BETA

144 Amendments of Othmar KARAS related to 2017/0353(COD)

Proposal for a regulation
Recital 17

(17) It is necessary to establish a ~~Union Product Compliance Network~~European Market Surveillance Forum, hosted by the Commission, aimed at coordinating and facilitating the implementation of joint enforcement activities by Member States, such as joint investigations. This administrative support structure should allow the pooling of resources and maintain a communication and information system between Member States and the Commission, thereby helping to strengthen enforcement of Union harmonisation legislation on products and deter infringements.

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 1 – paragraph 1

Th~~is Regulation lays down rules and procedures for the provision of compliance information about certain products that are the subje~~e present regulation has the objective to improve the functioning of the single market of goods by strengthening market surveillance of goods covered by legislative acts of the Union ~~acts~~ harmonising the conditions ofor their marketing ~~of those products. It establishes a framework for cooperation with economic operators in relation to such products.~~ , in order to ensure that they meet the requirements guaranteeing a high level of protection of public interests such as health and safety in general, health and safety in the work place, the protection of consumers, protection against counterfeit products, protection of the environment and security.

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 2 – paragraph 1 a (new)

1a. Articles 7, 8, 12, 14, 15 and 16 of this Regulation apply also to products that are subject to Directive 2001/95/EC on General Product Safety.

2018/05/24
Committee: IMCO

4a. Articles 26, 27, 28 and 29 shall apply to all products covered by Union legislation in so far as other Union legislation does not contain specific provisions relating to the organisation of border controls.

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 3 – paragraph 1 – point 12 – introductory part

(12) ‘economic operator’ means the manufacturer, the authorised representative, the importer or the distributor, the intermediaries or any other natural or legal person participating in the placing on the market of the products, and including:

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 3 – paragraph 1 – point 15

(15) ‘serious risk’ means a~~ny serious risk, including a serious risk where the effects are not immediate, requiring rapid intervention by the market surveillance authorities~~ non- compliance that results in a high likelihood of causing harm or injury to a user or any risk requiring rapid intervention and follow-up. Any product subject to an emergency decision based on Article 13 of Directive 2001/95 CE on General product safety should be considered as a product posing a serious risk;

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 3 – paragraph 1 – point 22 a (new)

(22a) ‘formal non-compliance’ means any non-compliance that does not lead to a breach of the essential requirements, including but not limited to the non- compliances as defined in article R34 of the reference provisions in Decision No. 768/2008/EC;

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 3 – paragraph 1 – point 22 b (new)

(22a) ‘distinct models ‘means models of products that are considered to be distinct as presenting different essential characteristics from one another, and that may have an impact on their safety.

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 4 – title

~~Person~~Economic operators responsible for compliance ~~information~~

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 4 – paragraph 1 – point a – point ii

(ii) a natural or legal person established in the Union who has a written mandate from the manufacturer designating him as a ~~person responsible for performing the tasks listed in paragraph 3~~uthorised representative and requiring him to perform those tasks listed in paragraph 3 on the manufacturer's behalf;

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 4 – paragraph 1 – point b

(b) the identity and contact details of the manufacturer, importer or ~~other person meeting the requi~~authorised repremsentsative of point (a) are publicly available ~~in accordance with paragraph 4~~ and are indicated or identifiable in accordance with paragraph 5.

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 4 – paragraph 1 a (new)

1a. The mandate shall be valid only when: (a) signed by the authorised representative to proof its acceptance; (b) signed by the issuing manufacturer.

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 4 – paragraph 1 b (new)

1b. In addition to the provisions laid down in Article 4(3), the authorised representative or where applicable an importer shall perform the following tasks: (a) immediately informing the manufacturer about complaints and reports from users about suspected incidents related to a product for which they have been designated; (b) terminating the mandate or the import of products concerned, if the manufacturer acts contrary to its obligations under this Regulation; (c) informing the competent authority of the Member State of any termination of a mandate as authorised representative.

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 4 – paragraph 2

2. For the purposes of this Article, ‘the person responsible for compliance information’ means the person, whether the manufacturer, importer or other person, meeting the requirements of paragraph 1(a) with respect to the product or, if there is more than one such person, any of them.deleted

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 4 – paragraph 3 – introductory part

3. The ~~person responsible for compliance information~~authorised representative, or the manufacturer established in the Union, or an importer shall perform the following tasks:

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 4 – paragraph 3 – point a

(a) if the Union harmonisation legislation applicable to the product provides for an EU declaration of conformity and technical documentation, verifying that the EU declaration of conformity and technical documentation have been drawn up and keeping the declaration of conformity and technical documentation at the disposal of market surveillance authorities for ~~the period required by that legislation~~at least 10 years, if not specified otherwise by that Union harmonisation legislation. Importers shall keep a copy of the declaration of conformity at the disposal of the market surveillance authorities and ensure that the technical documentation can be made available to those authorities, upon request;

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 4 – paragraph 3 – point b

(b) further to a reasoned request from a market surveillance authority, providing that authority with all the information and documentation necessary to demonstrate the conformity of the product in an official Union language ~~determined by the Member State concerned~~which can be easily understood by that authority and demonstrating the existence of different essential characteristics between its models within the meaning of the definition given in point (22b) of Article 3of this Regulation;

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 4 – paragraph 3 – point c

(c) cooperating with the market surveillance authorities, a~~t their request, on any action take~~nd taking immediate action to eliminate, or, if that is not possible, mitigate ~~the risks posed by the product.~~or remedy the case of a product presenting a risk or the case of a product being non-compliant with the requirements set out in Union harmonisation legislation or harmonised standards applicable to the product in question, at their own initiative or when required to do so by the market surveillance authorities;

