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6/2021 CONSULTAZIONI NI Dogane e commercio internazionale. Il contributo di Assonime alle consultazioni promosse dalla DG Trade in tema di programmi interni di conformità (ICP) ASSONIME - Riproduzione riservata
Il contributo di Assonime alle consultazioni in materia di programmi interni di conformità (ICP) 6/2021 Introduzione A novembre 2020 è stato raggiunto l’accordo sul nuovo testo del provvedimento di rifusione (c.d. recast) del Regolamento (CE) n. 428/2009 del Consiglio, del 5 maggio 2009, istitutivo del regime unionale di controllo delle esportazioni, del trasferimento, dell’intermediazione e del transito di prodotti e di tecnologie a duplice uso (dual use)1. La procedura legislativa di approvazione del provvedimento è tuttora in corso; la sua entrata in vigore si avrà dopo 90 giorni dalla pubblicazione nella Gazzetta Ufficiale dell’Unione europea, prevista per il mese di maggio 2021. In vista dell’adozione ufficiale del provvedimento di rifusione, Assonime intende richiamare fin d’ora l’attenzione sulla crescente importanza che i programmi interni di conformità (internal compliance programme, ICP), relativi ai controlli del commercio dei prodotti a duplice uso ai sensi del citato Reg. n. 428/09, sono destinati ad assumere con le nuove disposizioni2. Ed invero, tali programmi – già di per sé rilevanti nell’ambito delle attività di due diligence che gli operatori saranno tenuti a svolgere nel nuovo sistema normativo di trade controls3 – costituiranno anche un prerequisito ai fini dell’ottenimento di talune autorizzazioni all’esportazione4. In vista della particolare rilevanza che sarà attribuita agli ICP, è utile richiamare in questa sede le linee guida sui programmi interni di conformità, già emanate dalla Commissione europea con la Raccomandazione (UE) n. 2019/1318, del 30 luglio 2019. L’emanazione di tali orientamenti unionali era stata preceduta, nell’autunno del 2018, da ASSONIME - Riproduzione riservata una consultazione pubblica promossa dalla DG Trade della Commissione5, alla quale 1 Sull’argomento, si veda la Guida Assonime “Le regole doganali e il commercio internazionale”, par. 4.2.3. 2 Secondo la definizione riportata nel provvedimento di rifusione (c.d. recast) del Reg. (CE) n. 428/2009 (cfr.: art. 2, n. 2, del testo di compromesso approvato il 9 novembre 2020), per “programma interno di conformità (ICP)” devono intendersi politiche e procedure efficaci, appropriate e proporzionate adottate dagli esportatori per facilitare il rispetto delle disposizioni e degli obiettivi del presente Regolamento e dei termini e delle condizioni delle autorizzazioni attuate ai sensi del presente Regolamento, ivi comprese, tra l’atro, le misure di due diligence per la valutazione dei rischi correlati all’esportazione dei prodotti agli utenti finali e agli usi finali. 3 In questi termini, cfr.: considerando n. 4a), provvedimento di rifusione del Reg. (CE) n. 428/2009. 4 L’adozione di un ICP sarà richiesta agli operatori che intendano utilizzare un’autorizzazione generale dell’Unione europea per l’esportazione di tecnologie e software infragruppo (c.d. AGEU007, cfr.: All. II, sez. G, parte 3, provvedimento di rifusione del Reg. n. 428/2009). Per gli operatori interessati ad ottenere il rilascio di un’autorizzazione di esportazione globale, invece, l’Autorità competente potrà ritenere non necessaria l’adozione dell’ICP in considerazione delle altre informazioni di cui avrà tenuto conto durante il trattamento della domanda presentata dall’esportatore (cfr.: art. 10, par. 4, provvedimento di rifusione del Reg. n. 428/2009). 5 Targeted industry consultation on draft ICP guidance for dual-use export controls. 2
Il contributo di Assonime alle consultazioni in materia di programmi interni di conformità (ICP) 6/2021 Assonime aveva partecipato inviando il proprio contributo, allegato in versione integrale a questo documento. Come illustrato in una nota pubblicata sul sito della nostra Associazione6, le linee guida emanate con la Raccomandazione del 30 luglio 2019 sono volte ad aiutare le imprese a mantenere un rigoroso rispetto delle pertinenti disposizioni legislative e regolamentari dell’UE e nazionali, fornendo un quadro di riferimento per l’individuazione e la gestione dell’impatto dei controlli del commercio dei prodotti a duplice uso e per l’attenuazione dei rischi associati. In particolare, gli orientamenti espressi dalla Commissione con le linee guida, che "non hanno carattere vincolante", intendono fornire un quadro di riferimento per aiutare gli esportatori a individuare, gestire e attenuare i rischi associati al controllo del commercio dei prodotti a duplice uso; inoltre, forniscono indicazioni alle autorità competenti degli Stati membri per la loro valutazione dei rischi, nell’esercizio della loro responsabilità decisionale in merito alle autorizzazioni da rilasciare per l’esportazione, per i servizi di intermediazione, per il transito dei prodotti a duplice uso non comunitari o per il trasferimento, all’interno dell’Unione, dei prodotti a duplice uso di cui all’allegato IV del Reg. n. 428/2009. Nella nota in parola, Assonime aveva evidenziato i seguenti