What changed, Regulation (EU) 2019/1020

+ ## CHAPTER I — GENERAL PROVISIONS
− ### art_1
+ ### Article 1 — Subject matter
− Article 1
+ **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 pro…
− 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 providi…
+ **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.
− 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.
− 3. This Regulation also provides a framework for controls on products entering the Union market.
+ ### Article 2 — Scope
− ### art_2
+ **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 specifi…
− Article 2
+ **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.
− 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 ma…
+ **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.
− 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.
+ **4.** This Regulation is without prejudice to Articles 12 to 15 of Directive 2000/31/EC.
− 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.
+ ### Article 3 — Definitions
− 4. This Regulation is without prejudice to Articles 12 to 15 of Directive 2000/31/EC.
− 
− ### art_3
− Article 3
− 
+ (1) ‘making available on the market’ means any supply of a product for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge;
− | (1) | ‘making available on the market’ means any supply of a product for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge; |
− | --- | --- |
+ (2) ‘placing on the market’ means the first making available of a product on the Union market;
− | (2) | ‘placing on the market’ means the first making available of a product on the Union market; |
− | --- | --- |
+ (3) ‘market surveillance’ means the activities carried out and measures taken by market surveillance authorities to ensure that products comply with the requirements set out in the applicable Union harmonisation legislation and to ensure protection of the public interest covered by that legislation;
− | (3) | ‘market surveillance’ means the activities carried out and measures taken by market surveillance authorities to ensure that products comply with the requirements set out in the applicable Union harmonisation legislation and to ensure protection of the public interest covered by that legislat…
− | --- | --- |
+ (4) ‘market surveillance authority’ means an authority designated by a Member State under Article 10 as responsible for carrying out market surveillance in the territory of that Member State;
− | (4) | ‘market surveillance authority’ means an authority designated by a Member State under Article 10 as responsible for carrying out market surveillance in the territory of that Member State; |
− | --- | --- |
+ (5) ‘applicant authority’ means the market surveillance authority that makes a request for mutual assistance;
− | (5) | ‘applicant authority’ means the market surveillance authority that makes a request for mutual assistance; |
− | --- | --- |
+ (6) ‘requested authority’ means the market surveillance authority that receives a request for mutual assistance;
− | (6) | ‘requested authority’ means the market surveillance authority that receives a request for mutual assistance; |
− | --- | --- |
+ (7) ‘non-compliance’ means any failure to comply with any requirement under the Union harmonisation legislation or under this Regulation;
− | (7) | ‘non-compliance’ means any failure to comply with any requirement under the Union harmonisation legislation or under this Regulation; |
− | --- | --- |
+ (8) ‘manufacturer’ means any natural or legal person who manufactures a product or has a product designed or manufactured, and markets that product under its name or trademark;
− | (8) | ‘manufacturer’ means any natural or legal person who manufactures a product or has a product designed or manufactured, and markets that product under its name or trademark; |
− | --- | --- |
+ (9) ‘importer’ means any natural or legal person established within the Union who places a product from a third country on the Union market;
− | (9) | ‘importer’ means any natural or legal person established within the Union who places a product from a third country on the Union market; |
− | --- | --- |
+ (10) ‘distributor’ means any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a product available on the market;
− | (10) | ‘distributor’ means any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a product available on the market; |
− | --- | --- |
+ (11) ‘fulfilment service provider’ means any natural or legal person offering, in the course of commercial activity, at least two of the following services: warehousing, packaging, addressing and dispatching, without having ownership of the products involved, excluding postal services as defined in …
− | (11) | ‘fulfilment service provider’ means any natural or legal person offering, in the course of commercial activity, at least two of the following services: warehousing, packaging, addressing and dispatching, without having ownership of the products involved, excluding postal services as defined…
− | --- | --- |
+ (12) ‘authorised representative’ means any natural or legal person established within the Union who has received a written mandate from a manufacturer to act on its behalf in relation to specified tasks with regard to the manufacturer's obligations under the relevant Union harmonisation legislation …
− | (12) | ‘authorised representative’ means any natural or legal person established within the Union who has received a written mandate from a manufacturer to act on its behalf in relation to specified tasks with regard to the manufacturer's obligations under the relevant Union harmonisation legislat…
− | --- | --- |