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 4 – paragraph 3 – point c a (new)

(ca) when considering or having reason to believe that a product in question presents a risk or is not in conformity with the applicable Union harmonisation legislation or harmonised standard, immediately inform the manufacturer and, where applicable, other economic operators;

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 4 – paragraph 4

4. Manufacturers shall make the identity and contacts details of the person responsible for compliance information with respect to the product publicly available either on their website or, in the absence of a website, by any other means that allows the information to be readily accessed by the general public in the Union free of charge.deleted

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 4 – paragraph 5

5. The ~~identity and contact detail~~name, registered trade name or registered trademark and the contact details, including the postal address, and if available a website address of the person responsible for compliance ~~information~~ with respect to the product shall be indicated on ~~or identifiable from information indicated~~the product or where not possible because of the size or physical characteristics onf the product, on its packaging, or the parcel or an accompanying documents. When the manufacturer, the importer or the authorised representative use a website address in addition to the other required information to identify the person responsible for compliance, this website address can be used instead of the physical address, as defined in articles R2-6 and R4-3 of decision 768/2008/EC.

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 4 – paragraph 6

6. For the purposes of paragraph 1: (a) manufacturers may designate a person under paragraph 1(a)(ii) whether or not they have a right or obligation to appoint an authorised representative under the Union harmonisation legislation applicable to the product; (b) where the manufacturer has such a right or obligation under the Union harmonisation legislation, the appointment of an authorised representative under that legislation may count as a designation for the purposes of paragraph 1(a)(ii) provided the appointment meets the requirements of that paragraph.deleted

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 5 – paragraph 1

Where Union harmonisation legislation provides for the drawing up of an EU declaration of conformity, the manufacturer~~s shall make the declaration publicly available on their website or, in the absence of a website, by any other means that allows the declaration to be readily accessed by the general public in the Uni~~, importer or authorised representative shall make the declaration of conformity and technical file available to market surveillance authorities upon fre~~e of charge~~quest.

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 6 – paragraph 1 – subparagraph 1 (new)

The European Commission shall provide information with respect to the Union harmonisation legislation by means of the Your Europe portal referred to in [Regulation (EC) No XXX/XXX of the European Parliament and the Council].

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 7 – title

Co~~mpliance partnership arrangement~~operation between market surveillance authorities and economic operators

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 7 – paragraph 1 – subparagraph 1

AUpon request, a market surveillance authority ~~may enter into a partnership arrangement with an~~shall, where possible, taking into account available resources, provide economic operators established in its territory ~~under which the authority agrees to provide the economic operator~~ with advice and guidance in relation to the Union harmonisation legislation ~~applicable~~ to the products for which the economic operator is responsible.

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 7 – paragraph 1 – subparagraph 1 a (new)

The provision of advice by the market surveillance authorities shall not preclude independent, impartial and unbiased assessments by market surveillance authorities.

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 7 – paragraph 1 – subparagraph 2

~~The arrangement shall not cover the provision of conformity assessment activities that are entrusted to notified bodies under the Union harmonisation legislation.~~deleted

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 7 – paragraph 2

2. If a market surveillance authority enters into a partnership arrangement under paragraph 1, it shall enter that fact in the system referred to in Article 34, along with details of the scope of the arrangement and the names and addresses of itself and of the economic operator.deleted

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 7 – paragraph 3

3. If a market surveillance authority enters into a partnership arrangement under paragraph 1, other market surveillance authorities shall inform that authority of any temporary measure taken by them against the economic operator, and any corrective action taken by the economic operator, in relation to compliance with the applicable Union harmonisation legislation.deleted

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 7 – paragraph 4

4. A market surveillance authority that enters into a partnership arrangement under paragraph 1 may charge the economic operator fees representing the costs reasonably incurred by the authority in the exercise of its functions under paragraphs 1 and 2.deleted

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 8 – paragraph 1 – subparagraph 1

Market surveillance authorities may enter into memoranda of understanding with bcus~~inesse~~tom authorities, port and airport authorities, economic operators or organisations representing ~~businesse~~economic operators or end-users for the carrying out, or financing, of joint activities aimed at raising awareness, providing advice and guidance in relation to the Union harmonisation legislation, promoting voluntary actions, identifying non- compliance or promoting compliance in specific geographical areas or with respect to specific categories of products.

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 8 – paragraph 1 – subparagraph 1 a (new)

The market surveillance authority shall provide the draft memorandum to the Commission at least 2 months before its adoption and a report on its implementation every three years from the date of its adoption. The Commission shall provide an opinion to the market surveillance authorities on the draft memorandum and the implementation report.

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 8 – paragraph 2

2. A market surveillance authority may use ~~any~~ information resulting from activities carried out or financed by other parties to a memorandum of understanding entered into by it under paragraph 1 as part of any investigation undertaken by it into non-compliance, but only if the activity in question was carried out independently, impartially and without bias in full respect of competition laws and according to criteria and procedures developed under paragraph 3b.

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 8 – paragraph 3 a (new)

3a. A market surveillance authority and the parties referred to in paragraph 1 entering into memorandum of understanding, shall ensure that such memorandum contains provisions so as to safeguard the confidentiality, the objectivity, independence and impartiality of the parties and the activities concerned.

