1.   The objective of this Regulation is to improve the functioning of the internal market by strengthening the market surveillance of products covered by the Union harmonisation legislation referred to in Article 2, with a view to ensuring that only compliant products that fulfil requirements providing a high level of protection of public interests, such as health and safety in general, health and safety in the workplace, the protection of consumers, the protection of the environment and public security and any other public interests protected by that legislation, are made available on the Union market.

2.   This Regulation lays down rules and procedures for economic operators regarding products subject to certain Union harmonisation legislation and establishes a framework for cooperation with economic operators.

3.   This Regulation also provides a framework for controls on products entering the Union market.

1.   This Regulation shall apply to products that are subject to the Union harmonisation legislation listed in Annex I (‘Union harmonisation legislation’), in so far as there are no specific provisions with the same objective in the Union harmonisation legislation, which regulate in a more specific manner particular aspects of market surveillance and enforcement.

2.   Articles 25 to 28 shall apply to products covered by Union law in so far as there are no specific provisions relating to the organisation of controls on products entering the Union market in Union law.

3.   The application of this Regulation shall not prevent market surveillance authorities from taking more specific measures as provided for in Directive 2001/95/EC.

4.   This Regulation is without prejudice to Articles 12 to 15 of Directive 2000/31/EC.

1.   Notwithstanding any obligations set out in applicable Union harmonisation legislation, a product subject to legislation referred to in paragraph 5 may be placed on the market only if there is an economic operator established in the Union who is responsible for the tasks set out in paragraph 3 in respect of that product.

2.   For the purposes of this Article, the economic operator referred to in paragraph 1 means any of the following:

3.   Without prejudice to any obligations of economic operators under the applicable Union harmonisation legislation, the economic operator referred to in paragraph 1 shall perform the following tasks:

4.   Without prejudice to the respective obligations of economic operators under the applicable Union harmonisation legislation, the name, registered trade name or registered trade mark, and contact details, including the postal address, of the economic operator referred to in paragraph 1 shall be indicated on the product or on its packaging, the parcel or an accompanying document.

5.   This Article only applies in relation to products that are subject to Regulations (EU) No 305/2011 (34), (EU) 2016/425 (35) and (EU) 2016/426 (36) of the European Parliament and of the Council, and Directives 2000/14/EC (37), 2006/42/EC (38), 2009/48/EC (39), 2009/125/EC (40), 2011/65/EU (41), 2013/29/EU (42), 2013/53/EU (43), 2014/29/EU (44), 2014/30/EU (45), 2014/31/EU (46), 2014/32/EU (47), 2014/34/EU (48), 2014/35/EU (49), 2014/53/EU (50) and 2014/68/EU (51) of the European Parliament and of the Council.

1.   For the purposes of point (c) of Article 4(2), the authorised representative shall be mandated by the manufacturer to perform the tasks listed in Article 4(3), notwithstanding any other tasks mandated under the relevant Union harmonisation legislation.

2.   The authorised representative shall perform the tasks specified in the mandate. It shall provide a copy of the mandate to the market surveillance authorities upon request, in a Union language determined by the market surveillance authority.

3.   Authorised representatives shall have the appropriate means to be able to fulfil their tasks.

1.   Economic operators shall cooperate with market surveillance authorities regarding actions which could eliminate or mitigate risks that are presented by products made available on the market by those operators.

2.   Information society service providers shall cooperate with the market surveillance authorities, at the request of the market surveillance authorities and in specific cases, 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.

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

2.   Member States shall put in place procedures for providing economic operators, at their request and free of charge, with information with respect to the national transposition and implementation of Union harmonisation legislation applicable to products. For this purpose, Article 9(1), (4) and (5) of Regulation (EU) 2019/515 shall apply.

1.   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.

2.   The market surveillance authority in question and the parties referred to in paragraph 1 shall ensure that the agreement on joint activities does not lead to unfair competition between economic operators and does not affect the objectivity, independence and impartiality of the parties.

3.   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.

4.   The market surveillance authority in question shall make the agreement on joint activities, including the names of the parties involved, available to the public and shall enter that agreement in the information and communication system referred to in Article 34. At the request of a Member State, the Network established under Article 29 shall assist in the drawing up of the agreement on joint activities.

1.   Member States shall organise and carry out market surveillance as provided for in this Regulation.

2.   For the purposes of paragraph 1 of this Article, 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.

3.   Each Member State shall appoint a single liaison office.

4.   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. The single liaison office shall also assist in the cooperation between market surveillance authorities in different Member States, as set out in Chapter VI.

5.   In order to carry out market surveillance of products made available online and offline with the same effectiveness for all distribution channels, Member States shall 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.

6.   Where there is more than one market surveillance authority in their territory, Member States shall ensure that the respective duties of those authorities are clearly defined and that appropriate communication and coordination mechanisms are established to enable those authorities to collaborate closely and exercise their duties effectively.

1.   Market surveillance authorities shall conduct their activities in order to ensure the following:

2.   Market surveillance authorities shall exercise their powers and carry out their duties independently, impartially and without bias.

3.   Market surveillance authorities, as part of their activities set out in paragraph 1 of this Article, shall perform appropriate checks on the characteristics of products on an adequate scale, by means of documentary checks and, where appropriate, physical and laboratory checks based on adequate samples, prioritising their resources and actions to ensure effective market surveillance and taking into account the national market surveillance strategy referred to in Article 13.

In deciding on which checks to perform, on which types of products and on what scale, market surveillance authorities shall follow a risk-based approach taking into account the following factors:

4.   The Commission, after consulting the Network, may adopt implementing acts determining the uniform conditions of checks, criteria for determination of the frequency of checks and amount of samples to be checked in relation to certain products or categories of products, where specific risks or serious breaches of applicable Union harmonisation legislation have been continuously identified, in order to ensure high level of protection of health and safety or other public interests protected by that legislation. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 43(2).

