Position
Guidance on practical aspects of the implementation of Regulation (EU) No. 1025/2012
Federation of German Industries e.V.
Date: 27.08.2019
Guidance on the implementation of the Standardisation Regulation
Contents Introduction ............................................................................................................. 3 Basic Remarks ........................................................................................................ 4 Working Group for drafting the Guidance document ................................................. 4 Comments on questions and sections of the document „Guidance on practical aspects of the implementation of Regulation (EU) No. 1025/2012 – Consultation of stakeholders“ ............................................................................... 5 1. Objective of the Guidance .................................................................................. 5 a. The New Legislative Framework shall work as a role model for efficient division of roles and responsibilities ........................................................................................... 5 b. Process of introducing legal interpretations shall be clarified ................................ 6 c. Alignment of harmonised standards with international ISO/IEC/ITU standards ..... 7 2. Scope of the Guidance ....................................................................................... 7 Amendment of the Vademecum ................................................................................ 7 3.1 Structure of the Guidance - Standardisation request .................................... 8 a. A flexible work programme and a linking of the lifetime to that of the legal act ..... 8 b. Standardisation requests shall be relevant to the market ...................................... 8 3.2 Structure of the Guidance - Assessment of the standard, publication of its reference in the OJ and formal objections............................................................ 9 a. Transparent roles, responsibilities and phase gates ........................................... 10 b. Early involvement of the HAS Consultants in the working draft phase ................ 10 c. Timely delivery of HAS Consultant assessments in dialogue with the ESOs ...... 11 d. Resolution meeting and a process for recognition of responses by the Technical Committee ............................................................................................................... 11 e. Professional interaction between HAS Consultants and experts from the economy ................................................................................................................................ 12 f. Clarification of the meaning of the state of the art ................................................ 12 g. Establishing guidelines for the contract between EC and EY .............................. 13 h. Pre-assessment of international standards ......................................................... 13 i. Publishing in the OJEU without delay ................................................................... 13 j. EC implementing decision in L Series of OJEU shall contain the complete list of harmonised standards............................................................................................. 14 k. Utilisation of the formal objection and a transition period of at least 18 months for harmonised standards being replaced .................................................................... 15 About BDI................................................................................................................ 17 Imprint ..................................................................................................................... 17
Guidance on the implementation of the Standardisation Regulation
Introduction On 22 November 2018, the European Commission (EC) adopted a Communication on harmonised standards. The Communication provides an overview of the functioning of the European standardisation system and takes stock of the initiatives launched in recent years to support the implementation of the Standardisation Regulation (EU) No. 1025/20121, including in the light of the relevant case law of the Court of Justice. The Communication explained the steps taken recently by the EC to further improve the system and included four specific actions to be undertaken by the EC in the immediate future in order to enhance the efficiency, transparency and legal certainty for the actors involved in the development of harmonised standards. The third action announced in the Communication on harmonised standards is that the EC will elaborate a Guidance document on practical aspects of implementing the Standardisation Regulation, paying particular attention to the division of roles and responsibilities in the development process of harmonised standards as well as to efficiency and speed. The Communication provides that the Guidance document will be elaborated in consultation with stakeholders. Therefore, the EC has invited the stakeholders to participate in the development process in its consultation note from 7 July 2019. In this paper, the EC has also briefly described the objective, scope and planned structure of the Guidance document. This note is intended to be a first step in the stakeholder consultation process which will be followed by further steps as the work on the drafting of the Guidance document will progress.
Federation of German Industries Member Association of BUSINESSEUROPE
Address Breite StraĂ&#x;e 29 10178 Berlin Postal Address 11053 Berlin Germany Contact Bernd Wittenbrink
Regulation (EU) No 1025/2012 has, since its entry into force, provided the main legal framework for the European standardisation system, including the division of responsibilities and obligations of the key actors involved. 1
T: +493020281698 Internet www.bdi.eu E-Mail B.Wittenbrink@bdi.eu
Guidance on the implementation of the Standardisation Regulation
Basic Remarks The Federation of German Industries (BDI) welcomes the initiative for the Guidance on practical aspects of the implementation of the Standardisation Regulation (EU) No. 1025/2012 and its objective. The German industry sees a great need for clarification regarding the division of roles and responsibilities among the individual actors in the development process of harmonised standards. BDI would like to see the Guidance document making a decisive contribution in improving the process of request, development and assessment of standards. In particular, the Guidance document shall generate a transparent, efficient and predictable process, that ensures legal clarity and certainty for the EC, European as well as National Standardisation Bodies, standardisation experts and users.
