Explanatory Memorandum to COM(2012)772 - Standardising marine equipment - Main contents
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This page contains a limited version of this dossier in the EU Monitor.
| dossier | COM(2012)772 - Standardising marine equipment. |
|---|---|
| source | COM(2012)772  |
| date | 17-12-2012 |
Marine equipment represents a significant fraction of the value of a newly built ship, and its quality and good operation are critical for the safety of the ship and its crew, as well as for the prevention of maritime accidents and pollution of the marine environment.
The international maritime safety conventions contain specific requirements for ships to be properly equipped; furthermore they require flag States to ensure that the equipment carried on board ships complies with certain safety construction and performance requirements and to issue the relevant certificates. To that end both the International Maritime Organization (IMO) and the international and European standardization bodies produce testing standards for marine equipment. The IMO develops the convention requirements and the testing standards, and keeps them up to date, by means of a number of instruments such as Codes, Resolutions and Circulars.
The international conventions and testing standards leave certain discretion to the flag administrations. Although in general IMO instruments containing requirements and testing standards become mandatory, the IMO tradition to work by consensus may from time to time lead to the adoption of important safety standards for marine equipment by means of non-binding instruments; for the same reason, some IMO instruments occasionally have exceedingly generous deadlines for their implementation or none at all.
In its proposal for a directive on marine equipment, back in 1995, the Commission clearly identified the problems encountered in the Internal Market as a result of this state of affairs and in the absence of EU harmonisation in the marine equipment sector[1]. Member States were reluctant to mutually accept their respective conformity certificates even in the presence of comparable requirements – not at least without additional national controls; the result was multiple approval procedures for the same marine equipment. The Commission noted how harmonisation would lead to the elimination of important administrative barriers and open the internal market to marine equipment certified in the Member States, with significant economies of scale.
Council Directive 96/98/EC of 20 December 1996 on marine equipment[2] (MED) thus laid down common rules to eliminate differences in the implementation of international standards by means of a clearly identified set of requirements and uniform certification procedures. Today, these common rules continue to be necessary to achieve a smooth operation of the internal market in the marine equipment sector while ensuring a high level of safety and of environmental protection.
The experience gained in the implementation of the MED has highlighted four areas where the existing Directive does not fully meet its objectives. These are:
1.2.1. Identification of applicable requirements. The periodic amendment of Annex A of the directive
The specific technical requirements and testing standards applicable to equipment falling under the scope of the MED are listed in Annex A to the directive. Given the need to keep up with the legislative production of the IMO and, as appropriate, of the international and European standardization bodies, Annex A is in need of periodic updates.
IMO instruments and international standards normally leave a reasonable time between their adoption and their entry into force, ranging in most cases between twelve and twenty-four months. The system must be capable of bringing the new requirements into national legislation within that window, which is currently not the case. Until now, it has never been possible to fully meet the IMO deadlines, and the delay in the incorporation of the IMO requirements into the national legal orders of the Member States has reached peaks of several years.
This generates significant disturbance for the industry, which must produce to different standards for the European and international markets and has difficulties in identifying the applicable requirements. The risk of detention of European ships in foreign ports increases.
There is a clearly uneven, where not insufficient, degree of control of notified bodies by Member States administrations. The MED requirements on notified bodies currently do not provide detailed quality benchmarks for the notified bodies themselves or efficient ways of control for the Member States. Given that correctly functioning conformity checking procedures are the first and main line of defence to avoid the entry of non-compliant equipment in the market, concerns have been raised that these weaknesses may be confronting the industry with unfair competition from entities taking advantage of this situation.
Marine equipment is mostly placed on board when the ship is built or repaired – anywhere in the world and mostly away from the EU's borders. Thus the marine equipment that actually enters the physical territory of the Member States is only a fraction of the equipment covered by the Directive.
However, the MED only allows market surveillance to take place on equipment not yet placed on board and contains no detailed framework – to the point that market surveillance appears as an option rather than an obligation. Therefore the system in the MED does not adapt to the reality of the market and in practice makes it very difficult for the Member States to carry out effective market surveillance.
Market surveillance is therefore unlikely to provide the national authorities with sufficient information to prevent the placing of non-compliant products on board EU ships. This has a direct, negative impact on safety while compliant manufacturers have to face the difficulties associated with unfair competition and counterfeit.
Experience has highlighted structural weaknesses in the safeguard clause mechanism as currently laid down in the MED. There is no incentive for a Member State to carry out an exhaustive procedure during market surveillance and all the way to the adoption of restrictive measures, where sample testing is carried out independently and with sufficient guarantees of reliability. Nothing in the current text obliges the Member States to have a proper hearing of the manufacturer or put at its disposal any appeal mechanisms, let alone to seek voluntary correction of any shortcomings in the first place. This may lead, as in the above mentioned case, to premature notification to the Commission thus transferring to it the detailed examination of the substance. This also places on the Commission a burden which is well beyond its resources and technical capacities, even if the assistance of EMSA is taken into account.
