european food safety authority - decision of the executive …...2019-03-11 · 9 h. “members of...

Decision of theExecutive Director ofthe European FoodSafety Authority onCompeting InterestManagement

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Suggested citation: EFSA (European Food Safety Authority), 2018. EFSA rules on competing interestmanagement.

© European Food Safety Authority, 2018

Correspondence: [email protected]

Key words: conflicts of interest, declarations of interest, competing interests, independence, impartiality,

bias, trust, scientific excellence, transparency.

Reproduction is authorised provided the source is acknowledged.

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Table of contents1. Scope and definitions........................................................................................................... 8

Scope ......................................................................................................................8Article 1.Definitions ................................................................................................................8Article 2.Requirements for a complete Declaration of Interest ................................................. 11Article 3.Annual Declaration of Interest.................................................................................. 11Article 4.Oral Declaration of Interest ...................................................................................... 12Article 5.

2. Rules applicable to Experts ................................................................................................12

Annual Declaration of Interest.................................................................................. 12Article 6.General principles of screening of Experts’ Interests ................................................. 12Article 7.Screening process of Experts’ DoIs.......................................................................... 13Article 8.

3. Rules applicable to Hearing Experts and Observers ........................................................ 14

Hearing Experts ...................................................................................................... 14Article 9.Observers .............................................................................................................. 14Article 10.Staff of Union institutions, bodies or agencies ........................................................... 14Article 11.

4. Rules applicable to Network Members .............................................................................. 14

Network Members................................................................................................... 14Article 12.

5. Rules applicable to members of EFSA’s Governance Bodies...........................................15

Members of the Management Board ........................................................................ 15Article 13.Members of the EFSA Advisory Forum..................................................................... 15Article 14.

6. Procurement and grant awarding procedures .................................................................. 16Declaration of Interest of tenderers and participants in EFSA’s procurement and GrantArticle 15.

awarding procedures ........................................................................................................ 16Screening of the DoIs in the context of EFSA procurement and Grant awardingArticle 16.

procedures....................................................................................................................... 16

7. Implementation and enforcement ...................................................................................... 16

Coordination and implementation ............................................................................. 16Article 17.Review of the decisions........................................................................................... 17Article 18.Compliance and veracity checks and omissions by Experts ....................................... 17Article 19.Process regarding breaches of EFSA’s rules on CIM by Experts ................................ 17Article 20.Granting of waivers ................................................................................................. 18Article 21.

8. Common rules .................................................................................................................... 19

Advisory Committee ................................................................................................ 19Article 22.Training.................................................................................................................. 19Article 23.Transparency ......................................................................................................... 19Article 24.Protection of personal data ...................................................................................... 20Article 25.Entry into force ....................................................................................................... 20Article 26.

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DecisionEFSA –

European Food Safety

Authority

Decisionof the Executive Director on CompetingInterest Management

Decision No.:

REF. EFSA/LA/DEC/19568050/2018

Effective Date: 1 July 2018 Supersedes: .

EFSA/LA/DEC/18571869/2017,

EFSA/LRA/DEC/02/2014;

EFSA/2015/15303659/LRA

Approvals Signature Name

Originator Signature on the file Dirk Detken

Executive Director See Decision Bernhard Url

Introduction See citations and recitals of the annexed Decision

Description This decision lays down the rules to be followed by EFSA in order to manage competinginterests, with the aim of preventing the occurrence of conflicts of interest, among theprofessionals involved in its Management Board, Scientific Committee, Scientific Panels,Working Groups, peer review meetings, networks, Advisory Forum and outsourcingschemes.

References Treaty on the Functioning of the European Union

Charter of Fundamental Rights of the European Union

Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28January 2002 laying down the general principles and requirements of food law,establishing the European Food Safety Authority and laying down procedures in mattersof food safety

Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council of25 October 2012 on the financial rules applicable to the general budget of the Union

Commission Regulation (EC) No 2230/2004 of 23 December 2004 laying down detailedrules for the implementation of European Parliament and Council Regulation (EC) No178/2002 with regard to the network of organisations operating in the fields within theEuropean Food Safety Authority’s mission

Commission Delegated Regulation (EU) No 1268/2012 of 29 October 2012 on the rules ofapplication of Regulation (EU, Euratom) No 966/2012

Commission Decision of 30.5.2016 establishing horizontal rules on the creation andoperation of Commission expert groups, C(2016) 3301 final

European Parliament resolution of 8 May 2008 on the development of the framework forthe activities of interest representatives (lobbyists) in the European institutions

EFSA’s Policy on Independence adopted by the Management Board on 21 June 2017

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EFSA’s Management Board Decision concerning the establishment and operation of theEuropean Networks of scientific organisations operating in the fields within theAuthority’s mission

Decision of the Executive Director of the European Food Safety Authority concerningPesticides Risk Assessment Peer Review

Revision history - Amendment of Article 5(9) and Article 5(12)

- Update of entry into force (Article 26(1))

- Correction of typos

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AbbreviationsAuthority European Food Safety Authority

ADoIs Annual Declarations of Interest

ODoIs Oral Declarations of Interest

CoIs Conflicts of Interest

DoIs Declarations of Interest

EU European Union

IT tool Information Technology allowing the e-processing of DoIs

LA EFSA Legal and Assurance Services

MoU Memorandum of Understanding

PI Public Institution

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Decision of the Executive Director of theEuropean Food Safety Authority on

Competing Interest Management

The Executive Director of the European Food Safety Authority hasadopted the following decision

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1. Scope and definitions

ScopeArticle 1.

1. This decision lays down the rules on theestablishment and the implementation ofa system for managing competinginterests and ensuring the prevention ofconflicts of interests within EFSA. It aimsto contribute to EFSA’s commitment toensure that the scientific outputsproduced by the Authority are trustedand compliant with the principles laiddown in EFSA’s policy on independence

1.

2. The rules set out in the present decisionare addressed to all Concerned individualsas defined in Article 2(1)(k) below, unlessspecifically provided otherwise.

DefinitionsArticle 2.