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 8 – paragraph 3 b (new)

3b. The Commission shall adopt implementing acts regarding the memoranda of understanding, which specify the procedures and criteria under which authorities could carry out their activity ensuring that the market surveillance activities are implemented in independence and impartiality. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 63.

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 10 – paragraph 1

1. M~~arket surveillance authoriti~~ember States shall establish appropriate communication and coordination mechanisms ~~with o~~between their market surveillance authorities.

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 10 – paragraph 2 – introductory part

2. M~~arket surveillance authorities shall establish the following procedures in connection with products subject to the Union harmonisation legislation set out in the Annex~~ember States shall establish adequate procedures in order to:

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 10 – paragraph 2 – point a

(a) ~~procedures for following up of~~follow up complaints or reports on issues relating to risks arising in connection with products subject to Union harmonisation legislation;

2018/05/24
Committee: IMCO

(b) ~~procedures for monitoring any~~monitor accidents or anyd harm to ~~the~~ health ~~or safety of end-users~~ which are suspected tof hav~~ing~~e been caused by ~~such~~those products;

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 10 – paragraph 2 – point c

(c) ~~procedures for~~ verify~~ing~~ that corrective action ~~to be taken by economic operators~~ has been taken; and

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 10 – paragraph 2 – point d

(d) ~~procedures for collecting and exploring~~follow up scientific and technical knowledge concerning safety issues.

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 10 – paragraph 2 a (new)

2a. Member States shall establish appropriate communication and coordination mechanisms between market surveillance authorities and customs authorities, especially in view of counterfeit products. This includes standardised cooperation with customs authorities concerning identification and withdrawal of non-authentic and/or counterfeit products from the market.

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 11 – paragraph 1

1. Each Member State shall designate one or more market surveillance authorities in its territory. It shall inform the Commission, through the ~~Network~~Forum established under Article 31, and the other Member States of the market surveillance authorities designated by it and the areas of competence of each of those authorities, using the information and communication system referred to in Article 34.

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 11 – paragraph 3

3. The single liaison office of a Member State shall be responsible for coordinating the enforcement and market surveillance activities of the market surveillance authorities and authorities responsible for the control of products entering the Union market designated by that Member State.

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 11 – paragraph 5 a (new)

5a. Each Member State shall designate one single liaison office at national customs authorities for the cooperation between customs and market surveillance authorities. The single liaison office at the customs authority shall be responsible for the control of products entering the Union market and serve as a point of reference for the market surveillance authorities within the respective territory of their Member State.

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 12 – paragraph 1 – point b a (new)

(ba) the provision of the necessary assistance and advice to ensure that the operator remedies the non-compliance and prevents further occurrences of it.

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 12 – paragraph 1 – point b b (new)

(ba) the open, transparent and regular dialogue with economic operators and / or representative sector associations and foresee the necessary procedures for this in accordance with Article 7.

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 12 – paragraph 1 a (new)

1a. Market surveillance authorities shall perform appropriate checks on products on an adequate scale and with adequate frequency, by means of documentary, physical or laboratory checks, as appropriate, on the basis of adequate samples. When doing so, they shall take account of established principles of risk assessment, complaints and other information.

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 12 – paragraph 2 – introductory part

2. Market surveillance authorities shall prioritise actions for the largest risk- reduction opportunities and act in accordance with the principle of proportionality; they shall perform controls as part of their activities set out in paragraph 1, on a risk- based approach, taking into account, as a minimum, the following factors:

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 12 – paragraph 2 – point b

(b) the economic operator's past record of non-compliance, including the risk profiling ~~and the status of an authorised economic operator~~;

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 12 – paragraph 2 a (new)

2a. The methodology and criteria for assessing risks shall be harmonised in all Member States in order to ensure a level playing field for all economic operators.

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 12 – paragraph 3 – subparagraph 1 – point b a (new)

(ba) the product is recognized as non- compliant by any judicial or administrative court in the EU;

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 12 – paragraph 3 – subparagraph 1 – point b b (new)

(ba) the product is counterfeit.

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 12 – paragraph 3 – subparagraph 2

Where the products are withdrawn, recalled, prohibited or restricted, the market surveillance authority shall ensure that the Commission through the ~~Network~~information system established under Article 314, the other Member States and end-users are informed accordingly.

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 12 – paragraph 4 – introductory part

4. Market surveillance authorities shall perform their activities with a high level of transparency and shall make available to the general public any information that they deem relevant for the general public. They shall also ensure that the following information is entered in the system referred to in Article 34:

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 12 – paragraph 4 – point a

~~(a) the type, number and outcome of the checks performed by them;~~deleted

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 12 – paragraph 4 – point b

~~(b) the type and the number of non- compliances detected by them;~~deleted

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 12 – paragraph 4 – point c

~~(c) the nature of the temporary measures taken by them against economic operators and of the corrective action taken by economic operators;~~deleted

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 12 – paragraph 4 – point d

~~(d) details of the cases of non- compliance where penalties were imposed by them.~~deleted

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 12 – paragraph 5

5. Market surveillance authorities shall exercise their powers and carry out their duties independently, impartially and without bias and in accordance with the principle of proportionality.

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 12 – paragraph 5 a (new)

5a. Where the Commission considers or has reason to believe that an activity carried out under a memorandum of understanding set up under Article 8 is leading an authority to breach its obligations under Article 12 paragraph 5, it shall investigate the situation within three months and either call for a redress of the situation or terminate the memorandum after consultation of the Committee referred to in Article 63.

