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

Federal Public Service - Health, Food Chain Safety and Environment

20 April 2012 – NAREDI Legislation on Plant food supplements in Belgium

1 The regulatory system & legislation in Belgium

for food supplements with botanicals

FPS Health, Food Chain Safety and Environment

DG Animals, Plants and FoodSection Service Food, Feed & other consumption products

Update of the Decree on plants



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Royal decree on Plants : facts

- 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 2005maximum 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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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 of 29/08/1997concerning 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

List 1:

List 3:

Plants that may not be used in or as food.

Derogation possibilityEdible mushrooms

Plants - predosed form. To be notified.

(*) Maximum levels

List 2:

- In annex 3 lists:

- Applies to foods and supplements that contain plants



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Royal decree on Plants : scope

Apply to all foodList 1:

List 3:Only applies to Food supplements

List 2:

- In annex 3 lists:

- Applies to foods and supplements that contain plants



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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;

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;

• “foodstuffs in pre dosed form” “food supplements”



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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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• 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 …



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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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• 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 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

• Transposition of the advice of the Advisory commission- advice 2003 - 2008 = 100 advices+ 15 plants list 1, + 50 plants list 3, Warnings, Max. levels

www.ThePlantList.org !



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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)

Actualisation of the lists: past



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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)

Actualisation of the lists: present



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Actualisation of the lists: maximum levels

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%.

Brassica oleracea L.

progoitrine 20 mg, goitrine 5 mg. batch/batch

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

Glycine max (L.) Merrill

isoflavones exceeds 40 mg (expressed as glycoside of the main component).

Trifolium pratense L.

Pueraria lobata (Willd.) OhwiSalix alba L.

Salicin 96 mg.Salix fragilis L.

Salix pentandra L.

Salix purpurea L.

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

Aphanizomenon flos-aquae (L.) Ralfs ex Bornet & Flahault

Possible contamination of marine toxins, especially micro-cystine, should be excluded for each batch.

Borago officinalis L.

1 µg/kg toxic pyrrolizidine alkaloids

Aleurites moluccana (L.) Willd.

No phorbolesterseleostearine acid content < 1%.



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Actualisation of the lists: mandatory warnings

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

Brassica oleracea L.

- For persons with hypothyroidism or thyroid treatment, consult your doctor

Cyperus rotundus L.

- Do not use during pregnancy or lactation



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Actualisation of the lists: mandatory warnings

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.

Ocimum basilicum L.

- Do not use below 12 years - No long-term use without professional advice

Other warnings for: Nigella sativa, Juniperus communis,

Tabebuia impetignosa, Valeriana officinalis



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For questions regarding legislation on Botanicals:

[email protected]

+322/524.73.82 or 0478 94 55 01

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

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