1. For the purposes of this decision:

a. “Declaration of interest (DoI)”means all structured informationabout engagements outside EFSAthat potentially overlap with EFSA’sassignments, and which is submittedby individuals subject to thisdecision in the context of itsimplementation and discharge orrelated duties.

b. “Annual Declaration of Interest(ADoI)” means the annualsubmission of written information byConcerned individuals using aformat provided by EFSA.

c. “Oral Declaration of Interest(ODoI)” means the verbaldeclaration of relevant informationto be made by Concerned individualsat the beginning of each meetingwith respect to the items on theagenda of the meeting.

d. “Interest” means the objectiverelationship between a Concernedindividual, or his or her Close FamilyMembers, and a company,organisation, entity, product,

1 mb170621-a2 – EFSA’s policy on independence adopted by theEFSA Management Board on 21 June 2017.

business or other body (such ashaving a right or title, a claim, ashare, a business engagement, amembership, a paid or unpaidinvolvement, etc.). The types ofInterests taken into consideration inthis decision are outlined underparagraph 2 of this Article;

e. “Conflict of Interest (CoI)” meansany situation where a Concernedindividual has an Interest that maycompromise, or be reasonablyperceived as compromising, his orher capacity to act independentlyand in the public interest in relationto the subject of the work performedat EFSA2;

f. “Experts” means the members ofEFSA’s Scientific Committee,Scientific Panels, Working Groups,candidates having applied to the callfor expression of interest publishedby EFSA pursuant to Article 28(5) ofRegulation (EC) No 178/2002,3 andparticipants in peer reviewmeetings4 also when appointed by,or representing, Member States’authorities, and excluding HearingExperts and Observers, as defined inthis Article 2(1)(i) and 2(1)(j);

g. “Network Members” meansmembers of EFSA’s networks5, focalpoints or other networking activitiescarried out pursuant to Article 36 ofRegulation (EC) No 178/2002 (seeArticle 12);

2 Article 2(4) of Commission Decision of 30.5.2016 establishinghorizontal rules on the creation and operation of Commissionexpert groups, C(2016) 3301 final.3Regulation (EC) No 178/2002 of the European Parliament and ofthe Council of 28 January 2002 laying down the generalprinciples and requirements of food law, establishing theEuropeanFood Safety Authority and laying down procedures inmatters of food safety, OJ L 31, 1.2.2002, p. 1, as last amended.4 As defined in the Decision of the Executive Director of theEuropeanFood Safety Authority concerning Pesticides RiskAssessment PeerReview, No 14461368 of 18 September 2015.5Pursuant to the EFSA’s Management Board Decisionconcerning the establishment and operation of the EuropeanNetworks of scientific organisations operating in the fields withinthe Authority’s mission – mb180310 – item 7 doc 6.

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h. “Members of EFSA Governancebodies” means members of EFSA’sManagement Board and members ofEFSA’s Advisory Forum, (see Articles13 and 14);

i. “Hearing Experts” meansindividuals invited to provide theirinput to EFSA’s work without havinga decision making role therein, asper Article 15 of the “Decision of theExecutive Director concerning theselection of members of the ScientificCommittee, the Scientific Panels andthe selection of external experts toassist EFSA with its scientific work”(see Article 9);

j. “Observers” means individuals whoare neither Experts, Hearing Expertsnor members of the EFSAGovernance bodies, and who arepermitted by EFSA to attendmeetings and events organised byEFSA itself. Observers do not havethe power to participate in thediscussion nor to present their viewsor the data in their possession (seeArticle 10);

k. “Concerned individuals” meansExperts, Networks Members,members of EFSA’s Governancebodies, Hearing Experts, staff ofEuropean Union Institutions, bodiesor other agencies participating inEFSA’s meetings in their privatecapacity and without prejudice tothe Staff Regulations of theEuropean Union, tenderers andparticipants to grant awardingprocedures;

l. “Annual Earnings” means allincome (gross) that a Concernedindividual earned in the fiscal yearprior to the one in which the DoI issubmitted, including, and notlimited to, compensation, fees,honoraria, salaries, rents,sponsorships, fellowships, grants orother funding, pension rights,reimbursement of expenses,endowments and dividend yields. Itdoes not include earnings paid topersons other than the Concerned

individual or his or her Close FamilyMembers dependent on him or her.

m. “Public Institutions (PI)” meansany organisation included in the listdrawn up by EFSA’s ManagementBoard according to Article 2 ofCommission Regulation (EC)2230/2004.6 It also means any otherinternational, national, regional,local or academic institution, publicauthority, research institute or otherbody which carries out tasks relatedto EFSA’s remit, pursues publicinterest objectives, and receivesmore than 50% of its budget frompublic entities.

n. “Close Family Member” means:

i. a spouse, meant as the personengaged in the maritalrelationship with theConcerned individual;

ii. a partner with whom aConcerned individual hascontracted a registeredpartnership, on the basis of thelegislation of the relevant legalsystem;

iii. the direct descendants andascendants who are financiallydependent on the Concernedindividual.

o. “Procurement” means theprocedures followed by EFSA topurchase services, works or goodspursuant to its Financial Regulationand Title V of Regulation (EU,Euratom) No 966/20127 and its rulesof application.8

6 Commission Regulation (EC) No 2230/2004 of 23 December2004 laying down detailed rules for the implementation ofEuropean Parliament and Council Regulation (EC) No 178/2002with regard to the network of organisations operating in thefields within the European Food Safety Authority’s mission, OJ L379, 24.12.2004, p. 64–67.7 Regulation (EU, Euratom) No 966/2012 of the EuropeanParliament and of the Council of 25 October 2012 on thefinancial rules applicable to the general budget of the Union andrepealing Council Regulation (EC, Euratom) No 1605/2002, OJ L298, 26.10.2012, p. 1–96.8 Commission Delegated Regulation (EU) No 1268/2012 of 29October 2012 on the rules of application of Regulation (EU,Euratom) No 966/2012 of the European Parliament and of theCouncil on the financial rules applicable to the general budget ofthe Union, OJ L 362, 31.12.2012, p. 1.