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 13 – paragraph 2 – point a

(a) a~~n assessment~~vailable information ofn the presence and/or occurrence of non- compliant products, in particular taking into account the risk-based controls referred to in Articles 12(2) and 26(3), and market trends provided by the Commission that may affect non- compliance rates in the categories of product;

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 13 – paragraph 2 – point b

(b) the areas identified by Member States as a priority for the enforcement of Union harmonisation legislation;

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 13 – paragraph 2 – point d

(d) an assessment of the effective performance and coordination of market surveillance activities pursuant to this Regulation, and, where applicable, the identification of capacity building needs and measures;deleted

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 13 – paragraph 2 – point f

~~(f) a monitoring programme for the purposes of measuring progress in the implementation of the strategy and verifying compliance with this Regulation.~~deleted

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 13 – paragraph 2 a (new)

2a. When drawing up national market surveillance strategies, Member States shall give particular attention to products subject to an emergency decision based on Article13 of Directive 2001/95/EC.

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 13 – paragraph 3

3. Member States shall communicate their national market surveillance strategy through the system referred to under Article 34. The Commission shall define by means of implementing acts which data will be made public.

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 13 – paragraph 3 a (new)

3a. On the basis of the national market surveillance strategy mentioned in Article 13(1) and in (2), a peer review shall be organized within the framework referred to in Article 33 j) which shall cover: (a) an assessment of the enforcement and the coordination of market surveillance activities required by the present legislation and where necessary, the determination of the areas where market surveillance authorities should put additional effort in order to strengthen their activities; (b) an assessment of the cooperation with market surveillance authorities of another Member States and of the joint activities if necessary;

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 14 – paragraph 1 a (new)

1a. Market surveillance authorities shall exercise their powers in accordance with the principle of proportionality.

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 14 – paragraph 3 – introductory part

3. The powers conferred on market surveillance authorities under paragraph 1 shall include the following powers as a minimum to the extent that these relate to the subject matter and purpose of the inspection:

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 14 – paragraph 3 – point e – point 3

(3) to request a~~ny representative or member of staff of~~ person authorised to represent the economic operator to give explanations of facts, information or documents relating to the subject-matter of the inspection and to record ~~their~~his answers;

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 14 – paragraph 3 – point f

(f) the power to take samples of products free of charge in order to detect non-compliance and obtain evidence to the extent that this is proportionate in view of the value of the product and the severity of non-compliance;

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 14 – paragraph 3 – point h

(h) the power to ~~take~~adopt temporary measures, where there are no other effective means available to prevent a serious risk, including in particular temporary measures requiring hosting service providers to remove, disable or restrict access to content or to suspend or restrict access to a website, service or account or requiring domain registries or registrars to put a fully qualified domain name on hold for a specific period of time until the operator has made the necessary corrections according to the comments given by the authority;

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 14 – paragraph 3 – point m

~~(m) the power to order the restitution of profits obtained as a result of an instance of non-compliance;~~deleted

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 14 – paragraph 4

4. Market surveillance authorities shall publish, when they deem it relevant for the general public, any commitments given to them by economic operators, details of any corrective action taken by economic operators in their territory, and details of any temporary measures taken by the relevant market surveillance authority pursuant to this Regulation.

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 14 – paragraph 4 – subparagraph 1 (new)

Market surveillance authorities shall ensure that the economic operator shall be given the opportunity to comment on the information that the competent authority intends to publish or make otherwise available to the public, prior to its publication or release, and take reasonable steps, where appropriate, to ensure that the information which is published or made otherwise available to the public takes into account the comments expressed by the economic operator concerned or is published or released together with such comments.

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 14 – paragraph 4 a (new)

4a. The powers conferred on market surveillance authorities under paragraph 3 shall be also extended to counterfeit products.

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 14 – paragraph 5

~~5. Market surveillance authorities shall exercise their powers in accordance with the principle of proportionality.~~deleted

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 15 – paragraph 1 – subparagraph 1

Market surveillance authorities shall perform appropriate checks on the characteristics of products on an adequate scale and with adequate frequency, by means of documentary checks and, where appropriate, physical and laboratory controls on the basis of a ~~representative sam~~n adequate sample and according to the established risk assessment principles.

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 15 – paragraph 1 – subparagraph 2

In ~~deciding what checks to perform and on what scale~~order for the scope of market surveillance activities to be aligned across the Union, Member States shall use a sampling rate of 0.5 samples per 1.000 inhabitants per year as a minimum value. In determining actual sampling rates, market surveillance authorities shall take into account~~, in particular, establis~~ principles of risk of thed pr~~inciples of risk assessment and complaints~~oduct type, its intended uses and historical complaints for similar products. Checks to be performed on the sample should be determined by consideration of these same criteria.

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 15 – paragraph 1 – subparagraph 3

Where economic operators present test reports or certificates attesting conformity of their products with Union harmonisation legislation issued by an accredited conformity assessment body or any EU or non-EU laboratory accredited according to Regulation (EC) No 765/2008, market surveillance authorities shall take due account of such reports or certificates.

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 15 – paragraph 2 – subparagraph 2

The ~~authoritie~~economic operators shall cooperate with ~~economic operator~~authorities regarding actions which could prevent or reduce risks that are caused by products made available by those operators.

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 15 – paragraph 3

3. Where the market surveillance authorities of one Member State decide to withdraw a product manufactured in another Member State or placed on the market in another Member State, they shall inform the economic operator concerned without delay.