+ (13) ‘economic operator’ means the manufacturer, the authorised representative, the importer, the distributor, the fulfilment service provider or any other natural or legal person who is subject to obligations in relation to the manufacture of products, making them available on the market or putting…
− | (13) | ‘economic operator’ means the manufacturer, the authorised representative, the importer, the distributor, the fulfilment service provider or any other natural or legal person who is subject to obligations in relation to the manufacture of products, making them available on the market or put…
− | --- | --- |
+ (14) ‘information society service provider’ means a provider of a service as defined in point (b) of Article 1(1) of Directive (EU) 2015/1535 of the European Parliament and of the Council (3);
− | (14) | ‘information society service provider’ means a provider of a service as defined in point (b) of Article 1(1) of Directive (EU) 2015/1535 of the European Parliament and of the Council (33); |
− | --- | --- |
+ (15) ‘online interface’ means any software, including a website, part of a website or an application, that is operated by or on behalf of an economic operator, and which serves to give end users access to the economic operator's products;
− | (15) | ‘online interface’ means any software, including a website, part of a website or an application, that is operated by or on behalf of an economic operator, and which serves to give end users access to the economic operator's products; |
− | --- | --- |
+ (16) ‘corrective action’ means any action taken by an economic operator to bring any non-compliance to an end where required by a market surveillance authority or on the economic operator's own initiative;
− | (16) | ‘corrective action’ means any action taken by an economic operator to bring any non-compliance to an end where required by a market surveillance authority or on the economic operator's own initiative; |
− | --- | --- |
+ (17) ‘voluntary measure’ means a corrective action where not required by a market surveillance authority;
− | (17) | ‘voluntary measure’ means a corrective action where not required by a market surveillance authority; |
− | --- | --- |
+ (18) ‘risk’ means the combination of the probability of an occurrence of a hazard causing harm and the degree of severity of that harm;
− | (18) | ‘risk’ means the combination of the probability of an occurrence of a hazard causing harm and the degree of severity of that harm; |
− | --- | --- |
+ (19) ‘product presenting a risk’ means a product having the potential to affect adversely health and safety of persons in general, health and safety in the workplace, protection of consumers, the environment, public security and other public interests, protected by the applicable Union harmonisation…
− | (19) | ‘product presenting a risk’ means a product having the potential to affect adversely health and safety of persons in general, health and safety in the workplace, protection of consumers, the environment, public security and other public interests, protected by the applicable Union harmonisa…
− | --- | --- |
+ (20) ‘product presenting a serious risk’ means a product presenting a risk, for which, based on a risk assessment and taking into account the normal and foreseeable use of the product, the combination of the probability of occurrence of a hazard causing harm and the degree of severity of the harm is…
− | (20) | ‘product presenting a serious risk’ means a product presenting a risk, for which, based on a risk assessment and taking into account the normal and foreseeable use of the product, the combination of the probability of occurrence of a hazard causing harm and the degree of severity of the har…
− | --- | --- |
+ (21) ‘end user’ means any natural or legal person residing or established in the Union, to whom a product has been made available either as a consumer outside of any trade, business, craft or profession or as a professional end user in the course of its industrial or professional activities;
− | (21) | ‘end user’ means any natural or legal person residing or established in the Union, to whom a product has been made available either as a consumer outside of any trade, business, craft or profession or as a professional end user in the course of its industrial or professional activities; |
− | --- | --- |
+ (22) ‘recall’ means any measure aimed at achieving the return of a product that has already been made available to the end user;
− | (22) | ‘recall’ means any measure aimed at achieving the return of a product that has already been made available to the end user; |
− | --- | --- |
+ (23) ‘withdrawal’ means any measure aimed at preventing a product in the supply chain from being made available on the market;
− | (23) | ‘withdrawal’ means any measure aimed at preventing a product in the supply chain from being made available on the market; |
− | --- | --- |
+ (24) ‘customs authorities’ means customs authorities as defined in point 1 of Article 5 of Regulation (EU) No 952/2013;
− | (24) | ‘customs authorities’ means customs authorities as defined in point 1 of Article 5 of Regulation (EU) No 952/2013; |
− | --- | --- |
+ (25) ‘release for free circulation’ means the procedure laid down in Article 201 of Regulation (EU) No 952/2013;
− | (25) | ‘release for free circulation’ means the procedure laid down in Article 201 of Regulation (EU) No 952/2013; |
− | --- | --- |
+ (26) ‘products entering the Union market’ means products from third countries intended to be placed on the Union market or intended for private use or consumption within the customs territory of the Union and placed under the customs procedure ‘release for free circulation’.