Working Group for drafting the Guidance document BDI welcomes the consultation of stakeholders at the beginning of the elaborating process of the Guidance document. With regard to the further consultation process, BDI would like to recommend establishing a Working Group in which all stakeholders are represented. This Working Group shall get the task to draft the Guidance. This procedure was the usual one in many years ago and showed good results in reasonable time. The Guidelines for several sectorial legal acts (e.g. Machinery Directive, EMC Directive and Low Voltage Directive) are best practice examples for this procedure. Such a stakeholder Working Group procedure shall be reintroduced in general.
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Comments on questions and sections of the document „Guidance on practical aspects of the implementation of Regulation (EU) No. 1025/2012 – Consultation of stakeholders“ BDI would like to answer on the questions of the note on consultation of Guidance by presenting its position on the topics mentioned in the following chapter 1 (Objective of the Guidance), chapter 2 (Scope of the Guidance), chapter 3.1 (Structure of the Guidance – Standardisation request) and chapter 3.2 (Structure of the Guidance – Assessment of the standard, publication of its reference in the OJ and formal objections).
1. Objective of the Guidance BDI demands the following objectives for the Guidance document: a. The New Legislative Framework shall work as a role model for efficient division of roles and responsibilities b. The process of introducing legal interpretations shall be clarified c. Alignment of harmonised standards with international ISO/IEC/ITU standards
a. The New Legislative Framework shall work as a role model for efficient division of roles and responsibilities The James Elliot Case which seems to be the main justification for the recent EC demands is related to the Construction Product Directive where the function of harmonised standards differs considerably from all other New Legislative Framework (NLF)/New Approach legislation. The conclusions from this case law have put harmonised standards almost at the level of a legal act and of being mandatory. This has led to overly bureaucratic and inefficient processes in the European Standardisation System. One of the main consequences is a huge backlog of harmonised standards for different sectors not listed in the Official Journal of the European Union (OJEU) leading to a situation that self-assessment manufacturers – particularly small and medium sized enterprises (SMEs) – cannot benefit any more from the presumption of conformity. In addition, this backlog creates a lot of confusion about the present state of the art for the marketing of products, because the previous standards are in many cases listed in the OJEU until the new ones will replace them. Hence, the current bureaucratic processes in the European Standardisation System have led to considerable uncertainty among German enterprises, in
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particular among SMEs. Due to these uncertainties, BDI observes a decreasing willingness in German industry to participate in standardisation. However, harmonised standards are voluntary tools for manufacturers providing a presumption of conformity in view of NLF/New Approach legislation which is checked by market surveillance agencies. Therefore, it is not proportionate to handle standards as if they were legal acts. The NLF/New Approach has explicitly limited legal acts to a role to define essential requirements for products and relied for the detailed technical specifications on standards which describe the current state of the art and which are swiftly revised if technological progress and innovation so require. This separation has proven highly successful in the past, especially in terms of efficiency. All relevant legal cases like James Elliot Case have basically underlined the responsibility of the Commission to observe and guide the system in principle but not to regulate and verify every detail. Therefore, in BDI’s view, the EC would have the possibility to come back to a more proportionate approach which would facilitate the common goal to have market relevant harmonised standards developed and cited on time. Nevertheless, changes shall be handled with care and executed with a sense of pragmatism to not derogate the effectiveness of the NLF.
b. Process of introducing legal interpretations shall be clarified The James Elliot Case and other recent legal interpretations of the EC cannot readily be traced from the text of the Directives, associated mandates, or other formal documents transparent to all stakeholders. (Examples include the use of alternative evaluation methods and the rejection of manufacturer’s specification of performance levels.) The Guidance shall clarify the process by which such requirements can be introduced including the consultative process surround this and how the requirements can be unambiguously formulated for use by the ESOs (European Standardisation Organisation). Where this is derived from relevant case law, the rationale shall be clear to all stakeholders.
