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INTRO
INSIGHTS

MSR: Marketing non-food products in the EU

By
Paul Foley
The increasing complexity of international supply chains and a significant increase in online sales, have led to challenges for market surveillance authorities across the EU. The Market Surveillance Regulation or MSR, strengthens market surveillance and the enforcement of Union harmonisation legislation for the products that come within it.

Arising from the MSR and since 16th of July 2021, certain types of products (referred to in Article 4(5) of the MSR) may be placed on the EU market, only if there is an economic operator, established in the EU. The economic operator must perform the tasks set out in Article 4(3) of the MSR and where required by a market surveillance authority under Article 16(3), take corrective action which may include:

  • preventing the product from being made available on the market;
  • withdrawing or recalling the product immediately and alerting the public to the risk presented;
  • destroying the product or otherwise rendering it inoperable.

In order to identify and contact the economic operator, the name, registered trade name or registered trade mark, and contact details, including the postal address, of the economic operator referred to in Article 4(1) must be indicated on the product or on its packaging, the parcel or an accompanying document.

In addition to the above, the MSR applies to products that are subject to the Union harmonisation legislation listed (70 regulations and directives) in Annex I of the MSR (this list includes the Reach Regulation ((EC) No 1907/2006) in so far as there are no specific provisions in the Union harmonisation legislation, which regulate more specifically manner market surveillance and enforcement. In this context, Articles 25 to 28 (controls on products entering the EU) of the MSR apply, in so far as there are no specific provisions relating to the organisation of controls on products entering the Union market in Union law.

The application of the MSR does not prevent market surveillance authorities from taking more specific measures as provided for in the General Product Safety Directive (Directive 2001/95/EC). The MSR is without prejudice to Articles 12 to 15 of the eCommerce Directive (Directive 2000/31/EC).

Because of the obligations placed on economic operators, on online intermediaries (referred to below) and general MSR compliance obligations, it is essential to make changes to terms of business of exporters, of importers, those of online intermediaries under the eCommerce Directive and to put in place additional terms with an economic operator, particularly for example, where the manufacturer is established outside the EU.

The Market Surveillance Regulation or MSR

The Market Surveillance Regulation or MSR which had effect on the 16th of July 2021, aims at improving and modernising market surveillance. It also provides a framework for controls on products entering the Union market.

Requirements for accreditation and market surveillance (to ensure compliance) relating to the marketing of products in the EU are currently found in Regulation (EC) 765/2008, Decision 768/2008/EC and Directive 2019/95 (the General Product Safety Directive (which contains surveillance provisions for non harmonised consumer products))

The MSR deletes Articles 6 and 7 of Directive 2004 /42/EC makes substantial amendments to Regulation (EC) No 765/2008 (see Article 39 of the Market Surveillance Regulation) and substitutes new wording for Article 56(1) of Regulation (EU) No 305/2011 (See Article 40 of the Market Surveillance Regulation).

The requirement to have an economic operator established in the EU (Article 4)

The concept of an economic operator in Article 4(2) is new and is further defined as: (a) a manufacturer established in the Union; (b) an importer, where the manufacturer is not established in the Union; (c) an authorised representative who has a written mandate from the manufacturer designating the authorised representative to perform the tasks set out in Article 4(3) on the manufacturer's behalf; or (d) a fulfilment service provider established in the Union with respect to the products it handles, where no other economic operator as mentioned in Article 4(2)(a), or Article 4(2)(b) and Article 4(2)(c) is established in the Union.

Certain types of products may be placed on the market, only if there is an economic operator, established in the EU, who is responsible for:

  • (a) verifying (where a declaration of conformity is required) that the EU declaration of conformity or declaration of performance and technical documentation have been drawn up, keeping the declaration of conformity or declaration of performance at the disposal of market surveillance authorities for the period required by that legislation and ensuring that the technical documentation can be made available to those authorities upon request;

  • (b) further to a reasoned request from a market surveillance authority, providing that authority with all information and documentation necessary to demonstrate the conformity of the product in a language which can be easily understood by that authority

  • (c) when having reason to believe that a product in question presents a risk, informing the market surveillance authorities thereof

  • (d) cooperating with the market surveillance authorities, including following a reasoned request, making sure that the immediate, necessary, corrective action is taken to remedy any case of non-compliance with applicable Union harmonisation legislation applicable to the product in question, or, if that is not possible, to mitigate the risks presented by that product, when required to do so by the market surveillance authorities or on its own initiative, where the economic operator referred to in Article 4 (1) considers or has reason to believe that the product in question presents a risk.

