human pro bio tics and functioal foods

8/8/2019 Human Pro Bio Tics and Functioal Foods

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Human Probiotics & Functional Foods

A legal perspectiveBianca Herr

Regulatory and Technical Consultancy Services

Leatherhead Food International


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Probiotics were defined by a group of

experts convened by the Food and

Agriculture Organization of the United

Nations (FAO) as

"live micro organisms administered inadequate amounts which confer abeneficial health effect on the host".

What are Probiotics?

What are Prebiotics?

specific indigestible substances which

selectively support the growth ofbifidobacteria and possibly other microorganisms in the intestines.".

e.g. inulin, oligofructose


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What are Synbiotics?

products in which probiotics and

prebiotics are combined to produce asynergistically beneficial effect.".

What is a Probiotic foodstuff?

According to probiotic working group of

German Federal Institute for Consumer

Health Protection and Veterinary medicineBgVV (now BfR):

Probiotic foodstuffs are foods containingprobiotics in an amount sufficient to produceprobiotic effects when such food is ingested.


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Help to fight bacteria with pathogenic

effects in a natural way and at the same

time,

Beneficial for human and animal

digestive system which supportsgeneral well-being

Why add probiotics?

Also..

The EU market alone for probiotics and

yoghurts was worth 8 bn in the first half of

decade.

high consumer demand

market worth over 10 bn by 2010

growth in food market 1 2 % per year!

Why add probiotics?


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Traditional cultures used:

L. acidophilus group L. acidophilusand L.

johnsonii

L. casei group & L. reuteri

Bifidobacterium spp. B. animalis [B.

bifidum], B. longum, B. lactis, B. infantis, B.breve

Probiotic cultures

Situation in Italia

Definitions of pre- and probiotics

Widely accepted in food supplements >50 on the market

Yogurt - probiotic cultures must not substitute the fermentativeaction ofLactobacillus bulgaricusand Streptococcusthermophilus

When fermentation process is just carried out by other culturesyogurt but fermented milk

Guidelines on composition and labelling available on:www.ministerosalute.it/alimenti/dietetica/dieApprofondimento.jsp?lang=italiano&label=int&id=388

www.ministerosalute.it/alimenti/nutrizione/linee.jsp?lang=italiano&label=pro&id=398&dad=s


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Situation in Magyarorszg

Definitions are provided by Codex Alimentarius

Hungaricus 2-51 of Dairy products

Use of pro- and prebiotics widely used and

accepted in foods and food supplements in

Hungary

ca. 40 food supplement products

Situation in Deutschland

Use of pro- and prebiotics widely used and

accepted in Germanyca. 40 food supplement products, whereas

categorization as foodstuff or medicine

depending on concentration


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Situacin en EspaaNo existing legislation or guidance for prebiotics and probiotics

According to survey (2003), every year 16 % increase in sales of pre-

and probiotic products

Prebiotics (Fructooligosaccharides-FOS) are added among others to

dairy products, beverages, biscuits and bread

At present time the only probiotic foodstuff in the market are :

Yogurt, exclusively with Streptococcus thermophilusand

Lactobacillus bulgaricusoracidofilus

other fermented milks with Bifidobacteria, Lactobacillus casei

inmunitass, etc.

Drinks containing fruit juices, fermented milk and bacterial cultures.

EFSA Qualified Presumption ofSafety

Working document (2003) On a generic approach to the safetyassessment of microorganisms used in feed/food and feed/foodproduction proposed QPS a system to evaluate groups ofmicroorganisms to use as basis for establishing safety of

individual productsAim to harmonise situation without introducing unnecessary

legislative burden, but allowing for safety concerns to beaddressed

Address lack of harmonisation, proportionality (is there reallya risk?) and recognition of familiarity of microorganism

Intended as similar to USAs GRAS system

Streamline and provide quicker route to market for safemicroorganisms


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QPS - Principles

A group of organisms could be considered safe for use, provided:

Theiridentity could be establishedtaxonomy

There is sufficient familiarity on which to establish safety

Body of knowledge

There are no known pathogenic strains (or knowledge allows

to exclude existence of these)

Strains given QPS status would still be subject to qualifications

safe provided that (absence of antibiotic resistance,

restricted use etc.)

