Suitability Check of dossiers on Food Enzymes and services for applicants and other stakeholders Carla Martino Applications Desk Unit Info Session on Applications Technical meeting on Food Enzymes 27/05/2014 Info Session on Applications - Technical meeting on Food Enzymes 27/05/2014 TODAY’S TODAY S PRESENTATION Applications pp Desk as a front office and support desk for applicants Centralise and harmonise workflow on applications Suitability check of dossiers on Food Enzymes APDESK web form Customer oriented approach Info Session on Applications - Technical meeting on Food Enzymes 27/05/2014 APDESK VISION AND MISSION Vision Our vision is to facilitate high quality applications for regulated products that enhance innovation. Mission Lead a front office and support desk for all stakeholders with respect to applications for regulated products. Info Session on Applications - Technical meeting on Food Enzymes 27/05/2014 CENTRALISATION OF APPLICATIONS Applications are submitted to EFSA Individual scientific units EFSA / APDESK Risk assessment FIP U it Unit FEED U it Unit 9Reception 9Acknowledgement 9Administrative issues 9 Completeness check 9… VALID application GMO U it Unit NUTRITION U it Unit PESTICIDES U it Unit BIOHAZ U i Unit Info Session on Applications - Technical meeting on Food Enzymes 27/05/2014 FOOD ENZYMES – WORKFLOW APPLICATIONS Applicant EC Regulations EC 1331/2008 234/2011 Reception EFSA 30 WDS (legal DL) Suitable Not suitable Validity (by EC) Risk Assessment Negotiated deadline Adoption by the Panel 15 WDs* Publication *EFSA aims at publishing the opinion 15WDs after adoption Info Session on Applications - Technical meeting on Food Enzymes 27/05/2014 FOOD ENZYMES – WORKFLOW SUITABILITY CHECK Applicant Dossier EUROPEAN COMMISSION Regulations EC 1331/2008 234/2011 Mandate + Dossier EFSA Performs suitability it bilit check h k (30 WDs legal DL) Info Session on Applications - Technical meeting on Food Enzymes 27/05/2014 OVERVIEW ON DOSSIERS IN EFSA (update 27 27.05.2014) 05 2014) 41 dossiers received by EFSA: Number Outcome 23 S it bl Suitable 1 Opinion adopted 18 Under risk assessment phase 4 Additional data requested during the risk Status in EFSA Register of Question Finished In progress assessment Additional data request 10 Under suitability check Under consideration 8 Not suitable Waiting for full dossier Link to check the status of an application in the EFSA Register of Question: http://registerofquestions.efsa.europa.eu/roqFrontend/questionLoader?question=EFSA‐Q‐20xx‐xxxx Info Session on Applications - Technical meeting on Food Enzymes 27/05/2014 SUITABILITY CHECK (1) APDESK overview table Key d documents t to consult in order to prepare an application How to prepare and submit an application: li ti http://www.efsa.europa.eu/en/faq s/docs/apdeskhowtofoodadd.pdf Info Session on Applications - Technical meeting on Food Enzymes 27/05/2014 SUITABILITY CHECK (2) Administrative check Æ 9 name of the applicant 9 list of bibliographical references 9 confidential parts of the dossier Scientific check Æ 9 based on the following guidance documents: 1. Guidance 1 G id off the th Scientific S i tifi Panel P l off Food F d Contact C t t Material, Enzymes, Flavourings and Processing Aids (CEF) on the Submission of a Dossier on Food Enzymes for Safety Evaluation (EFSA-Q-2007-080) http://www.efsa.europa.eu/en/efsajournal/pub/1305.ht m 2. Explanatory Note for the Guidance of the Scientific Panel of Food Contact Material, Enzymes, Flavourings and Processing Aids (CEF) on the Submission of a Dossier on Food Enzymes (EFSA-Q2014-00183) http://www.efsa.europa.eu/en/supporting/doc/579e.pdf 3. Guidance on the risk assessment of genetically modified microorganisms and their products intended for food and feed use (EFSA-Q-2009-00521) http://www.efsa.europa.eu/en/efsajournal/pub/2193.ht m Info Session on Applications - Technical meeting on Food Enzymes 27/05/2014 SUITABILITY CHECK – POSITIVE ASPECTS ¾ ¾ ¾ ¾ Technical dossiers follow the structure of the EFSA guidance Administrative information well documented Bibliography provided Description of intended uses provided Info Session on Applications - Technical meeting on Food Enzymes 27/05/2014 NON SUITABILITY – MOST COMMON ISSUES IDENTIFIED (1) 1. Chemical composition i i Information to be provided in Technical h i l Dossier i 9 Batch-toB t h Batch variability Batch identification number C Consistent i t t iinformation f ti on th the chemical h i l composition between Certificates of Analysis/Annexes and main text Explanation of differences observed 9 Methods of analysis To be provided for parameters analysed (e.g. enzyme activity, ash, protein) 9 Significant side activities To be documented with experimental data, information on their inactivation to be provided Info Session on Applications - Technical meeting on Food Enzymes 27/05/2014 NON SUITABILITY – MOST COMMON ISSUES IDENTIFIED (2) 1. Chemical composition Information to be provided in