The regulatory system

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• 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
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Royal decree on Plants facts
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• 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

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Royal decree on Plants facts
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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

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Royal decree on Plants facts
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• 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

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Royal decree on Plants scope
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• Applies to foods and supplements that contain
  plants

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

- In annex 3 lists
Apply to all food
List 1
List 2
Only applies to Food supplements
List 3
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Actualisation of the Decree text
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• foodstuffs in pre dosed form ? food
  supplements

• Art. 1 Definitions
• 1 Plants living organisms capable synthesize
  organic compounds from inorganic material by
  means of photosynthesis, the parasitic plants and
  the mushrooms

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
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Actualisation of the Decree text
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• 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

• 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

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Actualisation of the Decree text
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• Art. 4. 2.
• It is forbidden to manufacture and market food
  supplements consisting of or containing one or
  more plants that1 are not listed in list 2 and
  list 3 in annex to this decree or2 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
  

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Actualisation of the Decree text
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• 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 are mentioned in article
  7 2 of Royal Decree of 19 March 2004 relating
  to fruit juices, nectars, fruit juices and
  certain similar products

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Actualisation of the Decree text
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• 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.

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

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

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Actualisation of the lists maximum levels
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Brassica oleracea L. progoitrine 20 mg, goitrine 5 mg. batch/batch
Camellia sinensis (L.) Kuntze tannins expressed as EGCG 1600 mg. Only the use of these solvents are allowed water, alcohol with a maximum amount of 25.
Citrus aurantium L. No meta-synephrin Maximum para-synephrin 20 mg.
Vaccinium vitis-idaea L. Maximum dose equivalent to 6,8 g dried leaf
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Actualisation of the lists maximum levels
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Glycine max (L.) Merrill isoflavones exceeds 40 mg (expressed as glycoside of the main component).
Trifolium pratense L. isoflavones exceeds 40 mg (expressed as glycoside of the main component).
Pueraria lobata (Willd.) Ohwi isoflavones exceeds 40 mg (expressed as glycoside of the main component).
Salix alba L. Salicin 96 mg.
Salix fragilis L. Salicin 96 mg.
Salix pentandra L. Salicin 96 mg.
Salix purpurea L. Salicin 96 mg.
Zingiber officinale Roscoe Maximum dose equivalent to 5 g of dried rhizome
Also levels for Urtica urens, Valeriana
wallichii
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Actualisation of the lists limit undesired
substance
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Borago officinalis L. 1 µg/kg toxic pyrrolizidine alkaloids
Aphanizomenon flos-aquae (L.) Ralfs ex Bornet Flahault Possible contamination of marine toxins, especially micro-cystine, should be excluded for each batch.
Aleurites moluccana (L.) Willd. No phorbolesters eleostearine acid content lt 1.
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Actualisation of the lists mandatory warnings
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Brassica oleracea L. - For persons with hypothyroidism or thyroid treatment, consult your doctor
Citrus aurantium L. - Do not use during pregnancy or lactation Not for use by persons treated for hypertension - Not for use by children under 12 years If signs of anxiety or nervousness, stop taking the product
Vaccinium vitis-idaea L. - Do not use when pregnant or breastfeeding
Cyperus rotundus L. - Do not use during pregnancy or lactation
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Actualisation of the lists mandatory warnings
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Ocimum basilicum L. - Do not use below 12 years - No long-term use without professional advice
Polypodium leucatomos Poir. Not to be used by heart patients.
Calophyllum inophyllum L. This oil is not suitable for consumption by vulnerable groups, in particular children under 12 years, adolescents under 18, pregnant and lactating women.
Other warnings for Nigella sativa, Juniperus
communis, Tabebuia impetignosa, Valeriana
officinalis
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Contact

• For questions regarding legislation on
  Botanicals
• Joris.Geelen_at_health.belgium.be
• 322/524.73.82 or 0478 94 55 01
• www.health.belgium.be 
• gt Food safety gt Foodstuffs gt Food supplements