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c. Alignment of harmonised standards with international ISO/IEC/ITU standards The harmonisation of European CEN/CENELEC/ETSI-standards with international ISO/IEC/ITU-standards is totally missing in the note on consultation. The German industry would like the EC to keep in mind the important role of international standards in the international trade of products. Thanks to the alignment of European harmonised standard with international standards, the technical requirements are almost identical worldwide, allowing the growth of the global market and a significant cost reduction on certification. Such international standards allow the best definition of the state of the art by involving all worldwide experts. It is vital for the European industry to consider this aspect when the assessment of harmonised standards is carried out to avoid unnecessary deviations compared to the international market and to avoid technical barriers to trade. Different technical requirements will lead to higher consumer prices in the EU. In BDI’s opinion, efficiency and predictability mean that CEN/CENELEC/ETSI harmonised standards are as much as possible identical with international ISO/IEC/ITU-standards. If modifications of ENstandards are inevitable, the measures foreseen by ISO and IEC (e.g. global relevance, regional Annex) shall be used. This allows for a parallel elaboration of ISO/IEC- and EN-standards. Moreover, wherever possible international standards developed with active contribution from European experts by ISO and IEC shall be taken over as European standards.
2. Scope of the Guidance Referring to the scope of the Guidance in chapter 2., BDI recommends the amendment of the Vademecum.
Amendment of the Vademecum As the EC has noted, the Guidance does not aim to replace the existing Guidance documents (Vademecum, Blue Guide) with regard to the implementation of the Standardisation Regulation, rather to complement these Guidance documents. Nevertheless, the separate document potentially leads to confusion and inconsistencies. www.bdi.eu
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Regarding the overall objective of better regulation there may be an opportunity, in the context of revising the Vademecum and including the essence of this Guidance document, to focus on the major process steps and define them as short as possible and as detailed as necessary, thus reducing complexity and uncertainty in the process.
3.1 Structure of the Guidance - Standardisation request BDI calls for the following measures under the heading of standardisation requests: a. A flexible work programme and a linking of the lifetime to that of the legal act b. Standardisation requests shall be relevant to the market
a. A flexible work programme and a linking of the lifetime to that of the legal act In BDI’s opinion, the EC's standardisation requests must be made compatible with the basic concepts practised in standardisation (e.g. international orientation, responsiveness to new standardisation needs, market relevance) and must allow for certain flexibility. In particular, no additional administrative hurdles with a view to a rapid listing of harmonised European Standards in the OJEU shall be created. As alternative to the current EC proposal (blueprint for standardisation requests; PPE regulation) a standardisation request shall basically specify the essential objectives which have to be fulfilled by all standards falling under this request. The work programme would then consist of all standards/standardisation projects that fulfil these objectives as proposed by CEN/CENELEC/ETSI and confirmed by the EC. Such an approach would facilitate legal certainty, predictability as well as the flexibility necessary for standardisation. To allow the constant maintenance of the portfolio of existing harmonised standards (adaptations to the state of the art) the lifetime of a standardisation request shall be linked to the that of the corresponding sectorial legal act.
b. Standardisation requests shall be relevant to the market In addition, all standardisation mandates shall be examined with regard to their market relevance. Only market relevant standards fulfil their purpose. www.bdi.eu
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Naturally, standardisation projects are only initiated when there is a market demand (bottom-up approach). Standardisation projects that are driven by political decisions (top-down approach) entail the risk of not being relevant to the market. Therefore, BDI calls for consultation of the industrial circles concerned in the early phase of the conception of a standardisation mandate by the EC. The Standards Market Relevance Roundtable “SMARRT”, created as a result of the Joint Initiative on Standardisation (JIS), would be a suitable platform for such a consultation. Also, appropriate consultation of the ESOs shall be ensured during the design phase of draft requests. This consultation is essential to ensure that the final standardisation request responds to market needs and that the necessary resources (expertise, funding, etc.) – to a large content spend by economy – are available. This process is a means to enable wider acceptance of the resulting standards and contributes more rapidly to the completion of the Single Market.