Moreover, the current safeguard clause mechanism is burdensome and lengthy, and thus exposes manufacturers to significant reputational damage for long periods until the case is finally decided.
Regulation 765/2008/EC of the European Parliament and of the Council setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93[3] lays down a common EU framework for accreditation and market surveillance. Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products and repealing Council Decision 93/465/EEC i sets out the common framework of general principles and reference provisions for the drawing up of EU legislation harmonising the conditions for the marketing of products (EU harmonisation legislation). According to Article 2, EU harmonisation legislation shall have recourse to the general principles set out in this Decision and to the relevant reference provisions of Annexes I, II and III. However, EU legislation may depart from those general principles and reference provisions if that is appropriate on account of the specificities of the sector concerned, especially if comprehensive legal systems are already in place.
Pursuant to Articles 90 and 91 TFEU, the Common Transport Policy (CTP) should contribute to the broader objectives of the Treaties, and hence the free movement of goods, and include measures to ensure the safety of transport. Within the framework of CTP and taking into account the specificities of marine equipment, the general objective of the proposed initiative is twofold:
· to enhance the implementation and enforcement mechanisms of the MED, thereby guaranteeing the proper functioning of the internal market for marine equipment while ensuring a high level of safety at sea and prevention of marine pollution;
· to simplify the regulatory environment while guaranteeing that IMO requirements are applied and implemented in a harmonised way across the EU, thereby contributing to ensuring that the conditions necessary for the competitiveness of the Union's industry exist pursuant to Article 173 TFEU.
This twofold general objective can be translated into more specific objectives:
· to find an optimal way to align MED on the New Legislative Framework (as required under Article 2 of Decision 768/2008/EC (the NLF Decision) while taking due account of the specificities of marine equipment in the field of market surveillance, conformity assessment of products and obligations of actors in the distribution chain.
· to shorten, simplify and clarify the transposition of amendments to IMO standards into the European and national legal frameworks.
Further to regular contacts with stakeholders since the coming into force of the MED in 1997, stakeholders were consulted in 2008 when the revision exercise was launched, by means of questionnaires to the Member States, the industry and the MarED group of notified bodies. A formal stakeholder consultation meeting was held on 27 November 2008 in Brussels. In April 2012, all stakeholders were contacted again by the Commission in order to obtain fresher views on the possible amendments of the directive or new data. The answers received largely confirmed the problems already examined.
The impact assessment focused on two alternatives to the baseline (statu quo) scenario, namely maximum alignment with the NLF and conditional alignment; in this latter case allowing for a number of MED-specific measures in order to cater for the sector's particular features. The analysis showed that while on the whole both options were appropriate, conditional alignment was the most effective and less burdensome solution and at the same time it had the most positive overall economic, social and environmental impacts.
The Commission's Impact assessment board was consulted twice, namely in September 2009 and in August 2012. The remarks on the initial version led to an in-depth reformulation of the impact assessment, i.a. refining the problem description, restructuring policy options and shortening the document. In its second opinion, the Board formulated a number of additional recommendations which have been incorporated in the final document.
The complete assessment can be found in the impact assessment report accompanying this proposal and is also published online at: ec.europa.eu/governance/impact/index_en .
Contents
- Legal elements of the proposal
- Budgetary implications
- 1.1. Background
- 1.2. Experience gained in the implementation of Directive 96/98/EC
- 1.2.1. Identification of applicable requirements. The periodic amendment of Annex A of the directive
- 1.2.2. Quality of the work of the notified bodies
- 1.2.3. Market surveillance
- 1.2.4. Safeguard clause
- 1.3. The new regulatory framework for the marketing of goods within the EU (NLF)
- 1.4. Objectives of the proposal
- 1.4.1. General objectives
- 1.4.2. Specific objectives
- 2. Results of consultation with the interested parties and impact assessment
- 3.1. Legal basis
- 3.2. Subsidiarity and proportionality principles
- 3.3. Choice of instrument
- 5. Content of the proposal
The legal basis for the proposal is Article 100 (2) TFEU.
The principles of subsidiarity and proportionality are fully respected.
Harmonisation by the EU results in a clearly identified set of requirements and uniform certification procedures capable of ensuring a high level of safety and of environmental protection whilst fostering the smooth functioning of the internal market.
The objectives of the EU in the marine equipment sector cannot be sufficiently achieved by the action of the Member States alone; they can be better achieved thanks to EU action.