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 15 – paragraph 3 a (new)

3a. In cases of identification of known or emerging risk related to the objectives set out in Article 1 of this Regulation and with regard to a particular product or a category of products, the Commission may adopt implementing acts to establish uniform conditions for the carrying out of the checks performed by the market surveillance authorities in relation to that particular product or category of products and the characteristics of that known or emerging risk. These conditions may include requirements for a temporary increase of the scale and frequency of checks to be carried out and the adequacy of samples to be checked.

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 15 a (new)

Article 15a Risk assessment 1. Risk assessment shall be based on available scientific or technical evidence. Risk assessment shall be carried out in accordance with the general risk assessment methodology and, where appropriate, Commission guidelines on the application of that methodology to a specific category of products. The Commission shall, by means of implementing acts, adopt the general risk assessment methodology. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 63. For products subject to Regulation (EC) No 1907/2006, risk assessment shall be carried out as appropriate in accordance with the relevant parts of Annex I to that Regulation. 2. In the context of the risk assessment, market surveillance authorities shall take into account the extent to which the product complies with the following: (a) any requirements laid down in or pursuant to Union harmonisation legislation that apply to the product and relate to the potential risk under consideration, taking full account of test, inspection and calibration reports or certificates attesting conformity and issued by a conformity assessment body accredited in accordance with Regulation (EC) No 765/2008, including assessments drawn up pursuant to Regulation (EC) No 1907/2006, for instance in connection with registration, authorisation, restrictions or reporting; (b) in the absence of requirements laid down in or pursuant to Union harmonisation legislation, specific rules laying down health and safety requirements for such products in the national law of the Member State where it is made available on the market, provided that such rules are in accordance with Union law; (c) any European standards the references of which have been published in the Official Journal of the European Union. 3. Compliance with any of the criteria referred to in points (a), (b) and (c) of paragraph 2 shall raise a presumption that the product adequately safeguards the public interests to which those criteria relate. However, this shall not prevent market surveillance authorities from taking action under this Regulation where there is new evidence that, despite such conformity or compliance, the product presents a risk. In that case, the market surveillance authority shall demonstrate that the product presents a risk. 4. The feasibility of obtaining higher levels of protection of the public interest concerned and the availability of other products presenting a lesser risk shall not be sufficient reason to consider that a product presents a risk. 5. The Commission may, on its own initiative or at the request of a market surveillance authority, have a risk assessment carried out by a Union testing facility, in accordance with Article 20. Such assessment shall be binding on all stakeholders. 6. In cases where Member State risk assessment practices differ and result in divergent interpretations as to the necessity of measures in respect of similar products, the Commission shall provide guidance on appropriate risk assessment practices. The Commission shall be assisted by the Scientific Committees established under Commission Decision 2004/210/EC and shall take into account all available scientific and technical evidence relating to the risks under consideration.

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 17 – paragraph 1

1. Any measure, decision or order taken or made by market surveillance authorities pursuant to Union harmonisation legislation or this Regulation to prohibit or restrict the making available of products on the market or to withdraw, recall or destroy products on the market shall be proportionate and shall state the exact grounds on which it is based and a substantive justification of proportionality.

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 17 – paragraph 3 – subparagraph 1

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 him 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.

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 17 – paragraph 4 a (new)

4a. When the product is the object of an information in Article 18(1), market surveillance authorities at the origin of this information are considered to have informed the Commission and the other Member States of the results of the product assessment and the measures associated with the product.

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 20 – paragraph 1

1. The Commission may designate, after the consultation with the European Market Surveillance Forum Board referred to in Article 32, Union testing facilities for specific products or a specific category or group of products or for specific risks related to a category or group of products which are made available on the market.

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 20 – paragraph 1 a (new)

1a. The Union testing facilitates shall serve the purposes of ensuring sufficient public laboratory capacity for all market surveillance in the Union and reliability and consistency of testing across the Union in the market surveillance framework. Market surveillance authorities or the Commission, in the context of its tasks under the Forum established by Article 31, may call upon the Union testing facilities to conduct tests on products or provide information and advice related to testing.

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 20 – paragraph 1 b (new)

1b. The establishment of Union testing facilities shall not affect the freedom of the market surveillance authorities to choose in which facilities products are tested for their market surveillance activities.

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 20 – paragraph 3 a (new)

3a. The designated Union testing facilities shall not hamper competition between testing laboratories and reduce the availability of testing laboratories capacity for economic operators.

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 20 – paragraph 4 – point c

(c) provide independent technical or scientific advice to the Commission including, the ~~Network~~Forum established under Article 31, and to the Member States;

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 20 – paragraph 4 a (new)

4a. Market surveillance authorities shall take due account of the test, results, analysis and conclusions of the Union testing facilities to adopt the appropriate market surveillance measures.

2018/05/24
Committee: IMCO

4b. For any test by the Union testing facilities requested by a market surveillance authority or multiple market surveillance authorities and not financed by the Union, the market surveillance authority or market surveillance authorities shall be charged the costs reasonably incurred for that test.

2018/05/24
Committee: IMCO

5a. In case of further dispute or disagreement by one or more Member States with the findings of Union testing facilities, an appropriate appeal procedure should be put in place for decisions of Union testing facilities.

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 20 – paragraph 5 b (new)

5b. The test reports issued by any designated Union testing facility shall be recognized in any other Member State.