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p. “Grants” means financial supportgranted by a PI in accordance withthe applicable legal framework, orby EFSA in accordance with Article36 of Regulation (EC) No 178/2002,Commission Regulation (EC) No2230/2004 or pursuant to Title VI ofRegulation (EU, Euratom) No966/2012 and its rules of application.

q. “Regulated Products” meansproducts, processes, organisms orsubstances submitted for evaluationby EFSA.

r. “Public interest duty” means a task,project, function or missionperformed by a Concernedindividual in the context of his or herengagement9 with a PI, carried outfor the benefit of the public and notfor the benefit of a specific legal ornatural person or associationthereof.

s. “Mandate” means the scientificmandate on which the ScientificCommittee, Panels, Working Groupsor peer review meeting is, or isexpected to be, involved.

t. “EFSA’s remit” means the powersdelegated to EFSA as per recital 36and Article 22 of Regulation (EC) No178/2002, or relevant sectoral EUfood law.

2. For the purpose of declaring Interests asdefined under paragraph 1, letter d, ofthis Article:

“Financial Investment” means anyI.economic stake or share in an entitywith a direct or indirect interestfalling within EFSA’s remit, includingits stocks, equities or bonds, or ofone of the entity’s subsidiaries or ofa company in which it has a holding.“Industry Financial Investments”means any form of the above held inbusiness operators directly orindirectly concerned by EFSA’soutputs. Financial instruments onwhich the Concerned individual has

9 I.e. Managerial Role, Membership of a scientificadvisory entity, Employment or OccasionalConsultancy.

no influence are not to beconsidered for the purposes of thisdecision.

“Managerial Role” means anyII.participation, paid or unpaid, in theinternal decision-making process(such as board membership ordirectorship) of an entity with aninterest falling within EFSA’s remit.Any managerial role whichcontributes more than 5% to theConcerned individual’s AnnualEarnings, shall be considered asOccasional Consultancy. If itcontributes more than 25%, it shallbe considered as Employment.

“Membership of a scientific advisoryIII.entity” means any participation in ascientific advisory entity, paid orunpaid, other than those set up byEFSA, with a direct or indirectinterest falling within EFSA’s remit.Any membership of a scientificadvisory activity which contributesmore than 5% to the Concernedindividual’s Annual Earnings, shall beconsidered as OccasionalConsultancy. If it contributes morethan 25%, it shall be considered asEmployment.

“Employment” means any form ofIV.occupation or business, part-time orfull-time, paid or unpaid, includingself-employment, with an employeror client directly or indirectlyconcerned with EFSA’s remit, or anyactivity defined in paragraph 2(I-V)of this Article that contribute formore than 25% to the Concernedindividual’s Annual Earnings.“Industry Employment” means anyEmployment with companies,business operators, industryassociations, lobbyingorganisations

10and other corporate

funded organisations directly orindirectly concerned by EFSA’sscientific outputs.

10 European Parliament resolution of 8 May 2008 onthe development of the framework for the activitiesof interest representatives (lobbyists) in the Europeaninstitutions (2007/2115(INI)) 2009/C 271 E/06.

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“Occasional consultancy” meansV.providing advice or services, paid orunpaid, to companies, tradeassociations or other private bodieswith an interest falling directly orindirectly within EFSA’s remit. Incase the consultancy contributesmore than 25% to the Concernedindividual’s Annual Earnings, it shallbe considered as Employment.

“Research Funding” means financialVI.support, including grants, rents andreimbursement of expenses,sponsorships and fellowships, forresearch or developmental workmanaged by, or benefiting, theConcerned individual, and beingprovided by public or privateentities. For each research activitycarried out, Concerned individualsindicate in their DoI whether thepercentage of (co-)funding receivedfrom the private sector during thetwo years preceding the submissionof the DoI exceeds 25% of the totalresearch budget relevant for thematter under consideration.

“Intellectual property rights” meansVII.patents, trademarks, inventorship,copyrights and/or other intellectualproperty rights, irrespective ofwhether they grant a financial gain,that are recognised by the applicablelaw and that fall directly or indirectlywithin EFSA’s remit. It does notinclude authorship or publications.

“Other memberships or affiliations”VIII.means any membership or affiliationwith entities with an interest fallingwithin EFSA’s remit, includingprofessional organisations, whichdoes not fall under the othercategories defined above and whichis relevant for the purposes of thisdecision.

“Other relevant Interests” meansIX.any Interest, involving or not afinancial transaction, that does notfall under the categories definedabove and which may be consideredas a source of CoI pursuant to thisdecision.

Requirements for aArticle 3.complete Declarationof Interest

1. Concerned individuals are required tosubmit true, accurate and up to date DoIs,without prejudice to EFSA’s right toperform audits and checks on theinformation received, also on a case-by-case basis.

2. Concerned individuals declare past orcurrent activities. Past activities aredeclared if they have taken place withinfive years preceding the date ofsubmission of the DoI.

3. Concerned individuals submitting DoIsprovide all relevant details on the subjectmatter of each declared Interest. Theyindicate the sector in which the activity isor was carried out, clarify the exactInterest and role of the entity ororganisation of relevance for eachInterest and specify their precise rolewithin that entity or organisation.Concerned individuals also provide otherinformation relevant for performing thescreening of the DoI, including theinformation to be submitted to calculatethe impact of each interest on theirAnnual Earnings and clarifications thatmay be requested by EFSA in the contextof the implementation of this decision.

Annual Declaration ofArticle 4.Interest

1. Concerned individuals are requested tosubmit the ADoI according to the rules setout in this decision and do so bysubmitting it through the dedicated ITtool or, in exceptional circumstances, byfilling the form provided by EFSA.

2. Any Concerned individual updates his/herADoI without delay and in any case within45 calendar days following any change inhis/her Interests. With the exception ofomissions resulting from force majeure,failure to do so is considered an omissionpursuant to Article 19 below.