sette elementi fondamentali, proposti e esaminati negli orientamenti adottati dalla Commissione europea, risultati essenziali, al termine delle consultazioni pubbliche, ai fini dell’efficacia del programma interno di conformità relativo ai controlli del commercio dei prodotti a duplice uso: ASSONIME - Riproduzione riservata 1. Impegno dell’alta dirigenza a garantire la conformità 2. Struttura organizzativa, responsabilità e risorse 3. Formazione e sensibilizzazione 4. Processi e procedure di verifica delle transazioni 5. Valutazione delle prestazioni, audit, segnalazioni e azioni correttive 6. Tenuta dei registri e documentazione 7. Sicurezza fisica e delle informazioni. Con una ulteriore consultazione pubblica, promossa nell’autunno 2020, la DG Trade della Commissione ha nuovamente invitato gli operatori a formulare le proprie 6 Vedi news legislativa Assonime dell’8 agosto 2019. 3
Il contributo di Assonime alle consultazioni in materia di programmi interni di conformità (ICP) 6/2021 considerazioni sul tema dei programmi interni di compliance, stavolta in relazione alla bozza di linee guida appositamente destinate agli enti e alle organizzazioni di ricerca7. Anche in questa occasione, Assonime ha fornito il proprio contributo alla consultazione – allegato anch’esso al presente documento – evidenziando, in particolare, il rapporto industria-ricerca e gli aspetti relativi alla ricerca sponsorizzata. Una prima elaborazione delle risposte pervenute alla DG Trade è stata presentata nell’ambito dell’edizione 2020 del consueto Forum annuale sui temi dell’export control, svoltosi l’11 dicembre scorso. A quanto ci consta, la Commissione prevede di pubblicare nella primavera del 2021 le linee guida in questione, che mirano a rielaborare i suddetti sette elementi chiave degli ICP per le strutture preposte alla ricerca. In considerazione della crescente importanza che i programmi interni di conformità sono destinati ad assumere nell’ambito della trade compliance8, Assonime intende proseguire l’approfondimento della tematica strategica degli ICP attraverso l’esame della nuova disciplina che regolerà il settore dei prodotti e delle tecnologie dual use nell’ambito del gruppo tecnico istituito dalla nostra Associazione con le imprese sull’export control. ASSONIME - Riproduzione riservata 7 Targeted consultation on draft EU compliance guidance for research involving dual-use items. Sul tema, si veda anche: Guidance note — Research involving dual-use items. 8 Come riportato al considerando n. 14) del provvedimento di rifusione della disciplina in parola, le linee guida per i “programmi di conformità interna” (ICP) saranno aggiornate al fine di contribuire alla parità di condizioni tra gli esportatori e a migliorare l’efficace applicazione dei controlli. Tali orientamenti dovranno anche tenere conto delle differenze in termini di dimensioni, risorse, campi di attività e altre caratteristiche e condizioni degli esportatori e delle filiali, come le strutture e gli standard di conformità all’interno del gruppo, evitando così qualsiasi “modello unico per tutti” e aiutando le proprie soluzioni per la conformità e la competitività. 4
Contribution ID: 157dd1ed-8dc8-4ea6-b877-39431e61fa1a Date: 15/11/2018 18:52:01 Targeted industry consultation on draft ICP guidance for dual-use export controls Introduction Effective controls on exports of dual-use goods, software and technology are vital for countering the proliferation of Weapons of Mass Destruction (WMD) and the destabilising accumulations of conventional weapons. Taking into consideration rapid scientific and technological advancements, the complexity of modern supply chains and the ever growing significance of non-state actors, effective export controls greatly depend on the awareness and active commitment of industry to comply with dual-use export control regulations. It is the responsibility of exporters dealing with dual-use items to comply with dual-use export control regulations and to refrain from participating in transactions where there are concerns that items are to be used for proliferation purposes. To this end, companies usually put in place a set of internal policies and procedures, also known as an "Internal Compliance Programme" (ICP), to ensure compliance with the relevant EU and national dual-use export control laws and regulations. The scope and the extent of these internal policies and procedures are usually determined by the size and the nature of the commercial activities of any specific company. From the legal point of view, Council Regulation (EC) No 428/2009[1] does not explicitly allude to the ICP ASSONIME - Riproduzione riservata mechanism, but Article 12(2) urges Member States - when assessing an application for a global export authorization - to "take into consideration the application by the exporter of proportionate and adequate means and procedures to ensure compliance with the provisions and objectives of this Regulation and with the terms and conditions of the authorisation". Consequently, in some Member States, the implementation of an ICP gives exporters access to simplified procedures for the export of dual-use items. Also, some Member States