accompanying document.
Sicom Testing through its services of CE marking, supports economic operators in fulfilling these obligations, carrying out all the necessary tests and preparing the technical documentation required for compliant placing on the European market.
Vigilance measures and consequences of non-compliance
Market surveillance authorities adopt severe measures when a product, used in accordance with its intended purpose or under reasonably foreseeable conditions, may endanger the health or safety of users, or does not comply with harmonisation legislation of the applicable Union.
In such circumstances, the authorities require the economic operator to take appropriate corrective measures and proportionate within a specified time limit. Measures may range from restoration of product conformity, including the rectification of formal non-conformities, to the ban on making the product available on the market, until the withdrawal or immediate recall resulting in the public being alerted to existing risks. In the most serious cases, this may lead to the destruction of the product. In intermediate situations, the authorities may impose the’affixing appropriate risk warnings that the product may present or the setting of preconditions for making the product available on the market.
In the case of products posing a serious risk, the authorities ensure that recall or withdrawal measures, if there are no other effective means to eliminate the risk. Such measures must be notified immediately to the European Commission and the other Member States through the information and communication system provided for in Article 34 of the Regulation.
The assessment of risk severity is based on an adequate analysis taking into account the nature of the hazard and the likelihood of its materialisation, while the possibility of obtaining higher levels of safety or the availability of safer alternative products do not in themselves constitute grounds for considering that a product poses a serious risk.
Checks on products entering the EU market
Regulation (EU) 2019/1020 pays special attention to products entering the Union market through customs controls. Member States designate the customs authorities, market surveillance authorities or other authorities responsible for the control of products entering European territory.
Products subject to Union law that are to be bound to the customs procedure of “release for free circulation” are subject to controls based on a risk analysis in accordance with Articles 46 and 47 of Regulation (EU) No. 952/2013 (Union Customs Code) and, where appropriate, on the risk-based approach provided for in Article 11(3) of Regulation (EU) 2019/1020.
The designated authorities suspend the release for free circulation of a product when it is not accompanied by the documentation required by Union law or there is reasonable doubt as to the authenticity, accuracy or completeness of that documentation. Suspension also takes place if the product is not marked or labelled accordingly applicable Union law, or bears the CE marking or other prescribed marking affixed in a false or misleading manner. Further grounds for suspension arise where the name and contact details of an economic operator with tasks relating to the product are not indicated or identifiable in accordance with Article 4, or for any other reason there is reason to believe that the product does not comply with Union law or presents a serious risk to health, safety, the environment or another public interest.
Release for free circulation takes place when, within four working days after suspension, the market surveillance authorities have not requested that the suspension be maintained, or when those authorities have communicated their approval. However, release for free circulation does not constitute proof of conformity with Union law.
If the supervisory authorities conclude that a product poses a serious risk or cannot be placed on the market as non-compliant, take measures to prohibit their release and require customs authorities to make appropriate entries in the customs IT system and accompanying documents. In the most serious cases, the authorities may order the destruction or decommissioning of the product, with costs to be borne by the natural or legal person who declared the product for free circulation.
The Italian Customs Agency divides its control activities into two main areas: that tax, quantity, quality, value and origin of goods, and that extra-tributary, which focuses on product safety, intellectual property and the protection of 'Made in Italy'.
How to bring a product back into conformity
When a product is blocked or found to be non-compliant, the economic operator must take immediate action corrective actions to restore compliance. The path to follow depends, understandably, on the nature of the non-conformity detected. For the documentary non-compliance, the operator must integrate missing documentation, by preparing the EC Declaration of Conformity signed by the legally responsible person, the instruction manual drawn up in accordance with the requirements of the applicable directives and in the language(s) of the country of destination, the correct affixing of the CE marking on the product or its nameplate, as well as any specific certification required.
For the substantial non-compliance, when the product has defects that render it effectively dangerous or does not comply with the essential safety requirements, the operator must proceed with technical modifications to the product itself, with subsequent re-testing of compliance. In some cases, it may be necessary to redesign critical components, install additional protection or modify the control system.
Once the changes have been made and complete documentation has been prepared, the product must be resubmitted for evaluation by the competent authorities. It is essential that the economic operator cooperates fully with the supervisory authorities, providing all requested information in a timely and transparent manner.
Sicom Testing offers comprehensive compliance restoration support, through services such as security tests, electromagnetic compatibility tests, radio tests for wireless devices, as well as the preparation of technical documentation and files required for certification. Our laboratory's many years of experience allow us to quickly identify critical issues and propose effective solutions for compliance.
The importance of prevention: advance checks
The complexity of the European regulatory framework and the severity of the consequences of non-compliance make a preventive approach. Economic operators wishing to place products on the European market must carefully plan the certification process from the initial design stages and production.
The advance checks on representative samples, before the shipment of entire batches, allow any problems to be identified at an early stage and corrective action to be taken when costs and time are still low. A product stuck in customs involves not only the immobilisation of the goods, but also storage costs, potential delays in deliveries to customers, reputational damage and, in the most serious cases, destruction of the product with total loss of investment.
Collaboration with qualified laboratories for pre-testing during the product development phase, in-depth analysis of the applicable directives and harmonised standards, careful preparation of all mandatory technical documentation and verification of correct labelling and marking are essential investments to ensure unhindered market entry.
Sicom Testing, through its comprehensive range of testing and certification services, supports companies at all stages of the processThe most common use of "Dalle" (often written as DALL-E) is to refer to a specific AI model developed by OpenAI. Based on your input, I'll provide a few possible interpretations: **1. DALL-E (AI Model):** * **Meaning:** DALL-E is an AI system that can create images from textual descriptions. You give it a prompt, and it generates original images based on that prompt. * **Example Usage:** "I used DALL-E to create a surreal image of a cat riding a bicycle on the moon." **2. "Dalle" as a misspelling of "daisy":** * **Meaning:** "Daisy" is a common, usually white and yellow, wildflower. * **Example Usage:** "The field was covered in beautiful white daisies." **3. "Dalle" as a typo or slang:** * Without more context, it's difficult to determine if "dalle" is a specific slang term or a typo for another word. **To give you the most accurate translation, could you please provide more context? For example:** * **What language do you think "dalle" is from?** * **Where did you see or hear "dalle"?** * **What was the sentence or phrase "dalle" was used in?** design tests during product development, and conformity testing for final certification, through to production checks during the entire product life cycle. Our laboratory's specialist competence in areas such as electronic and electrical equipment and radio products allows even the most complex certifications to be tackled with confidence.
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