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 21 – paragraph 2

2. Market surveillance authorities may charge economic operators administrative fees in relation to instances of non- compliance by that economic operator in order to enable the authorities to recover the costs of their activities with respect to these instances of non-compliance. Those costs shall be proportionate in relation to the non-compliance and may include the costs of carrying out testing for the purposes of a risk assessment, the costs of taking measures in accordance with Article 30(1) and (2), the costs and time taken by the staff of market surveillance authorities to perform the market surveillance controls and the costs of their activities relating to products that are found to be non- compliant and subject to corrective action prior to their release for free circulation. Costs of carrying out testing and/or risk assessment may only be charged in case the product itself is non-compliant or the manufacturer did not respond duly in reasonable time to requests by the market surveillance authority to correct non-compliances related to the CE mark, declaration of conformity or other informational legal requirements related to compliance.

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 22 – title

~~Requests for information~~Mutual assistance

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 22 – paragraph 1

1. ~~At t~~The request of an applicant authority, the requested authority shall supply any information that the requested authority deems relevant to establish whether a product is non-compliant and to ensure that the non-compliance can be brought to an end shall be efficient cooperation and exchange of information among the market surveillance authorities of the Member States, among the different authorities within each Member State and between market surveillance authorities and the Commission and the relevant Union agencies.

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 22 – paragraph 2

2. ~~The requested authority shall undertake~~On receipt of a duly motivated request from an applicant authority, the requested authority shall give assistance on an adequate scale by gathering and supplying the necessary information or documentation, by carrying out appropriate investigations or ~~take~~ any other ~~measures that are appropriate in order to gather the required information. Where necessary, those investigations shall be carried out with the assistance of other market surveillance~~appropriate measures, by assessing the conformity of the product, by determining the appropriate corrective measures and by participating in investigations initiated by the applicant authorit~~ies~~y.

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 22 – paragraph 3

3. ~~At the request of t~~The applicant authority~~, the requested authority may allow officials of the applicant authority to accompany their counterparts in the requested authority during the course of their inves~~ remains responsible for the case it has initigat~~ions~~ed.

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 22 – paragraph 3 a (new)

3a. When in conflict with national law, a request pursuant to the first subparagraph may not be used to demand the disclosure of information or documents.

2018/05/24
Committee: IMCO

4. The requested authority shall keep the applicant authority informed on actions and reply to the request under paragraph 1 using the procedure and within the time limits specified by the Commission under paragraph 5.

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 23

~~Requests for enforcement measures 1. At the request of an applicant~~Article 23 deleted The requested authority~~, t~~ shall The requested authority shall without delay take all necessary enforcement measures using the powers conferred on it under this Regulation in order to bring an instance of non- compliance to an end. 2. determine the appropriate enforcement measures required to bring an instance of non-compliance to an end. Where necessary, enforcement measures shall be determined and implemented with the assistance of other public authorities. 3. regularly and without undue delay inform and consult the applicant authority about the measures referred to in paragraph 2 that have been taken or which are intended to be taken. The requested authority shall without delay notify the applicant authority, the market surveillance authorities of other Member States, and the Commission of the measures taken by it and of their effect on the non-compliance in question. The notification shall be made using the system referred to in Article 34 and shall include the following information as a minimum: (a) been imposed; (b) ceased; (c) imposed and, if so, what; (d) the requested authority or the economic operator have been implemented. 4. to the request under paragraph 1 using the procedure and within the time limits specified bwhether temporary measures have whether the non-compliance has whether penalties have been whether other measures taken by The requested authority shall reply tThe Commission under paragraph 5. 5. implementing acts specifying the time limits, standard forms and further details of the procedures to be used for making and responding to requests for enforcement measures under paragraph 1. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 63.shall adopt

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 24 – paragraph 1

1. The applicant authority shall ~~provide sufficient information, in the case of~~carry out itself all investigations reasonably possible before launching a requests for ~~mutual~~ assistance ~~under Article 22 or 23,~~. The applicant authority shall provide all information available to enable the requested authority to fulfill the request, including any necessary evidence obtainable only in the Member State of the applicant authority.

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 24 – paragraph 2

2. Requests for mutual assistance under Article 22 or 23 shall be sent by the applicant authority to the single liaison office of the Member State of the requested authority and also to the single liaison office of the Member State of the applicant authority for information purposes. The single liaison office of the Member State of the requested authority shall pass the requests on to the appropriate competent authority, without undue delashall be transmitted directly to the requested authority.

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 25 – paragraph 1

1. Market surveillance authorities may use any information, document or a certified true copy of a 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 to the extent that these relate to the subject- matter and purpose of the inspection.

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 25 – paragraph 3

3. Products deemed to be non- compliant on the basis of a decision of a market surveillance authority in one Member State, shall be temporarily and with reservations presumed to be non- compliant by market surveillance authorities in another Member State, unless the assessment of the latter invalidates the non-compliance, or the economic operators can provide evidence to the contrary.

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 25 – paragraph 4 a (new)

4a. Only the European Market Surveillance Forum established under Article 31 of this Regulation can issue decisions that establish a presumption of non-compliance in all Member States. The Forum shall decide which measures, if any, are appropriate in view of the risks, the associated urgency to act, the principle of proportionality and the intent of non-compliance.

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 25 – paragraph 4 b (new)

4b. The decision of the Forum referred to in Article 25 (4) shall be subject to appeal to the Commission by the economic operators concerned. The Commission shall evaluate the reasoned decision by the Forum taking into account the risks, the associated urgency to act, the principle of proportionality and the intent of the unmet legal requirements. The Commission will take a final decision after consultation with the European Market Surveillance Forum within 6 months after the date of the appeal.