− | (26) | ‘products entering the Union market’ means products from third countries intended to be placed on the Union market or intended for private use or consumption within the customs territory of the Union and placed under the customs procedure ‘release for free circulation’. |
− | --- | --- |
+ ## CHAPTER II — TASKS OF ECONOMIC OPERATORS
− ### art_4
+ ### Article 4 — Tasks of economic operators regarding products subject to certain Union harmonisation legislation
− Article 4
+ **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…
− 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 …
+ **2.** For the purposes of this Article, the economic operator referred to in paragraph 1 means any of the following:(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…
− 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:(a) if the Union harmonisation legislation applicable to the product provides for an EU declarati…
− | (a) | a manufacturer established in the Union; |
− | --- | --- |
+ **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…
− | (b) | an importer, where the manufacturer is not established in the Union; |
− | --- | --- |
+ **5.** This Article only applies in relation to products that are subject to Regulations (EU) No 305/2011 (4), ►M1 (EU) 2016/425 (5)** ◄ ** and ►M1 (EU) 2016/426 (6) and (EU) 2023/1542 (7)** ◄ ** of the European Parliament and of the Council, and Directives 2000/14/EC (8), 2006/42/EC (9), 2009/48/EC…
− | (c) | an authorised representative who has a written mandate from the manufacturer designating the authorised representative to perform the tasks set out in paragraph 3 on the manufacturer's behalf; |
− | --- | --- |
+ ### Article 5 — Authorised representative
− | (d) | a fulfilment service provider established in the Union with respect to the products it handles, where no other economic operator as mentioned in points (a), (b) and (c) is established in the Union. |
− | --- | --- |
+ **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.
− 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:
+ **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.
− | (a) | if the Union harmonisation legislation applicable to the product provides for an EU declaration of conformity or declaration of performance and technical documentation, verifying that the EU declaration of conformity or declaration of performance and technical documentation have been drawn u…
− | --- | --- |
+ **3.** Authorised representatives shall have the appropriate means to be able to fulfil their tasks.
− | (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; |
− | --- | --- |
+ ### Article 6 — Distance sales
− | (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 the requirements set out in Union harmonisation legislation applicable to the product i…
− | --- | --- |
− 
− 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 ind…
− 
− 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), 20…
− 
− ### art_5
− 
− Article 5
− 
− 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.
− 
− ### art_6
− Article 6
− 
+ ### Article 7 — Obligation of cooperation
− ### art_7
+ **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.
− Article 7
+ **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 th…
− 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.
+ ## CHAPTER III — ASSISTANCE TO AND COOPERATION WITH ECONOMIC 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 i…
+ ### Article 8 — Information to economic operators
− ### art_8
+ **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.
− Article 8
+ **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 …
− 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.
+ ### Article 9 — Joint activities to promote compliance
− 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) …
+ **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 …
− ### art_9
+ **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.
− Article 9
+ **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.
− 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 r…
+ **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 Sta…
− 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.
+ ## CHAPTER IV — ORGANISATION, ACTIVITIES AND OBLIGATIONS OF MARKET SURVEILLANCE AUTHORITIES AND THE SINGLE LIAISON OFFICE
− 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.
+ ### Article 10 — Designation of market surveillance authorities and the single liaison office
− 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, …
+ **1.** Member States shall organise and carry out market surveillance as provided for in this Regulation.
− ### art_10
+ **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…
− Article 10
+ **3.** Each Member State shall appoint a single liaison office.
− 1. Member States shall organise and carry out market surveillance as provided for in this Regulation.
+ **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 a…
− 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 …
+ **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…
− 3. Each Member State shall appoint a single liaison office.
