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VDMj CONSEILREGULATORY CONSULTING & LICENSING

NUTRACEUTICALS – PARNUTS - HERBAL MEDICINESJacques VANDERMANDER

Pharmacist

NUTRACEUTICALS

UPDATE OF E.U. REGULATION IN 2011

European Health Care 2/23/2011

Rome, Italy

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SUMMARY

I Food supplements status versus fortified foods, Parnuts and oral medical devices

II Active ingredients regulations: vitamins and minerals, nutritional substances and botanicals

III Claims

III Notification process in Europe for food supplements

IV Additives regulation

V Contaminants

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I Food supplements status versus fortified foods, Parnuts and oral medical devices

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I Food supplements status versus fortified foods, Parnuts and oral medical devices

Definitions

FOOD SUPPLEMENTS: Directive 2002/46

(a) ‘food supplements’ means 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, alone or in combination, marketed in dose form, namely forms such as capsules, pastilles, tablets, pills and other similarforms, sachets of powder, ampoules of liquids, drop dispensing bottles, and other similar forms of liquids and powders designed to be taken in measured small unit quantities;

Dosage form similar to medicinesConcentrated

Nutritional or physiological effect

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I Food supplements status versus fortified foods, Parnuts and oral

medical devices

Definitions

FORTIFIED FOODS: Regulation 1925/2006

1. This Regulation harmonises the provisions laid down by law,regulation or administrative action in Member States which relate tothe addition of vitamins and minerals and of certain other substancesto foods, with the purpose of ensuring the effective functioning of the internal

market, whilst providing a high level of consumer protection. (a)

Food presentationNot concentratedNutritional effect

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I Food supplements status versus fortified foods, Parnuts and oral medical devices

Definitions

PARNUTS: Directive 2009/39 2. Foodstuffs for particular nutritional uses are foodstuffs which, owing to their special composition or manufacturing process, are clearly distinguishable from foodstuffs for normal consumption, which are suitable for their claimed nutritional purposes and which are marketed in such a way as to indicate such suitability. 3. A particular nutritional use shall fulfil the particular nutritional requirements: (a) of certain categories of persons whose digestive processes or metabolism are disturbed(b) of certain categories of persons who are in a special physiological condition and who are therefore able to obtain special benefit from controlled consumption of certain substances in foodstuffs(c) of infants or young children in good health.

Food presentationConcentrated or not concentrated

Nutritional effect but may be used for pathologies (Type I diabete)

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I Food supplements status versus fortified foods, Parnuts and oral medical devices

Definitions

ORAL MEDICAL DEVICE: Directive 93/42

‘medical device’ means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes andnecessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of: — diagnosis, prevention, monitoring, treatment or alleviation of disease,— diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,— investigation, replacement or modification of the anatomy or of a physiological process,— control of conception, and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means

Oral form not excludedMain action should not be pharmacologic or metabolic

Intended for pathologies

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II Active ingredients regulations:vitamins and mineralsnutritional substances

botanicals

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Substances Botanicals

Vitamins et

Minerals

Directive Européenne2002/46

Directive 2002/46

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Regulation 1924/2006Health claims art. 13---------------------------------------------------

Positive national lists + Traditional use

Mutual recognition

novel foods registration

Regulation 1170/2009

Directive 2008/100

E.U. regulations for food supplementsVDM j CONSEIL document

February 2011

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II Active ingredients regulations:

Vitamins and minerals

Sources are harmonized

RDA are harmonized

Maximum daily doses are not yet harmonized: major problem!!

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II Active ingredients regulations:

Nutritional substances

Substances and maximum daily doses are not harmonized: major problem!!

Positive lists in some EU countries useful for mutual recognition procedure

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II Active ingredients regulations:

Botanicals

Plants, plant parts, extraction process and maximum daily doses are not harmonized: major problem!!

Green tea leaves are:Food in all EU for teaFood supplements in all EU, but depending on extract process (dried leaves, aqueous extract, other extracts)Medicine in some EU countries

Positive lists in some EU countries useful for mutual recognition procedure.

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II Active ingredients regulations:

Novel foods: Regulation 258/97

Article 11. This Regulation concerns the placing on the market within the Community of novel foods or novel food ingredients.

2. This Regulation shall apply to the placing on the market within the Community of foods and food ingredients which have not hitherto been used for human consumption to a significant degree within the Community and which fall under the following categories:

(c) foods and food ingredients with a new or intentionally modified primary molecular structure;

(d) foods and food ingredients consisting of or isolated from microorganisms, fungi or algae;

(e) foods and food ingredients consisting of or isolated from plants and food ingredients isolated from animals, except for foods and food ingredients obtained by traditional propagating or breeding practices and having a history of safe food use;

(f) foods and food ingredients to which has been applied a production process not currently used, where that process gives rise to significant changes in the composition or structure of the foods or food ingredients which affect their nutritional value, metabolism or level of undesirable substances.