3. The ADoI is used by EFSA to decide onthe Concerned individual’s eligibility withrespect to his/her involvement regardingthe relevant EFSA activity.

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Oral Declaration ofArticle 5.Interest

1. Concerned individuals declare orally atthe beginning of each meeting anyInterest not already declared which mightbe considered prejudicial to theirindependence with respect to the itemson the agenda of the meeting.

2. The ODoI is used to identify whether theConcerned individuals should or not beexcluded from the discussion of a specificitem on the agenda or from participatingin a specific meeting.

3. Any ODoI shall be recorded in theminutes of that meeting in the sectiondealing with the outcome of EFSA’sscreening of Interests.

2. Rules applicable to Experts

Annual Declaration ofArticle 6.Interest

1. At least once every year, and in any casewithin 45 calendar days following anychange in his/her Interests, Expertsdeclare their Interests, as defined inArticle 2, by submitting an ADoI inaccordance with Articles 3 and 4.

2. Without prejudice to the StaffRegulations of the European Union, staffof European Union institutions, bodies oragencies participating as members in themeetings of EFSA’s scientific groups aresubject to DoI related requirements as setout in this decision.

General principles ofArticle 7.screening of Experts’Interests

1. The identification and prevention of CoIsare based on the evaluation of the ADoIand, where appropriate, of the ODoIgiven by the Expert.

2. Without prejudice to the application ofthe general principle referred to inparagraph 4 of this Article, Interests arescreened by EFSA by considering whetherthey are compatible with the tasks to beassigned to the expert, and with regardsto the Mandate in which the relevantScientific Panel, Working Group, PeerReview meeting or the ScientificCommittee shall perform its activity.

3. EFSA considers the review, assessment orrating by Experts of their own work as aCoI incompatible with the Experts’participation to these activities. Theconcept of “work” should be meant asinclusive of publications, papers, data,studies, results or scientific opinions, withthe exception of those adopted by EFSA’sscientific groups.

4. Current Industry Employment or currentIndustry Financial Investments areconsidered incompatible withmembership of EFSA’s ScientificCommittee, Scientific Panels, WorkingGroups or participation in peer reviewmeetings.

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5. The following activities are deemedincompatible with membership of therelevant Scientific Committee, ScientificPanel(s), Working Group(s) and peerreview meeting(s) when they regard theMandate of the scientific group:Managerial roles, Employment,Occasional Consultancy and membershipof Scientific Advisory Bodies with non PIs.Research Funding from the private sectorexceeding 25%

12of the funding relevant

for the scientific group also results in theincompatibility with membership of therelevant group.

13These incompatibilities

are applicable to the activities performedin favour of non-PIs, or with respect to

11 Paragraph 3.1 of EFSA’s policy on independence.12 Paragraph 3.4 of EFSA’s policy on independence.13 See Annex 1 for details on calculation.

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activities not performed by the Expert inthe exercise of Public Interest Duties, orcarried out in the performance of riskmanagement functions, and last for twoyears after the competing activity hasended.

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6. Activities carried out within PIs as part ofPublic Interest Duties, including teachingor research, do not constitute a CoI underthis decision. An exception to the aboveconcerns the risk management functionsthat are ongoing, or terminated in thetwo year prior to DoI submission, and thatare performed with PIs on the samesubject discussed in the EFSA scientificgroups.

7. Activities with PIs that are unrelated toPublic Interest Duties are assessed andvalidated as per the rules set out in thisArticle and presented in a tabular mannerin Annex 1.

8. For the purpose of screening DoIs andevaluating thresholds for employment,occasional consultancy, managerialactivity or membership of a scientificadvisory entity, all Annual Earningscoming from the same entity shall beconsidered as a single entry, also whenregistered under different forms oractivities.

9. The screening of interests of Close FamilyMembers is performed as for interests ofthe experts submitting the DoI, exceptfor:

a. paragraph 3, which shall not apply toClose Family Members,

b. paragraph 4, which shall apply toClose Family members only whenthe activities overlap with thesubject matter of the EFSA scientificgroup.

10. No EFSA assignment shall be declared orconsidered to be a source of CoI.

11. Memberships, affiliations or otherrelevant Interests not specificallyaddressed in Annex 1, shall be screenedon a case-by-case basis, taking intoconsideration the general principles set

14 Paragraph 3.2 of EFSA’s policy on independence.

out in this Article and the rationale behindEFSA’s policy on independence.

12. By way of derogation from paragraph 5,past activities classified as employment,managerial roles, scientific advisory roles,consultancy with, or Research Fundingexceeding 25% from, non-PIs held byparticipants in peer review meetings arecompatible with membership of thesemeeting(s) if the expert has an ongoingemployment with a PI. The samederogation from paragraph 5 shall applyto interests held by Close FamilyMembers of participants in peer reviewmeetings. Paragraph 5 shall instead applyto participants in peer review meetingsholding interests related to dossierssubmitted by legal or natural persons withwhom they, or their Close FamilyMembers: a. were employed; b. heldmanagerial or scientific advisory positionsor; c. to whom they tendered advice, inthe two years prior to DoI submission.

Screening process ofArticle 8.Experts’ DoIs

1. The officer identified as responsible bythe relevant working instructionsperforms the assessment of the ADoIsaccording to the criteria set out in Article7 and presented in a tabular format underAnnex 1, and sends them to LA along withthe result of the assessment. LA carriesout the validation of the assessment ofthe ADoIs according to the same set ofcriteria.

2. Before starting the discussion of any ofthe items on the agenda of the meeting,the officer identified as responsible by therelevant working instructions performsthe screening of the ODoIs in accordancewith the criteria laid down in Annex 1, andin the light of the principles set out inArticle 7 above.

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3. Rules applicable to HearingExperts and Observers

Hearing ExpertsArticle 9.

1. Hearing Experts submit an ADoI inadvance of a meeting to which they areinvited. No DoI screening, assessment orvalidation is performed for ADoIssubmitted by Hearing Experts.