However, the proposed Directive does not contain the detailed technical specifications applicable to marine equipment falling under its scope, but limits itself to mandating compliance with the requirements and testing standards contained in the international instruments while providing a mechanism to implement those requirements and standards in a uniform way. While conformity-checking procedures are harmonised, implementation is left entirely to the Member States, who remain responsible for ensuring that marine equipment due to be placed on board EU ships meets the requirements of the Directive. In case restrictive measures are adopted by a Member State as regards non-compliant equipment, the Commission is required to intervene only if objections are raised against these measures within a reasonable time. Therefore EU action does not go beyond what is strictly necessary to achieve the objectives spelled out in section 2.3.
A Directive continues to be the most appropriate instrument in order to achieve the objectives of the proposal. The measures envisaged represent a major modification of the provisions contained in Directive 96/98/EC and therefore, in the interests of clarity, this Directive should be repealed and replaced by a new Directive.
This proposal has no budgetary implications. The tasks devolved to the Commission, including those for which the assistance of the European Maritime Safety Agency is foreseen, are not expected to represent on the whole an increase in workload and will be carried out with existing resources.
Article 1 defines the objectives of the proposal in line with the relevant objectives laid down in the Treaties, as referred to in section 1.4 of this memorandum.
The scope of the Directive is defined in Article 3. Marine equipment is installed on board ships wherever they are built, repaired or supplied. Although marine equipment is of course also traded within the borders of the EU, the scope of the Directive is defined by reference to equipment which is a) due to be installed on board a ship flying the flag of a Member State, and b) for which the approval of the flag State is required by the international conventions. Similarly, the application of concurrent Directives is excluded, as only the marine equipment directive can ensure that marine equipment installed on EU ships complies with the requirements in the international conventions and instruments.
The requirements for marine equipment are defined in Article 4 by reference to the international conventions and instruments. As required by these, demonstration of compliance is confined to the specific applicable testing standards. Given the need to ensure continued consistency with the international regulatory framework, these requirements and standards must apply in their up-to-date version; this automatic update is consistent with the general policy followed by the EU in the area of maritime safety. The automatic update does not apply to testing standards as experience has shown it may lead to disproportionate effects.
Article 5 reflects another distinctive element of the marine equipment sector, namely, that the flag State has the responsibility to ensure that only equipment which has been duly approved in accordance with the then applicable requirements of the international instruments is placed on board ships flying its flag. Equipment should remain in conformity with those requirements, unless requirements subsequently adopted by the IMO apply to equipment already placed on board ships.
Article 6 provides the basis for the free movement of marine equipment within the EU, based on the concept of mutual recognition between Member States of equipment complying with the requirements laid down in the Directive. Article 7 governs the particular case of the transfer of a ship to a Member State's register based on the principle of compliance with the Directive requirements, but allowing for the acceptance of equivalent equipment in order not to place a disproportionate and unjustified burden on the ship owners or penalise EU flags.
Article 8 reflects the priority given to the international regulation of maritime safety, consistent with the global nature of shipping. However, it is necessary to ensure that failure by the IMO to produce appropriate standards does not impair the objectives of the Directive, and thus the Commission must be empowered to lay down appropriate specifications while awaiting the production of the international standards, by means of delegated acts.
Articles 9 to 11 deal with the wheel mark. As in the current Directive, a specific mark is necessary in order to distinguish equipment complying with the requirements in the international maritime safety conventions, which may be different from those contained in other EU harmonisation instruments applying to equipment which is similar in nature but is not for use or installation on board ships. However, the general principles governing the CE marking, in particular as laid down in Regulation 765/2008/EC, are applied mutatis mutandis. In order to facilitate control by the flag and port State authorities, and to combat counterfeit, Article 11 opens the possibility to use an electronic tag in addition to or in place of the wheel mark.
Articles 12 to 14 incorporate the reference provisions of Decision 768/2008 as regards the specific obligations of the economic operators. It must be taken into account that a) only a fraction of the marine equipment falling under the scope of the Directive is traded within EU borders, normally by ship yards and ship repairers, and b) as stated above, a specific mandate is placed on the Member States to ensure that only compliant equipment is installed on board ships flying their flags. As a result of this, a) for importers, the act of affixing the mark triggers the assumption of responsibilities and the effectiveness of their obligations, which must include granting access to their premises for national authorities carrying out market surveillance; b) the appointment of an authorised representative has been made compulsory for manufacturers located outside the EU; and c) in the case of importers and distributors, the respective obligations have been limited to those which are relevant for the sector, namely cooperation with market surveillance and, for importers, clear identification.
The conformity-checking procedures made available to manufacturers are listed in Article 15 and further developed in Annex II. Among the modules foreseen in Decision 768/2008 of the European Parliament and of the Council on a common framework for the marketing of products, only those modules which are consistent with the requirement for specific approval by the flag State as laid down in the international conventions and instruments have been retained. Slight adaptations in the text have been made for the same purpose. In order to facilitate the protection of legitimate intellectual property rights, all modules contain an obligation for the manufacturer to provide the notified body with a certified copy of the patent, license or document by which the applicant purports to have the right to make, use, sell or offer the marine equipment for sale or use its trademark; this document shall be made available to the competent courts upon request.