refer to ICP requirements in their national legislation or in their practice for the application of controls. Internationally, ICPs are increasingly considered as a key element of effective export control systems, as illustrated, for example, by the Wassenaar Arrangement Best Practice guidelines, and many governments actively promote ICP development and implementation by industry. For its part, the Commission proposal for a modernisation of EU export controls[2] emphasizes that "outreach to the private sector and transparency are essential elements for an effective export control regime. It is therefore appropriate to provide for the continued development of guidance to support the application of this Regulation". Therefore, in order to support exporters' efforts to ensure compliance with EU and national export laws and regulations, the European Commission and EU Member States, under mandate of the Dual-Use Coordination Group, set up a Technical Expert Group entrusted with drafting the attached guidance as a non-binding instrument identifying the core elements that are essential for an effective ICP for dual-use 1
export controls. The draft guidance focuses on the following 7 core elements: Top-level management commitment to compliance Organisation structure, responsibilities and resources Training and awareness raising Transaction screening process and procedures Performance review, audits, reporting and corrective actions Record-keeping and documentation Physical and information security Each core element is further detailed as follows: a section ‘What is expected from dual-use companies?’ describes the objective(s) of each core element and a section “What are the steps involved?” further specifies the actions and outlines possible solutions for developing or implementing compliance procedures. Furthermore, the draft guidance contains a set of frequent questions regarding ICPs and provide a list of diversion risk indicators and ‘red flag’ signs about suspicious enquiries or orders. Considering that ICPs, as industry tools, are of particular interest for exporters, the European Commission and EU Member States have decided to conduct a public survey providing the opportunity for exporters to give feed-back and inputs in relation to the draft guidance. ASSONIME - Riproduzione riservata We would therefore welcome feedback on the proposed seven core elements and the associated draft guidance material attached. The Commission will collect the data from the survey, and make it available to the experts of the Member States so that the Technical Expert Group may proceed with the finalization of the ICP guidance. The survey is anonymous; however, if you wish to discuss the results with your Member State’s competent authority, you are free to leave your contact details in the relevant comment box below. This EU Survey is open for a period of two months, ending on 15 November. A version of the survey in French and German will be available soon. Thank you for your participation. [1] Council Regulation (EC) No 428/2009 of 5 May 2009 setting up a Community regime for the control of exports, transfer, brokering and transit of dual-use items [2] COM(2016) 616 of 28 September 2016. Please indicate your preference when replying to this questionnaire: 2
Please indicate your preference when replying to this questionnaire: Please note that regardless of the option chosen, your contribution may be subject to a request for access to documents under the EU Regulation 1049/2001 on public access to European Parliament, Council and Commission documents. In such cases, the request will be assessed against the conditions set out in the Regulation and in accordance with applicable data protection rules. I consent to the publication of all information in my contribution in whole or in part, including my name or my organisation's name; and I declare that nothing within my response is unlawful or would infringe the rights of any third party in a manner that would prevent publication. I consent to the publication of any information in my contribution in whole or in part (which may include quotes or opinions I express) provided that it is done anonymously. I declare that nothing within my response is unlawful or would infringe the rights of any third party in a manner that would prevent publication. In this case, respondents should not include in their submissions any data or information that would allow themselves, or their organisations, to be identified, or their organisations, to be identified. About you You are replying as an individual in your personal capacity in your professional capacity or on behalf of an organisation Residence (Other) Austria Belgium Bulgaria Croatia Cyprus ASSONIME - Riproduzione riservata Czech Republic Denmark Estonia Finland France Germany Greece Hungary Ireland Italy Latvia Lithuania Luxembourg Malta Netherlands Poland Portugal Romania Slovak Republic 3