+ **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 collabora…
− 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 …
+ ### Article 11 — Activities of market surveillance authorities
− 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 bud…
+ **1.** Market surveillance authorities shall conduct their activities in order to ensure the following:(a) effective market surveillance within their territory of products made available online and offline with respect to products that are subject to Union harmonisation legislation;(b) the taking by…
− 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 c…
+ **2.** Market surveillance authorities shall exercise their powers and carry out their duties independently, impartially and without bias.
− ### art_11
+ **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 adequat…
− Article 11
− 
− 1. Market surveillance authorities shall conduct their activities in order to ensure the following:
− 
− | (a) | effective market surveillance within their territory of products made available online and offline with respect to products that are subject to Union harmonisation legislation; |
− | --- | --- |
− 
− | (b) | the taking by economic operators of appropriate and proportionate corrective action in relation to compliance with that legislation and this Regulation; |
− | --- | --- |
− 
− | (c) | the taking of appropriate and proportionate measures where the economic operator fails to take corrective action. |
− | --- | --- |
− 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 sa…
− 
+ (a) possible hazards and non-compliance associated with the products and, where available, their occurrence on the market;
− | (a) | possible hazards and non-compliance associated with the products and, where available, their occurrence on the market; |
− | --- | --- |
+ (b) activities and operations under the control of the economic operator;
− | (b) | activities and operations under the control of the economic operator; |
− | --- | --- |
+ (c) the economic operator's past record of non-compliance;
− | (c) | the economic operator's past record of non-compliance; |
− | --- | --- |
+ (d) if relevant, the risk profiling performed by the authorities designated under Article 25(1);
− | (d) | if relevant, the risk profiling performed by the authorities designated under Article 25(1); |
− | --- | --- |
+ (e) consumer complaints and other information received from other authorities, economic operators, media and other sources that might indicate non-compliance.
− | (e) | consumer complaints and other information received from other authorities, economic operators, media and other sources that might indicate non-compliance. |
− | --- | --- |
+ **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 …
− 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 seri…
+ **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 accoun…
− 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…
+ **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.
− 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:(a) procedures for following up on complaints or reports on issues relating to risks or non-compliance;(b) procedures for verifying that the corr…
− 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).
− | (a) | procedures for following up on complaints or reports on issues relating to risks or non-compliance; |
− | --- | --- |
+ **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 s…
− | (b) | procedures for verifying that the corrective action that was to be taken by economic operators has been taken. |
− | --- | --- |
+ ### Article 12 — Peer reviews
− 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).
+ **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.
− 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 surve…
+ **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 auth…
− ### art_12
+ **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.
− Article 12
+ **4.** The outcome of the peer reviews shall be reported to the Network.
− 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.
+ ### Article 13 — National market surveillance strategies
− 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 authorit…
+ **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 surveilla…
− 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.
+ **2.** The national market surveillance strategy shall include at least the following elements, when this does not compromise market surveillance activities:(a) the available information on the occurrence of non-compliant products, in particular taking into account the checks and controls referred t…
− 4. The outcome of the peer reviews shall be reported to the Network.
+ **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.
− ### art_13
+ ## CHAPTER V — MARKET SURVEILLANCE POWERS AND MEASURES
− Article 13
+ ### Article 14 — Powers of market surveillance authorities
− 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 …
+ **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. The national market surveillance strategy shall include at least the following elements, when this does not compromise market surveillance activities:
+ **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 act…
− | (a) | the available information on the occurrence of non-compliant products, in particular taking into account the checks and controls referred to in Articles 11(3) and 25(3), respectively, and, where applicable, market trends that may affect non-compliance rates for the categories of products, an…
− | --- | --- |
+ **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:(a) directly by the market surveillance authorities under their own authority;(b) by recourse to other public authorities in accordance with the div…
− | (b) | the areas identified by the Member States as priorities for the enforcement of Union harmonisation legislation; |
− | --- | --- |
+ **4.** The powers conferred on market surveillance authorities under paragraph 1 shall include at least the following:(a) the power to require economic operators to provide relevant documents, technical specifications, data or information on compliance and technical aspects of the product, including…
− | (c) | the enforcement activities planned in order to reduce non-compliance in those areas identified as priorities, including, where relevant, the minimum control levels envisaged for categories of products which have significant levels of non-compliance; |
− | --- | --- |
+ **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.