Strains not meeting conditions for QPS assessed case-by-case

QPS - Principles

Closed consultation in March 2007:

List of microorganisms already notified to EFSA

List of taxonomic units proposed for QPS status

Assessment of Bacillus Bacteria with respect to QPS

Assessment of gram positive non-sporulating bacteria

with respect to QPS

Assessment of yeasts with respect to QPS

Assessment of filamentous fungi with respect to QPS

http://www.efsa.europa.eu/EFSA/efsa_locale-

1178620753812_1178620759439.htm


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Nutrition & Health Claims

Regulation

Regulation (EC) No 1924/2006 of the

European Parliament and of the Council of

20 December 2006 on nutrition and health

claims made on foods

Corrigendum published 18 January 2007, into

force 19 January 2007, applies from 1 July2007.

Regulation on Nutrition &Health Claims key areas

Covers commercial communications (labelling, advertising,presentation, menus, branding)

General principles and conditions for all claims

Lists authorised nutrition claims (Annex)

EC register of well established health claims (Article 13)

Pre-market approval system (EFSA) for disease riskreduction and other health claims (Article 15 - 18)


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General Conditions Article 5

The substance must be present in the final

product in a quantity that will produce the

effect claimed (compare BgVV definition!)

.Survival issues of the bacteria?

The average consumer must be able to

understand the beneficial effect.

Scientific substantiation forclaims - Article 6

Based on and substantiated by generally

accepted scientific evidence.

Justify the use of the claim.

Produce all relevant elements and data

establishing compliance with this Regulation.


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Other

NUTRITIONCLAIMS

Ar t i c le 13 c la ims (we l l - accep ted)

Pre-market approval (EFSA)

(Articles 1518)

HEALTH

CLAIMS

Disease

risk-reductionand Children(Article 14)

Positive list

Claim Categories

Accepted Nutrition Claims

Low energy

Energy-reduced

Energy-free

Low fat

Fat-free

Low saturated fat

Saturated fat-free

Low sugar

Sugar-free

With no added sugars

Low sodium/salt

Very low sodium/salt

Sodium-free/Salt-free

Source of fibre/High fibre

Source of protein

High protein

Source of vitamins/minerals High vitamins/minerals

Contains name of nutrient

Increased (name of nutrient)

Reduced (name of nutrient)

Light/lite

Naturally/Natural

And any claim likely to have thesame meaning..


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Criteria for Nutrition ClaimsCONTAINS (name of nutrient or other substance)

May only be used where it complies with the generalprinciples: Must not be false or misleading

Must not give rise to doubt about thesafety/nutritional adequacy of other foods Must not state or imply that a balanced and varied

diet cannot provide appropriate quantities of nutrientsin general

Consensus that contains probiotics not a nutritionclaim Contains a specific strain - uncertain

Other

NUTRITION

CLAIMS

Ar t i c le 13 c la ims (we l l - accep ted)

Pre-market approval (EFSA)

(Articles 1518)

HEALTH

CLAIMS

Disease

risk-reductionand Children(Article 14)

Positive list

Claim Categories


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Health Claims

Definition ad Reg. 1924/2006:

any claim that states, suggests or implies that arelationship exists between a food category, a foodor one or its constituents and health

Health means a state of complete physical,

mental and social well-being and not merely theabsence of disease or infirmity.

(World Health Organisation Constitution)

Conditions for Use of Nutritionand Health Claims Article 4

Nutrient profiles - 19 January 2009

Taking into account:

Quantities of certain nutrients e.g. fat, saturated fattyacids, trans-fatty acids, sugars, salt/sodium

Role and importance of the food in the diet

Overall nutritional composition and presence of nutrientswith recognised effect on health


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Generally Permitted Health

Claims - Article 13

Future EC register of permitted health claims describingor referring to:

the role of a nutrient or other substance in growth,development and the functions of the body; or

psychological and behavioural functions; or

slimming or weight-control or a reduction in the sense

of hunger or an increase in the sense of satiety or tothe reduction of the available energy from the diet,

ARTICLE 13 Claims

Member states to provide the Commission with

lists of claims (diet and health relationships) 12

months after entry into force of the law withreferences to the relevant scientific justification

and conditions applying to them.

