Ad hoc meeting with industry association (AMFEP) · 2020-03-18 · Ad hoc meeting with industry...
Transcript of Ad hoc meeting with industry association (AMFEP) · 2020-03-18 · Ad hoc meeting with industry...
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Ad hoc meeting with
industry association
(AMFEP)Joint Dossiers on Food Enzymes
AMFEP input
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Topics
• Communication between EFSA and data holders
• Scientific gaps & Time frames
• EFSA opinions
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AMFEP’s main goal
Ensure that market is not disrupted and all the enzymes appear on the first positive list
• Keep the framework of the joint dossier
• Company specific data submission
To achieve this goal, resubmissions need to be done in atimeframe that is considered acceptable and feasible byEFSA/COM/Industry
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Communication between EFSA and data holders
• AMFEP will ensure that all relevant information is shared with all JD members
– Information from EFSA 16th March meeting
– Supportive documents smoothening the data gathering and data submission for JD members
– Any other relevant information
• Not all JD members are AMFEP members
• For each JD, AMFEP will provide an updated list of contacts
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• New submissions (microbial):
– full dossier with all generic or incomplete elements replaced with company-specific data
• Proposal AMFEP:
– Submission of company specific dossier directly to EFSA and not via AMFEP
– Further communication on the company specific dossier between EFSA and individual companies
• Will EFSA formally communicate on dossiers’ specific gaps?
Communication between EFSA and data holders
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Dossiers members will inform AMFEP, EFSA and EU Commission as soon as possible
Reasons could be : ‒ No longer interested in the specific enzymes for any reason (e.g. no
longer producing)
‒ No data available
‒ Merging of companies
Withdrawal from JD
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Timing
Analysis of scientific gaps & impact on submission timeline
Based on 3 main criteria
Study Time Resources Costs Total impact
pH curve x x x 1
CoA x x x 1
Allergenicity x xx x 2
Exposure ? x 2
QPS qualification xx x xx 2
DNA xx x xxx 3
WGS xx xxx xx 3
Tox studies xxx xx xxxx 4
?: will depend on the availability of FEIM models
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One example : the tox studies Current estimation:• 40-45 new toxicity studies to be conducted
• (for 56 new data packages – see next slide)
Challenges• Limited number of CROs can perform toxicity studies for food enzymes
• GLP analyses: transfer and validation enzyme essay time consuming
• Additional burden on top of compiling data on post 2015 and new enzymes
• Unexpected costs on especially low margin products
• Allow time to budget and spread costs
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Timing (cont.)
No. of joint dossiers Estimated no. of data packages
11 JD without tox requirements
65• 24 of non-microbial origin • 41 QPS micro-organisms
7 JD with tox requirements 56
Total number of company specific data package
121
Current estimation of expected number of new data packages • based on the number of JD and number of members in each JD
Fine tuning :
Possible withdrawals (Non-manufacturers, company strategy, burden…)
One company member of a JD can have several strains expressing the same enzyme (would lead to several new data pack/member)
This will come in addition to :• the currently evaluated dossiers• the new dossiers and extensions of use that will be
submitted
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JD – submission of company specific data packages
Timing (cont.)AMFEP proposal : Step-wise submission schedule, based on impact
• Responsibility of achieving (agreed) timelines lays with the individual companies.
• AMFEP will do everything in its power to facilitate timely submissions, but cannot give commitment on achieving timelines by individual companies.
Dossiers already submitted by 2015 DL
New dossiers / extension of use
Non-microbialorigin
1
24
QPS MO
2
41
Non-QPS MO
3
56
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Papain
• Produced from papaya (Carica papaya)- a fruit consumed throughout the world
• Papain is produced from the latex obtained from the green fruit as these contain high levels of papain
• Papaya latex has a long history of use including both food and pharma applications, a simple extraction process is used to obtain the pure commercial papain preparation from the latex
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Papain
• Clarification is needed of EFSA requirements
• Industry suggests
– Providing references showing the use of green papaya and papaya latex in food and pharma products
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EFSA opinions
• Given the fact that strain specific data are being submitted, how will this be reflected in the EFSA opinion?
• Due to the use of state of the art taxonomic identification techniques, differences in taxonomy will appear. How will EFSA deal with that?
• Timing: how will different timing by companies to submit additional information during the dossier evaluation impact the finalization of the opinions?
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Thank you for your attention!