1. List of Substances of the Competent Federal Government and Federal State Authorities Category: Plants and Plant Parts

2. 09. Februar 2015 32nd FLEP-Meeting Berlin2 What is the List of Substances? Collection of about 590 plants and parts thereof Categorisation of plants in view of use as food (ingredient) helpful tool concerning assessement of borderline products collection of information concerning risks of plants not legally binding Subject to updating

3. 09. Februar 2015 32nd FLEP-Meeting Berlin3 Why was the list built?

4. 09. Februar 2015 32nd FLEP-Meeting Berlin4 Initial mandate 2004 Meeting 2004: Ministry Federal States Authorities „…BVL shall create a list of substances that should be included in Annex III of Regulation (EC) No. 1925/2006“

5. 09. Februar 2015 32nd FLEP-Meeting Berlin5 Second mandate 2008 „…BVL shall finalize the list with helpful information for authorities“ Ministry AND „…extract a „Hitlist“ containing substances with concern when used in food supplements or fortified food“

6. 09. Februar 2015 32nd FLEP-Meeting Berlin6 Working group

7. 09. Februar 2015 32nd FLEP-Meeting Berlin7 Systematic approach

8. 09. Februar 2015 32nd FLEP-Meeting Berlin8 Decision Tree

9. 09. Februar 2015 32nd FLEP-Meeting Berlin9 Classification Sub-lists (referring to Annex III of Reg (EU) NO 1925/2006) List A List C Limited use as food/ food ingredient recommended Final assessment not possible because of missing data Use as food / food ingredient is not recommended List B

10. 09. Februar 2015 32nd FLEP-Meeting Berlin10 Classification Further possible categorisations No List (traditional) medicinal product Status of novelty in terms of Regulation (EC) No. 258/97 Use may be restricted because of pharmacological effect Use without recommended restriction NF/ not NFS

11. 09. Februar 2015 32nd FLEP-Meeting Berlin11 Examples

12. 09. Februar 2015 32nd FLEP-Meeting Berlin12 List A Examples

13. 09. Februar 2015 32nd FLEP-Meeting Berlin13 List B

14. 09. Februar 2015 32nd FLEP-Meeting Berlin14 List C: Examples

15. 09. Februar 2015 32nd FLEP-Meeting Berlin15 Hitlist

16. 09. Februar 2015 32nd FLEP-Meeting Berlin16 Hitlist Aconitum spp. Aristolochia spp. Brugmansia/ Datura spp. Catha edulis Digitalis spp. Dryopteris filix-mas Ephedra spp. Pausinystalia yohimbe Rauvolvia serpentina Salvia divinorum COM: 8 Plants are not used in food Art. 8 is not applicable

17. 09. Februar 2015 32nd FLEP-Meeting Berlin17 Ephedra spp: EFSA: Ephedra herb and its preparations containing ephedra alkaloids used as food supplements were of significant safety concern at the estimated use levels COM: Annex III Part A of Reg. (EC) No. 1925/2006 Prohibited substance

18. 09. Februar 2015 32nd FLEP-Meeting Berlin18 Pausinystalia yohimbe: EFSA: ADI cannot be derived because of missing data theoretical maximum daily intake may exceed the maximum approved daily dose of yohimbine from use as a medicinal product COM: Annex III Part C of Reg. (EC) No. 1925/2006 Substance under community scrutiny (4 years, national provisions applicable)

19. 09. Februar 2015 32nd FLEP-Meeting Berlin19 DEBEL FRIT BEFRITATBGCZDKHULTNLSESKUK Legally binding XXXXX??XX NotifiedXXX?XXX?X Positive listXXXXXXXXX Negative listXXXXXXXXX Food Supplements XXXXXXXXX Tea/ spicesXXXX All foodXXXXXXXX Borderline issues XX Comparison with lists from other Member States

20. 09. Februar 2015 32nd FLEP-Meeting Berlin20 Die Stoffliste im Internet Deutsche Version: www.bvl.bund.de/stoffliste_deu Englische Version: www.bvl.bund.de/stoffliste_eng

21. 09. Februar 2015 32nd FLEP-Meeting Berlin21 Thank you for your kind attention