Slovenia Spain Sweden United Kingdom Contact details (if you wish to discuss the results with your Member State’s competent authority) Assonime (Associazione fra le società italiane per azioni) EU Transparency Register Identification number: 15491122381-71 Filippo Mancuso (ph. 0039 06 695291, e-mail: filippo.mancuso@assonime.it) About the guidance material Do you agree with the assessment that the seven core elements are essential for an effective ICP for dual-use trade controls? Strongly agree Agree Disagree Strongly disagree No opinion/Don't know Please elaborate The seven core elements are undoubtedly essential, as well as a deep risk assessment clearly identifying the risk level of the transaction of actual and potential dual-use products. The core element particularly felt by the operators is Point 4. Transaction screening process and procedures, for which they stress the difficulty of screening, keeping track and sharing data of each transaction, in particular when the production and distribution processes are divided into several companies located in different countries. Consequently, ASSONIME - Riproduzione riservata Point 4 probably should deserve more and dedicated room and requirements within the document. Do you consider that any additional core element should be considered? Strongly agree Agree Disagree Strongly disagree No opinion/Don't know Please elaborate 4
In addition to the suggested actions to be taken at the organization, management and control level, companies could be advised about a correct evaluation of the necessary investments for the implementation of effective compliance programs and in order to prepare an adequate estimate of related costs. Moreover, it would be feasible to relate the costs with the expected benefits, to elaborate an accurate presentation aiming to the involvement of the top management. It is currently very difficult to obtain and outline a payoff for the dual-use production and export, so the Commission should support the operators, giving the recent trend of shifting responsibility and control costs increasingly borne by the operators. Risk assessment should also take into account reputational data. As highlighted by the BAFA, a violation of the export control legislation goes beyond criminal responsibility; public opinion could be influenced by the mere suspicion that a company might have illegally exported material usable for weapons of mass destruction. Protecting the reputation of one's company is certainly an incentive for management to commit itself to intensifying internal controls. The top management should take advantage of an ICP to protect the good name of the company. Please rate the usefulness of the section ‘What is expected from dual-use companies?’ in the EU ICP guidance. Not useful Somewhat Absolutely at all useful essential Top-level management commitment to compliance Organisation structure, responsibilities and resources Training and awareness raising Transaction screening process and procedures ASSONIME - Riproduzione riservata Performance review, audits, reporting and corrective actions Recordkeeping and documentation Physical and information security Please elaborate, if possible Please rate the usefulness of the section ‘What are the steps involved?’ in the EU ICP guidance. Not useful Somewhat Absolutely at all useful essential Top-level management commitment to compliance 5
Organisation structure, responsibilities and resources Training and awareness raising Transaction screening process and procedures Performance review, audits, reporting and corrective actions Recordkeeping and documentation Physical and information security Please elaborate (if possible) Please rate the usefulness of Annex 1 ‘Helpful questions pertaining to a company’s ICP’. Not useful at all Somewhat useful Absolutely essential Please elaborate, if possible The helpful questions are certainly useful as a starting point, if aimed at spreading a real culture of dual-use, ASSONIME - Riproduzione riservata with the final purpose to reduce today's limited awareness of possible duality of productions, as noticed in many even large and well-structured organisations. Please rate the usefulness of Annex 2 ‘Red flag questions to suspicious enquiries’. Not useful at all Somewhat useful Absolutely essential Please elaborate, if possible 6
A more timely update of the red flag questions would be useful, which more closely reflects the current operations of companies. Regarding the reliability of customers and partners such as traders or brokers, the AEO status or other reliability certification, or quality certification, could be a useful and tangible indicator. Suggesting to take into account the presence of recognized status attesting the reliability of the subjects involved in the transactions, could also be a stimulating factor to undertake one of the many accreditation paths with authorities. So a new red flag or an additional helpful question could be: "Do commercial partners and involved parties such as customers, traders, end-users etc. have certifications or intend to undertake paths for obtaining certifications of recognition of their reliability by their national authorities?”. Do you consider that any significant guidance material has been omitted? Yes No Please elaborate, if possile ASSONIME - Riproduzione riservata 7
