Legal provisions of COM(2012)772 - Standardising marine equipment - Main contents
Please note
This page contains a limited version of this dossier in the EU Monitor.
dossier | COM(2012)772 - Standardising marine equipment. |
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document | COM(2012)772 ![]() |
date | July 23, 2014 |
Contents
- CHAPTER 1 - GENERAL PROVISIONS
- Article 1 - Objective
- Article 2 - Definitions
- Article 3 - Scope
- Article 4 - Requirements for marine equipment
- Article 5 - Application
- Article 6 - Functioning of the internal market
- Article 7 - Transfer of a ship to the flag of a Member State
- Article 8 - Standards for marine equipment
- CHAPTER 2 - THE WHEEL MARK
- Article 9 - The wheel mark
- Article 10 - Rules and conditions for affixing the wheel mark
- Article 11 - Electronic tag
- CHAPTER 3 - OBLIGATIONS OF ECONOMIC OPERATORS
- Article 12 - Obligations of manufacturers
- Article 13 - Authorised representatives
- Article 14 - Other economic operators
- CHAPTER 4 - CONFORMITY ASSESSMENT AND NOTIFICATION OF CONFORMITY ASSESSMENT BODIES
- Article 15 - Conformity assessment procedures
- Article 16 - EU declaration of conformity
- Article 17 - Notification of conformity assessment bodies
- Article 18 - Notifying authorities
- Article 19 - Information obligation on notifying authorities
- Article 20 - Subsidiaries of, and subcontracting by, notified bodies
- Article 21 - Changes to notifications
- Article 22 - Challenges to the competence of notified bodies
- Article 23 - Operational obligations of notified bodies
- Article 24 - Obligation of notified bodies to provide information
- CHAPTER 5 - UNION MARKET SURVEILLANCE, CONTROL OF PRODUCTS, SAFEGUARD PROVISIONS
- Article 25 - EU market surveillance framework
- Article 26 - Procedure for dealing with marine equipment presenting a risk at national level
- Article 27 - EU safeguard procedure
- Article 28 - Compliant products which present a risk to maritime safety, to health or to the environment
- Article 29 - Formal non-compliance
- Article 30 - Exemptions based on technical innovation
- Article 31 - Exemptions for testing or evaluation
- Article 32 - Exemptions in exceptional circumstances
- CHAPTER 6 - FINAL PROVISIONS
- Article 33 - Exchange of experience
- Article 34 - Coordination of notified bodies
- Article 35 - Implementing measures
- Article 36 - Amendments
- Article 37 - Exercise of the delegation
- Article 38 - Committee
- Article 39 - Transposition
- Article 40 - Repeal
- Article 41 - Entry into force
- Article 42 - Addressees
CHAPTER 1 - GENERAL PROVISIONS
Article 1 - Objective
Article 2 - Definitions
(1) | ‘marine equipment’ means equipment falling within the scope of this Directive in accordance with Article 3; |
(2) | ‘EU ship’ means a ship flying the flag of a Member State and falling within the scope of the international conventions; |
(3) | ‘international conventions’ means the following conventions, together with their protocols and codes of mandatory application, adopted under the auspices of the International Maritime Organization (IMO), which have entered into force and which lay down specific requirements for the approval by the flag State of equipment to be placed on board ships:
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(4) | ‘testing standards’ means the testing standards for marine equipment set by:
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(5) | ‘international instruments’ means the international conventions, together with the resolutions and circulars of the IMO giving effect to those conventions in their up-to-date version, and the testing standards; |
(6) | ‘wheel mark’ means the symbol referred to in Article 9 and set out in Annex I or, as appropriate, the electronic tag referred to in Article 11; |
(7) | ‘notified body’ means an organisation designated by the competent national administration of a Member State in accordance with Article 17; |
(8) | ‘making available on the market’ means any supply of marine equipment on the Union market in the course of a commercial activity, whether in return for payment or free of charge; |
(9) | ‘placing on the market’ means the first making available of marine equipment on the Union market; |
(10) | ‘manufacturer’ means any natural or legal person who manufactures marine equipment or has marine equipment designed or manufactured, and markets that equipment under its name or trademark; |
(11) | ‘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; |
(12) | ‘importer’ means any natural or legal person established within the Union who places marine equipment from a third country on the Union market; |
(13) | ‘distributor’ means any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes marine equipment available on the market; |
(14) | ‘economic operators’ means the manufacturer, the authorised representative, the importer and the distributor; |