2. Participation to the meeting in theprevious paragraph is permitted only ifthe Hearing Experts has submitted anADoI.

3. Hearing Experts do not perform taskswhich are the responsibility of themembers of the EFSA scientific group.They may present topics and answerquestions, and may not draft or be

involved in the discussion or the adoptionof a scientific output.

ObserversArticle 10.

1. Observers are not required to submitDoIs.

Staff of UnionArticle 11.institutions, bodies oragencies

1. Without prejudice to the StaffRegulations of the European Union, staffof EU institutions, bodies or agenciesattending the meetings of EFSA’sscientific groups as Observers or HearingExperts are not required to submit DoIs.

4. Rules applicable to NetworkMembers

Network MembersArticle 12.

1. Network Members shall declare theirInterests as defined in Article 2(1)(d) bysubmitting an ADoI in accordance withArticle 4 above. No screening, assessmentor validation is performed by EFSA.

2. MoUs between EFSA and PIs specifyapplicable standards.

3. EFSA follows-up on serious and welldocumented cases of CoI substantiallyaffecting the work of the EFSA’s networkor EFSA’s reputation that are brought toits attention. In this event, the ExecutiveDirector shall submit the issue to theManagement Board which may ask thecompetent Member State to replace theConcerned individual.

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5. Rules applicable tomembers of EFSA’sGovernance Bodies

Members of theArticle 13.Management Board

1. Members of the EFSA ManagementBoard shall declare their Interests asdefined in Article 2(1)(d) by submitting anADoI in accordance with Article 4 above.

2. The Management Board members shalldeclare orally at the beginning of eachmeeting any newly emerging Interest or amodification of an already declared one.

3. EFSA shall provide an assessment of thedeclared Interests to the ManagementBoard, taking due account of thedecisions of the Council appointing itsmembers and of the notarial function theBoard enjoys with respect to EFSA’sscientific processes.

4. Before commencing the discussion of theitems on the agenda, the ManagementBoard shall reach a conclusion with regardto the assessment provided by EFSA and,where appropriate, recommend a follow-up, including the exclusion of theconcerned member from the discussionof specific items on the agenda.

5. If an identified CoI which maysubstantially affect the work of the Boardor EFSA’s reputation is not resolved bythe concerned member or by therecommended follow-up action, theBoard may ask for the replacement of theconcerned member pursuant to Article 15of its Rules of Procedure.

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15 mb270613 – Management Board Rules ofProcedure – adopted by the EFSA ManagementBoard on 27 June 2013.

6. For two years after their mandate asmembers of the Management Board hasexpired, the former Board members shallinform EFSA of any professionalengagement overlapping with EFSA’smission or tasks.

Members of the EFSAArticle 14.Advisory Forum

1. Members of the EFSA Advisory Forumshall declare their Interests as defined inArticle 2(1)(d) by submitting an ADoI inaccordance with Article 4 above.

2. EFSA follows up on serious and welldocumented cases of CoI substantiallyaffecting the work of the EFSA’s AdvisoryForum or EFSA’s reputation that arebrought to its attention. In this event, theExecutive Director shall submit the issueto the Management Board, which mayask the competent Member State toreplace the concerned individual.

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6. Procurement and grantawarding procedures

Declaration of InterestArticle 15.of tenderers andparticipants in EFSA’sprocurement andGrant awardingprocedures

1. Legal or natural persons taking part inEFSA’s public procurement proceduresconcerning EFSA’s scientific activities arerequired to submit a true, accurate and upto date DoI using the Form provided byEFSA and by declaring their Interests asdefined in Article 2(1)(d) in accordancewith Article 4 above. They update the DoIevery time a new interest emerges or analready declared one changes.

2. A DoI is submitted by each of themembers of the team the tenderer orGrant applicant is proposing to work onthe project connected to the publicprocurement procedure or Grant. They doso by declaring their Interests as definedin Article 2(1)(d) and by submitting a DoIin accordance with Article 4 above.

Screening of the DoIsArticle 16.in the context of EFSAprocurement andGrant awardingprocedures

1. EFSA screens DoIs submitted in thecontext of procurement and Grantawarding procedures according to thecriteria presented in a tabular format inAnnex 2. The DoI is validated by theAuthorising officer identified asresponsible by the relevant workinginstructions.

2. If the responsible Authorising officerconsiders that a CoI would occur if acontract or Grant is awarded, he/she shallask the tenderer/Grant applicant to put inplace, within a set deadline, appropriatemeasures to prevent the CoI.

3. The responsible Authorising officer shallassess the measures taken by thetenderer/applicant to ensure that the CoIno longer exists. If the tenderer/applicantis not able to adopt appropriatemeasures, EFSA shall exclude them fromthe procedure.

7. Implementation andenforcement

Coordination andArticle 17.implementation

1. The internal assignment of tasks andresponsibilities for the implementation ofthis decision is set out in standardoperating procedures and workinginstructions implementing the principles

of centralized handling and coordinationand of functional separation ofresponsibilities between the provision ofscientific advice and decision makingpower in competing interestmanagement.

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Review of theArticle 18.decisions

1. If a specific complaint is filed against adecision taken under the rules set out inthis decision, or if reconsideration of adecision is deemed appropriate toaddress an error, the Executive Directormay review that decision.

2. The decisions taken under these rulesmay be brought to the attention of theEuropean Ombudsman for allegedmaladministration pursuant to article 228of the Treaty on the Functioning of theEuropean Union (TFEU) or may bechallenged before the General Court ofthe European Union at the conditions setout in Article 263 TFEU.

Compliance andArticle 19.veracity checks andomissions by Experts

1. Twice a year, EFSA shall check thecompliance and the veracity of a randomsample of DoIs submitted in the contextof this decision by Experts, tenderers andgrant beneficiaries, and make theoutcome of this exercise publiclyavailable.

2. In the framework of this check, EFSA mayrequire from any Concerned individualhis/her declaration of personal income fortax purposes, as well as relevantdocumentation supporting the detailsprovided in the relevant DoI in order tocheck the veracity of the informationdeclared therein.