31st January 2008

Commission (based on opinion from EFSA) shall

compile a COMMUNITY LIST OF PERMITTED

CLAIMS 3 years after the law enters into force.

by 31st January 2010


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Reduction of Disease Risk Claims andClaims referring to Childrens

Development and Health - Article 14

May be made, subject to pre-marketauthorisation

Disease risk reduction claims mustinclude labelling/advertising statementindicating that the disease has multiple

risk factors and altering one of these riskfactors may or may not have a beneficialeffect

Contains a unique natural

culture, Bifidus Essensis,

specially selected by xx

researchers for its proven

benefits to your digestion.

Help keep your body in

balance with Probiotics

Understandable?

Understandable?


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Submitted claims to EFSA by

CIAA

For approx. 75! individual probiotic

bacteria claims have been submitted:

enhances/supports natural defences

helps balance/maintain the intestinal

flora

improves your intestinal transit

Prohibited Claims

x No claims on alcoholic beverages more than 1.2%alcohol (other than those which refer to low alcohol or a

reduction in alcohol or energy content).

x Suggestions health affected by not consuming a food

x References to rate or amount of weight loss

x References to recommendations of individual doctors orhealth professionals

x X% Fat free


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Check l i s t

Nutrient profiles

Contains claims

Interpretation of implied claims

Standard of scientific evidence

Understanding of the averageconsumer

Health Claims Additional Labelling

A statement indicating importance of a

varied diet

The quantity to obtain claimed effect

Pattern of consumption to obtain claimed

effect

If anyone should avoid the food

Warnings

name of probiotic bacteria


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Comparison to Japan

Since 1991 specific rules for functional foods

FOSHU Foods for Specified Health Use

Every food needs approval from Japanese

Health Nutrition Food Association and

authorisation from the Japanese Ministry for

Health and Welfare.

Statement This is a food for specified health

use

Food Safety

Regulation (EC) No. 178/2002

Food must be safe

Potential issues:- Antibiotic resistant strains

- Side effects e.g. systemic infections


Allows substances to be prohibited or restricted in

use

EFSA qualified presumption of safety


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The Novel Foods Regulation (EC)

258/97

Art 1(2): Definition

Foods or food ingredients which

has not been available on the EU market

forhuman consumption to a significant degree

before 15 May 1997

Mandatory pre-market safety assessment

Protective Cultures in meatand dairy products

Safe & clean?


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History

Traditional biotechnology

used since 1000s of years

preservation of food with

lactic acid fermentation

Kopenhagen and Kiel 1890 -

first starter cultures to

produce thick sour cream

What are protective cultures?

According to Danisco:

Protective cultures are bacteriaespecially selected and developed fortheir ability to control the growth ofpathogenic and/or spoilagemicroorganisms in fermented foods.


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What are protective cultures?

Examples of protective cultures:

Lactobacillus plantarum,

Lactobacillus rhamnosus,

Lactobacillus sakei,

Lactobacillus paracaseiand

Propionibacterium freundenreichiisubsp. shermanii.

Why add protective cultures?

Substitution of additives

Clean labelling

Extending shelf life

Influence taste

help to meet food safety

microbiological requirements


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Meat products

Lactic acid bacteria Lactobacillus sakeiusedin ham products

39 days fermentation achieved:

Double shelf life

Excellent sensory results

Dairy Applications

Growth control of yeasts and

moulds

Fresh fermented dairy products

(yoghurt, sour cream, quark,

cottage cheese)

Growth control of undesired

bacteria such as Leuconostoc,enterococci and

heterofermentative lactobacilli

Semi-hard and hard cheese

Growth control ofListeriaSoft and smear cheese

FunctionalityDairy applications


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Meat Applications

Growth control ofListeriaCooked meats, fresh ground

meats, etc.

Growth control ofListeriaDry and semi-dry cured meats

FunctionalityMeat applications

Applications

Used alone or in association with

ripening starters, protective cultures can

also bring:

- Texturising,

- Colouring or

- Flavouring


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Regulatory status

long history of safe use in food where

they can be used as ingredients.

!! Local regulations should always be

consulted concerning the status of

these products as legislation regarding

their use in food may vary from country

to country.

Food Safety


Article 14 - Food must be safe

Potential issues:

- Antibiotic resistant strains

- strains producing metabolites not safe to

human

EFSA qualified presumption of safety!


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Food Safety

problems with individual Lactobacillus

species clinical isolates

found in people with impaired immune

function

not identical with strains used in food

Importance lies within the specific

genetic makeup of the strain !!