(15) | ‘accreditation’ means accreditation as defined in point 10 of Article 2 of Regulation (EC) No 765/2008; |
(16) | ‘national accreditation body’ means national accreditation body as defined in point 11 of Article 2 of Regulation (EC) No 765/2008; |
(17) | ‘conformity assessment’ means the process carried out by the notified bodies, in accordance with Article 15, demonstrating whether marine equipment complies with the requirements laid down in this Directive; |
(18) | ‘conformity assessment body’ means a body that performs conformity assessment activities including calibration, testing, certification and inspection; |
(19) | ‘recall’ means any measure aimed at achieving the return of marine equipment that has already been placed on board EU ships or purchased with the intention of being placed on board EU ships; |
(20) | ‘withdrawal’ means any measure aimed at preventing marine equipment in the supply chain from being made available on the market; |
(21) | ‘EU declaration of conformity’ means a statement issued by the manufacturer in accordance with Article 16; |
(22) | ‘product’ means an item of marine equipment. |
Article 3 - Scope
2. Notwithstanding the fact that the equipment referred to in paragraph 1 may also fall within the scope of instruments of Union law other than this Directive, that equipment shall, for the purpose set out in Article 1, be subject only to this Directive.
Article 4 - Requirements for marine equipment
2. Compliance of marine equipment with the requirements referred to in paragraph 1 shall be demonstrated solely in accordance with the testing standards and by means of the conformity assessment procedures referred to in Article 15.
3. The international instruments shall apply, without prejudice to the conformity checking procedure set out in Article 5 of Regulation (EC) No 2099/2002 of the European Parliament and of the Council (8).
4. The requirements and standards referred to in paragraphs 1 and 2 shall be implemented in a uniform manner, in accordance with Article 35(2).
Article 5 - Application
2. Member States shall take the necessary measures to ensure that marine equipment on board ships flying their flag complies with the requirements in the international instruments which are applicable to equipment already placed on board. Implementing powers shall be conferred upon the Commission to ensure the uniform application of those measures, in accordance with Article 35(3).
Article 6 - Functioning of the internal market
Article 7 - Transfer of a ship to the flag of a Member State
2. In cases where the date of installation on board of marine equipment cannot be established, Member States may determine satisfactory requirements of equivalence, taking into account relevant international instruments.
3. Unless the equipment either bears the wheel mark or the administration considers it to be equivalent, it shall be replaced.
4. Marine equipment which is considered equivalent pursuant to this Article shall be issued with a certificate by the Member State which shall at all times be carried with the equipment. That certificate shall give the flag Member State’s permission for the equipment to be retained on board the ship and impose any restrictions or lay down any provisions relating to the use of the equipment.
Article 8 - Standards for marine equipment
2. In the absence of an international standard for a specific item of marine equipment, in exceptional circumstances where duly justified by an appropriate analysis and in order to remove a serious and unacceptable threat to maritime safety, to health or to the environment and taking into account any ongoing work at IMO level, the Commission shall be empowered to adopt, by means of delegated acts in accordance with Article 37, harmonised technical specifications and testing standards for that specific item of marine equipment.
It is of particular importance that the Commission carry out consultations with experts, including Member States’ experts, during the preparation of such delegated acts.
Those technical specifications and testing standards shall apply on an interim basis until such time as the IMO has adopted a standard for that specific item of marine equipment.
3. In exceptional circumstances where duly justified by an appropriate analysis and if it is necessary to remove an identified unacceptable threat to maritime safety, to health or to the environment due to a serious weakness or anomaly in an existing standard for a specific item of marine equipment indicated by the Commission pursuant to Article 35(2) or (3) and taking into account any ongoing work at IMO level, the Commission shall be empowered to adopt, by means of delegated acts in accordance with Article 37, harmonised technical specifications and testing standards for that specific item of marine equipment, to the extent necessary to remedy the serious weakness or anomaly only.
