INTRODUCTION TO THE REGULATORY CONTEXT OF PROBIOTICS IN THE EU:

HOW TO MOVE FORWARD

Rosanna PecereJOURNÉE PROBIOTIQUES ET MICROBIOTE INTESTINAL BY LYONBIOPOLE

5 FEVRIER 2019

1

Contents

1. IPA Europe

2. The Regulatory Framework : where do we stand?

3. IPA Europe propose workable solutions

4. Conclusions

2

1. IPA Europe: who we are

▪ IPA Europe is the European chapter of IPA, theInternational Probiotics Association; it was establishedin Brussels in 2015.

▪ IPA Europe addresses policy issues related to theprobiotic food products and follows the decisionmaking process within the European Institutions, FoodSafety Authorities and EU Member States.

▪ The members of IPA Europe are companies directlyengaged in the research and manufacture of probioticcultures or probiotic foods, supplements, nutritionalor therapeutic products: BioGaia, Chr. Hansen,Danone, DuPont, IPA, Lallemand, Lesaffre, Probi andYakult.

3

1. IPA Europe Objectives and Activities

IPA Europe is active on all of the following areas:➢Engage dialogue with all relevant stakeholders to increase awareness and

knowledge of probiotic food.

➢Develop consensus around scientific messages and increase scientific awareness

➢Establish probiotic standards and voluntary guidelines to define conditions of use of the term probiotic.

➢Participate actively in the consultation processes with authorities and with EFSA, in order to assure an appropriate environment for the use of claims in Europe.

➢Establish an harmonized legal status for probiotics in the EU, framing the trustful communication on probiotics towards consumers.

4

2. The Regulatory Framework : where do we stand?

THE SOURCE OF THE PROBLEM: THE 2007 INTERPRETATION

THE DIFFICULTIES IN THE PROCESS OF RECOGNITION OF AN HEALTH CLAIM

THE VICIOUS CIRCLE

Probiotic Foods in the EU

▪ In the EU, Probiotic foods, mainly fermented milks and supplements, falls within the scope of General Food Law.

▪ Communication on the nutritional & health effects of probiotics is regulated by the Nutrition & Health Claims Regulation 1924/2006 (NHCR):

✓ Food business operators have to obtain a prior-approval authorization from the EU Commission to be entitled to communicate on the beneficial effects of their products on the product label or in advertising, ie Health claim approval.

✓ NHCR applies to nutrition claims (such as "low fat", "high fibre") and to health claims. Only nutrition claims that are expressly indicated in the annex of the NHCR can be used (such as "Vitamin D is needed for the normal growth and development of bone in children")

6

Probiotic Food in the EU:The regulatory framework

▪ Almost 400 health claim applications with probiotics submitted for authorization

▪Only one was authorized - an article 13.1 claim on lactose digestion for themicroorganisms L. delbrueckii subsp. bulgaricus and Streptococcus thermophilus(minimum 108 CFU/g ).

▪ All other probiotic health claims applications have been either rejected or removed inview of the uncertainty of the assessment of EFSA.

▪ The most common reason for rejection was the insufficient characterization.

▪ Since there is no health claim authorized for individual strains (excep. the yogurtmicroorganisms) probiotic is considered by the European Commission as a healthclaim due to the scientific definition (FAO/WHO 2001: “live microorganism whichwhen administered in sufficient amount confer a health benefit to the host”).

Probiotic Food in the EUThe probiotic food industry faces a double problem:

Scientific level - EFSA: no authorised health claim on

probiotics in food

▪ In the EU, Probiotics is one of the categories of foods that have been the most negatively affected by the NHCR: no probiotic claim has received a positive assessment.