The guidelines reflect good practices already adopted by multinational corporations and corporate groups, which are used to perfom risk assessments and to use implemented procedures and internal controls, periodically reviewed, for some years now. The still lacking aspect in the guidelines could be the relations with the authority, which could provide certainty to the exporters, for example on the item classification or on the exclusion from the authorization procedures of some specific products. A continuous and constructive dialogue between authorities and companies, together with a sharing of data and practices could also support the authorities in the technical evaluations of the products and the very same internal compliance programs, through a cooperation of the internal companies’ technicians. As a matter of fact, the guidelines could contain a specific part dedicated to an effective cooperation between companies and authorities, also with a view to a future application of an e-licensing system. The guidelines could include a part dedicated to those offices and individuals within companies that usually deal with the control authorities, both for the issue of authorizations and in general for a future assessment of effectiveness, adequacy and proportionality of internal compliance programs, to which the authority itself will be called after the adoption of the new European regulation and which will be based, presumably on these guidelines and the seven key points listed. Consideration could also be given to a future certification at European level, recognized by all the Member States. The seven key elements considered in the guidelines seem to lack in the part relating to planning; some actions are needed to be implemented during and before the commercial negotiation and the drafting of contracts. The document could suggest a strong coordination between the internal offices of the companies responsible for trade compliance and the trade departments, in a very preventive phase. Among the red flags indicated in Annex 2 there should be questions related to the commercial negotiation, because even in that phase doubts could arise, and need to be solved (e.g. consider requests to send samples of material to specific countries). Specific contractual clauses that guarantee the company towards risk could be strongly suggested to be included in contracts, so that the alert could be prevented. The item classification is a fundamental and critical moment for companies, especially when the production processes are fragmented and located in different countries. In addition, companies must often face the analysis of borderline products. Therefore, specific indications about this phase and a commitment to give assurance by the authorities would certainly be welcome. Many authorities are equipped to provide analysis and quick answers. The Italian authority is deeply appreciated by the companies, as they usually receive ASSONIME - Riproduzione riservata precise and accurate answers in a very short time. Finally, the tailor-made approach, suggested by the guidelines for the implementation of internal compliance programs, is aimed at protecting small and medium-sized enterprises that, obviously, could face difficulties due to their structure, but a custom-made approach is needed as well for large multinational companies and their peculiar organisation. In our opinion, the guidelines omit a part related to the commercial phase of conclusion of transactions, preparation and conclusion of contracts, which should have inserted specific clauses, developing a real dual- use trade risk profile of the company. The fourth element does not give indications of preventive behaviour to each transaction, therefore a precise involvement of the commercial department in the evaluation of opportunities, the fourth element focuses instead on the phase following the conclusion of the transaction, that will be subjected to controls, monitored etc. at a later stage than the commitment made by the company. The control should be preventive to avoid slowdowns and to ensure a real fluidity of processes. It should give evidence at the time when the process of item classification, transaction risk assessment, license application etc. should start, placing it as early as possible with respect to the conclusion of the contract. Therefore, the critical moments will become two: the final step indicated in the guidelines as a last risk assessment performed before the actual shipment, and another one, that should be added as a suggestion in the document, to be performed before the actual conclusion/signature of the contract. Some contractual conditions are already quoted in the red flags, with reference to the payment and shipment methods or the eventual installation or technical assistance, but the guidelines could suggest other contractual clauses to be inserted, in order to prevent risks and to safeguard all transaction parts. 8
Do you have any proposals on the guideline for how to improve it? Do you have comments on any of the specific guidance parts? Any other comments? ASSONIME - Riproduzione riservata 9