It is of particular importance that the Commission carry out consultations with experts, including Member States’ experts, during the preparation of such delegated acts.
Those technical specifications and testing standards shall apply on an interim basis until such time as the IMO has reviewed the standard applicable to that specific item of marine equipment.
4. The technical specifications and standards adopted in accordance with paragraphs 2 and 3 shall be made accessible free of charge by the Commission.
CHAPTER 2 - THE WHEEL MARK
Article 9 - The wheel mark
2. The wheel mark shall not be affixed to any other product.
3. The form of the wheel mark to be used shall be as set out in Annex I.
4. Use of the wheel mark shall be subject to the general principles set out in paragraphs 1 and 3 to 6 of Article 30 of Regulation (EC) No 765/2008, where any reference to the CE marking shall be construed as a reference to the wheel mark.
Article 10 - Rules and conditions for affixing the wheel mark
2. The wheel mark shall be affixed at the end of the production phase.
3. The wheel mark shall be followed by the identification number of the notified body, where that body is involved in the production control phase, and by the year in which the mark is affixed.
4. The identification number of the notified body shall be affixed by the body itself or, under its instructions, by the manufacturer or the manufacturer's authorised representative.
Article 11 - Electronic tag
2. The Commission shall carry out a cost-benefit analysis concerning the use of the electronic tag as a supplement to, or a replacement of, the wheel mark.
3. The Commission may adopt delegated acts, in accordance with Article 37, in order to identify the specific items of marine equipment which can benefit from electronic tagging. It is of particular importance that the Commission carry out consultations with experts, including Member States’ experts, during the preparation of such delegated acts.
4. Implementing powers shall be conferred upon the Commission in order to lay down, in the form of Commission Regulations and in accordance with the examination procedure referred to in Article 38(2), appropriate technical criteria as regards the design, performance, affixing and use of electronic tags.
5. For the equipment identified in accordance with paragraph 3, the wheel mark may, within three years after the date of adoption of the appropriate technical criteria referred to in paragraph 4, be supplemented by an appropriate and reliable form of electronic tag.
6. For the equipment identified in accordance with paragraph 3, the wheel mark may be replaced, five years after the date of adoption of the appropriate technical criteria referred to in paragraph 4, by an appropriate and reliable form of electronic tag.
CHAPTER 3 - OBLIGATIONS OF ECONOMIC OPERATORS
Article 12 - Obligations of manufacturers
2. Manufacturers shall draw up the required technical documentation and have the applicable conformity assessment procedures carried out.
3. Where the compliance of marine equipment with the applicable requirements has been demonstrated by the conformity assessment procedure, manufacturers shall draw up an EU declaration of conformity in accordance with Article 16 and affix the wheel mark in accordance with Articles 9 and 10.
4. Manufacturers shall keep the technical documentation and the EU declaration of conformity referred to in Article 16 for at least 10 years after the wheel mark has been affixed and in no case for a period shorter than the expected life of the marine equipment concerned.
5. Manufacturers shall ensure that procedures are in place for series production to remain in conformity. Changes in marine equipment design or characteristics and changes in the requirements in the international instruments as referred to in Article 4, on the basis of which conformity of marine equipment is declared, shall be taken into account. When necessary in accordance with Annex II, manufacturers shall have a new conformity assessment carried out.
6. Manufacturers shall ensure that their products bear a type, batch or serial number or other element allowing their identification, or, where the size or nature of the product does not allow it, that the required information is provided on the packaging or in a document accompanying the product or both, as appropriate.
7. Manufacturers shall indicate their name, registered trade name or registered trade mark and the address at which they can be contacted on the product or, where that is not possible, on its packaging or in a document accompanying the product or both, as appropriate. The address must indicate a single point at which the manufacturer can be contacted.
8. Manufacturers shall ensure that the product is accompanied by instructions and all necessary information for safe installation on board and safe use of the product, including limitations of use, if any, that can be easily understood by the users, together with any other documentation required by the international instruments or testing standards.
