Patrizia Restani PlantLIBRA coordinator Dip. Scienze Farmacologiche e Biomolecolari Università degli Studi di Milano

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1 General information on the EU FP7 Project PlantLIBRA (Plant Food Supplements Levels of Intake, Benefit and Risk Assessment), and analytical identification of substances of concerns Patrizia Restani PlantLIBRA coordinator Dip. Scienze Farmacologiche e Biomolecolari Università degli Studi di Milano

2 PlantLIBRA partners

3 BE-4 FI-2 UK-4 NL-2 D-1 AU-2 CH-1 RO EUROPEAN PARTNERS FROM 10 COUNTRIES IT- 4 ES-1

4 4 ICPC Partners 20+1 EUROPEAN PARTNERS FROM 10 COUNTRIES Argentina Buenos Aires Brasil San Paulo South Africa Pretoria China Beijing

5 Operatori del settore (WP9)! Consumatori! (WP8) Data base (WP6) Contributo all aggiornamento del Compendium (EFSA) Diffusione dei risultati in Europa e nei paesi extra-eu produttori di materia prima Consumatori (WP9) Stakeholders WP9 Aspetti normativi (WP10) Valutazione Rischio/Beneficio (WP5) Definizione del consumo di PFS in Europa con indagine in 6 paesi (WP1) Metodi (WP7) Benefici: WP2 1. Letteratura scientifica 2. Alcuni studi clinici! " #$%&!' #!( #)* %&!( &+!,&!-. ),#!$#! +#%#&* &!. %#,&!. * )!/),. %)0#1* &! ' &,!+#$23#145&* &6#2#1!7!,#$%&! #* #0#),#! 8)+%* &+$!#* %&9+)* 1!,)!,#$%)!' #! ( #)* %&!' )!21* $#' &+)+&!#*!5)$&! )#!+#$.,%)%#!' #!: 8;! Rischi: WP3 and WP4 1. Letteratura scientifica 2. Dati da studi in vitro 3. Centri antiveleno

6 META DATABASE Project: development and application according to WPs necessity EXPECTED RESULTS Uploading data on PFS: - Composition - Botanical aspects - Benefits - Toxicological aspects - Adverse effects in humans - Methods of analysis (published and newly developed) Evaluators: recruitment and training

7 eplantlibra Database

8 Adverse effects-database

9 Quality is synonymous of safety T h e q u a l i t y c o n t r o l m u s t v e r i f y t h e a b s e n c e o f c o n t a m i n a n t s a n d o f u n w a n t e d / i l l i c i t s u b s t a n c e s T h e c o n s u m e r s s a f e t y m u s t b e g a r a n t e e d b y b o t h p r o d u c e r s a n d p u b l i c l a b o r a t o r i e s ( A s o r t o f a quality p o s t m a r k e t i n g S u r v e i l l a n c e )

10 Contaminants in PFS Misidentification (use of fingerprint and other analytical strategies) Presence of natural contaminants (mycotoxins) Environmental contaminants (heavy metals, PCB, etc.) Presence of unwanted contaminant from botanical origin (active amines, other regulated compounds) Illicit additions

11 PFS at risk for the presence of critical substances PFS FOR BODY WEIGHT CONTROL PFS FOR SPORT

12 A natural PFS for body-weight control

13 Too active!!! The activity of the product was too significant for a natural product People using this product showed a sort of addition The presence of an illicit addition was suspected

14 HPLC chromatograms of active amines E S HPLC chromatogram of ephedrine and sinephrine??? HPLC chromatogram of PFS

15 Relative Abundance Direct infusion electrospray ionization mass spectra of sample leisure slimming coffee_28-12# RT: AV: 290 NL: 5.85E5 F: + c ESI Full ms [ ] m/z

16 Searching for molecular weight.

17 Direct infusion electrospray ionization mass spectra of standard sibutramine

18 ...collaborating with police

19 A mixture of capsules found in a gym without any kind of indication

20 Fast methods for fast screening!!! HPTLC

21 HPTLC of active amines from Citrus and Ephedra spp. SN O S1 S2 P E N S O S1 S2 P E N SN= sinephrine O=octopamine S= sample P=pseudo-ephedrine E=ephedrine N=nor-ephedrine

22 Ephedrine presence confirmed by mass spectrometry Relative Abundance Reperto 2 cpr bianca piccola #1 RT: 0.01 AV: 1 NL: 1.65E5 T: + c ESI Full ms [ ] m/z Molecular Ion at m/z 166 associated with ephedrine in the sample

23 Conclusions Quality control cannot be limited to production The safety of consumers must be guaranteed by control of the products on the market It is important to organize a network of laboratories sharing and coordinating their expertise in this specific field All efforts must be coordinated for ensuring the consumers safety

24 Website

25 Partners...at kick off meeting June 2010 Picture by Gary Williamson...

26 Thank you for the kind attention and please look at