Microbiological Requirements

Hygiene Regulations No. 852/2004 and No.

853/2004

Regulation No. 2073/2005 on microbiological

criteria for foodstuffs, Listeriamonocytogenes, Salmonella, E. coli

- Provisions on meat and meat products

- Provisions on dairy products


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Clean labelling

Clean labels not regulated as such

Concept causes confusion

Focus on

Labelling requirements

Allergens

Additive versus ingredientDefinition of natural and labelling claims

Food Additives

Definition laid down in framework

Directive No. 89/107/EC

Additives legislation harmonised on EU

level via EC Directive No. 95/2/EC

Authorisation procedure laid down in No.

89/107/EC


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Food Additives

Definition:

any substance not normally consumed as a food initself and not normally used as a characteristicingredient of food whether or not it has nutritivevalue, the intentional addition of which to food for atechnological purpose in the manufacture,processing, preparation, treatment, packaging,transport or storage of such food results, or may be

reasonably expected to result, in it or its by-productsbecoming directly or indirectly a component ofsuch foods

Preservatives

Clean labelling?

Nisin is a bacteriocin,

produced by certain strains of the bacteriumLactococcus (Streptococcus) lactis ssp. Lactis.

Permitted via Directive No. 95/2 as preservative

for ripened cheese and processed cheese,

clotted cream and mascarpone.

Maximum levels apply.


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Starter cultures

traditionally used starter cultures are not

classified as additives.

recommendation for research on

traditionally used starter cultures having

effects on preservation, via acid orbacteriocin if regarding clean labelling

Preservatives & Colours

Clean labelling? Possible example for a starter

culture as a replacement for nitrites in

sausagesStaphylococcus carnosusand staphylococcus

carnosuscombined with staphylococcuscarnosus vitulinusdepending on productionprocess

Current re-evaluation of food colours by

EFSA


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Proposals for Additives, Enzymes and

Flavourings

Regulations July 2006

Current legislative procedure for:

Proposal establishing a common authorisation procedure for food additives, foodenzymes and food flavourings 2006/0143 (COD), (amended proposal on24/10/2007)

Food Additives (consolidated Regulation) 2006/0145 (COD), (amended proposal on24/10/2007)

Enzymes 2006/0144 (COD), (amended proposal on 24/10/2007),

Flavourings Regulation and certain food ingredients with flavouring properties for usein and on foods 2006/0147 (COD), (amended proposal on 24/10/2007)

http://ec.europa.eu/food/food/chemicalsafety/additives/prop_leg_en.htm

What other legislation needs

to be considered?


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GMO

GM food and feed Regulation (EC) 1829/2003

scientific assessment, authorisations and labelling ofGMOs and GM food and feed

Traceability and labelling of GMOs Regulation(EC) 1830/2003identification of GM products throughout supply chainand accurate labelling in accordance with (EC)1829/2003

Regulation (EC) 1829/2003

Applies to:

Food produced from GMO or GMM

Food additives

Flavourings

Enzymes (not microbial)

animal feed / feed additives

E.g.flour, oils and glucose syrups will have to labelled as GM ifthey are from a GM source


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258/97

Art 1(2): Definition

Foods or food ingredients which

has not been available on the EU market

forhuman consumption to a significant degree

before 15 May 1997

Mandatory pre-market safety assessment

The Novel Foods Regulation (EC)258/97

Art 1(2): Four current novel foods categories

a. Foods and food ingredients containing or consisting of GMOs **

b. Foods and food ingredients produced from, but not containing

GMOs **c. Foods with a new/modified primary molecular structure

d. Foods consisting of or from micro-organisms/fungi/ algae

e. Foods from plants/animals obtained by traditional practicesbut with no history of safe food use

f. Foods produced using a novel process

** removed from scope of (EC) 258/97 in April 2004 due to1829/2003 on GM foods and feeds


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Out of the scope of (EC) 258/97:

- Art 2 (1)) : Food additives,

Flavourings,Extraction solvents

- ANY food on sale in the EU prior to May 1997

- Processing aids

- Whole animals

- Products with medicinal function***

*** UK Medicine Healthcare Products Regulatory AgencyBorderline unit http://www.mhra.gov.uk


258/97

Thank you for your attention!

[email protected]

human pro bio tics and functioal foods

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