The guidelines contain a short reference to the AEO status as an asset for the company, considering the necessary self-assessment and the audit performed by customs authorities with the consequent corrective actions, because these activities could facilitate the evaluation of the companies’ ICP. Certifications and audits carried out by other authorities should have more weight and importance in the guidelines and in the evaluation of the ICP. As said above, the document should contain a specific part addressed to the authorities (as the EU AEO guidelines) which suggests to take into account, also for the purpose of speeding up the licensing procedures, the authorizations or certifications already in place in the company (AEO, legality rating, self-regulatory codes, quality standards etc.). The work of the AEO-ICP convergence technical working group is very important to companies. Now an in-depth analysis of the state of the art and a fresh restart of the work of the AEO-ICP Technical Expert Group would be useful and desirable. The controls of different authorities should be combined through a strong cooperation among them, avoiding extra work and additional costs for the public entities and companies as well. The promotion of the AEO status is very intense in all the Member States and at European level, so a document giving indications on internal compliance programs should strongly consider other authorizations and other forms of reliability recognition. The convergence between AEO and ICP has been examined in many studies, focusing on current relations between the export control measures for dual-use goods and the AEO guidelines, asking for example what are the differences and what are the similarities between the two programs and, as extreme proposal, if it is feasible, under current legislation, to have AEO as a mandatory requirement for export control. In the 2011 Green Paper on the EU export control framework, the Commission was already looking for an answer to the question. The new Union Customs Code places the AEO status as an important element of security and trade reliability, therefore greater attention was paid to the convergence with the ICP. Given the reference to an extensive interpretation of the subjects involved, the guidelines should give indications about the relationships of the companies with research institutions, universities, etc., and how to involve these entities in the risk assessment, soliciting the authorities to give more evidence and publicity to the agreements they have already signed with universities and research and technical public entities, and to increase them. At the same time the authorities could consider the possibility to establish similar agreements with private entities, such as companies having skilled and prepared technicians as internal workforce and staff. Many national authorities are not internally equipped for analysis and cannot easily provide businesses ASSONIME - Riproduzione riservata with certainty, so authorities should facilitate businesses in the search for reliable partners to turn to for the analysis of items, receiving trustworthy answers, considered by the authority in the authorization process. The guidelines could suggest to render compulsory the training for companies, providing authorities with precise indications on the contents (like performed at national level for the AEO required training). This kind of State intervention would also help companies to get the involvement and commitment of the top management. The companies have already implemented internal education and training programs, which will be reviewed in the light of the guidelines, once published. Given that Assonime is thinking about the opportunity to set up training seminars on dual-use, the indication that companies’ dual-use control staff must participate in training activities can only find our strong agreement. The Commission does not detail the content of the training, referring to future national initiatives and documents but, in the desirable part dedicated to the authorities, the guidelines could suggest them to adopt official guiding texts or to give broad guidelines on the content and a list of well-defined entities authorised and designated for training such as association or universities (looking at the AEO model), if not even organize the training themselves. The document in its top-down approach suggests that the compulsory training is promoted by the top management, but the business practices often suggests that the middle management and the operating personnel usually ask for courses and seminars. Here too, the top-down approach could prove to be ineffective or remain a dead letter, while an authority2business approach could be more concretely feasible. In conclusion, a realistic approach do not underestimate the importance of the middle management diligence and enterprising spirit. 10
Background Documents Draft EU Guidance Privacy_statement-draft_ICP_guidance.pdf Contact TRADE-EXPORT-CONTROL-PUBLIC-CONSULTATION@ec.europa.eu ASSONIME - Riproduzione riservata 11