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 25 – paragraph 4 c (new)

4c. The reasoned decisions of the Forum pursuant to Article 25(4) and the Commission decisions pursuant to Article 25(5) shall be made available to the general public; the public version of the decision shall not disclose business secrets or other confidential company information.

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 26 – paragraph 4 a (new)

4a. The Commission shall specify by means of implementing acts uniform control rates to be applied by customs authorities for products entering the Union market, based on risk assessment for product types as well as the number of products entering the Union market per port.

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 26 – paragraph 7 – subparagraph 1 – point d

(d) the ~~characteristic~~types of ~~any~~ products found to be non-compliant.

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 27 – paragraph 1 – point d a (new)

(da) the product or any presentation of the product bears without authorisation a trade mark that is essentially similar to a registered trade mark for that product, thereby not allowing its authenticity or origin to be guaranteed;

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 27 – paragraph 1 – point e

(e) for any other reason, there is a reasonable and justified cause to believe that the product ~~will~~does not comply with the requirements set out in the Union harmonisation legislation applicable to it w~~hen it is placed~~ith the aim of placing it on the market or that it ~~will~~ poses a serious risk.

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 27 – paragraph 3

3. Where the market surveillance authorities have a reasonable and justified reason to believe that a product will not comply with the Union harmonisation legislation applicable to it or will pose a serious risk, they shall require the authorities designated under Article 26(1) to suspend the process for its release for free circulation.

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 29 – paragraph 1

1. Market surveillance authorities shall treat ~~as a matter of priority products declared free for circulation by an authorised economic operator as set out in Article 38(2) of Regulation (EU) No 952/2013,~~ the release of products which isare suspended in accordance with Article 28 (1) of this Regulation equally for all economic operators.

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 31 – title

~~Union Product Compliance Network~~European Market Surveillance Forum

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 31 – paragraph 1

A~~n Union Product Compliance Network (‘the Network’~~ European Market Surveillance Forum (‘the Forum') is hereby established.

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 31 – paragraph 1 a (new)

The Commission shall support cooperation between market surveillance authorities via the Forum. It shall participate in the meetings of the Forum and its sub-groups.

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 31 – paragraph 1 b (new)

To perform the tasks set out in Article 32, the Forum shall be assisted by the Commission by means of an executive secretariat, that provides technical and logistic support to the Forum and its sub- groups, and the ADCOs.

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 32 – title

Composition of the ~~Union Product Compliance Network~~European Market Surveillance Forum

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 32 – paragraph 1

1. The ~~Network~~Forum shall be composed of a ~~Union Product Compliance~~European Market Surveillance Forum Board (‘E~~UPC~~MSF Board’), administrative coordination groups and a secretariat.

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 32 – paragraph 2

2. The E~~UPC~~MSF Board shall consist of one representative from each of the single liaison offices referred to in Article 11, and two representatives from the Commission, and their respective alternates.

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 32 a (new)

Article 32a Composition of the European Market Surveillance Forum 1. Each Member State shall be represented in meetings of the Forum by one or more representatives from each of the single liaison offices referred to in Article 11, and two representatives from the Commission, and their respective alternates. 2. The Forum shall meet at regular intervals and, where necessary, at the duly motivated request of the Commission or a Member State. 3. The Forum shall use its best endeavours to reach consensus. If consensus cannot be reached, the Forum shall adopt its position by a simple majority of its members. Members may request that their positions and the grounds on which they are based are officially recorded. 4. The Forum may invite experts and other third parties to attend meetings or provide written contributions. 5. The Forum may establish standing or temporary sub-groups. 6. Administrative cooperation groups for market surveillance (ADCOs), set up by the Member States for the implementation of the different parts of Union harmonisation legislation, shall be part of the Forum. 7. ADCOs may organize open meetings inviting on a case by case basis organisations representing the interests at Union level of industry, small and medium-sized enterprises, consumers, laboratories and conformity assessment bodies. 8. The Forum shall establish its rules of procedure. 9. The Forum shall cooperate with the Forum for Exchange of Information on Enforcement established by Regulation (EC) No 1907/2006.

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 33 – paragraph 1 – point h

(h) to organise the meetings of the E~~UPC~~MSF Board and administrative coordination groups referred to in Articles 32;

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 33 – paragraph 1 – point m

(m) to examine, on its own initiative or at the request of the E~~UPC~~MSF Board, any question covering the application of this Regulation and issue guidelines, recommendations and best practices in order to encourage consistent application of this Regulation, including by setting standards for minimum penalties.

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 33 – paragraph 2 – introductory part

2. The E~~UPC~~MSF Board shall have the following tasks:

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 33 a (new)