5.   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 shall take due account of those reports or certificates.

6.   Evidence that is used by a market surveillance authority in one Member State may be used as part of investigations to verify product compliance carried out by market surveillance authorities in another Member State, without any further formal requirements.

7.   Market surveillance authorities shall establish the following procedures in connection with products subject to the Union harmonisation legislation:

8.   With a view to ensuring communication and coordination with their counterparts in other Member States, market surveillance authorities shall actively participate in administrative cooperation groups (ADCOs) as referred to in Article 30(2).

9.   Without prejudice to any Union safeguard procedure pursuant to the applicable Union harmonisation legislation, products that have been deemed to be non-compliant on the basis of a decision of a market surveillance authority in one Member State shall be presumed to be non-compliant by market surveillance authorities in other Member States, unless a relevant market surveillance authority in another Member State concluded the contrary on the basis of its own investigation, taking into account the input, if any, provided by an economic operator.

1.   Peer reviews shall be organised for market surveillance authorities wishing to participate in such reviews, in order to strengthen consistency in market surveillance activities in relation to the application of this Regulation.

2.   The Network shall develop the methodology and the rolling plan for peer reviews among participating market surveillance authorities. When establishing the methodology and the rolling plan, the Network shall take into consideration, at least, the number and the size of market surveillance authorities in the Member States, the number of personnel available and other resources for performing the peer review, and other relevant criteria.

3.   Peer reviews shall cover best practices developed by some market surveillance authorities which may be of benefit for other market surveillance authorities, and other relevant aspects related to the effectiveness of market surveillance activities.

4.   The outcome of the peer reviews shall be reported to the Network.

1.   Each Member State shall draw up an overarching national market surveillance strategy, at least every four years. Each Member State shall draw up the first such strategy by 16 July 2022. The national strategy shall promote a consistent, comprehensive and integrated approach to market surveillance and to the enforcement of Union harmonisation legislation within the territory of the Member State. When drawing up the national market surveillance strategy, all sectors covered by the Union harmonisation legislation and all stages of the product supply chain, including imports and digital supply chains, shall be considered. The priorities set out within the work programme of the Network may also be considered.

2.   The national market surveillance strategy shall include at least the following elements, when this does not compromise market surveillance activities:

3.   Member States shall communicate their national market surveillance strategy to the Commission and other Member States through the information and communication system referred to in Article 34. Each Member State shall publish a summary of its strategy.

1.   Member States shall confer on their market surveillance authorities the powers of market surveillance, investigation and enforcement necessary for the application of this Regulation and for the application of Union harmonisation legislation.

2.   Market surveillance authorities shall exercise the powers set out in this Article efficiently and effectively, in accordance with the principle of proportionality, to the extent that such exercise relates to the subject matter and the purpose of the measures and the nature and the overall actual or potential harm resulting from the instance of non-compliance. Powers shall be conferred and exercised in accordance with Union and national law, including the principles of the Charter of Fundamental Rights of the European Union, as well as with principles of national law relating to freedom of expression and the freedom and pluralism of the media, with applicable procedural safeguards and with the Union rules on data protection, in particular Regulation (EU) 2016/679.

3.   When conferring powers under paragraph 1, Member States may provide for the power to be exercisable in one of the following ways, as appropriate:

4.   The powers conferred on market surveillance authorities under paragraph 1 shall include at least the following:

5.   Market surveillance authorities may use any information, document, finding, statement, or any intelligence as evidence for the purpose of their investigations, irrespective of the format in which and medium on which they are stored.

1.   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.

2.   The costs referred to in paragraph 1 of this Article may include the costs of carrying out testing, the costs of taking measures in accordance with Article 28(1) and (2), the costs of storage and the costs of activities relating to products that are found to be non-compliant and are subject to corrective action prior to their release for free circulation or their placing on the market.

1.   Market surveillance authorities shall take appropriate measures if a product subject to Union harmonisation legislation, when used in accordance with its intended purpose or under conditions which can be reasonably foreseen and when properly installed and maintained:

2.   Where market surveillance authorities make findings referred to in point (a) or (b) of paragraph 1, they shall without delay require the relevant economic operator to take appropriate and proportionate corrective action to bring the non-compliance to an end or to eliminate the risk within a period they specify.

3.   For the purposes of paragraph 2, the corrective action required to be taken by the economic operator may include, inter alia:

4.   Corrective actions referred to in points (e), (f) and (g) of paragraph 3 may only be required in cases where the product is liable to present a risk only in certain conditions or only to certain end users.

5.   If the economic operator fails to take corrective action referred to in paragraph 3 or where the non-compliance or the risk referred to in paragraph 1 persists, market surveillance authorities shall ensure that the product is withdrawn or recalled, or that its being made available on the market is prohibited or restricted, and that the public, the Commission and the other Member States are informed accordingly.

6.   The information to the Commission and the other Member States pursuant to paragraph 5 of this Article shall be communicated through the information and communication system referred to in Article 34. That communication of information shall also be deemed to fulfil notification requirements for the applicable safeguard procedures of Union harmonisation legislation.

7.   Where a national measure is considered to be justified in accordance with the applicable safeguard procedure, or where no market surveillance authority of another Member State concluded the contrary as referred to in Article 11(9), the competent market surveillance authorities in the other Member States shall take the necessary measures in respect of the non-compliant product and shall enter the relevant information in the information and communication system referred to in Article 34.

1.   Any measure, decision or order taken or made by market surveillance authorities pursuant to Union harmonisation legislation or this Regulation shall state the exact grounds on which it is based.

2.   Any such measure, decision or order shall be communicated without delay to the relevant economic operator, who shall at the same time be informed of the remedies available to it under the law of the Member State concerned and of the time limits to which those remedies are subject.