Regulatory level (Member States & COM): use of the term probiotic in food

▪ The expression "contains probiotics" is given as an example of health claim in the EC Guidance of 2007

▪ Consequently, there are divergent interpretations in the Member States on the use of the term "probiotic" in the labelling and advertising of food products

8

A claim is a nutrition claim if in the naming of the substance or category of substances, there is

only factual information

Nutrition claims examples: Contains lycopene; Contains

lutein

A claim is a health claim if in the naming of the substance, or

category of substances, there is a description or indication of a

functionality or an implied effect on health

Health claim examples: Contains antioxidants

Contains probiotics/prebiotics

EC GUIDANCE ON THE REGULATION N° 1924/2006 ON NUTRITION AND HEALTH CLAIMS MADE ON FOODS

Probiotic in the EU: the EC Guidance of 2007

The EU deadlock for “probiotic” does not protect consumers and does not favour innovation❑ The EU Guidance of 2007 is not legally binding and still it is

quoted as the main reference to prohibit without any “case by case” approach the use of the term “probiotic” to describe the particular microorganisms contained in food. Semantically speaking the word “probiotic” does not convey a specific health benefit…

❑The potential economic benefits, in term of prevention and healthcare cost saving of probiotics, are not fully explored in this context. How to differentiate a probiotic strain from a ferment if we cannot even name the category?

❑ The term “probiotics” cannot be used to indicate the presence of a specific ingredient in food and food supplements, but this is not the case for “pharmaceutical products” and “OTC”, nor to cosmetics, cleaning products, mattresses, pet foods.

10

The advertisement of a famous cosmetic brand use the

message of the positive effects of probiotics on gut to

advertise a cream!

Probiotic in the EU: the vicious circle The expression "contains probiotics" lacks any description of a bodily

function, which is a requirement for being considered a health claim.Where is the health claim in the term “probiotic”?

The term "probiotic" cannot be authorised as a health claim since one ofthe main conditions that a health claim authorization must met is to bespecific regarding the effect. The term “probiotic” does not describe anyeffect nor specific, nor general. Semantically speaking probiotic means “pro-life”.

Probiotic effects are strain specific, it is therefore a non sense to suggest thatprobiotic describe a health effect without clarifying which is such an effect.

Any nutrition claim suggest a beneficial effect (nutritional or physiologicalbeneficial effect), this is the case for “contains fiber”, “contains vitamins”,“contains iron” …Why there is a different approach for “contains probiotic”?

11

Generic Descriptor (Reg (EC) N. 907/2013) – Pro:- Derogation NHCR: no need to prove the health effect- Generic/traditional denomination, - Legal tool (art. 1.4 of NHCR+ Reg 907/13)- Conditions of use / framing use of denomination- The EU Commission has granted derogations to “Digestive

biscuits”, “cough drops”, “tonic waters” but refuses to grant a derogation for probiotics.

- The Commission required additional criteria on the use of the term “probiotics” - that the term is not understood by consumers as being beneficial-not foreseen in the NHCR

Revision of the EC Guidance 2007 – Pro:- Quite simple to implement- EU global solution- Requires Political consensus.- Needs to explain what will be the status of the term

“probiotic”, ie nutrition claim? Generic descriptor, other? - May open the "Pandora box"

"Contains probiotics" = nutrition claim of NHCR) (Reg (EC) N.1924/2006, art. 5- In line with preliminary works of NHCR, (Cf.: art.5 Nutrition

claim and the list in the ANNEX “Contains + name of the substance”).

- Consistent with other nutrition claims- Preferred option of some MS (already imp. Czech

Republic)- Conditions of use could be fixed

Reg. (EU) N. 1169/2011 on the provision of food information to consumers, art. 36 – Pro:- A possible option that was indicated by the EC in the past- Legally speaking does not provide the correct legal basis

for the adoption of conditions for the use of the term "probiotics", the only appropriate legal basis for such measures being the NHCR and not “Food Information to Consumers” (Cf.: Principle of LEX SPECIALIS).

- EU global solution

Possible legal approach for probiotics in the EU

Use of the term probiotic in the EU

▪ ITALY, NETHERLAND, CZECK REP, GREECE: the term probiotic is used/ the use is tolerated on label and in communication Until now the EC did not take any initiative at national level to go against the use of the term (no action in the CoJ, no letter to the Authorities).