Article 33a Coordinated enforcement tasks 1. The Commission shall have the following tasks: (a) to support the establishment and functioning of Union testing facilities referred to in Article 20; (b) to apply the instruments of international cooperation referred to in Article 35; (c) to develop and maintain the system referred to in Article 34, including the interface with the EU Single Window referred to in paragraph 4 of that Article, and provide information to the general public by means of that system; (d) to organise the meetings of the Forum and administrative coordination groups; (e) to assist the Forum to perform preliminary or ancillary work in connection with the implementation of market surveillance activities linked to the application of Union harmonisation legislation such as studies, mutual joint visits, research work, the development and maintenance of databases, training activities, laboratory work, proficiency testing, inter-laboratory tests and conformity assessment work, and to prepare and assist in the implementation of Union market surveillance campaigns and similar activities; (f) to organise peer reviews, common training programmes and facilitate exchanges of personnel between market surveillance authorities and, where appropriate, with the market surveillance authorities of third countries or with international organisations; (g) to carry out activities under programmes of technical assistance, cooperation with third countries and the promotion and enhancement of Union market surveillance policies and systems among interested parties at Union and international levels; (h) to facilitate technical or scientific expertise for the purpose of implementing market surveillance administrative cooperation. 2. The Forum shall have the following tasks: (a) to facilitate the exchange of information on non-compliant products and/or products presenting a risk, evaluations of products including risk assessment, test methods and results, recent scientific developments and other aspects relevant to control activities; (b) to facilitate the organisation of joint market surveillance and joint testing projects; (c) to exchange expertise and best practices, in particular regarding the implementation of market surveillance programmes; (d) to facilitate the organisation of training programmes and exchanges of national officials; (e) to facilitate the organisation of information campaigns and joint visit programmes; (f) to promote cooperation at Union level with regard to the tracing, withdrawal and recall of non-compliant products and/or products presenting a risk; (g) to promote the easy access, retrieval and sharing of product safety information collected by market surveillance authorities, including information on complaints, accidents, injury reports and investigation and test results; (h) to contribute to the development of guidance to ensure the effective and uniform implementation of this Regulation; (i) to provide advice and assist the Commission, at its request, with issues related to the implementation of this Regulation; (j) to propose the financing of activities foreseen in Article 36; (k) to contribute to uniform administrative practices with regard to market surveillance in the Member States; (l) to provide advice and assist the Commission with issues related to the further development of RAPEX and ICSMS; (m) to promote the cooperation and exchange of expertise and best practices between market surveillance authorities and authorities in charge of controls at the external borders. 3. The administrative coordination groups shall have the following tasks: (a) to coordinate the enforcement of Union harmonisation legislation within their area of competence; (b) to establish appropriate communication channels between national market surveillance authorities and the Network; (c) to establish and coordinate common actions such as cross-border market surveillance activities; (d) to develop common practices and methodologies for effective market surveillance; (e) to inform each other of national market surveillance methods and activities and to develop and promote best practices; (f) to identify issues of shared interest relating to market surveillance and suggest common approaches to be adopted.

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 34 – paragraph 1

1. The Commission shall 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. The aim is to enable sharing of relevant data between Member States and to allow the Commission to monitor market surveillance activities. The Commission, single liaison offices, market surveillance authorities and authorities designated in accordance with Article 26(1) shall have access to that system. The information and communication system shall be linked through a common interface to the existing electronic system of the customs administration, based on Regulation (EU) No 952/2013 of the European Parliament and of the Council laying down the Union Customs Code as well as to the Community Rapid Information System RAPEX, based on Directive 2001/95/EC of the European Parliament and of the Council on General Product Safety.

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 34 – paragraph 3 – point b

~~(b) any partnership arrangements entered into by them under Article 7;~~deleted

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 34 – paragraph 5 a (new)

5a. The information system shall allow file transmission between market surveillance authorities, and shall be the preferred instrument for requests for information referred to in Article 22.

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 35 – paragraph 1

1. TIn order to improve the efficiency of market surveillance in the Union, the Commission may exchange confidential market surveillance related information with regulatory authorities of third countries or international organisations where a framework for cooperation and information exchange of selected information referred to in paragraph 2 of Article 35 of this Regulation exists and where it has concluded confidentiality arrangements based on reciprocity with those authorities or organisations.

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 35 – paragraph 1 a (new)

1a. The European Commission shall ensure that any information exchanged under paragraph 1 is in accordance with applicable law (including on the processing of personal data and on the free movement of such data), and that information is shared only with regulatory authorities of third countries or international organisations that guarantee an adequate level of protection to the fundamental rights of economic operators, by means of their domestic law or the international commitments they have entered into.

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 35 – paragraph 2 – introductory part

2. The Commission may, following approval by the EMSF Board, set up a framework for cooperation and exchange of selected information contained in the information exchange system provided for in Article 12 of Directive 2001/95/EC, with applicant countries, third countries or international organisations. The cooperation or exchange of information may relate, inter alia, to the following:

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 35 – paragraph 3

3. The Commission may, following approval by the EMSF Board, 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 product or in respect of products or categories of product manufactured by certain manufacturers.

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 35 – paragraph 5 – introductory part

5. Approval may only be granted to a third country under paragraph 3 following a~~n audit with~~udits within relevant third country and, where appropriate, in the Union demonstrating that the following conditions are satisfied:

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 35 – paragraph 5 – point a a (new)

(aa) the third country possesses an efficient verification system of the compliance of products exported to the Union;

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 35 – paragraph 9

9. The Commission, following approval of the EMSF Board, shall withdraw an approval granted under paragraph 3 where it is revealed that the products entering the Union market do not comply with Union harmonisation legislation in a significant number of instances. The Commission shall immediately inform Member States and the affected third country.

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 38 – title

A~~pplicability of~~mendments to Regulation (EC) 765/2008 ~~and amendments to Union harmonisation legislation~~

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 38 – paragraph 1

Articles 15 to 29 of Regulation (EC) 765/2008 ~~shall not apply to Union harmonisation legislation set out in the Annex~~are deleted.

2018/05/24
Committee: IMCO

Proposal for a regulation
Article 61 – paragraph 5 a (new)

5a. Member States may not apply any penalties in case of minor formal infringement, timely correction of the non-compliance by the operator or first time non-compliance.

2018/05/24
Committee: IMCO