3.   Before a measure, decision or order referred to in paragraph 1 is taken or made, the economic operator concerned shall be given the opportunity to be heard within an appropriate period of not less than 10 working days, unless it is not possible to give the economic operator that opportunity because of the urgency of the measure, decision or order, based on health or safety requirements or other grounds relating to the public interests covered by the relevant Union harmonisation legislation.

If the measure, decision or order is taken or made without the economic operator being given the opportunity to be heard, the economic operator shall be given that opportunity as soon as possible thereafter and that measure, decision or order shall be reviewed promptly by the market surveillance authority.

1.   Market surveillance authorities shall 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 shall notify the Commission thereof immediately, in accordance with Article 20.

2.   A decision whether or not a product presents a serious risk shall be based on an appropriate risk assessment that takes account of the nature of the hazard and the likelihood of its occurrence. The feasibility of obtaining higher levels of safety and the availability of other products presenting a lesser degree of risk shall not constitute grounds for considering that a product presents a serious risk.

1.   Where a market surveillance authority takes or intends to take a measure pursuant to Article 19 and considers that the reasons which prompted the measure or the effects of the measure go beyond the territory of its Member State, it shall immediately notify the Commission of that measure in accordance with paragraph 4 of this Article. The market surveillance authority shall also inform the Commission without delay of the modification or withdrawal of any such measure.

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

3.   The information provided in accordance with paragraphs 1 and 2 shall include all available details, in particular the data necessary for the identification of the product, the origin and the supply chain of the product, the risk related to the product, the nature and the duration of the national measure taken and any voluntary measures taken by economic operators.

4.   For the purposes of paragraphs 1, 2 and 3 of this Article, the Rapid Information Exchange System (RAPEX) provided for in Article 12 of Directive 2001/95/EC shall be used. Paragraphs 2, 3 and 4 of Article 12 of that Directive shall apply mutatis mutandis.

5.   The Commission shall provide and maintain a data interface between RAPEX and the information and communication system referred to in Article 34 so as to avoid double data entry.

1.   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.

2.   For the purposes of paragraph 1, 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.

3.   Union testing facilities shall be accredited in accordance with Regulation (EC) No 765/2008.

4.   The designation of Union testing facilities shall not affect the freedom of market surveillance authorities, the Network and the Commission to choose testing facilities for the purpose of their activities.

5.   Designated Union testing facilities shall provide their services solely to market surveillance authorities, the Network, the Commission and other government or intergovernmental entities.

6.   Union testing facilities shall, within the area of their competence, perform the following activities:

7.   The activities referred to in paragraph 6 of this Article shall be remunerated and may be financed by the Union in accordance with Article 36(2).

8.   Union testing facilities may receive financing by the Union in accordance with Article 36(2) in order to increase their testing capacity or to create new testing capacity for specific categories of products or for specific risks related to a category of products for which the testing capacity is missing or is insufficient.

9.   The Commission shall adopt implementing acts specifying the procedures for the designation of Union testing facilities. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 43(2).

1.   There shall be efficient cooperation and exchange of information among the market surveillance authorities of the Member States, and between market surveillance authorities and the Commission and the relevant Union agencies.

2.   When a market surveillance authority is unable to conclude its investigation because of its inability to access certain information, despite having made all appropriate efforts to obtain that information, it may submit a reasoned request to the market surveillance authority of another Member State where access to this information can be enforced. In this case the requested authority shall supply to the applicant authority without delay, and in any event within 30 days, any information that the requested authority considers to be relevant in order to establish whether a product is non-compliant.

3.   The requested authority shall undertake appropriate investigations or take any other measures that are appropriate in order to gather the requested information. Where necessary, those investigations shall be carried out with the assistance of other market surveillance authorities.

4.   The applicant authority shall remain responsible for any investigation that it has initiated, unless the requested authority agrees to take over responsibility.

5.   In duly justified cases, a requested authority may refuse to comply with a request for information under paragraph 2 where:

1.   Where bringing non-compliance with regard to a product to an end requires measures within the jurisdiction of another Member State and where such measures do not result from the requirements of Article 16(7), an applicant authority may submit a duly reasoned request for enforcement measures to a requested authority in that other Member State.

2.   The requested authority shall without delay take all appropriate and necessary enforcement measures using the powers conferred on it under this Regulation in order to bring the instance of non-compliance to an end by exercising the powers laid down in Article 14 and any additional powers granted to it under national law.

3.   The requested authority shall inform the applicant authority about the measures referred to in paragraph 2 that have been taken or which are intended to be taken.

A requested authority may refuse to comply with a request for enforcement measures in any of the following situations:

1.   Before submitting a request under Article 22 or 23, the applicant authority shall endeavour to carry out all reasonable possible investigations.

2.   When submitting a request under Article 22 or 23, the applicant authority shall provide all available information in order to enable the requested authority to fulfil the request, including any necessary evidence obtainable only in the Member State of the applicant authority.

3.   Requests under Articles 22 and 23 and all communication related to them shall be made using electronic standard forms by means of the information and communication system referred to in Article 34.

4.   Communication shall take place directly between the involved market surveillance authorities or through the single liaison offices of the Member States concerned.

5.   The languages to be used for requests under Articles 22 and 23 and for all communication linked to them shall be agreed upon by the market surveillance authorities concerned.

6.   Where no agreement about the languages to be used can be reached between the market surveillance authorities concerned, the requests under Articles 22 and 23 shall be sent in the official language of the Member State of the applicant authority, and the replies to such requests shall be sent in the official language of the Member State of the requested authority. In such case, the applicant authority and the requested authority shall arrange for the translation of the requests, replies or other documents that it receives from the other authority.

7.   The information and communication system referred to in Article 34 shall provide structured information on mutual assistance cases to the single liaison offices involved. Using this information, single liaison offices shall provide any support that is necessary to facilitate assistance.

