Post on 26-Dec-2015
List of Substances of the Competent Federal
Government and Federal State AuthoritiesCategory: Plants and Plant Parts
32nd FLEP-Meeting Berlin 209. Februar 2015
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
32nd FLEP-Meeting Berlin 309. Februar 2015
Why was the list built?
32nd FLEP-Meeting Berlin 409. Februar 2015
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“
32nd FLEP-Meeting Berlin 509. Februar 2015
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“
32nd FLEP-Meeting Berlin 609. Februar 2015
Working group
32nd FLEP-Meeting Berlin 709. Februar 2015
Systematic approach
32nd FLEP-Meeting Berlin 809. Februar 2015
Decision Tree
32nd FLEP-Meeting Berlin 909. Februar 2015
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
32nd FLEP-Meeting Berlin 1009. Februar 2015
Classification
Further possible categorisations
No List(traditional)medicinalproduct
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
32nd FLEP-Meeting Berlin 1109. Februar 2015
Examples
32nd FLEP-Meeting Berlin 1209. Februar 2015
List A
Examples
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List B
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List C:
Examples
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Hitlist
32nd FLEP-Meeting Berlin 1609. Februar 2015
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 foodArt. 8 is not applicable
32nd FLEP-Meeting Berlin 1709. Februar 2015
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
32nd FLEP-Meeting Berlin 1809. Februar 2015
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)
32nd FLEP-Meeting Berlin 1909. Februar 2015
DE BELFRIT
BE FR IT AT BG CZ DK HU LT NL SE SK UK
Legally binding
X X X X X ? ? X X
Notified X X X ? X X X ? X
Positive list X X X X X X X X X
Negative list X X X X X X X X X
Food Supplements
X X X X X X X X X
Tea/ spices X X X X
All food X X X X X X X X
Borderline issues
X X
Comparison with lists from other Member States
32nd FLEP-Meeting Berlin 2009. Februar 2015
Die Stoffliste im Internet
Deutsche Version:
www.bvl.bund.de/stoffliste_deu
Englische Version:
www.bvl.bund.de/stoffliste_eng
32nd FLEP-Meeting Berlin 2109. Februar 2015
Thank you for your kind attention