Contribution ID: 730818c3-96d3-421b-9345-2268a4286531 Date: 30/11/2020 09:37:44 Targeted consultation on draft EU compliance guidance for research involving dual-use items Fields marked with * are mandatory. Introduction This guidance aims to help researchers and research organisations to identify, manage and mitigate risks associated with dual-use export controls and to facilitate compliance with the relevant EU and national laws and regulations. The guidance has 4 sections: Section 1 summarizes how research organisations can be affected by EU and national dual-use export control regulations and how important top-level management commitment to compliance is to implement proportionate and effective internal compliance measures. Section 2 provides for awareness information for researchers, including the basics of dual-use export controls and the potential impact on research related activities. Section 3 provides for specific guidance to compliance staff on how to set up and review an Internal Compliance Programme. ASSONIME - Riproduzione riservata Section 4 gives an overview of the regulatory framework for dual-use export controls. This guidance builds on the EU guidance on Internal Compliance Programme (ICP) for dual-use export controls published in August 2019[1], on existing guidance material for academia from EU Member States and on best practices provided by research organisations. Before finalising the work on these non-binding guidance and considering that the compliance subject is of particular interest for research organisations, the European Commission and the EU Member States decided to conduct a public survey to evaluate the usefulness of this draft guidance, providing the opportunity for relevant stakeholders to give feedback and inputs in relation to the draft guidance. The Commission will collect the data from the survey to finalise the guidance, and make it available to the national competent authorities and to the experts of the Member States in order to proceed with the finalisation of the Compliance Guidance. The survey is anonymous. However, if you wish to discuss the results with your Member State’s competent authority, you are free to leave your contact details in the relevant comment box below. This EU Survey is open until 30 November 2020. 1
Thank you for your participation. [1] COMMISSION RECOMMENDATION (EU) 2019/1318 of 30 July 2019 on internal compliance programmes for dual-use trade controls under Council Regulation (EC) No 428/2009 published on 5 August 2019 (OJ L 205) - http://data.europa.eu/eli/reco/2019/1318/oj About you * 1. You are replying as an individual in your personal capacity in your professional capacity or on behalf of an organisation * 2. Country of residence EU 27 (please select from EU27 list) Other (please specify) * EU 27 list Austria Belgium Bulgaria Croatia Cyprus Czechia Denmark Estonia ASSONIME - Riproduzione riservata Finland France Germany Greece Hungary Ireland Italy Latvia Lithuania Luxembourg Malta Netherlands Poland Portugal Romania Slovak Republic Slovenia Spain Sweden 2
About the guidance material 3. Please rate the overall user-friendliness of the guidance. Very good Average Not good at all * Length * Language * Readability Please elaborate on how to improve the user-friendliness (if needed) 4. Please rate the usefulness of the different sections in the guidance. Not Somewhat Absolutely useful useful essential at all * Glossary * Section 1 - Executive summary for management * Section 2 - Awareness for researcher * Section 3 - Setting up or reviewing an internal ASSONIME - Riproduzione riservata compliance programme for research involving dual-use items * Section 4 - Regulatory framework * Appendices Please elaborate on how to improve the structure (if needed) * 5. Are the examples and illustrations provided in sections 2 and 4 clear and clarifying the text? Agree Disagree No opinion/I don't know Please elaborate, possibly with suggestions for improvement. 3
* 6. Are the 7 core elements in section 3 well explained and practical enough to be implemented in a research environment? Agree Disagree No opinion/I don't know ASSONIME - Riproduzione riservata 4
Please elaborate, possibly with suggestion for improvement. Suggestions for improvement of each core element a. Top-level management commitment to compliance b. Organisation structure, responsibilities and resources Recommend to national authorities to provide training, even certified (e.g. BAFA in Germany); that could increase certainty c. Training and awareness raising and awareness and could be helpful to get the management commitment. Recommend a procedure aimed to establish strong cooperation between research entities and sponsors, a long term one, d. Export screening process and procedures especially when they are well-structured multinational companies. Such relations could help researchers to obtain more easily clear and correct information about the consignee and the end-user. e. Performance review, audits, reporting and corrective actions ASSONIME - Riproduzione riservata f. Recordkeeping and documentation g. Physical and information security 5
