RegulatoryManagement of Plant Products fileReferat 101-Grundsatzangelegenheiten, Lebensmittel 05....

Regulatory Management of Plant

Products

Florian Riedel

05. Oktober 2015 Seite 2BRAMA - Regulations on Botanicals

This presentation reflects the personal opinion of the author. It

is not an official statement of German authorities.

05. Oktober 2015BRAMA - Regulations on Botanicals Seite 3

• Plants and plant parts are an important part of a healthy and

balanced diet

• Traditional use:

- fruits, vegetables

- spices, herbs, tea

• „Modern“ use:

- food supplements

- Novel food

- FSMP

Plant use as food


• Borderline products:

• Unknown plants:

Food Supplement Medicinal product

e. g. Salvia hispanica, Argania spinosa

Challenges for law enforcers


• Herbs with possible health concerns:

• Psychoactive plants:

e.g.

• Digitalis purpurea

• Piper methysticum

Challenges for law enforcers

e.g.

• Datura stramonium

• Salvia divinorum

05. Oktober 2015 Seite 6

Legal basis

• no authorisation of food (ingredients) necessary (exemptions possible, e.g. novel

food)

• no specific regulations for the use of plants as food (ingredients)

• no lists with allowed or forbidden plants in European Food Law (exemption:

Ephedra spp. and Pausinystalia yohimbe)

But: General food law is applicable

Plant use as food

BRAMA- Regulations on Botanicals Seite 6


FoodReg. (EC) No

178/2002

General Food Law

Reg. (EC) No. 1925/2006

Fortification Law

Dir. 2002/46/EC Food Supplements

Reg (EC) No. 258/97

Novel Food

Reg. (EC) No. 1334/2008

Flavourings

Additives, Labelling, Hygiene, Residues,

Contaminants, Pesticides, Residual solvents, Irradiation

Medicinal products

Narcotic or psycotropicsubstances

Legal framework


Article 2: Definition of „food“

Any substance or product, whether processed, partially processed or

unprocessed, intended to be, or reasonably expected to be ingested by

humans

Food shall not include

• Medicinal products

• Narcotic or psychotropic substances

→ basically no authorisation required

→ Exemptions: Novel Food, Flavouring extracts of plants if the plants are not

food themselves

Regulation (EC) No. 178/2002

Basis Regulation

05. Oktober 2015 Seite 9Referat 101- Grundsatzangelegenheiten, Lebensmittel

Article 2:

other substance means a substance other than a vitamin or a mineral that has a nutritional or physiological effect

→ Plants/ Plant preparations

Article 8:

If addition of other substances results in greatly higher amounts than expected under normal conditions of consumption and/or would otherwise represent a potential risk to consumers:

• Prohibition (Annex III, Part A)

• Restrictions (Annex III, Part B)

• Scrutiny (Annex III, Part C)


Addition of plants to food

BRAMA - Regulations on Botanicals Seite 9


• 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

Hitlist Germany


Ephedra spp. and Yohimbe

Germany

• Request: Ephedra spp. and Pausinystaliayohimbe on Annex III part A

European Commission

• Mandate toEFSA for RiskAssessment

EFSA

• Ephedra: significant safety concern

• Yohimbe: Characterisationnot adequate, no conclusionpossible

European Commission

• COM Reg. No. 2015/403

• Ephedra: Part A

• Yohimbe: Part C



Novel Food

Article 1, Definition:

Plants are Novel Food, if they:

• have not hitherto been used for human consumption to a significant degree within the Community

→ Hitherto = 15th May 1997

and if:

• consisting of or isolated from plants, except when obtained by traditional propagating or breeding practices and having a history of safe food use

→ Plant preparations of plants which are not novel, may be novel anyway!


Perspectives on Novel Food –

Revision of Regulation

Facilitated procedure for plants from third countries:

“history of safe food use in a third country"

• Derived from primary production

• safety of the food in question has been confirmed with compositional data

• experience of continued use for at least 25 years in the customary diet of a significant

number of people in at least one third country

→ No authorisation but notification

→ NoBficaBon procedure shall be finished in about 6 months

Foods used exclusively in Food Supplements in the Union before 15th May 1997

• Official status “not Novel in Food supplements”

→ NaBonal lists of Member States on the use of food supplements may become more

important


Article 2, Definitions:

• Any substance or combination of substances presented as having properties for treating or preventing disease in human beings

• → Medicinal product by presentation

• Any substance or combination of substances which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis.

• → Medicinal product by function

Directive No. 2001/83/EC

Medicinal Products



Borderline products

Jurisdiction

C 319/05 (CJEU)

• National authorities must decide case-by-case if a product is a medicinal product

• Harmonization is not complete, differences in the classification of products between Member States are not avoidable

• For classification as a Medicinal Product a significant effect is needed

• No significant effect, if effect on physiological functions is no more than the effect of a foodstuff consumed in a reasonable quantity

• Risk to health of a product is an autonomous factor

→ Different classification by Member States is possible

→ Effect has to be significant


Single convention on Narcotic drugs, 1961:

• No definiton of “narcotic”

• Narcotic drugs are substances which are listed in schedule I or II of the convention

• → Plants: Cannabis, Coca, Papaver

Convention on Psychotropic Substances, 1971:

• No definition of “psychotropic

• Psychotropic substances are substances listed in schedule I-IV of the convention

• → no plants, but substances thereof e.g. Cathinone, Mescaline

Narcotic drugs

Psychotropic substances


05. Oktober 2015BRAMA - Regulations on Botanicals 17

Decision Tree

05. Oktober 201518. Dezember 2013 Seite 18Referat 101- Grundsatzangelegenheiten, Lebensmittel

Example: Aloe

Knowing the plant part may be important…

Gel

Juice

Gel

Juice



HMPC – Monograph


05. Oktober 2015 Seite 20BRAMA - Regulations on Botanicals Seite 20Referat 101- Grundsatzangelegenheiten, Lebensmittel

EFSA Compendium

Compendium of botanicals reported to contain natura lly occuring substances of possible concern for human health whe n used in food and food supplements

Substances of possible concern

Only in Juice of Aloe spp..


Summary

• No specific regulations on plants in Europe

• Plants may be used without authorization as (food) ingredient if they comply with European food legislation

• Exemptions: Novel Food, Flavour preparations

• Medicinal products are no foods, but plants may be used whether as food or medicinal product. This may depend on dosage or claiming of the product

• Narcotic drugs and psychotropic substances are no food. Member States may regulate further narcotic or psychotropic substances on national level.

• Accurate knowledge on used plant part and preparation is necessary for suitable regulatory management


Thank you for your attention

Seite 22

Kontakt:Florian RiedelMauerstraße 39 – 4210117 BerlinE-Mail: [email protected]: +49 30 18 444 10119

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