1.   Member States shall 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.

Each Member State shall inform the Commission and the other Member States of the authorities designated under the first subparagraph and of their areas of competence through the information and communication system referred to in Article 34.

2.   The authorities designated under paragraph 1 shall have the necessary powers and resources for the proper performance of their tasks as referred to in that paragraph.

3.   Products subject to Union law that are to be placed under the customs procedure ‘release for free circulation’ shall be subject to controls performed by the authorities designated under paragraph 1 of this Article. They shall perform those controls on the basis of risk analysis in accordance with Articles 46 and 47 of Regulation (EU) No 952/2013 and, where relevant, on the basis of risk-based approach as referred to in the second subparagraph of Article 11(3) of this Regulation.

4.   Risk-related information shall be exchanged between:

Where, in relation to products subject to Union law that are either in temporary storage or placed under a customs procedure other than ‘release for free circulation’, customs authorities at the first point of entry have reason to believe that those products are not compliant with applicable Union law or present a risk, they shall transmit all relevant information to the competent customs office of destination.

5.   Market surveillance authorities shall provide authorities designated under paragraph 1 with information on categories of products or the identity of economic operators where a higher risk of non-compliance has been identified.

6.   By 31 March of each year, Member States shall submit to the Commission detailed statistical data covering controls performed by the authorities designated under paragraph 1 with respect to products subject to Union law during the previous calendar year. The statistical data shall cover the number of interventions in the field of controls on such products with regard to product safety and compliance.

The Commission shall draw up a report by 30 June of each year, containing the information provided by the Member States for the previous calendar year and an analysis of the data submitted. The report shall be published in the information and communication system referred to in Article 34.

7.   Where the Commission becomes aware of a serious risk presented by products subject to Union law that are imported from a third country, it shall recommend to the Member State concerned to take appropriate market surveillance measures.

8.   The Commission, after consulting the Network, may adopt implementing acts laying down benchmarks and techniques for checks on the basis of common risk analysis on the Union level, in order to ensure a consistent enforcement of Union law, to strengthen the controls on products entering the Union market and to ensure an effective and uniform level of such controls. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 43(2).

9.   The Commission shall adopt implementing acts further specifying the details of the data to be submitted under paragraph 6 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 43(2).

1.   Authorities designated under Article 25(1) shall suspend the release of a product for free circulation if in the course of controls pursuant to Article 25(3), it is established that:

2.   Authorities designated under Article 25(1) shall immediately notify the market surveillance authorities of any suspension of release referred to in paragraph 1 of this Article.

3.   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 shall request the authorities designated under Article 25(1) to suspend the process for its release for free circulation.

4.   Notifications under paragraph 2 and requests under paragraph 3 of this Article may take place by means of the information and communication system referred to in Article 34, including through the use of electronic interfaces between this system and systems used by customs authorities, when they are available.

1.   Where the market surveillance authorities conclude that a product presents a serious risk, they shall take measures to prohibit the placing of the product on the market and shall require the authorities designated under Article 25(1) not to release it for free circulation. They shall also require these 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:

Market surveillance authorities shall immediately enter that information in the information and communication system referred to in Article 34.

2.   Where market surveillance authorities conclude that a product may not be placed on the market since it does not comply with the Union law applicable to it, they shall take measures to prohibit the placing of the product on the market and shall require the authorities designated under Article 25(1) not to release it for free circulation. They shall 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:

Market surveillance authorities shall immediately enter that information in the information and communication system referred to in Article 34.

3.   Where the product referred to in paragraph 1 or 2 is subsequently declared for a customs procedure other than release for free circulation and provided that the market surveillance authorities do not object, the notice required by paragraph 1 or 2 shall also be included, under the same conditions as required by paragraph 1 or 2, in the documents used in connection with that procedure.

4.   Authorities designated under Article 25(1) may destroy or otherwise render inoperable a product which presents a risk to the health and safety of end users where the authority in question considers that it is necessary and proportionate to do so. The cost of such measure shall be borne by the natural or legal person declaring the product for free circulation.

Articles 197 and 198 of Regulation (EU) No 952/2013 shall apply accordingly.

1.   A Union Product Compliance Network (‘the Network’) is hereby established.

2.   The purpose of the Network is to serve as a platform for structured coordination and cooperation between enforcement authorities of the Member States and the Commission, and to streamline the practices of market surveillance within the Union, thereby making market surveillance more effective.

1.   The Network shall be composed of representatives from each Member State, including a representative of each single liaison office referred to in Article 10 and an optional national expert, the chairs of ADCOs, and representatives from the Commission.

2.   Separate or joint ADCOs shall be established for the uniform application of Union harmonisation legislation. ADCOs shall be composed of representatives of the national market surveillance authorities and, if appropriate, representatives of the single liaison offices.

ADCOs meetings are intended only for representatives of market surveillance authorities and the Commission.

Relevant stakeholders, such as organisations representing the interests of industry, small and medium-sized enterprises (SMEs), consumers, testing laboratories, standardisation and conformity assessment bodies at Union level, may be invited to attend the ADCOs meetings depending on the subject matter of discussion.

3.   The Commission shall support and encourage cooperation between market surveillance authorities through the Network and participate in the meetings of the Network, its sub-groups and the ADCOs.

4.   The Network shall meet at regular intervals and, where necessary, at the reasoned request of the Commission or a Member State.

5.   The Network may establish standing or temporary sub-groups dealing with specific questions and tasks.

6.   The Network may invite experts and other third parties, including the organisations representing the interests of industry, SMEs, consumers, testing laboratories, standardisation and conformity assessment bodies at Union level, to attend meetings as observers or to provide written contributions.

7.   The Network shall use its best endeavours to reach consensus. Decisions taken by the Network shall be legally non-binding recommendations.

