Human Probiotics & Functional Foods
A legal perspective
Bianca Herr
Regulatory and Technical Consultancy Services
Leatherhead Food International
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What are Probiotics?

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 in
adequate amounts which confer a
beneficial health effect on the host".
What are Prebiotics?
specific indigestible substances which

selectively support the growth of
bifidobacteria and possibly other micro
organisms in the intestines.".
e.g. inulin, oligofructose
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What are Synbiotics?
products in which probiotics and

prebiotics are combined to produce a
synergistically beneficial effect.".
What is a Probiotic foodstuff?
According to probiotic working group of
German Federal Institute for Consumer
Health Protection and Veterinary medicine
BgVV (now BfR):
 Probiotic foodstuffs are foods containing
probiotics in an amount sufficient to produce
probiotic effects when such food is ingested.
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Why add probiotics?
Help to fight bacteria with pathogenic
effects in a natural way and at the same
time,
Beneficial for human and animal
digestive system which supports
general well-being
Why add probiotics?
Also..
The EU market alone for probiotics and
yoghurts was worth Ł 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!
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Probiotic cultures
Traditional cultures used:
L. acidophilus group  L. acidophilus and L.
johnsonii
L. casei group & L. reuteri
Bifidobacterium spp.  B. animalis [B.
bifidum], B. longum, B. lactis, B. infantis, B.
breve
Situation in Italia
Definitions of pre- and probiotics
Widely accepted in food supplements >50 on the market
Yogurt - probiotic cultures must not substitute the fermentative
action of Lactobacillus bulgaricus and Streptococcus
thermophilus
When fermentation process is just carried out by other cultures
 yogurt 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 Magyarorsz�g
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 Germany
ca. 40 food supplement products, whereas
categorization as foodstuff or medicine
depending on concentration
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Situación en Espańa

No 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 thermophilus and
Lactobacillus bulgaricus or acidofilus

other fermented milks with Bifidobacteria, Lactobacillus casei
inmunitass, etc.

Drinks containing fruit juices, fermented milk and bacterial cultures.
EFSA  Qualified Presumption of
Safety

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

Aim to harmonise situation without introducing unnecessary
legislative burden, but allowing for safety concerns to be
addressed
 Address lack of harmonisation, proportionality (is there really
a risk?) and recognition of familiarity of microorganism
ntended as similar to USA s GRAS system
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Streamline and provide quicker route to market for safe
microorganisms
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QPS - Principles
A group of organisms could be considered safe for use, provided:
 Their identity 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 July
2007.
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 risk
reduction 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 for
claims - 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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Claim Categories
NUTRITION HEALTH
CLAIMS
CLAIMS
Disease
Other
Article 13 claims
risk-reduction
(well-accepted)
and Children
(Article 14)
Positive list
Pre-market approval (EFSA)
(Articles 15 18)
Accepted Nutrition Claims
" Low energy
" Source of fibre/High fibre
" Energy-reduced
" Source of protein
" Energy-free
" High protein
" Low fat
" Source of vitamins/minerals
" Fat-free
" High vitamins/minerals
" Low saturated fat
" Contains name of nutrient
" Saturated fat-free
" Increased (name of nutrient)
" Low sugar
" Reduced (name of nutrient)
" Sugar-free
" Light/lite
" With no added sugars
" Naturally/Natural
" Low sodium/salt
And any claim likely to have the
" Very low sodium/salt
same meaning..
" Sodium-free/Salt-free
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Criteria for Nutrition Claims
 CONTAINS (name of nutrient or other substance)
May only be used where it complies with the general
principles:
Must not be false or misleading
Must not give rise to doubt about the
safety/nutritional adequacy of other foods
Must not state or imply that a balanced and varied
diet cannot provide appropriate quantities of nutrients
in general
Consensus that  contains probiotics not a nutrition
claim
Contains a specific strain - uncertain
Claim Categories
NUTRITION HEALTH
CLAIMS
CLAIMS
Disease
Other
Article 13 claims
risk-reduction
(well-accepted)
and Children
(Article 14)
Positive list
Pre-market approval (EFSA)
(Articles 15 18)
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Health Claims
Definition ad Reg. 1924/2006:
 any claim that states, suggests or implies that a
relationship exists between a food category, a food
or one or its constituents and health
 Health means a state of complete physical,
mental and social well-being and not merely the
absence of disease or infirmity.
(World Health Organisation Constitution)
Conditions for Use of Nutrition
and Health Claims  Article 4
Nutrient profiles - 19 January 2009
Taking into account:
Quantities of certain nutrients e.g. fat, saturated fatty
acids, trans-fatty acids, sugars, salt/sodium
Role and importance of the food in the diet
Overall nutritional composition and presence of nutrients
with recognised effect on health
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Generally Permitted Health
Claims - Article 13
Future EC register of permitted health claims describing
or 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 to
the 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 with
references 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 and
Claims referring to Children s
Development and Health - Article 14
May be made, subject to pre-market
authorisation
Disease risk reduction claims  must
include labelling/advertising statement
indicating that the disease has multiple
risk factors and altering one of these risk
factors may or may not have a beneficial
effect
Understandable?
Contains a unique natural
Help keep your body in
culture, Bifidus Essensis,
balance with Probiotics
specially selected by xx
researchers for its proven
benefits to your digestion.
Understandable?
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Article 14 claim?
Bowel
cleaning?
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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 or
health professionals
x X% Fat free
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Check list
" Nutrient profiles
"  Contains claims
" Interpretation of implied claims
" Standard of scientific evidence
" Understanding of the average
consumer
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
for human consumption to a significant degree
before 15 May 1997

