List of Substances of the Competent Federal

Government and Federal State AuthoritiesCategory: Plants and Plant Parts

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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

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Why was the list built?

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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“

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Working group

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Systematic approach

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Decision Tree

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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

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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

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Examples

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List A

Examples

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List B

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List C:

Examples

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Hitlist

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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

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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

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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)

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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

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Die Stoffliste im Internet

Deutsche Version:

www.bvl.bund.de/stoffliste_deu

Englische Version:

www.bvl.bund.de/stoffliste_eng

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Thank you for your kind attention