8.   The Network shall establish its own rules of procedure.

1.   In carrying out the tasks set out in paragraph 2, the Network shall address general, horizontal issues of market surveillance with a view to facilitating the cooperation among single liaison offices, as well as the Commission.

2.   The Network shall have the following tasks:

1.   In carrying out the tasks set out in paragraph 2, ADCOs shall address specific matters related to market surveillance and sector specific issues.

2.   ADCOs shall have the following tasks:

1.   The Commission shall further develop and maintain an information and communication system for the collection, processing and storage of information, in a structured form, on issues relating to the enforcement of Union harmonisation legislation, with the aim of improving the sharing of data among Member States, including for the purpose of requests for information, providing a comprehensive overview of market surveillance activities, results and trends. The Commission, market surveillance authorities, single liaison offices, and authorities designated under Article 25(1) shall have access to that system. The Commission shall develop and maintain the public user interface of this system, where key information for end-users about market surveillance activities shall be provided.

2.   The Commission shall further develop and maintain electronic interfaces between the system referred to in paragraph 1 and national market surveillance systems.

3.   Single liaison offices shall enter the following information in the information and communication system:

4.   Market surveillance authorities shall enter into the information and communication system in relation to products made available on the market for which an in-depth check of compliance has been carried out, without prejudice to Article 12 of Directive 2001/95/EC and Article 20 of this Regulation, and where applicable, in relation to products entering the Union market for which the process for the release for free circulation has been suspended in accordance with Article 26 of this Regulation, in their territory, the following information concerning:

5.   Where market surveillance authorities consider it useful, they may enter into the information and communication system any additional information related to the checks they perform and results of testing carried out by them or at their request.

6.   Where relevant for the enforcement of Union harmonisation legislation and for the purpose of minimising risk, customs authorities shall extract from national customs systems information on products placed under the customs procedure ‘release for free circulation’ related to the enforcement of Union harmonisation legislation and transmit it to the information and communication system.

7.   The Commission shall develop an electronic interface to enable the transmission of data between national customs systems and the information and communication system. This interface shall be in place within four years from the date of adoption of the relevant implementing act referred to in paragraph 8.

8.   The Commission shall adopt implementing acts specifying the details of implementation arrangements for paragraphs 1 to 7 of this Article, and in particular the data processing to be applied on data collected in accordance with paragraph 1 of this Article, and defining the data to be transmitted in accordance with paragraphs 6 and 7 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 43(2).

1.   In order to improve the efficiency of market surveillance in the Union, the Commission may cooperate with and exchange market surveillance related information with regulatory authorities of third countries or international organisations within the framework of agreements concluded between the Union and third countries or international organisations. Any such agreements shall be based on reciprocity, include provisions on confidentiality corresponding to those applicable in the Union, and ensure that any exchange of information is in accordance with applicable Union law.

2.   The cooperation or exchange of information may relate, inter alia, to the following:

3.   The Commission may approve a specific system of product-related pre-export control carried out by a third country on products immediately prior to their export into the Union in order to verify that those products satisfy the requirements of the Union harmonisation legislation applicable to them. The approval may be granted in respect of one or more products, in respect of one or more categories of products or in respect of products or categories of products manufactured by certain manufacturers.

4.   The Commission shall produce and maintain a list of those products or categories of products with regard to which approval has been granted as referred to in paragraph 3 and shall make this list available to the public.

5.   Approval may only be granted to a third country under paragraph 3 if following conditions are satisfied:

6.   Where such an approval has been granted, the risk assessment applied to import controls for those products or categories of products entering the Union market, referred to in paragraph 3, shall include the granted approvals.

Authorities designated under Article 25(1) may however carry out controls on those products or categories of products entering the Union market, including in order to ensure that the pre-export controls carried out by the third country are effective to determine compliance with Union harmonisation legislation.

7.   The approval referred to in paragraph 3 shall specify the competent authority of the third country under whose responsibility the pre-export controls are to be performed and that competent authority shall be the counterpart for all contacts with the Union.

8.   The competent authority, referred to in paragraph 7, shall ensure the official verification of the products prior to their entry into the Union.

9.   Where controls on products entering the Union market referred to in paragraph 3 of this Article reveal significant non-compliance, the market surveillance authorities shall notify immediately the Commission through the information and communication system referred to in Article 34 and adapt the level of controls on such products.

10.   The Commission shall adopt implementing acts approving each specific system of product-related pre-export controls, referred to in paragraph 3 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 43(2).

11.   The Commission shall regularly monitor the correct functioning of the approval granted under paragraph 3 of this Article. The Commission shall adopt implementing acts withdrawing that approval where it is revealed that the products entering the Union market do not comply with Union harmonisation legislation in a significant number of instances. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 43(2). The Commission shall immediately inform the third country concerned thereof.

12.   The system of product-related pre-export control shall be evaluated in accordance with Article 42(4).

1.   The Union shall finance performance of the tasks of the Network referred to in Article 31 and the peer reviews referred to in Article 12.

2.   The Union may finance the following activities in relation to the application of this Regulation:

3.   The Union shall finance the electronic interface referred to in Article 34(7), including the development of the information and communication system referred to in Article 34 to enable it to receive automatic flows of electronic data from the national customs systems.

4.   The Union shall finance the electronic interfaces referred to in Article 34(2) enabling the exchange of data between the information and communication system referred to in Article 34 and the national market surveillance systems.

5.   The Union's financial assistance with respect to the activities in support of this Regulation shall be implemented in accordance with Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council (52), either directly, or by entrusting budget implementation tasks to the entities listed in point (c) of Article 62(1) of that Regulation.

6.   The appropriations allocated to activities referred to in this Regulation shall be determined each year by the budgetary authority within the limits of the financial framework in force.