− | (d) | an assessment of the cooperation with market surveillance authorities in other Member States, as referred to in Article 11(8) and Chapter VI. |
− | --- | --- |
+ ### Article 15 — Recovery of costs by market surveillance authorities
− 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 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.
− ### art_14
+ **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 t…
− Article 14
+ ### Article 16 — Market surveillance measures
− 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.
+ **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:(a) is liable to compromis…
− 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 …
+ **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 p…
− 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:
+ **3.** For the purposes of paragraph 2, the corrective action required to be taken by the economic operator may include, inter alia:(a) bringing the product into compliance, including by rectifying formal non-compliance as defined by the applicable Union harmonisation legislation, or by ensuring tha…
− | (a) | directly by the market surveillance authorities under their own authority; |
− | --- | --- |
+ **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.
− | (b) | by recourse to other public authorities in accordance with the division of powers and the institutional and administrative organisation of the Member State in question; |
− | --- | --- |
+ **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 mark…
− | (c) | upon application to courts competent to grant the necessary decision to approve the exercise of that power, including, where appropriate, on appeal, if the application to grant the necessary decision was not successful. |
− | --- | --- |
+ **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 fo…
− 4. The powers conferred on market surveillance authorities under paragraph 1 shall include at least the following:
+ **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 Me…
− | (a) | the power to require economic operators to provide relevant documents, technical specifications, data or information on compliance and technical aspects of the product, including access to embedded software in so far as such access is necessary for the purpose of assessing the product's comp…
− | --- | --- |
+ ### Article 17 — Use of information, professional and commercial secrecy
− | (b) | the power to require economic operators to provide relevant information on the supply chain, on the details of the distribution network, on quantities of products on the market and on other product models that have the same technical characteristics as the product in question, where relevant…
− | --- | --- |
− 
− | (c) | the power to require economic operators to provide relevant information required for the purpose of ascertaining the ownership of websites, where the information in question is related to the subject matter of the investigation; |
− | --- | --- |
− 
− | (d) | the power to carry out unannounced on-site inspections and physical checks of products; |
− | --- | --- |
− 
− | (e) | the power to enter any premises, land or means of transport that the economic operator in question uses for purposes related to the economic operator's trade, business, craft or profession, in order to identify non-compliance and to obtain evidence; |
− | --- | --- |
− 
− | (f) | the power to start investigations on market surveillance authorities' own initiative in order to identify non-compliances and bring them to an end; |
− | --- | --- |
− 
− | (g) | the power to require economic operators to take appropriate action to bring an instance of non-compliance to an end or to eliminate the risk; |
− | --- | --- |
− 
− | (h) | the power to take appropriate measures where an economic operator fails to take appropriate corrective action or where the non-compliance or the risk persists, including the power to prohibit or restrict the making available of a product on the market or to order that the product is withdraw…
− | --- | --- |
− 
− | (i) | the power to impose penalties in accordance with Article 41; |
− | --- | --- |
− 
− | (j) | the power to acquire product samples, including under a cover identity, to inspect those samples and to reverse-engineer them in order to identify non-compliance and to obtain evidence; |
− | --- | --- |
− 
− | (k) | the power, where no other effective means are available to eliminate a serious risk:(i)to require the removal of content referring to the related products from an online interface or to require the explicit display of a warning to end users when they access an online interface; or(ii)where a…
− | --- | --- |
− | (i) | to require the removal of content referring to the related products from an online interface or to require the explicit display of a warning to end users when they access an online interface; or |
− | (ii) | where a request according to point (i) has not been complied with, to require information society service providers to restrict access to the online interface, including by requesting a relevant third party to implement such measures. |
− 
− 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.