3. If EFSA becomes or is made aware ofinformation that is not consistent with, orthat is missing from, the DoI of aConcerned individual, and if a preliminaryassessment of this information suggeststhat it concerns an Interest that shouldhave been declared pursuant to Articles 1to 7 of this decision, EFSA shall seekadditional information from theConcerned individual and ask him or herto update his or her DoI and to include themissing information.

4. Once the Concerned individual hascompleted this update, EFSA shall screenthe DoI in accordance with this decision.

Process regardingArticle 20.breaches of EFSA’srules on CIM byExperts

1. The omission of information that wouldhave resulted in a CoI is considered abreach of these rules.

2. In the event of an ascertained breach ofthe rules, the Management Board formembers of the Scientific Committee orScientific Panel, or the Executive Directorfor members of Working Groups or ofparticipants to peer review meetings,applies one of the following measures:

a. Reprimand letter;

b. Suspension from participation in anyEFSA activity, with correspondingsuspension of any compensationtherefrom, for a period of 6 monthsup to a maximum period of 1 year,without dismissal from the relevantbody or scientific group;

c. Dismissal from the relevant body orscientific group, which may or maynot be combined with a prohibitionon participating in further EFSAactivities for a period of 1 year up toa maximum period of 10 years.

3. To identify the measure to be applied, theManagement Board or the ExecutiveDirector, respectively, shall take intoaccount the following criteria:

a. Subjective element of the conduct(wilful misconduct vs. negligence);

b. Importance of the Interest as asource of influence on the Expert’sscientific positions;

c. Financial impact on the AnnualEarnings of the non-declaredInterest pursuant to Article 2(1)(litt.l) of this decision;

d. Role of the relevant Expert withinthe scientific group;

e. Timing of the omission (Interestalready existing at the time of theDoI vs. Interest arising later and notpromptly declared) and delay indeclaring.

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4. If a measure under letters b. and c. ofparagraph 2 of this Article is applied,EFSA shall perform a review of thescientific output(s) to which the Expert inquestion contributed. EFSA shall clarifywhether, and the extent to which, thatExpert influenced the outputs adopted bythe EFSA group(s) in which he or sheparticipated.

5. EFSA shall report the audit findings to theExecutive Director, and to the AuditCommittee of the Management Board.The Executive Director shall take allmeasures that are deemed fit to addressthese findings.

6. At least once a year, EFSA shall report tothe Audit Committee of its ManagementBoard on the findings identified inapplication of this Article, and on otherrelevant cases resulting from theimplementation of this decision.

Granting of waiversArticle 21.

1. This Article only applies to members ofEFSA’s Working Groups16 and peer reviewmeetings.17

2. When EFSA identifies a CoI concerning anExpert wanting to participate in aWorking Group, the secretariat of theWorking Group shall carry out a search foran alternative Expert. Exceptionally,where no suitable alternative Expert isfound, the officer responsible for the DoIassessment may request the issuing awaiver in respect of the Expert with theidentified CoI, by submitting to theExecutive Director a detailed reportoutlining the reasons supporting therequest.

3. Such a waiver may only be granted by theExecutive Director when the contributionof the concerned Expert is found to beessential for the completeness of the

16 mb170322-a4 - Decision of the Management Boardof the European Food Safety Authority concerningthe establishment and operations of the ScientificCommittee, Scientific Panels and of their WorkingGroups adopted by the Management Board on 22March 2017.17 Decision of the Executive Director of the EuropeanFood Safety Authority concerning Pesticides RiskAssessment Peer Review, No 14461368 of 18September 2015.

draft output, when no suitable alternativeExpert could be identified, and when theExpert’s contribution could not behandled through his or her participationas Hearing Expert.

4. No waivers shall be granted to Expertswith a current Industry Employment orwith a current Financial Investment in anentity impacted by EFSA’s outputs.

5. Waivers are recorded in the minutes ofthe meeting(s) and in the ensuingscientific output.

6. If a waiver is granted, the concernedExpert is invited to take part in thediscussions and in the drafting phase ofthe scientific output. Experts to whom awaiver has been granted are not eligiblefor chairmanship, vice-chairmanship andmay not be appointed as rapporteur.

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8. Common rules

Advisory CommitteeArticle 22.

1. At any point, EFSA may consult or refer amatter to an internal Committee with theresponsibility of reviewing and advisingon assurance and independence relatedmatters.

2. The Committee shall meet at least twice ayear and shall be in charge of:

a. validating the findings of complianceperformed pursuant to Article 19 ofthis decision;

b. advising on key operationaldecisions regarding theimplementation of theindependence related regulatoryframework.

TrainingArticle 23.

1. EFSA shall ensure that all staff membersimplementing this decision, and theConcerned individuals receive inductiontraining on how to comply with thisdecision. In particular, EFSA shall ensurethat all responsible officers, identified bythe relevant working instructions asresponsible for the screening of DoIs areproperly trained on the content of EFSApolicy on independence, of this decisionand of all the relevant workinginstructions.

2. For this purpose, EFSA shall implementtraining for all responsible officers andmembers of its Scientific Committee andScientific Panels, document and keeptrack of attendance, and keep on hand atall times an advisor to answer questionsor clarify doubts from the Concernedindividuals about how the rules should beimplemented. EFSA shall also makeavailable working instructions andsupporting materials to Working Groupmembers and participants to peer reviewmeetings.

TransparencyArticle 24.

1. In accordance with EFSA’s policy onindependence, EFSA shall make publiclyavailable on its institutional website interalia:

a. ADoIs of: (i) members of EFSA’sManagement Board; (iii) members ofEFSA’s Advisory Forum; (iv)members of OperationalManagement Team composed asindicated on EFSA’s website; (v)members of its Scientific Committeeor Scientific Panels, WorkingGroups, participants in peer reviewmeetings, including when appointedby, or representing, Member States’authorities, or members of itsnetworks;

b. The Consolidated Annual Report,which shall include informationabout independence-relatedactivities of EFSA (including numberof DoIs screened, CoIs prevented,breaches of the rules confirmed, therelevant measures applied underArticle 20 and the outcome of thecompliance and veracity checksperformed as per Article 19);

c. MoUs signed by EFSA with PIs;

d. The list of PIs;

e. Following the positive conclusion oftechnical and feasibilityconsiderations, all conclusionsreached by EFSA in the assessmentand validation process of its Experts’ADoIs;

f. A register of activities undertaken byformer members of EFSA’sManagement Board for two yearsafter their term of office has ended.