3.2 Structure of the Guidance - Assessment of the standard, publication of its reference in the OJ and formal objections In order to improve the development and assessment of the standards as well as the publication of their references in the OJEU and the formal objections, BDI is requesting the following: a. Transparent roles, responsibilities and phase gates b. Early involvement of the HAS Consultants in the working draft phase c. Timely delivery of HAS Consultant assessments in dialogue with the ESOs (see §10(5) of Regulation (EU) 1025/2012) d. Resolution meeting and a process for recognition of responses by the Technical Committee e. Professional interaction between HAS Consultants and experts from economy f. Clarification of the meaning of the state of the art g. Establishing guidelines for the contract between EC and EY h. Pre-assessment of international standards i. Publishing in the OJEU without delay (see § 10(6) of Regulation (EU) 1025/2012) j. EC implementing decision in L Series of OJEU shall contain the complete list of harmonised standards k. Utilisation of the formal objection and a transition period of at least 18 months for harmonised standards being replaced
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a. Transparent roles, responsibilities and phase gates The Standardisation Regulation and the abovenamed Guidance papers describe the European standardisation process and the role of the individual actors. Nevertheless, the involvement of the HAS Consultants, Desk Officers, EC’s Legal Service, and collegial checks is resulting in confusion, inconsistencies and delays that make the European standardisation much slower than the international process, making parallel votes of European standards with international standards impossible (despite the principle of the Frankfurt agreement). For that reason, BDI would appreciate gaining a more detailed insight into who in the EC can intervene at which stage or phase of the overall process. In particular, the role of the Legal Service is not clear to us. As the objective is to increase legal clarity and certainty as well as to improve transparency, predictability and efficiency – paying particular attention to the division of roles and responsibilities – such transparent roles, responsibilities and phase gates shall be included into the process, that clearly define which decision can be made at which stage and by whom.
b. Early involvement of the HAS Consultants in the working draft phase The formal assessment of the developed standards is important and is reflected in § 10(5) of Regulation (EU) 1025/2012. However, the introduction of an additional verification at the end of the harmonised standard development process has created problems. This formal process has contributed to considerable delays in the listing of harmonised standards in the OJEU. For example, the HAS Consultants had only been involved during the assessment phase (e.g. on the basis of the request draft (prEN)), so far. Therefore, BDI welcomes the recent duty of the Technical Committees (TC) to submit their draft standards already in the working draft phase for an early assessment by the HAS Consultants. However, the Guidance shall address a deeper involvement of the HAS Consultants and the EC in the drafting of a standard by attending drafting meetings, also on the international level. It would allow a better understanding of the concerns of all as well as to recover the main goal of standardisation: reaching a consensus between all stakeholders.
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Furthermore, the past process of the New Approach Consultants shall be analysed to look for further ‘best practices’ that could be added to early involvement of the HAS Consultants in the working draft phase.
c. Timely delivery of HAS Consultant assessments in dialogue with the ESOs The abovementioned final verification requires both sound knowledge of the legal framework and of the product covered by the standard. Basically, the combination of both knowledge fields is the domain of the ESOs and could not be expected from the EC Desk Officer. Hence, the final verification should not be managed just administratively and not depend on the opinion of a single EC Desk Officer. Rather, the Standardisation Regulation stipulates that EC and ESOs shall assess the documents together, see § 10(5) of Regulation (EU) 1025/2012. Thus, BDI claims that the establishment of a clear, timely predictable and earlier process for the final verification made by EC staff in dialogue with the ESOs must be ensured.
d. Resolution meeting and a process for recognition of responses by the Technical Committee In above sense, pending issues between a HAS Consultant and a TC need swift resolution to unblock the standardisation process. This is of particular importance at the final stage before the Formal Vote. Examples could be when the Consultants or the EC challenge fundamental technical principles, or when man-made law basically ignores the law of physics. Dealing with such situations in a consistent and transparent way is a key aspect of the overall process. The recent example with EN 62368-1 under RED showed that a formal process is either not existing or not visible to industry. Furthermore, improvement of the consistency of the HAS Consultant assessments is needed. The HAS Consultants provide feedback before the ESO’s national voting procedure. This allows correction before final approval of the standard, which is good progress. Nevertheless, the HAS Consultants remain consultative and the EC may still reject the standard if any reason is found afterwards during the collegial review. Also, where harmonised standards affect multiple EU legal acts the assessments of different relevant HAS Consultants led to diverging outcomes on the same essential requirement in the past. And even for a single EU legal act, the www.bdi.eu
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assessments of different HAS Consultants to a common item lacks sometimes consistency. Moreover, new findings often occur on parts that were never commented before, leading to blocking of the standardisation process. Thus, the TC shall have an option to call for a resolution meeting with the HAS Consultants and the EC Desk Officers to solve pending issues between a HAS Consultant and a TC or to ensure consistency of diverging assessments during a common review (by different HAS Consultants). Additionally, a clear and transparent process for the recognition of the responses made by the TCs in case of non/partly compliant HAS assessment – that results in the crucial Formal Vote stage – is needed. This is an essential measure to increase the currently insufficient number of positively assessed standards before its publication.
