1. Food Safety and Regulatory Measures 2016
Regulatory measures needed on unintentional Allergen Presence
Dr. Sylvia Pfaff

2. Content
Setting the scene – why is regulation of unintentional allergen presence important?
Summary of German stakeholder conference November 2015
Tolerable reactions after allergen intake
Protection of Allergic consumers
Agreed action level for peanut and portion size
Gaps in research and analysis
Further steps and measurements of regulators
Fragen

3. Regulation of unintentional allergen presence
Allergic patients have a better basis to make their risk assessment in purchasing foods.
Regulators may judge better the actual risk for allergic consumers and issue only impor-tant food recalls.
is important because
Food Industry has a clear guidance how to improve their allergen management system and label products.
Test kit companies and laboratories can adjust their products better and deliver a better service.
Retailers have more confidence in the performance of the food industry and processes.

4. German Stakeholder Conference Nov 2015
EU Comm.
Research
Medicine
Allergic Consumer
Laboratories
Government
Food Retail
Authorities
Food Industry
Patient Organisation

5. Each table had a mix of stakeholders

6. Some impressions of the discussions

7. Tolerable reactions after allergen intake
Zero risk for everybody is impossible …
subjective reactions are tolerable
mild objective reactions restricted to skin or bowels (but not at the same time!) are tolerable
reactions which affects organs or need medical treatment have to be avoided in any case
Protection Level: (90%) / 95% and 99% (depends on the allergen and the knowledge we have)

8. Protection of Allergic Consumers
This was/is the most important issue in the discussion.
Often allergic consumers want to the highest protection level as possible (zero risk).
Medical practitioners want a threshold to separate very sensitive patients from others and give guidance to the majority.
Food Industry need a practical threshold which can be monitored by analysis. Protection level is important but has to be affordable as well.

9. Agreed action level for peanut and portion size
Scientific data are sufficient for peanut (even very sensitive patients are included).
Threshold of 10 ppm peanut was supported (equals 2.5 mg/kg peanut protein).
Compared to the VITAL 2.0 reference dose of 0.2 mg a portion size of 80 g is safe for 99% of the peanut allergic community.
We estimate that also 100 g portion size will be safe for 95% of the peanut allergic community.

10. Agreed action level for peanut and labelling
However,
the food industry has to take into account that the threshold only counts for homogenous unintentional allergen presence.
the food industry has to establish a thorough allergen manage-ment system with minimising measures and allergen analysis
should the food industry exceeds the threshold without any ability to reduce the allergen presence further, the labelling “May contain: peanut” should be used.
To express the concept the term „May contain traces of xy” should be reduced to "May contain xy". It can be much higher as the threshold and we want to give a warning.

11. Gaps in research and analysis
Reference materials are still missing to compare test kits and analytical methods.
There is no standardized validation of analytical methods.
There are still (scientific) data gaps for some allergens (Europe has the longest list of allergens).

12. Further steps and measurements of regulators
Labelling of the unintentional allergen presence of tree nuts should highlight the single nut. The purchase decision will be easier for the allergic consumer.
Labelling shall be based on 100 g portion. The allergic consumer has to be trained by medical practitioners and nutritional experts to understand his safe portion.
Regulators shall understand the risk determination in using the medical reference dose of the VITAL 2.0 concept to balance the food recalls (e.g. a food recall with ppm peanut in bread is nonsense).

13. Thanks very much for your attention... ... I am ready for questions.