9. Manufacturers who consider or have reason to believe that a product to which they have affixed the wheel mark is not in conformity with the applicable design, construction and performance requirements and with the testing standards implemented in accordance with Article 35(2) and (3), shall immediately take the necessary corrective measures to bring that product into conformity, to withdraw it or to recall it, if appropriate. In addition, where the product presents a risk, manufacturers shall immediately inform the competent national authorities of the Member States, giving details, in particular, of the non-compliance and of any corrective measures taken.
10. Manufacturers shall, further to a reasoned request from a competent authority, promptly provide it with all the information and documentation necessary to demonstrate the conformity of the product, in a language which can be easily understood by or is acceptable to that authority, grant that authority access to their premises for market surveillance purposes in accordance with Article 19 of Regulation (EC) No 765/2008 and provide samples or access to samples in accordance with Article 25(4) of this Directive. They shall cooperate with that authority, at its request, on any action taken to eliminate the risks posed by products which they have placed on the market.
Article 13 - Authorised representatives
2. Fulfilment of the obligations laid down in Article 12(1) and the drawing-up of technical documentation shall not form part of the authorised representative’s mandate.
3. An authorised representative shall perform the tasks specified in the mandate received from the manufacturer. The mandate shall allow the authorised representative to do at least the following:
(a) | keep the EU declaration of conformity and the technical documentation at the disposal of national surveillance authorities for at least 10 years after the wheel mark has been affixed and in no case for a period shorter than the expected life of the marine equipment concerned; |
(b) | further to a reasoned request from a competent authority, provide that authority with all the information and documentation necessary to demonstrate the conformity of a product; |
(c) | cooperate with the competent authorities, at their request, on any action taken to eliminate the risks posed by products covered by its mandate. |
Article 14 - Other economic operators
2. Importers and distributors shall, further to a reasoned request from a competent authority, provide it with all the information and documentation necessary to demonstrate the conformity of a product in a language which can be easily understood by, or is acceptable to, that authority. They shall cooperate with that authority, at its request, on any action taken to eliminate the risks posed by products which they have placed on the market.
3. An importer or distributor shall be considered a manufacturer for the purposes of this Directive and shall be subject to the obligations of the manufacturer under Article 12, where it places marine equipment on the market or on board an EU ship under its name or trademark or modifies marine equipment already placed on the market in such a way that compliance with the applicable requirements may be affected.
4. For a period of at least 10 years after the wheel mark has been affixed and in no case for a period shorter than the expected life of the marine equipment concerned, economic operators shall, on request, identify the following to the market surveillance authorities:
(a) | any economic operator who has supplied them with a product; |
(b) | any economic operator to whom they have supplied a product. |
CHAPTER 4 - CONFORMITY ASSESSMENT AND NOTIFICATION OF CONFORMITY ASSESSMENT BODIES
Article 15 - Conformity assessment procedures
2. Member States shall ensure that the manufacturer or the manufacturer's authorised representative has the conformity assessment carried out, through a notified body, for a specific item of marine equipment, by using one of the options provided by means of implementing acts adopted by the Commission in accordance with the examination procedure referred to in Article 38(2), from among one of the following procedures:
(a) | where the EC type-examination (module B) is to be used, before being placed on the market, all marine equipment shall be subject to:
|
(b) | where sets of marine equipment are produced individually or in small quantities and not in series or in mass, the conformity assessment procedure may be the EC unit verification (module G). |
3. The Commission shall, by means of the information system made available for that purpose, keep an up to date list of approved marine equipment and applications withdrawn or refused and shall make that list available to interested parties.
Article 16 - EU declaration of conformity
2. The EU declaration of conformity shall follow the model structure set out in Annex III to Decision No 768/2008/EC. It shall contain the elements specified in the relevant modules set out in Annex II to this Directive and shall be kept up to date.
3. By drawing up the EU declaration of conformity, the manufacturer shall assume the responsibility and the obligations referred to in Article 12(1).
4. When marine equipment is placed on board an EU ship, a copy of the EU declaration of conformity covering the equipment concerned shall be provided to the ship, and shall be kept on board until the said equipment is removed from the ship. It shall be translated by the manufacturer into the language or languages required by the flag Member State, including at least a language commonly used in the maritime transport sector.
5. A copy of the EU declaration of conformity shall be provided to the notified body or to the bodies which carried out the relevant conformity assessment procedures.