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Protection of personalArticle 25.data

1. EFSA processes all DoIs pursuant toRegulation (EC) No 45/2001 of theEuropean Parliament and of the Councilof 18 December 2000 on the protection ofindividuals with regard to the processingof personal data by the Communityinstitutions and bodies and on the freemovement of such data.

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2. The purpose of the data processing is tosafeguard the independence of EFSA andits various bodies.

3. The legal basis for DoI processing isprovided in:

a. Articles 22, 37 and 38 of Regulation(EC) No 178/2002;

b. For DoIs of participants inprocurement and grant awardingprocedures, Article 107 of Regulation(EU) No 966/2012 of 25 October2012 on the financial rules applicableto the general budget of the Unionas well as Article 142 of CommissionDelegated Regulation (EU) No1268/2012 of 29 October 2012 on therules of application of Regulation(EU) No 966/2012.

4. The EFSA’s Executive Director is thecontroller for handling of the DoIs.

5. The recipients of the DoIs are the personsand bodies identified in this decision,without prejudice to the publicityrequirement specifically regarding ADoIslaid down in Article 38(1) litt. (d) ofRegulation (EC) No 178/2002.Furthermore, DoIs may be transferred tobodies in charge of monitoring orinspection in conformity with EU Law,including the European Court of Auditors,the Internal Audit Service, the EuropeanAnti-Fraud Office, the European

18 This decision was drafted also against thelegislative proposal updating the aforementionedRegulation, in the light of the Regulation (EU)2016/679 of the European Parliament and of theCouncil of 27 April 2016 on the protection of naturalpersons with regard to the processing of personaldata and on the free movement of such data, andrepealing Directive 95/46/EC (General DataProtection Regulation), OJ L 119, 4.5.2016, p. 1–88.

Ombudsman and the European DataProtection Supervisor.

6. The conservation period for DoIs percategory of data subjects is 10 years fromthe date of submission of the relevantDoI.

7. Concerned individuals have the right toaccess their DoI and to update or correctit at any time. To meet this requirement,the DoI IT tool, available uponusername/password authentication, ispermanently accessible to Concernedindividuals. If EFSA is aware ofinformation that is not consistent withthe declared interest, or of the failure tosubmit a DoI, the Concerned individualshall be contacted with the purpose ofupdating the DoI with the missinginformation. If an internal breach of therules procedure is opened, the Concernedindividuals shall be notified without delay.

8. Concerned individuals are also entitled tohave recourse at any time to theEuropean Data Protection Supervisor:http://www.edps.europa.eu.

Entry into forceArticle 26.

1. The present decision shall enter into forceon 30 June 2018, thereby repealing andreplacing DecisionEFSA/LA/DEC/18571869/2017 and shall beapplicable as of 1 July 2018.

2. As of 1 July 2018, the present decisionrepeals the Decision of the ExecutiveDirector of the European Food SafetyAuthority on the Committee on Conflictsof Interest of 29 February 201619, Article 8of the Decision of the Executive Directorof the European Food Safety Authorityconcerning Pesticides Risk AssessmentPeer Review and the provisions of theDecision of the Executive Director of theEuropean Food Safety Authority onDeclaration of Interest of 31 July 201420,with the exception of Articles 19 and 20thereof.

19 EFSA/2015/15303659/LRA.20 EFSA/LRA/DEC/02/2014.

21

3. The Executive Director shall review thisdecision by 1 December 2020, and at leastevery two years thereafter. As part ofeach review, the Executive Director shalldetermine whether any adjustment to

this decision is appropriate. The ExecutiveDirector shall communicate to theManagement Board the rationale andresults of such review, and thejustification for any such adjustment.

Done in Parma on 29 June 2018Signed

Bernhard UrlExecutive Director

Annexes:Annex 1: General principles and Screening Criteria for Experts’ ADoIs and ODoIs.Annex 2: Screening Criteria of the DoIs in the context of EFSA’s public procurement and

Grant awarding procedures

ANNEX 1

General Principles and Screening Criteria for Experts’ ADoIs and ODoIs.

ASSESSMENT APPROACH

Unconditional restrictions

Interests are considered incompatible with the involvement in any EFSA scientificactivity (not applicable to interests held by Close Family Members)

Qualified restrictions

Interests are screened by EFSA by considering whether they are compatible withthe tasks to be assigned to the Expert, with regard to the mandate of the relevantgroup/panel

Current financial investments in “Industry” concerned with EFSA’s outputs

Industry employment as described in Article 2(2)(IV) of this decision

Managerial Roles

Membership of scientific advisory entities

Employment in organisations other than food/feed industries

Occasional Consultancy

Research funding

Intellectual property rights

Other membership or affiliations

Other relevant interests

REVIEW OF SCIENTIFIC WORK

ADoIScientific Committee, Panels,Working Groups and peer reviewmeetings

ODoIScientific Committee, Panels,Working Groups and peer reviewmeetings

Eligibility Chair& Vice-chair

EligibilityMember

Participation inmeeting whenreview ofExpert’s work isnot in agenda

Participation inmeeting whenreview ofexpert’s work isin agenda

Assessment, rating or review ofExpert’s own work

which constitutes a part of thepublications, opinions, paper, study,test or protocol which the mandaterequires to review

YES YES YES NO

which is the only one to be reviewed orconstitute the main subject of themandate

NO NO NO NO

EXPERTS’ DoI SCREENING CRITERIA

Declared interest Time since declared interestended (in years)


ODoISScientific Committee, Panels,Working Groups and peer reviewmeetings


EligibilityMember

Participation,when interestnot overlappingwith agendaitem(s)