The situation in evolving in others countries:

▪ Eastern countries: strong interest on probiotics in Hungary and Poland;

▪ Denmark, together with other EU Member States, will discuss options to revise the EC Guidance of 2007.

It is still not allowed

▪ In Germany the situation is more complex, strong debate internally on health claim, they willprobably be more receptive with the scientific approach,

▪ Not allowed in Latvia, Lithuania,

▪ In UK (officially comply with the EU guidance but support to find an European solution) andIreland.

13

Ministry of Health

www.salute.gov.it

Indication for use in food and food supplements of probiotic microorganisms traditionally used for intestinal microflora balance

At national level, the Italian GUIDELINES ON PROBIOTICS AND PREBIOTICS are acomprehensive guidelines for probiotics in food. Czech Republic also issued a nationalguideline allowing the use of the term “contain probiotics.

Probiotics in the EU: the Italian Guidelines case

Probiotic Foods in the EU: the Italian GuidelinesITALIAN GUIDELINES ON PROBIOTICS

1.1 Characteristics of microorganisms that may used in food and in food supplements

1.2 Identification of specie and strain

1.3 Amount of microorganisms (usually at least 109 live cells per day)

1.4 Safety of probiotics

1.4 Indication for use (intestinal microflora balance)

16

In 2011, Argentina introduced a definition of probiotics and guidelines for the evaluation of probiotic products and ingredients

Brazil, Colombia and Ecuador use a protocol for the evaluation of a probiotic as a food ingredient, in addition to the FAO definition

The EU remains in an isolated position compared to other regions of the world, where public authorities consider probiotics as an ad hoc category of ingredients and acknowledge their particularities.

3. IPA Europe propose workable solutions

Proposals towards a workable EU Model

At present, the Commission responds to any queries for a solution to probiotics by referring to 2007 Guidance which indicates that probiotic is a health claim

❑ Using a document, with no legal effect that is over ten years old to justify a policy

approach that clearly does not work, is not acceptable. The guidance should be

reconsidered if asked by Member States (the Commission refused to initiate a work

on that)

❑ There is no impediment to the EC proposing a nutrition claim for probiotics – this

was already the intention during the preparatory work (the initial version of the

NHCR (2003) was indicating “probiotics” as nutrition claim; this was confirmed by

the Avis du Conseil Economique et Social in 2004)

18

Proposals towards a workable EU Model

➢ There are several interpretations and different practices in MembersStates on the use of the term “probiotics”

➢ We see a numbers of products marketed as “probiotics”, some MemberStates (MSs) are more open than others to the use of the term ‘probiotics’in communications on food products.

➢ Informed consensus has not been achieved between MS on the ECGuidance of 2007

19

To re-consider the interpretation of the EC Guidance of 2007

Proposals towards a workable EU Model

• Health Claims: Genuine innovation for health claims will require adapting Article 13.5 Criteria to realistic requirements applied globally in some Member States prior to harmonisation – and adopt a grade evidence approach.

• Nutrition Claim: Allowing a nutrition claims for probiotic for specific widely used bacteria strains is a simple common sense approach that the Commission can take. Appropriate conditions of use can be applied to prevent misuse of the term.

20

Request for the nutrition claim “Contains probiotics”.

The solution is possible in the current regulatory frameworkAt present, the European Commission responds to any queries for a solution to probiotics by referring to 2007 Guidance which indicates that probiotic is a health claim

The EC guidance, a document which is not legally binding, is used to justify a policy approach that clearly does not work

21

Two regulatory solution in line with the current regulatory framework:▪ to reconsider the EC guidance of 2007▪ to work of a proposal at EU level for a nutrition claim for

probiotics

There are no impediment to work in this direction, it is merely a question of the EC having a willingness to address the problem

IPA Europe: to develop coordinated activities on probiotic issues

To create the conditions for the positive evolution of the probiotic sector providing the appropriate

regulatory framework and condition of use (voluntary approach)

To meet the interest of consumers in being informed on probiotics – with a

prompt reply to negative messages and with a proactive communication on positive messages around probiotic

To develop consensus around scientific messages and to increase scientific

awareness

To engage in a long term vision - with the Codex activity, with an enhanced

cooperation with International Bodies

22

How to develop a comprehensive approach for the probiotic category

Probiotics : a category of ingredients scientifically defined

Still relevant after 18 years, the FAO/WHO definition ofprobiotics can be translated into four simple and pragmaticcriteria allowing to conclude if specific strains ofmicroorganisms can qualify as probiotic or not.