Article 17 - Notification of conformity assessment bodies
2. Notified bodies shall comply with the requirements laid down in Annex III.
Article 18 - Notifying authorities
2. Notified bodies shall be monitored at least every two years. The Commission may choose to participate as an observer in the monitoring exercise.
3. Member States may decide that the assessment and monitoring referred to in paragraph 1 are to be carried out by a national accreditation body.
4. Where the notifying authority delegates or otherwise entrusts the assessment, notification or monitoring referred to in paragraph 1 to a body which is not a governmental entity, that body shall be a legal entity and shall comply mutatis mutandis with the requirements laid down in Annex V. In addition, it shall have in place arrangements to cover liability arising out of its activities.
5. The notifying authority shall take full responsibility for the tasks performed by the body referred to in paragraph 4.
6. The notifying authority shall comply with the requirements laid down in Annex V.
Article 19 - Information obligation on notifying authorities
2. The Commission shall, by means of the information system made available for that purpose, make that information publicly available.
Article 20 - Subsidiaries of, and subcontracting by, notified bodies
2. Notified bodies shall take full responsibility for the tasks performed by subcontractors or subsidiaries wherever these are established.
3. Activities may be subcontracted or carried out by a subsidiary only with the agreement of the client.
4. Notified bodies shall keep at the disposal of the notifying authority the relevant documents concerning the assessment of the qualifications of the subcontractor or the subsidiary and the work carried out by such subcontractor or subsidiary under this Directive.
Article 21 - Changes to notifications
2. In the event of restriction, suspension or withdrawal of notification, or where the notified body has ceased its activity, the notifying Member State shall take appropriate steps to ensure that the files of that body are either processed by another notified body or kept available for the responsible notifying and market surveillance authorities at their request.
Article 22 - Challenges to the competence of notified bodies
2. The notifying Member State shall provide the Commission, on request, with all information relating to the basis for the notification or the maintenance of the competence of the body concerned.
3. The Commission shall ensure that all sensitive information obtained in the course of its investigations is treated confidentially.
4. Where the Commission ascertains that a notified body does not meet, or no longer meets, the requirements for its notification, it shall without delay inform the notifying Member State accordingly and request it to take the necessary corrective measures without delay, including de-notification if necessary.
Article 23 - Operational obligations of notified bodies
2. Where a notified body finds that the obligations laid down in Article 12 have not been met by a manufacturer, it shall require that manufacturer to take appropriate corrective measures without delay and shall not issue a conformity certificate.
3. Where, in the course of monitoring conformity following the issue of a conformity certificate, a notified body finds that a product no longer complies, it shall require the manufacturer to take appropriate corrective measures without delay and shall suspend or withdraw the certificate if necessary. Where corrective measures are not taken or do not have the required effect, the notified body shall restrict, suspend or withdraw the certificate, as appropriate.
Article 24 - Obligation of notified bodies to provide information
(a) | any refusal, restriction, suspension or withdrawal of a conformity certificate; |
(b) | any circumstances affecting the scope of, and the conditions for, notification; |
(c) | any request for information which they have received from market surveillance authorities regarding conformity assessment activities; |
(d) | on request, conformity assessment activities performed within the scope of their notification and any other activity performed, including cross-border activities and subcontracting. |
2. Notified bodies shall provide the Commission and the Member States, on request, with relevant information concerning issues relating to negative and positive conformity assessment results. Notified bodies shall provide the other notified bodies carrying out conformity assessment activities covering the same products with information concerning negative and, on request, positive conformity assessment results.
CHAPTER 5 - UNION MARKET SURVEILLANCE, CONTROL OF PRODUCTS, SAFEGUARD PROVISIONS
Article 25 - EU market surveillance framework
2. National market surveillance infrastructures and programmes shall take into account the specific features of the marine equipment sector, including the various procedures carried out as part of the conformity assessment, and in particular the responsibilities placed on the flag State administration by the international conventions.
3. Market surveillance may include documentary checks as well as checks of marine equipment which bears the wheel mark, whether or not it has been placed on board ships. Checks of marine equipment already placed on board shall be limited to such examination as can be carried out while the equipment concerned remains fully functional on board.