Mandatory pre-market safety assessment
Protective Cultures in meat
and dairy products
Safe & clean?
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History
" Traditional  biotechnology
used since 1000 s 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 bacteria
especially selected and developed for
their ability to control the growth of
pathogenic and/or spoilage
microorganisms in fermented foods.
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What are protective cultures?
Examples of protective cultures:
Lactobacillus plantarum,

Lactobacillus rhamnosus,
Lactobacillus sakei,
Lactobacillus paracasei and
Propionibacterium freundenreichii
subsp. shermanii.
Why add protective cultures?

Substitution of additives 
Clean labelling

Extending shelf life
nfluence taste
I

help to meet food safety

microbiological requirements
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Meat products

Lactic acid bacteria Lactobacillus sakei used
in ham products

39 days fermentation achieved:
Double shelf life
Excellent sensory results
Dairy Applications
Dairy applications Functionality
Soft and smear cheese Growth control of Listeria
Growth control of undesired
Semi-hard and hard cheese
bacteria such as Leuconostoc,
enterococci and
heterofermentative lactobacilli
Fresh fermented dairy products Growth control of yeasts and
(yoghurt, sour cream, quark,
moulds
cottage cheese)
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Meat Applications
Meat applications Functionality
Dry and semi-dry cured meats
Growth control of Listeria
Cooked meats, fresh ground
Growth control of Listeria
meats, etc.
Applications

Used alone or in association with
ripening starters, protective cultures can
also bring:
- Texturising,
- Colouring or
- Flavouring
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Regulatory status
ong history of safe use in food where
l
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
roblems with individual Lactobacillus
p
species  clinical isolates
ound in people with impaired immune
f
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, Listeria
monocytogenes, 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 ingredient

Definition 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 in
itself and not normally used as a characteristic
ingredient of food whether or not it has nutritive
value, the intentional addition of which to food for a
technological 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-products
becoming directly or indirectly a component of
such foods
Preservatives
Clean labelling?
is a bacteriocin,
Nisin

produced by certain strains of the bacterium
Lactococcus (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
raditionally used starter cultures are not
t
classified as additives.
ecommendation for research on
r
traditionally used starter cultures having
effects on preservation, via acid or
bacteriocin  if regarding clean labelling
Preservatives & Colours
Clean labelling? Possible example for a starter
culture as a replacement for nitrites in
sausages

Staphylococcus carnosus and staphylococcus
carnosus combined with staphylococcus
carnosus vitulinus depending on production
process

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, food
enzymes and food flavourings 2006/0143 (COD), (amended proposal on
24/10/2007)

Food Additives (consolidated Regulation) 2006/0145 (COD), (amended proposal on
24/10/2007)

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

Flavourings Regulation and certain food ingredients with flavouring properties for use
in 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 of
GMOs and GM food and feed
Traceability and labelling of GMOs Regulation
(EC) 1830/2003
identification of GM products throughout supply chain
and 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 if
they 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
for human 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 practices
but 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 to
1829/2003 on GM foods and feeds
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The Novel Foods Regulation (EC)
258/97
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 Agency
Borderline unit http://www.mhra.gov.uk
Thank you for your attention!
[e-mail]
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