The regulatory system & legislation in Belgium for food supplements with botanicals

The regulatory system & legislation in Belgium for food supplements with botanicals Update of the Decree on plants FPS Health, Food Chain Safety and Environment DG Animals, Plants and FoodSection Service Food, Feed & other consumption products

Royal decree on Plants : facts 2 • 1st publication in Belgian Official Journal 21/11/’97 • 9 decrees with adaptations ’99 - ’08 • Transposition of Directive 2002/46/EC May 2003 • Conditions of use, specific warnings and March 2005 • maximum levels for ~27 plants • Amending decree notified - EU COM – TRIS April 2010 • Justification warnings - COM  + advice July 2011 • Nat. procedure – Council of State + advice Dec 2011 • Nat. procedure - signature 19/03/12 March 2012 •  Publication Official Journal 4/4/2012

Royal decree on Plants : facts 3 Justification mandatory warnings • Based on scientific evaluation of Advisory commission • Case-by-case assessment to ensure a high but proportional level of consumer protection and information • potentially adverse effects identified, • available scientific data (+ EFSA Compendium), • the extent of scientific uncertainty evaluated • Measures take into account precautionary principle • consistent with previous measures

Royal decree on Plants : facts 4 • Royal decree of 29/08/1997 • concerning production and commercialization of • food composed of or containing plants or plant preparations • Defines: • - Lists of forbidden and authorized plants • - Notification requirements • Requirements labeling & advertising • Advisory Commission on Plant preparations

Applies to foods and supplements that contain plants Royal decree on Plants : scope 5 • - In annex 3 lists: • List 1: • Plants that may not be used in or as food. •  Derogation possibility • List 2: • Edible mushrooms • List 3: • Plants - predosed form. To be notified. • (*) Maximum levels

Applies to foods and supplements that contain plants Royal decree on Plants : scope 6 • - In annex 3 lists: • List 1: Apply to all food • List 2: Onlyapplies to Food supplements • List 3:

Actualisation of the Decree: text Art. 1 – Definitions: 1° Plants: living organisms capable synthesize organic compounds from inorganic material by means of photosynthesis, the parasitic plants and the mushrooms; 7 • “foodstuffs in pre dosed form”  “food supplements” • 8° Food supplements: foodstuffs the purpose of which is to supplement the normal diet and • which are concentrated sources of nutrients or other substances with a nutritional or physiological effect;

Actualisation of the Decree: text Art. 4. § 1. It is forbidden to manufacture and market foodstuff in pre dosed form, consisting of or containing one or more plants that are listed in list 2 and list 3 in annex to this decree if no prior notification to the Service was done 8 • Art. 4. § 1. • It is forbidden to manufacture and market food supplements, consisting of or containing one or more plants or plant parts that are listed in list 2 and list 3 in annex to this decree if no prior notification to the Service was done

Actualisation of the Decree: text 9 • Art. 4. § 2. • It is forbidden to manufacture and market food supplements consisting of or containing one or more plants that:1° are not listed in list 2 and list 3 in annex to this decree or;2° listed in list 2 and list 3 in annex to this decree but for which the limitations and conditions were not met, • if no prior notification to the Service was done …

Actualisation of the Decree: text 10 • Art. 4. § 5. ( Notification not required for:) • 3° … plant preparations in concentrated or dehydrated form that serve for the manufacturing of soft drinks, fruit juices and vegetable juices and of which the species arementioned in article 7 § 2 of Royal Decree of 19 March 2004 relating to fruit juices, nectars, fruit juices and certain similar products;

Actualisation of the Decree: text 11 • Art. 8. • Infringements of this decree are detected, identified and prosecuted under the royal decree of 22 February 2001 on the organization of the controls carried out by the Federal Agency for the Safety of the Food chain • and punished according to the aforementioned law of 24 January 1977.

Actualisation of the Decree: lists • Transposition of the advice of the Advisory commission • - advice 2003 - 2008 = 100 advices • + 15 plants list 1, + 50 plants list 3, Warnings, Max. levels • Transposition of the advice of Working Group ‘Plant parts’ • - Plants list 3 save & traditionally used parts mentioned • * New plants parts not forbidden but safety evaluation needed! • Genera of list 3 replaced by specific species • - Novel Food also works species specific (e.g. Salvia spp.) • Check of the nomenclature of all plants • - cooperation with experts of National Botanical garden •  www.ThePlantList.org !

Actualisation of the lists: past 13 • List 3: genus or species (~570) •  plant parts (62) •  mandatory warnings (19) •  limited substances (12): PA, AA, estragol… •  maximum levels AI (27)

Actualisation of the lists: present 14 • List 3: only species (~650) •  plant parts (all plants) • +11  mandatory warnings (30) • +4  limited substances (16): meta-synephrine • +13  maximum levels AI (40)

Actualisation of the lists: maximum levels 15

Actualisation of the lists: maximum levels 16 Also levels for : Urtica urens, Valeriana wallichii

Actualisation of the lists: limit undesired substance 17

Actualisation of the lists: mandatory warnings 18

Actualisation of the lists: mandatory warnings 19 Other warnings for: Nigella sativa, Juniperus communis, Tabebuia impetignosa, Valeriana officinalis

Contact • For questions regarding legislation on Botanicals: • Joris.Geelen@health.belgium.be • +322/524.73.82 or 0478 94 55 01 • www.health.belgium.be • > Food safety > Foodstuffs > Food supplements

The regulatory system & legislation in Belgium for food supplements with botanicals