4. Where the market surveillance authorities of a Member State, as defined in Regulation (EC) No 765/2008, intend to carry out sample checks, they may, when it is reasonable and practicable to do so, request the manufacturer to make the necessary samples available or to give on-the-spot access to the samples at the manufacturer’s own cost.
Article 26 - Procedure for dealing with marine equipment presenting a risk at national level
Where, in the course of that evaluation, the market surveillance authorities find that the marine equipment does not comply with the requirements laid down in this Directive, they shall without delay require the relevant economic operator to take all appropriate corrective actions to bring the marine equipment into compliance with those requirements, to withdraw the marine equipment from the market, or to recall it within such reasonable period, commensurate with the nature of the risk, as they may prescribe.
The market surveillance authorities shall inform the relevant notified body accordingly.
Article 21 of Regulation (EC) No 765/2008 shall apply to the measures referred to in the second subparagraph of this paragraph.
2. Where the market surveillance authorities consider that non-compliance is not restricted to their national territory or to ships flying their flag, they shall inform the Commission and the other Member States, by means of the information system made available by the Commission for market surveillance purposes, of the results of the evaluation carried out under paragraph 1 and of the actions which they have required the economic operator to take.
3. The economic operator shall ensure that all appropriate corrective action is taken in respect of all the products concerned that it has made available on the market throughout the Union or, as the case may be, placed or delivered to be placed on board EU ships.
4. Where the relevant economic operator does not take adequate corrective action within the period prescribed by the market surveillance authorities in accordance with the second subparagraph of paragraph 1, or otherwise fails to meet its obligations under this Directive, the market surveillance authorities shall take all appropriate provisional measures to prohibit or restrict the marine equipment being made available on their national market or placed on board ships flying their flag, to withdraw the product from that market or to recall it.
The market surveillance authorities shall inform the Commission and the other Member States, without delay, of those measures.
5. The information on the measures taken by the market surveillance authorities referred to in paragraph 4 shall include all available details, in particular the data necessary for the identification of the non-compliant marine equipment, the origin of the product, the nature of the alleged non-compliance and the risk involved, the nature and duration of the national measures taken and the arguments put forward by the economic operator concerned. In particular, the market surveillance authorities shall indicate whether the non-compliance is due to either:
(a) | failure of the marine equipment to comply with the applicable design, construction and performance requirements as laid down pursuant to Article 4; |
(b) | non-compliance with the testing standards referred to in Article 4 during the conformity assessment procedure; |
(c) | shortcomings in those testing standards. |
6. Member States other than the Member State initiating the procedure shall without delay inform the Commission and the other Member States of any measures adopted and of any additional information at their disposal relating to the non-compliance of the marine equipment concerned, and, in the event of disagreement with the notified national measure, of their objections.
7. Where, within four months of receipt of the information concerning the measures taken by the market surveillance authorities, as referred to in paragraph 4, no objection has been raised by a Member State or by the Commission in respect of a provisional measure taken by a Member State, that measure shall be deemed justified.
8. Member States shall ensure that appropriate restrictive measures in respect of the marine equipment concerned, such as withdrawal of the product from their market, are taken without delay.
Article 27 - EU safeguard procedure
2. For the purposes of paragraph 1, where the Commission is satisfied that the procedure followed in the adoption of the national measure is appropriate for an exhaustive and objective evaluation of the risk and that the national measure complies with Article 21 of Regulation (EC) No 765/2008, it may limit itself to examining the appropriateness and proportionality of the relevant national measure in relation to the said risk.
3. The Commission shall address its decision to all Member States and shall immediately communicate it to them and to the relevant economic operator or operators.
4. If the relevant national measure is considered justified, all Member States shall take the measures necessary to ensure that the non-compliant marine equipment is withdrawn from their market, and, where necessary, recalled. They shall inform the Commission accordingly.
5. If the relevant national measure is considered unjustified, the Member State concerned shall withdraw it.
6. Where the non-compliance of the marine equipment is attributed to shortcomings in the testing standards referred to in Article 4, the Commission may, in order to fulfil the objective of this Directive, confirm, modify or revoke a national safeguard measure by means of implementing acts in accordance with the examination procedure referred to in Article 38(2).