As regards the EU declaration of conformity, Article 16 aligns the Directive with Decision 768/2008. Like the affixing of the wheel mark, the act of drawing up of a declaration of conformity will trigger the manufacturer's responsibilities and obligations under the Directive. Additional provisions ensure that copies of the declaration will be deposited with the relevant notified body and can always be found on board, which will greatly facilitate control by market surveillance authorities, the flag State and the Port State authorities – at the price of a negligible additional administrative burden.
Articles 17 to 26 as well as Annexes III to V incorporate the reference provisions of Decision 768/2008 as regards notification, notifying authorities, notified bodies and their respective regimes. This inclusion opens the possibility for the Member States to have recourse to accreditation – which could help resolve the chronic paucity of resources in national maritime administrations. Furthermore, in order to reinforce the control of notified bodies in a context where the entire process comprising design, testing, certification, production, delivery and placing on board of marine equipment may entirely happen outside the EU borders, two additional safeguards have been added to the standard Member States' monitoring obligations: in the first place, monitoring of notified bodies should occur at least every two years; secondly, the Commission[5] may participate in the audits as an observer. As regards notified bodies, the possibility of a manufacturer's in-house notified body has been discarded, given that it is not appropriate for the restricted choice of conformity-assessment procedures referred to above.
By virtue of Articles 27 to 31, the Directive is fully aligned with the general EU market surveillance framework, including as regards the safeguard procedure. Checks on board may be necessary and are therefore regulated in Article 27. Article 29 contains two additional specific elements which appear to be necessary in the marine equipment sector.
· If the Commission is satisfied that the technical assessment carried out by the Member State concerned has been fair and objective, it should not be obliged to repeat this evaluation when reviewing the restrictive measures adopted by that Member State as regards non-compliant equipment. The objective is to ensure that the burden placed on the Commission is commensurate with the means at its disposal and to encourage the Member States to ensure a fair procedure and take all measures conducive to an exhaustive and objective evaluation of the risks.
· It is necessary to cater for the possibility that shortcomings are identified in the IMO standards. In this case, a mechanism similar to that described under Article 8 is provided for.
Articles 32 to 34 contain the specific regime in exceptional circumstances, largely taken from the existing Directive. This concerns exemptions in cases of technical innovation or for the purpose of testing and evaluation. More importantly, solutions are provided for the cases where ships cannot obtain supplies of wheel marked equipment in ports outside the EU in reasonable terms or where wheelmarked equipment has become unavailable in the market. In all these cases, the Member States may authorise the placing on board of non-wheelmarked equipment – subject to the necessary procedural constraints to ensure that these exemptions do not impair the objectives of the Directive.
Article 35 constitutes an essential part of the new Directive's architecture, with three distinctive elements:
· The requirement for marine equipment to comply with the specific design, construction and performance requirements laid down in the international instruments, including the relevant testing standards, as defined by the Legislator, will be uniformly implemented by empowering the Commission to identify from these instruments the requirements and standards corresponding to each item of equipment. This will be done by means of implementing acts. As shown in the impact assessment, the use of implementing Regulations is expected to resolve the problems of delay and legal uncertainty described above, inter alia given that transposition into the Member States' legal order will no longer be needed.
· Secondly, the Commission is also empowered to adopt common criteria and procedures for the application of these requirements and standards, a necessary measure to ensure that divergent interpretations by the Member States (e.g. in terms of time, scope or technical implementation) cannot have an impact on safety or on the smooth functioning of the internal market. In this respect, the preparatory work carried out by the group of notified bodies established by the Directive will be taken into account. In this case, the use of implementing acts has been considered the most appropriate course of action.
· Finally, the Commission is charged with the task of gathering and publishing a significant package of information. This codifies and expands existing practice and will facilitate the implementation of the Directive by all actors, as has been suggested during the stakeholder consultation.
Continued consistency of the new Directive with the international regulatory framework is ensured by means of the empowerment given to the Commission in Article 36, so that it can adopt delegated acts in order to update the list of relevant international conventions and of standardisation organisations as well as the references to international and European standards contained in the Directive. Aspecific criterion allowing the Commission to identify the relevant conventions (namely the requirement of flag approval of marine equipment) is provided, so that the update of the list by the Commission cannot constitute an indirect extension of the Directive's scope as defined in Article 3.
Article 40 provides for the repeal of Directive 96/98/EC and lays down the necessary transitional arrangements.
Articles 37(exercise of delegation), 38(committee procedures), 39 (transposition), 41 (entry into force) and 42 (addressees) contain standard legislative provisions.