BUT Can we answer to 2 questions:Which strains are probiotics?Which products contain probiotics?

How to develop a comprehensive approach for the probiotic category ▪The term "probiotics" is the commonname used to describe a category offoodstuffs and beverages to whichprobiotic bacteria (mainly, but notexclusively, of the Lactobacillus andBifidobacterium genera), have beenadded, to indicate the presence ofsuch microorganisms in those foods.

▪Products marketed are mainly dairyproducts, fermented milk drinks andfood supplements

The recognition of theprobiotic category wouldsolve the current impasseregarding probiotics in theEU, and even encourage thesubmission of individualprobiotic health claims.

24

Engagement of the industry: 4 Criteria to qualify a microorganism as ‘probiotic’

✓The Criteria document is on the IPA Europe website and was shared with a network ofstakeholders and MS Authorities.

✓The criteria are aligned with the existing national guidance/standard (IT, Czech Republic,Netherland)

✓A positive feedback was received by Countries willing to find an alternative way to deal withprobiotics and to communicate

✓ Supporting argumentation are prepared to explain that the criteria are science-based

✓The criteria as part of the work to define a global « probiotic » category

25

The IPA Europe Criteria document to qualify a microorganism to be termed as ‘probiotic’ in food, beverages and dietary supplements

Published by IPA Europe in May 2018 - It is part of the “voluntary approach”

✓ Characterised✓ Safe for intended use

✓ Scientifically documented in at least one human study

✓ Alive with Daily dose defined in human studies

8 February, 2019 PRESENTATION TITLE IN CALIBRI BOLD 26

Translating a concept into practical criteriaDefinition of probiotics

live microorganisms which when administered in adequate amounts confer a health benefit on the host

Translate

Define the Criteria Test operability

✓ Each operator lists micro-organisms meeting the criteria

✓ Check scientific rationale✓ Consolidate list of strains

✓ Genuses & Species covered in the list

Analyse

How to develop a comprehensive approach for the probiotic category

▪ A category approach for probiotics can be built – with an homologues structure as the dietary fibre category

▪ Based on revised guidelines, MS will be encouraged to use the same definition and measure/report in the same way, allowing a much more reliable monitoring of the consumption of probiotic in Europe.

The inventory of the Intake across Europe: needs to be done (there are different definitions of probiotics around Europe)

The concept of daily intake/dietary reference value and the relation to health: could be further explored

It will require to work on National Recommendations ieas fermented products (as it is currently the case for fibres)

Conclusion

• The market of probiotic food and food supplements is progressing in the main areas of the world except the EU

• Declining market volumes and growth rates in probiotic food supplements and the probiotic dairy category in the EU clearly reflect the difficult regulatory environment for probiotics

• The expectations of consumers are also changing in term of healthy habits and request of better information

• BUT the regulatory framework in the EU is blocked

28

Conclusion• The industry still supports the NHCR in its objectives of achieving

harmonisation, clarity and consumer protection,

• BUT but there needs to be recognition for the ‘probiotic’ category as such.

• This requires acceptance of the distinction between what probiotics ‘are’ – the category - and what they ‘do’ – the individual probiotics health claims.

29

THANK YOU FOR YOUR ATTENTION

For more information please contact :Rosanna Pecere, Executive Director IPA Europer.pecere@ipaeurope.org

FOLLOW US:WWW.IPAEUROPE.ORG@IPAEUROPE & LINKEDIN