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April 2020

Summary of EFSA ad hoc Conference Call on Joint Dossiers held on 16 March 2020

On March 16, 2020, EFSA organized a meeting with AMFEP and the EU Commission in which the future of the Joint Dossiers (JD) on food enzymes was discussed (link). In accordance with paragraph 5 of Article 2 of Commission Implementing Regulation (EU) No 562/2012, 18 JDs have been submitted by AMFEP acting in the name of several companies allowing combined data and thus lowering the burden for food enzymes, which have been on the market since at least 1992.

In June last year, EFSA indicated that the dossiers cannot be evaluated in the submitted format and that company and strain specific (for microbial enzymes) data are required. The current meeting was held to discuss the practicalities around the submission of company specific data packages and to further clarify the data requirements for plant and animal derived enzymes.

Under the given circumstances, the meeting was a 3-hour telephone conference, which was held in good harmony.

EFSA clarified and confirmed that company specific data packages can be submitted under the existing EU Commission mandate of the current JDs. This will allow the enzymes to qualify for inclusion in the first positive list, providing that they pass the evaluation assessment. This is an important prerequisite for AMFEP as it allows the enzymes to continue to be marketed, and it is in line with Whereas (13) of Regulation (EC) No 1332/2008 to “not disturb the existing food enzyme market”. Each newly submitted data package will receive an EFSA question number which will lead to an individual EFSA opinion.

For the animal and plant derived enzymes, EFSA identified   some gaps and unclarities, e.g., on production processes, source of raw materials and biochemical data. Possibilities for waiving toxicological studies were discussed, and it is important to have data on the edibility of the source material and comparable exposure levels of the raw material and the enzyme derived from it. In many cases It is   not easy to provide this data for plant and animal derived enzymes which have been in use for a very long time, and it is possible that additional toxicity studies may need to be performed. As time did not allow an in-depth discussion, a further meeting is foreseen between EFSA and AMFEP regarding this topic.

The 18 JDs will result in ca. 100 new data packages that will come on top of the dossiers submitted before the deadline of March 2015 (300 dossiers) In addition, in the region of another. Around 250 dossiers are expected to be submitted in coming years for newly developed enzymes as well as for extensions of use. Moreover, the additional requirements, especially when including a full toxicological package, require unexpected investments and additional resources from industry, EFSA and the EU Commission. Therefore, AMFEP introduced the idea of a stepwise approach for submission and asked for enough time to prepare the data package. EFSA acknowledged the concern but could not at the time of the meeting propose any concrete solution. Further discussions with the EU Commission are needed to solve this issue.

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