Technical Dossier 9 Optimum pH/temperature conditions To be provided for main enzyme activity/ies 9 Amino acids sequence To be provided if feasible to determine together with info on potential allerginicity 9 Modification of the enzyme by protein engineering Rationale for the modification to be provided Info Session on Applications - Technical meeting on Food Enzymes 27/05/2014 NON SUITABILITY – MOST COMMON ISSUES IDENTIFIED (3) 2. Toxicological data Information to be provided in Technical Dossier 9 Conformity of tox batch The conformity of the tox batch to specification/chemical composition of food enzyme under evaluation and its representativeness p to be p provided 9 Compliance of tox studies with GLP (OECD, Directive 2004/10/EC) (Art. 5(7) of Regulation (EC) 234/2011) GLP/OECD compliance statement to be provided Info Session on Applications - Technical meeting on Food Enzymes 27/05/2014 NON SUITABILITY – MOST COMMON ISSUES IDENTIFIED (4) 3. Waiving of t tox data d t 9 Rationale for waiving tox data 4. Omission of any y information required by EFSA Guidance 9 Rationale for omission of any mandatory information Information to be provided in T h i l Dossier Technical D i Rationale in line with Regulation g ((EC)) No 562/2012 or EFSA Guidance document on food enzymes Information to be provided in Technical Dossier Scientifically sound and well elaborated justification for the omission to be provided Info Session on Applications - Technical meeting on Food Enzymes 27/05/2014 WEB FORM TO ASK A QUESTION www.efsa.europa.eu /it/applicationshelpd esk.htm Info Session on Applications - Technical meeting on Food Enzymes 27/05/2014 WEB FORM TO ASK A QUESTION Requests per scientific area (Nov 2011-Apr 2014) Nutrition, 152 160 Pesticides, 138 140 Animal by products Animal by‐products Food ingredients, 114 120 100 Feed additives Food contact materials, 103 Food contact materials Food ingredients Feed additives, 88 Food processing Genetic modification 80 Nutrition Food processing, 64 Other 60 Pesticides Genetic modification, 41 Decontamination Other, 33 40 NA Animal by‐products, 12 Animal by products, 12 20 Decontamination, 9 NA, 2 0 Info Session on Applications - Technical meeting on Food Enzymes 27/05/2014 WEB FORM TO ASK A QUESTION Requests q p per affiliation (Nov 2011-Apr 2014) NGO/consumer group, 6 Consultant, 157 Other, 77 Private citizen/consumer, 37 Not indicated, 18 Public authority, 39 Science/academia, 66 NGO/consumer group Other Private citizen/consumer Public authority Science/academia Industry I d t Industry, 356 Not indicated Consultant Info Session on Applications - Technical meeting on Food Enzymes 27/05/2014 APDESK 2012 2012--2018: INTERACTIONS WITH STAKEHOLDERS WHAT Identify and map stakeholders’ needs (survey) APDESK initiatives Monitor stakeholders’ satisfaction and customer oriented approach Analysis of the applicant’s profile’ (report) WHEN 2012 - 2013 2014-2018 Feb 2015 Report on stakeholders’ stakeholders needs http://www.efsa.eur opa.eu/en/supportin g/pub/482e.htm Internal mandate http://registerofquestion s.efsa.europa.eu/roqFron tend/questionLoader?que stion=EFSA-Q-2014Q 00250 (mandate M2014-0106) Internal mandate http://registerofquesti ons.efsa.europa.eu/roq Frontend/questionLoad er?question=EFSA-Q2013-00788 Info Session on Applications - Technical meeting on Food Enzymes 27/05/2014 SERVICES ALREADY AVAILABLE IN EFSA Web form Adoptiion of Scientific c Opinion Info Session on Applications Submis ssion of doss sier Web form Direct formal communication with applicants (letters) CC & RA Evaluation period Pre-submission Prenotification of outputs (24h) Post-adoption Time APDESK web section: - FAQs -How to prepare an application table bl -Application workflow Guidance documents: -ADMINISTRATI VE -SCIENTIFIC Application workflow with estimated deadline Register of Question update Plenary meetings Agendas & Minutes Rationale for reaching conclusions provided in scientific opinions Info Session on Applications - Technical meeting on Food Enzymes 27/05/2014 CUSTOMER ORIENTED APPROACH ¾Work on-going on going within the REPRO Department under EFSA mandate M-2014-0106: Development of a Customer oriented approach for regulated products (May 2013- Dec 2018) 1) Framework contract to monitor stakeholders’ satisfaction on services se ices provided p o ided by b EFSA 2)) EFSA Internal Task force composed p of HoUs of REPRO to analyze in-depth options for developing a customer oriented approach for regulated products ¾ E-submission of applications mandate M-2014-0076) (Matrix project, EFSA Info Session on Applications - Technical meeting on Food Enzymes 27/05/2014 Any questions? Get in contact with us through our web form! form http://www.efsa.europa.eu/en/applicationshelpdesk/askaquestion. htm?ScientificArea=zero Any information? Check out our web section! section http://www.efsa.europa.eu/en/applicationshelpdesk.htm GRAZIE
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