7.   The appropriations determined by the budgetary authority for the financing of market surveillance activities may also cover expenses relating to preparatory work, monitoring, control, audit and evaluation activities which are required for the management of the activities set out in this Regulation and for the achievement of their objectives. These expenses shall include the costs of conducting studies, arranging meetings of experts, information and communication activities, including corporate communication of the political priorities of the Union in so far as they are related to the general objectives of market surveillance activities, expenses linked to information technology networks focusing on information processing and exchange together with all other related technical and administrative assistance expenses incurred by the Commission.

1.   The Commission shall take appropriate measures to ensure that, when activities financed under this Regulation are implemented, the financial interests of the Union are protected by the application of preventive measures against fraud, corruption and any other illegal activities, by effective controls and, if irregularities are detected, by the recovery of the amounts wrongly paid and, where appropriate, by effective, proportionate and dissuasive administrative and financial penalties.

2.   The Commission or its representatives and the Court of Auditors shall have the power of audit, on the basis of documents and of on-the-spot inspections, over all grant beneficiaries, contractors and subcontractors who have received Union funds under this Regulation.

3.   The European Anti-Fraud Office (OLAF) may carry out investigations, including on-the-spot controls and inspections, in accordance with the provisions and procedures laid down in Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council (53) and Council Regulation (Euratom, EC) No 2185/96 (54) with a view to establishing whether there has been fraud, corruption or any other illegal activity affecting the financial interests of the Union in connection with a grant agreement or grant decision or a contract funded under this Regulation.

4.   Without prejudice to paragraphs 1, 2 and 3, cooperation agreements with third countries and with international organisations, contracts, grant agreements and grant decisions resulting from the implementation of this Regulation shall contain provisions expressly empowering the Commission, the Court of Auditors and OLAF to conduct such audits and investigations, in accordance with their respective competences.

1.   Regulation (EC) No 765/2008 is amended as follows:

2.   References to the deleted provisions of Regulation (EC) No 765/2008 shall be construed as references to the provisions of this Regulation and shall be read in accordance with the correlation table in Annex III to this Regulation.

1.   The Member States shall lay down the rules on penalties applicable to infringements of this Regulation and of Union harmonisation legislation listed in Annex II that impose obligations on economic operators and shall take all measures necessary to ensure that they are implemented in accordance with national law.

2.   The penalties provided for shall be effective, proportionate and dissuasive.

3.   The Member States shall, by 16 October 2021, notify those provisions to the Commission, where they have not previously been notified, and shall notify it, without delay, of any subsequent amendment affecting them.

1.   By 31 December 2026 and every five years thereafter, the Commission shall carry out an evaluation of this Regulation in light of the objectives that it pursues and shall present a report thereon to the European Parliament, to the Council and to the European Economic and Social Committee.

2.   The report shall assess whether this Regulation achieved its objective, in particular with regard to reducing the number of non-compliant products on the Union market, ensuring effective and efficient enforcement of Union harmonisation legislation within the Union, improving cooperation between competent authorities and strengthening the controls on products entering the Union market, while taking into account the impact on business and in particular on SMEs. In addition, the evaluation shall also assess the scope of this Regulation, the effectiveness of the peer review system and of the market surveillance activities that receive Union financing in the light of the requirements of Union policies and law and the possibilities to further improve the cooperation between the market surveillance authorities and customs authorities.

3.   By 16 July 2023, the Commission shall prepare an evaluation report on the implementation of Article 4. The report shall in particular evaluate the scope of that Article, its effects and its costs and benefits. The report shall be accompanied, where appropriate, by a legislative proposal.

4.   Within four years after the first approval of a specific system of product-related pre-export control referred to in Article 35(3), the Commission shall carry out an evaluation of its effects and cost efficiency.

5.   In order to facilitate the implementation of this Regulation, the Commission shall draw up guidelines for the practical implementation of Article 4 for the purposes of market surveillance authorities and economic operators.

1.   The Commission shall be assisted by a committee. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011.

2.   Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.

Where the committee delivers no opinion, the Commission shall not adopt the draft implementing act in respect of the implementing powers referred to in Article 11(4), Article 21(9), Article 25(8), Article 35(10) and Article 35(11) of this Regulation, and the third subparagraph of Article 5(4) of Regulation (EU) No 182/2011 shall apply.

1.   The manufacturing, placing on the market and use of substances listed in Annex I, whether on their own, in mixtures or in articles, shall be prohibited, subject to Article 4.

2.   The manufacturing, placing on the market and use of substances listed in Annex II, whether on their own, in mixtures or in articles, shall be restricted, subject to Article 4.

3.   Member States and the Commission shall, within the assessment and authorisation schemes for existing and new substances under the relevant Union legislation, take into consideration the criteria set out in paragraph 1 of Annex D to the Convention and take appropriate measures to control existing substances and prevent the manufacturing, placing on the market and use of new substances, which exhibit characteristics of POPs.

4.   When preparing a proposal to the Council, pursuant to Article 218(9) TFEU, for the listing of a substance in accordance with the provisions of the Convention, the Commission shall be supported by the European Chemicals Agency (‘the Agency’), established by Regulation (EC) No 1907/2006, as referred to in point (c) of Article 8(1). The competent authorities of Member States may forward proposals for listing to the Commission. In the further stages of the listing process, the Agency shall provide support to the Commission and the competent authorities of the Member States, as referred to in point (e) of Article 8(1).

5.   The Commission and the Agency shall, in all stages of the process referred to in paragraphs 3 and 4, cooperate with and inform the competent authorities of the Member States.

6.   Waste consisting of, containing or contaminated by any substance listed in Annex IV is regulated by Article 7.

1.   Article 3 shall not apply in the case of:

2.   For a substance added to Annex I or II after 15 July 2019, Article 3 shall not apply for a six-month period if that substance is present in articles produced before or on the date that this Regulation becomes applicable to that substance.