7. Please rate the usefulness of the Appendices. Not Somewhat Absolutely useful useful essential at all * Appendix 1 - Research areas that are more likely to be impacted by dual-use export controls * Appendix 2 - Research scenarios of where export controls may come into place * Appendix 3 - List of red flags * Appendix 4 - Helpful questions when setting up a research organisation’s ICP * Appendix 5 - Flow chart of licence requirements for exports and intra-EU transfers of dual-use items * Appendix 6 - Examples of possible compliance organisation structure in a research organisation * Appendix 7 - Summary of licence requirements for dual- use ite * Appendix 8 - Technology Readiness Levels * Appendix 9 - References and contacts Please elaborate (if possible). ASSONIME - Riproduzione riservata * 8. Do you consider that any significant guidance material has been omitted or should be added? Yes No Please elaborate (if possible). 6
To improve the top management commitment and lead it to provide adequate resources for an effective compliance program, it could be useful to provide more specific guidance about relations with industry (sponsors, financing etc.). Taking into account the legislation on academic freedom and limits therein, some guidance about the introduction, or an assessment and improvement, of policy, procedures and rules on relations with industry could help research entities to avoid future problems, having certainty about how they intend to use the research involving dual-use items. The industry has managers and negotiators, big multinational companies have consolidated and periodically updated internal compliance programs; on the other hand, research entities are concentrated most on innovation and experimentation and they concentrate investments in research materials and resources, but could give detailed information about the different stages of the research life cycle and its screening procedure. On these premises, researchers and industries could help each other through a reciprocal useful partnership. Procedures set together, on a cooperation basis, should have particular attention to clear information about the consignee and the end-users, as the final recipient of the research results, especially if sent through intangible means. Attention must be paid to the transmission of software or technology by electronic media, including telephone, electronic mail or any other electronic means to a destination outside the European Union, without forgetting items listed in Annex IV to the EU dual-use Regulation. 9. Do you have any other proposals for improvement? Do you have other comments on any of the specific guidance parts? Any other comments? As the items marked with an * in the Glossary refer to definitions of the Council Regulation (EC) No 428 /2009, definition like “Export” and “re-export” consequently refer to the 1992 Customs Code instead of the new code issued in 2013. As the recast of the Regulation 428/2009 is expected in few months, it could be useful to specify the definition in force, the differences and anticipate probable new dispositions. Since exemptions from export controls are provided directly in the by-laws of some public research bodies (governmental and intergovernmental entities) a clarification would be useful in this regard to convince of the need of internal compliance program. ASSONIME - Riproduzione riservata An export control modern guidance cannot leave out a special mention to the important issue of intangible transfers, that is a central topic for software, technology, and research in general. Having regard to the expected future application of the Customs Code, this issue necessitates of great attention from authorities. The tracking of this kind of products is mentioned in the “Physical and information security” element, where it is stated that no standards are defined within the EU regulation on dual, but more references throughout the full documents could be useful to drive attention. Research is constantly evolving (e.g. AI, blockchain, digital twins, robotics etc.) and its scope is getting wider every day, guidance on export control in the research field needs to be constantly updated, looking beyond the annual publication of the export controls regimes lists. Regarding penalties and sanctions related to violation of export control legislation, internal procedures must be particularly careful about the risk of incurring in criminal proceedings, because they could seriously impact on the research, blocking experimentation or diffusion, and causing a great damage to the research field. On the other hand, law makers and authorities should define a way to strongly apply the penalty system and in the meanwhile safeguard the importance of pursuing research and innovation. In conclusion, this guidance could certainly be a basis for an improvement of awareness; it represents a sort of introduction to the dual use regulations for everyone, beyond the intended target and has the merit to spread knowledge about this important issue. 7
If you want to submit additional contribution, besides the ones provided in the survey, please send an email to: TRADE-EXPORT-CONTROL-PUBLIC-CONSULTATION@ec.europa.eu Background Documents EU compliance guidance for research involving dual-use items Privacy statement Contact TRADE-EXPORT-CONTROL-PUBLIC-CONSULTATION@ec.europa.eu ASSONIME - Riproduzione riservata 8
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