Participation,when interestoverlappingwith agendaitem(s)

FINANCIAL INVESTMENTS in food or feedIndustry

Current interest NO NO NO NO

Past from 0 to 2 years YES YES YES YES


MANAGERIALROLEMEMBERSHIP ofa SCIENTIFICADVISORYENTITY,OCCASIONALCONSULTANCYwith entities otherthan PI

Not overlapping withmandate of the scientificgroup

Current interest YES YES YES NO



Overlapping with mandateof the scientific group






EligibilityMember



Past from 0 to 2 years21 NO NO NO NO


EMPLOYMENT with food or feed Industry orother lobbying organisations directly or indirectlyconcerned by EFSA’s scientific outputs


Past from 0 to 2 years21

NO NO NO NO


NO YES YES YES

EMPLOYMENTwith entities otherthan food/feedIndustry and PI

Not overlapping withmandate of the scientificgroup



21 By way of derogation from Article 7(5), past activities classified as employment, managerial roles, scientific advisory roles, consultancy with, or Research Funding exceeding 25% from, non-PIs held byparticipants in peer review meetings are compatible with membership of these meeting(s) if the expert has an ongoing employment with a PI. The same derogation from Article 7(5) shall apply to interests held byClose Family Members of participants in peer review meetings. Article 7(5) shall instead apply to participants in peer review meetings holding interests related to dossiers submitted by legal or natural persons withwhom they, or their Close Family Members: a. were employed; b. held managerial or scientific advisory positions or; c. to whom they tendered advice, in the two years prior to DoI submission.





EligibilityMember




Overlapping with mandateof the scientific group



NO NO NO NO


NO YES YES YES

MANAGERIALROLE,SCIENTIFIC,MEMBERSHIP ofa SCIENTIFICADVISORYENTITY,OCCASIONALCONSULTANCY,EMPLOYMENTwith PI

Public interest duty (no RiskManagement tasks)

Current interest YES YES YES YES







EligibilityMember



Publicinterest duty(RiskManagementtasks) orNon-publicinterest duty

Notoverlappingwithmandate ofthescientificgroup




Overlappingwithmandate ofthescientificgroup


Past from 0 to 2 years NO NO NO NO


RESEARCH FUNDING not linked to the mandateof the scientific group




RESEARCH FUNDINGlinked to the mandateof the scientific group

Private funds < or =25%




Private funds > 25% Current interest NO NO NO NO


NO NO NO NO


INTELLECTUAL which is being Current interest NO YES YES NO





EligibilityMember



PROPERTY RIGHTSlinked to the mandateof the scientific group

reviewed as part of abroader scientificmandate or as part of alarge body of evidence



which is the only ormain subject of themandate


Past from 0 to 2 years NO NO NO NO


INTELLECTUAL PROPERTY RIGHTS not linked tothe mandate of the scientific group




.

Calculation of private research funds (to be performed by the Expert)

Step 1: determinationof the Expert’s overallresearch portfolio in €

Research funds directlyreceived and managed by theExpert during the two yearspreceding the submission ofthe DoI (Ex: 200,000 Euro)

+

Research funds benefiting theExpert during the two yearspreceding the submission ofthe DoI, and received ormanaged by his/herorganisation of affiliation (Ex:500,000 Euro)

+

Research funds directlyreceived and managed by theExpert’s Close Family Memberduring the two yearspreceding the submission ofthe DoI (Ex: 50,000 Euro)

+

Research funds benefiting theExpert’s Close Family memberduring the two year precedingthe submission of the DoI, andreceived or managed byhis/her organisation ofaffiliation (Ex: 250,000 Euro)

Step 2: determinationof the amountrepresenting basis forcalculation of % ofprivate and publicfunds

IN THE MANDATE

Research funds invested inscientific area(s) pertainingto the mandate of therelevant ScientificCommittee/Panel/WorkingGroup/peer review meeting

(Ex: 200.000 Euro)

Step 3: determinationof the % of researchfunds from privatesector

CONFLICT if > 25%

Ex: 60.000 Euro of the 200.000 Euroinvested in researches pertaining tothe mandate of the ScientificCommittee/ Panel/WorkingGroup/peer review meetingoriginate from private sources= 30%

NO CONFLICT if = OR < 25%

Ex: 40.000 Euro of the 200.000 Euroinvested in researches pertaining tothe mandate of the ScientificCommittee/Panel/WorkingGroup/peer review meetingoriginate from private sources =20%

OUT OF THE MANDATE

Research funds invested inscientific area(s) other thanthat/those pertaining to themandate of the relevantScientificCommittee/Panel/WorkingGroup/peer review meeting

(Ex: 800.000 Euro)

ANNEX 2

Screening Criteria of the DoIs in the context of EFSA’s public procurement and Grant awarding procedures

Declared interest Time since declared interestended

Participation in the tender orproject / awarding of Grant

Industry Employment or Industry FinancialInvestment

Overlapping with the subject of theproject

Current NO

Past 0 to 5 years YES

Not overlapping with the subject of theproject

Current or past 0 to 5 years YES

EMPLOYMENT with entities other thanfood/feed industry and PI


Current NO




MANAGERIAL ROLE , MEMBERSHIP of aSCIENTIFIC ADVISORY ENTITY,OCCASIONAL CONSULTANCY with entitiesother than PI


Current NO




MANAGERIAL ROLE,MEMBERSHIP of aSCIENTIFIC ADVISORYENTITY, OCCASIONALCONSULTANCY,EMPLOYMENTwith PI

Riskmanagementfunctions


Current NO




Risk assessmentfunctions

Overlapping or not overlappingCurrent or past 0 to 5 years YES

RESEARCH FUNDING with private funds < or= 25%

Linked to the subject of the project Current or past 0 to 5 years YES

Not linked to the subject of the project Current or past 0 to 5 years YES

RESEARCH FUNDING with private funds>25%

Linked to the subject of the project Current NO


Not linked to the subject of the projectCurrent or past 0 to 5 years YES

Intellectual Property Rights Overlapping with the subject of theproject

Current NO



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