The tasks of an Economic Operator who is an Authorised Representative (Article 5(2))

The Authorised Representative for the purposes of Article 4(2)(c) (when having reason to believe that a product in question presents a risk, informing the market surveillance authorities thereof) must be mandated by the manufacturer to perform the tasks listed in Article 4(3), notwithstanding any other tasks mandated under Union legislation.

The Authorised Representative must perform the tasks specified in the mandate. It must provide a copy of the mandate to the market surveillance authorities upon request, in a Union language determined by the market surveillance authority. Authorised representatives must have the appropriate means to be able to fulfil their tasks.

Co-operation Obligations (Article 7)

Note additionally Article 7(1) imposes obligations on economic operators to cooperate with market surveillance authorities and Article 7(2) imposes obligations on Information society service providers to cooperate with the market surveillance authorities, to facilitate any action taken to eliminate or, if that is not possible, to mitigate the risks presented by a product that is or was offered for sale online through their services.

Distance Sales (Article 6)

Products offered for sale online or through other means of distance sales are be deemed to be made available on the market, if the offer is targeted at end users in the Union. An offer for sale will be considered to be targeted at end users in the Union if the relevant economic operator directs, by any means, its activities to a Member State.

Market Surveillance Authorities

Designation of market surveillance authorities and the single liaison office (Article 10)

Member States must organise and carry out market surveillance as provided for in the MSR.

Each Member State shall designate one or more market surveillance authorities in its territory. Each Member State shall inform the Commission and the other Member States of its market surveillance authorities and the areas of competence of each of those authorities, using the information and communication system referred to in Article 34.

Each Member State must appoint a single liaison office. The single liaison office shall at least be responsible for representing the coordinated position of the market surveillance authorities and the authorities designated under Article 25(1) and for communicating the national strategies as set out in Article 13 (below). The single liaison office shall also assist in the cooperation between market surveillance authorities in different Member States, as set out in Chapter VI.

Member States must ensure that their market surveillance authorities and single liaison office have the necessary resources, including sufficient budgetary and other resources, such as a sufficient number of competent personnel, expertise, procedures and other arrangements for the proper performance of their duties.

Market Surveillance (Article 11)

Market Surveillance Authorities must conduct their activities as specified in Article 11 including where economic operators present test reports or certificates attesting the conformity of their products with Union harmonisation legislation issued by a conformity assessment body accredited in accordance with Regulation (EC) No 765/2008, market surveillance authorities must take due account of those reports or certificates.

Peer Reviews (Article 12)

Peer reviews must be organised for market surveillance authorities and the methology for doing so must be developed by the Network. Article 12 provides more detail on this.

National market surveillance strategies (Article 13)

Each Member State must draw up an overarching national market surveillance strategy, at least every four years. When drawing up the strategy, all sectors covered by the Union harmonisation legislation and all stages of the product supply chain, including imports and digital supply chains, must be considered. Article 13 provides more detail on the elements of the national market surveillance strategy.

Joint activities to promote compliance (Article 14)

Market surveillance authorities may agree with other relevant authorities or with organisations representing economic operators or end users on the carrying out of joint activities that have the aim of promoting compliance, identifying non-compliance, raising awareness and providing guidance in relation to the Union harmonisation legislation with respect to specific categories of products, in particular categories of products that are often found to present a serious risk, including products offered for sale online.

A market surveillance authority may use any information resulting from joint activities carried out as part of any investigation regarding non-compliance that it undertakes. These activities have to be transparent.

Powers and Obligations of Market Surveillance Authorities (Article 14, 15 and Article 16)

Articles 14 is designed to ensure a market surveillance authority is given the proper powers and Article 16 is designed to require a market surveillance authority act in defined circumstances.

Member States may authorise their market surveillance authorities to reclaim from the relevant economic operator the totality of the costs of their activities with respect to instances of non-compliance (Article 15(1)) with Article 15(2) specifying what these may include (not reproduced here).

