EU Market Surveillance Regulation penalties and fines

Article 41 requires Member States to lay down and implement penalty rules for infringements of Regulation (EU) 2019/1020 and of the Union harmonisation legislation listed in Annex II that imposes obligations on economic operators. It also required Member States to notify those provisions to the Commission by 16 October 2021 where they had not already done so and to notify later amendments without delay.

Article 41 requires national penalties to be effective, proportionate, and dissuasive. It does not set offence elements, liable persons, fine bands, turnover calculations, limitation periods, decision procedures, or appeal routes. Those points must come from the current law and procedure of the relevant Member State.

A penalty is distinct from a market-surveillance measure. Article 14 requires Member States to confer minimum investigation and enforcement powers. Article 16 requires an authority that finds risk or non-compliance to specify a period for appropriate and proportionate corrective action and provides for escalation if the operator does not act or the problem persists.

Restrictions, prohibition, withdrawal, recall, warnings, product destruction, online-interface action, and customs refusal can affect the business before a national penalty decision is final. Record each action under its own legal basis, responsible authority, product scope, deadline, and remedy rather than treating every consequence as part of the fine.

Article 4 applies to products under the legal acts listed in Article 4(5), or where another product act expressly makes Article 4 applicable. For those products, an EU-established economic operator must verify that required declarations and technical documentation have been drawn up, keep the declaration available for the period set by the applicable legislation, make technical documentation available on request, answer reasoned authority requests, notify authorities when it has reason to believe the product presents a risk, and cooperate on corrective action.

Articles 25 to 28 govern controls on products entering the Union market where Union law has no more specific rules for those controls. Release for free circulation can be suspended for missing or doubtful documentation, marking or labelling defects, false or misleading required marking, missing Article 4 operator details, suspected non-compliance, or suspected serious risk. A customs suspension or refusal is not itself an Article 41 fine.

A serious-risk finding requires a risk assessment. Under Article 3, the combination of the probability of a hazard causing harm and the severity of that harm must call for rapid authority intervention under normal and foreseeable use, including where effects are not immediate. Serious risk is therefore not a label for every formal non-compliance.

For products entering the Union market, an authority can suspend release. If a market surveillance authority concludes that a product presents a serious risk, Article 28 requires action to prohibit placement and prevent release for free circulation. A product that may not be placed because it does not comply with applicable Union law can also be refused release under a separate paragraph.

Article 15 allows, but does not require, Member States to authorise market surveillance authorities to recover from the relevant economic operator all costs of their activities for non-compliant products. Recoverable items may include testing, storage, border-related measures under Article 28(1) and (2), and activities for products subject to corrective action before release or placement. Whether cost recovery is available and how it is calculated depend on national law.

Article 18 applies to a measure, decision, or order under the Regulation or Union harmonisation legislation. It requires exact grounds, communication without delay, and notice of the remedies and time limits available under national law. The operator must normally receive an appropriate period of at least 10 working days to be heard, subject to an urgency exception and prompt post-measure review.