3. Where necessary, it may be determined in accordance with the procedure laid down in Article 13(2) whether a type of food or food ingredient falls within the scope of paragraph 2 of this Article.

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-II Active ingredients regulations: Novel foods: Regulation 258/97

1) Same rational as US rule for ingredients grandfathered under DSHEA (Dietary Supplement Health and Educational Act) in 1994:

>> all ingredient, including botanicals, sold in EU as food (supplements) ingredients before 1997 should not be classified as « novel foods »

>> issue of extraction process….

2) This European Regulation is a strong restriction to introduction of any non-EU botanical. Novel food dossier is extremely expensive (toxicology)

However, there is an emerging idea that traditional use in non-EU countries should be taken into account.

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III Health claims

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II Health claims

Regulation 1924/2006 lays down regulation on claims made on « foods ».

1. This Regulation harmonises the provisions laid down by law, regulation or administrative action in Member States which relate to nutrition and health claims in order to ensure the effective functioning of the internal market whilst providing a high level of consumer protection.

2. This Regulation shall apply to nutrition and health claims made in commercial communications, whether in the labelling, presentation or advertising of foods to be delivered as such to the final consumer.

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II Health claimsRegulation 1924/2006

Article 13Health claims other than those referring to the reduction of disease risk

and to children's development and health1. Health claims describing or referring to:(a) the role of a nutrient or other substance in growth, development and

the functions of the body; or

(b) psychological and behavioural functions; or

(c) without prejudice to Directive 96/8/EC, slimming or weight-control or a reduction in the sense of hunger or an increase in the sense of satiety or to the reduction of the available energy from the diet,

which are indicated in the list provided for in paragraph 3 may be made without undergoing the procedures laid down in Articles 15 to 19, if they are:

(i) based on generally accepted scientific evidence; and(ii) well understood by the average consumer.

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II Health claimsRegulation 1924/2006Article 132. Member States shall provide the Commission with lists of claims as referred to in paragraph 1 by 31 January 2008 at the latest accompanied by the conditions applying to them and by references to the relevant scientific justification.

3. After consulting the Authority, the Commission shall adopt, in accordance with the regulatory procedure with scrutiny referred to in Article 25(3), a Community list, designed to amend non-essential elements of this Regulation by supplementing it, of permitted claims as referred to in paragraph 1 and all necessary conditions for the use of these claims by 31 January 2010 at the latest.

5. Any additions of claims to the list referred to in paragraph 3 based on newly developed scientific evidence and/or which include a request for the protection of proprietary data shall be adopted following the procedure laid down in Article 18, except claims referring to children's development and health, which shall be authorised in accordance with the procedure laid down in Articles 15, 16, 17 and 19

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II Health claimsRegulation 1924/2006

Article 14

Reduction of disease risk claims and claims referring to children'sdevelopment and health1. Notwithstanding Article 2(1)(b) of Directive 2000/13/EC, thefollowing claims may be made where they have been authorised inaccordance with the procedure laid down in Articles 15, 16, 17 and19 of this Regulation for inclusion in a Community list of suchpermitted claims together with all the necessary conditions for the useof these claims:

(a) reduction of disease risk claims;

(b) claims referring to children's development and health.

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II Health claims

Evaluation process by EFSA:

More than 4.000 claims

December 2010: 40 % evaluated>>> Less than 5 % positive evaluations

Herbal claims evaluation stopped for time being (traditional use)

Final regulation published mid-2013?????????????????

Major concern for most European companies

After 2013:« White box » hypothesisChanges in marketing strategyInnovation still possible?

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III Notification process in Europe for food supplements

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II Notification process in Europe for food supplements

Most European countries require pre-marketing authorisation.

According to national rules:>simple letter with packaging copy>dossier + packaging.

StrategyIn the context of mutual recognition, it is extremely important defining in which country(ies) to start notification process in E.U.

Major concern:This notification doesn’t prevent risks of law suite for pharmaceutical statusof the product, either due to its composition and/or to its presentation

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IV Additives regulation

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IV Additives regulation

European harmonisation should be completed:* additives: Dir. Eur. 95/2 amended* sweeteners: Dir. Eur. 94/35 amended* coloring: Dir. Eur. 94/36 et 95/45 amended* aroma: Reg. Eur. 2232/96 amended

but

>reacessment process pending

>pharmaceutical excipients not clarified

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V Contaminants regulation

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V Contaminants regulation

Heavy metals

Pesticides

PAH

Mycotoxines

Nitrates

Radioactivity

Dioxine

Microbiology

European harmonisation almost completed

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Conclusion

* E.U. market is a big and young market for Nutraceuticals, with real potential

* Harmonisation is well advanced

* Claims regulation is a major concern, but:>Companies and associations are fighting strong to make this regulation “reasonable”> Companies have to adapt their strategy in this context

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Less papers in the future

Less complaints from authorities

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VDMj CONSEILJacques VANDERMANDER

jv@vdmj-conseil.com