Products presenting a serious risk (Article 19)

Market surveillance authorities must ensure that products presenting a serious risk, are withdrawn or recalled, where there is no other effective means available to eliminate the serious risk, or that their being made available on the market is prohibited. Market surveillance authorities must notify the Commission thereof immediately, in accordance with Article 20.

Use of information, professional and commercial secrecy (Article 17)

Market surveillance authorities must perform their activities with a high level of transparency and must make available to the public any information that they consider to be relevant in order to protect the interests of end users. Market surveillance authorities must respect the principles of confidentiality and of professional and commercial secrecy and must protect personal data in accordance with Union and national law.

Procedural rights of economic operators (Article 18)

Any measure, decision or order taken or made by market surveillance authorities pursuant to Union harmonisation legislation or the MST must state the exact grounds on which it is based and must be communicated without delay to the economic operator, together with the remedies available to the economic authority at law and the time limits.

Rapid Information Exchange System (Article 20)

Where a market surveillance authority takes or intends to take a measure pursuant to Article 19 (products representing a serious) and considers that the reasons which prompted the measure or the effects of the measure go beyond the territory of its Member State, it must immediately notify the Commission and must also inform the Commission without delay of the modification or withdrawal of any such measure.

If a product presenting a serious risk has been made available on the market, market surveillance authorities must immediately notify the Commission of any voluntary measures taken and communicated to the market surveillance authority by an economic operator.

In this context, the Rapid Information Exchange System (RAPEX) provided for in Article 12 of Directive 2001/95/EC must be used.

Controls on products entering the Union market (Article 25)

Member States must designate customs authorities, one or more market surveillance authorities or any other authority in their territory as the authorities in charge of the control on products entering the Union market.

Suspension of release for free circulation (Article 26)

Authorities designated under Article 25(1) must suspend the release of a product for free circulation if in the course of controls pursuant to Article 25(3) where required by Articles 26(1) and must immediately notify the market surveillance authorities of any suspension of release referred to in Article 26(1) of this Article.

Where the market surveillance authorities have reasonable grounds to believe that a product does not comply with the Union law applicable to it or presents a serious risk, they must request the authorities designated under Article 25(1) to suspend the process for its release for free circulation (Article 26(2)).

Release for free circulation (Article 27)

Article 27 provides a tight timeframe for the release of a product for free circulation, where its circulation has been suspended. It also sets out what is the effect of the release.

Refusal to release for free circulation (Article 28)

Article 28 deals with the situation where a product presents a serious risk, the market surveillance authority must take measures to prohibit the placing of the product on the market. It must require the authorities designated under Article 25(1) not to release it for free circulation and also require those authorities to include the following notice in the customs data-processing system, and, where appropriate, on the commercial invoice accompanying the product and on any other relevant accompanying document: ‘Product not in conformity — release for free circulation not authorised — Regulation (EU) 2019/1020’.

The Union Product Compliance Network (Articles 29 to 31)

The Union Product Compliance Network (‘the Network’) is established by Article 29, whose purpose is to serve as a platform for structured coordination and cooperation in the non-food area between enforcement authorities of the Member States and the Commission, and to streamline the practices of market surveillance within the Union, thereby making it more effective.

The composition and functioning of the Network is regulated by Article 30 and the role and the tasks of the Network are set out in Article 31 of the MSR.

Union testing facilities (Article 21)

The objective of the Union testing facilities is to contribute to enhancing laboratory capacity, as well as to ensuring the reliability and consistency of testing, for the purposes of market surveillance within the Union.

The Commission may designate a public testing facility of a Member State as a Union testing facility for specific categories of products or for specific risks related to a category of products. The Commission may also designate one of its own testing facilities as a Union testing facility for specific categories of products or for specific risks related to a category of products, or for products for which testing capacity is missing or is not sufficient.

Union testing facilities must be accredited in accordance with Regulation (EC) No 765/2008. Designated Union testing facilities will have to provide their services solely to market surveillance authorities, the Network, the Commission and other government or intergovernmental entities. The activities of a Union testing facilities are set out in Article 21(7).

Your Europe Portal

The Commission, in accordance with Regulation (EU) 2018/1724, must ensure that the Your Europe portal https://europa.eu/youreurope/ provides users with easy online access to information about the product requirements and rights, obligations and rules derived from the Union harmonisation legislation.


For advice on complying with the MSR, please email paul@paulfoleylaw.ie
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