Article 3 shall not apply in the case of a substance present in articles already in use before or on the date that this Regulation or Regulation (EC) No 850/2004 became applicable to that substance, whichever date came first.

Immediately upon becoming aware of articles as referred to in the first and second subparagraph, a Member State shall inform the Commission and the Agency accordingly.

Whenever the Commission is so informed or otherwise learns of such articles, it shall, where appropriate, notify the Secretariat of the Convention accordingly without further delay.

3.   Where a substance is listed in Part A of Annex I or in Part A of Annex II, a Member State wishing to permit, until the deadline specified in the relevant Annex, the manufacturing and use of that substance as a closed-system site-limited intermediate shall notify accordingly the Secretariat of the Convention.

Such notification may be made only if the following conditions are satisfied:

Within one month of submission of the notification to the Secretariat of the Convention, the Member State shall communicate the notification to the other Member States, to the Commission and the Agency, and shall give details of actual or estimated total manufacturing and use of the substance concerned and the nature of the closed-system site-limited process, specifying the amount of any non-transformed and unintentional trace contamination by any POP starting material in the final substance, mixture or article.

The Commission is empowered to adopt delegated acts in accordance with Article 18 in order to amend Annexes I and II by entering annotations expressly to the effect that manufacturing and use, as a closed-system site-limited intermediate, of a substance listed in Part A of the relevant Annex may be permitted, and to amend the deadlines in such annotations in cases where, following a repeat notification from the Member State concerned to the Secretariat of the Convention, express or tacit consent is issued under the Convention for the continued manufacturing and use of the substance for another period.

4.   Waste consisting of, containing or contaminated by any substance listed in Annex IV is regulated by Article 7.

1.   The holder of a stockpile, which consists of or contains any substance listed in Annex I or II, for which no use is permitted, shall manage that stockpile as waste and in accordance with Article 7.

2.   The holder of a stockpile greater than 50 kg, consisting of or containing any substance listed in Annex I or II, and the use of which is permitted shall provide the competent authority of the Member State in which the stockpile is established with information concerning the nature and size of that stockpile. Such information shall be provided within 12 months of the date that this Regulation or Regulation (EC) No 850/2004 became applicable to that substance, whichever date came first for the holder, and of relevant amendments to Annex I or II and annually thereafter until the deadline specified in Annex I or II for restricted use.

The holder shall manage the stockpile in a safe, efficient and environmentally sound manner, in accordance with the thresholds and requirements laid down in Directive 2012/18/EU of the European Parliament and of the Council (22) and taking all adequate steps to ensure that the stockpile is managed in a manner that will protect human health and the environment.

3.   Member States shall monitor the use and management of notified stockpiles.

1.   Within two years of the date of entry into force of this Regulation or Regulation (EC) No 850/2004, whichever date came first, Member States shall draw up inventories for the substances listed in Annex III released into air, water and land in accordance with their obligations under the Convention and the Protocol and shall subsequently maintain such inventories.

2.   Member States shall communicate their action plans on measures to identify, characterise and minimise, with a view to eliminating where feasible as soon as possible, the total releases of substances listed in Annex III as recorded in their inventories drawn up in accordance with their obligations under the Convention, to the Commission, the Agency and to the other Member States as part of their national implementation plans, pursuant to Article 9.

Such action plans shall include measures to promote the development of, and, where it is considered appropriate, shall require the use of substitute or modified substances, mixtures, articles and processes to prevent the formation and release of substances listed in Annex III.

3.   Member States shall, when considering proposals to construct new facilities or to significantly modify existing facilities using processes that release chemicals listed in Annex III, give priority consideration to alternative processes, techniques or practices that have similar usefulness but which avoid the formation and release of substances listed in Annex III, without prejudice to Directive 2010/75/EU of the European Parliament and of the Council (23).

1.   Producers and holders of waste shall undertake all reasonable efforts to avoid, where feasible, contamination of this waste with substances listed in Annex IV.

2.   Notwithstanding Council Directive 96/59/EC (24), waste consisting of, containing or contaminated by any substance listed in Annex IV to this Regulation shall be disposed of or recovered, without undue delay and in accordance with Part 1 of Annex V to this Regulation, in such a way as to ensure that the POP content is destroyed or irreversibly transformed so that the remaining waste and releases do not exhibit the characteristics of POPs.

In carrying out such a disposal or recovery, any substance listed in Annex IV may be isolated from the waste, provided that this substance is subsequently disposed of in accordance with the first subparagraph.

3.   Disposal or recovery operations that may lead to recovery, recycling, reclamation or re-use on their own of the substances listed in Annex IV shall be prohibited.

4.   By way of derogation from paragraph 2:

5.   The Commission may, where appropriate, and taking into consideration technical developments and relevant international guidelines and decisions and any authorisations granted by a Member State, or by the competent authority designated by that Member State in accordance with paragraph 4 and Annex V, adopt implementing acts concerning the implementation of this Article. In particular, the Commission may specify the format of the information to be submitted by Member States in accordance with point (b)(iv) of paragraph 4. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 20(3).

6.   Member States shall take the necessary measures to ensure the control and traceability, in accordance with Article 17 of Directive 2008/98/EC, of waste containing or contaminated by a substance listed in Annex IV to this Regulation.

1.   The Agency shall, in addition to the tasks allocated to it under Articles 9, 10, 11, 13 and 17, carry out the following tasks:

2.   The Forum shall be used to coordinate a network of the Member States' authorities responsible for enforcement of this Regulation.

The members of the Forum who are appointed by a Member State shall ensure that there is appropriate coordination between the tasks of the Forum and the work of their Member State competent authority.

The Forum shall involve the enforcement authorities of Member States responsible for waste when dealing with waste-related issues.