The Commission shall furthermore be empowered to adopt, by means of delegated acts in accordance with the procedure referred to in Article 37, interim harmonised requirements and testing standards for that specific item of marine equipment. The criteria laid down in Article 8(3) shall apply accordingly. These requirements and testing standards shall be made accessible free of charge by the Commission.
7. Where the testing standard concerned is a European standard, the Commission shall inform the relevant European standardisation body or bodies and shall bring the matter before the committee set up by Article 5 of Directive 98/34/EC. That committee shall consult the relevant European standardisation body or bodies and deliver its opinion without delay.
Article 28 - Compliant products which present a risk to maritime safety, to health or to the environment
2. The economic operator shall ensure that corrective action is taken in respect of all the products concerned that it has made available on the market throughout the Union or placed on board EU ships.
3. The Member State shall immediately inform the Commission and the other Member States. The information provided shall include all available details, in particular the data necessary for the identification of the marine equipment concerned, the origin and the supply chain of the marine equipment, the nature of the risk involved and the nature and duration of the national measures taken.
4. The Commission shall without delay enter into consultation with the Member States and the relevant economic operator or operators and shall evaluate the national measures taken. On the basis of the results of that evaluation, the Commission shall decide whether or not the measure is justified and shall where necessary propose appropriate measures. Article 27(2) shall apply mutatis mutandis for this purpose.
5. The Commission shall address its decision to all Member States and shall immediately communicate it to them and to the relevant economic operator or operators.
Article 29 - Formal non-compliance
(a) | the wheel mark has been affixed in violation of Article 9 or Article 10; |
(b) | the wheel mark has not been affixed; |
(c) | the EU declaration of conformity has not been drawn up; |
(d) | the EU declaration of conformity has not been drawn up correctly; |
(e) | technical documentation is either not available or not complete; |
(f) | the EU declaration of conformity has not been sent to the ship. |
2. Where the non-compliance referred to in paragraph 1 persists, the Member State concerned shall take all appropriate measures to restrict or to prohibit the marine equipment being made available on the market or to ensure that it is recalled or withdrawn from the market.
Article 30 - Exemptions based on technical innovation
2. The trial procedures shall in no way discriminate between marine equipment produced in the flag Member State and marine equipment produced in other States.
3. Marine equipment covered by this Article shall be given a certificate by the flag Member State which shall at all times be carried with the equipment and which gives the flag Member State’s permission for the equipment to be placed on board the ship and imposes any restrictions or lays down any provisions relating to the use of the equipment.
4. Where a Member State allows marine equipment covered by this Article to be placed on board an EU ship, that Member State shall forthwith communicate the particulars thereof together with the reports of all relevant trials, assessments and conformity assessment procedures to the Commission and to the other Member States.
5. Within 12 months of receipt of the communication referred to in paragraph 4, the Commission, if it considers that the conditions laid down in paragraph 1 are not met, may require the Member State concerned to withdraw the permission granted within a specified deadline. For this purpose, the Commission shall act by means of implementing acts. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 38(2).
6. Where a ship with marine equipment on board which is covered by paragraph 1 is transferred to another Member State, the receiving flag Member State may take the necessary measures, which may include tests and practical demonstrations, to ensure that the equipment is at least as effective as equipment which does comply with the conformity assessment procedures.
Article 31 - Exemptions for testing or evaluation
(a) | the marine equipment shall be given a certificate by the flag Member State which shall at all times be carried with the equipment, state that Member State’s permission for the equipment to be placed on board the EU ship, impose all necessary restrictions and lay down any other appropriate provisions as regards the use of the equipment concerned; |
(b) | the permission shall be limited to the period considered by the flag State as being necessary to complete the testing, which should be as short as possible; |
(c) | the marine equipment shall not be relied on in place of equipment which meets the requirements of this Directive and shall not replace such equipment, which shall remain on board the EU ship in working order and ready for immediate use. |
Article 32 - Exemptions in exceptional circumstances
2. The marine equipment placed on board shall be accompanied by documentation issued by a Member State of the IMO which is a party to the relevant conventions, certifying compliance with the relevant IMO requirements.
3. The flag State administration shall be informed at once of the nature and characteristics of such other marine equipment.
