Paper 5 - Dr Claudia Roncancio-Pena - AFMA

Legal basisRegulation (EC) No. 1831/2003 on additivesfor use in animal nutrition.Establish a Community procedure forauthorising the placing on the market anduse of feed additives and to lay down therules for the supervision and labelling of feedadditives and pre-mixtures

Legal basisRegulation (EC) No 178/2002 General principles / requirements of Food Law Establishment of EFSADECISION CONCERNING THE ESTABLISHMENT ANDOPERATIONS OF THE SC AND PANELS(MB 17 October 2002; MB 11 September 2007)Mandate of the FEEDAP Panel: to assess the safetyand/or efficacy for the target species, the user/worker,the consumer of products of animal origin and theenvironment, and the efficacy of biological and chemicalproducts/substances intended for deliberateaddition/use in animal feed

EFSA’s role Before Regulation (EC) No. 1831/2003ApplicantMSRapporteurEvaluationby MSSCAN + StandingCommittee After Regulation (EC) No. 1831/2003European CommissionApplicant EFSA European Commission+Standing Committee

The regulatory frameworkThe General Food LawRegulation (EC) 178/2002Feed HygieneReg. (EC) 183/2005Feed MaterialsReg. (EC) 767/2009Feed AdditivesReg. (EC) 1831/2003GuidelinesReg. (EC) 429/2008

How the process worksRisk ManagementRisk AssessmentEuropean CommissionEuropean ParliamentRequestMember StatesScientific OpinionReportLegislation

EFSA procedure for applications forauthorisationApplicantApplicationTechnical Dossier+ CRL statementFee/samplesof feedadditiveECApplicationEFSAAcknowledgementof receipt, 15dCRLInformMakeinformationavailableYESDossiercompleteNOReportMEMBERSTATESMake summaryavailable to publicScientific evaluation of thetechnical dossier

Scientific AssessmentScientific evaluation ofthe technical dossierNOSupplementaryinformation?YESApplicant is requested.Extension of the 6months time-frameScientific Panel prepares an OpinionOPINION ADOPTEDCommunication toCOMMISSION, MEMBERSTATES and ApplicantMake Opinion availableto public

FEEDAP – Number of questionsreceived vs. scientific outputs

Scientific outputs adopted underReg. (EC) No 1831/2003 since 2004

FEEDAP – Workload 20099 Plenary meetings (2-3 days)57 Standing WG meetings (1-3 days)10 Ad-hoc WG meetings (1-2 days)23 Other meetings/presentationsplus preparatory work

Scientific outputs : 2003-2008Scientific Opinions 147Guidance Documents for applicants 175 For the specific categories of additives11 Technical guidance documents dealing with horizontal issues: e.g.tolerance and efficacy studies in target animals, additivesalready authorised for use in food, consumer safety, user safety,extrapolation of data from major species to minor species,microbial studies, environmental risk assessment…1 Specific guidance document: for the re-evaluation of certain additivesalready authorised under Directive 70/524/EEC.Consultation on Guidance documents 1

Authorisation process 2006-2009Legislative acts: RegulationMS ConsultationStanding CommitteesFor vote: 4CODEX discussion : 1MS not in favour: 16013EC prepare a legislative actEC requestedadditional info: 14EFSA OpinionIn progress: 19414

Consolidated list of feed additivesCommunity Register of FeedAdditiveshttp://ec.europa.eu/food/food/animalnutrition/feedadditives/registeradditives_en.htm

Regulatory frameworkCommission Regulation (EC) No 429/2008on detailed rules for the implementation ofRegulation (EC) No 1831/2003 as regards the preparationand presentation of applications and the assessment andthe authorisation of feed additivesEntry into force11 June 2008

New elements Regulation (EC) No 429/2008Reflects the provisions of Reg. (EC) No 1831/2003Provides detailed rules for:specific categories of additives,extrapolation from major species to minor species,pets and other non-food producing animals,additives already authorised in food,modification/renewal/reevaluation,categories and definitions of target animals andduration of efficacy studies.

CharacteristicsRegulation (EC) No 429/2008FlexibilityUpdatedComprehensiveProportionalTransparentSets out the rules for the preparation andpresentation of dossiers and the assessment

Technical Guidance documentsTolerance/efficacyConsumer/UserEnvironmentMinor speciesMicrobial studiesFood additivesRe-evaluationZootechnIcalCoccidiostat

FEEDAP – Other interactionsApplicants are offered “Technical hearings”on the assessment process Pre-application meetings (usually dealt by the Unit) Requested during an assessment Requested after an assessment because of deficienciesidentified preventing a final safety assessmentFifteen technical hearings in 2008And 2009

Re-evaluation of feed additivesAbout 2,700 additives – included in the Communityregister – but never formally assessed or assessedaccording to different (national) standardsIntention is to ensure all feed additives have beenassessed to a common standardØ Number of dossiers speculativeØ Priority list of additives, proposed by FEEDAP,agreed at the Standing Committee on the FoodChain and Animal HealthØ Drip-fed to EFSA

FEEDAP – The WorkersThe FEEDAP Unit is divided in two teams:Team Opinions: Providing scientific support to the Panel on thepreparation of opinions.Team Applications: Dealing with administrative issues linkedwith the applications/dossiers.The Panel members represent over 500 years ofworking/research-based expertise covering:Animal physiology, biochemistry, pharmacology, toxicology,microbiology, (animal) nutrition (including fish), veterinarysciences, feed materials and technology, husbandry, productquality, ecotoxicology.

Members of the FEEDAP PanelChair of the FEEDAP PanelAndrew ChessonGabriele AquilinaGeorges BoriesPaul BrantomPier Sandro CocconcelliJoop de KnechtNoël DierickMikolaj Antoni Gralak,Jürgen GroppIngrid HalleNils-Gunnar IlbäckReinhard KrokerLubomir LengSven LindgrenAnne K. LundebyeHaldorsenAlberto MantovaniMiklós MézesDerek RenshawMaria Saarela

Thank you for your attentionQuestions?24