e. Professional interaction between HAS Consultants and experts from the economy HAS Consultants have been selected by EY, the HAS Contractor. But in some case, their professional opinion is contrary to that of the most renowned experts – European and/or globally – working in standardisation and in the respective TCs developing harmonised standards. A spirit of mutual respect – personal and professional – is desirable. No single expert shall claim a ‘monopoly of truth’ and conflicts shall be resolved in a professional and purposeful manner.
f. Clarification of the meaning of the state of the art Many comments from some of the HAS Consultants or desk officers have an uncommon interpretation of what is “state of the art”. It shall be clarified in the Guidance that state of the art means “the acknowledged level of development reached at a particular time as a result of the common methodologies employed by that time”. When the technical content of a standard has been approved during the international voting process (involving a diversity of experts from many countries worldwide), the compliance of the technical requirement in the standard with the state of the art shall be presumed to be acknowledged.
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g. Establishing guidelines for the contract between EC and EY The Guidance shall give guidelines for the contract between EC and EY. Especially, it shall make clear that limitations to the number of assessments at specific stages of the standards development are not required by any existing EU legislation and shall not be part of the contract between EC and EY. It shall be made clear that this contract has to follow the existing law, instead of creating new regulatory requirements as it does today when limiting the number of assessments. The current contract seems to contain such limitations – at least this argument was used to “finally reflect” the draft Annex Z of EN 82304-1 under the MDD.
h. Pre-assessment of international standards The increased number of formalistic demands often results in subsequent changes to the technical content, which hinders or in some cases render impossible the adoption of international standards. Such deviations from international standards not only are contrary to the spirit of the WTO TBT rules but impose a burden (and related costs) to businesses having to take into account different technical rules for different regional markets without justified reasoning. HAS Consultants shall be obliged to help prevent deviations from underlying international standards wherever possible and to duly justify them if required. A pre-assessment of international standards by HAS Consultant would reveal potential issues early in the process.
i. Publishing in the OJEU without delay For the basic idea of the NLF to work, it is essential that the harmonised standards are published without delay in the OJEU, see § 10(6) of Regulation (EU) 1025/2012. BDI would like the Guidance to reflect the need to keep alignment as far as possible of the list of harmonised standards in the OJEU with the publication of the ESOs. Due to the recent case law of the Court of Justice of the European Union, the European standardisation process almost has come to a standstill within the last years. Depending on the sector, the delay of publication of European standards compared to international standards reaches a long period of time, leading to obsolete products which are still covered by the presumption of conformity based on a harmonised standard already withdrawn by the ESOs. www.bdi.eu
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It happens that international standards are withdrawn and replaced by a later version before publication in the OJEU of the EU. Unjustified delays in the listing of harmonised standards in the OJEU have several negative consequences for manufacturers. They cannot benefit from the presumption of conformity and must possibly introduce alternative conformity assessment procedures. All this can lead to delays in the market launch of new products and to considerable additional costs, especially for SMEs. Furthermore, due to the huge backlog cumulated for almost 4 years in the approval process, some standards adopted years ago are rejected by the European EC or the HAS Consultant and cannot be published in the OJEU. One of the reasons is that the normative reference refers to the version publicly available the moment of drafting the standard. Such reasons shall be avoided, particularly because all standards, including their normative references, are systematically reviewed after some years by the ESOs.
