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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
Regulation (EC) No. 1925/2006
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
Regulation (EC) No. 178/2002
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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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
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
The Novel Foods Regulation (EC)
258/97
Thank you for your attention!