4. The flag State administration shall, at the earliest opportunity, ensure that the marine equipment referred to in paragraph 1, along with its testing documentation, complies with the relevant requirements of the international instruments and of this Directive.
5. Where it has been demonstrated that specific marine equipment bearing the wheel mark is not available on the market, the flag Member State may authorise other marine equipment to be placed on board, subject to paragraphs 6 to 8.
6. The authorised marine equipment shall comply, as much as possible, with the requirements and testing standards referred to in Article 4.
7. The marine equipment placed on board shall be accompanied by an interim certificate of approval issued by the flag Member State or by another Member State, stating the following:
(a) | the equipment bearing the wheel mark which the certified equipment is due to replace; |
(b) | the exact circumstances under which the certificate of approval has been issued, and in particular the unavailability in the market of equipment bearing the wheel mark; |
(c) | the exact design, construction and performance requirements against which the equipment has been approved by the certifying Member State; |
(d) | the testing standards applied, if any, in the relevant approval procedures. |
8. The Member State issuing an interim certificate of approval shall inform the Commission forthwith. If the Commission considers that the conditions of paragraphs 6 and 7 have not been met, it may require that Member State to revoke that certificate or take other appropriate measures by means of implementing acts. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 38(2).
CHAPTER 6 - FINAL PROVISIONS
Article 33 - Exchange of experience
Article 34 - Coordination of notified bodies
2. Member States shall ensure that the bodies notified by them participate in the work of the sectoral group, directly or by means of designated representatives.
Article 35 - Implementing measures
2. For each item of marine equipment for which the approval of the flag State administration is required by the international conventions, the Commission shall indicate by means of implementing acts the respective design, construction and performance requirements and the testing standards provided for in the international instruments. When adopting those acts, the Commission shall explicitly indicate the dates from which those requirements and testing standards are to apply, including the dates for placing on the market and placing on board, in accordance with the international instruments, and taking into consideration timeframes for ship-building. The Commission may also specify the common criteria and detailed procedures for their application.
3. The Commission shall, by means of implementing acts, indicate the respective design, construction and performance requirements newly provided for in the international instruments and which apply to equipment already placed on board, in order to ensure that equipment placed on board EU ships complies with the international instruments.
4. The Commission shall set up and maintain a database containing at least the following information:
(a) | the list and essential details of the conformity certificates issued pursuant to this Directive, as provided by the notified bodies; |
(b) | the list and essential details of the declarations of conformity issued pursuant to this Directive, as provided by the manufacturers; |
(c) | an up-to-date list of the applicable international instruments, and of the requirements and testing standards applicable by virtue of Article 4(4); |
(d) | the list and full text of the criteria and procedures referred to in paragraph 2; |
(e) | the requirements and conditions for electronic tagging referred to in Article 11, when applicable; |
(f) | any other useful information with a view to facilitating correct implementation of this Directive by the Member States, the notified bodies and the economic operators. |
That database shall be made accessible to the Member States. It shall also be made available to the public for information purposes only.
5. The implementing acts referred to in this Article shall be adopted in the form of Commission Regulations in accordance with the examination procedure referred to in Article 38(2).
Article 36 - Amendments
Article 37 - Exercise of the delegation
2. The power to adopt delegated acts referred to in Articles 8, 11, 27 and 36 shall be conferred on the Commission for a period of five years from 17 September 2014. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.
3. The delegation of power referred to in Articles 8, 11, 27 and 36 may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.
4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.
5. A delegated act adopted pursuant to Articles 8, 11, 27 and 36 shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.
Article 38 - Committee
2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply. Where the committee delivers no opinion, the Commission shall not adopt the draft implementing act and the third subparagraph of Article 5(4) of Regulation (EU) No 182/2011 shall apply.
Article 39 - Transposition
They shall apply those provisions from 18 September 2016.
When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
Article 40 - Repeal
2. The requirements and testing standards for marine equipment applicable on 18 September 2016 pursuant to the provisions of national law adopted by the Member States in order to comply with Directive 96/98/EC shall continue to apply until the entry into force of the implementing acts referred to in Article 35(2).
3. References to the repealed Directive shall be construed as references to this Directive.