j. EC implementing decision in L Series of OJEU shall contain the complete list of harmonised standards Until recently, the publishing of the harmonised standards as “communications�2 in the C Series of the OJEU was sufficient for the harmonised standards to provide presumption of conformity. Now, harmonised standards are published in the L Series of the OJEU as an implementing decision3. To avoid misinterpretation and to keep alignment with Standardisation Regulation (EU) No. 1025/2012 and the Blue Guide the Guidance should clarify that the application of harmonised standards remains voluntary and provides one option, which manufacturer can use to demonstrate compliance to the essential requirements. Additionally, BDI would like to remind the EC that the new format of EC implementing decisions for the publication of harmonised standards in the OJEU does not provide the necessary clarity and legal certainty for potential users of harmonised standards.
Lastly EU 2018 No. C 371/1 Commission communication in the framework of the implementation of Directive 2014/34/EU of the European Parliament and of the Council on the harmonisation of the laws of the Member States relating to equipment and protective systems intended for use in potentially explosive atmospheres. 3 E.g. EU 2019, No. L 75 Commission Implementing Decision (EU) 2019/436 of 18 March 2019 on the harmonised standards for machinery drafted in support of Directive 2006/42/EC of the European Parliament and of the Council. 2
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In particular, the identification of the correct relation between Annex I and Annex III of the implementing decision is a challenge and can create misinterpretations. Furthermore, for transparency reasons there exists a strong request to continue with the good practise of a consolidated list providing an overview of all harmonised standards. Thus, each EC implementing decision for the publication of harmonised standards in the OJEU shall be accompanied by an informative annex containing a consolidated list of all existing harmonised standards.
k. Utilisation of the formal objection and a transition period of at least 18 months for harmonised standards being replaced The relevant court cases have all the same origin of problem: the procedure of formal objection against the harmonised standard (as described in Article 11 of EU regulation 1025/2012) hasn’t been properly followed in any of the three court cases. We’d like to encourage the EC to advertise this procedure in an appropriate way to the member states. Also, in case of withdrawal of a harmonised standard due to a weakness in its requirements, we highly recommend a proper communication in the publication of the OJEU withdrawing the standard about the decision made specifying the awaited performance or requirements that weren’t covered by the harmonised standard. Likewise, such a decision cannot be practically implemented from one day to another by all stakeholders. This is why BDI recommends considering a transition period allowing manufacturers to update the design of their products, the technical documentation and the EU declaration of conformity. In consequence, the list of harmonised standards in the OJEU shall synchronize the “date of cessation of presumption of conformity from the OJEU” with the “date of withdrawal of conflicting standard” provided by the ESOs. Nevertheless, when the removal from the OJEU is published, the effective date of the removal from the OJEU shall not be earlier than 18 months from the publication date in the OJEU. 18 months is a reasonable transition period for requirements that doesn’t endanger the user of the equipment. Particular attention needs to be considered for Directives which doesn’t allow the use of Module A when no harmonised standard is listed in the OJEU. In case of module A is not possible anymore and a manufacturer is obliged to go to Module B+C (EU TEC) or H (full quality assurance), sufficient transition time needs to be foreseen to offer legal certainty to the manufacturer. In addition, the process of removing Harmonised Standards from the OJEU (stakeholders, reason, and procedure) needs to be transparent www.bdi.eu
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for the industry in order to prepare for such situation. This shall allow manufacturer updating the design of their product, the technical documentation and their EU declaration of conformity.
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About BDI The Federation of German Industries (BDI) communicates German industries’ interests to the political authorities concerned. She offers strong support for companies in global competition. The BDI has access to a widespread network both within Germany and Europe, to all the important markets and to international organizations. The BDI accompanies the capturing of international markets politically. Also, she offers information and politico-economic Guidance on all issues relevant to industries. The BDI is the leading organization of German industries and related service providers. She represents 36 inter-trade organizations and more than 100.000 companies with their approximately 8 million employees. Membership is optional. 15 federal representations are advocating industries’ interests on a regional level.
Imprint Federation of German Industries e.V. (BDI) Breite StraĂ&#x;e 29, 10178 Berlin, Germany www.bdi.eu T: +49 30 2028-0
Contact Bernd Wittenbrink Senior Manager +49 30 2028-1698 b.wittenbrink@bdi.eu
BDI document number: D 1073
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