3.   The Secretariat of the Agency shall carry out the tasks allocated to the Agency under this Regulation.

1.   When preparing and updating their national implementation plans, Member States shall, in accordance with their national procedures, give the public early and effective opportunities to participate in this process.

2.   As soon as a Member State has adopted its national implementation plan in accordance with its obligations under the Convention, it shall make it publicly available and communicate its publication to the Commission, the Agency and to the other Member States.

3.   When Member States are preparing and updating their implementation plans, the Commission, supported by the Agency, and the Member States shall exchange information on the content, including information on measures taken at national level to identify and assess sites contaminated by POPs, as appropriate.

4.   The Commission, supported by the Agency, shall maintain a plan for the implementation of Union obligations under the Convention and shall publish, review and update that plan, as appropriate.

1.   The Commission, supported by the Agency, and the Member States shall establish or maintain, as appropriate, in close cooperation, appropriate programmes and mechanisms, consistent with the state of the art, for the regular provision of comparable monitoring data on the presence of substances as listed in Part A of Annex III in the environment. When establishing or maintaining such programmes and mechanisms, due account shall be taken of developments under the Protocol and the Convention.

2.   The Commission shall regularly assess the possible need for the mandatory monitoring of a substance listed in Part B of Annex III. In the light of such an assessment and any data made available to it by Member States, the Commission is empowered to adopt delegated acts in accordance with Article 18 to amend Annex III in order to move, where appropriate, a substance from Part B of Annex III to Part A thereof.

1.   The Commission, the Agency and the Member States shall facilitate and undertake the exchange within the Union and with third countries of information relevant to the reduction, minimisation or elimination, where feasible, of the manufacturing, use and release of POPs and to alternatives to those substances, specifying the risks and the economic and social costs related to such alternatives.

2.   The Commission, the Agency and the Member States, as appropriate, shall promote and facilitate with regard to POPs:

3.   Without prejudice to Regulations (EC) No 1049/2001, and (EC) No 1367/2006 and Directive 2003/4/EC, information on the health and safety of humans and the environment shall not be regarded as confidential. The Commission, the Agency and the Member States that exchange information with a third country shall protect any confidential information in accordance with Union law.

1.   Without prejudice to Directives 2003/4/EC and 2007/2/EC, Member States shall draw up and publish a report containing:

Member States shall update the report annually as far as new data or information is available and otherwise at least every three years.

Members States shall give the Commission and the Agency access to the information contained in the reports.

2.   Where a Member State shares the information referred to in point (e) of paragraph 1 with the Information Platform for Chemical Monitoring, this shall be indicated by that Member State in its report and the Member State shall be considered to have fulfilled its reporting obligations under that point.

Where the information referred to in point (e) of paragraph 1 is contained in the report of a Member State provided to the Agency, the Agency shall use the Information Platform for Chemical Monitoring for compiling, storing and sharing that information.

3.   Regarding the substances listed in the Convention, the Commission, supported by the Agency, shall, at the intervals determined by the Conference of the Parties of the Convention, compile a report on the basis of the information provided by the Member States to the Agency in accordance with point (f) of paragraph 1 and communicate it to the Secretariat of the Convention.

4.   The Agency shall compile and publish a Union overview report on the basis of the data referred to in paragraphs 1 and 2 that is published or notified by the Member States. The Union overview report shall include, as appropriate, indicators for outputs, results and impact of this Regulation, Union overview maps and Member State reports. The Union overview report shall be updated by the Agency at least once every six months or following receipt of a request from the Commission.

5.   The Commission may adopt implementing acts concerning the minimum information to be provided in accordance with paragraph 1, including the definition of relevant indicators, overview maps and reports referred to in point (f) of paragraph 1. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 20(3).

1.   The Commission is empowered to adopt delegated acts in accordance with Article 18 to amend the Annexes I, II and III to this Regulation in order to adapt them to changes to the list of substances set out in the Annexes to the Convention or the Protocol, on the basis that the Union has supported the change concerned by means of a Council decision adopted in accordance with Article 218(9) TFEU, or to modify existing entries or provisions in Annexes I and II to this Regulation in order to adapt them to scientific and technical progress.

Whenever the Commission amends Annex I, II or III to this Regulation, it shall adopt a separate delegated act in respect of each substance.

2.   The Commission shall keep Annexes IV and V under constant review and shall, where appropriate, make legislative proposals to amend these Annexes in order to adapt them to the changes to the list of substances set out in the Annexes to the Convention or the Protocol or to modify existing entries or provisions in the Annexes to this Regulation in order to adapt them to scientific and technical progress.

1.   For the purposes of this Regulation, the revenues of the Agency shall consist of:

2.   Revenues and expenditure for activities under this Regulation shall be combined with those relating to activities under Regulation (EU) No 649/2012 and shall be reflected in the same section in the Agency's budget. The revenues of the Agency referred to in paragraph 1 shall be used for carrying out its tasks under this Regulation.

1.   The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.

2.   The power to adopt delegated acts referred to in Articles 4(3), 10(2) and 15(1) shall be conferred on the Commission for a period of five years from 15 July 2019. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.

3.   The delegation of power referred to in Articles 4(3), 10(2) and 15(1) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.

4.   Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making.

5.   As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.

6.   A delegated act adopted pursuant to Articles 4(3), 10(2) and 15(1) shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.

1.   Except in the case referred to in paragraph 2, the Commission shall be assisted by the Committee established by Article 133 of Regulation (EC) No 1907/2006. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011.

2.   For matters relating to waste, the Commission shall be assisted by the Committee established by Article 39 of Directive 2008/98/EC. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011.

3.   Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.

Where the committee delivers no opinion, the Commission shall not adopt the draft implementing act and the third subparagraph of Article 5(4) of Regulation (EU) No 182/2011 shall apply.