− 
− ### art_15
− 
− Article 15
− 
− 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 co…
− 
− ### art_16
− 
− Article 16
− 
− 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:
− 
− | (a) | is liable to compromise the health or safety of users; or |
− | --- | --- |
− 
− | (b) | does not conform to applicable Union harmonisation legislation. |
− | --- | --- |
− 
− 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 perio…
− 
− 3. For the purposes of paragraph 2, the corrective action required to be taken by the economic operator may include, inter alia:
− 
− | (a) | bringing the product into compliance, including by rectifying formal non-compliance as defined by the applicable Union harmonisation legislation, or by ensuring that the product no longer presents a risk; |
− | --- | --- |
− | (b) | preventing the product from being made available on the market; |
− | --- | --- |
− 
− | (c) | withdrawing or recalling the product immediately and alerting the public to the risk presented; |
− | --- | --- |
− 
− | (d) | destroying the product or otherwise rendering it inoperable; |
− | --- | --- |
− 
− | (e) | affixing to the product suitable, clearly worded, easily comprehensible warnings of the risks that it might present, in the language or languages determined by the Member State in which the product is made available on the market; |
− | --- | --- |
− 
− | (f) | setting prior conditions for making the product concerned available on the market; |
− | --- | --- |
− 
− | (g) | alerting the end users at risk immediately and in an appropriate form, including by publication of special warnings in the language or languages determined by the Member State in which the product is made available on the market. |
− | --- | --- |
− 
− 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 i…
− 
− 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 th…
− 
− 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…
− 
− ### art_17
− 
− Article 17
− 
+ ### Article 18 — Procedural rights of economic operators
− ### art_18
+ **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.
− Article 18
+ **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.
− 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.
+ **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 b…
− 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 becau…
− 
+ ### Article 19 — Products presenting a serious risk
− ### art_19
+ **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 shal…
− Article 19
+ **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 present…
− 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 no…
+ ### Article 20 — Rapid Information Exchange System
− 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 …
+ **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 ac…
− ### art_20
+ **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.
− Article 20
+ **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 natio…
− 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 accord…
+ **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*.
− 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.
+ **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.
− 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 …
+ ### Article 21 — Union testing facilities
− 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.
+ **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.
− 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.
+ **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.
− ### art_21
− 
− Article 21
− 
− 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.
+ **3.** Union testing facilities shall be accredited in accordance with Regulation (EC) No 765/2008.
− 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.
− 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.
− 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:(a) carry out testing of products at the request of market surveillance authorities, the Network or the Commission;(b) provide independent technical or scientific advice at the request of the…
− 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).
− | (a) | carry out testing of products at the request of market surveillance authorities, the Network or the Commission; |
− | --- | --- |
+ **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…
− | (b) | provide independent technical or scientific advice at the request of the Network; |
− | --- | --- |
+ **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).
− | (c) | develop new techniques and methods of analysis. |
− | --- | --- |
+ ## CHAPTER VI — CROSS-BORDER MUTUAL ASSISTANCE
− 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).
+ ### Article 22 — Mutual Assistance
− 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 …
+ **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.
− 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).
+ **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 …
− ### art_22
+ **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.
− Article 22
+ **4.** The applicant authority shall remain responsible for any investigation that it has initiated, unless the requested authority agrees to take over responsibility.
− 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.
+ **5.** In duly justified cases, a requested authority may refuse to comply with a request for information under paragraph 2 where:(a) the applicant authority has not sufficiently substantiated that the requested information is necessary in order to establish non-compliance;(b) the requested authorit…
− 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 Stat…
+ ### Article 23 — Requests for enforcement measures
− 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.
+ **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 t…
− 4. The applicant authority shall remain responsible for any investigation that it has initiated, unless the requested authority agrees to take over responsibility.
+ **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 gran…
− 5. In duly justified cases, a requested authority may refuse to comply with a request for information under paragraph 2 where:
+ **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) | the applicant authority has not sufficiently substantiated that the requested information is necessary in order to establish non-compliance; |
− | --- | --- |
− | (b) | the requested authority demonstrates reasonable grounds showing that complying with the request would substantially impair the execution of its own activities. |
− | --- | --- |
− 
− ### art_23
− 
− Article 23
− 
− 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 …
− 
− 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 …
− 
− 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) the requested authority concludes that the applicant authority has not provided sufficient information;
− | (a) | the requested authority concludes that the applicant authority has not provided sufficient information; |
− | --- | --- |
+ (b) the requested authority considers that the request is contrary to Union harmonisation legislation;
− | (b) | the requested authority considers that the request is contrary to Union harmonisation legislation; |
− | --- | --- |
… diff truncated at 500 changed lines …